My Conversation with Atul Gawande

by on July 19, 2017 at 8:14 am in Current Affairs, Economics, Education, Medicine, Philosophy, Science, Uncategorized | Permalink

Here is the podcast and transcript (no video), Atul was in top form.  We covered the marginal value of health care, the progress of AI in medicine, whether we should fear genetic engineering, whether the checklist method applies to marriage (maybe so!), whether FDA regulation is too tough, whether surgical procedures should be more tightly regulated, Michael Crichton and Stevie Wonder, wearables, what makes him weep, Knausgaard and Ferrante, why surgeons leave sponges in patients, how he has been so successful, his own performance as a medical patient, and much more.

Here is one excerpt:

COWEN: A lot of critics have charged that to get a new drug through the FDA, it takes too many years and too much money, and that somehow the process should be liberalized. Do you agree or disagree?

GAWANDE: I generally disagree. It’s a trade-off in values at some basic level. 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.

The process that we have regulation around both the ethics of what we’re doing and that we have some safety process along the way is totally appropriate. I think a lot of lessons about when the HIV community became involved in the FDA process to drive approaches that smoothed and sped up the decision-making process, and also got the public enough involved to be able to say . . . That community said, “Look, there are places where we’re willing to take greater risks for the sake of speed.”

People are trying to treat the FDA process as a technical issue. When what it is, is it’s an issue about what are the risks we are genuinely willing to take, and what are the risks that we’re not?


COWEN: The idea of nudge.

GAWANDE: I think overrated.


GAWANDE: I think that there are important insights in nudge units and in that research capacity, but when you step back and say, “What are the biggest problems in clinical behavior and delivery of healthcare?” the nudges are focused on small solutions that have not demonstrated capacity for major scale.

The kind of nudge capability is something we’ve built into the stuff we’ve done, whether it’s checklists or coaching, but it’s been only one. We’ve had to add other tools. You could not get to massive reductions in deaths in surgery or childbirth or massive improvements in end-of-life outcomes based on just those behavioral science insights alone. We’ve had to move to organizational insights and to piece together multiple kinds of layers of understanding in order to drive high-volume change in healthcare delivery.

Definitely recommended, this was one of my favorite “episodes.”

1 Alain July 19, 2017 at 8:42 am

If FDA regulation were a choice between steroids, antibiotics and heart surgery vs. a few tragedies, one would have to be insane to not pick the innovations.

Hopefully it is more a choice between the innovations very, very slightly later and the tragedies, in which case one might rationally pick the regulation.

Likely, it is actually “considerably” later and the regulation is a net harm.

2 carlospln July 19, 2017 at 1:08 pm

That damned evil FDA!

3 Hazel Meade July 19, 2017 at 8:45 am

The Tuskeegee study has nothing to do with innovation or drug regulation, it is about informed consent. It would be completely fine to allow people to sell drugs that are not approved, with the informed consent of the people taking them. Indeed it’s a pretty bizarre example to toss out considering that the people in the study were explicitly NOT given any drugs. Medical professionals merely monitored them to see what would happen if left untreated. Besides the fact that the drugs available at the time weren’t great anyway, and hadn’t passed FDA approval. If anything the thrust of the conventional wisdom on the issue is in the exact opposite direction – it would have been better to allow them to take a bunch of unapproved experimental treatments then to let them live in ignorance with syphillis just to study them. Worse, it’s almost an exact analogy for the FDA’s current policy on genetic testing from companies like 23-and-me – better to let people live in ignorance of what their genetic risk factors have, because if they knew what they were they might get unnecessary medical treatment.

4 The Other Jim July 19, 2017 at 8:59 am

No kidding. “Let’s mention everything bad that happened in the 1950s and blame it on the lack of an FDA” is not convincing.

Yet sadly, this dope thinks it is, so someone must be buying it.

Probably the same crowd that thinks Trump is a Russian agent who is about to start WW3 with Russia.

5 JWatts July 19, 2017 at 10:03 am

“The Tuskeegee study … the drugs available at the time weren’t great anyway, and hadn’t passed FDA approval.”

Connecting the Tuskeegee experiment with the FDA process is just a rather stretched appeal to emotion. It’s a high class version of calling the other side Nazis.

6 Alan Goldhammer July 19, 2017 at 10:15 am

Hazel wrongly writes, “Besides the fact that the drugs available at the time weren’t great anyway, and hadn’t passed FDA approval. If anything the thrust of the conventional wisdom on the issue is in the exact opposite direction – it would have been better to allow them to take a bunch of unapproved experimental treatments then to let them live in ignorance with syphillis just to study them. ” Penicillin was approved and widely available in 1947. All those in the non-treat group could have been cured at that point in time!!!

7 Hazel Meade July 19, 2017 at 11:00 am

The study actually started in the 1930s, before penicilin was available. of course, you’re correct that once it became available they should have been told so they could seek treatment.

8 Hazel Meade July 19, 2017 at 11:09 am

Or, I should say, really, they should have been told, from the beginning, in 1932, so they coudl decide if they wanted to participate in the first place.

9 wiki July 19, 2017 at 10:21 am

Excellent point. Furthermore, it’s not clear to me that standard boards in the 1950s would have approved both Tuskegee and frontal lobotomies. The latter especially were sufficiently common that it suggests that elite experts would have approved. It’s likely that tomorrow’s view of many problematic things today would go against current elite wisdom.

10 wiki July 19, 2017 at 10:22 am

I meant “would not have approved”

11 DBN July 19, 2017 at 10:21 am

When the Tuskegee experiment began, effective treatments for syphilis did not exist. The problem is that the study continued for almost thirty years after an effective treatment for syphilis – penicillin – had been developed.

12 Hazel Meade July 19, 2017 at 11:05 am

Right, the point is that saying Tuskeegee is an example of deregulation and innovation gone mad is just wierd and off the mark. We would obviously still require informed consent in all medical studies. The one has nothing to do with the other.

13 CL July 19, 2017 at 12:10 pm

It’s clear now what Gawande meant: We need the FDA so that there is no Penicillin so that there is no problem with the Tuskegee experiment. This man is a genius…

14 Hazel Meade July 19, 2017 at 12:29 pm

Well, as I noted, the fda’s stance on genetic testing is strikingly similar to the paternalistic attitudes of doctors in the Tuskegee study. Let’s not tell people they have syphilis/brac4 risk factors. They’ll just freak out and get a bunch of expensive ineffective treatments.

15 CL July 19, 2017 at 2:38 pm

Not to mention that the historic treatment of syphilis before penicillin was bloodletting, arsenic, and mercury, which isn’t always better than just doing nothing. I might have taken some arsenic but mercury and bloodletting? No, thanks.

16 Hazel Meade July 19, 2017 at 3:22 pm

My point is, if they had been told they had syphillis, they could have taken their chances with the arsenic and bloodletting or whatever. Or not. Informed consent gives people choices.

17 DBN July 19, 2017 at 4:09 pm

When the Tuskegee experiment was established, it was perfectly ethical, just as it would be perfectly ethical today to perform a longitudinal observational study on a disease with no effective treatment. That the experiment continued after the development of penicillin is not so much an example of deregulation (what was deregulated?) or innovation gone mad (what was being innovated?) as it was simply neglect. A decades-old, not very well monitored study simply continued on its own inertia because no one in a position of authority had been paying any real attention to it for years.

18 mulp July 19, 2017 at 12:55 pm

“The Tuskeegee study has nothing to do with innovation or drug regulation, it is about informed consent.”

So, a drug company seeking profits offers a drug to cure disease X without evidence the drug works or does not cause harm worse that the disease because doing the double blind testing is too costly, ie no profits made on drugs in testing, time lost making profit while finding out that the drug harms patients, no profits once the drug is found useless, …., constitutes informed consent?

The FDA quickly approves using unproven drugs with limited testing as long as those getting the drugs get informed consent, with no one told the treatment is effective, which means insurers do not pay for the treatment with no known benefit. Hope is not evidence.

So, the only obstacle to using untested drugs is making sure patients and everyone involved know the patient is fully informed and consenting to be a lab rat. Without that, it’s just like Tuskeegee.

19 Hazel Meade July 19, 2017 at 1:36 pm

It’s not “just like” Tuskeegee, because Tuskeegee involved not even telling people they had the illness, so as to prevent them from seeking treatment for it, which would muck up the study. There were no experimental treatments involved, and nobody was seeking approval for any.
You could call that “basic research”, but it’s hard to call it “drug innovation”.

20 CL July 19, 2017 at 2:31 pm

“So, the only obstacle to using untested drugs is making sure patients and everyone involved know the patient is fully informed and consenting to be a lab rat.”

Exactly. It should be all about consent. What’s your argument against that? I don’t see it. It’s hard to argue against that. I listen to it when you come up with something.

21 celestus July 19, 2017 at 8:52 am

Interesting that high blood pressure is brought up as one of the biggest problems in the country- the US has right about the lowest rate of elevated blood pressure in the world.

22 mulp July 19, 2017 at 1:30 pm

Treatment of blood pressure as a symptom has been done in the US increasingly for 70 years for patients able to afford seeing a doctor regularly and also pay for the drugs. This has provided a huge database to prove that treating the symptoms extends life and increases quality of life in reduced disability and mortality.

But certain populations do not have the means to see a doctor regularly and pay for the drugs. Enough time has provided data to prove the lack of treatment leads to premature mortality and disability in populations which become dependent on the welfare system. A working poor adult barely supporting his kids dying puts his kids increasingly if not totally on welfare.

And your chart reflects that with almost 20% of adult men in the US getting no treatment for the BP that requires it by standard of care.

My dad started being treated in the 50s. I started in the 70s in my mid 20s. Then the metric was 140/90. I have seen this change:

“A blood pressure of 140/90 mmHg or more is too high. People with levels from 120/80 mmHg to 139/89 mmHg have a condition called prehypertension”

Cdc estimates only half those with high BP are being treated sufficiently to control BP.

23 A clockwork orange July 20, 2017 at 11:20 am

California and montegomery, at montaingue, I’m coming for you Art Deco.

24 CL July 19, 2017 at 8:55 am

The answer by Gawande is so telling: Frontal lobotomies and the Tuskegee experiment have not much to do with the core and original task of the FDA. And his comparison to steroids and antibiotics (which saved billions of people until this very day) is just so laughable. Yes it’s just a “technical issue”, the issue about the risks we are willing to take indeed, and this guy would walk over billions of bodies without even blinking.

25 DBN July 19, 2017 at 10:16 am

They have nothing to do with the CURRENT mission of the FDA. The modern FDA does not oversee longitudinal disease studies or medical procedure development. They oversee drug and medical device approval. Neither example Dr. Gawande gives is relevant to the FDA’s mission, or would have been prevented by the modern FDA.

26 mulp July 19, 2017 at 1:56 pm

Ethics in testing and research has nothing to do with why the FDA exists?

Without the FDA, you believe doctors would spend a lot of time providing all the information on drugs being prescribed so the patient could sign the standard documents every patient or guardian signs before surgery?

The FDA provides efficiency is standardizing the informed consent to for every drug, with pharmacists treated to interpret and explain them for individual drugs as well as interpret interaction data.

And the FDA does study long term data which drug makers are required to supply, except often do not, so the FDA reacts to reports, eh

“MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

“If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.

“However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.

“You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.”

27 CL July 19, 2017 at 2:46 pm

You write so much (more like copy and paste so much) but you have nothing to say.

28 DBN July 19, 2017 at 4:12 pm

That’s for drug research. Neither example Dr. Gawande gave involved drug research. The FDA does not involve itself in research outside of the context of drugs or medical devices.

29 Ted Craig July 19, 2017 at 9:08 am

“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.”
The FDA has existed since 1906, evolving over time. The names was changed to Food and Drug Administration in 1930 and was moved to the forerunner of HHS in 1953. It was overhauled and expanded in 1955. I don’t know what he means by “no real FDA.”
The Tuskegee experiment took place from 1932 to 1972. I learned that on Wikipedia, not on Tyler’s broken link to the often-obnoxioius Medium. It was a government program and only stopped because of a whistleblower, not the FDA.
Frontal lobotomies reached their peak in the early 1950s and greatly declined in use after the introduction of chlorpromazine in the mid-’50s. Somebody like Alex might argue that a more active FDA would have delayed chlorpromazine and extended the use of lobotomies.

30 JWatts July 19, 2017 at 10:08 am

“not on Tyler’s broken link to the often-obnoxioius Medium.”

I registered on Medium to watch one of Tyler’s broadcast. Now they automatically email a daily digest. I am amazed at the quality of the topics. Quite often there just blog rants by people that have little to no knowledge of the topic they are ranting about.

I think the idea of Medium is good, but they need much better curation.

31 DBN July 19, 2017 at 10:13 am

Indeed. This interview doesn’t give the impression that Dr. Gawande understand what the FDA actually does. They don’t oversee all human research trials, and are not in a position to prevent a recurrence of the Tuskegee experiment. Nor do they oversee the development of medical procedures, like the frontal lobotomy. The two examples he gave have nothing to do with the FDA.

32 Alan Goldhammer July 19, 2017 at 10:17 am

The modern FDA has only existed since 1962 when the Kefauver amendments were passed to require proof of both safety and efficacy. I suspect that is the point Gawande is trying to make.

33 JWatts July 19, 2017 at 11:21 am

Maybe, but even if you grant him a charitable interpretation, claiming that the FDA is the primary agency stopping events such as the Tuskegee experiment and frontal lobotomies is a pretty tenuous proposition.

34 mulp July 19, 2017 at 2:07 pm

So, no drug makers outside the US or EU ever produce and sell drugs that would approach the ethics of Tuskeegee?

Nor would any doctors prescribe treatment like that represented by Tuskeegee?

“”The biggest disaster imposed on us was Duesberg with his statements that HIV did not cause AIDS,” says Max Essex, chairman of the Harvard School of Public Health AIDS Initiative. Essex has been conducting research on AIDS since 1983, including field research in Botswana and Southern Africa.

Between 2000 and 2005, as neighboring African countries were ramping up HIV prevention programs, South Africa stubbornly stuck to the notion that HIV was not the cause of AIDS. “I think Duesberg played the biggest role in giving [former South African President Thabo Mbeki] a convenient excuse to avoid supplying drugs,” says Essex.

Researchers including Essex examined the human toll of those lost years of treatment. Their results, published in 2008 in the Journal of Acquired Immune Deficiency Syndrome, estimated that 330,000 South African adults died because of lack of treatment, and 35,000 infants were born with HIV.

If that was the biggest disaster, no doubt the cruelest of the AIDS false cure claims was the virgin cleansing myth that took hold in sub-Saharan Africa, as well as parts of India and Thailand. Some men believed they could be cured of AIDS by having sex with a virgin. That reportedly led to the rape of younger and younger girls — even babies, by some accounts.

Other unproven AIDS “cures” have kept people from seeking life-saving treatments: herbal remedies, potions to rub into the skin, chemicals like Virodene (derived from an industrial solvent), oxygen therapy and electronic zappers.”

35 CL July 19, 2017 at 2:41 pm

Stop using so much e’s in Tuskegee, please.

36 sunbomb July 19, 2017 at 9:11 am

First time I was exposed to anything Gawande, even though I was familiar with his name. “Love does not follow a checklist” is a great sentence.

37 Thanatos Savehn July 19, 2017 at 10:21 am

The problem in McAllen, TX wasn’t too much capitalism it was too much fraud. The things he saw in medicine were going on in the law, in education, etc. when the State had had enough and began indicting lawyers and doctors and businessmen for kickbacks and bribery and extortion and pill peddling and etc. things got better across the board. Obamacare didn’t set McAllen back on the path of the righteous, the rule of law did.

38 JWatts July 19, 2017 at 11:24 am

“The problem in McAllen, TX wasn’t too much capitalism it was too much fraud. ”

There’s a tendency for people who don’t like capitalism much to classify fraud as an aspect of capitalism, even though fraud is a much broader issue than pure economic transactions.

39 Alan Goldhammer July 19, 2017 at 10:21 am

One key point that Gawande gets wrong is how drug safety is studied. He seems to think that pharma companies totally are out of the picture once the drugs are approved which is untrue. Companies maintain strong pharmacovigilance departments that study the ongoing post-approval safety of the drug and are required by regulation to file yearly reports on the drug and expedited reports (within 30 days) when a serious adverse reaction is found in the patient population being treated. One can argue that the available tools are still in need of refinement but there is research going on right now to improve data base searching and algorithms.

40 carlospln July 19, 2017 at 1:16 pm

“Companies maintain strong pharmacovigilance departments that study the ongoing post-approval safety of the drug and are required by regulation to file yearly reports on the drug and expedited reports (within 30 days) when a serious adverse reaction is found in the patient population being treated”

Yeah, that worked a treat for Vioxx [Merck].

41 mulp July 19, 2017 at 2:12 pm

They must do that work to comply with FDA law and regulations.

Drug companies that fail to report problems with drugs that the FDA discovers by way of direct reporting by patients and doctors can be very bad for the drug company, depending on who is making enforcement decisions at the FDA at the time.

42 Boonton July 19, 2017 at 10:29 am

Signal v Noise. How exactly do you tell if a drug works if you do not do a carefully controlled clinical trial?

Anecdotes miss the point. Sally Sue took X and she didn’t have a heart attack tells you nothing about X. Even if Sue took X and her cancer went into remission that still doesn’t tell you much about X.

This problem becomes even more critical when you consider some drugs are meant for long term management of complex diseases like diabetes or to lower the risk that a certain condition does not become a full blown disease.

Traditionally drug testing has been ad hoc. Someone tries something and reports whether or not it works. That is fine if the signal is very, very strong like with an antibiotic or a vaccine against rabies. If they almost always work you don’t need much of a clinical trial to prove that. But then that works in today’s environment. If some clinical trial starts and they start seeing 99% of the people getting the drug are cured it is common to stop the trial early and switch the control population over to the new drug. In that happy case drug approval is greatly accelerated. The challenge is not an earth shattering magically fantastic drug but a drug that modestly improves upon the existing drugs on the market. The first will sail to approval quickly and the company with that drug will be happy to do the studies to prove it. The second is not so obvious a win without a really controlled study.

I’ve not heard what type of ‘reform’ would help in those cases.

43 Michael Tinkler July 19, 2017 at 10:49 am

The Tuskegee Experiment started in 1932.
Moniz got the frickin’ Nobel Prize in Medicine in 1949 for the frontal lobotomy, which shows what medical science thought about lobotomies.

What does the FDA in the 1950s have to do with either of them?

44 Boonton July 19, 2017 at 10:58 am

OK perhaps Thalidomide would have been a better example. Absent an FDA how would the marketing of the drug in the US have proceeded?

45 tibro2017 July 19, 2017 at 11:16 am

When you realize how much power Dr. Gawande–a politically connected surgeon/researcher at an elite medical school in an major northeastern city–stands to gain from any sort of increased regulation, it is easy to see why he is all for more central planning and more rules. Telling all those stupid hick doctors in the flyover states how to do their jobs would probably be a lot of fun!

46 Hazel Meade July 19, 2017 at 1:24 pm

Right, a lot of people make their money off of pharmaceuticals.
FDA regulation keeps competing products off the market.

47 mulp July 19, 2017 at 2:33 pm

What competing vaccines for malaria, dengue, HIV, triple-E, Lyme, etc exist that the FDA is keeping off the market to protect the sellers of the generally poor performing drug treatments for the diseases caused by those pathogens?

Which drug providing quick cure of Lyme disease is kept off the market by the FDA?

Nature and science do not respond to your free lunch economic theories.

Eliminating the requirement to do any work will not result in the invisible supply of cures materializing to meet demand once the FDA no longer requires workers prove they have an effective drug treatment or effective medical device by producing data.

48 Hazel Meade July 19, 2017 at 3:26 pm

Well, yes actually it will. Upfront capital costs directly impede the funding of new business ventures. There’s no way a small businessman can bootstrap himself into getting a drug to market. He needs millions of dollars of upfront capital investment from venture capital companies to get started, and those people have to be willing to sit on their ass for 10 years to wait to see any ROI.
It should be obvious that that is GOING to reduce the rate of research and development of new medical products. Eliminating those capital costs, yes, it WILL increase the the supply of cures.

49 Boonton July 19, 2017 at 3:53 pm

Errr what ‘upfront capital costs’ are you thinking of? Building labs, developing ways to screen thousands of compounds looking for ones that trigger the biological response you want? Figuring out if the ‘hits’ you get can be put into a form that can be ingested or injected or snorted or absorbed into a human body? Figuring out will if the human formulation can actually be manufactured? Figuring out if the human formulation actually works on the disease you are targeting?

That does indeed require large upfront capital costs but I’m not seeing how that’s the FDA’s fault. That seems to be part of the nature of trying to invent a new drug. In reality there are smallish businesses in this space, however. You can, for example, concentrate just on coming up with possible compounds that might work. You can then sell the rights to the promising ones you find to larger pharma companies so your company itself can concentrate on just one part of the line and still get paid. Your drugs may not come to market for a decade or ever for that matter but you could still have a positive flow of sales nonetheless.

Granted this is probably not the sort of thing you’re going to be able to do with $1,000 in a savings account and getting Grandma/grandpa giving you another $10K to help you get started but you don’t need a billion either.

50 Hazel Meade July 19, 2017 at 5:50 pm

You could still have a “positive flow of sales”, but venture capitalists look for the highest return, they don’t just look for anything that’s profitable. The longer you have to go before achieving profitability the fewer venture capitalists will invest in your company. It’s more or less a linear relationship. Longer drug approval times = less investment in new drugs.

51 Boonton July 20, 2017 at 5:40 am

Evidence? Has R&D spend on new drug discovery fallen or increased over the last two decades? Have times to approval increased or decreased?

It all depends upon the drug. A true miracle drug that is very effective in treating a disease and has few side effects will sail through approval very quickly because the clinical trials will be a slam dunk. Often, though, there’s no way to know how effective your drug is until you get to trials. What seemed like a sure fire thing in the lab and animal studies turns out to be of only modest benefit in humans.

52 Hazel Meade July 20, 2017 at 10:41 am

I love it when people on the left repeatedly announce their belief that marginal effects don’t exist.
When you increase the price of something … people just keep spending the same amount on it! Just like the minimum wage!

53 albatross July 21, 2017 at 1:29 am

You don’t have to assume anything nasty about Gawande–he is the sort of person who is likely to have his voice heard when regulations are considered, which naturally makes regulations seem less threatening and more reassuring to him. Some guy in Ottomwa, IA who gets the regs imposed on him and suddenly can’t get an antibiotic for his sinus infection or something will just as naturally find the prospect less appealing.

54 Scoop July 19, 2017 at 11:20 am

I’d be very curious to see how Guwande would respond to these counter arguments, and the fact that Tyler did not press him — although they’re all pretty obvious counter arguments – is why I don’t find Tyler’s conversations very valuable.

Guwande is a very bright guy. He might have convincing arguments. But there’s no way to know, unless the moderator discredits his superficial answer and forces him to give real answers. Tyler never calls interlocutors on sloppy thinking so he gets a lot of it.

55 Scoop July 19, 2017 at 11:21 am

Sorry, Gawande

56 Todd K July 19, 2017 at 11:32 am

Tyler should have Russ Roberts on the line to pipe in when push back against a guest is called for.

57 Gordon Mohr July 19, 2017 at 5:02 pm

Or even just Alex!

58 JWatts July 19, 2017 at 1:34 pm

“Tyler never calls interlocutors on sloppy thinking ”

Agreed, it’s hard to tell if the thinking on this is superficial or if the interviewee has a deep point.

59 CL July 19, 2017 at 2:45 pm

TC should have pressed him much more. I’m always open for new convincing arguments but unfortunately TC did not press in this direction at all.

60 mulp July 19, 2017 at 2:55 pm

What exactly do you challenge him on with specific data?

Ie, what counter data do you use in making medical decisions for yourself and your family?

Ie, do you make sure everyone in your family never takes any drugs or takes action to lower BP below 120/80? And do you work to get your resting BP above 140/90?

If you or a family member was diagnosed as infected with HIV, would you follow the anti-colonial African treatment recommendations to cure the disease white people infected Africans with: sex with virgins, etc? After all, those African treatments for HIV/AIDS would never be approved by the FDA so that means they are cheap and effective, right?

61 albatross July 21, 2017 at 1:25 am

I think Guwande was thinking of the difference in culture of medicine between early in the last century and now, not just the FDA. He was saying that the less regulated, less rigid world of that time allowed for great innovation (open heart surgery) but also great disasters (frontal lobotomies, Tuskeegee experiment). How high the bar is to get a drug or device into patients is part of that culture, and that’s less a question of technology than a question of values.

I would have enjoyed a bit more discussion of this idea. You can imagine a tradeoff curve between risk to patients of unproven treatments and medical advances. The societal/values decision is about where on that curve we want to be–slide to the right and we accept more risk for more innovation, or slide to the left and we accept less risk and less innovation.

The technology and economics questions arise when you ask how close the tradeoffs we are making are to the best possible tradeoff curve for our level of understanding. If there are changes to how the FDA operates or how drug development gets paid for that would give us a better tradoff (faster innovation at the same risk level, say), we would like to know how to do that.

There’s also a time discounting sort of argument here–accepting more risk for patients today probably makes life better for patients fifty years. OTOH, I have a doctors appointment tomorrow but will probably be dead in fifty years, which way do I want the tradeoff made?

62 Daniel Weber July 19, 2017 at 11:49 am

COWEN: Michael Crichton: doctor, Harvard, writer. What do you think?

GAWANDE: Where is he now?


63 Anon July 20, 2017 at 2:56 am

All he was implying was is he generally overrated now , or underrated?

64 rayward July 19, 2017 at 11:53 am

We won’t know for many years the extent of the damage being done as the result of parents having lost faith in the safety of vaccinations. If people lose faith in the safety of drugs as the result of loose oversight, the consequences could be catastrophic. Blind faith in markets to provide essential oversight and safety is cultish and equivalent to witchcraft and reliance on faith healers. I suspect that critics of FDA regulation would prefer desperate people to act as human guinea pigs to determine the safety and efficacy of drugs rather than rely on science. That certainly seems to be Tabarrok’s preference; he often defends loose oversight by referring to people with fatal diseases who have little to lose.

65 Hazel Meade July 19, 2017 at 1:21 pm

Most of us think that in the absence of the FDA, there would be some other private market based safety and efficacy testing regime. Perhaps several competing organizations. I’m not sure why putting faith in private organizations is more cultish than having faith in government bureaucracies. Both of them are susceptible to bad incentives. FDA drug approvers aren’t omniscient super humans. Profit making isn’t any worse an incentive than political expediency. They can both corrupt and influence science.
At least the profit motive would tend to work to push a private for-profit drug efficacy certification company to try to keep their reputation intact. Political incentives at the FDA might work to get approvers to pass something just because a congressman or the president wants them to. This is the advantage of a private system, if consumers lose faith in them, there is another competing organization ready to steal their market share.

66 mulp July 19, 2017 at 3:01 pm

So, you trust the health system in Africa more than the US?

You would treat a diagnosis of HIV by sex with virgins as was prescribed in Africa?

Why don’t you think the health care system and state of the art in health care isn’t centered in Africa?

Why don’t you advocate adopting everything African for health care based on its free market and charity funding and lack of government funding or regulation making it the global leader?

67 jak July 19, 2017 at 4:20 pm

Americans don’t rape babies to cure aids because the FDA, good point sir.

68 Boonton July 19, 2017 at 4:58 pm

Most of us think that in the absence of the FDA, there would be some other private market based safety and efficacy testing regime. Perhaps several competing organizations. I’m not sure why putting faith in private organizations is more cultish than having faith in government bureaucracies….

Do we have any model for this? There’s two ways of promoting a new ‘drug’. One way is to do rigorous testing and prove scientifically that the thing works. The other method is the snake oil method…loose ‘evidence’ consisting of faulty logic, anecdotes, and other appeals that hit our emotional buttons but glide over rigorous evidence.

How about autos? I feel like there’s a lot of ‘additives’ offered that promise improved ‘performance’. Which model has taken over there? Rigorous testing from free market based ‘consumer information agencies’ or the snake oil method? How about ‘supplements’ which are not quite free to sell based on zero evidence but are much more loosely regulated than actual drugs.

69 Hazel Meade July 19, 2017 at 6:01 pm

Do you use additives? Do you feel that sufficient evidence is publicly available to make up your own mind about whether to use additives?

Same with supplements. Can you prove they don’t work for some people in some situations? Do you think they should be banned?

70 Boonton July 20, 2017 at 5:46 am

Same with supplements. Can you prove they don’t work for some people in some situations? Do you think they should be banned?

I’ve used a few, melatonin for sleep and my wife’s used alpha liporic acid for some of the side effects of chemotherapy. I’ve also taken vit. C and zinc.

The first clearly does something. The second seems to do something. The last two probably do nothing but I couldn’t declare they don’t work even for some people. A large double blind clinical trial might prove whether or not the last two really do something useful. However who has an incentive to do it? If you manufacture C or zinc you are free to sell it without funding a trial so if you were to fund it the best that could happen is you’d prove it is useful….which helps your competition as much as you….but then you could end up proving they are useless so you studied your product to death.

71 Hazel Meade July 20, 2017 at 10:43 am

So you’re saying that sales of Zinc and Vitamin C should be banned in order to give someone an incentive to do a double blind clinical trial.

I don’t know whether to laugh or cry.

72 Floccina July 20, 2017 at 2:09 pm

You make a valid point so, how about one step at a time and we let people get meds not quite through the entire process? As outlined here:
Also make it easy for chemically equivalent generics to go market. If those work out as net positive we take further steps?

Do you think the FDA should stricter less strict or do you think that they have it just right?

This related though not directly:

73 Paul July 19, 2017 at 11:54 am

Bad medical stuff from the past happened because of misguided intellectual fads, of which government was just as susceptible as anybody else (think eugenics). The idea that FDA bureaucrats are more enlightened than the rest of us is just sully.

74 CL July 19, 2017 at 12:12 pm

It’s sully indeed.

75 Tristan July 19, 2017 at 1:42 pm

Next time you are at Harvard you should interview Louis Menand!

76 Alan Goldhammer July 19, 2017 at 1:51 pm

+1 Big Time; that would be an amazing conversation

77 Anonymous July 19, 2017 at 5:03 pm

I am a Kaiser member, on lipitor. I have always been skeptical about that. I was amazed to hear in this podcast that Kaiser knocked heart disease from number 1 cause of death for us members by pushing us all to do it.

.. I better go take a pill.

78 TGGP July 19, 2017 at 8:55 pm

The FDA was founded in 1906, and it was real. 60 years from now, might someone else say that in the early 21st century we didn’t have a “real” FDA either?

79 Todd Kreider July 19, 2017 at 11:25 pm

TYLER COWEN: How far are we from having an AI that is capable of actually doing diagnosis to people? That is, they might speak into a Skype connection, something like Watson would hear what they say, and they would then diagnose the person well enough that this would be a usable form of healthcare? Is that far, close?

ATUL GAWANDE: Massively far. I think it’s one of the hardest things…

Cowen omitted a critical part of the diagnosis – tests – and those will give far more accurate information for Watson’s successor to analyze. Doctors are on the way out once this combination is achieved in the 2020s, and that isn’t “massively far” but quite near.

80 Alvin July 20, 2017 at 1:08 am

This guy is a f-cking idiot. I’m not wasting my time listening to his nonsense. Frontal lobotomies and the Tuskegee experiment involved the practice of medicine, ethical standards and informed consent – absolutely nothing to do with the purpose and function of the FDA. If he wants to argue racism, eugenics, or a failure or need for institutional review boards, then fine. But it didn’t involve approval of drugs or medical devices. He’s stupid.

81 tony cohen July 20, 2017 at 3:04 am

Atul Gawande seems to be fairly smart and spends a lot of time thinking about health care. And yet many here assume he is an idiot. Of course, it is allowable to think that a smart man who thinks a lot about a subject is a total idiot because their beliefs and desired outcomes are different from yours, but that may say more about ‘your’ intelligence levels than his. So strange that Mr. Cowen would choose to spend his precious time with ‘this idiot’ then with the sterling commentators on his own blog…

82 Hazel Meade July 20, 2017 at 10:44 am

I don’t think he’s an idiot, but occasionally smart people say really stupid things, like using Tuskeegee as an example of why deregulation is bad.

83 Alex Hillis July 21, 2017 at 1:29 pm

Thanks for putting out these episodes Tyler, always intellectually stimulating in a media landscape where many efforts fall flat.

It all came together for me at the end with Gawande’s recommendation of Frightened Rabbit, of which I’ve long been a fan. He’s right that Midnight Organ Fight is a superb breakup album. Scots know a special kind of sadness!

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