Washington Blade - October 25, 2002
Rhonda Smith

"It's not as though I'm hiding my HIV status from anybody. I'm open and out about it to my bosses," said Steve, a 49-year-old psychologist in Washington, D.C., who spoke with the Blade on the condition that his last name not be used. "But this was stigmatizing."

Steve, who was diagnosed with HIV in 1984, said the loss of fat in his face as a result of using the AIDS drug cocktail known as highly active anti-retroviral therapy (HAART) made his cheeks hollow and probably signaled to others that he had the chronic illness.

"It's not like it was normal aging or something," he said of his facial appearance. "I'm not into plastic surgery or anything, but I just didn't want to look bad before my time."

Some gay men with HIV/AIDS who have been taking the HAART regimen have turned to New-Fill in recent years to counteract facial wasting caused by lipodystrophy. This condition involves losing fat on the arms, legs and face and gaining it around the stomach and above the shoulders as a result of taking the AIDS-related medications. Some HIV-positive women on the therapy gain weight in their breasts.

Very limited supply available

New-Fill, which is currently available from only a very limited number of medical providers - one doctor in Florida and another California, and in limited quantities from the New York City-based Direct Access Alternative Information Resources - has not yet been approved by federal regulators for widespread use in the United States.

DAAIR is a non-profit, members-only buyers club created in 1991 to help people with HIV/AIDS and other chronic illnesses by providing them with information and, sometimes, experimental pharmaceutical drugs unavailable in this country.

The two doctors - Douglas Mest in Hermosa Beach, Calif., and Peter Engelhard in Miami Beach, Fla. - obtained "investigational device exemptions" from the Food & Drug Administration to offer New-Fill to patients.

"I did it because I thought it was important," said Engelhard, a doctor of osteopathic medicine who was specially trained in cosmetic dermatology. "I have a niche population of patients with HIV. Lots show up looking for options to treat lipodystrophy."

Fred Bingham, founder and executive director of DAAIR, declined to comment about whether his organization still makes New-Fill available, though it is advertised on the organization's Web site.

"New-Fill simply stimulates the formation of collagen, a natural body substance," he said. "Because it's a natural process within the body, it's completely safe and non-allergenic and non-reactive, meaning the immune system does not form a response to it as it does with other artificial fillers used in cosmetic surgery. It should have been available yesterday."

New-Fill is a synthetic polymer called polyactic acid. Europeans began injecting it 20 years ago in part to erase pockmarks, wrinkles and other telltale signs of aging.

When New-Fill is injected into a patient's face, it triggers the body's own production of collagen. Proponents of this procedure, such as Bingham, say the development of new collagen in the patient looks natural and creates what appears to be a new layer of skin. They also said the cosmetic results last longer and are superior to cheek implants or injections of filler substances such as silicone or collagen.

New-Fill also does not have side effects like those some patients experienced with silicone - red, inflamed irritated areas that caused lumpiness and an abnormal appearance.

"I have seen some patients who have had [New-Fill injected]," said Dr. Michael Olding, chief of plastic surgery and director of cosmetic surgery and the laser center at George Washington University Medical Center in the District of Columbia. "It certainly makes a dramatic improvement."

"Unfortunately," he said, "we don't know the long-term outcome of using it because it's not approved by the Food & Drug Administration yet."

While Olding does not inject New-Fill, a number of other medical providers can perform the service through their arrangements other than the FDA exemption. Among those providers to have performed the procedure is Dr. Cheryl Burgess of the Center for Dermatology in the District of Columbia.

Olding said he refers people to Burgess because patients have told him they used to be able to purchase New-Fill in France and Mexico and bring it to U.S. doctors and ask them to inject it.

Burgess said that at the behest of the FDA she traveled to Mexico a little more than a year ago for training about New-Fill and was certified by Dr. Jorge Tagle at the Baja Facial Implants Clinic in Tijuana. Tagle has conducted the Mexican trials of New-Fill and is considered an authority on the procedure.

"When I got trained, there were six or seven physicians certified to do New-Fill injections in the United States," Burgess said. "But immediately after I got certified last October, the FDA banned the personal use of this product because it had not been approved for use as a medical device."

Now, Burgess said she only performs New-Fill injections on patients who were undergoing the treatment before the FDA banned it.

An expensive treatment

DAAIR sells New-Filler treatment kits with two vials of the drug for $250. Each single treatment involves multiple injections of New-Fill into the cheeks and temples.

Burgess in D.C. charges $250 per vial to inject New-Fill. She said a person might need three or four vials of the product during the first of three sessions they must undergo for the full treatment. There is a three-week period between each session. The second session might require two or three vials of New-Fill, she said, and the final session might involve one or two vials.

Patients usually pay out-of-pocket for the New-Fill kits and for physicians to inject it because insurance companies and health maintenance organizations generally do not cover cosmetic procedures.

Richard Klein, HIV/AIDS program director in the Office of Special Health Issues at the FDA, said New-Fill was originally imported by DAAIR under the FDA's "personal importation policy." This allows people with serious and life-threatening illnesses to access products approved outside the U.S. but not in this country as long as they use them under the care of a licensed physician.

"But under the Food, Drug & Cosmetic Act, New-Fill is defined as a medical device and not as a drug," Klein said, noting that it could not be used in the U.S. like other drugs could under the personal importation policy.

"New-Fill is considered a physical apparatus implanted or placed inside the body to affect a function or structure," he said. "It's not metabolized to do its work like a drug is."

Bingham, from DAAIR, said defining New-Fill as a device instead of as a drug was "overreactive" and made it more difficult for people in the U.S. to access it.

Klein said there is no scientific data outlining what happens when patients use New-Fill.

"It's approved in Europe for filling in wrinkles, laugh lines, and pockmarks," he said. "But here it's being proposed for pretty extensive facial reconstruction."

Klein noted that after 20 years of usage, people in the U.S. still do not know whether the use of silicone implants increases autoimmune illnesses in patients.

"So there's definitely something to worry about when you're using a product that's never been tested for this use in soft tissue," he said, "in terms of if it's going to have some kind of long-term adverse event."

New-Fill is manufactured by Biotech Industry S.A., a company with offices in France and Belgium. Klein said he suggested to Biotech officials in Luxembourg that they conduct a clinical trial of New-Fill to see if it was safe to use in part because they have a large market of potential customers in the U.S. ready to use it. Biotech officials wanted to know how to file for an investigational device exemption with the FDA, he said, but they did not follow up with Klein after that conversation about six months ago.

The FDA also has suggested that doctors in the U.S. file individual investigational device exemptions, like Mest and Engelhard did, so they could conduct their own clinical trials involving New-Fill. But this can be an expensive and time-consuming process.

More recently, a U.S. company has purchased the right to market New-Fill. The company, which Klein declined to identify, has expressed an interest in conducting a clinical trial involving New-Fill but has not filed an application with the FDA to do so.

"We're perfectly happy to work with a company on trials so we can eventually get the product on the market," Klein said. "The way it is now, only a select group of people have access to New-Fill. And that's a very select group of people who can afford to get it."

Rhonda Smith can be reached at rsmith@washblade.com.

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