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Interesting Article From the New York Times

Posted Apr 06 2010 12:56pm

Beware the Corporate MD Shill


By NATASHA SINGER
Published: January 31, 2010

In the rarefied world of fashion magazines, beauty editors have often relied on a coterie of prominent dermatologists and plastic surgeons to keep them current on advances in cosmetic medicine. This symbiotic relationship has benefited magazines eager for beauty scoops and doctors seeking visibility — and patients.

But now the Food and Drug Administration has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine.

The F.D.A. recently sent a warning letter to Dr. Leslie Baumann, a well-known dermatologist and clinical researcher in Miami Beach, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved.

Dr. Baumann’s comments in the media in 2007 violated restrictions on drug promotion, according to the letter; the agency asked Dr. Baumann to explain how she intended to prevent similar violations in the future.

Under the Obama administration, the F.D.A. has stepped up scrutiny of drug advertising, dispatching many warning letters about misleading commercials and online marketing efforts. But this is believed to be the first time the agency has warned an individual investigator — a medical researcher who oversees a clinical trial — for apparently promoting an unapproved drug.

Dr. Baumann is far from the only cosmetic doctor to have jumped the gun. Some talk show hosts and beauty editors (including this reporter in her previous job at W magazine) have often turned to clinical investigators for news of the latest cosmetic medical treatments.

Now, some industry experts say the F.D.A. warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products — or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.

“It’s a wake-up call,” said Nancy Behrman, owner of Behrman Communications, a public relations firm in Manhattan. Her firm has represented cosmetic medical companies as well as doctors. “The whole business has spiraled out of control, and we need to step back and slow it down.”

Federal rules bar drug makers and investigators on their clinical trials from promoting a drug before the agency has approved the product. Dr. Baumann violated the restrictions, the F.D.A. letter said, because she was an investigator on a clinical trial for Dysport and promoted it well before the drug’s approval in April.

“Early data shows it may last longer and kick in faster than Botox,” Dr. Baumann told the fashion magazine Allure in 2007. She made similar comments that same year to Elle magazine and during an appearance on the “Today” show on NBC in January 2009.

In response to a query from a reporter, Dr. Baumann said in a statement that she had discussed the F.D.A.’s concerns with members of the agency’s staff in a conference call last week and that the agency now considered the matter closed. Medicis Pharmaceutical, which markets Dysport in the United States as treatment for furrows between the eyebrows, was not involved in Dr. Baumann’s comments to the press, the F.D.A. letter said.

Thomas W. Abrams, director of the agency’s Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not promote any unapproved prescription drug — or an unapproved use of an already approved drug — as being safe or effective if the agency has not yet deemed it to be so, he said.

“You can’t promote a prescription drug before it is approved, whether they are diabetes drugs or heart drugs or for cosmetic uses,” Mr. Abrams said.

The federal restrictions are meant to keep drug makers and their clinical investigators from conveying misleading or unduly favorable first impressions about a drug to health care providers or the public, Mr. Abrams said.

Similar restrictions prohibit companies and investigators from promoting an unapproved medical device or the unapproved use of an approved device, the agency said.

Some magazine editors said they hoped the warning letter would not have a chilling effect on investigators, the people who have hands-on experience with experimental drugs and devices.

“There is real value in a doctor involved in a clinical trial because they know about the products in a way that other doctors are only getting by hearsay,” said Linda Wells, the editor in chief of Allure.

Allure has been particularly reliant on Dr. Baumann’s expertise. The monthly magazine quoted her in 10 articles last year and mentioned her in another, according to a Nexis search.

Dr. Baumann, a former professor of dermatology at the University of Miami medical school who recently opened a dermatology research center in Miami Beach, says she has been a clinical investigator or consultant for about 40 makers of drugs, devices or cosmetics
“I understand that as a clinical investigator for many different drugs, I am held to a higher standard than ordinary treating physicians,” Dr. Baumann wrote in a statement sent in response to a reporter’s query.

Medicis, meanwhile, said in a statement responding to a reporter’s question last week that the company “respects and observes the F.D.A.’s prohibitions on pre-approval promotion, which are designed to protect the integrity of the F.D.A.’s product approval process and to further patient safety.”

In the wake of the agency’s warning letter, some often quoted cosmetic doctors like Dr. Fredric S. Brandt, a dermatologist in Manhattan and Coral Gables, Fla., are wondering what they can and cannot say. Dr. Brandt is an investigator and consultant for Medicis; Allergan, the maker of Botox; and Ortho-Neutrogena, as well as an investigator for a dozen other makers of dermatology products.

For many years, Dr. Brandt has held an annual event for beauty editors at the Four Seasons Hotel in Manhattan. At those gatherings, he has recapped cutting-edge developments that he learned about at professional medical society meetings, and he has delivered his own reviews about unapproved products for which he was an investigator.

Dr. Brandt was also the featured guest at a Medicis dinner for beauty editors, held at Le Bernardin in Manhattan two years ago. The invitation to the event promised a discussion on “innovative products on the horizon.” These turned out to include Dysport, a product for which Dr. Brandt was an investigator.

In a phone interview last week, Dr. Brandt said he would continue to talk to journalists about products in the pipeline. But he might limit his future comments to scientific facts and published studies.

“We have been talking about new products in the pipeline for years, and I think there is nothing wrong with that,” Dr. Brandt said. “But we are going to have to keep our opinions to ourselves.”

Medicis declined to comment about the dinner at Le Bernardin.(This reporter attended the event. The New York Times paid for my filet mignon; dinner, with tip, came to $115.54. )

Ms. Wells of Allure said that it was important for her magazine to report on advances in cosmetic medicine, informing readers when products were still under F.D.A. review. Should the new warning letter muzzle clinical investigators, Allure has other resources, she said.

“We hear about products approved in Europe, Canada or South Africa a year before they are approved in the U.S.,” Ms. Wells said. “We will figure out other ways to report the story.”

But Didi Gluck, the executive beauty director at Shape magazine, said she typically waits for federal approval before she publishes information about a cosmetic medical product.

“If it’s still in clinical trials, then it’s of no benefit to the readers anyway, so wait until it is safe for them,” Ms. Gluck said. “That’s what a responsible reporter should do.”

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