NTN: FDA caught red handed in scientific fraud

[Guest guest]

" NewsTarget Insider " <insider

NTN: FDA caught red handed in scientific fraud

Wed, 19 Jul 2006 12:53:41 -0700

 

 

 

 

NewsTarget Insider Alert (www.NewsTarget.com)

HEALTH WARNINGS / CRITICISM

------------------------------

(Please forward to others who may benefit)

 

 

Yet another drug safety scandal is emerging over the FDA's reliance

on fraudulent clinical trial data to approve Ketek, an antibiotic drug.

...

 

From http://www.newstarget.com/019698.html

 

The FDA has once again been caught red-handed ignoring the dangers of

a widely-prescribed drug and compromising the health of millions.

Internal email messages have now surfaced about how the FDA pushed the

antibiotic drug Ketek despite urgent warnings from its senior drug

safety scientists. The details of this scandal further highlight the

dubious operations of the Food and Drug Administration, which

consistently places the profits of drug companies as a higher priority

than public health.

 

Ketek was approved under suspicious circumstances in the first place.

A key clinical trial for the drug, involving 24,000 patients, was

repeatedly found to be fraudulent, according to FDA investigators. One

FDA document concluded that Sanofi-Aventis hid safety dangers from the

FDA -- dangers the FDA later discovered on its own.

 

One FDA safety scientist, Dr. Cooper, wrote, " I tried to argue that

given Aventis's track record in which they have proven themselves to

be nontrustworthy that we have to consider the possibility that they

are intentionally doing a poor job of collecting the postmarketing

data to protect their drug sales. "

 

Dr. David Graham added, " For F.D.A. to refer to its being reassured

by postmarketing data from Latin America and Europe as a basis for

declaring `Ketek is safe' is in my opinion a great abuse of such

surveillance data. "

 

Yet the drug was approved anyway, and the FDA now cites a known

fraudulent study to defend the drug and argue against its withdrawal.

 

Four FDA safety officials (Dr. Charles Cooper, Dr. David Ross, Dr.

Rosemary Johann-Liang and Dr. David Graham) ultimately sounded the

alarm over Ketek's safety in internal emails. As now seems routine at

the FDA, they were ignored. (See The Rise and Fall of Rezulin to see

another such example.)

 

Story continues at:

http://www.newstarget.com/019698.html

 

 

Also posted today:

 

When fast food restaurants outnumber grocery stores, city residents

die earlier from disease

http://www.newstarget.com/019697.html

 

Sunscreen offers near-zero protection when rubbed in

http://www.newstarget.com/019695.html

 

Migraine with " aura " linked with heart disease risk

http://www.newstarget.com/019694.html

 

San Francisco approves universal health care coverage

http://www.newstarget.com/019693.html

 

Medics arrested, charged with killing patients during Hurricane

Katrina chaos

http://www.newstarget.com/019686.html

 

Censorship, intimidation emerges in power struggle over Canadian

medical journal and the Canadian Medical Association

http://www.newstarget.com/019685.html

 

 

To your health,

- Mike Adams, the Health Ranger

 

===============================================================

Research proves it! Type-2 diabetes can be cured.

 

Now get the book that has taught thousands how.

Reverse diabetes in 25 days using safe, natural methods.

Results 100% guaranteed or your money back.

 

http://www.truthpublishing.com/HaltDiabetes.html

===============================================================

 

 

Not yet a r? Sign up at:

http://www.NewsTarget.com/ReaderRegistration.html

 

Please DO NOT reply to this email. To contact NewsTarget,

email: reply

 

Privacy policy: http://www.newstarget.com/privacypolicy.html

 

------------------------------

The NewsTarget Insider is published by Truth Publishing,

which is solely responsible for all content.

Truth Publishing, Inc.

2F, 164 Gong-Yi Rd.

Taichung, Taiwan R.O.C. 404