HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Tuesday, December 21, 2004

Times x 2

Two articles of note in today's New York Times:

  1. APills_1n op-ed piece by Merrill Goozner ("Overdosed and Oversold") that argues for:
    1. an independent arm of F.D.A. that contracts with independent clinicians and scientists for the final testing of all new drugs and medical devices. After a company submits its drug application based on safety and early efficacy trials, this arm would design the protocols to learn not just if the new drug is effective versus a placebo, but how it compares to other therapies and how it can be most effectively used. At the same time, the F.D.A. agency would need an adequately financed post-marketing system that would follow through on a drug's safety, using information and financing independent of the drug manufacturers. It should also reimpose the pre-1997 restrictions on direct advertising to consumers, one of the elements that led to vast popularity of Celebrex and Vioxx among arthritis patients.

      Congress should also set up an independent agency for conducting comparative trials for thousands of existing therapies. This new center, perhaps housed at the National Institutes of Health, would also evaluate the cost-effectiveness of new technologies and finance the work of scientists who want to test older, off-patent medicines for new uses. And it could oversee the creation and updating of clinical practice guidelines free from commercial sponsorship so that hospitals and doctors can base their decisions on objective evidence.
  2. Lawrence K. Altman ("The Ultimate Gift: 50 Years of Organ Transplants") commemorates the 50th anniversary of "the first 21transplant2_1 successful organ transplant, a kidney transplant from a living donor performed in Boston in 1954."  Now,

surgeons have learned how to transplant virtually every vital organ in the human body. They have also branched out to transplant an array of nonvital body parts including, most recently, the hand. In the near future, face transplants, still a subject of controversy, are likely to become a reality: last month, the Cleveland Clinic became the first institution to receive approval for the operation.

The patient stories include Robert Phillips, who received his sister's kidney in 1963 and is the world's longest organ transplant survivor.  Altman discusses the controversy swirling around a proposal to do facial transplantation and some of the ideas proposed to deal with chronic shortages of organs, but little or nothing about the growing debate over whether transplantation represents a serious misallocation of medical resources that could be better spent on primary and preventative health care services.


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