[Congressional Record Volume 144, Number 7 (Thursday, February 5, 1998)]
[Senate]
[Pages S462-S463]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       NOMINATION OF DR. SATCHER

  Mr. KENNEDY. Mr. President, first of all, I want to express the 
appreciation of all of us to the majority leader for scheduling this 
nomination promptly in this session. I thank the majority leader for 
scheduling this Satcher nomination, and also for filing the cloture 
motion.
  We had an opportunity to make the presentation, and the excellent 
presentation by Senator Frist yesterday, which I thought was just so 
compelling. There were those who took some issue with the record of Dr. 
Satcher. But I do believe that at the end of the day yesterday the 
membership would be convinced of the quality of this extraordinary 
nominee and the incredible opportunity that all America has for his 
service when he is confirmed, which I expect will be on Tuesday next.
  So we look forward to the opportunity to vote and to hopefully see 
Dr. Satcher in that important position.
  In response to questions raised yesterday, I also am including a copy 
of a letter from Dr. Harold Varmus, Director of the National Institutes 
of Health, to Senator Ashcroft regarding studies of maternal-to-infant 
transmission of HIV in developing countries.
  I ask unanimous consent that these materials be printed in the 
Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

         Department of Health and Human Services, National 
           Institutes of Health,
                                   Bethesda, MD, February 3, 1998.
     Hon. John Ashcroft,
     U.S. Senate,
     Washington, DC
       Dear Senator Ashcroft: Your ``Dear Colleague'' letter 
     criticizing Dr. David Satcher's support for studies of 
     maternal-to-infant transmission of HIV in developing 
     countries has been brought to my attention. I am writing to 
     offer a different view of the situation from my perspective 
     as the Director of the National Institutes of Health, a 
     sister agency in the Department of Health and Human Services 
     that also conducts studies to prevent transmission of HIV in 
     the developing world.
       Virtually all parties involved in this difficult issue 
     acknowledge that there are many factors to be considered in 
     determining whether to use a placebo-controlled group in a 
     clinical trial; several of these factors are discussed in an 
     attached article from the New England Journal of Medicine, 
     co-authored by Dr. Satcher and me a few months ago. For the 
     trials in question, the general design of the studies was 
     carefully considered by the World Health Organization and the 
     Joint United Nations Program on HIV/AIDS, and the specific 
     studies we support have been reviewed and approved by duly 
     constituted Institutional Review Boards in the United States 
     and in the countries in which the studies are being 
     performed.
       The essential point is that the studies are designed to 
     provide information useful to the management of HIV infection 
     in the countries in which the studies are done; to act 
     otherwise and generate knowledge applicable only in wealthier 
     parts of the world would, in my opinion, be exploitative of 
     the subjects of the study. Viewed in this context, it is 
     entirely appropriate that we are supporting studies in the 
     developing world that would not be conducted in the United 
     States.
       The article to which you allude in your ``Dear Colleague'' 
     letter, by Dr. Marcia Angell, the Deputy Editor of the New 
     England Journal of Medicine, presents a view that is not 
     generally accepted in the medical community. Indeed her views 
     have been strongly contested by many knowledgeable 
     physicians, scientists, and ethicists, including some members 
     of the Editorial Board of the Journal who have offered their 
     resignations in protest. (The enclosed essay by Dr. Satcher 
     and me was also written in response to Dr. Angell's article.)
       Finally, I must take issue with the contention that the 
     current CDC- and NIH-supported trials are similar to the 
     infamous Tuskegee study. In that study, the course of a 
     disease (syphilis) was observed without attempts to 
     intervene, and informed consent was neither sought nor 
     obtained from the research subjects. In the current studies, 
     the goal is to find useful means to prevent transmission of 
     HIV, the studies are closely supervised by many knowledgeable 
     people, and informed consent has been obtained from each 
     enrolled individual. The analogy to Tuskegee is inappropriate 
     and distracting.
       I appreciate that there are legitimate concerns about the 
     ethical conduct of clinical trials in developing countries, 
     but the debates need to be described in a fashion that gives 
     due consideration to the arguments on both sides. 
     Furthermore, Dr. Satcher's position on these trials should 
     not, in my opinion, constitute grounds for opposing his 
     nomination to be Surgeon-General of the United States. 
     Indeed, even Dr. Sidney Wolfe of Public Citizen, one of the 
     strongest critics of the position Dr. Satcher and I have 
     taken, is an ardent supporter of Dr. Satcher's nomination.

[[Page S463]]

       I offer these comments on your letter in hopes that they 
     will be useful to you and your colleagues in considering Dr. 
     Satcher's nomination to this important post.
           Sincerely,
                                              Harold Varmus, M.D.,
     Director, NIH.

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