Botox Blog Part II: The Petition

Dr. Hema Sundaram Health Guide
  • 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.

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    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.


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    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?


    *Patient's names have been changed to protect their identity.


    See Hema's Botox Blog Part I: Facts and Myths.

Published On: February 25, 2008