Print

Print


>New York Press Volume 17, Issue 52
>WWW.NYPRESS.COM
>DECEMBER 28, 2004
>
>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 consequence, you might argue that
>all is lost.
>
>
> 2004 New York Press


--