NEWS - Lawmaker Calls for FDA Whistleblower Inquiry

[Guest guest]

Reuters

Wed 24 November, 2004

Lawmaker Calls for FDA Whistleblower Inquiry

WASHINGTON (Reuters) - A U.S. lawmaker called on Wednesday for a probe

of reports that Food and Drug Administration officials tried to

discredit a veteran scientist who testified over Merck & Co. Inc.'s

withdrawal of Vioxx.

In a letter to the Department of Health and Human Services, Senate

Finance Committee Chairman Sen. Grassley asked whether agency

managers contacted a whistle-blower protection group to tarnish the

reputation of Graham, the associate director for science in the

Office of Drug Safety.

Grassley, an Iowa Republican, asked the department's Acting Inspector

General Levinson to look into the charges immediately and

coordinate with committee staff by Dec. 1.

The request follows media reports that some FDA managers called The

Government Accountability Project, saying Graham had intimidated other

staffers and that his data was an example of misconduct. The reports

first surfaced online in the British Medical Journal on Tuesday.

Graham himself contacted the group first after he started to feel

intimidated by his superiors while preparing his congressional

testimony, the medical journal said.

If FDA managers did make the calls, Grassley wrote, " it appears that

these activities may have been coordinated by FDA management and may

have involved the misuse of government resources, including government

property and time. "

Grassley's letter followed last week's Finance Committee hearing over

the FDA's oversight of Vioxx, which Merck pulled from the market after a

study found the painkiller can cause heart-related complications and

death.

Graham told the hearing he felt pressured to change his findings, based

on patient insurance records, that Vioxx users had a 50 percent greater

chance of heart attack and sudden cardiac death than people who took

Pfizer Inc.'s Celebrex.

Graham, after testifying, said he was " certainly " concerned about

returning to work. " I was frightened before. Senior management at FDA

did everything in their power to intimidate me prior to my testimony, "

he said.

Graham could not immediately be reached on Wednesday. The Government

Accountability Project did not return calls seeking comment.

FDA spokesman Brad Stone said the agency acknowledged the right of

employees to raise their concerns to oversight groups but respected

their right to privacy.

" FDA had no prior knowledge of any employee's contact with the

Government Accountability Project concerning this matter, " Stone said in

a statement.

http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews & storyID=6911947 & secti\

on=news

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org