Thursday, November 19, 2009
Thursday, November 12, 2009
Surgery at a Spa? Buyer Beware.
New York Times
Published: November 4, 2009
THERE is little to suggest that the TriBeCa MedSpa in Manhattan is a medical facility, at least in the traditional sense. In the waiting area, called the Tranquillity Room, a waterfall cascades down one wall. A client may have a pedicure or facial before entering a softly lighted space where a plastic surgeon performs laser Fraxel treatment or some other minimally invasive procedure that would cost twice as much in a harried doctor’s office.
TriBeCa MedSpa is one of 1,800 medical spas in the United States, hybrid facilities that offer treatments like laser hair removal and liposuction alongside massages and other traditional spa fare. In recent years, the business has become a growth industry: from July 2007 to December 2008, the number of medical spas increased 85 percent, according to the International Spa Association, far outpacing the growth of day, destination and resort spas.
The kinds of procedures performed in medical spas has also increased. At the Park Avenue Medical Spa in Armonk, N.Y., for instance, clients who have undergone chemosurgery for skin cancer, which may leave the skin pitted, can receive reconstructive surgery, a treatment that falls outside the strictly aesthetic category and may point in the direction the industry is evolving.
“It certainly seems like the wave of the future,” said Dr. Gerald Ginsberg, a cosmetic surgeon and medical director of the TriBeCa MedSpa, who noted that, increasingly, patients are becoming “customers” searching for the best deal in what he calls “today’s medical emporia.” All the more reason, in his mind, that it is important to enforce regulations “to ensure we’re offering the best care for the best price.”
In fact, despite the many well-regarded facilities like TriBeCa MedSpa, the rapidly growing industry is coming under increased scrutiny. Proposed legislation to tighten controls over the credentials of those who can own a medical spa; what procedures can be performed in such places; and how much training someone must have to perform particular procedures is making its way through several state medical boards, including those in Massachusetts, New York, Utah and Florida, where the death last month of a patient, Rohie Kah-Orukotan, is generating renewed concern.
On Sept. 25, Mrs. Kah-Orukotan, a 37-year-old nurse, entered the Weston MedSpa in Weston, Fla., for a minimally invasive liposuction procedure to remove fat from her abdomen and thighs. During the treatment, she suffered seizures and never regained consciousness.
Michael Freedland, the family’s lawyer, said she was given Lidocaine and propofol, a drug that induces sedation and is believed to have contributed to the death of Michael Jackson.
The case, which is still under investigation, raises several issues that concern experts around the country. First, should the treatment — which may actually have been, by the state’s classification, a more advanced, or Level II, liposuction procedure — have been performed at Weston MedSpa, which is licensed as an electrolysis facility, not a medical facility?
“We believe Mrs. Kah-Orukotan received more than a minimally invasive Level I liposuction procedure in a setting that was inappropriate,” Mr. Freedland said. In fact, a new rule before the state’s board of medicine would not allow any surgical procedure that requires sedation to occur outside of a registered Level II surgery facility.
And then there is the question of the experience of the doctor who performed the procedure on Mrs. Kah-Orukotan. Dr. Omar Brito Marin, a medical doctor with a specialty in occupational medicine, learned liposuction in a three-day intensive course, according to his lawyer, Brian Bieber, who said he believes no malpractice was committed in the case.
For some industry observers, the issue of training and experience is the cause for perhaps the greatest concern. Dr. Darrick Antell, a plastic surgeon in Manhattan, noted that all too frequently someone who starts out performing one procedure migrates to another with only minimal experience. “Someone may start out doing laser hair removal, and next thing you know they’re doing treatments for cellulite,” said Dr. Antell, who said that personnel in medical spas are pushing the boundaries of what is allowed.
Wendy Lewis, an aesthetic surgery consultant and author of “Plastic Makes Perfect,” said: “The incident in Florida is nothing short of tragic, and I feel for that woman’s children and family. But I say, buyer beware.”
Such sentiment applies to another popular medical spa procedure: laser hair removal. For years, complaints of second- and even third-degree burns from laser hair removal procedures have been reported. Yet in places like New York State, it is still not considered a medical procedure, despite vigorous protests from many in the medical community.
“In New York, legally, even a barber could do it, not that he would,” said Dr. David Goldberg, a cosmetic dermatologist in New Jersey, New York and Florida, as well as a law professor at Fordham University and a legal counsel to the Medical Spa Society.
In Massachusetts a medical spa task force has been set up to advise the state legislature on how best to regulate the facilities. “We are trying to set some standards here, yet make it flexible enough to accommodate rapid changes in the industry,” said Russell Aims, chief of staff of the Massachusetts Board of Registration in Medicine.
“We don’t want to say to the consumer, ‘Don’t go get these procedures done,’ or to a physician that he or she can’t profit from this potentially lucrative business, but I think it’s around the time I saw a place offering walk-in Botox shots at a mall that I became concerned,” Mr. Aims said.
“To me it’s a lot like the mortgage industry,” said Dr. Ranella Hirsch, a dermatologist in Cambridge, Mass., and an advocate for more stringent regulations of medical spas. “While it may allow more accessibility to treatments and procedures, it’s also brought a much higher level of permanent injury,” she said. Dr. Hirsch added that she thinks a system of federal regulations of medical spas would be more cohesive than the current state-by-state model but believes that is unlikely to happen, since medical and other professional boards, like nursing, electrology and aestheticians boards, are regulated and licensed by individual states.
“What is likelier to happen (and currently under way) is that national organizations like the American Society for Dermatologic Surgery, which represents member dermatologists nationwide, provide guidelines for legislative guidance state by state,” she said in an e-mail message.
Despite all the safety and regulatory controversies concerning medical spas, there are thousands of satisfied medical spa customers. Among them is Gail Fox of Palm Beach Gardens, Fla., who went to the Anushka Cosmedical Center Spa and Salon in West Palm Beach, for facial fillers that were administered by a nurse practitioner and found the experience “a pleasure.” “The service was on sale so the price was right. That’s what drew me in. The pace was slower than at my dermatologist’s office. All my questions were answered, and I didn’t feel pressured,” Ms. Fox said.
“These places can offer a wonderful opportunity for a consumer to reduce stress and get treatment for the whole body,” said Lynne McNees, president of the International Spa Association. But, she added, “just because someone is in a white coat, it doesn’t mean he or she is a qualified to perform a procedure on you.”
Both Ms. McNees and Hannelore Leavy, executive director of the International Medical Spa Association, emphasized the efforts their associations are making to educate the medical spa consumer. For instance, Ms. Leavy’s organization has a section on its Web site that pertains to current legislation affecting medical spas.
“If someone is cutting you open or injecting something into you it’s not a spa service, it’s a medical one,” Ms. McNees said. “You’re going to need to know who is performing that procedure, know their credentials and accreditations and really do your homework,” she said. “I tell everyone, ‘If you don’t know, don’t go.’ ”
Thursday, September 17, 2009
The Alternative Medicine Cabinet: Arnica for Pain Relief By Anahad O'Connor
More than a third of American adults use some form of complementary or alternative medicine, according to a recent government report. Natural remedies have an obvious appeal, but how do you know which ones to choose and whether the claims are backed by science? Today, New York Times “Really?” columnist Anahad O’Connor begins a weekly series exploring the claims and the science behind alternative remedies that you may want to consider for your family medicine cabinet.
The Remedy: Arnica
The Claim: It relieves pain.
The Science: Arnica Montana, a plant native to mountainous areas of Europe and North America, has been used for centuries to treat a variety of pain. Athletes rub it on muscles to soothe soreness and strains, and arthritis sufferers rub it on joints to reduce pain and swelling. It’s believed that the plant contains derivatives of thymol, which seems to have anti-inflammatory effects.
Either way, scientists have found good evidence that it works. One randomized study published in 2007 looked at 204 people with osteoarthritis in their hands and found that an arnica gel preparation worked just as well as daily ibuprofen, and with minimal side effects. Another study of 79 people with arthritis of the knee found that when patients used arnica gel twice daily for three to six weeks, they experienced significant reductions in pain and stiffness and had improved function. Only one person experienced an allergic reaction.
The Risks: Arnica gels or creams can cause allergic reactions in some people, but it is generally safe when used topically. However, it should never be rubbed on broken or damaged skin, and it should only be ingested when in a heavily diluted, homeopathic form
Monday, July 20, 2009
New York nips facelift firm for astroturfing
But they're still grinning...
Posted in Music and Media, 15th July 2009 18:35 GMT
A facelift firm is being slapped with a $300,000 fine by New York state for flooding the internet with fake positive reviews about itself.
State Attorney General Andrew Cuomo said the case is believed to be the first in the US to punish so-called "astroturf" marketing.
Under a settlement deal announced Tuesday, the cosmetic surgery outfit Lifestyle Lift agreed to cut out publishing anonymous positive reviews about the company on internet message boards and websites and pay the state $300,000 in penalties.
Lifestyle Lift, which mostly targets consumers though infomercials as a "minor one-hour" facial firming procedure, has a history of aggressively guarding its reputation online. The company has filed several lawsuits alleging trademark violations against websites that publish negative reviews or comments about the company.
Cuomo's office alleges Lifestyle Lift's president decided negative internet postings were causing a significant loss of face and ordered his employees to pose as satisfied customers on various internet message boards and websites. Internal emails discovered in the investigation show specific marching orders to engage in the illegal activity:
"Friday is going to be a slow day - I need you to devote the day to doing more postings on the web as a satisfied client," one email to employees read.
"Put your wig and skirt on and tell them about the great experience you had," stated another.
Lifestyle Lift also created stand-alone websites and blogs made to appear as if they were created by independent, satisfied customers.
"I decided to create this website because I wanted to share my story with others," one such website stated. "After my first consultation, I went online and read horror stories about Lifestyle Lift. People were trashing Lifestyle Lift, their employees, their doctors, etc...I got scared and seriously thought about canceling my procedure. I was getting cold feet. What was with all the negative posts online? Those negative stories did not ad up at at...
"I realized quickly that most of that stuff was probably made up: the reviews were using long medical terms that only a doctor would use..." it continued. "I also talked to my doctor about it.... He told me that many of the negative stories I was reading online were probably from envious doctors and just made up because he never heard any of this from his patients."
According to the settlement, Lifestyle Lift employees will no longer pose as customers on the internet. The company also agreed not to promote its services without disclosing they are responsible for the contentThursday, June 4, 2009
A Face From an Infomercial
IT used to be that a cosmetic surgery patient who was tired of sagging jowls would discreetly ask for names of reputable doctors who did face-lifts. A surgeon, building a practice as word of mouth about his skills spread, became, in effect, his own brand.
But now face-lifts themselves are being branded. Certain minimally invasive procedures are marketed directly to patients in a one-size-fits-most approach. Patients pick an operation — usually after seeing it touted online, on TV or in magazines — and are referred by a national organization to a doctor.
Two procedures sold this way are the Lifestyle Lift, which an ad in Family Circle describes as “revolutionary” and a way to “remove wrinkles, frown lines and sagging skin” in about an hour; and the QuickLift, which also benefits from nationwide marketing that promotes a short recovery and only local anesthesia.
Because these procedures, priced at $4,000 and $5,900, contrast with more extensive face-lifts requiring general anesthesia and usually costing more, they have become popular: More than 100,000 patients have received the Lifestyle Lift alone since 2001, according to the company.
But some surgeons think branded face-lifts are problematic. It is not the procedures themselves that disturb critics — many plastic surgeons and otolaryngologists (head and neck surgeons) offer their own quick-recovery face-lifts. But some doctors are concerned that patients may be so persuaded by advertising that they don’t seek a second opinion or investigate the full range of options. Consumers may pick a minimally invasive procedure when the results they seek may require more complex — and expensive — intervention.
“What’s new is this is plastic surgery being marketed to the public as a widget,” said Dr. Brian Reagan, a plastic surgeon in San Diego. “People are buying, so buyer beware.”
In this new landscape, patients are encouraged to seek an advertised procedure rather than work with a surgeon to select from a menu of options. What’s more, some patients are now “looking not for the best doctor, but the one who has the magic wand,” said Dr. Reagan, who has given a lecture titled “Invasion of the Mini-Lifts ... Coming to a Clinic Near You.”
Dr. David M. Kent, an osteopath and facial plastic surgeon who founded Lifestyle Lift, said he employs nearly 100 doctors in 31 offices who are trained to do Lifestyle Lifts. (The company also has 10 doctors in private practice who license its brand.) “Every single patient gets the same basic face-lift,” he said, explaining that it consists of lifting underlying layers of muscle and connective tissue, and trimming skin. Patients also receive custom nips and tucks as needed.
The QuickLift, which roughly 10,000 patients have had since 2003, is sold differently. Doctors who offer it maintain their own practices and might also offer traditional face-lifts. A company, MDCommunications, helps those physicians market the QuickLift by placing television spots and optimizing how fast a doctor is found online.
Dr. Dominic A. Brandy, the developer of the QuickLift, coined the term to describe his adaptation of an S-lift, an operation that uses teardrop-shaped sutures to suspend sagging features. Dr. Brandy said he improved on the S-lift by pulling the face vertically instead of toward the ears.
Currently, 25 to 30 doctors receive patients through QuickLiftMd.com. The doctors attended a one-day workshop priced at $1,950 (and sometimes a few other days of training) taught by Dr. Brandy, a cosmetic surgeon with a background in emergency medicine.
Teresa Bradley, 47, found her QuickLift surgeon on the company’s site. Even before meeting him, she had decided QuickLift was for her. “I researched the procedure,” she said. “It was excellent.” But she has agonized over the results. “He lifted one side very high and left the other side hanging,” she said.
Now Ms. Bradley said she realizes the QuickLift is only as good as the surgeon doing it.
In response, Dr. Brandy said, “When you teach somebody a procedure, even if they use the basic same procedure, skill levels are so different.”
The American Society of Plastic Surgeons hasn’t taken a stand on branded procedures. But its president, Dr. John W. Canady, advised, “Go get a second opinion from someone who doesn’t have a big ad.”
Patients should be presented with a range of options, said Dr. David S. Kung, a board-certified plastic surgeon in the Washington, D.C., area. He considers deeper-plane face-lifts “the gold standard,” because they “last the longest and they can effect the maximal change,” he said. But he sees a place for middle-of-the-spectrum face-lifts, which in his opinion, include the QuickLift, Lifestyle Lift and another (nonbranded) lift, the minimal access cranial suspension.Dr. Kent said that before patients meet a Lifestyle Lift surgeon, they see a consultant and watch a video in which the company’s medical director explains its philosophy. Then they meet with a surgeon before deciding whether to proceed.
But three Lifestyle Lift patients and Dr. Mario S. Yco, a board-certified otolaryngologist who was an employee of the company for about a year, said that patients were urged to put down a deposit before they met with a surgeon.
“The consultant sold the surgery,” said Dr. Yco, who practices in Encinitas, Calif. Often by the time he saw patients, the surgery was booked. “There were many patients I had to cancel,” he said, explaining that he didn’t deem them appropriate candidates.
In response, Dr. Kent said, “It’s never a consultant that decides whether or not a patient should have surgery.” He described the company’s consultants as “people-friendly people.” They make sure patients “understand what they are getting into, explain the things we offer, talk about the doctor,” he said.
Dr. Yco said he was amazed at the power that advertising had over Lifestyle Lift patients. “They are sold by the concept, they are not sold by the surgeon’s credentials,” he said. “Unfortunately if they are not satisfied, it’s a big drop for them.” He added, “It’s like lemmings going down a cliff.”
In May, on the job site Monster.com, the Manhattan branch of Lifestyle Lift ran an ad seeking applicants to be plastic surgery consultants. “No medical experience needed,” it said, adding that the right candidate would have an “ability to match the offerings of Lifestyle Lift with the desires of Clients.”
Sharron Bryant, a manager for Lindt Chocolates in Dallas, who got a Lifestyle Lift in 2007, said she had a “high pressure” consultation and put down a deposit before meeting a surgeon. Ms. Bryant, then 59, paid $6,100 for a Lifestyle Lift and chin liposuction. She never needed pain medication during her weeklong recovery, she said.
But she disliked the loose skin that remained on her jowls and neck. “I got nothing for the money,” she said. She later paid $8,200 for a traditional face-lift from a different surgeon.
With “every plastic surgery procedure, there’s a certain number of people afterwards that are unhappy,” Dr. Kent said. “There’s nothing wrong with them medically. They are just dissatisfied.”
On Realself.com, a Web site where patients discuss cosmetic surgery, 37 percent of the 170 people who reviewed the Lifestyle Lift said the procedure was “worth it,” while 63 percent didn’t think so.
Leigh Floyd, 46, a technical writer in Houston, is an “extremely satisfied” customer of Lifestyle Lift, which she partly attributed to her realistic expectations. “You won’t look 20” afterward, she said, “because it’s still your 40-year-old skin.”
But she was most impressed by the skill of her surgeon, Dr. Kevin R. Smith, a Houston otolaryngologist. “His sutures were so tiny,” she said. “I just know I picked the right doctor.”
Here’s some advice for those considering face-lifts.
•
Check whether your surgeon is certified by one of the boards of the American Board of Medical Specialties at abms.org. They require physicians to complete residency training in a specialty and to pass rigorous oral and written exams.
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Before you schedule an operation, meet the surgeon to make sure you’re on the same page. “The best surgeons will give you their honest opinion whether they can achieve what you’re looking for,” said Dr. John W. Canady, the president of the American Society of Plastic Surgeons.
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Don’t settle for a hasty consultation. The downside as well as the upside of an operation should be covered, said Dr. Robert Singer, a plastic surgeon in La Jolla, Calif.
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You should never feel as if you’re being sold a procedure. “If you’re getting a high-pressure sales pitch for a procedure, personally that would worry me,” Dr. Canady said.
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It never hurts to get a second opinion.Thursday, May 7, 2009
What to Know Before Going Under the Liposuction Knife
From a swank office on Beverly Hills' Rodeo Drive, Craig Alan Bittner built a busy cosmetic-surgery practice that specialized in a procedure he called liposculpture.
He spread the word through magazine ads in which he referred to himself as Dr. Lipo 90210. He sent out mailings showing before-and-after pictures of women's love handles, thighs and abdomens. Though he touted liposculpture as "an advanced technique," the procedure is essentially a marketing term for common liposuction surgery, medical experts say.
Body Sculpting
What to do before going for liposuction:
- Learn about liposuction and find surgeons at asds.net and plasticsurgery.org.
- Check if a doctor is certified in plastic surgery or dermatology at abms.org.
- Ask how a doctor would handle a medical emergency.
Then, in December, Dr. Bittner, who is in his early 40s, shuttered his Beverly Hills Liposculpture practice. The California Medical Board is looking into patient claims that Dr. Bittner allegedly allowed unlicensed office staff to perform cosmetic surgery. Investigators from the board's enforcement arm executed a criminal search warrant of his offices in Beverly Hills and Irvine, Calif., and his Santa Monica residence in November. The warrant, signed by a state superior court judge, sought information concerning at least 15 of Dr. Bittner's patients, whose names were listed on the warrant; employment records for office staff; and "evidence tending to show the unlicensed practice of medicine."
No charges have been filed against Dr. Bittner, and it remains unclear whether he engaged in any wrongdoing pending the outcome of the California board's inquiry. "Investigations are not public record," said Candis Cohen, a board spokeswoman.
Dr. Bittner's current whereabouts couldn't be confirmed. In a farewell letter to patients left on his Web site, he wrote that he was relocating to South America to do volunteer work with a small clinic "where I can help those most in need." In a telephone interview last month, Dr. Bittner denied any wrongdoing and said he "retired" because he wasn't enjoying his work anymore. He didn't say where he was calling from, and the line went dead midconversation.
Dr. Bittner claimed that what prompted the board's scrutiny of him was an unusual element of his practice -- using his patients' harvested fat to fuel his car. Dr. Bittner publicized this unorthodox use of body fat on a now-defunct Web site, lipodiesel.org.
The field of cosmetic surgery is rife with inflated promotional claims and malpractice suits. Still, the controversy over this high-profile practitioner of liposuction, the most common form of cosmetic surgery, spotlights some lessons for patients in how to pick a doctor in this popular field.
![[dr. lipo]](http://s.wsj.net/public/resources/images/PJ-AO460_pjHEAL_DV_20090216224919.jpg)
Dr. Craig Alan Bittner promoted "liposculpture" in ads until closing his practice.
Plastic surgery has for years attracted doctors from unrelated specialties who are able to acquire a minimum level of training in cosmetic medicine by attending courses for brief periods, medical experts say. Liposuction surgeons may end up competing for patients mainly on the basis of aggressive marketing and advertising claims that tell consumers little about their medical qualifications. Fully trained plastic surgeons and dermatologists frequently complain about having to compete with newcomers who have little experience in the field.
State records show that Dr. Bittner graduated from the Johns Hopkins University School of Medicine in 1993. He is a licensed doctor with board certification in interventional radiology, a field unrelated to cosmetic medicine. In the telephone interview, he said his liposuction training came from a two-month apprenticeship with a dermatologist in South Florida, who he said is now deceased. He also said he trained with surgeons in Europe and attended programs at meetings of the American Academy of Dermatology.
Consumers seeking cosmetic surgery are able to check a doctor's credentials by going online. Details about a physician's board certification can be found at the American Board of Medical Specialties Web site (abms.org). Medical experts generally recommend choosing someone who is board certified either in plastic surgery or dermatology and has performed large numbers of liposuction surgeries. Patients also should check with a state medical agency Web site to see if any action has been taken against a physician's license.
John Canady, professor of plastic surgery at the University of Iowa and president of the American Society of Plastic Surgeons, said patients should question a surgeon about plans for handling a medical emergency. He says prospective patients should ask what the doctor's procedure is for handling events such as a heart attack during surgery, or an infection which could develop later. If doctors seem to be "dancing around" answering questions about their credentials, training or emergency procedures, "I would start to feel very uncomfortable," Dr. Canady said.
There were 456,828 liposuction procedures performed in 2007, the latest data available, an increase of 13% from a year earlier, according to the American Society for Aesthetic Plastic Surgery. To perform liposuction, a practitioner must be a doctor, but isn't required to have any special licensing or certification. In many states, a licensed physician assistant can participate in the surgery, but only under a doctor's supervision.
Cosmetic surgeons say they are seeing fewer patients because of the recession. Still, magazines, newspapers and the Internet continue to be full of ads for liposuction, many offering steep discounts.
One liposuction patient drawn by Dr. Bittner's marketing was Kelli Michael, a 35-year-old nutritional-products salesperson in Southern California. Ms. Michael said she contacted Dr. Bittner two years ago after doing an online search. "Every time I put in anything that had to do with liposuction, his name was the first to pop up," she said. "He was on Rodeo Drive, so you would think he would be good," she added.
Ms. Michael said she complained to Dr. Bittner repeatedly about the results of her surgery, which she claims left her with uneven scar tissue "as hard as a rock" above her belly button. She said Dr. Bittner dismissed her complaints. Ms. Michael said she told a medical board investigator late last year that Dr. Bittner appeared only at the end of her surgery and that most of it was performed by "a man and a woman, taking turns." She didn't recall their full names.
Ms. Michael was among the patients whose names were listed on the search warrant seeking records from Dr. Bittner's practice.
Other patients have filed malpractice suits against Dr. Bittner, claiming that he allowed unlicensed staff in his office to perform parts of their operations.
Benjamin Gluck, a Los Angeles criminal attorney representing Dr. Bittner and his practice, denied any wrongdoing by anyone in Dr. Bittner's office. "No criminal charges have been filed against him," Mr. Gluck said, adding, "We are litigating the search warrant and the manner in which it was executed." He said the investigators improperly took legal files and correspondence with attorneys.
"We believe the evidence supports our actions," said Ms. Cohen, the medical board spokeswoman, in response to Mr. Gluck's challenge of the search warrant.
Dr. Bittner said he faces four malpractice suits. "It's not surprising that after 7,000 cases, there are four lawsuits, especially in a bad economy," he said in the telephone interview. As for the criminal probe, he said that certain parts of the surgeries done at his Beverly Hills practice were lawfully performed by licensed physician assistants under his supervision. "On every single patient, I did the final work, the sculpting," Dr. Bittner said.
This isn't Dr. Bittner's first run-in with the California Medical Board. Before turning to liposuction, he operated a chain of radiology-imaging shops in California and other states. He offered magnetic resonance imaging, or MRI, that he claimed was better than mammography for detecting breast cancer. In 2003, the California board claimed this was false advertising in a civil suit it filed against him and the company he founded, HealthScan America Inc. The shops closed at about the same time. In 2004, a California state court ruled against the business and ordered it to pay $1 million in penalties. The court dismissed Dr. Bittner from the suit.
Dr. Bittner said in the telephone interview that his approach to preventive medicine using MRI to screen for breast cancer was "ahead of its time."
Annual mammograms are still the staple prescription for women at average risk of breast cancer. But the American Cancer Society in 2007 issued new guidelines recommending annual MRIs, in addition to mammograms, for women with certain genetic mutations tied to breast cancer and those whose family history signaled a significantly elevated lifetime danger of the disease, among other high-risk categories.
In promotional materials for his liposuction practice, Dr. Bittner identified himself as Alan Bittner, using his middle name. Earlier, in promotional materials for his radiology shops, he identified himself as Craig Bittner, using his first name.
Dr. Bittner defended his use of discarded body fat from his patients to fuel his car and said he received signed consents from patients who were told of the intended use. Still, "the medical board went ballistic" about this practice, he said.
Using medical waste obtained from liposuction as a biofuel "is not currently an approved alternative treatment technology," according to the California Department of Public Health. To seek approval, an individual would have to submit an application to the department for this alternative use. There is no record of Dr. Bittner filing such an application, a department spokesman said.
The practice spurred "death threats against me and my staff," Dr. Bittner said. "I thought it was a great thing to demonstrate to the world how many ways there are to solve the energy crisis."
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.
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
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.
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 sideMonday, April 13, 2009
So Botox Isn’t Just Skin Deep
Botox is used by Dr. Andrew Blitzer to treat vocal cord problems; he injects it into the larynx.
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.
Dr. Blitzer also uses the drug to treat severe jaw muscle pain.
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
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
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.
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.”