BioPharmaLife

The Risk For Bristol

2010-06-07T15:54:00.000+05:30

Bristol-Myers Squibb wants to dominate an emerging field of medicine that unleashes the immune system against tumors. Its melanoma drug ipilimumab is one of the stars of the American Society of Clinical Oncology meeting in Chicago.

"We intend to be at the leading edge" of the new field, says Bristol-Myers chief scientific officer Elliott Sigal, speaking from his 31st story hotel room overlooking the sprawling convention center. "This is just the first step." Bristol has more immune-boosting cancer drugs in early stages of testing, including one called PD1 antibody.

But getting the melanoma drug approved could prove surprisingly tricky. Its main trial included an unconventional control arm, which could raise eyes at the FDA. Instead of comparing Bristol's ipilimumab to a placebo or to standard treatments (there are few options in melanoma), the trial compared ipilimumab to a vaccine called gp10o. Patients who got ipilimumab lived longer.

The interpretation most melanoma researchers are making here is that ipilimumab is effective, and the vaccine essentially acted as a placebo.

But the FDA may ask: How do researchers know that the vaccine is not toxic, and that this--not effects of ipilimumab--accounted for the difference in survival between the two patient groups?

"That is a credible scientific question. It is a question that I asked when I first saw the data: how do we know for sure that gp100 is not causing some [negative] change," says Sigal.

Trading FDA, Clinical Trial Binary Events: New Features at mikehavRx.com

2010-06-07T15:51:00.000+05:30

Several new free and premium features have been added to the mikehavRx.com Index Updates service and website to provide investors and traders with time-saving information to make their own investing decisions. The service is provided in the form of PDF files located at the subscriber home page (in the format illustrated above this paragraph) that can be accessed upon successful log-in. Currently, 23 PDFs are available to premium subscribers, including 17 files for each of the passively managed stock index components and six reports for the actively managed Regulatory Catalyst Index.

BioRunUp.com is now collaborating with mikehavRx.com to provide investors with free articles, select binary event data, and binary event investing strategies. The subscriber home page and calendars page now includes integrated news feeds, twitter feeds, and RSS feeds for mikehavRx.com, BioRunUp.com, FDA / clinical trial news, stock market news, bio-pharmaceutical industry news, and medical news. Other recently updated pages at mikehavRx.com include the frequently asked questions (FAQS) and videos page for additional resources and links.

The Regulatory Catalyst Index reports are sorted by company name, stock ticker, catalyst date, stock price, and the date of most recent update for each entry and are updated on regular stock market trading days between 6-8pm (ET) along with a new daily stock watch list report that includes up to 50 companies with the company name, stock ticker, price at regular market close, percentage change, 52-week high / low, and comments / strategy.

Research consent forms -- pull up a chair and make yourself comfortable

2010-06-07T15:50:00.000+05:30

Participation in clinical trials is critical to progress in medicine. But researchers have a difficult task in how to present research opportunities to people using consent forms. A study published Tuesday shows that the forms are more accurate than ever before but are becoming unreasonably long.

Researchers at the University of Pennsylvania Law School and Columbia University examined 215 research protocols and their accompanying consent forms from the years of 1977 to 2002. Consent forms are mandated by law and by institutional review boards to ensure that the rights and safety of research participants are protected. Through the years, more effort has been made to ensure that people have all the information they need regarding the potential risks and benefits of participating in research. Indeed, the study found that the problem of discrepancies between the information in the study protocol and the information presented to consumers in the consent form has improved dramatically. Discrepancies were found 57.7% of the time in 1977 studies compared to 0% in 2002 studies.

However, that effort has resulted in much longer forms: from an average of fewer than two pages in 1977 to more than five pages today. Other studies have suggested that consent forms that are even four pages long are unlikely to be read because of the length and time involved.

Human Experimentation at the Heart of Bush Administration's Torture Program

2010-06-07T15:44:00.000+05:30

High-value detainees captured during the Bush administration's "war on terror" who were subjected to brutal torture techniques were part of a Nazi Germany-type program involving illegal human experimentation, the purpose of which was to collect research "data," according to a disturbing new report that calls on President Barack Obama, Congress and other government agencies to immediately launch inquiries and Attorney General Eric Holder to investigate the allegations.

The findings contained in the 27-page report, "Experiments in Torture: Human Subject Research and Evidence of Experimentation in the 'Enhanced' Interrogation Program," is based on extensive research of previously declassified government documents that shows the crucial role medical personnel played in in establishing and justifying the legality of the Bush administration's torture program.

The report said the research and experimentation of detainees its authors have documented is not only a violation of the Geneva Conventions, but is a grave breach of international laws, such as the Nuremberg Code, established after atrocities committed by Nazis were exposed in the aftermath of World War II.

Global biotech firms seek partnerships in India for bigger gains

2010-06-07T15:43:00.000+05:30

BANGALORE: The global biotechnology industry is moving towards strategic partnerships in a bid to create faster and cost-efficient means of drug discovery. The Indian advantage — demonstrated through high-quality scientific talent pool, lower operational costs, development speed and access to a large market — is drawing big firms to rapidly externalise their R&D.

Five years ago, big biotechnology firm collaborations in India were restricted to fee for service models and it is now evolving to those based on co-development. Take for instance, Bristol-Myers Squibb’s collaboration with Biocon, which has helped it to considerably reduce the time involved in delivering active pharmaceutical ingredients.

“Partnerships now range from discovery to early clinical development, which have significant upsides even for the partnering firms,” Dr CSN Murthy, Aurigene Discovery Technologies CEO, said on the second day of industry event Bangalore India Bio 2010.

Drugmaker AstraZeneca is another case. AstraZeneca is currently altering its R&D strategy by slimming down operations in the US and Europe and reinvesting it in Asia across India, China and Japan. “We have elevated our expectations on the externalisation of R&D to 40% of our products from 25%,” said Jit Patel, director-strategic planning, business & development at AstraZeneca R&D, USA.

Spanish Biotech Company Buys Talecris for $4 Billion

2010-06-07T15:41:00.000+05:30

PARIS — Grifols, the Spanish health care group that produces treatments based on blood plasma, said Monday that it had agreed to acquire Talecris, a U.S. company, for $4 billion including debt.

The deal marks the second attempt to sell Talecris, a maker of blood plasma drugs, to help its majority owners cash out.

Victor Grifols, chief executive of the Barcelona company, praised Talecris’s “strong clinical research capability and new research into recombinant therapies,” adding that the deal would expand Grifols’s product line, geographic reach and manufacturing scale.

Plasma is the liquid component of blood in which cells are suspended. Talecris collects plasma, which contains blood proteins, at centers around the United States to use as the basis of its treatments.

Grifols will pay $19 cash for each share of Talecris common stock — the same price at which the U.S. company listed in its initial public offering last autumn — as well as 0.641 new, nonvoting Grifols shares, valuing Talecris shares at the implied price of $26.16, or a 53 percent premium over the 30-day average Talecris share price.

Talecris shares closed Friday down 55 cents, or 3.37 percent, at $15.91 on the Nasdaq. Grifols stock dropped 6 euro cents, or 0.7 percent, to 9.27 euros on Friday in Spain.

Specialists hail cancer treatment results

2010-06-07T15:38:00.001+05:30

CANCER specialists have welcomed the much anticipated results of a decade-long trial of a treatment for early breast cancer that cuts a six-week course of tumour-destroying radiation to a single half-hour session.

"The results are extremely encouraging," says David Joseph, a radiation oncologist and director of the cancer division at Perth's Sir Charles Gairdner Hospital.

The goal of the procedure, intra-operative radiation therapy, is to make treatment more convenient and comfortable for women, while retaining as much of their affected breast as possible.

Theoretically, IORT could be performed at any hospital or treatment centre, and is cheaper to deliver since fewer medical visits are needed.

"That's why my [professional] college was originally not supportive of this concept," claims Joseph, co-chairman of the targeted intra-operative radiation therapy trial, or TARGIT, a head-to-head comparison of partial breast radiotherapy with conventional whole breast radiotherapy.

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Joseph claims critics gradually came around thanks to positive early results and strong support from patients.

As to the full results, he claims: "We're getting better results and less toxicity for patients with this treatment."

Along with co-leader Michael Baum, an oncologist with University College London, Joseph will present results of the multicentre trial today in Chicago at the American Society of Clinical Oncology's annual meeting.

Findings confirm the single-dose technique is as safe and effective as conventional radiotherapy for many women following removal of a tumour.

Policy & Regulations ICMR to hold 'public debate' series on Knowledge Management policy for Health

2010-06-06T17:31:00.000+05:30

Mumbai
Nearly two months after issuing the draft guidelines on Knowledge Management policy for Health - Service, Education and Research, the Indian Council of Medical Research (ICMR) will soon embark on a series of 'public debate' in different regions of the country to evolve a consensus on the issue among the various stakeholders. After the elaborate debate, the ICMR, if needed, will make the necessary amendments in the guidelines.

The first 'public debate' will be held in Delhi at ICMR headquarters on July 26 for the northern region. The second debate for the western region will be held in Mumbai at National Institute for Research in Reproductive Health on August 23 and the third debate for the southern region will be held at Tuberculosis Research Centre in Chennai on September 28. The last of the series of debate will be held at National Institute of Cholera & Enteric Disease in Kolkata on October 25.

Meanwhile, the ICMR has extended the date for making comments, suggestions and criticism on the draft policy from May 31 to July 15, 2010. The ICMR had earlier invited comments, suggestions and criticisms from experts and others on the draft policy till May 31 to improve the quality and contents of the draft policy.

The drat policy proposes to establish an appropriate authority for developing and implementing a comprehensive plan for utilization of knowledge network for health service delivery, medical education and research.

Indian doctor leads breakthrough in breast cancer research

2010-06-06T17:22:00.000+05:30

An Indian oncologist is among three experts in the U.K. who have achieved a breakthrough in the treatment of breast cancer after a 10-year trial that demonstrates that a single dose of radiation during surgery is just as effective as a prolonged course of radiotherapy.

Goa-origin Jayant Vaidya, who works at the University College, Royal Free and Whittington Hospitals, designed and led the trial called interoperative radiotherapy (TARGIT) involving 2,000 women along with oncologists Jeffrey Tobias and Mike Baum.

The new approach means selected patients receive just one dose of radiation during surgery to remove breast cancer.

A probe is inserted into the breast so that it can target the exact site of the cancer.

Dr. Vaidya said: “This has been my dream for the last 15 years. The new treatment could mean that many more women could conserve their breasts. TARGIT saves time, money and breasts.”

He added: “Scientifically, the results change the way of thinking about breast cancer and its treatment.

It suggests that in selected patients the whole breast does not need to be treated and that the radiation dose and that the radiation dose can be much lower.”

Dr. Vaidya, who hails from a prominent doctors family from Goa, studied at the Peoples’s High School, Panaji, Dhempe College, and the Goa Medical College.

Dr. Tobias, who enrolled the first ever patient on the trial at the former Middlesex Hospital in London along with Dr. Vaidya, said: “I think the reason why it works so well is because of the precision of the treatment.

Glaxo Plc, under fire for large-scale global clinical trials of a diabetes drug that is said to spawn heart risks, is looking to shift the trials to c

2010-06-05T02:43:00.001+05:30

Glaxo Plc, under fire for large-scale global clinical trials of a diabetes drug that is said to spawn heart risks, is looking to shift the trials to countries like India, Pakistan and China.

“The Drugs Controller General of India (DCGI) has given them permission to conduct the trials in India,” said Chandra M Gulhati, editor of Monthly Index of Medical Specialties (MIMS), a journal on drugs available for prescription in India.

Efforts to contact the DCGI, Surinder Singh, were unsuccessful.

Gulati said Glaxo has started recruiting patients in India, Pakistan, China owing to the difficulty in getting subjects in the west.

“Two potential sites for the trial in the US have already withdrawn citing, difficulty in finding patients. Hence they are coming to India,” Gulati said.

A Glaxo spokesperson told DNA Money institutional review boards and ethics committees around the world have approved the study, and patient safety is monitored by an independent data monitoring committee, which includes international experts in heart diseases, diabetes, and statistics.

Glaxo has added 53 new testing sites for the medicine since March this year.

Of these, 10 are in India -Bangalore, Kochi, Karnal, Mumbai, Nashik, Pune, Kottayam and Vijayawada.

The company is conducting trials to assess the cardiac safety of diabetes medicine rosiglitazone compared with another of its products, pioglitazone.

The trials, codenamed TIDE, are being conducted on 16,000 people in 14 countries.

“This is unethical as the aim of the trials is to prove which of the two drugs is more dangerous,” said a healthcare expert, not wishing to be named.

The US Food and Drug Administration is also assessing the situation.

Ruth Macklin of the department of epidemiology & population health, Albert Einstein College of Medicine, New York, said the Glaxo trials violate principles in research ethics.

Recession prompts rethink at Institute for Clinical Research

2010-06-04T03:46:00.000+05:30

The Institute for Clinical Research has been “rethinking who we are as an organisation” following what board chair Janette Benaddi says was probably “one of the most challenging” years ever for the ICR in 2009.

That has necessitated “very many necessary and radical changes”, driven largely by the recession but also by member needs, Benaddi told the ICR 31st Annual Conference and Exhibition in London last month.

The UK-based organisation will need to continue adapting in a fluid global environment for clinical trials, Benaddi warned. But the ICR’s core aim is still to help its members with career development, raise standards and spread knowledge – “a professional organisation for professional people”.

The organisation brought in external consultants to help it review how best the ICR could be structured to ride out a difficult period, Benaddi told PharmaTimes Clinical News. The “radical changes” mentioned have only just started coming into effect, but they are essentially about diverting resources from marketing into membership services.

That has to be the ICR’s prime objective, Benaddi stressed. So while it is putting more effort into training and professional development, the focus remains on being a membership rather than a training organisation.

Ethics Experts Call For Refocus of Scientific and Ethical Review to Ensure Integrity of Research Process

2010-06-04T03:43:00.000+05:30

In a paper published this week in the journal Science, experts caution that important ethical issues in the testing of new therapies like stem cells may not be receiving the attention they deserve. Carnegie Mellon University's Alex John London joined McGill University's Jonathan Kimmelman and Marina Emborg of University of Wisconsin-Madison and Wisconsin National Primate Research Center to examine the way scientists, physicians, and regulators evaluate risk and benefit when testing new drugs in human beings for the first time. According to their report, scientists and regulators tend to focus on how individual patients should be protected from risks, and as a result, overlook how medical advance itself can be adversely affected by poorly designed clinical trials.

For the past few decades, numerous highly innovative therapies have been introduced into human testing, including genetic-based approaches, stem cells and therapies aimed at reprogramming the immune system. Patients with serious illnesses often flock to these studies in hope of a cure. These studies are often controversial, however, because some scientists and regulators consider them too risky while others suggest it is unethical to deny critically ill patients access to these studies.

London and his co-authors argue that debates over access neglect key ethical issues. "Right now, ethical oversight is highly focused on protecting research participants and giving individuals access to scientific developments," said London, associate professor of philosophy and director of Carnegie Mellon's Center for the Advancement of Applied Ethics and Political Philosophy. "These are important issues. But ethical oversight needs to also ensure that decisions about launching human testing are based on a range of considerations that are not easily captured in the current focus."

"What is often overlooked," said Kimmelman, associate professor at McGill's Biomedical Ethics Unit and Department of Social Studies of Medicine, "is that allowing studies of poor scientific quality to proceed potentially undermines the entire scientific enterprise, because they undermine trust, consume scarce research resources, and weaken incentives for medical scientists to perform the best research they can."

Experts voice concern over GSK's TIDE trial on controversial drug Avandia

2010-06-04T03:40:00.000+05:30

Even as the multinational drug major GlaxoSmithKline (GSK) has started patient enrolment in TIDE trial on the controversial diabetes drug rosiglitazone (Avandia) at 10 sites in India, experts in the field have questioned the propriety of conducting such a trial which, they fear, will put hundreds of ill-informed patients at risk of morbidity and mortality in the country.

Avandia became a controversial drug when the medical experts raised concern that the drug could expose diabetes patients to an increased risk of heart failure and possible death.

According to reports, Drugs Controller General of India (DCGI) Dr Surinder Singh has already given permission to the GSK to conduct Thiazolidinedione Intervention in vitamin D Evaluation (TIDE) trial on rosiglitazone (Avandia) at 10 sites in India including St Johns Medical College, Bangalore. Sources said that the patient enrolment for the trial at St. Johns Medical College has already begun. Other trial sites in India are Mumbai, Nasik, Pune, Cochin (two), Kottayam, Trichy, Vijayawada and Karnal.

It is part of an international clinical trial, at the behest of US FDA, to examine the cardiovascular effects of treating diabetes patients with one of two drugs — rosiglitazone and pioglitazone.

Experts argue that since 2007 huge amount of data has been generated worldwide which conclusively proves that rosiglitazone is inferior to pioglitazone in its cardiovascular safety profile thus making the trial virtually meaningless.

They are of the view that several clinical trials have already confirmed that rosiglitazone increases the risk of heart attacks, whereas pioglitazone is at best neutral or perhaps somewhat protective. Not a single study has suggested that pioglitazone might carry more risk. Most physicians in US have already switched from rosiglitazone to pioglitazone with four times as many prescriptions written for pioglitazone than for rosiglitazone in 2008.

Clinical trials beckon India with a $26 billion purse

2010-06-04T03:37:00.001+05:30

Experts and investors at the Bangalore India Bio-2010 on Wednesday made a strong plea for a strong interface between the academia and industry to enable the country to grab huge opportunities in Biotechnology research, especially in clinical trials.

Dr Moni Abraham Kuriakose from Narayana Hrudayalaya, participating in a panel discussion on the issue, said, “India has highly trained work force, world-class health facilities, 221 medical colleges and a huge cost advantage in clinical trials. But still, the potential has not been fully utilised.”

India has 50% to 75% cost advantage in clinical trials and “we have a great opportunity to bag a huge share of the $26 billion clinical trials market in the world. India has just about 500 to 1,000 clinical investigators and it is too small, when compared with countries like the USA which has 50,000 of them. India is training about 1,000 clinical investigators each year and it should be ramped up to at least 10,000,” he said.

Dr Kuriakose wanted the government and private sector to initiate measures to develop research culture in medical colleges and hospitals, and encourage research as a career.

Dr Ravi Kumar Banda, managing director of Xcyton Diagnostics Ltd, said “There are large gaps between the industry, academia and investor that need to be bridged. Institutes and research facilities should develop technology platforms or proof of concept for a product to showcase to the industry. Most collaborations fail because of the way the academia approach the industry. Some of the academic institutions like the Indian Institute of Science have good infrastructure. But not even 20% of its potential is being used for research and development.”

Indian business invests in Minnesota

2010-06-04T03:33:00.000+05:30

The University of Minnesota College of Veterinary Medicine has received $3 million to expand research and teaching in veterinary orthopedic surgery.

The gift is from the Tata Group, a worldwide business conglomerate based in India. Ratan N. Tata, chairman of the Tata Group, was first put in contact with Dr. Michael G. Conzemius, a professor at the veterinary college, in 2008. The $3 million will be used to establish the Tata Group chair in orthopedic surgery, create an endowment supporting research in small animal orthopedic surgery, and develop an exchange program between the University of Minnesota and the Karnataka Veterinary School in Bangalore.

Dr. Conzemius has been appointed to the Tata Group chair in orthopedic surgery. A professor of surgery at the college since 2006, Dr. Conzemius leads a research team that is internationally recognized for basic and applied clinical research in elbow replacement systems, gait analysis, and the genetics of ligament injury and repair.

Malaysia Offers Good Incentives For Indian Biotech Companies

2010-06-03T01:23:00.000+05:30

Malaysia which offers attractive incentives and infrastructure for companies venturing into biotechnology can anticipate more collaboration with Indian biotech companies in future.

Malaysian Biotechnology Corporation's (BiotechCorp) Chief Executive Officer Datuk Iskandar Mizal Mahmood said with the facilities provided Indian companies should have no problem in expanding their operations here.

"We anticipate not just higher but more significant collaborations with the Indian fraternity," he said in a statement Wednesday in conjunction with BiotechCorp's participation at the three-day Bangalore India Bio 2010 conference and exhibition which began Wednesday.

Iskandar said Malaysia offered a strategic base for companies in active pharmaceutical ingredients, contract manufacturing, contract research organisation and medical device and diagnostics.

He said memorandum of understandings have been signed with two reputed Indian companies and global biotech giants, BioCon Ltd and Dr Reddy's Laboratories Ltd.

"The potential with BioCon will mark a significant progress for Malaysia in the area of biological products while collaboration with Dr Reddy's will explore a joint drug discovery research programme and the setting up of a pharmaceutical manufacturing facility in the country.

This is the century of innovation, Krishna tells USIBC

2010-06-03T01:20:00.003+05:30

The India-United States Business Council celebrated its 35th anniversary in Washington, DC, where Indian External Affairs Minister S M Krishna [ Images ] spoke about Indo-US business ties and the long way that the two countries had travelled together. Founded in 1975, the council is dedicated to fostering better trade ties beteween the largest and the oldest democracies in the world.

Terry McGraw, Chairman of the India-US Business Council, Indra Nooyi, CEO of PepsiCo,Ron Sommers, President of the USIBC, William Cohen, Chairman, Cohen Group , I am glad to be here among you all in Washington, DC, which brings back nostalgic memories of long years back. Many of those who witnessed those years are still excited about those times.Shephard Hill, President of Boeing International, Thank you for your warm words of introduction.

Ladies and Gentlemen,

I am especially pleased to join you in celebrating 35 years of the US India Business Council – and in recognizing the contribution of many pioneering entrepreneurs like those present here today, who have built the strong, resilient edifice of the India US bilateral economic partnership. Their vision and leadership achieved a mutually beneficial synergy that bridges distances, spans the oceans that lie between us and enriches the bilateral economic discourse in a way that just was not imaginable 35 years ago. Terry Mc Graw, I congratulate you and the past and present members of the USIBC.

As Prime Minister Dr Manmohan Singh [ Images ] said in this very building a few months ago, "In today's economically integrated world, economic relationships constitute the bedrock on which social, cultural and political relationships are built."

The India-US example, similarly, draws its strength not merely from engagement and understanding between governments, but from the vitality of private partnerships and the warmth of ties between our peoples. .

Ladies and gentlemen, the 20th century was a century of capital accumulation; the 21st Century will be the Century of innovation.

We see this in India – where we are presently witnessing a revolution of entrepreneurship, creativity and innovation. It has made our manufacturing sector modern and globally competitive through market-induced "frugal engineering". It has made our services sector a powerful instrument of modernization and a major source of exports. And, it is turning India into a global hub for innovation, design and development and manufacturing.

India's responsible corporate sector is a key player in our innovation initiative. Three years ago, the State Bank of India [ Get Quote ] found a low cost and easy-to-operate solution for banking in remote areas of India. The "Tiny Branch", as the State Bank of India called it, costs a little over US $ 300 per branch and is made up of a mobile phone and a finger print scanner. This set can hold data of up to 50,000 customers, can record details in 11 languages and is operated by women recruited at village level. Furthermore, the devices work on battery using solar energy. State Bank of India hopes to install 250,000 of these tiny branches across Indian villages.

Collaboration is the future: pharma firms

2010-06-03T01:08:00.001+05:30

For years, pharmaceutical and biotechnology companies have been sceptical of involving other companies in their research. But, that notion is slowly changing. With cost effectiveness and duration of research becoming critical to the commercial success of a product, collaborations with other companies and academic research institutions have become the need of the hour.

“The industry is moving towards a model of strategic partnership,” said Patrick Keohane, vice president, R&D, AstraZeneca-Asia Pacific, USA. With Asia emerging as an attractive destination in the last few years, the company said it has slimmed down its operations in Europe and the US in terms of sites and workforce. “We are focusing on re-investing in places like India and China,” said Keohane. To grow its India operations, the company has entered into tie-ups with Indian companies like Jubilant Organosys and Torrent Pharmaceuticals, and is looking to enter more collaborations in India.

Same is the case with most of the major pharma companies in the world. Around 63 per cent of Merck and Co’s revenues in 2009 was attributable to alliance products and patents. Moreover, the company has also entered into alliances with academic institutions like Harvard University and Imperial College, London.

Rikke Festersen, head-R&D, Novozymes South Asia believes that innovation through partnership is becoming a preferred model in business. “There should be a mutual profit sharing based on funding, ideation, technological contributions and overall risks,” said Festersen. The Danish company, which has an R&D presence in Bangalore has 6,000 patents to its name. The company has entered into partnerships with Indian academic institutions in 2009-10 for three projects.

One North East in talks with CROs

2010-06-03T01:04:00.001+05:30

One North East England, a European regional development agency, is in talks with clinical research organisations (CROs) and biotech companies to start operations in Europe.

At least two CROs from the city have evinced interest in the proposals, according to its India representative Shankar Ramachandran.

He said One North East was home to over 600 pharmaceutical, life sciences and medical technology companies. It would offer the Indian CROs scope to conduct Phase I first-in-man studies there. The Indian guidelines allow such studies for only Indian originated molecules, he said.

The region's healthcare and life sciences economy is valued at 4 billion pound. The research and clinical base would offer opportunities for Indian companies to collaborate in oncology, aging, genetics, medical diagnostics and others. The region also has 400 supply chain companies.

Novella Clinical Inc. Acquires Prologue Research International

2010-06-03T01:00:00.001+05:30

Novella Clinical announced today the acquisition of Prologue Research International, Inc. (Prologue) an Ohio-based full service Clinical Research Organization (CRO) that focuses exclusively on oncology drug development. "The acquisition of Prologue strengthens our oncology therapeutic franchise and is a strategic addition to our earlier announced deal this year with OSI Pharmaceuticals," says Richard Staub, President and Chief Executive Officer. Mr. Staub continues, "Prologue's experience includes the management of more than 120 oncology trials across a wide variety of indications with a customer base that does not overlap with Novella Clinical's. With Prologue, Novella will expand its support to oncology Sponsors with the creation of a dedicated business unit focused exclusively on oncology drug development, with the objective of bringing much needed products to market to improve the lives of people with cancer."

Tom Ludlam, Prologue's President and CEO, states, "We are excited to be joining forces with Novella Clinical. Combining Prologue's experienced oncology team with Novella Clinical's oncology team, their infrastructure and e-based technology allows us to better serve current and future customers in the design and execution of complex oncology programs across geographic regions. As important, Novella Clinical and Prologue share a common culture, centered on customer service and executional excellence."

BioPharm Systems to Participate in the 2010 Oracle Partner Showcase at DIA's 46th Annual Meeting

2010-06-03T00:54:00.001+05:30

BioPharm Systems, a leading provider of clinical trial, data, and safety solutions, will participate in the 2010 Oracle Partner Showcase at the Drug Information Association's (DIA) 46th Annual Meeting in Washington, DC from June 13-17. This is Oracle's second year offering the unique opportunity for Oracle Health Sciences partners to participate in the event. Partners are selected based on their unique Oracle Health Sciences value proposition and impact on the Oracle Health Sciences Global Business Unit revenue.

"We are proud that we have been selected two years in a row to take part in Oracle's Partner Showcase at the DIA. It is a testament to BioPharm's commitment to Oracle. We are a long-standing partner of Oracle's and have been closely involved with their clinical applications for over 15 years," said Alex Sefanov, president and CEO of BioPharm Systems. "The DIA's Annual Meeting will allow us to exhibit our unique solutions and demonstrate our expertise with Oracle Health Sciences products."

In addition to providing a holistic view of services and solutions that enhance the comprehensive set of Oracle's clinical development, safety and pharmacovigilance software applications, BioPharm Systems will be demonstrating ASCEND, its clinical trial management system (CTMS) accelerator. ASCEND is a pre-configured and enhanced version of Oracle's Siebel Clinical application, designed to assist small and mid-sized life sciences organizations in managing their clinical trials. The company's CTMS accelerator significantly reduces implementation costs and timeframes, and includes robust capabilities found on many companies' wish lists.

ERT: ERT Closes the Acquisition of the Research Services Division of CareFusion Corporation

2010-06-01T23:45:00.001+05:30

ERT (eResearchTechnology, Inc.), a global provider of technology
and services to the pharmaceutical, biotechnology and medical device industries, announced the successful closing of the acquisition of the Research Services Division of CareFusion Corporation (CRS). CRS is a leading provider of respiratory diagnostics services and manufacturer of diagnostic devices and also offers cardiac safety and ePRO services. The combined company offers a market leading position in the clinical research market for cardiac safety services, cardiac safety consulting, respiratory services, ePRO services, and medical devices. The acquisition will serve to diversify ERT's revenue base, expand its global footprint and increase the potential for development of new services and products in clinical research and healthcare delivery.

Dr. Michael McKelvey, President and CEO of ERT, said "ERT is pleased to announce that we have completed the acquisition of CareFusion's Research Services Business. The acquisition expands ERT's capabilities, allows us to pursue new markets and reinforces our position as the leading service and technology provider enabling our customers to more efficiently collect, interpret and deliver clinical data during all phases of drug development." As previously reported, ERT paid $80.8 million in cash for CRS and the acquisition allows ERT to integrate all of the CRS offerings into its existing portfolio, delivering the following six strategic benefits:

* Establishes ERT as one of the market leaders in respiratory core lab services in the clinical trials market

* Provides ERT with a leading diagnostic device capability

* Expands ERT's revenue base in cardiac safety

* Provides scale for ERT's ePRO business, as well as expanding the depth and breadth of its ePRO services

* Expands significantly ERT's global footprint

* Accelerates ERT's movement into healthcare solutions The completion of this acquisition and the subsequent combination of these two organizations will allow ERT to further innovate to produce better science at a lower cost with the best user experience for the benefit of its clients.

Trial nod for diabetic drug with heart risks

2010-06-01T00:36:00.000+05:30

India’s apex drug regulators have approved a clinical trial of a medicine that could expose diabetes patients to an increased risk of heart failure and possible death, medical experts have warned.

The Central Drugs Standard Control Organisation has approved a study in India that will be a part of an international clinical trial to examine the cardiovascular effects of treating diabetes patients with one of two drugs — rosiglitazone and pioglitazone.

Both drugs provide effective blood glucose control. But over the past three years, studies have indicated that rosiglitazone carries a higher risk of heart failure than pioglitazone. A joint statement last year from the American Diabetes Association and the European Diabetes Association had advised against the use of rosiglitazone in the control of diabetes.

But the clinical trial, supported by the pharmaceutical company GlaxoSmithKline and planned at dozens of sites in 15 countries, including 10 cities in India, will test rosiglitazone and pioglitazone in men and women above 50 who have diabetes.

Medical experts in India and North America have described the clinical trial as unethical, arguing that it ignores “accumulating evidence” and “a wealth of data” that suggests rosiglitazone carries greater risk than pioglitazone.

“It is most unethical and inhuman to administer a drug that is already known to be inferior to the molecule it is being compared with,” said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India, an independent journal of medicines.

One objective of the study is to determine how much more harm one drug causes than the other drug, said Ruth Macklin, a professor of epidemiology at the Albert Einstein College of Medicine, New York.

MNX sets up in Australia to offer Pacific Rim logistics

2010-06-01T00:30:00.000+05:30

MNX has opened a temperature controlled distribution centre in Melbourne, Australia to serve the Pacific Rim region’s pharma industry.

Australia and the Pacific Rim region have been identified by MNX as a growth region for temperature controlled logistics, storage and transportation services. Last year World Courier also opened a site in Melbourne in response to growth in the clinical trial sector.

MNX has now also acted to meet rising demand from Asia Pacific. Its Melbourne distribution centre is capable of storing products at temperatures ranging from -8ºC to +25ºC. MNX added that the site is suitable for combating the temperature extremes experienced in the region.

Opening the site is part of MNX’s efforts to boost its pharma capabilities. Scott Carson, CEO of MNX, said: “Meeting the specialised requirements of pharmaceutical organisations and clinical trial logistics has been a logical extension of MNX’s resource set over the last three years.”

New survey identifies healthcare data upsurge

2010-06-01T00:26:00.001+05:30

Research from a global survey by BridgeHead Software has found that medical images, scanned documents, e-mail, and advances toward the electronic electronic medical record (EMR) are the likely causes for the upsurge in healthcare data that is already challenging hospitals and is set to grow further in the foreseeable future.

Results from the Data Management Healthcheck 2010, a global survey into the healthcare industry’s ongoing strategies for managing their IT systems, found that more than two-thirds (69%) of healthcare organizations expected their data volumes to increase this year. Less than 6% expected data volumes to stay constant and 1% expected data volumes to decrease.

The majority (65%) of respondents who expected their data volumes to increase said PACS imaging files were the main culprits, followed by EMR files (45.5%) and scanned documents, e.g. proof of insurance and healthcare proxies (43%).

Significantly, 84% of respondents said over half their healthcare organizations’ data were over six months old. Yet only 26% claimed to have a full archiving capability that migrated content to the appropriate storage tiers as dictated by their predefined policies.

The research also discovered that over 44% of hospitals were managing more than 5 TB on a primary store. Only 12% said they were managing less than 1 TB on a primary store.

“Data volumes are increasing as the world of healthcare continues to embrace the digital age,” said John McCann, director of marketing at BridgeHead Software. A troubling trend we’ve noticed, however, is that some healthcare organizations are not paying due attention to their data management and storage solution strategies.”

Many of the hospitals’ IT infrastructures are not prepared to handle the rise in data resulting from the increased use of medical images, the continued move towards the electronic health record (including historical document scanning), and the massive upsurge in office-based computing; e.g., e-mails, spreadsheets, and word processing documents, he said.

Quintiles hires Nycomed UK team; plans cuts in US

2010-05-31T01:37:00.000+05:30

Contract research organisation (CRO) Quintiles Transnational has boosted its UK marketing teams through a deal with Nycomed but is planning cutbacks at US operations in RTP.

In a deal announced late last week, a UK based health solutions teams run by Nycomed will transfer to Quintiles while continuing to work with the Swiss drugmaker on a contractual basis.

Nycomed said that the deal, which follows the formations of its UK focused co-marketing agreement with US drugmaker Merck & Co for the chronic obstructive pulmonary disease (COPD) drug Daxas, is a “win-win” situation.

Melissa Thomas, Nycomed’s UK MD, said: “The team has continued employment in an exciting new healthcare model and will be exposed to new opportunities through global industry leader Quintiles; whereas Nycomed continues to have access to their expertise.”

ICON firms up imaging capabilities with Timaq acquisition

2010-05-31T01:35:00.000+05:30

Underlining the growing importance of medical imaging technology to cost-efficient drug development, Irish contract research organisation (CRO) ICON has acquired Timaq Medical Imaging, a leading European provider of advanced imaging services to the pharmaceutical and biotechnology industries, for an undisclosed sum.

Clinical trials have increasing recourse to medical imaging, whether for inclusion criteria, safety assessment or as secondary and surrogate endpoints that support early ‘go/no-go’ decisions. ICON itself is already a leader in the use of core imaging laboratories, having conducted more than 500 imaging trials on behalf of clients worldwide, the company notes.

Based in Zurich, Switzerland, Timaq was co-founded in 2003 by Dr Gustav von Schulthess, chairman of radiology and director of the Nuclear Medicine Department at the University Hospital of Zurich.

As ICON pointed out, Professor von Schulthess is one of the pioneers of combined PET/CT (positron emission tomography/computed tomography) imaging, which can show metabolic or chemical activity in the body, as well as the body’s anatomical structures, as a single, fused image.

Doctors' role in drug studies criticized

2010-05-31T01:28:00.001+05:30

Richard Page thinks Multaq is an excellent new drug for treating atrial fibrillation, a type of irregular heartbeat that affects more than 2 million Americans.

And Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, should know. He co-authored a large, international study that led to the drug's approval by the Food and Drug Administration last year, a move that could mean hundreds of millions in sales for Sanofi-Aventis, the company that makes the drug.

But in putting his name on the influential paper, Page allowed Sanofi-Aventis to dictate the terms. He vouched for the accuracy and completeness of the study despite not seeing the raw data. The company, which paid for the study, collected that information and performed the analysis without an external audit for accuracy or completeness.

Page says it comes down to trusting the drug company.

"These companies, if they were falsifying data, wouldn't be kept in business if that were found out," he said. "I was satisfied and remain satisfied that the study was conducted in an appropriate way."

But more and more critics say there is something wrong with the way medical research is done in America. They point to a growing number of scandals in which drug companies have been accused of suppressing or manipulating research and skewing results to make their drugs look better and safer.

In the Multaq case, Page and all six co-authors had financial ties to Sanofi-Aventis at the time of the study.

Two authors worked for the company and owned its stock. Page and the four other authors moonlighted as consultants or speakers.

Questions are being raised about a finding in the paper that the drug reduced cardiovascular deaths - a claim that was disallowed by an FDA panel.

A spokeswoman for Sanofi-Aventis said the company conducts its clinical trials to the highest scientific standards with rigorous analysis and accurate reporting of clinical data. That includes the Multaq trial, spokeswoman Carrie Melia said in an e-mail to the Journal Sentinel.

Yet studies paid for by drug companies are much more likely to have positive results than studies paid for by nonprofit organizations with nothing to gain from a drug's success in the marketplace.

For instance, with cardiovascular treatments, 40% of trials paid for by nonprofit sources showed favorable results, compared with 66% among drug industry-funded studies, according to a 2006 study in JAMA, the Journal of the American Medical Association.

When outside authors don't have complete access and control of data and protocol, manipulation is easier, said Eric Campbell, an associate professor at Harvard Medical School who researches conflicts of interest in medicine.

"If data are cut and shaved and trimmed and manipulated to make a point and that doesn't represent truth or the way a drug behaves, science is harmed and, more importantly, patients are harmed," Campbell said.

Consider the case of the popular painkiller Vioxx, which was pulled from the market in 2004 by its maker, Merck.

Pharma intending agents form Assn, to take up issue of delay in registration of import licenses

2010-05-31T01:23:00.000+05:30

Even as the drug importers in the country are annoyed over the issue of inordinate delay in getting the registration and re-registration of import licenses from the DCGI office, the intending agents of the pharma industry in the country have come together to form an association to take up the matter with the DCGI office.

According to sources, around 50 intending agents in the country have come together and have formed the All India Pharma Intending Agents Association.

The intending agents are the mediators between the manufacturers and the importers. The DCGI issues Form 41 to the intending agents and against the Form 41 the intending agents issue Form 9 to the importers as per the Drugs and Cosmetics Act and then the importer applies to the DCGI for Form 10 which permits them to import the registered drugs. The validity of Form 41, Form 9 and Form 10 is for three years from the date of issuance.

BR Sikri has been selected as the president of the new association while Gautham Shah has been selected as the vice-president. Darshan Thakur is the treasurer and Rana is the general secretary of the new association which will be registered soon. The association had its first meeting in Mumbai recently.

Association president BR Sikri said that at present, there is no proper platform of the intending agents in the country to express their grievances with the drug authorities. The Association is intending to meet the DCGI on June 11 on the issue of delay in getting the registration and re-registration of import licenses from the DCGI office.

Clinical Trials International Summit 2010

2010-05-31T01:06:00.001+05:30

Sep.1-2,2010,Shanghai,Clinical Trials International Summit 2010 will be held by JFPS China, supported by Contract Research Organization Union (CROU) and Chinese Pharmacological Society. The event will attract senior clinical trial practitioners from world famous pharmaceutical companies, biotechnology companies, medical device companies,contract research organizations (CRO), laboratories and clinical research centers.

Clinical Trial is always regarded as the most time consuming phase in new drug’s R&D. In order to shorten the R&D cycle and accelerate the launch of new products, more and more pharmaceutical companies choose to outsource their clinical trials to more professional clinical research organizations. Drug development outsourcing encouraged the booming of a huge new market.

This summit will focus on:
1.The Development Trends of China Biomedical R&D Model
2.Function Mode of IRB in China and Its Governance Mechanism
3.Latest Achievements of Global Translational Medicine Research
4.Clinical Research Development Status in India and Its Reference Value for China
5.China's First Large Scale Vaccine Clinical Trial in Hepatitis E
6.How to Implement Global Trials in China and Make the Clinical Trials Data to be Accepted in Global

The speakers are Trial Director & Clinical Director from Pfizer, Wockhardt, Bristol-Myers Squibb,Merck,Ranbaxy Laboratories,aTyr Pharma,Intrexon Corporation,GlaxoSmithKline,Novo Nordisk,Bayer HealthCare,Biogen Idec,Innovax...

Quintiles layoffs hit Triangle

2010-05-22T06:53:00.000+05:30

Clinical research organization Quintiles Transnational has implemented layoffs in Durham and throughout its global work force of more than 20,000 people spread across 60 countries.

Quintiles spokesman Phil Bridges confirmed that the company laid off workers on May 20, but he declined to provide an exact number. Bridges said the total number of layoffs was fewer than the number of open jobs the company has listed in the United States.

Quintiles currently lists 351 open U.S. jobs.

The privately held company does not release financial information but some industry estimates put the CRO’s annual revenue at about $3 billion.

Charles Winker, a spokesman for the North Carolina Department of Commerce, said that he has not seen any filings from Quintiles under the Workers Adjustment and Retraining Notification Act, or WARN, a federal law that requires a notice to be filed if the number of layoffs reach a certain threshold at a particular location. Bridges said that the cuts were made in Durham as well as other locations throughout the company’s global footprint.

Internal Audits For Pharma and Biotech

2010-05-22T06:46:00.000+05:30

An internal audit or also known as a quality audit says in 21 CFR 820: “Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.” I would like to make an important point that although this is a Quality System Regulation requirement, the need for internal or quality audits are also necessary in the pharmaceutical drug, biological drug, food, cosmetic, and dietary supplements industries.

Within the regulated industries, I will discuss quality audit requirements for five departments: Quality Assurance, Clinical, IT, Manufacturing, and Laboratory. In this article, I will offer some suggestions as to target areas to audit within each of the five functional areas.

Internal Audits / Quality Audits
! I will refer to both internal audit and quality audit in this article so consider them one in the same, as they are use interchangeably in the industry. Briefly, let’s establish the two main objectives of internal audits. The two main objectives are to ensure that your organization is following the applicable code of federal regulations as well as following your own work instructions, standard operating procedures, or policies. Let’s start with Quality Assurance.

Quality Assurance
! The Quality Assurance (QA) Department is responsible for performing the internal audits throughout the organization and unfortunately, they cannot audit themselves. Therefore, I recommend a third part auditor perform an internal audit of the Quality Assurance Department to avoid any conflict of interests. A third party auditor should be checking to ensure the QA Department is following their own procedures as well as performing their internal audits. Additionally, they should ensure audit corrective actions are being followed up on for internal audits, including CAPAs associated with audit findings. I will now provide an example of a recent FDA observation pertaining to quality audits: “ Procedures for conducting quality audits you were not defined. Specifically, the frequency of quality audits for each audited area is not defined in your firm’s Quality Manual and/or SOPs.” Next, we will discuss the Clinical
Department and what areas a QA Department should be looking at.

Clinical
The single most important area a QA Department can audit is the Trail Master Files for clinical trials. For example, you want to make sure there are informed consents for all of the enrolled patients. A recent 483 Observation issued to Hsueh, Willa A. , M. D., Principal
Investigator, stated: “The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, for trial NN2211-1574: All subjects screened and enrolled in trial NN2211-1574 were primarily Spanish speaking and according to the principalinvestigator, were initially consented orally by a bilingual subinvestigator using English informed consent forms. However, no documentation exists of the translation. The informed consent document also did not contain a description of the procedures to be followed.” As always, QA should also check Clinical’s procedures to ensure they are following them. Lack of following procedures is by large the most common audit finding when conducting quality audits. Consequently, organizations find themselves out of control because procedures are not being adhered to. Federal FDA Investigators like to target situations like these because it is a key indicator to them that an organization is out of control. Next, let’s talk about the IT Department.

IT
The IT department is responsible for data security and data integrity. An underlying network must be qualified in order to ensure the security and integrity of the data that resides on it. In addition to the network, the applications and networked applications must be
validated as well. A recent Warning Letter to Genzyme cited the following: “ Your firm failed to maintain computerized systems in a validated state”4 Some key areas to focus your attention are the validation of regulated applications as well as the maintenance and qualification state of the network. Standard operating procedures an auditor should be checking are: change control for both software and hardware, configuration management for the network, computer system validation lifecycle, network qualification, backup restore, disaster recovery, and security. Some questions you should ask as an auditor are: Does your data get backed up regularly? If so,
where are the backup tapes stored? Offsite? Do you exercise a Disaster Recovery Plan? Is there physical security for the Data Centers? Can I see your change log for both software and hardware? Can I see a recent example of a computer system validation of a system? These are all good questions to ask when auditing the IT area. Training records for SOPs should also be
checked to ensure employees, contractors, and consultants are trained on the procedures they
are carrying out. Next, we turn to Manufacturing.

Software Vendor Audits

2010-05-22T06:43:00.001+05:30

Introduction
A software vendor audit is a prerequisite to using a software application for regulatory purposes. In this article, I will explain the importance of performing software vendor audits, some of the challenges, and what areas to target during an audit. Software vendor audits are an integral part of your quality system. There are two reasons why software vendor audits are an integral part of your quality system. First, software vendor audits are a requirement of the quality system. Secondly, software applications either have a direct impact to patient safety or an indirect impact to patient safety. The second point leads us into why software vendor audits are so crucial.

Importance of software vendor audits
The main reason why software vendor audits are so important is ultimately patient safety. As mentioned earlier, software applications used for regulatory purposes can have a direct impact or indirect impact on patient safety. Therefore, it is essential that we not only validate them for their intended use, but evaluate the software development behind the finished product. Software applications used for regulatory purposes must be reliable and perform consistently in order to avoid data integrity issues. The integrity of the data created, processed, stored, and archived in these regulated software applications is paramount. Furthermore, the security of the software application is just as important. 21 CFR Part 11, Electronic Records and Electronic Signatures helps ensure both data integrity and adequate security. 21 CFR Part 11 leads me into the next section of common challenges with software vendor audits.

Common challenges with software vendor audits
The biggest challenge associated with software vendor audits is verifying 21 CFR Part 11 compliance. Often times software vendors claim their application is 21 CFR Part 11 compliant because they have an audit trail or because they know Part 11 is a buzzword that attracts potential clients. I find that in most cases, software vendors that claim their respective application is Part 11 compliant simply do not understand Part 11. Consequently, they end up with a software product that is not 21 CFR Part 11 compliant. Here is a very important point to consider. Although a software vendor may have all of the 21 CFR Part 11 functionality built into their application, it is invalid if the software vendor does not show objective evidence. In other words, the vendor must test all of the 21 CFR Part 11 functionality and provide objective evidence. An example of objective evidence is a screenshot of a test result. Time and time again, software vendors fail to test their Part 11 functionality.

Another crucial point is that just because the vendor tested for Part 11 in their environment, does not preclude you from testing 21 CFR Part 11 requirements in your environment. The same holds true for the reciprocal. If the vendor has not tested for Part 11, does not mean that your testing will suffice. At the end of the day, the FDA wants to see 21 CFR Part 11 requirements tested by both parties in their own environments.

FDA to Implement Quality Measures Internally, Asks Drugmakers to Do the Same

2010-05-22T06:35:00.001+05:30

The FDA is working to improve the quality of NDAs and ANDAs submitted to the agency in the wake of manufacturing incidents such as the 2007 Chinese tainted heparin scandal, while putting in place a quality management system within the agency’s centers. The race among generic-drug makers to be the first to file an application for a product has led to poor quality submissions and is one example of how an inadequate focus on quality among manufacturers has become a burden on the FDA and its reviewers, Janet Woodcock, CDER director, said at the 2010 GPhA/FDA Quality by Design Workshop.

Washington Drug Letter

United States: Health Care Reform: Impacts on Clinical Research

2010-05-22T06:28:00.001+05:30

On March 23, 2010, the Patient Protection and Affordable Care Act (PPACA) was signed in to law. Although there have been many articles and announcements written about the overall influence of the reform, this client alert will specifically address the impact on clinical research.

PPACA Provisions' Impact on Clinical Research

* COVERAGE FOR CLINICAL TRIAL PARTICIPANTS - Any group health or health insurance plan may not deny the individual participation in a clinical trial, may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and may not discriminate against the individual on the basis of the individual's participation in such trial. This legislation uses the same definition of routine patient costs as appears in the CMS Clinical Trials Policy.
* COMPARATIVE EFFECTIVENESS RESEARCH - Expands scope of clinical research to compare different therapies against one another as a means to improve value-based healthcare. This comparison may include both pharmaceutical and non-pharmaceutical therapies or a combination thereof. A nonprofit Patient-Centered Outcomes Research Institute will also be established to direct research priorities. Clinical research will need to identify comparative effectiveness opportunities while still answering fundamental standard of care questions.
* QUALIFYING THERAPEUTIC DISCOVERY PROJECT CREDIT - Establishes a 50% investment tax credit for "qualifying investment" in any "qualifying therapeutic discovery project" (i.e. projects designed to treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials, and clinical studies, or carrying out research protocols). This provision differs from traditional investment tax credits by adopting an approach that will allow companies to apply for a non-taxable cash grants in lieu of a tax credit. This may potentially promote more investment in clinical research. Click here to read more on tax credits and cash grants for small and mid-sized life sciences companies .
* HEALTH CARE FRAUD & ABUSE CONTROL FUND - Increases funding for fraud & abuse control by $250 million, over ten years, and expands data collection requirements as defined by the Health and Human Services Secretary under MMIS (Medicaid Management Information System). Over half of this funding will be supplied in years 2011 and 2012. Consistent with recent OIG work plans, these increases will amplify compliance enforcement throughout the entire research community and institutions must prepare for this adherence.
* REQUIREMENT FOR COMPLIANCE PROGRAM -

Any medical provider enrolled in title XIX or title XXI must establish a compliance program with core elements specific to its industry. The core elements will be established by the Secretary in consultation with the Inspector General of the Department of Health and Human Services. Institutions with large research portfolios may need to ensure that research is covered as part of a comprehensive compliance program.
* PHYSICIAN PAYMENT SUNSHINE PROVISIONS - Beginning in 2012, drug and device manufacturers that provide payments or other transfers of value to physicians (anything of value in excess of $100 annually), must submit an electronic report to the government. In September 2013, manufacturers must ensure that this information is publicly available through an internet Web site that is easily searchable and contains descriptive information which can be aggregated and downloaded.

There is an exemption for product samples and educational materials for patient use (not intended to be sold), loaned device (less than 90 days) items under warranty, discounts, in-kind items used for charity care, payments made to physicians who are patients, ownership in publicly traded securities or mutual funds.

Also, publication of payments for services furnished in connection with clinical trials of new drugs or devices; or new uses of drugs or may be delayed until the drug or device is approved or four (4) years after the payment was made.
* MEDICAL DEVICE EXCISE TAX - The recently passed health care reform legislation will impose an excise tax of 2.3 percent on medical device manufacturers, producers or importers for the sales of taxable medical devices. The tax, which takes effect in 2013, will apply to a range of medical devices, but does not include eyeglasses, contact lenses, hearing aides, and any other medical devices determined by the Secretary to be of a type which is generally purchased by the general public at retail for individual use. Although device industry groups have been generally supportive of health care reform, leading medical device associations believe that the excise tax will negatively affect innovative device research and development.

Source: Mondaq.com

Malaysia calling for Indian biotech cos

2010-05-22T02:30:00.000+05:30

Indian biotech companies are increasingly looking to make major investments in Malaysia, lured by the south-east Asian country’s tax sops, easy market access and better infrastructure.

A number of companies, including industry majors such as Biocon, Avesthagen, have recently indicated plans to manufacture in Malaysia through their own units or tie ups. The move is likely
to have great implications for India’s biotech policy.

Malaysia is positioning itself as a cost-competitive country and a regional hub for global biotech companies as it expects to benefit from the knowledge transfer and contribution to GDP. It is drawing Indian companies with a 10-year tax holiday, duty exemptions, customised incentives for large investments, access to ASEAN markets through free trade agreements and no restrictions on equity.

India’s own biotech efforts towards setting up R&D centres, funding entrepreneurship and creating public-private partnerships to promote innovations are being widely accepted by industry players. Yet, many of these moves have been more recent in nature and India does not present an attractive investor climate as Malaysia with its financial incentives and favourable drug policies, industry players say.

Stempeutics Research, which has tied up with Cipla to market its products, had invested Rs 25 crore in Malaysia in 2008, citing the ease in getting approvals.

“The Malaysian government’s regulations for stem-cell products are more flexible and the guidelines are only evolving,” BN Manohar, president of Stempeutics said. Regulatory approval for stem-cell research is seven months in Malaysia versus 18 months in India.

2 sites pull out of trials for GSK's Avandia

2010-05-22T02:18:00.003+05:30

GlaxoSmithKline and some physicians are having trouble recruiting patients for a large clinical trial of its controversial diabetes drug Avandia. The drug has been linked to an increased risk of heart attacks, but GSK officials have said it is a safe and effective product. Federal regulators are considering whether to halt the so-called TIDE clinical trial early because of Avandia's health risks. Two sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have pulled out of the safety study, The Wall Street Journal reported Thursday. The British company, which has its North American headquarters in Research Triangle Park, declined Both sites were closed recently because of an inability to recruit patients, said GSK spokeswoman Mary Anne Rhyne. The trials were closed by mutual agreement with the sites and the Population Health Research Institute, an independent academic research group conducting the study. There are 170 sites worldwide recruiting patients for the TIDE trial, including 21 in the United States, according to the federal website clinicaltrials .gov .

Merge Healthcare and Cato Research Ltd. Establish New Five--Year Technology Transfer Agreement

2010-05-22T02:13:00.001+05:30

Merge Healthcare /quotes/comstock/15*!mrge/quotes/nls/mrge (MRGE 2.20, +0.10, +4.76%) , a leading Health IT solutions provider, announced today that it was selected by Cato Research Ltd. to provide the proprietary etrials EDC solution through Merge's technology transfer program. This new agreement expands Merge's partnership with CATO to provide additional technology for clinical trials management, as well as extending the relationship for an additional five years.

"We have enjoyed a long-standing partnership with Merge Healthcare for their clinical trial solutions," noted Allen Cato, M.D., Ph.D., and CEO of Cato Research Ltd. "The etrials(R) technology has been consistent and intuitive, and the Merge team has been quick to help us use it successfully. Adding the etrials EDC platform in a technology transfer model will enable our company to efficiently build and deliver solutions to help our customers run cost-effective clinical studies."

The technology transfer program allows CATO to use the etrials EDC system to build and deploy custom clinical trial studies that leverage the powerful reporting capabilities of Merge's technology. Because the etrials EDC solution is built on a SaaS platform, it can be licensed on a subscription or study basis. In addition, Merge's etrials IVR(TM) and ePRO(TM) solutions can be integrated with the EDC system to provide comprehensive eClinical solutions. Merge's team of clinical trial experts will also provide training and support to CATO.

US FDA should disclose more about site inspections, says taskforce

2010-05-20T20:45:00.001+05:30

The US FDA should change its disclosure policy relating to manufacturing site inspections according to new draft recommendations by the Department of Health and Human Services (HHS) Transparency taskforce.

The proposal, part of a list published yesterday, calls for the agency disclose of the name, address and drug product made at facilities it inspects as well as any resulting recommendations and warning letters.

Currently the Food and Drug Administration (FDA) only “posts inspection reports (Form 483s and EIRs) when a high level of public interest is anticipated” or those that are “frequently requested.”

The Taskforce also advises that the FDA starts routinely publishing details of drugs and device review applications, including when such submissions are withdrawn or placed on hold.

The group, which was set up at the behest of the Obama administration, also recommends that the FDA publishes the findings of investigations of institutional review boards (IRB) overseeing clinical trials.

Recall powers and IRB

The Taskforce also want the FDA to play more of a role in communicating the information it receives from pharmaceutical companies when the initiate product recalls.

They explained that currently “[the] FDA does not have mandatory recall authority, except under limited circumstances, but a firm may initiate a recall at any time.

“FDA issues a written notification that a recall is terminated to the recalling firm, but does not notify the public when a recall has been terminated.”

Instead the group suggests that: “When a system is set up that provides FDA with authority to require companies to submit certain information to the Agency when they initiate [a recall, the agency] should disclose this information as soon as practicable.”

The group, which was set up at the behest of the Obama administration, also recommends that the FDA publishes the findings of investigations of institutional review boards (IRB) overseeing clinical trials.

Taskforce chair Joshua M. Sharfstein, said: “We invite public comment on these draft proposals, including input on whether we have struck the right balance between disclosure and confidentiality in support of public health. Because FDA cannot implement all of the proposals at once, we are asking for input on how to prioritize.

Source: in-pharmatechnologist

OHRP: Central, External IRB OK for Multicenter Trial

2010-05-20T20:42:00.002+05:30

A single, central institutional review board (IRB) is sufficient in a multicenter clinical trial, especially if a centralized review improves the efficiency of the IRB, according to an HHS Office for Human Research Protections (OHRP) letter. OHRP agrees with the FDA’s position on the benefits of relying on a central IRB for multisite research rather than local boards, it says in an April 30 letter to the Carolinas Medical Center. To clear up ongoing confusion about the use of external IRBs, OHRP recently posted the letter and an April 13 query from the medical center.

Source: FDANews

FDA Proposes Far-Reaching Transparency Initiative; Public Peek at Industry R&D Failures

2010-05-20T20:34:00.000+05:30

The Food and Drug Administration's transparency task headed by deputy commissioner Joshua Sharfstein today proposed opening the drug and device industry's research and development process to an unprecedented level of public scrutiny. The agency is proposing to publicly disclose the existence of:

* Individual investigational new drug applications (which are submitted by company and academic researcher before they are allowed to try an experimental drug or device in human subjects);
* The withdrawal or termination of INDAs and the reasons for those actions;
* Immediate public posting of all new applications for drugs, biologics, generics, new devices or similar devices (submitted for agency review when efficacy trials are completed);
* The withdrawal or rejection of new applications (approvals have always been announced);
* The full text of response letters for new drug, device and biologic applications, whether or not approved by the agency; and
* Whether an application received an orphan product designation (needed by 300,000 patients or less), and if it did, whether it was withdrawn or abandoned for safety reasons and whether, if approved, it would represent a significant therapeutic breakthrough for a rare disease.

While obviously a boon to patient advocacy groups, this information will also be of great interest to company rivals, Wall Street analysts, industry consultants and academic and independent observers who closely monitor R&D activities. The only current source of specific industry R&D activities is a self-reporting database contained on the Pharmaceutical Research and Manufacturers Association website and Securities and Exchange Commission filings, which often do not report R&D activities until they are nearing the final stages of the process and are most relevant to stockholders.

In a perspective published today by the New England Journal of Medicine, Sharfstein and agency attorney Afia K. Asamoah noted "not all these proposals will necessarily be implemented. Some may require changes in law or regulation, and some may require substantial amounts of resources." The agency will be taking public comments until July 20.

ASSAf calls for revitalisation of clinical research in South Africa

2010-05-20T20:30:00.001+05:30

Clinical research in South Africa is in urgent need of government support, better strategic planning and co-ordination, and closer co-operation between stakeholders, says a recent report from the country’s Academy of Science.

“There is little likelihood that continuation of the present situation is compatible with rebuilding and sustaining solid research capacity in the clinical domain, nor can the ideal of well-coordinated state support for a health system, built on the ‘intelligence’ of good clinical research, ever be realised,” warns the peer-reviewed report by the Academy of Science of South Africa (ASSAf).

According to the ASSAf, clinical research activity and capacity in South Africa has “declined dramatically”. In that light, and following discussions with the Pharmaceutical Industry Association of South Africa, the ASSAf decided to undertake a study that would generate recommendations for revitalising clinical research nationally within the framework of essential health research.

The report was written by a 13-member panel representing a wide range of health scientists and scholars from across South Africa and chaired by Professor Bongani Mayosi of the University of Cape Town.

The report identifies the following barriers to advancing the clinical research environment in South Africa:

• Inadequate public engagement. The government does not promote clinical research enough in the public domain, while researchers do not engage sufficiently with issues of importance to research participants and policymakers, the ASSAf panel says.
• Lack of research planning, regulation and co-ordination. This problem includes an inefficient regulatory framework for clinical trials and new drug registration that is stifling innovation in clinical research. South Africa also needs a coordinated national plan “to balance excellence on the world stage (i.e., quality and impact) with relevance to local problems”, the report’s authors suggest.
• Inadequate capacity (human resources and infrastructure). Falling under this heading are poor teaching and matriculation rates for science and mathematics in schools; lack of appropriately trained clinical scientists and the career structure to support them (with a ‘frozen’ demographic oriented to “ageing white” males); and lack of appropriate facilities and infrastructure, with a “virtual absence” of dedicated clinical research centres.

• Lack of adequate and appropriate funding. This includes insufficient funding for clinical trials and other types of clinical research. The cost-recovery regime of the provincial department of health and the National Health Laboratory Service “prohibits investigator-driven, non-industry clinical research in academic health complexes”, the report says.

• Absence of monitoring and evaluation. According to the ASSAf, there is no monitoring of adherence to standards and the performance of individual researchers, academic institutions, research councils, government departments, the health industry and other research funders in South Africa.

Research ICMR to conduct research on rickettsial diseases, calls for proposal

2010-05-20T20:25:00.000+05:30

The Indian Council for Medical Research (ICMR) will soon conduct multicentric task force project research on rickettsial diseases. It has already invited proposals for the research and the broad areas covered under the research projects will include study on the prevalence, incidence and dynamics of transmission of the rickettsial diseases in India.

The ICMR study on rickettsial diseases is of great importance since it has affected many people from across the different states in India. Highest number of rickettsial disease in India has been documented from Jammu and Kashmir, Himachal Pradesh, Uttaranchal, Rajasthan, Assam, West Bengal, Maharashtra, Kerala and Tamil Nadu.

“The aim behind initiating the research on rickettsial diseases is to gather database that can be used to study the diseases. As of now there is no available data to support anything on the rickettsial diseases. Moreover the reported numbers are an underestimate due to lack of community based data and non-availability of confirmatory laboratory tests,” senior scientist from ICMR Dr Arvind Nath said.

Veeda Clinical lays off bulk of UK staff as recession bites

2010-05-20T20:20:00.001+05:30

Anglo-Indian contract research organisation (CRO) Veeda Clinical Research has laid off the bulk of its staff in the UK as global recession and more tentative outsourcing of early-phase trials take their toll on the company’s operation in Derriford, Plymouth.

The UK business is making 32 out of 47 employees redundant, although some of these are part-timers. Veeda Clinical is maintaining a core presence at the Derriford site and says the redundancies are a “pragmatic but hopefully short-term response” to a “cumulative slowdown” in contracts for Phase I trials.

Phase I is the main focus of the UK operation and Veeda Clinical’s “bread and butter”, the company noted. The recession has hit early-phase development services particularly hard as pharmaceutical and biotechnology companies reprioritise their R&D pipelines.

Added to that is the UK’s continuing problems with attracting clinical trial business in an increasingly competitive global marketplace. At the end of last year, Department of Health data showed the number of early-phase trials approved in the UK had dropped to 210 in 2009, a five-year low.

Veeda Clinical itself signed a collaborative agreement with the Malaysian Ministry of Health last July to open a Phase I and Early Clinical Development Unit in Kuala Lumpur. Earlier that month, it sold Veeda Laboratories Ltd, a biomarker laboratory services subsidiary in Oxford,UK, to Dublin-based CRO ICON for an undisclosed sum.

The company also has a large operation in India and facilities in Belgium, while Veeda Oncology, the specialist research services subsidiary launched in 2008, is active both in Europe and the US.

Veeda Clinical stressed that its current problems were confined to the UK market and that other parts of the business were both growing and recruiting.

The hope, though, is that the situation in Derriford will pick up in the autumn. If that happens, Veeda Clinical said, it has a “very, very strong intention” to bring staff back on board.

The company was formed in October 2005 through a merger of Ahmedabad, India-based ClinSearch Labs Pvt Ltd, the UK contract research organisation Phase I CTU Ltd and Triphasic Clinical Trials Laboratories of Plymouth.

Source: PharmaTimes

DCGI approves Lifecell International's BMAC kits to market in India

2010-05-14T17:23:00.001+05:30

Chennai-based Lifecell International (P) Ltd and the US based medical device company, Harvest Technologies, have received the approval from DCGI for promoting BMAC (Bone marrow aspirate concentrate) kits in Indian Market.

Sources from the Lifecell said BMAC System is an easy to use, point of care, autologous system that can rapidly produce a concentration of mononuclear cells (MNC) consistent with those concentrate reported in numerous human clinical trials. Existing methods to produce a stem cell concentrate therapy are time consuming, labour intensive, and require complex logistical considerations.

The BMAC System conveniently processes either 60mls or 120mls of bone marrow aspirate within a 15 minute process step that can be conducted in the point of care setting. It produces a MNC concentrate that is unsurpassed in the number of cells the system can yield as well as ensuring that the cells remain viable during the process. A typical yield from processing just 60mls of aspirate is over 220 million MNC’s of which approximately 10 million are CD34+ with over 3200 Colony Forming Units (CFU’s).

EU agency prepares to assess first stem cell drug

2010-05-14T17:12:00.001+05:30

The first regenerative medicine based on stem cells could be filed for approval in Europe later this year, bringing the groundbreaking medical technology a step closer to reality.

The European Medicines Agency (EMEA) said on Wednesday it had been informed about the "intent of a European manufacturer to submit the first application for marketing authorization for a stem cell-based product."

Drugmakers typically send a letter of intent to the London-based watchdog four to six months before a formal application, a spokeswoman said, so this would imply a filing toward the end of 2010.

The EMEA declined to name the company involved.

In preparation for the first of a possible wave of applications, officials from the EMEA met this week with drug company officials, regulators from the United States and Japan, and academic scientists to discuss guidelines for approving such treatments.

Research into stem cells has increased dramatically in recent years and there are currently some 40 clinical trials underway in the European Union exploring the use of stem cells to regenerate lost or damaged tissues and tackle various cancers. The majority use adult mesenchymal stem cells.

Stem cells -- which are particularly flexible when taken from days-old embryos -- are the body's master cells and can potentially be used to repair the heart, spinal cord, liver, pancreas, eyes and other parts of the body.

But their use is controversial and involves risk -- notably the danger that foreign cells might be rejected or could proliferate uncontrollably, leading to tumors.

Pharmacovigilence programme to start on July 1 with 10 medical colleges in 1st phase

2010-05-14T01:52:00.003+05:30

The much awaited national pharmacovigilance programme, is expected to begin in 10 medical colleges across the country from July 1 this year. The first phase of the programme will be launched in 10 of the 300 medical colleges in the country and the DCGI plans to further extend it to 40 other colleges by next year and 60 the next. DCGI said that by 2014, all the 300 medical colleges will be participating in the national pharmacovigilence programme.

The national level pharmacovigilence programme will have a two pronged approach and will be targeted for five years initially. In the budgetary provisions the pharmacovigilence programme was granted with Rs 85 lakh against the expectation of Rs 1.5 crore. This programme was supposed to be launched earlier in the month of April but it had repeatedly got delayed due problems in the Union Health Ministry. The DCGI expressed that funding is the most important aspect right now for the success and development this programme. Almost 50 per cent of the allotted money will be used on HR to increase the manpower since its an issue that's been haunting the DCGI's office from the past several years.

The programme will be run in three units that comprises of the medical colleges, other institutes and CDSCO. AIIMS will act as the main centre for the national pharmacovigilence programme, whereas the CDSCO will be providing funds, manpower, training etc to the AIIMS and other institutes involved in this programme. This programme will be started in 10 medical colleges this year.

Speaking about the reason behind choosing medical colleges for the implementation of this programme DCGI said that they were the best choice since they have a systematised data bank on various subjects. Moreover, every medical student have to study pharmacovigilence as a subject in their curriculum and hence are well versed with its principles. The DCGI's office through the CDSCO's zonal and sub-zonal offices will be funding these medical colleges with required infrastructure, training, etc. The DCGI stressed on the need to ensure that each medical college should have their own pharmacovigilence cell. He also invited private institutes and other government aided programmes to participate in this national pharmacovigilence programme for better understanding and success at national level.

ADDRESSING FRAUD IN RESEARCH

2010-05-14T01:44:00.001+05:30

P A Francis

An unfortunate trend that is emerging in the global pharmaceutical industry is the growing number of frauds in clinical research. Frauds never used to be known in the past but quite a few cases are coming out in the public now. Clinical trials is the final stage in the development of a new drug candidate and granting of marketing approval for it depends on the safe trial reports the companies submit to drug control authorities. Trial reports should not, therefore, indicate serious adverse drug reactions of the new drug. With the global pharma industry finding it extremely tough to get a new drug molecule from research for some years, even some of the top companies do indulge in submitting falsified research reports. The most recent revelation in this regard is about Dr. Scott Reuben, a former member of Pfizer Inc' s speakers' bureau. He had agreed to plead guilty to faking dozens of research studies that were published in international medical journals. Another case is that of Avandia of GSK. The recently released US Senate committee report has uncovered that GSK concealed information that the diabetic drug caused tens of thousands of heart attacks in patients who took it. The 334-page report also indicts the US Food and Drug Administration for failing to properly regulate the drug and ignoring the truth about its dangers.

e-Book: A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim

2010-03-10T16:54:00.002+05:30

Editorial Reviews

Product Description

"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity."

-- Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA

The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.

Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.

Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:

In-depth information on conducting clinical trials of medical devices and biologics
The role and responsibilities of Institutional Review Boards, and
Recent developments regarding subject privacy concerns and regulations.

Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

Download

Clinical trials come out of closet in India

2010-03-10T13:57:00.000+05:30

NEW DELHI: Clinical trials in India are finally becoming transparent. There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry-India (CTRI).

According to records collected by the Indian Council of Medical Research and the Drug Controller General's office, between July-December 2007, only 11 trials were registered. The number increased to 137 between Jan-Dec 2008 and then to an all-time high of 546 between Jan-Dec 2009.

This year, while January saw 58 trials registered, February recorded 60.

CTRI was launched by ICMR in July 2007 with the hope that trials conducted for testing efficacy of new drugs would become transparent. There were fears that India had become a hotbed for illegal clinical trials, thanks to the diverse genetic and patient pool and drug naive population.

Sourse: Read Full Story

Kendle Receives Approval From Indian Government To Proceed With Development Of Operations Center In Special Economic Zone

2010-03-10T13:48:00.000+05:30

Kendle (Nasdaq: KNDL), a leading, global full-service clinical research organization, today announced the Company has received approval from Indian authorities to proceed with development of a new operations center in a Special Economic Zone (SEZ) in the upcoming Ahmedabad-Gandhinagar Knowledge Corridor. The new SEZ center represents an important and strategic investment for Kendle and demonstrates the Company's commitment to further invest in Asia/Pacific to meet customer needs. The new unit is expected to be operational by mid April.

"Continued expansion throughout the Asia/Pacific region is crucial to the future growth of Kendle," said Stephen Cutler, PhD, Senior Vice President and Chief Operating Officer. "Our increased capacity in the region will allow us to better meet the growing demands of our customers who are seeking to capitalize on India's rapidly expanding high-quality biopharmaceutical capabilities. The new SEZ operations center will be ideally suited to deliver best-in-class services to our customers seeking high-quality, innovative and cost-effective solutions for their clinical development needs."

Sourse: Read Full Story

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2009-05-22T03:18:00.001+05:30

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Genta - Waiting For Genasense To Make Sense

2008-12-02T19:24:00.002+05:30

Biopharmaceutical company Genta Inc. (GNTA.OB) has been waiting for too long to get FDA clearance for its controversial antisense cancer drug Genasense. On December 3, the FDA is expected to decide whether Genasense injection merits approval for Chronic Lymphocytic Leukemia.

Genasense, known generically as Oblimersen Sodium, is an antisense drug, which works by blocking a protein called Bcl-2, making cancer cells more vulnerable to death. Bcl-2 is one of the proteins produced by cancer cells that prevents cancer cells from dying. Blocking Bcl-2, therefore, may enable cancer treatments to be more effective.

In December 2003, Genta sought approval from the FDA for Genasense in the treatment of advanced melanoma, the most deadly form of skin cancer based on results from one of its Phase III clinical trials. The trial enrolled 771 patients with advanced melanoma who had not previously received chemotherapy. The patients were randomized to receive Genasense plus Dacarbazine, or Dacarbazine alone. The primary endpoint of the trial was to compare the overall survival between the two treatment arms.

According to the trial results, Bayer's Dacarbazine, which is commonly used in the treatment of advanced melanoma, when combined with Genasense delayed the median time before the disease worsened to 74 days from 49 days, reflecting a 51% improvement. Dacarbazine when combined with Genasense also resulted in an improvement in durable response rate of 6 months and a 72% increase in overall anti-tumor response rate.

However, Genasense failed to produce any improvement in overall survival rate and the FDA's Oncologic Drugs Advisory Committee declined to support the approval of the drug.

On April 30, 2004, the staff of the ODAC (Oncologic Drugs Advisory Committee) of the FDA stated in briefing materials in advance of the May 3, 2004 ODAC meeting that the Phase 3 clinical trial of Genasense failed to demonstrate a survival benefit, which was the primary trial endpoint. As a result of the announcement, the stock dropped $5.83 or 40.4% to close at $8.60 on an unusually high volume of over 30 million shares traded.

On May 3, 2004, the FDA panel voted 13-3, recommending the FDA to reject Genasense as the trials did not achieve the primary goal of prolonging lives. Following the news, Genta shares fell more than $3 per share to close at $5.11 that day.

On May 13, 2004 Genta withdrew its new drug application with the FDA for Genasense in the treatment of advanced melanoma.

The advisory committee's move dealt a blow to Genta's stock price and by the end of May 2004, the stock had fallen to $2.30, which reflected a decline of 81% since the start of 2004.

Then came yet another bad news, which sent Genta's stock price into a tailspin. Pharmaceutical giant Aventis, which had a collaboration agreement with Genta, since 2002, to develop and commercialize Genasense, bailed out of the partnership in November 2004. (Aventis merged with Sanofi to form Sanofi-Aventis in August 2004). Genta's stock price, which had already been on the wane, deteriorated further settling around $1.30, following Aventis terminating its partnership with Genta.

Sourse: Read Full Story

Pfizer Left And They Survived

2008-11-26T16:35:00.001+05:30

So what happens after pharmaceutical giant Pfizer abruptly shutters a big research and development campus?

Hopefully, we won't ever have to find out here in southeastern Connecticut. But it's at least a little encouraging to know that there have been some promising stirrings from the ashes of the facility in Ann Arbor, Mich., which Pfizer shut down last year.

Stephen Rapundalo can see the now-empty Pfizer plant in Ann Arbor from his office window, and it's not a pretty sight, especially for Rapundalo, who is a city councilor.

”I drive by it every day and it's sad to see it empty,” he said. “There are some relatively new buildings there, and many of us were surprised when they closed it.”

And yet Rapundalo, who was a research scientist at Pfizer until he lost his job in the company's 2005 “adapting to scale” downsizing, is an example of the positive things that can happen in a post-Pfizer world.

Rapundalo is now president and chief executive officer of MichBio, a non-profit trade group dedicated to developing the biotech industry in Michigan, one he says is still growing, despite two big waves of Pfizer layoffs in recent years.

Some of the growth comes from former Pfizer employees who have either started their own companies or joined others, part of a developing cafeteria of small companies that can do drug development research work.

Some offer services, like conducting clinical trials, to the big pharmaceutical companies, including Pfizer. Others are developing their own drugs and show a nimbleness that the big players may find hard to match.

One Michigan startup by former Pfizer scientists is developing what the founders believe to be a better treatment for type 2 diabetes, one without the side effects of current drugs. They started out in a spare bedroom of someone's house, have found some big backers and have raised more than $10 million.

The company hopes to make it through a third phase of drug trials and get Food and Drug Administration approval to bring the drug to market by 2013.

Or maybe one of the big companies will buy them before then.

”Generally speaking, the large pharmaceuticals seem to be moving to a model where they are largely an end development and marketing company that will have to feed its research and development from the outside,” Rapundalo said.

Rapundalo estimates about 16 new companies were formed by ex-Pfizer employees after the 2003 layoffs in Kalamazoo, which followed Pfizer's purchase of Pharmacia. He says another 25 or so emerged after the Ann Arbor closure last year.

About a third of the people laid off last year in Ann Arbor have stayed in the area and work in the industry, he said. And he added some who went to other Pfizer facilities, in San Diego, St. Louis, England and Groton, have returned.

”We have developed a real strength here largely as the result of the downsizing of Pfizer,” he said. “The skill set has stayed.”

As for the plant in Ann Arbor, it's on the market, all 2 million square feet of it.

I'm glad things are working out in Michigan for many of those who lost their Pfizer jobs. And I hope we never get the post-Pfizer test here in Connecticut.

By David Collins

Source: TheDay.com

FDA delays J&J, Basilea antibiotic approval

2008-11-26T16:11:00.001+05:30

* U.S. approval for MRSA treatment ceftobiprole delayed

* FDA says needs further site audits, other data

* New U.S. application planned within the year

* Basilea stock down 27 pct

ZURICH, Nov 26 (Reuters) - U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson (JNJ.N) and Basilea (BSLN.S), saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic to treat deadly superbug MRSA, is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent to 110.00 Swiss francs by 0848 GMT.

"At current it is difficult to gauge the extent of the impact on the approvability of ceftobiprole by the FDA," Piper Jaffray analyst Richard Parkes said.

A delay of six months or more seems inevitable, but the precedent of Theravance's (THRX.O:) telavancin -- an antibiotic whose approval was delayed due to what appear to be similar reasons -- is encouraging, Parkes said.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted until issues of data integrity had been resolved, the companies said.

"The FDA has indicated that they cannot approve the NDA (new drug application) for ceftobiprole at this time," J&J said in a statement. "They have asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union.

However, it has hit delays in the United States. The FDA had already issued an approvable letter for the antibiotic in March, indicating that further assessment of clinical data was needed.

A new application in the United States is planned within a year and European authorities have had no problems with the drug, Basilea Chief Executive Anthony Man told reporters.

The emergence of hospital superbugs such as MRSA, which are resistant to existing medicines, has increased the need for alternative treatments and re-focused attention on antibiotics.

"The agency has requested information on J&J's clinical quality assurance programmes and also asked for a new audit plan that also addresses deficiencies in contract research organisation monitoring," Basilea added. "We are deeply disappointed with the further delay in the review."

Source: Reuters

Regulatory Changes Afoot in India

2008-11-25T18:42:00.001+05:30

As part of its broader examination of the clinical research process within its borders, India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS). Currently, Phase I studies by international companies are limited largely to experimental therapies deemed to have a sufficient amount of safety data approved by the U.S. Food and Drug Administration (FDA) or other regulating body in the drug’s country of origin.

Public discourse on the issue is unlikely before the end of India’s elections in March, notes Debashis Ghosh, vice president and global head of life sciences and healthcare at TCS. Prior to that, a Central Drug Authority bill is expected to be introduced in Parliament that seeks to centralize licensing authority for regulating the healthcare sector, including pharmaceuticals. The bill has separate provisions for medical devices, which are currently undifferentiated from drugs in regulations, as they are by the FDA.

The Central Drugs Standard Control Organisation (CDSCO) itself is being restructured, beginning with its recent move into larger quarters in New Delhi to accommodate a rising influx of trial-related regulatory documents, says Sherlekar. CDSCO has made no secret of the fact that it would like to fully automate operations as well as be a body under India’s Ministry of Health (MOH). At the moment, it reports to the MOH but responds to inquiries from a handful of other ministries.

Some time ago, registration of clinical research organizations (CROs) in India became mandatory, says Sherlekar. All the major international CROs operate here, as well as many small CROs both native and foreign. An official count has yet to be published.

The Indian Council of Medical Research, an agency of the MOH, has been actively working toward establishment of a mandatory clinical trials registry to improve the reliability of data generated and minimize duplication of trials, says Sherlekar. A voluntary registry was launched in mid-2007.

India’s clinical research market has been growing 20 percent annually over the last three to four years and the industry expects the trend to continue at least through 2012, says Sherlekar. The market is currently valued at over $200 million.

Growth in clinical research outsourcing has been happening “simultaneously” in terms of both CRO activity and “functional outsourcing” of specific tasks such as data management, says Ghosh. Even basic research and computational biological work is being outsourced to Indian pharmaceutical firms and drug discovery companies like Advinus Therapeutics, sister to TCS.

India’s strengths as a hub for clinical research include infrastructure and robust training in Good Clinical Practice, says Sherlekar. But due to exponential growth in this industry sector, it will be challenged to keep pace with the demand for clinical monitors and research associates. On the other hand, many institutes have popped up with curricula that “caters to the need.” Companies outsourcing clinical trial work to India have also invested a significant amount of time on education, often using the “train the trainer approach,” Ghosh adds.

Source: Bio-IT World

Oncology Services Europe launch India CRO operations with OSI

2008-11-25T18:36:00.001+05:30

Oncology Services Europe (OSE), a full service Contract Research Organization, specialized in clinical drug development in Oncology launched its India operations with establishment of independent clinical services company Oncology Services India (OSI) in Ahmedabad, Gujarat. OSI will offer a complete clinical service range from Phase I (first-in-men) to Phase IV (PMS) trials.

With commencement of Indian operations, the basis of a new international “Oncology Specialist” within the global CRO business has been established. The new entity in India combines the best of clinical research capabilities of Europe and India.

Announcing the initiative, Chief Executive Officer of Oncology Services India (OSI), Dr. Vimal Sanghavi, said, “Oncology Services is looking to replicate the success of its European experience of multi-centric global trials in Indian subcontinent. Clinical trials have grown increasingly global, larger and more complex. Government regulations are progressively more stringent, requiring more studies with larger patient populations especially in Oncology. India is a favourable destination for conducting multinational clinical trials in the oncology segment. Availability of large number of therapy-naive patients in various cancer entities, highly qualified and experienced investigators and hospitals in India, coupled with the latest technological infrastructure, is the driving force of OSI.

The two companies complement technical strengths of each other and shall gain expertise from the synergies in technical areas of clinical research. With assignments underway and initial plans to offer services to offshore clients, apart from Indian clients, OSI is all set to establish a new benchmark for Indian clinical research industry. I am sure this will further win confidence of global research & development fraternity and attract a lot of clinical trial business in Asia Pacific region.”

Oncology Services Europe (OSE) is looking to tap the high growth potential of clinical services sector in Oncology segment of India. With proven expertise in clinical services segment and vast experience of handling assignments for leading international pharmaceutical / biotech companies, Oncology Services is offering comprehensive and diverse range of clinical services under one roof in India. Company is looking to tap lion’s share of country's $ 300-million clinical trials market is expected to grow at an annual growth rate of 15 % over the next four years. By 2011, this will bring nearly 15 % of the total global clinical trials to India and will generate annual revenue of $1 billion, according to market studies and research statistics.

Sharing his views on commencement of Indian operations, Chief Executive Officer of Oncology Services Europe (OSE), Dr. Wolfgang Beier, said, “By extending presence in India, OSE can reap definite benefits of faster recruitment for quality data and cost effective clinical services for its global clients. Clinical services are now a global opportunity for India with a strong competitive edge based on speed and quality of clinical development. Pharmaceutical / biotech companies are looking to outsource their clinical trials management to partners who know how to work within changing regional and global clinical trial regulations.

By expanding our capacity to serve the needs of both multinational and local pharmaceutical companies, we will be able to bring a higher level of project management, quality and expertise to facilitate clinical trials. OSI will have unlimited access to expertise and technology assistance of our European operations. Our experience of dealing with international clients with diversified needs in terms of clinical services will be an asset to our Indian operations.”

- End -

About Oncology Services:

Oncology Services Europe, based in Munich, Germany, is a specialized CRO in oncology clinical trials, provides technical expertise in terms of professional project management, and inter disciplinary consulting competence regarding the clinical development of anti-cancer drugs. It offers vast experience in undertaking Phase I – Phase IV including non-industrial studies. The list of esteemed clientele includes multinational pharmaceutical companies across European Union and US. Its Indian subsidiary, Oncology Services India, based in Ahmedabad, Gujarat, is afull-service Oncology CRO offering services from pre-clinical to post-marketing studies. It offers customized services of Project Management, Monitoring, Data Management, Biostatistics, EDC trials, Regulatory Consulting and Drug Development Consulting. OSI will participate in theyearly external audit procedure, which is part of the Standard Quality Management at OSE. Thus, the two companies can guarantee the client a high level of professionalism in conducting clinical trials based on an identical set of Standard Operating Procedures (SOPs) in the core business of clinical research.

Source: India PR wire

New Arena for Testing of Drugs: Real World

2008-11-25T18:32:00.000+05:30

Sylvia Syvenky went for a routine dental appointment in early October, expecting to have two caps on her teeth replaced. But something went terribly wrong.

Click to enlarge

FILLING GAPS Sylvia Syvenky, 70, is part of a study on heart failure, an effort to determine which treatment is best for typical patients with complex symptoms.

Ian Jackson for The New York Times

“I felt like I was choking,” Mrs. Syvenky said. “I couldn’t take a breath. All sorts of gurgly sounds were coming out of me.”

She was rushed by ambulance to University Hospital near her home in Edmonton, Alberta, where doctors placed a mask on her face and forced air into her lungs. They told her she had heart failure. After her condition improved, they asked her to sign up for a study of a new drug to help with breathing.

Mrs. Syvenky is like many with heart failure who arrive at hospitals, unable to breathe. Yet she is the last person who would normally be asked to join a research study. At age 70, she was much older than typical study participants and her symptoms were too complex.

But now there is a growing movement to gather a new kind of evidence, the kind that will fill some of the biggest gaps in medical science: What treatment is best for typical patients with complex symptoms, like Mrs. Syvenky? Many are elderly with several chronic conditions and taking several unrelated medications. And what are the long-term effects of a treatment — death rates, side effects, progression of the disease?

A group of advocates, including medical researchers, medical societies and insurers, is lobbying Congress to pay for an Institute for Comparative Effectiveness Research that would assess treatments and identify gaps in evidence. When there are gaps, the institute would initiate what are being called “real world,” or “pragmatic,” clinical research trials to gather the evidence.

Some leading researchers who used to defend the status quo say they have switched.

“There has been a 90-degree turn” in thinking, said Dr. Eugene Braunwald, an eminent cardiologist at Harvard Medical School. “I personally have swung around.”

Although thousands of medical studies are completed every year, most have relatively limited goals. They often carefully select patients who have few medical problems other than the one under study, making it easier to get one clear result. They may not look at effects over the long term, assuming that if a treatment helps initially, patients will be better off.

But while such studies can help a drug acquire approval or answer a restricted research question, they can leave patients and doctors in a lurch because they may not tell how the new drug or treatment will work once it is tried in real patients with complex problems. Such limited studies, while they can have value, may no longer be enough, particularly when care has become so expensive and real evidence more crucial.

“They are at the heart of why we have trouble making decisions,” said Dr. Scott Ramsey, a professor of medicine at the University of Washington.

It is an issue that arises again and again. For example, it is one reason for the debate over the popular diabetes drug Avandia, or rosiglitazone. When the drug was tested, the main question was whether it lowered blood sugar, which it did. Then, after it was on the market, some researchers found hints of increased risks for heart attacks, the major killer in diabetes. But there was no way to know for sure from the studies that led to the drug’s approval.

At the same time, a move to conduct many more pragmatic trials would involve nothing less than a rethinking of how medical research is financed and managed.

“There’s this gulf between what questions researchers have found interesting to study and what questions industry and the N.I.H. have chosen to fund and what users of information most want to know,” said Dr. Sean Tunis, director of the Center for Medical Technology Policy, a nonprofit group that studies ways to get better medical evidence.

“One starts from the head and the other starts from the tail and they don’t meet in the middle.”

Dr. Robert Califf, a cardiology professor at Duke University School of Medicine and principal investigator in the heart failure study, cites the study Mrs. Syvenky entered as a model of what is so urgently needed in medicine.

The study, the largest ever in heart failure, is 15 times larger than any previous study of nesiritide. Unlike those that led to the drug’s approval, it is enrolling patients like those doctors see every day. Anyone showing up at one of 450 medical centers around the world, unable to breathe because of heart failure, is eligible. Participants are randomly assigned to get an infusion of nesiritide or a placebo, a saltwater infusion. And the study, comparing the treatments, asks two simple questions: Are patients still alive a month later? And were they readmitted to the hospital?

Dr. Califf knows the evidence problem all too well. He spent years working on committees that formulate medical guidelines for treating heart disease patients. And over and over again, he says, he and other committee members ran into a problem. The studies did not ask whether one treatment was better than another and they did not ask what happened over long periods in typical patients with their complicated medical problems.

“We looked at the A.C.C. and A.H.A. guidelines,” Dr. Califf said, referring to the American College of Cardiology and the American Heart Association. “Fifteen percent of the guidelines were based on good clinical evidence. And cardiology is where we have the most evidence.”

He added that he was not indicting studies that looked at a more limited group of patients and often studied a drug’s effects for a shorter time.

“You have to figure out the right dose. Is there a chance it could work?” Dr. Califf said. But something more is needed.

The Food and Drug Administration does not have a hard and fast rule about what it takes to show that a drug is effective, said Dr. Robert Temple, director for medical policy at the F.D.A.’s Center for Drug Evaluation and Research. A lot depends on what is known about the drug’s short-term effects and how well they predict long-term outcomes.

But, he added, there are practical concerns with large pragmatic trials because companies have to look at a wide range of possible effects when they test a drug. “If you do a large outcome study in 10,000 people in the same way you do short-term studies, you’ll never finish,” Dr. Temple said.

“There’s no white hat, black hat here,” said Dr. Kevin Weiss, president and chief executive of the American Board of Medical Examiners. “Pharmaceutical companies are trying to do what they are supposed to do. The F.D.A. is trying to do what it is supposed to do. But they are not fully connected to what the public needs.”

That was part of the problem with nesiritide. At first, all was well. The drug dilates blood vessels, making it easier for the heart to pump blood into the rest of the body. Patients breathed better.

The F.D.A. approved the drug in 2001 based on studies that asked about breathing in the first few hours and excluded patients with symptoms as complex as Mrs. Syvenky’s, even though she is typical of half of all people with heart failure. The patients in the original studies, mostly white men, had an average age of 60. Yet more than 800,000 Americans aged 65 and older were hospitalized for heart failure in 2006, the most recent year for which statistics are available.

In 2005, questions arose. Researchers lumped together data from several nesiritide studies. One analysis reported damage to kidney functions and the other found increased death rates. Sales plummeted.

But no single study was large enough to determine if those risks were real, and merging smaller studies in a so-called meta-analysis can be misleading.

In fact, said Dr. Adrian Hernandez, a cardiologist at Duke University, meta-analyses have been a risky business. When their conclusions were tested in subsequent studies, they have been correct just 60 percent of the time. They are good for generating hypotheses or perhaps when clinical trials are impractical. But as evidence? They are about as accurate as tossing a coin.

With fears about the drug growing, Johnson & Johnson, the drug’s maker, asked Dr. Braunwald to put together an expert panel to advise it.

The questions about nesiritide were so pressing, Dr. Braunwald’s panel concluded, that the drug should be given to only the sickest patients in a hospital setting. In the meantime, the company needed to conduct a large pragmatic trial looking at clinical outcomes in typical patients.

“The data on which the drug was approved were very sketchy,” Dr. Braunwald said in a recent interview. “And since the question had been raised by these two meta-analyses, which in themselves were controversial, the idea of a pragmatic, outcomes-based clinical trial was very natural.”

Dr. Steven Goodman, an oncologist and biostatistician at Johns Hopkins University School of Medicine, wants to insert a reality check on large pragmatic clinical trials.

“When they are first described, they sound wonderful,” he said. But, he added, there’s a rub. “You often give up the ‘why.’ ”

Pragmatic trials, he explains, are most feasible when they are as simple as possible, measuring important outcomes like hospitalizations or deaths but not things like how much medication is taken, how well a procedure is performed or how accurately an X-ray is read.

An operation, for example, may not work well in the real world because it takes more skill and training than is typically found outside a few medical centers. A pragmatic trial will show the surgery is not working but not why.

Scientists, Dr. Goodman added, do not like giving up on the why. And that leads to a question of who is going to pay for these studies. Medicare pays for medical care but does not sponsor studies. Insurance companies, said Dr. Goodman, who helps review evidence for Blue Cross Blue Shield, may be seen as having a conflict if they sponsor studies because they may have to pay for treatments that are shown to be effective.

Drug companies sometimes do pragmatic studies, said Alan Goldhammer, the vice president for regulatory affairs at Pharma, a trade group for drug companies. But usually that is when “there are issues relating to the drug and the ability to affect drug and marketplace.”

At the National Institutes of Health, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, “many of us would love to do many more of these studies.” But, she added, “we have a limited budget and there is only so much that we can do.”

The nesiritide study was a direct result of Dr. Braunwald’s panel’s recommendation. Johnson & Johnson is paying for it. But the study’s overall conduct, design and analysis are coordinated at Duke University through an academic consortium and led by an independent academic executive and steering committee.

When the study began, some heart specialists said it could never enroll enough patients. Who would agree to be randomly assigned to a placebo or a drug to ease breathing?

So far, however, recruitment is ahead of schedule, Dr. Hernandez said, which he attributes to the researchers’ enthusiasm. And, he adds, there are already more patients from North America in this study than in any acute heart failure study ever done.

Source: StarNewsOnline.com

17 lose licence to make obesity drug

2008-11-25T18:25:00.001+05:30

India’s drug regulator has cancelled licences granted to 17 companies to produce anti-obesity drug rimonabant

New Delhi / Hyderabad: India’s drug regulator cancelled on Friday licences granted to 17 companies to produce anti-obesity drug rimonabant after Europe’s drug regulator recommended that member countries not allow the previously approved drug to be sold because it caused serious psychiatric side effects including suicidal tendencies.

The regulator had previously approved the sale of the generic version of the drug here by companies including Zydus Cadila, Sun Pharmaceutical Industries Ltd, Torrent Pharmaceuticals Ltd and Ranbaxy Laboratories Ltd.

Such approval, for drugs already patented and being sold elsewhere merely requires so-called bio-equivalence studies that seek to show that the drug’s generic version acts the same way the patented one does. The drug, created by Sanofi-Aventis SA isn’t patented in India.
Rimonabant was touted as the next blockbuster drug when it was launched by Sanofi Aventis in June 2006 in the European Union (EU) under the brand name Accomplia.
Interestingly, the drug wasn’t approved by the US drug regulator and wasn’t launched in that country. Apart from 18 countries in the EU, Sanofi Aventis was selling the drug in 14 countries including some in Latin America.
“Europe’s drug regulatory authority—European Medicines Agency (EMEA) suspended the manufacture of the drug in the UK and the European Union and the US food and drug administration did not approve it at all due to reports of severe (psychiatric) side effects. So, we are also suspending any further manufacture of the drug in India,” said drug controller general of India (DCGI) Surinder Singh. He added that the Central Drugs Standard Control Organization (CDSCO, the name of the organization headed by Singh) would not wait for any reported adverse reaction data from within India since “the country’s pharmacovigilance system is not very strong yet”.
All state licensing authorities have also been informed of the suspension of the drug in the market and rimonabant, under any brand name, should no longer be available for purchase. “We have a communication from the (drugs) regulator asking us to stop manufacturing rimonabant. We are complying with this communication with immediate effect,” said a Sun Pharma spokesperson. The company said it hadn’t received any reports of an adverse reaction to the drug it launched in 2007.

The drug was first launched in India by Torrent Pharma as Rimoslim in May 2007. Total sales from all 17 brands of rimonabant were worth Rs13 crore in the first nine months of this year, with Zydus Cadila’s Slimona selling the most (Rs4 crore), according to data from research firm ORG IMS.

Despite all the hype, rimonabant did not catch the fancy of many doctors in the country. “I used to prescribe versions of rimonabant to my patients for obesity and metabolic syndrome. But within a few months I started receiving complaints of severe depression, suicidal tendencies, irritability, lack of concentration, headache and reduction in social interaction from many patients,” recalls Dr Vipin Mishra, senior consultant, endocrinology, at Fortis Healthcare Ltd’s Fortis Hospital. Mishra added that he stopped prescribing the drug after the initial few months because “...it wasn’t very effective”.
EMEA’s recommendation was based on post-marketing data or details of post-launch feedback from the company and consumers. On 23 October, EMEA’s committee for medicinal products for human use (CHMP) concluded that the benefits of rimonabant no longer outweighed its risks and recommended the suspension of its marketing licence.

Following this, the UK suspended sales of the drug.

“Taking into account the concerns raised by some national and regional regulatory authorities, we decided to suspend the sales of rimonabant (Acomplia) in all the 32 countries,” Sanofi-Aventis spokesperson Jean-Marc Podvin said in a telephonic conversation with Mint.
The company also suspended so-called phase III human clinical trials of the drug in several countries, including India, that would have allowed the company to apply for marketing approval for Acomplia. “All rimonabant related clinical trials, currently going on in about 50 (additional) countries, have been suspended. Further, we have stopped development related activities related to this drug,” Podvin said. He declined details of how much the company had spent on these trails in India and other markets.

Subsequently, Pfizer Inc. announced it was terminating the phase III development of a similar molecule CP-945,598. “While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,” said Martin Mackay, president, Pfizer Global research and development, in a press release.

In the first nine months of the calendar year 2008, rimonabant contributed $81 million (Rs401 crore) to the $26,201 million revenue of Sanofi-Aventis. “We expect the impact of rimonabant sales suspension on company’s whole year profits to be in the range of $50 million,” Podvin said.

Source: LiveMint

Rs250 cr to make drugs regulatory process completely paperless

2008-11-24T18:27:00.002+05:30

New Delhi: The ministry of health and family welfare will invest close to $50 million (Rs250 crore) in the Central Drugs Standard Control Organization’s (CDSCO) e-governance initiative. The initiative, the first of its kind in the world, will be developed by New York-based technology solutions providerMGRM. The application aims to enable transparency and efficiency in the working of the CDSCO.

“Details of licensing, regulation, monitoring and even inspection audits will seamlessly be available through the software,” says K.V.R. Murthy, group chairman of MGRM.

People-friendly step: Drugs controller general of India Surinder Singh says the World Health Organization has shown interest in the project. Manoj Kapparath / Mint

This will work not only for companies, who will be able to submit all applications and data online, but will also smoothen the interface between various officials of the drug controller’s office. Companies will even be able to file, track and review their patent applications online.

“Once an application is submitted online,” explained drugs controller general of India (DCGI) Surinder Singh, “the information or protocol will be split according to work category and will then go to the official assigned for that job. This means that no one person will have access to complete information except a few senior officials.”

This model of work distribution will ensure privacy and data protection since officials in the ministry or in a company will not have permission to change or download any data from the site.

In fact, according to the proposed plan, unauthorized attempt to access information will immediately send off an alert making it difficult to break into the system. The first phase of the project is expected to be completed in a year, following which CDSCO, along with MGRM, will float a national tender inviting developers to bid for the project. The project itself is expected to be up and running by 2013.

“The e-governance project will most of all benefit the general public. The way we intend to develop it, public will have access to list of medicines that are banned, approved and that can cause allergic reactions,” said Murthy.

That apart, the project will also aid companies in tracking the movement of their applications and would then be able to base their development targets based in this.

The DCGI’s e-governance initiative has received interest from the World Health Organization and Health Canada—the Canadian health regulator.

“They have approached us and have shown a lot of interest in signing an MoU (memorandum of understanding) on the same,” said Singh. What is even more comforting is that adverse drug reactions in volunteers who enrol for multiple clinical trials in quick succession at the prospect of high remuneration will not be able to do so. Finger printing software, part of the project, will interlink clinical trial softwares, allowing companies to enrol only first time volunteers.

In most developed countries, though the pharma companies can submit applications online, the processing is done through physical transactions. The e-governance initiative will make India’s regulatory process completely paperless.

Source: LiveMint.com

India's biotech sector set to thrive despite downturn

2008-11-24T18:25:00.001+05:30

India is one of the top biotech hubs in the world and despite a slowing global economy, the sector is expected to not just survive, but thrive.

The election of Barack Obama as incoming US president looks to be a shot in the arm for the Indian pharmaceutical industry. He has promised increased spending on public health and this could benefit India, one of the largest generic drug suppliers in the US.

India is also a favourite for investment in clinical research.

The Confederation of Indian Industries estimates that the biotechnology sector will attract investment worth US$5 billion by 2010.

Kiran Majumdar Shaw, chairman, MD, BIOCON, said: "The reason this is happening is because a large part of drug development is attributed to clinical development - recruiting patients, the speed and cost of these kind of trials all play a very important role in commercializing products.

“And again given the fact that India has a huge advantage in this particular space, I think we can create a large business portal out of this."

And unlike other sectors, a global meltdown is a boon for the biotech industry of India.

Indian biotech companies are working on acquiring units in US and Europe on the cheap, after their valuations fall.

There will also be more collaborations between foreign and domestic firms.

Mr Shaw continued: "I think you will see more and more collaborations, partnerships and joint ventures to bring down the cost and make this whole process more affordable."

But there is still scope for improvement.

India needs to revamp its educational infrastructure to build capacity in research.

Experts also said India needs a well-equipped national regulatory body to ensure that the industry meets global standards.

Despite being in a nascent stage, the growth rate of Indian biotech has been phenomenal. Since the last three years the industry has grown between 35 to 40 per cent. More innovations in medicine, engineering and even agriculture look set to come.

Source: Media Corp News

Pushing past the placebo: Legislating for a new kind of clinical trials

2008-11-24T18:21:00.002+05:30

In January, a study published in the Journal of the American Medical Association on the first two commercially available drug-eluting stents found no significant differences in clinical outcomes.

In August, a report in the New England Journal of Medicine concluded that patients with stable angina who underwent percutaneous coronary intervention showed slightly more improvement over those treated with medication. But that added benefit disappeared by 36 months.

Then in September, a study in the NEJM found that arthroscopic surgery for osteoarthritis of the knee provided no additional benefit over physical and drug therapy.

What these very different studies have in common is that they compare the effectiveness of one treatment option with another instead of on its own. Although more of this type of research is being conducted than ever before, physicians, insurers and consumer groups widely agree that not enough comparative-effectiveness data exist on pharmaceuticals, medical devices and procedures.

When drugs and devices go through the Food and Drug Administration approval process, they're compared with placebos. Few are tested in head-to-head trials. "They just have to be better than nothing," said David O. Barbe, MD, chair of the AMA Council on Medical Service, speaking on his own behalf.

Less than 0.1% of the money spent on health research is for studies that compare the effectiveness of two products.

Medical procedures often don't have clinical effectiveness data attached, noted Gail Wilensky, PhD, a former Medicare administrator and senior fellow at Project Hope, an international health advocacy organization.

But if some leading politicians and policy experts have their way, much more comparative-effectiveness research will be generated soon. In his health platform, President-elect Barack Obama calls for starting an independent institute to guide comparative-effectiveness research. In August, Senate Finance Committee Chair Max Baucus (D, Mont.) and Senate Budget Committee Chair Kent Conrad (D, N.D.) introduced a measure that would form a national entity to fund and oversee such research. The bill is expected to be at the center of congressional debate on the issue next year.

The concept of a national comparative-effectiveness body has support in the health care, insurance, consumer and public policy world. But many details, some controversial, must be worked out. How should the national entity be structured? Should it examine cost effectiveness as well? How will public and private payers use the data? How can patient-doctor decision-making be protected?

The rationale for more comparative effectiveness research is twofold: improving quality and lowering costs. Experts say providing the research results to physicians and the public will improve health care decision-making and thus boost quality. Meanwhile, giving the right treatment to the right patient would reduce spending on complications and hospitalizations. Another common belief is that many newer, costlier medical products or services would be found to offer little or no additional benefit than the older, less-expensive alternatives.

"I regard it as a strategy to help us learn how to spend smarter and treat better," Wilensky said, noting this will help slow the unsustainable health spending growth rate. The nation spent an estimated $2.2 trillion last year on health care, which is projected to nearly double by 2017, according to the Centers for Medicare & Medicaid Services.

Many doctors are interested in the benefits comparative effectiveness promises for the practice of medicine. "These are the questions that we as clinicians ask ourselves all the time -- what's the best treatment for my patient?" said Carrie Nelson, MD, program director for the Rush-Copley Family Medicine Residency Program in Aurora, Ill., and assistant professor in the Dept. of Family Medicine at Rush Medical College in Chicago.

The U.S. spent an estimated $2.2 trillion on health care services in 2007.

Most of the information doctors get about medications comes from drug reps who have conflicts of interest, said Dr. Barbe, a family physician. Doctors want more independent research on the comparative effectiveness of various medical options, Drs. Barbe and Nelson said.

Data also would strengthen the doctor-patient relationship, research advocates said. "It would help patients understand their situations so they can be truly informed participants in the decision-making process," said Neil Kirschner, PhD, senior associate for regulatory and insurer affairs for the American College of Physicians.

Some resources already exist for physicians who want this type of data. In 2003, Congress authorized the Agency for Healthcare Research and Quality to support comparative effectiveness research. AHRQ makes findings public through guides for patients, clinicians and policymakers. But experts view that effort and a few private initiatives as too fragmented and too small to have enough of an impact. Plus, there is no one place physicians can go to access data easily.

These issues have helped spur the call for a national research body.

"The need for a centralized, adequately funded comparative-effectiveness research entity is apparent," states an AMA Council on Medical Services report approved at the Association's Interim Meeting in November. The report includes nearly a dozen principles that the entity should follow, including that physicians and patients have a significant oversight role and that the research it sponsors be disseminated in a timely manner. The American College of Physicians also has formal policy calling for such a body.

What about costs?

Many in the health care community agree that the entity should be independent and protected from political pressure, have adequate and stable funding, involve all stakeholders, use rigorous scientific standards and operate transparently. But disagreements exist on whether the body should focus solely on clinical comparative effectiveness or also consider treatment costs.

Wilensky opposes having the body review costs because it is controversial and could jeopardize clinical effectiveness research. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said any initiative should focus on comparing health outcomes, not cost effectiveness.

Comparative effectiveness weighs medical treatments against each other, rather than against a placebo.

But some doctors want both efforts handled by the same body, as long as it's done with care. "Now the primary entity dealing with costs is the health plans," Dr. Barbe said. "It raises the issue of conflict of interest."

Creating separate infrastructure for cost analysis also would be wasteful, said Barbara McAneny, MD, chair-elect of the AMA Council on Medical Service, speaking on her own behalf.

If cost data came from an independent national entity, it would be trusted more, Dr. Barbe said. But findings on a procedure's clinical effectiveness should come first and be reported separately from cost-effectiveness data, he noted.

If two treatments are clinically equivalent, doctors need to know which one is less expensive, Dr. McAneny said. One of the profession's ethical obligations is to be an effective steward of the nation's limited health care resources, added the ACP's Kirschner.

More patients are seeking this information as insurers shift more costs onto them, Dr. Barbe said. "Physicians are in the best position to help them decide when it's worth it to spend more for a certain treatment."

Consumers Union, publisher of Consumer Reports, is comfortable comparing treatments' costs and clinical benefits. It does both in its Best Buy Drugs reports, noted Gail Shearer, the organization's director of health policy analysis and director of Best Buy Drugs. "People are ready to talk about value."

Limiting the entity's scope

The AMA and other physician organizations are adamant that any national entity not be involved in coverage or payment determinations, a position with which the trade group America's Health Insurance Plans agrees. But the data generated would help inform insurers' decisions, said Karen Ignagni, AHIP president and CEO. Medicare officials also are monitoring the research out of AHRQ.

Many experts predict payers will use the data to establish tiered co-pays for services, much as they do now for drugs. They also might take clinical and cost-effectiveness data into account in their payment policies.

Plans already make coverage decisions, only they're based solely on cost, Dr. Barbe said. Adding clinical-effectiveness data "will help us hold payers accountable. Right now, we don't have the information we need to say they're denying treatment they should not deny."

But the way plans might use the data raises concerns. Patients are not all the same, Dr. Barbe noted. A treatment deemed the most effective in general may not work for subgroups of patients because of factors such as age, sex, race or comorbidities.

Experts stress that treatment decisions must remain in doctors' and patients' hands and that an easily navigable exceptions or appeals process must be built into insurance coverage. That way patients who wouldn't benefit from the treatment generally accepted as most effective might be able to access an alternative without paying more.

Knowing which types of patients would benefit most from a given intervention will require more studies on subpopulations. Wilensky estimates that $4 billion to $6 billion per year should be invested in the research. Of the $2.2 trillion spent on health care annually, only 5% is dedicated to research, and less than 0.1% goes toward comparative effectiveness studies.

With the election of Obama and the interest from lawmakers, many policy experts predict that comparative-effectiveness legislation will get serious consideration in 2009, either as part of a larger health system reform bill or on its own. "It's a white-hat issue" that appeals across party lines, said Shawn Friesen, government affairs associate for the American College of Surgeons, which supports the idea of the research but has not yet adopted formal policy.

If a bill becomes law it will be years before a large enough body of evidence exists to have a major impact on medical practice and spending, notes a December 2007 Congressional Budget Office report. For research to have an effect, CBO notes, doctors and patients would need to use the data.

Physicians who do a particular procedure that is profitable might need to adapt if research finds it less effective than clinically equivalent, less-costly treatments, Kirschner said. This transition could at times be hard for them.

"People get used to doing what they do, and when they're asked to make a change that affects their livelihood, it's difficult," he said. "That's the human part of this."

Source: AMNews

Rural Population Key to China’s Clinical Research Market

2008-11-22T14:49:00.002+05:30

In his presentation at China Trials 2008 in Shanghai, “Conducting Global Post-Marketing Surveillance Studies in China—Opportunity and Practical Issues,” Mark Engel, president and chairman of Excel PharmaStudies, a large China-based contract research organization, identified two megatrends that will drive post-marketing surveillance studies to China: the rapid aging of its population and its increasingly insured rural population.

With Congress recently giving approval for the U.S. Food and Drug Administration to enforce post-marketing studies by fining sponsor companies for not doing them, the clinical research environment has become subject to more stringent requirements than expected. Engel described the fallout: Clinical trials are now larger than expected, their duration is longer and their requirements are broader. As an example, he said that any diabetes submission now requires a long-term cardiovascular surveillance study.

“There is a tremendous, rapid rise in surveillance projects in China,” Engel said.

He cited costs that were 30% of the U.S., access to patients and speed as factors in sponsor companies deciding to go to China. But, what will really drive the market in the future is the fact that more of China’s population will be insured in the coming years. More will be seeking medical care and will be able to spend money for it.

“The ruralization of healthcare is the next great driver,” he said.

Engel broke down the patient pool of 1.3 billion in China by insurance coverage: 250 million people have insurance coverage; another 250 million are partially covered by insurance; and 800 million have limited insurance coverage.

The rural population in China is rarely enrolled in a health insurance plan, but this will change, Engel said. In 2015, people living in rural areas of China will receive $150 each from the government to spend on medical care.

Twenty percent of longer-term patients in urban hospitals are already from rural areas, according to Engel.

Engel explained that there are 700 million people in the rural market, served by 1 million rural physicians and that there will be a rapid increase in rural physicians. There are already “significant programs to educate rural physicians” in place, he said.

Envisioning the China of 2015, Engel sees the number of products available increasing and the standard of care available improving. “Treatment regimens will change and the professionalism of physicians will change. Distribution costs to rural areas will drop 14% within the next four years.”

At that time, Engel also believes that “it will be much, much easier to enroll larger numbers of patients.” If clinical research infrastructure keeps up with the pace of ruralization of healthcare, China should continue growing its clinical research market.

Source: ClinicalTrialToday

CombinatoRx adds to job cuts; 55 remain

2008-11-21T12:02:00.000+05:30

Weeks after cutting its staff levels nearly in half, CombinatoRx Inc. is increasing the number of cuts by an additional 30 positions. Combined with the 45 percent reduction announced on Nov. 5, the Cambridge-based company will now have reduced its staff size by 65 percent.

CombinatoRx (Nasdaq: CRXX) said it was undertaking the cuts immediately, so it can focus on identifying novel product candidates. The staff reductions should let the company run without a need for any more equity financing for at least four more years, officials said.

Following the cuts, CombinatoRx will have approximately 55 employees, mostly in research activities and partnering product assets. The company is also planning to consolidate its Cambridge facility, according to officials. CombinatoRx started its job cuts about one month after disappointing trial results for Synavive, a drug intended to treat knee osteoarthritis,

In its Phase 2b clinical trial of Synavive, CombinatoRx found a placebo and Synavive turned up statistically insignificant results in a knee pain measurement test for patients walking on a flat surface. As a result of the clinical trials results, CombinatoRx stock dropped 73 percent at about 11 a.m. on Oct. 4, the day it announced the failed test, from $3 per share to 80 cents per share.

Last October, CombinatoRx reported it had signed definitive agreements with unnamed institutional investors to sell up to 5.6 million shares of its common stock, raising a combined $35 million in a registered direct offering.

CombinatoRx reported a net loss of $53.3 million on total revenue of $15 million in 2007.

SuperGen gets FDA approval for clinical trial

2008-11-21T10:34:00.003+05:30

SuperGen Inc. has received clearance from the Food and Drug Administration to begin clinical trials of an anticancer compound, triggering a $5.2 million milestone payment from SuperGen.

With the approval of the new-drug application, Dublin-based SuperGen (NASDAQ: SUPG) will pay a $5.2 million milestone payment to the former stockholders of Montigen Pharmaceuticals Inc., with the consisting of $2.8 million in cash and approximately $2.4 million in equity, representing approximately 1.5 million shares of SuperGen common stock.

The study will evaluate the safety and tolerability of SGI-1776, an orally administered, small-molecule anticancer compound.

The first clinical trial program will enroll patients with solid tumors, with specific emphasis on hormone refractory prostate cancer and refractory non-Hodgkin's lymphomas.

Source: Business Times

Viagra firm abandons EU action

2008-11-21T10:33:00.000+05:30

The makers of anti-impotence drug Viagra have withdrawn their bid to make it available without a prescription.

Drug company Pfizer had wanted to make 50 milligram tablets freely available in the European Union.

But in a letter to the European Medicines Agency (EMEA), Pfizer said it would withdraw the application in the light of concerns from EMEA's Committee for Medicinal Products for Human Use.

A spokeswoman for EMEA said: "One concern was that its use with a lack of proper medical supervision could delay diagnosis of the underlying causes of erectile dysfunction which can include heart disease."

Viagra, the marketing name of the drug sildenafil citrate, overcomes impotence by blocking an enzyme that limits blood flow to the penis.

Rory O'Connor, Pfizer's vice president of Medical and Regulatory Affairs, said: "Sildenafil citrate has a proven safety profile that has been well established in extensive post-marketing studies and in more than 120 clinical trials.

"We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians and the benefits they get from our therapies."

Pharmaceutical Industry Hustlers - Part II

2008-11-20T11:08:00.002+05:30

By Evelyn Pringle on November 18, 2008

Pushers of SSRI Antidepressants. To gain approval for treating children, all a drug company has to do is submit two positive studies to the FDA to prove a medication is safe and effective for kids. However, after 20 years of feeding the new generation of antidepressants to tens of thousands of kids in clinical trials, the only one ever approved is Prozac.

Collectively, these antidepressants are referred to as SSRI's (selective serotonin reuptake inhibitors) and include Paxil, Zoloft, Celexa and Lexapro. When the term SSRIs is used, it often refers to their chemical cousins Effexor, Wellbutrin and Cymbalta as well.

The drug companies, "by their sheer economic clout," have become the single most dominant influence in our healthcare system, and the "ambiguities of children's mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence," says Dr Lawrence Diller, a behavioral-developmental pediatrician and author of, "The Last Normal Child," in the July 13, 2008, San Francisco Chronicle.

"In this climate," he explains, "drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than non-drug (e.g., parenting and education) approaches."

That is why we are seeing famous (or infamous) Newsweek cover boys - like a 10-year-old "who has taken 38 psychiatric medications in his short, unhappy life," he says.

Dr Joseph Glenmullen, author of "Prozac Backlash," testified at a hearing before the US House Energy and Commerce Committee on February 10, 2005, and explained how important lawsuits have been in unearthing the internal company documents, which reveal the antidepressant-induced suicidality risk. Both the FDA and the pharmaceutical industry knew about this side effect over a decade ago, he said.

Dr Glenmullen noted that the FDA failed to adequately educate doctors and the public and called it a "most dangerous scenario" when neither the doctor nor the patient knows how to recognize antidepressant-induced suicidality.

He pointed out that only Prozac was FDA approved for depressed children, and all other antidepressants studied had failed to demonstrate they were more effective than placebo. He faulted the FDA for failing to require drug manufacturers to tell doctors in the labels that the drugs had been studied and failed to show efficacy.

He noted that one million American children were on antidepressants for everything from shyness to school anxiety to headaches to attention deficit disorder. "How can the FDA allow this to happen when it has acknowledged that the drugs can make children suicidal?" he asked.

"Family doctors write 70% of prescriptions for antidepressants and know little about how to diagnose and treat antidepressant-induced suicidality," he pointed out.

Once the FDA approves a drug, doctors can prescribe it for any purpose, a practice called off-label prescribing. "Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists," says Dr Diller.

He advises that none of the psychiatric drugs have been studied for more than two or three months regarding long-term safety or effectiveness with children, with the exception of stimulants used for ADHD. Drug companies oppose this kind of thorough follow-up on drugs "not only because it is expensive, but because they don't really want to find out whether their drugs continue to work over time or if long-term side effects develop," he states in the paper, "A Prescription for Disaster," published by Salon.com on May 23, 2002.

"Currently, that kind of research is a job for the country's trial lawyers," he writes.

"But this de facto system of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature," Dr Diller points out.

Highly Paid Hustlers in motion

The "failure of clinical trials to provide safety information about the effects of long-term use is at the heart of the debate about the legitimacy of prescribing psychotropic drugs for children," according to Vera Hassner Sharav, President of the Alliance for Human Research Protection in the 2003 paper, "Children in Clinical Research: A Conflict of Moral Values," published in the American Journal of Bioethics.

No SSRI was approved for children before 2003. However, by "the early 1990's, it didn't matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old," says Professor Jonathan Leo in the 2006 paper, "The SSRI Trials in Children: Disturbing Implications for Academic Medicine."

He points out that "the child psychiatry profession fully endorsed the use of these drugs well before the FDA approved them, and, in an even odder twist," he says, "the profession endorsed the use of them well before any of the major studies in children were even published."

"It appears that one reason for doing the studies in the first place was to justify already well-accepted prescribing patterns," according to Professor Leo.

"If a trend is created 'because everyone else is doing it' then it appears that the child psychiatry profession's use of these drugs in the late 1990's more closely resembled a trend instead of a logical scientific undertaking," he explains.

The first major studies claiming SSRI's were safe and effective for children began to appear in the late 1990's. In all the published studies, papers and poster presentations used at medical seminars, conferences and other events to expand the "well-accepted prescribing patterns," to doctors in every field of medicine, there are the names of the same "Highly-Paid Hustlers,” also known as "key opinion leaders," because they are supposedly so highly respected by their peers.

They include, but are not limited to, Drs Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Dr Biederman and the gang at Harvard almost single-handedly instigated the epidemic in the off-label prescribing of drug cocktails to children, of 2, 3 or even 4 drugs at a time, in combinations that have never been tested on animals much less humans. The mental illness always known as "manic-depression" was now "bipolar disorder," and in the mid-90's, Dr Biederman, and a few more "opinion leaders" started claiming that a great number of children were afflicted, possibly even as early as in the womb, some said.

"Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States' most influential doctor when it comes to determining whether their children are normal or mentally ill," says Dr Diller, in an article entitled, "Are Our Leading Pediatricians Drug Industry Shills?" in the July 13, 2008, San Francisco Chronicle.

"Biederman and his team," Dr Diller writes, "are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs."

"The science of children's psychiatric medications is so primitive and Biederman's influence so great," he says, "that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs."

"This happens in the absence of a drug trial of any kind - instead," Dr Diller notes, "the decision is based upon word of mouth among the 7,000 child psychiatrists in America."

"That's why Iowa Sen. Charles Grassley's recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic," he says.

"If true," Dr Diller notes, "this scandal is yet one more stake in the heart of American academic medicine's credibility with frontline doctors like him, and more importantly, with the parents of the children he deals with every day."

Until the "bipolar" profiteering scheme was set in place by publishing a couple bogus studies and then passing them around to doctors all over the country at medical seminars and conventions, manic-depression was unheard of in children. It still is in other counties.

Most parents are not aware of the life-long consequences of a childhood mental-illness diagnosis. Children with medical records showing treatment become ineligible for a wide range of occupations. An early diagnosis can also make it difficult to obtain health insurance for life.

In the age of computerized recordkeeping, there can be no deleting of this damning information. Just as there is no scientific way to prove that anyone has a mental disorder, there is no way to disprove it either. Once diagnosed, a child will never escape the label.

Dr Emslie was busy pumping out new marketing tools last year, this time in the form of a treatment guideline to promote the off-label use of psychiatric drugs to toddlers. However, the "respectable" medical journals continue to publish this kind of trash.

He is the first author on a December 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry that reviewed the developmental considerations related to preschool psycho-pharmacological treatment, presenting current evidence bases for specific disorders in early childhood and described the recommended algorithms for medication use in 3- to 6-year-olds.

This "Preschool Psychopharmacology Working Group" claims it was developed to review existing literature and to develop recommendations to guide clinicians considering psycho-pharmacological treatment in very young children. "The purpose of this effort," the authors note, "is to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications."

Not one single psychiatric drug is approved for children under 6; not alone and not together with any other. Yet the Group says it has established algorithms for the treatment of ADHD, disruptive behavior disorders, major depressive disorder, bipolar disorder, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, pervasive developmental disorders (such as autism) and primary sleep disorders.

On May 5, 2006, United Press International reported on a Duke University study where investigators studied 307 children between the ages of 2 and 5 and claimed they detected signs of depression, anxiety and other mental illnesses. The rate was about the same as with older children and not much lower than within adults, they said. UPI made sure to mention that the research was funded in part by the "pharmaceutical giant Pfizer."

Judging by the results of this "study," the “Hustlers” recruited another 30 toddlers as potential customers for daily drug cocktails in one sweep. Notably missing from all the above lists of "disorders" is a condition that could account for half of the stigmatizing labels in one age group, commonly known throughout time as the "Terrible Twos."

Sad aftermath

Of all the harmful actions of modern psychiatry, the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society, says Dr Peter Breggin, author of the new book, "Medication Madness."

Many children who end up seeking help from Dr Breggin are already on four or five drugs at one time. He says millions of children are growing up with "drug-intoxicated brains."

Not only do these medications suppress spontaneity and volition, he warns, but the psychiatric approach teaches children that they cannot, without medication, learn to manage their own behavior. In effect, the children are taught that they cannot exercise and develop self-determination, autonomy or free will, he explains.

Pennsylvania psychiatrist Dr Stefan Kruszewski also warns that "young children who are medicated do not learn to adapt and develop coping strategies as they move through the developmental stages of childhood."

"They rely on a false belief that drugs can solve problems," he says, "rather than relying on their own innate creative potential or the help of family, friends, and schooling."

"Psychiatry was once plagued by ‘boundary violations,’ where physicians exploited the dependence of their patients," Dr David Healy explains in the 2006 paper, "The Latest Mania: Selling Bipolar Disorder." But he says:

"All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine."

"The extensive prescription of these medications for children," Dr Diller warns, "without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties."

"Catastrophic side effects may be rare," he says, "but they become predictable when we treat so many children with so many drugs."

"There is nothing more despicable than a doctor knowingly telling normal children they are mentally ill for profit," says Dr Fred Baughman, author of, "ADHD Fraud - How Psychiatry Makes Patients of Normal Children."

"Because the children made into 'patients' are normal to begin with," Dr Baughman contends, "those who treat them with psychiatric drugs are guilty not of an iatrogenic medical mistake, but a willful for-profit poisoning."

"What should we call it when children die pursuant to a fraudulent diagnosis," he asks. "First degree murder? Second degree murder? Justifiable homicide? Manslaughter?"

In an expert report recently submitted in litigation involving a Paxil-induced suicide by a 13-year-old boy, Dr Glenmullen discusses a case where that question begs to be answered when he tells the court: "It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today."

There are many families suffering all over the country as a result of the drugging-children-for-profit schemes set in place by the Highly-Paid Hustlers. "For us it has been four and a half years without resolution or closure," says Mathy Milling Downing, whose daughter Candace hung herself in January 2004 after being prescribed Zoloft at age 12 because she was nervous when taking tests at school.

"Every day hurts," Mathy says. "One never gets over the loss." Prior to her death, the Downings saw no signs of Candace being depressed or suicidal.

They were not told to watch for signs of suicide. The doctor did not inform them that Zoloft was not approved for children, and they were assured that Zoloft was safe.

The Downings would later learn that their daughter’s physician was on Pfizer's payroll. "Although we realize that Candace's doctor only made about $12,000 acting as a Pfizer consultant, it's not the amount that bothers us," Mathy says.

"It's the medical compromise. It's the lack of informed consent. It's placing economical gain above the well-being of an innocent child and a trusting family," she states.

"I just want to know when 'Greed before Need' will diminish and doctors will once again place a patient's well-being first," she says, "before financial gain."

"What has happened to the Hippocratic Oath that doctors are supposed to take?" Mathy wants to know.

Rough estimates

In "Let Them Eat Prozac," Dr Healy discusses how he reached his estimates for the high number of suicides and suicide attempts that could be attributed to Prozac alone. An April 2000 paper in the Archives of Psychiatry looked at the rates for suicide attempts on newer antidepressants compared to placebo and reported SSRI rates higher than placebo.

These figures made it possible for him to estimate how many people had made suicide attempts. "If ten per thousand make an attempt on Prozac and five per thousand or less do so on placebo or other antidepressants, and if (as is conventionally estimated) 40 million people worldwide have had Prozac," he writes, "then there will have been 200,000 more suicide attempts on Prozac than had Prozac not been used."

"Conventional wisdom is that there is one suicide for every ten attempts," he explains. "These would give 20,000 suicides over and above the number who would have committed suicide if they had been left untreated or been treated with older agents."

Dr Healy then accessed the FDA’s Adverse Event Database to look at suicides reported and found there were over 2,000 as of October 1999. "The FDA estimated their database picked up only between one and ten per cent of serious adverse events," he writes.

"This gives a spread between 20,000 and 200,000 suicides on Prozac," he concludes.

There is no way to know how many people have suffered needlessly because the drugmakers lied about the suicide risk for so many years. According to Dr Healy, aside from the need to save lives, if emergent suicide linked to a drug is not correctly attributed to treatment, patients suffer a long-lasting injury to their self-esteem and self-confidence as a consequence.

"If patients have engaged in actual suicidal acts as a result of treatment and the connection to treatment is not made, given that prior suicide attempts appear to increase the risk of future successful suicides, it appears possible that the risk of a future successful suicide has been increased accordingly," he warns in a June 2003 briefing paper on "Antidepressants and Suicide."

Read Pharmaceutical Industry Hustlers – Part I

Source: bestsyndication

Fisher BioPharma mulls additional unit in Gujrat, India

2008-11-20T11:03:00.002+05:30

Fisher BioPharma, a part of the US-based Thermo Fisher Scientific Inc., is now mulling an additional unit at its upcoming clinical trials logistics management facility in the Pharma Special Economic Zone (SEZ) here in Gujarat. The unit could be of one of its sister concern companies which might be present in domains like design services, support services, project management and IT services.

Provider of a complete range of high-end analytical instruments as well as laboratory equipment, Thermo Fisher Scientific Inc., through Fisher BioPharma has set up a packaging, distribution and logistics management facility for tightly regulated pharmaceutical samples to patients participating in clinical trials across the globe.

“Having set up this facility, we are evaluating whether any of our sister concern laboratory companies or support services companies that cater to our Europe and US facilities could come up here as well. These companies could be in domains like design services, support services, project management or IT services,” said Heinz Stamm, president (Europre and Asia), Fisher BioPharma.

The current logistics management facility has been set up at an investment of around $ 17 million (Rs 68 crore approx.) on an area of 150,000 sq ft. The facility complements the company's existing clinical services operations in the US, Europe and Asia.

By next year, Fisher BioPharma expects to bag anywhere between 50-100 trials from India. “We are not clinical research organisations. Rather we are into logistics management of these trials. In India, there are around 900 such trials going on which are spread across the world. We expect to bag anywhere between 50 and 100 such trials in the coming year,” said Ram Gupta, president and managing director.

“India continues to be a major market of focus for us as we expand our capabilities to support clinical research and development,” said Marijn Dekkers, president and chief executive officer of Thermo Fisher Scientific.

Thermo Fisher now has a larger presence in India with more than 600 employees and 20 facilities, including the new full-service clinical packaging and distribution facility at Ahmedabad. The estimated revenue from India in 2008 for the company is around $ 125 million (Rs 500 crore approx.).

Source: Business Standard

Quintiles, SAS Announce Development of First-Ever Clinical Trials Statistical Programming Certification

2008-11-20T10:57:00.001+05:30

Quintiles, the world's No. 1 pharmaceutical services company, and SAS are developing a unique program to produce certified specialists in the use of SAS programming to evaluate clinical trials results, the companies announced today.

The Quintiles-SAS Clinical Trials Statistical Programming Certification will certify that the successful candidate has shown that he or she has the expertise necessary to organize, analyze, and report clinical trials results. Incorporating industry-specific data, language and concepts, SAS and Quintiles will develop an exam and related training materials that emphasize the SAS skills statistical programmers need in the pharmaceutical and biotechnology industries.
"We're responding to a customer need through this collaboration with Quintiles," said Herbert Kirk, Vice President, SAS Education Division. "The pharma and biotech industries have statistical requirements that our standard certification exams don't measure. With this new certification, our pharma customers can hire people with confidence."

Michael Fiola, Senior Director, Quintiles Global Biostatistics, said, "This initiative demonstrates Quintiles' commitment to advanced training in the statistical evaluation of clinical trial results, which is altogether fitting for a company founded by biostatisticians. We believe we have the industry's most talented, best trained and most highly engaged workforce to help our customers develop and deliver better medicines more quickly. This program illustrates our dedication to delivering the best clinical trials statistical programming in the world."
Fiola says development of the Quintiles-SAS Clinical Trials Statistical Programming Certification program is expected to be completed and ready for release in time for the Pharmaceutical SAS Users Group Conference in Portland, Oregon, May 2009.

About Quintiles
Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, strategic partnering and commercialization for the pharmaceutical, biotechnology and medical device industries. With more than 22,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's Web site at www.quintiles.com.

About SAS
SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. With innovative business applications supported by an enterprise intelligence platform, SAS helps customers at 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world THE POWER TO KNOW(R).

SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. (R) indicates USA registration. Other brand and product names are trademarks of their respective companies. Copyright (C) 2008 SAS Institute Inc. All rights reserved.

Source: Marketwatch

Wyeth claims no GCP lapse as India suspends vaccine trial

2008-11-20T10:52:00.001+05:30

Wyeth says that there were no GCP (good clinical practice) lapses in its now-suspended Indian pneumococcal conjugate vaccine trial. The Drugs Controller General of India (DCGI) halted the trial following the death of an infant, alleging that the company had flouted the inclusion-exclusion criteria for the study.

The Wyeth study aimed to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared with Prevenar (PCV7), when given concomitantly with routine paediatric vaccinations in India. Wyeth's Prevenar is available in more than 90 countries and is part of the national immunisation programme in 29 of these.

The trial, which was being conducted across India in Chandigarh, Maharashtra, New Delhi, Punjab, Tamil Nadu and Karnataka, has been suspended pending the DCGI's review of the case. The study involved a total of 354 infants in each of two cohorts, the first of which was completed earlier. The second cohort is subject to the suspension.

Source: SCRIP

Adolescents are under-represented in clinical research

2008-11-20T10:44:00.002+05:30

Recent European legislation designed to increase the number of children in clinical trials has had a positive impact in ensuring that paediatric patients are included in medicine testing.

But a commentary published in the journal Clinical Pharmacology & Therapeutics(December 2008 issue) argues that adolescents remain overlooked by clinical researchers.

The authors - Bill Kapogiannis and Donald Mattison – point out that data collated by the US National Institute for Allergy and Infectious Disease (NIAID) found that only 5.4 per cent of 9,500 participants in HIV trials conducted at the institute were adolescents, while other research indicates similarly low levels in cancer studies.

They suggest that low participation rates in trials may be one reason why adolescents experience poor survival rates in cancer trials compared to children and adult patients

Kapogiannis and Mattison believe that it is critical that adolescents are actively recruited into clinical trials in order to avoid the risk of unpredictable pharmacological responses to medicines.

Physical changes, such as puberty, can change adolescent patients’ response to medicines, they note. And “in addition to physical changes, adolescents are susceptible to psychosocial factors that can affect taking the drug as directed, and place them at risk for additional disorders,” according to Kapogiannis and Mattison.

Adherence to medication regimens is a well-recognised problem with adolescents. Peer pressure, a wish to be more independent, and the use of illicit drugs or alcohol and mood disorders are all factors that are seen with adolescents and can impair compliance.

“Adolescents are exposed to many marketing campaigns and are at risk for misuse of products, but few studies look at this group,” write the authors. For example, studies suggest a third of adolescents use over-the-counter medicines at higher than the recommended label dose

Kapogiannis and Mattison also point out that the high rate of clinical trials in children masks the fact that in many cases they involve drugs predominantly marketed and used in adults.

Increasing the recruitment of adolescents into trials requires a wide-ranging approach that solves challenges relating to “trial design, safety, legal, ethical, regulatory, and operational factors,” according to the authors.

“Ethical research with adolescents should focus on two goals: protection from research risk and appropriate inclusion in clinical research that will improve our understanding of therapeutics,” they conclude.

Source: Outsourcing-pharma.com

Innovative Clinical Trial Design and Management - Trends, success stories and impact upon research and development budgets - Report Summary

2008-11-20T10:38:00.002+05:30

Innovative Clinical Trial Design and Management
Trends, success stories and impact upon R&D budgets

Report overview Key findings...

The costs associated with developing drugs have risen dramatically over the past decade and fewer drugs are obtaining regulatory approval. The pharmaceutical industry is continually exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs.

These innovative clinical trial designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy.

‘Innovative Clinical Trial Design and Management’ is a new report published by Business Insights that explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of the potential cost and time savings that innovative trial designs can offer throughout the clinical development process.

Use detailed case studies to explore recent adaptive trial implementations, identify the companies pioneering and supporting innovative designs and understand the most effective planning and logistics strategies... 15

Key findings...

Major pharma companies are implementing adaptive trials to improve dose-finding in the Phase 2 setting. The use of adaptive clinical trials will increase across the industry over the next 2-3 years.

Adaptive clinical trial designs are more effective than traditional designs in cases where there is uncertainty surrounding the dose, effect size and variability, clinical endpoint or patient populations.

The planning and execution of adaptive designs is more complex than the traditional approach. Successful implementations require teams of statisticians, data managers, clinicians and drug supply and logistics managers to work together as early as possible.

Predictive biomarkers have been found to require detailed prospective analysis far earlier in the clinical development process, and with the same clarity as traditional drug approvals. Post-hoc correlations were previously thought to be good enough for identifying the biomarkers used to predict the patients most likely to respond well to a new treatment.

Regulatory authorities are supportive of adaptive trials, particularly in the Phase 2 setting. However, there are concerns over the confidentiality of data and companies have been asked to demonstrate that the parties involved in running the study will remain unaware of ongoing adaptations.

Key questions answered...
• How can adaptive trials improve the success rates of clinical drug projects?
• How are pharma companies implementing adaptive trials and what major hurdles can prevent such implementations?
• What is the position of the FDA and EMEA in regards to different types of adaptive trial?
• How can logistical and strategic planning be managed most effectively?
• Which companies are offering services to support adaptive clinical trials?
• Which companies are co-developing drugs and diagnostic products?

Key issues examined by this report...

• Adaptive trial implementations. The aim of adaptive trials is to improve the information value of clinical trials whilst maintaining their integrity and validity. The use of adaptive trials in the early phases of drug development should yield better information and lead to the earlier termination of unsuccessful compounds.

• Dose finding improvements. The availability of new Bayesian study designs that acknowledge prior information and allow for the testing of a wider range of doses has enabled more accurate dose-finding. This may have important consequences for the success of future Phase 3 clinical programs

• Seamless trial speed. Major pharma companies are interested in the prospect of combining drug development phases into ‘seamless trials’, with the potential to reduce the length of clinical development programs in the Phase 2b/3 setting

• Regulatory issues. Engaging with the FDA/EMEA during the protocol design stages of an adaptive trial is important, especially for studies intended for use in packages of pivotal clinical data. The EMEA’s current position on adaptive clinical trial design is summarized within a reflection paper published in October 2007, while draft FDA guidance is expected in 2008.

Source: Companiesandmarkets.com

Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cance

2008-11-20T10:33:00.002+05:30

Amgen and Millennium: The Takeda Oncology Company, a subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4052), today announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended following a planned safety data review of 600 patients by the study's independent Data Monitoring Committee (DMC). Motesanib is part of a broad co-development program between Amgen and Takeda.

The DMC recommended that enrollment in the study, which allowed both squamous and non-squamous NSCLC patients, be suspended based on an observation of higher early mortality rates in the motesanib group compared to the placebo group. In addition, the DMC recommended that the patients with squamous NSCLC immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis. The DMC did not recommend discontinuation of motesanib therapy for the patients with non-squamous NSCLC. The DMC will review updated data after three months.
Amgen, in collaboration with Takeda Bio Development Center, is implementing both of the DMC's recommendations and notifying worldwide regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMEA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), as well as motesanib clinical investigators.

"While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC. Working with our development partner, Takeda, we will continue to evaluate the therapeutic potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumors."
"NSCLC continues to be an area where new and effective therapies are needed. We look forward to the follow up recommendations from the DMC in order to chart the best path forward for the development of this molecule," said Nancy Simonian, M.D., chief medical officer, Millennium: The Takeda Oncology Company.
MONET1 (Motesanib NSCLC Efficacy and Tolerability Study) Trial Design
This Phase 3, multicenter, randomized, placebo-controlled, double-blind trial has enrolled 1,100 of 1,240 planned patients with advanced NSCLC. Patients with either squamous or non-squamous NSCLC were allowed in this study. Squamous NSCLC is a histological subtype of NSCLC and accounts for approximately one-third of the study population. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate in patients with measurable disease, duration of response and safety. Patients were randomized 1:1 to receive carboplatin and paclitaxel administered every three weeks with or without 125 mg motesanib taken daily.

About Motesanib
Co-developed by Amgen, Takeda Pharmaceutical Company, and Millennium: The Takeda Oncology Company, motesanib is an investigational, highly selective, oral agent that is being evaluated for its ability to inhibit angiogenesis by targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3). It is also under investigation for its potential direct anti-tumor activity by targeting a family of proteins called tyrosine kinases, including platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor (c-kit), two proteins involved in cell proliferation.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disorder, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com.
About Takeda
Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com.

About Millennium
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, http://www.millennium.com.

Source: MarketWatch

UTMB employees get notice of layoffs

2008-11-19T10:15:00.003+05:30

The dreaded day has arrived for thousands of UTMB employees in Galveston. The hospital has begun the process of notifying the workers of exactly who is getting laid-off.

University of Texas Medical Branch (UTMB) workers have known about the layoffs for more than week, but that does little to lessen the blow of losing your job.Most of those individuals who are being notified today that they are losing their jobs are being told face to face, through a phone call or through an email. They all primarily worked in the clinical side of things at the hospital. Most of those workers have not been at work because they haven't been able to return to the hospital after Hurricane Ike damaged the building so badly.

"Yeah, it's time to go. I got my orders," said unemployed worker Tino Gonzalez. For the last 20 years, Gonzalez has worked in Human Resources at UTMB. He is among the 3,000 employees who no longer have a job.

"Everybody is kind of nervous about it," said UTMB spokesperson John Kolen. "And I don't think really a whole lot of people want to be here today to get the bad news or to give the bad news."

"I don't know yet, but I will be OK," said employee Katsuhiro Kiat, PhD.

Kiat works in the research department and although cuts will be made in his department he doesn't feel his job will be lost. He does think that the UTMB Board of Regents is using the damage caused by Hurricane Ike as an excuse for needed downsizing.

"Unfortunately, I would say the storm and the financial across of the state could have exposed the weakness of this institution. That is what I can see," said Kiat.

By the end of the year, the 116 year old institution will be scaled down to a 200 bed unit. The hospital's spokesman John Kolen says it could be years before the hospital is fully operational as it was before Hurricane Ike.

"It would be ideal if we could hire back former employees but by the time we are ready to hire them back, they will more than likely have already found jobs," said Kolen.

Mr. Gonzalez told Eyewitness News he was going to take the advice of his 13-year-old son who told him to take a couple of weeks off and maybe start looking for a job at the beginning of the year.

UTMB is staffing two Employee Help Centers, one centrally located on the mainland and one on the island (http://www.utmb.edu/utmbemployeehelpcenter). Both centers are open 8 a.m.-5 p.m., Monday through Friday. Services and resources include job search counseling, job fairs, training on interviewing, resume writing and online job searches, employee benefit and retirement counseling, financial counseling and training, and counseling for personal issues.

Tomorrow, UTMB will be notifying more employees and hope to have everyone notified by the beginning of next week.

Source: ABC13

DATATRAK Adds Diverse Lynx to Its CRO Connect Program

2008-11-19T09:57:00.001+05:30

DATATRAK International, Inc. , a technology and services company focused on global eClinical solutions for the clinical trials industry, today reported that it has signed Diverse Lynx to its CRO Connect program.

DATATRAK's CRO Connect program is a non-exclusive enterprise agreement and accreditation relationship that empowers CROs to design and deploy their own EDC trials using DATATRAK's unified eClinical platform. As a CRO Connect partner, Diverse Lynx will be able to offer eClinical services to its clients through a standardize offering.
"We are pleased to add Diverse Lynx to our CRO Connect program," stated Dr. Jeffrey A. Green, Chief Executive Officer of DATATRAK International, Inc. "Collaboratively, this program allows Diverse Lynx to offer our standardized eClinical platform to best serve their sponsor's clinical trial needs. Our CRO model allows them to offer very predictable research and development costs while eliminating wasted time involved with negotiation and contracting under the trial-by-trial mode. This model has tremendous advantages to DATATRAK and Diverse Lynx with solid visibility of revenues over a multi-year period of time combined with a greatly diminished cost of sales."
"Our partnership with DATATRAK International is a big step towards offering absolute clinical data management services for data capture, processing, analysis and management services in the most cost effective approach with the highest quality. We now have a strong data management infrastructure to match our organization in Europe, Japan and Asian countries, covering over 20 countries," said Shubhendra Varma, President of Diverse Lynx. "At Diverse Lynx, we take this partnership several steps further by emphasizing long-term, value-added relationships and a commitment to understand our sponsors' business needs."

About DATATRAK International:
DATATRAK International, Inc. is a worldwide technology company focused on the provision of multi-component eClinical solutions and related services for the clinical trials industry. The Company delivers a complete portfolio of software products that were created in order to accelerate clinical research data from investigative sites to clinical trial sponsors and ultimately the FDA, faster and more efficiently than manual methods or loosely integrated technologies. DATATRAK's eClinical software suite can be deployed worldwide through an ASP offering or in a licensed Enterprise Transfer model that fully empowers its clients. The DATATRAK software suite and its earlier versions have successfully supported hundreds of international clinical trials involving thousands of clinical research sites and encompassing tens of thousands of patients in 59 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the clinical development of 16 drugs and one device that have received regulatory approval from either the United States Food and Drug Administration or counterpart European bodies. DATATRAK International, Inc. has offices located in Cleveland, Ohio, and Bryan, Texas. Its common stock is listed on the NASDAQ stock Market under the ticker symbol "DATA".

Visit the DATATRAK International, Inc. web site at www.datatrak.net .

About Diverse Lynx:
Diverse Lynx is a rapidly growing Information Technology and, Clinical Research and Data Management Company focused on providing contract research services to develop drugs and clinical trials to leading pharmaceutical, Biotech companies and government agencies globally. Its IT division provides a litany of diverse services that include staff supplementation through workforce contracting, e-business consulting, web-based applications, Client Server Applications, network solutions and other in-house and offshore software developments. Its Clinical Trial & Data Management division offers clinical research support to the global pharmaceutical industry and supports sponsors in their clinical trial management, pharmacovigilance and safety risk management, data management and regulatory affairs in the area of Oncology, Neurology, Psychiatry, Cardiology, Nephrology, Infectious Diseases and therapeutics vaccines. Headquartered out of New Jersey, USA with an office in India, Diverse Lynx has collaboration throughout Europe as well as in Japan and Russia. For more information please visit Diverse Lynx website at www.diverselynx.com .

Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management's expectations and beliefs concerning future events impacting the Company and are subject to uncertainties and factors (including those specified below) which are difficult to predict and, in many instances, are beyond the control of the Company. Factors that may cause actual results to differ materially from those in the forward-looking statements include the limited operating history on which the Company's performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs; fluctuations in the Company's quarterly results; the viability of the Company's business strategy and its early stage of development; the timing of clinical trial sponsor decisions to conduct new clinical trials or cancel or delay ongoing trials; the Company's dependence on major customers; government regulation associated with clinical trials and the approval of new drugs; the ability of the Company to compete in the emerging EDC market; losses that potentially could be incurred from breaches of contracts or loss of customer data; the inability to protect intellectual property rights or the infringement upon other's intellectual property rights; the Company's success in integrating its acquisition's operations into its own operations and the costs associated with maintaining and/or developing two product suites; and general economic conditions such as the rate of employment, inflation, interest rates and the condition of capital markets. This list of factors is not all inclusive. In addition, the Company's success depends on the outcome of various strategic initiatives it has undertaken, all of which are based on assumptions made by the Company concerning trends in the clinical research market and the health care industry. The Company undertakes no obligation to update publicly or revise any forward-looking statement.

Source: MarketWatch

Clinical Trials: Dying for Access

2008-11-18T19:20:00.001+05:30

It costs on average $802 million to develop a new drug, but not every drug makes it to market. Many are stuck in clinical trials and could take more than a decade to get approved. Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies. Others believe it's better to be safe than sorry. Lives hang in the balance of this debate.

From a bright and beautiful teen to a woman with wisdom and compassion beyond her 21 years, Abigail Burroughs fought hard before losing her battle with neck cancer. In the last seven months of her life, she not only fought her disease, but the federal government as well.

"I wish that they would just sit down and get to know me and then be able to sit down and look me in the eye and tell me, 'No,'" she said in an interview before her death.

The Food and Drug Administration refused Abigail access to a drug that may have prolonged and even saved her life. After she died, the drug she was fighting for -- Erbitux -- was approved.

"There is just this mindset that if we have any kind of change it will hurt the clinical trial system," said Frank Burroughs, Abigail's father.

Abigail's father created the Abigail Alliance to take her fight to Capitol Hill. The ACCESS act, before the house and senate right now, allows terminally ill patients who have exhausted all other options access to investigational drugs.

"There's a lot of lives that could be saved and extended ... tens of thousands of lives," Frank said.

Even Steve Walker and his wife Jennifer, both scientists, well versed in policy, government regulations and research, were no match for the FDA. Stage four colon cancer ravaged her body.

"Jennifer was 45 years old at the time and far from done with making her mark in life," Walker, co-founder of the Abigail Alliance, told Ivanhoe. "We intended to beat it, but being scientists, we knew very quickly that the chances of doing that were not good."

They talked with the FDA for months to get aggressive drugs already approved in 29 other countries.

"They don't work with you if you're a patient," Walker said. "In fact, they do the opposite. They aggressively serve and function as a barrier against your attempts to stay alive."

Some experts believe using experimental drugs could end in disaster.

"I don't think patients are in need of experimental drugs," Colin Begg, Ph.D., a board member on the Society for Clinical Trials, said. "What they are in need of are drugs that actually work."

The Society for Clinical Trials opposes the ACCESS legislation calling it "a bad law." it claims the history of medicine proves many drugs that initially seem promising are later revealed to be worthless or harmful.

"Statistics show that 90 percent of all drugs that pass phase 1 testing are ultimately shown to be ineffective or too toxic," Dr. Begg explained.

It typically takes pharmaceutical companies six years after discovering a promising molecule to gather enough data to begin clinical trials. Completing a trial takes another seven years. The FDA says it's time well spent. Cheri Gunvalson says it's time her son doesn't have.

"I believe that there will be nothing more difficult on this earth than to watch my child deteriorate and to lose my child," Cheri Gunvalson said. Her son Jacob is living with a rare form of muscular dystrophy.

"I have hope to just get this drug … to just get it before it's too late," Jacob said.

In August, a federal judge ordered the drug developer PTC therapeutics to give Jacob the experimental drug that could stop the progression of his disease. An appellate judge has since granted a stay, stopping Jacob from getting the drug right now

"With younger boys, it may help them get stronger, but with a boy at Jacob's stage, it's just to preserve what he has, so the longer we wait, the less function he has left to preserve," Cheri explained.

"What's got me down? That I might not get this drug, and if I don't get this drug, we all know what that means," Jacob added.

Experts fear granting early access to patients like Jacob means other patients won't sign up for controlled clinical trials.

"It's likely there will be a disincentive to patients to actually participate in the kinds of trials that will tell us in the long run what drugs work and which ones don't," Dr. Begg said.

"Nothing could be further from the truth," Frank said. "A patient would have to first try to get into a clinical trial and if they could not get into a clinical trial, then they could have access to a new drug that's in development."

"The doctors would have all these choices, but they wouldn't have any evidence," Dr. Begg stated.

"These are not drugs, these are not therapies, these are research activities and people need to understand that." said Michael A. Grodin, M.D., professor and director of the Law, Medicine, Ethics and Human Rights Program at Boston University in Mass.

"Those patients are literally being driven to the grave by an FDA that doesn't know how to get out of the way," Walker remarked.

The two drugs the Walkers fought are now approved by the FDA. All 16 drugs the Abigail Alliance requested earlier access to are now approved.

"Over a million people who could have benefitted from these drugs never had a chance to get them," Frank said.

The Alliance is focusing on approval of nine more cancer drugs. Although it's too late for his daughter, Frank and the others will push forward for the lives they've lost and the lives they may save.

"I work every day for her, but I work every day for a lot of other people," Frank explains.

"Jennifer didn't want help just for her … she wanted help for everyone," Walker said about his wife.

"I need to know at the end of the day that I've done everything that I can to save his life," Cheri said.

The ACCESS act also pushes for placebo-free drug trials in hopes more people will get involved in clinical trials if they know they will be receiving the drug in question.

Source: News4jax

Clinical trials needed to speed cancer fight

2008-11-18T18:27:00.002+05:30

THE RECENT $13.5 million award against two cancer doctors at Dana-Farber is a travesty ("$13.5m awarded in hospital death," Metro, Nov. 6). It is always sad when a cancer patient dies. Amy Altman had an extremely rare and difficult-to-treat tumor known as Ewing's sarcoma.

I am sure as a participant in a clinical trial, she signed an informed consent and acknowledged beforehand that severe complications, including death, could occur. Unfortunately, she died from the adverse effects of chemotherapy and her weakened immune system. To argue, as the patient's lawyers did, that her cancer doctors "wrote off" her diarrhea and that her death could have been prevented is untenable.

There is a real downside to cases such as this one. There has not been a new drug approved in the United States for sarcomas in over 25 years. The only way in which breakthrough medicines will be approved is through rigorous clinical trials. Without patients participating in trials, drug development will stop, and progress toward curing cancer will end. If this unjustified lawsuit scares patients and doctors from taking part in clinical trials, great harm will come to cancer patients in dire need of new treatments.

Misguided malpractice lawyers should think twice before they destroy the very system of clinical care and research that is needed to develop new cancer drugs. One day, they may also be patients.

HARVEY J. BERGER, M.D., Cambridge
The writer is chairman and chief executive of ARIAD Pharmaceuticals. The Dana-Farber Cancer Institute and the Center for Sarcoma and Bone Oncology are participating in clinical trials of a drug developed by the company for those with sarcomas and other solid tumors.

Source: The Boston Globe

Quest Diagnostics' Laboratory in India Accredited by Two Leading Laboratory Accrediting Organizations

2008-11-18T07:41:00.001+05:30

Less than one tenth of one percent of labs in India are CAP and NABL accredited

- Quest Diagnostics' laboratory also becomes one of only five labs in India to achieve NGSP certification for Hemoglobin A1c testing for diabetes

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that its wholly-owned subsidiary Quest Diagnostics India Pvt. Ltd. has received certificates of accreditation from the College of American Pathologists (CAP), a leading international laboratory accrediting organization, and the National Accreditation Board for Testing and Calibration Laboratories (NABL), the sole government-authorized laboratory accreditation body in India, for its diagnostic and clinical trials laboratory in Gurgaon, India. Accreditation by CAP and NABL is widely regarded in the international diagnostic industry as signifying that a laboratory performs diagnostic testing at the highest quality standards.

In addition, the National Glycohemoglobin Standardization Program (NGSP) has awarded Level I Laboratory Certification to the Quest Diagnostics' laboratory in Gurgaon. Level I Laboratory Certification, which is recommended by NGSP for laboratories conducting diabetes-related clinical trials, indicates that a facility's testing fulfills NGSP's rigorous standards for delivering accurate hemoglobin A1c (HbA1c) testing for diabetes. The Quest Diagnostics lab is one of only five laboratories in India to be certified by the international program. The prevalence of type 2 diabetes in India is expected to grow more rapidly than in any developed or developing nation, climbing from 28 million patients in 2007 to more than 60 million by 2017.

"Accreditation by both CAP and NABL is a major accomplishment because it indicates to physicians, hospitals, pharmaceutical companies and patients that all major areas of a laboratory's operations exhibit the highest level of quality assurance," said Palat Krishna Menon, M.D., Ph.D., medical director for Quest Diagnostics India Pvt. Ltd. "Level 1 certification by NGSP is also an important achievement because it means that physicians and pharmaceutical companies can trust that our HbA1c testing results in India correlate to the most rigorous global standards and provide the basis for making reliable treatment decisions for patients with diabetes."

The accreditation programs of CAP and NABL are designed to promote laboratory excellence by certifying only those laboratories that fulfill rigorous criteria for quality assurance. Both accrediting organizations conduct onsite audits to evaluate quality processes and other facets of a lab's operations, and only accredit those labs that demonstrate the highest quality standards. CAP and NABL investigators accredited the Quest Diagnostics' facility in Gurgaon approximately two months after performing separate onsite audits in September 2008. More than 100,000 diagnostic laboratories operate in India according to estimates, but only approximately a dozen are NABL and CAP accredited.

Quest Diagnostics began operating its 65,000 square-foot, state-of-the-art laboratory in Gurgaon, a satellite city of Delhi, in March 2008. The business offers the broadest range of diagnostic and wellness testing services in the industry, including esoteric testing, clinical trials central lab and support services, and risk assessment services to life insurance companies under the ExamOne(R) brand.

About CAP

The College of American Pathologists (CAP) is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high-quality and cost-effective medical care. For more information, visit www.cap.org.

About NABL

NABL is an autonomous body under the government of India's department of science and technology. It was established to promote competence of testing and calibration laboratories through third-party accreditation. NABL assesses medical laboratories against the International Organization of Standardization (ISO)'s 15189 standard for medical laboratories. NABL has signed mutual recognition agreements with Asia Pacific Laboratory Accreditation Co-operation (APLAC) and the International Laboratory Accreditation Co-operation (ILAC). For more information, visit www.nabl-india.org.

About NGSP

The National Glycohemoglobin Standardization Program (NGSP) aims to establish standards for HbA1c clinical laboratory testing across the diagnostic industry. The NGSP was formed in 1996 after the seminal Diabetes Control and Complications Trial (DCCT) demonstrated that HbA1c levels correlate with a patient's risk of developing diabetes disease complications, such as heart disease. The International Diabetes Federation and American Diabetes Association recommend treatment goals for patients with diabetes largely on HbA1c levels. For more information, visit www.ngsp.org.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.questdiagnostics.com.

Source: FoxBusiness

Recession not to hit clinical trials: CROs

2008-11-18T04:39:00.002+05:30

Indian clinical research organisations (CROs) do not see any near-term impact of recession as large pharma customers such as

AstraZeneca and Glaxo continue to send more work to India, where these trials could be conducted at one-fifth of the US cost.

The $200-million Indian clinical research outsourcing market will reach up to $600 million by 2010, according to a joint study done by research firm KPMG and the Confederation of Indian Industry (CII) in September this year. “Credit restrictions will prompt global biotech companies to see greater favour in outsourcing clinical trials to India,” Partner- Healthsciences Practice, Ernst & Young India, Ajit Mahadevan said.

While the cost of clinical trials vary on the basis of complexity and disease segment, a simple trial in India can cost 15-20% of the US price, while a more sophisticated trial—involving imaging systems—may be 50-60% of the US price. Studies suggest that R&D expenditure is increasing by 15% per year, making global biopharmaceutical companies look for cheaper options. India scores high due to faster enrollments, speed of completion, large and diverse patient pool as well as increasing private healthcare network.

“Biopharmaceutical discovery generally involves a commitment of $350-400 million till the pre-clinical phase, writing it off will not be easy. This will put pressure on companies to continue trials,” said Institute of Clinical Research (India) chairman Shiv Raman Dugal.

With many bio-pharmaceutical companies’ clinical trials already in the pipeline, and with patent expiry dates remaining constant, Indian CROs working for them are somewhat insulated from any slump so far.

Experts such as Dr Vasadeo Ginde, who is the president and managing director of iGate Clinical Research, believe that while work coming from smaller biotech companies might get affected in the long-term, bigger biotech companies will increasingly seek to leverage India’s cost advantages. “Moreover, since they manage their own CROs, impact will be neutral to positive. India currently has about 360 trials underway, including phaseI to phase IV studies,” he added.

Meanwhile, companies such as Biocon’s Clinigene continue to see more trials coming their way.

“It is possible that the slowdown could mean a significant increase in revenues over the next year,” said Biocon CRO unit COO Dr Arvind Atignal.

Source: EconomicsTimes

Jubilant Augments Clinsys Clinical Research(R) Through Acquisition of TrialStat ClinicalAnalytics(R), an EDC Platform

2008-11-18T04:27:00.002+05:30

Jubilant Organosys Ltd. announced today that its subsidiary Clinsys Clinical Research, Inc.(R), New Jersey, a global contract research organization (CRO), has acquired TrialStat ClinicalAnalytics(R) from TrialStat(R) for a purchase consideration of CAD 750,000.

TrialStat ClinicalAnalytics (TrialStat CA) is a Web-based electronic data capture (EDC) solution currently used by a wide range of pharmaceutical and CRO customers worldwide. TrialStat CA is the industry's first EDC platform to allow all aspects of a study to be configured, deployed and managed through a browser interface, enabling customers to start their studies quickly and cost-effectively.

Clinsys extensive global resources will enable TrialStat to continue its proven record of growth, customer service and product innovation. This agreement will give TrialStat's existing CRO and biopharmaceutical customer base a broader scope of services.

"The Company had identified TrialStat ClinicalAnalytics as one of the most innovative EDC solutions on the market and was determined to include it in its offerings to its customers globally," said David E. Williams, Chief Executive Officer of Clinsys.

Commenting on the acquisition, Mr. Shyam S Bhartia, Chairman & Managing Director and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Organosys Ltd., said, "The addition of the TrialStat CA and its proven EDC offering will allow Clinsys to continue to expand its integrated solutions for pharmaceutical, biotechnology and medical device organizations. This acquisition is an excellent fit and addresses the industry's continuously evolving requirements in EDC."

Source: MarketWatch

Biocon to invest Rs 100 cr in R&D

2008-11-17T20:38:00.001+05:30

Biotechnology major Biocon will be investing Rs 100 crore in the next fiscal in enhancing its Research and Development (R&D) to keep pace with increased orders from multi-national firms as leading global firms have cut down on their expenditure of R&D.

"We will be investing Rs 100 crore in 2009-10 for enhancing our Research and Development," Biocon Chairperson and Managing Director Kiran Mazumdar Shaw told reporters on the sidelines of India Economic Summit here.

The company has earmarked an investment of Rs 60 crore for the current fiscal, she added.

"We have seen an increase in research activities coming to our company during the current financial crisis as there has been a pressure on big pharma companies, mainly from western world, to cut expenditure on R&D," Shaw said.

The current economic downturn has not affected Biocon much, she added.

On the source of funding the expansion plan, she said, it would be through internal accrual.

When asked about the company's forecast during the current fiscal Shaw said: "We will meet what we had internally forecasted.... It will be a double digit growth."

On its R&D programme she said, two of its molecules for the treatment of diabetes and psoriasis is under development and have entered in phase-III of clinical trials.

FDA to Open Offices in China, India by Year’s End

2008-11-17T15:41:00.002+05:30

In an effort to enhance its ongoing import safety plan, the FDA will establish its first permanent offices abroad before the end of this year to monitor imported devices, drugs and food.

Over the next year, the agency expects to spread more than 60 agency regulators across China, India, Europe and Latin America.

The first overseas offices will be established in Beijing and New Delhi with eight U.S. nationals in China and 10 in India. Additional staff will be posted in Shanghai and Guangzhou, China, and at least one other location in India has yet to be determined.

Foreign-based officials will provide technical advice, conduct additional inspections and work with government agencies and private groups interested in developing certification programs. The FDA said it plans to work closely with local authorities and industries that ship medical products and food to the U.S.

While a formal agreement has been made between the U.S. and China to establish these offices, HHS is in the process of getting India’s permission. HHS signed a memorandum of understanding with China last year to create product-tracking systems and share more information.

Source: FDANews

Intervein Laboratories receives accreditation from CAP

2008-11-17T08:48:00.000+05:30

INTERVEIN LABORATORIES Pvt Ltd, Ahmedabad, Gujarat, India, has been awarded an accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists(CAP) based on the results of a recent on-site inspection. The laboratory’s director was advised of this national recognition and congratulated for the “excellence of the services being provided”.

During the CAP inspection process, inspectors examine the laboratory’s records and quality control of procedures for the preceding two years. CAP inspectors also examine the entire staff’s qualifications, the laboratory’s equipment, facilities, safety program and record as well as overall management of the laboratory. This stringent inspection program is designed to specifically ensure the highest standard of care for the laboratory’s patients.

“Apart from laboratory services, we also provide clinical trial services like data management, project management, site trainings and site support, logistics and archiving of samples and data”, said Ms. Devina Bhardwaj, CEO of Intervein.

Intervein Laboratories is one of its kind in the country. It is an independent Central Laboratory catering services to only specimens from clinical trials. The lab does not analyse retail samples or samples from clinics. At Intervein, each clinical trial is handled in a customized way by a dedicated GCP/GLP trained team.

Intervein soon plans to extend its services into molecular diagnostics and imaging facilities thus making it a core lab for clinical trials.

Source: Merinews

New definition of counterfeit worries drug cos, NGOs

2008-11-17T08:41:00.000+05:30

The Indian drug industry and public health interest groups have voiced strong concerns over the new definition of counterfeit drugs that has been proposed by a WHO-funded body. They also fear that the softer stance of the government and its decision to attend the meeting of this body, allegedly backed by global pharma MNCs, may block drugs export by Indian companies.

The drug controller general of India (DCGI) on Friday met few industry bodies and NGOs to take their views ahead of a IMPACT (International Medical Products Anti-Counterfeiting Taskforce) meeting which will take place in Germany later this month. IMPACT is a WHO body founded in 2006 to address the issue of counterfeit drugs.

The new definition proposed by IMPACT considers drugs as counterfeit if there is a false representation about its identity, history or source. Besides, if similar deviations are found in packaging, container and labelling, the drugs will also be deemed counterfeit, even if they contain the right chemical ingredient. “This is not about quality. An attempt is being made to link packaging and labelling with the efficacy and quality of drugs , “ an industry source who was part of the meeting said.

Indian drugmakers have now emerged as a key player in the global drug industry and have eaten into the business of global majors. As patent of most top blockbusters drugs are set to expire in the next few years, global pharma companies are under pressure to maintain their sales.

Indian industry players say global pharma MNCs are now putting up barriers in different forms to block India made drugs. Earlier in May this year, the Indian health ministry and the industry had jointly opposed the definition of counterfeit drug as suggested by IMPACT.

Source: The Econimics Times

Novartis to shift 100 jobs

2008-11-17T08:38:00.001+05:30

At a time when global pharmaceutical companies such as Merck and Pfizer are trimming their workforce to beat the economic blues, Novartis, the Swiss pharmaceutical major, has decided to shift 100 jobs to India.

The company plans to make Hyderabad as its back office hub for data management in clinical research and financial service segments. Though Novartis’ global recruitments shows no increase in numbers, its Hyderabad office will see an addition of at least 100 people in the coming months, said Jurgen Brokatzky-Geiger, head (human resources), Novartis.

Speaking to Business Standard, Geiger said the cut in the workforce in the pharmaceutical companies have more to do with the business realities than with the current global crisis. Even Novartis had announced a cut of about 3,000 jobs last year, though the company has not made any similar move this year.

On the outsourcing plans of Novartis in India, Geiger said the Hyderabad office, started two years ago, will turn out to be the sourcing hub for several operations of Novartis.

“We have big centre in Hyderabad, which was started two years ago. We are creating new jobs there and shifting some operations from our headquarters in Basel (Switzerland) and from the US,” he said.

Novartis is putting infrastructure to put all these people in one place and the centre is expected to turn operational next year. It will be the back office for Novartis’ pharmaceutical operations and will find many PhDs and post-graduates working there, Geiger added.

Novartis had initially planned to turn its Hyderabad centre as an R&D hub. The plan for the facility was announced in 2006 after Novartis signed a memorandum of understanding (MoU) with Andhra Pradesh government for allotment of land near Hyderabad.

However, the project did not take off. The company had blamed Indian position on intellectual property rights protection as a reason for going slow on its R&D plans. Novartis has two domestic subsidiaries, of which Novartis India is listed on Indian stock exchanges.

Source: Business Standard

Seven-Year Clinical Trial $8.5 Million Funding For Novel IBS Treatment Developed At UB

2008-11-16T10:26:00.000+05:30

Irritable bowel syndrome is a chronic, debilitating disorder affecting 25 million people in the U.S -- 14-24 percent of women and 5-19 percent of men.

No reliable and satisfactory medical treatment exists for the full range of IBS symptoms, which can cause severe physical and psychological distress and deprive sufferers of their quality of life.

Based on a successful pilot study of a primarily at-home, self-administered cognitive behavior therapy program, a University at Buffalo behavioral scientist has received $8.5 million from the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) to conduct a seven-year, multi-site clinical trial of the program developed at UB.

The UB trial is the largest IBS clinical trial conducted to date and one of the largest behavioral trials funded by the NIH.

Jeffrey M. Lackner, Psy.D., assistant professor in the department of medicine, UB School of Medicine and Biomedical Sciences, and director of its Behavioral Medicine Clinic at Erie County Medical Center, is principal investigator.

The trial will be conducted at three sites: UB, University at Alabama-Birmingham and Northwestern University. Following a 12-month planning period, 480 patients between the ages of 18 and 70 with moderate to severe IBS will be recruited over the following four years. Participants will be assigned randomly to one of three treatment groups: standard cognitive behavior therapy (CBT), in which patients will receive 10 weekly one-hour sessions with a therapist; home-based CBT plus 4 one-hour therapist sessions over 10 weeks; or education and support.

Participants will be reassessed at five points during the 12 months following the intervention to determine the long-term effectiveness of each treatment.

"In the short term, we hope to show that a self-administered version of cognitive behavior therapy for IBS is as effective as standard in-office treatment, but is more efficient, more accessible and less costly to deliver," said Lackner.

"In the long term, we hope to show that a self-administered behavioral treatment program maintains its effectiveness over time, can enhance the quality of patient care, improve clinical outcomes and decrease the economic costs of one of the most prevalent and intractable GI disorders."

Lackner noted that the trial addresses a major priority of the NIDDK of improving the quality of care for IBS and the surgeon general's call to develop relatively simple behavioral approaches for enhancing the long-term health of chronically ill Americans.

Vaccine trial have been suspended by India’s drug quality regulator after the death of an infant

2008-11-16T09:34:00.003+05:30

Patient trials of an advanced pneumonia vaccine by the domestic unit of US drug giant Wyeth Inc. have been suspended by India’s drug quality regulator after the death of an infant on whom the vaccine was tested in a trial in Bangalore.

The child had a pre-existing cardiac disorder. Indian drug rules prohibit testing on human subjects with such conditions without the prior approval of the drugs controller general of India (DCGI), the drugs quality regulator.

The inclusion of an infant with a cardiac condition in the Wyeth vaccine test violates India’s drug testing rules that strictly monitor subjects on who such tests are conducted. Wyeth had been permitted to conduct tests only on healthy babies, according to the regulator. The trial was being conducted on healthy babies who were between 42 and 72 days old.

“The baby was suffering from a cardiac abnormality and should not have been included in the trial at all. It seems that the ‘inclusion-exclusion’ criteria protocol has not been adhered to by the investigator,” said Surinder Singh, drugs controller general. “We have suspended all further trials across the country.”

The incident brings to the fore an ongoing debate among the medical and drugs community in the country on allowing foreign companies to conduct what are called phase III trials here for a drug that is not marketed anywhere else in the world. Until January 2005, such human trials for a molecule developed outside India were allowed only under that the drug was already approved for use abroad and was being sold in the market.

Though the Indian regulator has suspended several drug trials in the past, all of them have been over adverse reactions or efficacy issues, and not for violation of the rules themselves, drug regulation experts said.

“This is the first reported instance I can recall,” said Chandra M. Gulati, one of India’s top experts in drug regulations, and editor of Monthly Index of Medical Specialities.

Under the inclusion-exclusion protocol, if the investigator or the company decides to include or exclude a subject from its trial not fitting into approved criteria such as age, weight and health conditions, it must take prior permission of the licensing authority, in this case, DCGI.

It was not immediately clear at which link in the testing chain the mistake occurred. Wyeth Ltd, the Indian unit, said the tests were conducted by GVK Biosciences Pvt. Ltd, contracted for the trials. But Singh said Wyeth had conducted the trials on its own.

A GVK Biosciences spokeswoman said it couldn’t comment because of “client confidentiality”. The tests were done at Bangalore’s St John’s Hospital’s National Academy of Health Sciences.

The Wyeth phase III trial—the final stage of testing before a drug is approved for sales—was part of global clinical trials to assess the safety, tolerability and immunogenicity of a pneumococcal conjugate vaccine that fights 13 strains of bacteria compared with seven strains in the company’s current vaccine, Prevenar, the only vaccine of its kind.

Singh said he would be sending his drug inspectors to investigate the death of the baby, next week. “Further action will be taken based upon the outcome of our investigation,” he said. “We want to take very stern action. You (the company) should select the right type of child and subject. When the child has died, you are telling us that the child had a cardiac abnormality. We will not allow companies to fiddle with the safety system set out for clinical trials in India.”

Wyeth said the child who died had been administered Prevenar and not the new 13-strain variant.

“The event occurred in the control group, which used the current worldwide standard vaccine for prevention of pneumococcal disease and which has been administered safely more than 200 million times worldwide during the past seven years,” a company spokesperson said in an email. The test was comparing efficacy of Prevenar and the new variant.

Gulati predicted Wyeth would be eventually held responsible even if it contracted a testing firm for the trials: “Ultimately, the sponsor (that is, the company) is legally responsible though if there is any injury, then in a court case summons will also be issued to the investigator (for negligence), hospital (for not monitoring the trial properly) and DCGI (for not conducting inspection of the trial).”

The trial, begun in 2007, was being conducted on 350 children in India. Some 250 have already been tested. Wyeth is still allowed to collect the data.

Source: LiveMint

Pharmaceutical Industry Hustlers – Part I

2008-11-12T09:16:00.001+05:30

Thursday, 6 November 2008, 1:25 pm
Column: Evelyn Pringle

SSRI Antidepressants Pushers

By Evelyn Pringle

After twenty long years, it appears that the epidemic in mental disorders in America might be coming to an end. It won't happen because of any great medical breakthrough but rather because the perpetrators of the greatest healthcare fraud in history are finally being exposed. The demolition of the giant "psycho-pharmaceutical complex" appears to be on the horizon.

For far too long, the focus has been on the drugmakers only. In recent months, the spotlight has shown where it belongs - on the highly-paid opportunists responsible for fueling the epidemic in prescribing of psychiatric drugs by doctors in every field of medicine and the research institutions that enabled the process.

The antidepressants known as selective serotonin reuptake inhibitors, or SSRI's, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at the center of the storm. These drugs have been prescribed to more Americans than any other class of medications over the past two decades. Cymbalta, Effexor and Wellbutrin are often referred to as SSRI's, but they are slightly different chemically. However, the drugs all carry similar side effects and warnings.

The top sales pitch for SSRI's has been the "chemical-imbalance-in-the-brain" myth. "There is no evidence whatsoever that depression is caused by a biochemical imbalance," says Dr Peter Breggin, one of the world's leading experts on psychiatric drugs and author of the new book, "Medication Madness."

People take for granted pronouncements such as, "You have a biochemical imbalance," and "mental disorders are like diabetes," he explains in the book.

"In reality," Dr Breggin writes, "these are not scientific observations - they are promotional slogans, so adamantly repeated in the media and by individual psychiatrists that people assume them to be true."

"The psycho-pharmaceutical complex fosters these falsehoods in order to promote the widespread use of their products," he says. "Reluctant patients by the millions are pushed into taking drugs by doctors who tell them with no uncertainty that they need medication."

"If you have got a biochemical imbalance in your brain," Dr Breggin advises in the book, "the odds are overwhelming that your doctor put it there with a psychiatric drug."

All Eyes on Glaxo

At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly SmithKline Beecham), due to reports that the company is under investigation by the US Department of Justice, as well as the Senate Finance Committee, with Iowa's Senator Charles Grassley, the ranking Republican on the Committee, leading the charge.

The report that led to the investigation by Senator Grassley was generated in litigation and was only recently made public after it was unsealed by the court. It was submitted by Dr Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School and author of "The Antidepressant Solution" and “Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives.” He was retained as an expert by the Los Angeles-based law firm of Baum, Hedlund, Aristei & Goldman. The litigation involves several Paxil-induced suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA approved, that people taking the drug were 8 times more likely to engage in suicidal behavior than people given a placebo, or sugar pill. Now, it stands to reason that even the most depressed person would decline to take Paxil if given these facts. Also, parents certainly would decline if they were told about the risks.

Dr Glenmullen explains that, by submitting what he refers to as "bad" Paxil numbers to the FDA, Glaxo was able to avoid adding a warning about suicide to the label when the drug was approved. "GlaxoSmithKline's 'bad' Paxil numbers carried the day: The FDA approved Paxil on December 29, 1992, with no warning to doctors or patients of the significant increased risk of suicidal behavior," he writes.

Instead, Glaxo listed suicide and suicide attempts that took place during the "run-in" period of the studies as if they happened in the placebo group. The run-in period, also called the "wash-out" phase, occurs when all patients are taken off their existing drugs to let the old drugs wash out of their systems, and all patients are given placebos. The rationale for washing out old drugs is to prevent them from confusing the results of the study, so that patients start out in a similar condition, according to the report.

The official trial only begins after the wash-out phase, once the patients are assigned to receive either the antidepressant or a placebo. The patients who continue to receive the placebo are referred to as the “placebo group.”

"Confusing the pre-study placebo wash-out phase with the placebo group in the actual study is improper," Dr Glenmullen writes, "especially when the concern is a potentially lethal side effect."

The "correct data shows that suicide attempts in patients on Paxil occurred at a rate eight times higher than the rate in patients on placebo," he notes.

Senator Grassley has also asked the FDA to go back and review the clinical trial data submitted on Paxil. In a statement on the Senate floor on June 11, 2008, he said: "Essentially, it looks like GlaxoSmithKline bamboozled the FDA."

"We cannot live in a nation where drug companies are less than candid, hide information and attempt to mislead the FDA and the public," he stated. "These companies are selling drugs that we put in our bodies, not sneakers."

"When they manipulate or withhold data to hide or minimize findings about safety and/or efficacy they put patient safety at risk," Senator Grassley said. "And with drugs like Paxil, the risks are too great."

A good start

As the Glaxo scandal unravels, the public will learn that other antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest Laboratories are equally guilty. Likewise, there are many more supposedly independent academic doctors who have been receiving substantial financial benefits from drug companies than are currently identified in the media as being under investigation.

Exposing Harvard University’s Joseph Biederman, Thomas Spencer, Timothy Wilens, Stanford's Alan Schatzberg, Brown University's Martin Keller, Melissa DelBello at the University of Cincinnati, and Drs Karen Wagner and John Rush, who operated out of the University of Texas, might be a good place to start, but the trail of Big Pharma’s funding “academic research” for marketing purposes certainly does not end with a handful of psychiatrists.

According to Senator Grassley's June 4, 2008 statement in the Congressional record, although conflict-of-interest disclosure forms make it appear that the Harvard psychiatrists only received a couple hundred thousand from drug companies over the past 7 years, the true figures show Dr Biederman received over "$1.6 million," Dr Spencer "over $1 million" and Dr Wilens "over $1.6 million" in payments from the drug companies.

"Based on reports from just a handful of drug companies," he states, "we know that even these millions do not account for all of the money."

Senator Grassley also notes that Dr Schatzberg owns stock worth more than $6 million in one drug company. Ed Silverman reports on Pharmalot that there are "30 or so physicians at two dozen universities which the Senate Finance Committee is probing concerning disclosure of grants from drugmakers." The names of those 30 doctors, along with the research mills they operate out of, need to be made public.

The new book, "Side Effects: A Prosecutor, a Whistleblower, and a Best-selling Antidepressant on Trial," by investigative journalist Alison Bass, provides the inside scoop on the fraudulent SSRI research conducted at Brown University by Dr Keller.

The book also supplies background information on the financial ties between the so-called "opinion leaders" in psychiatry and the other antidepressant makers. For instance, Ms Bass explains that Drs Schatzberg and Keller worked as a team a decade ago to promote Bristol-Myers Squibb's antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored symposium that touted the benefits of Serzone, and Dr Keller was one of the paid speakers at the event. The same year, Dr Keller received $77,400 in consulting fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of Medicine also touting the benefits of Serzone. The drug was removed from the market in 2004 after it was found to cause liver damage but not before a number of patients died.

Ms Bass reports that Keller did not report any income from Glaxo on his 1998 tax return. But during her research for "Side Effects," she discovered he had earned personal income from Glaxo in 1998, as well as subsequent years. Keller admitted as much during a September 2006 deposition for a lawsuit filed against Glaxo, she says.

It is no longer a case where Americans need only be concerned about the amount of money the academics are pulling in. The pharmaceutical industry also has a stronghold on most major research institutions in this country. Many could not exist if the drug companies withdrew all their research funding, a state of affairs that did not occur by accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific Misconduct Blog, when all is said and done:

"The chief villains remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students."

Universities keep corrupt academics on board for good reason. "Side Effects" reports that, between 1990 and 1998, "Martin Keller brought in nearly $8.7 million in research funding from pharmaceutical companies."

The clinical trial industry itself provides a perfect slush fund. Spending in the U.S. was an estimated $25 billion in 2006 and is expected to reach about $32 billion by 2011. Most of the money for trials comes from private industry, and federal funding assumes a second place position, with the National Institute of Health budgeting $3 billion for clinical trials in 2006, according to the paper, "State Medical Board Responses To An Inquiry On Physician Researcher Misconduct," by Dr Stefan Kruszewski, Dr Richard Paczynski and Marzana Bialy, in the Journal of Medical Licensure and Discipline 2008: Vol 94 No 1.

Paxil Study 329

"Side Effects" also covers the whole sordid affair on Paxil Study 329, the most infamous fraudulent pediatric trial of all time. The study "offers a landmark for the point at which science turned into marketing," according to Dr David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales School of Psychological Medicine at the University of Wales, and an outspoken critic of the psycho-pharmaceutical complex, with 21 books to his name, including "The Creation of Psychopharmacology."

He explains that, in 1998, Glaxo's original assessment of Study 329 had concluded that it and another study had shown Paxil did not work for children, but that it would not be "commercially acceptable" to publicize this finding. "Instead the positive findings from the study would be published; they were in an article whose authorship line contains some of the best known names in psychopharmacology (Keller et al., 2001)," Dr Healy writes in the 2007 paper, "The Engineers of Human Souls & Academia."

Dr Keller gets most of the “credit” for the study, which was completed in the mid-90's. Keller et al had some difficulty getting it published at first, but finally found a journal willing to take the bate in 2001, the Journal of the American Academy of Child and Adolescent Psychiatry. In all, 20 academics allowed their names to be attached to this ghostwritten infomercial, and not one has stepped forward to acknowledge wrongdoing or to admit that a mistake was made.

Long before the paper was published, the authors of study 329 were fanned out all the way to Canada giving lectures and presentations to prescribing doctors at medical conferences and seminars to promote the off-label use of Paxil for kids. More than any other paper, Study 329 led to an epidemic in pediatric prescribing. "After its publication, the use of antidepressants for children skyrocketed," Dr Glenmullen notes.

These handsomely paid “key opinion leaders” all deserve to have their names in lights, especially Drs Graham Emslie and Karen Wagner from the University of Texas.

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the only payment she reported to the university was $600 in 2005, according to Senator Grassley. Dr Wagner also failed to disclose earnings of more than $11,000 from Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a “state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.”

“The Children's Medication Algorithm Project, or CMAP, was supposed to determine which psychiatric drugs were most effective for children and in what order they should be tried at state-funded mental health centers,” the Morning News explains.

The academics who developed the CMAP include Drs Wagner and Emslie. Records show Dr Emslie may have made up to “$125,000 from drug companies since 2004,” according to the report in the Morning News.

While Dr Keller took the lead on pushing Paxil for children and adolescents, Dr Emslie was the main man on the Prozac trials, and Dr Wagner was the queen bee on Zoloft studies. The co-authors of papers that appear in the medical literature encouraging the use of SSRI's for kids include Drs Biederman, Schatzberg, Wilens and, of course, Charles Nemeroff.

Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry department after Senator Grassley’s investigation revealed that he failed to disclose to his university more than a million dollars in drug industry income. All total, Nemeroff had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to report at least $1.2 million.

A complete list of academics who should to be investigated can be found among the authors of the SSRI papers and studies highlighted in the 2006 Third Edition of, "Essentials of Clinical Psychopharmacology," described as "a synopsis and update of the most clinically relevant material from 'The American Psychiatric Publishing Textbook of Psychopharmacology,'" by none other than Drs Schatzberg and Nemeroff.

Keep Following the Money

On July 10, 2008, Senator Grassley extended his investigation to include psychiatry's top industry-funded front group with a letter to Dr James Scully, Medical Director and Chief Executive Officer of the American Psychiatric Association, asking for "an accounting of industry funding that pharmaceutical companies and/or the foundations established by these companies have provided to the American Psychiatric Association."

The Senator wants records from January 2003 to the present. According to the July 12, 2008, New York Times, in 2006, the "industry accounted for about 30 percent of the association's $62.5 million in financing."

A factor rarely discussed in this debate is the amount of money doctors who prescribe SSRI's make during brief office calls charged at regular rates. This practice has taken a tremendous toll on public healthcare programs and has resulted in higher insurance premiums and overall healthcare costs for all Americans.

In fact, the bilking of public healthcare programs is what led to the current investigations by the Finance Committee, which has the responsibility of overseeing spending in Federal programs. When doctors prescribe drugs for unnecessary uses, public programs not only have to pay for the drugs, they must also pay the fees of the prescribing doctors and for the medical care for injuries caused by the drugs. Government spending tied to the prescribing of psychiatric drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services' Office of Inspector General, discussed kickbacks to doctors and told the panel:

"Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective."

Mr Morris explained that, "kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements."

Vermont is a rare state in requiring the pharmaceutical industry to disclose the money paid to doctors. On July 8, 2008, Vermont’s Attorney General William Sorrell released the state's annual report on "Pharmaceutical Marketing Disclosures," which lists the payments made by drug companies in 2007. Of the top 100 recipients, once again, psychiatrists received the highest payments. Eleven psychiatrists received a total of $626,379, or about 20% of the total value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it's impossible to embarrass them. Last year, the press ran major stories when this report came out, highly critical of how much money they were making. This year, the average amount rose by 25%.

The report also analyzes the payments based upon the drugs being marketed. Of the top 10 drugs for which disclosures were reported, five are used to treat mental illness and include Lilly's Cymbalta and Forest Lab's Lexapro. Ironically, Cymbalta sales are also up 25%, according to Lilly's latest SEC filing.

Overall, estimates indicate that the drug industry spends $19 billion annually on marketing to physicians in the form of gifts, travel, meals and other consulting fees, according to a May 22, 2008, press release by Senator Grassley's office. In the November 1, 2007, New England Journal of Medicine paper, "Doctors and Drug Companies — Scrutinizing Influential Relationships," Dr Eric Campell, associate professor at the Institute of Health Policy at Massachusetts General Hospital and Harvard Medical School, writes:

"Individual physicians can take some steps to maximize the benefits for patients and minimize the risks associated with their own industry relationships. They can start by recognizing that such relationships are designed to influence prescribing behavior and by carefully considering the potential effects that their own associations may have on their patients."

"And they can bear in mind," he says, "that the costs of industry dinners, trips, and other incentives are passed along to their patients in the form of higher drug prices."

Antidepressant prescribing is more rampant in this country than any other. The US accounted for 66% of the global market in 2005, compared to 23% in Europe and 11% for the rest of world, according to a December 2006 report by Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and hospital visits in 2005 showed that the most commonly prescribed drugs were antidepressants, with 48% of the prescriptions issued by primary care physicians. They have remained in the number one position ever since. Last year, 232 million prescriptions were filled for antidepressants worth nearly $12 billion, according to a March 2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing all the way to the bank. For example, in 2007, Pfizer CEO Jeff Kindler's pay package was worth $9.5 million, according to the March 14, 2008, Wall Street Journal. A previous CEO, David Shedlarz, left last year with an "exit package" worth over $34 million. In 2007, the total value of Wyeth's then-CEO Robert Essner's pay package was $24.1 million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a result of the mental illness epidemic occurring only in the US. Attorneys General all over the country are using consumer fraud statutes to sue the drug giants to recoup the money lost due to the illegal off-label promotion of psychiatric drugs and the concealment of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney General consumer fraud class-action lawsuits against Glaxo since 2004, on behalf of individuals and entities such as insurance companies in California, Florida, Illinois, Massachusetts, Minnesota, Missouri, New Jersey, North Dakota, Ohio and Washington.

The cases are based on documents showing Glaxo promoted Paxil for kids, fully aware that Paxil failed to out-perform a placebo in the clinical trials and had higher suicidality rates. A national class settlement of individual claims was reached in April 2007 in which Glaxo agreed to reimburse parents for all of the money paid for Paxil prescriptions for their children. A national class settlement on behalf of third party payors (insurance companies) was just approved in September 2008.

If not for the few law firms willing to stay the course, the truth would never have been revealed. Baum Hedlund has been pursuing the SSRI makers for nearly two decades. Most recently, it has taken up the fight for babies born with birth defects caused by SSRI's.

Because the industry was so successful at keeping the original SSRI trial data hidden, the drugs’ most serious side effects largely became public only as a result of the bravery and integrity of such medical experts as Dr Healy, Dr Glenmullen and Dr Breggin, who could not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning about an increased risk of suicidality, knowing all the long that the risk existed. Now, the companies are making the irresponsible argument (in defense of lawsuits claiming they failed to warn doctors and the public of the risk) that the FDA did not require them to add a warning, so they are immune from liability.

Worse yet, the industry-controlled FDA under the Bush Administration is supporting this audacious preemption defense and siding with the SSRI makers against private citizens in courts all over the country, telling judges to rule in favor of the drug companies and throw out the SSRI cases before they even make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a case involving federal preemption, in Wyeth v Levine, on November 3, 2008.

Source: scoop.co.nz