Posted on August 14, 2014 at 3:38 PM
Earlier this week (Monday, August 11), the WHO convened a panel of ethicists, physicians, scientists, and members of the general public to review the ethics of providing experimental treatments for people afflicted in the current Ebola outbreak. The WHO issued a brief statement the following day. The statement itself is a bit sketchy; the WHO said that a (presumably much more detailed) report of the meeting would be issued to the public on August 17.
The top-line conclusions from WHO this week:
- Basic ethical principles were affirmed.
- “It is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”
- There is not only a scientific, but also a moral imperative to collect and share data from anyone treated in any context (formal clinical trial, “compassionate use,” and so on) with experimental agents for Ebola.
- “More detailed analysis and discussion” is needed about how, ethically, to:
- Balance the desire for direct benefit to patients/subjects with the need to conduct rigorous scientific evaluations and collect the data;
- Prioritize among different experimental agents;
- Allocate scarce resources of the various agents.
So, on the surface, it sounds like they did not get too far. I suppose there could be many reasons for that, not the least of which could be the urgent timeframe and a possible limit of details available to the panel going in to their meeting. But all they really said is that it’s OK to try experimental treatments on sick people.
Attempting to read between the lines:
- I infer that the group intended to emphasize that first human use could be in affected patients and did not have to be preceded by human safety testing in healthy volunteers, as is normally the case for most experimental drugs (with anti-cancer agents being a notable exception).
- Asserting a moral imperative to share data does set up a conflict with drug companies, that often want or need to keep details of their clinical trial data confidential, to a point, and to a certain time. Of course, the recent push for more complete public disclosure of clinical trial data in general works in the direction of the WHO committee’s point in this case.
- I think that observers were hoping for more from the WHO on the points identified for further discussion.
I hope to explore matters more fully next week after the WHO’s fuller report of this meeting is available.
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