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Fraudulent formulae

Article-Fraudulent formulae

Key iconKey Points

  • Counterfeit and unapproved injectables and other products being used in the United States is a growing problem
  • Most who utilize unauthorized drugs and devices are nonphysicians
  • Pharmaceuticals companies, professional associations, and physicians are working together to combat the problem

Dr. Narurkar
NATIONAL REPORT — Though figures are scarce, experts say the problem of counterfeit and unapproved injectables and other products being used in the United States is as pernicious as it is multifaceted. Solutions include heightened vigilance, individual responsibility and common sense, they add.

Vic Narurkar, M.D., tells Cosmetic Surgery Times that based on his observation, "We do think it's a growing problem. To what extent, it's hard to quantify" how many physicians or nonphysicians are using unapproved or fake products.

But in his practice, "We're seeing at least two adverse events a month" — typically ineffective neurotoxins and fast-fading faux fillers — in patients treated elsewhere, explains Dr. Narurkar, a San Francisco-based board-certified cosmetic surgeon in private practice who is assistant clinical professor of dermatology at U.C. Davis Medical Center and immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery. In such cases, he says, "We don't know if they're diluting the neurotoxin or what material they're using." Simultaneously, he says there's a "huge problem" with illegally compounded 5-aminolevulinic acid (5-ALA) preparations that mimic Levulan (Dusa Pharmaceuticals; see related story, page 8). Likewise, Dr. Narurkar states, "A company in California claims to sell refurbished Fraxel (Reliant Technologies) tips. Nobody knows" how they do it or whether the process is safe.

It is clear, however, who typically uses unapproved items, sources say. "Ninety-nine percent of the people who use unauthorized drugs and devices are nonphysicians" such as medical spa aestheticians in malls and other locations, states Ranella J. Hirsch, M.D., a Boston-based dermatologist in private practice and chair of the American Society for Dermatologic Surgery (ASDS) scope of practice committee. Additionally, she emphasizes that improper use of authorized products can be as harmful as impostors.

"We're not just dealing with dermatologists and plastic surgeons. There's a whole cadre of noncore specialists, medical spas and others who I believe are more likely" than dermatologists and cosmetic surgeons to skirt the Food and Drug Administration (FDA), says Dr. Narurkar. Furthermore, as cosmetic treatments gain popularity, "The more pressure there may be to compete monetarily," says Joseph Niamtu, D.M.D., a Richmond, Va.-based cosmetic facial surgeon who serves on the Cosmetic Surgery Foundation's Board of Directors. "But if an OB/GYN can do a C-section, they can certainly inject a little Botox in the forehead." Also, he says it's hypocritical to complain about noncore specialists performing cosmetic treatments when the nurse in many cosmetic surgeons' practices perform the same procedures.

SCARED STRAIGHT Dr. Niamtu says that although unapproved cosmetic treatments represent a relatively small problem, it could be bigger. Before the recent case surfaced involving an unlicensed Florida osteopath who injected himself and three friends with an unlicensed research-grade botulinum toxin, explains Dr. Niamtu, "It was significantly escalating. The incident probably scared a lot of people straight."

Dr. Hirsch
Importation of products unapproved by the FDA represents a larger problem, according to Alastair Carruthers, M.D., ASDS president. "What happens often is that people will go somewhere like Brazil or Mexico," hear from a colleague that a locally available material is as good as its FDA-approved counterpart, and bring a sack full over the border.

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