Federal Appeals Court Decision On Access To Experimental Medications

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Experimental Medications

Several newspapers recently featured opinion pieces addressing a decisionlast week by the U.S. Court of Appeals for the District of ColumbiaCircuit that found terminally ill patients do not have the right toobtain access to unapproved experimental drugs that potentially arelifesaving. Summaries appear below.

  • Las Vegas Review-Journal:The "proper" legal question in this case might be where Congress "findsany delegated power to restrict consensual commerce betweenwell-informed doctors and patients who want to try these medicines, andmanufacturers willing to sell them," according to a Review-Journaleditorial. Rather than determining the constitutionality of regulatingmedicine, it would be easier to "simply set up the protocols theplaintiffs seek, allowing the experimental use of drugs alreadyconfirmed as reasonably safe for human use, in specific cases where amentally competent patient is otherwise at death's door" -- which iswhat 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 to12 experimental drugs that if "available to people denied entry toclinical trials" might have "helped more than one million mothers,fathers, sons and daughters live longer, better lives," Trowbridge, anadjunct scholar at the alliance, and Walker, co-founder of the allianceand its chief adviser, write in a Journal opinion piece.The Abigail Alliance will appeal the decision to the U.S. Supreme Courtand 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 andWalker write. They continue that the decision "is massive humantragedy, made even worse by the fact that it didn't and doesn't have tobe this way" (Trowbridge/Walker, Wall Street Journal, 8/14).
  • Bruce Fein, Washington Times:It "seems both mindless and cruel" for FDA to block terminally illpatients' access to "a drug that carries the sole hope of life," Fein,a constitutional lawyer with Bruce Fein & Associates and chair ofthe American Freedom Agenda, writes in a Timesopinion piece. Fein writes that terminally ill patients "should enjoyaccess to any drug recommended by physicians to treat theirafflictions, but only after receiving a comprehensive tutorialexplaining the safety risks and probability of success." He adds,"Absolute patient-physician autonomy should prevail" (Fein, Washington Times, 8/14).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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