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Mobile, Alabama Personal Injury Lawyer Blog | Long & Waite
Friday, September 26, 2008
Published Drug Trials Skewed to Make Drug Seem More Effective
Many people think that the Food and Drug Administration (FDA) tests drugs to make sure they are safe and effective before approving them. However, the truth is that the FDA never tests drugs. It counts on the drug's sponsor to perform the tests and submit the results as part of the approval process. Once a drug is approved, however, it depends on doctors to prescribe it and patients to agree to take it, and the decision to prescribe or take a drug depends on the information available to the doctor and the patient. Now, it appears that information is being systematically limited by drug manufacturers.
A recent study published in PLoS Medicine, a peer-reviewed open-access journal published by the Public Library of Science, shows that clinical trials supporting a drug's approval are published less than half the time (43 %). In addition, the trials are more likely to be submitted and published if they show that the newly approved drug is significantly better than placebos and existing alternatives. In fact, if what is described as a "pivotal" study shows that the drug is significantly better than alternatives, it is more than twice as likely to be published, whereas studies showing that a drug is only marginally better if at all languish unpublished.
What is the effect of this? Consider the drug Trasylol, used to control bleeding during open heart surgery, which was suspended from use last year, after as many as 30 people were killed by it every day, nearly 1,000 people a month, when it became the most popular drug for the application, even though studies showed it was only marginally better, if at all, than alternatives. There is evidence that some damaging studies of the drug were concealed, that, if they had been known by doctors, might have prevented the drug from being used except when it was the only choice. This would've cut into Bayer's $700 million annual take from the drug, but it might have saved thousands of lives.
Drug companies regularly conceal information about their new wonder drugs from the public. They especially conceal evidence that their drug is no better than existing alternatives or even placebos, but this information must be made public. Often, the only way to bring this information into the public eye is to expose it in court.
If you have been hurt by a defective prescription drug, you have not only a right, but a certain responsibility to pursue a legal action against the manufacturer. Your lawsuit can stop a doctor from prescribing dangerous drugs, and save others from injury or even death. Contact the experienced dangerous drug lawyers at Long & Waite Attorneys at Law, P.C. today for a free initial case evaluation.
posted by
Dr. Candelaria
at
10:55 AM
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