Results for “fda” 402 found
The panel also seemed intrigued by preliminary data suggesting that Johnson & Johnson recipients may be better off with a booster shot from Moderna or Pfizer. Although no vote was taken, Dr. Peter Marks, who oversees the F.D.A.’s vaccine division, said regulatory action to allow boosters with a different vaccine was “possible.”
While some experts emphasized that the data was based on small groups of volunteers and short-term findings, others urged the F.D.A. to move quickly with what has fast become known as a mix-and-match approach, especially for recipients of Johnson & Johnson’s vaccine, which is much less widely available.
“I’m sold already,” said Dr. Mark Sawyer, an infectious disease specialist with the University of California San Diego School of Medicine. “We need flexibility and to improve access to everyone.”
Others said they worried that the public would end up bewildered if the government kept broadening the categories of people eligible for boosters and which vaccine could be used for extra shots.
“I hope we can do this in a way that doesn’t look like we’re changing rules all the time,” said Dr. Stanley Perlman, a professor of immunology at the University of Iowa.
Health officials and committee members suggested on Friday that the single-shot Johnson & Johnson vaccine had long been less protective. In a particularly biting critique, Dr. Amanda Cohn, a high-ranking C.D.C. medical officer, said a single dose of Johnson & Johnson’s vaccine offered less protection than two doses of the mRNA vaccines made by Pfizer or Moderna — a gap that would only grow if it remained a one-shot regimen while the other two-shot vaccines were followed by a booster…
The experts generally agreed that the protection conferred by a single dose was inadequate, but at least some were unconvinced that the second dose would bolster that protection significantly.
The smart people I know who started with J&J took this matter into their own hands some time ago, typically opting for an mRNA supplement. They are just “people,” yet they had “skin in the game” and they are miles ahead of the FDA and CDC as formal institutions. Here is a research paper on the question. Here is another. And here is a Paul Sax tweet and Op-Ed: “Don’t know anyone who disagrees with this, and the data have been highly suggestive for months.” And this is after the authorities insisted for months that all vaccines will be treated the same.
Again, I will repeat the perennial question: do our public health agencies wish to maximize their own status and control and feeling of “having done everything properly as they were trained,” or do they wish to maximize the expected value of actual outcomes for the citizenry? If it is not the latter, and too often it is not, I say they are oppressive frauds. (And please don’t try to tell me this kind of craperoo is boosting their credibility — in fact they have lost massive credibility with America’s public intellectual class, both left wing and right wing and for that matter centrist.)
I really do not have much sympathy for Kyrie Irving and Bradley Beal and their ilk, but in fact their views are more understandable than you might think from reading MSM. Their generalized mistrust is not so crazy, even though they are quite wrong in this particular instance. By the way, don’t take those aspirin any more!
Operation Warp Speed showed that we can move much faster. FDA delay in approving rapid tests shows that we should move much faster. There is a window of opportunity for reform. The excellent Bart Madden and Siri Terjesen argue for the Promising Pathways Act.
One particularly exciting development is the Promising Pathway Act (PPA), recently introduced in Congress. PPA would reduce bureaucracy via legal changes and provide individuals with efficient early access to potential new drugs.
Under PPA, new drugs will receive provisional approval five to seven years earlier than the status quo via a two-year provisional approval. Drugs that demonstrate patient benefits could be renewed for a maximum of six years, and the FDA could grant full approval at any time based on real-world as opposed to clinical trial data documenting favorable treatments results.
The PPA allows patients, advised by their doctors, to choose early access to promising but not-yet-FDA -approved drugs. Patients and doctors would make informed decisions about using either approved or new medicines that demonstrate safety and initial effectiveness compared to approved drugs.
…Patients and doctors can log into an internet registry database for early access drugs that would contain treatment outcomes, side effects, genetic data, and biomarkers. Scientific researchers, as well as patients, will also benefit from the identification of subgroups of patients who do exceptionally well or fail to respond.
Data from the registry will open knowledge pathways to improve the biopharmaceutical industry’s research outlays to benefit future patients.
With radically lower regulatory costs plus heightened competition as more companies participate, expect substantially lower prescription drug prices for provisional approval drugs.
Here is the text of the PPA.
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.
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.
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.
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.
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.
Operation Warp Speed was by far the most successful government program against COVID. But as of yet there is very little discussion or history of the program. As just an indication I looked for references in a bunch of pandemic books to General Perna who co-led OWS with Moncef Slaoui. Michael Lewis in The Premonition never mentions Perna. Neither does Slavitt in Preventable. Nor does Wright in The Plague Year. Nor does Gottlieb in Uncontrolled Spread. Abutaleb and Paletta in Nightmare Scenario have just two index entries for Perna basically just stating his appointment and meeting with Trump.
Yet there are many questions to be asked about OWS. Who wrote the contracts? Who chose the vaccines? Who found the money? Who ran the day to day operation? Why was the state and local rollout so slow and uneven? How was the DPA used? Who lifted the regulations? How was the FDA convinced to go fast?
I don’t know the answer to these questions. I suspect when it is all written down, Richard Danzig will be seen as an important behind the scenes player in the early stages (I was involved with some meetings with him as part of the Kremer team). Grogan at the DPC seems under-recognized. Peter Marks at the FDA was likely extremely important in getting the FDA to run with the program. Marks brought people like Janet Woodcock from the FDA to OWS so you had a nominally independent group but one completely familiar with FDA policy and staff and that was probably critical. And of course Slaoui and Perna were important leaders and communicators with the private sector and the logistics group but they have yet to be seriously debriefed.
It’s also time for a revisionist account of President Trump’s Council of Economic Advisors. Michael Kremer and I spoke to the DPC and the CEA early on in the pandemic and argued for a program similar to what would later be called OWS. The CEA, however, was way ahead of the game. In Sept of 2019 (yes, 2019!) the CEA produced a report titled Mitigating the Impact of Pandemic Influenza through Vaccine Innovation. The report calculates the immense potential cost of a pandemic and how a private-public partnership could mitigate these costs–all of this before anyone had heard the term COVID. Nor did that happen by accident. Thomas Philipson, the CEA chair, had made his reputation in the field of economic epidemiology, incorporating incentives and behavioral analysis in epidemiological models to understand HIV and the spread of other infectious diseases. Eric Sun, another CEA economist, had also written with Philipson about the FDA and its problems. Casey Mulligan was another CEA chief economist who understand the danger of pandemics and was influenced by Sam Peltzman on the costs of FDA delay. So the CEA was well prepared for the pandemic and I suspect they gave Trump very good advice on starting Operation Warp Speed.
In short, someone deserves credit for a multi-trillion-dollar saving government program! More importantly, we know a lot about CDC and FDA failure but in order to know what we should build upon we also need to know what worked. OWS worked. We need a history of how and why.
“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.
Australia is now one of the most authoritarian states in the world. Conor Friedersdorf writes:
Australia is undoubtedly a democracy, with multiple political parties, regular elections, and the peaceful transfer of power. But if a country indefinitely forbids its own citizens from leaving its borders, strands tens of thousands of its citizens abroad, puts strict rules on intrastate travel, prohibits citizens from leaving home without an excuse from an official government list, mandates masks even when people are outdoors and socially distanced, deploys the military to enforce those rules, bans protest, and arrests and fines dissenters, is that country still a liberal democracy?
As I noted earlier, Australia is in clear contravention of the UN Declaration of Human Rights, Article 13 of which states:
- Everyone has the right to freedom of movement and residence within the borders of each state.
- Everyone has the right to leave any country, including his own, and to return to his country.
To give Australia’s approach its due, temporary restrictions on liberty were far more defensible early in the pandemic…Had it behaved rationally and adequately valued liberty, a rich nation like Australia would have spent lavishly—before knowing which vaccines would turn out to be most effective—to secure an adequate supply of many options for its people. It could afford to eat the cost of any extra doses and donate them to poorer countries. Australia then could have marshaled its military and civil society to vaccinate the nation as quickly as possible, lifted restrictions more fully than Europe and the United States did, and argued that the combination of fewer deaths and the more rapid return to normalcy made their approach a net win.
Instead, Australia invested inadequately in vaccines and, once it acquired doses, was too slow to get them into arms. “Of the 16 million doses of the AstraZeneca vaccine that have been released to the government by manufacturer CSL, only about 8 million have gone into the arms of Australians,” The Age reported on August 21, citing concern about blood clots and a widespread preference for the Pfizer vaccine.
…Because of its geography, Australia is a neighbor and an observer of authoritarian countries as varied as China and Singapore. But its own fate, too, may turn on whether its people crave the feeling of safety and security that orders from the top confer, or whether they want to be free.
Australians largely support the restrictions but to me that makes them all the more disturbing.
Temporary restrictions on liberty can be justified in an emergency if the restrictions produce something else of great value but respecting the great value of liberty and individual rights means doing everything in one’s power to limit the scope of and lift such restrictions as quickly and completely as possible.
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.
We have vaccine abundance in the United States but not test abundance. Germany has test abundance. Tests are easily available at the supermarket or the corner store and they are cheap, five tests for 3.75 euro or less than a dollar each. Billiger! In Great Britain you can get a 14 pack for free. The Canadians are also distributing packs of tests to small businesses for free to test their employees.
In the United States, the FDA has approved less than a handful of true at-home tests and, partially as a result, they are expensive at $10 to $20 per test, i.e. more than ten times as expensive as in Germany. Germany has approved over 50 of these tests including tests from American firms not approved in the United States. The rapid tests are excellent for identifying infectiousness and they are an important weapon, alongside vaccines, for controlling viral spread and making gatherings safe but you can’t expect people to use them more than a handful of times at $10 per use.
We ought to have testing abundance in the US and not lag behind Germany, the UK and Canada. As usual, I say if it’s good enough for the Germans it’s good enough for me.
Addendum: The excellent Michael Mina continues to bang the drum.
That is a key theme of my latest Bloomberg column, here is one excerpt:
In the U.S., President Joe Biden’s administration is now pushing third booster shots for people who already have been vaccinated. That might be a good idea, but it too creates additional uncertainty for travel and migration — and for social interaction more broadly. If three doses are so important, should people be allowed to travel (or for that matter interact indoors) with only two doses? The bar is raised yet again.
Of course the issues do not end with the third dose. If the efficacy of the second dose declines significantly in less than a year, might the same happen with the third dose? How long before four doses are necessary, or maybe five? Or what if yet another significant Covid variant comes along, and only some people have a booster dose against that strain? What then counts as being “sufficiently vaccinated”?
Many Americans seem to be keen to get their third dose, but by the nature of counting that number is fewer than the number willing to get two doses. Furthermore, many people might just tire of the stress of dealing with an ongoing stream of obligatory booster shots and stop at one or two.
The sad reality is that the “two-dose standard” may not last very long, whether abroad or domestically (the same is true of the even weaker one-dose standard with Johnson & Johnson and AstraZeneca). Vaccine mandates will become harder to define and enforce, will be less transparent, and will probably be less popular.
If you tell people that three doses are needed for safety, but two doses are enough to get you into a concert or government building, how are they supposed to sort out the mixed messages? It is not obvious that enough people will get the third dose in a timely manner to make that a workable standard for vaccine passports.
Add to that the problems with the Johnson & Johnson vaccine, which originally the government urged people to get. Now those people are not being given comparable chances to obtain boosters — in fact, they are not yet being given specific guidance at all. Are they orphaned out of any new vaccine passport system, or will (supposedly dangerous?) exceptions be made for them? Or do they just have to start all over?
The big international winner from all this is likely to be Mexico, which has remained an open country and is not relying on vaccine passports. In general I do not admire Mexico’s lackadaisical Covid response, but the country may end up in a relatively favorable position, most of all when it comes to tourism and international business meetings.
As for the U.S. and Europe, the temptation to escalate required safety measures is understandable. But the previous vaccine standards were largely workable ones. If they are made tougher, they might break down altogether.
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.
Delta is the fourth wave of covid, and amazingly the US policy response is even more irresolute than the first time around. Our government is like a child, sent next door to get a cup of sugar, who gets as far as the front stoop and then wanders off following a puppy.
The policy response is now focused on the most medically ineffective but most politically symbolic step, mask mandates. An all-night disco in Provincetown turns in to a superspreader event so… we make school kids wear masks in outdoor summer camps? Masks are several decimal places less effective than vaccines, and less effective than “social distance” in the first place.* Go to that all night disco, unvaccinated, but wear a mask? Please.
If we’re going to do NPI (non pharmaceutical interventions), policy other than vaccines, the level of policy and public discussion has tragically regressed since last summer. Last summer, remember, we were all talking about testing. Alex Tabarrok and Paul Romer were superb on how fast tests can reduce the reproduction rate, even with just voluntary isolation following tests. Other countries had competent test and tracing regimes. Have we built that in a year? No. (Are we ready to test and trace the next bug? Double no.)
What happened to the paper-strip tests you could buy for $2.00 at Walgreen’s, get instant results, and maybe decide it’s a bad idea to go to the all night dance party? Interest faded in November. (Last I looked, the sellers and FDA were still insisting on prescriptions and an app sign up, so it cost $50 and insurance “paid for” it.) What happened to detailed local data? Did anyone ever get it through the FDA’s and CDCs thick skulls that even imperfect but cheap and fast tests can be used to slow spread of disease?
…And then we indulge another round of America’s favorite pastime, answers in search of a question. Delta is spreading, so… extend the renter eviction moratorium. People who haven’t paid rent in a year can stay, landlords be damned.
All true. I got dispirited on testing. It’s insane that we don’t have cheap, rapid testing and good ventilation ready for a new school year. As I wrote about earlier, even the American Academy of Pediatrics is shouting from the rooftops that the FDA is deadly slow. The eviction moratorium is a sick joke. Just a backhanded way to redistribute wealth without a shred of justice or reason. Disgusting.
Here’s one more bit (but read the whole thing there is more.)
To learn from the mistakes, and institutionalize better responses would mean to admit there were mistakes. One would think the grand blame-Trump-for-everything narrative would allow us to do that, but the mistakes are deeply embedded in the bureacracies of the administrative state. Unlike bad admirals in WWII, nobody less than Trump himself has lost their job over incompetent covid response. The institutions have an enormous investment in ratifying that they did the best possible job last time. So, as in so many things (financial bailouts!) we institutionalize last time’s mistakes to keep those who made them in power in power — which means we do not learn from mistakes.
A good case can be made that Project Bioshield is the most important piece of legislation passed in the last twenty years. Passed under President Bush in 2004, Project Bioshield’s primary goal was to create advance market commitments to purchase countermeasures for chemical, biological, radiological or nuclear agents (CBRN). Several billion dollars have been spent in this area promoting anthrax and smallpox vaccines and various antitoxins for botulism and nuclear threats. The record on these advance market commitments is mixed with some notable failures.
The second thing the act did is to reduce some paperwork requirements on purchases and research funding. Those seem fine although the simplified procedure is itself too complex and the amounts such simplified procedures apply to are too small, e.g.
The Project Bioshield Act authorizes the HHS Secretary to use an expedited award process for grants, contracts, and cooperative agreements related to CBRN countermeasure R&D Activity, if the Secretary deems a pressing need for an expedited award exists. The authority is limited to awards of $1.5 million or less.
The third aspect of the act was not considered a big deal at the time but is the one that has proved to be the most important. Project Bioshield created the Emergency Use Authorization (EUA). In other words, prior to 2004 the FDA had no clear legislative authority to authorize an unapproved vaccine, drug or device. Without Project Bioshield and the EUA procedure the FDA might have eventually found some way to authorize vaccines before full approval. Britain, for example, used a temporary authorization procedure. Or the FDA might have sped up full approval but given the FDA’s lethargic record it’s easy to imagine that this would have taken months longer than the EUA process. As a result, the EUA procedure created by Project Bioshield probably saved 100,000 or more lives.
Important Addendum: It’s also worth mentioning that the EUA procedure doesn’t just apply to approvals it also allows changes in dosage and labeling. Susan Sherman, the senior attorney with the HHS Office of the General Counsel, noted in 2009 that a drug that had been approved for individual health in a non-emergency might have to be used very differently for public health in an emergency and that the EUA process could be used to adjust to these differences:
“You can change the labeling. You can change the information. You can change the dosage. You can give it to populations for which wasn’t approved.” She continued, “In some sense we had to match up in practice a public health response where you might not have the precise labeling that your physician would prescribe to you. There are a lot of variables that are necessary for the public health responders that don’t necessarily match what the approved drug would look like if you just went to your physician and got it because you had that illness.
In other words, the EUA process was made to allow for procedures such as fractional dosing. It’s too late for fractional dosing in the United States (but we should use it for boosters) but fractional dosing remains a vital tool to deal with the global shortage of vaccines.