Invited Speaker

Toxic Toxins: 2010
Arnold William Klein
USA

According to a recent article posted on Newsinferno.com, Health Canada has announced that the label for Botox and Botox Cosmetics sold in that country will be updated to include new safety warnings (see Attachment 2). The warnings will now include the risk of the toxin spreading to other distant parts of the body. Possible symptoms of “distant toxin spread,” which can be fatal, include muscle weakness, swallowing difficulties, pneumonia, speech disorders and breathing problems, Health Canada said.

The article noted that in October, Health Canada reported that five Canadians had died following Botox injections, prompting it to launch an investigation. At the time, Health Canada said it was also looking into eight reports of serious reactions following Botox treatment. The Botox reactions reported in Canada included throat swelling, respiratory arrest, difficulty swallowing, and aspiration pneumonia, an infection that occurs when food or liquids are inhaled into the respiratory tract and lungs.

It has long been known that large dilutions of botulinum toxin (Botox) could result in the toxin migrating and reaching unintended muscles. Past U.S. Food & Drug Administration studies have found that problems with dilution were the greatest cause of adverse reaction with Botox. Even so, in a 2007 article published in Dermatologic Surgery, the author, a Canadian dermatologist, concluded that dilution of botulinum toxin was not critical. A few years prior, an attempt was made by the lead consultant of Allergan to publish this same article, but a review of the submitted paper uncovered serious problems and contradictory data, including graphs, which suggested a worsening of wrinkle severity from baseline after the Botox wore-off . Furthermore, small sample sizes and adverse events in the larger dilution groups were noted. In light of these concerns, the article was rejected for publication. The authors then resubmitted the article, but removed the baseline data, which suggested wrinkles worsened after the toxin wore off. I spoke to the editor of the journal and once aware, he promised to address the problem with the authors. I was both shocked and appalled to see the article appear with the altered data in Dermatologic Surgery in January 2007.

In January 2008, the advocacy group Public Citizen released a safety analysis of Botox procedures from FDA records covering 1997 to 2006 (see Attachment 4). Altogether there were 658 adverse effects from injections. Among these included potentially life-threatening pneumonia and fluid in the lungs and difficulty swallowing. There were also 16 deaths. This data comes from drug manufacturers, so Public Citizen believes the actual numbers could be much higher. And in fact, the FDA has over 180 reports of life-threatening adverse reactions to Botox, with 80 requiring hospitalization. In the U.S., Botox is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic is approved for temporary improvement in the appearance of moderate to severe facial frown lines.

As Allergan, the manufacturer of Botox, teaches anyone who can hold a needle how to inject this potentially toxic substance, the number of serious reactions and deaths will increase. Profit has replaced patient safety as the major theme of Continuing Medical Education courses, thus setting the stage for a potential medical disaster. Compounding this is the presence of forged medical data. The recent news of Dr. Scott S. Reuben’s faked data for 21 studies involving Vioxx, Celebrex, and other drugs has caused a ruckus in the medical world. But this isn’t the first case of forged data being released by a physician or physicians with strong ties to the pharmaceutical industry (as noted above). In another article in the same January 2007 issue of Dermatologic Surgery, the very same foreign physician who submitted the Botox dilution conclusions attempted to include my name and another physician’s on an article regarding the supposed safety of the injectable type B toxin, Myobloc. We both demanded our names be removed. We were then offered $10,000.00 by the company who manufactures Myobloc to include our names on this paper. We both voiced concern that this article was incomplete and did not reflect the true toxicity of this agent as had been shown in other studies, including Japanese studies that have shown Myobloc to be much more toxic than originally believed. In clinical use, this toxin had been known to cause distant side effects such as dysphagia (inability to swallow) when used in normal doses. Our names were removed from the article, but the manufacturer nonetheless refused to include this important safety data. The article concluded that this toxin was both safe and effective. In the U.S., Myobloc is approved for the treatment of adults with cervical dystonia. Physicians such as Dr. Reuben (and the Canadian dermatologist noted above) are supported by America’s biggest pharmaceutical companies. They are the very same people who run medical societies, edit and advise trade publications, appear on the Internet and television, and speak before the FDA. It’s physicians like this who are responsible for the FDA approval of synthetic permanent inject able agents as well as other synthetic products that are placed under the skin.

Some of these products include Artefill (inject able Plexiglas), Sculptra (ground-up suture material), and Radiesse (inject able bone). These compounds have severely scarred and impaired the health of people around the world, and as a result, are no longer used in most countries. They have gained approval despite a total lack of information and scientific data concerning their behavior once implanted. Following and August 2007 article posted in The Wall Street Journal, Artes Medical Inc., the company that manufactures Artefill, filed for bankruptcy.

The field of aesthetics has been badly damaged by these deliberate acts. I have voiced my serious concerns and raised questions about the alteration of data published in peer-reviewed journals and as a result, I have been terminated from one manufacturer’s advisory board and from the editorial boards of the three major peer-reviewed dermatology journal publications. Somehow and in some way, we must warn the public of the potential danger that exists at the end of the needle.