FDA SUPPRESSED SAFETY STUDY

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FDA SUPPRESSED SAFETY STUDY

" GM WATCH " <info

 

Thu, 2 Dec 2004 11:12:59 GMT

 

 

FDA SUPPRESSED SAFETY STUDY

http://www.gmwatch.org

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So this is the agency responsible for GM crop/food approval. As the

scientist who forwarded this article commented, " This is what you get

when

industry pulls all the strings in Washington! "

 

He also noted, " It is also interesting that The Lancet is yet again at

the centre of another scientific publication scandal; remember it was

its editor Richard Horton that was threatened with having to face the

'consequences' if he chose to publish Arpad Pusztai's and Stan Ewen's

paper. " Their paper exposing the damaging health effects of a GM food was

published after successful peer review despite the campaign to suppress

the findings.

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Nature 432, 537 (02 December 2004); doi:10.1038/432537a

http://www.nature.com/cgi-taf/DynaPage.taf?file=/nature/journal/v432/n7017/full/\

432537a_fs.html

 

Suppressed study raises spectre of flawed drug regulation in US

EMMA MARRIS

 

FDA under pressure to reform after Vioxx is withdrawn.

 

[WASHINGTON] Amid claims that it suppressed publication of a study into

the safety of a painkiller, the US Food and Drug Administration (FDA)

is under increasing pressure to reform the way in which it monitors

approved drugs.

 

Vioxx, a prescription painkiller made by New Jersey-based Merck, was

withdrawn by the company on 30 September after a study it had

commissioned linked the drug to an increased risk of heart attacks.

 

But the FDA — the world's largest drug regulator — is facing detailed

allegations that it pressed one of its top drug-safety officials to

withdraw a paper on Vioxx from publication in The Lancet. The study,

led by

David Graham, associate director for

science at the FDA's Office of Drug Safety, also linked the drug to

heart attacks. Graham estimates that Vioxx has been responsible for

several thousand deaths since it was approved in 1999.

 

On 18 November, Graham, a 20-year FDA veteran, vaulted into the

national spotlight when he testified at a Senate hearing on Vioxx that

the

agency was " broken " . The hearing raised questions about why the FDA

waited

for Merck to take action, when Graham's preliminary data earlier in the

year had suggested that the drug should be withdrawn.

 

Now the agency is under attack for suppressing Graham's Vioxx paper,

which he hoped to publish at the time of the hearing. According to

extracts from e-mails printed in USA Today on 29 November, Steven Galson,

acting director of the FDA's Center for

Drug Evaluation and Research, contacted editors at The Lancet and made

reference to an internal FDA report that contained allegations that

Graham might have manipulated data in his study.

 

Richard Horton, The Lancet's editor, reacted with irritation. " One

could read such an allegation as an attempt to introduce doubt into our

minds about the honesty of the authors, " he wrote, " doubt that might be

sufficient to delay or stop publication of

research that was clearly of serious public interest. "

 

The FDA said in a statement that Graham had submitted the paper

" without going through the long-established peer review and clearance

process

established for scientific papers submitted by FDA scientists " .

 

Graham says that the charges of data manipulation arose from

corrections that he made between an earlier abstract and the final

version of the

paper. He ultimately withdrew the paper on 16 November, saying that he

feared for his job. " I got a very explicit e-mail from Dr Galson saying

I could not let it be published, and if I did, I and The Lancet would

be responsible for the consequences. " He says he may now remove his name

from the study so that it can be published without the need for FDA

approval. " The FDA is engaged in an act of scientific censorship, " he

claims.

 

Under pressure

 

Graham says he is now being pressured by Lester Crawford, the FDA's

acting commissioner, to accept a transfer to a desk job, and expects

to be

ordered to move within the week. " I am a scientist, " he says. " Removing

me would be an act of retaliation. "

 

In a statement, the FDA said that it does not " condone any form of

employee retaliation. In fact, as we have repeatedly stated, we encourage

internal scientific debate. "

 

Alastair Wood, an associate dean of Vanderbilt University in Nashville,

Tennessee, and one-time contender for the post of FDA commissioner,

slammed the agency's response to the Vioxx affair, which he says probably

killed more people than the 11

September terrorist attacks. " We've had a major public-health

disaster, " he says. " Yet we have no forum for open discussion, no way

to move

forward. Instead, each side has got into their bunkers. "

 

And Vera Sharav, president of the Alliance for Human Research

Protection, a New York-based patient-advocacy group, thinks the whole

agency

badly needs shaking up. " The leadership has to go, " she says. " A firewall

has to go up between FDA reviewers and industry. "

 

But criticism of the drug-safety agency is reaching far beyond vocal

groups such as Sharav's. The Journal of the American Medical Association

has just published an editorial calling for the Office of Drug Safety

to be " decoupled " from the rest of the FDA (P. B. Fontanarosa et al. J.

Am. Med. Assoc. 292, 2647–2650; 2004). And Senator Chuck Grassley

(Republican, Iowa), chair of the Senate finance committee, says that

he will

introduce legislation to move it from " under the thumb " of the Office

of New Drugs, the powerful branch of the FDA responsible for drug

approval.

 

 

 

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