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.
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