54% of the experts consulted had financial conflicts of interest in the drugs they were evaluating, a violation of federal law. However, since 1998, the FDA had waived the restrictions more than 800 times.
The conflicts involved included being employed by a drug company working on the development of a drug and then serving on an FDA committee to evaluate it, holding stock in the company involved, or receiving consulting fees or research grants from companies involved.
While the FDA does reveal when a conflict of interest exists, it keeps the details of the disclosure secret. As a result there is no way to determine which drug company is involved or the financial interest at stake.
With few exceptions, the FDA follows the advice of the committees that review drugs for approval.
By way of commentary, this article points out one of the reasons that taking drugs has become so dangerous. Patient safety concerns come into question when the people responsible for saying the drug is safe are the same ones who stand to gain financially from its approval. As previously reported in this publication, studies report that serious Adverse Drug Reactions result in approximately 106,000 deaths every year. This figure accounted for nearly 5% of all causes of recorded death in 1994 making Adverse Drug Reactions the fourth leading cause of death in the United States. These conflicts of interest are intolerable at best and deadly at worst.
In Touch Vol. 4, No. 11 November 2000 ISSN 1525-416X
© 2000