Monday, August 20, 2007

Update on the Abigail Alliance case

Several newspapers recently featured opinion pieces addressing a decision last week 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. Summaries appear below.
  • Las Vegas Review-Journal: The "proper" legal question in this case might be where Congress "finds any delegated power to restrict consensual commerce between well-informed doctors and patients who want to try these medicines, and manufacturers willing to sell them," according to a Review-Journal editorial. Rather than determining the constitutionality of regulating medicine, it would be easier to "simply set up the protocols the plaintiffs seek, allowing the experimental use of drugs already confirmed as reasonably safe for human use, in specific cases where a mentally competent patient is otherwise at death's door" -- which is what FDA "should have done in the first place" (Las Vegas Review-Journal, 8/9).

  • Ronald Trowbridge and Steven Walker, Wall Street Journal: 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," Trowbridge, an adjunct scholar at the alliance, and Walker, co-founder of the alliance and its chief adviser, write in a Journal opinion piece. The Abigail Alliance will appeal the decision to the U.S. Supreme Court and agrees "with only one thing in the majority opinion" -- that "Congress should pass our pending legislation, called the Access Act, now" as part of the Prescription Drug User Fee Act, Trowbridge and Walker write. They continue that the decision "is massive human tragedy, made even worse by the fact that it didn't and doesn't have to be this way" (Trowbridge/Walker, Wall Street Journal, 8/14).

  • Bruce Fein, Washington Times: It "seems both mindless and cruel" for FDA to block terminally ill patients' access to "a drug that carries the sole hope of life," Fein, a constitutional lawyer with Bruce Fein & Associates and chair of the American Freedom Agenda, writes in a Times opinion piece. Fein writes that terminally ill patients "should enjoy access to any drug recommended by physicians to treat their afflictions, but only after receiving a comprehensive tutorial explaining the safety risks and probability of success." He adds, "Absolute patient-physician autonomy should prevail" (Fein, Washington Times, 8/14).
Reprinted with permission from You can view the Kaiser Daily Reports online, search the archives, and sign up for email delivery at The Kaiser Daily Reports are published for, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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