Botox Blog Part IV: The Italian Rat Study

Dr. Hema Sundaram Health Guide
  • A recent Newsweek article, entitled "A New Reason To Frown", calls into question the safety of Botox treatments. It reports the results of an Italian study, published earlier this month in the Journal of Neuroscience, in which rats' whiskers were injected with botulinum toxin. However, what is not pointed out in the Newsweek article is that this single study in rats is inconsistent with nearly twenty years of thorough research into Botox that shows it to be safe. Furthermore, the rat study didn't even use Botox and the study methods are unproven. The Newsweek article also references the Public Citizen petition about Botox, which I have written about in earlier sections of this blog.

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    Botox is FDA-approved for the treatment of frown lines, as well as for numerous debilitating medical conditions for which it relieves significant suffering. As I've written before, it is vital that any cosmetic treatments should be stringently tested for safety. It's reassuring to note that Botox is one of the most extensively studied medications, and research continues to this day.


    The flaws in the rat study have been pointed out in several comments about the Newsweek article. One of these comments is evidently from a dermatologist, who writes: "This is a classic case of bad science and irresponsible reporting." This has been met with the response from another reader: "I assume you make money off of botox. Only one who has money to gain would defend the crap".


    Though it saddens me to see a fellow professional characterized as unethical simply for giving his or her medical opinion of a research study, I appreciate that some members of the public may suspect the motives of doctors who defend the treatments they use to treat their patients. I'd like to point out a couple of facts in this regard.


    First, no cosmetic surgeons have a vested interest in continuing to treat their patients with Botox unless they truly feel it's safe. We all have numerous other methods of skin rejuvenation at our disposal. If Botox were not available to my patients, I expect that they would simply opt to have more laser surgery, chemical peels and filler injections. So the argument that a doctor who uses Botox has money to gain by pointing out the flaws in this study is invalid. Second, the vast majority of cosmetic surgeons who treat their patients with Botox have had the treatment themselves, and have treated their family members with it too. This reflects their confidence in the safety of Botox. In contrast, think of tobacco company executives, who marketed a dangerous product (cigarettes) to consumers while blatantly abstaining from smoking



    If you've read the Newsweek article, or any other media coverage of the Italian rat study, here are four facts you might like to know about it.


    1.     The study didn't use Botox

    The study used a laboratory-made research grade botulinum toxin, which is significantly different to Botox and is not suitable for human use. Conclusions about Botox cannot be drawn from this single rat study that did not use Botox.


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    2.     The study was in rats, not humans

    Why does this matter? Because actual Botox was shown to be safe and effective when it was approved by the FDA for medical use 19 years ago. There have been many further studies since then, resulting in thousands of scientific papers. The results of this single rat study with another botulinum toxin are inconsistent with scientific evidence and results from studies of Botox. We cannot generalize from a single rat study using a non-Botox test substance to treatment of humans with Botox.


    3.     The doses used were very high

    The Newsweek article states that the doses of non-Botox botulinum toxin used in the study were "comparable to those used in people". However, the botulinum toxin injected into rats' whisker pads was actually 150 times more per body weight than the approved dose of Botox to treat frown lines.   


    4.     An indirect, unproven testing method was used

    The study researchers did not look directly for the presence of botulinum toxin in the rats. Instead, they looked for the presence of a marker which has not been used previously for this type of research.  It is difficult, if not impossible, to draw valid conclusions from a study whose results hinge entirely upon the use of an indirect, unproven marker.


    Read other entries in Hema's Botox Blog.





Published On: April 28, 2008