Letters To The Editor Address Opinion Piece On Access To Experimental Medications For Terminally Ill Patients

Main Category: Public Health
Also Included In: Pharma Industry / Biotech Industry
Article Date: 22 Aug 2007 - 5:00 PDT

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The Wall Street Journal on Monday published letters to the editor addressing an Aug. 14 opinion piece by Ronald Trowbridge, an adjunct scholar with the Abigail Alliance, and Steven Walker, co-founder of the alliance and its chief adviser, about a decision earlier this month by the U.S. Court of Appeals for the District of Columbia Circuit that found terminally ill patients do not have the right to obtain access to unapproved experimental drugs that potentially are lifesaving. According to Trowbridge and Walker, the Abigail Alliance, which filed the lawsuit against FDA in 2003, has pushed for access to 12 experimental drugs that if "available to people denied entry to clinical trials" might have "helped more than one million mothers, fathers, sons and daughters live longer, better lives" (Kaiser Daily Health Policy Report, 8/14).

• Michael Broder: Trowbridge and Walker's theory that "'safe and effective' drugs are being denied to millions of patients" has "flaws that may stem from confusion about the nature of studies done in support of drug approval in the U.S. and about some essential concepts in statistics," Broder, president of the Partnership for Health Analytic Research, writes in a Journal letter to the editor. Broder continues that Trowbridge and Walker's argument that "lay people with cancer should be able to do whatever they want if they believe it will help" might "be worth debating, but the debate is not clarified by their writings" (Broder, Wall Street Journal, 8/20).
  
  
• David Holcberg: "The government has no right to forbid individuals from taking medicine they believe would benefit them," and the "only moral policy the government can adopt is to let doctors and patients exercise their right to make their own choices," Holcberg of the Ayn Rand Institute writes in a Journal letter to the editor. Holcberg concludes, "Pharmaceutical companies, medical associations and other private organizations can provide the necessary data for doctors and patients to make informed choices" (Holcberg, Wall Street Journal, 8/20).
  
  
• Peter Pitts: Both sides of the debate on experimental drugs want the "same thing -- expanded access to drugs under clinical investigation," Pitts, director of the Center for Medicine in the Public Interest, writes in a Journal letter to the editor. Expanded access to experimental drugs "simply can't and shouldn't morph into total, unfettered access," but that "doesn't mean the status quo is working," Pitts writes. He continues, FDA "needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review," and the Abigail Alliance and its supporters "need to keep up the pressure to reform the current system" (Pitts, Wall Street Journal, 8/20).
  
  
• Michael Scott: Trowbridge and Walker "imply that only the Abigail Alliance has taken action to advocate for (or indeed has any interest in advocating for) the early approval of important new therapeutic agents for cancer or other disorders," which is a "complete falsehood," Scott, a board member of the International Myeloma Foundation, writes in a Journal letter to the editor. In addition, Trowbridge and Walker's editorial makes the "outrageous suggestion that the FDA is solely responsible for tens of thousands of deaths as a consequence of its decision processes," Scott continues. FDA "may not be perfect, but this statement is a disgrace," he writes (Scott, Wall Street Journal, 8/20).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.