Dr. Klein has stated that physicians need to be trained and educated on the proper use of Botox and that the FDA needs to be much tougher in protecting the public. There has been evidence of Botox being used improperly and he alleges that Allergan, the manufacturer of Botox, has misrepresented the data they have on the drug.
Dr. Klein reviewed a 2003 study that was submitted to the Dermatologic Surgery journal by foreign doctors doing work for Allergan. The review had to deal with diluting Botox. What the author of the review was trying to show was that certain levels of dilution not detract from the safety and efficacy of the product. However, a review of the paper showed some serious issues with the manuscript, which included graphs that showed worsening of wrinkles after the Botox wore off. The study was not published due to these various issues with the paper. At a later date, the same author submitted the same study with different results. When Dr. Klein alerted the editor of the journal, he was told that the issue would be resolved.
However, the same study still appeared two years later in an edition of Dermatology Surgery that was sponsored by Allergan. The study included the data that was altered despite the statement to Klein by the publications editor that the situation would be resolved. It may have been resolved at the moment, but did not have an impact when Allergan sponsored the review. Klein stated that he felt the data was altered to benefit the pharmaceutical company at the expense of the health of the patients.
Klein later shared his concern regarding the improper dilution of the drug causing serious risks to patients such as the drug spreading to unintended areas of the body, which could cause paralysis and even death. Shortly after Klein raised his concerns, the same foreign doctor who had conducted the study that appeared in the Dermatology Surgery journal, submitted another article about the drug Myobloc, which has also been suspected of causing paralysis and death. It is injected in the same manner as Botox. Dr. Klein and another doctor were named as the authors, although they said they had nothing to do with it and had never seen it prior to it being published.
READ MORE LEGAL NEWS
In February, the FDA announced that Myobloc and Botox have both been associated with swallowing issues and respiratory issues. There has been at least one death. Public Citizen, an American watchdog group, found that there have been 180 severe reactions and 16 deaths associated with Botox use in a 9 year period. There has only been one cosmetic-related death.
By Ginger Gillenwater