Wednesday, March 10, 2010


Drug industry has a vital stake in safety studies that can make or break a newly developed drug and as long as the safety protocols are strictly adhered to there my not be any problem in accepting the data generated. How ever serious concerns are being expressed about the transparency in making the safety data available to the public and often adverse findings are suppressed. More reprehensible is the tendency amongst some scientists to "doctor" the results to suit the interest of the sponsor. Here is a suggestion from an academician for tackling this issue.

Once a drug is approved, all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it. There should be big financial penalties for withholding relevant information. Drug studies sponsored by industry must be truly independent--outside of company control. Companies should give outside investigators independence over every aspect of the study. There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science. And on all sides there should be a commitment to protect against the intimidation of academics who are willing to raise questions about the safety and effectiveness of company products. The free flow of information about the effects of drugs and medical devices will best serve the public's interest.

It is a dilemma because safety studies are very expensive and time consuming. Only the industry has the necessary resources to shoulder the responsibility and when the very credibility of the developer is under scrutiny, an independent verification is a must. While this is true for drugs, same principle must apply to foods also and those who make health claims must organize unbiased and independent verification of their claims before making them in public.


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