Having a Little Work Done (at the Mall)

January 13, 2008 on 5:02 am | In Uncategorized | Comments Off

ANDREW RUDNICK snickered when he first saw a medical spa offering Botox and laser hair-removal services on a visit to a Las Vegas mall in 2002. He laughed at the thought of someone — anyone — shopping for the latest fashions, grabbing a bite to eat and then, oh yeah, strolling in for a quick shot of Botox to zap out a nasty wrinkle.

“I couldn’t understand why anybody in a mall would walk in and have their legs lasered, never mind Botox,” he recalled. He parked himself on a bench near the spa and watched in amazement as shoppers strolled in. He owned a weight-loss and laser center in Boston at the time, and the sight was a revelation. “I counted the traffic in and out and saw the revenue, and said, ‘Wow! This is a retail business.’ ”

Returning to Boston, he scouted retail locations. He dropped the weight-loss part of his business to focus on skin care and laser treatments, renamed the company and opened his first Sleek MedSpa that same year. He has since opened six more — near Boston and in New York and Florida, all in upscale malls or retail areas. “It took off like a bat out of hell,” he said.

Thanks in part to television shows like “Extreme Makeover” and “Nip/Tuck,” the number of Americans seeking chemical peels, laser procedures, Botox shots and wrinkle-filler injections is soaring. According to the American Society for Aesthetic Plastic Surgery, such “noninvasive” treatments have increased more than 700 percent since 1997. Botox received Food and Drug Administration approval in 2002.

THE stampede of doctors and entrepreneurs rushing to fill that demand has left some doctors and plastic-surgery trade groups wondering about the expertise of some of the people providing these services. For many Americans, price and convenience come first, with few questions about the experience and qualifications of the person injecting the treatments.

For its part, Sleek MedSpa says some of its outlets have on-site physicians while others have doctors as medical directors off-site, and nurse practitioners and physician’s assistants who handle day-to-day treatments. If there were an emergency a nurse couldn’t handle, the nurse would call 911, Mr. Rudnick said. He added that no such emergency had ever arisen.

Kim Wanderley, 39, a stay-at-home mom from Parkland, Fla., said she thought it was “great” when she spotted a Sleek MedSpa at the Town Center mall in Boca Raton in 2006. “If it had been in Ohio, people might have blinked twice, but this is South Florida,” where vanity rules, she said. “People do not take aging lightly, without a fight, here.”

While Sleek MedSpas lack the feng-shui ambience of a traditional beauty spa, they don’t exude the sterile atmosphere of a doctor’s office, either. The spa in Boca Raton is contemporary and sophisticated, Mrs. Wanderley said, with videos of cosmetic procedures streaming across a flat screen, skin-care products lining another wall and before-and-after picture brochures scattered around the waiting room.

And it’s convenient. “I can be in and out in a half-hour,” she said, and “it gives me an excuse to go to the mall afterward to do a little shopping.” If a procedure causes redness or bruising, the spa offers a convenient back-door exit to the parking lot.

Mrs. Wanderley acknowledges that 10 years ago, she would have thought this “way too excessive and ridiculous,” she said. “But now I’m one of the bozos on the bus.” She started out requesting microdermabrasion facial treatments and has since added Botox shots and Restylane filler injections to her medspa repertoire.

Mr. Rudnick estimates that 50 percent of his company’s mall clients are walk-ins like Mrs. Wanderley. Sleek MedSpa’s revenue, which was $1.5 million in 2002, surged to more than $14 million in 2007, Mr. Rudnick says, and he expects that total to double this year. Profit margins are in the 20 to 25 percent range, he said, and over the next four years he expects to open 40 more locations in 25 cities.

Sleek MedSpa is among dozens of companies operating medical spas, often called medspas. Hannelore Leavy, founder and executive director of the International Medical Spa Association, estimates that there are 2,000 to 2,500 medspas nationwide, up from 25 in 2002.

There has also been a surge in the number of nonsurgical cosmetic procedures. Of the 11.5 million cosmetic procedures performed in 2006, more than four in five were noninvasive treatments, according to the aesthetic plastic-surgery society. From 1997 to 2006, the number of surgical cosmetic procedures rose 98 percent, and noninvasive treatments jumped 747 percent.

Nonsurgical treatments “are effective, they’re safe and they’re affordable — and there’s no down time,” said Dr. Foad Nahai, a plastic surgeon in Atlanta and president of the society.

Some doctors’ offices are joining in. In New York, Dr. Bruce K. Moskowitz, an ophthalmologist and oculofacial plastic surgeon, says demand on the cosmetic side of his business has skyrocketed, to 50 percent of his business, from 25 percent 15 years ago. To meet demand, he opened a medspa in his office; patients in the waiting room can read brochures about Botox and fillers when they come in for eye checkups.

Dr. Moskowitz’s qualifications for cosmetic procedures run long and deep, given that he had been using Botox for facial twitching disorders as far back as 1991, long before the F.D.A. approved it for cosmetic use. And his oculofacial expertise gave him insight into how facial muscles and nerves respond to filler injections and other cosmetic treatments.

Industry experts attribute the surge in cosmetic procedures to aging baby boomers as well as to television shows.

Marian Salzman, author of more than a dozen books on cultural trends and current affairs, said she predicted 10 years ago in “Next: Trends for the Near Future” that cosmetic procedures would become mainstream.

Affordable and walk-in cosmetic surgeries were among the trends she had forecast, Ms. Salzman said. “I used to say they’re going to be as prevalent as salons,” she recalled, adding that “people used to roll their noses up at me and say it’s obscene, it’s ridiculous.”

The youngest boomers, those born from 1955 to 1964, are driving the trend, she said. “They will do absolutely anything to prolong youthfulness to stay in the game,” she said, “and if that means a filler here or Botox there or hair implant there, then so be it — they’ll do it.”

At the same time, television shows helped make cosmetic procedures appear safe and stylish. By the time the Mötley Crüe frontman Vince Neil went under the knife in 2005 before millions of viewers on “Remaking Vince Neil” on VH1, cosmetic surgery had truly arrived in mainstream America.

“Virtually every office patient I see talks about the reality TV shows,” says Dr. Paul Wigoda, a plastic surgeon who runs a cosmetic surgery business in Fort Lauderdale, Fla., owns the MeDaySpa in Miami Beach and is medical director of two Sleek MedSpas in Florida. After watching the shows, he says, patients feel more comfortable about the procedures.

DR. NAHAI and other plastic surgeons worry that shows like “Extreme Makeover” gloss over the risks, and edit out the bruising and recovery. “I tell every patient — forget the word ‘cosmetic,’ and remember the word ‘surgery,’ “ he said. “And there’s no such thing as surgery without risk.”

Lou Gorfain, an executive producer of “Extreme Makeover,” which was broadcast on ABC, dismissed such criticism, saying, “We did show the bruising and the pain and risky surgery that it is.” And Linda Klein, a producer and medical adviser of “Nip/Tuck” on FX, said the series tries to show that surgery is “not a pretty sight” — and emphasized that the show is fictional.

The death of Kanye West’s mother in November, from complications following a tummy tuck and breast reduction surgery, pushed concerns about procedures into the spotlight.

Sometimes, surgical horror stories can make noninvasive procedures look more attractive. Still, even nonsurgical procedures, like Botox shots and laser treatments, have their own risks, especially if the person giving the treatment isn’t fully trained, cautioned Dr. Richard D’Amico, president of the American Society of Plastic Surgeons and chief of plastic surgery at the Englewood Hospital and Medical Center in Englewood, N.J. In the wrong hands, he said, lasers can burn and Botox can cause drooping eyelids or paralysis until the toxin wears off in three to six months.

In the most dire case, if an injection gets into a blood vessel and the product gets into the retinal artery, a patient could be blinded, Dr. D’Amico said.

He said it was crucial that people check the credentials and experience of those who offer cosmetic treatments.

Even the kind of doctor needs to be scrutinized, he said. In the past, cosmetic procedures were done solely by plastic surgeons, dermatologists and ocular plastic surgeons. Today, even podiatrists and dentists are moving into the field. No federal or state laws regulate what doctors can or cannot do once they have state licenses, according to the American Society of Plastic Surgeons.

Some just take weekend courses on cosmetic procedures and then set up shop, Dr. Nahai said. Only those certified by the American Board of Plastic Surgeons have undergone formal training of at least six years in plastic surgery and passed an exam on the procedures, Dr. D’Amico said.

Taking a weekend course or watching someone on a DVD isn’t enough, Dr. Nahai said. “If an airline told you the pilot had simply watched someone fly a plane as his only training, would you want him to take you up in the air?” he asked.

Many people are attracted by the price, savoir-faire settings and convenience of medspas. Unlike doctors’ offices, most are open seven days a week.

Kristen Salera, 24, from South Weymouth, Mass., started getting chemical peels after seeing a Sleek MedSpa in Braintree, Mass., last year. Troubled by acne, she had been curious about cosmetic procedures but had never consulted a plastic surgeon. After dropping into the medspa, she was impressed with the staff and the cost.

“Friends who went to a medical office paid double what I was paying,” she said. Later, she signed up for mesotherapy, in which injections go into areas of fat, to dissolve hard-to-lose cellulite on her upper thighs.

Many experts say medspas are in their infancy, with tremendous growth potential. Aging baby-boomers are driving much of the demand, with 12,000 Americans turning 50 every day, or one every eight seconds, according to AARP. “This is a huge market,” said John Buckingham, chief executive of Solana MedSpas, a development and consulting company that helps doctors and entrepreneurs set up medspas.

New drugs on the horizon may bring more price competition, thus attracting more consumers. The Medicis Pharmaceutical Corporation is awaiting F.D.A. approval of a Botox alternative, Reloxin; it is expected to get the green light in 2008 and will compete head-to-head with Botox, from Allergan.

Most of the youth-enhancing effects of Botox and cosmetic fillers wear off within three to nine months, making it necessary for patients to get repeat shots. This aspect makes industry experts view the business as largely recession-proof.

The treatments are also seen as a stepping stone to possible plastic surgery. “This is a gateway drug. I started with microdermabrasion and already I’m doing Restylane as well,” said Mrs. Wanderley, who doesn’t rule out plastic surgery at some point.

IN addition to Sleek MedSpa, the industry includes chains like Sona MedSpa International, Pure Med Spa, Dermacare Laser and Skin Care Clinics and American Laser Centers, which was recently sold to two private equity firms for about $230 million.

Despite the boom, some other medspas have flopped. Skin Nuvo International, which operated 40 mall-based clinics, had problems with its hair-removal equipment and wound up filing for Chapter 11 bankruptcy protection in 2005. And HealthWest Inc. and SkinKlinic have closed shop.

Mr. Rudnick is bullish on the sector’s growth and is already planning a network of full-service cosmetic surgery facilities. The first opened adjacent to his New York medspa in October.

“We know one thing for sure: people aren’t getting any younger,” he said. “We know another thing for sure: they all want to look younger.”

Food From Cloned Animals Seems Safe, a Panel Finds

January 12, 2008 on 5:41 am | In Uncategorized | Comments Off

Meat and milk from cloned animals seem to pose no special health risks, said a draft report released Friday by the European Food Safety Agency. It was a first step toward the eventual sale of such products within the European Union.

“It is very unlikely that any difference exists in terms of food safety between food products originating from clones and their progeny compared with those derived from conventionally bred animals,” the report said.

It acknowledged that cloned animals were prone to more diseases than conventionally bred animals, but it added that humans would not suffer because unhealthy clones would be excluded from the food chain as is the case with conventionally bred animals.

The decision prompted an immediate outcry from environmental groups, which already were at odds with the agency over its conclusion that there was “no evidence” that genetically modified crops posed a health or environmental risk.

Helen Holder of Friends of the Earth International, an environmental group, said from Brussels that Friday’s decision was “weak and unsatisfactory.” She continued: “They clearly acknowledge that these animals have more diseases and that there is only limited data about the environmental impact. And then they go on to conclude that meat and products from cloned animal products are O.K. for Europeans to eat. It makes no sense.”

The European Food Safety Agency is a scientific body that advises the European Commission, which asked for its opinion on cloned animal products early in 2007. Its ruling is not binding and does not take into account the ethical aspects of cloning, which will be reviewed separately by the European Group on Ethics in Science and New Technologies, an advisory panel.

The decision also does not take into account European public opinion, which strongly favors natural foods. “So now we feed our animals with genetically modified plants. And the animals will be clones,” Ms. Holder said. The European public “doesn’t want these things.”

Based on the expert panels’ opinions, the European Commission will decide whether to allow the sale of such products on the Continent. But under international trade law, it is difficult for the commission to exclude unpopular products that its scientific advisers say are safe.

Last year, the World Trade Organization concluded that European efforts to ban genetically modified crops constituted an unfair trade barrier. The commission is under threat of penalties if member states do not open their markets to such products. Many areas, including large parts of Greece, Italy and Austria, have refused.

Friday’s decision was particularly important because the United States Food and Drug Administration is also expected to rule this month on the safety of products from cloned animals. It, too, is expected to conclude that the products are safe. That could allow commercial production of such products to move forward. There is currently a moratorium, although a fledgling agricultural cloning industry in the United States is waiting for a green light.

The possibility that meat and dairy products from cloned animals could soon arrive on Europe’s doorstep prompted the European Commission to action.

“As the technology has developed, so does the possibility that such products will come on the market, which is why E.F.S.A.’s scientific advice on the matter is important,” said Karen Talbot, a spokeswoman for the agency, which is based in Parma, Italy.

While cloning animals is still a young and inefficient technology, scientists expect it will improve greatly in the coming years. Using the process, the genes from an animal with desirable characteristics are inserted into an unfertilized egg. The egg can then grow into an exact duplicate of the “parent” animal.

In theory, the procedure can produce meatier cows or pigs that are better able to resist diseases.

In practice, the process produces a relatively high proportion of deformed animals that cannot survive, although scientists with the European Food Safety Agency said such rates were likely to decline as the technology improved.

James Kanter contributed reporting from Paris.

Merck Licenses Bone Drug for Generic Sale

January 12, 2008 on 4:58 am | In Uncategorized | Comments Off

Merck & Company said on Friday that it had signed a deal for an authorized generic form of its blockbuster osteoporosis drug Fosamax to become available after the United States patent on the drug lapses on Feb. 6.

“We can confirm an authorized generic deal for Fosamax has been signed, although specific details of the deal are proprietary,” said a Merck spokesman, Ron Rogers.

Fosamax, with the chemical name alendronate, has annual sales of about $3 billion, making it the world’s top-selling osteoporosis drug. Now available in a once-weekly formulation, it was the first member of the widely used family of treatments known as bisphosphonates that inhibit cells called osteoclasts, which break down bone tissue.

An authorized generic is a copycat form of a company’s branded medicine that is sold through a licensing agreement, usually with a generic-drug manufacturer. Such deals allow the original seller of a branded drug to hold on to more revenue from the medicine once it loses patent protection and becomes prey to competition from generics.

An authorized generic can significantly hurt sales of rivals waiting to be introduced once a branded drug’s patent lapses.

Analysts have said cheaper generics will not only batter sales of Fosamax, but could also hurt another once-weekly bisphosphonate, Actonel, sold by Procter & Gamble and the French drug maker Sanofi-Aventis.

Boniva, a newer bisphosphonate sold by Roche Holding and GlaxoSmithKline, is taken only once a month.

Barr Pharmaceuticals said Friday that it planned to introduce its generic version of the basic 70-milligram form of Fosamax on Feb. 6.

Study Finds Possible Targets for H.I.V. Drugs

January 11, 2008 on 9:12 pm | In Uncategorized | Comments Off

Using a new type of genetic screen, researchers at Harvard Medical School have identified 273 proteins that the AIDS virus needs to survive in human cells, opening up new potential targets for drugs.

Their work, published online on Thursday by Science magazine, used RNA interference to screen thousands of protein-making genes; previously, scientists had identified only 36 human proteins that the virus uses to break into cells, hijack their machinery and start reproducing.

“This is just terrific work,” said Dr. Robert C. Gallo, director of the Institute of Human Virology at the University of Maryland and a co-discoverer of the virus. “I think it’s destined to be one of the top papers in this field for the decade.”

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases and the government’s top AIDS expert, called the Harvard team’s work “elegant science,” but added a caution.

“It remains to be seen if any of these proteins they identified are useful clinically,” Dr. Fauci said. “This is hypothesis-generating, not hypothesis-solving. It creates a lot of work — someone has to go down each of these pathways.”

The lead author on the paper, Dr. Stephen J. Elledge, is a geneticist, and this is his first work on the human immunodeficiency virus, which causes AIDS. His previous work has been on cancer, Dr. Elledge said, trying to figure out how cells sense when their chromosomes are broken, and this paper was a collaborative effort.

“I can’t even grow H.I.V. in my lab,” Dr. Elledge said, so he had to use virus grown by Dr. Judy Lieberman, director of the medical school’s AIDS division and one of the co-authors.

Dr. Elledge’s team used a library of tens of thousands of different short interfering RNAs, bits of genetic code — each of which, when introduced into a cell, knocks out the cell’s ability to make a single protein.

Next, about 21,000 samples of cells, each crippled in its ability to produce one protein, were placed in separate wells on laboratory plates and dosed with the virus.

If the virus could not reproduce normally in a given well, it suggested that the missing protein was one of those it needed.

Of the 273 human proteins identified, only 36 had been previously found by other methods.

The virus, which is itself only a short string of genetic material inside a protective capsule, can make only 15 proteins, so it has to adopt human proteins to its own use.

The advantage of targeting human proteins is that the virus would presumably not be able to mutate to avoid drugs that block them, Dr. Elledge said. Right now, virus strains evolve resistance to antiretroviral drugs, which attack the 15 proteins made by the virus itself, like reverse transcriptase and protease. The mutations force AIDS patients to switch drug regimens — not always successfully.

The disadvantage is that blocking human proteins can, obviously, be fatal to humans. But, as Dr. Gallo pointed out, cancer therapy works that way — doctors try to block proteins that feed fast-growing tumor cells without killing too many other fast-growing cells, like those in the bone marrow.

Right now, Dr. Elledge said, only one drug that targets one of the known human proteins, a receptor called CCR5, has been developed, and it has just won approval.

The new screening technology, known as siRNA, is now used in many laboratories, so this work could theoretically have been done elsewhere, or by using older, more laborious methods.

Dr. Elledge said he benefited from working at Harvard, which could afford the expensive robotics and imaging technology needed.

“And I had lots of collaborators and very dedicated people,” he said.

To confirm that the newly identified proteins were important to the life cycle of the virus — which Dr. Elledge described as “opaque” — the team ran further tests on three of them.

Many of the proteins identified by the screen are already known to be important to cells in the immune system, which is the port of entry for H.I.V.

Dr. Abraham L. Brass, a co-author, said the screening method undoubtedly missed other proteins the virus needs, “but the majority of the ones we found are highly likely to play a role in H.I.V. propagation.”

Books of The Times: A Physician Caught Trying to Heal Himself

January 11, 2008 on 5:04 am | In Uncategorized | Comments Off

“Corpses had always made me queasy,” Sandeep Jauhar writes in “Intern,” the brutally frank chronicle of his medical apprenticeship. Dead bodies lead a long list of aversions. When giving a rectal examination to one patient, he turns aside and vomits. Unpleasant odors and icky tactile sensations disturb him.

Rarely has a more conflicted or unpromising candidate entered the field of medicine, and this mismatch gives “Intern” its offbeat appeal. There are many accounts of American medical training, but none related by a narrator quite so wobbly, introspective, crisis prone and fumbling.

In a book filled with colorful medical anecdotes, Dr. Jauhar’s own case stands out. Half the time it’s not clear whether he should be treating others or others should be treating him, which does in fact happen when he develops a herniated disc midway through his training, complicated by a deep depression associated with a rolling existential crisis. The inside look at the workings of the medical internship system is fascinating, but it cannot compete with Dr. Jauhar’s own psychological adventure, a quasireligious journey from agnosticism to robust faith, with occasional dips into outright atheism.

Dr. Jauhar, now the director of the Heart Failure Program at Long Island Jewish Medical Center and an occasional contributor to The New York Times, opted for medical school just as he finished his doctoral dissertation on quantum dots. Years of training as a physicist went right out the window when, in one of his many episodes of self-doubt, he questioned the value of his work and his ability to rise to the top. A career-guidance test found that he was best suited to be a lawyer, a college professor, a human resources director or a flight attendant.

For Dr. Jauhar’s parents, who emigrated from India when he was a child, medicine had always been the favored choice. His older brother, Rajiv, was already well on his way to a successful career as a cardiologist. Breezy, confident and ultracompetent, Rajiv serves as a maddening counterfoil to his struggling younger brother, whose waffling and zigzag career path infuriates their father. “You like to blow on cold milk,” he complains.

Dr. Jauhar enters his new profession determined to avoid what he calls “cookbook medicine” and eager to find creativity and beauty. In his first year as an intern, simply learning the recipes and mastering basic techniques nearly kills him. The patients are not too safe either. It takes a strong stomach to read Dr. Jauhar’s description of his fumbling attempt to tap into an artery for the first time.

The workload is crushing, the information flow seemingly unmanageable. There are too many patients to care for, too much personal history to absorb, too many decisions for a sleep-deprived brain to make. “It was hard to develop perspective because everything seemed equally necessary,” Dr. Jauhar writes of his training at New York Hospital in Manhattan.

He was afraid: “When you didn’t know what you were doing from moment to moment, it seemed like anything could happen.” When he wasn’t afraid, he worried that he was shortchanging patients. “If you did everything, you felt overwhelmed,” he writes. “If you didn’t, you felt guilty.”

After sweeping changes in training first proposed in the late 1980s, hospitals no longer keep interns on call for days at time, but Dr. Jauhar argues that the new system, with shorter shifts, has its own shortcomings. Interns do not follow a case over several days. Instead each new shift starts from scratch.

“Which was safer: to be cared for by a fatigued resident who knew you, or a rested resident who did not?” he writes. The answer is not clear.

Then again, Dr. Jauhar is a great doubter. In his darkest moments he fails to see the point of intensive-care units, where doctors often seem to pursue extreme methods, practically torturing patients, simply out of the compulsion to act. “So much of what doctors did in the I.C.U. seemed to be of marginal benefit, action for no good, clear, definable purpose,” he writes.

Medicine itself could seem almost fraudulent at times. Weary of ordering nonessential tests simply to protect himself, Dr. Jauhar sinks into despondency. What was the point? “Most of my patients were going to be fine despite anything I did, and if they were going to die — well, that was probably going to happen despite me, too,” he writes. Perhaps journalism might be a better career choice, he wonders. Dad tears his hair out. Rajiv tells him not to worry so much. “You can’t save everyone,” he says cheerily.

Small moments of satisfaction carry him along. He visits a dying patient at home, unheard of and, at his hospital, highly suspect. He receives a dressing down. Making a house call without supervision has exposed the institution to legal risk. He learns to surrender some of his anxieties, a natural consequence of increasing competence, and to lower his expectations. “For most of internship, I had been tormented by an ideal, which I had to get rid of in order to survive,” he writes.

After months of self-torment and vacillation, Dr. Jauhar achieves something like peace. He discovers that he likes being a doctor and that, amazingly enough, he’s rather good at it. There’s a nice moment late in the book when he savors the early evening mood in his ward. The patients have eaten dinner, and the chaos of the day has subsided. The hospital floor feels like a village, and as he makes his rounds, he regains the sense of personal contact, the beauty and creativity, that drew him to medicine in the first place.

It is a remarkable transformation. Dr. Jauhar presented the American system of medical education with its stiffest test yet, and it passed with flying colors. Against the odds it turned him into a doctor.

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