Sunday, January 15, 2017

Candidates for Head of NIH and Head of FDA

The current head of NIH, Francis Collins, has been widely popular and many are advocating that he be kept in position under the Trump administration.

However, other names are being floated as head of NIH.   On January 13, 2017, Nature's headline is:  "Surprising contenders emerge for NIH's Trump Chief;" see the online article here.

More after the break, including coverage of FDA candidates.

Turning to NIH

According to Nature, Francis Collins has had what is essentially a job interview for retaining his position; and Congressman Andy Harris of Maryland has been interviewed as well.  Harris was active on the 21st Century Cures legislation; he opposes abortion and research on marijuana.  For a December 1 article on Harris, here.

 According to Nature, biotech billionaire and physician-scientist Patrick Soon-Shiong has also met with Trump regarding the NIH position.

In an update on STAT on January 24, it was reported Soon-Shiong has had not one but "several meetings" with Trump over national health policy in January (here).

Finally, Nature mentions other candidates who are being rumored as possibilities, but haven't necessarily been interviewed.  These include evidence-based-medicine guru at Stanford, John Ioannidis, and Geoffrey Ling, a retired Army neurosurgeon who directed biotechnology at DARPA.

FierceBiotech has a January 14 article focusing on Soon-Shiong, here.  Soon-Shiong was a very early proponent of the  Cancer Moonshot cancer program and met with Trump in mid-November (here).

Turning to FDA 

Leaving aside NIH candidates, for FDA, candidates (see Fierce Biotech article here) have included investor Jim O'Neill and Balaji Srinivasan, CEO of a bitcoin startup called   O'Neill has advocated more libertarian views on FDA (e.g. release drugs and products and let markets decide.)   Srinivasan, via tweets and other media, has vocalized concerns that FDA doesn't fully weigh the harms of slow drug approvals when it weighs the risks that might occur if a drug is approved.  (In my own words, I think this means, we might have 1000 lives saved by slow and cautious approvals, balanced by 100,000 lives saved during the time created by faster approvals.)

O'Neill and Srinivasan are both well-known to Trump advisor Peter Thiel.
  • O'Neill held several HHS positions under Bush II, including editor of the Secretary's speeches, and then shifted into venture capital.  He holds a BA from Yale and a Master's from University of Chicago.  
  • Srinivasan holds BS/MS/PhD degrees in engineering from Stanford (MS, chemical; MS/PhD, electrical), co-founded genetics laboratory Counsyl, and has been a Board Partner at Andreessen Horowitz and cofounder of which provides software/hardware for Bitcoin. 
    • (See an opinion piece, "Srinivasan hates FDA, but Silicon Valley likes Srinivasan," here.)  According to one news report this weekend, Srinivasan deleted his Twitter account (which contained a range of posts critical of FDA.)
    • Srinivsan published a 2010 paper on the use of advanced sequencing for prenatal recessive carrier screening of severe genetic disorders, here.
  • For coverage of O'Neill and Srinivasan at WSJ, January 13, here.
  • For coverage at Bloomberg, January 13, here, and January 17, here.
  • For coverage at STAT, January 12, here.

In December, I saw  Scott Gottlieb, a physician who has notable policy credentials and strong conservative credits, as an early front-runner for the FDA position.  A conservative blogger wrote "Gottlieb for FDA" on January 15 (here).   The influential journal National Law Review ran an article on January 20, "How Will Trump Change the FDA," focusing almost entirely on Gottlieb's positions (here).  Despite the generic headline, the article cites Gottlieb by name 19 times.

On January 23, STAT called out Dr. James Gulfo (MD/MBA) as another potential candidate for FDA, here.  See also MassDevice, here, Fierce Biotech, here.  Gulfo wrote a recent WSJ op ed on a new drug approval system (here) (also at The Hill, here) and he wrote a book called, "Innovation Breakdown: How FDA and Wall Street Cripple Medical Advances."

In a Bloomberg article, drugmakers argued that the FDA chief should have clinical experience, here.

It wouldn't be impossible for Administrator Robert Califf to stay on, being confirmed just 11 months ago by a Republican Senate.  Califf left his post just before the Inauguration.