[Ezliving_Jim]

Doctor objects to AAD logo appearing on sun protection products
Source: Dermatology Times
By: Lisette Hilton
Originally published: December 1, 2007


Dr. Spencer

National report — A long-time honorary member of the American Academy of Dermatology (AAD) is calling for a special meeting of the AAD membership to debate the academy's "Seal of Recognition" program for sun protection products.

A. Bernard Ackerman, M.D., director emeritus of the Ackerman Academy of Dermatopathology in New York City, says the program represents a "shocking conflict of interest."

Dr. Ackerman says he and some 60 colleagues have submitted a petition asking the AAD to schedule a discussion of the program — which charges manufacturers thousands of dollars for the right to display the academy's logo on sun protection products — at the AAD's February 2008 annual meeting in San Antonio.

The AAD is reviewing the petition, according to spokeswoman Jennifer Allyn.


Dr. Ackerman

Meanwhile, supporters of the program, which was launched in May 2007, say it will greatly enhance the academy's sun education efforts.

Under the Seal of Recognition program, the AAD charges companies thousands of dollars for the right to display the academy's logo on sun-protection products that meet certain criteria. Academy members who back the program say it will greatly enhance the organization's skin cancer education efforts.

"The AAD seal ... will allow consumers to identify products that at least have a basic benchmark of effectiveness," says James Spencer, M.D., M.S., professor of clinical dermatology, Mount Sinai School of Medicine, New York. Dr. Spencer is in private practice in St. Petersburg, Fla., and chairs the academy committee that oversees the Seal of Recognition program.

"All the money generated from this (program) is applied to the review process itself, and to skin cancer education and research. Period," Dr. Spencer says. "It does not go to general operating funds. It does not go into anybody's pockets."


Dr. Lim

But Dr. Ackerman strongly opposes the arrangement.

"I am revolted by it," he says. "The patient should never be used as a vehicle for self-aggrandizement by either an individual physician or an association of physicians."
In a letter to the AAD, Dr. Ackerman says the AAD membership should debate the seal program, then vote on whether the academy should rescind it, at the proposed special session in February. Dr. Ackerman says he has more than 60 signatures for the petition.

One dermatologist who says he may sign the petition is Peter C. Lombardo, M.D., who practices in New York City and is past president of the New York State Society of Dermatology. Dr. Lombardo, like Dr. Ackerman, says the program is unethical and "a slippery slope."

"I am very much against it. I think it has no value whatsoever," he says. "The (academy) does not have an independent testing organization that tests one product against the other and finds out which deserves the Seal of Recognition. And they accept the data from whatever company is willing to pay the fee.

"If you decide not to pay the fee, then you do not get the Seal of Recognition," he says. "So the whole matter is the fee. I think that if the academy needs money, this is not the way to do it. They should raise dues."

Program details
According to AAD press materials, for a product to receive the AAD Seal of Recognition, it must meet all these criteria: It must have a sun protection factor (SPF) of 15 or higher; it must provide evidence of broad-spectrum protection (protection against both UVA and UVB rays), evidence of water resistance and product stability and evidence of phototoxicity testing; and it must comply with the Food and Drug Administration (FDA) Sunscreen Monograph.

Before granting the use of the AAD seal to a product, the academy's Melanoma/Skin Cancer Committee reviews each application and the corresponding documentation to ensure the product meets the program criteria.

Products applying for the seal must submit extensive formulation and scientific testing data. Once approved, the product must display the following statement: "The American Academy of Dermatology recognizes this product for its sun-protection benefit."

Companies must pay a $10,000 fee per product to apply for the logo and an additional $10,000 annual fee per product to use it. Proceeds are earmarked for the AAD's skin cancer prevention effort and will not be distributed elsewhere, according to AAD vice president Henry W. Lim, M.D., chairman, department of dermatology, Henry Ford Hospital, Detroit, Mich.
Nothing new?

One well-publicized case of such a program gone sour occurred during the latter 1990s, when the American Medical Association's board agreed to an exclusive endorsement of several Sunbeam healthcare products in return for royalties of potentially $2 million a year, according to an Oct. 20, 1997, article in Physician's Weekly.
Any revenue from the deal was intended to help fund AMA public health campaigns, according to a Sept. 8, 1997, article on CNN Money.

AMA members and the public were so up in arms about the move that the AMA tried to withdraw the deal, and Sunbeam sued for breach of contract. Executive AMA heads fell, and the icon organization paid a reported $9.9 million as a settlement to Sunbeam Corp. and attorneys, according to an article in the Aug. 17, 1998, American Medical News.

Proponents say that while the AMA's effort crashed, others have not. They say the AAD is a latecomer among nonprofit organizations when it comes to commercially lending its name and credibility, and that many of these programs have been successful revenue-generators and long-running.

The American Dental Association permits use of its logo on Crest toothpaste. The Skin Cancer Foundation's Seal of Recommendation has been awarded, for a fee, to hundreds of sun-protection products. The American Cancer Society lends its name to Neutrogena sunscreens for a reported $300,000 annual fee.

'Not our place'
Still, Dr. Ackerman sees problems with the AAD program on several fronts.

The AAD did not hold a referendum of the membership when it decided to approve the program, he says. Dr. Ackerman says he is alarmed that the academy, itself, does not test the products but rather reviews data supplied by the companies.

And he says he does not understand why the academy does not offer the service for free instead of charging what he says is an outrageous amount.

"This is symbolic, emblematic of what has happened to American medicine and dermatology, in particular," he says. "This kind of thing must be stopped, because it erodes society."
Dr. Ackerman does not think that a medical organization should sell products under any circumstances.

The trend is a "slippery slope" toward promoting cosmetics and other products, Drs. Ackerman and Lombardo say.

"Next they are going to want to do things like clothing to protect from the sun; then cosmeceuticals," Dr. Lombardo says.

Counterpoint
Dr. Lim says the Seal of Recognition program is not so much a promotion of products as it is recognition that products meet basic criteria for sun protection.
"It is based on a set of objective criteria, and the process is that the products would be reviewed by an independent consultant to make sure that the products fulfill and meet the criteria that have been set," he says.

In fact, Dr. Lim says, the academy has contracted with an independent photobiologist, who has no financial conflict of interest with any company in the sun protection industry, to review the data.

The AAD's board of directors has discussed this type of program many times over the years, Dr. Lim says.

"It has been discussed very thoroughly, and the final decision for approval was (made) by the board of directors," he says. "The reason that the board agreed on and approved this program is that we are comfortable with the criteria that we have set, and we are confident with the process — that it is an independent and very objective process.

"We are comfortable with the knowledge that the proceeds coming from this Seal of Recognition will be used to support public education on skin cancer prevention, which has long been a mission of the academy."

Dr. Spencer says company-submitted data is accurate because the information is what the companies provide the FDA.

"Sunscreens are regulated as drugs by the FDA; they are not cosmetics," he says. "Let me assure you that there is no way that these companies would defraud the FDA. Defrauding the FDA is a federal crime."

As for whether this is a "slippery slope," Dr. Spencer says the Seal of Recognition program is limited to sun protection products and is not applicable to beauty products.

However, there is a proposal before an AAD committee, he says, requesting that the seal program not only be available for sunscreens but also for sun-protective clothing, hats and laundry products with sun protection.

Searching for answers
One dermatologist says he's now more comfortable with the seal program, after seeking additional information.

When he first heard about the seal, Samuel L. Moschella, M.D., senior consultant, department of dermatology, Lahey Clinic Medical Center, Burlington, Mass., says he e-mailed the academy that he was very concerned about potential ethical and legal issues.

But he says he feels more at ease now that he understands the review process.

"I did not understand the whole program until I called the academy and had a half-hour talk with various members ... whom I respect. There are controls," Dr. Moschella says.

"Superficially, you may make assumptions that are unrealistic, and that is what I did. I am now comfortable with the board's decision to go on and approve the approach to this program."

But Mark A. Hurt, M.D., a dermatopathologist in Maryland Heights, Mo., who is an affiliate AAD member, remains against the Seal of Recognition.

Dr. Hurt says he sees the program as a conflict of interest for the AAD. He is a clinical instructor (unpaid) at Washington University School of Medicine, department of internal medicine, division of dermatology, St. Louis, and clinical associate professor (unpaid) at St. Louis University, St. Louis.

"The AAD, in my opinion, should be a forum for the exchange of ideas and not a clearinghouse to endorse specific products for money, which is what they are doing," he says.