Results for “fda” 402 found
Ashish Jha, dean of the School of Public Health at Brown University, has had it with the FDA:
Nearly all public-health authorities in the country are urging people to get vaccines. We see the incredible results that the vaccines have had and how many lives they’re saving, and still the F.D.A. has not offered full, permanent approval of the vaccine. President Biden suggested it might take several more months. How do you understand that, or how can that be defended, if it can be?
I find it incredibly puzzling what exactly the F.D.A. is doing. The F.D.A. says that it typically takes them six months or sometimes as much as a year to fully approve a new product. And, generally, we appreciate that. There are two components to that. One is that they want to see a large amount of data, and they want to go through that carefully, and I think that’s essential. Then the second is that there’s a process, which can take a while. This is a global emergency, and while all of us want to make sure that the F.D.A. does its job, most of us also feel that just operating on standard procedures may not be the right thing to do here, and that there are things that can be sped up. Just as with the development of vaccines, we didn’t cut any corners. We did all the steps, but we did it much, much faster. The F.D.A. has to go much, much faster.
The other thing about the data—the amount of data that the vaccines have generated, the number of people who’ve been vaccinated, and the scrutiny that the data has received. I mean, my goodness, this data has been scrutinized and looked over more than—
I’d imagine it’s more than any data in modern history, right?
Any therapy, any vaccine ever. These are the most highly scrutinized medical products we have ever had, and I don’t understand what the F.D.A. is doing.
I’m pleased that Jha and others like Eric Topol are becoming frustrated with FDA delay. But take it from an OG, the FDA is doing what it has always done. What has changed isn’t the FDA but that more people are paying attention now that they have something personal at stake.
I am reminded of this story from 2016:
Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
…When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”
I do hope that when the pandemic is over we don’t forget that for patients with life-threatening diseases it’s always been an emergency.
Hat tip: John Chilton.
A Massachusetts school can continue to use electric shock devices to modify behavior by students with intellectual disabilities, a federal court said this month, overturning an attempt by the government to end the controversial practice, which has been described as “torture” by critics but defended by family members.
In a 2-to-1 decision, the judges ruled that a federal ban interfered with the ability of doctors working with the school, the Judge Rotenberg Educational Center, to practice medicine, which is regulated by the state. The Food and Drug Administration sought to prohibit the devices in March 2020, saying that delivering shocks to students presents “an unreasonable and substantial risk of illness or injury.”
Although the F.D.A.’s ban was national, the school in Canton, Mass., appears to be the only facility in the United States using the shock devices to correct self-harming or aggressive behavior…
The treatment, in which students wear a special fanny pack with two protruding wires, typically attached to the arm or leg, can deliver quick shocks to the skin when triggered by a staff member with a remote-control device.
Here is the full NYT story. You might argue this treatment can be useful in many cases, but what exactly is the error rate here? How high an error rate should we be willing to accept? What recourse do the victims have, noting that many probably live under guardianship? How might you model the incentives of the staff at the facility who use this? How well do “prison guards” behave more generally?
As a side note, I think this matter should be handled by legislation rather than the FDA.
Nightmare Scenario opens with Anthony Fauci stripped to his skivvies and wondering whether the white powder he has just been exposed to in his NIH office is anthrax, ricin, or a hoax. The first and last he can survive, ricin is a death sentence. A security team douses him with chemicals and moves him to another office where a portable shower has been deployed. Fauci showers, calls his wife, and waits for the test results.
Nightmare Scenario is the best of the recent books on the pandemic (I earlier reviewed Lewis’s The Premonition and Slavitt’s Preventable). Based on hundreds of interviews it’s a true inside account. It doesn’t contain much in the way of analysis but that’s a strength in a journalistic history. Rather than a strict review, I will note a couple of things that jumped out to me.
An astounding amount of time was spent at the highest level of government on what do do about the Americans stuck on the Diamond Princess and other cruise ships. I was almost screaming at the book at this point “there’s just 437 Americans on the cruise ship! Pay attention to the 328 million Americans at home!” It’s ridiculous that 437 Americans should occupy the President’s time but that’s what happens when people think the President is their father (or mother) who needs to show them that he cares.
Governance by the 24 hour news cycle is by no means solely a Trump failing. Biden doesn’t need to know anything about the Miami tower collapse, for example. It’s a tragedy but a state and local matter. But the 24-hour news cycle means that politicians don’t think more than a step ahead, often to a bizarre extent. When the Dow dropped, Larry Kudlow rushed to get on the news to say the “virus is contained”. What was he thinking? If true, this would reveal itself in time and the Dow would rise. If false, he gains at best a couple of days of bump and then lose credibility. Similarly, what was Pence thinking when he wrote in a June of 2020 WSJ op-ed “There Isn’t a Coronavirus Second Wave.” You can’t confidence game a virus.
The CDC botched the initial test and when Joe Grogan at the Domestic Policy Council questioned Azar, Redfield and Fauci he was told “Everything is taken care of. The CDC is remedying the situation.” After repeated delays, the FDA sent an expert to investigate what was going on with the CDC test:
When Stenzel gained access to three key labs developing the test, he couldn’t believe what he saw. In two of the three labs, the agency wasn’t following standard operating procedure. And he discovered the CDC had put together the test in the same lab where it was running the test on live virus samples. That was a violation of the most basic manufacturing practices… “If you were a commercial entity, I would shut you down.” p.81
The CDC failing to use standard operating procedures wasn’t Trump’s fault. The rot is deep.
I was hoping to get more information from Abutaleb and Paletta about Pfizer’s peculiar change in study design. Pfizer released their trial design in mid-September. Articles in the Washington Post and the New York Times were clear that Pfizer planned to look at their data once 32 trial participants had been infected. President Trump, following Pfizer CEO Bourla, thus predicted that there would be vaccine news in October, before the election. Instead Pfizer announced their terrific results on Monday November 9, after the election. When the announcement came people were surprised that between mid-September and November the trial design had been changed. STAT News, for example, noted:
In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases.
Abutaleb and Paletta report that the Trump team was furious when they discovered that the good news had been delayed and then they say the following:
FDA officials, of course, had no control over when Pfizer reported its results, because the company could report them only after a certain number of people in the trial had contracted coronavirus.
This is blatantly false. FDA officials have only to signal what they want from a company and the company will comply. Moreover, it was precisely by changing the number of people who needed to have contracted coronavirus that control was exerted. What exactly was said in this “discussion with the FDA” that caused Pfizer to wait? Probably not coincidentally it was also in October that Nancy Pelosi began to worry that British immune systems were different than American immune systems.
Abutaleb and Paletta have nothing good to say about Jared Kushner (unlike Birx who was obviously a source) but if you read between the lines Kushner comes off surprisingly well. At the very least, he moves quickly and sometimes gets things done. Abutaleb and Paletta offer this critique:
Kushner was correct that the normal processes for procuring supplies were cumbersome and slow. But circumventing those processes risked wasting taxpayer money, buying faulty supplies, or running afoul of government contracting laws. There were protections in place to try to prevent the government from overpaying for products or supplies and to try to ensure that companies did not receive unfair advantages…” p. 258.
Oooh, overpaying for products. As if that never happens when the processes are followed. All of this makes it clear that there would have been big errors under other administrations but they would have been different errors like moving even slower so as not to run “afoul of government contracting laws.”
One thing which comes through in The Premonition, Preventable and Nightmare Scenario is that quite a few people understood the crisis early. On January 18, Scott Gottlieb texted Joe Grogan to warn him about the virus in Wuhan. Grogan takes it seriously (it may have been Grogan who was responsible for inviting Kremer and I to speak to the DPC on accelerating vaccines.) On January 28, deputy national security advisor Matthew Pottinger warned Trump that he could be facing the deadliest pandemic since the 1918 flu. But Gottlieb had already left the administration, Grogan would resign early, and when Pottinger started wearing a mask to work he was considered an alarmist and was frozen out of decision making. Many others had or would soon leave:
Who was left? A mix of family members, twentysomethings, hangers-on, fourth-stringers, former lobbyists, sycophants…That created tremendous pressure on the government officials who remained in their positions in 2020. Many of them were totally unprepared for what was coming. Many of them were so focused on their own survival that it never occurred to them to focus on anyone else’s. p.31.
Overall, Nightmare Scenario is an excellent read.
Preston Estep was alone in a borrowed laboratory, somewhere in Boston. No big company, no board meetings, no billion-dollar payout from Operation Warp Speed, the US government’s covid-19 vaccine funding program. No animal data. No ethics approval.
What he did have: ingredients for a vaccine. And one willing volunteer.
Estep swirled together the mixture and spritzed it up his nose.
…Estep and at least 20 other researchers, technologists, or science enthusiasts, many connected to Harvard University and MIT, have volunteered as lab rats for a do-it-yourself inoculation against the coronavirus. They say it’s their only chance to become immune without waiting a year or more for a vaccine to be formally approved.
Among those who’ve taken the DIY vaccine is George Church, the celebrity geneticist at Harvard University, who took two doses a week apart earlier this month. The doses were dropped in his mailbox, and he mixed the ingredients himself.
Church say…he believes the vaccine designed by Estep, his former graduate student at Harvard and one of his protégés, is extremely safe. “I think we are at much bigger risk from covid considering how many ways you can get it, and how highly variable the consequences are,” he says.
I’m a big fan of the RadVac vaccine and was recently asked to give a talk about the vaccine and the pluses and minuses of the open source approach. In my talk I cover patents, when it was rational to take an unapproved vaccine, the FDA, paternal medicine versus the Consumer Reports model and more. I’m especially pleased with this talk.
Addendum: Great set of posts from johnswentworth from LessWrong on making the vaccine and then testing it.
Like Michael Lewis’s The Premonition which I reviewed earlier, Andy Slavitt’s Preventable is a story of heroes, only all the heroes are named Andy Slavitt. It begins, as all such stories do, with an urgent call from the White House…the President needs you now! When not reminding us (e.g. xv, 14, 105, 112, 133, 242, 249) of how he did “nearly the impossible” and saved Obamacare he tells us how grateful other people were for his wise counsel, e.g. “Jared Kushner’s name again flashed on my phone. I picked up, and he was polite and appreciative of my past help.” (p.113), “John Doer was right to challenge me to make my concerns known publicly. Hundreds of thousands of people were following my tweets…” (p. 55)
Slavitt deserves praise for his work during the pandemic so I shouldn’t be so churlish but Preventable is shallow and politicized and it rubbed me the wrong way. Instead of an “inside account” we get little more than a day-by-day account familiar to anyone who lived through the last year and half. Slavitt rarely departs from the standard narrative.
Trump, of course, comes in for plenty of criticism for his mishandling of the crisis. Perhaps the most telling episode was when an infected Trump demanded a publicity jaunt in a hermetically sealed car with Secret Service personnel. Trump didn’t care enough to protect those who protected him. No surprise he didn’t protect us.
The standard narrative, however, leads Slavitt to make blanket assertions—the kind that everyone of a certain type knows to be true–but in fact are false. He writes, for example:
In comparison to most of these other countries, the American public was impatient, untrusting, and unaccustomed to sacrificing individual rights for the public good. (p. 65)
Data from the Oxford Coronavirus Government Response Tracker (OxCGRT) show that the US “sacrifice” as measured by the stringency of the COVID policy response–school closures; workplace closures; restrictions on public gatherings; restrictions on internal movements; mask requirements; testing requirements and so forth–was well within the European and Canadian average.
The pandemic and the lockdowns split Americans from their friends and families. Birthdays, anniversaries, even funerals were relegated to Zoom. Jobs and businesses were lost in the millions. Children couldn’t see their friends or even play in the park. Churches and bars were shuttered. Music was silenced. Americans sacrificed plenty.
Some of Slavitt’s assertions are absurd.
The U.S. response to the pandemic differed from the response in other parts of the world largely in the degree to which the government was reluctant to interfere with our system of laissez-faire capitalism…
Laissez-faire capitalism??! Political hyperbole paired with lazy writing. It would be laughable except for the fact that such hyperbole biases our thinking. If you read Slavitt uncritically you’d assume–as Slavitt does–that when the pandemic hit, US workers were cast aside to fend for themselves. In fact, the US fiscal response to the pandemic was among the largest and most generous in the world. An unemployed minimum wage worker in the United States, for example, was paid a much larger share of their income during the pandemic than a similar worker in Canada, France, or Germany (and no, that wasn’t because the US replacement rate was low to begin with.)
This is not to deny that low-wage workers bore a larger brunt of the pandemic than high-wage workers, many of whom could work from home. Slavitt implies, however, that this was a “room-service pandemic” in which the high-wage workers demanded a reopening of the economy at the expense of low-wage workers. As far as the data indicate, however, the big divisions of opinion were political and tribal not by income per se. The Washington Post, for example, concluded:
There was no significant difference in the percentage of people who said social distancing measures were worth the cost between those who’d seen no economic impact and those who said the impacts were a major problem for their households. Both groups broadly support the measures.
Perhaps because Slavitt believes his own hyperbole about a laissez-faire economy he can’t quite bring himself to say that Operation Warp Speed, a big government program of early investment to accelerate vaccines, was a tremendous success. Instead he winds up complaining that “even with $1 billion worth of funding for research and development, Moderna ended up selling its vaccine at about twice the cost of an influenza vaccine.” (p. 190). Can you believe it? A life-saving, economy-boosting, pandemic ending, incredibly-cheap vaccine, cost twice as much as the flu vaccine! The horror.
Slavitt’s narrative lines up “scientific experts” against “deniers, fauxers, and herders” with the scientific experts united on the pro-lockdown side. Let’s consider. In Europe one country above all others followed the Slavitt ideal of an expert-led pandemic response. A country where the public health authority was free from interference from politicians. A country where the public had tremendous trust in the state. A country where the public were committed to collective solidarity and the public welfare. That country, of course, was Sweden. Yet in Sweden the highly regarded Public Health Agency, led by state epidemiologist Anders Tegnell, an expert in infectious diseases who had directed Sweden’s response to the swine flu epidemic, opposed lockdowns, travel restrictions, and the general use of masks.
Moreover, the Public Health Agency of Sweden and Tegnell weren’t a bizarre anomaly, anti-lockdown was probably the dominant expert position prior to COVID. In a 2006 review of pandemic policy, for example, four highly-regarded experts argued:
It is difficult to identify circumstances in the past half-century when large-scale quarantine has been effectively used in the control of any disease. The negative consequences of large-scale quarantine are so extreme (forced confinement of sick people with the well; complete restriction of movement of large populations; difficulty in getting critical supplies, medicines, and food to people inside the quarantine zone) that this mitigation measure should be eliminated from serious consideration.
Travel restrictions, such as closing airports and screening travelers at borders, have historically been ineffective.
….a policy calling for communitywide cancellation of public events seems inadvisable.
The authors included Thomas V. Inglesby, the Director of the Johns Hopkins Center for Health Security, one of the most highly respected centers for infectious diseases in the world, and D.A. Henderson, the legendary epidemiologist widely credited with eliminating smallpox from the planet.
Tegnell argued that “if other countries were led by experts rather than politicians, more nations would have policies like Sweden’s” and he may have been right. In the United States, for example, the Great Barrington declaration, which argued for a Swedish style approach and which Slavitt denounces in lurid and slanderous terms, was written by three highly-qualified, expert epidemiologists; Martin Kulldorff from Harvard, Sunetra Gupta from Oxford and Jay Bhattacharya from Stanford. One would be hard-pressed to find a more expert group.
The point is not that we should have followed the Great Barrington experts (for what it is worth, I opposed the Great Barrington declaration). Ecclesiastes tells us:
… that the race is not to the swift, nor the battle to the strong, neither yet bread to the wise, nor yet riches to men of understanding, nor yet favor to men of skill; but time and chance happeneth to them all.
In other words, the experts can be wrong. Indeed, the experts are often divided, so many of them must be wrong. The experts also often base their policy recommendations on factors beyond their expertise, including educational, class, and ideological biases, so the experts are to be trusted more on factual questions than on ethical answers. Nevertheless, the experts are more likely to be right than the non-experts. So how should one navigate these nuances in a democratic society? Slavitt doesn’t say.
Slavitt’s simple narrative–Trump bad, Biden good, Follow the Science, Be Kind–can’t help us as we try to improve future policy. Slavitt ignores most of the big questions. Why did the CDC fail in its primary mission? Indeed, why did the CDC often slow our response? Why did the NIH not quickly fund COVID research giving us better insight on the virus and its spread? Why were the states so moribund and listless? Why did the United States fail to adopt first doses first, even though that policy successfully saved lives by speeding up vaccinations in Great Britain and Canada?
To the extent that Slavitt does offer policy recommendations they aren’t about reforming the CDC, FDA or NIH. Instead he offers us a tired laundry list; a living wage, affordable housing, voting reform, lobbying reform, national broadband, and reduction of income inequality. Surprise! The pandemic justified everything you believed all along! But many countries with these reforms performed poorly during the pandemic and many without, such as authoritarian China, performed relatively well. All good things do not correlate.
Trump’s mishandling of the pandemic make it easy to blame him and call it a day. But the rot is deep. If we do not get to the core of our problems we will not be ready for the next emergency. If we are lucky, we might face the next emergency with better leadership but a great country does not rely on luck.
In The Premonition Michael Lewis brings his cast of heroes together like the assembling of the Avengers. In the role of Captain America is Charity Dean, the CA public health officer who is always under-estimated because she is slight and attractive, until she cracks open the ribcage of a cadaver that the men are afraid to touch. Then there is Carter Mecher, the redneck epidemiologist who has a gift for assembling numbers into coherent patterns. And Richard Hatchett the southern poet who finds himself at the head of The Coalition for Epidemic Preparedness (CEPI), the world’s most important organization during the pandemic; and Joe DiRisi the brilliant, mad scientist picked by the Chan Zuckerberg Initiative as the person most likely to cure disease…all of them. As you might expect from Michael Lewis, it’s all terribly well done, albeit formulaic and sometimes over-the-top, e.g.
Charity’s purpose was clear….she was put on earth to fight battles, and wars, against disease. To save lives and perhaps even an entire country. p. 200-201
But Lewis has a bigger problem than over-the-top writing.
The heroes were defeated. Lewis likes to tell stories of brilliant mavericks like Billy Beane and Michael Burry who go against the grain but eventually, against all odds, emerge victorious. But six hundred thousand people are dead in the United States and whatever victory we have won was ugly and slow. Indeed, Lewis assembles his mighty team but then The Premonition trails off as the team is defeated by bureaucracy, indecision, complacency and malaise before they even have a chance to enter the real battle against the virus. It’s telling that none of Lewis’s heroes are even mentioned in Andy Slavitt’s Preventable (about which I will say more in a future post).
To be fair, Lewis’s heroes are fascinating, brilliant people who did some good. As part of the Kremer team I interacted a bit with Richard Hatchett and CEPI. Hatchett headed CEPI and understood the danger of SARS-COV-II before anyone else and with Bill Gates’s support started funding vaccine production and shoring up supply lines before anyone else was off the starting line. CEPI was magnificent and their story has yet to be told in full measure. Had Lewis’s heroes been in charge I have no doubt that many lives could have been saved but, for the most part, the heroes were sidelined. Why and how that happened is the real question but Lewis’s story-telling skills aren’t the right skills to answer that question.
If there is one central villain in The Premonition, it’s the CDC. Lewis acknowledges that his perspective has changed. In The Fifth Risk, the system (the “deep state” used non-pejoratively if you will) is full of wisdom and power but it’s under threat from Trump. In The Premonition, Trump is an after-thought, at best a trigger or aggravating factor. Long before Trump or the pandemic:
Charity had washed her hands of the CDC. “I banned their officers from my investigations,” she said. The CDC did many things. It published learned papers on health crisis, after the fact. It managed, very carefully, public perception of itself. But when the shooting started, it leapt into the nearest hole, while others took fire. “In the end I was like ‘Fuck you’, said Charity. “I was mad they were such pansies. I was mad that the man behind the curtain ended up being so disappointing.” p. 42
As the pandemic starts the CDC fails repeatedly. At the beginning of the pandemic on January 29 the government had started to repatriate Americans from Wuhan bringing some of them to a National Guard base just outside of Omaha. But shockingly the CDC doesn’t test them for the virus.
Never mind that every single one of the fifty-seven Americans in quarantine wanted to be tested: the CDC forbade it. And [James] Lawler [US Naval Commander and national security coordinator on pandemic response] never understood the real reason for the CDC’s objections…Whatever the reasons, fifty-seven Americans spent fourteen days quarantined in Omaha, then left without having any idea of whether they’d been infected, or might still infect others. “There is no way that fifty-seven people from Wuhan were not shedding virus,” said Lawler. p. 176
Many of the people brought home from China are not even quarantined just told to self-quarantine:
…When local health officers…set out to find these possibly infected Americans, and make sure that they were following orders to quarantine, they discovered that the CDC officials who had met them upon arrival had not bothered to take down their home addresses.
…[Charity] posed a rude question to the senior CDC official moved on the call: How can you keep saying that Americans are at low risk from the virus if you aren’t even testing for the virus. She’d been answered with silence, and then the official move on to the next topic. [p.206-207, italics in original]
And all of this is before we get to the CDC’s famously botched test an error which was amplified by the FDA’s forbidding private labs and state governments to develop their own tests. Charity Dean wanted California to ignore the CDC and FDA and, “blow open testing and allow every microbiology lab to develop its own test.” But Dean is ignored and so by as late as February 19, “Zimbabwe could test but California could not because of the CDC. Zimbabwe!” p. 223. The failure of testing in the early weeks was the original sin of the crisis, the key failure that took a containment strategy ala South Korea and Taiwan off the table.
Lewis’s most sustained analysis comes in a few pages near the end of The Premonition where he argues that the CDC became politicized after it lost credibility due to the 1976 Swine Flu episode. In 1976 a novel influenza strain looked like it might be a repeat of 1918. Encouraged by CDC head David Sencer, President Ford launched a mass vaccination campaign that vaccinated 45 million people. The swine flu, however, petered out and the campaign was widely considered a “debacle” and a “fiasco” that illustrated the danger of ceding control to unelected experts instead of the democratic process. The CDC lost authority and under Reagan the director became a political appointee rather than a career civil servant. Thus, rather than being unprecedented, Trump’s politicization of the CDC had deep roots.
Today the 1976 vaccination campaign looks like a competent response to a real risk that failed to materialize, rather than a failure. So what lessons should we take from this? Lewis doesn’t say but my colleague Garett Jones argues for more independent agencies in his excellent book 10% Less Democracy. The problem with the CDC was that after 1976 it was too responsive to political pressures, i.e. too democratic. What are the alternatives?
The Federal Reserve is governed by a seven-member board each of whom is appointed to a single 14- year term, making it rare for a President to be able to appoint a majority of the board. Moreover, since members cannot be reappointed there is less incentive to curry political favor. The Chairperson is appointed by the President to a four-year term and must also be approved by the Senate. These checks and balances make the Federal Reserve a relatively independent agency with the power to reject democratic pressures for inflationary stimulus. Although independent central banks can be a thorn in the side of politicians who want their aid in juicing the economy as elections approach, the evidence is that independent central banks reduce inflation without reducing economic growth. A multi-member governing board with long and overlapping appointments could also make the CDC more independent from democratic politics which is what you want when a once in 100 year pandemic hits and the organization needs to make unpopular decisions before most people see the danger.
Lewis hasn’t lost his ability to write exhilarating prose about heroic oddballs. Page by page, The Premonition is a good read but the heroes in Lewis’s story were overshadowed by politics, bureaucracy and complacency–systems that Lewis’s doesn’t analyze or perhaps quite understand–and as a result, his hero-centric story ends up unsatisfying as story and unedifying as analysis.
Nearly a year ago, I wrote Frequent, Fast, and Cheap is Better than Sensitive, arguing for rapid antigen tests:
A number of firms have developed cheap, paper-strip tests for coronavirus that report results at-home in about 15 minutes but they have yet to be approved for use by the FDA because the FDA appears to be demanding that all tests reach accuracy levels similar to the PCR test. This is another deadly FDA mistake.
See also my posts Infected versus Infectious and Rapid Tests. The EMA and then the FDA finally did start approving these tests. So how well are they working? Pretty damn well. Canada has two innovative programs. First, in Nova Scotia pop-up clinics have been using rapid tests for asymptomatic people:
During the third wave that hit Nova Scotia over the past month, the province’s community rapid testing centres have correctly sniffed out at least 285 COVID-19 cases in asymptomatic people, or about 10 per cent of all confirmed cases in this time period, according to the Nova Scotia Health Authority.
While most provinces reserve testing only for symptomatic people or close contacts of a case, Nova Scotia’s pop-up centres allow asymptomatic people to simply show up and get a rapid test for free, with results sent to them within an hour. The whole process relies largely on volunteers without a health-care background.
Furthermore, the true number of cases credited to rapid testing is probably much higher. When a rapid test correctly identifies a positive case, the person’s close contacts such as their family get PCR lab tests that don’t show up in the rapid test statistics.
Lisa Barrett, an infectious diseases specialist and the driving force behind the rapid testing program, said it’s hard to say for certain, but taken altogether it’s possible rapid antigen testing has helped Nova Scotia find up to 18 per cent of all cases during the third wave.
“This is the early detection system,” Barrett said. Rapid testing tends to catch people early on in their infection when they’re full of virus, meaning positive cases are found and put into isolation fast — likely days before they would have been found with a PCR test, if they were found at all.
Michael Mina argues that since the rapid antigen detected cases are among the most infectious cases, detecting these cases is probably worth half of all the PCR testing.
Second, Canada’s CDL Rapid Screening Consortium is now in 200 sites with 50 large companies and rapidly expanding. A very interesting, just published paper in The Lancet runs an experiment that suggests that these testing regimes can work. The experiment rapidly tested 1000 people and the negatives were then randomly assigned either to be sent-home to conduct their regular life or to attend a multi-hour concert with masks but also singing, dancing, alcohol and no-social distancing. After 8 days there were two infections in the at-home group and no infections in the Concert group which suggests that this type of rapid testing can be used to open and keep-open concerts, schools, universities, airplanes and workplaces.
What’s the point of testing now that we have vaccines? Two reasons. First, most of the world still hasn’t been vaccinated so testing will be a very useful stop-gap measure until vaccination is more widely distributed. Indeed, the success of these programs shows what we lost by not acting more quickly a year ago. Second, although the pandemic is (essentially) over in the United States (as predicted) there will likely be an uptick in the fall among the unvaccinated and you want rapid tests to be available rapidly in hot-spots. In other words, rapid deployment of rapid tests will help us to avoid outbreaks in the future.
7. Yuan Longping, RIP (NYT).
8. Famous musicians pick their favorite Bob Dylan songs. Would mine be “Highway 61”? “Mr. Tambourine Man”? “Tangled Up in Blue”? “Don’t Think Twice It’s Alright”? Too many choices. Bob is today 80 years old. The most overrated is perhaps “Desolation Row”, with its pretentious lyrics?
Yahoo: With little fanfare, the U.S. Food and Drug Administration gave Pfizer permission this week to store its COVID-19 vaccine in a typical refrigerator for one month — freeing the vaccine from the need to be shipped in cumbersome boxes stuffed with dry ice.
Among authorized COVID-19 vaccines, Pfizer’s vaccine was notorious for its ultra-cold storage requirements. Now, as the only vaccine authorized for children ages 12 to 17, this new flexibility could dramatically accelerate the effort to vaccinate America’s teens and adolescents.
Pfizer spent millions on its cold storage technology and now discovers that it isn’t strictly necessary–that wasn’t a mistake, Pfizer did the right thing–but it’s a good reminder of how new this technology is and also how the clinical trial decisions are not written in stone.
Straussian take: Investigate fractional dosing.
Science News: Though no one solution works for all places, public spaces need to focus on proper ventilation, air filtration, germicidal ultraviolet lights and air quality monitoring rather than rigorously disinfecting surfaces, say many scientists who cite evidence that the virus lingers in the air.
“This is what’s really frustrating,” says Jose-Luis Jimenez, an aerosol scientist at the University of Colorado Boulder. “We’ve wasted billions and billions of dollars on disinfecting, which doesn’t serve any purpose whatsoever, yet things like having a $50 filter in every classroom, we haven’t done.”
Similarly, in an excellent piece Derek Thompson writes:
Too many U.S. institutions throughout the pandemic have shown little interest in the act of learning while doing. They etched the conventional wisdoms of March 2020 into stone and clutched their stone-tablet commandments in the face of any evidence that would disprove them. Liberal readers might readily point to Republican governors who rejected masks and indoor restrictions even as their states faced outbreaks. But the criticism also applies to deep-blue areas. Los Angeles, for instance, closed its playgrounds and prohibited friends from going on beach walks, long after researchers knew that the coronavirus didn’t really spread outdoors. In the pandemic and beyond, this might be the fundamental crisis of American institutions: They specialize in the performance of bureaucratic competence rather than the act of actually being competent.
The CDC’s announcement should be curtains for theatrical deep cleanings. But until companies, transit authorities, retailers, and magazines embrace the value of scientific discovery and the joy of learning new things, the show, and the soap, will go on.
Fortunately, there has been some recent learning. The Indian government now advises:
Aerosols could be carried in the air for up to 10 metres and improving the ventilation of indoor spaces would reduce transmission…“Ventilation can decrease the risk of transmission from one infected person to the other. Just as smells can be diluted from the air through opening windows and doors and using exhaust systems, ventilating spaces with improved directional air flow decreases the accumulated viral land in the air, reducing the risk of transmission. Ventilation is a community defense that protects all of us at home or at work,” it stated.
One thing which puzzled me even before the pandemic was the lack of interest in UVC even though there is credible evidence that it reduces hard to kill superbugs.
The large study, published in The Lancet, finds machines that emit the UV light can cut transmission of four major super bugs by a cumulative 30 percent. The finding is specific to patients who stay overnight in a room where someone with a known positive culture or infection of a drug-resistant organism had previously been treated.
“Some of these germs can live in the environment so long that even after a patient with the organism has left the room and it has been cleaned, the next patient in the room could potentially be exposed,” said Dr. Deverick J. Anderson, MD, an infectious disease specialist at Duke and lead investigator of the study. “Infections from one of these bugs are tough to treat and can be truly debilitating for a patient.”
The attentive reader will note that this also implies airborne transmission.
Even the FDA is moderately supportive of UVC:
UVC radiation is a known disinfectant for air, water, and nonporous surfaces. UVC radiation has effectively been used for decades to reduce the spread of bacteria, such as tuberculosis. For this reason, UVC lamps are often called “germicidal” lamps.
UVC radiation has been shown to destroy the outer protein coating of the SARS-Coronavirus, which is a different virus from the current SARS-CoV-2 virus. The destruction ultimately leads to inactivation of the virus. (see Far-UVC light (222 nm) efficiently and safely inactivates airborne human coronavirusesExternal Link Disclaimer). UVC radiation may also be effective in inactivating the SARS-CoV-2 virus, which is the virus that causes the Coronavirus Disease 2019 (COVID-19).
Scott Alexander has a good post on prescription only Apps.
Trouble falling asleep? You could take sleeping pills, but they’ve got side effects. Guidelines recommend you try Cognitive Behavioral Therapy For Insomnia (CBT-i), a medication-free process where you train yourself to fall asleep by altering your schedule and sleep conditions.
…Late last year, Pear Therapeutics released a CBT-i app (formerly “SHUT-i”, now “Somryst”) which holds the patient’s hand through the complicated CBT-i process. Studies show it works as well as a real therapist, which is very well indeed. There’s only one catch: you need a doctor’s prescription.
The app is $899. The surprise is that it doesn’t seem that this is an FDA requirement (at least on the surface. It’s murky why no one else is offering a cheap app). Scott thinks it’s a play on the insurance companies:
My guess is that prescription-gating is necessary because it’s the last step in the process of transforming it from an app ($10 price tag) to a “digital therapeutic” ($899 price tag). The magic words for forcing insurance companies to pay for something is “a doctor said it was medically necessary”. Make sure that every use of Somryst is associated with a doctor’s prescription, and that’s a whole new level of officialness and charge-insurance-companies-lots-of-money-ability.
The good news is, Somryst has partnered with telemedicine provider UpScript. I know nothing about UpScript, but I suspect they are a rubber-stamping service. If you don’t have a doctor of your own, you can pay their fee, see a tele-doctor, and say “I would like a prescription for Somryst”. The tele-doctor asks if you have insomnia, you say yes/no/maybe/no hablo inglés, and the tele-doctor hands you a Somryst prescription and charges you $45.
On the one hand, at least this saves you from Doctor Search Hell. On the other, it involves paying $45 for the right to pay $899. So it’s kind of a wash.
In a way this is worse than an FDA requirement because at least we could mock an FDA requirement mercilessly and perhaps change it. Instead it seems that a combination of incentives and murky constraints have pushed patients, insurers and innovators into an equilibrium in which cheap things become expensive. It’s enough to keep anyone up at night.
We were told that the J&J pause was necessary to prevent vaccine hesitancy. I never understood the certainty people expressed on this point, even people who were relatively good on other issues. In anycase, as the excellent Daniel Bier argues, the best explanation for the data right now is that the J&J pause increased vaccine hesitancy.
Could the plunge timing have been a coincidence? Perhaps the eager had already gotten their vaccinations, leaving only the less eager and more hesitant. Maybe. But note that younger people were getting vaccinated rapidly before the pause and at increasing rates in line with the rates of the older people who had been vaccinated before them. But then the vaccination rates of the young plummeted, just as for the old. In other words, the plunge started in all age groups at the same time but at very different levels of vaccination. The similar timing across age groups is easy to explain if it was the J&J pause (everyone saw the pause at the same time) but it requires multiple coincidences to explain why every age group would reach their hesitancy point at different levels of vaccination but at the same time.
My view is that neither the CDC nor the FDA should be playing psychological games with the public. Just give it to us straight. In this case, since there was never much doubt that the J&J vaccine was much safer than COVID, a bulletin to physicians would have been appropriate to the circumstances. We don’t know for certain what would have happened under that counterfactual (although the data from Britain v. Europe on the AZ pause suggest a bulletin would not have generated the same hesitancy) but it would have been the right decision on the evidence.
See Bier’s tweet thread for further breakdown of the data.
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 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.
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…
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.