Drug safety: cover-up

St. Louis Post-Dispatch: The Food and Drug Administration's most basic responsibility is to protect Americans from unsafe or ineffective medicines. Yet officials from big drug companies and the agency testified last week before Congress that the FDA suppressed clinical trial results showing that when given to children, certain anti-depressants were no more effective than sugar pills.
Unbelievably, the FDA prevented at least three companies from disclosing the results of those studies on their drug labels. Janet Woodcock, an FDA deputy commissioner, said the agency did so because it believed the studies were not conclusive, and because it feared that revealing the results would scare doctors and patients away from using the drugs.
That opinion was not shared by an FDA doctor who reviewed those and other clinical trials of antidepressants in children, or by British drug regulators. Both the doctor and the British regulators concluded that the evidence was strong enough to warrant an immediate warning about an association between certain anti-depressants and suicidal behavior in children and young people.
But while British authorities issued a warning, higher-ups at the FDA overruled the doctor and squelched the caution here. The doctor's conclusions came to light because of hearings held by a House Energy and Commerce subcommittee.
Great cost
The studies suppressed by the FDA came at great cost to American taxpayers. In return for performing the studies on children, drug companies were granted lucrative patent extensions by Congress worth billions of dollars.
At issue is a class of anti-depressants called selective serotonin reuptake inhibitors, or SSRIs. These drugs -- Paxil, Prozac, Celexa and Zoloft -- have been a major advance for treating adults. But increasingly they have been prescribed for children and adolescents. Only Paxil has been approved for that use.
Last week, as the subcommittee was hearing about the FDA's suppression of study results, a group of prestigious medical journals unveiled a plan for drug trials to be publicly registered in advance, so companies could no longer conceal unfavorable results.