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Founding Father of Modern Cosmetic Dermatology Seeks to Warn Public of Misrepresented Data and Inappropriate Use of Botox
Date:3/6/2008

BEVERLY HILLS, Calif., March 6 /PRNewswire/ -- World-renowned dermatologist, Dr. Arnold Klein, is on a mission to inform the public about the dangers surrounding one of the most popular injectable cosmetic agents: Botox. According to Forbes.com, Botox is the second-most recognized prescription drug brand in the world behind Viagra. Klein says that in many instances, the use of Botox has replaced traditional surgery. "To properly use this," Klein continued, "physicians need to be properly trained and educated and the U.S. Food and Drug Administration needs to be far more aggressive in protecting the public," Klein said. "Not only is there evidence of misuse and improper administration of Botox," Klein continued, "there is additional evidence of misrepresentation of data by Botox manufacturer Allergan."

In 2003, Dr. Klein reviewed a study submitted by foreign doctors working for Allergan to the American Society of Dermatologic Surgery's journal Dermatologic Surgery regarding the dilution of Botox. The author was trying to show that certain dilutions of the Botox formula would not significantly detract from the product's safety and efficacy. "A review of the paper uncovered serious problems with the manuscript, including graphs demonstrating a worsening of wrinkle severity after the Botox wore-off," revealed Klein. Based on these problems the study was denied publication. The author then resubmitted the study with different data. Dr. Klein alerted the editor of Dermatologic Surgery to this highly suspect data change. Dr. Klein was assured that this problem would be resolved.

"Ultimately, this same study appeared anyway two years later in a special Allergan sponsored edition of Dermatology Surgery with the altered data," charged Klein. According to Klein, the data that was published was changed to support the author's original claims, and was never part of the study that he and several other doctors reviewed. "Needless to say I have serious problems with this," said Klein. "Here we have a foreign doctor without a license to practice medicine in the United States presenting what I believe is altered data to the medical community on behalf of a pharmaceutical company within American medical literature, which is widely considered to be the holy grail of medicine."

Klein shared this concern with many physicians that improper dilution of the Botox solution posed a serious danger to patients by increasing the risk that it would spread to unintended areas of the body. Shortly thereafter, the same foreign doctor and Allergan consultant who submitted the Botox article submitted another suspect article regarding Myobloc, another injectable toxin. This study included Dr. Klein and another respected doctor as authors even though they had never seen it. Both doctors immediately demanded their names be removed from the study, and refuted the study's claims. After Dr. Klein and an esteemed physician in New York repeatedly raised concerns over these issues, they were let go from their advisory board positions with Allergan.

"Now we're in a situation where the uses for Botox are growing everyday and it is being administered by doctors in a variety of specialties, many of whom have little or no training and experience with the product, but who are under the impression that this diluted product is safer than it really is because of irresponsibly published studies with faulty data," said Klein. "The FDA needs to step in, re-evaluate the safety of the certain dilutions of Botox and ensure that future studies published in American medical journals, which affect FDA approved products, are submitted by doctors licensed to practice medicine in the U.S."

In February 2008, the FDA issued a statement that Botox and Myobloc have been linked to serious respiratory and swallowing problems and at least one death. American watchdog organization Public Citizen analyzed the FDA's own database and found 180 serious adverse reactions and 16 deaths linked to Botox between 1997 and 2006, with one death linked to cosmetic use. "If Botox was used by properly trained and educated doctors this would not be the case," concluded Dr. Klein.

Arnold William Klein MD

Professor of medicine and dermatology at UCLA. He is a member of 28 professional organizations including the American Academy of Dermatology. Dr. Klein is a founder of the American Foundation for AIDS Research (amFAR) and Rose-Tarlow-Arnold W. Klein Breast Cancer Foundation at UCLA. He also founded the Elizabeth Taylor AIDS Clinic at UCLA. Dr. Klein also serves as a trustee to numerous Boards of Directors, including the Jennifer Jones-Simon Foundation, the UCLA Center for the Health Sciences, The Discovery Eye Foundation and the Hereditary Disease Foundation. Dr. Klein has been honored with a chair in dermatology at UCLA, the Arnold Klein, MD, Chair In Dermatology.


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SOURCE Arnold William Klein MD
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