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Friday, May 14, 2010

ADDRESSING FRAUD IN RESEARCH

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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.


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