Los Angeles Daily News - June 5, 1994
KEITH STONE, Staff Writer

Roche stopped researching the drug called a TAT gene inhibitor despite published studies showing that it might work when combined with other chemicals.

"We have to be very selective, and we have to make sure we spend our money on drugs that have a lot going for them," said Dr. Juergen Drews, president of international research and development for Roche.

The Bay area men and other AIDS activists contend that Roche abandoned the drug for business reasons forcing them to make it clandestinely.

"To abandon things because it is not profitable is a crime," said Dave Blanco, a San Luis Obispo resident who packages the bootleg TAT drug for the amateur chemists and has been selling it to 23 people.

"We are doing the right thing," Blanco said. "We are doing what we can do."

As the AIDS epidemic moves into its 13th year with no cure or effective drug, these amateur chemists have joined a national underground that is working outside the law and in the shadows of pharmaceutical companies.

Driven by mistrust and frustration, these self-taught chemists are copying drugs not yet on the market, experimenting with treatments approved for illnesses other than AIDS, and even testing herbs, vitamins and other compounds.

"AIDS research in the mainstream is just too slow-and everyone is afraid of their own shadow," said one of the Bay Area chemists, a Lancaster native who asked not to be identified for fear that Roche and the FDA would investigate the lab.

Contributing to suspicions and uncertainty is what scientists concede has been a fundamental flaw in the search for AIDS drugs: because so little is known about the fatal virus, treatments could be passed over when they deserve mole attention.

"One of the problems of AIDS drug development is developing tests to determine if a product is actually showing a benefit," said Donald Pohl, public health specialist in the Food and Drug Administration's Office of AIDS and Special Health Issues.

"When there is great uncertainty and a lack of acceptable therapeutic options, there are always going to be people trying to reach for straws," he said.

Law-enforcement agents say they have come across at least nine laboratories that claim to be making AIDS remedies.

Under California and federal food and drug laws, the manufacture of unapproved and unlicensed AIDS drugs is illegal. In some cases, it could be a felony punishable by imprisonment.

There is also the question of whether the Bay Area men are violating Roche's patent.

Roche has no plans to stop them, Drews said. "We are not happy about it, but there is very little we can do," he said.

Until last week, the chemists had thought their clandestine lab was safe from discovery. Housed in a former factory, there is no way to know from the outside that it contained a laboratory.

That all changed with a knock on their door: Police, firefighters and a health inspector told the chemists they were acting on an anonymous complaint that the lab might be hazardous.

The chemists agreed to allow then in, and the group began to take photographs and an inventory of the chemicals.

The lab is painstakingly clean and ordered, with bottles neatly shelved and acids and flammable materials stored in specially built metal vaults.

Three hours later, they left without saying what steps they would take next, if any.

Now the two chemists wonder whether the FDA and Roche will be next, although they said they are not worried.

"We still think we are doing the right thing," one man said. "To prosecute someone for making AIDS treatments that no one else will make is not going to fly politically."

For the chemists, it was not a matter of their own health; neither is infected with the AIDS virus. But the disease had begun to attack a friend identified only as Ken, "a companion whom we loved very much -- and who needed something."

"We didn't think there was a lot of hope with What was available ... in the mainstream medicine, so we thought we ought to try to accelerate the process for him and find something that was cutting edge technology," one of the amateur Chemists said.

In 1991, the 50-year-old men put aside their computer consulting business and plunged into organic chemistry. Before their first batch was ready, Ken died in 1992 at 35.

The chemists decided not to close the lab, however. "We thought we should continue working on something for other people," one of them said.

They said they decided to concentrate on the TAT drug because at the time AIDS activists and researchers alike held it up as having great promise.

The theory is that the drug disables a protein called TAT or transactivator of transcription and thereby stops the virus from replicating. In test tube studies, the drug prevented the virus from infecting cells.

"It certainly is not the silver bullet; it is not going to cure AIDS. But it could be the best treatment on the horizon right now,'' one of the chemists said.

TAT also was the drug of choice because they felt it was within their ability to make. But with no recipe, they were left to pore over Roche's patent.

Although one holds a doctoral degree in biological sciences and the other a master's degree in mathematics, neither has had extensive training in chemistry. Much of what they know comes from "Organic Laboratory Techniques" and other texts in their laboratory library.

They weren't sure they had the right molecular structure for the TAT drug until it was flashed briefly on a screen during the Amsterdam AIDS conference in 1992.

"And right now the methods we are using aren't even in the patents," he said.

Of chief concern to Roche, the FDA, and some activists is the quality of the Bay area drug and whether people are risking their lives by taking it.

"We need treatments that we understand what they are doing," said Derek Linker treatment advocate for the Gay Men's Health Crisis in New York. "We don't need some bootleg pill sold by someone out of a suitcase that we don't know what it is."

Twenty-three people are taking the Bay area drug.

One of themes Jeff Terry, 28, has been on the treatment for the past year. The New York man pays $67.50 for a 10-day supply.

"There aren't a tremendous amount of options a person has. I was willing to take the risk,' he said. The former medical technician believes the drug is responsible for delaying the rot of AIDS. Terry's doctor declined to comment.

"I cross my fingers and hope that it is doing something," Terry said. "That is really the best you can do. I've seen positive results in my blood work."

Blanco and the chemists mailed a sample to Dana-Farber Cancer Institute to use in experiments and to validate the quality of their drug. The researchers said their received the drug, but have not tested or used it.

The two chemists said they perform their own purity tests and quality control, producing about 30 grams a month.

The cost of each bottle of 90, 25 mg capsules breaks down to about $45 for laboratory time and raw materials, $5 to encapsulate and bottle the drug, and a small amount for mailing, Blanco said

Some profit remains, but Blanco and the chemists insist that no one is getting rich off TAT.

The chemists said they have invested $60,000 in the lab. "At the moment we're losing money, but I hope we will be able to support the lab and ourselves," one of them said.

Copyright (c) 1994. Los Angeles Daily News. Reproduced with Permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, Los Angeles Daily News, Los Angeles, CA (818) 713-3000.
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