Risky Business

This article is part of the Vegas Cosmetic Surgery and Aesthetic Dermatology Show Coverage.

In April, the Food and Drug Administration issued a warning to more than 350 medical practices that they may have purchased unapproved versions of onabotulinumtoxinA (Botox, Allergan) sent by foreign suppliers. This is the most recent alarm in a series of events dating back several years. Eight experts discussed their views on the counterfeit market at the recent Vegas Cosmetic Surgery and Aesthetic Dermatology meeting in Las Vegas. 

VIDEO courtesy of xMedica: Experts discussed their views on the counterfeit injectables market and off-label product usage during the recent 2013 Vegas Cosmetic Surgery and Aesthetic Dermatology meeting.

Susan Weinkle, M.D., Bradenton, Fla., who moderated the panel, summed up the group’s consensus by stating, “Patient safety needs to be first and foremost. We need to use products that have been evaluated, that companies have put their research dollars behind to have data to support using them safely in our patients.” 

Counterfeit neuromodulators and fillers are a very important patient safety issue.Have you encountered them? Have you seen your colleagues encounter them? What are your thoughts going forward dealing with this? How should the industry deal with this problem? -Susan Weinkle, M.D., Bradenton, Fla.

Amy Taub, M.D., dermatologist, Chicago

I’m in the middle of the country where people are a lot more conservative. So I wouldn’t say that I’ve seen a lot of cases or heard about a lot in my area. The only thing that happens in my area, which I’m really shocked at, is there’s a physician near me who does a lot of fillers who purchases them from a friend physician in Canada. And you know that in Canada it’s quite a bit less expensive. So he’s basically paying maybe $70 less per syringe for his filler than I am, and he discounts it so that he’s maybe doing an injection for $400 or $450 for a cc of Restylane (hyaluronic acid, Medicis). I find that to be really unscrupulous; but it’s not counterfeit - it’s a different thing. I always buy direct from the vendor or their authorized dealer, and would never buy from a second party.

Michael Perski, M.D., plastic surgeon, Encino, Calif.

I think it’s a problem, and I think that if we didn’t learn anything from the Tucson, Ariz., company, Toxin Research International (TRI) that was selling animal experimental-only Botox that was used on humans by a few unscrupulous individuals -which resulted in several people being paralyzed because the number of units were probably thousands of times more than they were supposed to be - then we’ve learned nothing.

I think it’s important, particularly in the U.S., to use U.S. products. You never know where they’re coming from. I have patients who come in and say, “I have this product. Will you inject it for me? You can charge me.” I advise everybody not to do that.

Rebecca Fitzgerald, M.D., dermatologist, Los Angeles

Anytime there’s money to be made there may be someone trying to exploit that. I think we all get fliers across our fax machines for “discount” products - some with familiar names and packaging - but not sold through the regular channels. I think it’s important to be aware that this is risky business and avoid it. Additionally, I practice in a big metropolitan area and on rare occasions patients have come in to the office with their own product for injection. Bad idea, as you have no idea where the product came from or what’s really in the syringe. I think that you have to be very, very careful to avoid that trap.

Benjamin Bassichis, M.D., plastic surgeon, Dallas

We don’t see a lot of that in our practice. We get the weekly fax from China, but I don’t see a lot of patients with the counterfeit stuff in our practice.

Welf Prager, M.D., dermatologist, Hamburg, Germany

I buy products directly from the companies or from pharmacies. I do not even buy reimports that are offered through international pharmacies because there are rumors that they might be fake products. I’ve never had problems sticking to this rule.

Derek Jones, M.D., dermatologist, Los Angeles

I think that all of us probably receive emails advertising non-FDA approved counterfeit fillers or toxins.  When I see those emails I now delete them. If you like the look of (Bernie) Madoff in handcuffs sitting in a jail, then buy those fillers or toxins, because that’s what may happen to you. It is simply illegal.  

There is no defense whatsoever. In the U.S., we should only be using FDA-approved products, preferably FDA product that is specifically approved for a cosmetic indication. There’s been a bit of controversy surrounding a hyaluronic acid (HA) newcomer called Expression. It’s been approved by the FDA as a surgical intranasal splint. However, it’s being indirectly marketed off-label as an injectable HA for facial wrinkles and folds, although safety and efficacy have not been formally studied for this purpose. The company is advertising through histologic comparisons to Restylane and Juvéderm (Allergan), leading the M.D. to believe the indications are the same. My colleagues have seen significant adverse events with it when used as an injectable filler for wrinkles and folds. So it is possible for us to be misled regarding the safety of a product. It is critically important to understand the data and the FDA approval process, a product’s specific FDA-approved indications and associated safety and efficacy data, and to critically analyze product claims.

Michael Kane,  M.D., plastic surgeon, New York

I have patients that come into New York that want me to inject some other product that they bring in. I’m not a technician so I just don’t do that. I get the fax blasts like everyone else from China and Canada for the really cheap stuff and I don’t do that either. It’s amazing the kind of advertisements and brochures that come across your desk.

I used to forward some of this on and I used to save some of these brochures. In fact, I was involved in the FDA’s prosecution of the person behind the TRI-tox scandal because I had certain brochures that I’d kept for years. And I knew exactly what was going on there. The other thing that would amaze you if you saw the list of names of doctors who were buying TRI-tox; there are names on that list that all of us would know. I just don’t get it for a few dollars here and there.

Dr. Weinkle

You’re right, colleagues that we recognize and know nationally. That is absolutely unscrupulous. We need to stress over and over that we’ve worked too long and hard to get to where we are. Patient safety needs to be first and foremost. 

It’s one thing as a physician to take a product that is approved for an aesthetic indication and use it off-label. We all know that when we use a neurotoxin (a neuromodulator) anywhere other than the glabella - if we use it in crow’s feet, if we use it in the platysmal band, the DAO (depressor anguli oris), all the places that we choose to use it for aesthetic purposes -  we’re using that product off-label. But it is approved for an aesthetic indication.  

Now when someone brings a hyaluronic acid into your office that has no aesthetic indication and you choose to use it off-label, you’re on shaky ground. You don’t have a lot of data to back you up on its safety in the dermis, the deeper planes, the face - or for aesthetic purposes. Those companies are putting the onus on us as physicians and putting our patients’ safety at risk, which is really not appropriate in this day and age.

We had the wild, wild west when we started 10 years ago. Now we’ve learned a lot and there are rules that we need to play by. 

Promoting products off-label is against the law in the United States. And we as physicians need to help back that up. It’s absolutely inappropriate for companies to come to us and try to encourage us to use a product off-label for an aesthetic purpose when it’s not approved for that. So I really feel in the view of patient safety, as leaders in our communities for these types of procedures, we have to stand our ground on that.

Dr. Jones

Susan says something very important that comes out of the 1997 FDA Modernization Act - that promoting anything we do off-label is against the law. That’s true. The act states that FDA-approved devices and drugs may only be used off-label for indications that are unique to a given patient, within the context of an established physician-patient relationship. Therefore, its against the law to advertise on your website or other media for off-label purposes. So if you take it one step further, formerly is it against the law to promote botulinum toxin for aesthetic indications other than the glabellar fold? Or promoting on your website a specific type of lip filler that doesn’t have FDA approval for the lips? I think the answer is yes, and a lot of M.D.s and advertising professionals don’t realize this. Now, of course, digital media is just way too large for the FDA to run out and be monitoring what everyone does. But I think that as we go about promoting our practices that we’re aware of what the law says, particularly the 1997 FDA Modernization Act. DT