liot 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.