EFTA Document EFTA01786277

From: Donald Rubin <~ Sent: Wednesday, December 7, 2016 3:38 PM To: jeffrey E. Subject: Re: Placebo effects, EB, etc. Different ways to follow up. 1. The next time =hat we're in the same town, we could talk about the statistical =deas 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. 2. =nbsp;l can send some recent things on the topic of placebo response, =hich are still not that wonderfully written. 3. If interested in exploring =nvesting in EB, I can put you in touch with Adriaan, who lives in =msterdam. Are =ny of these appealing? I prefer 1 to 2. I think a face to =ace version of 3 could be arranged either here or there. Let me =now. On Dec 7, 2016, at 9:35 AM, jeffrey E. <[email protected]> wrote: I'm always interested in unique idea On =ed, Dec 7, 2016 at 10:12 AM Donald Rubin =rote: Hello =effrey, I'm glad that Martin has put us in touch for = couple of reasons. First, I think we have some mutual interests =oncerning the complications of doing experiments with humans, rather =han plants or animals or tires. One complication is noncompliance =ith the assigned treatment, which we briefly discussed at the dinner, =ut the more interesting one is the placebo effect, which can be =igantic, for example in "viagra" type studies, which we =idn't get around to discussing except indirectly in the context =f the Emotional Brain (EB) female viagra issue. More generally, this is related to FDA standards for =pproving drugs. A slight aside: in January I'm one of =hree people getting honorary degrees from the Medical Faculty of the =niversity of Uppsala in Sweden, where one of the others is Robert =aliff, the current Commissioner of the FDA (the other is Marcia McNutt, =he current President of the National Academy of Sciences), so I should =et the chance to bend his ear at various meals (a former commissioner =E2$4 under Bush II — was a partial PhD student of mine when =e was getting his MD at Harvard and his PhD in Econ at MIT, and remains = good friend: Mark McClellen, who is interested in this stuff and =emains quite influential in DC, I think). But the reason for rambling about the FDA and =lacebo effects is the following. This morning I just had an =xchange of emails with the CEO of EB, whom I've known and =orked with for about three years, Adriaan Tuiten. He wrote that =DA has agreed with EB's proposal for more trials, and the EB =oard of directors just approved the issuance of about 12 million Euros =n stock to pay for these trials. Adriaan thinks that they may =ave enough connections now, EFTA_R1_00108986 EFTA01786277 but would you be interested in =articipating? I already have some stock, which I earned though =onsulting. I think EB is interesting but still needs more wisdom =hen it comes to their statistics (I've been to FDA with them =wo or three times, and I think they still need help with some of their =deas e.g., using SNPs). If interested in tossing some money their =ay, let me know. In any case, I very =uch enjoyed our last conversations, and I look forward to seeing you =gain, either in Cambridge or in NYC, which I'll probably get to =n the next couple of weeks. Best wishes, =on Donald B. Rubin John L. Loeb Professor of Statistics Department of Statistics, Harvard University 1 Oxford Street Cambridge MA =2138 617-495-5498 On Dec 2, 2016, at 9:41 AM, =effrey E. <[email protected] <mailto:jeevacation®gmail.com» =rote: great On Fri, Dec 2, =016 at 9:40 AM, Donald Rubin wrote: Great, thanks Martin. Sometime when I get to NYC, which = often do to visit Columbia connections, I'd like to be in =ouch, and give Jeffery more lectures in statistics — I think he =as some potential! Also, =artin, should we try to touch base on Monday? The rest of the =eek is pretty much shot for me with visitors. 2 EFTA_R1_00108987 EFTA01786278 Best, Don > On Dec 2, 2016, =t 9:32 AM, Nowak, Martin A. < • wrote: > Don , Jeffrey > I would like to =ut you in direct email contact. >=also cc =. >_ 3 EFTA_R1_00108988 EFTA01786279 please =ote The information =ontained in this communication is confidential, =ay be attorney-client privileged, may constitute =nside information, and is intended only for the =se of the addressee. It is the property of JEE Unauthorized use, disclosure or copying of this communication or any part thereof is strictly =rohibited and may be unlawful. If you have =eceived this communication in error, please =otify us immediately by return e-mail or by =-mail to [email protected] <mailto:[email protected]> , and destroy this communication and all copies =hereof, including all attachments. copyright =all rights reserved 4 EFTA_R1_00108989 EFTA01786280