OP-ED

Why the WHO ethics advisory group is a start but hardly sufficient

Screen Shot 2014-08-12 at 5.37.18 PMThe much awaited WHO ethics advisory group on the use of experimental drugs to combat Ebola has issued its statement.  While a start it is no more than a baby step.

The advisory panel did decide that they found the case for using experimental drugs in African populations ethical.  While they did not say much about why they reached this conclusion it seems valid in that when facing a deadly plague the overwhelming majority of people infected would want a drug, even one that has barely been tested, to try to save themselves or a family member.  In reaching this conclusion the committee puts to rest the argument that experimental drugs could not go to Africans at all or ought to go to Americans or Europeans first in order to avoid the charge of exploitation.  In a plague that kills 90% of its African victims complaints about unwarranted exploitative research seem a bit ridiculous even against a long history of misuse and abuse of poor desperate persons in poor African nations.

The committee did not say a good deal more other than that informed consent and choice ought to be respected.  This is far less helpful.

Informed consent and choice are wonderful values but they need spelling out in the context of a deadly plague impacting desperately poor and often uneducated populations with little access to health care.  Who is to get the consent.  What help will be given to potential subjects to insure their comprehension?  If those who get a new drug or vaccine are injured by it do they have any redress?  Who will pay the costs of getting the treatment and of travel, food and housing that associate with experimentation?  And who will consent for children, prisoners, the mentally ill or those rendered incompetent by Ebola?  Can a government or tribal leader consent for a community.  Must an IRB or research ethics committee review all scripts be they written or oral that will be used to get consent?

The committee also had nothing to say about the obligation of companies to make experimental drugs available.  Consent does not matter if a company will not release an experimental drug for reasons of money, fear of adverse events or worries that they cannot manage a large scale release.

 And even if a company is willing to release its drug shouldn’t some independent scientific body vouch for its reasonableness.  There are quacks, charlatans, fast buck artists and crooks more than willing to say their remedy, potion, nostrum and gris gris stick is the answer to Ebola.  Who is to stop them or at least restrain them when the infected are looking for any life-preserver?

Lastly, the committee gave no advice about who ought to go first when supplies of experimental (or for that matter proven) therapies are scarce.  Should children get priority?  Only those who can be monitored over time to assess the outcome of an intervention.  What about health care workers, funeral directors, cleaning personnel and food providers who go in harms way—ought they get priority over others?

Ethical choices are hard.  Ebola has left us with many more than the WHO committee addressed.

Arthur L Caplan is Director of the Division of Medical Ethics at NYU Langone Medical Ctr and the head of the Division’s Project on Compassionate Care

 

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XHRmLQAppthemes november couponAlex CapronKajolehLeonard Kish Recent comment authors
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XHRmLQ
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121059 288798fantastic . Thanks for informations . Ill be back. Thanks once more 633346

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Guest

Wonjderful blog you have hhere but I wass wondering if you
knew of any user discussion forums that cover the same topics
talked about in this article? I’d really like to be a part
of community where I can get suggestions frm other knowledgeable ppeople that share the same interest.
If you have any recommendations, please let me know. Appreciate it!

Kajoleh
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Kajoleh

This is rather a delicate issue and i guess one of the reasons the WHO committee gave the verdict they gave was because they are as desperate as the victims themselves!, But while this is the truth of the matter, there surely aught to be some form of regulation on this. The WHO ethics committee’s verdict sounds rather blanket to me and may pose a great danger to our poor African community. Clearly, using a drug substance that is still in its early preclinical stage poses a greater danger than one that has gone through at least the whole preclinical… Read more »

Leonard Kish
Guest

What is the likelihood that a new drug at this stage will have deadly side effects? If it’s less than the 90% death rate of Ebola, and I have Ebola, I’ll take it my chances, but all patients should be aware of risks on both sides, but hwo well can we determine those risks?

allan
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allan

Remembering the health battles that occurred in this first world Nation’s history: The treatment of childhood leukemia, HIV, etc. They were not neat and organized battles that many bureaucrats like to see. They were messy. The innovators were frequently faced with disagreeable circumstances blocking their inevitable advancements. Ethics are not completely static. They vary with the nature of the battle. The ethical details cannot be created by those that do not have their feet in the ground. Those specific ethics will have to be formed on the spot where the catastrophe exists based upon those most responsible for treatment and… Read more »

Cyndy Nayer
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Another story that hit my inbox says that 2-3 medical groups will decide who in America gets the new HepC drugs. Dr. Caplan, perhaps your efforts could pull together a broader band of folks that are not all clinical in order to create a framework for these beginning ethics and the pioneers who are stepping into the art and science of health value. I’d be happy to work with you to broaden the reach beyond clinical.

Saurabh Jha
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Saurabh Jha

As Dr. Caplan has alluded. ethics do not operate in vacuum. There are ethics and then there is common sense, which is the mother of all ethics, meta-ethics. Suspension of common sense is gravely unethical. Common sense tells us that to worry about, even suggest informed consent (and other first world indulgences) when there is an epidemic of Ebola is akin to Marie Antoinette playing the fiddle (mixed metaphor there). The WHO is, how do I put it politely, of constrained usefulness. No, it is US’s much maligned big pharma that can most likely come to the rescue here. Might… Read more »