Friday, December 15, 2006

Captain Drew's Real Doctor Hoary Plantain Solution

Well it's media week (or month, frankly, looking back over recent posts) here at Pallimed...

The current New Yorker has a feature article by Jerome Groopman about the movement here in the US to expand dying patients' access to experiment drugs. This includes proposed rules by the FDA to--essentially--expand, simplify, and make more economically viable 'compassionate use' of drugs that are in phase III trials (or are looking good late into phase II trials). That, such as it is, seems pretty reasonable and a good thing.

On the other hand, the article also describes a movement, centered around the group "Abigail Alliance ," which is promoting a position that dying patients have a right to receive experimental drugs in sort of a de-regulated 'compassionate use for everyone no matter what the drug is' fashion. There is related legislation floating around which tries to enact this--and my understanding of this legislation is that it would include drugs which have passed only phase I testing (someone in the article points out you could easily get shark cartilage past phase I). In addition, a D.C. District Court of Appeals recently upheld a decision that access to experimental drugs is a "constitutional right." This, to me, is the real story here. The consensus of the legal experts quoted in the article is that this decision is bunk. It's sort of discussed as a reverse-Cruzan decision (Cruzan: patients can refuse medical treatments even if life-prolonging vs. This one: patients have a right to medical treatments even if bunk[=not life prolonging=no even preliminary human evidence that likely to be beneficial]). Cruzan & similar decisions however have their basis in well established common law (informed consent rulings, right of the individual to determine what is done to their body, unwanted touching is battery, Schloendoff case, etc.), whereas this ruling is based in, well, nothing per the legal experts in the article. (It's being appealed.)

Contemplating what this ruling could lead to if upheld is fun in a sick way. If dying patients have a constitutional right to new drugs which have no evidence to support their use in such patients, then why don't they have a right to any treatment? Why not the right to die with a tube down their throat, hemorrhaging, hooked up to CVVH, with a 24 year old anesthesia prelim cracking their ribs, getting bilateral femoral central lines placed simultaneously, receiving purified sea-cucumber extract which didn't kill anyone, after all, in phase I testing. Because, after all, if the result is death anyway, shouldn't people have the right to demand any treatment they want (and, given that it's a constitutional right-n-all, I guess us doctors, nurses, anesthesia prelims, pharmacists, etc. will have to provide it). This seems so far from established professional and legal norms that one assumes it will not come to pass.

One more thing before I change track here. A quote:
"The judges in Abigail Alliance reasoned that the same right of self-determination that allows someone to refuse treatment allows him to "choose to use potentially life-saving investigational new drugs." They pointed out that for "over half of our Nation's history"—until the passage, in 1906, of the Pure Food and Drug Act, which made it a crime to sell mislabelled or adulterated medicines—"a person could obtain access to any new drug without any government interference whatsoever.""

I practially choked on my dinner reading this. If the court really thinks we need less 'government interference' in taxpayers' access to drugs then 1) I'll start synthesizing LSD in my basement tonight (call me in about a week), and 2) if you suffer from aches, pains, rheumatism, dropsy, chilblains, hysteria, canker sores, onanism, sugar diabetes, female complaints, or geriatric profanity disorder, I highly recommend the patented Captain Drew's Real Doctor Hoary Plantain Solution--it's all-natural, cheaper than a trip to the doctor's, & comes with a 100%-satisfaction-guarantee.

Enough of that.

Groopman, who you can tell is not a fan of the court ruling, does however frame the article in his own experience in treating AIDS patients around the time protease inhibitors were being developed--including losing patients who likely would have lived much longer if they had access to on-trial antiretrovirals--and very skillfully and compassionately talks in the article about the balance between safety and access to potentially life-prolonging therapies.

Thanks to Dr. Marcin Chwistek for alerting me to this.

(Related NPR story here.)

(And in a story with some consonance with the above discussion, the woman in a PVS in the UK effectively treated her state of being awake instead of curing her of her state of being in a whose family's petition for withdrawal of life-prolonging medical treatments was denied by a judge because they hadn't given her zolpidem [yes, Ambien, I kid you not--there are a handful of case reports suggesting people temporarily responded to it] tried zolpidem. It made her sleep. And because zolpidem effectively treated her state of being awake, as opposed to effectively treating her state of being in a PVS, the judge has ruled that the family's petition for ceasing life-prolonging treatment can be honored. The family had argued that it would be cruel to even try the treatment as even temporary awareness of her state would have been needlessly cruel to the poor woman.)

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