Sunday, April 19, 2009

Don’t Let Any Doctor Touch Your Skin…


…until you read this. In search of a good deal, young women are getting laser hair removal from gynos and Botox from dentists—sometimes with disastrous results. Find out how to stay safe.

March 23, 2009
Cosmetic surgery

After saving up for months, Amy was ready to get laser treatments for acne scars on her chin. Then she saw an ad in a local paper for a doctor doing cosmetic work; the prices listed were very reasonable. “I did research and discovered he was board-certified in internal medicine, not dermatology, but I thought, Who cares?” recalls the West Coast resident. “His office was in a fancy zip code, when I met him he seemed competent, and he’d gone to a good school. So I gave myself a thirty-seventh-birthday present.” After two laser sessions, though, her skin was worse—not only did the scars on her chin appear unchanged, but three new ones had cropped up on her cheeks; they looked like red, angry cigarette burns.

Once, only dermatologists and plastic surgeons did in-office cosmetic procedures such as laser work, liposuction and lip plumping. But the booming aesthetic industry has attracted gynecologists, urologists and even oral surgeons who want a piece of this multibillion-dollar pie—and the results aren’t always beautiful.

Close to 60 percent of doctors surveyed by the American Society for Dermatologic Surgery (ASDS) have seen an increase in complications since 2005 from cosmetic work done by nonspecialist M.D.s as well as aestheticians and the like at medi-spas. Derms and plastic surgeons told Glamour about women left with second-degree burns on their pubic area after laser hair removal, lumpy lips from misguided collagen injections and droopy, over-Botoxed lids.

Women in their twenties and thirties are more at risk. Since non-derms often advertise discounted rates, “they tend to attract younger, cost-conscious patients,” notes Susan Van Dyke, M.D., a board-certified dermatologist in Paradise Valley, Arizona, who’s developed a name for herself fixing badly done cosmetic work. “They’re known as ‘derm pretenders,’” adds Kenneth Beer, M.D., a clinical instructor in dermatology at the University of Miami. “Some even list themselves in the phonebook as ‘dermatologists.’”

Statistics show that, despite the ailing economy, procedures like Botox and laser hair removal remain popular among women younger than 35. “Women still want these things,” says Dr. Van Dyke, “but now they want to find the lowest price possible. And that often means poor-quality work.”

Are so-called derm pretenders legal? In a word, yes. “Once medical students have gone through basic training and earned an M.D., they have the right to practice in whatever area of medicine they want to—but that doesn’t mean they are fully trained as specialists,” says Kevin B. Weiss, M.D., president of the American Board of Medical Specialties. Doctors who choose to specialize in one area, such as dermatology, undergo years of residency. And when new technologies crop up, they can take seminars to learn the techniques.

Non-derms who decide to offer cosmetic services may go to some of those same courses. Although laws vary by state about who can actually perform the procedures, sometimes it’s a free-for-all. “Here in Arizona,” says Dr. Van Dyke, “you could be a window washer, go take a class and start doing laser treatments.” That’s where dermatologists are said to have an edge: They typically know exactly how to treat skin complications that may arise.

The trend isn’t going away anytime soon. As insurance companies reduce payments to doctors for basic appointments, a lot of M.D.s say they need supplemental income. “When I was practicing family medicine, I was coming home at nine at night and still not making enough money to support my family,” says one doctor who now does Botox, wrinkle fillers and laser treatments at a California medi-spa. “So are there financial reasons for me to have gone into cosmetic dermatology? Absolutely. But I took many courses and practiced on friends and family before I performed on patients. And when I was on a learning curve, I’d be honest and tell them that I hadn’t done many of those procedures. And I have never had a complaint.”

Others in the medical field are also unconvinced certification in a specialty is critical. “Physicians add to their skill sets all the time with continuing education,” says Lori J. Heim, M.D., president of the American Academy of Family Physicians. “It’s not about who is doing what. The danger to patients comes from people who are not well-trained. It has less to do with what you’re board-certified in.”

Yet that remains a point of contention among top experts. “Board certification in a specialty is the only reliable measure of competence,” says Clarence Braddock III, M.D., associate dean at Stanford University School of Medicine. He also questions doctors who advertise doing cosmetic work: “Persuading patients to get procedures they don’t need raises ethical concerns.” Those ubiquitous WE OFFER LASER HAIR REMOVAL signs in ob-gyn offices can make women uncomfortable too. As Lily Hamburger, 23, a staffer at a nonprofit group in Washington, D.C., puts it, “I do not want to worry that my gynecologist is judging the way I look down there.”

With the economy in free fall, a number of reputable dermatologists are offering patients more value for their money. “Some have promotions, such as if you get your lips plumped up, the second syringe of filler may be less expensive,” says Dr. Van Dyke. But be wary of doctors who advertise rock-bottom prices or, worse, offer coupons. “I wish I hadn’t been so sold on price,” says Amy, who spent $5,000 to have a board-certified dermatologist fix her wreck of a laser job and still has to use cover-up. “You get what you pay for.”

A Cheap, Fast and Possibly Deadly Route to Beauty


Published: April 16, 2009

Like almost every woman, Fiordaliza Pichardo just wanted to look beautiful, so a few years ago, she began getting silicone injections from a woman she met through a friend in order to plump up her thighs and derriere.

Photograph provided by Mona Rivera of 1010 WINS

Fiordaliza Pichardo died a day after receiving a silicone injection.

She never expected to pay such a high price for her looks.

In March, a day after receiving an injection, Ms. Pichardo, 43, died of what the medical examiner later determined was a silicone embolism in her lungs.

The city’s health department fears that the illegal use of silicone as an alternative to cosmetic surgery is on the rise. The city’s poison control center has received three calls in the last 10 months from doctors who have treated patients injected with silicone; Ms. Pichardo’s case was not among them. In the previous two years, there were only two such cases.

Health department officials say there may be other cases that have gone unreported, since doctors are not legally obligated to report silicone poisoning or even death, and since silicone is hard to detect through X-rays or CT scans. The department was planning Thursday to send an advisory by e-mail and fax to thousands of doctors advising them to watch for silicone poisoning cases.

Nationally, reports of buttock enhancement using silicone and similar thick liquids have surfaced from the Northeast to Miami, and the Food and Drug Administration is also planning to issue a warning on the dangers of such practices, Siobhan DeLancey, a spokeswoman, said Thursday.

“This seems to be kind of an underground occurrence, so it’s difficult to get numbers of actual events and to know exactly what these people are being injected with,” Ms. DeLancey said. “It’s important to note that none of the products that are reportedly being used are approved for this purpose.”

Ms. DeLancey said silicone was not approved for injection into tissues at all, only for use in the eyes and in certain implants where it is contained and cannot leak into tissue. She said the F.D.A. had the ability to conduct criminal investigations, and would encourage victims to come forward “so that we can document the problem.”

Across the Internet, chat rooms, Web sites and blogs have sprung up discussing buttock injections.

The victims have become caught up in an underground beauty industry that uses injections of black-market, medical-grade silicone or industrial-grade silicone as a cheap, fast and easily accessible way to plump up breasts, buttocks, thighs and even wrinkles.

The injections are popular among Latina women and transgender women, who may be unable to afford conventional plastic surgery and who tap into it through unlicensed practitioners working through word of mouth, city officials said.

Although side effects are fairly rare, silicone can migrate through the bloodstream, creating potentially fatal clots in the lungs, as it did in Ms. Pichardo’s case, said Dr. Nathan M. Graber, director of environmental and occupational disease epidemiology for the New York City Department of Health and Mental Hygiene. It can also migrate through tissues, leading to ugly lumps and chronic pain.

The injections are administered at home, in motel rooms, in makeshift offices or at “pumping parties,” where the guests take turns injecting one another, officials said.

Young transgender women often seek out silicone injections because they are a quick way of making bodies more feminine, unlike hormone treatments, which may take years to work, said Dr. Nick Gorton, an emergency room doctor who treats transgender patients at the Lyon-Martin Health Services clinic in San Francisco.

“If you go to a pumping party, you can have it tonight,” Dr. Gorton said. “It’s a big temptation, especially among young people who, when you’re 20, you’re not thinking about your own mortality.”

People are often reluctant to report side effects, because they feel that they are turning in a member of their community, health officials said.

Industrial-grade silicone can be bought at a hardware store. But Dr. Graber said there have been reports of the use of substitutes like castor oil, mineral oil, petroleum jelly and even automobile transmission fluid.

Dr. Suhail Raoof, chief of pulmonary medicine at New York Methodist Hospital, treated a woman with silicone poisoning in 2007. She came in complaining of shortness of breath, chest pain and coughing, reminiscent of pneumonia, he said, and told doctors that she had been injected with about 500 milliliters of silicone in each buttock about half an hour earlier.

Because silicone is not visible on an X-ray or a CT scan, Dr. Raoof said, diagnosis is difficult without a biopsy. Doctors used deduction to diagnose the cause of the woman’s symptoms, and she survived, he said.

Ms. Pichardo was not so lucky.

Ms. Pichardo’s 19-year-old daughter, Marinés Rodriguez, said that her mother began getting silicone injections several years ago after a friend introduced her to a cosmetologist.

Ms. Rodriguez said the cosmetologist went to Ms. Pichardo’s home in the Bronx and to other clients in Manhattan and Miami. A cup of silicone cost $800, and the cosmetologist would inject half a cup to two cups in a single session, Ms. Rodriguez said. Her mother, she said, “didn’t really care about the price. It was more that she knew somebody who had this first.”

Ms. Pichardo came to trust the woman. “She felt that was her friend, nothing could go wrong,” Ms. Rodriguez said.

Ms. Pichardo was last injected on March 17, and died the next day. Doctors thought she had pneumonia, Ms. Rodriguez said, and the family never thought to mention the silicone injections — which were discovered during the autopsy — because they thought they were harmless.

The medical examiner has ruled her death a homicide because she was injected by an unlicensed nonmedical practitioner, said Ellen Borakove, a spokeswoman for the medical examiner. No charges have been filed. Paul J. Browne, a police spokesman, said, “We believe she has fled to the Dominican Republic and we are in discussions with the district attorney as to next steps.”

Ms. Rodriguez said the family was distraught, but found it hard to be angry. The day after her mother died, she said, the cosmetologist visited to pay her condolences. “We didn’t think she did it on purpose,” she said.

Tuesday, April 14, 2009

Botox Rival Faces Delay in FDA Marketing Approval


By Catherine Larkin and Naomi Kresge

April 14 (Bloomberg) -- Competition for the Botox shot, America’s most popular cosmetic procedure, was delayed as U.S. drug regulators discuss labeling and a strategy for evaluating and mitigating risks of the new wrinkle smoother.

Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen said today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox. The delay should be a matter of weeks, according to brokerage Aurel BGC.

“We look forward to feedback from the FDA in the near term,” David Schilansky, Ipsen’s investor relations officer, said in a telephone interview. Ipsen is in talks with the FDA about a risk-mitigation plan for both aesthetic and medical use of the drug, he said.

Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Reloxin will be $160 million by 2012.

Nachman and other analysts have said they expected the FDA to delay Reloxin approval until later this year over questions about how the company plans to track use in order to minimize potential risks seen with other botulinum toxins. Yesterday was a deadline for the FDA to make a decision on Reloxin.

Medical Uses

In December, the agency delayed a decision on Dysport, Ipsen’s version of Reloxin for medical uses, to finish work on a risk-management program to ensure safe use.

Medicis, of Scottsdale, Arizona, has rights to sell Reloxin in the U.S. Approval would trigger a $75 million payment to Ipsen, which developed the drug.

U.S. regulators will decide before the end of May on the use of Dysport for medical conditions, according to a report today by brokerage Aurel BGC.

“The company indicated to us that there’s a strong probability that the FDA will give its response on the botulinum toxin for aesthetic uses once it’s reviewed the dossier for medical indications,” according to Aurel. “The decision of the FDA is thus pushed back some weeks.”

Fashionable Drug

Allergan, which got 32 percent of its revenue from Botox sales in the fourth quarter, is cutting 5 percent of its workforce this year to brace for the competition and lower demand for cosmetic procedures in the recession.

Almost 2.5 million Americans had Botox injections last year, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It quickly became fashionable among aging celebrities as a non-surgical way to appear younger.

Botox earned $1.31 billion for Allergan in 2008, split between cosmetic use and treatment of neurological disorders. Allergan estimates it has an 83 percent share of the global market for neurotoxins that paralyze certain muscles or nerves.

The FDA warned consumers in February 2008 that botulinum toxins may spread beyond the site of the injection and cause botulism, a potentially deadly muscle-weakening illness. The greatest risk was seen with high doses of the drug, used by some doctors to treat limb spasms caused by cerebral palsy, an approved use in many countries outside the U.S.

Galderma, a joint venture between Nestle SA and L’Oreal SA, has European marketing rights to a version of Dysport for aesthetic uses, called Azzalure. Medicis bought rights in 2006 to develop and sell the drug for those purposes in the U.S., Canada and Japan.

Solstice Neurosciences Inc., a closely held company in Malvern, Pennsylvania, sells a botulinum toxin called Myobloc in the U.S. for cervical dystonia, a disorder that causes the head to become twisted to one side

Monday, April 13, 2009

So Botox Isn’t Just Skin Deep


Michael Falco for The New York Times

Botox is used by Dr. Andrew Blitzer to treat vocal cord problems; he injects it into the larynx.

Published: April 11, 2009
Dr. Andrew Blitzer, the director of the Center for Voice and Swallowing Disorders at St. Luke’s-Roosevelt Hospital Center in Manhattan, has an antidote for speech impediments caused by vocal cord problems: he injects Botox into the larynx. DR. MARK STILLMAN, the director of the Center for Headache and Pain at the Cleveland Clinic, has a treatment for people with frequent migraines: he injects Botox around the head and neck. Dr. Fredric Brandt, a dermatologist in Manhattan and Coral Gables, Fla., has a novel procedure for oily skin and skin redness.
You guessed it: Botox.
Over the last decade, Botox has become a synonym for the eradication of wrinkles, a kind of shorthand for the entire enterprise of cosmetic medicine. But now, with the popularization of new medical uses, therapeutic applications of the drug are poised to outstrip the cosmetic treatment in both revenue and prominence.


In the hunt to discover the next blockbuster medical use for Botox, doctors have injected it experimentally into muscles and glands all over the body, making it medicine’s answer to duct tape. According to recent medical journals, physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs.

“We see it as a molecule that keeps on giving. As we understand it more, it gives us new ideas of how to use it,” says Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker.

No other therapeutic agent “has so many demonstrated uses,” he says.

But some health advocates worry that doctors are widely adopting novel uses for Botox before federal guidance and rigorous clinical studies have established safe and effective dosages for the new treatments.

“It’s trial and error with a nerve poison,” says Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group. Last year, the group petitioned the Food and Drug Administration to require a warning label for injectable toxins.

BOTOX is a purified form of botulinum toxin, a nerve poison produced by the bacteria that cause botulism, a disease that paralyzes muscles and can be fatal. Injections of Botox act like minuscule poison darts that temporarily blunt chemical nerve signals to certain muscles or glands, reducing their activity.

The F.D.A. has approved Botox to treat four problems: eye muscle disorders, neck muscle disorders, excessive sweating — and that deadly age giveaway, eyebrow furrows. But Allergan, a $14.5 billion specialty pharmaceutical company, owns or has applied for patents on more than 90 uses for the drug.

Dr. Brin of Allergan says Botox has a long safety track record — backed by 30 years of favorable research, studies on 11,000 people worldwide and 17 million treatments in the United States since 1994.

“That safety profile has enabled us to continue to explore the product in deeper parts of the body and in more novel areas,” Dr. Brin says. Allergan does not promote unapproved uses of the drug, he says.

Botox was developed in the 1970s by Dr. Alan Scott, an ophthalmologist in San Francisco who was searching for a cure for crossed eyes. He theorized that minute doses of a nerve poison used to weaken the muscles that pull crossed eyes inward could treat the malady, and he experimented with a variety of paralytic agents.

Then a biochemist who had isolated and purified a strain of botulinum toxin for potential military use as a biological weapon sent Dr. Scott a sample. It worked.

Dr. Scott named the new drug Oculinum. In 1989, the F.D.A. approved it to treat crossed eyes and twitching eyelids. Allergan bought Oculinum in 1991 for about $9 million, rebranding it Botox. When David E. I. Pyott became chief executive of the company in 1998, Botox had $90 million in annual sales. Last year, sales topped $1 billion.

“Nobody at Allergan understood how big a gold mine they were sitting on,” Mr. Pyott says.

Drug companies often rely on multiple products to fill their pipelines. But at Allergan, Botox became a virtual pipeline in and of itself after the arrival of Mr. Pyott, who recognized that it was a medication that could be serially reincarnated for other applications.

Doctors, who are permitted to use approved drugs in unapproved ways as they deem appropriate, were already using Botox off-label at the time on body parts other than eye muscles. Some physicians reported that patients had unexpected side effects — fewer headaches, for example, or smoother skin — after they had Botox.

Mr. Pyott invested heavily in expanding in-house research and encouraged doctors to formalize their anecdotal observations with published research. He also recognized that some Americans would be willing to pay handsomely for injections that tempered wrinkles. To prove the efficacy of the drug, the company sponsored clinical trials to use Botox for cosmetic medical purposes and for other muscle disorders.

Over the last nine years, the F.D.A. has approved Botox to treat neck muscle spasms and to hinder excessive sweating. The agency also approved the same drug, under the name Botox Cosmetic, to smooth forehead wrinkles.

Last year, Botox had worldwide sales of $1.3 billion, divided about equally between cosmetic and medical uses. Among botulinum toxins, Botox has an 83 percent share of the market, Allergan said.

But, with competing toxins set to enter the American market, Allergan has positioned Botox for other medical uses. Mr. Pyott says he expects therapeutic sales of the drug to soon eclipse sales of Botox Cosmetic.

Health insurers sometimes cover medical uses of Botox; a treatment for a clenched jaw might cost $1,000 every three months, for example. But for cosmetic treatments, which dipped slightly at the end of last year, consumers must pay cash.

“The therapeutic will end up being bigger than the cosmetic even if the economy recovers because there are some big unmet medical needs there,” Mr. Pyott says.

In the next few months, the company is expecting federal approval to market the drug for stroke victims suffering from limb tightness or spasms.

Later this year, Allergan plans to seek approval to market the drug for chronic migraine headaches, Mr. Pyott said. He also said the company eventually plans to seek F.D.A. approval to market Botox for benign enlarged prostate.

But many doctors are not waiting for federal sanction to inject Botox for these and other disorders. While Allergan doesn’t break down Botox sales, Gary Nachman, an analyst at Leerink Swann, an investment bank, estimates that perhaps as much as half of Botox sales already come from off-label uses.

Enlarge This Image
Michael Falco for The New York Times

Dr. Blitzer also uses the drug to treat severe jaw muscle pain.



Michael Falco for The New York Times

Allergan, Botox’s maker, owns or has applied for patents on more than 90 uses for it.

“It’s the magic bullet,” says Mr. Nachman.

BOTOX is so widely adopted in medicine — and ingrained in popular culture — that some doctors don’t think that novel uses are experiments.

Several years ago, Dr. Kamran Jafri, a facial surgeon in Manhattan, started injecting Botox just under the skin of the face, a technique that he says reduces pore size, blotchiness and oily skin.

“Dosing is by trial and error,” Dr. Jafri says. “I don’t think it’s experimental because it’s a treatment I’ve been doing a lot and it’s been working.”

Such ad hoc uses of Botox are perfectly legal for doctors. But some medical professionals are concerned that doctors are experimenting with and adopting Botox therapy before clinical trials and government approval have established safe doses for new indications — and without definitive proof that the new treatments work.

While life-threatening complications following use of Botox and other botulinum toxins are rare, a few people have died after they were treated. In some cases, the toxin has spread from the injection site, causing serious swallowing and breathing problems. For example, several children with cerebral palsy died after receiving large doses in their limbs.

“It is possible to over-inject. This is a poison,” says Dr. Frederick Burgess, the chief of anesthesia at the V.A. Medical Center in Providence, R.I. “Things can go wrong. It is rare, but it happens.”

Last year, Public Citizen petitioned the F.D.A., asking for a stronger warning on botulinum toxins that would emphasize the risk of diffusion from the injection site and the need for patients to seek immediate medical care for swallowing or breathing difficulties. The Canadian health authority instituted such a labeling change earlier this year.

Mr. Pyott of Allergan says that there have been a few serious problems following Botox injections — but not necessarily directly caused by the drug. Some patients had serious illnesses prior to treatment, he said.

“Physicians have experimented with higher and higher doses,” Mr. Pyott says. “Like any drug, if you take too much, you can have side effects.”

The F.D.A is reviewing the safety of botulinum toxins, according to an agency press release. Last year, the agency also postponed approval of a new toxin called Dysport for use in neck muscle problems. The F.D.A. asked the manufacturer to first develop a plan for communicating the risk of the drug to doctors and patients.

On Monday, the F.D.A. is due to issue a decision on the cosmetic version of Dysport, called Reloxin.

Johnson & Johnson is also developing an anti-wrinkle injection called PureTox.

But industry analysts predicted that the F.D.A. would postpone approving any new botulinum toxins until regulators have finalized a stronger warning label for all of the brands.

WHEN Mr. Pyott arrived at Allergan, it specialized in eye-care pharmaceuticals. Over the last decade, he has turned it into the house that Botox built, expanding credibility for the drug in various medical specialties by buying complementary businesses.

To solidify Allergan’s dominance in appearance medicine, for example, the company spent $3.2 billion in 2006 to acquire Inamed, a leading maker of skin-plumping injections and breast implants. In preparation for the planned introduction of Botox as a treatment for headaches, overactive bladder and enlarged prostates, the company has also established itself in neurology and urology by developing or marketing other specialty drugs, Mr. Pyott says.

The possibility of lucrative new uses for Botox has not gone unnoticed. After rumors of a possible merger with GlaxoSmithKline last month, Allergan stock rose almost 24 percent over the course of two days, to $48.95; it now trades at $47.47. Both companies declined to comment on merger rumors.

“This is a bad time to sell because they are not going to get rewarded for all of the wonderful stuff in the pipeline,” says Ronny Gal, an analyst at Sanford C. Bernstein. “I would stay independent for a couple of years.”

Mr. Gal says sales of Botox could double within the next five to seven years, provided that the F.D.A. approves new major medical uses. One million people or more might seek Botox injections for chronic headaches, while the audience for benign enlarged prostate would be “practically every man over the age of 75,” Mr. Gal says.

MR. PYOTT has a master plan, meanwhile, to expand the Botox franchise even further. The company is developing new iterations of the drug intended to treat specific targets, such as pain receptors, without weakening muscles.

Allergan also owns or has applied for patents on dozens of other uses for its toxin, a move to pre-empt competitors from marketing their products for expanded uses.

“I feel a little bit like I am sitting with a beautiful vessel inside the harbor but I forgot to give you the map to where our mines are,” Mr. Pyott says of the Botox patents that he said were filed in different countries. “There could be a big bang when you hit one of our patents.”

But Mr. Gal, the analyst, devoted his Christmas vacation to unearthing about 90 patent applications worldwide by Allergan. These included Botox for sinus headache, fibromyalgia pain, ulcers, inner ear disorders and uterine problems as well as appearance treatments like “buttock deformity.”

Nevertheless, there are still a few ailments that Botox does not claim to solve. Botox doesn’t work on stuttering, for example, because it involves too many parts of the anatomy — including the lips, the larynx and the tongue, says Dr. Brin of Allergan.

“Stuttering is too complicated,” Dr. Brin says a little wistfully. “It didn’t pan out.”

Surgeon studies benefits of scar-reducing tape


Sunday, April 12, 2009
BY ABIGAIL LEICHMAN
NorthJersey.com
SPECIAL TO THE BERGEN RECORD

An Englewood Cliffs plastic surgeon is leading a study on an elasticized tape that may reduce or prevent raised scars.

Dr. Steve Fallek said he became intrigued by Kinesio Tex Tape — developed by a Chinese chiropractor in the 1970s — while watching the 2008 Olympic Games. Beach volleyball player Kerri Walsh had the tape fixed to her shoulder, reportedly to enhance circulation and to stabilize the muscles after surgery.

Fallek contacted the company and discovered that Tex Tape, widely used by physical therapists, also has been helpful in preventing and minimizing raised scars.

"There are anecdotal reports that people swear by it not only for muscle pain and recovery from surgery and injury, but also to prevent and minimize keloid scars," said Fallek, who also practices in Manhattan and writes about plastic surgery in magazines such as Us Weekly and Life and Style.

"So many products on the market claim to promote healing, but there are no scientific studies that any of these things work," he said. "I wanted to do a study to test this one out."

Fallek began the investigation early in March and is seeking additional participants ages 18 and over who have one of two types of thick, collagen-based scars: hypertrophic and keloid.

Hypertrophic scars are generally red and raised but do not grow beyond the boundaries of the original wound. Keloids, most common in African-Americans, keep growing indefinitely. "The body lays down scar tissue and doesn't turn off the healing process," explained Fallek.

Kinesio provided tutorials to Fallek on how to apply the tape, and it is supplying the product for the study at no cost. The applications are non-invasive, painless and free to study participants. "The only restriction is anyone who's sensitive to adhesives," he said.

A plastic surgeon's typical anti-scar arsenal consists of products ranging from sunscreen, Vitamin E, silicone gel sheeting and cocoa butter to steroid injections, laser surgery and massage. Fallek said he's often asked about advertised products such as Mederma, which is made of onion extract, but there is no scientific proof of its effectiveness.

"Everybody is interested in preventing and minimizing scars, and there's so much misinformation out there," he said. "I thought we could take this to a different level since nobody has scientifically studied this before."

To inquire about participating in the study, contact Fallek's North Jersey office at 201-541-4181 or info@fallekplasticsurgery.com.

An Englewood Cliffs plastic surgeon is leading a study on an elasticized tape that may reduce or prevent raised scars.

Dr. Steve Fallek said he became intrigued by Kinesio Tex Tape — developed by a Chinese chiropractor in the 1970s — while watching the 2008 Olympic Games. Beach volleyball player Kerri Walsh had the tape fixed to her shoulder, reportedly to enhance circulation and to stabilize the muscles after surgery.

Fallek contacted the company and discovered that Tex Tape, widely used by physical therapists, also has been helpful in preventing and minimizing raised scars.

"There are anecdotal reports that people swear by it not only for muscle pain and recovery from surgery and injury, but also to prevent and minimize keloid scars," said Fallek, who also practices in Manhattan and writes about plastic surgery in magazines such as Us Weekly and Life and Style.

"So many products on the market claim to promote healing, but there are no scientific studies that any of these things work," he said. "I wanted to do a study to test this one out."

Fallek began the investigation early in March and is seeking additional participants ages 18 and over who have one of two types of thick, collagen-based scars: hypertrophic and keloid.

Hypertrophic scars are generally red and raised but do not grow beyond the boundaries of the original wound. Keloids, most common in African-Americans, keep growing indefinitely. "The body lays down scar tissue and doesn't turn off the healing process," explained Fallek.

Kinesio provided tutorials to Fallek on how to apply the tape, and it is supplying the product for the study at no cost. The applications are non-invasive, painless and free to study participants. "The only restriction is anyone who's sensitive to adhesives," he said.

A plastic surgeon's typical anti-scar arsenal consists of products ranging from sunscreen, Vitamin E, silicone gel sheeting and cocoa butter to steroid injections, laser surgery and massage. Fallek said he's often asked about advertised products such as Mederma, which is made of onion extract, but there is no scientific proof of its effectiveness.

"Everybody is interested in preventing and minimizing scars, and there's so much misinformation out there," he said. "I thought we could take this to a different level since nobody has scientifically studied this before."

To inquire about participating in the study, contact Fallek's North Jersey office at 201-541-4181 or info@fallekplasticsurgery.com.

Thursday, April 2, 2009

Heads Up, Botox



Ron Heflin/Associated Press
Published: April 1, 2009

IN the seven years since its approval for cosmetic use, Botox has succeeded in winning over the hearts and brows of many a desperate housewife — not to mention an age-defying politician or two. The wrinkle smoother has made billions for its maker, Allergan, and made it harder and harder to guess the age of news anchors. She could be 50; only her dermatologist really knows.


A NEW WRINKLE Will Reloxin, expected to be approved by the F.D.A. this year, be more effective or affordable?

But this blockbuster drug may soon face fierce competition if the Food and Drug Administration approves Reloxin, another injectable made from the botulinum toxin, which has had success temporarily smoothing wrinkles in other countries.

The buzz among doctors that has been spreading in the news media and on beauty-oriented Web sites like RealSelf.com is that Reloxin works more quickly and lasts longer than the roughly four months Botox does. Dr. Leslie Baumann, a University of Miami dermatologist who did some of the clinical trials for Botox and Reloxin, recently said on NBC’s “Today” show, “It’s time that we have something that lasts a little bit longer” than Botox.

But does the truth match the early expectations for Reloxin? Much is at stake for Medicis Pharmaceutical, the American drug company that has licensed the wrinkle smoother from its French maker, Ipsen, and has conducted the pivotal trials, which have been presented to the F.D.A. for approval. So far, studies have not proven definitively that either Botox or Dysport (as Reloxin is known in Europe and South America) has an edge in terms of how long it lasts or how quickly it takes effect.

“To be honest, if you just talk about aesthetics, there are no good comparative trials on Dysport and Botox,” said Dr. Berthold Rzany, an author of “Botulinum Toxin in Aesthetic Medicine” and the director of evidence-based medicine at Charité, the university hospital in Berlin, Germany.

Only small studies exist, Dr. Rzany said, adding that at least 300 participants would be needed to prove that one of the drugs lasts longer. Choosing a longer-lasting product would matter to consumers because both drugs are expensive. In England, a visit for Botox or Dysport costs roughly $250 to $430, said Dr. John Curran, the former president of the British Association of Cosmetic Doctors. (There is no information yet about how it might be priced in the United States.)

In the run-up to Reloxin’s possible approval by the F.D.A., several doctors in England, France, Germany and Brazil, who have injected both Botox and Dysport for cosmetic purposes, were interviewed to see what could be gleaned from their years of experience.

The resounding response is that one drug doesn’t necessarily keep the wrinkles at bay longer than the other. A skilled doctor can achieve similar results with either Botox or Dysport, the doctors agreed, but at least three doctors said that Dysport was less expensive for them to use.

Dosing is at the heart of much of the controversy about which wrinkle relaxer lasts longer, most of the foreign doctors said. A different amount of Dysport than Botox is needed to tame, say, frown lines or crow’s feet, but exactly how much is still a matter of debate. If approved, Reloxin will be deemed appropriate for the area between the eyebrows, but like Botox, doctors will likely inject it in other parts of the face as well.

“Educational efforts around appropriate utilization and dosing will be massive pending F.D.A. approval,” said Jonah Shacknai, the chief executive of Medicis.

But doctors in the United States will still face a learning curve, foreign doctors said. Going from Botox to Reloxin is akin to mastering a new language.

Dr. Doris Hexsel, a researcher and a dermatologist in private practice in Brazil, said that in 2004, three years after Dysport was approved there for cosmetic use, it took her a month to become familiar with the new drug after years of working with Botox. While she used a dosage that many other doctors found to be safe for the lower face, she was not entirely happy with the outcome.

“I gave to my patients stronger results than I would like,” said Dr. Hexsel, the author of medical books about botulinum toxins. She adjusted the dosage and, she said, “patients are happier with Dysport.” She added that she doesn’t wish to promote one drug over the other.

Some doctors say there is no grounds for asserting that one drug outlasts the other.

“If anyone out there is saying that Dysport is better than Botox, they are marketing,” Dr. Curran said. “They are both very good products. They do an excellent job medically and aesthetically. By altering the dilution you can get the same effect.”

Dr. Benjamin Ascher, a plastic surgeon in Paris who specializes in botulinum toxins, feels the same way. “Reloxin is a little bit stronger, which is not necessarily good or bad,” said Dr. Ascher, who has had research financed by Allergan and Ipsen. “When you have a product that works, it matters how much you put in the injection.”

Dr. Robin Stones, a medical director at Court House Clinics, which has seven outposts in England, uses both drugs. “There are certain situations when I may choose one or the other,” but not because of “patient preference,” Dr. Stones said. “Clients don’t tell me there’s any difference.”

By contrast, Dr. Nick Lowe, a dermatologist with patients in London and Santa Monica, Calif., thinks that Botox and Dysport work differently. He capitalizes on those differences and occasionally injects both drugs in a single visit to separate areas. If a patient has prominent crow’s feet around the eyes, “where you want a little more spread,” he said, he uses Dysport, which “definitely lasts a bit longer.”

Want to tame upper-lip lines? Botox, which he said doesn’t spread as much, is Dr. Lowe’s choice. (But for his own brow, Dr. Lowe, who used to consult for Allergan, prefers Dysport. “I get a slightly more natural look,” he explained, adding, “I don’t like that Dr. Spock look.”)

The F.D.A. will most likely update Medicis in mid-April, but most analysts expect a final decision on Reloxin later this year.

IF Reloxin is approved, an injector’s expertise will matter even more, doctors said. Dr. Seth Matarasso, a dermatologist in San Francisco who lectures about Botox, said he is still shocked that some doctors know little about facial anatomy, dilution procedures and complications. A new botulinum toxin, he said, is “a concern for the neophyte or someone who doesn’t inject a lot.”

Kate Lyra, an actress living in Rio de Janeiro and a patient of Dr. Hexsel’s, found an upside to Dysport. Five years ago, she said it tamed her slight frown lines and crow’s feet for about eight months, compared with five months with Botox.

“It definitely lasts much longer,” she said of Dysport. But, if the doctor lacks expertise, she said, you could be saddled with “a very odd expression” for longer.

At this point, it is unclear whether Reloxin will be less expensive than Botox for American doctors, and whether they will pass along savings to patients. Ultimately, the prospect of Reloxin injections lasting longer than Botox may make all the difference.

Consider a patient of Dr. Ascher’s who spoke on the condition that she not be named. Dr. Ascher had treated her frown lines and crow’s feet with Botox every four months, before switching to Dysport, which she said lasts five to six months.

“I am only going twice a year,” she said, “and only paying half.”