ANC Today Article is Inaccurate and Contradicts ANC and Government Policy

 

 

 

Contents

TAC response to ANC Today article that potentially undermines government's mother-to-child transmission prevention programme and attacks the TAC

Letter from TAC to ANC

 

ANC Today article of 17 December 2004 undermining government's mother-to-child transmission prevention programme and attacks the TAC

 

 

 

 

Contents

 

TAC response to ANC Today article that potentially undermines government's mother-to-child transmission prevention programme and attacks the TAC

Letter from TAC to ANC

 

ANC Today article of 17 December 2004 undermining government's mother-to-child transmission prevention programme and attacks the TAC

 

 

 

We also recommend Theo Smart's excellent analysis of John Solomon's inaccurate Associated Press article which contributed to the latest furor over nevirapine. See:

http://www.essentialdrugs.org/edrug/archive/200501/msg00001.php ANC Today Article is Inaccurate and Contradicts ANC and Government Policy Letter from TAC to ANC ANC TODAY ARTICLE – 17 December 2004

 

 

 

 

An article titled Nevirapine, drugs and African guinea pigs was published in the 17 December edition of ANC Today (reprinted below). The author of the article is nameless. The article makes false and defamatory accusations against the TAC, but more importantly it contains scientific inaccuracies that have the potential to undermine public confidence in government's mother-to-child transmission prevention programme, thereby endangering the lives of infants born to women with HIV.

The writer of the article is either confused or deliberately trying to mislead; his or her views contradict ANC and government policy. The TAC has sent a letter to the ANC (reprinted below) requesting the organisation to withdraw the article and apologise to the TAC. It is unfortunate that the article has based its arguments on an Associated Press report of 13 December which has subsequently been shown to contain serious inaccuracies.

The most important of the false allegations and inaccuracies made explicitly or implicitly in the article are described here.

 

Allegation 1:

Correction:

Nevirapine is used to treat people with AIDS, in which case it is taken everyday for life in combination with other antiretrovirals; this is known as chronic use. For most people with AIDS, this is a life-saver. Unfortunately, nevirapine has life-threatening side-effects for a small number of people and some have died. In all likelihood they would have died of AIDS if they had not taken antiretrovirals. This has been known for a number of years, including during the court case between the TAC and government over the provision of mother-to-child transmission prevention services. Nearly every useful medicine has benefits and risks. There is overwhelming scientific evidence that the benefits of nevirapine when used to treat people with AIDS outweigh the risks. This is why the South African Medicines Control Council has registered nevirapine for this purpose.

Nevirapine can also be used to prevent transmission of HIV from mother-to-child. The Uganda trial tested if nevirapine is effective for mother-to-child transmission prevention when a single dose is given to mother and a single dose is given to the newborn child. The trial found that nevirapine halves the transmission from mother to child. It also found that nevirapine is safe when used like this; no life-threatening side-effects could be attributed to nevirapine when used as a single dose to mother and child. At least seven other trials have confirmed the results of the Ugandan trial including a much larger trial conducted in South Africa.

Single-dose nevirapine is safe and effective for preventing mother-to-child transmission of HIV. This is not merely the opinion of the TAC. It is the opinion of the South African Medical Association, the Rural Doctors Association, the Southern African HIV Clinicians Society, the World Health Organisation and every reputable HIV research and activist organisation in the world.

Single-dose nevirapine is the regimen that was chosen by government for its mother-to-child transmission prevention programme (as the writer correctly states – there is an incorrect perception that the TAC or Constitutional Court chose single-dose nevirapine for the South African public health sector). Denouncing it as unproven and dangerous therefore contradicts government programmes and policy.

The writer has echoed the mistake of the Associated Press article of confusing the occasional life-threatening side-effects of nevirapine when used as a chronic medicine with single-dose nevirapine used for mother-to-child transmission prevention.

It is true that a former employee of the NIH has made allegations that the Uganda trial was not conducted properly, but he has stated quite clearly that his allegations are not based on any evidence regarding the safety and efficacy of nevirapine, but are related to the specific conduct of the trial. The TAC cannot comment on these allegations and we note that a second independent review of the trial is now underway. However, there is sufficient evidence of the safety and efficacy of single-dose nevirapine without even considering the Uganda trial. Tens of thousands of women and infants have already taken single-dose nevirapine and not a single life-threatening reaction to the drug has been recorded. There is however compelling evidence that many infants have been saved from contracting HIV because of this health intervention.

However, there are more effective methods of preventing mother-to-child transmission than single-dose nevirapine which involve using a combination of antiretroviral medicines and the TAC has frequently called on government to switch to these where it is feasible to do so. These better regimens typically include nevirapine, but not necessarily. The Western Cape Government has already introduced a more effective regimen. For health facilities where it is not currently feasible to do so, a plan should be developed to ensure that the more effective regimens are introduced over time.

 

 

Allegation 2:

Correction:

Critically the Constitutional Court ruled that government could use other treatments to prevent mother-to-child transmission if they became available. Other more effective treatments are available and, except for the Western Cape government which uses nevirapine in combination with other antiretrovirals to prevent mother-to-child transmission, government has not taken steps to switch to these more effective regimens. The TAC will continue to campaign for government to do so.

 

 

Allegation 3:

Correction:

 

 

Allegation 4:

Correction:

The resistance issues with single-dose nevirapine were known even at the time of the Constitutional Court case on mother-to-child transmission prevention. The Court actually stated "As far as resistance is concerned, the only relevance is the possible need to treat the mother and/or the child at some time in the future. Although resistant strains of HIV might exist after a single dose of nevirapine, this mutation is likely to be transient. At most there is a possibility of such resistance persisting, and although this possibility cannot be excluded, its weight is small in comparison with the potential benefit of providing a single tablet of nevirapine to the mother and a few drops to her baby at the time of birth. The prospects of the child surviving if infected are so slim and the nature of the suffering so grave that the risk of some resistance manifesting at some time in the future is well worth running."

 

 

Allegation 5:

Correction:

The TAC has a long record of fighting the drug companies; in fact it has a much better record on this than either the government or the ANC. We campaigned against the drug company Pfizer which led to the company providing a life-saving opportunistic infection drug, fluconazole, at no cost to government. In 2001, we joined a court case on government's side to force multinational drug companies to withdraw their legal action against government. We also called for worldwide demonstrations against the drug companies – and these took place. This resulted in the drug companies withdrawing their litigation. In 2003, we forced two large companies, GlaxoSmithKline and Boehringer Ingelheim, into a settlement that has resulted in generic versions of AZT, lamivudine and nevirapine becoming available at much cheaper prices which will benefit the national procurement process that is underway. Our legal representatives, the AIDS Law Project, were awarded a prize by the Department of Trade and Industry for this. Currently we are pressurising another company, MSD, to allow competition on its antiretroviral drug efavirenz. There are many other examples.

The TAC does not take money from drug companies. The organisation's finances are open for anyone to verify this. No-one in the TAC leadership is any way connected to drug companies or makes any money from selling drugs. We are independent of the pharmaceutical industry. We hope that the ANC can also claim this, but the ANC does not disclose its sources of funding, so we do not know. It is currently involved in litigation protecting the secrecy of its sources of funding along with most other political parties.

 

 

Allegation 6:

 

Correction:

 

 

 

We have frequently offered to work with government; some provincial governments do work productively with the TAC. Many TAC members, including most of the TAC leadership, support the ANC. But in return for that support we expect the ANC to support the delivery of high-quality public health-care. That includes supporting the rollout of treatment for people with HIV/AIDS as outlined in the Department of Health's comprehensive plan published in November 2003. ANC Today should inform its readers and members about where treatment is available and the scientifically established facts about antiretroviral medicines. The TAC would support the ANC in any such effort.

[END OF RESPONSE TO ANC TODAY -

 

 

 

 

Almost all the major clinical trials on nevirapine were done on a majority of white men. Many Europeans, Africans, black and white Americans, Asians and Latino people living with HIV/AIDS use nevirapine daily. The most serious health threat that faces our country is the prevention and treatment of HIV/AIDS. To date fewer than 20,000 people in the public sector are on anti-retroviral therapy while more than 45 000 people in the private sector have access to ARVs. Those of us who can afford to have the chance to live, while poor and mainly black people die because of bureaucratic neglect by the Minister of Health and her supporters in government. A section of the ANC leadership frequently misuses the allegation of racism to cover up mistakes or lies. Racism is one of the most enduring problems in our country and in the world but the faceless writers of the ANC Today misuse our racial oppression to promote their AIDS denialism.

 

The author ends the article with he following statement: "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'".

 

It is true that the TAC promotes the use of antiretroviral treatment by people with AIDS in environments where they can be properly monitored. There is a very good reason for this. South Africa's best statisticians all estimate that millions of people are infected with HIV and consequently hundreds of thousands die each year of AIDS. Antiretroviral treatments are the only medicines currently available that have been scientifically demonstrated to be able to substantially prolong the lives of people with AIDS. People with AIDS in wealthy countries such as the United States, and even some poorer ones, such as Brazil, Thailand and Botswana, have access to these medicines which have changed HIV from being a death-sentence to a disease that can be managed (like diabetes). The TAC believes everyone, including poor people, should have the choice to take life-saving medicines and this is why it promotes the responsible use of antiretrovirals.

 

The writer accuses the TAC of promoting the sale of antiretrovirals at all costs. It also implies that the TAC is representing the interests of drug companies and not poor people by doing this.

 

Resistance is a problem with most antibiotic and antiviral medicines. It means that the virus or microbe that the drug is meant to destroy changes so that it the drug is no longer effective. It is possible that some women who take single-dose nevirapine might not be able to effectively use the drug in future. Scientists are not sure if this is the case and are still investigating this issue. When a women resistant to nevirapine starts antiretroviral treatment (to treat AIDS as opposed to preventing transmission to her unborn infant) she would then not use nevirapine in her regimen. However, there are many other antiretroviral treatments available besides nevirapine that can be used by women who are resistant to nevirapine.

 

The writer favourably quotes the following from the Associated Press article "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." The Associated Press article and the ANC Today writer (by uncritically quoting this) imply that the resistance issue with single-dose nevirapine is new. It is also misleading with regard to future treatment options for women who take single-dose nevirapine.

 

The TAC has never denied the reality of any scientifically established scientific truth. In contrast, it is unfortunate that some HIV denialists very senior in government and the ANC have frequently done so - in contradiction of both the official government and ANC policy. The views expressed by the TAC on antiretrovirals are based on the latest scientific research. All statements by the TAC regarding the science of nevirapine are also made by South Africa's medical associations and the World Health Organisation.

 

The writer argues "despite the fact that it [TAC] 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."

 

The Constitutional Court ruling had no relevance on whether the research or investigations at the 18 pilot sites was continued or not. Indeed, research was continued and Health Systems Trust (a research body commissioned by government) has published important results of this research. The 18 pilot sites were not conducting a drug trial; they were researching the operational issues associated with rolling out nevirapine. The Constitutional Court correctly pointed out that the "decision by government to provide nevirapine to mothers and infants at the research and training sites is consistent only with government itself being satisfied as to the efficacy and safety of the drug. These sites cater for approximately 10% of all births in the public sector and it is unthinkable that government would gamble with the lives or health of thousands of mothers and infants. In any event, the research and training sites are intended primarily to train staff and to study the operational problems of the comprehensive prevention of mother-to-child transmission package."

 

The writer states that the "necessary investigative work [i.e. providing single-dose nevirapine at 18 pilot sites], 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 the Constitutional Court, in a case brought by the TAC, compelled the government to roll the programme out throughout the country.

 

There is no evidence that the NIH or anyone else has covered up evidence of adverse events due to nevirapine, either in the Ugandan trial or anywhere else. Nor is there any evidence of a conspiracy between the manufacturer of nevirapine and the NIH. It is true that there were problems with the trial in Uganda, but an audit was conducted to examine the trial's shortcomings. The conclusion from this was that the scientific results of the trial remained unaffected. Some adverse events were unreported in the initial published report written on the trial but this was corrected in the audit. None of these adverse events were due to nevirapine. The women on the trial had HIV and many of them became ill or died from HIV-related opportunistic infections.

 

The writer quotes the Associated Press article to allege that the US research institution, the National Institutes of Health (NIH), conspired with the manufacturer of nevirapine to hide evidence of serious adverse events associated with the drug that surfaced in a trial conducted by the NIH in Uganda. The article states that the NIH "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." BACK TO CONTENTS]

Mr. Kgalema Motlanthe

Secretary-General

African National Congress

PO Box 61884

MARSHALLTOWN

2107

21 December 2004

Fax: 011 376 1134/ 011 832 2126

Dear Comrade Kgalema

ANC TODAY – REQUEST FOR APOLOGY AND RETRACTION

On 17 December 2004 the ANC published Volume 4 No 50 of ‘ANC Today", which is described as the ‘Online Voice of the ANC’. In an article entitled ‘Nevirapine, drugs & African guinea pigs" in that publication, the following statements were made about our organisation the Treatment Action Campaign (TAC):

1 The TAC ‘is determined to continue to pursue its mission to promote the widest possible use of anti-retroviral drugs in our country, at all costs’.

2 The TAC ‘is quite ready even to deny the reality of established scientific truths’.

3 The TAC is ‘(i)ntent to sustain public pressure for the expansion of the market for anti-retroviral drugs in general, and nevirapine in particular’.

4 ‘(T)o guarantee and improve the sale of anti-retroviral drugs’ is ‘the central mission of the treatment campaign of the Treatment Action Campaign’.

5 ‘Strangely for an organisation that presents itself as African, passionately concerned about the health and 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"’.

These statements are both untrue and seriously defamatory of TAC.

The article ends with the following statement: "Whose interests does the TAC serve?" In the context of the article, this contains a clearly defamatory innuendo that the TAC is not genuinely concerned about the health and lives of people in South Africa, and that it serves other interests, presumably those of racists and the drug companies. This too, is both untrue and seriously defamatory.

These statements cannot be construed by any stretch of the imagination as fair comment. Many people across the country, the continent and throughout the world take the ANC as a serious and authoritative source of information. The statements, read in the context of the article as a whole, defame TAC and cause serious damage to its reputation nationally and internationally and its work to prevent and treat HIV/AIDS in communities.

The statements and article also do serious damage to the struggle against HIV/AIDS. For instance, the statements in the article on nevirapine are wilfully misleading. They undermine one of the most important public health interventions.

We urge the ANC to be guided by scientists, clinicians, HIV/AIDS experts and not denialist ideologues. It is a tragedy that at a time when new infections, illness and death continue in our communities that ANC Today prints untruths, distortions and slander instead of guiding and giving hope.

TAC hesitates to even consider litigation against the ANC as the party of freedom, democracy and social justice. But unless the steps set out in this letter are taken by the organisation, we will regretfully be obliged to consider litigation in order to protect and vindicate our reputation and work.

The TAC requests that you take the following steps:

1 Publish in ‘ANC Today’ a retraction and apology in terms which are to be agreed between the ANC and TAC.

2 Issue this apology and retraction to the media.

The identity of the author of the article is not disclosed. We shall be obliged if you would kindly advise who the author was. Similarly, the identity of the editor of ‘ANC Today’ is not disclosed in the publication. We shall be obliged if you would kindly advise who the editor was.

Our National Executive committee will be meeting in mid-January 2005. We urge you to undertake the steps outlined by then as a sign of comradeship and co-operation in the HIV/AIDS epidemic. We look forward to hearing from you at your earliest convenience but by no later than close of business on 14th January 2005 so that we may consider this matter at our NEC.

Yours faithfully

Zackie Achmat Sipho Mthathi

TAC Chairperson TAC Deputy-Chairperson

[END OF LETTER TO ANC -

 

 

BACK TO CONTENTS]

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?

[END OF ANC TODAY ARTICLE -

[END OF TAC NEWSLETTER]