Botox Blog Part II: The Petition

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?

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

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