Who's in Charge? - Pharmaceutical Technology

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Who's in Charge?
Courts are denying the terminally ill access to experimental drugs, leaving many with no options.


Pharmaceutical Technology


Michelle Hoffman
An anthropologist of the future studying 21st–century America might be forgiven if she failed to understand our true position on the sanctity of life. On one hand, our future anthropologist would find groups of people passionate about the right-to-life of the unborn. Yet, the same anthropologist might find a shocking disregard for the life rights of those already born. I live here, and I don't understand it.

A few months ago, I expressed my confusion over policies that forestall research on human embryonic stem cells that might result in treatments for very ill people. Now, I'm confused about a recent District Court decision denying the terminally ill access to experimental drugs. On Aug. 7, the US Court of Appeals for the District of Columbia decided, in Abigail Alliance v. Andrew Von Eschenbach, that the due process clause of the Fifth Amendment does not extend to terminally ill patients who seek experimental drugs to save their lives.

In previous decisions, this clause has been interpreted by the US Supreme Court to extend to "the rights to marry, to have children, to direct the education and uprbringing of one's children, to marital privacy, to use contraception, to bodily integrity, and to abortion." The Abigail Alliance, an advocacy group for terminally ill patients, argued that due process could also protect "persons in mortal peril" to "try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks." The court rejected that argument.

In the opinion of dissenting Judge Judith Rogers, the majority opinion relied on "tragic wordplay." Judge Rogers wrote: "In the end, it is startling that the oft-limited rights to marry, ... , to have children, to control the education and upbringing of children, ... , and to control one's own body even if it results in one's own death or the death of a fetus have all been deemed fundamental rights ... but the right to try to save one's life is left out in the cold ...."

There exists, it's important to note, a mechanism for terminally ill patients to obtain experimental drugs under a "compassionate use" provision. However, in a very passionate editorial in the Wall Street Journal (Aug. 14, 2007), Ronald Trowbridge and Steven Walker, volunteers with the Abigail Alliance, maintain that many people die while waiting to learn whether they will be given access to a drug for compassionate use. The math, if they are correct, is staggering. More than 520,000 people died while waiting to learn whether they might be able to use some 12 experimental cancer drugs. On the other hand, the US Food and Drug Administration grants some 650 people per year access to investigational drugs for all diseases and drugs, a number that Trowbridge and Walker call "a pathetic, even cruel, pittance."

California attorney Alex Coolman is not involved in the case but keeps a close eye on it for his blog dedicated to pharmaceutical and drug issues http://www.druglaw.typepad.com/). His May 19, 2006, entry notes that, "Industry itself seems somewhat unclear about the opportunities and requirements related to expanded access, which likely leads to delays in the development and implementation of such programs." In order to have the compassionate use provision applied more evenly for all terminally ill patients, the Abigail Alliance argued that these patients were guaranteed access under the Constitution.

I am not a Constitutional scholar, so I will leave a discussion of the correctness of this approach to those who are. My thoughts are more simple-minded. Why, I wonder, are terminally ill patients not good subjects for clinical trials? Wouldn't it be useful to know how the most refractory of patients respond to a given drug? After all, if a drug can be effective on patients who are resistant to available treatments, wouldn't that bode well for patients with less severe disease?

I understand that clinical trials are highly controlled; enrollees must meet very strict criteria in order for the data to be meaningful. However, this is a time when the drug industry is rethinking its approach to clinical trials, in many cases favoring evidence-based trials in real-world situations, as opposed to the more highly controlled (and contrived) trials that are currently the norm. Including the most severely ill patients in these trials could, I think, only add to an understanding of the efficacy of a drug, while also providing some desperately ill people with a possible second chance.

There must be some way to provide the gravely ill with drugs that might improve their lives, and possibly save them. And that goes back to my original question. Who are we, really, with respect to an individual's right to life?











Send your comments or story ideas to Editor-in-Chief Michelle Hoffman at
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