EDITORIAL: HIDING THE DATA ON DRUG TRIALS
June 1, 2005 08:05

"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 the [May 31st New York] 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 website. 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."
*****
The New York Times, 06/01/2005

The case of a diet drug plaintiff in Philadelphia was
recently bumped out of court at a preliminary stage
after the drug's manufacturer, Wyeth Corp., made a
successful argument based on the learned intermediary
doctrine. It's not the first time Wyeth has won
summary judgment in a fen-phen case by citing the
doctrine, but, with the North Carolina plaintiff's
appeal to the Pennsylvania Superior Court, Common
Pleas Judge Norman Ackerman has written an opinion
explaining why he believes the plaintiff failed to
meet her burden in Lineberger v. Wyeth.
*****
Melissa Nann Burke, The Legal Intelligencer, Law.com,

"For months now, much of the [Illinois] corporate
media have essentially taken the side of the medical
malpractice insurance industry in the debate over how
to solve the malpractice insurance problem. The
industry is pushing hard for caps on non-economic
damages and these media voices have gone right along
with the program, equating such caps as being the only
'real, meaningful reform' - as The Southern Illinoisan
did in its editorial of May 18th. The trouble is,
experience shows that caps will not solve the problem,
because they don't address the real causes of the
problem. Their only certain result is to further line
the pockets of a heavily monopolized and unregulated
insurance industry, while undermining the people's
right to have compensation for their injuries
determined by a jury of their peers. The main causes
of the rise in medical malpractice insurance rates
are a) the medical malpractice insurance industry is
heavily monopolized, b) the insurers lost money on
their investments when the stock market went bust and
c) they are not regulated in Illinois."
*****
Rich Whitney, The Southern Illinoisan, 06/01/2005

WSTM-TV NBC 3, Wed, 01 Jun 2005 6:31 PM PDTMassive Drug Recall http://www.wstm.com/Global/story.asp?S=3414594&nav=2aKDaYWvThe FDA is shocked is about one of the biggest drug recalls in history. Nearly fifty drugs and millions of Americans are effected. Able... (Read Article)

Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

June 1, 2005
05-22

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II