Friday, May 27, 2011

More than a Few are Practicing Medicine without a License

Virtually every day, there is a a story relayed to me by a client, patient, or medical provider in which a person received questionable "advice" from a "practitioner". There are FAR too many non-physicians practicing medicine. The simplistic version of the practice of medicine is the diagnosing or treating medical conditions. It would also include the use of medical devices.

Today, I was on a conference call and one of the participants was relaying the story of a medical condition that had recently become more of a problem. The comments were made in passing and the individual was explaining why there was a delay in responding to a prior conference call.

It was a fairly serious medical condition. One of the conference call attendees proceeded to diagnose what the problem was and recommend a homeopathic remedy. I was very familiar with the "theory" behind the remedy. However, I was also aware that this proposed "remedy" had potentially dangerous side effects and that there is NO medical or scientific evidence to support its use in this situation.

I intervened and was told that I do not know what I am talking about and that allopathic doctors receive one hour of nutritional training so they do not know anything. I was compelled to illustrate that I have two doctorates and I would not have made the statement that the "practitioner" made. The "practitioner" had all of a high school diploma and little to no health training. I also was compelled to indicate that she was not a nutritionist.

There are colon hydro therapists, herbalists, personal chefs, juicing advocates, raw food enthusiasts, estheticians and many others that are practicing medicine every day. The more alarming thing is that there are MANY people that jeopardize their health by listening to these people. There are so many websites, blogs, webinars, retreats, etc being promoted by those of dubious credentials, knowledge and experience...all vying for a piece of the pie.

I am not suggesting that there is a lot of merit to many homeopathic concepts...I worked as a consultant with the Grand Father of Complimentary and Alternative Medicine (CAM) in the United States, Robert Atkins M.D. I saw first handed how such such remedies can be beneficial and save lives. However, there is a lot of ...for lack of a better term..."quackery" going on.

Actually, the most alarming this is that states are not doing anything about it on any concerted level.

Wednesday, May 25, 2011

An Emerging and Disturbing Trend in Medical Spas....

For those that follow the medical spa industry, there is always a new product or service that is being touted as the latest and greatest in the industry. Many are little more than marketing hype.

One emerging trend is the hCG diet. Supporters argue that it has allowed many to lose weight. Others maintain that there is no scientific evidence that indicates that it is effective. They further opine that any weight loss is a result of near starvation diet levels of calorie intake (less than 500 calories per day).

hCG is human chorionic gonadotrophin and it is a pregnancy hormone. It is non existent in the male anatomy except for a brief period after birth. It only exists on women during pregnancy. It use is linked to near starvation diets in the weight loss use.

It is important to note that its use is not FDA cleared. By itself, this is not a concern because physicians routinely utilize medical and prescriptive materials "off label" if they believe that it is warranted in a given situation.

However, it is appearing in many non-physician owned medical spas. The HCG dispensed in such settings cannot be medical grade hCG and popular belief is that the non medical grade hCG is non efficacious for weight loss. In fact, in January of 2011, the FDA determined that homeopathic hCG is "fraudulent and illegal" when sold for weight loss. Even in a medical setting, with physicians utilizing medical grade hCG, the product must carry a warning which indicates that there's no proof they accelerate weight loss, redistribute fat, or numb the hunger and discomfort typical of a low-calorie diet.

The bottom line is that there is no scientific evidence to suggest that hCG works.

The disturbing thing is that I have noticed many medical spas that are touting outrageous results from the use of hCG. It appears that many spas are promoting hCG without differentiating between homeopathic grade and medical grade.

In any event, the use of such a product must be carefully watched. Practitioners need to exercise extreme care in providing this service. Extreme caution must be made in marketing the service. From what I have observed, there are a lot of fraudulent claims that may result in severe damage to patients and client...

Saturday, May 21, 2011

Another Reason that the Medical Spa Business is SOOO Difficult

One of the challenges that I have routinely encountered is that there is another attorney involved in a medical spa matter and he or she does not know the legal nuances of the industry. Recently, I had an attorney that was resisting a critical course of action for a medical spa.

The attorney was not well versed in these areas and kept requesting support for my position on HIPAA. She wanted me to show her where it is necessary to include a Business Associate Agreement in a medical spa setting. This is a basic thing for a medical spa and it is not written anywhere that "medical spa, you must do this". The law does not work that way in this country. It is subject to interpretation. however, this was a basic tenet of medical spa law.

It is difficult to sometimes say why something is "necessary" in this area of law. In this instance it was prudent to complete a Business Associate Agreement (BAA). My argument then became, "there is NO harm in completing a BAA, and potentially tremendous harm in NOT executing one, so why not complete one"?? More resistance.

There are two basic lessons here...first, realize that when an attorney, in any area of law, is unfamiliar with a particular issue, they will reject it and say no because they are not comfortable in agreeing with the position on the issue.

Second, always entrust your counsel and guidance to an attorney that is well versed in the issues you face. All too frequently, I get referred to someone's "attorney" in a complicated business matter and it turns out that the attorney handled a personal injury claim for them!!

Wednesday, May 18, 2011

FDA's New Agressive Policies on Websites and Skin Care

Recently, I have had several clients receive warning letters from the FDA regarding their websites or retail skin care products.

In regard to websites, the FDA makes various claims that the particular sites are making unsubstantiated claims regarding efficacy of products and services. In each cases, I strongly disagree with the FDA. In one instance, the website merely stated that a procedure "lessened the appearance of wrinkles". Those are appropriate words for an appropriate procedures.

In other website issues, the FDA is claiming that the procedure was not cleared for marketing of the respective procedure. This is ludicrous to me beause a physician can claim whatyever they want to - the FDA has no jurisdiction over them and their independent medical judgment. A physician can claim whatever they want, but they cannot claim that it is "FDA approved". This is a misnomer anyway as the FDA does not "approve" anything.

In regard to skin care, the FDA is cracking down on physicians that compound and offer prescription strength products in an over the counter format. They are also concerned with claims about claims made in skin care. In one example, the product merely claimed to "hydrate" the skin. The FDA had a problem with this?? The product contained hyaluronic acid which is agruably nature's best emollient since it binds to water and retains 1000 times its molecular weight in water. It is more than fair to say that it "hydrates" the skin.

In yet another skin care example, the FDA took exception to a clain that the product softened the appearance of wrinkles. What is wrong with that?? If they are going to start enforcing such language, there will be no marketing on any product. Cosmetics make far more medical claims every day in TV and print ads.

The point is that the FDA appears to be embarking on a course to strictly enforce its policies - to the point of over-stepping their bounds...

Friday, May 13, 2011

The Importance of Reviewing Leases for Medical Spas

Leases are rarely considered an important aspect of medical spa issues. However, I have had numerous instances where a lease became a major problem; and others in which it helped alleviate a problem. Many lease related issues arise but the most important is the "intended use" provision of the lease.

A medical spa should be considered a medical facility even if it is non-physician owned. Accordingly, the use and zoning should be appropriate for a medical practice. This is not a minor issue. Medical zoning is typically such that there are certain areas of a municipality that are zoned for medical use. There are parking issues, handicap parking issues and electric and plumbing issues.

There are also "exclusive" use issues that pertain to most medical spas. Skin care is a frequent issue. Occasionally, there will be an existing tenant that has an exclusive right to retail skin care. This would prohibit you from retailing skin care in your space. Therefore, it is essential to identify to the landlord the totality of your business and ask whether there are any "exclusive use" issues with existing tenants.

I was contacted this week by a spa that has an exclusive use issue with a SHOE STORE!! The shoe store had the exclusive use for MASSAGE! The spa may have to locate to a new facility!!

Tuesday, May 3, 2011

Bin Laden Cover Up

OK, I will go on record as saying that I believe that Bin Laden is dead.....BUT (and you heard it first here)...there is a massive amount of bullshit surrounding his "death" and we are not being told the truth. A lot hapopened in a twelve hour period - they killed him, ran DNA to confirm death, took NO PICTURES of the dead him to the USS Vinson thousands of miles away and performed a Muslim burial at sea...ALL WITHIN TWELVE HOURS???? C'mon. First of all, they did not run DNA in twelve hours.....and where did they get a sample of his DNA to run against??

This reminds me of a story of my beloved day she returned home with a dead squirrel in her mouth...joyously proclaiming that she was responsible for the rodent's demise...upon brief inspection, I noted that the aforementioned squirrel had tire tracks over its body...I told the dog that it was already dead when she captured it no victory here.

The analogy?? Bin laden is dead...the US is taking credit but there is a lot more to this story.....we are being deceived for a little change of pace...