Update on Aesthetic Medical Devices

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance.

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine.

Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com

Day of Prayer in SOME Schools but Not in the USA

Very interesting.....I do a lot of stem cell research in Russia and Ukraine and a lot of DNA research in Iceland...distressed real estate pays the bills since the grant from the Federal Govt stopped being paid in 2009...anyway....I am planning on being in Urkaine at the end of the month and one of the graduate students commented that I will be there for a day of prayer.

I inquired what that was since I am familiar with most Russian and Ukrainian holidays (and they have a LOT of them-LOL)!! It was explained to me that in their version of elementary school and high school, the students go to school on September 1 and it is called the "day of prayer". They dress in black and white and carry candles to pray for success in the new school year.

I was floored by this since if you tried to do that here, various organizations would file a lawsuit so fast your head would spin around like Linda Blair in the Exorcist.

It is really tragic that people have more freedom in previously Communist countries than we do in many regards. Also realize that they have religious diversity there too...Orthodox, Christian, Jewish, Muslim...pretty much the same mix that we have and yet they are able top come together for a "Day of Prayer" in school. No lawsuits, no bitterness and hatred...traditions honored, not torn apart.



paddy Deighan http://www.homesavers.pro

Deer Placenta as a Nutritional Supplement....OH, PLEASE!!!

Today was another interesting day….a client called and asked my legal and scientific opinion on deer placenta. Apparently, a raw food/vegan guru, David Wolfe is touting it as the next great nutritional supplement. The client indicated that she does seem to have thicker hair and better skin after taking this supplement for over a year. The first clue that this was quackery was that the “nutritional supplement” costs only $60 per month. Placenta extract (let’s call it what they really want to say, “stem cells”) is really expensive to formulate and the conditions under which placenta extract are formulated are extreme. There is no way that a legitimate source of animal placenta extract can be formulated and sold at such a price.

Secondly, why deer placenta?? Websites indicates that deer are a “higher order” animal and that it is appropriate to harvest placenta from such animals for human consumption. Well, folks, sheep is the closest animal genome to the human genome. Porcine (pig) is second. So, why deer??

Third, the FDA regulates any animal extract as a drug and these product s hawked by Ron Teeguarden and David Wolfe are not FDA cleared. The agency would shut them down in a minute if they knew about the claims made for these products. Teeguarden and Wolfe never mention the words “stem cells” because they probably know that the FDA utilizes proprietary software to search for such products. They are trying to avoid scrutiny …and as well they should because they are selling products that would be regulated and they are making outrageous claims.

Fourth, the harvesting of placenta extract is expensive. It requires rapid lyophilization of the tissue almost immediately after extraction. Again, this is costly, time consuming and logistically challenging. I can all but guarantee that these nutritional supplements are not lyophilized.

Finally, and legitimate product that is placenta based, would and should be stored in a cold environment. The stem cells derived from placenta extract cannot get warm or hot. They do not necessarily need to be cold, but they cannot get hot or even warm. The products sold by Teeguarden and Wolfe are shipped in a normal manner and hence, they get warm or hot at some point in the manufacturing or delivery process. Any active cells have been deactivated by the time a consumer ingests the cells.

Save your money folks and do not be sucked in by claims made by pirates such as David Wolfe and Ron Teeguarden.

Paddy Deighan, J.D. PhD

Nu U Medical Spas Sued by Illinois AG..Many Med Spas Should Pay Attention

The Illinois Attorney General has filed a lawsuit against Nu U Medical Spas in the Chicago area. The issues presented are remarkably similar to many medical spas owned by non-physicians. This case should be a warning to many in the industry.

The suit alleges that Nu U utilized deceptive marketing and that it is performing unsupervised medical treatments. One of the concerns was over the spas’ use of Lipodissolve to “melt” fat. There are many issues with the use of Lipodissolve but the lawsuit focuses upon the fact that it is not FDA cleared and many organizations such as the American Academy of Dermatology, The American Society for Dermatologic Surgery and the American Society for Plastic Surgery do not condone use of the product. There is little evidence to support its use and a lot of evidence that it does little, if anything.

However, the main issue that I want to discuss is one that affects many medical spas, especially the non-physician owned ones. Lipodissolve is an injected treatment, it requires a physician’s order, but Nu U allegedly administers the fat-reducing treatment without a doctor’s order. Many non-physician owned medical spas have non-medical personal injecting dermal fillers such as Botox Cosmetic, Restylane, Juvederm and Collagen without a doctor’s order. In fact, more often than not a doctor does not even see the patient prior to the procedure. In The Nu U matter, the Attorney General found that fact despite its outward claims, Nu U allegedly “fails altogether to monitor and evaluate patients by licensed physicians.”

Another interesting aspect of the case is something that I routinely blog about: The corporate practice of medicine. The Illinois Attorney General argues that the Nu U Medical Spas have violated the Illinois Corporate Practice of Medicine Statute. Forty-five of the fifty states have such statutes and they are violated openly and routinely. These are serious statutes with severe criminal and civil penalties and I am at a loss to figure out why so many violate these statutes on a daily basis. Oops, I do know why…it is called profit!!

When May Physicians Introduce New Technology to Patients??

I recently blogged about stem cell applications and it is prudent to discuss an issue that applies to any new medical technology and advancements. The question is: “when can I as a medical provider, introduce new technology, especially if it is not yet FDA cleared”?

This is a very important question. The answer is difficult and there are never any guaranteed correct answers. The law in the USA is typically a moving target. For one thing, the law necessarily lags behind technology (in every aspect of technology – not just medicine). However, medicine is a bit different because we have the FDA to protect patients and provide a process for clearing products and services for treatment. The problem is that it is a time consuming process.

This discussion starts with the fact that the FDA does not have jurisdiction over physicians. It regulates devices and products and the claims that may (or may not) be made about them. The FDA cannot interfere with the physician’s “independent medical judgment”. Accordingly, physicians are free to utilize a product or a device in a manner that they believe will prove beneficial for a patient. They must uphold their Hippocratic Oath to “do no harm” and clearly, the physician should be able to indicate and articulate why the treatment or procedure was performed on a patient.

A physician should study the science and if he or she reasonably concludes that this treatment or product will benefit the patient within the physician independent medical judgment, then it may be acceptable to perform the treatment or procedure. It would also be beneficial to illustrate that peers are doing it as well to help indicate a standard of care for the particular use.

The problem with a new, non-FDA cleared treatment is the marketing of it. The internet has made it easier for patients to find you but it has also made it easier for the FDA to find you! It is tricky and difficult to market new technology, but as I am known to say, “There is always a way!”

Stem Cell Applications: Fact or Fiction

Since I am also a scientist involved in stem cell and DNA applications, many people ask me for guidance on these subjects. There are already many stem cell treatments and applications. There are many valuable treatments with stem cells. There are SOME topical stem cell products that have promise and value. One such product is SCM Forte Many others are hype such as those that are "phyto" based. Folks, "phyto" is plant derived stem cells and there is less than ZERO evidence that these are efficacious in humans. These are shameless attempts to cash in on a trend.

There are many treatments in which stem cells have a lot of promise. There are over 220 applications for stem cells in the human genome. There are three basic ways in which stem cells are introduced to humans: oral capsules, injection intra muscular and injection at point of need/trauma. There are also multiple forms of stems cells - too many to list and the answer to which treatment is best depends upon what you are treating, how the cells were extracted and amplified and the source of the stem cells.

There is a lot of unfounded hype about treatments. I travel frequently and I can tell you that in other countries, people are paying bookoo bucks for worthless treatments. Most of the cells are worthless or not efficacious in the human genome. They also may not have been extracted properly or amplified in a lab properly. There are also many companies and medical practices that are unabashedly thumbing their noses at the FDA as they promote useless treatments and make totally unsubstantiated claims.

There is no question that stem cells will be the next wave of medical breakthrough. The do work and can literally repair anything in the human genome. However, the challenge will be to separate fact from fiction. If you are thinking of incorporating stem cell products or treatments into your center, call me and review the science.

Physician Delegation Principles in Medical Spas and Aesthetic Medicine

It seems that my blogs regarding esthetician injectors of Botox® Cosmetic and dermal fillers such as Restylane® and Juvéderm® have become a contemptuous topic of conversation. I received a call from a cosmetic surgeon in Texas and this prompted me to further elaborate on the issue that I have presented. Accordingly, I wanted to elaborate.

The first area of explanation is that there is no license in any state for a “medical aesthetician”. It is a term that was created several years ago to identify estheticians working in a medical setting (physician office or hospital). I have advocated that estheticians not utilize the term because it is arguably deceptive. The public (the clients and patients) would likely believe that a person utilizing this term has higher scope of practice and can perform more medically oriented procedures. The Federal Trade Commission (FTC) has addressed issues such as this in the past and it consistently maintains that utilization of such terms is deceptive to the public.

Additionally, in most states, the esthetician license is not recognized in a medical practice or hospital. Most boards of cosmetology maintain that a physician is not the appropriate supervisor for cosmetology. Accordingly, estheticians working in most medical settings are doing so under the physician delegation principles within the particular state.

States have varying regulations on physician delegation. Arguably in some instances and in some states, a physician could delegate any medical procedure to any individual. However, this rationale is based upon state delegation laws. Federal law would prohibit much of the conduct that we are experiencing in the medical aesthetics area. I hesitate to even utilize the term “federal law” in this regard because it is not so much a particular regulation or statute that is a problem. The federal issues are the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) that are at issue. The brief explanation of why estheticians and others are not able to inject Botox Cosmetic and dermal fillers such as Restylane and Juvederm is that in the case of Botox Cosmetic, it is a prescription drug and in the case of the dermal fillers, they are medical devices. Injectors are also utilizing syringes and exposing the patient to a potential for bleeding and these additional issues necessarily mandate that estheticians not inject substances.