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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The Public Editor The Sources’ Stake in the News

By CLARK HOYT
Published: January 16, 2010

WHEN The Times interviewed Michael Chertoff about airport security after the underwear bomber tried to blow up a passenger jet on Christmas Day, he said full-body scanners should be deployed at airports. Chertoff, the former secretary of homeland security, did not volunteer that he is a consultant to a company that makes such equipment, and though they spoke to him twice, reporters never asked if he had a financial stake in the matter.

Peter Galbraith, a former diplomat, wrote several Op-Ed columns a few years ago supporting a strong and independent Kurdistan. The editors who published his pieces learned only in November — from a front-page article — that Galbraith’s business ties to a Norwegian oil company operating in Kurdistan positioned him to earn millions.

Jonathan Gruber, a prominent M.I.T. health economist, wrote an Op-Ed column and was quoted frequently in other Times columns, news articles and blogs on health care reform before it came to light that he had a contract worth nearly $400,000 to analyze health proposals for the Obama administration.

Neil Sadick, a famed Manhattan dermatologist, was quoted in a Skin Deep column discussing electronic devices for the home treatment of acne, but the article did not say that Sadick has a business relationship with a company that makes one of the devices.

These examples have resulted in five embarrassing editors’ notes in the last two months — two of them last week — each of them saying readers should have been informed of the undisclosed interest. And on Thursday, the standards editor sent Times journalists a memo urging them to be “constantly alert” to the outside interests of expert sources. The cases raised timeless issues for journalists and sources about what readers have a right to know and whose responsibility it is to find it out or disclose it.

The ideal expert source is entirely independent, with no stake in an outcome. But in reality, the most informed sources often have involvements, which is why they know what they know. Readers are entitled to disclosure so they can decide if there is a conflict that would affect the credibility of the information.

But each recent Times case showed how tricky it can be to navigate the ethics of disclosure.

Chertoff, who championed full-body scanners as head of the Department of Homeland Security, long before he went into private business, said it was no secret that he had become a consultant to corporate clients through the Chertoff Group, a risk-management firm he formed in March. He said that when two Times reporters, Eric Liptonand John Schwartz, called and the subject turned to scanners, it was up to them to ask whether he had ties to that industry. “I always answer when I’m asked,” he said. “But I don’t think it is my obligation to put myself in the head of a reporter” to decide what the reporter needs to know.

Chertoff did tell NPR and CNN interviewers when they asked.

Lipton and Schwartz agreed that they should have asked Chertoff, but both expressed disappointment that he did not volunteer obviously germane information. Bob Steele, a professor at DePauw University and a journalism values scholar at the Poynter Institute, said, “I believe a source does have an affirmative obligation to reveal any competing loyalties, even if the source isn’t sure they create a direct conflict of interest.”

Interestingly, Chertoff wrote an Op-Ed article for The Washington Post, published New Year’s Day, that carried a one-sentence biography divulging that his clients included a scanner manufacturer — a note he said he volunteered.

“If I’m affirmatively getting out there,” he said, as opposed to being called by a reporter, “I make it my business to disclose.” That’s a distinction I don’t buy. What difference does it make whether a source seeks a forum or a reporter happens to call? Knowing Washington’s culture of revolving doors and news spin, the Times reporters should have asked the obvious question. But if Chertoff had a connection he thought the public needed to know in one instance, he should have made it clear in the others.

Galbraith said he regretted not telling Times editors that he had business interests in Kurdistan when he wrote Op-Ed columns published in 2005 and 2006. He did provide a vague disclosure for one in 2007. But he disputed the November editors’ note that said he could have benefited from an independent Kurdistan because he had a stake in an oil field there.

He said his support of an independent Kurdistan was against the interests of DNO International, the oil company with which he had a relationship, because it had invested $300 million in Iraq, expecting it to remain unified. “I did not promote or discuss matters of specific interest to my clients and, indeed, my generally pessimistic view of Iraq’s future was not consistent with the interests of companies trying to attract investors for projects in the country,” he said.

Galbraith asked where the line was if an Op-Ed contributor was writing about political issues in a country where he also had economic interests. Because politics and economics so often go hand in hand, I would say someone in his shoes should disclose all interests to editors and discuss whether any pose a conflict that needs to be disclosed to readers. That is what The Times requires of all Op-Ed columnists, in plain, written language.

Gruber, the health care economist, wrote an Op-Ed column in July supporting an excise tax on so-called Cadillac health plans. Not long before, he had signed a contract with the Department of Health and Human Services to analyze the economic impact of various health care proposals in Congress. He did not tell Op-Ed editors, nor was the contract mentioned on at least 12 other occasions when he was quoted in The Times after he was consulting for the administration. After a blogger reported on Gruber’s government contract on the Daily Kos Web site, Gruber did volunteer it to Steven Greenhouse, a Times reporter interviewing him for an article on the excise tax. Greenhouse said he included the fact in a draft but struck it because the article was too long. Greenhouse said that Gruber’s views on the tax were so well-known that he did not think they would be influenced by a consulting contract. But had he realized how large the contract was, Greenhouse said, “I would have stood up and paid lots more attention.”

Gruber said, “I guess it never occurred to me that the fact that I was doing technical modeling would matter.” He said he has long supported the tax and that the administration opposed it when he wrote his column, so he was hardly bending his views to a government paymaster.

Sometimes, there can be misunderstandings even when a reporter asks. Camille Sweeney, the freelancer who interviewed Sadick about acne treatments, said she asked the dermatologist a specific question: Had he been paid by any manufacturer for tests he performed on the products? He said he had not. But after the article was published, a Times editor recalled seeing an endorsement by Sadick for a hair removal product by one of the manufacturers.

What is the lesson from all this? Lipton said, “I do need to ask whenever I call a person for comment as an expert if they have any financial relationship with the topic.” He said he has posted a reminder on his computer: “Ask if hired gun.”

Botched Laser Doctor-Beware

Surgery at a Spa? Buyer Beware.

Béatrice de Géa
New York Times


Published: November 4, 2009

THERE is little to suggest that the TriBeCa MedSpa in Manhattan is a medical facility, at least in the traditional sense. In the waiting area, called the Tranquillity Room, a waterfall cascades down one wall. A client may have a pedicure or facial before entering a softly lighted space where a plastic surgeon performs laser Fraxel treatment or some other minimally invasive procedure that would cost twice as much in a harried doctor’s office.



TriBeCa MedSpa is one of 1,800 medical spas in the United States, hybrid facilities that offer treatments like laser hair removal and liposuction alongside massages and other traditional spa fare. In recent years, the business has become a growth industry: from July 2007 to December 2008, the number of medical spas increased 85 percent, according to the International Spa Association, far outpacing the growth of day, destination and resort spas.

The kinds of procedures performed in medical spas has also increased. At the Park Avenue Medical Spa in Armonk, N.Y., for instance, clients who have undergone chemosurgery for skin cancer, which may leave the skin pitted, can receive reconstructive surgery, a treatment that falls outside the strictly aesthetic category and may point in the direction the industry is evolving.

“It certainly seems like the wave of the future,” said Dr. Gerald Ginsberg, a cosmetic surgeon and medical director of the TriBeCa MedSpa, who noted that, increasingly, patients are becoming “customers” searching for the best deal in what he calls “today’s medical emporia.” All the more reason, in his mind, that it is important to enforce regulations “to ensure we’re offering the best care for the best price.”

In fact, despite the many well-regarded facilities like TriBeCa MedSpa, the rapidly growing industry is coming under increased scrutiny. Proposed legislation to tighten controls over the credentials of those who can own a medical spa; what procedures can be performed in such places; and how much training someone must have to perform particular procedures is making its way through several state medical boards, including those in Massachusetts, New York, Utah and Florida, where the death last month of a patient, Rohie Kah-Orukotan, is generating renewed concern.

On Sept. 25, Mrs. Kah-Orukotan, a 37-year-old nurse, entered the Weston MedSpa in Weston, Fla., for a minimally invasive liposuction procedure to remove fat from her abdomen and thighs. During the treatment, she suffered seizures and never regained consciousness.

Michael Freedland, the family’s lawyer, said she was given Lidocaine and propofol, a drug that induces sedation and is believed to have contributed to the death of Michael Jackson.

The case, which is still under investigation, raises several issues that concern experts around the country. First, should the treatment — which may actually have been, by the state’s classification, a more advanced, or Level II, liposuction procedure — have been performed at Weston MedSpa, which is licensed as an electrolysis facility, not a medical facility?

“We believe Mrs. Kah-Orukotan received more than a minimally invasive Level I liposuction procedure in a setting that was inappropriate,” Mr. Freedland said. In fact, a new rule before the state’s board of medicine would not allow any surgical procedure that requires sedation to occur outside of a registered Level II surgery facility.

And then there is the question of the experience of the doctor who performed the procedure on Mrs. Kah-Orukotan. Dr. Omar Brito Marin, a medical doctor with a specialty in occupational medicine, learned liposuction in a three-day intensive course, according to his lawyer, Brian Bieber, who said he believes no malpractice was committed in the case.

For some industry observers, the issue of training and experience is the cause for perhaps the greatest concern. Dr. Darrick Antell, a plastic surgeon in Manhattan, noted that all too frequently someone who starts out performing one procedure migrates to another with only minimal experience. “Someone may start out doing laser hair removal, and next thing you know they’re doing treatments for cellulite,” said Dr. Antell, who said that personnel in medical spas are pushing the boundaries of what is allowed.

Wendy Lewis, an aesthetic surgery consultant and author of “Plastic Makes Perfect,” said: “The incident in Florida is nothing short of tragic, and I feel for that woman’s children and family. But I say, buyer beware.”
Such sentiment applies to another popular medical spa procedure: laser hair removal. For years, complaints of second- and even third-degree burns from laser hair removal procedures have been reported. Yet in places like New York State, it is still not considered a medical procedure, despite vigorous protests from many in the medical community.


“In New York, legally, even a barber could do it, not that he would,” said Dr. David Goldberg, a cosmetic dermatologist in New Jersey, New York and Florida, as well as a law professor at Fordham University and a legal counsel to the Medical Spa Society.

In Massachusetts a medical spa task force has been set up to advise the state legislature on how best to regulate the facilities. “We are trying to set some standards here, yet make it flexible enough to accommodate rapid changes in the industry,” said Russell Aims, chief of staff of the Massachusetts Board of Registration in Medicine.

“We don’t want to say to the consumer, ‘Don’t go get these procedures done,’ or to a physician that he or she can’t profit from this potentially lucrative business, but I think it’s around the time I saw a place offering walk-in Botox shots at a mall that I became concerned,” Mr. Aims said.

“To me it’s a lot like the mortgage industry,” said Dr. Ranella Hirsch, a dermatologist in Cambridge, Mass., and an advocate for more stringent regulations of medical spas. “While it may allow more accessibility to treatments and procedures, it’s also brought a much higher level of permanent injury,” she said. Dr. Hirsch added that she thinks a system of federal regulations of medical spas would be more cohesive than the current state-by-state model but believes that is unlikely to happen, since medical and other professional boards, like nursing, electrology and aestheticians boards, are regulated and licensed by individual states.

“What is likelier to happen (and currently under way) is that national organizations like the American Society for Dermatologic Surgery, which represents member dermatologists nationwide, provide guidelines for legislative guidance state by state,” she said in an e-mail message.

Despite all the safety and regulatory controversies concerning medical spas, there are thousands of satisfied medical spa customers. Among them is Gail Fox of Palm Beach Gardens, Fla., who went to the Anushka Cosmedical Center Spa and Salon in West Palm Beach, for facial fillers that were administered by a nurse practitioner and found the experience “a pleasure.” “The service was on sale so the price was right. That’s what drew me in. The pace was slower than at my dermatologist’s office. All my questions were answered, and I didn’t feel pressured,” Ms. Fox said.

“These places can offer a wonderful opportunity for a consumer to reduce stress and get treatment for the whole body,” said Lynne McNees, president of the International Spa Association. But, she added, “just because someone is in a white coat, it doesn’t mean he or she is a qualified to perform a procedure on you.”

Both Ms. McNees and Hannelore Leavy, executive director of the International Medical Spa Association, emphasized the efforts their associations are making to educate the medical spa consumer. For instance, Ms. Leavy’s organization has a section on its Web site that pertains to current legislation affecting medical spas.

“If someone is cutting you open or injecting something into you it’s not a spa service, it’s a medical one,” Ms. McNees said. “You’re going to need to know who is performing that procedure, know their credentials and accreditations and really do your homework,” she said. “I tell everyone, ‘If you don’t know, don’t go.’ ”

The Alternative Medicine Cabinet: Arnica for Pain Relief By Anahad O'Connor

What alternative remedies belong in your home medicine cabinet?

More than a third of American adults use some form of complementary or alternative medicine, according to a recent government report. Natural remedies have an obvious appeal, but how do you know which ones to choose and whether the claims are backed by science? Today, New York Times “Really?” columnist Anahad O’Connor begins a weekly series exploring the claims and the science behind alternative remedies that you may want to consider for your family medicine cabinet.

The Remedy: Arnica

The Claim: It relieves pain.

The Science: Arnica Montana, a plant native to mountainous areas of Europe and North America, has been used for centuries to treat a variety of pain. Athletes rub it on muscles to soothe soreness and strains, and arthritis sufferers rub it on joints to reduce pain and swelling. It’s believed that the plant contains derivatives of thymol, which seems to have anti-inflammatory effects.

Either way, scientists have found good evidence that it works. One randomized study published in 2007 looked at 204 people with osteoarthritis in their hands and found that an arnica gel preparation worked just as well as daily ibuprofen, and with minimal side effects. Another study of 79 people with arthritis of the knee found that when patients used arnica gel twice daily for three to six weeks, they experienced significant reductions in pain and stiffness and had improved function. Only one person experienced an allergic reaction.

The Risks: Arnica gels or creams can cause allergic reactions in some people, but it is generally safe when used topically. However, it should never be rubbed on broken or damaged skin, and it should only be ingested when in a heavily diluted, homeopathic form

New York nips facelift firm for astroturfing

But they're still grinning...

By Austin Modine

Posted in Music and Media, 15th July 2009 18:35 GMT

A facelift firm is being slapped with a $300,000 fine by New York state for flooding the internet with fake positive reviews about itself.

State Attorney General Andrew Cuomo said the case is believed to be the first in the US to punish so-called "astroturf" marketing.

Under a settlement deal announced Tuesday, the cosmetic surgery outfit Lifestyle Lift agreed to cut out publishing anonymous positive reviews about the company on internet message boards and websites and pay the state $300,000 in penalties.

Lifestyle Lift, which mostly targets consumers though infomercials as a "minor one-hour" facial firming procedure, has a history of aggressively guarding its reputation online. The company has filed several lawsuits alleging trademark violations against websites that publish negative reviews or comments about the company.

Cuomo's office alleges Lifestyle Lift's president decided negative internet postings were causing a significant loss of face and ordered his employees to pose as satisfied customers on various internet message boards and websites. Internal emails discovered in the investigation show specific marching orders to engage in the illegal activity:

"Friday is going to be a slow day - I need you to devote the day to doing more postings on the web as a satisfied client," one email to employees read.

"Put your wig and skirt on and tell them about the great experience you had," stated another.

Lifestyle Lift also created stand-alone websites and blogs made to appear as if they were created by independent, satisfied customers.

"I decided to create this website because I wanted to share my story with others," one such website stated. "After my first consultation, I went online and read horror stories about Lifestyle Lift. People were trashing Lifestyle Lift, their employees, their doctors, etc...I got scared and seriously thought about canceling my procedure. I was getting cold feet. What was with all the negative posts online? Those negative stories did not ad up at at...

"I realized quickly that most of that stuff was probably made up: the reviews were using long medical terms that only a doctor would use..." it continued. "I also talked to my doctor about it.... He told me that many of the negative stories I was reading online were probably from envious doctors and just made up because he never heard any of this from his patients."

According to the settlement, Lifestyle Lift employees will no longer pose as customers on the internet. The company also agreed not to promote its services without disclosing they are responsible for the content