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!”

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...