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More Information on Ethics and Clinical Trials

Letter Concerning Continuing Efforts to Amend Declaration of Helsinki

March 1, 2004

Dr. Delon Human
World Medical Association
28 Avenue des Alpes
01212 Ferney-Voltaire Cedex
France
Fax: 011-33-4-50405937

Dear Dr. Human:

Public Citizen’s Health Research Group welcomes the recommendation by the workgroup on Paragraph 30 of the Declaration of Helsinki to leave that paragraph unchanged. The final language agreed to in October 2000, after extensive consultation with medical associations and others from around the world, is a reasonable statement of what should be a bedrock ethical principle: that participants in clinical trials have the right to any treatment proved effective during the trial. (A more extensive discussion of Public Citizen’s position on Paragraph 30 can be found at http://www.citizen.org/hrg1674 and is incorporated here by reference.)

We are therefore strongly opposed to either the addition of a preamble to the Declaration or a note of clarification to Paragraph 30, two options offered by the Workgroup. The preamble is simply unnecessary. In a long-winded way, it simply reiterates what is widely known: that the Declaration itself does not have the force of law and that its interpretation can, at times, be challenging. The purpose of the lengthy preamble can therefore only be to dilute all that follows — and not just Paragraph 30.  Every element of the Declaration would be covered by this language; the net effect is to make an already-difficult-to-enforce document still weaker.

A note of clarification is similarly unnecessary, but is at least as likely to be dangerous. The “clarification” to Paragraph 29 (another target of the U.S. government and the pharmaceutical industry) is widely agreed to have shed more shadow than light. The difficulties encountered in writing Paragraph 30 in 2000 and then in the consideration of rewriting it will, with certainty, arise again, producing the same stalemates. Moreover, the language offered as the basis for such a clarification already has the elements of dilution: researchers might be required to explain “what is being proposed” (as opposed to requiring the offering of effective treatments), “a comprehensive explanation of risks and benefits” (what exactly are the benefits to patients of not receiving effective, potentially life-saving treatments at trial completion?), and “a detailed explanation of what will and will not be available” (again, a retreat from requiring the provision of treatment).

Clearly, there are challenges to interpreting Paragraph 30. But the same can be said of any number of other paragraphs not distinguishable by their being the subjects of hostility from the U.S. government and the pharmaceutical industry. Each of these paragraphs also establishes ethical principles, the exact interpretation of which will occur on the ground. The 2000 Declaration of Helsinki offered, for the first time, in language that was as clear as was possible, an enunciation of what ought to have been standard practice for decades. There is no justification for retreating from that important step forward. It is time to get past the delay-of-game tactics of Paragraph 30’s opponents and beginning to ensure that the fundamental ethical principles it enshrines are actually enforced.

Yours sincerely,

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

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

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