Results for “fda” 324 found
Update on Rapid Antigen Tests
In July of 2020 in Frequent, Fast and Cheap is Better than Sensitive, I wrote:
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.
It’s depressing that we are still moving so slowly on these issues but the media has finally gotten on board. Earlier I mentioned David Leonhardt’s article. Here is Margaret Hartmann in the New York Magazine.
In many Asian and European countries, at-home COVID-19 tests are cheap and easy to find in stores. CBS News reported this month that home antigen tests are now used routinely in the U.K., where they are free and “readily available at pretty much every pharmacy in the country.”
The situation is drastically different here because U.S. health officials focused on getting people vaccinated against COVID-19 and never leaned into asymptomatic testing as a strategy to fight the pandemic. While some foreign governments moved quickly to encourage screening and subsidize the cost of at-home tests, the Food and Drug Administration’s approval process moved much more slowly.
….The FDA said it needed to ensure that the tests were accurate, but many scientists countered that the agency was letting the perfect be the enemy of the good.
Note also that this is a way of saying that the politicians have now also had it with the FDA:
In addition to ramping up production of tests already on the market, the government is also working to speed up the approval process. On October 4, the FDA authorized Flowflex, an at-home antigen test produced by ACON Laboratories that is expected to retail for around $10 per test. And on October 25, the Department of Health and Human Services announced that the FDA will streamline its authorization process, and the National Institutes of Health will spend $70 million on a new program to “establish an accelerated pathway” to aid test makers seeking approval for their products.
From Kalshi Markets
I wanted to reach out and provide some updates about new markets on the Exchange that may be of interest. We have a new market on whether the FDA will approve a vaccine for kids, in addition to a market on whether the CDC will identify a “variant of high consequence” (Delta is only a “variant of concern”). We also have markets about whether the Fed will taper at its next meeting, whether the U.S. will raise the debt ceiling before October 19, and whether or not Jerome Powell will be replaced….We also have markets on whether the capital gains and corporate tax will be raised, in case that’s of interest.
Go trade!
From the comments, on boosters and Covid policy
My first reaction upon hearing that boosters were rejected was to ask the same thing: would these same “experts” say that, because the vaccines are still effective without boosters, vaccinated persons don’t need to wear masks and can resume normal life? Of course not. They use the criterion “prevents hospitalization” for evaluating boosters (2a) but switch back to “prevents infection” when the question is masks and other restrictions. What about those that are willing to accept the tiny risk of side effects to prevent infection so that they can get back to fully normal life? The Science (TM) tells us that one can’t transmit the virus if one is never infected to begin with.
Also, one of the No votes on boosters said that he feared approval would effectively turn boosters into a mandate and change the definition of fully vaccinated. So, it appears that the overzealousness to demand vaccine mandates has actually contributed to fewer people getting access to (booster) vaccines, thus paradoxically contributing to spread. A vivid illustration of the problem with, “That which is not mandatory should be prohibited.”
The biggest problem with public health professionals continues to be (1) elevation of their own normative value judgements — namely that NPIs are no big deal no matter how long they last — which have nothing to do with scientific expertise, (2) leading them to “shade” their interpretation of data to promote their preferred behavioral outcome rather than answering positive (non-normative) questions with positive scientific statements, (3) thus undermining the credibility of public health institutions (FDA, CDC) and leading to things like vaccine hesitancy.
That is from BC.
What’s the Right Dose for Boosters?
The Biden administration says booster shots are coming, but the FDA hasn’t decided on the dose. Moderna wants a half-shot booster. Pfizer a full shot. But could the best dose for Americans and for the world be even less?
COVID-19 vaccines are the first successful use of mRNA vaccine technology, so a lot remains unknown. But identifying the smallest dose needed to provide effective boosting is critical to protect Americans from adverse effects, increase confidence in vaccines, and mitigate global vaccine inequity.
We’ve known since earlier this year that a half-dose of the Moderna vaccine produces antibody levels similar to the standard-dose and newer information suggests that even a quarter-dose vaccine may do the same. If a half or quarter dose is nearly as effective as a standard dose for first and second shots then a full dose booster may well be an overdose. The essential task of a booster is to “jog” the immune system’s memory of what it’s supposed to fight. Data from the world of hepatitis B suggest that the “reminder” need not be as intense as the initial “lesson.” And in the cases of tuberculosis, meningitis, and yellow fever vaccines, lower doses have been as good or better than the originals.
Lower doses could also reduce risks of adverse effects.
That’s myself and physicians Garth Strohbehn and William F. Parker on the Med Page Today. Strohbehn is an oncologist and specialist in optimizing doses for cancer drugs. William Parker is a pulmonologist and professor of medicine at the University of Chicago.
Monday assorted links
1. You can now buy a $475 NFT ticket to see Beeple’s $69 million NFT at an IRL party. The ticket also includes one drink.
3. In the early stages of pandemics, do they spread more amongst people of higher status?
4. The exclusionary history of the FHA.
5. Excerpts from me on how to read.
6. The Japanese are better at reading Twitter.
7. Tensions between the CDC and Biden administration mount. Which one do you think is coming closer to trying to maximize expected value? It turns out even the FDA thinks the CDC is too slow.
Yet another underreported medical scandal — the overmedicated elderly
“Add Dx of schizophrenia for use of Haldol,” read the doctor’s order, using the medical shorthand for “diagnosis.”
But there was no evidence that Mr. Blakeney actually had schizophrenia.
Antipsychotic drugs — which for decades have faced criticism as “chemical straitjackets” — are dangerous for older people with dementia, nearly doubling their chance of death from heart problems, infections, falls and other ailments. But understaffed nursing homes have often used the sedatives so they don’t have to hire more staff to handle residents…
The share of residents with a schizophrenia diagnosis has soared 70 percent since 2012, according to an analysis of Medicare data. That was the year the federal government, concerned with the overuse of antipsychotic drugs, began publicly disclosing such prescriptions by individual nursing homes.
Today, one in nine residents has received a schizophrenia diagnosis. In the general population, the disorder, which has strong genetic roots, afflicts roughly one in 150 people.
Schizophrenia, which often causes delusions, hallucinations and dampened emotions, is almost always diagnosed before the age of 40.
Here is more from the NYT, not unrelated to issues of guardianship of course. Furthermore, this tale does not exactly fit the usual “not enough medical care for the poor” narratives, and perhaps that is why the issue has not caught on more. The medical profession even appears to be slightly…suboptimal in its ethical procedures.
For the pointer I thank Michelle Dawson.
Wednesday assorted links
1. Is America’s aerospace industry regenerating?
2. Sam Enright’s guide to recreational math videos on-line.
3. “A good start” — they should be working for us, not us for them. And yes I believe in following the science — the science of expected utility maximization. They are the ones who do not really believe in science, just their own status within their own branch of science.
4. What kind of Berkeley protest is this?
Solve for the Fairfax County third dose equilibrium
I am genuinely unsure how this one is going to play out:
There is no proof of medical condition required to receive a third dose of vaccine at one of the Fairfax County Health Department vaccination sites, and individuals will not be asked to provide medical documentation.
Then there is this insanity, for people who in expected value terms need it most:
There is not enough information to recommend an additional vaccine dose for people who have received the Johnson & Johnson vaccine. Studies are currently underway to evaluate the protection provided by the Johnson & Johnson vaccine to people with weakened immune systems. Recommendations for these people will be coming in the near future. The Centers for Disease Control and Prevention does not recommend that people with a compromised immune system who have received a dose of the Johnson & Johnson vaccine start a new vaccination series with Pfizer or Moderna.
But I guess we’ll be telling them something different a few weeks from now! Or maybe not. Here is the cited press release.
Electric shock devices on humans now allowed once again
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.
Further Monday assorted links
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?
9. Why the new Elon Musk rocket really will matter?
10. Why a new business surge in black communities during the pandemic? (NYT)
Cold Storage No Longer a Constraint
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.
Windows not Windex
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).
Prescription Only Apps????
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.
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.
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!