Relief for Migraine Sufferers Boosts Allergan’s Stock after Fed Crackdown

For migraine sufferers, the recent FDA approval of Botox as a migraine treatment gives them access to the only thing that might actually work—injections of Botox.

Migraine victims have long awaited a drug that would avoid migraines, not just treat them after they start. Studies prove Botox’s ability to block nerves that cause a migraine. In one study, chronic migraine sufferers getting Botox injections had 9 fewer days of headaches per month compared with those receiving a placebo, who reported 6.7 fewer.

In another study that was funded by Allergan, Botox users reported 7.8 fewer days per month of any headaches (including migraines) compared with 6.4 days’ fewer headaches reported by those receiving the placebo injections.

Guilty Plea

Allergan had previously been ordered by the Justice Department to pay $375 million in fines for unauthorized promotion of Botox for headaches and cerebral palsy from 2000 to 2005. The fine was lowered to $350 million upon Allergan’s willingness to plead guilty to the charges. Allergan was also ordered to forfeit $25 million in assets and to stick to a 5-year mandated plan to disclose any payments to doctors and annually certify that their various divisions meet federal health care requirements.

Who can use it?

Men and women who have a migraine headache at least 15 days a month with pain lasting at least four hours qualify for treatment. It is assumed that health insurance carriers will approve this as a covered expense, since no other treatment has provided similar results. Treatment includes multiple injections around the neck and head every 3 months.

Allergan spokesperson, Caroline Van Hove, believes that insurers are unlikely to fight coverage of the drug since “this is a population that hasn’t responded to any of the conventional treatments.” Botox was cleared for migraine treatment earlier this summer in the UK and the company anticipates approvals in the rest of Europe and Canada yet this year.

Stock Market Reaction

Allergan (AGN) is running around $72 per share this month (Oct 2010). A month ago it was averaging $66 per share. The company, which generated $1.3 billion in 2009 sales, may earn $1 billion more in annual revenue with the migraine approval, said Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, in a May 2010 report.

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.

Botox® Efficacy Enhanced By Oral Supplements

According to recent research conducted by Charles Soparkar, M.D., Ph.D., F.A.C.S., a dietary supplement that combines zinc and phytase increases the effectiveness of Botox® Cosmetic on patients. Plastic Surgery Practice reports that the supplement, trademarked as ZYTAZE™, is patent-pending and may be available to patients as early as this month.

The study analyzed 44 patients who had taken the oral supplements prior to being injected with botulinum toxin (Botox®, Dysport®, or Myobloc®). Forty-one of the 44 patients showed noticeable results. Multiple subjects were being treated for blepharospasm, or eyelid spasms, and had previously responded poorly to the injections.

Soparkar and his team will present the findings at the American Society of Ophthalmic Plastic & Reconstructive Surgery’s 41st Annual Fall Scientific Symposium in Chicago on October 14, 2010.

"Surprisingly, the results showed that in over 90% of the patients studied, the zinc/phytase combination resulted in a remarkable improved responsiveness to treatment of blepharospasm using the same amount of botulinum toxin as previously used," Soparkar told Plastic Surgery Practice.

"The toxins seemed to have greater effect and last longer. Potentially, this could mean using less toxin, offering patients financial savings, greater safety, and more consistent results."

Perhaps future findings will prove that the natural inclusion of diets rich in phytase and zinc can also improve the results of botulinum toxin injections. Pythase can currently be found in many grains and oil seeds, while foods like oysters and wheat germ are great sources of zinc.

A Forecast For the North American Facial Injectable Market

Cosmetic injectables are hands down the most popular aesthetic treatment in North America. The North American facial injectable market consists of four different types of fillers: collagen, Hyaluronic acid (HA) dermal fillers, botulinum toxin (BTX), and particle and polymer filler (PPF). There is a modest growth projected for facial fillers between 2010 and 2014 based on their rising popularity and the approval of new products.

According to BusinessWire.com, the more facial filler products that are available in the future, the greater the competition will be. Companies will have to spend more time and money on creating brand awareness. This will lead to a more informed audience, which can create a whole new set of challenges for the companies who make the injectables. While the recession may hinder the growth of filler companies slightly, it is predicted that they will still remain profitable over the next few years.

The introduction of Sculptra Aesthetic and Dysport® in 2009 into the PPF and BTX markets created new competition for Botox® Cosmetic. While Botox® remains the king of the throne, the “Dysport® Challenge” helped increase the popularity of the new injectable.

It is also projected that the collagen filler market will shrink excessively in 2011 following Allergan and ColBar LifeScience’s withdraw from the market in 2010. With new products expected to gain Canadian and U.S. approval, it will be interesting to see how the market responds. New facial injectables, which can be introduced into any product segment, could theoretically affect average selling prices and heighten competition within the market.

Unsupervised Physician Extenders Are a Key Malpractice Concern

Dr. Goldberg was recently interviewed by Denise Napoli of Skin & Allergy News magazine. Here is the published May, 2010 article in its entirety.

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Improper use of "physician extenders," a lack of informed consent, and patient dissatisfaction are some of the top reasons why patients sue, and all are easily preventable, according to Dr. David J. Goldberg.

The first - the use of unsupervised or improperly trained physician assistants, nurse practitioners, or other physician extenders - hits home for many dermatologists. According to the American Academy of Dermatology, in 2010, 36% of physicians will use NPs and PAs in their practice, up from 30% in 2007 and 20% in 2002, Dr. Goldberg said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation in Santa Monica, Calif. "NPs and PAs who work for core physicians are clearly the most qualified nonphysicians to perform these procedures," said Dr. Goldberg, director of dermatologic laser research at Mount Sinai School of Medicine, New York. Many have received cosmetic training through the Aesthetic Extender Symposium (www.aestheticextendersymposium.com), he said.

However, there are still risks. A 2006 American Society for Dermatologic Surgery survey found that 51% of ASDS members reported seeing nonphysician, nonsupervised physician-extender complications in their practice, with the two most common being misdiagnosed skin cancer and scarring following dermatologic procedures.

"If the [physician extender] is sued, so will be the provider who is affiliated with the PE," said Dr. Goldberg, who also is on the faculty of Fordham University School of Law in New York.

Poorly informed or uninformed consent is another moneymaker for medical malpractice lawyers in the field of dermatology, according to Dr. Goldberg. "Because dermatologists tend to see large numbers of patients, there is a tendency to be overwhelmed by the paperwork associated with quality informed consent," he said.

One procedure to be especially careful about is botulinum toxin type A injections - there were 2,464,123 in 2008, according to the American Society for Aesthetic Plastic Surgery. The black box warning on Botox reads "swallowing and breathing difficulties can be life threatening and there have been reports of death."

Dr. Goldberg encouraged physicians to instruct patients to read the warning on botulinum toxin "each and every time" they receive it. He also encouraged discussion about these risks and the procedure's other rare but potential side effects, including generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, and urinary incontinence.

He noted that many of these potential complications have never been reported with the cosmetic use of botulinum toxin.

Finally, Dr. Goldberg said that dermatologists can keep legal troubles at bay simply by keeping patients happy. He cited a 2006 retrospective chart study of all patients who received botulinum toxin injections over a 2-year period at a private dermatology clinic. The retention rate was 55%. However, the "institution of a 2-week posttreatment evaluation increased the retention rate from 55% to 67%," said Dr. Goldberg (Dermatol. Surg. 2006;32:212-5).

"Probably more important in keeping patients happy - and keeping them coming back - is to communicate with patients," he advised. "Treat each patient as if they are special. Pay total attention to their concerns. They will appreciate your one-on-one interaction with them."

Dr. Goldberg is a founding director of the Aesthetic Extended Symposium. SDEF and this news organization are owned by Elsevier.

NY Plastic Surgeon Group Pleads Guilty to Felony Misbranding of a Drug

A large Albany, NY plastic surgery group has pleaded guilty in federal court to felony misbranding of a drug. The Plastic Surgery Group, a well-known association of seven board-certified plastic surgeons, pleaded guilty to using a non-FDA approved TRI-toxin on its patients seeking treatments with BOTOX® for facial wrinkles. During the time period of February 2004 until December, 2004, approximately 150 patients were injected with the unapproved substance, believing they were being treated with BOTOX®.

The group, whose members include Dr. Douglas Hargrave, Dr. E. Scott Macomber, Dr. Steven Lynch, Dr. John Noonan, Dr. William DeLuca, Jr., Dr. Jeffrey Rockmore and Dr. Susan Gannon, was ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with it's plea of guilty to one felony count of misbranding drugs. Additionally, Doctors De Luca, Hargrave, Rockmore, Lynch and Noonan were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, as well as a fine of $5,000. The group's practice administrator, Peter M. Slattery, and RN Susan F. Knott, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. Drs. Macomber and Gannon were not individually charged.

We see the use of non-approved toxins and fillers in South Florida, New York and New Jersey all the time. However, it is unusual to see plastic surgeons involved. Usually the people serving up non-approved injectables are non-physicians from other countries. Consumers need to be aware of this practice and seek appropriate providers for their aesthetic care.

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

Topical Botox is for real

One of the best presentations at the IMCAS was by Dr. Michael Kane, a plastic surgeon from NY, who presented the phase 2b data from Revance's RT001 - also known as "topical botox."

This topical preparation allows the botulinum toxin molecule to penetrate the skin and affect the targeted underlying musculature. In the study Dr. Kane presented, they developed a wrinkle score for crows feet - periocular wrinkles and showed the results of the Revance toxin. The preparation significantly improved the wrinkles at rest - which was most impressive as all the other toxin studies show improvement with motion. The toxin is also thought to be very effective in treating axillary hyperhydrosis - aka underarm sweating.

Bottom line - no needle botox is going to be a blockbuster.

Revance is privately held, but we'll go to a quote from Colin Stewart's "In Your Face" blog for the details on their deal with Medicis.

"...Medicis Pharmaceutical, which sells the popular dermal filler Restylane and the new Botox-like injection Dysport, decided in 2007 that RT001 was promising enough that the company paid Revance $20 million for an option to buy it.

In the deal, Medicis acquired a 10 percent stake in Revance plus an option to buy the company outright or to acquire an exclusive North American license for RT001."

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

Cosmetic Bootcamp in Boca Review

Dr. Pozner and I just returned from Cosmetic Bootcamp at the Boca Hotel and Resort. This was a meeting run by renowned dermatologists Ken Beer of Palm Beach, Mary Lupo of New Orleans and Vic Narukar of San Francisco.

They run a few cosmetic bootcamps per year and this one was targeted towards practice management. Dr. P gave 3 lectures - lasers and lights for a cosmetic practice - speaking about the usual devices we use such as Sciton fractional and TRL resurfacing, and newer devices such as Ulthera, Zeltiq, Liposonix and Ultrashape.

He gave another lecture on the role of the internet in cosmetic practices - using web sites, blogs, Facebook etc. my last lecture was on laser safety - pretty dull subject but there were some laser complications thrown in to keep everyone awake for that 8 a.m. talk on Sunday (ouch - considering we were out with Dr. Pozner and family until late on Saturday eve!!!)

There were some excellent lectures at this meeting. Mark Nestor spoke about the Botox and Dysport black box warnings - we covered this in a previous blog post. There was a discussion about new toxins such as Xeomin and Puretox. Doris Day did her usual excellent job.

This meeting was unique in that its emphasis was not so much on cosmetic doctors as attendees. They were there, but in addition, their administrative staff members were in also attendance . A variety of issues were discussed that looked at keeping patients happy. These included an emphasis on both receptionists and clinical staff understanding the needs on each patient in the office.

I personally lectured on a variety of legal issues that relate to running a cosmetic practice. I also discussed Latisse, the FDA approved eyelash enhancer from Allergan. One of the most fascinating talks was one given by Atesh Chendra, Vice President of Administration at the Breakers Hotel in Palm Beach, FL. He discussed his 25 year experience in creating the ideal environment for hotel goers and applied these concepts to the cosmetic medical office. Overall, the meeting was fascinating.

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

Lipstick down, Botox Up.

Dubai newspaper The National is saying that American lipstick sales are going down, while Botox and Restylane are on the way up. This is in contrast to the former prevailing wisdom that lipstick sales boom during recessions, while supposed luxuries like cosmetic surgery wane.

From the article:

"But this time around, that is not happening. In 2008 annual lipstick sales actually dropped five per cent, according to Inside Cosmeceuticals, which tracks cosmetics purchases in the US and UK.

Now, it seems, Americans – both men and women – are splurging on a more modern luxury: cosmetic injections.

The American Society of Plastic Surgeons reports that surgical cosmetic procedures like nose jobs and tummy tucks dropped off nine per cent from 2007 to 2008. However minimally invasive procedures such as Botox, which eases wrinkles, and Restylane, which puffs up sagging skin, are up more than five per cent."

Thanks for reading,

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

Injectable fillers no longer on the "down-low"

A recent study from the research arm over at ASAPS (American Society for Aesthetic Plastic Surgery) regarding injectable fillers concluded that 87% of patients "come out" about it and 70% receive support from those who they tell.

We see that at SMAC... people are very happy to speak about their injectables, but for other things it is kept quiet.

Also, Dr. G and I are speaking at the Multi-Specialty Foundation meeting at the Bellagio in Vegas, and I will follow that up by speaking at The Aesthetic Show at Caesar's Palace later this weekend. Hot topics from these meetings will be posted on Twitter (@jpoznermd) and blogged about next week.

Survey Reveals Injectable Procedures are Mainstream and Accepted Medical Aesthetic Treatment Options [Press Release]

Yet another Botox competitor coming: Xeomin

An article this week on Modern Medicine's website had a rundown of Botox's upcoming competitors.  It had two that have been mentioned repeatedly over the last few months: Dysport and PurTox not far behind, but it also threw in Xeomin, which is made by a company called Merz. 

Merz is a well-respected German company.  They sell other dermatology products in the US and will be well-received when they come to the Botox market in this country... Xeomin is already available in Europe.

Here's what ConsultingRoom.com had to say about it: 

"It is widely accepted that the bacterial protein present in other products play a role as promoters of an immune reaction, resulting in a loss of effect and reduction in duration of activity. Studies show that Xeomin(r), without the complexing proteins, has the lowest content of protein of all of the available botulinum toxins and furthermore show that repeated application of Xeomin(r), even in high doses, does not induce the formation of neutralising anti-bodies.

This means that Xeomin(r) is able to provide similar results to those achievable with the other products without the risk of antibody formation, providing continual long lasting effects. This could be relevant when large doses are being used for medical indications, but many industry experts questions the relevance when this product is used for cosmetic purposes."

Thanks for reading,

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

More plastic surgery statistics: the ASPS releases theirs today

The American Society of Plastic Surgeons, which polls over 6,000 member plastic surgeons but extrapolates to include 24,000 physicians "most likely to perform cosmetic and reconstructive plastic surgery procedures, resulting in the most accurate census available", released their annual statistics today for the year of 2008.

You can find them here.

They paint a much sunnier picture for minimally invasive procedures, which went up 5% compared to 2007. The trend of laser skin resurfacing continues, going up 15%, while Botox boasts an 8% gain next to a 5% gain from soft-tissue fillers.

In this, traditional procedures went down only 9%, with liposuction seeing a big 20% drop. We continue to assert that many of these procedures have shifted over to general practitioners and OBGYNs, to the detriment of patients everywhere.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Study: Botox makes you happier?

Sharon Begley at Newsweek reported on a very interesting study published in this month's issue of Cerebral Cortex, by "Andreas Hennenlotter and Bernhard Haslinger of the Tcchnische Universitat Munchen and the Max Planck Institute of Human Cognitive and Brain Sciences", in Germany.
The result?

For Botox patients, however:

"Before Botox, imitating pictures of sad or angry facial expressions caused a large increase in activity in the amygdala, a key emotion region for, especially, anger and anxiety. But after Botox, imitating the angry expressions caused a much lower level of activity in the left amygdala."

Putting on an angry face before you actually feel angry, without Botox, will you angry due to what is called "facial feedback," a concept first outlined by Darwin.

Patients sometimes say they feel happier after Botox, but they just thought it was because they did something nice for themselves...

Lab Notes: Hello Botox, Bye-Bye Anger? [Newsweek Labnotes Blog]

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Botox can prevent baldness?

According to recent tests conducted by Dr. Simon Ouiran from Epione, Botox can delay and prevent baldness.

From the article (courtesey of Grinza):

"Ouiran discovered the hair loss prevention properties of Botox while he was treating his mother from debilitating headaches—a side effect of chemotherapy. The doctor followed the advice of Allergan, the world’s leading Botox manufacturer, by using Botox as a way to alleviate migraines through scalp injections.

After injecting the cosmetic drug to his mother’s scalp, not only were her headaches gone, her hair also began re-growing.

“Of course, I was happily surprised by the result,” said Dr. Ourian. “So I decided to share this discovery with several of my regular patients. Because hair loss is a significant source of insecurity for many people, both men and women, there was no shortage of volunteers with thinning hair. The results for many were astonishing, and for some, a single session yielded dramatic results.”


We should wait for any peer-review results but this is another interesting off-label use for Botox. As you can tell from our pictures, we are anxiously awaiting trials of Botox to treat hair loss.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Botox sales holding steady despite bad economy

According to an article by Natasha Singer in Wednesday's New York Times, Allergan is reporting a slight drop in sales of Botox for the fourth quarter of 2008.

From the article:

"The company reported that sales of Botox — both for wrinkle-smoothing and for medical problems like eyelid spasms — fell about 3 percent, to about $329 million in the fourth quarter, compared with the corresponding quarter in 2007.

Meanwhile, Allergan’s sales of skin-plumping injections — called dermal fillers or facial fillers — fell 8.8 percent, to about $56 million in the quarter, compared with the year-earlier period.

The company’s sales of breast implants were about $71 million in the fourth quarter of last year, down 12 percent compared with the same period in 2007.

“You could forecast that with implants, but the bigger question was, ‘How have injectables been holding up?’ ” said Gary Nachman, an analyst with Leerink Swann, a health care investment bank. “Now, even the injectables have been impacted significantly.”

The sky is not falling. This is actually good news for Botox, as we would have expected a bigger drop. If anything, only a 3% drop in filler and a 9% drop in filler is pretty strong in this economy.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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