So far, tests have provided them with information and results shocking to many; Botox is not meant only for facial reconstruction. No, it has been proven in numerous medical journals to aid in chewing and swallowing problems, fibromyalgia, ulcers, pelvic muscle spasms, hair loss, pain from missing limbs, and multiple other problems. And that's not all. As doctors across the U.S. embark in clinical trials, they have found new ways to fight age-old problems. It is being injected around the head and neck to help migraine sufferers, directly into the larynx to defeat speech impediments, and Dr. Brandt, a Manhattan dermatologist, has devised an innovative new way to beat the red and oiliness of skin through its unique features. These discoveries have sent its earnings spiraling upward, its medicinal income now poised to outweigh its cosmetic influx.
Currently, the F.D.A. has approved Botox to treat four problems: stress induced wrinkles at the eyebrows (the number one seller), eye and neck muscle disorders, and excessive sweating, but Allergan, the $14.5 billion pharmaceutical company backing Botox, quickly discovered that it was capable of much more. They now own, or have applied for, patents on more than 90 uses for the drug and have researchers working to discover even more ways it can be used. Some of the newest drugs they are looking into marketing are for overactive bladders, enlarged prostates, or stroke victims suffering from spasms.
Health insurers sometimes cover medical uses of Botox, but cosmetic treatments, or beauty work, must come out of a customer's own pocket. The New York Times shows that the therapeutic needs of society will soon outweigh cosmetic desires due to our economic downturn and health issues. Supported by 30 years of research, studies on 11,000 people worldwide, and 17 million treatments administered in the United States since 1994, Dr. Brin feels strongly that Botox is a "molecule that keeps on giving" and it should continue to be studied due to the vast knowledge and possibilities that could lie within.
Thousands of doctors are not waiting for federal approval to begin therapeutic Botox injections. Gary Nachman, an analyst at the investment bank Leerink Swann, has estimated that almost half of Botox sales are coming from off-label uses. This experimental treatment is perfectly legal for doctors, but it has many medical professionals nervous because without further study and clarification, safe doses have not been established and there is no definitive proof of its success. Even worse, there have been life-threatening complications following Botox injections and other botulinum toxins recorded, some leading to death. Dr. Frederick Burgess, the chief of anesthesia in Rhode Island, explained that "It is possible to over inject. This is a poison, and things can go wrong. It is rare, but it happens."
The F.D.A. was petitioned last year by Public Citizen for stronger warning labels and awareness to be given about botulinum toxins. For many, Botox is seen as harmless and the papers needed to sign before undergoing experimental treatment are half-read. Public Citizen wants labels to explain the symptoms and problems a patient may endure, such as swallowing or breathing difficulties and the diffusion from a patient's injection site. This labeling change was adopted in Canada earlier this year and stands before F.D.A. for approval across the globe. PureTox, developed by Johnson & Johnson, is a Botox infused anti-wrinkle cream fighting to get onto the market, but without F.D.A. warning labels, industry analysts predict botulinum toxins will be at a standstill.
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