FAUX TOX?

I f you perform a lot of cosmetic dermatology, you have probably had many opportunities to purchase materials from offshore sources or from suppliers offering to mix the products for you. The allure of this, depending on the size of your practice, is the possibility of saving between a few hundred dollars to enough money to buy a new luxury car. With patients constantly shopping for the best price, there is pressure to cut costs. On top of this added pressure, most patients are unaware of how a physician should be trained to administer Botox, and they don’t know what dilution rates are common, what the country of origin is for the Botox or what the overall quality is of the product. With patients unaware of so many details, it’s easier for some unscrupulous physicians to “cut corners.” Patients may not know what is being used on them and are happy to pay $200 for what they think is a Botox injection (even when it’s diluted down to 10 units per ml). In my community, chiropractors, pathologists, gynecologists and even veterinarians are injecting fillers into people in their homes, and at hotels and hair salons. Unfortunately, virtually no regulation of this practice on a state or federal level exists, and the companies selling non-approved filler substances are not doing anything to ensure that a “medical director” is purchasing their products. Competing for customers and trying to keep prices down may make the constant faxes and e-mails to purchase “research” botulinum toxin or hyaluronic acid compounded by pharmacies tempting. But before you give in to that temptation, consider the following situation and see why the risks outweigh the benefits. Learning From Mistakes In my community, there is now one person fewer injecting fillers. As most physicians are aware, an unlicensed osteopath recently injected botulinum toxin (labeled as “research”) into patients — with disastrous results. (See “Unapproved Botulinum Toxin in Florida,” on page 30.) What can the more mainstream, well-trained medical community learn from this experience? It’s tempting to dismiss the incident as irrelevant if you are not engaging in these types of behaviors, but I think there are some lessons to be learned. First of all, if you try to save money on materials by using material from a non-pharmaceutical source, you do so at your own peril and your patients’. It’s true that most patients will never know whether you are using real Botox and not diluting it out — they only know the price. At the end of each day, however, I think it is important to be able to sleep at night and this is why I would never try to economize with anything relating to patient safety. Or, for those of you who are less philosophical at this time of year, consider this — if you choose to purchase products that are compounded, you are on your own if there is a bad outcome. There is no company to stand behind you with FDA regulatory documents and liability insurance. There is no Allergan to come to your backing in a court case, as they recently did for one of our colleagues, as well as myself, when sued by the makers of a cream that our study showed had the same efficacy as placebo. That would be a most unpleasant situation to be in, and I would urge anyone thinking about buying from the next “toxin research company” to consider this. The same situation exists for those in our community who are purchasing Restylane from outside the country. In the event that your lot was not maintained in a temperature-controlled environment and your patient has a problem, you are on your own. Whatever premium you are paying to purchase from Medicis instead of South America will suddenly look cheap if this occurs. Protecting the Reputation of Dermasurgeons Cosmetic dermatology is a field where your practice grows not based on the size of your advertising, but based on your reputation and standing in the medical community. In order to be a long-term cosmetic physician, I think it is important to use products that you know to be the best, not merely the cheapest. The news about the Florida osteopath who poisoned patients with a “research” botulinum toxin brings another issue to light. We, the dermasurgery community, must be more active in educating our patients and the public. We should work with state and federal regulators to educate the public about the dangers of receiving unapproved products and of receiving care in a non-medical environment that isn’t equipped to handle emergencies. We can avoid another incident like the one in Florida.