Placebo effects, EB, etc.

Don, Jeffrey

I would like to put you in direct email contact.

also cc Lesley.

m

Great, thanks Martin. Sometime when I get to NYC, which I often do to visit Columbia connections, I'd like to be in touch, and give Jeffrey more lectures in statistics — I think he has some potential!

Also, Martin, should we try to touch base on Monday? The rest of the week is pretty much shot for me with visitors.

Best, Don

great

Hello Jeffrey,

I'm glad that Martin has put us in touch for a couple of reasons. First, I think we have some mutual interests concerning the complications of doing experiments with humans, rather than plants or animals or tires. One complication is noncompliance with the assigned treatment, which we briefly discussed at the dinner, but the more interesting one is the placebo effect, which can be gigantic, for example in "viagra" type studies, which we didn't get around to discussing except indirectly in the context of the Emotional Brain (EB) female viagra issue.

More generally, this is related to FDA standards for approving drugs. A slight aside: in January I'm one of three people getting honorary degrees from the Medical Faculty of the University of Uppsala in Sweden, where one of the others is Robert Califf, the current Commissioner of the FDA (the other is Marcia McNutt, the current President of the National Academy of Sciences), so I should get the chance to bend his ear at various meals (a former commissioner — under Bush II — was a partial PhD student of mine when he was getting his MD at Harvard and his PhD in Econ at MIT, and remains a good friend: Mark McClellen, who is interested in this stuff and remains quite influential in DC, I think).

But the reason for rambling about the FDA and placebo effects is the following. This morning I just had an exchange of emails with the CEO of EB, whom I've known and worked with for about three years, Adriaan Tuiten. He wrote that FDA has agreed with EB's proposal for more trials, and the EB board of directors just approved the issuance of about 12 million Euros in stock to pay for these trials. Adriaan thinks that they may have enough connections now, but would you be interested in participating? I already have some stock, which I earned though consulting. I think EB is interesting but still needs more wisdom when it comes to their statistics (I've been to FDA with them two or three times, and I think they still need help with some of their ideas e.g., using SNPs). If interested in tossing some money their way, let me know.

In any case, I very much enjoyed our last conversations, and I look forward to seeing you again, either in Cambridge or in NYC, which I'll probably get to in the next couple of weeks.

Best wishes, Don

Donald B. Rubin
John L. Loeb Professor of Statistics
Department of Statistics, Harvard University
1 Oxford Street
Cambridge MA 02138