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More Information on Ethics and Clinical Trials

Letter on UNAIDS Guidance Document on HIV Preventive Vaccine Research

February 11, 2000

Peter Piot, M.D., Director
UNAIDS Program
20 Avenue Appia
1211 Geneva 27
Switzerland

Dear Dr. Piot:

We have received a copy of the long-delayed UNAIDS Guidance Document on Ethical Considerations in HIV Preventive Vaccine Research. While in many respects the document represents a significant improvement over the November 1998 version, which did not even honestly reflect the spectrum of views expressed at the UNAIDS regional consultation meetings, the current language is written so broadly that it can be read to support research practices that do not adequately protect participants in HIV vaccine trials. We agree that on many of the most controversial issues no consensus was reached; this no doubt presented a challenge in writing the Guidance Document. But the current version has instead opted for a non-prescriptive approach, simply laying out the options in many instances, and leaving large loopholes that we believe most researchers will exploit. The most serious of these are addressed below.

Guidance Point 2: "Attention needs to be given immediately to how a successful vaccine, and other benefits resulting from the research, will be made readily and affordably available to the communities and countries where such a vaccine is tested, as well as to other communities and countries at high risk for HIV infection."

While this section of the document demonstrates more concern for the post-trial availability of HIV vaccines than its predecessor, it still is fundamentally toothless. What does it mean to say that one needs to give "attention" to something? Why is there not a suggestion that the agreement be in writing? If this document's claimed interest in capacity building is to be taken seriously, it would advocate for post-trial availability far more strongly. Please recall that this was a consistent theme at the regional workshops: "All regions agreed that the historical examples of 'developing country' participation in vaccine research where access to the final product has not occurred must not be repeated in HIV vaccine research."[1] To not aggressively advocate for post-trial availability is to invite exploitative research of the kind that has too often sullied the reputations of Western researchers in the past.

Guidance Point 11: "Participants in the control arm of a future phase III HIV preventive vaccine trial should receive an HIV vaccine known to be safe and effective when such is available, unless there are compelling scientific reasons which justify the use of a placebo."

This point, too, is an improvement over previous language, but it is still inadequate. It appropriately shifts the emphasis of the document so that the default position is that effective HIV vaccines would be delivered. But the Guidance Document lists "scientific reasons which justify the use of a placebo." While we agree with the two reasons listed, the Guidance Document states that these scientific justifications for continued placebo use include these two reasons; in other words, there may be additional, unspecified scientific reasons to use a placebo. This opens a loophole for justifying studies without known effective vaccines for the control arm for reasons such as "efficiency." There is probably little disagreement over the stated reasons; what is of concern is what you have left unsaid.

Guidance Point 14: "Consideration should be given to providing counseling through an agency or organisation that is independent of the investigators in order to prevent any real or perceived conflict of interest."

It is obvious that, were an independent group to be responsible for the risk reduction elements of an HIV vaccine trial, the potential for and appearance of conflict of interest would be greatly diminished. It is therefore far too weak to simply suggest that an independent group be "considered." As you well know, there is no enthusiasm for such a group among researchers; the Vaxgen trials do not, to our knowledge, employ independent counselors. You may have covered yourselves with this statement, but it will have no impact in the field.

Guidance Point 16: "Care and treatment for HIV/AIDS and its associated complications should be provided to participants in HIV preventive vaccine trials, with the ideal being to provide the best proven therapy, and the minimum to provide the highest level of care attainable in the host country in light of the circumstances listed below."

This section is an improvement over the previous version, for it at least puts forth a standard of treatment to be aspired to should a trial participant acquire HIV. But the list of "circumstances" to be considered, while not unreasonable in and of themselves, again opens the door to less-than-exhaustive attempts to realize the "ideal." Option 3 (providing treatment "at a level consistent with that available in the host country") is in fact the reincarnation of the argument that researchers are obligated to provide no more than the local "standard of care." This was explicitly rejected at the Geneva meeting. In practice, this Guidance Point provides just enough wiggle room for researchers to provide no or inadequate treatment to those acquiring HIV infection during the trial in countries where antiretrovirals are not available. This is what many of the researchers were seeking.

A recently proposed HIV study in Cambodia illustrates our point. A Bahamas-based company is proposing testing a homeopathic remedy among orphans with HIV (see attached article from Agence France Presse, February 7, 2000). While this is not an HIV vaccine trial and the treatment of orphans does raise unique ethical issues, assuming that these orphans would not be provided with anti-HIV therapies, this is precisely the kind of study that the Guidance Document would permit. Because many of the HIV vaccine studies will select option 3 (the "standard of care" option), those studies will resemble the proposed Cambodian study inasmuch as they prospectively follow HIV-positive patients without providing optimal anti-HIV therapy. A document that, by analogy, permits the kind of exploitation contemplated in Cambodia is a defective document.

In sum, while this document is clearer than its predecessor and often articulates important ethical principles, it is written so as to leave sufficient leeway for many (if not most) researchers to proceed as they seem always to have intended: denying known effective treatments based on poverty, continuing to provide placebos even after an effective HIV vaccine is identified and making less than good faith efforts to secure post-trial availability of an effective vaccine. This document may sound good to some, but when you know that on the ground patients will be treated improperly, you have accomplished little.

Yours sincerely,

Peter Lurie, M.D., M.P.H.
Deputy Director

Sidney M. Wolfe, M.D.
Director
Public Citizen's Health Research Group


References

[1] Summary [of regional workshops]. In: Guenter D. UNAIDS-sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (draft), June 3, 1998. 

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