FDA: Most Drug Makers Skip Study Listings

[Guest guest]

FDA:

Most Drug Makers Skip Study Listings

July 7, 2004

WASHINGTON (AP) -- The drug industry is

largely ignoring a federal law requiring that thousands of medical studies be

listed on a government database, federal research suggests.

The Internet-based database,

ClinicalTrials.gov, opened in 2000. It's not meant to be a comprehensive

list, but any study of a treatment's effectiveness against a serious disease

is supposed to be listed. The requirements were further spelled out for

industry in 2002 Food and Drug Administration guidelines.

An FDA check against its own internal

research lists shows that in 2002, just 48 percent of industry-funded studies

for cancer therapies alone were reported to the public database. In contrast,

more than 90 percent of National Cancer Institute-funded studies were listed, said FDA Associate Commissioner Theresa Toigo.

The FDA hopes to finish its evaluation of

2002 study listings by year's end, but Toigo said

there are no signs that treatments for other diseases fared better - or that

compliance has improved much since.

FDA officials say the law includes no

penalties for database violations, so it's unclear what can be done to spur

compliance.

While this database lists only the existence

of certain studies, doctor groups are debating whether some more

comprehensive registry might ensure that all results of such studies

eventually are made public. Doctors recently learned that drug makers never

published many studies where childhood antidepressant use failed, publicizing

only positive results.

Some 5,754 ongoing studies -- just 13

percent of them industry-funded -- were listed on ClinicalTrials.gov Tuesday.

Drug companies conduct the vast majority of the nation's treatment studies.

Even among drug giants, listings vary: AstraZeneca listed 20 ongoing studies, for example,

compared with Merck & Co.'s three. A Merck spokeswoman didn't immediately

return a phone call.

The industry's Pharmaceutical Research and

Manufacturers of America wrote companies in 2002 and again last fall

reminding them of the law. " We have and will continue to encourage our

member companies to post clinical trial information on the government Web

site as required, " said spokesman Court Rosen.

Copyright 2004 The

Associated Press. All rights reserved. This material may not be published,

broadcast, rewritten, or redistributed.

Hugs,

Deanna

LUPUS Serenity

Prayer...

Lord, grant me the serenity to accept the things I cannot

change, the courage to change the things I can, and the wisdom to hide the

bodies of doctors I shot when they said, You're perfectly healthy, it's all in

your head "