Healthy Skepticism Library item: 70

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Publication type: news

Safety issue concerns Grassley: The senator sees his probe of the drug approval process as vital to consumers' well-being.
REGISTER WASHINGTON BUREAU 2004 Dec 15

Full text:

Washington, D.C. – Although he’s 71, the only drug that Sen. Charles Grassley takes is baby aspirin, which his doctor advises to guard against a heart attack.

Nonetheless, the Iowa Republican said he fully understands the apprehension and confusion that might be felt by Iowans who take prescription drugs after revelations of problems in the drug-approval process at the Food and Drug Administration. The disclosures came during a congressional hearing that Grassley spearheaded.

“I would advise a single individual to always talk to your doctor,” Grassley said. “Ask the doctor if they have full confidence in what the FDA has said about a particular drug. That’s what I would do if I was prescribed something that had bad news about it.”

Grassley, who is chairman of the Senate Finance Committee, began to push the issue of drug safety this year when he questioned FDA actions in connection with warnings on antidepressants.

In November, an FDA scientist, Dr. David Graham, charged in a Grassley-led hearing that the agency is “incapable of protecting America” from more drug disasters such as those linked to Vioxx.

The popular and heavily marketed painkiller – with $2.5 billion in sales in 2003 – was taken off the market Sept. 30 by its maker, Merck & Co., after public release of a study that linked it to heart attacks and strokes if taken continuously for 18 months or longer. Graham also raised questions about five other prescription drugs.

The black eye for Merck and the FDA and the splash of national publicity did not sit well with everyone in Congress.

“One or two senators, who will go unnamed, have told me I had no business having that hearing,” said Grassley, whose committee has no direct control over the FDA.

In addition, “some staff have told my staff that ‘Merck’s a good supporter of the Republican Party – why are you doing this?’ “ Grassley said.

Campaign finance records compiled by the Center for Responsive Politics show Merck vaulted from 17th place in 2002 into fifth place in 2004 among drugmakers contributing to federal candidates and parties.

Merck’s political action committee, employees and family members gave 72 percent of their contributions to Republicans – including $1,500 to Grassley, who during his recent re-election campaign was repeatedly criticized by Democratic opponent Art Small for accepting so many campaign contributions from pharmaceutical companies.

Grassley said that he accepts campaign contributions as long as they have no strings attached, and that he assumed Merck’s PAC had probably given to him just as others had who were interested in contributing to the senator who oversees Medicare. “It didn’t stop me from doing what had to be done,” he said.

His interest in cracking down on the industry predated Election Day, he said. He cited letters he wrote last spring questioning an FDA decision to not make public a scientific report that eventually led to a public health advisory on antidepressants.

This probe probably has more of a direct effect on consumers than any other he has undertaken, Grassley said. “(FDA) shortcomings can probably have more of a negative impact on safety and public health than any of the agencies I’ve ever dealt with,” he said.

Since the hearing, Grassley has asked for an investigation by the inspector general for the Department of Health and Human Services into whether upper-level staff members at the FDA attempted to discredit Graham.

In June, he had also asked the Government Accountability Office, an investigative agency, to look at the relationship between the Office of New Drugs, which approves drug licenses, and the Office of Drug Safety, where Graham is the associate director for science. Grassley said in a letter that the Office of New Drugs appears to “often and dramatically” influence the other office, which is supposed to safeguard the public.

Lester Crawford, acting FDA director, has issued statements assuring the public of the safety of the drug-approval process.

But Sandra Kweder, deputy director of the Office of New Drugs, recently acknowledged in an interview with Cox Newspapers that “there are a lot of concerns out there” about how the FDA is performing.