Irritable Bowel Syndrome Message Boards | Doctors group launches war on drug ads

Doctors group launches war on drug ads

American Medical Association seeks waiting period for FDA approval before marketing new prescriptions, devices to public.

By BLYTHE BERNHARD
The Orange County Register

Dr. Melvyn Sterling, internist practicing in Orange
"The reason those ads are there is to sell the drug, not to educate the public."

If there's an ailment, there's an ad for a prescription drug aimed at fighting it � from toe fungus to impotence.

Prescription drug advertising has swelled to a $4.8 billion industry since the U.S. Food and Drug Administration relaxed its restrictions on the ads in 1997, allowing for descriptions of the drugs' purpose. Many doctors say the ads are coming so fast that they don't have time to learn about the benefits and risks of a new drug before patients start requesting prescriptions.

Last month, the American Medical Association asked the FDA to impose a waiting period before new drugs and devices can be marketed to consumers.

"Doctors just want to make sure they have a chance to get up to speed on new drugs before the patients are being urged to seek these medications because of heavy advertising," said Dr. Ron Davis, the association's president-elect.

The ads can disrupt the patient-doctor relationship and contribute to risinghealth-care costs when patients insist on receiving new, more expensive drugs, said Davis, who works in the Henry Ford Health System in Detroit.

The drug industry's lobby, Pharmaceutical Research and Manufacturers of America, is opposed to a mandatory waiting period for drug ads. The lobby has voluntary guidelines encouraging drug companies to educate doctors and submit ads to the FDA for approval.

In response to the medical association's ruling, the lobby released a statement that reads, in part:

"Direct-to-consumer advertising provides doctors and patients with accurate, educational information about disease and treatment options."

Davis acknowledged that drug advertising can raise awareness and encourage communication between doctors and patients, but added that tighter regulations are necessary.

"We hope that the FDA will step forward and show leadership in this area," Davis said. "If that doesn't happen then legislation may be needed to make it a requirement."

Dr. Melvyn Sterling, an internist who practices in Orange, attended the medical association meetings that led to the policy changes. He said people should consider the source when reading or watching drug ads.

"The reason those ads are there is to sell the drug, not to educate the public," Sterling said.

And the ads aren't just coming in magazines and television.

A local pharmaceutical company, Valeant, flies a yellow banner off its Costa Mesa building: "New Zelapar orally disintegrating tablets. Now FDA approved!" The banner doesn't mention what the drug is used for (Parkinson's disease).

Officials for Valeant did not respond to requests for comment for this story. Irvine pharmaceutical company Allergan, which markets wrinkle smoothers and dry eye treatments in magazines, also did not respond.

Drug safety is another reason doctors are hoping for an advertising moratorium. Clinical drug trials sometimes are conducted with too few subjects for serious side effects to show up.

One famous example � the heavily promoted arthritis pill Vioxx � was later recalled because of a serious risk of heart attacks and strokes.

Patients should be aware of safer, cheaper alternatives, doctors said.

"A patient with arthritis should typically be given a trial on regular aspirin," Davis said. "The ads sometimes are for very expensive drugs when there are much less expensive drugs available that the patient should try first � A lot of patients are looking for that magic pill. "

It's not just new drugs for old ailments that concern doctors. Drugs are marketed for conditions that a few years ago didn't have a name: irritable bowel syndrome, restless leg syndrome and female sexual dysfunction, among others. Depending on the marketing, "SAD" can mean seasonal affective disorder or social anxiety disorder.

"To market a drug, it's best to market a disease," said Dr. John Abramson, author of "Overdo$ed America" and a clinical instructor at Harvard Medical School. "Much of the advertising is convincing people that they need drugs when often they don't need drugs, or what's being treated is ordinary, regular life."

Abramson said a moratorium on new drug advertising is a good first step, but that it's getting harder for doctors to find objective information on drugs.

Drug companies sponsor most of the clinical trials that appear in the doctors' medical journals, often next to ads for the drugs.

"There's now much, so much commercial influence that doctors aren't able to get the unbiased, non-commercial scientific truth," he said.

http://www.ocregister.com/ocregister/money/homepage/article_1203782.php

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