L.A. Village View, April 15-21, 1994, pg 6.
David Bacon

In 1984, a doctor in private practice on the San Francisco peninsula, L. Bruce Mills, began to work with patients suffering from Kaposi's Sarcoma, instructing them to apply an easily available chemical, dinitrochlorobenzene (DNCB), to their skin. KS is an opportunistic infection associated with AIDS; at that time, the disease was only just being named. Mills knew that previous studies had documented DNCB's effect on patients with warts, making them disappear. In using DNCB on KS lesions, he saw that they also seemed to diminish in number and severity after the chemical was swabbed onto patients' skins even on parts of their bodies far from any outbreak.

"We were stunned," says Blaine Elswood, who worked with Mills at the time. According to Elswood, Mills, who had no malpractice insurance to cover any kind of experimental treatment, "was terrified because this was all going on in his office." But with no cure for AIDS, Mills continued instructing patients in DNCB application. Elswood recalls Mills as "a desperate and compassionate doctor. He had been diagnosing and referring patients to the KS clinic at the University of California San Francisco Medical Center. And they would be dead within weeks."

Eventually, in 1986, Mills wrote a brief account of his experience with DNCB for the Journal of the American Academy of Dermatology. He noted that the T-cell counts of his patients improved (the level of T-cells, key components of the immune system, is an important gauge of the progression of AIDS). Even more important, he saw that unrelated lesions also started to fade, which could be attributed to a general increase in cell-mediated immunity.

One of Mills' patients was Jim Henry, who read about the treatment in an article published by a San Francisco gay newspaper. The HIV-positive Henry got a supply of DNCB from another person using it in San Diego and started to use it himself. "Jimmy began," Elswood says, "and the genie was out of the bottle." Henry organized "guerrilla clinics," in which he and several others dissolved DNCB crystals in acetone and distributed bottles of it, teaching people in San Francisco's gay community how to apply it to their skin.

For a brief moment in 1986, the guerrilla clinics grabbed the attention of the national media. But the coverage was patronizing and did as much to discourage people from trying DNCB as it did to popularize its use. "The media presented us as just a bunch of desperate people painting ourselves because no real cure for AIDS was available," Henry remembers.

Soon afterwards, the Burroughs-Wellcome drug company was licensed to manufacture and distribute AZT. AZT was actually developed by the National Cancer Institute as an anti-cancer drug, but it was never released because it was considered too toxic. In a massive wave of publicity, the drug was heralded as the cure for AIDS. Even Henry stopped using the DNCB-soaked swabs. Six months after being diagnosed with AIDS itself, he began taking AZT. "I used AZT for nineteen months," Henry says, "and then ddI [a similar drug] for fourteen months more. Finally, my doctors told me I was dying, and that there wasn't anything else they could do for me."

Henry went back to DNCB. His body was still sensitized, and the swabs provoked the same skin reaction they had before. His CD8 cell count increased the first year, and then his CD4 count (CD8 and CD4 cells are T-cells whose counts are a gauge of the immune system's health). He gained weight and his health improved. Today, Henry's doctors can no longer detect AIDS symptoms. The insurance carrier for his extended-disability insurance has told him that they are going to discontinue payments, since he is now well enough to return to work.

Patients suffering from AIDS don't actually die from the HIV virus itself, and the connection between the HIV virus and AIDS is still not clearly understood. Under normal conditions, the body is infected by a large number of viruses, which the body controls through the cell-mediated immune-defense system. In patients with AIDS, something affects the ability of the immune system to control those infections. AIDS suppresses the immune system, and patients die of the opportunistic infections they get as a result.

Drugs such as AZT are intended to be virus killers. By contrast, DNCB is a contact-sensitizing agent. It causes a localized allergic reaction, in much the same way poisonoak does, stimulating the body's own cell-mediated immune system, which then attacks the opportunistic infections brought on by AIDS.

While Henry's case is dramatic, one case alone clearly doesn't prove the efficacy of any AIDS treatment. No clinical trials--controlled, doubleblind tests which precede FDA drug approval have been conducted on DNCB. But studies of DNCB patients have been carried out by Dr. Raphael Stricker, in conjunction with other doctors, and the results have been chronicled in two articles in Immunology Letters.

The first study, published in 1991 by Stricker, Elswood, and Donald Abrams (head of the AIDS clinic at San Francisco General Hospital), stated that DNCB "is a powerful modulator of Langerhans cell numbers and function." These cells, a key component of the immune system, are depleted and their function is impaired in AIDS-related conditions. "Zidovudine (AZT) does not restore epidermal Langerhans cell numbers in AIDS conditions," the report said. It concluded that "DNCB applications resulted in normalization of other laboratory abnormalities associated with AIDS, including anemia, thrombocytopenia and hypergammaglobulinemia."

The second study, published in 1993 by Stricker, Elswood, and a group of researchers from California Pacific Medical Center and the University of California School of Medicine in San Francisco, actually measured changes in T-cell counts and viral loads in a selected group of patients. The levels of CD4, CD-8, and natural killer cells were measured in 20 HIV-positive patients before and after beginning a course of treatment with DNCB. The level of CD-4 cells remained the same, while the number of CD-8 and natural killer cells increased significantly.

Using a sophisticated new measure for the amount of HIV virus present in the body, the RT-PCR test, the study found that the viral load declined after using DNCB. "DNCB application had a significant effect on viral replication," it concluded. Half the patients in the study were already using AZT. They experienced less improvement than patients who weren't using AZT.

Stricker and Elswood also followed a number of long-term DNCB users over a period of four years. They reported that the "subjects remained clinically stable for up to 27 months during DNCB use." As Stricker explains, "We originally started with 24 people. Thirteen continued using DNCB, of whom two developed KS, which is in remission. Eleven stopped because they thought they didn't need DNCB anymore. Four contracted AIDS, and three are dead."

Despite these findings, DNCB is not being embraced by the medical establishment. Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, which oversees AIDS research nationally, says that "right now we don't have any controlled, firm data that it [DNCB] is effective. That doesn't mean that it's not. There are claims that people are getting a substantial boost in immunity. It's difficult to interpret that if there are no controlled studies."

Why, then, are there no controlled studies? Why haven't there been any clinical trials of a drug that, based on anecdotal evidence, shows such promise? (Only one clinical trial of DNCB is presently being conducted in this country, by Dr. Mark Loveless at the Oregon Health Sciences University; the year long trial is just beginning and involves 60 people.)

For one, Stricker believes that the problem of combined medications may make it almost impossible to conduct clean clinical trials in this country. AIDS patients now take a large variety of medications, which complicates the problem of narrowing the-focus in clinical trials. Stricker is providing assistance to clinical trials of DNCB involving 200 patients which began at the Karolinska Institute in Sweden in January. He believes that the Swedish medical system offers a better chance of controlling the other medications taken by patients. "When I spoke to the Swedish doctors," he says, "I told them that a great advantage of DNCB is that it is so cheap compared to drugs like AZT. They just gave me a blank stare. They said that in Sweden's nationalized health-care system, the cost of drugs was not important, since there are no companies which make them for profit."

More than anything else, it is the profit motive that is responsible for the lack of clinical trials of DNCB in the U.S. A bottle of DNCB, which provides 30,000 topical applications, costs $70. A month' s supply of AZT is sold by Burroughs-Wellcome for $150.

DNCB has been on the market for many years. It is unpatentable. Pharmaceutical companies have no interest in developing drugs if they cannot patent them, and use their monopoly in order to set prices which will make a profit. The whole system for the development and distribution of drugs is dependent on profits. It costs over $200 million to set up the pilot studies, clinical trials, and other tests which result in FDA approval. If there is no chance of making back that investment and a profit on top of it, then drug companies have no motivation to test a possible drug. "Where there's no profit motive, there's no drug," Stricker notes bitterly.

The FDA does have a program called "the orphan-drug program," which is supposed to fund the investigation of drugs which pharmaceutical companies might find unprofitable to pursue. In 1988, Elswood wrote a protocol for clinical trials of DNCB, together with Dr. Abrams, and even got an IND (investigative new drug) number from the FDA. They asked the orphan-drug program for $100,000. The FDA told them that they could only apply for money for clinical trials after a pilot study had been done, and that the program didn't fund pilot studies.

Elswood concludes that "the program isn't supposed to find new drugs. It's supposed to subsidize the unprofitable drugs of big pharmaceutical companies."

Fauci says that the National Institutes of Health is waiting for someone to present it with a proposal. "As independent scientists, we don't say what will be studied. People put in a protocol, which is put in front of a peer review. To my knowledge, no one has made such a proposal," states Fauci, who is conducting biopsies of lymph nodes taken from patients of both Stricker's and Loveless' studies. (Fauci and other researchers believe that the HIV virus attacks the lymphatic system long before it reaches the bloodstream, destroying the lymph nodes, which play an active role in the body's immune defenses.) NIH investigations, he says, are "based on priorities. There's little convincing data [about DNCB], which makes people reluctant to move ahead."

To this Stricker responds, "That's not a very logical conclusion, that unless someone pushes us there's no reason to do anything. That's why we've gotten where we are, where what we have is AZT." In the wake of a number of recent studies on AZT, particularly the Concorde study published in Lancet magazine, doubts are mounting about the effectiveness of the drug. The Concorde study, notes Elswood, showed that people who take AZT soon after testing positive for HIV the recommended procedure may even die more quickly than those who take AZT later on. Stricker calls AZT "a horrible drug" which he believes suppresses the immune system.

After AZT was originally developed by the federal government, Burroughs-Wellcome and other companies bid for a license to manufacture and sell it. The government takes a royalty from the sale of each prescription. The drug has been immensely profitable. Since AZT was licensed in 1986, sales of the drug in the U.S. by Burroughs-Wellcome, the U.S. subsidiary of Wellcome PLC, total $1.013 billion. Worldwide AZT sales (including the U.S.) total S1.776 billion and make up about twelve percent of the company's total sales income from all products. Other companies have made additional millions from the manufacture and sale of other AIDS medications that, like AZT, belong to the nucleosides drug family.

Funding from Burroughs-Wellcome has become important to AIDS agencies. Many AIDS activists, especially in the San Francisco chapter of ACT UP, charge that this funding influences the kind of information distributed in the community about alternative remedies for AIDS. Elswood, for instance, claims that Project Inform, an organization established to disseminate information about AIDS treatment, "won't publicize a therapy where a company doesn't pay." He and others point to a recent $170,000 grant given by Burroughs-Wellcome to Project Inform for computer equipment, and wonder whether this money has impacted the group's attitude about alternatives to AZT such as DNCB.

Sticker's study, which has now run out of money, was originally funded by a grant from the Elizabeth Reed Taylor Foundation. The grant was obtained by Joe Brewer, a co-founder of Project Inform. Although Project Inform support is acknowledged in the study, Brewer was later demoted, according to Stricker.

ACT UP activists have organized forums around the county to publicize DNCB treatment themselves. Hundreds of people have attended the DNCB forums, seeking an alternative. DNCB treatment has also been publicized by the recent printing of the Anarchist AIDS Medical Formulary by Charles Caulfield and Billi Goldberg, a guide to alternative AIDS treatments.

While ACT UP insists that the perspective of AIDS organizations on DNCB has been swayed by their relationships with drug companies, others disagree. John Brisbane, who directs the Treatment Alternatives Program for the Brothers Network, a local project of the National Task Force on AIDS Prevention, calls the idea of Burroughs-Wellcome influence on organizations such as Project Inform "absolutely ludicrous." Brisbane participated in the first DNCB forums but then withdrew. He also stopped using DNCB after three months, saying he found the inflammation it caused extremely painful and that he didn't notice any positive reaction. Nevertheless, he's advised many clients about DNCB. "Any kind of treatment empowers people, especially when they do it for themselves," he says.

For Blaine Elswood, the experience of trying to win acceptance of DNCB led to a crisis of belief, and his description of that crisis finds echoes among other AIDS activists. "It isn't just AIDS," he says, "it's the whole goddamn medical system. I thought the battle was just to get this drug recognized. I was a pretty conservative guy, and my premise was that we had the best medical system in the world, in a free county. AIDS threw me for a loop. DNCB is like a poison pill for thee whole system. My own personal belief system in this country has come unraveled."

Stricker sees the root of the problem in the orientation of the medical establishment. "The medical community is married to a theory of how to kill the virus. At our present level of technology, we can't do that. They've ignored the idea of keeping the virus in check. It's been an extremely costly blind alley."

Copyright (c) 1994 - L. A. Village View. Reproduced with Permission. Reproduction of this article must be cleared through the Editor, L. A. Village View - (310) 477-0403.
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