“Hideous!” is how New York City HIVer Tom Weise describes the November decision by the FDA to block imports of an injectable gel used to reverse HAART-induced facial wasting. After three cosmetic-surgery treatments with the simple sugar polylactic acid (PLA), Weise says, "my sunken temples, eyes and cheeks were gone."
Weise is one of 267 HIVers who have received PLA treatments (under the brand name New-Fill) since June through the HIV buyers club DAAIR, which imported the product from Mexico. An FDA policy adopted in 1989 under activist pressure allows noncommercial importation of unapproved treatments for life-threatening diseases. But, according to the FDA's Richard Klein, the agency questions whether an injectable qualifies. "The policy was predicated on the idea that it would be a tablet" -- not a surgical procedure requiring specialized training. The FDA, he says, is concerned about the lack of long-term data and possible harmful side effects.
But Fred Bingham, DAAIR's director and a PWA, notes that three recent European studies of PLA found dramatic facial restoration and no serious problems in several hundred HIVers. "Every doctor I've talked to has said it's 100 percent safe," Bingham says. "A lot of people who need this treatment can't wait the two or three years it may take before it gets FDA approval."
According to Weise's doc, Gervais Frechette, MD, PLA works by stimulating the growth of collagen, a skin-building protein. "Most patients need between four and six sessions," says Frechette, who has already administered PLA to more than 100 HIVers. (Most U.S. doctors charge $500 per session, not counting the $250 for the New-Fill vials themselves.) The end result, he says, is a much more natural look than is provided by such other methods as cheek implants or silicon injections.
DAAIR will soon launch a 500-person clinical trial. Meanwhile, Bingham says, it will fight the FDA's red light. "Stopping the treatment of people who've already started is particularly onerous. We're assembling an activist coalition to demand that they be allowed to finish." After that, Bingham is gunning for a permanent policy allowing importation.
Still, Weise revels in having the new face of AIDS. "I was stunned -- PLA has taken away five years of aging from HIV," he says. "It's a pity that the FDA has stepped in without knowing that it helps so many people."
For more info on New-Fill, contact DAAIR at 888.951.LIFE.