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[sSRI-Research] Out of Control: AIDS & the Corruption of

Medical Science_Harper's

 

 

 

 

 

Out of Control: AIDS & the Corruption of Medical Science_Harper's

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

For those who thought John LeCarre's 'fictional' Book / Movie, The

Constant

Gardner, was over the top in its depiction of a ruthless pharmaceutical

company and corrupt practices in AIDS drug research, read the

non-fictional

account, OUT OF CONTROL: AIDS and the corruption of medical science, By

Celia Farber in the current issue of Harper's magazine.

 

This riveting, informative article begins by describing the toxic

effect of

the AIDS drug, Nevriapine, and the rapid physical deterioration and

ultimate

death of, Joyce Ann Hafford, a 33-year old pregnant mother of a 13

year old

boy. As the facts of the case unfold, it seems that her life was

sacrificed

on the altar of AIDS research . Hafford was told she was HIV positive

on the

basis of a single screen which, unbeknown to her, is a test known to

have a

high rate of false-positives. [1] Though she was perfectly healthy and

showed no signs of any of the HIV markers, she agreed to participate in a

Phase III clinical trial (PACTG 1022) of nevirapine because she was

told it

would protect the baby she was carrying.

 

" The objective of the trial, PACTG 1022, was to compare the " treatment

limiting toxicities " of two anti-HIV drug regimens. " However, women

in AIDS

drug experiments such as this are not informed that " 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. "

 

Hafford was enrolled in the trial and in early June, 2003, and " on June 18

took her first doses of the drugs. " Her older sister, Rubbie King,

recalled:

" She felt very sick right away, 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. "

" 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 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. " The family could not afford the $3,000

for an

autopsy, so none was performed.

 

" There was a liver biopsy, however,which revealed, according to internal

communiqués of [NIH Division of AIDS] DAIDS staff, that Hafford had

died of

liver 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 death

to the

drug itself, at all. They said that her disease, AIDS, must have

progressed

rapidly. "

But her sister realized something was very wrong: " '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. "

 

In fact, Farber reports, " Joyce Ann Hafford never had AIDS, or

anything even

on the diagnostic scale of AIDS. " Of note: Nevirapine was one of the

experimental drugs tested in children and babies in foster care in

violation

of federal regulatory protections. [2] And many of the foster babies

in the

AIDS drug / vaccine trials did not have AIDS either.

 

" The conclusion of the PACTG 1022 study team was published in the journal

JAIDS in July of 2004. " The study was suspended because of greater than

expected toxicity and changes in nevirapine prescribing information. " The

authors reported that within the nevirapine group, " one subject developed

fulminant hepatic liver failure and died, and another developed S t e

v e n

s -Johnson syndrome " (i.e. skin necrolysis-a severe toxic reaction that is

similar to internal third-degree burns, in which the skin detaches

from the

body).

 

Patients recruited for clinical trials in experiments that involve

high risk

and high financial stakes---particularly those from disadvantaged

populations-all too often encounter an arrogance bordering on

unconscionable

disregard for the rights and dignity of the subjects whose lives are

devalued by an elitist corps of powerful intersecting self-interest groups

who are not held accountable by anyone. Disadvantaged, members of a

minority

cannot possibly challenge powerful doctors who are shielded by powerful

institutions. They and subsequently their families have no leverage.

 

John Solomon, of the Associated Press, who first reported about the

controversy surrounding Nevirapine, and Joyce Ann Safford's death, noted

that Nevirapine had been hailed by the vested AIDS community as a " life

saving " 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 to

African nations as a " cheap solution " for protecting African babies from

AIDS. AP reported the President had not been informed by NIH

officials that

the drug had in fact been found to cause " thousands of severe reactions

including deaths. " [3]

Farber sheds light on the apparent disconnect between what the

evidence from

clinical trials (PACTG 1022) and the highly publicized Nevirapine trials

conducted in Uganda (HIVNET 012) show, and the false claims made for

public

consumption.

 

When the drug's manufacturer, Boehringer Ingelheim inspected the Uganda

trial (HIVNET 012): " They were the first to discover what a shambles the

study was. " According to Boehringer's pre-FDA inspection 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. "

 

Farber writes that the DAIDS then hired a private contractor, a company

named Westat, to go to Uganda and do another pre-FDA inspection. This time

the findings were even more alarming: the major problems that clearly

disqualified the trial included:

.. " loss of critical records " including " one of two master logs " that

included follow-up data on adverse events, including deaths. "

.. " 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. "

.. " 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. "

 

Clearly, the Uganda trial failed to meet minimal safety and scientific

standards.

Yet, Farber reports, though the two inspections had now declared HIVNET to

be " a complete mess, " and DAIDS officials were well aware of the

facts, " the

ways in which the various players were tethered together made it

impossible

for DAIDS to condemn the study without condemning itself. " Thus, according

to DAIDS' 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. "

 

Framed another way, DAIDS trivializes Ugandans' human right to protections

ensured by minimal standards of safety and scientific validity in medical

experiments that they are asked to participate in. Within two weeks

of the

devastating report by Westat, DAIDS officials knowingly deceived the

public

by issuing the following patently false statement:

" There is no question about the validity [of the HIVNET results] . . . the

problems are in the rather arcane requirements in record keeping. "

 

Farber then comments on the politics and undisclosed pervasive

conflicts of

interest that undermine the credulity of most claims made by vocal AIDS

activists about treatment success, noting the uncritical media that

broadcasts propaganda:

" So-called community AIDS activists were sprung like cuckoo birds from

grandfather clocks at the appointed hour to affirm the unwavering AIDS

cathechism: AI D S 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. "

 

" 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. "

 

[note] " 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. "

 

AIDS advocates may be largely responsible legislation (1997 FDA

Modernization Act , FDAMA) that speeded up the drug approval process by

short circuiting safety tests. The unintended consequences are that

the bar

for drug safety has been lowered. Furthermore, their lobbying efforts have

undermined the sin quo non of medicine-which requires proof of safety and

effectiveness for treatments. This has set us back to the time when snake

oil purveyors roamed the countryside selling their, at best, worthless

potions, at worst, lethal ones.

 

The buzzword in AIDS (as well in psychiatry) is neither effectiveness nor

safety-it is " access, " which has the advantage of short-circuiting the

question of whether the treatments actually work.

 

Prior to FDAMA, the burden of proof that a drug was safe and effective

rested on manufacturers. Since then, under pressure from manufacturers who

were 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 Vioxx

being

approved without evidence of their safety.

 

While reading Farber's riveting account of the documented scientific facts

that emerged in clinical trials of the AIDS drug, Nevirapine-evidence that

belies the claims made by stakeholders in the AIDS drug enterprise--one is

struck by the similarity of the disconnect in psychiatry between the

scientific data and claims made. One is also struck by the similarity

between the politics of AIDS and psychiatry. In both there is a disconnect

between the scientific data and the ideology upon which practice

guidelines

rest. In both of these contentious fields the prevailing opinions rest on

theories, but no firm scientific knowledge. And most troubling of all, in

both fields there is an aversion for debate and intolerance of critics who

dare to challenge the prevailing ideology in AIDS and psychiatry--critics

are shunned as pariahs.

 

This sorry state of affairs--so antithetical to the essence of

academia and

the Socratic tradition--leads one to suspect that those in the seats of

power--in AIDS and psychiatry --are unable to refute any opposing

arguments.

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 fear

their authority and the status quo would be toppled, they impose

intellectual stagnation that hinders discovery of new improved

paradigms of

care.

 

References:

 

1. Is a Positive Western Blot Proof of HIV Infection? Eleni

Papadopulos-Eleopulos, Valendar F. Turner and John M. Papadimitriou

BIO/TECHNOLOGY VOL.11 JUNE 1993

http://www.virusmyth.net/aids/data/epwbtest.htm ; see also,

http://www.virusmyth.net/aids/index/hivtests.htm

 

2. See, letters of determination by the Office of Human Research

Protections,

May, 2005: http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf

February, 2006: http://www.ahrp.org/cms/content/view/82/31/

 

3. See: Woman Died During Aids Study

http://www.ahrp.org/infomail/04/12/16.php

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

OUT OF CONTROL: AIDS and the corruption of medical science, By Celia

Farber

in the current issue of Harper's magazine.

 

See excerpt below:

 

" ...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.'...

 

" 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 h u g e 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-today 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 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 fla gship

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... "

........

 

Although HIVNET was designed to be a randomized, placebocontrolled,

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 H o

p k i

n s 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 publ ished 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 M o rbidity 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. 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 followup 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 fin dings [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 HIVpositive 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....cut

....

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of

which

has not always been specifically authorized by the copyright owner. Such

material is made available for educational purposes, to advance

understanding of human rights, democracy, scientific, moral, ethical, and

social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in Title 17 U.S.C.

section 107 of the US Copyright Law. This material is distributed without

profit.

 

 

 

 

 

 

 

 

 

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