FDA fails public, doctor says Nissen

[Guest guest]

FDA fails public, doctor says Nissen

Says agency allows use of unsafe drugs

Wednesday, February 14, 2007

Eaton

Plain Dealer Bureau

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Washington - A prominent Cleveland Clinic cardiologist on Tuesday

accused the Food and Drug Administration of making inappropriate

concessions to the pharmaceutical industry that put dangerous drugs

on the market and let sales continue after safety questions were

raised.

" The American people no longer trust the FDA to protect their

health, " said E. Nissen, head of the Clinic's Department of

Cardiovascular Medicine. He urged Congress to pass legislation to

boost the safety of drugs and medical devices.

Nissen and a half-dozen other witnesses before the House Commerce

subcommittee on oversight and investigations described repeated

cases where the FDA ignored evidence that drugs were unsafe.

" FDA managers were afraid to be perceived as holding up an important

drug, and so they felt pressured to ap prove it, " said Ross, a

former FDA em ployee who told how the agency didn't act on evi dence

that the antibiotic Ketek, made by Sanofi Aventis, causes liver

failure.

The day before the hearing, FDA revoked approval for Ketek's use in

treating acute bacterial sinusitis and bronchitis. The product can

now be used only to treat pneumonia. It will also carry new labels

that warn of potential side effects.

The FDA issued a statement Tuesday that stressed its commitment to

drug safety and said it has " well-established formal dispute

resolution mechanisms " that let employees challenge agency decisions

they disagree with.

" Every drug product has risks, " the FDA statement said. " Each time a

prescription is written, health-care professionals are making an

assessment of whether or not the benefits of a particular treatment

outweigh the risks for their individual patient. "

Democrats on the committee said representatives from the FDA and

drug companies will testify at future hearings. The committee's top

Republican, Joe Barton of Texas, cautioned against rushing to

judgment before the committee gets all the evidence.

Other Republicans were more critical of the FDA. GOP Sen.

Grassley of Iowa, a longtime FDA critic, told the subcommittee the

agency discourages scientific dissent in its ranks, is " too cozy "

with drug makers, and has withheld documents subpoenaed by the

Senate Finance Committee.

" The FDA . . . . needs an overhaul to make the agency more

transparent, more forthcoming, and more independent minded, "

Grassley said.

Nissen described his frustration serving on an FDA advisory panel

that recommended in 2001 that the arthritis drug Vioxx contain a

warning that it could cause heart attacks.

Nissen said it took 14 months before the drug's maker, Merck & Co.,

agreed to accept a weakly written warning.

Another FDA official who testified before the committee, physician

J. Graham, said thousands of Vioxx users died of heart attacks

before Merck voluntarily stopped selling the drug in 2004. He called

FDA a " new drug approval factory " and suggested that preapproval and

postapproval of drugs be handled by different personnel.

After listening to tales of how Vioxx, Ketek, and drugs for diabetes

and ADHD were approved for sale despite evidence of lethal side

effects, members of Congress said changes are needed.

" If the FDA's own medical reviewers are prevented from raising

questions about the safety and effectiveness of drugs, the FDA

cannot possibly fulfill its stated mission, " said Massachusetts

Democratic Rep. Ed Markey.

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