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Just a Joke ha ha
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William Wagner
medicine forum Guru


Joined: 29 Apr 2005
Posts: 809

PostPosted: Wed Jun 01, 2005 7:00 pm    Post subject: Just a Joke ha ha Reply with quote

http://online.wsj.com/article/0,,SB111758233990247602,00.html?mod=djemHL


This just a part of the article due to copyright respect.


SCARY SCARY Why try to understand this stuff ( Being Polite) when it
is a joke?


............................................

Drug Makers Seen
As Slow to Finish
Postmarket Studies
By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
June 1, 2005
WASHINGTON -- Pharmaceutical companies haven't completed about half of
the studies ordered by the Food and Drug Administration as part of the
agency's accelerated-approval system for new drugs, according to a
congressional-staff review.
The review, by Rep. Edward J. Markey (D., Mass.), focused on the
accelerated-approval program, which requires pharmaceutical companies to
continue studying an approved drug after it goes on the market.
FDA spokeswoman Suzanne Trevino said agency officials couldn't comment
on the report because they hadn't seen it. "Accelerated approval has an
important role and gives earlier access to life-saving medicines," she
said.
Using FDA and Securities and Exchange Commission data, the Markey staff
looked at 91 studies ordered on 42 products that were approved from 1993
to October 2004. The FDA's accelerated-approval process was established
in 1992.
Of the 91 studies, 46 have been completed, 42 haven't and three have
been delayed. Half of the unfinished studies are yet to begin. The
oldest outstanding study was ordered in 1996 for a Shire Pharmaceuticals
Group PLC drug used to treat a small group of people who faint as a
result of low blood pressure. A Shire spokesman said the company
acquired the marketing rights to the drug in 2000 and agreed to do two
studies, one of which is completed and the other is continuing.
The Markey review also found that 68% of the companies didn't disclose
with the SEC that they were required to conduct studies. It is unclear
if companies were required to divulge that information. SEC regulations
require firms to disclose "material" information to investors.
"It is outrageous that drug companies and the FDA have been dragging
their feet when it comes to conducting required postmarketing studies,"
Mr. Markey said. "They are laughing at the FDA, and sometimes it seems
as if the FDA is treating it as a joke as well."


...........

More at above URL but you have to purchase it.


Bill

--
Garden in shade Zone 5 S Jersey USA
Long -75.0246 Lat 39.637876
Enjoy http://terrafly.fiu.edu/
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