April 15 marks the 10-year anniversary of the Food and Drug Administration’s approval of Botox for cosmetic use. But it has been nearly two centuries since the toxin was identified. Here’s a timeline in the development of the now-popular wrinkle reliever, beginning in the early part of the 19th century. Apparently, it all started when someone encountered a spoiled sausage.
And the rest is history …
Happy Birthday Botox!
Happy Birthday Botox!
1820s: German doctor Justinus Kerner identifies a toxin in spoiled sausages that causes food poisoning. The paralytic illness caused by Kerner’s “sausage poison” earns the name “botulism,” from a Latin word (“botulus”) for sausage. Kerner speculates that small doses of the toxin might be used to treat nerve disorders and excessive sweating.
1895: Belgian bacteriologist Emile Pierre van Ermengem discovers that Clostridium botulinum bacteria produce the botulism toxin.
1920s: Botulinum Toxin Type A is first isolated from the Clostridium botulinum bacteria in a purified form as a stable acid precipitate by Dr. Herman Sommer at the University of California, San Francisco.
1940s: During World War II, American scientists explore potential use of botulinum toxin as a weapon. The U.S. produces botulinum toxin capsules for Chinese prostitutes to drop into the food of high-ranking Japanese officials. The plan is not put into effect because the military found it to be ineffective as a weapon.
1946: Researcher Edward J. Schantz, Ph.D. succeeds in purifying Botulinum Toxin Type A into crystalline form, for the first time providing scientists with the raw material necessary to study the molecule in greater detail.
1949: Researcher Dr. Arnold Burgen and colleagues in London discover that botulinum toxin blocks communication between nerves and muscles.
1960s: Ophthalmologist Alan Scott in San Francisco injects botulinum toxin into monkeys to see whether it relaxes muscles that cause crossed eyes.
1978: Scott wins approval from the Food and Drug Administration for extensive multi-site tests of botulinum toxin as a treatment for crossed eyes in humans. He calls the drug Oculinum and establishes Oculinum Inc. to make and sell it.
1987: Canadian ophthalmologist Dr. Jean Carruthers (pictured above with her husband) notices that patients injected with the toxin were losing their frown lines. Her husband, Canadian dermatologist Dr. Alastair Carruthers, injects botulinum toxin into the forehead of their receptionist, Cathy Bickerton Swann, to smooth her wrinkles.
Late 1980s: Doctors begin using botulinum toxin as a treatment for involuntary contraction of neck muscles, also called cervical dystonia.
1988: Allergan acquires the rights to Dr. Scott’s product, Oculinum.
1989: Allergan secures the first FDA approval for Oculinum as a treatment for crossed eyes and excessive blinking and received FDA approval to change the name to Botox.
1993: Doctors in England notice that spasm patients sweat less when treated with Botox.
December 2000: FDA approves Botox as a treatment for cervical dystonia.
April 15, 2002: FDA approves Botox injections for frown lines between the eyebrows under the name Botox Cosmetic.
2004: Allergan launches clinical trials of Botox for migraine sufferers.
2004: Los Angeles socialite Irena Medavoy sues Allergan for ailments that she says were caused by Botox that was injected to ease her migraines. A 9-3 jury verdict goes against her.
July 2004: FDA approves Botox as a treatment for severe underarm sweating.
May 2007: Actress Virginia Madsen becomes the first celebrity to openly discuss her Botox cosmetic treatments and is featured in the Botox advertising campaign, “Keep the Wisdom. Lose the Lines.” She tells People magazine, “I am not using these injectables to look 25. I don’t want to be 25. I just want to look like me. I am 45, and I am in the best shape that I have ever been in my life.”
2008: U.S. Department of Justice launches probe of Allergan’s marketing practices, subpoenas documents related to off-label use of Botox as a treatment for migraines.
2008: Advocacy group Public Citizen urges FDA to impose stricter regulations on Botox and similar products, cites 16 patient deaths that occurred after neurotoxin injections.
2009: Actress and singer Vanessa Williams reveals she has been treated with Botox cosmetic. She becomes the spokesperson for a charitable education campaign whereby Botox Cosmetic donates $250,000 to non-profit Dress For Success.
April 2009: FDA requires Allergan to expand warnings on the Botox label, but says cosmetic use of Botox is not linked to deaths.
October 2009: Allergan sues the FDA, seeking the right to tell doctors about all the effects of Botox and other drugs, not just the effects related to FDA-approved therapies.
March 2010: In $60 million lawsuit, Santa Ana jury decides that Botox injections did not cause the death of cerebral palsy patient Kristen Spears, 7.
March 2010: FDA approves Botox as a treatment for spasms of the arms and hands in adults.
May 2010: Oklahoma jury orders Allergan to pay $15 million to Dr. Sharla Helton, 47, who says cosmetic Botox injections left her in pain and unable to work.
September 2010: In court in Santa Ana, Allergan settles the case of Sondra Bryant of Texas, a 70-year-old nurse who died in 2008 after injections to ease her neck pain. Terms of the settlement were not announced.
October 2010: FDA approves Botox to treat chronic migraines.
April 2011: A federal jury in Virginia orders Allergan to pay $212 million to a 67-year-old man who said he was left brain-damaged and bedridden in 2007 after receiving off-label Botox injections to ease trembling and cramps in his hand. The Virginia jury rejects Allergan’s contention that Botox was not to blame for Douglas Ray Jr.’s disabling injuries. The panel awarded him $12 million in compensatory damages plus $200 million in punitive damages.
August 2011: The FDA approves Botox for treating overactive bladders in those who lose control because of damage to the nervous system, including those with multiple sclerosis or spinal cord injury.
September 2011: Allergan settles the case of a San Francisco-area woman who had cosmetic injections and said she developed systemic problems, including weakness and fatigue, her attorney Ray Chester said. Terms of the settlement were not released.
October 2011: Actress Courtney-Thorne Smith becomes the latest actress to promote Botox, and tells People magazine she’d been getting the injections for about 10 years.
October 2011: A suit brought by Cynthia Van Den Boom of Richmond, Va., was settled before trial was to start the following month. Van Den Boom, who was injected with Botox for neck pain, suffered brain damage, her attorney Ray Chester said. Terms of the settlement were not disclosed.
February 2012: An Orange County jury hangs on the question of whether Allergan is to blame for a 46-year-old man contracting a devastating disease — Guillain-Barre Syndrome – that he says he got four days after getting Botox injections for back pain. Allergan’s attorney, Vaughn Crawford, said while the company was looking into potential risks in 2008, the year Thomas McGee got his injections, there was no medical evidence that Botox caused the disease.
March 2012: After Allergan alleges its trade secrets were stolen, a federal judge in Santa Ana blocks another company, Merz, from marketing Botox rival Xeomin. U.S. District Judge Andrew J. Guilford says he was troubled that some Allergan employees signed contracts with Merz and then e-mailed themselves Allergan company data before giving their final notice.
March 2012: Allergan discloses it has submitted an application with the FDA for the use of Botox as treatment of overactive bladder in adult patients with symptoms of urinary incontinence who have not responded to other treatments for OAB (overactive bladder).
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