Max Fink and Donald Klein: E-mail exchange
Pierre Baumann and Francois Ferrero: An official inquiry of the clinical research activities (1946-1972) of Roland Kuhn (1912-2005) - Preliminary notes
(Prepared by Olaf Fjetland)
On June 3, 2017, Max Fink wrote:
A thread has begun among Barney’s club members, whether Roland Kuhn obtained patient consent for his IMI trials, as these were started at the time of the Nuremberg trials.
My recollection is that we did not ask for written consent in our CPZ-IMI-PLO HH study, nor in my ECT studies.
And, did you ask for written consent at Columbia for your studies, e.g., lactate infusions? If yes, when did it begin?
On June 4, 2017. Donald Klein replied:
I recall our discussions with Lew Robbins, The Director of Hillside Hospital about that exact point because it was not an abstract legal/ethical administrative issue but the practical matter that our first overriding concern was to find out if they worked.
They were already in wide use but largely had only anecdotal support. Several widely accepted anecdotally supported treatments had been busts. You had your negative insulin studies, I had my negative mepazine studies, to confirm this scepticism. However, we were concerned that public acknowledgement of a randomized placebo group would ignite such flames that the possibility of actually determining therapeutic value would be ruined. Further our patients would be carefully monitored for toxicity.
Years later it seems that these concerns about placebo rejection were real but mostly unnecessary but who knew it then?
Lew Robbin's, a distinguished training Analyst from The psycho-analytic Mecca, Menninger's, could not be accused of being a narrow pharmacological advocate. He quite quickly came around to defending what became all our views since unlike most analysts then, he recognized their probable clinical importance. There were no IRB's then, So Lew Robbins made the decision for us to go ahead in this deceptive fashion that raises the hackles of some historically ignorant ethicists. Our studies took place in the early 1960s. A useful quick historical reference is, "USPHS memo on review boards 1966” Memorandum issued by the Research Grants Division of USPHS on Feb. 8, 1966
Statement of Policy
No new, renewal, or continuation research or research training grant in support of clinical research and investigation involving human beings shall be awarded by the Public Health Service unless the grantee has indicated in the application the manner in which the grantee institution will provide prior review of the judgement of the principal investigator or program director by a committee of his institutional associates. This review should assure an independent determination: (1) of the rights and welfare of the individual or individuals involved, (2) of the appropriateness of the methods used to secure informed consent, and (3) of the risks and potential medical benefits of the investigation. A description of the committee associates who will provide the review shall be included in the application.
-tie to funding for enforcement; reflection of government support for medical research
-involvement of institution
-involvement of committee of "associates" for independent judgement
-safeguard of individual rights
-beyond informed consent, requirement of description of method
-determination of risks v/s benefits
In 1969 the committees were expanded to include non-scientific members.
When I went to Columbia in 1976 a lot of this ethical supervision was well in place. Our lactate studies were all IRB approved. I think the first publication was about 1981. Our studies probably started a couple of years earlier.
Hope this helps.
On June 4, 2017, Donald Klein added to his reply:
Your query re early lactate infusions jogged my memory. About 1978 we had accumulated considerable diverse staff, and was impatient to go. However, started to feel they were dithering--perhaps anxious. So, at our next Staff meeting I declared that the first lactate infusion would take place in 10 days, Art Rifkin would run the first infusion and be in medical charge. The first subject would be me.
This actually whipped things into shape. On infusion day as Art slipped the needle into my arm, he jovially said, “Well I guess I'm going down in psychiatric history as the man who killed Don Klein".
I didn't panic but was considerably annoyed. Couldn't use that data since it wasn't subject blind. On inspection saw nothing in particular.
After report to the IRB re feasibility, substantial discussion ensued. Could I give myself informed consent, and even worse, had not signed it.
November 16, 2017