A flawed system of drug research, or why new drugs often do more harm than good

The August doldrums have settled in. Pharmalot is on vacation, as are most state and federal legislators. But there’s a few items I’d like to take note of, since I too was on vacation when this news broke:

1. Stanford University finally saw the light and removed its chief of psychiatry, Alan Schatzberg, as principal investigator of an NIH study after Sen. Chuck Grassley continued to question Schatzberg’s alleged conflicts of interest in the study. As you may recall from my previous blogs, Schatzberg owned $6 million in stock in Corcept at the same time that he was principal investigator of a study examining the effectiveness of Corcept’s drug, RU-486, in treating psychotic depression. Grassley, a ranking member of the Senate Finance Committee, charged that Schatzberg failed to fully disclose his financial interests in Corcept to Stanford or the NIH, which is funding the RU-486 study. As Stanford said in its statement to the Senate Finance Committee, “having Dr. Schatzberg as the principle investigator on this grant can create an appearance of conflict of interest.” Here’s the letter Stanford sent to the NIH notifying them of its long overdue action.

2. Research reported at the annual meeting of the American Sociological Association echoes what I conclude in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial: Americans are often exposed to unacceptable side effects because of flaws in the way new drugs are tested and marketed. Donald Light, a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, reported that two in every seven new drugs result in side effects serious enough for FDA action after the drugs have been approved, including black box warnings, adverse reaction warnings, or even withdrawal of the drug. Light also contended that drug makers design trials to minimize evidence of toxic side effects. For instance, they sample a healthier population of patients than those who will actually take the drug, excluding people who are older or have multiple health problems, according to GoozNews. Trials are also not run long enough to detect long-term side effects, Light says. In his talk, the sociologist noted that while current system of drug approval allows companies to boast that a drug is safe and effective, in reality, the label should read “apparently safe based on incomplete information…” Light concludes, as Side Effects does, that the FDA’s sped-up drug reviews during the ’90s and the first part of this century only led to significantly increased black box warnings and drug withdrawals after great harm was done.

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