Trump’s Anti-Regulator

In the latest edition of “Dude, really?” news to come from the post-election US…

Wait: let me start that again.  In the latest edition-that-I’ve-had-time-to-digest-because-I-really-can’t-keep-up-with-this-stuff edition of “Dude, really?” news to come from the post-election US, it would appear that a strong candidate to head the Food and Drug Administration under Donald Trump is one Jim O’Neill.  According to the Scientific American,

O’Neill would be an unusual choice. He is not a physician, and lacks the strong science background that nearly all former commissioners have had in recent years.

A graduate of Yale University, with a master’s degree from the University of Chicago, O’Neill went to work at the Department of Health and Human Services in 2002, after a stint as speechwriter at the Department of Education. He worked his way up to principal associate deputy secretary, where he advised the HHS Secretary on all areas of policy, according to his LinkedIn page.

Now, so far, that is probably not too big a deal.  Since the head of the FDA is not actually involved in doing any bench science, the fact that he lacks a strong science or medical background needn’t matter too much.  What does matter is that the person in charge of the agency should be able to to consult the right kind of person and so on: in other words, to be broadly scientifically literate, and to have access to specialists.  That sets a much lower bar.  Medical or pharmacological expertise, after all, is much more likely to mean expertise in one comparatively narrow area within each subject than it is to mean a thoroughgoing expertise in the whole field; therefore even someone with a strong science background would have to rely on advice from others when it comes to things outside the postholder’s particular area of study.  Indeed, by the time you’ve worked up the administrative experience to lead an agency, it’s probably a while since you cleaned your last test-tube – so even your notional expertise may not be quite as cutting edge as you’d like to think.  And, working the other way, being a whizz-bang scientist is perfectly compatible with being terrible at what is essentially a senior civil-service gig.

So… not a medic, not a scientist?  Not necessarily a problem.  You just have to know which people to ask what questions – and that’s what you’d be doing anyway.*

But, of course, there’s a “but”.  Actually, there’s several “but”s.

Like, for example, it’s one thing not to have a strong scientific background; but it’s quite another to reveal that

one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics.

They… they what?  They like science, and they’ve got a generally pro-attitude to curing disease?  And this comes as a surprise?  Oh, crikey.

O’Neill, the piece tells us,

has also said that organ donors should be allowed to be paid. “There are plenty of healthy spare kidneys walking around, unused,” he said in a speech at a 2009 Seasteading conference.

Meh.  The arguments for organ sales are nothing particularly new, and while I think that there are serious objections to the idea – possibly insurmountable ones – I’m also willing to accept that there is a shortage of organs for transplant, that it would be better if there were more, and that even morally iffy answers to a problem might be worth considering if the shortage is sufficiently serious: all kinds of things that we’d think morally dodgy might become permissible in the right (wrong) circumstances.  So while this proposal from O’Neill may be fairly headline-grabbing, it’s probably nothing astonishing.  Indeed, it’s fairly bog-standard seminar room stuff.  Some people’ll buy the idea; others won’t.  It’s not, by its very nature, lunatic.

But here’s the really startling thing.  He

has called for eliminating the agency’s mandate to determine whether new medicines are effective before approving them for sale.

“Let people start using them, at their own risk,” the candidate** said in a 2014 speech to a biotech group.

Eeeep.

In 2014, in a talk to a group gathered to discuss regenerative medicine, he recalled his days at HHS and expressed disdain for the FDA’s process.

“As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don’t deny that[.]”

The problem, O’Neill told the group, is the overall structure and incentives of the regulatory system.

“Every time the FDA commissioner approves something and someone gets sick who used it, the commissioner is summoned to a congressional committee that also controls his budget and forced to testify under oath, why he made this rash decision…It’s a miserable process,” O’Neill said.

O’Neill has proposed that the FDA only require companies to prove drugs are safe before they are sold – not that they actually work.

Now, I know I’ve been a bit rude about libertarians in the past; and just like I’m willing to hear out the arguments for organ sales, I’m willing to accept the idea that there’s overregulation of drugs as being one that might be true.  I don’t know whether there actually is overregulation, but there might be.  Now, the way that O’Neill is presented here could be seen as saying that it’s not the rash decision that’s the problem, but the fact that the person who made it is held accountable.  That probably isn’t what anyone means to say, though.  A more charitable, and more defensible, reading would be that regulators – and the legislatures to which they’re accountable – should be a bit more lenient when it comes to risky-but-plausible decisionmaking.  Fine.  That’s a debate that’s worth having, and a debate that may never end, because so much depends on how willing the public is to tolerate risk; that willingness will ebb and flow over time.  Exactly how one separates regulation from overregulation is therefore going to be a matter of ongoing dispute.

However, it doesn’t follow from that that the best thing to do would be to let people use drugs wholly at their own risk.

Indeed, that would probably be the singularly worst response.  The fact that something can be shown to be safe is not enough.  In a publicly-funded health system, it’s not enough because a person pursuing a safe-but-ineffective treatment may thereby have foregone something that does work.  By the time they choose the next treatment on the list, it may be too late.  (Here’s a hyperbolic example: suppose someone started touting wheatgrass pills as a cancer treatment.  It’s not going to do any harm; but by the time you realise it’s not doing any good, your tumour may be much less amenable to treatment.)  In a privately-funded system such as exists in the US, things’re even worse, because the profit motive is so much more important from the supply side, and whether or not you can pay for a medicine is so much more important from the demand side.  Add to the mix that the iller you are, the more likely you are to clutch at whatever straws may be offered, and you’ve got a recipe for the vulnerable pissing their money away while the FDA congratulates itself for having done a good job in supplying the diuretics.

If this is O’Neill’s considered position, and if he gets the job, and if his considered position determines how he does the job – an important series of ifs, I admit; but if all that comes to pass, I can’t see it ending prettily.

 

* Disclaimer: I mean, here’s me, who’s had the right for 8 years to chunter away at will on a British Medical Association website, notwithstanding that my scientific knowledge extends to almost two GCSEs – almost one of which was in a “wet” science – at almost grade A.  I’m really not going to complain about others being out of their depth, am I?

** Candidate, or potential candidate?  I’m not sure.