FOUR GRADE EVENT
Are AIDS drugs worse than the disease? Don't ask the people who make them.

By Celia Farber

After 20 years of hysteria, alarmism, misplaced recrimination and guilt, AIDS fatigue has beaten the newspaper-reading mind into a kind of blank. Citizens can't be faulted for not knowing how exactly to respond to last week's eruption of scandal from an NIH whistle-blower named Jonathan Fishbein, an AIDS researcher charged with overseeing clinical trials here and abroad. A reverberating language of bureaucracy and euphemism surrounds AIDS stories, making it impossible to know what has actually transpired. When people die from AIDS drugs, for instance, the word "death" is studiously avoided. I have seen medical articles documenting the fact that more people now die of toxicities from AIDS drugs than from the vanishingly opaque syndrome we once called AIDS. Death was referred to as a "grade four event," thus placing it eerily within the acceptable parameters of predictable phenomena in AIDS research—not as a failure, a crisis or even something to lament.




John Solomon broke the first in a series of stories in the Associated Press on Dec. 14. The lede read:



Weeks before President Bush announced a plan to protect African babies from AIDS, top US health officials warned that research in Uganda on a key drug was flawed and may have underreported severe reactions, including deaths, government documents show.



The story held many shocking revelations, but was quickly spun upside-down and inside-out by the AIDS spin machine, which can take any horror and reduce it to banality, keeping the strict focus off of government malfeasance. What Fishbein disclosed was that NIH AIDS research chief Edmund Tramont had airbrushed and cooked damning clinical data from a large experimental trial in Uganda that tested a drug called Nevirapine against AZT, in pregnant HIV-antibody-positive women, intended to reduce HIV transmission. Tramont had censored reports of thousands of toxic reactions to the drug, and "at least 14 deaths," concealing from the White House the truth about the drug, just before Bush rolled out his $500 million plan to push Nevirapine across Africa.



Additional data not widely reported in the media revealed that there were 16 more deaths in babies on Nevirapine, bringing the total to 30, and 38 babies died on AZT (the other arm of the study). The ominous data coincided with findings from an aborted study in South Africa in the late 1990s (stopped due to toxicities and deaths); it was disturbing enough that the drug's manufacturer, Boehringer Ingelheim, withdrew its application to have the FDA approve the drug for use in pregnant women in all Western nations, including the U.S.



In 2000, the FDA put out a black-box label on the drug (which is approved for use in HIV-positive adults as part of a "cocktail therapy"), warning that it could cause fatal kidney damage and a syndrome that causes the flesh to blister and peel as though burned.



This is the drug that countless campaigners—spanning the political spectrum from George Bush to Bono—wish to give all Africans "free access" to. South African President Thabo Mbeki has been savagely pilloried for attempting to stop the drug's distribution to black South Africans. South African lawyer and journalist Anthony Brink's scathing report "The Trouble With Nevirapine" documented the long-known "problems" with the drug. The report was widely read by South Africa's leadership, and is the source of furious debate between black South Africans and the mostly white-run media, which still ridicules all criticism of U.S.-imported AIDS drugs and protocols as being a symptom of not caring about AIDS victims.



Nevirapine is a cheap drug, believed to reduce the transmission of HIV antibodies from mother to child if given before and during birth, despite there being no reliable data to prove that Nevirapine "drastically reduce[s]" transmission." (On average, in women who are well nourished, about eight percent of babies born to HIV-positive mothers with no intervention wind up HIV-antibody-positive; of these, disease progression is not tied to HIV status but rather to the overall health of the mother.) Wild claims about reduction in transmission are based on outdated, flawed research and ignore critical facts. In Africa, for instance, the test used to detect for HIV antibodies cross-reacts with the very proteins of pregnancy, meaning the women may not be true positives to begin with. Furthermore, every baby carries ghost antibodies from its mother for up to 18 months, which it eventually sheds, so all data about HIV status prior to that window of time is useless—but consistently cited anyway.



Nevirapine is a non-nucleoside reverse transcriptase inhibitor—a class of drug designed in the hopes of being less toxic than AZT. This isn't asking much, since AZT is chemotherapy that simply terminates DNA synthesis.



"Of all the AIDS drugs, Nevirapine is the most acutely toxic," explained Dr. Dave Rasnick, a fierce critic of the government's AIDS research agenda, and a former drug developer. "It shows its toxic effects quickly. It has been documented in the medical literature for years that a single dose of Nevirapine can kill a person. People don't normally drop dead from taking a protease inhibitor, but that is what happens with Nevirapine. The rationale for this stuff is just as bizarre as it could be."



He continued: "Liver toxicity is the leading cause of death of HIV-positive people in America and Europe in the cocktail era."



Some months ago, I asked Rasnick to send me documentation of this seemingly unfathomable statement, which he did. The statement is in line with interviews I did with healthcare workers back in 2000, who reported that many more people are hospitalized from the effects of the AIDS drugs than from any of the 30-odd symptoms that originally constituted the definition of AIDS (i.e., a disintegration of the immune system).



This would seem to be a p.r. problem for the AIDS industry. But as we learned from the spin that followed the Fishbein revelations, death by AIDS drugs is not viewed as something that should get in the way of a well-intentioned research agenda—either in the West or in Africa.















The high dudgeon, when it came, was directed not at the NIH for experimenting to lethal effect on pregnant Ugandan mothers, cooking and deleting data, stating openly that African research can't be held to the same standards as Western research, or any of the other disturbing things that came out of Tramontgate.



The ire was aimed at the Associated Press and its reporters for spreading alarm about Nevirapine in Africa, which raised "fears that many women there will stop taking the drug."



The New York Times led the Orwellian spin, in a December 21 article by Donald McNeil Jr. The lede went right to the heart of the matter: The dyspepsia of activists and public health experts.



A series of articles critical of past trials of an important AIDS drug has created a furor in Africa, causing many public health experts to worry that some countries will stop using the drug, which prevents mothers from infecting their babies with the virus that causes AIDS.



It went on: "On Friday, The National Institutes of Health for Allergy and Infectious Diseases, an arm of the National Institutes of Health, sharply criticized the articles, saying, 'It is conceivable that thousands of babies will become infected with HIV and die if single-dose Nevirapine for mother-to-infant HIV prevention is withheld because of misinformation.'"



Misinformation? The AP stories were specifically about the transmogrification of information into misinformation that Tramont engineered for his White House report. He cooked data. He deleted information about toxic reactions and death. In what kind of inverted universe is this not a gross violation of the entire premise of science and medicine?



Nature soon followed suit. From an article dated December 23, this dizzying opener:



Scientists and patient advocates this week united to defend an HIV treatment against allegations that a key clinical trial was flawed. A doctor from Global Strategis for HIV Prevention was quoted: 'This is the most successful therapy in the entire AIDS epidemic. It should not be attacked.'



"We are now living in a time of psychotic science, or abnormal science as I call it," said former New York Native publisher Chuck Ortleb, who was boycotted by the activist group ACT UP for publishing scathing critiques of AZT in the 1980s—a drug that was later proven to shorten rather than lengthen life. "That's why there are no controls in AIDS science, no dissent, why it's all science by press release. These self-appointed AIDS czars pretending to speak for the gay community, pretending to be revolutionaries, pretending to be anti-government when in fact they've always worked hand in hand with the government."



In recent years, Ortleb has turned to writing satirical novels, plays and a soon-to-be-released film called The Last Lovers on Earth, which is centered on a future dystopia in which AIDS research has been so successful that all gay men are dead.



"With their logic," Ortleb says, "this risk-benefit analysis, it doesn't matter if people die on the drugs, because they died so that the rest of the world could be saved."



His most recent send-up is a fictional press release for a new medical group called "Doctors Without Borders, Brains or Ethics," and focuses on protecting the AIDS establishment from criticism, "before the infection of skepticism spreads."















Let us not forget that Nevirapine is a drug that was pulled by its own manufacturer from use in the West, after an investment of many millions of dollars. It remains banned for use in pregnant first-world women.



Still, the NIH is using it on American women, in experimental trials you never heard about—until now. Alongside the revelations about the Ugandan trial, the AP stories brought to light that Joyce Ann Hafford, a 33-year-old, perfectly healthy, eight-months pregnant HIV-positive woman from Tennessee died from liver failure in an NIH trial testing Nevirapine. Her liver counts had been way off for days, and still doctors didn't take her off the drug.



The doctors told her family, naturally, that she had died of AIDS. The trouble is, cocktail-drug deaths are easily distinguished from AIDS deaths. This was not the case with AZT, a drug that simply decimated the immune system. Cocktail deaths are caused primarily by liver toxicity, heart attacks and strokes—from the effects of the drugs on the body's fat metabolism.



Hafford's death crystallizes the raging conflict between the establishment point of view that HIV is deadly and drugs save lives and the "denialist" or dissident point of view that HIV is not deadly at all by itself, but AIDS drugs are. Hafford had no so-called AIDS symptoms; she was simply HIV positive. She also had an older healthy child, which suggests that HIV may not be as lethal as advertised. By refusing to lament her death, or even the scores of Ugandan deaths, and instead attacking the messenger, the AIDS establishment has shown itself to be lost, with a broken compass, on the map of medicinal ethics.



Once it becomes acceptable to kill patients in experimental clinical trials and cover it up, without

The Food and Drug Administration, sometimes criticized in past years for being too cozy with corporations, has lately come under attack for exactly the opposite failing.

A powerful bloc of critics in industry and the Republican Congress is pushing to overhaul the FDA, claiming the agency is too tough on drug companies, unnecessarily inhibiting innovation and delaying the approval of new drugs and medical devices.

Leading the charge is Speaker of the House Newt Gingrich, who has labeled the FDA the "number one job-killer" in the country, and called its head, David Kessler, "a bully and a thug." Gingrich's Progress & Freedom Foundation has announced a radical plan to privatize much of the FDA's oversight of drugs and medical devices. Not surprisingly, the foundation has financial backing from some of the biggest names in the pharmaceutical industry, including Bristol-Myers Squibb Co., Eli Lilly & Co., and Marion Merrell Dow. Glaxo, manufacturer of Imitrex (see main story), has also given an undisclosed amount to the foundation, in addition to contributions of approximately $325,000 to the Republican Party and Republican candidates (including $4,000 to Gingrich) in the last election alone. As a whole, the drug industry contributed more than $1.6 million to the Republican Party in the 1993-94 election cycle.