New York — Jean Carruthers, M.D., thinks it might be appropriate for her and her dermatologist husband, Alastair, to change their middle names to "determination."
And the Carruthers now have a 15-year retrospective study to prove the drug's safety — an aspect often cited as a patient concern. The study coincides with Botox's 15th anniversary. The Carruthers couldn't be happier that a drug they have believed in for many years and that has been in existence as a compound since 1979 now has the safety data to back its cosmetic use.The Carruthers are credited with being the pioneers of the cosmetic application of botulinum toxin type A, which was initially cleared by the U.S. Food and Drug Administration (FDA) in 1989 for treatment of blepharospasm and strabismus, and approved in 2000 for treatment of abnormal head position and neck pain associated with cervical dystonia. In 2002, Botox was approved under the name of Botox Cosmetic for treatment of glabellar lines between the brows. Its latest approval, granted in July, was for hyperhidrosis.
The study The study, Long-Term Safety Review of Subjects Treated with Botulinum Toxin Type A for Cosmetic Use, was presented at the recently concluded American Academy of Dermatology Academy '04 meeting in New York.
The study shows Botox is safe and well-tolerated for facial cosmetic procedures when used in multiple treatment sessions over an extended period of time, and when administered by a qualified and trained healthcare professional.
According to Alastair, looking back, the current study's positive results have been long-awaited.
"Getting accepted has been frustrating for so long," he tells Cosmetic Surgery Times. "We could see the potential, we knew it was a winner, but no one was listening to us."
"They were frightened," Jean continues. "There was an article published in 1969 that called botulinum type A 'the most poisonous poison.' That stuck in the consciousness of a lot of people. It had to overcome that reputation.
"Even though its use started in ophthalmology, it was dermatologists who had the open minds to accept it as a really interesting new treatment," Jean says. "It is a privilege to be able to present our retrospective study here (at Academy '04)."
Legacy The Carruthers describe the success of Botox as "absolutely amazing." A belief in themselves, the product and a healthy dose of tenacity fueled them.
"It was such a fringe idea in 1987; we never would've believed it would enjoy the success it's having today," Jean says. "It was quite difficult to get 30 participants to put our first study together. People would say, 'You want to inject what in my face?' We got used to disbelief. We got used to people saying, 'no thanks,' yet when you injected them and saw the results, it was so rewarding. We knew it was just a matter of keeping at it."
Still overcoming obstacles Even though Botox has overcome many of the obstacles that it first confronted, the education battle is still not over.