Botox

As a dermatologist, it thrills me to see how happy Botox makes my patients, whether I’m treating them medically for excessive sweating or cosmetically for wrinkles.

Excessive sweating is no laughing matter. To those whose personal and professional lives, and clothing, it ruins, Botox often seems like a miracle. Take Jodie*, who told me that my Botox treatment of her underarms made her wedding day, and saved her dress. Or Peter, who’s 21 and told me that Botox treatment of his palms allowed him to hold hands with a girl for the first time in his life. We can certainly all live with wrinkles but, as I’ve written previously , cosmetic surgery is inspiring and uplifting if you use it to project a positive image and to balance how you look with how you feel. Anne, a recently widowed 53-year-old, was one of the first patients to visit me after I opened my private practice. The Botox and laser treatments that I gave her helped her to cope with the stress of her husband’s death and the toll it had taken on her appearance and self-image.

A recent Los Angeles Times article about the petition provides insight into how much Botox can improve the life of children with cerebral palsy. It includes an interview with a pediatric orthopedic surgeon, Dr. Hank Chambers, who says that he’s given 20,000 Botox injections to cerebral palsy sufferers and never had a complication. Dr. Chambers speaks with authority in describing Botox as “a spectacular treatment” and avowing that it has “changed lives”, as his own son has cerebral palsy and has himself been treated with Botox.

Dr. Chambers comments that some doctors who are not expert in treating cerebral palsy might inject patients with doses of Botox that are much higher than recommended guidelines. Although this could cause problems with muscle control elsewhere in the body due to spread of Botox, Dr. Chambers also notes that children with cerebral palsy already have muscle control problems, so it’s difficult to determine the role, if any, of Botox.

On February 8, the FDA announced that it will be reviewing the safety profile of Botox and Myobloc, with particular emphasis on their use in large doses for children with cerebral palsy and similar conditions. The FDA’s statement that “reactions may be related to overdosing” and that “there is no evidence that these reactions are related to any defect in the products” seems to echo Dr. Chambers’ thoughts.

During a public teleconference following its announcement, the FDA’s neurology chief, Dr. Russell Katz, stated that this review involves “a relative handful of serious adverse events” in a patient population that is already “very sick” and confirmed that none of these is related to the cosmetic use of Botox.

The product labeling for Botox already warns that patients with pre-existing neuromuscular diseases may be at increased risk of significant side effects from regular Botox doses that would not cause problems in healthy patients. So what this seems to boil down to now is that the FDA and the drug manufacturers will discuss whether a warning should be added to the product labeling for Botox stating that some children with cerebral palsy could also experience significant side effects from Botox, especially if they are given high doses which might encourage spread of Botox to other parts of the body.

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.

So, for now, let’s sit tight and put our trust in the FDA. And, by all means, discuss the petition with your doctor. I’d also like to hear from you if you have had Botox treatment (or if someone you know has), either for medical or cosmetic purposes. Has Botox treatment impacted your life, or the life of someone you know? And, if so, in what ways? How would you feel if Botox was no longer available or restricted in its availability?

Over the past decade, I have trained many physicians from throughout the country in the use of Botox for cosmetic purposes and for excessive sweating. I have lectured on these subjects at medical conferences and at educational programs for allied health professionals, and I will continue to do so. I believe that accurate, scientific education, training and communication are essential to optimize our understanding of Botox and other minimally invasive cosmetic procedures, as they continue to increase in popularity.

*Patients’ names have been changed to protect their privacy

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.

And then there are the millions of patients who have Botox for cosmetic reasons, to smooth out frown lines and other wrinkles on their faces. 10 million Americans of all ages have been treated with Botox over the past three decades, more than a million of them for cosmetic purposes. It’s been noted that even if Botox had caused 12 deaths between 1997 and 2006, your chances of dying from Botox treatment would be far less than your chances of being killed by a tornado.

Let’s add a little more context to this. Do you think of nonsteroidal anti inflammatory drugs such as aspirin, ibuprofen (Motrin) and naproxen (Aleve) as unsafe? These over-the-counter painkillers, along with their prescription counterparts, have actually been proven to cause about 2000 deaths per year in the UK alone, in those taking them for at least two months.

But the fact is that Botox has not been proven to cause any deaths – remember that line in the petition stating that “causality cannot be proved”. Let’s look at the one death that allegedly occurred from wrinkle treatment. This one woman died from bacterial pneumonia in the winter of 2004…. seven weeks after she received Botox. While this death, due to an infection that’s prevalent in winter, is undoubtedly tragic, I fail to see the logic of linking it to a cosmetic treatment that was administered almost two months previously. According to this woman’s medical records, the physician who treated her pneumonia felt the same way.

So how did Public Citizen come by the data in its petition? The group searched ten years of the FDA’s Adverse Event Reporting System (AERS) Database, to which doctors and drug manufacturers are required to report any undesirable event that happens to a patient after receiving any treatment. But a report to the AERS database of death in a patient who has received Botox treatment does not mean that the treatment caused the death. It only means that a patient who received Botox died at some point afterwards. As the FDA itself cautions, “for any given report, there is no certainty that a suspected drug caused the reaction.” That sounds an awful lot like, “causality cannot be proved”, doesn’t it?

The text of the petition is posted here, and I’d be interested in your thoughts. How do you interpret the line, “causality cannot be proved”? And do you think it’s reasonable to link the death of a woman from bacterial pneumonia to Botox seven weeks previously?