In January, Public Citizen, a consumer advocacy group cofounded by Ralph Nader, issued a strongly worded petition to the FDA, stating that the Federal agency should increase its warnings about botulinum toxin-based products.
The group said the agency should also warn patients and physicians about the use of Botox and Myobloc because of serious reactions linked to the drug.
Public Citizen pointed out that the FDA, unlike sister regulatory agencies in Europe, has not issued any warnings about the dangers of using the toxin. The petition pointed to patient deaths following Botox treatments, citing conditions such as paralysis of the esophagus and aspiration pneumonia.
Public Citizen not only wants the government to send a warning letter directly to physicians, alerting them to the problems associated with the drug, but also asked the FDA to label the products with a “black box” warning, the strongest warning the agency can make. It wants the FDA to require physicians to give patients a medication guide at the time of the injection, warning them of possible symptoms of adverse reactions and other information.
The term “Nader’s Raiders” was coined in the 1960s, as consumer advocate Nader was seen by many as a politically connected whistleblower who successfully took on giant US companies, such as General Motors.
After Nader’s failed US presidential bid in 2000, Public Citizen distanced itself from its cofounder but continued to blow the whistle on multinationals.
The new phalanx of whistleblowers, rechristened “Nader’s Neo-Raiders” by some in the media, included Sidney Wolfe, MD, who is currently director of Public Citizen’s Health Research Group and the primary spokesperson for the Botox petition.
Our industry reacted quickly but with aplomb. Allergan pooh-poohed the allegations, going after Public Citizen’s interpretation of the FDA data.
Allergan’s chief medical officer, Sef Kurstjens, MD, PhD, calmly responded that Public Citizen is mistaken in its conclusions. The ASDS and the ASPS responded that the current labeling of all Botox products is adequate for its intended use by trained physicians.
Many experts reminded all concerned that Botox is currently FDA-approved for treatment of glabellar wrinkles, and that any other treatments are considered off-label.
Botox is a safe treatment if done right. If injected aesthetically for the upper face, the most dramatic side effect might be bruising or a droopy eyelid. It is possible that Public Citizen did, indeed, misinterpret or overstate the FDA data. Botox that was used for nonaesthetic purposes—or used in a poorly performed treatment—might have yielded the reported esophageal complications.
However, the Neo-Raiders and their supporters will not be put on public trial here. The onus is clearly on Allergan, Solstice Neuroscience (makers of Myobloc), and the industry in toto. The media has remained mostly neutral in assessing the issue, although historically it has sided with the Nader sensibility.
The aesthetic industry is entering a critical phase, in which safety concerns for patients simply must assume the highest possible importance. Of course, physicians and their support staff take this aspect of their work seriously on a daily basis.
Let’s head up to the 40,000-foot level, though, and look at a bigger picture. The consumer’s perception of how our industry reacts to safety issues is more critical than reality.
Public Citizen, remember, has an agenda or two. One is an anti-FDA viewpoint—Wolfe has been very outspoken against the FDA for years, and works diligently to reverse drug approvals based on whatever evidence the group can swing. One of the drug approvals Wolfe was unhappy with was Botox.
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My recommendation to those involved on the aesthetic side of the issue: tread carefully.
If the public grows convinced that Botox is dangerous, then we have some praying to do. When responding to these types of complaints, don’t throw too much medical jargon into your response—most people won’t know what you’re talking about.
Meanwhile, straight-talking groups like Public Citizen will win the battle of words, and possibly the hearts and minds, of your future aesthetic customers. And that would be tragic.