EFTA Document EFTA01786583

From: Donald Rubin < Sent: Wednesday, December 7, 2016 5:11 PM To: jeffrey E. Subject: Re: Placebo effects, EB, etc. OK. I'll get back to you after = make contact with Adriaan again, and my plans settle a bit. On =ec 7, 2016, at 10:38 AM, jeffrey E. <[email protected]> wrote: three way skype for 3. and yes 1 face to face On Wed, Dec 7, 2016 at 11:37 AM, Donald Rubin =span dir="ltr class=a <mailto > wrote: Different ways =o follow up. 1. The next time that we're in the same town, =e could talk about the statistical ideas underlying ways to disentangle =lacebo effects from biological effects of drugs and why that's =mportant for FDA approvals and for prescripts in the docs office —=different answers, I think. 2. I can send some recent things =n the topic of placebo response, which are still not that wonderfully =ritten. 3. If interested in exploring investing in EB, I can =ut you in touch with Adriaan, who lives in Amsterdam. Are any of these =ppealing? I prefer 1 to 2. I think a face to face version =f 3 could be arranged either here or there. Let me know. On Dec 7, 2016, at 9:35 AM, jeffrey E. <[email protected]> wrote: I'm always interested in =nique idea On Wed, Dec 7, 2016 at 10:12 AM =onald Rubin < > wrote: Hello Jeffrey, EFTA_R1_00109484 EFTA01786583 I'm glad that Martin =as put us in touch for a couple of reasons. First, I think we =ave some mutual interests concerning the complications of doing =xperiments with humans, rather than plants or animals or tires. =ne complication is noncompliance with the assigned treatment, which we =riefly discussed at the dinner, but the more interesting one is the =lacebo effect, which can be gigantic, for example in "viagra4.=9D type studies, which we didn't get around to discussing =xcept indirectly in the context of the Emotional Brain (EB) female =iagra issue. More generally, this is =elated to FDA standards for approving drugs. A slight aside: in =anuary I'm one of three people getting honorary degrees from =he Medical Faculty of the University of Uppsala in Sweden, where one of =he others is Robert Califf, the current Commissioner of the FDA (the =ther is Marcia McNutt, the current President of the National Academy of =ciences), so I should get the chance to bend his ear at various meals =a former commissioner — under Bush II — was a partial =hD student of mine when he was getting his MD at Harvard and his PhD in =con at MIT, and remains a good friend: Mark McClellen, who is =nterested in this stuff and remains quite influential in DC, I think). =nbsp; But the reason for rambling =bout the FDA and placebo effects is the following. This morning I =ust had an exchange of emails with the CEO of EB, whom I've =nown and worked with for about three years, Adriaan Tuiten. He =rote that FDA has agreed with EB's proposal for more trials, =nd the EB board of directors just approved the issuance of about 12 =illion Euros in stock to pay for these trials. Adriaan thinks =hat they may have enough connections now, but would you be interested =n participating? 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 much =njoyed our last conversations, and I look forward to seeing you again, =ither in Cambridge or in NYC, which I'll probably get to in the =ext couple of weeks. Best wishes, Don Donald B. Rubin John L. Loeb Professor of =tatistics Department of =tatistics, Harvard University 1 Oxford Street Cambrid e MA 02138 617-495-5498 <tel:(617)%20495-5498> On Dec 2, 2016, at 9:41 AM, =effrey E. <[email protected] <mailto:[email protected]» wrote: great 2 EFTA_R1_00109485 EFTA01786584 On Fri, Dec 2, 2016 at 9:40 AM, Donald =ubin <[email protected]> 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, Martin, should we try to touch base on Monday? =he rest of the week is pretty much shot for me with visitors. Best, Don > On Dec 2, 2016, at 9:32 AM, Nowak, Martin = wrote: > Don , Jeffrey > I would like to put you in direct email =ontact. 3 EFTA_R1_00109486 EFTA01786585 > also cc Lesley. >m &n=sp; please note The information contained in =his communication is confidential, may be =ttorney-client privileged, may constitute inside information, =nd is intended only for the =se of the addressee. It is the property of JEE Unauthorized use, disclosure =r copying of this communication or any part =hereof is strictly prohibited and may be unlawful. If you =ave received this communication in error, please =otify us immediately by return e-mail or by e-mail to =a href="mailto:[email protected]" =lass="m_-1196805788815373682gmail_msg" =arget="_blank">[email protected], and destroy this communication and =11 copies thereof, including=all attachments. copyright -all rights reserved 4 EFTA_R1_00109487 EFTA01786586 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_001 09488 EFTA01786587