|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?