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Allergan, the maker of Botox, has agreed to pay $600 million in fines for marketing their product for uses for which it hasn’t been FDA approved.

Documents released by the Justice Department outlined claims that Allergan had built Botox sales by promoting it for unapproved treatments to relieve conditions like migraines, muscle spasticity and cerebral palsy in children, according to the New York Times. Doctors are allowed to prescribe drugs in off-label ways that they deem medically appropriate, but it’s illegal for a drug maker to promote these off-label uses.

Allergan has denied the criminal and civil accusations, except for the one misbranding charge, said Caroline Van Hove, an Allergan spokeswoman.

While Botox is best known as a wrinkle fighter, it has been approved to treat a range of  muscle and gland disorders, including uncontrolled blinking and excessive underarm sweating, and its uses continue to grow.  The New York Times reports, ”This year, the agency again expanded the use of Botox, permitting injections for increased muscle stiffness in the elbows and hands, and it is now considering whether to approve Botox as a preventive treatment for severe migraines.” Allergan is also studying Botox as a treatment for overactive bladders, in addition to owning patents on several other potential treatments.

In an e-mail to a reporter,  Ms. Van Hove wrote, “I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm, and we adamantly deny any implication that this occurred.”

She also stressed that Allergan has spent hundreds of millions of dollars in research and development of new uses for Botox. The drug is approved in 81 countries to treat 21 different conditions, she added.

Botulinum toxin injections (Botox, Dysport) were the top plastic surgery procedure in the world last year, according to statistics recently released by the International Society of Aesthetic Plastic Surgery (ISAPS).

Billed as the first reliable international plastic surgery data ever surveyed, the data showed that botulinum toxin injections were performed 2,860,238 times last year, 32.7% of all non-surgical procedures.

It was followed by hyaluronic acid injections as the number two non-surgical procedure, which made up 20.1% of all non-surgical procedures. The rest of the top 5 non-surgical procedures were laser hair removal (13.1%); autologous fat injections (5.9%); and IPL laser treatment (4.4%).

Chemical peel, microdermabrasion, laser skin resurfacing, sclerotherapy, and laser treatment of leg veins rounded out the top 10.

The number of non-surgical procedures topped the number of surgical procedures, “reflecting both advances in cosmetic surgery innovation and the desirability of less expensive treatments,” according to ISAPS.

Liposuction was the top plastic surgery procedure, representing almost 19 percent of all surgical procedures. It was followed by breast augmentation (17%); eyelid lift (13.5%); rhinoplasty (9.4%); and tummy tuck (7.3%).

The top procedures do vary among countries. “It is not always liposuction and breast augmentation that are No. 1,” says Foad Nahai, MD, ISAPS President and a plastic surgeon in Atlanta. For instance, injectables are not yet as popular in other countries as they are in the U.S., he says.

The United States had more than 3 million plastic surgery procedures (surgical and non-surgical) performed in 2009, making it the country with the most procedures.

The top 5 countries, by total number of procedures, were:

1. United States (17.5% of total procedures)
2. Brazil (14.3%)
3. China (12.7%)
4. India (5.2%)
5. Mexico (4.8%)

“It is no surprise to me that the United States has the largest number of aesthetic procedures, and same with Brazil,” says Dr. Nahai. “But countries like China and India with emerging economies are generating a lot wealth and as that wealth is passed around, people are choosing to their spend discretionary income on aesthetic procedures.”

For more information on the statistics, visit the ISAPS website.

A disturbing trend at cosmetic and dermatology centers is being reported at msnbc.com: “cosmetic” criminals who get non-surgical cosmetic treatments and then leave without paying or write a bad check.

The Latest “Beauty Bandit”

The latest case was a woman who received over $3,000 worth of Botox and dermal fillers in a Fort Lauderdale dermatology center and then disappeared after telling staff she had to run to an ATM.

Dubbed the “Beauty Bandit,” the suspect was arrested recently, but others have been reported, including cases in Newport Beach, Calif.; Port St. Lucie, Fla.; Tampa, Fla.; Brisbane, Australia and Kenton, England.

“From talking to our doctors, this is a problem that’s occurring from coast to coast,” says Jeff Karzen, spokesman for the American Academy of Cosmetic Surgery.

The Upswing in Cosmetic Crimes

According to msnbc.com, doctors are pointing to the bad economy as one factor in the increase in these crimes, nicknamed “pricks-and-runs.” Another reason some cite is the perceived “necessity” of cosmetic procedures.

Botox is no longer considered a luxury says Dr. Jon Grazer, a Newport Beach plastic surgeon who was hit by a Botox bandit last year. “It’s something people have to have, and if they can’t afford it because of the economy, I think it’s going to push them to get it by whatever means they can.”

“We’ve had it happen three times,” says Las Vegas cosmetic surgeon Dr. Samir Pancholi. “The first time, it was a woman in her 50s who came in and got treatment, then said, ‘My purse is in the car, I’ll go grab it and be right back.’ Then she was gone.”

Avoiding “Pricks-and-Runs”

To avoid falling victim to these “beauty bandits” again, many offices affected by these crimes are changing their payment rules, such as  requiring all new patients to pay prior to receiving treatment.

XEOMIN is the latest botulinum toxin type A product to be approved by the FDA, after Botox and  Dysport. A product of Merz Pharmaceuticals, XEOMIN has been approved for therapeutic treatment of adults with cervical dystonia or blepharospasm.

The National Institute of Neurological Disorders and Stroke defines dystonias as movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. Focal dystonia, which includes cervical dystonia (twisting of the neck and sometimes the shoulders) and blepharospasm (excessive eyelid spasm), affects about 295 people out of one million in the U.S., according to a study conducted in Rochester, Minnesota.

The approval of XEOMIN comes after two U.S. clinical trials. The Journal of Neurological Sciences cited a study on the efficacy and safety of XEOMIN, in which XEOMIN showed “non-inferiority” to Botox when used to treat cervical dystonia. XEOMIN “is a safe and effective treatment for CD [cervical dystonia]” it concluded.

Xeomin, according to Merz, is the only botulinum toxin that doesn’t require refrigeration prior to reconstitution. Merz believes this may simplify product distribution and storage and help ensure product integrity at the time of injection.

Merz had announced earlier this year that it was acquiring BioForm Medical, a leader in the U.S. and European dermal filler markets with its Radiesse dermal filler. Merz will be renamed “Merz Aesthetics” after the acquisiton is complete.

Revance Therapeutics, a privately held specialty biopharmaceutical company in California, is exploring a Botox product that could be applied to the skin in cream form—no needles necessary, reports WCBS-TV in New York City.

Revance says that it will be two years before clinical trials of the product, called RT001, are complete. Then the FDA will decide whether to approve the drug, which is being tested for use on crow’s feet, according to WCBS-TV.

Some doctors worry about the safety of such a product. In an interview with WCBS-TV, Dr. David Colbert, a New York City dermatologist, says he worries that a Botox lotion product would be so popular that black market versions would be sold online without oversight and that the potential muscle paralyzing effects could be dangerous.

“I think it’s a brilliant idea, but I’m more concerned about the welfare of people who would use it irresponsibly,” he says.

Patients in the early trials tended to see a moderate reduction in wrinkles around their eyes after using the product for a month. The product is being tested on crow’s feet because the skin around the eyes is thin and susceptible to bruising when Botox is injected.

Dr. Richard Glogau, a clinical professor of dermatology at the University of California, San Francisco, who is a primary investigator for the study, said after early trials that Revance needed to rework the formulation so the drug would stay where it was applied and not spread to other parts of the body.

Dr. Anthony Youn, a plastic surgeon in Michigan, had some interesting thoughts on the product’s potential. He writes on his website: “I think a huge application of this topical botulinum toxin is in sweat reduction. Could you imagine an antiperspirant stick with this product that lasts several months with each application and leaves no residue? I’d buy it!”

To watch the WCBS-TV segment, go to http://wcbstv.com/video and search for “Botox cream.” (Pictured: before & after use of RT001 for 28 days; image via WCBS-TV)

The U.K.’s drug regulator became the first in the world to approve Botox as a tool for preventing chronic migraine headaches, Allergan announced last week. Best known as a wrinkle treatment, it can now be used on migraine patients in the U.K. who have headaches at least 15 days a month, including migraines on 8 days.

Allergan’s clinical trial involved 1,384 adults who had a history of migraines and experienced 15 or more headache days of which at least 50 percent were migraine or probable migraine during the 28-day period.  At the end of the baseline period, patients were randomized to receive either Botox injections or placebo.

By week 24 following treatment, patients who received Botox averaged 8.2 fewer migraine days, which was significantly greater than the change from baseline observed in placebo treated patients of 6.2 days.

Lee Tomkins, director of Migraine Action, stressed it was not a “cure” but it offered hope for those who suffer the most frequent migraines. Migraine symptoms may include severe headache; visual disturbances such as spots or flashing lights; sensitivity to light, noise, or smells; and nausea and vomiting.

“We have been following these studies really closely and the evidence is really pretty solid. These people spend half their lives in pain. Even if they get half the attacks, it can really improve their quality of life,” said Tomkins.

In the United States, the Food and Drug Administration is likely to decide this month whether the product can be sold for migraines, Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, said in May. In the U.S., in addition to treating wrinkles Botox can be used to treat eye muscle spasms and muscle stiffness in the elbow, wrist, and fingers in adults with upper limb spasticity.

Botox was the number one minimally-invasive cosmetic procedure in 2009 according to the American Society of Plastic Surgeons’ most recent statistics, which showed that the procedure was performed 4.8 million times in the U.S. last year for cosmetic purposes. Dr. Stacy performs the procedure in her Bellevue, Washington office.

Botox is famous for its ability to smooth wrinkles in the face, and now Johns Hopkins researchers may have found another use that goes beyond the cosmetic.

The researchers gave patients with thoracic outlet syndrome (TOS), a debilitating nerve compression disorder, one low-dose injection of Botox in a neck muscle. After the Botox, the patients reported a significant reduction in their short-term pain.

The study suggests that Botox could be a less-invasive alternative to the syndrome’s treatment of last resort—surgery to remove a rib.

“There haven’t been many alternatives to the use of surgery to treat this syndrome,” says the study’s lead author, Paul J. Christo, M.D., M.B.A., an assistant professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. “Botox seems to be an effective treatment that avoids surgery’s obvious drawbacks, such as its invasive nature and long recovery time.”

The effect from Botox lasts only a few months, so repeated injections would be necessary to maintain the results. However, repeated treatments could lead to the development of antibodies to the compound in patients; as a result Botox would no longer block the pain. Dr. Christo says that means that not all patients with TOS are candidates for Botox.

Botox’s use as a cosmetic procedure remains very popular, even as more therapeutic uses are discovered. The American Academy of Cosmetic Surgery reported that it was the number one less-invasive cosmetic procedure in the United States in their 2009 cosmetic surgery statistics. Botox is one of the services Dr. Stacy offers at her Bellevue, Washington office and is the most popular cosmetic treatment in Bellevue and Seattle, according to her website.

The full release on the study, Botox Eases Nerve Pain in Certain Patients, can be viewed at the Johns Hopkins Medicine website.

These articles are pretty common in Cosmo, but it’s a little surprising to see them in the men’s magazine, Details.  Nonetheless, the fellas definitely need some guidance in this area.

The 5 Tips You Need to Fight Aging offers a very practical spin on the topic; lift weights, tame that hair (or lack thereof) and take care of your skin by doing the following:

• In the morning, rub on both a moisturizer with SPF to protect against sun damage and a cream with vitamin C to help rebuild collagen and plump up your skin.
• At night, put on an anti-oxidant cream
• Get a gentle 20 percent glycolic-acid peel every couple of months
• Get “Botoxed” and restore volume to the face with fillers.

Beginning September 18th 2009,   Dr. Lynn A. Jones will welcome Stacy J Davies MD of Dr. Stacy Cosmetic to provide non-surgical cosmetic services for face and body, including Botox, Juvederm, Radiesse, SmartLipo, Thermage, and Fraxel.  Dr. Stacy will be available in Dr Jones’ Bellevue Place office every Friday beginning mid-September 2009.

If you’re a local resident of the Bellevue area, we’re looking forward to helping you improve your appearance through the best minimally invasive procedures and the finest medical grade skin care products.  Contact us for more information about scheduling an appointment in Bellevue!

People sound plenty optimistic about the economy this week, but competition on the job market is still really fierce.  We’ve had more than a few patients at our Maple Valley location say they suspect that their age, or appearance is affecting their job prospects to some extent.

When you’re competing with young adults just out of college, who often accept a much lower wage, you need to present yourself in the best possible light.  To improve their chances, many job seekers have turned to a talented hair stylist for a new look, or their local surgeon for Botox or Dysport wrinkle injections.

Botox is the most popular non- invasive cosmetic procedure in the United States.  According to the American Society of Plastic Surgeons, more than 5 million treatments were done last year. The cost of a single treatment is relatively low, but will vary, and it definitely pays to keep an eye out for monthly specials and events.

If you are going for treatments prior to a job interview, give yourself at least 7 days to heal and let the results take effect. Remember, doing well on an interview is not only about how you look, but whether you exude confidence about yourself and your ability to do the job.

Ask about our special Botox and Juvéderm rebate programs today!