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Poisoning African mothers

Why is Africa testing nevirapine on breast feeding mothers?

Will South Africa hold out? Risks include death

A drug that achieved less than placebo, except for destroying the liver

skeletonsuit1.jpgIn March 2006, investigative AIDS reporter Celia Farber published a damning piece in Harpers magazine which exposed the corruption of NIAID administered research on a particularly nasty AIDS drug, nevirapine, a potentially deadly concoction aimed at preventing the harmless transmission of HIV from mother to baby in the womb.

The intensively checked article quoted the vicious side effects the drug is capable of bestowing on unlucky patients, up to and including death, and recounted the attempts of NIAID officials at manipulating the results of a Uganda study to suggest it was more safely effective than it was at preventing the transmission of HIV from mother to foetus than a placebo, which it wasn’t.

skeletonfire.jpgHafford was on the drug regimen for thirty-eight days. “Her health started to deteriorate from the moment she went on the drugs,” says King. “She was always in pain, constantly throwing up, and finally she got to the point where all she could do was lie down.” The sisters kept the news of Hafford’s HIV test and of the trial itself from their mother, and Hafford herself attributed her sickness and nausea to being pregnant. She was a cheerful person, a non-complainer, and was convinced that she was lucky to have gotten into this trial. “She said to me, ‘Nell’ —that’s what she called me—‘I have got to get through this. I can’t let my baby get this virus.’ I said, ‘Well, I understand that, but you’re awful sick.’ But she never expressed any fear because she thought this was going to keep her baby from being HIV positive. She didn’t even know she was in trouble.”

(For those who haven’t read this seminal expose of the skeletons under the suits of AIDS officials and researchers, here is the relevant excerpt:

Excerpt from Out of control: AIDS and the corruption of medical science

skeletonsuit.jpgJoyce Ann Hafford was a single mother living alone with her thirteen-year-old son, Jermal, in Memphis, Tennessee, when she learned that she was pregnant with her second child. She worked as a customer service representative at a company called CMC Call Center; her son was a top student, an athlete and musician. In April 2003, Hafford, four months pregnant, was urged by her obstetrician to take an HIV test. She agreed, even though she was healthy and had no reason to think she might be HIV positive. The test result came up positive, though Hafford was tested only once, and she did not know that pregnancy itself can cause a false positive HIV test. Her first thought was of her unborn baby. Hafford was immediately referred to an HIV/AIDS specialist, Dr. Edwin Thorpe, who happened to be one of the principal investigators recruiting patients for a clinical trial at the University of Tennessee Medical Group that was sponsored by the Division of AIDS (DAIDS)—the chief branch of HIV/AIDS research within the National Institutes of Health.

The objective of the trial, PACTG 1022, was to compare the “treatment-limiting toxicities” of two anti-HIV drug regimens. The core drugs being compared were nelfinavir (trade name Viracept) and nevirapine (trade name Viramune). To that regimen, in each arm, two more drugs were added—zidovudine (AZT) and lamivudine (Epivir) in a branded combination called Combivir. PACTG 1022 was a “safety” trial as well as an efficacy trial, which means that pregnant women were being used as research subjects to investigate “safety” and yet the trial was probing the outer limits of bearable toxicity. Given the reigning beliefs about HIV’s pathogenicity, such trials are fairly commonplace, especially in the post-1994 era, when AZT was hailed for cutting transmission rates from mother to child.

The goal of PACTG 1022 was to recruit at least 440 pregnant women across the nation, of which 15 were to be enrolled in the University of Tennessee Medical Group. The plan was to assign the study’s participants to one of two groups, with each receiving three HIV drugs, starting as early as ten weeks of gestation. Of the four drugs in this study, three belong to the FDA’s category “C,” which means that safety to either mother or fetus has not been adequately established.

Joyce Ann Hafford was thirty-three years old and had always been healthy. She showed no signs of any of the clinical markers associated with AIDS—her CD4 counts, which measure the lymphocytes that are used to indicate how strong a person’s immune system is, and which HIV is believed to slowly corrode, were in the normal range, and she felt fine. In early June 2003, she was enrolled in the trial and on June 18 took her first doses of the drugs. “She felt very sick right away,” recalls her older sister, Rubbie King. “Within seventy-two hours, she had a very bad rash, welts all over her face, hands, and arms. That was the first sign that there was a problem. I told her to call her doctor and she did, but they just told her to put hydrocortisone cream on it. I later learned that a rash is a very bad sign, but they didn’t seem alarmed at all.”

Hafford was on the drug regimen for thirty-eight days. “Her health started to deteriorate from the moment she went on the drugs,” says King. “She was always in pain, constantly throwing up, and finally she got to the point where all she could do was lie down.” The sisters kept the news of Hafford’s HIV test and of the trial itself from their mother, and Hafford herself attributed her sickness and nausea to being pregnant. She was a cheerful person, a non-complainer, and was convinced that she was lucky to have gotten into this trial. “She said to me, ‘Nell’ —that’s what she called me—‘I have got to get through this. I can’t let my baby get this virus.’ I said, ‘Well, I understand that, but you’re awful sick.’ But she never expressed any fear because she thought this was going to keep her baby from being HIV positive. She didn’t even know she was in trouble.”

On July 16, at her scheduled exam, Hafford’s doctor took note of the rash, which was “pruritic and macular-papular,” and also noted that she was suffering hyperpigmentation, as well as ongoing nausea, pain, and vomiting. By this time all she could keep down were cans of Ensure. Her blood was drawn for lab tests, but she was not taken off the study drugs, according to legal documents and internal NIH memos.

Eight days later, Hafford went to the Regional Medical Center “fully symptomatic,” with what legal documents characterize as including: “yellow eyes, thirst, darkening of her arms, tiredness, and nausea without vomiting.” She also had a rapid heartbeat and difficulty breathing. Labs were drawn, and she was sent home, still on the drugs. The next day, July 25, Hafford was summoned back to the hospital after her lab reports from nine days earlier were finally reviewed. She was admitted to the hospital’s ICU with “acute and sub-acute necrosis of the liver, secondary to drug toxicity, acute renal failure, anemia, septicemia, premature separation of the placenta,” and threatened “premature labor.” She was finally taken off the drugs but was already losing consciousness. Hafford’s baby, Sterling, was delivered by C-section on July 29, and she remained conscious long enough not to hold him but at least to see him and learn that she’d had a boy. “We joked about it a little, when she was still coming in and out of consciousness in ICU,” Rubbie recalls. “I said to her, ‘You talked about me so much when you were pregnant that that baby looks just like me.’” Hafford’s last words were a request to be put on a breathing tube. “She said she thought a breathing tube might help her,” says Rubbie. “That was the last conversation I had with my sister.” In the early morning hours of August 1, Rubbie and her mother got a call to come to the hospital, because doctors had lost Hafford’s pulse. Jermal was sleeping, and Rubbie woke her own daughter and instructed her not to tell Jermal anything yet. They went to the hospital, and had been there about ten minutes when Joyce Ann died.
* * *

Rubbie recalls that the hospital staff said they would clean her up and then let them sit with her. She also remembered a doctor who asked for their home phone numbers and muttered, “You got a lawsuit.” (That person has not resurfaced.) They hadn’t been sitting with Hafford’s body long when a hospital official came in and asked the family whether they wanted an autopsy performed. “We said yes, we sure do,” she says. The hospital official said it would have to be at their expense—at a cost of $3,000. “We said, ‘We don’t have $3,000.’ My sister didn’t have any life insurance or anything,” says Rubbie. “She had state health care coverage, and we were already worried about how to get the money together to bury her.” Consequently, no autopsy was done. There was a liver biopsy, however, which revealed, according to internal communiqués of DAIDS staff, that Hafford had died of liver failure brought on by nevirapine toxicity.

And what was the family told about the cause of Hafford’s death?

“How did they put it?” Rubbie answers, carefully. “They told us how safe the drug was, they never attributed her death to the drug itself, at all. They said that her disease, AIDS, must have progressed rapidly.” But Joyce Ann Hafford never had AIDS, or anything even on the diagnostic scale of AIDS. “I told my mom when we were walking out of there that morning,” Rubbie recalls, “I said, ‘Something is wrong.’ She said, ‘What do you mean?’ I said, ‘On the one hand they’re telling us this drug is so safe, on the other hand they’re telling us they’re going to monitor the other patients more closely. If her disease was progressing, they could have changed the medication.’ I knew something was wrong with their story, but I just could not put my finger on what it was.”

When they got home that morning, they broke the news to Jermal. “I think he cried the whole day when we told him,” Rubbie recalls. “My mom had tried to prepare him. She said, ‘You know, Jermal, my mom died when I was very young,’ but he was just devastated. They were like two peas in a pod those two. You could never separate them.” Later on, Jermal became consumed with worry about how they would bury his mother, for which they had no funds and no insurance. The community pitched in, and Hafford was buried. “I haven’t even been able to go back to her grave since she passed,” says Rubbie.
* * *

Rubbie King is haunted by many questions, including whether her sister was really infected with HIV,11. HIV tests detect footprints, never the animal itself. These footprints, antibodies, are identified by means of molecular protein weights, and were limited to two in 1984, when the first test was developed and patented, but over the years expanded to include many proteins previously not associated with HIV. Like most Americans, Hafford thought that a single HIV-positive test meant that she “had” HIV—a surefire death sentence. But a majority of HIV-positive tests, when retested, come back indeterminate or negative. In many cases, different results emerge from the same blood tested in different labs. There are currently at least eleven different criteria for how many and what proteins at which band density signal “positive.” The most stringent criteria (four bands) are upheld in Australia and France; the least stringent (two bands), in Africa, where an HIV test is not even required as part of an AIDS diagnosis. The U.S. standard is three reactive bands. It has been pointed out that a person could revert to being HIV negative simply by buying a plane ticket from Uganda to Australia. and also what the long-term damage might be to Sterling, whom Rubbie is now raising, along with Jermal and her own child. Sterling, in addition to the drugs he was exposed to in the womb, was also on an eight-week AZT regimen after birth. One of the reasons the family suspects Hafford may have been a false positive is that St. Jude’s Children’s Research Hospital has not released Sterling’s medical records, and although they have been told that he is now HIV negative, they never had any evidence that he was even born positive. (All babies born to an HIV-positive mother are born positive, but most become negative within eighteen months.)

Hafford’s family was never told that she died of nevirapine toxicity. “They never said that. We never knew what she had died of until we got the call from [AP reporter] John Solomon, and he sent us the report,” says Rubbie King. “It was easier to accept that she died of a lethal disease. That was easier to handle.” The family has filed a $10 million lawsuit against the doctors who treated Hafford, the Tennessee Medical Group, St. Jude’s Children’s Research Hospital, and Boehringer Ingelheim, the drug’s manufacturer.22. Dr. Thorpe declined to comment, citing ongoing litigation, as did the Tennessee Medical Group, the Regional Medical Center at Memphis, and St. Jude’s Children’s Research Hospital.

Rubbie King made a final, disturbing discovery when she was going through Hafford’s medical records: In addition to discovering that her sister had only ever been given a single HIV test, she also came across the fifteen-page consent form, which was unsigned.
* * *

On August 8, 2003, Jonathan Fishbein, who had recently taken a job as the director of the Office for Policy in Clinical Research Operations at DAIDS, wrote an email to his boss, DAIDS director Ed Tramont, alerting him that “there was a fulminant liver failure resulting in death” in a DAIDS trial and that it looked like “nevirapine was the likely culprit.” He said that the FDA was being informed. He was referring to Joyce Ann Hafford. Tramont emailed him back, “Ouch. Not much wwe can do about dumd docs!”

This email exchange came to light in December 2004, when AP reporter John Solomon broke the story that Fishbein was seeking whistle-blower protection, in part because he had refused to sign off on the reprimand of an NIH officer who had sent the FDA a safety report concerning the DAIDS trial that launched the worldwide use of nevirapine for pregnant women. The study was called HIVNET 012, and it began in Uganda in 1997.

The internal communiqués from DAIDS around the time of Hafford’s death made it clear that doctors knew she had died of nevirapine toxicity. Tramont’s reply to Fishbein suggests that he thought blame could be placed squarely with Hafford’s doctors, but it was the NIH itself that had conceived of the study as one that tested the “treatment-limiting toxicities” of HIV drugs in pregnant women.

The conclusion of the PACTG 1022 study team was published in the journal JAIDS in July of 2004. “The study was suspended,” the authors reported, “because of greater than expected toxicity and changes in nevirapine prescribing information.” They reported that within the nevirapine group, “one subject developed fulminant hepatic liver failure and died, and another developed Stevens-Johnson syndrome.” Stevens-Johnson syndrome is skin necrolysis—a severe toxic reaction that is similar to internal third-degree burns, in which the skin detaches from the body. Another paper, entitled “Toxicity with Continuous Nevirapine in Pregnancy: Results from PACTG 1022,” puts the results in charts, with artful graphics. A small illustration of Hafford’s liver floats in a box, with what looks like a jagged gash running through it. Four of the women in the nevirapine group developed hepatic toxicity.
* * *

As Terri Schiavo lay in her fourteenth year of a persistent vegetative state, and the nation erupted into a classically American moral opera over the sanctity of life, Joyce Ann Hafford’s story made only a fleeting appearance—accompanied by a photo of her holding a red rose in an article that was also written by the AP’s John Solomon. But soon a chorus of condemnation was turned against those who were sensationalizing Hafford’s death and the growing HIVNET controversy to condemn nevirapine, which had been branded by the AIDS industry as a “life-saving” drug and a “very important tool” to combat HIV in the Third World.

So-called community AIDS activists were sprung like cuckoo birds from grandfather clocks at the appointed hour to affirm the unwavering AIDS cathechism: AIDS drugs save lives. To suggest otherwise is to endanger millions of African babies. Front and center were organizations like the Elizabeth Glaser Pediatric AIDS Foundation, which extolled the importance of nevirapine. Elizabeth Glaser’s nevirapine defenders apparently didn’t encounter a single media professional who knew, or cared, that the organization had received $1 million from nevirapine’s maker, Boehringer Ingelheim, in 2000.33. “Our mission of eradicating AIDS is always informed and driven by the best available science, not by donations,” said Mark Isaac, Elizabeth Glazer’s vice president for policy, when asked to comment. “The full body of research, as well as our extensive experience, validates the safety and efficacy of single-dose nevirapine as one of several options to prevent mother-to-child transmission of HIV.” This was no scandal but simply part of a landscape. Pharmaceutical companies fund AIDS organizations, which in turn are quoted uncritically in the media about how many lives their drugs save. This time the AIDS organizations were joined by none other than the White House, which was in the midst of promoting a major program to make nevirapine available across Africa.44. Africa, as the news media never tires of telling us, has become ground zero of the AIDS epidemic. The clinical definition of AIDS in Africa, however, is stunningly broad and generic, and was seemingly designed to be little other than a signal for funding. It is in no way comparable to Western definitions. The “Bangui definition” of AIDS was established in the city of Bangui in the Central African Republic, at a conference in 1985. The definition requires neither a positive HIV test nor a low T-cell count, as in the West, but only the presence of chronic diarrhea, fever, significant weight loss, and asthenia, as well as other minor symptoms. These happen to be the symptoms of chronic malnutrition, malaria, parasitic infections, and other common African illnesses. (In 1994 the definition was updated to suggest the use of HIV tests, but in practice they are prohibitively expensive.) Even when HIV tests are performed, many diseases that are endemic to Africa, such as malaria and TB, are known to cause false positives. The statistical picture of AIDS in Africa, consequently, is a communal projection based on very rough estimates of HIV positives, culled from select and small samples, which are extrapolated across the continent using computer models and highly questionable assumptions.

America is a place where people rarely say: Stop. Extreme and unnatural things happen all the time, and nobody seems to know how to hit the brakes. In this muscular, can-do era, we are particularly prone to the seductions of the pharmaceutical industry, which has successfully marketed its ever growing arsenal of drugs as the latest American right. The buzzword is “access,” which has the advantage of short-circuiting the question of whether the drugs actually work, and of utterly obviating the question of whether they are even remotely safe. This situation has had particularly tragic ramifications on the border between the class of Americans with good health insurance, who are essentially consumers of pharmaceutical goods, and those without insurance, some of whom get drugs “free” but with a significant caveat attached: They agree to be experimented on. These people, known in the industry as “recruits,” are pulled in via doctors straight from clinics and even recruited on the Internet into the pharmaceutical industry and the government’s web of clinical trials, thousands of which have popped up in recent years across the nation and around the world. Such studies help maintain the industry’s carefully cultivated image of benign concern, of charity and progress, while at the same time feeding the experimental factories from which new blockbuster drugs emerge. “I call them what they are: human experiments,” says Vera Hassner Sharav, of the Alliance for Human Research Protection in New York City. “What’s happened over the last ten to fifteen years is that profits in medicine shifted from patient care to clinical trials, which is a huge industry now. Everybody involved, except the subject, makes money on it, like a food chain. At the center of it is the NIH, which quietly, while people weren’t looking, wound up becoming the partner of industry.”

By June 2004, the National Institutes of Health had registered 10,906 clinical trials in ninety countries. The size of these trials, which range from the hundreds to more than 10,000 people for a single study, creates a huge market for trial participants, who are motivated by different factors in different societies but generally by some combination of the promise of better health care, prenatal care, free “access” to drugs, and often—especially in the United States—cash payments. Participating doctors, whose patient-care profits have been dwindling in recent years because of insurance-company restrictions, beef up their incomes by recruiting patients.
* * *

Dr. Jonathan Fishbein is hardly a rabble-rouser. But he is a passionate advocate of “good clinical practice,” or GCP, a set of international standards that were adopted in 1996, as clinical-trial research boomed. The GCP handbook states: “Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.” During the decade prior to his arrival at DAIDS, Fishbein had overseen and consulted on hundreds of clinical trials for just about every pharmaceutical company. Fishbein knew, before he took his job as director of the Office for Policy in Clinical Research Operations at DAIDS, that there was a troubled study haunting the whole division. Nobody was supposed to talk about it, but it hung heavily in the air. “Something about Uganda, that’s all I knew,” he says. There was a trial staged there, a big one, that had been plagued with “problems,” and there was also a lot of talk about one particular employee connected to this trial who would need to be disciplined. Soon he discovered just how bad the situation was. “The HIVNET thing,” he recalls, “it hit me like a fire hose when I walked in there.”

Fishbein’s position was new. “It sounded like a very important position,” he says. “I was to oversee the policies governing all the clinical-research operations, both here and abroad.” He was told he would have “go‒no go” authority over individual trials. It wasn’t long before Fishbein realized that he was, in effect, taking a job that was the equivalent of piloting an already airborne plane. “They had all these trials going on, and hundreds of millions of dollars flowing in every year, but there was apparently no one in a senior position there who really had clinical expertise—who knew all the nuances, rules, and regulations in the day-to-day running of clinical trials.” DAIDS, when Fishbein came to work there in 2003, was running about 400 experimental trials both in the United States and abroad.

A DAIDS project officer close to the HIVNET study closed the door when she had her first meeting with Fishbein. She had also crossed over from the private sector, and so she and Fishbein shared a disillusionment over how much shoddier and more chaotic the research culture was within the government, compared with industry. “I’m really frightened about the stuff that goes on here,” she told him. “We really need somebody.” This project officer, who for her own protection cannot be named, told Fishbein that the division’s flagship study in Africa—HIVNET 012—had been wracked with problems and completely lacking in regulatory standards. She told Fishbein that the trial investigators were “out of control,” and that there was no oversight of them, and nobody with either the inclination or the authority to make them adhere to safety standards. What Fishbein subsequently learned entangled him in a story with eerie echoes of John Le Carré’s Constant Gardener.
* * *

For our purposes, the story of nevirapine begins in 1996, when the German pharmaceutical giant Boehringer Ingelheim applied for approval of the drug in Canada. The drug had been in development since the early 1990s, which was a boom time for new HIV drugs. Canada rejected nevirapine twice, once in 1996 and again in 1998, after the drug showed no effect on so-called surrogate markers (HIV viral load and CD4 counts) and was alarmingly toxic. In 1996, in the United States, the FDA nonetheless gave the drug conditional approval so that it could be used in combination with other HIV drugs.55. Asked to comment about the Hafford case, HIVNET 012, and the larger nevirapine controversy, Boehringer Ingelheim provided the following statement: “Viramune ® (nevirapine) was an innovation in anti-HIV treatment as the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of drugs. Now in its tenth year of use, Viramune has been used as a treatment in more than 800,000 patient-years worldwide.”

By this time, Johns Hopkins AIDS researcher Brooks Jackson had already generated major funding from the NIH to stage a large trial for nevirapine in Kampala, Uganda, where the benevolent dictator Yoweri Museveni had opened his country to the lucrative promise of AIDS drug research, as well as other kinds of pharmaceutically funded medical research. HIVNET 012, according to its original 1997 protocol, was intended to be a four-arm, Phase III, randomized, placebo- controlled trial.66. The study was originally titled “HIVNET 012: A Phase III Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates.” “Randomization” means that people are randomly chosen for one arm of the study or another, a procedure that is supposed to even out the variables that could affect the outcome. “Placebo controls” are the bedrock of drug testing and are the only way to know whether the treatment is effective. Phase I trials involve a small group of people, twenty to eighty, and are focused on safety and side effects. In Phase II trials the drug is given to an expanded cohort, between 100 and 300, to further evaluate safety and begin to study effectiveness. Phase III drug trials expand further the number of people enrolled, often to more than 1,000, and are meant to confirm a drug’s effectiveness, monitor side effects, and compare it with other treatments commonly used. A small Phase I trial preceded HIVNET 012 that studied the safety, primarily, of nevirapine in pregnant women but also looked at efficacy. It was called HIVNET 006, and it enrolled twenty-one pregnant women for initial study. Of twenty-two infants born, four died. There were twelve “serious adverse events” reported. The study also showed that there was no lowering of viral load in the mothers who took the study drug (the industry’s agreed-upon standard for interrupting maternal transmission). Its sole sponsor was listed as the National Institute of Allergy and Infectious Diseases (NIAID), though one of the investigators was a Boehringer employee. The “sample size” was to be 1,500 HIV-1 infected Ugandan women more than thirty-two weeks pregnant. The four arms they would be divided into were 1) A single dose of 200mg nevirapine at onset of labor and a single 2mg dose to the infant forty-eight to seventy-two hours post-delivery, and 2) a corresponding placebo group; 3) 600mg of AZT at onset of labor and 300mg until delivery, with a 4mg AZT dose for the infant lasting seven days after birth, and 4) a corresponding placebo group. There were to be 500 women in each “active agent” arm and 250 in each placebo arm. The study was to last eighteen months, and its “primary endpoints” were to see how these two regimens would affect rates of HIV transmission from mother to child, and to examine the “proportion of infants who are alive and free of HIV at 18 months of age.” Another primary objective was to test the “safety/tolerance” of nevirapine and AZT. HIVNET’s architects estimated that more than 4,200 HIV-positive pregnant women would deliver at Mulago hospital each year, allowing them to enroll eighty to eighty-five women per month. Consent forms were to be signed by either the mother or a guardian, by signature or “mark.” One of the exclusion criteria was “participation during current pregnancy in any other therapeutic or vaccine perinatal trial.”
* * *

Although HIVNET was designed to be a randomized, placebo-controlled, double-blind, Phase III trial of 1,500 mother/infant pairs, it wound up being a no-placebo, neither double- nor even single-blind Phase II trial of 626 mother/infant pairs. Virtually all of the parameters outlined for HIVNET 012 were eventually shifted, amended, or done away with altogether, beginning with perhaps the most important—the placebo controls. By a “Letter of Amendment” dated March 9, 1998, the placebo-control arms of HIVNET were eliminated. The study as reconstituted thus amounted to a simple comparison of AZT and nevirapine.

On September 4, 1999, The Lancet published HIVNET’s preliminary results, reporting that “Nevirapine lowered the risk of HIV-I transmission during the first 14‒16 weeks of life by nearly 50 percent.” The report concluded that “the two regimens were well-tolerated and adverse events were similar in the two groups.” The article also reported that thirty-eight babies had died, sixteen in the nevirapine group and twenty-two in the AZT group. The rate of HIV transmission in the AZT arm was 25 percent, while in the nevirapine group it was only 13 percent. As Hopkins Medical News later reported, the study was received rapturously. “The data proved stunning. It showed that nevirapine was 47 percent more effective than AZT and had reduced the number of infected infants from 25 to 13 percent. Best of all, nevirapine was inexpensive—just $4 for both doses. If implemented widely, the drug could prevent HIV transmission in more than 300,000 newborns a year.”

With the results of the study now published in The Lancet, Boehringer, which previously had shown little interest in HIVNET, now pressed for FDA approval to have nevirapine licensed for use in preventing the transmission of HIV in pregnancy.
* * *

There were complications, however. On December 6, 2000, a research letter in The Journal of the American Medical Association warned against using nevirapine for post-exposure treatment after two cases of life-threatening liver toxicity were reported among health-care workers who’d taken the drug for only a few days. (One of them required a liver transplant.) The January 5, 2001, issue of the CDC’s Morbidity and Mortality Weekly Report (MMWR) contained an FDA review of MedWatch—an informal reporting system of drug reactions—that highlighted an additional twenty cases of “serious adverse events” resulting from fairly brief nevirapine post-exposure prophylaxis. “Serious adverse events” were defined as anything “life-threatening, permanently disabling,” or requiring “prolonged hospitalization, or [. . . ]intervention to prevent permanent impairment or damage.” The MMWR stressed that there probably were more unreported cases, since the reporting by doctors to MedWatch is “voluntary” and “passive.”

But NIAID was on another track altogether, either oblivious of or undeterred by the toxicity controversy. In 2001, Boehringer Ingelheim submitted its supplemental licensing request to the FDA. The request was submitted based entirely on the results of HIVNET, as published in The Lancet. Around the same time, the South African Medicines Control Counsel (MCC) conditionally approved nevirapine for experimental use in mother-to-child transmission treatment. To its credit, however, the FDA decided to go to Kampala, inspect the site, and review the data itself.

Since Boehringer had not originally intended to use this study for licensing purposes, it decided to perform its own inspection before the FDA arrived. Boehringer’s team arrived in Kampala and did a sample audit. They were the first to discover what a shambles the study was. According to Boehringer’s preinspection report, “serious non-compliance with FDA Regulations was found” in the specific requirements of reporting serious adverse events. Problems also were found in the management of the trial drug and in informed-consent procedures. DAIDS then hired a private contractor, a company named Westat, to go to Uganda and do another preinspection. This time the findings were even more alarming. One of the main problems was a “loss of critical records.” One of two master logs that included follow-up data on adverse events, including deaths, was said to be missing as the result of a flood. The records failed to make clear which mothers had gotten which drug, when they’d gotten it, or even whether they were still alive at various follow-up points after the study. Drugs were given to the wrong babies, documents were altered, and there was infrequent follow-up, even though one third of the mothers were marked “abnormal” in their charts at discharge. The infants that did receive follow-up care were in many cases small and underweight for their age. “It was thought to be likely that some, perhaps many, of these infants had serious health problems.” The Westat auditors looked at a sample of forty-three such infants, and all forty-three had “adverse events” at twelve months. Of these, only eleven were said to be HIV positive. The HIVNET team had essentially downgraded all serious adverse events several notches on a scale it had created to adapt to “local” standards. That downgrade meant, among other things, that even seemingly “life-threatening” events were logged as not serious. Deaths, unless they occurred within a certain time frame at the beginning of the study, were not reported or were listed as “serious adverse events” rather than deaths. In one case, “a still birth was reported as a Grade 3 adverse event for the mother.”

As a defense, the HIVNET team often cited ignorance. They told the Westat monitors that they were unaware of safety-reporting regulations, that they’d had no training in Good Clinical Practice, and that they had “never attempted a Phase III trial.” The principal investigators and sub-investigators “all acknowledged the findings [of the audit] as generally correct,” the Westat report said. “Dr. Guay and Dr. Jackson noted that many (‘thousands’) of unreported AE’s and SAE’s occurred. . . . They acknowledged their use of their own interpretation of ‘serious’ and of severity.” “All agreed” that the principal and subinvestigators “had generally not seen the trial patients,” and “all agreed” that in evaluating adverse and serious adverse events “they had relied almost entirely on second or third hand summaries . . . without attempting to verify accuracy.” Westat also discovered that half the HIV-positive infants were also enrolled in a vitamin A trial, which effectively invalidates any data associated with them.
* * *

In light of the Westat report, DAIDS and Boehringer asked the FDA for a postponement of its inspection visit. The FDA responded by demanding to see the report immediately. On March 14, 2002, the FDA called a meeting with DAIDS, Boehringer, and the trial investigators. “They reprimanded the whole gang,” says Fishbein. Then they said to Boehringer: Withdraw your application for extended approval, if you want to avoid a public rejection.” Boehringer complied with the FDA’s demand, though statements put out by NIAID made it sound as if the company had withdrawn the application for FDA approval in a spirit of profound concern for protocol. In South Africa, a few months later, the news focused on the angry chorus of AIDS experts and activists, speaking as one. The South African MCC was reconsidering its approval of nevirapine for pregnant women because of Boehringer’s withdrawal and the growing HIVNET controversy. The Associated Press reported that “activists fear the government, notorious for its sluggish response to the AIDS crisis, is pressuring the council to reject nevirapine, and that it could misrepresent the current discussions as proof the drug is toxic. Studies show nevirapine given to HIV-pregnant women during labor and to their newborn babies can reduce HIV transmission by up to 50 percent.” The problem with such statements, of course, is that the study in question was precisely the one that established the claim that nevirapine cut HIV transmission.
* * *

Two inspections had now declared HIVNET to be a complete mess: Boehringer’s own and Westat’s, which had been performed in conjunction with DAIDS. But the ways in which the various players were tethered together made it impossible for DAIDS to condemn the study without condemning itself.77. Brooks Jackson declined to comment for this article. Laura Guay responded with the following statement: “Several in-depth reviews of the conduct and results of the HIVNET 012 trial as well as the data collected from subsequent trials and PMTCT programs, have substantiated the HIVNET 012 conclusions that Nevirapine is safe and effective in preventing mother-to-child HIV transmission. Nevirapine remains one of the most important tools for the prevention of mother-to-child HIV transmission in the developing world, where there are still hundreds of thousands of HIV- infected pregnant women who do not have access to any HIV testing, antiretroviral therapy, or HIV care at all. For many programs struggling to establish PMTCT programs with limited resources, Nevirapine is often the only option available.” Family Health International, the NIH contractor originally responsible for monitoring HIVNET 012, contested the Westat report and said that the results of the study had been validated by the NIH and the Institute of Medicine. But DAIDS was well aware of what had transpired.

According to DAIDS’s public version of events, which was dutifully echoed in the AIDS press, the trouble with HIVNET was that it was unfairly assailed by pedantic saboteurs who could not grasp the necessary difference between U.S. safety standards and the more lenient standards that a country like Uganda deserved. Two weeks after the fifty-seven-page Westat report was delivered, the deputy director of NIAID, Dr. John LaMontagne, had set the tone by stating publicly: “There is no question about the validity [of the HIVNET results] . . . the problems are in the rather arcane requirements in record keeping.” DAIDS was so dismissive of the Westat report that Westat’s lawyers eventually put officials on notice that they were impugning Westat’s reputation.

Meanwhile, as the investigations continued, nevirapine had long since been recommended by the World Health Organization and registered in at least fifty-three countries, and Boehringer had begun shipping boxes of the drug to maternity wards across the developing world. In 2002, President Bush announced a $500 million program to prevent maternal transmission of HIV in which nevirapine therapy would play a major role—despite the fact that the drug has never received FDA approval for this purpose.
* * *

In 2003, when Jonathan Fishbein was drawn into the HIVNET saga, the cover-up (for that, ultimately, is what the NIH response had become) was ongoing. In response to the massive failures documented by Boehringer and Westat, DAIDS embarked on a “re-monitoring review” in an attempt to validate the study’s results. Ordinarily, an outside contractor would be retained for such a complex project, but Tramont made the decision to keep the remonitoring in-house. Drafting the review was a massive undertaking that took months of research, lengthy interviews with the investigators, and painstaking analysis of poorly organized documentation, as the DAIDS team attempted to learn what had actually taken place in Kampala. Even so, Tramont wanted the HIVNET site reopened in time for President Bush’s visit to Uganda. In March 2003, Tramont and his staff gathered together the different sections and substantially rewrote the report, especially the safety section, minimizing the toxicities, deaths, and record-keeping problems. The rewritten report concluded that nevirapine was safe and effective for the treatment of mother-to-child transmission of HIV, thus saving HIVNET 012 from the scrapheap of failed scientific studies.

While preparing the safety review section, however, an NIH medical officer named Betsy Smith noticed a pattern of elevated liver counts among some of the babies in the AZT arm. Following FDA regulations, she drafted a safety report documenting this finding and gave it to Mary Anne Luzar, a DAIDS regulatory affairs branch chief. Luzar forwarded the safety report to the FDA. The HIVNET investigators were furious; Tramont, who had previously signed off on the safety report, ordered a new version to be drafted, essentially retracting the previous one, and sent it to the FDA.88. Smith and Luzar have been forbidden by the NIH to speak to the press about HIVNET. Luzar was deposed by Fishbein’s attorney in his wrongful-termination lawsuit, Stephen Kohn, in December 2004, and this account is partially based on her deposition. The political stakes were very high: nevirapine was now a major element in the Administration’s new $15 billion African AIDS program—on July 11, President Bush even toured the HIVNET site in Kampala, which DAIDS had reopened for the occasion over Fishbein’s objections.

By late June 2003, Jonathan Kagan, the deputy director of DAIDS, asked Fishbein to sign off on a reprimand of Luzar for insubordination. Fishbein reviewed the HIVNET documentation and concluded that Luzar had done nothing wrong, that she had simply followed protocol. Fishbein’s refusal to go along with Luzar’s reprimand amounted to a refusal to participate in the HIVNET cover-up. In July, Tramont sent an email to all DAIDS staff instructing them not to speak about HIVNET at all. “HIVNET 012 has been reviewed, re-monitored, debated and scrutinized. To do any more would be beyond reason. It is time to put it behind us and move on. Henceforth, all questions, issues and inquiries regarding HIVNET 012 is [sic] to be referred to the Director, DAIDS.”99. At this point the story grows ever more complicated, as Fishbein supported Luzar in a sexual-harassment claim against Kagan.

What followed, as internal emails and memorandums clearly show, was a vicious and personal campaign on the part of Kagan and Tramont to terminate Fishbein’s employment. DAIDS officials wrote emails in which they worried about how to fire him without creating repercussions for NIAID director Anthony Fauci, who had given Fishbein a commendation for his work. The communiqués took on conspiratorial tones as Tramont led the operation and mapped out its challenges. On February 23, 2004, Tramont emailed Kagan: “Jon, Let’s start working on this—Tony [Fauci] will not want anything to come back on us, so we are going to have to have ironclad documentation, no sense of harassment or unfairness and, like other personnel actions, this is going to take some work. In Clauswitzian style, we must overwhelm with ‘force.’ We will prepare our paper work, then . . . go from there.” The web now included several more NIH/NIAID employees, who weighed in with suggestions about how best to expel Fishbein without leaving damning legal fingerprints on the proceedings.

Fishbein spent months trying to get a fair hearing, petitioning everyone from Elias Zerhouni, the director of the NIH, to Secretary of Health Tommy Thompson. It was around this time that Fishbein became a “ghost.” Nobody addressed him in the corridors, in the elevators, in the cafeteria. “There was an active campaign to humiliate me,” he says. “It was as if I had AIDS in the early days. I was like Tom Hanks in Philadelphia. Nobody would come near me.”

In March 2004, Fishbein began seeking whistle-blower protection. He met with congressional staff and attracted enough attention on Capitol Hill to force the NIH to agree to a study by the National Academy’s Institute of Medicine (IOM). The terms of that inquiry were skewed from the outset, however, and the nine-member panel decreed that it would not deal with any questions of misconduct. The panel ignored Fishbein’s evidence that DAIDS had covered up the study’s failures and relied on testimony from the HIVNET investigators and NIH officials. Not surprisingly, it found that HIVNET’s conclusions were valid. Six of the nine members on the panel were NIH grant recipients, with yearly grants ranging from $120,000 to almost $2 million.1010. An internal NIH investigation, which was obtained by the Associated Press last summer, vindicated many of Fishbein’s charges and concluded that “it is clear that DAIDS is a troubled organization,” and that the Fishbein case “is clearly a sketch of a deeper issue.” Kagan and Tramont did not return repeated calls for comment. Instead, an NIH spokesman, Dr. Cliff Lane, said that the agency stands by HIVNET 012.

Fishbein dismissed the IOM report as a whitewash. Indeed, the report’s conclusions are hard to credit, given the overwhelming evidence uncovered by the Westat investigation and documentation such as the following email, which was sent by Jonathan Kagan to Ed Tramont on June 19, 2003. Tramont was considering HIVNET researchers Jackson and Guay for an award:

Ed—I’ve been meaning to respond on this—the bit about the award. I think that’s a bit over the top. I think that before we start heaping praise on them we should wait to see if the lessons stick. We cannot lose sight of the fact that they screwed up big time. And you bailed their asses out. I’m all for forgiveness, etc. I’m not for punishing them. But it would be “over the top” to me, to be proclaiming them as heroes. Something to think about before pushing this award thing . . .

NIAID has issued a total ban against any employee speaking to the press about Fishbein’s allegations. Instead, they have posted “Questions and Answers” about the matter on their website. The first question is: “Is single-dose nevirapine a safe and effective drug for the prevention of mother-to-infant transmission of HIV?” Fishbein has said that due to the spectacular failures of the HIVNET trial, the answer to this is not known, and not knowable. Fishbein believes that ultimately the HIVNET affair is not “about” nevirapine or even AIDS, but about the conduct of the federal government, which has been entrusted to do research on human beings and to uphold basic standards of clinical safety and accuracy.

NIAID answers its first question mechanically and predictably: “Single-dose nevirapine is a safe and effective drug for preventing mother-to-infant transmission of HIV. This has been proven by multiple studies, including the HIVNET 012 study conducted in Uganda.” The phrase “safe and effective” has been baked into both the question and the answer, rendering both blank and devoid of meaning. The “multiple studies” line is a familiar tactic, designed to deflect from the study that is actually being addressed, and that is HIVNET 012.
* * *

A short letter published in the March 10, 2005, issue of Nature quietly unpegged the core claim of NIAID and its satellite organizations in the AIDS industry regarding nevirapine’s “effectiveness.” Written by Dr. Valendar Turner, a surgeon at the Department of Health in Perth, Australia, the letter read:

Sir—While raising concerns about “standards of record keeping” in the HIVNET 012 trial in Uganda, in your News story, “Activists and Researchers rally behind AIDS drug for mothers,” you overlook a greater flaw. None of the available evidence for nevirapine comes from a trial in which it was tested against a placebo. Yet, as the study’s senior author has said, a placebo is the only way a scientist can assess a drug’s effectiveness with scientific certainty.

The HIVNET 012 trial abandoned its placebo group in early 1998 after only 19 of the 645 mothers randomized had been treated, under pressure of complaints that the use of a placebo was unethical.

The HIV transmission rate reported for nevirapine in the HIVNET 012 study was 13.1%. However, without antiviral treatments, mother-to-child transmission rates vary from 12% to 48%. The HIVNET 012 outcome is higher than the 12% transmission rate reported in a prospective study of 561 African women given no antiretroviral treatment.

The letter concluded by asking: “On what basis can it be claimed that ‘there’s nothing that has in any way invalidated the conclusion that single-dose nevirapine is effective for reducing mother-to-child transmission’? Without supporting evidence from a placebo-controlled randomized trial, such statements seem unwarranted.” HIVNET claimed to reduce HIV transmission by “nearly 50 percent” by comparing a nevirapine arm to an AZT arm. Turner’s letter points out that 561 African women taking no antivirals transmitted HIV at a rate of 12 percent. Had nevirapine been asked to compete with that placebo group, it would have lost. As it was, there was no placebo group, so HIVNET’s results are a statistical trick, a shadow play, in which success is measured against another drug and not against a placebo group—the gold standard of clinical trials. The question should not be, Is nevirapine better than AZT? but, Is nevirapine better than nothing?

Independent evidence suggests that it is not.

A 1994 study, for example, that gave vitamin A to pregnant HIV-positive mothers in Malawi reported that those with the highest levels of Vitamin A transmitted HIV at a rate of only 7.2 percent. This is consistent with a vast body of research linking nutritional status to sero-conversion, as well as to general health. Another study on the efficacy of nevirapine in mother-to-child transmission was performed by researchers from Ghent University (Belgium) in Kenya and published in 2004.

Dr. Ann Quaghebeur, who led the Ghent study, was reached at her home near London. I asked her what she thought of the reaction to HIVNET 012. She replied in a very quiet voice, almost a whisper. “Our results showed that nevirapine had little effect. I actually felt it was a waste of resources. HIVNET was just one study, but usually before you apply it in a field setting there should be a few more studies to see if it works in real life. What I think they should have done is wait for more studies before they launched this in all those countries.” When I asked her how she explained this, she replied, “Well, I want to be careful, there seems to be an industry now.”
* * *

The failure of the HIVNET researchers to properly control their study with a placebo group is not as unusual as one might think. In fact, this failure is perhaps the outstanding characteristic of AIDS research in general. The 1986 Phase II trial that preceded the FDA’s unprecedented rapid approval of AZT was presented as a double-blind, placebo-controlled study, though it was anything but that. As became clear afterward through the efforts of a few journalists, as well as the testimony of participants, the trial was “unblinded” almost immediately because of the severe toxicity of the drug. Members of the control group began to acquire AZT independently or from other study participants, and eventually the study was aborted and everyone was put on the drug. As in the case of HIVNET, documents obtained by journalist John Lauritsen under the Freedom of Information Act subsequently suggested that data-tampering was widespread. Documents were altered, causes of death were unverified, and the researchers tended to assume what they wished to prove, i.e., that placebo-group diseases were AIDS-related but that those in the AZT group were not. So serious were the deviations from experimental protocol at one Boston hospital that an FDA inspector attempted to exclude data from that center. In the end, however, all the data were included in the results, and the FDA approved the drug in 1987.1111. AZT, which was developed as a chemotherapeutic agent in 1964 but shelved because of its extreme toxicity, is a DNA chain terminator, which means that it brings DNA synthesis to a halt. It is therefore an extremely efficient cell killer. HIV is a retrovirus, and as such replicates itself by inserting its genes into a cell’s genome so that when the cell divides a new copy of the virus is produced. AZT prevents the replication of HIV by killing infected T-cells; unfortunately, it kills all dividing cells indiscriminately, whether they are infected with a retrovirus or not, and will very quickly decimate even a healthy person’s immune system. AZT’s manufacturer, GlaxoSmith Kline, chose not to comment for this article.

AZT was approved in record time, but that record didn’t stand for long. In 1991, the FDA approved another DNA chain terminator, ddI, without even the pretense of a controlled study. Anti-HIV drugs such as Crixivan were approved in as little as six weeks, and cast as a triumph of AIDS activism. This pattern of jettisoning standard experimental controls has continued up to the present, as the HIVNET affair amply demonstrates, and has characterized not only research into new drugs designed to exterminate HIV but the more fundamental questions at the root of AIDS research….
The Farber article ended with a long and accurate rundown of Berkeley retrovirologist and cancer researcher Peter Duesberg’s debunking reviews of HIV as a cause of AIDS, leaving most readers with a clear impression that the field needed a radical reassessment of its paradigm, as well as its research ethics.

It evoked an energetic response from Dr Robert Gallo, well known for his seminal triumph in first discovering HIV in the mail from Luc Montagnier of the Pasteur Institute, and AIDS activists in New York and South Africa whose strenuous resistance to paradigm review is typically funded by companies who make and sell AIDS drugs.

The lengthy self-justification was put up at AIDSTruth.org, a site run by John P. Moore, who researches the effects of microbicides on HIV transmission among macaques at Weill Cornell in New York City, and it can be studied there for its many flaws, which were carefully detailed in a long answer to every point, one by one, which can be seen at the Reappraising AIDS site of the Committee for the Scientific Reappraisal of HIV∫AIDS.

Here is their introduction, if you want to read it:

Correcting Gallo: Rethinking AIDS Responds to Harper’s ‘Out of Control’ Critics

In its March, 2006 issue, Harper’s magazine published “Out of control: AIDS and the corruption of medical science”, an article by Celia Farber which described the death of one woman in a US-based clinical trial of Nevirapine in pregnant HIV-positive women, and the shoddy, corrupt or perhaps outright fraudulent trial of the same drug in Uganda. She described the coverup that occurred, and raised important questions about the effectiveness and safety of HIV/AIDS research. For brevity we will refer to this as “the Farber article”.

Shortly after this article was published, on March 3rd to be exact, a document started circulating entitled “Errors in Celia Farber’s March 2006 article in Harper’s Magazine”. Half of its authors were researchers: The lead author was Robert Gallo, MD, who claims to have discovered HIV. Others were microbiologist John Moore PhD, of Cornell University , Jeffrey Safrit PhD, senior program officer for the Elizabeth Glaser Pediatric AIDS Foundation (which receives money from the Nevirapine manufacturer) and a medical professor, Daniel Kuritzkes MD. The remaining four are activists for AIDS drug treatment, HIV vaccines and medical marijuana. We will refer to this as “the Gallo document”.

After the Rethinking AIDS response the website “AIDSTruth.org” wrote that they “are aware that the AIDS denialist group, Rethinking AIDS, has finally prepared what they deem to be a rebuttal of our exposure of the errors perpetrated by Celia Farber in her Harper’s Magazine article. We have looked over the AIDS denialists’ response. It is characteristically superficial and silly, further exposing the Rethinking AIDS group’s misunderstanding of the science of HIV/AIDS. We will not be responding further to it. The AIDStruth website will continue to post, at periodic intervals, information that is relevant to understanding how HIV infection causes AIDS and how AIDS can be treated with anti-retroviral drugs.”

We would be happy to enter into a constructive debate but this response to our detailed scientific survey indicates that they are unwilling or, more likely, unable to respond to our challenges with substantive science of their own.

The Gallo document claims to have noted 56 errors in the Farber article. The purpose of this website is to address all of these. For each supposed error, relevant text from the Farber article is given, followed by the error description from the Gallo et al document, and then our response, including references identified as “RA”.
Our analysis of the Gallo et al document attacking the Celia Farber article in the March, 2006 issue of Harpers magazine is broken down into the following sections. In each file a quotation from the Farber article is marked as “Farber”, the entire text of the Gallo document is marked as “Gallo” and our response is marked as “RA” (Rethinking AIDS). When we supply a section of references they are marked “Refs.”
breastfeed.jpgOn nevirapine, the following was the exchange. Note that the conclusion is that not only does nevirapine not contribute any significant lowering of the rate of HIV transmission from mother to foetus to newborn (the oft repeated assertion is false, it is clear) but in more than one study doing nothing ie taking a placebo achieved better results: there was lower transmission than when nevirapine, with all its sickening and killing potential, was used.

“The Tanzania Trial of Vitamins was conducted between 1995 and 2003 among 1078 HIV-1-positive women who were pregnant at enrollment to ascertain the effect of vitamin supplements on MTCT, pregnancy outcomes, and other survival and health endpoints…Antiretroviral medications were not available in Tanzania at the time of the study…Of the 925 live births that occurred in the group of women considered for analyses, HIV status at birth was known for 838; of these, 60 (7.2%) were positive.” [2]

By comparison, the HIVNET 012 study in Uganda gave the rate of HIV transmission for nevirapine as “8.2% at birth” and “11.9%” at 6 weeks [3]. The latter figure is similar to the 6-week rate of 11.1% in the placebo group of another large clinical study in Tanzania that did not involve antiretrovirals [4]. Furthermore, a large prospective study in South Africa, in which “no woman received antiretroviral therapy,” reported that the 3 month rate was only 14.6% “for those exclusively breastfed for 3 months” [5]; this is only slightly higher than the 13.1% for nevirapine at 3 months (3). In Kenya, the 3 month HIV transmission rate with nevirapine “was 18.1%, similar to the 21.7% before the intervention” [6].


http://www.rethinkingaids.com/GalloRebuttal/Farber-Gallo-30.html

Rethinking AIDS
The Group for the Scientific Reappraisal of the HIV/AIDS Hypothesis

Item #30: Nevirapine and a Study with 561 People

Farber

The HIV transmission rate reported for nevirapine in the HIVNET 012 study was 13.1%. However, without antiviral treatments, mother-to-child transmission rates vary from 12% to 48%. The HIVNET 012 outcome is higher than the 12% transmission rate reported in a prospective study of 561 African women given no antiretroviral treatment.
Gallo

Farber quotes Turner referring to a study of 561 people.

We are not sure what the 561 person study is that Turner refers to. No reference is supplied by Farber. We have given references above demonstrating that transmission is generally in the 25% region after a few months.
RA

Turner is referencing an African study published in 1998 that stated that “Presence of HIV-infection was assessed in 158 children [of HIV-positive mothers]…Overall, 19 children were diagnosed as HIV-infected [12%, even though there was no access to antiretroviral therapy or other interventions] ” [1] AT

The website aidstruth.org, run by mainstream AIDS researchers, published an accusatory article by Nathan Geffen and Jeanne Bergman that notes correctly that this Ladner research was interrupted by the tragic civil war in Rwanda. They unfortunately then leap to the conclusion that, if this missing data was known, “The actual figure for perinatal HIV transmission was almost certainly much higher [than 12%]”.
VT

Dr. Valendar Turner, the main target of this piece, has responded effectively at theperthgroup.com/LATEST/Geffen.html.
RA

Additional research by us uncovered another study that produced very similar results, an HIV transmission rate of 7.2% at birth, in a much more stable African country, Tanzania. No war interrupted this trial. Consequently, data on HIV status on birth was available for 838 of 925 mothers:

“The Tanzania Trial of Vitamins was conducted between 1995 and 2003 among 1078 HIV-1-positive women who were pregnant at enrollment to ascertain the effect of vitamin supplements on MTCT, pregnancy outcomes, and other survival and health endpoints…Antiretroviral medications were not available in Tanzania at the time of the study…Of the 925 live births that occurred in the group of women considered for analyses, HIV status at birth was known for 838; of these, 60 (7.2%) were positive.” [2]

By comparison, the HIVNET 012 study in Uganda gave the rate of HIV transmission for nevirapine as “8.2% at birth” and “11.9%” at 6 weeks [3]. The latter figure is similar to the 6-week rate of 11.1% in the placebo group of another large clinical study in Tanzania that did not involve antiretrovirals [4]. Furthermore, a large prospective study in South Africa, in which “no woman received antiretroviral therapy,” reported that the 3 month rate was only 14.6% “for those exclusively breastfed for 3 months” [5]; this is only slightly higher than the 13.1% for nevirapine at 3 months (3). In Kenya, the 3 month HIV transmission rate with nevirapine “was 18.1%, similar to the 21.7% before the intervention” [6].

In the study of nevirapine and AZT in Uganda [3], 120 of “the 616 assessable babies,” or 19.5% , were left out of the 3 month analysis (see section, “Primary efficacy analysis”). This proportion is only slightly less than the 22% (60 of 275) who were missing from follow-up in the Ladner study [1] due to civil war in Rwanda.

The main point, that the Gallo document ignores, is that trials without a placebo cannot conclude that either active treatment A (e.g. AZT) or active treatment B (e.g. Nevirapine) is better than doing nothing (i.e. a placebo). It could be argued that in the Tanzanian trial [2], which was conducted by Harvard researchers, the rate of HIV seropositivity in infants was reduced due to the provision of vitamin supplements. But, if that is the case, it is shocking that less effective toxic drugs are preferred over cheap and non-toxic vitamins (which also have other benefits unlike drugs intended to be specific for HIV).
Refs

1. Ladner J et al. Chorioamnionitis and pregnancy outcome in HIV-infected African women. J Acquir Immune Defic Syndr. 1998 Jul 1; 18(3): 293-8.
2. Villamor E et al. Wasting during pregnancy increases the risk of mother-to-child HIV-1 transmission. J Acquir Immune Defic Syndr. 2005 Apr 15; 38(5): 622-6.
3. Guay L. A. et al. HIVNET 012 randomized trial. Lancet 354:795-802, 1999.
4. Baylin A. et al. Effect of vitamin supplementation to HIV-infected pregnant women on the micronutrient status of their infants. Eur. J. Clin. Nutr. 59:960-968, 2005. (See Table 1.)
5. Coutsoudis A et al. Influence of infant-feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa. Lancet 354:471-476, 1999.
6. Quaghebeur A. et al. Low efficacy of nevirapine (HIVNET012) in preventing perinatal HIV-1 transmission in a real-life situation. AIDS 18:1854-6, 2004.
Reasonable people who read all this material surely concluded that AIDS drug research was highly suspect until reviewed and reformed (one prominent player who evidently concluded that is President Clinton, according to his remarks to this writer last year) and that with its potentially horrific side effects and complete ineffectivennss nevirapine was the last drug one wanted to give pregnant women. Indeed, as we recall it is or was not dispensed in the States for that very reason.

Meanwhile it seems that nothing or healthy nutrients have a better effect.

skeleton2.jpgIn a classic example of how the HIV∫AIDS paradigm based government-media-science -health-corporate-charity system surrounds any threatening invasion of truth cells with an army of neutralising and counter asserting antibodies, and eventually expels them from the body politic, all this revelation was stifled by media silence or one-sided dismissal and eventually dispensed with, the coup de grace being administered by the New Yorker article recently by Michael Specter (see earlier post) which blithely discounted it all as passe and reasserted the established line.

Now Henry H. Bauer, one of the world’s experts in resistance to paradigm change, whose just published book, The Origin, Persistence and Failings of HIV∫AIDS Theory (McFarland, $35) is a comprehensive and unusually cool and penetrating reappraisal of the scene, showing readers a record number of overlooked impossibilities in the current conventional wisdom, has commented on the last NAR post (supporting Mbeki in his fight against scientific illiteracy) by drawing our attention to a shocking fact – shocking to those familiar with the scientific literature, that is, even if the Harper’s article, which the full review proved totally accurate, is discounted for some reason.

breastgood.jpgNevirapine is being tested around Africa as a preventive for HIV transmission from mothers to newborns in breastfeeding. Only South Africa has made an effort to hold out and prevent such a trial taking place, but it looks as if the activists are about to prevail.

Trials of nevirapine in babies are already underway elsewhere in Africa. A trial in Kampala, Uganda, involves 125 newborns at Mulago hospital, and a second at a clinic in Chitungwiza, Zimbabwe, has around 75 infant participants.

A third trial is expected to begin soon in Tanzania. But without the fourth — the South African trial — there was a risk that the project would not have enough participants to render it statistically significant.

Here is the full SciDev.Net report in all its horrid detail:South Africa: HIV Trial Gets Long-Awaited Go Ahead

SciDev.Net (London)

9 August 2007
Posted to the web 10 August 2007

Sharon Davis And Christina Scott

After years of legal wrangling and controversy, authorities finally approved an anti-HIV drug trial. Sharon Davis and Christina Scott report.

A clinical trial investigating ways to prevent newborns from contracting HIV through breast milk is set to proceed in South Africa, following a court judgement overruling the apparent reluctance of the country’s drugs regulators to let the trial go ahead.

South Africa’s Medicines Control Council (MCC) finally approved the trial last week (30 July) after a protracted battle between the MCC and paediatric HIV/AIDS researchers that ended in court.

The situation highlights problems in scaling up HIV/AIDS research in South Africa. The Sydney Declaration at the recent International AIDS Society conference in Australia (22-28 July) called for an increase in research in the developing world (see Scientists: Don’t neglect HIV/AIDS research).

The trial

Research presented at the conference indicated that breastfeeding by HIV infected mothers accounts for one third of all mother-to-child HIV transmissions in the developing world.

“Many HIV-infected women in South Africa and other African countries do not have the luxurious choice of breastfeeding alternatives, and would still choose to breastfeed despite knowing the risks of HIV transmission to their babies through breast milk,” said Daya Moodley, from the Nelson Mandela School of Medicine at the University of KwaZulu-Natal (UKZN) in Durban, South Africa.

In the developed world, formula milk provides a safe alternative to breastfeeding. But bottle-feeding is a risky option in many parts of Africa with poor access to clean water or electricity, and can trigger severe gastrointestinal illnesses in infants.

A US$7.5 million trial, sponsored by the US-based National Institutes of Health (NIH) and led by Moodley and her team at UKZN, aims to test the effectiveness of the antiretroviral (ARV) drug nevirapine as a treatment to block HIV infection in babies breastfed by HIV positive mothers. Nevirapine has been registered with the MCC since April 2000 for the treatment of HIV in adults, adolescents and children with HIV/AIDS.

Three hundred and fifty babies of HIV-infected mothers will be enrolled in the trial. Half the newborns will be given nevirapine and half a placebo for six months or until they stop breastfeeding. The researchers will then monitor the children for signs of HIV infection until 18 months of age. The trial has a double-blind design, meaning neither the participants or researchers know who is receiving which treatment.

South African studies into the safety of nevirapine for babies were completed in 2000 after approval about a year earlier by the MCC.

Yet it was only last week that the MCC approved the trial.

“The MCC is supposed to make a decision within three months of submission by researchers,” said Quarraisha Abdool Karim of the Centre for the AIDS Programme of Research in South Africa (CAPRISA) and co-principal investigator of the global HIV Prevention Trials Network leadership group.

“This is important research. In KwaZulu-Natal and many rural areas, formula feeding is not an option. This delay in research targeted at reducing risk in some of the most vulnerable populations is outrageous,” she told SciDev.Net.

Safety concerns

The dispute between the MCC and the researchers has run for four years. The researchers first applied for MCC approval in November 2003, and the application was eventually rejected in December 2004. The MCC continued to oppose the trial despite several court orders and its own appeals committee approving the trial in February 2006.

Gratification

The MCC’s main concern was the use of a placebo in the trial as a comparison for nevirapine.

Peter Eagles, chairperson of the MCC, told SciDev.Net two weeks ago (27 July) that the MCC is worried about infants in the placebo arm of the trial being exposed to HIV through breastfeeding.

But Pretoria High Court judge Willie Hartzenberg, dismissing the MCC’s application for leave to appeal previous court verdicts (3 July), found the MCC’s allegations that the trial would lead to the infection of babies with HIV to be unsound. He noted that the clinical trial would not place any mother or child in a position worse than they would have been without the trial.

Moodley said, “There is a misunderstanding that women will be forced to breastfeed in the trial. There is no threat of coercion of women to breastfeed and participate in the trial.” Only HIV positive mothers who elect to breastfeed despite the risk of mother-to-child transmission will be enrolled in the trial.

The MCC has also questioned the use of nevirapine to prevent mother-to-baby transmission of HIV. The council told South African newspaper The Argus (30 July) that it has rejected the findings of the HIVNet012 study conducted in Uganda — regarded by researchers as the ‘pivotal study’ on nevirapine for single-dose use to prevent mother-to-baby HIV transmission. “We are no longer able to continue accepting HIVNet as a basis for registering nevirapine for single-dose use in preventing HIV transmission from mother to child in South Africa,” Peter Eagles was quoted as saying.

According to Moodley, “The local and international scientific committee, funding agencies and support staff involved in the clinical trial have been preparing intensively to ensure that we will be able to provide clear scientific evidence on the efficacy and safety of the drug regimen in children in the trial.”

“This clinical trial, like other drug trials, includes intensive laboratory and clinical monitoring for potential side effects and benefits of nevirapine in children,” she adds.

Hoosen ‘Jerry’ Coovadia, of the UKZN medical school and one of the research team, said, “The South African government has been rightly worried about research which is inappropriate for the developing world. They have accused external agencies of abusing vulnerable populations.”

“But here is a study specifically addressing a problem of predominantly African children, which would be of benefit to many poor children in the developing world,” he told SciDev.Net.

“[The trial] will help reduce a substantial proportion of the 300,000 children globally who are infected each year through HIV infected breast milk. [The MCC] held us back on something which could have saved lives.”

Further delays

Following the Pretoria High Court hearing, Judge Hartzenberg ordered the MCC to approve the trial immediately (3 July). The judge stated that the actions of the MCC were “obstructive” and said that the medical evidence refuted the council’s allegations that the research would encourage HIV infection in newborns.

But weeks after the court’s decision, Maryann Francis, a spokesperson from the UKZN, confirmed that the clinical trials were still on hold (24 July). She said the MCC had recently requested additional documentation — including informed consent paperwork, insurance certificates, ethics committee approvals and financial declaration of sponsorship from the NIH — before the trials at Durban’s Prince Mshiyeni Hospital could proceed.

Peter Eagles told SciDev.Net that the MCC’s request for more paperwork was legitimate because, since the council decided not to approve the trial, they “did not request the normal documentation required” at the time. However, the researchers say copies of the documentation were supplied earlier and have repeatedly gone missing at the MCC.

Coovadia said they sent the paperwork demanded by the MCC to the State Attorney on 26 July.

That same week Peter Eagles said the council was still considering further legal action, seeking to oppose the decision by Judge Hartzenberg, despite being refused permission to appeal. “We are not happy with the [judge’s] decision, and our lawyers are looking into this,” he told SciDev.Net.

But last week the MCC decided to approve the trial. It is not known what prompted the MCC to take the decision after a month’s delay following the court verdict. The MCC did not respond to queries about this.

The situation in South Africa

The MCC’s stance has led to claims of unscientific behaviour from HIV/AIDS health workers and activists. There are fears that MCC scientists have caved in to pressure to adopt the stance of South Africa’s ruling African National Congress party, denying that HIV is the cause of AIDS and refuting the scientific consensus on the use of ARV drugs.

Although South Africa has one of the highest HIV/AIDS infection rates in the world, president Thabo Mbeki has gone on record as saying that he knows no one with HIV. South Africa’s health minister, Manto Tshablala-Msimang, has encouraged people to tackle the disease by eating beetroot, lemons and olive oil. The South African health department has also repeatedly raised concerns about the effectiveness and cost — as well as the alleged toxicity — of ARVs.

HIV/AIDS health workers and activists are particularly concerned at the MCC’s failure to act against unproven ‘cures’ that have not gone through safety and efficacy tests, but are nevertheless peddled by a number of businesses and individuals. These include Matthias Rath, a German physician operating in South Africa who advocates herbs and vitamins as a viable alternative to ARVs. The MCC did not respond to queries about these allegations.

Nathan Geffen of the South African AIDS activist non-governmental organisation, the Treatment Action Campaign, says the MCC has refused to act against the “illegal distribution of medicines” by a number of other businesses and individuals profiting from unproven herbal “pseudo-cures”.

“Yet in [the case of the nevirapine trial], the MCC has acted against the advice of experts and its own appeal committee and attempted to block an ethical trial of a proven medicine with the potential to save the lives of many children,” Geffen told SciDev.Net.

Trials of nevirapine in babies are already underway elsewhere in Africa. A trial in Kampala, Uganda, involves 125 newborns at Mulago hospital, and a second at a clinic in Chitungwiza, Zimbabwe, has around 75 infant participants.

A third trial is expected to begin soon in Tanzania. But without the fourth — the South African trial — there was a risk that the project would not have enough participants to render it statistically significant.

Daya Moodley and her team hope to begin the trial within two months. “Our struggle was not intended for the financial gain of this project but the mere fact that we would provide important evidence of a way of protecting thousands of children from HIV if breastfed by their HIV-positive mothers.”
breastfed.JPGWhy is this wrong? One reason is that we already have a study from Durban which showed in 1999 that women with HIV who were breastfeeding transmitted at lower rates than women with HIV who did not breast feed, rates lower or comparable to the rates later claimed for pregnant women who were being given nevirapine (in a study without proper placebo control, as is usual in AIDS drug research).

In other words, women who breastfeed already lower their rate down to or below the rate for women who are given nevirapine when pregnant.

We are merely quoting the scientific literature, of course, which here is Coutsoudis A et al. Influence of infant-feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa. Lancet 354:471-476, 1999.

But this may seem irrelevant to the enthusiastic agitators and media reporters of HIV∫AIDS, since the scientists never bother to mention it.

breast-baby-strap-514web.jpgWe think that they would think again if their own wives and sweethearts were faced with the choice of nevirapine or nothing, when told that the scientific papers show that nothing is at least as good and often better.

After all, is achieving nothing or worse worth the risk of liver failure and death?

The conclusion of the PACTG 1022 study team was published in the journal JAIDS in July of 2004. “The study was suspended,” the authors reported, “because of greater than expected toxicity and changes in nevirapine prescribing information.” They reported that within the nevirapine group, “one subject developed fulminant hepatic liver failure and died, and another developed Stevens-Johnson syndrome.” Stevens-Johnson syndrome is skin necrolysis—a severe toxic reaction that is similar to internal third-degree burns, in which the skin detaches from the body. Another paper, entitled “Toxicity with Continuous Nevirapine in Pregnancy: Results from PACTG 1022,” puts the results in charts, with artful graphics. A small illustration of Hafford’s liver floats in a box, with what looks like a jagged gash running through it. Four of the women in the nevirapine group developed hepatic toxicity.

Somehow we don’t think that those who rush to try this drug out on black people in socially remote (to them) regions of the fabled dark continent would hurry to test it on their own near ones and dear ones.

Not to mention that breastfeeding is something which should be encouraged in Africa, where it helps to cure the nutritional deficits that newborns are otherwise subject to in poorer communities. One hardly wants to discourage mothers from breastfeeding by claiming that they might transfer HIV to their babies unless they take a poisonous drug which increases the chances of doing so.

Even on the dark fantasy continent of HIV∫AIDS that cannot make any sense at all.

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