Brainstorm Health: FDA Commissioner Gottlieb to Resign, HIV Stem Cell Transplant, Vaccine Testimony

An earthquake rumbled across the health industry Tuesday as Department of Health and Human Services (HHS) Secretary Alex Azar confirmed reports that Food and Drug Administration (FDA) Commissioner Scott Gottlieb has handed in his resignation, effective one month from now.

Some viewed Gottlieb with skepticism when he was first tapped for the job, given his previous financial interests in a number of health care firms. But he quickly became one of the more-touted FDA administrators in recent history among drug makers, public health advocates, and the media alike. Gottlieb has been an unusually prolific social media user (by “FDA Commissioner” standards) and regularly issued lengthy press statements on the agency’s initiatives over the past two years. That was a notable change from former FDA chiefs, and for a highly technical, traditionally hush-hush agency.

Gottlieb’s pet projects at the FDA included expediting generic drug approvals in an effort to fight higher costs, creating new frameworks for getting digital health technologies and cellular and genetic therapies to market, and cracking down on the e-cigarette and tobacco industries.

“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarettes use, chronic disease, and more,” wrote Azar in a tweet.

Those moves prompted their own criticisms. The e-cigarette industry asked whether such a fiery opposition to vaping could undermine an effective tobacco cessation tool; skeptics of using digital health data collection to fuel clinical trials worried the approach could weaken scientific studies.

But Gottlieb’s proponents say he was willing to propose ambitious, practical new ideas in an era of political stasis. And some in the life sciences sector are now questioning whether the next FDA commissioner can match that same standard.

“This is stating the obvious, but who the FDA Commissioner is matters a lot. Especially these days with incredible new technologies like cell therapy, gene therapy, and others. Need to have a good partner at FDA to make sure they are developed efficiently and safely,” prominent biotech investor Brad Loncar tweeted. (Biotech index funds slumped about a half point to one percent following the reports of Gottlieb’s resignation.)

Initial reports suggest that Gottlieb was frustrated with the long commute between Connecticut, where his family lives, and Washington, DC, as well as the recent federal government shutdown that put a major crunch on FDA staff. His resignation letter implies that he’s satisfied with what he’s accomplished over the past two years, particularly on the public health and anti-tobacco front. But will his successor keep the ball rolling?

Read on for the day’s news.

DIGITAL HEALTH

Bone marrow transplant reportedly frees second patient of HIV. British doctors report that a second HIV patient has—for now—had the virus eradicated from his system. The first patient to successfully undergo the same procedure was Timothy Brown, the so-called "Berlin patient," who had the bone marrow (or stem cell) transplant done more than a decade ago. The study authors note this shouldn't be seen as a "cure"; the results, nonetheless, are "highly significant," according to the researchers. (NPR)

THE BIG PICTURE

Teen defies parents, faces down Congress to promote vaccines. Here's something I doubt most would have had the gumption to do as an adolescent—Ohio teenager Ethan Lindenberger testified before a Senate committee today to promote vaccines. Lindenberger defied his parents, who oppose vaccination, to get his own shots in order to promote public health. Here's what he had to say—a revealing look at how anti-vaccine messages take hold to begin with: "My mother would turn to anti-vaccine groups online and on social media looking for her evidence and defense, rather than health officials and through credible sources. Her love, affection, and care as a parent was used to push an agenda to create false distress, and these sources which spread misinformation should be the primary concern of the American people." (The Verge)

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