December 1, 2004
Open Up Drug Research
Some doctors have stopped prescribing anti-depressants to children and teenagers for fear the drugs might increase their risk of suicide. Yet recent studies in Great Britain and the United States show anti-depressants to be generally safe and effective even among the young.
All test data about these and other drugs do not have to be made public, however. So when safety questions arise, as they have about anti-depressants, researchers find they cannot look at an entire body of work in search of possible missed warnings among the results. Doctors are left to wonder what they don't know about the drugs they might prescribe.There should be no secrets when it comes to the safety of drugs on the market.
A bill in Congress would require makers of drugs and medical devices to report the results of all clinical trials in a public database. Lawmakers should pass it.
What ought to be a no-brainer, though, is likely to be a test of their integrity when they take up the measure: The deep-pocketed pharmaceutical industry says it sees no need for mandatory reporting. Rather, some manufacturers promise they will voluntarily release more study results on industry Web sites.
Voluntary reporting will not restore faith in a system fraught with potential conflicts of interest for drug makers and researchers alike.
Manufacturers have an obvious interest in publishing positive trial results. But what about negative or inconclusive results? Drug makers who pay for clinical trials say they own the resulting data, and they do not always release the data.
Old assumptions that academic institutions will ensure impartial research and reporting no longer hold true. For one thing, clinical trials often are conducted by a growing private testing industry. Only 35 percent of the money the drug industry spent for that purpose went to academic researchers in 2002, half what it was in 1991.
For another, medical schools that want the remaining dollars have an incentive to give industry sponsors tighter control over their findings, and sometimes do. The New York Times reports that few schools require the results of clinical trials to be made public as a condition of participation.
Well, the federal government can require full disclosure, and it should.
Its job is to protect the lives and health of its citizens, including regulating the food and drugs they consume. Doing that right takes all the data.