The not-Botox deaths in Florida

agen_botulism.jpgJAMA has released an abstract showing that the doctor in Florida who injected himself and three others with botulism, may have used enough to kill himself 2857 times. They also state that "no cases of botulism with detectable serum toxin have previously been attributed to cosmetic or therapeutic botulinum toxin injections."

Results  Clinical characteristics of the 4 case-patients were consistent with those of naturally occurring botulism. All case-patients had been injected with a highly concentrated, unlicensed preparation of botulinum toxin A and may have received doses 2857 times the estimated human lethal dose by injection. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21 to 43 times the estimated human lethal dose; pretreatment serum from the fourth epidemiologically linked case-patient was not available. A 100-µg vial of toxin taken from the same manufacturer's lot as toxin administered to the case-patients contained a toxin amount sufficient to kill approximately 14 286 adults by injection if disseminated evenly.

Conclusions  These laboratory-confirmed cases of botulism demonstrate that clinical use of unlicensed botulinum toxin A can result in severe, life-threatening illness. Further education and regulation are needed to prevent the inappropriate marketing, sale, and clinical use of unlicensed botulinum toxin products.

They should have said: The more doctors do this, the fewer the doctors that will be doing this.

Black Market Botox....A Better Buy?

Botox: $50 for 100mu?

Thought that would grab your attention.  I've heard you can find Botox on the internet for that price.  I wouldn't recommend it.

Occasionally a patient will ask me to explain why those people in Florida "died from Botox."  They are referring to a story that was widely publicized in early 2005 about some people in Florida who were sent to the hospital after receiving phony Botox injections and becoming paralyzed.  There was another story around the same time of a woman in California who died from Botox injections done by a hair stylist.  Hair stylist?  Yes, you read that right.  The very important distinction is that they didn't actually ever have Botox injected into them.  They were duped and actually had raw-grade Botulinum toxin type A used on them. 

Right about now you might be thinking, well that would certainly never happen to me.  My vials all say Botox and have the purple, red, orange colors on the box.  Matter of fact, I'm guessing that the guy in Florida thought his product was safe since he used it on himself.  I actually know a physician who had ordered, but never used, this killer Botox that he ordered from the same source. He thought he'd found a better source to get the real thing at a cheaper price.

Botox is a trademarked name for a substance that is made by Allergan. Anything else is phony and potentially very dangerous and most certainly not worth the savings that might be had.  This bootleg industry has become so prolific that I wanted to be sure everyone knew what to look for and what to avoid.  Fake Botox is frequently made in China or Korea. Authentic Botox is made and distributed world wide by Allergan and has a hologram indicating it's credibility.

To view the hologram on a vial of Botox:

1) Examine the vial under a desk lamp or fluorescent light source

2) Rotate the vial back and forth between your fingers; look for horizontal lines of rainbow color on the label

3) Confirm that the name "ALLERGAN" appears within the rainbow lines.

I'm guessing that this black market industry will soon learn how to counterfeit the hologram as well.

Filler Injections: The old and the new.

From a Wall Street Journal Article: Face Time: The new injectables.

restylane_treatment.jpgOn the Market Now

 Botox: A neurotoxin drug that is by far the most common injectable, with more than three million procedures reported last year. Botox temporarily paralyzes muscles with a series of tiny shots, smoothing frown lines between the eyebrows and crow's feet around the eyes. It is the only neurotoxin approved for cosmetic use in the U.S. Lasts three to four months. Average physician fee: $363. From Allergan Inc., Irvine, Calif.
 
 Restylane: The second-most-common injectable, with about 700,000 procedures in the U.S. last year, Restylane is a filler that plumps up creases under the skin and is mostly used on the lower face. It is made from hyaluronic acid, a natural sugar that binds to water, creating temporary volume. Lasts six months or longer. Average price for all hyaluronic acids: $557. From Medicis Pharmaceutical Corp. (A thicker version, Perlane, is awaiting FDA approval. Medicis is also developing other versions to complement its brand, including Lipp, Fine Lines and SubQ.)
 
 Juvéderm: A new hyaluronic acid in limited release that is going up against Restylane. Doctors like its ease of injection, but competition will focus on relative cost and duration. The cost to physicians is slightly more than Restylane, but retail pricing won't be clear until after Allergan officially launches Juvéderm in January. Allergan's older Hylaform and Captique products don't last as long as Juvéderm or Restylane.
 
 CosmoDerm: A collagen product that, unlike its 18-year-old predecessors, Zyderm and Zyplast, doesn't require an allergy skin test several weeks before treatment. Zyderm and Zyplast are harvested from cows, whereas CosmoDerm and its sister product CosmoPlast are made in a laboratory from human collagen, a natural component of the skin. CosmoPlast is used in deeper lines and furrows. Treatments are also popular in the lip border and fine lines above the mouth. Average fee for all collagen products: $390. Allergan.
 
 Radiesse: Made from tiny calcium particles that create a scaffold for the body's own collagen to grow. Approved for craniofacial surgery. In August, an FDA panel recommended approval for smile-line wrinkles, but the agency hasn't ruled yet. Some dermatologists who use it off-label for cosmetic applications caution that particles can migrate and cause nodules, especially in the lips. Some tests show it lasts perhaps a year or longer. Average fee: $914. From BioForm Medical Inc., San Mateo, Calif.
 
 Sculptra: A synthetic polymer that stimulates new collagen production. Approved in 2004 for treating facial fat loss in HIV patients, but used off-label by some cosmetic dermatologists. It is reported to last a year or more. There have been some reported incidences of delayed small bumps under the skin. Average physician fee: $876. From Dermik Laboratories, a unit of France's Sanofi Aventis.
 
 ArteFill: A permanent implant approved last month for treating smile lines. Early versions of the product, sold in Europe and Canada, caused reactions called granulomas in some patients. Many doctors won't use it, but advocates say it's especially good for acne scars. Results are reported to be very dependent on the medical practitioner's technique. Price hasn't been announced. Artes Medical Inc., San Diego.
 
 Silicone: A permanent, liquid injectable that is making a comeback. Many doctors stopped using it a decade ago, especially after silicone breast implants were taken off the market. It remains controversial, but some dermatologists are using a purified product sold by Alcon Inc. for eye surgery. Like ArteFill, it's an option for permanent filling of facial scars.
 

Coming Soon

 Evolence: A collagen product developed by the Israeli company, Colbar LifeSciences, that was recently purchased by pharmaceutical titan Johnson & Johnson. Evolence is reported to be in late-stage human tests in the U.S. Dermatologists are buzzing about its potential to last a year or more and supplant other collagens on the market.
 
 Puragen Plus: A hyaluronic acid filler, expected to last about six months, about the same duration as Restylane and Juvéderm. Mentor Corp. launched Puragen in Europe last year. Puragen Plus includes an anesthetic, lidocaine, that the company says make the injections less painful than those of other fillers. Mentor hopes to launch in the U.S. late next year.
 
 Laresse: A biomaterial used in spine surgery that has been developed as a filler, expected to last about six months. Launched in the U.K. this summer. Entering U.S. human tests soon, possibly on the market in 2008. FzioMed Inc., San Luis Obispo, Calif.
 
 Aquamid: A permanent filler made from a biomaterial used in contact lenses and other medical devices. Sold for cosmetic use throughout Europe. FDA human tests expected to begin in the U.S. soon. Contura International A/S, Denmark.
 
 Reloxin: A Botox-like drug undergoing human tests in the U.S. Expected launch in 2008. Physicians hope it will break Botox's monopoly and bring down prices. Sold in Europe under the brand name Dysport. At the Palm Desert meeting, preliminary data were presented by a U.K. physician indicating it might not last as long as Botox. Medicis has U.S. rights.
 
 Puretox: Another potential Botox rival. Technology licensed by Mentor from the University of Wisconsin. A researcher there decades ago helped develop the purification process for botulinum toxin that later became Botox.

The Disappearing Botox Reps.

The worst thing your medical spa can do is to overpromise and underdeliver.

Six months ago I had a visit from a Botox rep that described his position as a new "practice building rep". He handed out a few rhinestone studded 'Botox' t-shirts and promised to help build our Botox revenue. (We had showed up on some Allergan screen for increasing Botox revenue 400% in a year.) I was told that Allergan had empowered these new reps to do whatever they needed to do to help clinics with increasing sells.

So what happened.

Nada. Zippo. Zilch...