Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this country.
There are appointments pending from President Trump at the federal Food and Drug Administration and the Centers for Disease Control and Prevention. Sonny Perdue, the administration’s pick for Agriculture secretary, also will play a big public health role, as will the personnel decisions that may be made at the troubled National Institutes of Health, where, for now, Francis Collins will continue to lead.
Will the FDA be run by a venture capitalist?
The administration has met with at least three candidates to head the FDA, a critical watchdog agency over medications and medical devices. Changes are needed at the agency, and I’ve written how its stewardship was a matter of major focus in the $6.3 billion 21st Century Cures Act—well-intentioned legislation that critics fear gave too much relief to Big Pharma and medical device makers from badly needed regulatory oversight.
There may be even greater worry about what will go on at the FDA if President Trump appoints either of two Silicon Valley entrepreneurs who have talked to him about running the agency, according to Stat, the health information site. Both are sharp critics of the FDA, which is fine. Yet neither has the background in medical science that FDA chiefs typically have, and both hold idiosyncratic views.
Jim O’Neill, a tech venture capitalist, Libertarian, and, one of the Silicon Valley candidates, essentially, contends that modern medicine does not force any patient to take any drug nor to be hooked up to any device. Therefore, he says, patients should be aware there’s risk involved with both and live with that — meaning he sees FDA looking quickly at Big Pharma submitted safety data, then allowing drugs to enter the market without testing or proving they work or that they meet rigorous safety standards.
Balaji Srinivasan, an engineer and founder of an electronic money (bitcoin) company and a firm that developed a DNA screening test, sees the FDA as a roadblock to the advancement of medicine. He not only wants much faster drug and medical device approvals from regulators, he has advocated futuristic views in which software and technology allow developers and manufactures to bypass government oversight. Srinivasan, also now in tech venture capital investing, and O’Neill both are proponents of the creation of sea-based tech communities, which, because they are off shore, would not be subject to laws or oversight by existing nations.
These two candidates have been promoted to the incoming administration by Peter Thiel, arguably the most prominent and among the few Silicon Valley venture capital investors to endorse Trump.
Thiel (shown above), a billionaire who helped found PayPal and was an early backer of Facebook, emerged as the silent $10 million backer of a lawsuit by onetime pro wrestler Hulk Hogan against the gossip site Gawker, a subsidiary of which also had posted a piece headlined, “Peter Thiel is totally gay, people.” Thiel may have become a historic figure as the first man to say onstage in his address to the Republican presidential convention that he is gay. He has been advising Trump on science and technology.
Scott Gottlieb, a former FDA deputy commissioner, a physician, a fellow at the American Enterprise Institute, and a venture capitalist himself, too, also is in the running for FDA chief.
Disease-fighting CDC copes with anxiety, uncertainty
Meantime, at the federal Centers for Disease Control and Prevention, anxiety is running high among staff with Tom Frieden, a physician and a 2009 appointment of President Obama, having departed his post and leaving the agency to be run by one of his chief deputies.
The CDC has dealt with and will continue to confront a huge number of health issues and crises, including the war on Zika, and figuring how to cope with much less preventive health care funding due to a slash in the budget that was a compromise in the 21st Century Cures Act. It’s unclear who Frieden’s successor will be, and whether the administration will find someone with international standing, capacity to manage a big organization that often operates in crises, and other top-level skills. It’s also unclear how the president will view CDC work on issues like fighting tobacco, alcohol, and substance abuse, as well as sexually communicable diseases.
Are woes at NIH deeper, and cause for a new leader?
Over at the NIH, Collins, a physician and pioneering gene researcher, will continue as director. But the Wall Street Journal has published a detailed examination of the institution and its woes, indicating that the president may want to change leadership and opt for another candidate, such as Andy Harris, a Maryland Republican congressman, a doctor, and someone who has talked to Trump about wanting the post.
I’ve written how hygiene and safety concerns that started in some NIH pharmacies blew up, leading officials to halt some big research efforts, to sweep out top administrators, and to reexamine whether the institution had gone too far in downplaying patient care and safety. Collins asked top health care leaders to serve on a blue-ribbon panel to evaluate what further steps NIH might need to undertake to protect its hard-earned, oft-deserved reputation as one of the nation’s elite medical research and clinical care facilities.
Yes, the Ag Sec matters, a lot, in U.S. health
The Kaiser Health News, a nonpartisan news service focused on health policy, deserves credit for pointing out that Sonny Perdue, a former Georgia governor and the president’s nominee to head the federal Agriculture Department, will exercise huge sway over Americans’ health.
The Ag agency, Kaiser notes, carries out federal programs affecting: nutrition assistance, especially the so-called food stamp program that Republicans long have assailed; rural medicine, an area that critics have said would be especially hard hit by a repeal and replacement of Obamacare; health education, especially national dietary standards, which I’ve written about; and, of course, with the CDC and other agencies, food hygiene and safety, especially in prevention of food-borne illnesses that fell millions annually.
Perdue is a veterinarian, a longtime Georgia politician, and a staunch Republican of a more traditional sort — he’s tied to Big Business, especially Big Agriculture. He’s played the role of ethics reformer in his state’s politics, and has steered an administration through a controversy over incorporating the Confederate stars and bars into a revised Georgia flag.
