Author + information
- Douglas L. Mann, MD, Editor-in-Chief, JACC: Basic to Translational Science∗ ()
- ↵∗Address for correspondence:
Dr. Douglas L. Mann, Editor-in-Chief, JACC: Basic to Translational Science, American College of Cardiology, Heart House, 2400 North Street NW, Washington, DC 20037.
The February 2017 Editor’s Page of JACC: Basic to Translational Science focused on 3 ways that a Trump Presidency might affect translational research (1). The most important area of uncertainty at that time was President Trump’s choice of individuals who would be charged with leading governmental agencies responsible for the funding of science through the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). President Trump’s decision to have Dr. Francis Collins, who was appointed by President Obama, continue to serve as Director of the NIH was viewed enthusiastically by the scientific community. Although many in the cardiovascular community (myself included) lamented the departure of Dr. Rob Califf as the commissioner of the FDA, the appointment of Dr. Scott Gottlieb as his successor has been viewed favorably because of his support for the 21st Century Cures Act, which Gottlieb believes will facilitate faster approvals of new therapies by the FDA. However, President Trump’s nomination for the Secretary of the Department of Health and Human Services (HHS), Dr. Thomas Price, ended abruptly in September 2017, when Dr. Price resigned in the face of mounting criticism over the Secretary’s use of private charter jets and military flights to conduct his job. Since then, President Trump has nominated, and the Senate has confirmed, Mr. Alex Azar to serve as the Secretary of HHS. Given that the Director of the NIH and the Commissioner of FDA report to the Secretary of HHS, it is reasonable to ask how Mr. Azar might affect medical innovation and the translation research space.
Who Is Alex Azar, and How Does He View Medical Innovation?
Alex Michael Azar, II, earned his law degree from Yale Law School in 1991. He served as a law clerk for Associate Justice Antonin Scalia of the Supreme Court of the United States, and also served as an Associate Independent Counsel for Kenneth W. Starr in the Office of the Independent Counsel, where he worked on the first 2 years of the investigation into the Whitewater controversy. He is widely regarded as a conservative’s conservative. Relevant to his nomination for the position of Secretary of HHS, Mr. Azar served as the Deputy Secretary of HHS under George W. Bush (2005 to 2007). As Deputy Secretary, Azar supervised all operations of the Department and led government efforts to encourage worldwide pharmaceutical and medical device innovation. After President Obama was elected, Mr. Azar departed HHS to become the President of the U.S. division of Eli Lilly and Company (2007 to 2017). In connection with his position at Lilly, Mr. Azar also served as a member of the board of directors of the Biotechnology Innovation Organization, which is the world's largest biotechnology trade association dedicated to helping to create an environment for successful innovation across the health care, agricultural, industrial, and environmental biotechnology sectors.
Mr. Azar is widely regarded by health policy leaders as bright, effective, and competent, as well as someone who has a history of working well with a variety of different interest groups. Mike Leavitt, who was Azar’s direct report when he was HHS secretary under President Bush, stated: “He's precise, highly motivated, he has high standards for performance for himself and for other people” (2). Although he has no direct medical training, Mr. Azar was able to grasp the complexities and nuances of medical innovation, and was instrumental in devising the legal rationale that led to a compromise position on federal funding for embryonic stem cell research during the Bush Administration. Mr. Azar’s open criticism of the Patient Protection and Affordable Care Act (ACA) and his call for repeal of ACA has not engendered a great deal of enthusiasm for his selection on the Democratic side of the isle. Indeed, Democratic Senators were quick to point out as President of the U.S. division of Eli Lilly and Company, Azar was responsible for steep price increases for insulin and other drugs. Where Azar stands on drug pricing today is less clear. In a speech given in 2006 Mr. Azar commented that: “A vigorous and profitable drug industry is not a problem to be solved but a goal to be encouraged….governments lean too much toward short-term savings and succumb to the temptation to control expenditures through direct price controls, cuts in reimbursement rates, delayed market access and other subtle and not-so-subtle practices that either restrict the amounts paid for innovative products or reduce consumption of innovative medicines and devices” (3).
As the newly confirmed Secretary of HHS it is unclear how Mr. Azar will prioritize the importance of science and medical innovation versus all of his other responsibilities. In contrast to Dr. Price, who spoke in favor of increasing funding for federal research agencies, including the NIH, Mr. Azar’s views on supporting federal research are less well known. In theory, Mr. Azar’s experience with the pharmaceutical industry should have taught him the importance of supporting innovation in the biotech sector and the pharmaceutical industry. However, theory and practice often diverge, particularly in times of partisan politics, which we are currently experiencing. My view is that Mr. Azar brings a much-needed blend of government and industry experience to the job of running a large and extremely complex governmental department. Mr. Azar has gone on record as stating that he is intent on delivering on the mission of HHS to enhance and protect the health and well-being of every American through innovation. He has also stated that marshalling and leading the resources of HHS requires never being satisfied with the status quo and anticipating and preparing for the future (4). If these statements truly reflect Mr. Azar’s ideology, then count me in as a front row supporter of his selection as the Secretary of HHS. However, in my more pragmatic moments I suspect that, given President Trump’s campaign promise to derail the Affordable Care Act, 110% of Mr. Azar’s time will be devoted to health care policy, rather than supporting the medical innovation that is required to accelerate the pace of cardiovascular translational science. As always, we welcome your thoughts, and would ask you to share your opinions on how Mr. Trumps’ choice for Secretary of HHS will affect translational medicine, either through social media (#JACC:BTS) or by e-mail ( ).
- 2018 The Author
- Mann D.L.
- ↵Maron DF. What you need to know about Alex Azar, Trump's HHS nominee. Scientific American. November 28, 2017. Available at: https://www.scientificamerican.com/article/what-you-need-to-know-about-alex-azar-trumps-hhs-nominee. Accessed January 21, 2018.
- ↵Goldstein A. Health & Science: key things to know about HHS nominee Alex Azar. The Washington Post. 2017. Available at: https://www.washingtonpost.com/national/health-science/key-things-to-know-about-hhs-nominee-alex-azar/2017/11/28/bc70aa70-d459-11e7-95bf-df7c19270879_story.html?utm_term=.77189625a982. Accessed January 21, 2018.
- ↵Sullivan T. Senate confirmation hearing for Alex Azar: open payments to remain open. Policy and Medicine. 2018. Available at: http://www.policymed.com/2018/01/senate-holds-confirmation-hearing-for-alex-azar.html. Accessed January 21, 2018.