Hiding the Data on Drug Trials

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June 1, 2005

Hiding the Data on Drug Trials

 

Any Americans gullible enough to believe that the drug industry can be

trusted to report fully on what clinical trials it is sponsoring or

what results were found must be sorely disappointed by recent

developments. A government survey determined that three of the largest

drug companies have effectively reneged on their pledges to list

trials in a federal database. A report in yesterday's Times by Alex

Berenson reveals that this intransigence also extends to a voluntary

industry database. It looks as if demands from researchers and the

medical profession for full access to clinical trial data will

continue to be frustrated.

 

Companies already provide the data to the Food and Drug

Administration, which is required to keep much of it confidential. A

public listing of trials is important to prevent drug makers from

hiding results that reflect badly on their drugs while publishing only

results that make their drugs look good. By law, the companies are

supposed to register important trials with a government Web site. Most

manufacturers are complying, but the three big obfuscators - Merck,

GlaxoSmithKline and Pfizer - are often getting around the requirement

by not naming the drugs they are testing, instead using phrases like

" an investigational drug. " Merck was the worst offender, failing to

provide a drug's name some 90 percent of the time. Glaxo withheld a

name 53 percent of the time, and Pfizer 36 percent of the time.

 

Merck and Pfizer are also the most prominent withholders of trial

results from the industry's voluntary database. As Mr. Berenson

reported, Pfizer has posted only a few results of clinical trials, and

Merck has posted none. That meager contribution appears to satisfy the

weak guidelines set by the industry, but it offers a sorry contrast

with the record of Eli Lilly. Lilly appears to have been quite

scrupulous in listing its current trials with the government site and

has posted the results of hundreds of completed clinical trials on the

industry site. Surely if one big company can make its trials

transparent, other drug makers can do the same.

 

A coalition of medical editors has just stiffened its announcement

that leading journals will soon refuse to publish the results of any

clinical trial that has not complied with tough international

standards for transparency. That should apply useful pressure to

recalcitrant companies. But the best hammer would be federal

legislation to compel all companies to provide critical information

when a trial is begun and full results when a trial is completed, with

stiff penalties for noncompliance.

 

* Copyright 2005 The New York Times Company