Category: Medicine
The new Biden health initiative
The Biden administration today began to flesh out a proposal for a new agency—modeled on the military’s Defense Advanced Research Projects Agency (DARPA)—that would seek to speed the development of medical treatments by funding risky, innovative projects. The agency, dubbed ARPA-Health (ARPA-H), would be housed at the National Institutes of Health and have a 2022 budget of $6.5 billion, according to a White House spending request released today.
Few other details about ARPA-H have been released, except that it would initially focus on cancer and diseases “such as diabetes and Alzheimer’s.”
…Under the DARPA model, projects would not be vetted by peer reviewers, but instead, funding decisions would be made by program managers. And instead of multiyear grants, the agency would disburse awards as milestone-driven payments; program managers could also cancel projects that they decide aren’t panning out.
Here is the full story, via NQ.
C’mon people, listen to Shruti
We assess India’s healthcare capacity by comparing several countrywide and state-level metrics: per capita spending on healthcare, healthcare spending priority in budgets, hospital bed capacity, and capacity in terms of doctors, nurses, and total healthcare personnel. We find that, overall, India has very fragile healthcare infrastructure for dealing with the COVID-19 outbreak. We make three recommendations: (1) India’s private-sector healthcare system has more capacity than government facilities, so the Indian government will need to rely on and incentivize the private sector by increasing funding and removing bottlenecks. (2) Healthcare capacity varies across states, and the union government should identify and assist at-risk states. (3) Compared to rural areas, urban areas are very poorly served by the state hospitals, creating an urgent need for state governments to identify and assist at-risk, high-density urban areas.
That is part of a Mercatus working paper by Shruti Rajagopalan, with Abishek Choutagunta, April 2020.
India Authorizes Any Vaccine Authorized by a Stringent Regulator
Mint: In a move that could potentially pave the way for Pfizer and Johnson & Johnson’s covid-19 vaccines in India, the Centre on Tuesday said it would allow the granting of emergency licensure for vaccines that have received authorization in the US, UK, Europe, Japan or from the World Health Organization (WHO).
This is good news and a smart move. But what’s frustrating is that Pfizer was the first company to apply for an EUA from India in December of 2020 but India demanded that they conduct a clinical study on the Indian population and Pfizer pulled its application. In other words, India could have had a third vaccine approved and in use but “vaccine nationalism” reared its ugly head. Only now, as the bodies burn in the streets, has the Indian government acknowledged that the FDA and the EMA are reasonably careful judges of safety and efficacy.
It’s true that the cold storage requirements make the Pfizer vaccine somewhat difficult to use in India’s villages but it would have been fine to use in the major cities.
Naturally, the FDA and the EMA should also recognize each other as peer regulators.
The Biden administration populist thinking about vaccine export
…top White House aides rejected that [export] recommendation over concerns that the domestic stockpile was not large enough yet — and that the optics of sending doses abroad during a big push to make vaccines more available to U.S. citizens. In subsequent weeks they repeatedly overruled administration health experts who felt it was a mistake to keep millions of doses in storage as outbreaks intensified across the world.
“The optics clearly were that we needed to take care of our own population first. Let’s not worry about the demand yet, we still have a problem at home,” said one person briefed on the matter, who requested anonymity to describe the internal divisions. “The public health people don’t see that in the same way.”
Here is the full story.
Shout it From the Rooftops and Sometimes People Will Listen
Shout it from the rooftops and sometimes lots of other people will start shouting and then sometimes other people will listen!
The U.S. will begin sharing its entire pipeline of vaccine from AstraZeneca once the COVID-19 vaccine clears federal safety reviews, the White House told The Associated Press on Monday, with as many as 60 million doses expected to be available for export in the coming months.
The move greatly expands on the Biden administration’s action last month to share about 4 million doses of the vaccine with Mexico and Canada. The AstraZeneca vaccine is widely in use around the world but not yet authorized by the U.S. Food and Drug Administration.
…About 10 million doses of AstraZeneca vaccine have been produced but have yet to pass review by the FDA to “meet its expectations for product quality,” Zients said…That process could be completed in the next several weeks. About 50 million more doses are in various stages of production and could be available to ship in May and June pending FDA sign-off.
Let’s also get our J&J vaccine factories up and running and soon we will have Moderna and Novavax to export as well. Keep it coming! An American plan to vaccinate the world.
Are Covid travel bans counterproductive for emerging economies?
Sometimes, yes:
…two opposing forces constitute the first-order determinants of total infections at any point in time. On one hand, the longer a travel ban lasts, the less time community transmission exists in the rural sink. Ceteris paribus, this will decrease rural infections. On the other hand, the longer the restrictions remain, the longer migrants are contained within a hotspot where infection rates are rapidly increasing. Consequently, the probability that migrants are infected with Covid-19 rises over time until the city achieves herd immunity, in turn increasing the rate at which they seed the rural sink with infections once the ban is lifted. This drives up cumulative cases at any future date.
In some cases, for travel bans to work they have to be very long. That is from a new paper by Fiona Burlig, Anant Sudarshan, Garrison Schlauch, who also provide evidence from India, and also from cross-country evidence, to support their analysis.
How well did Medicare pay-for-performance work?
For pain management, and pain management, only, it seems it worked just fine:
Medicare uses a pay-for-performance program to reimburse hospitals. One of the key input measures in the performance formula is patient satisfaction with their hospital care. Physicians and hospitals, however, have raised concerns regarding questions related to patient satisfaction with pain management during hospitalization. They report feeling pressured to prescribe opioids to alleviate pain and boost satisfaction survey scores for higher reimbursements. This overprescription of opioids has been cited as a cause of current opioid crisis in the United States. Due to these concerns, Medicare stopped using pain management questions as inputs in its payment formula. The authors collected multiyear data from six diverse data sources, employed propensity score matching to obtain comparable groups, and estimated difference-in-difference models to show that, in fact, pain management was the only measure to improve in response to the pay-for-performance system. No other input measure showed significant improvement. Thus, removing pain management from the formula may weaken the effectiveness of the Hospital Value-Based Purchasing Program at improving patient satisfaction, which is one of the key goals of the program. The authors suggest two divergent paths for Medicare to make the program more effective.
That is from a new paper by Lu Liu, Dinesh K. Gauri, and Rupinder P. Jindal. Overall, why did incentives fail us so badly?
Via the excellent Kevin Lewis.
Me on the end of the Great Stagnation
Here is some (edited) transcript from an AEI symposium, via Jim Pethokoukis:
We’ve come up with great new ideas, took a little while to figure out how to use them and how to spread throughout the economy, and eventually they made big differences. Are we assuming that these new technologies are like the ones in the past and they’ll have that eventual impact?
I think the new innovations will be special in at least one significant way: A lot of them will not contribute that much to per capita GDP. So, if you take the mRNA vaccines, they’re influencing what would normally be called the “cyclical component.” If you think of older people as more likely to die from COVID-19 . . . by saving lives — I’m not suggesting per capita GDP will go down — but the impact on human welfare will be much greater than what would appear to be the long-term secular trend in GDP. Also, two of the big advances that might happen are a vaccine against HIV/AIDS and an effective vaccine against malaria. Those would be incredible advances for humanity, but I don’t know how much they would show up in US per capita GDP or productivity — possibly not really much at all.
The other new wave of innovations, which you could call green energy — again, you could be very optimistic about those, but the main thing they’re doing is helping us avoid a catastrophe. So they’re boosting GDP relative to a quite awful counterfactual of just continuing to burn coal and other fossil fuels. But I’m not sure we’ll feel we have higher standards of living relative to what we were used to simply because there’s a solar panel on your home. It might in some ways make your energy supply better, but again, it will be hidden by the counterfactual. So, it will be a very strange kind of technology boom when I look at the two main areas where I see a lot of progress.
If we go through a period where none of this stuff is really showing up in data and maybe it’s not obvious that people’s living standards are rising, do we risk having less societal tolerance for the kinds of disruptions that economic growth and progress naturally make?
Here’s one of my fears: The biomedical innovation progress is so fast but the rest of the economy stays relatively static, so we become older as a society more quickly than we had been expecting. You could have a lot more status quo bias — just more entrenchment, 10 years more of a problem — and we could, in a funny way, innovate ourselves into a tighter complacency and a tighter stagnation.
I’m not rooting against increases in life expectancy. Ceteris paribus, I would take them, obviously. But that said, you want to be careful about the order in which progress comes, and I’m not sure if we’re going to get it in an optimal order.
Here is the complete excerpt.
The petty narcissism of small vaccine differences
That is the topic of my latest Bloomberg column, here is one excerpt:
My survey of the cultural vaccine landscape in the U.S. includes the four major vaccines — from Pfizer, Moderna, AstraZeneca and Johnson & Johnson.
Pfizer, distributed by one of the largest U.S. pharmaceutical firms, is the establishment vaccine. Since it initially had a significant “cold chain” requirement, it was given out at established institutions such as big hospitals and public-health centers with large freezers. It is plentiful, highly effective and largely uncontroversial.
Moderna — the very name suggests something new — is the intellectual vaccine. The company had no product or major revenue source until the vaccine itself, so it is harder to link Moderna to “Big Pharma,” which gives it a kind of anti-establishment vibe. Note also that the last three letters of Moderna are “rna,” referring to the mRNA technology that makes the vaccine work. It is the vaccine for people in the know.
Moderna was also, for a while anyway, the American vaccine. It was available primarily in the U.S. at a time when Pfizer was being handed out liberally in the U.K. and Israel. As a recipient of two Moderna doses myself, I feel just a wee bit special for this reason. You had to be an American to get my vaccine. Yes, the European Union had also approved it, but it failed to procure it in a timely manner. So the availability of Moderna reflects the greater wealth and efficiency of the U.S.
Then there are the AstraZeneca and Johnson & Johnson vaccines…
And:
To the extent vaccines turn into markers for a cultural club, vaccine hesitancy may persist.
It might be better, all things considered, if vaccines were viewed more like paper clips — that is, a useful and even necessary product entirely shorn of cultural significance. Few people refuse to deploy paper clips in order to “own the libs” or because they do not trust the establishment. They are just a way to hold two pieces of paper together.
To be clear, the primary blame here lies with those who hesitate to get vaccinated. But behind big mistakes are many small ones — and we vaccinated Americans, with our all-too-human tendency to create hierarchies for everything, are surely contributing to the mess.
Recommended!
Africa fact of the day
More than 1.7 million doses of the world’s first malaria vaccine have been administered in Ghana, Kenya and Malawi, benefitting more than 650,000 children!
Here is more.
The petition that is French
A survey of more than 2,600 industry professionals by the Union of Oenologists showed that among those who had caught COVID-19, more than a third said the disease had affected their ability to do their work. Some student wine tasters had dropped out of courses after falling ill with the virus, the union said.
Union boss Didier Fages said the body had written to President Emmanuel Macron and Prime Minister Jean Castex to ask that wine tasters be moved to the front of the queue for anti-COVID shots to safeguard livelihoods.
Here is the full story.
When doctors stay in their lane
Here is the paper, showing massive overdiagnosis, even following testing. If you don’t wish to click through, here is a nice summary:
summary:
Clinicians widely overestimated chance of disease especially after testingCardiac ischemia after + ECG—EBM 2-11%, median answer 70%
UTI after + urine cx—EBM 0-8.3%, answer 80%
Breast CA after + mammo—EBM 3-9%, answer 50%
Pneumonia after + CXR EBM 46-65%, answer 95%— Dan Morgan (@dr_dmorgan) April 12, 2021
“RCTs for me but not for thee”?
Zeke Emanuel, a professor of healthcare management at the University of Pennsylvania and a former coronavirus adviser to US president Joe Biden, said: “I understand they wanted to be transparent, but did they really have to announce a complete pause? “My concern is this will unnecessarily undermine confidence in the vaccine, and possibly all [Covid-19] vaccines. Are people going to know the difference?”
Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore, said: “The damage is done, this is going to be hard to resume. All [the CDC] can do is say how rare this is, show how safe and efficacious the J&J vaccine is. But this action is going to be hard to reverse.”
Here is the full FT piece. Since lives are at stake, how about this for a proposal? The FDA is allowed to suspend the use of any positive expected value vaccine only after running an RCT on their underlying theory of credibility and public risk communication in the relevant context. (NB: asking about attitude change is not nearly good enough!) And after they run the RCT, they have to wait three weeks to schedule the meeting on evaluating the data. After all, that is how long it takes, right?
Estamos de acuerdo?
By the way, one reader wrote to me: “I submit to you that the credibility of the FDA on the relative safety of various vaccines may be a minor issue in the pool of issues that prevent the level of vaccinations we would like to see.” Do we even know if that is true or false?
From the comments, on FDA credibility
The Covid culture that is Australia
Health Minister Greg Hunt has refused to guarantee Australia’s borders will open even if the whole country has been vaccinated against COVID-19.
Australia’s borders have been shut since March 2020 and will remain closed until at least the middle of June, leaving more than 36,000 Australians trapped overseas, unable to return due to caps on the number of quarantine spaces.
The closure also bans citizens from leaving the country unless they have an exemption or are travelling to New Zealand.
Mr Hunt suggested at a news conference in Canberra on Tuesday the international border closures could last much longer and stay in place even if the entire population had been vaccinated against the coronavirus.
“Vaccination alone is no guarantee that you can open up,” Mr Hunt said.
“If the whole country were vaccinated, you couldn’t just open the borders.”
“We still have to look at a series of different factors: transmission, longevity [of vaccine protection] and the global impact – and those are factors which the world is learning about,” he said.
Really people? Via Chris.
That is from Sure. So what is the best piece on FDA credibility? (Yes, I know the work of Daniel Carpenter and have a CWT with him coming out and we do address this directly.) And what has the FDA itself done to study the issue of its own credibility?