WITH THERAPIES LIKE THIS, WHO NEEDS DISEASE ?
Cheryl Nagel's dream was on the verge of becoming tangible reality in late October of 1990. She and her husband Steve had wanted a child of their own for a long time. Now her flight was arriving deep in the heart of Eastern Europe, Romania. Steve could not take the time off, so her mother accompanied Cheryl to the remote city of Timisoara. Cheryl felt out of place, having traveled so far from her suburban home just outside Minneapolis; back home Steve cooked for a restaurant, while she worked as a realtor's assistant.But when they heard the news of turbulence in that country and then of the orphanages full of desperate children, the Nagels knew where they had to go.
Arriving turned out to be the easy part. Touring the surrounding area, Cheryl and her mother soon met Lindsey, a baby girl only several days old. She had been born in the small coalmining town of Petrosani, nestled deep in the Transylvanian Alps. She had been given up by her impoverished mother, who was already burdened by caring for three older daughters. But Cheryl found the adoption process absurdly difficult, considering the desperate economic and social condition of the country. Constant shortages of the littlest things, even light bulbs, could cause delays, and a phone call overseas took four hours to connect before she could hear the reassuring sound of her husband's voice. After two weeks of paperwork, bureaucratic stalling, and struggling with a strange language, Cheryl returned to the United States to recoup her energy. Returning to Romania within a few weeks,however, she overcame the final hurdles and retrieved the two-month-old baby.
Lindsey was a happy, healthy child, her slightly small size reflecting the norms for her original family. The Nagels took her for a complete checkupwith a clinic near Minneapolis. The doctor's battery of tests included one for HIV. To everyone's astonishment, Lindsey was confirmed positive. Upon investigation, the Nagels discovered that Lindsey's birth mother did not have the virus. This left only one possible source- the blood transfusion Lindsey had received (despite having had nothing more than a brief ear infection) in Romania's backward medical system, where the method was carelessly used as a treatment for almost any illness. Lindsey still seemed a picture of health. However, the Nagels were now told she had the deadly "AIDS virus."
Then the nightmare began. Steve and Cheryl agreed to treat Lindsey prophylactically, that is, to delay the onset of symptoms as long as possible. They were referred to a specialist at the Children's Hospital in Minneapolis, where the doctor examined Lindsey and found no symptoms at all. No infections, no abnormalities, nothing. "She is [a] very bright, smiling and happy girl," noted the doctor, who nevertheless decided to head off a potential AIDS pneumonia immediately. Lindsey was prescribed Septra, to be taken three times each week.
The drug is known by dozens of brand names, including Bactrim. Septra is a sulfa drug, a remnant of the era before penicillin and the other antibiotics. Sulfa drugs do not target invading microbes as narrowly as the antibiotics and so have become notorious for their side effects. According to the Physician's Desk Reference, Septra can cause "nausea, vomiting, anorexia, "and "bone marrow depression," and also includes "rash, fever, [and] leukopenia" among its side effects. (1) Even the drug's manufacturer, Burroughs Wellcome, strongly recommends against using Septra for more than two weeks, in children or adults. Young Lindsey, however, would take the drug for some nine months.
When the Nagels brought their daughter back a week later, the specialist announced that Lindsey's Tcell count was perfectly normal. Nor had any infections shown up. But given the HIV infection, the doctor wanted to slow the presumably inevitable appearance of AIDS. This time she prescribed the only drug approved for AIDS therapy- AZT (a chemotherapeutic drug designed to kill growing cells; see below). Lindsey began swallowing a total of120 milligrams of the drug every single day, in addition to her Septra.
AZT stands for azidothymidine, a drug often marketed under the names Zidovudine or Retrovir. As with Septra, AZT is produced by the pharmaceutical giant Burroughs Wellcome. Both drugs have toxic effects. But compared to the sulfa drug, AZT amounts to poison. The doctor herself admitted some of the effects in her medical report of the visit, stating that Lindsey's "mother was explained the side effects of Zidovudine which are primarily bone marrow suppression with anemia, sometimes nausea and vomiting and rarely the cause of other symptoms like skin rash.", If anything, this understated the effects. AZT kills dividing cells anywhere in the body-causing ulcerations and hemorrhaging; damage to hair follicles and skin; killing mitochondria, the energy cells of the brain; wasting away of muscles; and the destruction of the immune system and other blood cells. Children are affected more severely, because many more of their cells are growing than in adults. (3) Amazingly, AZT was first approved for treatmentof AIDS in 1987 and then for prevention of AIDS in 1990.
Totally unaware of the toxicity of this controversial drug, the Nagels faithfully fed their daughter the AZT syrup four times a day. At their next visit the following month, the doctor strangely began praising Lindsey's "improvement" (4) Upon reflection, the Nagels grew puzzled. What "improvement" could the doctor have meant, since Lindsey had suffered no medical problems at all before the treatment began? In fact,their daughter was already changing for the worse. Despite gaining slightly in weight, she was beginning to fall behind the proper growth rate for her five months of age. She was also losing her appetite, feeling too sick to drink her milk.
This process continued for months. Lindsey developed no infectious diseases, but her appetite continued to decline. The doctor acknowledged that the child was falling further behind the normal growth curve. By the time Lindsey reached her first birthday on October 15, 1991, her adoptive parents began to lose patience. The doctor seemed to believe the lack of growth had more to do with HIV infection than with any drug effects of Septra or AZT. As the Nagels began reading up on the officially recognized "side effects"of these drugs, their uneasiness turned to outright anxiety when they found perfect descriptions of their daughter's condition. Becoming suspicious of their doctor for not admitting or discussing these side effects, Steve and Cheryl took Lindsey to Dr. Margaret Hostetter at the University ofMinnesota clinic. They felt overwhelmed and wanted clearer advice.
Dr. Hostetter possessed all the poise and confidence of her twin appointments as a university professor and director of the clinic's infectious disease program. Exuding an urbane but authoritative charm, she at first appeared much more professional and much friendlier than the other physicians. "Thank you for referring this lovely family to me," she wrote to Lindsey's first pediatrician after her November visit. (5) Running a complete battery of tests, she decided to take Lindsey off the Septra immediately. But the Nagels did notice that the doctor seemed to blame Lindsey's weight loss on HIV, rather than on drug side effects.
As soon as the Septra prescription ended, Lindsey began rebounding.Within one month her weight had again increased, though hardly back to normal, and her appetite recovered slightly. Amazingly, Dr. Hostetter completely missed the point. She had increased Lindsey's AZT dosage at the same timeas ending the Septra, so at the Nagels's next visit she credited the baby girl's improvement to the AZT. In fact, she discussed plans to increase the AZT yet again. Even the experimental drug ddI, another powerful drug similar to AZT and just approved by the FDA, started cropping up among the doctor's suggestions.
After the rapid side effects of the sulfa drug had disappeared, the slower toxicity of the extra AZT began taking over. Lindsey stopped improving, and her weight, though still rising slowly, could no longer keep up with the normal growth rate for her age. She remained at the bottom end of the healthy weight range. By March she virtually stopped growing altogether. Her parents, fending off an increasing nervousness with each passing month, nevertheless kept up the daily syrup-feeding routine. The doctor praised Lindsey's nonexistent progress at each visit.
A few weeks later, the doctor had stretched the Nagels's patience by pressuring them to put Lindsey on ddI (a chemotherapy like AZT; see below).The young girl's T-cell levels were dropping, she said, and new drugs might help combat the deadly HIV. Investigating for themselves, the Nagels discovered that all children normally start with more than three thousand T-cells per microliter at birth, declining to about one thousand before adulthood.(6) Lindsey's counts were coming down near the standard, healthy rate. Naturally, the Nagels refused ddI therapy. But now they were reconsideringAZT as well.
The tension finally erupted a few days after Lindsey's second birthday on October 15, 1992. Steve and Cheryl woke up one night to the tormented screams of their daughter. Racing into her room, they found her sitting up and tearfully clutching her legs. The muscle pains were unbearable. Leg massages, Tylenol- they used anything that would allow Lindsey to sleep again. The same thing happened the next evening. And the next one. Night after night, the pain returned with ruthless consistency to deprive the entire family of sleep for a whole month. The Nagels recognized precisely what was happening to their daughter: Based on their own study, they had already learned that AZT produces muscle wasting as one of its "side effects." (7)
By chance they stumbled across an article discussing Peter Duesberg's dissent against AZT treatment for AIDS. Upon tracking down his phone number and calling, they received an earful about the drug's toxic effects. From there the Nagels talked with several other scientists dissenting against the HIV hypothesis. By early November the picture had become clear. The day they received a letter from Duesberg with scientific documents on AZT and on the shaky evidence for an AIDS virus, the Nagels stopped feeding their daughter the drug. Lindsey's changes took even her parents by surprise:
After Lindsey was off AZT, she became a "new" child almost overnight. She started sleeping much better, including longer hours... Her muscle cramps went away. She started eating at least 2-3 times as much every day as she had ever eaten before. She would now drink milk, and especially around other youngsters, would drink as much as 6 ounces at a time. She would never drink milk before unless we added chocolate syrup, not a very nutritious drink...
She displayed a much calmer demeanor. Lindsey was described almost as"hyperactive" by several people, including maternal grandparents who babysat a lot. This was a night and day difference! Lindsey, before, could not sit still for 5 minutes, and was seemingly agitated all the time...
After seeing our nutritionist for only 2 months, and ridding Lindsey's body of toxic effects of being on AZT and Septra, Lindsey, now at 27 months, had an upswing on the chart. Her weight has been going up ever since. Now for the first time in 21 months, Lindsey is at 24 pounds, and is back onthe chart at the 10 th percentile. (8)
Dr. Hostetter knew nothing about Lindsey's being off AZT. The Nagels contacted the physician to demand an open discussion about the drug's merits at their next visit, to take place in early December of 1992. They were caught completely off guard by the doctor's reaction:
The parents felt too intimidated by the meeting to let the doctor know they had ended the AZT treatment. In a letter written one week afterward to the Nagels's private physician, Hostetter noted that Lindsey had grown remarkably well during the previous two months, and warned that "we, unfortunately, might well see a return of Lindsey's previous failure to thrive were we to discontinue this drug."(10)
When the Nagels finally informed the doctor in writing and switched Lindsey to a chiropractor and nutritionist, Hostetter's mood turned downright ugly. Her response letter thundered a stream of dire warnings:
Hostetter followed up the letter with an angry call to the Nagels's chiropractor- on New Year's Eve. "She wanted to warn our chiropractor that she had no right to be seeing Lindsey," recalled Cheryl. "She also said that there are foster homes to provide care for children who were in Lindsey's predicament! (Living with parents who wouldn't give their daughter AZT.)" (12)
Hoping to stall Dr. Hostetter and to get a second opinion, the Nagels took their adopted daughter to another physician referred by Hostetter. But all he gave them was the same opinion. He recommended they restore Lindsey's treatment, and his nurse practitioner called AZT a "wonderdrug", a term even its manufacturer, Burroughs Wellcome, has never dared use.
Lindsey remains off AZT and all other toxic drugs. Her healthy growth pattern continues, she suffers no unusual diseases, and she is developing normally. Two years after suffering from AZTinduced leg cramps in 1994, she became a budding star in a local ballet school. And on October 15, 1995, Lindsey celebrated her fifth birthday- with HIV and without AZT- in excellent health. According to public health officials, she should already have died of AIDS because babies with HIV are supposed to survive only about two years.
Not everyone is so fortunate. In 1987 three years before Lindsey was born in faraway Romania, Doug and Nancy Simon brought their daughter Candice into the world, in a town south of Minneapolis. Their daughter certainly seemed healthy enough, but by the time she reached one and a half years of age, the doctor discovered she had antibodies against HIV. Investigation traced the infection to her mother, who had contracted the virus from her husband. He, in turn, had contracted it from a blood transfusion several years earlier. None of them suffered from AIDS.
The Simons took Candice to the Minneapolis Children's Hospital, the same one where Lindsey Nagel would be given Septra and AZT a couple of years later. Candice, too, became a victim of AIDS medicine. Doctors there prescribed interferon, a powerful anti-metabolic drug that shuts down cell function. (13) They later added AZT to her regimen, a treatment that, unlike in Lindsey's case, would last three and a half years. The constant testing added to the parents' sense of being overwhelmed: Xrays, blood samples,brain scans. For a while, Candice appeared to handle the therapy without too many problems.
Then her condition took a nosedive. Her appetite declined to dangerously low levels. The hospital became almost a second home, and by late 1992 she could no longer leave her bed. A new symptom, hauntingly reminiscent of Lindsey's AZT poisoning, took effect: "When the pain hit she would double over in her bed like a safety pin and, wild-eyed, grab her ankles until it eased." (14) Soon the doctors found malignant cancer spreading tumors throughout her stomach area. For the pain they prescribed morphine, then surgically cut the nerves to her intestines. Candice could no longer eat on her own, and the doctors began feeding her directly to her blood through intravenous tubes. Though five years old, she had lost control of her intestines and had to wear diapers.
In June of 1993, only three days before she turned six years old, Candice died painfully. Nearby, Lindsey Nagel had already stopped AZT seven months earlier and was recovering her health spectacularly. But Candice continued the drug right up to the end. Now both her parents take AZT as well. (15)
The Nagels know of the Simons's situation and consider themselves lucky for not having followed through on their daughter's AZT treatment.
The death and resurrection of AZT
The virus hunters have always aspired to the glories of their predecessors, the bacteria hunters. Medicine still takes credit for eliminating bacterial diseases with antibiotics such as penicillin. These drugs attacked their bacterial targets with tremendous specificity, meaning they did little direct damage to the host's body. Antibiotics became known as the "magicbullet" for bacterial infections. Fire them into the body, and kill only invading bacteria.
But for viruses the problem was different. These are nonliving microbes, made of proteins, DNA or RNA, and sometimes even a tiny membrane- molecules all made entirely by human cells inside a human body. How could any drug possibly discriminate between the production of proteins and DNA made for viruses and those made for their human hosts? Despite neverending searches for "magic bullets" against viruses, the efforts have produced little but failure. In principle, an antiviral drug may never be possible. The only solution offered has been vaccination, which prevents viruses from entering cells.
The 1975 Nobel Prize for Medicine, awarded for Howard Temin's discovery of the protein "reverse transcriptase", popularized this unique retrovirus enzyme. Many virus hunters switched into chasing retroviruses, and the reverse transcriptase protein took on mythic proportions. It did, after all, copy the virus' genetic information from RNA molecules "backward" into DNA, this new copy integrating somewhere into the genetic DNA structure of the infected cell. Normally, the cell keeps its genetic material in DNA, copying selected genes into RNA as needed. This "reverse" feature of the retrovirus protein inspired virus hunters to make it their key target for "magic bullet", drugs. At least in diseases caused by retroviruses, they speculated, some effective drug could be found. Once AIDS was blamed on HIV, a retrovirus, the race was on to find a drug that could inhibit the viral reverse transcriptase.
Drug development since World War II had also been heavily shaped by cancer research. Cancer, too, fueled ambitions among doctors to find "magic bullets" that could destroy the cancer tissue without killing the host. First came surgery, the attempt simply to cut out the tumor; this method has serious limitations. Radiation also became popular, based on the hope that tumors could be burned away by Xrays or other highenergy beams before destroying the body, but radiation therapy has mostly proved disappointing. Chemotherapy, using powerful cellkilling drugs, came into vogue during the 1950s. Starting in World War I, researchers observed the destruction of blood cells by mustard gas, the chemical warfare agent used to hideous effect in the trenches of Europe's battlefields. A few attempts to use this drug against cancer turned up with minimal results, largely because mustard gas was so toxic to the patient.
Shortly after James Shannon took over the NIH in 1955, he instituted several major research programs to attract vast new budgets from Congress. The largest of these became the VirusCancer Program, which ultimately converted itself into the war on AIDS. The second largest project aimed to develop chemotherapy agents to treat cancer. The 1950s and 1960s therefore saw a proliferation of drugs designed to kill growing cells. At first,the goal seemed straight forward: Since cancer is made of persistently dividing cells, find a drug that prefers to kill cells that grow. The biggest problemwith this concept lay in the body's own tissues, many of which replenish themselves constantly with rapidly growing cells. Therefore cancer patients undergoing chemotherapy experience devastating side effects, including hair loss; muscle wasting; severe weight loss due to intoxication of the intestines and benign intestinal microbes; anemia and the need for blood transfusions; and destruction of the immune system, composed mostly of white blood cells. Decades before the appearance of AIDS, chemotherapy patients often died of the same Pneumocystis carinii pneumonia that later killed young homosexual men. (16)
AZT was invented under this program in 1964. Jerome Horwitz, heading a lab at the Detroit Cancer Foundation and financed with an NIH grant, created a chemically modified form of a DNA building block. Every time a cell divides, it must copy its complete genetic code, allowing one copy for each new cell. Genetic information is stored as a sequence of four "letters" in long chains of DNA, known as chromosomes. Each building block of DNA is linked to the one before it, almost like train cars. But Horwitz's altered DNA building block, azidothymidine (AZT), surreptitiously enters the growing DNA chain while a cell is preparing to divide, and acts as a premature "caboose," blocking further DNA building blocks from being added. In short, the cell cannot copy its DNA sequence and dies trying. AZT was the perfect killer of dividing cells. However, when he tested the compound on cancerridden mice, it failed to cure the cancer. (17) Horwitz was so disappointed he never bothered publishing the experiment and eventually abandoned that line of research. The drug must have killed the tumors, which contain dividing cells, but it so effectively destroyed healthy growing tissues that the mice died of the extreme toxicity. (18) The drug was shelved, and no patent was ever filed.
Twenty years later, Gallo's 1984 press conference announcing HIV as the "AIDS virus" set in motion a new hunt, this time for a "magic bullet" drug to act against the virus. The federal government had promised treatment, and it had to deliver. Some virus hunters, including Jonas Salk, scurried to invent an HIV vaccine. Others searched for an antiviral drug and turned to the cancer chemotherapy program for alreadydeveloped chemicals. The fastest way to put a drug to market would be to select one that had finished some testing in the past.
Burroughs Wellcome became the pharmaceutical company positioned at the right place and the right time. One of the giants in the industry, the Britishbased company maintains a relatively unusual corporate structure as a mostly nonprofit, charitable institution. Most of its profits are paid, not to stockholders, but as grants and donations to biomedical research institutions. By throwing so much money around, Burroughs Wellcome has bought enormous influence throughout government and universities, especially through its American branch. A large number of scientists and physicians had developed informal ties to the company, having been paid to test its pharmaceuticals many times over the years.
The company's head researcher in the United States, David Barry, recognized the opportunity after Gallo's press conference. Barry knew his way around the federal bureaucracy in getting a drug approved. He had originally worked at the FDA during the 1970s as a virologist. His research had focused on the flu viruses, and he occasionally dabbled in retroviruses after they became popular. Upon switching to Burroughs Wellcome, he paid more attention to herpes viruses, also a hot research item. He brought to his new job a vast network of connections with fellow virus hunters and top FDA people.(19) Upon hearing the official call for antiHIV drugs, Barry turned to the company shelves for previously rejected substances. If one of these could be approved, the company would save vast sums of research and development money. The political pressure for a quick solution played in his favor.
The key lay in winning FDA approval, which counted for more than mere permission to sell. The agency bans most potential drugs, automatically suppressing the competition and granting treatment monopolies for approved drugs. This monopoly alone can be worth hundreds of millions of dollars to the pharmaceutical company holding the patent. Back in the days when snake oil could freely be sold as a nostrum, drugs would sell only according to the reputation of the producer and their effectiveness against disease.Now the public depends on, and trusts, FDA screening procedures.
Barry selected a handful of drugs and quietly forwarded them to a couple of Burroughs Wellcome's former collaborators. One of them was Dani Bolognesi, a veteran retrovirus hunter and professor at North Carolina's Duke University, who not only knew Barry but also was so close to Gallo he belonged to the "Bob Club." Bolognesi tested the substances in his laboratory, checking whether they would prevent HIV from multiplying while infecting cells in the test tube. One of the drugs clearly proved most potent against the virus- compound S, as it was codenamed. Its real name was AZT.
Bolognesi then referred Barry to Sam Broder, the man in charge of Gallo's laboratory at the National Cancer Institute. Broder had joined the NIH in the early 1970s, just as Gallo's star was beginning to rise. Broder made his career testing and developing cancer chemotherapy, but he also allied himself to Gallo and thereby practiced a bit of virus hunting himself, soon becoming a full member of the "Bob Club." Politically savvy, he could see by the early 1980s that the time had come to switch his emphasis from cancer to AIDS and immediately after Gallo's press conference he mobilized NIH researchers to find a drug. According to Bruce Nussbaum, "The hallmark of Broder's operation was... simple: Find a drug that had been tested for a previous disease. Make sure it had a big corporate sugar daddy behind it. Push the bureaucracy like hell to move it along. And talk it up. Talk it up."(20)
Broder's tenacity made him a perfect advocate for AZT; Barry realized that Broder, if properly recruited, would aggressively push through the bureaucracy to get AZT approved. So Barry sent compound S to Broder late in 1984, who discovered its powerful effect on HIV and waxed enthusiastic. Broder was so completely hooked, he soon became known as "Mr. AZT."
Barry, Broder, and Bolognesi together published their laboratory experiments on AZT. They reported that only a tiny concentration was needed to block the virus from multiplying. Of course, this would mean nothing if the same dose of AZT would also kill the Tcells in which the virus grew, in which case it would destroy the immune system before the virus supposedly could. Further tests gave an answer that sounded too good to be true: At least one thousand times as much AZT was needed to kill the Tcells as to stop the virus. (21) This theoretically meant doctors could use small doses of the drug to stop HIV without seriously damaging their patients' immune systems. No one bothered to check this fantastic result. The Burroughs Wellcome and NIH researchers somehow had to explain their success, and they billed AZT as a compound that specifically attacked reverse transcriptase, the retrovirus enzyme. In other words, they quickly declared, they had finally found a "magic bullet." (22)
AZT, however, did not really attack reverse transcriptase directly. It only did what it had been designed to do originally- stop the synthesis of DNA. Since reverse transcriptase copies retroviral genes into DNA, the drug certainly interfered with its normal function. But the infected Tcell, meanwhile, produces its own DNA. Every time the cell divides, it must copy one hundred thousand times more DNA than the small virus, giving AZT one hundred thousand chances to kill the cell for every opportunity to block the virus. Since retroviruses can make viral DNA only in cells making their own DNA, the drug could not possibly attack the virus without also killing the cell, casting suspicion on the BolognesiBroder experiments. Recent studies conducted by smaller laboratories have tested AZT on other samples of Tcells, finding that the same low concentration that stops HIV also kills the cells. According to these studies, the real cellkilling dose is one thousand times lower than that reported by Broder, Barry, and Bolognesi. AZT is definitely toxic, indiscriminately killing virusinfected and uninfected Tcells alike. Broder and his collaborators have never corrected their original reports, nor have they explained the huge discrepancies between their data and other papers. To this date the Physician's Desk Reference quotes the low toxicity of AZT reported by Broder, Barry, Bolognesi, and colleagues in 1986, although the real toxicity of the drug is one thousand times higher according to more than six independent studies published since.(23)
They also overlooked two even more fundamental problems with their lab experiment: (1) The virus against which Broder and colleagues tested AZT was actively growing in the test tube. But in the body of an infected person, antibodies neutralize HIV years before AIDS appears, if it comes at all. In persons with antibody against HIV, the virus is inactive, not making any viral DNA at all. Thus AZT in a human being cannot attack the virus anyway, for it has already become dormant. It can attack only growing humancells. (2) AZT, like all other chemotherapeutic drugs, is unable to distinguish an HIVinfected cell from one that is uninfected. This has disastrous consequences on AZTtreated people: since only 1 in about 500 Tcells of HIV antibodypositive persons is ever infected, AZT must kill 499 good Tcells to kill just one that is infected by the hypothetical AIDS virus. This is called a very bad therapeutic index in pharmacology! It is a tragedy for people who already suffer from a Tcell deficiency.
A toxic chemotherapy was about to be unleashed on AIDS victims, but no one had the time to think twice about its potential to destroy the immune systems of people who might otherwise survive. The pressure was on to find a drug. Barry used this as leverage when he began quiet negotiations with key FDA officials, arguing that AZT should be rushed through the approval process with reduced testing requirements. Broder was doing his bit, championing the drug through every channel of NIH power at his disposal. FDA officials relented and agreed to help the drug through in order to save time. Given the toxicity of AZT, Burroughs Wellcome would need every break it could get to win approval.
Barry and Broder were the right team to get that break. Says Nussbaum in Good Intentions: "David Barry was the puppet master, and his favorite marionette was Sam Broder. While Broder was charging around promoting AZT at the National Institutes of Health, Barry was working quietly behind the scenes orchestrating a whole panoply of actors who would ensure the drug's ultimate commercial success." (24)
Broder rushed AZT through its Phase I trials, the tests to determine its toxicity in humans. FDA cooperation allowed him to cut corners, making the drug appear to have minimal side effects. Now they were ready for the Phase II study, to see whether the drug would actually fight AIDS symptoms.
The AZT CoverUp
Doubleblind, placebocontrolled studies form one of the cornerstones of medical science. This rigorous gold standard puts any promising new treatment to the ultimate test: When applied to humans, does it really work? If properly structured, such a study throws out the prejudices of the researchers and yields the bottom line. A group of people with the appropriate disease is carefully selected, then secretly divided into two subgroups matched for every important characteristic. To test a therapy for tuberculosis, for example, both groups would contain the same number of tuberculosis patients. One group is given the treatment, the other aplacebo- a "sugar pill," meaning a sham treatment that appears identical to the therapy itself. This removes any interfering effect of patient psychology or actions. And the study is conducted in a doubleblind fashion, so that neither the patients nor the doctors know who is receiving treatment and who gets placebo, until the experiment is finished.
Under normal circumstances, AZT's Phase II trial would have been such a doubleblind, placebocontrolled study. But the intense political pressure to approve an AIDS drug, enhanced by fastspreading rumors in the homosexual community of AZT's powerful benefits, forced FDA officials to take shortcuts. Although the study was finally published as if it had been a doubleblind, placebocontrolled test, it most definitely was not. (25) The drug's toxicity inevitably unblinded the study within weeks, its effects on patients being painfully obvious. (26)
David Barry structured the entire study from beginning to end. He tapped Burroughs Wellcome's informal network of scientific collaborators, selecting twelve medical centers around the country for participation. By providing$10,000 per study patient to each clinic involved, he induced a whopping fiftyone researchers to jump on board, a group heavily weighted with old virushunting peers of Barry's. Just having that many wellconnected medical scientists helped swing the political balance in his favor, and it locked in their own loyalties to AZT. Even Michael Gottlieb, who reported the first five AIDS cases, joined in. There was hardly a medical institution left in the country that was not involved and that could have offered an independent second opinion. Barry chose Margaret Fischl, a virologist at the University of Miami, to head the experiment.
Thus, Burroughs Wellcome not only coauthored (Drucker, NusinoffLehrman, Segreti, Rogers, Barry), but also paid for the licensing study of its own product. But nobody seemed to mind this blatant conflict of interest- not the many nonBurroughs Wellcome researchers on the study; not the NIH,which co-sponsored the study; not the FDA; not the editor of the New England Journal of Medicine, which published the study.
A total of 282 AIDS patients was recruited, roughly half being put on AZT and the other half receiving the placebo. The trial, conducted in 1986, was scheduled to treat each patient for six months. After four months the announced results seemed stupendous- so amazing, in fact, that the study had to be aborted early. Fischl and her associates decided they could not ethically continue to withhold such a wonderful drug from the placebo group. Nineteen placebo recipients had died during the study, compared to only one member of the AZT group. Fortyfive in the placebo group developed opportunistic AIDS diseases, versus only twentyfour in the AZT group. And while the Tcell counts of the placebo patients continued to decline,the AZT group saw a temporary surge in their Tcells. Results like these could propel almost any drug to FDA approval.
But even an inspection of the officially published data reveals some grim problems. The study does not indicate that Fischl and colleagues sorted their patients according to use of such recreational drugs as heroin or poppers. Since most were homosexual men, this could complicate matters if, for example, the placebo group contained more heavy drug users. Fischl herself also admitted that an undocumented number of the patients were allowed to take other medical drugs during the study, a factor that introduced another wild card.
When pioneer AIDS researcher Joseph Sonnabend, from New York, "first read the AZT study report, he had a lot of questions but the first one had nothing to do with AZT: Why had so many placebo patients died? 'I was suspicious of the study from the beginning because the mortality rate was simply unacceptable', he said. 'My patients were simply not dying in those sort of numbers that rapidly.' Sonnabend had an added difficulty. The causes of death provided to the FDA did not match those in the research Fischl had written for the New England Journal of Medicine. 'Sloppy research,' Sonnabend said." (27)
Still, taking the results at face value, a shocking picture of AZT toxicity emerges. Sixtysix AZT recipients suffered "severe" nausea- a category that would have been mentioned only if this was clinically serious- as compared to twentyfive in the placebo group. All AZT users saw their muscles waste away, while only three placebo recipients suffered this symptom. And a full thirty in the AZT group survived only with multiple blood transfusions to replace their poisoned blood cells, compared to five similar cases among the placebo users. The lesspublicized "side effects" of AZT more than abolished its presumed benefits. (28)
A followup study on those same patients found that Fischl's neat picture mysteriously vanished once everyone was put on AZT. Within months, the death rate of the original AZT test group rapidly caught up to the former placebo group. After a year, onethird of both groups had died. Fischl, "the Queen of AZT," (29) and her coworkers shrugged off these new results, suggesting that AZT's miraculous effects somehow wore off after a few months.
Or perhaps the benefits never existed in the first place. A flood of previously concealed information has surfaced since the trial, all showing that it became unblinded from the start. The controls completely broke down.
The doctors certainly found out quickly who took AZT and who did not, because AZT induces serious destruction of blood cells and the bone marrow that produces them. Bruce Nussbaum, in his 1990 book Good Intentions, described the mood in the trial's first month:
For those doctors who may have missed AZT patients vomiting up blood, the routine blood tests gave away the secrets. Michael Lange was one ofthe researchers in the trial, interviewed for a 1992 British television documentary:
The patients, needless to say, often found out what they were taking by such clues. But they had other methods. For one thing, the AZT and placebo pills tasted different at the study's beginning. When doctors finally caught some patients tasting each other's pills, they fixed the problem. This came too late, of course, for full damage control. The patients who missed this opportunity discovered other ways around the controls. According to Christopher Babick, an AIDS activist with the People With AIDS Coalition:
The patients had bought the early rumors of AZT's incredible healing powers, and they really did not want to take a placebo. Some of the placebo group secretly did use AZT, explaining the presence of its toxic "side effects" among those patients. The AIDS activist group Project Inform, originally an opponent of AZT, tried to dislodge the trial's internal working papers to confirm that the "placebo group" members with toxicity symptoms had used AZT; despite invoking the Freedom of Information Act, they never could get the documents released. The trial's organizers pulled one final stunt to help AZT succeed. The original plan had called for each patient to participate for six months.
But long before the sixmonth "doubleblind, placebo controlled trial" was over, the "blinded," researchers saw that theAZT group was doing better than the placebo group. How did they see this,if the study was blinded? The researchers could monitor the tally of AZT versus placebo either by AZT's toxicity or by something else.
As soon as the tally appeared to favor AZT over the placebo, the FDA oversight committee aborted the trial. Insisting they were acting on ethical considerations, the organizers immediately provided AZT to all patients. Patients spent an average of about four months in the original study, some less than one month. The final analysis included all patients, with projected guesses to fill the gaps in the data. As the followup study later observed, the death rate among the original AZT group quickly caught upto the former placebo group. (33) Had the trial not been unblinded, or had the FDA chosen to wait the full six months, the relative death rates would have looked radically different. In any case, Fischl's pretense of doubleblind controls smacks of dishonesty. (34)
Once the controls broke down, the study began to unravel. While some"placebo" recipients were actually taking AZT, some of the "AZT"recipients were being taken off the drug. Many of the patients simply could not tolerate AZT, and the physicians had to do something to save their lives. "Drug therapy was temporarily discontinued or the frequency of doses decreased... if severe adverse reactions were noted," admitted Fischl in the fine print of her paper. "The study medication was withdrawn if unacceptable toxic effects or a [cancer] requiring therapy developed."(35) This astonishing slip reveals that the doctors did indeed know who was using AZT. But never did Fischl tell how many "AZT" patients were taken off the drug, nor for how long.
Other patients dropped out of the trial altogether. Some 15 percent of the AZT group disappeared, possibly including patients with the most severe toxic effects. Fischl and her collaborators never bothered accounting for the loss, fueling the suspicion that they could have even dropped the sickest patients themselves.
This is a likelier possibility than it first sounds. Author John Lauritsen succeeded in obtaining documents released under the Freedom of Information Act and found many examples of incomplete or altered data. Causes of death were never verified, as by autopsy, and report forms often listed "suspected" reasons. (36) Naturally, Fischl and colleagues tended to assume that diseases in the placebo group were AIDSrelated, while assuming diseases in the AZT group were not. The symptom report forms looked even worse. Mysterious changes appeared, often weeks after the initial report for a given patient,including scratching out the original symptoms. The unexplained tamperings generally had no initials indicating approval by the head researcher. Other symptom reports were copied onto new forms but often lacked the original form for comparison. And on some forms reporting toxic effects of AZT, the symptoms were crossed out months later.
During the trial, an FDA visit to one of the test hospitals in Boston uncovered suspicious problems. "The FDA inspector found multiple deviations from standard protocol procedure," an FDA official later commented,"and she recommended that data from this center be excluded from the analysis of the multicenter trial." (37) Months after the trial hadfinished, the FDA finally decided to inspect the other eleven centers.By then much of the evidence had been lost in the confusion. Far too many patients had been affected by test rule violations, and the FDA ultimately chose to use all of the data, good or bad, including data from the Boston center. One FDA official let the cat out of the bag on the hopeless mess:"Whatever the 'real' data may be, clearly patients in this study, both on AZT and placebo, reported many disease symptoms/possible adverse drug experiences." (38)
Other than allegedly reducing death, the Phase II trial made two other claims on behalf of AZT: (1) It raised the Tcell levels of immunedeficient AIDS patients and reduced the number of opportunistic infections they suffered. All testing violations aside, AZT can temporarily raise Tcell counts. So can various other poisons and even severe bleeding after a long period.When some tissue is attacked by a toxin, or blood is lost due to an accident, the body tends to overcompensate for the loss by producing too many replacements-as long as it can. (39) At some point even the ability to replace white bloodcells becomes overtaxed and the Tcell counts collapse downward, exactly as observed in the Fischl study. A temporary increase in Tcells does not necessarily indicate the patient is improving. (40) (2) AZT blocks DNA production, not only in human Tcells or retroviruses, but also in any bacteria that might exist in the body. Thus, it can act as an indiscriminate antibiotic, killing opportunistic infections while destroying the immune system. Even Burroughs Wellcome had previously billed the drug as an antibacterial.This effect could explain the lower number of such infections in the AZT group. But the effect lasts only a short time; once the body's immune systemis devastated by AZT, the microbes take over permanently.
Ignoring all the chaos, the FDA approved the drug on the basis of this experiment. Apparently, the strategy of involving many medical researchers from many institutions had paid off. There was only one critical voice questioning a therapy that infiltrates a DNA chain terminator into human bodies indefinitely, the voice of the retired bacteriologist Seymour Cohen:
Several leading scientists, even virologists, also felt uneasy about the whole affair. But they preferred to remain silent or restricted their concerns to informal comments to the press. For example, Jay Levy at theUniversity of California at San Francisco had been one of the first scientists to isolate HIV. A Newsday article described his comments on the drug: "I think AZT can only hasten the demise of the individual. It's an immune disease," he said, "and AZT only further harms an already decimated immune system." (43) Even Jerome Groopman, one of the PhaseII participating scientists, harbored serious reservations. The head of a research group at a prominent Boston hospital, he quickly discovered the effects of AZT on his patients. "When Groopman gave it to 14 patients on a compassionate basis, only 2 were still able to take it after 3 months.'We found it nearly impossible to keep patients on the drug,' Groopmansays." (43)
Sam Broder, on the other hand, never seemed to entertain a second thought."When the Wright Brothers took off in their first airplane it probably would have been inappropriate to begin a discussion of airline safety,"he nonchalantly told the Presidential HIV Commission in 1988. (44)
But Martin Delaney, founder and head of the AIDS activist group Project Inform, San Francisco, was furious:
David Barry had already negotiated behind closed doors with the FDA for rapid approval. He held a strong bargaining position, given the political climate. (46) But even that took too long for him, and he demanded special permission for Burroughs Wellcome to sell AZT while waiting for the official approval. FDA officials scrambled for an answer, dredging up a permit known as the Treatment IND. This method had almost never been used. Within days the technicalities were ironed out, and Barry had his permit to sell.
Next, he had to get the official permission. He wanted it fast, and based on less scientific data than normally required. Again the FDA complied, cutting the process down to several months. Even AZT studies on mice were dropped from the requirements. The final hurdle lay in a meeting of an advisory committee of scientists and doctors, whose recommendation would likely determine AZT's fate. The panel met for a single day in Januaryof 1987. The dice were loaded in his favor, for two of the eleven panel members were paid consultants for Burroughs Wellcome. (47) The FDA granted special permission for those two researchers to remain on the committee with full voting powers. (48)
Dozens of scientists from the Phase II trials showed up to argue their case, packing the room with virtual cheerleaders. They spent hour after hour flashing huge quantities of data past the committee, some of it so new that no one had had the time to review it beforehand. The followup results on the patients, showing higher death rates after everyone wenton AZT, were cleverly buried in an avalanche of confusing statistics. Dazed, the members of the committee began to feel anxious that something had gone wrong in the testing process. Then Barry played his ace: a highranking FDA official, Paul Parkman, showed up and spoke, despite not having been scheduled to do so. After only a minute of suggesting most of the panel's concerns could be addressed, Parkman closed with a dramatic statement:"I think we can probably arrive at a plan that will satisfy people here." (49) Suddenly, the arguments stopped, and the mood shifted from opposition to support for AZT. FDA officials had never before interfered in these meetings, and the entire committee was shocked. "Did you hear that?" the panel chairman said to an associate. "He's telling us to approve it." (50)
Few in the room knew that Parkman was a personal friend of Barry; they had once worked together on virology projects. The panel ended up recommendingAZT, with only the chairman voting against it. Burroughs Wellcome quickly patented the drug, something no one else had ever bothered to do.
The FDA endorsement could seem a cruel joke perpetrated by heartlessAIDS scientists. Patients on AZT receive little more than white capsules surrounded by a blue band. But every time lab researchers order another batch for experimentation, they receive a bottle with a special label. A skullandcrossbones symbol appears on a background of bright orange, signifying an unusual chemical hazard. The label appears on bottles containing as little as 25 milligrams of AZT, a small fraction (1/20 to1/50) of a patient's daily prescribed dose. The adjoining warning on the label reveals secrets not conveyed to the unwitting patient: "TOXIC. Toxic by inhalation, in contact with skin and if swallowed. Target organ(s):Blood Bone marrow. If you feel unwell, seek medical advice (show the label where possible). Wear suitable protective clothing." (51)
ddI and other DNA chain terminators claim a piece of AZT's action
A different pharmaceutical giant, BristolMyers Squibb, produced another DNA chain terminator, ddI. The company sorely wanted to pull this drug off the shelf and into production, hoping to get a piece of the action from Burroughs Wellcome. Sam Broder, after working in the mid1980s to promote AZT, was only too happy to help along any such chemotherapy. He performed lab experiments on cultured cells, again wrongly trying to argue that the drug blocked HIV production more effectively than it killed Tcells.
BristolMyers began sponsoring research on AIDS patients. But they performed no controlled study, never comparing ddI's effects to placebo in matched groups. (52) The studies did, however, reveal a couple of additional toxic reactions not produced by AZT. It can cause fatal damage to the pancreas, and it can destroy nerves throughout the body. (53) On an experimental basis, a number of doctors began giving ddI to thousands of AIDS patients who could not tolerate AZT. Hundreds of unexplained deaths occurred among these patients, but the FDA managed to quell growing concerns. (54)
The FDA advisory committee, meeting to vote on ddI's approval, convened in July 1991. On that day, the panel reviewed the sloppily gathered data on the drug, which was compared to unmatched and untreated AIDS patients from years earlier. On this questionable basis, the committee was told ddI worked as well as AZT. Given the astonishing lack of a controlled study, the panel leaned against approval. That is, until FDA director David Kessler personally intervened on behalf of ddI and pressured the committee to "be creative." (55) The members changed their minds, voting to license the drug, albeit with restrictions. Doctors could prescribe it only for patients they felt did not benefit from AZT, leaving ddI as a secondary treatment and the second drug ever to win "fasttrack" FDA approval.
But even four years after its approval for human consumption, Anthony Fauci, director for AIDS research at the National Institute of Allergy and Infectious Diseases (NIAID), stated to the New York Times: "ddI had never been compared with a placebo in a large study." (56)
Since that time, the AIDS establishment has backed yet other DNA chainterminating chemotherapies, including dideoxycytidine (ddC), a drug also developedby Jerome Horwitz in the 1960s and now marketed by HoffmannLa Roche. The FDA has approved ddC, but only for use in combination with AZT or ddI.
The consensus dissolves
In the years following AZT's approval, a flood of studies on AIDS patients have poured forth, illustrating frightening toxicity. None have included placebo groups, an omission rationalized by ethical concerns that patients should not be denied such a miracle drug. But the numbers speak for themselves.
Two years after the end of the Fischl Phase II trial, a group of French physicians working at the Claude Bernard Hospital in Paris published another study on hundreds of AIDS patients. All used highdose AZT for an average of seven months. Onethird of the patients experienced a worsening of their AIDS conditions, and a slightly higher percentage developed newAIDS diseases. By nine months, one of every five patients had died, a rate far higher than in the Fischl study, which also used the high dose. "The bone marrow toxicity of AZT and the frequent need for other drugs with hematological [blood] toxicity meant that the scheduled AZT regimen could be maintained in only a few patients," wrote the authors. This has matched other findings; in most studies, half of any group of people suffer an immediate reaction so severe that they must stop. The French doctors cast a cloud of pessimism, noting that "in AIDS and ARC patients, the rationale for adhering to highdose regimens of AZT, which in many instances leads to toxicity and interruption of treatment, seems questionable."(57)
In England, one group of researchers described the medical consequences of AZT in thirteen patients; all thirteen developed severe anemia (Mirand Costello). A subsequent Australian study reported the consequences of treating more than three hundred patients for one to oneandahalf years. More than half developed a new AIDS disease during the first year, and exactly half needed blood transfusions to survive. Nearly onethird died. A Dutch study found still deadlier results: After little more than a year, most of their ninetyone patients needed blood transfusions and almost threequarters died. The Dutch researchers despaired at prescribing AZT, warning that most of their patients simply could not stay on the drug for loss of blood cells. (58)
A new complication surfaced in 1990. The National Cancer Institute analyzed the status of AIDS patients who had participated in Broder's Phase I trial and uncovered the fact that of all the people using AZT for three years, half were developing lymphoma. (59) This is a deadly cancer of white bloodcells, akin to leukemia but forming solid tumors in the body, and also happens to be included on the official list of AIDS diseases blamed on HIV. Since AZT was killing and damaging those same white blood cells, the drug stood out as the likely culprit. Virus hunters rushed to the drug's defense. Some massaged the statistics to lower the lymphoma rate, while others turned the news completely upside down by claiming AZT actually helped patients live longer-long enough to get lymphoma! (60) Paul Volberding, one of the leading organizers in the Phase II trial, told one interviewer,"So we see the Iymphomas as an unfortunate reflection of our success at this point rather than a reason for real caution." (61)
Certainly AIDS officials can hardly be accused of caution when it comes to AZT. Nor does their explanation wash, since only 3 percent of all AIDS patients tend to get lymphoma as their AIDSdefining disease (62)_not (50) percent as in Broder's AZT trial. AZT, furthermore, has given evidence of cancercausing abilities when tested. (63)
A few small studies have tested the reverse to see what happens to AIDS patients who stop AZT use. In one group of four patients who developed massive blood cell loss weeks after starting AZT, three recovered after the doctor took all four off the drug. (64) Another group of five patients suffered muscle wasting, a symptom that disappeared in four cases only a couple of weeks after stopping AZT; two of these patients lapsed back into the condition after restarting the drug. (65) In the most dramatic such experiment, a doctor took eleven of his worsening AIDS patients off AZT. The immune systems of ten immediately rebounded, and several continued improving. (66)
Yet no amount of warning data could dissuade AIDS officials from abandoning their 'antiviral" compound. Having won approval for treating AIDS patients, Burroughs Wellcome and the NIH moved to have AZT recommended as a preventive drug, for HIVpositive people without symptoms. This time Anthony Fauci directed the experiment as a project of NIAID, the NIH division he headed. Burroughs Wellcome again financed much of the study, paying hospitals for participating, and several of its consultants again joined in. Margaret Fischl and many other Phase II researchers signed up, and Paul Volberding secured the top position as organizer. But now a stupendous number of scientists were recruited: The final paper mentioned 130 authors,which Volberding called "a partial list." The investigators read like a who's who among leading virus hunters and medical doctors involved in AIDS research. With that many prominent researchers involved, few colleagues remained to act as independent reviewers. The study's political success was virtually guaranteed, regardless of its outcome.
Volberding and his colleagues enrolled more than thirteen hundred HIVpositive healthy persons from AIDS risk groups, none of whom had AIDS diseases.The subjects were divided into three groups- placebo, highdose AZT,and, because of growing worries about the drug's toxicity, a lowdoseAZT group. Protocol 019, as Fauci designated it, quickly degenerated into a repeat performance of the Phase II trial. More cancers, including Kaposi's sarcoma, occurred in the placebo group, hinting that more users of poppers or other recreational drugs may have ended up there, biasing the results in favor of AZT. The double blind controls broke down again, a fact that was covered up publicly. But in the text of the paper, Volberding acknowledged that the dropout patients tended to come from the AZT treatment groups, removing some of the sickest victims. Having also anticipated sharing ofAZT between patients, he had their blood tested for the actual presence of the drug. Nine percent of the "placebo" group were caught with traces of AZT, while almost 20 percent of the AZT groups showed no evidence of ever having used the drug.
The study was terminated early, after patients had been treated for an average of one year. The final analysis showed the AZT groups with fewer AIDS diagnoses than the placebo, but the toxic "side effects"of AZT swamped this small difference. The low dose group had as many sick people as the placebo group, although their blood disorders and immune deficiencies were not called "AIDS." The highdose group suffered by far the most, having dozens of deathly ill patients. (67) By calling diseases in the placebo group "AIDS," while avoiding that diagnosis for the AZT groups, Volberding successfully won an FDA recommendation for using the drug on healthy HIVpositive people.
In 1994 Volberding published a stunning aftermath to Protocol 019. TheTcells of 29 percent of the men in the placebo group had increased gradually over two years, while those of the AZT recipients had decreased.(68) It is probable that under clinical surveillance the 29 percent whoseTcells increased, despite the presence of the alleged Tcell killerHIV(!), had given up or reduced their recreational drug use.
After studying patients for another five years, Volberding, the father of AZT prophylaxis, came to a new conclusion about AZT: "Zidovudine[AZT]... does not significantly prolong either AIDSfree or overall survival." (69) Stated otherwise, hundreds of thousands of healthy people had taken AZT for five years for no "significant" reason, assuming that DNA chain termination is indeed "not significant."
In an article entitled "Early Intervention: An Idea Whose Time Has Gone?" the New York Native writes on Volberding's latest insight: "The same group of people that has continued to insist that 'early intervention' with AZT is necessary and beneficial- despite data showing that people who take AZT earlier also die earlier and that their quality of life is so diminished as to negate completely any alleged benefits from AZT- have now published research showing that, after all, AZT does not prevent progression to 'AIDS, or delay death. The magnitude of this aboutface cannot be overstated." (70)
Not totally convinced by Volberding's original trial, other researchers put together two longterm studies on AZT's preventive effects. An American research group sponsored by the Department of Veterans Affairs ran a twoyear trial comparing patients who used AZT before symptoms (the "early" group) to those using it afterward (the "late"group). These scientists found that the early group actually died slightly more often and a bit faster than the late group, but the differences were small. They concluded AZT showed no survival benefits whatsoever when used for prevention. (71) The news hit the stock market with force, knocking down the value of Burroughs Wellcome shares some 10 percent in one day.
British and French scientists organized a similar study, known as the Concorde trial, while Volberding's study was still in progress.The Concorde study treated two groups with AZT, one before AIDS symptoms (the early group) and the other after (the late group). Only people withoutAIDS symptoms were recruited into the study, the late group receiving a placebo until after they contracted AIDS. Apparently, the researchers were seeing enormous toxicity as the study progressed, for midway through, a minor crisis erupted. The scientists became divided over whether to continue or abort early. At a meeting behind closed doors, an audience member secretly recorded Chairman Ian Weller as he voiced the increasing concerns: "If there is benefit [to AZT therapy], is it maintained, or will it wear off? In which case we may do more harm than good." (72) The study organizers voted to continue, albeit nervously.
After each patient had participated for three years, the researchers came out in 1994 to announce publicly that they could find no difference in survival between the early and late treatment groups. In reality, the early AZT group had done worse than estimated. The death rate in the AZT group was 25 percent higher than in the control group hardly a recommendation for AZT prophylaxia. (73) The doubleblind controls again seem to have dissipated, for symptomfree patients could easily know they were on AZT by its potent toxicity. Many of these AZT patients could no longer tolerate the nausea, vomiting, and anemia, but they did not have the courage to confront their doctors. So, according to at least one report, "They have thrown their tablets down the toilet." (74) This would artificially lower some of the apparent toxicity in the early group.
But the news of no positive benefits did stun the AIDS establishmentsi n all countries, sending various officials scrambling for excuses to explain away the Concorde results. This study has provided the heaviest blow yet against AZT, and the first signs of retreat are beginning to emerge. Based on a preliminary report on the Concorde study, on June 25, 1993, an NIH panel formally announced new guidelines for AZT use, recommending that doctors and patients use more caution. "AZT has benefits, but we are admitting that it is not as good a drug as we thought it was," said the committee chairman. (75)
Further bad news came from America. One investigation of AZT, as prophylaxis against AIDS dementia, showed in 1994 that contrary to expectation- therewas twice as much dementia in AZTtreated homosexuals than in untreated counterparts. (76) Also in 1994, a large American study reached an even more damning verdict on AZT prophylaxis. It found that HIVpositive hemophiliacs had 2.4 times higher mortality and a fouranda halftimes higher AIDS risk rate than untreated HIVpositive hemophiliacs. (77) It may not have been just a coincidence that Sam Broder resigned, apparently, at the height of his career, as director of the National Cancer Institute in December 1994. (78)
In April 1995 an American study found that AZT treatment doubled or quadrupled the risk for HIVpositive male homosexuals to develop Pneumocystis pneumonia. (79) In July 1995 the British Medical Journal publishedthat AZT prophylaxis reduces the time to death of HIVpositive AIDS patients from three years without AZT to two years with AZT. (80)
The emerging concerns about AZT treatment are summarized dramaticallyin a letter from a German doctor to the editor of Nature:
In his response to Koehnlein, John Maddox, the editor of Nature, wrote on September 20, 1995:
American gay activists from ACT UP San Francisco who used to conformwith the HIV orthodoxy have recently also begun to protest AZT therapy with violence. Crashing the tenyear anniversary party of Martin Delaney'sAIDS organization, Project Inform, and turning over tables at the plush Hyatt Regency Hotel in San Francisco, protesters shouted into the faces of Delaney and his guests Larry Kramer and Anthony Fauci: "Tony Fauci, you killed our friends! This is where the murder ends!"
According to Spin reporter Celia Farber, the protesters picked the occasion because "Project Inform, they insist, has become so entrenched with authoritarian, establishment, oldboynetwork views on AIDS that it has betrayed the community." (81)
In a press release the ACT UP protesters listed their complaints of May 6, 1995:
On July 22, 1995, even the establishment media sent out a signal of distress. The New York Times published the following letter condemning AZT studies:
Considering the faithful commitment of the New York Times to the HIV orthodoxy since 1984, the publication of this letter assumes outstanding significance. In this era of centralized, government sponsored science,an article against politically correct science can be fatal for a journalist. In such a climate the publication of a letter is a journal's last resort of expressing a dissenting opinion.
AZT, known for decades as a failed and toxic cancer chemotherapy, was resurrected for political reasons and rushed through the FDA's first fasttrack approval. By its very nature, such a drug could only worsen AIDS, if not cause some AIDS diseases by itself. (84) One experiment after another, despite flaws, has confirmed the drug's toxicity in humans, yet only now is the AIDS establishment slowly backing down. The virus hunters bring tremendous political and financial momentum behind each of their projects, and AIDS treatment is no exception.
Preventing HIV infection - the last stand of the AZT lobby
The recent growth of opposition to AZT may save lives in the future, but it is coming too late for some victims. Convinced of the drug's alleged success, the AIDS establishment has aggressively promoted AZT wherever it could despite the drug's poor performance. Often the treatment is paid for by one federal program or another, creating an indirect subsidy of Burroughs Wellcome by the taxpayers. In 1992 at least 180,000 people worldwide took the drug every day. (85)
Frustrated with its failures to cure AIDS, and then even to prevent it, the AZT lobby has concentrated on a last front to save its drug: the prevention of infection. As usual in the rush to "save lives" there was no time for theory. To prevent HIV infection, a drug would have to shut down all cell growth in the body for several weeks. This is because retroviruses like HIV depend on cell division for reproduction and therefore infection. If only a few cells continue to divide, the defense against HIV would be useless. But to achieve a complete shutdown of cell division, so much AZT must be administered that survival is impossible. Even the highest doses ever prescribed would not suffice. Given the choice between lethal doses of AZT that could prevent infection but would likely kill the patient and not to use AZT at all, the AZT establishment chose to compromise. By treating with the known doses, most patients would survive long enough to obscure all drugmediated diseases by HIVmediated diseases that are "expected" to occur late after infection.
The early months of 1989 brought an unusual notice posted in the buildings of the NIH. Entitled "HIV Safety Notice," it announced a new policy established by the director himself. Any employee of the NIH who underwent accidental exposure to HIV, as for example by a needlestick injury, would be offered preventive AZT. According to the notice, "The advisory group in providing their recommendations emphasized that administrationof AZT should be initiated as soon as possible, preferably within hours following the exposure." (86) Only first aid for the injury itself would precede AZT. Numerous medical institutions have since adopted this policy, and a 1993 report in Lancet revealed the practical application. The paper described a doctor who was accidentally stuck by a needle and thus exposed to HIVinfected blood. The doctor began taking AZT within the hour, and continued for six weeks- too quickly even to do an HIV test.(87) Thus, medical workers may use AZT even if they never become infected with HIV. (88) But this doctor became HIVpositive despite the toxic prophylaxis.
A second and more disturbing announcement reached the public in the summer of 1989. NIAID, the NIH division under Anthony Fauci, declared it would be conducting trials of AZT on pregnant mothers infected with HIV. A drug that interferes with growth can lead only to physical deformities in babies developing in the womb. The study, financed through the NIH budget, ironically recruited mothers who had been injection drug addicts. Apparently Fauci believes heroin addiction poses less of a threat to children than does HIV; some of their babies, moreover, may never even contract the virus from their mothers but will receive AZT anyway. Following his lead, the French joined Fauci's trial, and the British government, in 1993, beganon its own a study of AZT effects on HIVpositive babies. (89)
However, to prescribe a known mutagenic drug to a pregnant woman was a risky departure from the foremost medical principle,: "First, do no harm." According to AIDS reporter Celia Farber in April 1995:
In February of 1994, Fauci's AmericanFrench trial on pregnant women was abruptly terminated. Fauci and his collaborators claimed victory becauseAZT had reduced "maternal HIV transmission rate by twothirds"- from25 percent without treatment to 8 percent with AZT treatment. (91) This euphemism was chosen for the net result that out of 180 babies born toAZTtreated mothers, 13 had been found HIVpositive, compared to 40 out of 184 born to placebotreated mothers. (93) In other words, to save 27 babies (17%) from HIV infection, 180 mothers and 153 of their unborn infants (who either did not pick up HIV from their mothers or picked it up despite AZT) were first treated for six to twenty weeks every five hours with 100 mg AZT and then again intravenously during delivery. In addition, the newborn babies were given 2 mg AZT every six hours for the first six weeks of their lives. (93)
In view of the possible genetic damage from AZT, Fauci acknowledged "longterm follow up of all of the children... is essential to learn more about the risks and benefits of the treatment beyond these encouraging early results." Recommendations on treatment were said to be "pending developments of consensus on the balance between known benefits and unknown risks." (94)
There is of course a double irony in this apparent caution. First, the benefit of being HIVfree is currently not known, because there is no proof that HIV causes AIDS. (95) Second, the risk of AZT is certainly not "unknown"- thirty years after it was first developed to kill human cells for cancer chemotherapy.
After declaring victory against HIV transmission, the double blind controls were officially broken prematurely and AZT was offered to all mothers.(96) Clearly, the 124 primary and secondary authors of the maternal transmission study achieved "consensus" on playing down the "adverse experiences" of babies on AZT, acknowledging only that the level of "hemoglobin at birth in the infants in the Zidovudine group was significantly lower than in the infants in the placebo group." (97) However, the "neutropenia, high bilirubin levels, and anemia" reported prior to final publication (98) were not documented in the consensus paper. (99)The AZTinduced neutropenia, the medical term for a critical shortage of the majority of immune cells in the blood, could very well be the explanation for the AZTmediated reduction of HIV transmission. Since HIV replicates in blood cells, and blood cell synthesis is inhibited by AZT, it is no surprise that HIV is less likely to be transmitted if the cells in which it replicates are killed by AZT, both in the mother and the unborn child.
An editorial in Lancet did not share Fauci's optimism: "The most worrisome aspect is the possibility of longterm adverse effects on children exposed to Zidovudine (AZT) during fetal life, especially since the vast majority would not have been infected anyway." (100) Indeed,the asyetunpublished side effects of the AmericanFrench study confirm this sinister projection. According to Farber's article:"There were two birth defects: One had extra digits and a heart defect, the second had an extra digit on both hands. The report concluded that neither case was related to AZT therapy." (101)
A formal request by the New York Native for an official account of the unpublished birth defects was denied by the Assistant Secretary for Health, Dr. Philip R. Lee. Lee advised the reporter on January 6, 1994, to "sue the federal government." (102)
But a study from outside the United States provided a clearer picture: Eight spontaneous abortions, eight "therapeutic", abortions, and eight serious birth defects including extra digits were recorded among babies of 104 HIVpositive pregnant women treated with AZT. (103)
The trust in medical authority breaks down
Long-term survivors of AIDS know better than to use AZT. Michael Callen was diagnosed with fullblown AIDS in 1982 before HIV had even been isolated. Given little time to live, he discovered Joe Sonnabend and switched doctors. Callen had participated in the fasttrack homosexual scene for a decade, including sex with more than three thousand partners and the attendant drug abuse. His lifestyle changed radically on Sonnabend's advice, although he began taking enormous amounts of antibiotics and sulfadrugs. Because of his cleanedup lifestyle and his ongoing refusal to take AZT, Callen lived twelve years with an AIDS diagnosis until he died with pulmonary Kaposi's sarcoma in 1994. He told his story in his1990 book Surviving AIDS, along with the stories of several other longterm survivors who tend to avoid AZT. For that matter, the CDC estimated that one million Americans had HIV by 1985, but twothirds of those have not developed AIDS at all in the past ten years. Most HIVpositives have never received AZT.
In New York, Michael Ellner runs a selfhelp group to help AIDS patients live. Named HEAL (HealthEducationAIDS Liaison), it strongly advises members against AZT. And a 1990 article in Parade magazine profiled thirteen AIDS cases who had survived their diagnosis for five years. They rejected AZT as counter productive. "It's incredible, isn't it, that the drug designed to save you can also kill you," says Mike Leonard, a survivor. "It can make you anemic, and you end up having to get blood transfusions." (104)
In London HIVpositive male homosexuals ar risk for AIDS formed a survivor group called "Continuum." In August 1993 there was no mortality during 1.25 years in all 918 members of that group who had "avoided the experimental medications on offer" and chose to"abstain from or significantly reduce their use of recreational drugs, including alcohol." (105) Assuming an average tenyear latent period from HIV to AIDS, the virusAIDS hypothesis would have predicted at least 58 (half of 918/10 x 1.25) AIDS cases among 918 HIVpositives over 1.25 years. Indeed, the absence of mortality in this group over 1.25 years corresponds to a minimal latent period from HIV to AIDS of more than 1,148 (918 x 1.25) years. As of July 1, 1994, there was still not one singleAIDS case in this group of 918 HIVpositive homosexuals. (106)
Other individuals began to take their health in their own hands ratherthan rely on medical authority for the "treatment" of HIV. Interms of notoriety, the list is led by one of the nation's top basketballstars, Earvin '"Magic" Johnson. In November 1991, Magic proved to be HIVpositive when he applied for a marriage license. Magic was totally healthy until AIDS specialists Anthony Fauci, from the NIH, DavidHo, now director of the Aaron Diamond AIDS Research Center in New York, and Magic's personal doctor advised AIDS prophylaxis with AZT. Magic's health changed radically within a few days. The press wrote in December1991: "Magic Reeling as Worst Nightmare Comes True- He's Getting Sicker."Only after he began taking AZT did Magic's health begin to decline. He"had lost his appetite and suffered from bouts of nausea and fatigue "and complained. "I feel like vomiting almost every day." (107)
But then suddenly Magic's AIDS symptoms disappeared- and so did all further news about his AIDS symptoms and treatment. Had Magic's virus suddenly become harmless, or was Magic taken off AZT? No paper would mention whether Magic was taken off AZT. Nobody knew, except those who joked, "There is no magic in AZT, and there is no AZT in Magic.," Indeed. it is very unlikely that he could have won the Olympics in 1992 on AZT, considering his strong reactions to the toxic drug in 1991. The silence of the AIDS establishment seems to confirm this assumption. Nothing would have beena better advertisement for the troubled AIDS drug than having returned AIDS patient Magic to an Olympic victory. But no such announcement was made. At last Magic broke the silence himself. After a "motivational" AIDS talk in Tallahassee, Florida, in the spring of 1995, Magic responded to a teacher that "He had been taking AZT for a while, but has stopped."(108) The media preferred not to mention the news.
About six years earlier another young man fought the battle of his life,having been discharged by the U.S. Navy for being HIV antibodypositive. Raphael Lombardo has won his oneman campaign against the Navy and the AIDS establishment all by himself. His letter proves that true science does not depend on institutional authority:
The stories of those who believed in AZT
Not all AIDS victims are fortunate enough to question medical authority. The resulting tragedies can sometimes turn into a media circus promoting the HIV hypothesis. Of all the cases hyped up for their AIDS scare value, the Florida woman who supposedly caught AIDS from her dentist has becomethe most notorious.
Kimberly Bergalis: The story began in late 1986, in the small town of Stuart on Florida's Atlantic coast. David Acer, a dentist who had begun his private practice five years earlier, felt a bit under the weather and saw a physician. Acer was also an active homosexual, a fact that led him to seek an HIV test. The result came back positive. Although disturbed by the news, he still felt reasonably healthy and saw no reason to stop his dental practice, nor apparently his fasttrack lifestyle.
One year later he experienced worsening symptoms and a visit to his doctor confirmed the diagnosis: fullblown AIDS. A Kaposi's sarcoma covered the inside of his throat and his Tcell count had fallen dangerously low. Both symptoms suggested the extensive use of poppers and other drugs so common in the homosexual bathhouse scene. Acer could see his life slowly wasting away. He continued practicing dentistry while remaining discreet about his sexual life and failing health, making sure to follow the standard guidelines for protecting his patients from infection.
That December, in 1987, he pulled two molars from a nineteen yearold college student, Kimberly Bergalis. At the time he had no idea the business major would one day be touted as his hapless victim.
The story picks up again in May 1989, when Bergalis developed a transient oral yeast infection. Later that year, during the emotional stress of preparingfor an actuarial exam for the state of Florida, she felt some ongoing nausea,and she became dizzy during the test itself. Afterward, the symptoms disappeared. But a brief pneumonia that December sent her to the hospital, where the doctor decided out of the blue to test her for HIV. As chance would have it, she had antibodies against the virus.
Up to this point, none of her occasional diseases differed from the common health problems many HIVnegative people encounter. But the positive HIV test changed her whole attitude, as well as her medical treatment.Within three months the CDC had heard of her case, possibly aided by the presence of several EIS members in the Florida health department, and sent investigators to probe further. The CDC team included such EIS members as Harold Jaffe, Ruth Berkelman, and Carol Ciesielski. Bergalis denied any intravenous drug use or blood transfusions and insisted she was a virgin. During the prolonged examination, the CDC officers stumbled across David Acer's positive HIV status and made the connection to Bergalis. Before the HIV hypothesis of AIDS, no medical expert in his right mind would ever have entertained the slightest thought that a dentist with a Kaposi's tumor and a patient with a yeast infection had anything in common. But in the era of AIDS, doctors tended to discard common sense. That the dentist and patient both carried a dormant virus was enough.
Excited by its discovery, the CDC boldly advertised its results in its weekly newsletter, the same one that nine years earlier had broadcast the first five AIDS cases. The July 27, 1990, issue prominently featured their amazing leap of logic- that the dentist must somehow have infected Bergalis. Naturally, the CDC's speculation leapt straight to the front pages and primetime television news broadcasts.
Acer died in early September 1990. Bergalis meanwhile sought medical care at the University of Miami, where she was treated with an unidentified "experimental" method. Certainly this was the appropriate place for such therapies. Margaret Fischl, the head of the Phase II AZT trial, worked at that medical center, which had served as one of the twelve facilities sponsored by Burroughs Wellcome for the study. So Bergalis was prescribed AZT. (110)
Suddenly she started a precipitous decline in health. In an angry letter, she partly acknowledged her symptoms resulted from the toxic drug:
This represented only the beginning. Her yeast infection worsened and became uncontrollable, she lost more than thirty pounds, her hair gradually fell out, her blood cells died and had to be replaced with transfusions, and her muscles wasted away. Her fevers hit highs of 103 degrees, and by late 1990 her Tcell count had dropped from the average of 1,000 to a mere 43. She looked just like a chemotherapy patient which she now was.
The CDC saw its golden opportunity in the Bergalis case. It publicized a second report on the Bergalis case, announcing its belief that four of Dr. Acer's other patients had also been infected by him, and even surveyed the patients of other HIVpositive doctors and dentists suggesting that all HIVpositive patients had also been infected by their doctors. Such CDCfunded organizations as Americans for a Sound AIDS Policy aggressively promoted public fear with these speculations. A media feeding frenzy resulted, with every major television talk show, and every national magazine, running scare stories. (113) The CDC's relentless publicity had its expected effect: By mid1991, more than 90 percent of the public believed HIVpositive doctors should be forced to inform their patients of their status, and a clear majority favored banning such doctors from medical practice. (113) Many doctors, angered by the publicity campaign,"accused the federal Centers for Disease Control of unduly alarming the public." (114)
The CDC certainly had an agenda behind its campaign. In July of 1991, the agency issued a set of proposed rules that would require doctors to follow extraordinarily burdensome measures. supposedly to protect their patients from HIV infection. By hyping up the Bergalis case, the CDC had created enough public panic and backlash to favor its proposed regulations. To dramatize the point, Bergalis was brought in to testify before a stunned Senate in October of 1991. Her muscles largely destroyed by AZT, she had to be brought in a wheelchair. Her furious testimony, whispered into the microphone, made a powerful emotional impact on the attentive congressmen and the television audience.
Congress soon passed a new law requiring the states to adopt the CDC guidelines-or else begin losing federal funds. When the medical profession resisted the new rules, the Occupational Safety and Health Administration (OSHA), which works closely with the CDC, stepped in with parallel rules of its own. On threat of criminal prosecution, laboratory and medical workers must now follow incredibly restrictive regulations on their practices and equipment, and must deal with extra bureaucratic red tape.
Blaming her deteriorating condition on the latent virus supposedly passed on by her dentist, Bergalis sued the Acer estate. She received a $1 million award, plus unannounced compensation from the dentist's insurance company. She parceled out the money to a variety of friends, family members, andAIDS organizations, and told her father to purchase '"a new, red Porsche and deliver it to my aunt with a large bow on top." (115) Had sheknown better, she could have instead sued Burroughs Wellcome.
Bergalis died in December 1991 at twentythree years of age, having taken AZT for up to two years. Her death became the ultimate symbol of the deadly powers of HIV. No one pointed out that, according to the HIV hypothesis, the virus should take ten years to kill its victims, particularly someone like Bergalis with no other risk factors. She had died within four years of her initial visit to Dr. Acer. As her symptoms would indicate,AZT must have killed her instead.
In December 1992, another former patient of Dr. Acer tested positive for HIV, but had no symptoms. Two months later, eighteenyearold Sherry Johnson began taking AZT. She has since begun wasting away, admitting she periodically feels sick.
The CDC continued to exploit the Bergalis story as proof of the risk of doctortopatient HIV transmission. Some eleven hundred of Acer's two thousand former clients volunteered for HIV tests. Seven of these were positive, including Bergalis, two of them having standard risk factors for AIDS. That left five people who supposedly caught the virus from Acer. Expanding its search, the CDC tested almost sixteen thousand total patientsof some thirty-two HIVpositive doctors around the country, finding eightyfour infected patients. Though admittedly baffled by how HIVcould pass from doctors and dentists to the patients, the CDC nonetheless advertised the alleged threat. Curiously, when confronted with an unexpected outcome for an unproved test, the CDC did not proceed with caution. It published its findings in July 1990 without further verification.
Apart from HIV being a harmless virus, the evidence that this virus has ever been medically transmitted remains dubious. Based on their own research, insurance companies concluded that the HIV strains in the five patients were different from that in Acer, meaning each caught it from a different source. (116) A study out of Florida State University has backed this conclusion. (117) Even the CDC acknowledged this evidence, thoughit still preferred to believe the dentist had infected Bergalis. But the CDC's own numbers give away the reality. An estimated 1 million Americans have HIV, in a total population of 250 million. Thus, 1 in 250 Americans have the virus. Five HIVinfected patients of Dr. Acer, out of 1,100 tested, comes to 1 in 220, virtually identical to the national average. So does the proportion of HIVpositives from the patients of the 32 doctors, which works out to 1 in 188. These HIV positive patients merely represent random samples from the general population.
And where did these people get the virus? HIV is probably transmitted much as other retroviruses, from mother to child during pregnancy. There is no evidence that Kimberly Bergalis's mother has never been tested for HIV antibodies, nor that the mothers of Dr. Acer's other patients were tested. Perhaps Kimberly carried the harmless virus for twenty-three years.
The CDC's theory that AIDS was transmitted from Dr. Acer to his patient began to crumble in the mainstream press in 1994 when an investigative reporter researched the alleged victims of Dr. Acer. "He found weak evidence, shoddy science, and the work of a very accomplished malpractice attorney." (118)
The report first casts doubt on the time course of AIDS transmission from Dr. Acer to his patients. "She developed AIDS just two years after the surgery, and only 1 percent of HIV positive patients develop the fullblown disease that quickly." (119) The investigation disclosed that one of the six other patients that Acer presumably infected had visited the dentist's office only once for a cleaning by a hygienist, not by Acer himself. (120) The report further calls into question the exclusive reliance of the CDC and the malpractice attorney of the "Acer six" on the DNA finger printing technique to match Acer's virus with those of his patients. This same technique had also been used to determine that the NIH researcher Gallo had claimed HIV obtained from his French rival Montagnier as his own. Several experts have directly challenged the DNA fingerprinting that linked Acer to his patients, claiming that instead Bergalis's virus matched other HIV strains much more closely. (121) In view of this, a writer in the New York Times commented, "The CDC owes it to the public to reopen [Acer's] case." (122)
The reinvestigation of the "Acer six" provides unknowingly yet another reason why the "CDC owes it to the public to reopen [this]case": It supports the hypothesis that AIDS is caused by recreational drugs and AZT. Only three of the "Acer six" have developed AIDS, and every one of them was on drugs: Bergalis was on AZT; a thirtyyearold male was involved with "drug dealers, and a homosexual relationship;" and another male was a "notorious crack head." (123)
While on AZT, Bergalis once told a reporter she hoped to also get dideoxyinosine(ddI), another experimental AIDS drug. This drug and ddC, two products of cancer chemotherapy research, work in precisely the same way as AZT. Chemically altered building blocks of DNA, they enter the growing chain of DNA while a cell is preparing to divide and abort the process by preventing new DNA building blocks from adding on. So, like AZT, ddI and ddC kill dividing cells and have similar toxic effects. They destroy white bloodcells and therefore can cause AIDS. The only difference between ddI, ddC, and AZT lies in how easily each is absorbed into the body; people who absorb one evidently may not be equally affected by the other.
Alison Gertz: Both ddI and ddC have begun to claim their victims. In 1988, twentytwoyearold New York socialite and aspiring graphic artist Alison Gertz entered the hospital for a fever and diarrhea. At some point the doctor decided to test for HIV and found antibodies against HIV. Gertz's transient illness was rediagnosed as AIDS. She had not injected drugs, although her wilder days at Studio 54 bespoke the cocaine and other free drugs available to patrons. A process of elimination traced her infection to a onenight stand with a bisexual male-six years earlier. The announcement left her feeling depressed, but she began a lecture circuit at high schools and colleges, admonishing students that AIDS could come from a single sexual encounter. Television talk shows followed, as did the cover of People magazine and Woman of the Year for Esquire. Even the World Health Organization circulated a documentary featuring her story.
Gertz started AZT treatment in 1989. The 1990 People magazine profile recounted the consequent disaster:
The doctors switched her to the stillexperimental ddI, which Gertz apparently did not absorb as well and thus allowed her partly to recover. She mixed the powder in her drink twice every day. Her immune system and general health declined, though more slowly. "Gertz remains susceptible to infections like thrush, a fungus that frequently affects the mouth," stated the People article. "She has lost 30 lbs. since last summer, naps each afternoon and continues to visit her doctor every 10 days." (125) Ultimately, the ravages of the chemotherapy took her life in August 1992, the news media advertising her death as AIDSrelated. She was only twentysix.
A backlash is now rising against the toxic and irrational treatment approaches to AIDS. In 1993, during the Ninth International AIDS Conference in Berlin, Germany, medical reporter Laurie Garrett was interviewed onthe MacNeilLehrer News Hour. She described the growing discontent among scientists and patients alike:
Arthur Ashe: This lesson almost saved the life of the late Arthur Ashe, the tennis star and onetime Wimbledon champion who died in 1993, supposedly of AIDS. Ashe's medical problems surfaced in 1979 with a heart attack, despite his young age of 36. In December he underwent quadruplebypass surgery. His chronic heart condition continued plaguing him, and by 1983 he had doublebypass surgery. A blood transfusion during either one of the operations may have carried HIV.
His heart condition and its complications nagged him for several years.Then in 1988 he entered the hospital for toxoplasmosis, a protozoa! disease relatively uncommon in humans. The germ resides in cattle and household pets, and in 17 percent to 50 percent of the U.S. population, but most people never succumb to the disease because of healthy immune systems.This also happens to be one of the many diseases on the AIDS list, so the doctor tested and found Ashe to be HIVpositive. Although his toxoplasmosis soon disappeared, Ashe was pronounced an AIDS victim. His disease was retroactively blamed on HIV, not on his heart condition.
Yet his condition hardly seemed contagious. Neither his wife nor his daughter, born three years after his second transfusion, ever developed any AIDS conditions. Indeed, his immune system must have neutralized HIV quite effectively, as Ashe never transmitted the virus to his family.
His daily medicine intake expanded to a virtual pharmacy. He continuedto take several drugs for his heart problems, one to lower cholesterol by interfering with liver function, another to slow down the heartbeat, and three others, including nitroglycerin, to lower blood pressure. To these his doctors added a spectrum of antibiotics, all with mild to serious side effects, to prevent the possibility of opportunistic infections. Ashe took Cleocin to fight further toxoplasmosis, nystatin to slow down yeast infections, and toxic pentamidine to stave off Pneumocystis pneumonia. Two other drugs were prescribed against possible brain seizures. Eventually his daily regimen included some thirty pills, only a few of them vitamins.
But just as soon as Ashe received his AIDS diagnosis in 1988, his doctor pushed him into taking AZT. He started on an unbelievably high dose, nearly double the seriously toxic levels used in the Phase II trial. His doctor only gradually lowered the dose over the next four years. "I refuse to dwell on how much damage I may have done to myself taking the higher dosage," Ashe later admitted. (127)
In early 1992 he established an acquaintance that came close to rescuing him. A close friend arranged a series of meetings with Gary Null, a NewYorkbased radio talk show host and nutritionist. Null introduced Ashe to the evidence of AZT's toxicity and against the HIVAIDS hypothesis, desperately trying to convince him to halt the therapy. For the next ten months, Ashe "'wrestled with the possibility of breaking away from the medical establishment to seek alternative treatment for AIDS," according to one columnist. Ashe never met Peter Duesberg, but became familiar with his arguments. "He read everything; he studied what we gave him and asked lots of questions," recalled Null. (128) In October, Ashe announced the lessons he was learning in a column he wrote for the Washington Post: "The confusion for AIDS patients like me is that there isa growing school of thought that HIV may not be the sole cause of AIDS, and that standard treatments such as AZT actually make matters worse. That there may very well be unknown cofactors but that the medical establishment is too rigid to change the direction of basic research and/or clinical trials." (139) But psychological pressure stopped Ashe short from rejecting AZT. As Null stated, "He wanted to do it, but he would say,"What will I tell my doctors?,"(130)
In his 1993 book, Days of Grace: A Memoir, Ashe openly acknowledgedhis interest in alternative AIDS hypotheses:
Ashe faithfully summarized the main points against the HIV hypothesis and for the drugAIDS hypothesis and explained the deadly effects of AZT and the flaws of its Phase II trial. "Some tolerate [AZT] for a while, then must give it up. Still others cannot tolerate it at all," wrote Ashe. "To my relief, I tolerate AZT fairly easily." (132) With that rationalization, he sealed his fate.
During 1992, his doctors placed him on ddI. Each morning he sprinkled the powder on his cereal, in addition to the AZT pills he swallowed throughout the day. By this time he was wasting away rapidly, his underweight frame hidden by loose clothes. He began rotating in and out of the hospital.January of the following year brought more bad news: Now he had a serious case of Pneumocystis pneumonia that his poisoned immune system could no longer fight off. He never recovered. On February 6, 1993, he breathed his last.
The list of celebrity AIDS patients who died on AZT for their belief in medical authority includes ballet star Rudolf Nureyev, who died in 1993, Randy Shilts, the author of the bestseller And the Band Played On, who died in 1994 and many more.
As a thoroughly politicized epidemic, AIDS began with a falsehood and ended in tragedy. Virus hunters in the CDCdirected public health movement first made the new syndrome appear contagious. Virus hunters in the NIHfunded research establishment then blamed AIDS on a retrovirus. And virus hunters in the NIH, CDC, FDA, and pharmaceutical industry exploited the situation by resurrecting failed cancer chemotherapeutic drugs for AIDS treatment. In the crisis atmosphere created by the CDC, which allowed no time to think before acting, such toxic drugs as AZT, ddI, and ddC could bypass the normal review procedures and achieve a sanctified monopoly status. The final results have been an unnecessary death toll and an artificially expanding AIDS epidemic.
To make all this possible, the virus hunters from all fields
first had to join forces. They have used their combined influence,
often behind the scenes, to mobilize the government, media, and
other institutions behind a global war on AIDS. Few outsiders
have realized just how coordinated the whole strategy has been.
The story behind this war, and how its leaders are actively suppressing
dissent, is told in the rest of the book Inventing the AIDS
Virus (Regnery Publ. Inc., Washington D.C. 1996). *
1. Physician's Desk Reference, 1993.