Allergan to Pay Over $600 Million Settlement

Allergan, the maker of Botox®, is being forced to pay over $600 million following a civil settlement and charges that marketed the popular drug for off-label purposes. According to the New York Times, Allergan was marketing Botox®—which is currently used to treat wrinkles and hyperhidrosis—for the off-label treatment of migraines.

Botox® is currently not approved by the Food and Drug Administration for the treatment of migraines. The issue was not that Botox® was being used to treat migraines; it was that doctors were receiving incentives from Allergan if they actively promoted the headache treatment to their patients. The Justice Department issued this statement:

“In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops to teach doctors and their office staffs how to bill for off-label uses, conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®, and operated the Botox® Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses. Allergan also lobbied government health care programs to expand coverage for off-label uses, directed physician workshops and dinners focused on off-label uses, paid doctors to attend “advisory boards” promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox® for off-label indications.”

Allergan, based in Irvine, CA, admitted to marketing unapproved uses of Botox®—including treatment of headaches and blepharospasm—between 2000 and 2005. The company agreed to pay $225 million to resolve civil charges that it endorsed falls Medicare and Medicaid claims, however, they denied liability. The company is schedule to pay between $610-$615 million in the third quarter of 2010, nearly half of Botox®’s $1.3 billion from last year.

Botox® was originally approved by the FDA in 1989 for the treatment in hyperhidrosis and then again in 2002 for wrinkle reduction. There is still concern as to whether or not the settlement will have an effect on the FDA’s decision on whether or not to approve Botox® for migraine treatment. The FDA’s decision is due to be announced at the end of October.

Patients Need Less Botox® Over Time for Same Results

A recent study performed by Oregon Health & Science University shows that patients can decrease the frequency of Botox® injections after approximately two years and still see similar cosmetic benefits.

The study was run by Roger A. Dailey, M.D., F.A.C.S., professor and Lester Jones Endowed Chair of oculofacial plastic surgery in the OHSU School of Medicine. "After two years of treatment at recommended intervals, patients can potentially cut the frequency, and thus the cost, of their Botox® treatments by half," said Dailey.

Dailey’s study was presented at the American Society for Aesthetic Plastic Surgery conference in Washington, D.C., on April 24. Allergan, Inc., the maker of Botox® Cosmetic, sponsored the study with an unrestricted educational grant.

The study also found Botox® to have a wrinkle-preventing—or prophylactic—effect. Patients who were administered injections between their 30s and 50s not only eliminated existing wrinkles, but also prevent new wrinkles from forming.

Previous studies suggested that patients should be injected with Botox® every three months in the glabellar region—the area between the eyebrows—to maintain a wrinkle-free appearance. According to Dailey, the frequency and cost of the treatment deterred some patients from starting or continuing a Botox® regimen.

The study monitored 50 women between the ages of 30 and 50. The women were injected regularly with Botox® over the course of two years. "We found that after the patient receives Botox© Cosmetic injections every four months for two years, the frequency of the injections can be changed to every six months and still achieve good results," said Dailey. "This demonstrates patients have the ability to achieve good results with broader treatment schedules and ultimately at a lower overall treatment cost.”

According to the American Society for Aesthetic Plastic Surgery, 2,557,068 patients underwent Botox® treatments in 2009 (257,786 of which were men). Botox® was approved by the FDA for cosmetic purposes in 2002.

The Hawaii Dermatology Seminar

I am currently co-directing the Hawaii Dermatology Seminar on the Big Island of Hawaii. This meeting has a long 34-year history of providing quality education to dermatologists from throughout the United States. My co-directors, Joe Fowler, MD from Louisville, KY and Christopher Zachary, MD from the University of California at Irvine, are well-recognized leaders and teachers of all aspects of dermatology. The meeting is divided into 5 segments expanding into 5 days.

The first day is dedicated solely to melanoma – a timely topic considering that the meeting takes place in sunny Hawaii. The next 2 days are dedicated to medical dermatology including acne and psoriasis. The 3^rd day covers pediatric dermatology with the final 2 days dedicated to cosmetic laser treatments and other new aspects of cosmetic dermatology. I will give you an update on these last 2 days at the beginning of next week.

David J. Goldberg, MD

Actress: Steroids are to Athletes as Botox is to Her?

Actress Rachel Weisz (best known for being in The Mummy) is in the news today for comparing the use of Botox and other wrinkle-killing injections to the use of performance-enhancing drugs for athletes.


"Rachel told Harper's Bazaar magazine: "It should be banned for actors, as steroids are for sportsmen."

The distinction that we would like to make is that steroids have known, well documented, life-long complications. Botox, when used solely for cosmetic purposes, has virtually no long-term side effects.

Should they ban makeup, lighting, and photoshop touch-ups on the movie posters?

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Botox a cure for baldness?

Colin Stewart at the OC Register's In Your Face blog wrote yesterday about a story in Britain's Daily Telegraph featuring Beverly Hills plastic surgeon Dr. Simon Ourian, who claims that he has been having success regrowing patients' hair with Botox.

"It’s not a claim that’s made by Botox-maker Allergan of Irvine. The announcement came from cosmetic surgeon Dr. Simon Ourian of Beverly Hills, who says injections in patients’ scalps have produced hair growth.

“It doesn’t make sense that Botox would cure baldness,” says Dr. Christopher Zachary, chairman of the UCI Department of Dermatology. “I have injected men numerous times high on the [forehead] and have never seen any hair growth.”

“It simply does not make sense, physiologically. I think he might have the same success if he injected lemonade,” says bariatric surgeon Dr. Brian B. Quebbemann of Newport Beach."

We're going to throw in our own two cents here: we wish.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ