Sometimes punditry is fouled by contaminants that keep you from experiencing its full-bodied, high-octane mixture of speculation and freshman-political-philosophy-seminar level of relevance to everyday life. This is not one of those times:
Put aside the question of whether it should be the top 20 countries or top 5 or even just US, EU, and UK. I'd like to hear from health experts who oppose this why something like it isn't a good idea — or is it a good idea and the politics are just hard? https://t.co/QOIynmMfDU pic.twitter.com/UgrbEpSuYL
— Ezra Klein (@ezraklein) February 1, 2021
Why, pray tell, would health experts oppose a free-for-all where someone signing a piece of paper (tracked by what entity) can buy some random drug approved in the EU (prescribed by, and sold by, someone and something)? I can only imagine a hundred or so reasonable objections to this asinine and half-baked idea.
The article containing the quote claims that the US doesn’t have the Astra-Zeneca COVID vaccine because it wasn’t a US pharma company that invented it, and this is a pattern with the FDA. That could be, but color me skeptical. The notion that we need to bypass the FDA using some kind of Walter Mitty machinery, instead of pressuring the FDA to approve the Astra-Zeneca vaccine, is like saying that my car doesn’t accelerate well on the freeway, so I’ll strap rockets to the roof.
I’d just chuckle and move on if this guy wasn’t one of our most “important” opinion writers. It’s pure David Brooks to dip into some econ journal, pull out a dumb take, and broadcast it to the world, while prefacing it with even a dumber take.
Open Thread – Press Watch
bbleh
But it’s getting him noticed! Eyeballs! Clicks! Likes! Retweets! The coin of today’s realm!
That it’s uninformed, easily refuted drivel is entirely beside the point.
Scotius
One word: Thalidomide
Chet
That your argument is essentially “I’m sure there are good reasons against this, but I don’t know what they are” completely proves Klein’s point.
pensive
@Scotius: that’s what I was going to say!
Baud
A TPP for drugs!
Seriously, the reason it can’t happen because that’s the type of thing you negotiate in trade agreements. And you can’t do a quicky trade agreement in time to help with COVID.
Four Seasons Total Landscaping mistermix
@Chet:
I know, right? As soon as anyone comes up with a hare-brained alternative scheme to one of the most carefully constructed and reviewed government regulatory regimes (drug regulation), someone pointing and laughing needs to take that scheme seriously and issue a point-by-point refutation of the scheme.
Just like AOC needs to debate everyone who challenges her to a debate over twitter.
Otherwise, how can we have a full and free exchange of ideas? /s
Barbara
Sigh. I do think that regulatory conformance across nations with robust approval process is a worthwhile goal but it can’t be carried out on an individual basis. For one thing, duh, you have to obtain the product and it’s more complicated than you might think. E.g., a practitioner has to prescribe it. A distributor has to make it available to a reputable and licensed dispensing entity. And I know that there exist ways to make this happen via Internet but that’s putting individuals basically at risk of knowing they need to resort to offbeat ways of obtaining treatment. This isn’t ideal and alternatives do exist!
Basically, the goal would be to create a fast track approval process in the U.S. once approval by any of a number of listed countries has met certain threshold criteria. That would streamline approval in the U.S. But the place where the U.S. most lags Europe at the present time is in the world of biosimilars. Creating this pathway for biosimilars would be especially useful. Ezra is spitballing with minimal understanding of how things actually work. It’s not just the willingness of individuals to take the drugs, it’s the willingness of manufacturers to make them available on a large scale in a country where official topline approval has not occurred.
bbleh
@Four Seasons Total Landscaping mistermix: OMG you’re canceling Chet, not to mention Ezra! You’re stifling speech with political correctness! You’re violating their Constitutional rights
(Also using humor against the unarmed.)
Four Seasons Total Landscaping mistermix
@Barbara: And one more thing: Ezra (and the author quoted) write from the perspective of extreme privilege. If Ezra’s kid supposedly needed drug X, then Ezra could spend the time, effort and money to jump through the hoops to research the drug, get some doctor to prescribe it, and then pay (big bucks) to buy it and get it shipped from Europe.
This is in a world where a lot of lower-middle-class parents who aren’t on Medicaid and can barely afford their shit insurance won’t get their kid a strep test because they can’t afford the co-pay.
Martin
Thalidomide is a good answer. But so are marijuana and mifepristone/misoprostol.
I would here differentiate between policy and rules, because a lot of our policy problems are actually rules problems.
Change the above idea to ‘the FDA will review all approved drugs from the top 20 countries (as listed by Congress) within 90 days and all vaccines within 30 days, publicly publishing evidence for why the studies used to approve them in the host country is flawed or incomplete.’ Basically, mandate the FDA approve them, but if the don’t feel they can, they need to publicly peer-review the original studies and publish those results. 90 and 30 days doesn’t sound like much time, but nobody approves drugs without months-long clinical trials, which the FDA would be looking at before the clock even started. If they can’t provide evidence for why the drug shouldn’t be approved, it automatically gets an emergency approval.
The problem with the way a lot of federal rules work and some laws is that they are crafted to make government inefficient and poorly serve the public. You always want to set things up so that that the burden is on the administration and not on the drug company, immigrant, taxpayer, and so on. That way, when the people don’t believe in the role of government take power, doing nothing results in the worst outcome for them. It forces them to do the job, to review the drug, to hear the immigration case, etc.
The idea is a good one, but the presented construct is bad. My adjustment does nothing more than change the incentives of the FDA and achieves more or less the same result.
burnspbesq
Ezra is following Cornel West into comic irrelevance.
Speaking of half-baked ideas, what is up with Auntie Maxine bumping Katie Porter off the Financial Services Committee?
Barbara
@Four Seasons Total Landscaping mistermix: You know, I don’t even go there, and it won’t work like that. It would be risky and a total hassle for just about everyone, even those who can afford it. You will have a million websites that pop up to try to target consumers who are doing internet searches for a given disease. The potential to be taken advantage of is just enormous. Basically, these kinds of ideas (especially half baked in this instance) are the result of an appreciation that are drug approval and pricing policies are broken and need to be fixed, but letting individuals “self-regulate” is just stupid.
Barbara
@Martin: You can mandate FDA approval but you can’t mandate the manufacturers to make them available. And with the exception of biosimilars, it is not clear to me that there is any issue with FDA approval of drugs. Maybe someone can cite me an example.
Four Seasons Total Landscaping mistermix
@burnspbesq:
The “official story” is that Porter asked for assignments to Oversight and Reform, and Natural Resources, and then asked for a waiver to be on Financial Services, which is supposed to be an exclusive appointment. Waiver denied, though it was apparently approved last cycle, but that could be because there were more seats to give out.
https://thehill.com/policy/finance/534335-porter-loses-seat-on-house-panel-overseeing-financial-sector
Mathguy
@Four Seasons Total Landscaping mistermix: OT, but what the deal with Rochester police pepper spraying 9 year olds?
trollhattan
While many hours of our teevee watching are taken up with advertising for prescription drugs (“Do not take Fixatol if near death.”) there’s still the role of the doctor who must prescribe it. Klein writes as though the only thing between us and the drugs of our dreams is a pesky recalcitrant FDA. Or would he like to skip that too.
w_seattle
This looks like one of Ezra’s blind spots from back in his American Prospect days. He always gave lots of deference to Tyler Cowen / Tabarrok as having “interesting” takes on things from a libertarian perspective. I imagine they are all socially friendly within the beltway, so Ezra assumes good faith despite the George Mason U (and Koch) connections. If you click through to the underlying link, Tabarrok’s name shows up within a few lines… enough for me to stop.
JoyceH
@Four Seasons Total Landscaping mistermix:
I really don’t have a problem with this. Yes, she was great on Financial Services, but I think it’s time to utilize her special skills in Oversight and Reform.
trollhattan
@Mathguy:
Those little fuckers know what they did.
Four Seasons Total Landscaping mistermix
@Mathguy: It was an “irritant” not pepper spray. (According to the police.)
The issue is that a 9 year old was throwing a major tantrum because she was in a horrible home situation and also claimed that her mom’s boyfriend had stabbed mom. Mom apparently had blood on her clothes. Police were called and since cops only have two modes –“tell citizen to comply” and “punish citizen for noncompliance” — they lost patience and pepper sprayed the kid. She was in handcuffs at the time so obviously a huge threat to the police. Also, just to make a shituation worse, we have a new team of mental health experts that are supposed to go on these calls, but they weren’t called by the police.
(Also the account of what happened on the video is from my wife, who watched it, because I just don’t want to see a 9 y.o. get pepper sprayed. Call me weak.)
comrade scotts agenda of rage
Waaaaay back in the day, I can remember reading two blogs, one by a RWNJ on his own journey out of that mindset and another by a young kid that had a panda as a graphic.
Which online “source” do I still read and count as valuable? You can figure it out. Ezra is yet another example of the Peter Principle. Not nearly as bad as so many of our major, pundit figures (Mrs Greenspan, Chuck Fucking Todd, Chris Fucking Cilizza, George Fucking Will, David Fucking Brooks, etc. al), but he’s aspiring!
They get into corporate, traditional media and it’s as if their brains ooze out of their ears. Oh wait, that’s a job requirement to “get ahead”.
Four Seasons Total Landscaping mistermix
@Barbara: You mean the privileged would not be able to buy superior Eurodrugs via this asinine scheme? That is a feature, not a bug, because then Ezra could devote some columns to “fixing our Eurodrug process” and the Times could also write explainers for their privileged readers on how to best obtain Eurodrugs.
Roger Moore
The US isn’t the only country with a competent drug regulator. It might make sense to have some kind of reciprocal approval process where the US accepts drug approval from, for example, the EU, UK, Japan, and Canada. But we don’t have a system like that now, and IMO it’s crazy to think about implementing it now. And, looking at the actual evidence, it’s AstraZeneca that’s held back on asking for approval pending a better clinical trial, not the FDA who have turned them down.
Peale
@Four Seasons Total Landscaping mistermix: I had heard that Chemical X, which is normally used to create PowerPuff Girls, is also good for swelling related to hammer toes. But its only been approved for that in Sweden. Or so they said in this article I read online. I totally should be allowed to take it if I sign a consent.
Hoodie
This is funny because I was just listening to an interview with Klein on the Obama Boyz podcast this morning and he was mostly on point about the silliness of bipartisanship as it’s currently interpreted and why Dems should move forward with reconciliation and nuking the filibuster. They were even joking about the phony legitimacy that is conferred on people with NTY editorial columns. This might be viewed as evidence of the dilettante effect of being a NYT columnist.
Four Seasons Total Landscaping mistermix
@Hoodie:
Yeah, I thought he was getting better, but then I read this and realize that he’s reached his peak functioning.
Peale
@Roger Moore: Yes. This is complaining that FDA’s clinical trial policies are too stringent for small start ups like (checks notes) AstraZeneca to comply with so they didn’t bother to apply.
Mathguy
@Four Seasons Total Landscaping mistermix: I’m just trying to picture the mental state of someone that thinks it’s a good idea to pepper spray a handcuffed 9 year old girl.
Nope, can’t.
Mathguy
I also swear that Klein is just trolling people with this amazingly moronic tweet.
MattF
There’s the uncomfortable fact that policy is hard. A lot of smart people, a lot of politics, a lot of legalisms, a lot of statistical complexity… And a lot of wannabe pundits who have chosen ‘contrarianism’ as a business plan.
Martin
@Barbara: Generally I agree there’s not much issue, but there are categories of politicized drugs that there are issues with. There is also the category of drugs that are literally a persons last hope for survival that the FDA hasn’t approved, usually because there isn’t a sufficient clinical trial for them, often because you can’t create one. Congress has been grappling with that for some time.
Thalidomide is kind of a good example here. The FDA has approved it for use in treating certain cancers after promising tests in other countries. Not re-approved as it was never approved in the US to begin with because of flaws in the studies that got it approved in W Germany (notably that it didn’t do any of the things they claimed it coudl do). But it took the better part of a decade for the FDA to approve it for cancer treatment because of the previous history of the drug.
It’s also worth noting that most developed countries now have drug screening/approval systems similar to the FDAs. Much of Europe didn’t back in the 50s when Thalidomide was being used, so it’s a little bit of a strawman as none of the top 20 nations would have approved it today for the use it was marketed for.
Fair Economist
Reciprocal drug approval would create a huge venue shopping problem, and worsen the pressure for corruption and regulatory capture since they’d only have to be done in one place.
danielx
NYT editors actually permitting reporters to label lies as such.
Baby steps.
As Trump Raked In Cash Denying His Loss, Little Went to Actual Legal Fight
Kent
This seems like a solution in search of a problem. Is the US shortage of vaccines due to the fact that the FDA is slow in approving several of them? I seriously doubt it. We have a WORLDWIDE shortage of vaccine right now and no amount of clever hand-waving by Ezra Klein is going to change that.
Besides. We live in a world in which the nation state is the final arbiter when it comes to food and drug safety. That is most democratic and it is the world we live in. Hence we get chlorine-washed chicken here in the USA because the FDA approves it, while they aren’t allowed to buy chlorine-washed chicken in the EU because they haven’t. By contrast, you can get unpasteurized French cheeses in the EU but not in the US for the equivalent reasons. Are either of those two rules wrong? IDK. But the alternative is to have some unaccountable trans-national agency like the WTO make all these decisions and take them out of the hands of our own FDA and I’m not sure I’m comfortable with that. And I expect the Europeans wouldn’t be either.
Jim Appleton
So iDJT publicly berating Georgia Republicans is hhm, hhe, but Harris doing a radio interview in WV without Manchin’s blessing is going to be the end of Biden …
MattF
@danielx: Also true in today’s NYT major article on Trump’s election fraud claim.
Barbara
@Four Seasons Total Landscaping mistermix: He doesn’t understand drug approval. Many companies decide where to initiate approval based on a variety of factors. As I said above, there is merit to figuring out how to streamline approval across good regulatory processes, like an international rationalization of how products are approved so that a company could use the same application process or at least the same data and data formatting across countries.
WaterGirl
@Hoodie: I know! I found it somewhat disturbing that I agreed with pretty much everything Ezra Klein said in that interview.
BruceFromOhio
@Jim Appleton:
Perhaps you missed our hosts’ take on that. Biden gonna be just fine.
Martin
@burnspbesq: You want Katie on Oversight vs Financial. None of the good work she did on Financial went anywhere because of insufficient oversight of their regulators.
Hoodie
@Four Seasons Total Landscaping mistermix: Perhaps the problem is that when someone gets a post like NYT columnist or host of Sunday morning show, they feel compelled to act like they know something outside of their otherwise narrow band of knowledge and experience, i.e., they’re expected to be deep thinkers on any subject imaginable, week after week. Examples include Chuck Todd, who was innocuous as a numbers analyst for election coverage but a disaster as a pundit, and Krugman, who is a great economist but has been pretty bad at commenting on politics. So the upshot may be that no one can do the job of editorial page columnist/TV pundit as it’s typically set up because the job is programmed for failure.
danielx
@MattF:
I guess my reaction goes like this:
That’s nice, but only now they are permitted to say he’s a lying sonofabitch when they’ve known it beyond a doubt for decades?
BruceFromOhio
The Pure Essence of Snake Oil Punditry
That feels better. Sorry, Ezra!
Chetan Murthy
Wait, the argument for why this is a bad idea is trivially simple (and 4SMM is again spot-on). This is just another version of the “sell insurance across state lines” grift, or the “ship toxic waste to countries with weak governance, and dump it there”. Or “select the audit firm that offers you (wink wink nudge nudge) the easiest time in your audit”. Or “select the bond rating firm that offers you the highest rating”.
When there are multiple independent authorities that can each approve some product for sale in all their jurisdictions, you end up with jurisdiction-shopping, and that’s a vicious circle down for everybody. Sure, nobody’s arguing that the EU will start accepting FDA certifications; but you know it’s coming — The Economist will write a chin-stroking (and something else too) article about it the day after the US chooses to accept EU certifications.
That’s not how cross-certification is supposed to work: in every other area of business, and I mean EVERY OTHER AREA (I’ve read about this a good bit because of Brexit) either (a) all parties sign up for supranational bodies’ regulatory edicts (that they all agree to as members of that body) or (b) they negotiate bilateral agreements which specify mutual recognition: in which case almost invariably there are durable inspection regimes and dispute settlement procedures including court jurisdictions.
Examples of #a include UN-level auto-certification body, EU-level “everything”; of #b include EU-Canada trade agreements.
And even with those agreements, there are still careful reams of paperwork involved in making sure that when somebody attests that product shipment NNNN came from factory FFFF, it did indeed do so — because there’s a shit-ton of fraud and such to deal with. And all of this, is as nothing compared to what would be needed for, y’know, *pharmaceuticals”.
Let’s remember that we already have ENORMOUS difficulty ensuring that foreign manufacturers of base materials in India and China produce adequately pure compounds — there have been many instances — documented instances (remember the heartburn drug fiasco, or ibuprofen?) — where factories in China (and IIRC India too — this isn’t some China-bashing) were working hard to skirt the FDA inspection regime.
There are similar concerned that the EU has raised with the UK in the context of Brexit.
The idea that somehow this can all be waved-away with the flick of a pen …. fugeddaboudit.
Roger Moore
@Barbara:
I know there are some differences in approval specifically in peptide drugs, which is the little niche of drug approval I know something about. The example I know specifically is Carbetocin, an oxytocin analog used to treat postpartum bleeding. It’s approved in many other countries and is part of WHO’s list of essential medicines, but it isn’t approved in the US. I’m not sure why not, but it’s a long-standing issue.
sdhays
@Four Seasons Total Landscaping mistermix: Just to add to what you said, my understanding is that Financial Services and Oversight Reform are both “exclusive”, so she was kind of asking for two waivers, or a special super-duper waiver. Not unprecedented, apparently, but also pretty unusual.
pacem appellant
@Martin: The Twitters didn’t take kindly to Porter trying to get a waver for Finance (and going around Maxine Waters to get the approval, which was ultimately denied), WHILE simultaneously grandstanding on voting against a waiver for Secretary Austin since he hasn’t been out of service for seven years. I felt it was a false equivalency, but twitter’s gotta twitter. And that nontraversy is in the memory hole now.
schrodingers_cat
@danielx: They committed a journalism after the defeat of the Ogre was defeated and no longer the king of the castle. How brave.
Barbara
@Chetan Murthy: It’s not really the same as selling insurance across state lines. There are some technical differences in the way products are dosed and delivered, and more differences in areas such as labeling for safety and indications, but a lot of countries do normalize these things across borders. For instance, Canada might accept dosage and administration that might have been approved in the UK unless it has some good reason to reject it. These drugs are chemical ingredients, by and large, and the same manufacturing facilities ship products out to multiple countries. So there is actually room for some international streamlining.
BruceFromOhio
@Barbara:
Welcome to Pharmacy Island! (a subsidiary of Amazon)
Roger Moore
@Peale:
Realistically, what happened is that AstraZeneca had some really strange results in their clinical trials that make people question how trustworthy their data is. The UK went ahead and approved their vaccine anyway, but they’ve decided not to ask for an EUA in the US until after they’ve run another trial. People who are desperate to get vaccinated want to ignore the problems with the trial and start using the vaccine anyway. I can understand where they’re coming from, but I think the better solution is to work at getting greater availability of the Pfizer and Moderna vaccines.
Booger
@Fair Economist: We’d have drugs with Liberian and Bahamanian flags!
JR
The reason we don’t have the AstraZeneca vaccine is that it is garbage and the clinical studies supporting it are a joke. I am deeply surprised that it got approved anywhere based on the data published.
The J&J vaccine is also not great, both in terms of efficacy and the way they studied it. But it is at least acceptable.
The Novavax vaccine looks very promising but it is much more difficult to update for new virus variants than mRNA vaccines.
(Note that I work, and have been working for the last 8 months, on one of the approved vaccines)
schrodingers_cat
Is Ezra a pharmacological expert? I didn’t think so. So baby Broder’s opinion on this is as good as mine is. And I probably have had more chemistry than he has had.
Enhanced Voting Techniques
[double post, please delete]
Enhanced Voting Techniques
Because is the same useless, entitled mentality that produced the Trump admin. IF there is something wrong with the FDA we should fix it, not take the easy way out and off shore it’s job to Europe.
Chetan Murthy
@Barbara:
Your description makes things worse, not better. When what’s being approved is the end-product drug, at least we’re relying on the foreign regulator to ensure control of all steps in the manufacturing process, and assuming that it’s not possible for adulteration to happen to only batches headed overseas, etc. But for inputs which are brought to the US in bulk (i.e. “chemical ingredients”, not actual end-user-packaged drugs) the risks are MUCH greater: there have been documented cases where manufacturers have fiddled with formulations for different batches, destined for different recipient countries.
You can’t assume good faith on the part of drug manufacturers, is my point. When entire batches of product are never released into the source country’s market, the manufacturer has no reason to apply the same controls they would apply otherwise.
Again: I’m saying that importation of intermediate inputs is -worse- than importation of end-user-packaged drugs.
Also, re: insurance, I didn’t mean that it was exactly the same; rather, that it is well-known why we don’t allow “selling insurance across state lines” — it results in race-to-the-bottom regulator-shopping. That’s the danger here.
Roger Moore
@Martin:
There is actually a special program just for that case. It’s officially called “Expanded Access” but is often called compassionate use. The FDA tends to be very conservative about approving drugs, but that’s because there is a history of drugs that were approved too soon and wound up having terrible side effects. Thalidomide is obviously the most famous, but it’s far from the only one. There’s a saying that safety rules are written in blood, and our drug safety rules are no exception.
Dopey-o
Racism? Misogyny?
Porque no los dos?
Chetan Murthy
@JR:
Maybe worth remembering why it’s important that we get a high-protection vaccine: people who get the vaccine (any vaccine, any vaccine) will act as if they are immune. This is human nature. So a vaccine that only gives them 66% protection, is much more dangerous, public-health-wise than one that gives 95% protection. They’re going to act as if they’re immune.
Barbara
@Chetan Murthy: I am not going to argue with someone who has only limited understanding of drug approval. Just not going to do it.I will say, however, that I would not propose proxy approval based on one country’s approval, but an approval process that adheres to agreed upon standards arrived at through international cooperation. Such things as how data is formatted and reported vary a lot from one country to the next. U.S. and Canada already cooperate on these kinds of issues.
And just so you know, it really is different from selling insurance across state lines. I have to understand both kinds of regulatory frameworks to do my day job, and the issues are different.
JoyceH
@JR:
The efficacy that interests me is its 100% effectiveness in preventing death, and almost as good at preventing hospitalization. If J&J is the first vaccine I could get, I’d take it in a heartbeat.
Gvg
He seems to be ignoring that a doctor should prescribe a drug because a medical expert thinks you have a condition that would benefit more from treatment than be hurt. A doctor that knows your own medical history, what your underlying conditions are and what else you are taking that might interfere with good results. A doctor you can check with if the results aren’t good. All drugs can have side effects or not work well for you. Many drugs are not actually good for you but of you have a serious condition they goos might outweigh the bad. I.e. cancer drugs are poisons that target cancer cells more than healthy cells but can have lifelong bad effects anyway.
he doesn’t even mention a doctor in his suggestion. Well maybe he is skipping over that but doctors try to keep up with new research and info, but I can’t see them all being able to add watch the Medical news from 20 other countries in multiple languages So that you will be able to on rare occasions be able to prescribe something your patient thinks he needs, that there is no supply source for in this country anyway.
i am sure though that if we increased the FDA budget so that they could actually hire more reviewers and staff for years without stupid Republican nutters trying to shut the government down every year, that would actually get us more drugs faster and safer. I think Klein just wants to sound off and get attention rather than actually help.
i think the debt ceiling thing needs to be ended. If Congress passes spending for something, the US has already agreed to the debt and it’s redundant to have a law requiring another agreement. All it does is allow idiots to grab attention.
HumboldtBlue
And now for something completely different.
Just a dog wearing overalls skateboarding like a badass.
Fair Economist
@Mathguy:
Even worse, she was upset her mother’s boyfriend had stabbed her mother, who was covered in blood at the time. And they handcuff and pepper spray the KID?
Roger Moore
@Barbara:
No, they aren’t. Most people think of a drug as being a single substance, like ibuprophen. But in pharma speak, that single substance is known as an active pharmaceutical ingredient (API), and that is not what is actually approved by the regulatory agencies. A drug is what you get by compounding one or more APIs- sometimes in very specific physical form- with appropriate binders, dispersants, fillers, etc. that give it the pharmacokinetic properties you want. It’s that compounded form that’s actually approved by the regulatory agencies, and it’s a much more complex thing that just the API.
Barbara
@Roger Moore: I guarantee you that this is an area that Tony Fauci understands better than anyone else, because it was a key issue in the development and studying of AIDS drugs. Basically, HIV positive people were guaranteed to die from the disease and many simply refused to participate in randomized clinical trials that are — for good reason — the hallmark of furthering research and approval of drugs. They had to come up with a different way to foster approval of HIV medications. However, outside of situations where a company cannot conduct a randomized trial, many companies worry that “expanded” use programs can compromise ultimate approval. This would be a bigger problem in oncology than most other areas, but one reason for that is so many oncology drugs are what you might call only marginally efficacious to begin with.
Of course, you know all this already!
artem1s
Glibertarian’s ideas of how the free hand of the market would just solve everything. And what do you do about the insurance companies when they say, “sorry, no thanks, we’re not reimbursing you for this massive lawsuit waiting to happen?” Sounds like a sure way for pharma companies to experiment without having to pay for expensive trials. The consumer signed off on it and wants to take the risk, right?
cokane
Some poorer income countries do this, allowing the usage of pharmas that have been approved by the US. Pretty common in small-sized Latin American countries. And it’s understandable there, where expertise is more scarce.
But man, it’s moronic in the US. Either we have a government by the people or we don’t. I don’t want to sound too nationalistic here, but it really could create a crisis of legitimacy if the US is legalizing things based on other countries. Plenty of valid critiques of the FDA to be made, but you also don’t reform them by outsourcing their function.
Barbara
@Roger Moore:
Yes, I realize that there are other ingredients, but the reality is that a single factory is manufacturing and shipping drugs for many different countries. It’s not at all equivalent to insurance contracts that are negotiated with different providers in different states and regions.
Dan B
@Barbara: If Ezra’s theoretical “Power to the Rich Individuals” paradise were realized we might have had T***p a l’Orange pumped full of bleach and hyrdoxychloroquine!
Oh, nevermind, no other country approved either.
Next try…
Barbara
@Chetan Murthy: There are type 1 regulatory errors — Thalidomide — and type 2 regulatory errors, where a regulator expects perfection and ignores the escalating cost of not having the drug on the market. Stated another way, if you don’t approve J&J and it takes two to three times as long to vaccinate the entire population, you will have people who would have been immune who get the disease. I don’t have the statistical background to even begin to understand which path would be worse from the perspective of disease burden, but I suspect approval is the safer course, especially since I anticipate a significant number of people will not get a second shot of the other vaccines, so their real world efficacy might end up being lower than what they could be.
CODave
@Roger Moore: YES! My wife spent decades in Regulatory Affairs at a variety of Pharma companies. Her views on the data first released from AZ trials were simple: the data was crap. So bad that there was no way in Hades that the FDA would approve it. AZ had to rerun the trials.
Puddinhead
@JR: The one thing that has always concerned me about the RNA- and DNA-based vaccines is variability in the amount and quality of antigen produced by the body from patient to patient. Obviously, they work, so maybe it’s not much of an issue, but different variants might not be as amenable to that approach as the wild-type Spike protein (they could just as easily be better too). That being said, the nimbleness of being able to change the nucleic acid sequence now while these strains are emerging rather than having to do a whole new small to production scale protein prep and QC is impressive. It’s a nice club to have in the bag under the present circumstances, even though I happen to be biased towards protein-based vaccines.
Chetan Murthy
@Barbara:
The issue isn’t regulatory error, they are:
1. regulatory capture
2. venue shopping
and 3. flouting of regulations b/c impossible to enforce when product is -all- sent out-of-jurisdiction.
I’ll add
4. lack of judicial jurisdiction makes remedy impossible. [manufacturer and victim in different countries — which court will allow the case to go forward? It’s why the ECJ exists, ffs]
schrodingers_cat
Some light hearted OT music.
A. R. Rahman’s first big hit in the Hindi movies, Rangeela, the lead actor Urmila Matondkar in this movie is a friend’s friend. It was a huge hit in the 90s.
Urmila’s character is a back-up dancer in the movies who daydreams of hitting the big time.
Title track.
Barbara
@Chetan Murthy: Have you read anything I’ve written? I don’t favor abandoning country by country approval. And just so you know, drugs are made all over the world and shipped to different countries RIGHT NOW. The FDA inspects plants all over the world.The issue of type 1 and 2 errors is seen within a single country’s existing approval framework. How much information is enough? FDA did not approve Thalidomide because a single doctor was concerned about data suggesting vascular complications. By the time the data might have been available, its horrific effects became known. One reason that the doctor in question was so rigorous about her review was that Thalidomide was being prescribed for a temporary non-life threatening condition, so any side effects were potentially worrisome, especially since it was intended to be given to pregnant women.FDA is justly proud of that history, but it’s still the case that caution also has its costs.
MomSense
@pacem appellant:
C’mon, you don’t try to go around Auntie Maxine. It wasn’t about Austin.
schrodingers_cat
@MomSense: Another one term Congresswoman (now in her second term) with a head the size of Jupiter because of media notoriety.
Chetan Murthy
@Barbara: Heh, I think we’re failing to read each -other’s- comments.
Sure, your proposal is better than Klein’s. But I was responding to Klein’s proposal, which is *literally* “get it approved in any of the top 20 countries, and you can sell i there”.
Notwithstanding, you’ve forgotten that my argument was not about whether well-run FDA regulation can work; it was about all the ways that relying on 20 different regulatory bodies, with competing interests and competing drug manufacturers attempting to capture them, and 20 different court systems with non-overlapping jurisdictions, can fail.
It’s got almost nothing to do with the details of how any one regulator would do their work, because that’s not the issue. The issue is what happens when you can engage in venue-shopping, and all the other ways in which regulators can be evaded.
Contra what you wrote about drugs being shipped overseas right now, the FDA actually does inspections in those countries right now. And there’s been quite a spate of discoveries of manufacturers who cheat in ways specifically designed to evade FDA regulators. The idea that that won’t happen if the FDA doesn’t even bother to show up to inspect the plants is ….. questionable.
trollhattan
@HumboldtBlue:
Dang, that’s a dog who LOVES to skateboard.
janesays
@Four Seasons Total Landscaping mistermix: It’s absolutely because there were fewer seats available this time. Elections have consequences – losing those 11 seats meant more than just losing those 11 seats. It also meant a reduction in committee seats.
Ken
“I’m not a doctor, but I play one on TV advertisements for drugs.”
Which ads I will never understand, especially one I’ve been seeing lately for something like “small-cell lung cancer not having [specific genetic variant]”. How many people watching at home leap up saying “That’s exactly what I have! Why hasn’t my doctor told me about this medicine?”
oldster
@w_seattle:
I was going to say this: part of how Klein (and Yglesias) keep their credibility despite being left-leaning technocratic wonks is by occasionally making contrarian libertarian sounds.
This proves that they do not just love big gummint for its own sake, as the rest of us liberals surely must do, since Fox News says so.
So it’s effectively a way of saying, “I’m not like those other progressives — I’m a cool girl, see?”
I agree with you, also, that Cowen is pure poison. Tabarrok I am not as familiar with. But Cowen is like a numerate McArdle — all the bad ideas, fewer math mistakes, just as bloodthirsty and wicked nonetheless.
Geminid
@sdhays: I think Financial Services is one of the five “exclusive” House Commitees, but Oversight is not. Part of the story was that incoming Democratic Caucus members submitted their top three desired committees postings, and Porter put Financial Services third on her list.
Roger Moore
@Ken:
That they’re willing to spend all that money on ads for a very specific disease should tell you just what the margins on those drugs are like.
Le Comte de Monte Cristo, fka Edmund Dantes
I can fix American pharma tomorrow.
1. Prohibit mass market advertising of regulated medications – if it requires a prescription, it doesn’t get advertised.
2. When the thousandth person dies of a condition that can be prevented or cured by a medication that is covered by IP protection but is either too expensive or there is too little manufactured for them to get it, the CEO, CFO, COO and every Director will be forced to eat copies of the patent approvals until they either explode from paper bloat or release the patents, whichever comes first.
Barbara
@Chetan Murthy:
Which is exactly what I said.
Geminid
@Geminid: Correction. There are not five but four “exclusive” House Commitees: Financial Services, Energy and Commerce, Appropriations, and Ways and Means. The Caucus Steering Committee determines committee assignments.
Le Comte de Monte Cristo, fka Edmund Dantes
@Roger Moore:
“Ask your doctor if mifestripriatinoniol for your symptoms of oily nose is right for you. Side effects may include depression, psychosis, rage, priapism, incontinence, diarrhea, constipation, genital lesions, genitourinary disfunction, hair loss, hair growth or suicidal thoughts….”
No One You Know
@Chetan Murthy: That’s a fact. But not just limited to drugs as ingredients. My doctor flatly directs “no generics” for one of my prescriptions because the major offshore manufacturers dilute it. He named Teva as the worst offender for another patient. That patient’s drug nearly killed him in the hospital because there wasn’t enough actual antidepressant in the dose.
This led to a standoff when my pharmacist wanted to give me Teva anyway… and as the line watched and listened, I had to tell him point blank to fill it as ordered.
I still wonder why it was so important to him.
Roger Moore
@Le Comte de Monte Cristo, fka Edmund Dantes:
The only problem with your ad snippet is that mifestripriatinoniol sounds like a generic name for the drug, while the ads will always use the much easier to pronounce brand name. So, to pick a drug I happen to know a lot about, they will talk about Linzess rather than linaclotide.
J R in WV
@burnspbesq:
I forget what exactly happened, but Ms Porter asked Madame Speaker for something without running it past Maxine, thus pissing off a very senior Congresswoman and committee chairwoman since Jesus was a puppy.
Oops.
Hard Learning Experience! Katie will survive, and Maxine will forgive her. She is too good to stay on the outs for very long!
J R in WV
@danielx:
Also, too, I see tiny news stories about a “missing 20 million doses” of CoronaVirus-19 vaccine. Wife, with 45 years of news experience tells everyone who will listen that often the biggest stories first appear as tiny stories in the back of the paper, with an 18-point head. I think this is a current example of that sort of news.
Those 20 million doses of vaccine are missing at all~!!~ They were stolen, with a street value of $10,000 per dose that’s $200,000,000 dollars work of vaccine.
I’ve read several stories of bribe offers on that order of money for shots for rich family men.
Would Trump do that? In a hot minute he would.!!!!
Those injections are NOT missing, they were stolen by people working for the Boss, Trump!!!
burnspbesq
@Enhanced Voting Techniques:
‘The primary thing “wrong” with the FDA is that it takes its mission seriously and is competent to carry it out, which causes approvals to not happen two weeks ago.
Kathleen
Anya
I don’t get this blog’s dislike of Ezra Klein? He’s one of the good guys. It’s not possible to always agree with someone but I don’t think he deserves the hate he gets.
In terms of the issue at hand, I feel like the EU has more stringent regulations than the US so I wouldn’t think their drug approval process is less safe or lax. I just think as others have mentioned this would require a trade agreement.
Kathleen
@Le Comte de Monte Cristo, fka Edmund Dantes: But..but.. the people in the commercials are always smiling so it can’t be bad. Plus, I’d hate to miss seeing the blinking bladder tugging at its human and dragging her to the bathroom thus forcing her to miss her Nobel Prize acceptance.
J R in WV
@J R in WV:
This should say “Those 20 million doses of vaccine are NOT missing at all~!!~ They were stolen…”
billcinsd
@Chet:
Isn’t that Klein’s point?
Miss Bianca
@Fair Economist:
Does anyone know whether the bf is a cop?
I only wish I were kidding.
J R in WV
Also agree that medication should not be advertised commercially at all. In JAMA, or the New England Journal, or Lancet, maybe. To me and you and the plumber? No way!
Chet
@Four Seasons Total Landscaping mistermix:
Just to be clear, the “hairbrained alternative scheme” we’re talking about here is to assume that Europe’s drug regulators aren’t substantially more incompetent or corrupt than our own, and that the human body works the same way in Buffalo that it does in Brussels. But, you know, go off – only tens of thousands of lives are at stake, it’s fine.
Chet
@burnspbesq:
Well, no, what we’re talking about is the FDA’s assumption that no other first-world drug regulatory authority is competent or incorruptible, so FDA approval has to start independent of any of the findings of those other regulators.
But there’s no logical reason to assume that’s true. Europeans don’t get demonstrably worse outcomes from their drug approval process than we do – it’s probably the opposite, in fact – so there’s no reason their approval effort can’t stand in for our own.