Friday, March 14, 2008

Skin for Sale - "prostituting" dermatologists


No - it's not about Eliot and Kristen. Although there are similarities (see the quote in red, below).

From Howard Wolinsky, Contributing Writer, MedPage Today :

The American Academy of Dermatology is locked in a furor with a subset of its membership over whether to sell its name, prestige, and a special seal for endorsement of commercial sunscreens.
The imbroglio has an eerie similarity to the infamous Sunbeam logo-for-sale scandal that rocked the AMA a decade ago.

The AAD's internecine squabbling has featured strong invective between the academy's leadership and a former AAD board member, A. Bernard Ackerman, M.D. (pic), a dermatopathologist from New York, who considers the seal plan disgraceful and a sellout of ethical principles.

The academy leadership believes Dr. Ackerman is living in a day gone by, in a time when a thick wall still separated academia and the pharmaceutical industry.

The bickering reached the stage of an angry exchange between the academy's counsel, Rob Portman, and Dr. Ackerman, a prominent member of the AAD.

Dr. Ackerman alleged that the attorney tried to censor a presentation at a special session on the issue at the academy's annual meeting in San Antonio. The attorney had no comment on the allegations and Dr. Ackerman's presentation was given as planned.

Dr. Ackerman, who received the "Master Dermatologist Award" for outstanding contributions to dermatology from the AAD in 2004, minced no words on his distaste for the plan. In interviews with MedPage Today, he dismissed academy protestations concerning extensive testing of the endorsed products.

He argued that testing isn't the point. The point, he insisted, is that taking money for an endorsement for any product, even a sunscreen, crosses an ethical line into the dark side for an academic group such as the AAD. Dr. Ackerman is a professor of dermatology and pathology at SUNY Downstate Medical Center in Brooklyn.

Even though the academy is charging only $5,000 to apply for an endorsement, and then $10,000 annually, Dr. Ackerman likens this to the not-so-fine line between an inexpensive prostitute and an expensive one.

In that, he was backed by Arthur Caplan, Ph.D., director of the Center for Bioethics at the University of Pennsylvania. "I can't believe they're this stupid in this day and age when you've got people on the prowl everywhere looking for conflicts of interest," said Dr. Caplan. "It's worse than selling indulgences. It's just flat-out prostitution."

The academy's leadership, for its part, views the seal program as educational, a proper role for an academic group. In addition to selling its name for use on sunscreens, it also plans to put its imprimatur on other sun-protection products, including cosmetics/moisturizers, clothing, hats, laundry additives, shade structures, and window films/tints.

The AAD has set minimum standards for each product category and has an independent scientist evaluate applications, including companies' documentation from independent labs.
The academy maintains that the AAD Seal of Recognition program, which has a special seal rather than using the AAD logo, in no way resembles the AMA's misbegotten endorsement programs for Sunbeam.

The academy's program focuses on its mission to educate the public about the importance of sun protection. Yet the AMA also said it planned to use funds from Sunbeam for public health education programs.

The AAD allocated up to $550,000 to establish the seal program. Last year, the academy accepted the first two sunscreen products into the AAD Seal of Recognition program. Both were Johnson & Johnson Aveeno Sunblock Lotions with SPF 55.

The AAD stressed that, unlike the AMA's Sunbeam deal, the academy's program was not an exclusive endorsement. Stephen Stone, M.D., a dermatology professor at Southern Illinois University School of Medicine, who was AAD president when the organization adopted the seal program two years ago, also noted that the AAD will rely on independent testing provided by manufacturers in deciding whether to grant its seal.

James Spencer, M.D., a St. Petersburg, Fla., dermatologist, who chairs the AAD Seal committee, said the point of the program is to drive the use of sunscreen. "There's no debate on the desirability of using sunscreen within the dermatology community. It's a good idea -- like brushing your teeth. The American Academy of Dermatology would like to do everything it could possibly think to do to lower the incidence of skin cancer. Everything."

Diane Baker, M.D., of Portland, Ore., the immediate past president of the AAD, said that by requiring manufacturers to prove broad-spectrum protection against UVA and UVB, the program has standards that exceed the FDA's simple labeling of SPF.

Dr. Baker said the academy is raising the bar by factoring in UVA protection in sunscreens and moisturizers/cosmetics.

"What makes Dr. Ackerman uncomfortable and indeed many people uncomfortable," Dr. Spencer said, "is that there's a fee. And the appearance is, 'Gee, well, is this a fundraiser?' And the answer is no. The idea of this is to be revenue neutral, just to cover administrative expenses." Any money left over is earmarked for public education on skin cancer.

Dr. Ackerman scoffed at this. Dr. Ackerman said, "That's not the issue. This is the business of what you charge as a prostitute. Are you a $5 hooker? Or are you a $5 million hooker? The AAD just didn't think as big as the AMA."

He said he was puzzled by AAD's rates: "They don't do their own testing. And it costs all that money to have someone look at their data?"

Dr. Spencer portrayed the $5,000 charge as minuscule for major manufacturers. He said, "The AAD's annual operating budget is $34 million. C'mon. Five thousand, $10,000 is not going to affect them."

Dr. Spencer also minimized membership interest in the issue, noting that only 80 dermatologists, mainly from Dr. Ackerman's home turf in New York, signed a petition calling for a meeting. He said the issue did not even draw a quorum at the special meeting here.
But Dr. Ackerman said he only needed 50 signatures from members and obtained them from New York but also elsewhere around the country from dermatologists concerned about the future of their specialty and their profession.

The absence of a quorum, he asserted, was because the AAD gave the membership only 10 days notice of the special meeting and scheduled it at a time when most members had already gone home.

Dr. Baker, who runs a clinical research firm with her allergist husband, stood by the seal program. She also believes that in the modern world physicians and their associations need to work hand-in-glove with industry on behalf of patients.

"It gets right down to whether you believe that a professional organization should take donations in any form from or have any kind of financial relationship with pharmaceutical companies or not," she said. "I think Dr. Ackerman believes we should not. I think there is a more practical group of individuals who know that we live in the United States of America and that we need each other."

"The pharmaceutical industry is the industry that provides medication to our patients," she continued. "They need physicians because we are the ones that prescribe it. And patients need both. We have to find a way to work with industry that is of benefit and doesn't require or pose a conflict of interest or at least limit that as much as possible. To me, that gets down to doing what's in the best interests of the patient. We envisioned this program as a way to help physicians advise their patients."

Countered Dr. Ackerman, "An academy is an academy. It's supposed to be academic. AAD is far from it."

In the presentation that the AAD attorney allegedly tried to censor, Dr. Ackerman showed slides he said were based on information from the AAD and faculty disclosures. Dr. Ackerman said six of seven AAD officers in 2006 and four of seven in 2007 had ties to companies that manufacture sunscreens.

During the special session, he targeted in a slide presentation:
*Dr. Spencer for consulting for IVAX, L'Oréal and Neutrogena, makers of sunscreens.
*Dr. Baker for a consulting arrangement with Basilea Pharmaceutica, Ltd., L'Oréal, OrthoNeutrogena, Merck, Connetics, and Galderma, all of which manufacture sunscreens.
*Dr. Stone for serving as a consultant to Procter & Gamble and Bradley Pharmaceuticals, makers of sunscreen.

*Henry Lim, M.D., vice president of the AAD and chairman of the AAD Council on Science and Research, for ties to Johnson & Johnson, the first company to be awarded the Seal of Recognition for its Aveeno sunscreens. Dr. Lim broke two appointments for interviews and failed to respond to e-mails from MedPage Today.

Dr. Baker said, "I do not feel that I have a personal conflict of interest with regards to the relationships I've had with industry. We sign contracts with them to provide a service for doing these clinical investigations and we follow the protocol."

She said her research arrangements had nothing to do with another division of that same company receiving a Seal of Recognition for its sunscreen.

Moreover, Dr. Baker said that when she had dealings with drug companies, she tried to "make it as clear as possible that I, as a private practitioner, this is part of my relationship with you and it has nothing to do with me being president of the American Academy of Dermatology or immediate past president as I am now."

Dr. Stone, in an e-mail, confirmed he has had an advisory relationship with Bradley on a new medication for genital warts, and with P&G on matters unrelated to sunscreens.
He said that prior to email query from MedPage Today, he was unaware of a Bradley Pharmaceutical sunscreen.

He said, however, that to "the best of my knowledge, neither of those companies has applied for the seal."

But he had no objection to either company applying for the seal, which he said was "available to any sunscreen manufacturer that produces a sunscreen which meets certain evidence-based criteria for sun protection."

Dr. Spencer said that two years ago, while on the faculty at Mount Sinai School of Medicine in New York, he "consulted, meaning giving advice as a practicing physician," but that did not create a conflict of interest.

The criteria for receiving the Seal of Recognition are "public and verifiable and evenly applied to all applicants," Dr. Spencer said.

Moreover, Dr. Spencer flatly denied receiving any payments or personal benefits from his work with the seal program.

Dr. Baker said Dr. Ackerman is a purist and that physicians need to work with industry on behalf of the public's health.

Dr. Ackerman said it is unacceptable for the doctors involved in the seal program to have been involved with companies that made sunscreen, no matter whether they were consulting on products other than sunscreens.

Dr. Stone said, "Clearly, if the AAD is going to take a position on sunscreens in any way, they will be bringing into the process the most knowledgeable experts in the field -- and equally obviously, those experts are the ones most likely to be used as consultants and researchers by companies in that arena."

Dr. Ackerman described Dr. Stone's response as "an exercise in sophistry and duplicity." He said it mattered "not a whit" that he does not discuss sunscreens with the companies for whom he consults. "The conflict of interest is that he serves as consultant to companies that manufacture sunscreens at the same time that he, as president, advocated a seal program to an academy that then promotes the products of those companies."

Dr. Baker said she was "a little disappointed that Dr. Ackerman chose to make it a more personal attack on conflict of interest and I personally don't believe I have any conflict of interest in supporting this program for the academy. I feel I don't stand to gain anything financially from it in any way."

Dr. Spencer dismissed Dr. Ackerman as "our (AAD) gadfly."

MedPage Today

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