From: Donald Rubin

From: Donald Rubin Sent: Wednesday, December 7, 2016 5:47 PM To: jeffrey E. Subject: Re: Placebo effects, EB, etc. Think so. Where will you be? On =ec 7, 2016, at 12:25 PM, jeffrey E. <[email protected]> wrote: ar you around on the weekend in cambridge.? =nbsp; On Wed, Dec 7, 2016 at 1:10 PM, Donald Rubin mails wrote: OK. ='ll get back to you after I make contact with Adriaan again, =nd my plans settle a bit. On Dec 7, 2016, at 10:38 AM, =effrey E. <[email protected] <mailto:[email protected]> wrote: three way skype for 3. and =es 1 face to face On Wed, Dec 7, 2016 at 11:37 AM, =onald Rubin Different ways to follow up. wrote: 1. The next time =hat we're in the same town, we could talk about the statistical =deal underlying ways to disentangle placebo effects from biological =ffects of drugs and why that's important for FDA approvals and =or prescripts in the docs office — different answers, I =hink. that wonderfully written. lives in =msterdam. arranged either here or there. 2. = can send some recent things on the topic of placebo response, which =re still not 3. If interested in exploring =nvesting in EB, I can put you in touch with Adriaan, who Are =ny of these appealing? I prefer 1 to 2. I think a face to =ace version of 3 could be Let me =now. EFTA_R1_00109659 EFTA01786714 On Dec 7, 2016, at 9:35 AM, jeffrey E. <[email protected]> wrote: I'm always =nterested in unique idea On Wed, Dec 7, 2016 at 10:12 AM =onald Rubin wrote: Hello =effrey, l'= glad that Martin has put us in touch for a couple of reasons. =irst, 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 =enerally, this is related to FDA standards for approving drugs. A =light aside: in January I'm one of three people getting =onorary degrees from the Medical Faculty of the University of Uppsala =n Sweden, where one of the others is Robert Califf, the current =ommissioner of the FDA (the other is Marcia McNutt, the current =resident of the National Academy of Sciences), so I should get the =hance to bend his ear at various meals (a former commissioner — =nder Bush II — was a partial PhD student of mine when he was =etting his MD at Harvard and his PhD in Econ at MIT, and remains a good =riend: Mark McClellen, who is interested in this stuff and remains =uite influential in DC, I think). But the =eason for rambling about the FDA and placebo effects is the =ollowing. This morning I just had an exchange of emails with the =EO of EB, whom I've known and worked with for about three =ears, Adriaan Tuiten. He wrote that FDA has agreed with EB'= proposal for more trials, and the EB board of directors just approved =he issuance of about 12 million Euros in stock to pay for these =rials. Adriaan thinks that they may have enough connections now, =ut would 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 =NPs). 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 =ishes, Don Donald B. Rubin John L =oeb Professor of Statistics Department=of Statistics, Harvard University 1 Oxford =treet 2 EFTA_R1_00109660 EFTA01786715 On Dec =, 2016, at 9:41 AM, jeffrey E. <[email protected]> wrote: great On Fri, Dec 2, =016 at 9:40 AM, Donald Rubin wrote: Great, thanks Martin. Sometime when I =et to NYC, which I often do to visit Columbia connections, I'd =ike to be in touch, and give Jeffery more lectures in statistics —=1 think he has some potential! Also, Martin, should we try to touch base on =onday? The rest of the week is pretty much shot for me with =isitors. Best, Don > On Dec 2, 2016, at 9:32 AM, Nowak, Martin = <mailto wrote: > Don , Jeffrey 3 EFTA_R1_00109661 EFTA01786716 > I would like to put you in direct email =ontact. > also cc >m &nbs=; please note The =nformation contained in this communication is confidenti=l, may be attorney-client privileged, may constitute=inside information, and is intended only for the use =f the addressee. 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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 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 5 EFTA_R1_00109663 EFTA01786718