NEWS - Drug companies' promised trials not yet started

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HealthCentral.com

March 2006

Drug Companies' Promised Trials Not Yet Started

Drug companies have not even started two-thirds of the follow-up studies

that they agreed to undertake once their medicines were approved for the

market, according to a government report.

The drugs often received expedited approval from federal regulators on

condition that the studies be carried out, the Associated Press reported.

The Food and Drug Administration said in an annual report that, as of Sept.

30, 65 percent of the 1,231 so-called " post-marketing " drug studies that

companies had pledged to carry out were still pending.

" That doesn't mean they will never be started, " said Dr. ,

director of the FDA's Office of New Drugs, explaining that 116 of the 797

studies were committed to during the 12 months ending in September. The

clinical trials required under the commitments can take six months to a year

to design and launch, he added.

Other studies had been committed to years earlier, but the FDA didn't

provide a breakdown.

FDA spokeswoman Kathleen Quinn said the agency feels that " these numbers

show drug companies are taking this thing seriously. "

But Dr. Jerry Avorn, a Harvard Medical School professor and author of

Powerful Medicines, in which he criticizes the FDA's post-marketing system,

said the numbers show the system is broken.

" This new information is an embarrassing continuation of similar reports

issued by FDA each year on the appalling state of the medication safety

studies it has 'mandated' drug manufacturers to perform. It is scandalous

that of the supposedly active studies, about two-thirds haven't even been

started yet, " Avorn said.

The report, posted to the FDA Web site, lists 231 studies as ongoing, 28 as

delayed and three as terminated as of Sept. 30. Another 172 studies are

listed as completed or terminated, with a final report submitted to the

agency.

http://www.healthcentral.com/newsdetail/408/1507864.html

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