Lipodissolve victory in Nebraska: Proposed Nebraska Legislative bill aimed to ban Lipodissolve fails

New York, NY (FEBRUARY 28, 2008) --
Lipodissolve wins Nebraska ruling. The Nebraska Legislative notified ASAL on February 27, 2008, that a bill pushed by Dr Joel Schlessinger, to be raised in the Nebraska Legislative against Lipodissolve was 'indefinitely phoned'.

In a nationwide campaign against Lipodissolve, lead by notorious serial smut-bringer in effort to market a competing drug, Dr Joel Schlessinger of Nebraska, [1,2,3] a legislative bill was introduced to ban the treatment by State Senator, Rich Pahls of Omaha. The bill proposed that doctors would be prohibited from administering certain substances aimed at dissolving fat under a bill introduced in the Nebraska Legislature. The bill would affect Lipodissolve, amongst other treatments administered by injection. The bill says the substances including sodium deoxycholate could not be administered for dissolving fat unless as part of clinical testing approved by the U.S. Food and Drug Administration.

Ron Schroeder, an aide to Pahls, said in a media announcement that the senator introduced Legislative Bill 713 because of concerns raised by Dr. Joel Schlessinger. Opposition to the bill was raised by objections, not only from ASAL's administration and medical consultants, but by numerous local senators, and representatives of the state's medical board.
In the process of communication, ASAL was immediately contacted by Senator Joel Johnson's office to notify our medical consultants that bill 713 (LB 73) was "killed" in the hearing.

Dr Joel Schlessinger 'defamation' campaigns

Dr Joel Schlessinger has initiated months of negative, nationwide media attention against Lipodissolve via public websites, forums and pressuring letters to the likes of State Medical Boards and the FDA.
He has said in media reports that there has not been enough research to show whether Lipodissolve is safe and effective.  Interestingly, ASAL has received feedback over several months, which indicates that Dr Schlessinger's efforts to vilify Lipodissolve in the media, both by name and anonymously, may originate from a desire for personal gain as oppose to his unconvincing concerns for patient safety. Lipodissolve safety reports are actually high, in fact, far higher than cosmetic surgery procedures.

It is also interesting to note that Lipodissolve criticism originated from a pharmaceutical corporation (Kythera Biopharmaceuticals) that has a new product on the market similar to Lipodissolve, but a product that has long been viewed to have extensive risks associated to it. This product was initially applied for use only on lipomas, but is now intended to compete directly with Lipodissolve.

Dr Schlessinger is recruiting patients for and conducting trials on the new Kythera product as well as serving as a consultant for numerous other pharmaceutical & medical corporations [4]. His criticism of Lipodissolve is emerging in perfect timing for early marketing of the new product, following the completion of their Phase I trials.

In the ASCDAS 2007 Annual Meeting on November 29, 2007, Dr Schlessinger gave a presentation called "Mesotherapy - Lipodissolve controversy" which was sponsored by an "unrestricted educational grant" provided by Kythera Biopharmaceuticals who have also sponsored various other published studies [5, 6].
It is noteworthy to mention that members of the ASCDAS (for whom Dr Schlessinger served briefly as a former president) contradict the doctor’s view and many are avid supporters of Lipodissolve injections.

The walk of shame

ASAL administration responds, "The doctor deserves to do the walk of shame. There is room for everyone in this market and our interest by introducing Lipodissolve has been more from a medical perspective than commercial. The doctor has shown complete violation of ethical medical conduct. It is sad that a physician with such high credentials and a former president representing a medical society, does something like this in pretence of patient safety, and puts his name in disrepute."

"Dr Schlessinger proposes that his private studies reveal "bruising, pain, swelling, bloating," in six patient cases. This is no description of danger from a medical treatment. The doctor has singled out Lipodissolve although the treatment has very high safety reports. Why would a physician run nationwide defamation campaigns in media over normal side effects common in so many medical treatments? If he has never been certified in Lipodissolve, how does he know the exact and accurate protocols? How are the described effects a good enough reason to urge a ban of the procedure? It would be absurd to claim that the doctor has never come across bruising, swelling and bloating in his surgical patients and therefore, his criticism is non-sensical and has raised eyebrows amongst physicians as highly questionable.
And most importantly, why would a busy physician spend so much private time, costs, and energy on running such strong media and internet smut campaigns against a specific treatment? While one of the worse reactions from cosmetic surgery is death, a known cause noted on the FDA website for public information, Dr Schlessinger has made no efforts campaigning against cosmetic surgery and protecting his patients from the known potential risks. In addition, an enormous 1/10 cosmetic surgical treatments have been reported to have poor results or some form of unwanted outcome. Over 15% of plastic surgery patients have reported being fully dissatisfied with their treatments. In recent statistics on patient websites of rated cosmetic treatments, liposuction surgery received a mere 53% satisfaction rate."

To view Dr Joel Schlessinger's name as a participating commerical benefactor on behalf of a pharmaceutical company, please view this link.

Schlessinger caused losses for millions

During this period Dr Joel Schlessinger's actions have caused substantial financial losses to medical clinics across the country, estimated to total several million dollars per month.

"All this is a pity because Lipodissolve is a good procedure and was developed for patients, first and foremost, as well as for surgeons to offer a milder treatment option. In the past year alone the demand for Lipodissolve has exploded and caused a pseudo-version of the treatment to go beyond control. The ASAL Lipodissolve is not a miracle cure. Like any medical treatment, it has both plus and minus points. For a simple, mild, and cost-effective procedure, it is very promising. It was initially intended for plastic surgeons as a complementary treatment to their practice, but the surgeons seem to have turned their back on it in concerns of turf protection. Many treatment cases by our physicians show astonishing cosmetic results. Best cosmetic results can be had on the right patient candidate. Before being used by medical professionals, they should assure they have training and the right knowledge of the actual protocols before providing the ASAL Lipodissolve".

This is not the first time Lipodissolve has been in the target zone. Lipodissolve has been compared to Botox®, as the same controversy surrounded Botox® in its introduction. Botox® now is the most popular nonsurgical treatment of all. Turf protection has caused rife in the past. The medical term for Lipodissolve is Injection Lipolysis, by which it is known abroad. In Europe during initial introduction of the procedure to the medical community, sensational claims held by plastic surgeons to discourage patients from seeking Lipodissolve treatments diverted far from evidential medical facts. This lead to disputes that ended in court proceedings in Germany, where injunctions were issued in 2004 against defamatory published statements against Lipodissolve that lacked detailed, scientific evidential data. More than four years later, Lipodissolve critics have not put together sufficient scientific data to prove any life-threatening affects of the treatment to ban Lipodissolve.

FDA approved studies by ASAPS

In a positive development amongst these intentional efforts to distract patients and to remove something that will not be removed, Dr Leroy Young of the New Trends Taskforce with the American Society of Aesthetic Plastic Surgery (ASAPS) is conducting an FDA approved trial on phosphatidylcholine injections. Dr Young has a more level-headed approach and has said, "It would be good if this turns out to work, but if it doesn't work and all these people are wasting their money we need to say that too."

Good for you Dr Young! We too want facts to be known and hope these studies will be based on accurate protocols and medications contained in actual Lipodissolve, and not imitation procedures.

Reference:
1. Omaha World-Herald
January 23, 2008
Fat-dissolving procedure targeted for regulation

Schlessinger, Joe
2. Lipodissolve, is it safe?
September 24, 2007
(privately paid newswire by the doctor)

3. Will Lipodissolve continue to be popular?
December 12, 2007
(privately paid newswire by the doctor)

4. Dr. Schlessinger is a researcher and advisor for connetics corporation; Galderma laboratories, lP; medicis
Pharmaceutical corporation; obagi medical Products; and Stiefel laboratories, Inc.
Dr Schlessinger has received sponsorship from Kythera Pharmaceuticals.

Some or all of these researchers have been Sponsored by Kythera Pharmaceuticals.

5. Lipomas treated with subcutaneous deoxycholate injections
(Dr A Rotunda; Am Acad of Derm;Oct 17, 2005)

6. Detergent Effects of Sodium Deoxycholate Are a Major
Feature of an Injectable Phosphatidylcholine
Formulation Used for Localized Fat Dissolution
(Dr A Rotunda; Dermatol Surg 2004;30:1001–1008)

7. Dr Joel Schlessinger is named as one of the sponsored researchers on behalf of Kythera Pharmaceuticals for ATX-101 (Sodium Deoxycholate for Injection) Phase 2 Study for the Treatment of Superficial Lipomas

Other finanically sponsored researchers on behalf of Kythera Pharmaceuticlas include:
Gary D. Monheit, M.D.
Birmingham, Alabama

Stacy R. Smith
San Diego, California

Steven Grekin, D.O.
Warren, Michigan

David J. Goldberg, M.D.
Westwood, New Jersey

Neil S. Sadick, M.D., New York

Michael H. Gold, M.D.
Nashville, Tennessee