MBEKI VERSUS LEON SA President Debates AIDS

Sunday Times (SA) 9 July 2000

'... as public representatives we have no right to be proponents and blind defenders of dogma'

(Letter from Mbeki to Tony Leon)

DEAR TONY
July 1 2000

Thank you for your letters of June 19 and 27, 2000 relating to the AIDS issue. Thank you also for the copy of the letter of the South African CEO of Glaxo Wellcome, Mr J P Kearney.

As you are aware, during the last few months, I have tried to familiarise myself with all elements relating to the HIV-AIDS matter.

Necessarily, this has also meant studying as much literature as possible on the question of anti-HIV retroviral drugs.

What I said in parliament was based on the information I had managed to garner on the issue you raised. As you correctly indicate, this related to the efficacy of AZT in stopping HIV infection in cases of rape.

Your statement, that 80% of women raped by HIV-positive men would not become HIV-positive if they are given AZT, has no scientific basis whatsoever.

In this regard, I suggest that, among others, you obtain a copy of the publication of the US CDC, MMWR September 25, 1998/47 (RR17).

Among other things, the CDC says: "no data exist regarding the efficacy of (antiretroviral drugs) for persons with nonoccupational HIV exposure... " (As you must be aware, 'nonoccupational exposure' includes rape.)

"Some physicians believe that antiretroviral agents are indicated for persons with possible sexual, injecting-drug-use, or other nonoccupational HIV exposure. However PHS (the US Public Health Service) cannot definitely recommend for or against antiretroviral agents in these situations because of the lack of efficacy data on the use of antiretroviral agents in preventing HIV transmission after possible nonoccupational exposure. Efficacy and effectiveness data and additional epidemiologic information is needed... " and,

"Research is needed to establish if and under what circumstances antiretroviral therapy following nonoccupational HIV exposure is effective."

The CDC makes this equally important statement:

"Postexposure antiretroviral therapy should never be administered routinely or solely at the request of a patient. It is a complicated medical therapy, not a form of primary HIV prevention. It is not a 'morning-after pill'..." (My emphasis).

In the same report, the CDC says that:

"The risk for HIV transmission... per episode of receptive vaginal exposure is estimated at 0.1%0.2%."

In this regard, you might care to consider what it is that distinguishes Africa from the United States, as a consequence of which millions in subSaharan Africa allegedly become HIV positive as a result of heterosexual sexual intercourse, while, to all intents and purposes, there is a zero possibility of this happening in the US.

In your letter to me of June 19, you make the extraordinary statement that AZT boosts the immune system.

Not even the manufacturer of this drug makes this profoundly unscientific claim. The reality is the precise opposite of what you say, this being that AZT is immuno-suppressive.

Contrary to the claims you make in promotion of AZT, all responsible medical authorities repeatedly issue serious warnings about the toxicity of antiretroviral drugs, which include AZT.

For example, in its Report, MMWR May 15, 1998/Vo. 47/No. RR-7. the CDC says:

"The selection of a drug regimen for HIV PEP (post-exposure prophylaxis) must strive to balance the risk for infection against the potential toxicity of the agent(s) used. Because PEP is potentially toxic, its use is not justified for exposures that pose a negligible risk of transmission."

In this context, please bear in mind the 0.1%0.2% risk of transmission indicated by the CDC with regard to receptive vaginal exposure.

The matter is not in dispute between us that AZT is not licensed by the South African MCC for use in rape cases. Further to this, Glaxo Wellcome has not applied to the MCC for such a licence.

Indeed, the approved package insert for AZT makes no claim about the efficacy of AZT with regard to rape cases.

I would presume that the reason that Glaxo Wellcome has not applied for a licence is precisely because it knows that there is no scientific evidence it could produce to justify this application.

It is very strange that you have proven scientific information which Glaxo Wellcome, the CDC, the MCC and every responsible medicalauthority does not have, that 80% of rape victims in our country would not have become HIV positive if they had been given AZT.

It may be that I underestimate the scientific expertise of which your Party disposes.

Accordingly, I am ready to change my views on this matter, to pay due tribute to such expertise, if it is demonstrated that you do, indeed, have such expertise.

If it is necessary, I can present the argument about the obvious logical absurdity of the claim that viral infection can be stopped by the use of drugs, provided that the virus was communicated in circumstances of forced heterosexual sexual intercourse.

It is in this context, apart from extant scientific information, that the issue I raised in the National Assembly about AZT not being a vaccine assumes its relevance. The PEP argument about AZT (and other anti-retrovirals) cannot be sustained unless vaccine-like efficacy is attributed to these antiretroviral drugs.

Accordingly, the statement you make in your 19 June letter that I am "correct to indicate that AZT is not a vaccine, which I (you) did not suggest it was", is inconsistent with your argument that AZT should be used as though it were a vaccine.

I am very disturbed at Mr Kearney's statement that your incorrect statements about AZT and rape are "essentially accurate on the scientific aspects of using AZT as post-exposure prophylaxis in individuals who have been raped."

I imagine that all manufacturers of antiretroviral drugs pay great attention to the very false figures about the incidence of rape in our country, that are regularly peddled by those who seem so determined to project a negative image of our country.

What makes this matter especially problematic is that there is a considerable number of people in our country who believe and are convinced that most black (African) men carry the HI virus.

In addition to this, reflecting a view among these about rape in our country, Charlene Smith was sufficiently brave, or blinded by racist rage, publicly to make the deeply offensive statement that rape is an endemic feature of African society.

This is what she wrote recently in the US Washington Post:

"Here, (in South Africa), HIV is spread primarily by heterosexual sex - spurred by men's attitude towards women. We won't end this epidemic until we understand the role of tradition and religion - and of a culture in which rape is endemic and has become a prime means of transmitting the disease, to young women as well as children."

The hysterical estimates of the incidence of HIV in our country and sub-Saharan Africa made by some international organisations, coupled with the earlier wild and insulting claims about the African and Haitian origins of HIV, powerfully reinforce these dangerous and firmly-entrenched prejudices.None of this bodes well for a rational discussion of HIV-AIDS and an effective response to this matter, including the use of anti-retroviral drugs.

Whatever his obligations as the Chief Executive of the company that manufactures AZT, I think it is grossly unethical that Mr Kearney should seek to increase the sales of AZT, and therefore Glaxo Wellcome's profits, by exploiting the justified health concerns of our people.

I consider it deeply offensive and contemptuous of our people, our country and its laws that, as you and Charlene Smith say, Glaxo Wellcome should promote the sales of AZT by selling 'cutprice' AZT in our country for use by rape victims, knowing very well that this is in violation of the law and that no scientific evidence exists proving the efficacy of this drug in cases of rape.

I have noted the fact that Mr Kearney seeks to achieve his commercial purposes "together with you and your Party."

It is amazing and completely unacceptable that you, the Leader of the Official Opposition, should consider all of this, including blatant disrespect for the rule of law, as "irrelevant", the word you use in your letter to me.

You will remember that during the debate around the legislation we introduced enabling the parallel import of drugs and medicines, to make these affordable for our population that is deeply mired in poverty, your party was correctly and needlessly very vocal about the necessity to ensure that all pharmaceutical products available to our people should be subject to approval by the MCC.

Why is a double standard now being applied with regard to AZT, making the need for the certification of drugs by the MCC "irrelevant"?

Only recently, your party has been very strident in demanding respect for the rule of law in Zimbabwe.

Why is a double standard now being applied with regard to AZT, making the requirement for observance of the rule of law "irrelevant"?

In his letter to you, Mr Kearney says his company is committed "to improve access to drugs for HIV-positive individuals."

In more direct and plain language, this means that, consistent with its normal and understandable commercial objectives, Glaxo Wellcome is committed to increase the sales of AZT in our country, in competition with antiretroviral drugs manufactured by other companies.

If Mr Kearney did not pursue this objective as vigorously as possible, his company would be entitled to terminate his contract.

You and I, as public representatives of our people, pursue, or should pursue, a different objective. With regard to the matter under discussion, our objective must surely be to improve the health of all our people.

I think that it is dangerous that any of our public representatives and political parties should allow themselves to be used as marketing agents of particular products and companies, including drugs, medicines and pharmaceutical companies.

I accept that it is perfectly within their right for private individuals, such as Charlene Smith, to play this role, as it would be for you, in your private capacity.

In the controversy that has attended the questions our government has raised about various matters relating to HIV-AIDS, much has been said about us, in a sustained effort to force us uncritically to accept a so-called orthodox view.

We have resisted this pressure and will continue to do so, because of the decisive importance of an accurate understanding of AIDS and its specifics in our own country.

I trust that our discussion about AZT and rape will convince you that despite the fervent reiteration of various assertions, supported by many scientists, medical people and NGO's, about the existence of some unchallengeable and immutable truths about HIV-AIDS, as public representatives we have no right to be proponents and blind defenders of dogma.

Whatever the intensity of the campaign to oblige us to think and act differently on the HIVAIDS issue, the instinctive human desire in the face of such a barrage, to obtain social approval by succumbing to massive and orchestrated pressure, will not lead us to become proponents and blind defenders of dogma.

The cost of AIDS in human lives is too high to allow that we become blind defenders of the faith.

Unless you have evidence to demonstrate that what I have said about AZT and rape is wrong, I would expect that you make a public statement distancing yourself from the false claims so regularly propagated in this country, concerning the efficacy of AZT as post-exposure prophylaxis in cases of rape, propaganda in which you joined.

Not only is this the only honourable thing to do, but, as a high-level public representative, I believe you have an obligation to correct the misleading impression on the matter we are discussing that you and your Party have conveyed on more that one occasion, in parliament and elsewhere.

Needless to say, to uphold the rule of law and to fulfil the government's obligations with regard to the health of our people, we will follow up on the matters you have brought to our attention, concerning the disturbing behaviour of Glaxo Wellcome.

Given that the matters about which you have written to me were discussed openly in the National Assembly, during which debate I suggested that you convey my views to Glaxo Wellcome, I believe that it would be correct that we make the correspondence between us available both to the National Assembly and the general public.

Once again, I would like to suggest that you inform yourself as extensively as possible about the AIDS epidemic. Again, for this purpose, I would like to recommend that you access the Internet.

On the various websites, you will find an enormous volume of literature, including CDC, WHO and UNAIDS documents, editions of various highly respected science journals as well as "dissident" articles.

As you know, many frightening statements are made with great regularity about the incidence of HIV-AIDS in our country and continent and the threat this poses to our very survival as a country, a continent and as Africans.

I believe that it is imperative that all our public representatives should base whatever they say and do on the HIV-AIDS matter, on the truth and not necessarily on the comfort of fitting themselves into the framework of whatever might be considered to be 'established majority scientific opinion'.

---

'What concerns me about your letter is the tendency to turn questions of fact into questions of motive'

(letter from Tony Leon to Mbeki published in Sunday Times July 9, 2000)

DEAR PRESIDENT MBEKI
July 7 2000

Thank you for your letter of the 1st of July. I appreciate the great time and effort that you have obviously put into your response, although I find much of the tone and content unhelpful in promoting rational debate on this important matter.

If I understand your letter correctly, you argue against the provision of AZT to rape victims on two grounds:

Firstly, you argue that there is "no scientific evidence" to support the argument that the provision of AZT could prevent the transmission of HIV to rape victims.

Secondly, you claim that the risks of potential transmission are so low that they do not warrant the use of AZT, which as you correctly point out can have severe side effects.

You base your argument on numerous quotes from the publication of the Centers for Disease Control in America, Morbidity and Mortality Weekly Report, September 25, 1998/ Vol 47/ No. RR-17. I do not believe that, when read as a whole, the document supports your arguments. I will deal with each argument in turn.

The evidence from the CDC report which you provide to support your first argument is a quote from the CDC which says "no data exist regarding the efficacy of (antiretroviral drugs) for persons with nonoccupational HIV exposure ... "; the fact that the US Public Health Service "cannot definitely recommend for or against antiretroviral agents in these situations because of the lack of efficacy data"; and that further research is needed "to establish if and under what circumstances" such therapy would be effective.

The CDC report is extremely even-handed. It scrupulously weighs up the evidence both for and against the provision of anti-retroviral drugs following non-occupational HIV exposure. You have unfortunately only quoted the arguments against. A point that must be made at the beginning is that the CDC does allow the provision of anti-retroviral drugs by physicians to rape victims. The document is an attempt to highlight the "potential benefits and risks" and so provide a guide to physicians on whether or not to pursue such a course of treatment. The CDC has published formal guidelines for physicians should they choose to use AZT.

The reason for the lack of "efficacy data" is that there have been no prospective trials conducted to measure the effectiveness of AZT for non-occupational exposure. It is simply impossible to conduct such trials because one would need to establish beyond doubt the HIV status of both the rape suspect and the rape survivor before and after the rape.

While this in itself is almost impossible, the fact that it is illegal to test for HIV against a person's will makes such research harder still. The best that can be done is to conduct a retrospective case control study. One is currently being conducted by the CDC.

It is for this reason that the CDC is unable to recommend either for or against antiretroviral drugs for rape victims. This does not mean that there is "no scientific basis whatsoever" for my statement that the provision of AZT would reduce HIV transmission to rape survivors.

In fact, the CDC report evaluates data from various trials, which could have a bearing on the potential efficacy of anti-retroviral PEPs. It makes reference to various trials conducted on animals, but I will deal only with its references to studies on humans. Two are of significance: Firstly, the CDC quotes the study (which I referred to in my letter) from a 1995 survey where investigators used "case control surveillance data from health care workers" in Europe and America to document that AZT use "was associated with an 81% decrease in the risk for HIV infection after percutaneous exposure to HIV-infected blood." According to the CDC this study "demonstrated antiretroviral effectiveness" following needle stick injuries.

The CDC also refers to the study where there was a 67% reduction in transmission of HIV from mother to child when AZT was administered during pregnancy, labour, and for six weeks after birth. The CDC states that there was evidence that a "prophylactic effect" on the foetus before, during or after birth "could account for some reduction in perinatal transmission".

Although the CDC report acknowledges that these studies "might not be directly relevant to non-occupational exposure" they do "suggest that antiretroviral agents are potentially valuable for treating HIV exposures in these settings".

These trials are obviously not conclusive for they have to be extrapolated to nonoccupational settings. However, they do suggest that antiretroviral agents can act as a postexposure prophylaxis and reduce a person's risk of acquiring HIV infection after exposure. The CDC report states "it can take several days for infection to become established in the lymphoid and other tissues. During this time, interventions to interrupt viral replication could represent an opportunity to prevent an exposure from becoming an established infection."

Thus, if providing AZT to rape victims can prevent an exposure to HIV from becoming an established infection (and there is substantial evidence to suggest it can) the benefit is massive, if not priceless. The victim is literally saved from a death sentence.

Which brings me to your second argument, which is that the chances of HIV transmission from rape are so small, and the side-effects of AZT are so large, that providing such treatment to rape victims is not really worth the candle.

You quote the CDC as saying that in selecting a drug regimen for post-exposure prophylaxis the physician should "balance the risk for infection against the potential toxicity of the agent(s) used. Because PEP is potentially toxic, its use is not justified for exposures that pose a negligible risk of transmission." You then state, "in this context, please bear in mind the 0.1% - 0.2% risk of transmission indicated by the CDC with regard to receptive vaginal exposure." You seem to be implying that "receptive vaginal exposure" constitutes a "negligible risk of transmission" and that consequently it is not worth providing rape survivors with AZT with potentially toxic side effects.

This is disingenuous for two reasons: Firstly, the risk of HIV transmission following rape (particularly in South Africa) is not "negligible" at all. Rape does not constitute "receptive" sex and as such is likely to lead to trauma and consequently a far greater risk of HIV transmission. The risk is compounded in South Africa by the high levels of HIV in the population as well as the prevalence of Sexually Transmitted Diseases, which greatly increase the possibility of HIV transmission. Secondly, the CDC is not referring to rape or consensual sex when it states that PEPs are not "justified for exposures that pose a negligible risk of transmission". Rather, it is referring to contact between infected body fluid and intact skin. This would be clear had you quoted the whole sentence from the CDC report, which reads, "Because PEP is potentially toxic, its use is not justified for exposures that pose a negligible risk of transmission (e.g. potentially infected body fluid on intact skin.) " (My emphasis.)

This is just one example of where you have pruned quotes to make them fit your argument. Elsewhere you quote the CDC report as saying "Postexposure antiretroviral therapy should never by administered routinely or solely at the request of a patient. It is a complicated medical therapy, not a form of primary HIV prevention. It is not a 'morning-after pill ... ' (your emphasis)" Yet you omit to mention that the report continues (from precisely the point where you left off) "but, if proven effective, can constitute a last effort to prevent HIV infection in patients for whom primary prevention has failed to protect them from possible exposure." (My emphasis)

Reading through your letter I had the strong feeling that you have reached your conclusions already. You then selectively choose quotes to support your argument, and ignore others that don't. If the quotes do not quite fit your purposes, you lop off the awkward parts.

What is most disturbing about your letter is the way you impute sinister motivations on the bona fide actions of others. You seem to believe that the request by my Party, Charlene Smith and others for the government to provide AZT to rape victims, and the offer by Glaxo Wellcome to provide it at greatly reduced prices, is all part of a giant conspiracy. You imply that this conspiracy is the result of some unholy alliance between a civil society motivated by racism and an international pharmaceutical industry driven by greed.

It seems that underlying your letter is a belief that civil society is once again being driven by an overriding desire to reaffirm "its belief that its racist stereotype of Africans [is] correct" (ANC statement to HRC on racism in media).

Out of a "determination" to project a "negative image" of South Africa unnamed forces peddle what you describe as "very false figures" on the incidence of rape in this country. You claim that the AIDS debate in South Africa is being driven (and distorted) by people "who are convinced that most black (African) men carry the HIV virus". Among their number you name Charlene Smith who you claim was "blinded by racist rage" when she wrote that rape was endemic in South African society.

You proceed to complain that by publishing "hysterical estimates" (your emphasis) and by making "wild and insulting claims" about the African origins of HIV, the international community is (whether out of accident or design) acting to "reinforce these dangerous and firmly-entrenched prejudices".

You then claim that the international pharmaceutical companies are driven by even more sinister motivations. You suggest that the sole and overriding desire of the pharmaceutical companies is to maximise their profits by exploiting every available opportunity to flog their drugs to South Africa, regardless of their efficacy or toxicity . You claim that having had their interest pricked by the high incidence of rape in this country, Glaxo Wellcome set out to cynically exploit the "justified health concerns of our people" in order to (once again) "increase the sales of AZT". To top off this giant-racialcapitalist-conspiracy, you accuse Charlene Smith and I of being "marketing agents" of the pharmaceutical companies.

(For the record: Neither I nor the Democratic Party have received any financial assistance of any nature from Glaxo Wellcome.)

What concerns me about your letter is the tendency to turn questions of fact into questions of motive. This method of propaganda may be useful means of silencing (or isolating) your critics without responding to their arguments, but is not particularly conducive to rational debate.

It is somewhat hypocritical to accuse overseas opinion of intolerance and then to try to shut down dissent domestically by labelling people "racists" or "pawns of the pharmaceutical industry".

Your statement that the government will take steps against the "disturbing behaviour of Glaxo Wellcome" is frankly sinister.

Your determination to resist the imposition of what you call the "dogma" of scientific opinion seems to be matched only by a desire to impose your own.

Yet what is most worrying for South Africa is that it seems your party has actually started to believe its own propaganda. Instead of identifying, confronting, and then dealing with the immense problems facing our country, the ANC is perpetually chasing shadows.

You seem more concerned with the possibility that high rape and AIDS figures might confirm the prejudices of some, than with the massive human tragedy in our country which those figures are merely an indication of. In consequence, your obsession with the motives of others has begun to harm the interests of the very people you claim to represent.

As the earlier part of my letter has indicated, there are strong scientific grounds for providing post-exposure prophylaxis to victims of rape. I cannot see how the offer by Glaxo Wellcome to provide AZT to rape survivors at reduced prices can be described as "grossly unethical".

Similarly, I cannot see how you can equate the provision of AZT to rape survivors with the state sponsored campaign of terror and intimidation in Zimbabwe. It is a nonsensical comparison.

I, like you, am a layman on these matters. You are entitled to your personal opinion on whether AZT is effective in reducing HIV transmission, and indeed, whether HIV even causes AIDS. However, it is wrong for you to use your current position (which was gained on the basis of political rather than medical talent) to block the provision by your government of such treatment.

It is perfectly consistent with the CDC report (which you quote!) for our government to make available AZT for prescription to rape victims. Obviously, our doctors must weigh up the risks and benefits of prescribing such treatment. They must act both with the informed consent of the patient, and according to proper guidelines such as the CDC provides.

The point is that the physician and the patient must be left to make that decision. By denying rape victims AZT you are denying them the choice.

With all due respect, you lack both the moral right and the medical expertise to make such a life and death decision.

I agree that this correspondence should be made available to the National Assembly and the general public.