That is what Tyler Cowen gives Atul Gawande when he says,
In the 1950s, we had no real FDA, and you had the opportunity to put out, to innovate in all kinds of ways, and that innovation capability gave us modern cardiac surgery and gave us steroids and antibiotics, but it also gave us frontal lobotomies, and it gave us the Tuskegee experiment and a variety of other things.
I thought that this comment of Gawande’s was pure demagoguery, and it should have received pushback.
The primary reason we abhor frontal lobotomies and the Tuskegee experiment is lack of patient consent. Patient consent is not the focus of the FDA at all. You do not need an FDA to enforce the patient’s right to consent. In fact, you can argue that the FDA acts contrary to patient consent, because it tells people what drugs they cannot have even if they are fully aware of the evidence regarding the risks of the drugs and the data on the drugs’ effectiveness.
Also, contrary to popular myth, the FDA does not deny cancer patients experimental drugs; the problem is, the odds of such drugs working are close to nil
First, it is easy to go online and find regulations on patient consent and FDA testing. They have regulated this activity for several decades.
Second, we are by definition discussing new drugs. Subjects are consenting in the absence of information. The whole point is to use the trials to discover the risks.
Yes, we don’t need an FDA to enforce the patient’s right to consent. But what would emerge? Would the liabilities clear, and would the market work, or would it lock up due to uncertainty over liability exposure? Would the regulation just take place under another name?
No, it isn’t primarily consent. Consent was still garnered from the guardians in the case of lobotomies. Lack of knowledge would have prohibited realistic consent in Tuskeegee but the primacy of experiment over ethics was accepted, or who would have consented? Consent without knowledge or worse, false knowledge, isn’t consent at all, but we don’t a know what we don’t know. It is easy to delude ourselves and others with false confidence or false hope and compromise ethics, especially of the desperate.
When has he pushed back? I like Cowen’s conversations, find them entertaining and sometimes useful, and have even attended two of them. I would attend more if the timing were more convenient – it’s a real shame so many DC events occur during normal work hours. But the atmosphere is always far too chummy and even obsequious. Yes, I undertsand you’re not going to get many prestigious guests if you have a reputation for being an adversarial or hostile interviewer, (unless you’ve got the platform of a major cable news program I guess) but the flip side of that coin is just participating in the PR management of these public intellectuals, and providing “Hollywood Insider” content for their fan clubs.
In general this problem makes it very hard for me to listen to interviews, even Cowen’s, with all the obvious push-back questions popping in my head but without any satisfaction or closure. The Chetty one was particularly egregious in this respect, since there are plenty of obvious criticisms of his work that are both common sensical and devastating. It’s like watching a trial in which the defense is letting the prosecutor gets away with all kinds of mischief, having “Objection! Objection!” constantly pop up in one’s mind, but then watching the defense counsel just sit there, nodding along.
Overall we would benefit from more adversarialness in the scrutiny of the most prestigious public intellectuals, and their ability to consistently avoid that seems to be another point in favor of increasing ‘Complacency’.
Agreed. Tyler’s a pussycat in these talks. Charlie Rose presses incumbent Dems harder.
I’m not going to suggest it isn’t also in his self-interest to be cordial, but the alternative is being largely insular like EconTalk is to an extent.
(I suspect Cowen might say that he would expect his audience to see the “obvious objections.”)
I don’t think EconTalk is that insular. A lot of their topics aren’t strictly politically contentious, too. Like the CEO of that agriculture company he had on, it was pretty informative about the industry and wasn’t really partisan like a lot of macroeconomic issues.
I think David Beckworth’s podcast probably strikes a good balance; I wanted him to confront Jason Furman more, maybe just because I find more to object with him than the other guests but also because he seemed to talk as though his position was self-evident and didn’t need to be argued; but Beckworth did challenge him by mentioning research contradicting his stance on fiscal stimulus. Is this something Cowen would do? In any case, Beckworth gets, in my opinion, the best guests one could hope for in an economics podcast, and from a diverse schools of thought. He must be doing something right.
Tyler seems remarkably incurious in these talks. You don’t have to go into full cross examination mode to find out what the other person really thinks. You just have to be curious about how they got to where they are.
I think it’s much more about making sure we see him talking to important people than anything that gets said when he talks to them.
I would not dispute that. But it is interesting that our instinct is not to criticize his guests for the same thing.
This is incredibly concrete thinking, and just like what was seen at Cowen’s site. Dont just excerpt that particular sentence, look at the entire paragraph, and what Gawande makes clear is that it is the mindset which allows for a lot of the good stuff, also allowed for the bad.
Steve
The FDA regulates neither surgical procedures nor medical research protocols, so what is Gawande talking about?
The excerpt was an off the cuff metaphor on tradeoffs. Gawande discusses FDA approval more clearly later on. For example the HIV community becoming involved in the approval process indicating the willingness to take greater risks to speed approval. Also there has been acceleration of approval of drugs with tests on small numbers of people and monitoring afterwards to catch problems such as occurred with Vioxx. The problem is pressure to approve drugs but not conduct surveillance.
These are kind of no-brainers, so as with everything like this I’m not sure if I should be ecstatic or outraged.
Also, drugs should really never be thought of as “approved.”
Perhaps Paul said it best when he said: “Everything is permissible (allowable and lawful) for me; but not all things are helpful (good for me to do,)”
Vioxx is actually a good example of what can go wrong on both sides of the coin with one-size-fits-all FDA approval. On the one hand, it had more risk for severe side effects than they knew when they approved it.
On the other hand, some people claim it’s the best drug for them and nothing else has worked as well for them since. But they aren’t allowed to assume the risk and make their own decision.
We are really arguing over the extent to whether a market is efficient and rational, whether people have free will or are easily (mis)led, etc. I keep telling people that I promise I do a better job than my doctor in the same way I ore skilled at handguns than the average cop. They just keep repeating (not in so many self-aware words) “but we have to design markets for the idiots.”
I have thought he should’ve provided some resistance to many of the things I’ve heard on his series, but he has always made it quite clear that it is a dialogue he wants, not what the listeneres may want. I suppose that could be a disingenuous shield against getting into some contentious discussions, but I choose to take him at his word. I guess both could be true.
Is it really a valuable “dialogue” if one side isn’t allowed to probe the other side’s premises?
I think that is right. Reqiring a bit more justification from the guests would provide more value, at least for me.
Don’t know if this has been mentioned yet, but the Tuskegee Trials were sponsored by the government. So that would mean the quoted commentator is suggesting we need government regulation to protect us from government. Bit of a conundrum.
And who was getting labotamized? Gut suggests that it would have mostly been the severely mentality ill, who were likely under care of the state.