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Posted on May 8, 2015 at 4:05 AM

I recently read a paper written by my colleagues at Alden
March Bioethics Institute entitled “
In Particular Circumstances Attempting
Unproven Interventions and Circumstances is Permissible and even Obligatory

I do not entirely agree with my colleagues. I do not
disagree that there are some very limited circumstances in which unproven
interventions are warranted nearly all of which are in the research or
compassionate use context. The recent Ebola crisis is an example of that where
the use of monoclonal antibodies against the Ebola virus was consistent with
theory and prior scientific precedent. However we must balance that against the
harm done. The consumption of available ZMapp antibody in compassionate use
likely precluded the opportunity to conduct clinical trials in a timely manner
to determine if it actually did provide any benefit. Had it been used to prove
efficacy it could have justified the investment necessary to prepare it large
quantity and let future physicians and patients make informed decisions on its
use. Moreover the manner in which the compassionate use was implemented, nearly
exclusively available to US and European health care workers and barely any
availability to Africans could hardly be considered just. During the next Ebola
outbreak we may be faced with the same circumstances because we still do not
really know its efficacy. There is now enough ZMaap available to conduct trials
and these have been initiated but there may not be enough patients available to
conduct them.

They site as justification for such use that “The fact that
there exists a measure of consensus among able and prudent providers suffices
to make particular innovative interventions permissible or obligatory…” There
have been many such consensuses which have been, when subjected to clinical
trials, found to be wrong. One which comes to mind was certain types of
arthroscopic knee surgery. Many patients were provided this ineffective
intervention at considerable cost and some risk with no apparent benefit. This
scenario has been repeated over and over again and the type of use they
advocated will assure this is repeated.

They have not made any compelling effective argument for use
of unproven interventions to be obligatory. In fact there would be very serious
consequences for any such obligatory unproven intervention. If an unproven
therapy is considered to be obligatory for a particular set of patients with a
given disease than all such patients must be provided with that intervention.
This means that no study can ever be done of that intervention and the
intervention can never be tested for efficacy. The potential for harm here
exceeds that in the case described above. No patient or physician will ever be
able to make an informed decision. At one point they characterized randomized
clinical trial as a luxury. It is very difficult to agree with that statement.

Even beyond these issues are the questions of who will pay
for such unproven interventions and who would be responsible for possible
consequences of their use. I hope my colleagues do not mind my challenging their
position but I think it needs reconsideration.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.  

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