The Fight Against Aids -- Buyers' Clubs Sell Unproven Drugs, Draw Fda Inquiry

David Barr has been infected with HIV for at least three years. He is healthy and has no symptoms of AIDS - and he intends to keep it that way as long as possible.

To hold the fatal disease at bay, Barr, 36, takes four drugs to fight human immunodeficiency virus and prevent secondary infections. Three of those drugs he can get by prescription at his corner drug store. One he can't.

The fourth drug, a promising HIV-fighting drug called DDC, Barr buys underground at the PWA Health Group in New York City, one of more than a dozen buyers' clubs that serve an estimated 10,000 clients throughout the country.

In the coming weeks, those buyers' clubs will be visited for the first time by officials from the Food and Drug Administration who will check procedures, inventory and distribution to see whether laws are being broken.

DDC is a big reason for the FDA's sudden interest. DDC is a chemical, first synthesized in the 1960s, that can be easily obtained for laboratory research.

But DDC also is being developed as a patented, anti-HIV pharmaceutical by Hoffman-La Roche Inc., based in Nutley, N.J., and that's where the regulatory arm of the FDA comes in.

"We have been aware of buyers' clubs for a number of years," FDA spokesman Brad Stone said. "They distributed things like vitamins, minerals and nutritional supplements at little or no cost.

"But in the last few months, we have heard reports of them dealing in other types of products, clearly drugs. They seem to be getting into large-scale importation, and possibly commercialization," Stone said. "We need to evaluate whether these things are occurring and whether they are in violation of the law."

DRUG COMPANIES ANGRY

People facing life-threatening illnesses have long sought unapproved cures. What is new about the HIV buyers' clubs is that they have begun to go head-to-head with pharmaceutical companies, marketing experimental drugs such as DDC while the drugs are still in clinical trials.

The recorded message at one buyers' club in San Francisco states: "You have reached the Healing Alternatives Foundation. DDC is now in stock. I repeat, we do have DDC in stock. The price is $49.07 plus tax for 400 tablets of .25 milligrams. All DDC is tested for content and purity. For information on how to order by mail, continue listening."

"We have never seen anything quite like this before," Stone said. "We don't want to deny desperately ill patients access to things they feel might help them. But we have to protect the public."

The health of the people taking underground drugs is certainly one concern, but there are others.

An independent supply of experimental drugs could interfere with research into their safety and efficacy. It could also make drug companies leery of spending money if they fear they will not be able to recoup their investment through the exclusive right to sell the drugs.

Hoffman-La Roche, for example, has spent five years and several million dollars to develop DDC. It is unlikely that the price of the drug, once approved, will be close to the roughly $1 a day charged by buyers' clubs.

Dr. Paul Oestreicher, assistant director of public policy for Hoffman-La Roche, said DDC trials were far enough along before the bootleg DDC that its presence has not interfered with the validity of the data. But the development of future drugs could be made more difficult, he said.

In Chicago, Dr. John Pottage, infectious disease specialist at Rush Presbyterian-St. Luke's Medical Center, said about 10 percent of the HIV-infected patients he sees obtain some of their drugs through buyers' clubs.

"They have the drugs that they are given in clinical trials analyzed, and if they are on a placebo or want to be on another drug, they get it through a buyers' club," Pottage said. "It becomes a problem if they don't tell you, because then the results of the study are invalid."

HOW A CLUB WORKS

Derek Hodel, director of the PWA Health Group in New York, said his 4 1/2-year-old organization hopes the coming round of visits - which FDA's Stone calls "exploratory inspections" - will not interfere with its work.

"We are hopeful that the FDA will continue to allow buyers' clubs to operate as they have," Hodel said. "We have always been very frank and open about what we are doing. Many of our activities would not be in violation of the law, and it is unclear whether our DDC sales are in violation."

About 90 percent of the club's business involves importing drugs that have been approved in Europe but not in the U.S., Hodel said, a practice that is legal under FDA rules that permit people with a life-threatening disease to import drugs for their own use.

But the club also sells DDC, a decision that Hodel said represented "a step beyond where we had gone before, and not one that we would like to have to take again. . . . We would prefer people obtain drugs from the manufacturer."

PWA Health Group requires people buying DDC to have the written consent of their doctor, Hodel said.

Lenny Kaplan, head of the Fight for Life buyers' Club in Fort Lauderdale agrees. "Everybody in this business would be glad to step out of it, to put it in the hands of doctors. But those doctors have to have greater access to the drugs people with AIDS need."

DDC is not yet widely available from Hoffman-La Roche. Although about 9,000 patients have received it through clinical trials and expanded access programs, thousands more who would like to take it cannot meet the strict eligibility requirements.

Barr, for example, is infected with HIV but does not yet have AIDS, so he is not eligible for clinical trials. And since he and his doctor have chosen to combine DDC with the drug AZT, he cannot obtain DDC through the expanded access program.

Early studies show that when DDC and AZT are taken together they are more powerful at lower doses. That means fewer side effects for patients and, researchers hope, a reduced likelihood that HIV will develop a resistance to either anti-viral drug.

HIV causes acquired immune deficiency syndrome by destroying the body's immune system, leaving the person vulnerable to severe infections. AIDS is transmitted through sexual intercourse, through shared hypodermic needles, from mother to child before or during birth and, very rarely, through blood transfusions.

Hodel said that as soon as DDC is available above ground, he will stop selling it. He blames the slowness of the FDA in approving drugs for the underground's existence.

"Nobody wants to buy this stuff on the underground," Hodel said. "People come here because they have to. If the system were addressing people's real-world treatment needs, the underground would not exist." --------------------------------------------------------------- DDC demand -----------

A common use of the drug DDC is in combination with the drug AZT. The combination was widely discussed at the Seventh International AIDS Conference in Florence, Italy, last June.

Almost immediately, DDC appeared underground. Patients, usually with their doctors' approval, began to mix and match the two powerful anti-virals, taking buyers' club DDC along with their prescription AZT.

Hoffman-La Roche, meanwhile, was still testing DDC and filed for FDA approval in October.

Approval could come within six months.

Chicago Tribune --------------------------------------------------------------- Where buyers' clubs are ----------------------- Operating out of small offices, storefronts and lofts, buyers clubs sell to more than 10,000 clients in all 60 states.

San Francisco . Los Angeles . San Diego . Tucson . Boulder . Denver . Dallas . Atlanta . Washington D.C. New York . Atlanta . Fort Lauderdale .

Source: Chicago Tribune --------------------------------------------------------------- Fred Birchman / Seattle Times