By Frank Green

Cleveland Free Times 5 May 1999

HIV patients find that the current drug treatments arenít necessarily the answer.

Like everyone else ó HIV patients and their families, medical researchers, doctors, educators, activists and the general public, all fed a steady dose of glowing reports in the media ó Michael Cooper and Steven Goldring believed that the drug cocktails introduced in 1996 had ushered in a new era of AIDS treatment. The cocktails were supposed to transform AIDS from a fatal disease to a treatable condition. From that point forward, any progress in survival rates was attributed to the drugs, even though the number of AIDS deaths had begun to decline three years before they were approved.

The new treatments werenít just called cocktails to make them sound palatable. Like mixed drinks, they combined several different drugs into one potent whammy of a weapon that was supposed to knock HIV off its feet. The combination usually included two nucleoside analogs like AZT, ddI and d4T ó none of which had proven to be effective on their own ó and one protease inhibitor, a new class of drug. This blitzkrieg strategy was called HAART (highly active antiretroviral therapy).

Not long before, clinics had begun using a new laboratory test to measure viral load, the amount of HIV in the body. When studies were conducted on HAART, it was this measurement, known as a surrogate marker, rather than the presence or absence of symptoms, that determined a patientís progress. The higher the viral load, the sicker the person was said to be, regardless of how he actually felt. (Another surrogate marker, T-cell counts, had been used to measure progress since early in the epidemic.) When drug cocktails were shown to increase T-cells and lower viral load, they were deemed a success.

The announcement of the results of the early studies of HAART brought euphoria to the AIDS community. HIV-positive people like Cooper and Goldring, who had resisted treatment in the past, or whose treatments had proven ineffective, flocked to the cocktails like fruit flies to wine.

"There was such hysteria," Cooper recalls. "There were these new tests and new treatments and everybody was living longer. There was an awful lot of hype. I mean, nothing good had happened for the last 15 years. AZT was a nightmare for most people."

Cooper has been HIV-positive for 17 years. He declined AZT treatment when it was offered early in the epidemic, because he had watched so many people die while taking it. Heís never progressed to an AIDS diagnosis, a fact he attributes to a positive attitude.

"Even in the early days," he says, "I didnít believe I was going to die. I took care of my body. I took vitamins, ate properly, worked out at the gym. Iím still very healthy. I never even get colds. I get ear infections once in a while, but it has nothing to do with HIV." Yet when the drug cocktails were said to eradicate HIV from the body, he decided to take them.

There are many side effects associated with the drugs used in HAART. Diarrhea, gas, nausea, heartburn and headaches are common. AZT and its relatives have been implicated in a high incidence of neuropathy (a nerve disorder that can result in numbness, tingling, abnormal reflexes and even paralysis), pancreatitis and anemia. People taking protease inhibitors have been rushed to the emergency room with painful "kidney sludge." Elevated levels of liver enzymes, cholesterol, blood sugar and triglycerides are showing up on lab tests, pointing to more serious problems down the road.

But one side effect overshadows the others because itís so unusual. People taking protease inhibitors are metamorphosing like silly putty as their bodies redistribute fat in strange ways. Theyíre losing weight in the legs, arms and face, while growing paunches in the abdomen, breasts and back ("buffalo hump"). In the May issue of POZ magazine, one patient undergoing treatment complains that she looks "like a marshmallow on toothpicks." A new term , lipodystrophy, was coined to describe this condition.

Cooper took the drugs for a while without experiencing side effects, but he was concerned that levels of cholesterol and triglycerides in his blood were rising. "After about nine months," he says, "I started to gain weight. But people said I looked thinner because my face was getting gaunt."

After talking to Christine Maggiore, a healthy, pharmaceutical-free HIV-positive mother and founder of the alternative AIDS education group Alive & Well, who informed him about the dangers of HAART, he decided to quit taking the drugs. "My doctor was annoyed at first," he says, "but ultimately, he supported my decision. I feel great these days, and I havenít looked back."

Steven Goldring, a local writer and performer, has been HIV-positive for 16 years. His monologue piece, And Now, for My Next Life, presented recently at Dobama Theatre, offered a hopeful perspective on AIDS. Instead of talking about death and medical dependency, he emphasized survival and self-determination. "Itís not like I want to second-guess the medical profession," he says, "but I have to go with what I know in my heart."

In the fall of 1996, Goldring came down with pneumocystis carinii pneumonia (PCP), one of the 40-odd diseases that result in an AIDS diagnosis when a personís HIV-positive. "I was scared," he says. "This was when the cocktails first started coming out, so I decided to try them." He also took drugs for pneumonia. After the PCP cleared up, he continued on the cocktail.

"All my numbers were great," he recalls. "My T-cells were up, and my viral load was down. But I felt horrible. Here I was, a vegetarian who never even took aspirin, and all of a sudden Iím on all these powerful drugs. I had to take pills three or four times a day, some with meals, some without. My whole life revolved around drugs.

"I felt awful. I was all bloated, and I kept breaking out into rashes. I had to keep getting up through the night to go to the bathroom, so I was always exhausted. I had horrible neuropathy in my feet, to the point where I could hardly walk.

"I felt my body falling apart ó not from HIV, but from the drugs. I was always very aware of my body, and I could feel that I was putting poison into it. I finally went to my doctors and told them I didnít want to take the drugs anymore, and they called me a fool. They were very dramatic and told me it was suicidal to stop." Instead of stopping treatment, his doctors gave him a different combination of drugs.

"The new combination was even worse. My speech was slurred. I kept losing my equilibrium, and I fell down the stairs in my house. That was the last straw. I just stopped taking them. My T-cells went down and my viral load went up, but I felt healthy again." Today, two years after quitting treatment, he feels better than ever.

Stories like these arenít unusual. More and more patients are refusing drug therapy, often against the advice of their doctors. Theyíre beginning to question the mainstream approach to AIDS because theyíve seen whatís happened to the other HIV-positive people they know. Many have died while taking AZT and other AIDS drugs, while many people who have avoided treatment remain healthy nearly 20 years after an HIV diagnosis.

Dr. Peter Duesberg, a leading virologist who has long been critical of the medical establishmentís approach to AIDS, points out that even mainstream researchers and advocates arenít happy with current treatment strategies. "Look at the latest ads for AMFAR," he says, referring to a national AIDS research fundraising organization. "They say what I endorse, that nothing has been achieved in AIDS research. Despite all the talk [about the benefits of treatment], we havenít cured a single patient."

Dr. David Rasnick, a visiting researcher at the University of California, Berkeley and founder of a Bay-area biotechnology firm, has been involved in protease research for nearly 25 years. In the early 1980s, he was looking for a practical application for his expertise in the biochemistry of protease and other enzymes.

He remembers one day vividly. "On April 23, 1984, [Dr. Robert] Gallo held a press conference and revealed to all the world that he had found the probable cause of AIDS. He dropped the word probable after a couple days, and AIDS became known as an infectious disease caused by a retrovirus."

Rasnick was involved at the time with a network of Bay area researchers known as the Peptide Group. The virologists in the group had shown that all viruses are encoded for at least one protease that was essential for the virusís maturation. Retroviruses like HIV had a particular variety called an aspartyl protease. "Within two weeks of Galloís announcement," Rasnick remembers, "I was designing aspartyl protease inhibitors."

He wasnít alone. Many chemists associated with pharmaceutical companies and biotechnology firms began working on the same thing. The rush was on to find a way to prevent proteases from developing, thereby crippling viruses. "It was a very exciting time for scientists," Rasnick recalls. "HIV was our Andromeda Strain."

But by 1985, he had begun to question whether HIV is really the cause of AIDS. "Nobody could quantify it," he says. "It was often undetectable in the body. At first, I thought theyíd found the wrong virus. Scientists ruled out a hundred viruses before they found the one that causes polio. Our bodies are full of viruses, though most of them donít do anything. But I soon gave up the notion that AIDS is contagious. It just doesnít follow the model of an infectious disease."

Though itís often represented to be an undeniable fact, the theory that AIDS is caused by HIV is actually unproven. The fact that many people with AIDS test positive for antibodies to HIV doesnít necessarily mean that HIV causes AIDS. In science, correlation does not equal causation.

From the beginning of the epidemic, the existence of healthy HIV-positive people has been a glaring hole in the theory. Mainstream AIDS scientists postulate a latency period during the which the virus remains inactive, theorizing that itís only a matter of time before it causes damage. The length of this period continues to grow as people remain healthy. At first, it was maintained that HIV-positive people get sick within five years. Now the latency period is said to be 20 years or more, because people have remained healthy that long.

Many AIDS researchers now suggest that there may be co-factors involved in an HIV-positive patientís progression to AIDS. Some maintain that thereís an additional virus involved, and that a person must be exposed to the other virus as well as HIV in order to progress to AIDS. Others contend that some people are genetically equipped to fight off HIV, while most do not have this protection. One thingís certain: the current focus on HIV as the sole cause of AIDS in research insures that theories like these will remain unproven for some time to come.

The situation is further complicated by the fact that there are people with AIDS conditions who test negative for HIV. As reported by Celia Farber in Spin magazine, researchers began reporting cases of HIV-negative AIDS as early as 1992. And this doesnít include cases of Chronic Fatigue Syndrome, an immune deficient condition with symptoms similar to AIDS, though itís not usually fatal.

Most researchers contend that these people do not have AIDS. But thatís because the definition of HIV/AIDS is circular. There are about 40 different diseases that result in an AIDS diagnosis when a person is HIV-positive. A person with the same disease who tests HIV-negative doesnít have AIDS, even though their symptoms are identical. In other words, AIDS is defined by the presence of HIV, and HIV is defined as the virus that causes AIDS. Thatís circular reasoning.

In 1993, the definition of AIDS was expanded by the Centers for Disease Control to include HIV-positive people who have no illness or symptoms at all, but whose T-cell counts fall below a certain level. This change caused the number of AIDS cases to double overnight, which was useful to organizations that rely on numbers of cases to raise funds.

Dr. Leonard Calabrese, head of clinical immunology at the Cleveland Clinic, believes that most people who test HIV-positive will eventually develop AIDS without treatment. "But itís not black and white," he says. "Like most infections, HIV does not have the same clinical course in everyone. Some people do better than others. We think it must have something to do with their individual immune systems. But people who have stayed healthy for 15 years without treatment are a small percentage of the people who are infected."

Dr. Michael Lederman, professor of medicine at Case Western Reserve University and principal investigator of the AIDS clinical research unit at University Hospital, is more blunt. "Thereís no doubt," he says, "that AIDS is caused by exposure to the human immunodeficiency virus."

Despite the position of mainstream specialists like these, some patients, doctors and scientists question the theory that AIDS is caused by HIV. David Rasnick now agrees with Peter Duesberg, who has long maintained that retroviruses like HIV are harmless. In his books Infectious AIDS: Have We Been Misled? and Inventing the AIDS Virus, Duesberg contends that AIDS results not from exposure to a virus, but from prolonged exposure to various environmental and lifestyle factors that compromise the immune system, such as drug abuse, malnutrition, the blood products used to treat hemophilia and AIDS treatments themselves.

Rasnickís change in thinking isnít as unusual as it used to be. Ten years ago, Duesberg was pretty much a lone voice crying in the wilderness. But thatís no longer the case. The Group for the Scientific Reappraisal of the HIV/AIDS Hypothesis, founded by Dr. Charles Thomas of Harvard University, counts several hundred prominent scientists among its members, including three Nobel Prize winners.

Rasnickís company eventually pulled out of the race to develop protease inhibitors for HIV, but he continued to follow the work his colleagues were doing with interest. "Prior to HIV," he reminds us, "protease research was a backwater, esoteric field. Even though itís one of the largest classes of enzymes, involved in almost all physiological functions, you didnít hear much about it before AIDS.

"In 1993, The Wall Street Journal reported that Merck [a large pharmaceutical company] was planning to pull out of HIV/protease research because it wasnít working. Then the company did a 180-degree turnaround and tooled up a plant in Georgia and went full blast commercializing Crixivan. They were trying to recoup some of their investment. Theyíd already spent $500 million developing the drug.

"When the FDA approved protease inhibitors for AIDS treatment in 1996, they broke the record for speed of approval. The companies had reported data on surrogate markers, but they never did clinical studies, which is the most expensive part of drug development. Suddenly, it was unethical to wait for clinical trial results."

Surrogate markers are measurements like T-cell and viral load counts. Not everyone agrees that they provide an accurate picture of health. "T-cell counts are worthless as surrogate markers," Rasnick contends. "Even mainstream researchers admit that. Thatís why they came up with viral load. But viral load is even worse. Itís pure Orwellian deception. People think PCR tests look at whole HIV, but they donít. At best, theyíre looking at two strands of DNA that make up 3 percent of the genome."

Dr. Kary Mullis, who won the 1993 Nobel Prize in Chemistry for developing polymerase chain reaction (PCR) technology, which made viral load testing possible, insists that the tests are useless as a diagnostic tool in AIDS treatment. Frustrated with what he believes is a misuse of his invention, Mullis became an outspoken member of the Group for the Scientific Reappraisal of the HIV/AIDS Hypothesis.

"Doing a PCR test is like counting bumpers in a junkyard," Rasnick explains. "The real test of whether a car is going to work is to put the key in the ignition and drive it off the lot. Instead, they just count bumpers and make a calculation. Twenty cars divided by two bumpers per car means 10 working cars. Now, that might work in a new car lot, but itís not going to work in a junkyard." The analogy, of course, is that the bodies of people with AIDS are like junkyards piled mile-high with various diseases and drugs.

Driving the car off the lot would be analogous to walking away from the hospital with a clean bill of health. But to this day, not a single protease inhibitor has been proven to be effective in terms of clinical symptoms. "It sets a dangerous precedent," Rasnick warns, "not just for AIDS, but for all diseases. Drug companies no longer have to demonstrate that drugs make people better to get them approved."

Drug companies now promote a half-dozen different protease inhibitors with slick ads in gay magazines and alternative newspapers. They are among the most expensive drugs ever marketed. Agenerase, the latest protease inhibitor to be approved by the FDA, is being marketed by Glaxo Wellcome, the company that makes AZT. Agenerase costs $16.80 per day, or $6,132 per year. Protease inhibitors range in price from $5,000 to $7,500 per year, and nucleoside analogs are also very expensive. Since the drug cocktails include three or four different drugs, a patient can pay $20,000 a year for the cocktail alone. That doesnít include the price of doctorís visits, laboratory tests or drugs used to treat the side effects brought on by the cocktail.

Most drugs used in modern medicine are prescribed for a short time and are stopped as soon as symptoms clear up. Thatís not the case with the new AIDS drugs. HIV-positive people are advised to stay on the drugs for their entire lives, even if the level of virus in their blood becomes undetectable. The theory behind this practice is that HIV will return in a new and more virulent form if treatment is stopped. Like so much else in the science on which current AIDS strategy is based, the theory remains unproven.

Given the high cost of AIDS drugs, activists have been agitating since the beginning of the epidemic for price decreases and free "compassionate access" for the poor. In the early years, before the Concorde study [a large clinical study of the use of AZT in AIDS treatment published in 1993] proved that AZT was not only ineffective, but possibly deadly, many activists clamored for wider access to the drug. Now they want wider access to the drug cocktails.

When doctors began to prescribe protease inhibitors along with AZT, the era of drug cocktails was born. Some AIDS patients who were already sick improved for awhile on the new combinations, and it wasnít long before drug companies began promoting early treatment for healthy HIV-positive people.

If the drugs are as ineffective as Rasnick and Duesberg contend, why did some patients feel better after they started taking them? Dr. Roberto Giraldo, a Colombian-born infectious disease specialist living in New York, attributes their progress to the placebo effect. "Patients who believed they were dying were suddenly given hope," he reminds us. "It was their change in attitude that impacted their health."

It soon became apparent that the drugs were far from the panacea they were made out to be. More than half the patients undergoing treatment are now expected to "fail" on the medications. "After a while," Giraldo says, "the placebo effect wears off, and the side effects take over."

When people taking the cocktails started to get sick again, AIDS researchers came up with another unproven theory to account for it. They maintained that patients develop resistance to the drugs over time, and that the solution is to keep switching them to different combinations.

"The difference has been dramatic in terms of well-being and survival," Calabrese says. "But it comes with a price. People have been locked into very complex medical regimens. There are a lot of pills and a lot of side effects. Some patients develop resistance to the drugs. They donít work for everybody, but many patients have dramatically improved on them."

"When the combination drug regimens came out," Lederman says, "AIDS mortality rates plummeted by 70 percent. Thereís no doubt that people are living longer. Weíre not sure yet about the mechanism of some of the side effects, so we donít know how to treat them. Itís not clear whether fat distribution, for example, is caused by protease inhibitors or the powerful antivirals that are used in treatment."

"I donít see why they call them side effects," Duesberg complains. "Since they have no benefit, these are the main effects of the drugs. Most people who have been put on DNA terminators in the past 10 years have either died or continue to suffer." The DNA terminators include AZT and several other nucleoside analogs commonly used in AIDS cocktails. Originally designed to treat cancer, a disease of persistently growing cells, they prevent the formation of new cells by blocking the development of DNA chains.

While destroying cancer and HIV cells, these drugs, which are now called antivirals, can also destroy healthy blood cells, as well as cells in the digestive system, central nervous system and muscle tissue. Their destructive power is the reason they were never approved for cancer treatment. "Long-term use of DNA terminators," Duesberg believes, "can only result in death."

Rasnick agrees: "In the Concorde study, there was a 25 percent greater mortality rate in people who took AZT sooner rather than later. This was confirmed by a study conducted by the Veterans Administration. As a result, the AIDS establishment now considers it malpractice to use AZT monotherapy [AZT without other drugs] in adults. Yet they recommend it for infants. If that isnít Lewis Carroll through the looking glass, I donít what is.

"Protease inhibitors can be toxic, too. Everything weíre learning about them, weíre learning in people, because they were rushed to market without completing animal studies. The list of side effects keeps growing. While inhibiting aspartyl protease in HIV, they can also inhibit human enzymes. Nobody knows what the long-term effect will be.

"Ritonavir [a protease inhibitor made by Abbott Laboratories], for example, inhibits the liver enzymes that detoxify [fat-soluble] drugs. [AIDS patients] are taking 30 to 50 pills a day, and they add another drug that plugs up the damn. Concentrations build up to toxic levels in the body, and it kills people.

"One of the most sinister aspects of this whole thing," Rasnick concludes, "is that the drug companies are now in league together. The toxic effect of one companyís drug is used to make another companyís drug more absorbable. Itís insane."

Despite diabetes, neuropathy, buffalo humps and all the other problems associated with drug cocktails, many patients arenít as quick to stop treatment as Cooper and Goldring were. They believe that theyíre better off with the drugs than without them. As one patient put it in POZ magazine, "Ií d rather be alive with a hump than dead and rotting in my grave." But are they being given the information they need to make an informed decision?

Steven Goldring says that he wasnít. "They just foisted the drugs on me," he says, "without explaining what they did or what the side effects were. I don ít feel like I was given a real choice."

"The key to empowering people is giving them all the information," Cooper agrees. "Doctors arenít doing that. They only tell one side of the story. Ií m very skeptical of everything they tell me. I do my own research and make up my own mind."

Thereís a big push these days from AIDS doctors for early intervention. HIV-positive people are advised to begin treatment with the drug cocktails a s soon as theyíre diagnosed, even though theyíre still healthy. This is based on yet another unproven theory ó that the drugs are more effective at the early stages of what has become known as "HIV disease."

"People who test positive," Christine Maggiore says, "face so much pressure to follow doctorís orders and adhere to the drug protocols. Itís hard for most people to fight, not just on an intellectual level, but emotionally as well. People who decide to take another path not only lose their relationship with their doctor, they often lose the support of their friends as well."

Maggiore says that meetings of Alive & Well, her grass-roots nonprofit organization in Los Angeles that provides alternative information on AIDS causation and treatment, often function as support groups for HIV-positive people. "We provide a safe place for people to question. I mean, you can get thrown out of a doctorís office just for asking questions. If you refuse drug treatment, some doctors will no longer work with you. Theyíre very touchy about it."

Part of the problem is that doctors themselves are often unaware of the controversy surrounding mainstream AIDS theory. "Most of the information they get after medical school comes from pharmaceutical companies," Maggiore scoffs, "or from their own incestuous journals, which censor opposing views."

Pharmaceutical companies are directly or indirectly involved in most AIDS research, and theyíve also become a force in AIDS education. The free treatment information magazines provided to HIV-positive people are funded by drug companies, and advertisements for drugs have become a major source of revenue for gay publications. Many AIDS service organizations and advocacy groups accept at least some funding from drug companies.

A new program starting up at the Antioch Baptist Church on Cedar Avenue is a good example. The Agape Program is designed "to heighten awareness about the HIV/AIDS pandemic in the African-American Community." HIV testing will be encouraged so that patients can be referred for early intervention. Major funders for the program include the Cleveland Clinic and two drug companies ó Bristol-Myers Squibb and Auguron Pharmaceuticals ó all of which stand to profit from the referrals.

Even when theyíre aware of opposing views about AIDS causation and treatment, many AIDS doctors dismiss the arguments of dissident scientists out of hand. "They donít want us to be right," Giraldo says, "because it means theyíve been killing their patients."

Doctors also worry about being sued for malpractice, and AIDS educators worry about losing their jobs. Despite the problems with the theory that exposure to HIV leads to AIDS, itís generally accepted as an indisputable fact. Michael Cooper works as a counselor for an AIDS service organization, and asked that I change his name for this article. "My boss doesnít want me to talk to you," he told me. "I could lose my job for telling the truth."

Scientists, too, get into trouble for questioning mainstream AIDS doctrine. "Thereís no incentive for being a whistle blower or iconoclast," Maggiore says. "This is especially true of AIDS, which is as much a political as a medical phenomenon. If you question anything about the mainstream approach, youíre accused of being homophobic and promoting unsafe sex."

Look at Peter Duesberg. Before he began proposing an alternative theory of AIDS causation, he was one of the top virologists in the country, the head of a state-of-the-art laboratory bustling with activity. Now he canít get funding for research and routinely has papers rejected by leading scientific journals. The graduate students who used to clamor to work with him at the University of California have drifted away, because theyíre advised that associating with him is bad for their careers.

"Duesberg is an unconscionable jerk," CWRUís Lederman fumes. "You can quote me on that. Iím sorry you talked to him."

"Iíve lost everything," Duesberg tells me, "even friends. Iím thinking about leaving the country. In Europe, scientists have a more open spirit of inquiry." He believes part of the problem in the United States is that the government has a stranglehold on research, and heavily promotes its own biases. "I used to have this romantic conception about science as a search for truth. After what Iíve experienced, thatís hard to maintain."

"The AIDS establishment is making an example of him," Maggiore asserts. "Heí s become the focus for those who want to squash the scientific reappraisal of AIDS. Heís not the lone voice anymore, but he was the first. Itís tough for a scientist of his stature to be the focal point of ridicule by people who want to protect their vested interests. Instead of addressing his assertions, they make fun of him.

"I admire him for sticking to his views. If it wasnít for Peter, I donít think Iíd be alive and well today. Most of the people I know who followed the advice of AIDS doctors are either dead or living a life thatís completely stilted by HIV, taking dozens of pills a day and suffering from the side effects. He let me know that there was information out there that would substantiate living a long life without resorting to toxic drugs."

Maggioreís group, Alive & Well, is part of a loose network of alternative AIDS information organizations around the country. Run by volunteers without funding from the government or pharmaceutical companies, they provide people with the information theyíre not getting from doctors or the mainstream media. Many are chapters of Health Education AIDS Liaison (HEAL), founded by Michael Ellner in New York in the early days of the AIDS epidemic.

These grass-roots groups, many of which are led by healthy HIV-positive people, emphasize three things. They point out that HIV tests are non-specific and can cross-react with other viruses and physical conditions, including pregnancy, so a positive test result doesnít necessarily mean that a person harbors HIV. They endorse the notion that HIV has not been proven to cause AIDS. And they question the wisdom of taking AZT, protease inhibitors and other AIDS drugs, insisting that theyíre not only unnecessary, but dangerous.

Not all people going off AIDS cocktails hold such radical views. Michael Cooper, for example, isnít so sure that HIV doesnít lead to AIDS. "Iím not convinced either way," he tells me. "Maybe there are co-factors, and thatís why some people get sick and others donít. All I know is that I feel a lot healthier now that Iím not taking the drugs."

Steven Goldring says that staying on the drug-free path heís chosen can be difficult. "My numbers arenít wonderful," he confides, referring to surrogate markers. "Every time I go to the doctor they try to get me to go on the cocktail again. But I refuse. I see the people taking the drugs. They look horrible. They have no energy.

"Iím just going on my experience. Iíve looked at both sides, and I think Ií ve made an informed decision. You have to listen to your body and be honest with yourself.