[e-farmacos] Las practicas de la industria en NY Times

["Palomino, Hector" <hpalom66@hotmail.com>]

Amigos, adjunto un comentario editorial de NY Times, repecto a ciertas 
practicas de empresas del sector.

Saludos,

Hector Palomino
Lima
(Peru)


June 6, 2004
When Drug Companies Hide Data

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.

Copyright 2004 The New York Times Company