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ANC TODAY ARTICLE – 17 December 2004

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Nevirapine, drugs & African guinea pigs

Some years ago, our national licensing authority, the Medicines Control Council,

MCC, provisionally licensed the drug Nevirapine for mother-to-child-prevention of

HIV transmission (MTCT). The licence was provisional because the manufacturer had

not supplied all the necessary information required to license drugs.

Some time after this, the same manufacturer failed to supply the US drug

licensing authority, the Food and Drug Administration, FDA, with the same

information requested by the MCC. When the FDA asked them to supply this

information, the manufacturers withdrew their application and have not

resubmitted it ever since.

In this regard, AP has reported that because of the known problems about the

Uganda "study", "NIH at first sought to postpone the FDA review of nevirapine,

then top NIH and FDA officials arranged for the drug maker to pull its U.S.

application rather than risk a public rejection that might scare African

countries looking for U.S. guidance on the drug."

This tells the deeply disturbing and frightening story that "top" U.S. government

officials were ready to hide from "African countries looking for U.S. guidance on

the drug", the adverse effects of nevirapine they knew very well, and which they

were certain would oblige the FDA to reject the licence application of the drug


In other words they entered into a conspiracy with a pharmaceutical company to

tell lies to promote the sales of nevirapine in Africa, with absolutely no

consideration of the health impact of those lies on the lives of millions of


Sensitive to all these developments, our national Health Department decided to

introduce the now provisionally-licensed nevirapine in 18 trial sites throughout

our country, both to make the drug available to our people and to try to answer

the many unanswered questions about the drug.

This necessary investigative work, targeted at ensuring that our public health

system did not further compromise the health of our people, especially the poor

who depend exclusively on the public health system, had to come to a stop,

because essentially the Constitutional Court ruled that there should be a general

"roll-out" in terms of the availability of nevirapine.

Having carried out further investigations concerning this drug, this year the MCC

directed that nevirapine should no longer be used as mono-therapy for purposes of


As was to be expected, various individuals and NGOs in our country dedicated to

the marketing of anti-retroviral drugs, immediately spoke out against the

decision of the MCC, which was based on the obligation of the Council to protect

the health and lives of our people from harmful drugs.

And then earlier this month, the news agency Associated Press (AP) revealed that

indeed the MCC decision was fully justified. The agency reported that the

clinical "study" carried out in Uganda to validate nevirapine as a correct

intervention to address MTCT, was scientifically faulty and could not be used to

authorise the use of nevirapine for MTCT.

"Among other things it said, Dr. Betsy Smith's report, finished in January 2003,

said the Uganda trial suffered from "incomplete or inadequate safety reporting"

and records on patients were "of poor quality and below expected standards of

clinical research."

"She strongly urged NIH not to make sweeping conclusions about nevirapine based

on the Uganda research. "Safety conclusions from this trial should be very

conservative," she wrote."

The news agency also reported:

"The government's chief AIDS researcher removed some negative safety conclusions

from a subordinate's report on a U.S.-funded drug experiment, then ordered the

research to resume over objections from his staff, memos show.

"As justification, Dr. Edmund Tramont, chief of the National Institutes of

Health's (NIH) AIDS Division, cited his four decades of medical experience and

argued that Africans with an AIDS crisis deserved some leniency in meeting U.S.

safety standards, according to interviews and documents obtained by the

Associated Press.

"Tramont's staff, including his top deputy, had urged more scrutiny of the Uganda

research site to ensure it overcame record-keeping problems, violations of

federal patient safety safeguards and other issues. These problems had forced a

15-month halt to the research into using a single dose of nevirapine to prevent

African babies from getting AIDS from their mothers.

"AP reported on Monday that NIH knew about the problems in early 2002 but did not

tell the White House before President Bush launched a plan that summer to spread

nevirapine throughout Africa.

"Now, officials have new concerns that the lone dose of nevirapine may cause

long-term resistance to AIDS drugs in the hundreds of thousands of African

patients who received it, foreclosing future treatment options."

AP also reported that "Westat, a medical auditing firm hired by NIH to visit and

audit the Uganda site" found in March 2002 that, "It appeared likely, in fact,

that many adverse events and perhaps a significant number of serious adverse

events for both mother and infant may not have been collected or reported in a

timely manner.

"Westat reported there were 14 deaths not reported in the study database as of

early 2002 and that the top two researchers in Uganda acknowledged thousands of

bad reactions that weren't disclosed."

During the same month it reported the highly unethical conduct concerning the

alteration of the report on the Uganda "study", Associated Press reported on the

death of a woman in the US who had been prescribed an anti-retroviral regimen

that included nevirapine. It said:

"In July 2003, the Tennessee woman (Ms Hafford) was hospitalized and on a

respirator, and top government scientists were monitoring reports of her

worsening condition. NIH officials suspected the drug regimen was the cause as it

contained nevirapine. Since at least 2000, the government has warned that

nevirapine could cause lethal liver damage or rashes when taken in multiple doses

over time.

"Ouch! Not much [we] can do about [dumb] docs," Dr. Edmund Tramont, chief of

NIH's AIDS Division, wrote in an e-mail after his staff reported that physicians

continued giving Hafford nevirapine and Combivir despite signs of liver failure."

In this case, evidently, Dr Tramont blamed "dumb doctors". In the earlier case

relating to the Uganda "study" and the felt need to dispense nevirapine in

Africa, regardless of the grave health concerns expressed by his team of

scientists, according to AP he had pleaded political imperatives.

AP reported that, "Tramont wrote in 2003 e-mails that he reopened the clinics (in

Uganda despite the objections of his scientific team) because he didn't want NIH

"perceived as bureaucratic but rather thoughtful and reasonable" and that it was

important to encourage Africans' fight against AIDS "especially when the

president (George W.Bush) is about to visit them."

Having been kept completely in the dark about what the U.S. government medical

scientists knew about nevirapine and MTCT, understandably and honestly President

Bush announced that "This major commitment of my government, (relating to the

expenditure of large sums of money to fight HIV and AIDS especially in Africa and

the Caribbean), to prevent mother-to-child HIV transmission, is the first of this

scale by any government, anywhere." Nevirapine would be the drug given to

Africans on the continent and the Diaspora to meet this unprecedented commitment!

Clearly, what was important for Dr Tramont was not the health of the African

people, but the success of President Bush's visit to our continent, during which

he would market nevirapine to convince all of us that he is concerned about our

health, not knowing that the US state medical research authorities had kept him

ignorant about the serious concerns relating to the use of nevirapine.

In other words, Dr Tramont was happy that the peoples of Africa should be used as

guinea pigs, given a drug he knew very well should not be prescribed.

Understandably outraged at this contemptuous attitude towards the lives of

Africans, which is informed by the conviction that they are worth nothing,

compared to perceptions about US state institutions and the image of an innocent

President Bush, the prominent African American US leader, Rev Jesse Jackson

issued the following statement:

"I read with outrage and disbelief that Dr. Edmund Tramont, chief of the National

Institutes of Health's AIDS Division, had removed some negative safety

conclusions from a subordinate's report on a U.S.-funded drug experiment for

Africa and then ordered the research to resume over objections from his staff.

"According to news reports, Dr. Tramont doctored the final document to under

report thousands of severe reactions, including deaths and long-term resistance,

to Nevirapine. This was not a thoughtful and reasonable decision, but a crime

against humanity. Furthermore, upon learning of the potential lethal side effect

of Nevirapine, President Bush and his administration did nothing to stop the

shipment and usage of the drug in Africa. They must be held accountable for their


"Africa, a continent with the world's largest HIV/AIDS population, claiming about

25 million of the estimated 38 million people infected with HIV/AIDS, is once

again being marginalized. For the millions of Africans who pined their faith and

hope on U.S. moral leadership in the fight against this pandemic, disappointment

and devastation are understatements in expressing their feelings.

"Moreover, for the National Institute of Health (NIH) to know about the problems

in early 2002 but failed to inform the White House before President Bush launched

a plan that the same year sought to increase the distribution of nevirapine

throughout Africa, is an outrage. The President should demand nothing less than a

thorough investigation of the matter. The fact that Dr. Tramont rushed to

secretly alter the report findings and then dismissed the objections of

professional safety monitors hired by NIH, when President Bush was about to visit

Africa, seems to be a political decision.

"I call upon both houses in Congress to open a thorough investigation of this

catastrophe and hold the NIH and the Bush administration responsible for

spreading this deadly drug. With more than 5,000 Africans dying a day from

HIV/AIDS, the U.S. should double its efforts in fighting this pandemic, instead

of adding to the agony.

"Research standards and drug quality that are unacceptable in the US and other

western countries must never be pushed onto Africa. We should stop discounting

the lives of Africans. We are all God's children, created equally. And where

there is suffering, it is our moral obligation to do all we can to save humanity.

"Keep Hope Alive!"

The Republican Finance Committee Senate Chairperson, Senator Charles Grassley was

similarly outraged by the conduct of Dr Tramont of the NIH. He has therefore

asked the US Justice Department to investigate this conduct.

AP reported that "In a letter released Monday, Grassley said he was compelled to

do so by 'the serious nature of these allegations and the grave implications if

the allegations have merit' "

AP also reported that the NIH had hired an auditor, who "first helped disclose

the problems" with the nevirapine saga. The auditor, Michael Hensley, had said

that "NIH officials were in a rush to declare that things were OK."

Most interestingly, and specifically with regard to our own country and people,

Mr Hensley told AP: "It seemed to me we were drawing conclusions too quickly

across the board, especially the implementation of nevirapine in South Africa."

As will inevitably happen, in time the truth will come out! This includes the

truth about the origins of the enormous pressure that was put on our government

to make nevirapine generally available throughout the public health system.

As the foregoing shows, many people and institutions especially in the United

States are deeply worried about what Senator Grassley described as the "grave

implications" of the AP disclosures about the nevirapine affair. We too agree

that these disclosures have grave implications.

But obviously, the TAC does not agree. It is determined to continue to pursue its

mission to promote the widest possible use of anti-retroviral drugs in our

country, at all costs. In this regard, despite the fact that it is a mere NGO,

and not a body of suitably qualified scientists, it is quite ready even to deny

the reality of established scientific truths.

Consequently, despite and in the face of everything we have reported in this

article, it issued a statement which said, among other things: "The criticisms

levelled by the parties involved in the NIH news story, that broke two days ago,

do not provide evidence questioning the safety or efficacy of short-course

nevirapine. It is false, as has been reported in some places and by the

Department of Health, that short-course nevirapine has been associated with

thousands of adverse events. There is to date not a single life-threatening

adverse event associated with this regimen which is widely used in the developing


Desperate to ensure that the truth does not undermine its drug marketing

campaign, the TAC said, "The TAC is angry and considering legal advice on the

Department of Health's continued misinformation campaign on nevirapine."

Intent to sustain public pressure for the expansion of the market for anti-

retroviral drugs in general, and nevirapine in particular, the TAC also said:

"Reporting in South Africa over the last 24 hours regarding this (NIH) news story

has been sloppy, with many journalists failing to understand the content or

context of what is being debated. This has the potential to undermine public

confidence in nevirapine unnecessarily. Science reporting in South Africa is

generally poor and the TAC will endeavour in the future to work with journalists

and other organisations to improve the quality of science reporting."

And so, to guarantee and improve the sale of anti-retroviral drugs, this being

the central mission of the treatment campaign of the Treatment Action Campaign,

the TAC boldly proclaims that it is a Science Institute that is capable of

improving the quality of scientific reporting in our country, and undoubtedly

especially "scientific reporting" about nevirapine and other anti-retroviral


It counts our courts as its ally, which, presumably because of past experience,

it is confident would adjudicate the scientific and health controversy that has

arisen concerning nevirapine, in its favour. Perhaps our judges will have to

decide whether they are a scientific review panel or an institution that has

oversight over the faithful implementation of our Constitution and our laws.

But to make doubly sure that it achieves its objective of marketing anti-

retroviral drugs at all costs, the TAC also pledges to position itself as the

central adjudicator of what should appear in our mass media as quality science

reporting! And the quality science reporting it seeks should be such that it does

not unnecessarily "undermine public confidence in nevirapine". Naturally!

Michael Hensley said it seemed to him that despite the known adverse effects of

the drug, the NIH was very keen to expedite "the implementation of nevirapine in

South Africa." Jesse Jackson wrote that "We should stop discounting the lives of


Strangely for an organisation that presents itself as African, passionately

concerned about the health and the lives of Africans, the TAC seems quite happy

to "discount the lives of Africans", and to ensure "the implementation of

nevirapine in South Africa", regardless of "the significant number of serious

adverse events for both mother and infant (that) may not have been collected or

reported in a timely manner during the course of the Uganda "study".

Whose interests does the TAC serve?