Watching the Watchmen: Who Will Replace Gottlieb at the FDA

While the FDA has been laser-focused on the vaping industry, it’s valuable to keep an eye on them too. With Scott Gottlieb’s recent departure, the FDA has been left with a vacancy in its highest office. While Ned Sharpless has temporarily filled in as acting commissioner, the question remains: Who will replace Gottlieb in a permanent capacity?

 

Upon his resignation, Mr. Gottlieb himself refused to comment specifically, giving only generic answers about “some good names in the mix”. That having been said, industry insiders and journalists have certainly begun to speculate. With the vape industry facing increasing national challenges, it’s important to know who these people are. Depending upon their bona fides, connections, and history, there may be some contenders worthy of support and others worthy of protest. Let’s take a look at the names most people think are being tossed around. At the end of each summary, we’ll give you a rating out of 10. The higher the number, the more likely we think this person is to make vaping a capital offense and declare nicotine a Schedule 1 Drug. The lower the number, the more likely they are to just leave our industry alone.

 

Top Contenders

Amy Abernethy

Amy Abernethy is currently the principal deputy commissioner. Her work history includes work as the chief medical officer at Flatiron Health and she only recently took on the role of principal deputy commissioner earlier this year. Her role at the FDA thus far has largely consisted of technological systems analysis. By all accounts, she has been instrumental in helping the department analyze the increasingly massive volume of data they receive from electronic medical records. She also headed up an effort which ended up showing the inefficiencies of oxygen tanks in helping patients overcome shortness of breath.

 

Abernethy is a Duke alumni, as well, where she was mentored by former FDA Commissioner Robert Califf. So, it seems, Abernethy has been in training for this position for at least the majority of her life. According to industry experts, she is also a little short of experience when it comes to the various areas over which the FDA has dominion. This is a potential strike against her, but not the issue that’s most damning for our purposes. In fact, an inexperienced FDA Commissioner would probably be favorable as opposed to one who has spent decades fermenting in the toxic environment of U.S. Government.

 

The more important strike against Abernethy is her time at Flatiron Health. If the company’s name sounds ominous yet unfamiliar, that’s because it is both of those things. Flatiron is a subset of Roche, which is – you guessed it – Big Pharma. Roche primarily operates in the oncology area of medicine, with roughly 60% of its money tied up in development and patents in that field, which makes it a particularly offensive aggressor as far as Big Pharma companies go. It owns the patents to Rituxan, Herceptin, and Avastin, which are all used to combat cancer.

 

If you’re looking for any particularly heinous stories about Roche’s business dealings, it’s not particularly easy to find. In fact, there’s no clear evidence of any moral or legal wrongdoing on either the company or Abernethy’s part. There is, however, the simple fact, that Abernethy has extremely clear and recent ties to Big Pharma. If you’ll remember, Big Pharma is not an ally in the fight for national vaping reform.

 

Moreover, Roche is a company that specifically makes its money off of cancer. If you think they would support a rise in the most effective smoking cessation tool available, you’d be wrong. Roche, as a representative of Big Pharma, is certainly not above smothering the vape industry in order to promote cancer and boost its own profits. At the same time, Abernethy cannot be separated from Roche, in terms of where her interests and motivations lie.

Danger to Vaping: 8/10

 

Ned Sharpless

Sharpless is the current acting commissioner of the FDA, so you’ve probably heard of him by now. He’s the one currently carrying out the agenda laid forth by Gottlieb himself, and, as such, many people’s favorite for the permanent position. Unlike Gottlieb (who was purely an industry shill), Sharpless actually does have a history of doing actual work. He was once the head of UNC’s Lineberger Comprehensive Cancer Center, where he performed work as both a physician and a scientist, conducting research while also attending to patients.

 

Like the rest of the candidates on this list, Sharpless is a technocrat with an interest in biology and science. That is, he really likes the idea of solving just about everything with data and technological advances. In 2017, he created biotech for cancer drugs (raising over $100 million dollars) and later blood tests. There’s nothing particularly problematic about this history, other than the general stupidity of technocracy in general.

 

However, as the current acting commissioner, we know a fair bit about his stance on vaping. Just a few days ago, Sharpless tweeted: “ We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to… kids.” Earlier in the day he even went so far as to call out e-juice brands by name, so it’s clear that he intends to carry forth Scott Gottlieb’s agenda during his time as acting commissioner. If elected, he’ll likely take things even further.

Danger to Vaping: 9/10

 

Brett Giroir

Giroir is the current assistant secretary for health at the U.S. Department of Health and Human Services (HHS). As you read through these candidates, you’re likely starting to get a fairly consistent image of the kind of person the FDA likes to put in charge. Government experience? Check. Bunch of academic bona fides? Check. Ties to powerful industries? Check.

 

Giroir, at least, is another one of these people who actually did some work before setting themselves up to head departments for the rest of their lives. He graduated from Harvard with a degree in biology as the first college grad in his family, before going on to receive an M.D. from University of Texas. He began as a pediatrician and then a professor before selling his soul to become the CEO of a biotech startup. Most damning, however, Giroir is the architect of many of Trump’s opioid policies, responsible for saving absolutely zero lives and mismanaging the hell out of an actual epidemic in this country.

 

Giroir is also a big war guy, serving for a ton of different groups and initiatives with “Defense” in the title. The Defense Sciences Study Group, Chemical and Biological Defense Panel, and Defense Advanced Research Projects Agency – to name a few. Basically, he was the guy in charge of developing chemical weapons and defenses against them, although that likely isn’t in the official reports issued by those groups.

 

Finally, the other big news item surrounding Giroir was his appointment to the HHS. Obviously, he’s a Trump appointee, which comes with its own baggage, but the specifics swirling around his installment were a bit concerning. His confirmation was conducted swiftly and via voice vote, where the names and quantities of Senators voting is not recorded. At the time, in early 2018, Democrats vocally expressed concern that Giroir would not stand up to Trump’s misogynistic policies, specifically regarding Plan B medication and Title X grants.

 

At the end of the day, Giroir seems like a standard Texas red state guy. He probably has some heinous, personal opinions, and may well enact some policies which are terrible. On the topic of vaping, however, the threat doesn’t really seem to be there. He lacks the explicit ties to Big Pharma we see with other candidates, and no statements were found at the time of this publication to clarify his specific stance on e-cigarettes.

Danger to Vaping: 3/10

 

The Long Shots

Janet Woodcock

Woodcock is the current leader of the FDA’s Center for Drug Evaluation and Research. This is quite a powerful position in the agency, and she’s also extremely veteran, having worked in the FDA for 33 years. As a career FDA woman, one could easily surmise that she’s gunning for that top Commissioner spot. On the other hand, commissioners are historically not chosen from the pool of career FDA people. On the other, other hand, the Trump administration is hardly known for following historical precedent – and the FDA Commissioner is a politically-appointed position.

 

During her time with the FDA, Woodcock has primarily been enmeshed with the FDA’s drug review operations. During the past couple of years, she has developed organizations and enhancements for these policies, making a name for herself primarily as a regulator. She also has a history as a chemist and holds a medical degree as well.

 

While Janet Woodcock holds a slightly lesser position than the other people on this list of candidates, her veterancy makes her a viable and threatening contender. While many people with their fingers on the pulse of the FDA surmise that she may simply retire after finishing her current projects, you never can be too sure. She is also one of the FDA’s most skilled testifiers when it comes to taking a trip up to Capitol Hill.

 

Lately, she’s also been specifically involved with the very process that Gottlieb sought to force vaping companies into: namely, the applications for FDA approval. While her history shows her to be primarily a bureaucrat rather than a crusading firebrand, her fame as a regulator make her a slightly worrisome figure in this race. On the other hand, she has less connections to the biotech industry and Big Pharma and there’s even a chance that her lifelong dedication to a single bureau of the U.S. government could make her a faithful and objective ally of the truth within the agency.

Danger to Vaping: 5/10

 

Mark McClellan

McClellan is a name which may be familiar to those of you old enough to remember the W. Bush years. At the time, he was appointed by President Bush to the role of FDA commissioner, in addition to having run the Centers for Medicare and Medicaid Services. He was also Scott Gottlieb’s mentor at the FDA, and shares a great deal of similarities with the most recent former director.

 

While he has been largely staying out of the limelight while working at Duke, we know a great deal about McClellan’s tendencies and policies as an FDA commissioner since he’s done it before. At the time, people argued that McClellan was a great boon to the department, given his history of expertise in both science and economics. It’s hard to say whether that was truly a good thing, but it was definitely true that pharmaceutical executives loved the guy as it seemed to be his priority to help companies make as much money as they could.

 

During his time with the FDA, McClellan was perhaps best known for drawing a connection between pharmaceutical companies lining their pockets and the wellbeing of the general populace. While this connection has been made since then, his point was the exact opposite of what people usually point out. By McClellan’s estimation, the more money goes into Big Pharma’s pockets, the better off the people are. After all, capitalism ensures the best allocation of resources, therefore pharmaceutical companies are sure to use all their profits researching and developing better, cheaper medications which will enhance the general population’s quality of life!

 

None of this was true then, of course, and it certainly isn’t true now. So it’s clear that McClellan is something of an idiot, which befits a man appointed during the Bush years.  What’s left up for speculation, however, is how this particular idiot would handle something like vaping. There’s two important factors to consider: First, his coziness with Big Pharma and monied interests, in general. He loves to keep the CEOs happy and make sure there’s nothing interfering with their cash flow. Second, the way in which he curried favor with these companies was to slash regulations. In fact, he famously knifed elements of the approval process, saying that they’d beef up the part of their process which pulled dangerous drugs after the fact. “Get the drugs out there first and we’ll just pull ‘em if folks start dying” was basically the policy.

 

So McClellan hates regulation, but loves Big Pharma – and when it comes down to choosing, the money always wins. Smart money says McClellan would rather regulate vaping to appease his favorite CEOs than slash regulations and risk upsetting them. But you never know for sure.

Danger to Vaping: 6/10

 

Jerome Adams

Jerome Adams is the surgeon general right now. Like Gottlieb and Giroir, Adams is a Trump administration figure – and a major threat to the vaping industry. His connection to the Trump administration isn’t Adams’ only similarity to Gottlieb, the man also hates vaping.

 

That seems to wrap this section up, but let’s at least go through the due diligence of describing Adams’ history and work experience. Adams began as an anesthesiologist before rising to the rank of health commissioner in Indiana, working under everyone’s favorite politician: Mike Pence. From there, it doesn’t take a rocket scientist (or anesthesiologist) to see how he became the surgeon general.

 

Some people believe that Adams would be unlikely to take a role with the FDA due to the perks and visibility of his current role as the surgeon general. Those close to him also point out that the man loves to travel all over and set his own priorities. However, the surgeon general is largely a figurehead. Although the position carries a certain amount of clout and prestige, he lacks the regulatory capacity he would have if he were in charge of the FDA.

 

What else would happen if he were in charge of the FDA? God help us, this is the man who originated the myth of the teen vaping epidemic. In an official advisory issued on December 18, 2018, Adams said, “I am officially declaring e-cigarette use among youth an epidemic in the United States.” From that day forward, it’s been open season on the vaping industry, as mainstream media outlets, politicians, and pharmaceutical companies have taken turns battering and chipping away under the guise of a “youth vaping epidemic”.

 

Since then, the surgeon general has easily been the leader of false information dissemination. He encouraged parents to educate themselves and their children on “the dangers of vaping”, and regularly perpetuated unsubstantiated myths without every mentioning the obvious and well-documented health benefits of vaping in the general public.

 

If Jerome Adams becomes the FDA commissioner, it could very well mark the end of vaping as we know it. If you see this man’s name anywhere near the appointment to the FDA, it’s time to hit the streets. Let’s hope his current position speaking loudly from behind a podium is easy and appealing enough to keep him far away from the actual halls of power.

Danger to Vaping: 10/10

 

The Dark Horses

Jim O’Neill

One of the more interesting characters on this list, O’Neill is a lifelong libertarian whose position in any kind of power is typically marked by his zeal for deregulation. His qualification for the position of FDA commissioner is basically that he was the principal associate deputy secretary with the HHS. While he is an absolute scumbag for a number of reasons, he doesn’t seem to pose much of a threat to the vaping industry. By the same token, however, industry insiders are absolutely terrified of O’Neill’s libertarian tendencies.

 

O’Neill is famous for saying that as long as treatments seem “safe enough”, patients should be able to use them at their own risk. Basically, it is his belief that the FDA shouldn’t really force companies to jump through a whole lot of hoops before getting their drugs on the market. If they’re bad, they can always be pulled later. He’s also got a lot of ties to Trump, however, as he is connected to famed Trump advisor Peter Thiel. For this reason, O’Neill was on the short list in 2016 before the position ultimately went to Gottlieb.

 

In a lot of ways, Jim O’Neill has some similarities to McClellan, as his only real loyalty seems to be to deregulation, money, and power. As we’ve already mentioned, this makes him a moral atrocity and a real danger in a position of power within the FDA, but perhaps not a threat to vaping specifically. Also, unlike McClellan, Jim O’Neill doesn’t seem particularly cozy with Big Pharma, as he also completely lacks any medical training or scientific background.

 

O’Neill is a truly difficult person to root for in this scenario, but he genuinely seems so hellbent on deregulation that he may be the only candidate who seems like he might actually leave vaping alone. With a soul as black as night, it’s unlikely that pleas for “the children” and invocation of the “vaping epidemic” would sway him from his single-minded determination. On the other hand, thousands of people will probably die from unsafe medications. Fortunately for us, we’re only looking at these candidates from a single-issue point-of-view.

Danger to Vaping: 2/10

 

Joe Gulfo

Another candidate whose name was originally floated in 2016, Joe Gulfo is a diagnostics startup CEO with a penchant for reform. Back when he was considered for the now-vacant commissioner position, he proposed a four-tier system for drug approval, with differing levels according to a drug’s proven benefits. He’s another candidate with a great affection for Trump, although he has a history of criticizing the man, before retracting his tweets and claiming that they were made on accident.

 

He’s also an “ideas guy” who has publicly advocated for sweeping changes to be made within the FDA. He argued that over-regulation is costing American lives and believes that biomarker data alone should be sufficient for drug approval, rather than the FDA’s current policy of following only hard clinical endpoints.

 

To put it simply, Gulfo has a lot of ideas which fall in line with some of the other, more libertarian, candidates on this list. While he never goes so far as O’Neill, Gulfo’s basic premise seems to be that drugs get caught up in red tape far too often. The red tape should thus be removed, in order to allow drugs to get through.

 

Finally, Gulfo seems like he may be a good choice. While other deregulation candidates have some serious issues (the nihilism of O’Neill or the coziness with money that marks McClellan), Gulfo seems like he may potentially offer the same benefits without the disturbing side effects. However, since his consideration for the FDA was 2 years before the surgeon general issued his apocalyptic statement regarding e-cigarettes, it’s hard to determine where exactly he would fall on the issue of vaping – but his track record seems promising.

Danger to Vaping: 2/10

 

That about sums up the candidates we’ve got to look at. There’s obviously a ton of other well-qualified potential candidates out there, but these are the names which first come to mind. None of them are great. All of them are either too technocratic or too tied up with Big Pharma or too obsessed with their own personal crusades to be truly reliable, and, most importantly, not a single one of them have actually said anything to indicate that they would step up to defend the vape industry.

 

When all is said and done, it’s not particularly likely that any of these candidates will be the “savior” of vaping in America. As always in American politics, we’ve just got a field of mediocre options and we’re forced to hope for the lesser of multiple evils. To wrap it up, here are the power rankings, in order from worst to least bad:

 

  1. Jerome Adams – 10/10
  2. Ned Sharpless – 9/10
  3. Amy Abernethy – 8/10
  4. Mark McClellan – 6/10
  5. Janet Woodcock – 5/10
  6. Brett Giroir – 3/10
  7. Jim O’Neill – 2/10
  8. Joe Gulfo – 2/10