It's been a busy couple of months in my office for Botox, despite a petition issued last month by Ralph Nader's consumer watchdog group, Public Citizen, to the Food & Drug Administration (the FDA).
You've probably heard about this petition, as it's been making the media rounds for the past few weeks, sometimes accompanied by panic-inducing headlines. It asks the FDA to issue a warning letter to physicians about Botox and another, unrelated treatment called Myobloc. What strikes me is the complete lack of panic in my patients, whether they're having Botox for the first or the fiftieth time. In the words of 57-year-old Marcy*, one of my ‘regulars' who came in for a Botox touch-up last week: "I've had plenty... and I'm not dead yet!" The only people asking me about "the dangers of Botox" are media reporters.
What also strikes me is what a closer look at the petition reveals. It claims that Botox and Myobloc have caused "serious problems, including hospitalizations and deaths" and, specifically, that Botox has caused 11 deaths from medical use and 1 from cosmetic use between 1997 and 2006. (The other 3 deaths listed in the petition are claimed to be due to Myobloc, a product I don't use). However, a closer look at the petition reveals the telling words, "Additional limits to our data include: causality cannot be proved".
That's a pretty big limiting factor.
If causality cannot be proved, how valid is this petition? And if the petition itself admits that there is no proof Botox caused any of the deaths listed in the petition, then why is Dr. Sidney Wolfe of Public Citizen telling the media: "Nobody should die from the medical use of Botox. The fact that they are shows that patients don't have a clue about these problems"?
It troubles me that this statement and others made by representatives of the group are not consistent with what is written in the petition. While I have every respect for consumer advocacy, I feel that these inconsistencies have resulted in misleading, sensationalized media reports that only serve to cause confusion and are not in the public's best interests.
Despite the popular image of Botox as a wrinkle-fighter, it was actually introduced to our country 30 years ago to treat a medical condition - lazy eye - in both adults and children, and it was FDA-approved for this purpose 18 years ago. Botox is used now for a plethora of other medical conditions. Some are serious and painful, like cervical dystonia, which causes incurable painful spasms and prolonged muscle contractions in the neck, upper back and shoulders. Some are less painful but still physically and socially debilitating, such as migraine headaches, overactive bladder and excessive sweating (medically known as hyperhidrosis). More studies are under way to investigate and confirm other promising uses for Botox, many of which will also relieve significant suffering.