EFTA01786441.pdf

From: Donald Rubin < Sent: Wednesday, December 7, 2016 2:12 PM To: Jeffrey E. Subject: Placebo effects, EB, etc. Hello =effrey, lo,=99m glad that Martin has put us in touch for a couple of reasons. =nbsp;First, I think we have some mutual interests concerning the =omplications of doing experiments with humans, rather than plants or =nimals or tires. One complication is noncompliance with the =ssigned treatment, which we briefly discussed at the dinner, but the =ore interesting one is the placebo effect, which can be gigantic, for =xample in "viagra" type studies, which we didn't =et around to discussing except indirectly in the context of the =motional Brain (EB) female viagra issue. More generally, this is related to FDA =tandards for approving drugs. A slight aside: in January l'= one of three people getting honorary degrees from the Medical Faculty =f the University of Uppsala in Sweden, where one of the others is =obert Califf, the current Commissioner of the FDA (the other is Marcia =cNutt, the current President of the National Academy of Sciences), so I should get the chance to bend his ear at various meals (a former =ommissioner — under Bush II — was a partial PhD student =f mine when he was getting his MD at Harvard and his PhD in Econ at =IT, and remains a good friend: Mark McClellen, who is interested in =his stuff and remains quite influential in DC, I think). =nbsp; But the =eason for rambling about the FDA and placebo effects is the following. =nbsp;This morning I just had an exchange of emails with the CEO of EB, =hom I've known and worked with for about three years, Adriaan =uiten. He wrote that FDA has agreed with EB's proposal =or more trials, and the EB board of directors just approved the =ssuance of about 12 million Euros in stock to pay for these trials. =nbsp;Adriaan thinks that they may have enough connections now, but =ould you be interested in participating? I already have some =tock, which I earned though consulting. I think EB is =nteresting but still needs more wisdom when it comes to their =tatistics (I've been to FDA with them two or three times, and I =hink they still need help with some of their ideas e.g., using SNPs). =nbsp;If interested in tossing some money their way, let me =now. In any =ase, I very much enjoyed our last conversations, and I look forward to =eeing you again, either in Cambridge or in NYC, which I'll =robably get to in the next couple of weeks. Best wishes, Don Donald B. Rubin John L. Loeb Professor of Statistics Department =f Statistics, Harvard University 1 Oxford Street Cambridge MA 02138 On Dec 2, 2016, at 9:41 AM, jeffrey E. <[email protected]> wrote: great EFTA_R1_00109276 EFTA01786441  On Fri, Dec 2, 2016 at 9:40 AM, =onald Rubin wrote: Great, thanks Martin. Sometime when I get to NYC, which I often do =o visit Columbia connections, I'd like to be in touch, and give =effery more lectures in statistics — I think he has some =otential! Also, Martin, should we try to touch base on Monday? The rest of =he week is pretty much shot for me with visitors. Best, Don > On Dec 2, 2016, at 9:32 AM, Nowak, Martin A. <[email protected]> wrote: > Don , Jeffrey > I would like to put you in direct email contact. > also cc Lesley. >m please note The information contained in this =ommunication is confidential, may be attorney-client =rivileged, may constitute inside information, and is =ntended only for the use of the addressee. It is the =roperty of JEE Unauthorized use, disclosure =r copying of this communication or any part thereof is =trictly prohibited and may be unlawful. If you have =eceived this communication in error, please notify us =mmediately by return e-mail or by e-mail to [email protected], and destroy this =ommunication and all copies thereof, including all =ttachments. copyright -all rights reserved 2 EFTA_R1_00109277 EFTA01786442 3 EFTA_R1_00109278 EFTA01786443