Can Shots Safely 'Melt Away Fat'?

By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, June 26, 2007



Physicians Spar Over Injections Touted As an Easy Alternative to Liposuction



Beauty sometimes demands toughness, as many women discover, but Suzanne Thomas had never imagined she would agree to have 72 injections of a fat-burning chemical cocktail in her neck and chin.
Yet that is the treatment called lipo-dissolve that the 35-year-old Fairfax County preschool computer teacher underwent -- twice -- several months ago to eradicate the jowls and double chin she had long hated. Thomas said the discomfort was worth it because "I absolutely love my results."
"I just really didn't want to do anything invasive like liposuction," said Thomas, who, with three children younger than 6, would have little time to recuperate from cosmetic surgery. Her procedures, which cost a total of $1,000, were performed at MedSculpt, a six-month-old center in Rockville that specializes exclusively in the controversial fat-loss technique.
Marketed as a safer and less invasive alternative to liposuction, proponents say lipo-dissolve is useful for treating small "problem areas" such as love handles, bra fat and a softening jaw line. A growing number of doctors, nurses and even spa personnel are offering the procedure known in medical circles as injection lipolysis -- and more colloquially as the "flab jab."
But critics, among them officials of the American Society of Plastic Surgeons, the American Society of Dermatologic Surgery and the American Society for Aesthetic Plastic Surgery (ASAPS) say there is no convincing evidence that lipo-dissolve is effective -- or safe -- and they warn patients to stay away from fat-loss shots.
The procedure is similar to mesotherapy, an older treatment that involves injections of various drugs, vitamins or herbs to banish the dimpled flab known as cellulite. Lipo-dissolve injections typically contain two ingredients believed to work synergistically. As with mesotherapy, the formula, which is not approved by the Food and Drug Administration, is prepared by compounding pharmacies, which are subject to little regulation.
Lipo-dissolve "is catching on because it works," said Robert Adrian, one of the Washington area's best-known and busiest cosmetic dermatologists, who says he has treated 400 patients in the past three years. Adrian, whose Web site says the procedure "literally melts away fat in just a few short treatment sessions," maintains that most of his patients have achieved good long-term results.
Roger Friedman, a well-known Maryland plastic surgeon who is medical director of MedSculpt, which is set to open a second center in Tysons Corner on Thursday, says the procedure appeals to patients looking to lose inches without surgery.
"It's something plastic surgeons need in their armamentarium," said Friedman, who performs both lipo-dissolve and liposuction.
Officials of ASAPS, whose membership includes cosmetic dermatologists and plastic surgeons, vehemently disagree. Fat-loss injections, the group cautioned recently, are "scientifically unproven," lack approval from the FDA and use "poorly defined ingredients." The group cited "numerous reports of complications . . . including bacterial infection, granulomas [disfiguring masses of chronically inflamed tissue] and localized necrosis [tissue death]." To assess its safety and efficacy, the society is sponsoring a small placebo-controlled study of the procedure under the supervision of the FDA.
Medical experts aren't the only ones who have reservations. Kansas recently became the first state to regulate the treatment, sparked by concerns about the rapid proliferation of clinics and spas performing lipo-dissolve and the qualifications of practitioners.
Science or Snake Oil?

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"There is no real evidence that this is an advance over snake oil," said Alastair Carruthers, president of the dermatologic surgery society and a clinical professor at the University of British Columbia in Vancouver. What some proponents tout as impressive results, he said, appear to be temporary. And patients who shell out thousands of dollars of their own money for fat-loss injections, critics note, are more likely to watch what they eat and to exercise, which may explain why lipo-dissolve patients say they are satisfied with their results.
Safety remains a paramount concern, according to Carruthers. He said he recently treated a woman in her 40s who nearly lost both lower eyelids after she developed a potentially sight-threatening complication following lipo-dissolve injections administered by a physician. The shots killed tissue under her eyes.
Cosmetic dermatologist Elizabeth Tanzi of Washington said she has treated several patients with red lacy discolorations on their legs caused by lipo-dissolve. It is not clear whether the marks are permanent, she said.
Lipo-dissolve typically contains a mixture of phosphatidylcholine, which is derived from soybeans, and sodium deoxycholate, a bile salt that aids waste removal.
This cocktail, often dubbed "PCDC," is prepared in compounding pharmacies, which typically make small quantities of drugs for specialized treatments. Quality control and sterility can be spotty or nonexistent, experts say.
Using a fine needle, the PCDC solution is injected into fat deposits, typically in the abdomen, face, hips or back.
For large areas such as the stomach, as many as 120 injections may be required at one time. Sometimes the shots are administered using a rapid-fire instrument called a "mesogun" rather than a syringe. Numbing cream may be used first.
PCDC shots cause redness, temporary burning or pain and considerable swelling. The injections are believed to trigger an inflammatory response that results in the breakdown and excretion of fat; proponents say the mechanism by which this occurs is unknown. Two to six treatments are usually required, each of which costs $300 to $1,500.
When performed by experienced physicians, Adrian said, lipo-dissolve is safe and effective. Many doctors critical of the procedure, he contends, lack "basic scientific knowledge" and have ulterior economic motives.
"Lipolysis represents a significant threat to anyone who does liposuction," Adrian said. Typically plastic surgeons, not dermatologists, perform liposuction.
"This is not a procedure developed in some garage behind a house," he added, noting that it has been widely used in Europe.
To Friedman, the opposition to lipo-dissolve is reminiscent of the hostility that greeted liposuction when it was introduced in the United States in the 1980s. It has since become one of the most popular cosmetic procedures, and studies have demonstrated its safety and effectiveness, he said.
Safety Concerns

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The debate about lipo-dissolve mirrors the controversy surrounding mesotherapy, which was invented in France more than half a century ago. It is used to treat a host of problems including headaches, gout and cellulite.
Mesotherapy has been associated with serious complications. Brazil, known for its freewheeling attitude toward cosmetic medicine, banned injections of phosphatidylcholine, a common mesotherapy ingredient, in 2003 after the treatment had become so popular that shots were being given in gyms and beauty salons.
Two years ago the Centers for Disease Control and Prevention investigated the cases of 14 patients in the Washington area who developed prolonged swelling and skin ulceration from infections caused by mesotherapy injections administered by a man who claimed to be a physician from Colombia but did not have a valid medical license.
Although Friedman and others say that lipo-dissolve and mesotherapy are different, Carruthers said he fails to understand the distinction.
Michael Olding, chief of plastic surgery at George Washington University Medical Center and a spokesman for the American Society of Plastic Surgeons, said it is unclear what's in lipo-dissolve. "There is no accepted standard of what is included in these injections," he said.
In March, three people died after receiving injections of a drug made in a compounding pharmacy in Texas that was administered to patients at an alternative medicine clinic in Portland, Ore. Investigators found that the medicine, used to treat back pain, was 10 times more potent than the label indicated.
And two years ago, a contaminated solution used in open-heart surgery was linked to the death of four patients at Mary Washington Hospital in Fredericksburg. The solution was made by a large compounding pharmacy in Maryland; federal officials subsequently found significant contamination at the plant.
Lipo-dissolve proponents, including MedSculpt officials and Adrian, say that no deaths have been reported anywhere from the procedure and that their shots are carefully prepared in reputable pharmacies.
But in Tanzi's view, basic questions about the treatment remain unanswered.
"I had a baby two months ago," she said. "If I thought it worked and was safe, I'd have it." ·

Fonte: http://www.washingtonpost.com/wp-dyn/content/article/2007/06/22/AR2007062201870.html - 26/06/07

Making Botox Both Medicine and Cosmetic

By BARNABY J. FEDER
Published: June 23, 2007

David E. I. Pyott, 53, became president and chief executive of Allergan in 1998 after spending his earlier management career in the nutrition subsidiaries of Novartis and Sandoz. The stock stood at $15.74 and the company was best known for its contact lens care solutions.
Allergan, based in Irvine, Calif., spun off the lens care and eye surgery businesses into Advanced Medical Optics in 2002. Since then, its identity has been increasingly linked to Botox, its branded delivery system for minute doses of a bacterial toxin that can paralyze muscles for several months. Thanks to Botox’s growing portfolio of cosmetic and medical applications, Allergan has forecast Botox sales this year of up to $1.16 billion.
But the company also makes a range of pharmaceuticals for various eye and skin care products. Wall Street has applauded the company’s strong growth and strategic moves like the $3.4 billion acquisition last year of Inamed, which made Allergan a leader in silicone breast implants and implants to treat obesity in addition to giving it Juvéderm, a new injectable gel for combating wrinkles. Yesterday, the stock closed at $114.47, down $2.79. Mr. Pyott discussed these recent developments. Following are excerpts:
Q. How should we think of today’s Allergan?
A. We’re seen as a biologics company because of Botox. Our valuation is in line with Genentech. But we are a very small version of Johnson & Johnson in many ways. Wall Street likes that a third of our business is discretionary spending. It’s a hedge against Medicare and insurers tightening their coverage.
Q. You started out viewing Botox strictly as a medical product, right?
A. Yes. Dr. Alan Scott was treating crossed eyes and fluttering eyelids, which is how we got into the business. We thought we’d get $5 million in worldwide sales. Fortunately, we got that wrong.
Q. Botox’s medical sales will top $500 million this year. How does the medical market work?
A. Twenty indications have been approved in various countries. Cervical dystonia (a neck muscle disorder that pulls the head out of position) is the biggest approved medical use in the U.S. Excessive sweating — that’s hyperhidrosis — is another interesting application, which affects eight million people in the U.S. The price per vial for medical and cosmetics is the same almost everywhere in the world but you need 300 to 400 units to treat spasticity in a leg or arm, compared to 20 to remove a crease between the eyes.
Q. But far more people are now getting Botox for cosmetic purposes and that segment is growing faster, right?
A. Last year, worldwide, Botox use accelerated in cosmetics by 32 percent. Botox for therapeutics grew 17 percent. In the short term, cosmetics will become more than 50 percent of the use. But it could swing back at the end of the decade. We are working on headache relief and bladder control for people with spinal cord injuries. We’re looking at 2009 for approval on the headache and 2011 for bladder control.
Q. People have been opening storefronts in shopping centers for Botox treatments. Is misuse a concern?
A. Patients should receive their treatments in an appropriate medical setting from people who are well trained. If you are just looking for a simple removal of the crease between the eyes, most people can do that. If you are looking to change the shape of the eyebrows, it requires a very precise weakening of six or seven muscles and that’s where you need an expert.
We heavily discourage — we even mandate — that our sales people don’t go to places like spas. We will supply to anyone who can establish their credentials as a medical professional. If it’s someone new, we make sure they have a valid license through a state medical society.
Q. Isn’t the huge amount of money spent on Botox for cosmetic purposes — and your other products like dermal fillers and breast implants — a horrifying sign of misplaced priorities in American society?
A. This is a worldwide phenomenon wherever there is a buildup of wealth. The cosmetic use comes out of the entertainment budget.
Q. So how reliant are you on the state of the economy?
A. People ask and I have to tell them it doesn’t seem to have much effect if you look back to what happened after the Internet bubble burst. We go down to households with $50,000 but most have a lot more than that.

Fonte: http://www.nytimes.com/2007/06/23/business/23interview.html?ref=health - 23/06/07

Cartilha da beleza

Ana Paula Araújo

Encontrar uma mulher satisfeita com o corpo, rosto e cabelos é uma tarefa difícil. Segundo elas, sempre tem algo para melhorar. Prova disso é que o Brasil é o terceiro maior consumidor de cosméticos do mundo. Para evitar danos à saúde, a Agência Nacional de Vigilância Sanitária lançou um manual do que pode e do que não pode ser usado.
Cabelos lisos só no salão e com produtos liberados pela Vigilância Sanitária. Uma lição que Paula Ferreira aprendeu depois de uma experiência traumática com uma escova progressiva feita em casa. “Meu cabelo continuou caindo, eu não sabia o que fazer. Depois todo o meu couro cabeludo passou a descamar”, conta a gerente de loja.
Mas, com os produtos, certos, ela viu que não precisava desistir do visual que tanto queria. “Eu procurei um produto adequado, que desse o mesmo efeito e sem provocar os mesmos danos que ela havia sofrido”, diz Luiz França, cabeleireiro
As opções para cuidar da aparência são muitas, e a brasileira não faz por menos: o país é o terceiro maior consumidor de cosméticos, atrás apenas dos EUA e do Japão. Para regular esse mercado, a Vigilância Sanitária lançou uma cartilha com orientações para os profissionais da beleza.
A Anvisa recebe por ano de três mil e quatro mil pedidos de registro de novos produtos. Para quem quer experimentar as novidades, a vigilância orienta:
- Só compre produtos com a embalagem limpa e não danificada; - Verifique se o produto tem registro na Anvisa; - Não use cosméticos com prazo de validade vencido; - Sempre observe as advertências e restrições de uso; - Para as crianças, somente produtos infantis.
"Produtos que oferecem milagres têm que ser evitados. Não existe cosmético capaz de eliminar rugas, capaz de fazer crescer cabelos, eliminar celulite ou emagrecer. Se isso consta no rótulo, não compre", orienta Cláudio Maierovitch, diretor da Anvisa.
Fugindo das armadilhas... “Querer estar melhor é sempre sinal de saúde. E saúde sempre gera beleza”, garante o dermatologista Celso Sodré.
A Anvisa também alerta que produtos contrabandeados ou feitos em laboratórios clandestinos podem conter ingredientes diferentes dos descritos no rótulo e há riscos de alergias e queimaduras.


Fonte: Jornal Hoje - 16/06/07

You Can Smooth or Zap but Will the Results Hit Home?

By MELENA RYZIK
Published: June 14, 2007

IN pursuit of a glowing, smooth, youthful complexion, Ann Runnels, 44, has tried Botox, microdermabrasion, injectable fillers, Fraxel lasers (a treatment said to stimulate cell growth) and the usual array of creams, ointments and $120-a-bottle serums.
“My father was an oilman and cattle rancher and I spent my whole life out in the sun,” said Ms. Runnels, who lives in Kyle, Tex., and works at home helping her husband with his real estate business. “Now I’m seeing fine lines show up, and I try to be proactive about it.”
So when she read a rave review of an odd-looking mallet-like device called a Baby Quasar on a skin-care message board last year, Ms. Runnels thought, well, it couldn’t hurt. She ordered the light-emitting gadget, affectionately called a Baby Q by its devotees. It cost $399, but she was impressed with its sturdy packaging and was eager to see the results. “I used it immediately,” she said.
As quickly as the next morning, she said, “my skin looked plumper.” She was so pleased that a few months later she upgraded to the full-size Quasar, a more powerful professional machine that costs $1,800.
Though the fight against wrinkles long ago went high tech (and high cost), it is only recently that technologies such as pulsing heat, L.E.D.s and electrical currents have become safe and easy enough for consumers to use on themselves. Years after women first started recreating professional treatments with at-home spa days, a growing array of devices have migrated from the aesthetician’s office to the bathroom, where they now compete with topical solutions, medications and other prescribed remedies to combat aging.
Though it is hard to say exactly how many of these products exist, new ones seem to arrive daily: the HairMax LaserComb, for “thicker, fuller, healthier looking hair”; the DermaVie, for microdermabrasion; the Crystalift, a vacuum, to “resurface” the skin. That they often cost hundreds or even thousands of dollars is little deterrent to people for whom youth is priceless — or at least financially attainable.
“If you do the math, a spa session or a clinic session would probably cost $100 for a cosmetic treatment, whereas if you do this for five minutes a day, it has the same results,” said Donna Regii, a manager at Bliss, the spa chain. The company stocks NuFace, which emits microelectrocurrents and at $450 is a top seller.
But as an increasing number of devices fill up electrical outlets, many dermatologists question their efficacy, if not their safety.
“One of the major issues with these home-use devices is they promise more than they can deliver,” said Dr. Arielle Kauvar, a dermatologist and associate professor at New York University School of Medicine who specializes in laser-assisted treatments. The claims they make — that skin will be tightened or fine lines and wrinkles minimized — are largely cosmetic, so the manufacturers do not need approval by the Food and Drug Administration, only clearance, said Dr. Kauvar, which is easier to get.
A manufacturer that claims scientific proof of its product’s effectiveness is probably using the term loosely. For example, the makers of the RejuvaWand, an L.E.D.-based massaging tool said to “reverse the signs of aging” that came on the market in February, promote their two-month clinical trial. But the trial involved only 36 women, with no controls. Of the 36 women, 31 reported their skin had improved, said Marc Maisel, a company founder. The participants used a gel with hyaluronic acid, which also can plump skin, Dr. Kauvar said.
NuFace, too, advertises its scientific appeal. Based loosely on a procedure used to treat Bell’s palsy, the hand-held device emits electrical microcurrents meant to stimulate muscles, which the makers claim tightens the skin. But it hurts. So does the ThermaClear, a heat pulsing tool for combating acne. Applied to the skin, it emits a hot zap, enough to make you recoil. NuFace stings. Except for the eye-crossing bright light it emits, RejuvaWand is not painful, though it does carry an explicit warning not to look into the beam, even when it is off.
Once customers are buzzing or zapping in their own rooms, it is hard to say what they are doing. NuFace is recommended for use only once a day, and is not for pregnant women or people with pacemakers or subject to seizures.
Nevertheless, the company is besieged with questions from customers about increasing the frequency. “They think if one time’s good, then twice is even better and three times is even better than that,” said Tera N. Valdez, the vice president for sales and marketing for Skin Star Inc., NuFace’s manufacturer. “It is really important not to overstimulate the muscles.” (Prolonged use could cause the muscles to atrophy, she said, though the likelihood is “very slim.”)
Alternately, the devices can be too targeted. ThermaClear specifies that it be used on mild or moderate acne only; no blackheads, whiteheads or hard pustules. Using it in combination with prescription treatments or on sensitive skin is discouraged and best results are achieved if the pimple is zapped right away.
How many treatable pimples does that add up to? Not many, Dr. Kauvar said: “What these devices can do is get rid of an individual pimple a little faster, but you’re doing nothing to prevent further pimples. If that’s your goal, there’s certainly nothing wrong with that.”
But, she added, “if someone is zapping something that they think is a pimple but it really isn’t, or they’re spreading an infection around the face, they can get into trouble.”
Safety is generally not the issue; price and efficacy are: NuFace costs $450, RejuvaWand $199.95 and ThermaClear $149.99.
“I don’t think people are going to hurt themselves,” said Dr. William P. Coleman, clinical professor of dermatology and adjunct professor of plastic surgery at Tulane University School of Medicine. “I think they’re much more likely to waste their money.”
He added: “When I read these claims, none of them are based on true science, none of them are based on articles in peer-reviewed journals. They’re all based on a kernel of science, and extrapolating that to the advertisers’ benefit.”
For example, the name of the Baby Quasar suggests that it is a laser, a clinically-proven treatment; in fact it is a high-powered L.E.D. like the kind found in a remote control, Dr. Coleman said. RejuvaWand also uses L.E.D.s. Likewise, the marketing materials for ThermaClear draw parallels to lasers, though it is essentially a heating element.
Heat does help decrease pimples. But, Dr. Coleman said, “I still don’t know whether using warm water or a Q-tip that’s been warmed up” is any less effective. Microcurrents and lasers approved for home use are likely to be too weak to do anything, he added.
The Baby Q was not even intended for home use, its manufacturer said. But last fall a few people bought the Baby Q and posted glowing comments on message boards. The company’s sales went from a handful every few months to the thousands, said Alex Webster, director of sales at AdvanThera, which makes the device.
Ms. Runnels eventually returned the $1,800 Quasar, which she found too painful. “It just got so hot,” she said, “I couldn’t even put my hand to it. It made my rosacea worse and my skin drier.”
She exchanged it for her old Baby Q, which she uses in combination with her vitamin C and olive oil serums, Restylane fillers and occasional Botox. “It’s not like a miracle worker,” she said. “You can’t really say what it does.”

Fonte: http://www.nytimes.com/2007/06/14/fashion/14skin.html?pagewanted=2&ref=health - 14/06/07

Congresso Brasileiro de Medicina Estética debate novas tecnologias

Rio - O 14° Congresso Brasileiro de Medicina Estética, promovido pela Sociedade Brasileira de Medicina Estética, que acontece de 6 a 9 de junho no Rio, no Centro de Convenções do Hotel Intercontinental, em São Conrado, vai abordar o crescimento da medicina estética no Brasil e a necessidade do profissional se capacitar para atuar com novos métodos e tecnologias do mercado.
A entidade médica revela ainda que a média anual de procura de médicos pela especialização em medicina estética, tem aumentado 30% ao ano. De acordo com o dermatologista Valcinir Bedin, presidente da SBME, regional São Paulo, a indústria cosmética e da beleza movimenta no Brasil aproximadamente 4 bilhões de dólares anuais, sendo o segundo no ranking mundial. O primeiro é os Estados Unidos. Segundo o médico, em tratamentos estéticos, sem incluir produtos, o consumo médio gasto são de 500 milhões de dólares por ano. Cerca de 6000 mil médicos atuam na área da Medicina Estética no país. E para não desrespeitar a comprovação científica que deve fundamentar qualquer princípio médico, as controvérsias se tornam evidentes a cada novo aparelho ou técnica lançado no mercado. A compreensão desse fenômeno de teorias e técnicas acontece através de confrontações terapêuticas, que prometem melhorar os resultados dos tratamentos estéticos.
A presidente da Sociedade Brasileira de Medicina Estética da Regional Rio, Angela Chichierchio explica que o evento é uma ótima oportunidade para o médico se atualizar, sobre as principais modificações em tratamentos já consagrados e quais resultados oferecem as principais técnicas e produtos internacionais encontrados no mercado de Medicina Estética. Novas tecnologias do universo da beleza De acordo com o presidente da SBME, Aloízio Faria de Souza, o evento vai enfatizar os tratamentos para gordura localizada, celulite, rejuvenescimento facial, entre outros. Dentre os tratamentos em discussão, técnicas de rejuvenescimento facial, como a tecnologia de plasma, do aparelho Portrait, o Aluma, o preenchimento com PMMA, os aparelhos Thermacool e Fraxel, terapias com ácido polilático, entre outros. A mesa de discussão sobre tratamentos no combate da celulite vai apresentar as novas tecnologias dos aparelhos Dermosonic e Dhermia, o Thermacool Body, com nova ponteira para uso corporal e a Carboxiterapia, com e sem gás carbônico aquecido. Já os tratamentos que visa o combate à gordura localizada serão questionados resultados oferecidos pelos aparelhos de radiofreqüência profunda e controlada, o aparelho com tecnologia de ultra-som Ultrashape e a cirurgia que propõe corrigir o excesso de tecido (gordura ou pele), na região abdominal. “Um debate que promete ampla discussão ainda é o uso do GH, hormônio de crescimento por homens e mulheres, na busca pelo rejuvenescimento. Não podemos deixar de assimilar o que pode prejudicar o desequilíbrio hormonal na saúde humana”, destaca a médica Angela Chichierchio. SERVIÇO:14ª Congresso Brasileiro de Medicina EstéticaLocal: Hotel Intercontinental - Centro de ConvençõesEnd. Prefeito Mendes de Moraes, 222 - São Conrado – Rio (RJ)Dias: 6 a 9 de junho de 2007 – De 8h30min às 18h.

Fonte: http://odia.terra.com.br/ciencia/htm/geral_103019.asp - 06/06/2007