NEWS - US FDA Scientist Won't Present new Pain Drug Data

[Guest guest]

US FDA Scientist Won't Present new Pain Drug Data

Feb 14, 2005 - By Heavey

WASHINGTON (Reuters) - A veteran scientist at the U.S. Food and Drug

Administration said on Monday he had decided against presenting new data on

the heart risk of pain relievers at a highly anticipated meeting later this

week, saying he felt intimidated by FDA officials.

Graham, associate director for science and medicine at the FDA's

Office of Drug Safety, had planned to present the as-yet-unpublished

information to a panel of health experts who will discuss safety issues with

pain relievers like Merck & Co. Inc.'s now withdrawn Vioxx.

The FDA called for the public meeting after several studies showed a link

between some of the drugs and heart attacks or strokes. The experts will

also discuss whether Pfizer Inc.'s Celebrex and Bextra, drugs similar to

Vioxx, should remain on the market.

But Graham told Reuters in an interview that an e-mail from his supervisor

Seligman said that if he continued to press for inclusion of the new

data he would be doing so at his own risk.

" The tone of it is (that) I'm being insubordinate, " he said.

An FDA spokeswoman said agency officials told Graham it was his choice as to

whether he wanted to present. " We just prefer that published literature be

presented, " she said.

But Graham said it was not a real choice. " Because I feel so threatened by

management, it's not worth taking the risk, " he said he told his

supervisors.

The study in question examined data from California's Medicaid program,

called Medi-Cal, and is larger than any previous related study and looked at

more than 15,000 heart attack patients, Graham said.

" Our findings are important to the safety of a number of marketed pain

relievers, " he said.

The pain medicines, a type of non-steroidal anti-inflammatory drug (NSAID),

are part of a class known as -2 inhibitors.

At a congressional hearing in November, Graham testified about his worries

over the agency's handling of drug safety.

His testimony, which included warnings about other drugs he considered

unsafe, caused the FDA to defend its drug approval process and raised

concerns of public interest groups and others about whether the 20-year

agency veteran would be fired or reassigned.

" This is an instant replay, " said Graham, who is scheduled to speak on the

second day of the three-day meeting due to start on Wednesday.

Graham said managers had not " spoken to me to say 'your perception is

wrong " ' about the risk to his job or to encourage him to present the new

findings.

Sen. Grassley, chairman of the Senate Finance Committee that held

the November hearing, said the FDA first told Graham he could not present

the study but later, in Seligman's e-mail, said it was Graham's decision to

make.

In part of the e-mail quoted by Grassley, Seligman said, " I think we've

already articulated our preference that your talk cover the key studies in

the published literature. Clearly, you would like to cover more than this

which is your call. "

Grassley said Graham was " being sent mixed messages. "

" Dr. Seligman is clearly saying to Dr. Graham proceed at your own risk, " the

Iowa Republican wrote in a letter to FDA Acting Commissioner Lester Crawford

sent late Monday.

Grassley also questioned the FDA's defense that only published studies

should be presented, noting that Graham was reportedly asked to present

information from an unpublished Merck study.

http://abcnews.go.com/Health/wireStory?id=499676

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org