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Battle for drug safety moves to House floor

Trust in our drug safety system continues to erode. A March 2007 Consumer Reports national poll found that more than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect them from harmful prescription drugs.

People died while taking Vioxx and Paxil, due to side effects not fully explained but slowly emerging as millions of people began to take the drugs. The FDA approves new drugs quickly, often based on tests conducted on just a few thousand subjects. Once approved and widely advertised, the drugs may prove more dangerous than originally thought, but the FDA doesn’t have the tools it needs to rapidly respond and effectively notify doctors and the public.

Legislation is on the way: Proposals to empower the FDA to protect you–and to reinvigorate the reputation of our drug safety system–must pass this year, but the best reforms may not get into the bill unless lawmakers see strong grassroots support. The best proposals are currently incorporated into HR 1561 (Waxman/Markey) introduced in the House.

This bill would require:

  • a warning symbol for the first two years a new drug is out on the market–you should know that the drug’s safety isn’t fully understood yet.
  • ongoing review of a drug’s safety during the first 7 years after the drug has been on the market to identify and assess side effects that may have emerged.
  • drug companies to perform follow-up safety studies on a drug once on the market, and change warning labels at FDA request if serious hazards appear–with the authorization for harsh fines on companies that fail to take corrective action.
  • drug companies to limit direct-to-consumer ads for up to three years for high risk drugs.
  • release to the public all clinical trial findings (other than Phase 1 trials conducted early in the develpment process).

Congress must act now to give the FDA the authority it needs to require drug companies to conduct follow-up safety studies on drugs, make changes to a drug’s label where safety problems arise, and publicly disclose ALL drug side effect information.

Here’s what the New York Times recently opined about the broken state of our drug oversight system:

New York Times
May 14, 2007
The Danger in Drug Kickbacks

The explosion in the use of three anti-anemia drugs to treat cancer and kidney patients illustrates much that is wrong in the American pharmaceutical marketplace. Thanks to big payoffs to doctors, and reckless promotional ads permitted by lax regulators, the drugs have reached blockbuster status. Now we learn that the dosage levels routinely injected or given intravenously in doctors’ offices and dialysis centers may be harmful to patients.

As Alex Berenson and Andrew Pollack laid bare in The Times on May 9, wide use of the medicines—Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — has been propelled by the two companies paying out hundreds of millions of dollars in so-called rebates. Doctors typically buy the drugs from the companies, get reimbursed for much of the cost by Medicare and private insurers, and on top of that get these rebates based on the amount they have purchased.

Although many doctors complain that they barely break even or even lose money on the costly drugs, for high-volume providers the profits can be substantial. One group of six cancer doctors in the Pacific Northwest earned a profit of about $1.8 million last year thanks to rebates from Amgen, while a large chain of dialysis centers gets an estimated 25 percent of its revenue, and a higher percentage of its profits, from the anemia drugs. It seems likely that these financial incentives have led to wider use and the prescribing of higher doses than medically desirable.

Although the drugs are deemed valuable in fighting severe anemia, there is scant evidence they help much in moderate cases and some evidence that high doses can be dangerous. Half of the dialysis patients in this country are now receiving enough of the drugs to raise their red blood cell counts to levels deemed risky by the Food and Drug Administration. And last week a panel of cancer experts urged the F.D.A. to impose additional restrictions on use of the drugs in patients receiving cancer chemotherapy, based on studies that the drugs might make some cancers worse or hasten the deaths of patients.

Use of Procrit has also been fueled by television ads suggesting that it makes elderly cancer patients more energetic and, pushing all the emotional buttons, allows them to keep up with their grandchildren. That claim has not been established to the F.D.A.’s satisfaction, and a top official said last week that his agency owes the public a good explanation for why it allowed the ads to continue.

With any luck, the advisory panel’s concerns should cause many oncologists to think twice before dispensing the anti-anemia drugs. But the surest way to slow the overprescribing is to stop the rebates. Federal laws already bar drug companies from paying doctors to prescribe medicines in pill form. That prohibition should be extended to injected and intravenous medicines.

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