New York Times Editorial Gets it Right: When Drug Companies Hide Data

Sun, 6 Jun 2004

At last, the New York Times editorial board has come to recognize that: “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.”

The Alliance for Human Research Protection is gratified that our call for openness and full disclosure has been heard. We applaud Attorney General Eliot Spitzer for focusing his lawsuit precisely on industry’s practice of concealing adverse drug data, thereby confounding the ability of physicians “to prescribe medicines wisely.”

Concealment of the adverse data was made possible by industry’s willing accomplices in the medical research community. Those who conducted the trials and those who published reports based on partial, selective findings, we believe, participated in the fraud.

It is our fervent hope that The Times will refrain from prematurely reporting “positive” findings–when these are based on partial, unvalidated data. We also urge the New York Times to take the lead and adopt a policy of disclosure that informs readers of the financial ties of the medical experts cited in Times reports. It does not serve the public interest to lend

A glaring example of the Times’ failure to do so, was a recent (June 2) front page article, Antidepressant Seen as Effective for Adolescents. The article failed to inform readers that the researchers who conducted the Prozac trials in adolescents-in 1997, 2002, and the current trial-have extensive, ongoing financial ties to antidepressant drug manufacturers–including Eli Lilly.

The claimed positive prior findings of Dr. Graham Emslie, the co-investigator of the current Prozac trial, have been disputed when independently analyzed. Psychiatrists who have conducted trials in children and adolescents dispute those claimed positive findings–as does an independent FDA statistical analysis of the data.

Contrary to the published claimed findings, “there was no increase in remission or recovery rate with the medication, and no difference in the child’s depression self-rating, parent ratings, global psychiatric symptoms or global functioning. As noted in an independent statistical analysis of the data (12), this trial failed both of its predetermined primary outcome measures.”

See, Garland J. Facint the evidence: antidepressant treatments in children and adolescents. Canadian Medical Association Journal. CMAJ . February 17, 2004; 170 (4) online at: http://www.cmaj.ca/cgi/content/full/170/4/489 See also: FDA. CDER. Application 18-936 / SE 5-064 (Eli Lilly, fluoxetine, Prozac). Statistical Analysis. Online at: http://www.fda.gov/cder/foi/nda/2003/18936S064_Prozac%20Pulvules_statr.pdf

The Times’ placement of the article on the front page is highly suspect. A pronouncement that antidepressants were found to be “effective”–on the basis of an unpublished, unvalidated report of partial data–served Lilly’s financial interests, much as one of its misleading “infomercials” does. The Times article also misled patients and doctors into believing that the findings were objectively arrived at because the study was funded by the National Institute of Mental Health. However, the Times should have disclosed to readers that the NIMH paid researchers have extensive financial ties to drug manufacturers–and those ties may influence the claimed results.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

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http://www.nytimes.com/2004/06/06/opinion/06SUN2.html?pagewanted=print&position=
THE NEW YORK TIMES
June 6, 2004
When Drug Companies Hide Data
EDITORIAL

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

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