When Drug Companies Hide Data
Source: New York Times
Published: June 6, 2004
Eliot Spitzer, New York's attorney general, has a knack for terrifying industries that need to be disciplined. Fresh from his sallies against improper mutual fund trading and brokerage houses that tout stocks they know to be junk, Mr. Spitzer has now taken on pharmaceutical companies that suppress data showing their drugs to be useless or possibly even dangerous. Whatever the legal outcome of his first case in this area, Mr. Spitzer has identified a problem that needs to be fixed if doctors and patients are to make the best medical decisions.
The attorney general's civil suit accuses the drug giant GlaxoSmithKline of committing fraud by concealing negative information about Paxil, a drug used to treat depression. The suit says that the company conducted five clinical trials of Paxil in adolescents and children, yet published only one study whose mixed results it deemed positive. The company sat on two major studies for up to four years, although the results of one were divulged by a whistle-blower at a medical conference in 1999 and all of the studies were submitted to the Food and Drug Administration in 2002 when the company sought approval for new uses of Paxil. At that time it became apparent that Paxil was no more effective than a placebo in treating adolescent depression and might even provoke suicidal thoughts.
It is outrageous that any company should have the power to mislead doctors and their patients by stressing only positive results and hiding negative findings. The companies do have to submit their clinical trials when first seeking approval to market a new drug, and the F.D.A. publishes summaries of the data after approval. But once a drug is on the market, a company need not report any new trials that cast doubt on the drug's effectiveness unless it seeks further F.D.A. approvals. Safety information is supposed to be promptly reported to the agency, but whether a particular finding affects safety is mostly left to the companies to decide. The F.D.A. treats much of the data it gets as proprietary.
Mr. Spitzer wants to hold GlaxoSmithKline liable for damages under a state consumer protection law, an approach that could prod the industry toward more responsible conduct. But surely even bolder action is called for. The drug companies should be forced to make public the results of all of their clinical trials the moment they are completed, and the findings should be disseminated widely to doctors in an easy-to-understand format. Only then will patients be confident that their doctors have enough information to prescribe medicines wisely.