The sordid story of AIDS research.

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SSRI-Research@Sun, 12 Mar 2006 23:34:18 -0800 (PST)[sSRI-Research] Out of Control: AIDS & the Corruption ofMedical Science_Harper'sOut of Control: AIDS & the Corruption of Medical Science_Harper'sALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org/cms/FYIFor those who thought John LeCarre's 'fictional' Book / Movie, TheConstantGardner, was over the top in its depiction of a ruthless pharmaceuticalcompany and corrupt practices in AIDS drug research, read thenon-fictionalaccount, OUT OF CONTROL: AIDS and the corruption of medical science, ByCelia Farber in the current issue of Harper's magazine.This riveting, informative article begins by describing the toxiceffect ofthe AIDS drug, Nevriapine, and the rapid physical

deterioration andultimatedeath of, Joyce Ann Hafford, a 33-year old pregnant mother of a 13year oldboy. As the facts of the case unfold, it seems that her life wassacrificedon the altar of AIDS research . Hafford was told she was HIV positiveon thebasis of a single screen which, unbeknown to her, is a test known tohave ahigh rate of false-positives. [1] Though she was perfectly healthy andshowed no signs of any of the HIV markers, she agreed to participate in aPhase III clinical trial (PACTG 1022) of nevirapine because she wastold itwould protect the baby she was carrying."The objective of the trial, PACTG 1022, was to compare the "treatmentlimiting toxicities" of two anti-HIV drug regimens." However, womenin AIDSdrug experiments such as this are not informed that "Of the four drugs inthis study, three belong to the FDA's category "C," which means thatsafetyto either mother or fetus

has not been adequately established."Hafford was enrolled in the trial and in early June, 2003, and "on June 18took her first doses of the drugs." Her older sister, Rubbie King,recalled:"She felt very sick right away, within seventy-two hours, she had avery badrash, welts all over her face, hands, and arms. That was the firstsign thatthere was a problem. I told her to call her doctor and she did, but theyjust told her to put hydrocortisone cream on it. I later learned thata rashis a very bad sign, but they didn't seem alarmed at all."Hafford was on the drug regimen for thirty-eight days. "Her health startedto deteriorate from the moment she went on the drugs," says King. "She wasalways in pain, constantly throwing up, and finally she got to the pointwhere all she could do was lie down.""On July 16, at her scheduled exam, Hafford's doctor took note of therash,which was "pruritic and macular- papular," and

also noted that she wassuffering hyperpigmentation, as well as ongoing nausea, pain, andvomiting.By this time all she could keep down were cans of Ensure. Her blood wasdrawn for lab tests, but she was not taken off the study drugs,according tolegal documents and internal NIH memos. Eight days later, Hafford went tothe Regional Medical Center "fully symptomatic," with what legal documentscharacterize 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 Hafford wassummonedback to the hospital after her lab reports from nine days earlier werefinally reviewed. She was admitted to the hospital's ICU with "acute andsub-acute necrosis of the liver, secondary to drug toxicity, acute renalfailure, anemia, septicemia, premature separation of the

placenta," andthreatened "premature labor." She was finally taken off the drugs but wasalready losing consciousness." The family could not afford the $3,000for anautopsy, so none was performed."There was a liver biopsy, however,which revealed, according to internalcommuniqués of [NIH Division of AIDS] DAIDS staff, that Hafford haddied ofliver failure brought on by nevirapine toxicity.What the family was told about the cause of Hafford's death:"They told us how safe the drug was, they never attributed her deathto thedrug itself, at all. They said that her disease, AIDS, must haveprogressedrapidly."But her sister realized something was very wrong: "'On the one handthey'retelling us this drug is so safe, on the other hand they're telling usthey're going to monitor the other patients more closely. If herdisease wasprogressing, they could have changed the medication.' I knew something waswrong

with their story, but I just could not put my finger on what itwas."In fact, Farber reports, "Joyce Ann Hafford never had AIDS, oranything evenon the diagnostic scale of AIDS." Of note: Nevirapine was one of theexperimental drugs tested in children and babies in foster care inviolationof federal regulatory protections. [2] And many of the foster babiesin theAIDS drug / vaccine trials did not have AIDS either."The conclusion of the PACTG 1022 study team was published in the journalJAIDS in July of 2004. "The study was suspended because of greater thanexpected toxicity and changes in nevirapine prescribing information." Theauthors reported that within the nevirapine group, "one subject developedfulminant hepatic liver failure and died, and another developed S t ev e ns -Johnson syndrome" (i.e. skin necrolysis-a severe toxic reaction that issimilar to internal third-degree burns, in which the skin

detachesfrom thebody).Patients recruited for clinical trials in experiments that involvehigh riskand high financial stakes---particularly those from disadvantagedpopulations-all too often encounter an arrogance bordering onunconscionabledisregard for the rights and dignity of the subjects whose lives aredevalued by an elitist corps of powerful intersecting self-interest groupswho are not held accountable by anyone. Disadvantaged, members of aminoritycannot possibly challenge powerful doctors who are shielded by powerfulinstitutions. They and subsequently their families have no leverage.John Solomon, of the Associated Press, who first reported about thecontroversy surrounding Nevirapine, and Joyce Ann Safford's death, notedthat Nevirapine had been hailed by the vested AIDS community as a "lifesaving" drug and a "very important tool" to combat HIV in the Third World.In fact, President Bush allocated $500

million for the drug to be given toAfrican nations as a "cheap solution" for protecting African babies fromAIDS. AP reported the President had not been informed by NIHofficials thatthe drug had in fact been found to cause "thousands of severe reactionsincluding deaths." [3]Farber sheds light on the apparent disconnect between what theevidence fromclinical trials (PACTG 1022) and the highly publicized Nevirapine trialsconducted in Uganda (HIVNET 012) show, and the false claims made forpublicconsumption.When the drug's manufacturer, Boehringer Ingelheim inspected the Ugandatrial (HIVNET 012): "They were the first to discover what a shambles thestudy was." According to Boehringer's pre-FDA inspection report, "seriousnon-compliance with FDA regulations was found" in the specificrequirementsof reporting serious adverse events. Problems also were found in themanagement of the trial drug and in

informed-consent procedures."Farber writes that the DAIDS then hired a private contractor, a companynamed Westat, to go to Uganda and do another pre-FDA inspection. This timethe findings were even more alarming: the major problems that clearlydisqualified the trial included:. "loss of critical records" including "one of two master logs" thatincluded follow-up data on adverse events, including deaths.". "The records failed to make clear which mothers had gotten whichdrug, when they'd gotten it, or even whether they were still alive atvarious follow up points after the study.". "Drugs were given to the wrong babies, documents were altered, andthere was infrequent follow-up.". "The infants that did receive follow-up care were in many casessmall and underweight for their age. It was thought to be likely thatsome,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, onlyeleven were said to be HIV positive."Clearly, the Uganda trial failed to meet minimal safety and scientificstandards.Yet, Farber reports, though the two inspections had now declared HIVNET tobe "a complete mess," and DAIDS officials were well aware of thefacts, "theways in which the various players were tethered together made itimpossiblefor DAIDS to condemn the study without condemning itself." Thus, accordingto DAIDS' public version of events, which was dutifully echoed in the AIDSpress, "the trouble with HIVNET was that it was unfairly assailed bypedantic saboteurs who could not grasp the necessary differencebetween U.S.safety standards and the more lenient standards that a country like Ugandadeserved."Framed another way, DAIDS trivializes Ugandans' human right to protectionsensured by minimal standards

of safety and scientific validity in medicalexperiments that they are asked to participate in. Within two weeksof thedevastating report by Westat, DAIDS officials knowingly deceived thepublicby issuing the following patently false statement:"There is no question about the validity [of the HIVNET results] . . . theproblems are in the rather arcane requirements in record keeping."Farber then comments on the politics and undisclosed pervasiveconflicts ofinterest that undermine the credulity of most claims made by vocal AIDSactivists about treatment success, noting the uncritical media thatbroadcasts propaganda:"So-called community AIDS activists were sprung like cuckoo birds fromgrandfather clocks at the appointed hour to affirm the unwavering AIDScathechism: AI D S drugs save lives. To suggest otherwise is to endangermillions of African babies. Front and center were organizations like theElizabeth Glaser

Pediatric AIDS Foundation, which extolled theimportance ofnevirapine. Elizabeth Glaser's nevirapine defenders apparently didn'tencounter a single media professional who knew, or cared, that theorganization had received $1 million from nevirapine's maker, BoehringerIngelheim, in 2000.""This was no scandal but simply part of a landscape. Pharmaceuticalcompanies fund AIDS organizations, which in turn are quoteduncritically inthe media about how many lives their drugs save. This time the AIDSorganizations were joined by none other than the White House, which was inthe midst of promoting a major program to make nevirapine available acrossAfrica."[note] "Africa, as the news media never tires of telling us, has becomeground zero of the AIDS epidemic. The clinical definition of AIDS inAfrica, however, is stunningly broad and generic, and was seeminglydesignedto be little other than a signal for funding. It is

in no waycomparable toWestern definitions. The "Bangui definition" of AIDS was establishedin thecity of Bangui in the Central African Republic, at a conference in1985. Thedefinition requires neither a positive HIV test nor a low T-cell count, asin the West, but only the presence of chronic diarrhea, fever, significantweight loss, and asthenia, as well as other minor symptoms. Thesehappen tobe the symptoms of chronic malnutrition, malaria, parasiticinfections, andother common African illnesses. "AIDS advocates may be largely responsible legislation (1997 FDAModernization Act , FDAMA) that speeded up the drug approval process byshort circuiting safety tests. The unintended consequences are thatthe barfor drug safety has been lowered. Furthermore, their lobbying efforts haveundermined the sin quo non of medicine-which requires proof of safety andeffectiveness for treatments. This has set us back to the time

when snakeoil purveyors roamed the countryside selling their, at best, worthlesspotions, at worst, lethal ones.The buzzword in AIDS (as well in psychiatry) is neither effectiveness norsafety-it is "access," which has the advantage of short-circuiting thequestion of whether the treatments actually work.Prior to FDAMA, the burden of proof that a drug was safe and effectiverested on manufacturers. Since then, under pressure from manufacturers whowere emboldened by the AIDS activists' demand for speedy approval, the FDA(in essence) presumes safety and efficacy unless someone proves otherwise.Hence, we are again confronted with unsafe, lethal drugs such as Vioxxbeingapproved without evidence of their safety.While reading Farber's riveting account of the documented scientific factsthat emerged in clinical trials of the AIDS drug, Nevirapine-evidence thatbelies the claims made by stakeholders in the AIDS drug

enterprise--one isstruck by the similarity of the disconnect in psychiatry between thescientific data and claims made. One is also struck by the similaritybetween the politics of AIDS and psychiatry. In both there is a disconnectbetween the scientific data and the ideology upon which practiceguidelinesrest. In both of these contentious fields the prevailing opinions rest ontheories, but no firm scientific knowledge. And most troubling of all, inboth fields there is an aversion for debate and intolerance of critics whodare to challenge the prevailing ideology in AIDS and psychiatry--criticsare shunned as pariahs.This sorry state of affairs--so antithetical to the essence ofacademia andthe Socratic tradition--leads one to suspect that those in the seats ofpower--in AIDS and psychiatry --are unable to refute any opposingarguments.Thus, they adopt a position akin to academic Stalinism or, if one prefers,religious

dogma that tolerates no dissent.By abusing their power to stifle ideas that contradict their own for feartheir authority and the status quo would be toppled, they imposeintellectual stagnation that hinders discovery of new improvedparadigms ofcare.References:1. Is a Positive Western Blot Proof of HIV Infection? EleniPapadopulos-Eleopulos, Valendar F. Turner and John M. PapadimitriouBIO/TECHNOLOGY VOL.11 JUNE 1993http://www.virusmyth.net/aids/data/epwbtest.htm ; see also,http://www.virusmyth.net/aids/index/hivtests.htm2. See, letters of determination by the Office of Human ResearchProtections,May, 2005: http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdfFebruary, 2006: http://www.ahrp.org/cms/content/view/82/31/3. See: Woman Died During Aids Studyhttp://www.ahrp.org/infomail/04/12/16.phpContact: Vera Hassner Sharav212-595-8974veracare "Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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