FDA Scientist Won’t Present New Pain Drug Data – FDA to Create Independent Drug Safety Board

Tue, 15 Feb 2005

A culture of intimidation prevents FDA safety officers from disclosing important safety information about widely marketed drugs.

Reuters reports: “Criticism of how the FDA monitors the after-market safety of drugs has grown in the past year, starting with concerns about suicides in youth who took antidepressants and followed by Merck’s September withdrawal of Vioxx. Questions have also been raised about the safety of Pfizer Inc.’s Celebrex and Bextra, painkillers similar to Vioxx, and about whether they should remain on the market.”

Dr. David Graham’s testimony before the Senate Finance committee about the undisclosed lethal effects of painkillers such as Vioxx, and about FDA’s incapacity to prevent future lethal drugs from being widely marketed, was the catalyst for an upcoming 3 day hearing this week.

Reuters reports: “The FDA called for the joint meeting of its Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee late last year, after several studies showed a link between some of the drugs and heart attacks or strokes.”

But Dr. Graham, a senior FDA safety officer, is prevented from testifying about the the evidence from a large patient database that includes 15,000 patients who suffered heart attacks.

Shouldn’t the public be told as soon as possible about evidence showing a link between increased heart attacks and the other painkillers in the Vioxx class (COX 2 inhibitors)– Celebrex and Bextra? Dr. Graham has indicated that FDA administrators are intimidating him to the point that he fears for his job.

Reuters reports that the Secretary of Health and Human Services announced the formation of a safety monitoring board (DSMB) ‹thereby conceding that FDA’s current safety monitoring of drugs is deficient. It is unclear, however, under whose jurisdiction the safety monitoring board will function? Who the DSMB will be accountable to? And Who will determine the composition of the board?

Clearly, the safety monitoring board must be separate and apart from the Center for Drug Evaluation & Research (CDER)‹or it will lack the necessary independence to assure the public that drug safety is the priority, not an inconvenience.

That FDA administrators are attempting to silence their own safety officer from presenting evidence of drug-related harm to an advisory panel convened for that purpose does not speak well of FDA’s good faith!

Contact: Vera Hassner Sharav
212-595-8974

http://www.alertnet.org/thenews/newsdesk/N14672365.htm
US FDA scientist won’t present new pain drug data
14 Feb 2005 23:05:37 GMT
Source: Reuters
By Susan Heavey

WASHINGTON, Feb 14 (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, saying he felt intimidated by FDA officials.

David Graham, associate director for science and medicine at the FDA’s Office of Drug Safety, had planned to present the as-yet-unpublished information at a public meeting of a panel of health experts to discuss safety issues with pain relievers like Merck & Co. Inc.’s now withdrawn Vioxx.

The FDA called for the joint meeting of its Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee late last year, after several studies showed a link between some of the drugs and heart attacks or strokes.

But Graham told Reuters in an interview that an e-mail from managers said that if he continued to press for inclusion of the new data he would be doing to 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.

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 and discuss whether Pfizer Inc.’s Celebrex and Bextra, drugs similar to Vioxx, should remain on the market.

The pain relievers, a type of non-steroidal anti-inflammatory drug (NSAID), are part of a class known as Cox-2 inhibitors.

On Friday, Sen. Charles Grassley, chairman of the Senate Finance Committee that held the November hearing, asked FDA officials why the agency denied Graham’s request.

“Given the urgent regulatory and drug safety issues… why did FDA management not prioritize internal review of the Medi-Cal study for presentation,” the Iowa Republican wrote in a letter.

“Our findings are important to the safety of a number of marketed pain relievers,” said Graham, who is represented by legal counsel from the whistle-blower protection group Government Accountability Project,

But on Monday 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.

FDA to Create Independent Drug Safety Board
February 15, 2005 11:20:00 AM ET
By Lisa Richwine

WASHINGTON (Reuters) – The U.S. Food and Drug Administration said on Tuesday it was creating an independent drug safety board after the agency’s monitoring of drugs already in the marketplace was criticized amid the withdrawal of arthritis drug Vioxx.

The announcement comes on the eve of a three-day FDA meeting called to discuss the safety of painkillers like Merck & Co. Inc.’s Vioxx that have been linked to an increased risk of heart disease and stroke.

Health and Human Services Secretary Michael Leavitt announced the new safety board in a meeting with FDA staff and was later due to give a news conference.

Criticism of how the FDA monitors the after-market safety of drugs has grown in the past year, starting with concerns about suicides in youth who took antidepressants and followed by Merck’s September withdrawal of Vioxx.

Questions have also been raised about the safety of Pfizer Inc.’s Celebrex and Bextra, painkillers similar to Vioxx, and about whether they should remain on the market.

The FDA already has an Office of Drug Safety but consumer groups and some lawmakers have said it lacks sufficient independence and resources.

At a congressional hearing in November, a veteran FDA drug safety scientist testified that the FDA was virtually defenseless against another Vioxx.

The new board will include representatives from the FDA and medical oversight experts from other agencies like the Veterans Administration, an administration official said, and will consult with patient and consumer groups.

The Bush administration proposed a 24 percent increase in funding for FDA’s Office of Drug Safety in its recent 2006 budget proposal, including 25 additional employees.

© 2005 Reuters

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