Sunday, April 12, 2009

Botox: Pharma's Answer to Duct Tape

“We see it as a molecule that keeps on giving. As we understand it more, it gives us new ideas of how to use it,” says Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker (see NYT: "So Botox Isn’t Just Skin Deep").

"In the hunt to discover the next blockbuster medical use for Botox, doctors have injected it experimentally into muscles and glands all over the body, making it medicine’s answer to duct tape," says the New York Times. "According to recent medical journals, physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs."

Of course, these are all off-label uses of Botox, meaning that the FDA has not approved the marketing of Botox for these purposes.

But now, with the poor economy, and sales of Botox for approved cosmetic uses down, off-label uses of Botox "are poised to outstrip the cosmetic treatment in both revenue and prominence."

No wonder that Allergan has not signed on to PhRMA's DTC advertising guidelines and continues to run "reminder ads" (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway").

BTW, it isn't likely that Allergan will EVER want to get official FDA approval for ANY of the above-mentioned uses of Botox. Can you imagine what the reminder DTC ads might look like for "drooling" and "anal fissures?" Wait..hair loss. That one MAY be possible!

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