[SSRI-Research] Lawmaker Alleges FDA, Merck Collaborated (Conspired?)

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Sat, 22 Jul 2006 15:54:32 -0400

[sSRI-Research] Lawmaker Alleges FDA, Merck Collaborated

(Conspired?)

 

Associated Press

 

Lawmaker Alleges FDA, Merck Collaborated

 

http://www.forbes.com/home/feeds/ap/2006/07/19/ap2891282.html

 

By ANDREW BRIDGES , 07.19.2006, 08:21 PM

 

A federal health official worked with drug maker Merck to discredit a

government whistleblower who publicized safety risks associated with

the painkiller Vioxx, a lawmaker alleged Wednesday in seeking an

investigation.

 

Sen. Charles Grassley, R-Iowa, asked the inspector general at the

Health and Human Services Department to probe whether the Food and

Drug Administration and Merck acted in concert to call into question

the safety findings made by Dr. David Graham, an FDA drug safety official.

 

In a letter Wednesday, Grassley cited handwritten notes made by the

Merck employee documenting an Oct. 13, 2004, conversation with the FDA

official that suggests the two collaborated.

 

The FDA official mentioned an " opportunity to get (the) message out "

on Graham, a longtime employee of the agency, and provide journalists

with a company critique of him, according to notes quoted in the letter.

 

" It is no secret that Dr. Graham was and is a critic of the FDA.

However, that does not mean the FDA should scheme with drug sponsors

to discredit its own employees, " Grassley said in the letter to

Inspector General Daniel Levinson. The FDA, Grassley said, must

maintain a " clear, bright line between the regulated and the regulator. "

 

FDA spokeswoman Susan Bro had no comment.

 

Merck & Co. Inc. said in a statement that it has the " right to express

our views when we believe information others have presented is not

fair and balanced. Dr. Graham's conclusions with regard to Vioxx

differed from those of the FDA and to that extent, the FDA and Merck

separately expressed their scientific views to the public and

scientific community. "

 

Merck announced the voluntary withdrawal of Vioxx in September 2004,

citing a study that showed the pain medication could double risk of

heart attack or stroke if taken for 18 months or longer.

 

Two months later, Graham testified before a Senate committee that the

FDA had fumbled its handling of Vioxx, and mishandled safety problems

with five other widely used drugs. The FDA defended its oversight of

Vioxx before the hearing; an agency official later dismissed Graham's

research as " junk science. "

 

The following month, 22 members of Congress signed a letter asking the

FDA to investigate the " smear campaign " against him.

 

Merck now faces more than 16,000 Vioxx-related lawsuits.

 

The meeting cited by Grassley was held two weeks after the drug was

withdrawn.

 

FDA e-mails seen by The Associated Press indicate that the agency

shared in advance with Merck details about a presentation that Graham

was to make in France in August 2004 about the dangers of Vioxx. The

e-mails suggested that such a practice was commonplace.

 

Merck then issued a statement saying it stood by the safety of Vioxx.

An FDA spokeswoman at the time said removing the drug was " not on the

table. "

 

The notes excerpted by Grassley indicate the FDA later went even

further in helping Merck rebut Graham's work.

 

The FDA's Dr. Brian Harvey suggested to Merck's Dr. Ned Braunstein " an

official rebuttal on Graham, " according to the notes, which were

admitted as evidence in a federal Vioxx trial.

 

Graham said he was " quite shocked " to learn about Braunstein's notes.

 

" This actually demonstrates more clearly just how widespread the

organized campaign to discredit and smear me was, " according to a

transcript of a sworn deposition that Graham gave May 9, 2006.

 

Attorneys for Merck have sought to keep portions of the deposition

from jurors, saying they go beyond anything Graham has said

previously. The deposition was seen by the AP.

 

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