New US guidelines make the case for ongoing scientific inquiry

ANC Today 20 April 2001

In Vol 1 No 4 of this journal we carried reviews of articles on HIV/AIDS that had appeared in two United States publications. Both these articles reported on forthcoming new guidelines on the use of anti-HIV drugs that the US government would issue. These were issued on February 5, this year as "HIV Treatment Guidelines Updated for Adults and Adolescents".

In this article, for the information of our readers, we will quote some elements from these guidelines to illustrate the critical importance of a considered and scientific response to the questions posed especially in the New York Times article. We would also suggest that our readers should familiarise themselves with the contents of the Interim Report of the Presidential AIDS Advisory Panel, especially the further scientific work the panel decided to embark upon.

We believe that the quotations from the guidelines that follow emphasise the importance and urgency of this scientific work.

The press statement issued to announce the Guidelines quotes Anthony S. Fauci, MD, director of the (US) National Institute of Allergy and Infectious Diseases and co-chair of the panel that drew up the guidelines as saying: "Although anti-retroviral therapy has provided extraordinary benefits to many patients, we know that we cannot eradicate HIV infection with currently available medications. We also recognise that serious toxicities are associated with long-term use of anti-retroviral drugs."

As foreseen by the US publications we cited, the guidelines lay down a radical departure from previous practice in the following terms: "The new Guidelines recommend considering starting anti-retroviral therapy when an asymptomatic HIV-infected person's CD4+T-cell count falls below 350 cells per cubic millimetre (mm3); previous Guidelines recommend consideration of therapy for asymptomatic patients with a CD4+T-cell count lower than 500 cells/mm3."

"For asymptomatic HIV-infected patients with CD4+T-cell counts higher than 350 cells/mm3, treatment should be considered when the level of HIV in plasma is high (more than 30,000 copies per millilitre (ml) when using the branched DNA test, or more than 55,000 copies/ml when using the RT-PCR test); previous Guidelines recommended consideration of therapy at lower levels of plasma HIV (10,000 copies/ml measured by branched DNA, or 20,000 copies/ml measured by RT-PCR)."

For our readers to understand how radical these changes are and what this means in terms of the science of HIV/AIDS, we propose that you refer to the article in Business Week we reviewed in an earlier edition.

The same press release to which we have referred quotes John G. Bartlett, M.D., chief of the division of infectious diseases at the Johns Hopkins University Medical Center and CO-chair of the Panel that produced the Guidelines as saying: "The updated guidelines recognise that we do not yet have the data we need to make definitive recommendations about the optimal time to start treatment. We highlight the uncertainty, allow for flexibility, encourage an individualised approach to treatment, and, at the same time, try to provide guidance."

The release further quotes Dr Fauci as saying: "We are very concerned about a number of toxicities associated with the long-term use of anti-retroviral drugs. Particularly alarming is the alteration of fat metabolism that can emerge during treatment. We are seeing an increasing number of patients with dangerously high levels of cholesterol and triglycerides. The good news is that new anti-HIV treatments have dramatically improved the quality of life for many patients, and the incidence of AIDS and AIDS-related deaths has dramatically decreased. The bad news is that we now must find ways to deal with unanticipated toxicities, including the potential for premature coronary disease."

In the Summary, the guidelines spell out a number of recommendations, including:

  • "Care should be supervised by an expert."
  • "Therapeutic decisions require a mutual understanding between the patient and the health care provider regarding the benefits and risks of treatment."
  • "Patient education and involvement in therapeutic decisions is important for all medical conditions, but is considered especially critical for HIV infection and its treatment."
  • "Anti-retroviral regimens are complex, have major side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance due to non-adherence to the drug regimen or suboptimal levels of anti-retroviral agents."

Later, the Guidelines contain the following recommendations, among others:

"Decisions regarding initiation or changes in anti-retroviral therapy should be guided by monitoring the laboratory parameters of plasma HIV RNA (viral load) and CD4+ T-cell count, as well as the clinical condition of the patient. Results of these two laboratory tests give the physician and vii) the unknown durability of effect of the currently available therapies."

"It is necessary for the patient to be entered into a continuum of medical care and services, including social, psychological, and nutritional services, with the availability of expert referral and consultation. In order to achieve the maximum flexibility in tailoring therapy to each patient over the duration of his or her infection, it is imperative that drug formularies allow for all FDA-approved NRTI, NNRTI, and PI as treatment options."

The readers should bear in mind that these guidelines were drawn up by US scientists, based on US experience. Nevertheless their applicability extends beyond the US, in as much as the drugs used in the US are the same as those used in the rest of the world, including South Africa.

The reader should also note that the US scientists take great care to emphasise that not enough is known about HIV/AIDS for them to set guidelines without qualifying these with many observations intended to introduce as much 'flexibility' as possible. Accordingly, they advise that everything is relative and provisional and requires specific responses to each individual patient, under the supervision of experts on the use of anti-retroviral drugs. Furthermore, they advise a comprehensive diagnostic approach to each patient to establish the overall health status of each patient including sustained hi-tech medical, psychological, social and nutritional support for each patient.

In sum, the US scientists argue that the certainties about HIV/AIDS that are trotted out in our country everyday rest on a very shaky scientific basis. They further assert that the use of anti-retroviral drugs requires the very sophisticated medical supervision that the US as a highly developed country has, but which we do not have, as a developing country.

They further warn that the 'alarming' toxicity of these drugs is such that they cause both known and as yet unknown diseases. As has been publicly stated by both Drs Robert Gallo and John G. Bartlett of the US, under certain circumstances these drugs may create more problems than they solve.

The problem with all this is that it refers to questions of life and death for individual human beings. Such a situation does not admit of inhuman games or clever intellectual point scoring. It also does not allow for the propagation of unscientific slogans that the time for scientific inquiry is over.

The uncertainties admitted and explained in the Guidelines and the New York Times and BusinessWeek articles mean that further and urgent scientific work and debate is required to confront the serious problem of AIDS. We can only hope that our government and the scientists concerned with do everything in their power to speed up the experiments explained in the report of the Presidential Panel.

In the meantime, this we must say, that it is time that our scientific establishment stops treating the issue of HIV/AIDS as a political issue rather than a medical/scientific matter. Morality and human decency dictates that all our scientists should adopt this position and refuse to join in the propagation of lies.


Guidelines for the Use of Anti-retroviral Agents in HIV-Infected Adults and Adolescents, US Government, February 2001


HIV/Aids: Questions that require answers, ANC Today Vol 1, No 4