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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

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 r
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SOURCE Arnold William Klein MD
Copyright©2008 PR Newswire.
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