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More Information on Ethics and Clinical Trials

Letter on New Draft of Declaration of Helsinki

September 29, 2000

Dr. Delon Human
World Medical Association
28 Avenue des Alpes
01212 Ferney-Voltaire Cedex
France

Dear Dr. Human:

We are writing to offer our perspectives on the new draft Declaration of Helsinki to be discussed by the World Medical Assembly at its annual meeting in Edinburgh on October 3-7, 2000. In most respects (see below), the draft Declaration is an improvement over the previous draft from May 2000 and a dramatic improvement over the disastrous version of March 1999. However, perhaps unintentionally, the current draft now makes no mention whatsoever of what interventions must be provided to patients during the trial, the very issue that prompted the revision of the Declaration in the first place. Without such language, researchers will be left without guidance on their ethical responsibilities in this area, a situation of great hazard to poor patients, particularly those in developing countries.

The current Declaration of Helsinki provides that "In any medical study, every patient — including those of a control group, if any — should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists." A revision of the Declaration was undertaken, in part because we pointed out that this principle had been violated in a series of perinatal HIV prevention studies in Africa and Thailand in which patients were provided placebos or drugs not proven to be effective instead of the effective drug AZT. In the first draft revision, made available in March 1999, this language was revised to read "In any biomedical research protocol every patient-subject, including those of a control group, if any, should be assured that he or she will not be denied access to the best proven diagnostic, prophylactic or therapeutic method that would otherwise be available to him or her," an obvious attempt to require researchers to provide no more than what study participants could afford, not what was optimal scientifically. After much protest from around the world, this section was altered in May 2000 to read "In any medical study, every patient — including those of a control group, if any — should be assured of proven [not best proven] effective prophylactic, diagnostic, and therapeutic methods." In a letter to you on July 31, 2000, we pointed out that, while an improvement over the previous draft version, this language would still permit the provision of suboptimal therapies, as long as these were more effective than nothing — a de facto institutionalization of two-tiered research. Again, there was worldwide criticism of this language, leading to the current language: "In medical research, particularly that comparing currently accepted best proven methods against new methods, every patient (including those of a control group, if any) — should be assured of access to the best proven prophylactic, diagnostic, and therapeutic methods at the conclusion of the study." (Section 24b)

While we are happy to see the resurrection of the phrase "best proven," we are dismayed to see the phrase "at the conclusion of the study" at the end of this key sentence. This section of the Declaration has always dealt with the provision of interventions during the trial and has never dealt with post-trial availability issues. From a draftsmanship point of view, this section now starts with intra-trial issues, shifts to post-trial issues (in the same sentence) and then returns to intra-trial issues. (The part of the sentence referring to active-controlled trials is also a confusing intrusion.) Moreover, post-trial availability has already been handled quite effectively in Section 24a ("Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research. The protocol presented to the ethical review committee must include a realistic plan to deliver those treatments identified through such research to the populations from which the subjects have been drawn. ") and so there is no need to mention it here.

The net effect of the addition of the phrase "at the conclusion of the study" is that there is now no place in the current draft Declaration where the issue of what must be provided to trial participants during the trial is addressed, even though this was the very issue that prompted the most controversy in the first place. This leaves researchers with a literal carte blanche to do as they please - and we have seen what they did even when the current language of the Declaration precluded it.

When we called to discuss this with you, you indicated that the phrase "at the conclusion of the study" had been added so as not to fall into a supposed problem with the current Declaration: following the "best proven" mandate would prevent the introduction of new interventions because those receiving the new interventions would by definition not be receiving the best proven therapy. Of course, this theoretical concern has never in reality been an obstacle to the introduction of new interventions — witness the numbers of new drugs that have successfully been introduced around the world. But if you wish to avoid even the appearance of a problem, we suggest the following language for Section 24b:

In medical research, every patient (including those of a control group, if any) should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods. This does not exclude the use of inert placebo in studies where no proven prophylactic, diagnostic or therapeutic method exists. New methods can be compared to the currently accepted best proven methods if the community of researchers is in equipoise over whether the new method will prove at least equal to the best proven method with respect to safety, efficacy or cost-effectiveness.

We also note that the sentence "The Declaration of Helsinki provides ethical standards to guide physicians all over the world" has been removed. This is very unfortunate. This sentence is a succinct statement of the high aspirations of the Declaration and an accurate description of how the Declaration has served us well. Its inclusion is essential.

We would also like to note with approval the following additions in the current draft Declaration:

  • Discussion of the roles of ethical review committees and of researchers' responsibilities to report adverse events (Section 10);
  • Extension of the Declaration to include specimens taken from humans and secondary data (Section 28);
  • The first concrete expression of the need for concrete plans to assure post-trial availability of effective interventions (Section 24a);
  • Enhanced public disclosure of study designs and results (Section 13); and
  • Stipulation that certain populations who are not competent to provide consent should not be the subjects of experiments unless other subjects are not suitable (Section 19).

In sum, in many respects, the current draft Declaration is an improvement over the existing Declaration and over previous draft revisions. But the (we presume inadvertent) exclusion of any mention of what treatments must be provided to subjects during the trial is an error that must be corrected or else the Declaration will provide no guidance in precisely the area where guidance is most called for. You have indicated to us that during the course of this debate, hundreds of people from around the world contacted you, many urging the retention of the "best proven" standard, resulting in the rejection of the March 1999 and May 2000 language. Please ensure that the current draft is amended so that their collective voice is properly reflected in the final version of the Declaration.

Yours sincerely,

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

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

cc: David Rothman

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