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Posted on August 7, 2014 at 2:48 PM

A comment to my post from last week started with the statement, “The whole discussion [of whether discussions of value are just Trojan Horses for unjust rationing] would be less strained if money wasn’t so scarce in health care.”  If by this is meant, conversations about medical expenses would be easier if the prices weren’t so high—well, sure.  If what is meant is more like, “Health care costs are so high and budgets are so strained that we have to view every health resource as essentially scarce, because the money is scarce,” then I’m not sure I agree.

In the latter case, I think that Dr. Daniel Sulmasy’s distinction between allocation and rationing, made in a 2007 article in the Journal of Clinical Oncology (subscription required), is worth recalling.  In that article, Dr. Sulmasy argued that “the ordinary language distinction between allocation and rationing is morally meaningful.”  Allocation refers generally to the apportioning of resources.  Rationing, on the other hand, implies restriction of use due to scarcity, and entails a method of sharing such scarce resources, with a moral justification for the method, when demand exceeds supply.  So, Medicaid officials deciding how much money to spend on, say, the treatment of hepatitis as opposed to some other medical service is an allocation decision.  That there is not enough money to afford every medical intervention everyone might think beneficial does not change that.  A plan for cancer doctors to recommend the less expensive of two equally-effective treatments is more of an allocation decision than a rationing decision.  Sulmasy does also say, however, that deciding a fictitious Mrs. Jones should not receive a cancer drug “because there isn’t enough money to go around and the resources ought to spent instead on cancer prevention is a rationing decision.”  If we grant him that, then the distinction between allocation and rationing gets blurred at the margin.  Similarly, a decision by Medicaid officials that prisoners with hepatitis C should not get Sovaldi but others in the Medicaid program should, because there isn’t enough money to go around, would qualify as a rationing decision.

I was arguing that the ASCO program is more about allocation than rationing.  I think we should resist the thinking that all health care is in scarce supply because we can’t afford everything for everyone all the time.  And I disagree that is, strictly speaking, rationing.  Maybe I’m getting the argument wrong, or maybe it’s a distinction without a practical difference, but I think that blurring the distinction Sulmasy made is a big part of what strains the discussion.

Now, I used the phrase “unjust rationing” at the start of this post.  I would allow that some rationing is justified.  A case in point is the decision to give what few vials of experimental anti-Ebola monoclonal antibodies (actually, a cocktail of three antibodies) preferentially to two U.S. medical missionaries.  There has been some outcry over that in the general conversation.  I find that outcry unfortunate.

The decision to favor the two missionaries to be at least the first to get this treatment is justified by a greater moral responsibility to them on the part of Samaritan’s Purse, and the government of the U.S., of which they are citizens.  (The CDC says that NIH was not involved in “approving” the treatment in this case.)  It could be argued that as medical professionals they might be preferred based on their potential to return to caregiving (although I imagine that if they survive, they won’t be going back to West Africa quickly.)  And it could be argued that their treatment, as part of a plan to return them to the U.S. for better supportive care than is available in the field, made the treatment more likely to help them than some others with the disease.  None of that strikes me as inherently unjust, although I would allow that a lottery system to allocate the experimental treatment would also have been supportable—just not as strongly so in this case, in my opinion.  (We should recall that at least one other dedicated physician has succumbed to the disease.)

Broader issues are raised by the question, can others receive the same experimental treatment?  Or if not, why not?  I must speak generally and be circumspect because I do not know the operational or regulatory details of the case, but it seems straightforward that, supplies permitting, trying the same treatment for others with Ebola is ethically justifiable under the rubric of emergency research.  There are no good options, a dismal prognosis, and a potential for direct benefit to research subjects, three points which would justify accepting greater risks to the subjects/patients in this case.  Or so it seems.  And that in turn implies that eligibility criteria for experimental treatment could be relaxed.

Supply of the antibodies is extremely limited, according to the CDC.  Read between the lines of their Q+A, and one wonders whether the company developing the treatment is worried that it can’t make enough to treat people in the current outbreak and also do the kind of early human safety testing that is usually required.  Suppose they can’t make enough, and what they use is diverted to treating victims of the outbreak.  A reasonable scientific issue is whether one would be able to tell from the effort whether the drug appears to be safe and effective.  It could remain eminently unclear, in which case the effort—and the drug supply—would arguably have been wasted.  A bit of an allocation issue, perhaps.

Also at issue—and again, I do not know details—would be other regulatory matters:  Are the manufacturing criteria for the antibodies appropriate, and not too strict?  Would FDA approve emergency use of the antibodies, and issue the necessary approvals promptly?  Are there truly show-stopping—or show-slowing—regulatory obstacles to proceeding now?

I don’t know the answer to these, and, frankly, I imagine that everyone involved is trying to expedite as many potentially helpful steps as much as possible.  It has also been suggested that FDA is restricting this work out of some sense of regulatory self-interest.  I have not seen any evidence for that, and I find that allegation, as I read it, also unfortunate.   The World Health Organization will reportedly convene a panel of ethicists to review the issues.  What little I have seen makes it sound like they are concerned about how to ration an extremely limited supply among the many who are afflicted with the disease.

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