Botox Blog Part III: The Reality, and The FDA Review

In other words, should childhood cerebral palsy also be considered a neuromuscular disease for the purposes of Botox product labeling?

The doses of Botox that are used for cosmetic purposes are so tiny that there should be no concern in any healthy patient. Over a million people have been treated with Botox for cosmetic purposes, and not one has ever been shown to have died due to this treatment. Like all the cosmetic surgeons I know, I already advise patients with neuromuscular diseases or other debilitating conditions not to have Botox for cosmetic purposes.

I am one of a small group of expert dermatologists and plastic surgeons across the country that serve as Principal Investigators for FDA studies of new cosmetic therapies. As a Principal Investigator, I know from first-hand experience how thoroughly the FDA evaluates any new therapy before approving its use in the U.S. - even a therapy like Botox, which was previously used safely for both medical and cosmetic purposes for many years in many other countries.

I also know that the FDA continues to monitor these therapies even after approval, to ensure that the highest standards of safety and effectiveness are being met. In my opinion, our FDA is the strictest and most stringent in the world, and I am glad of that. I believe that American consumers are better protected than their counterparts anywhere else in the world.

I'm reassured to know that the FDA is keeping an eye out for the welfare of my patients. Besides FDA regulations, I have another rule that guides me in caring for the men and women who place their trust in me every day. I call it the "rule of mom". Basically, I won't treat my patients with anything that I wouldn't feel comfortable giving to my own family (such as my mother) - and to myself. (After over twelve years in practice, some of my long term patients are practically family anyway!)

There are some treatments that have been approved by the FDA but still fail my "rule of mom" because I don't feel their benefits outweigh their disadvantages, and I don't offer them to my patients. The FDA explicitly states in its announcement that it is not advising health care professionals to discontinue prescribing Botox. Given this, along with the thousands of Botox injections I have administered with excellent results and no safety problems whatsoever, I have absolutely no reservations about continuing to offer Botox treatment for wrinkles and excessive sweating to my patients.

Perhaps also, when all's said and done, Dr. Wolfe of Public Citizen not only misquoted his organization's own petition but was also wrong when he asserted that "patients don't have a clue". Perhaps they do have a clue, and that's why they're not rushing, lemming-like, to condemn a treatment that the FDA approved as safe decades ago and that, since then, has saved innumerable men, women and children from intractable pain and suffering.