ANC TODAY ARTICLE – 17 December 2004
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
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
maker.
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
Africans.
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
MTCT.
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
inaction.
“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
world.”
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
drugs!
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
Africans”.
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?
