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FDA Approves American Rapid Antigen Test

I wrote earlier:

What makes the FDAs failure to approve more rapid antigen tests even more galling is that the test being sold cheaply in the Amsterdam supermarket is the Flowflex, an American test made by Acon Labs in San Diego.

Well the FDA has finally approved the Acon test! Apparently it is good enough for the Germans and for US citizens. Hoorah! USA Today notes:

ACON expects to make 100 million tests per month by the end of this year. Production could double to 200 million monthly tests by February, according to the FDA.

…The United Kingdom and Germany have made significant purchases of home tests and widely distributed them to their residents to slow the spread of coronavirus. Such large government purchases allowed manufacturers to continue making tests even when demand softened as cases dropped.

The Biden administration will spend nearly $1.2 billion to purchase up to 187 million home tests from Abbott Laboratories and Celltrion Inc., company officials confirmed. The Department of Defense announced additional contracts totaling $647 million to buy 60 million kits from Abbott and three other testing vendors: OraSure Technologies, Quidel and Intrivio Holdings.

The FDA has authorized seven antigen-based tests that can be used at home without a prescription. The EU has authorized 21 tests beginning with the letter A (I am not sure all of these are authorized for home use but you get the idea.) Turtle slow. Still this is a big improvement.

Frankly, I think all the pressure from people like Michael Mina amplified by myself and others over 18 months and culminating in David Leonhartd’s NYTimes article Where Are the Tests? finally pushed them over the edge.

The NYTimes on the FDA and Rapid Tests

In July of 2020 I wrote in Frequent, Fast, and Cheap is Better than Sensitive:

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.

…The PCR tests can discover virus at significantly lower concentration levels than the cheap tests but that extra sensitivity doesn’t matter much in practice. Why not? First, at the lowest levels that the PCR test can detect, the person tested probably isn’t infectious. The cheap test is better at telling whether you are infectious than whether you are infected but the former is what we need to know to open schools and workplaces.

It’s great that other people including the NYTimes are now understanding the problem. Here is the excellent David Leonhardt in Where are the Tests?

Other experts are also criticizing the Biden administration for its failure to expand rapid testing. Even as President Biden has followed a Covid policy much better aligned with scientific evidence than Donald Trump’s, Biden has not broken through some of the bureaucratic rigidity that has hampered the U.S. virus response.

In the case of rapid tests, the F.D.A. has loosened its rules somewhat over the past year, allowing the sale of some antigen tests (which often cost about $12 each). But drugstores, Amazon and other sellers have now largely run out of them. I tried to buy rapid tests this weekend and couldn’t find any.

The F.D.A.’s process for approving rapid tests is “onerous” and “inappropriate,” Daniel Oran and Dr. Eric Topol of Scripps Research wrote in Stat News.

For the most part, the F.D.A. still uses the same cumbersome process for approving Covid tests that it uses for high-tech medical devices. To survive that process, the rapid tests must demonstrate that they are nearly as sensitive as P.C.R. tests, which they are not.

But rapid tests do not need to be so sensitive to be effective, experts point out. P.C.R. tests often identify small amounts of the Covid virus in people who had been infected weeks earlier and are no longer contagious. Rapid tests can miss these cases while still identifying about 98 percent of cases in which a person is infectious, according to Dr. Michael Mina, a Harvard epidemiologist who has been advocating for more testing

Identifying anywhere close to 98 percent of infectious cases would sharply curb Covid’s spread. An analysis in the journal Science Advances found that test frequency matters more for reducing Covid cases than test sensitivity.

As I said on twitter what makes the FDA’s failure to approve more rapid antigen tests especially galling is that some of the tests being sold cheaply in Europe are American tests just ones not approved in the United States. If it’s good enough for the Germans it’s good enough for me!

The FDA and CDC Standards on the J&J Vaccine and the Immunocompromised are Unintelligible

Last week the FDA authorized and the CDC now recommends a third mRNA booster for the immunocomprimised. The CDC says:

Who Needs an Additional COVID-19 Vaccine?

Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. This includes people who have:

  • Been receiving active cancer treatment for tumors or cancers of the blood
  • Received an organ transplant and are taking medicine to suppress the immune system
  • Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
  • Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

That’s very reasonable but the headline is inaccurate because the CDC then goes on to say:

The FDA’s recent EUA amendment only applies to mRNA COVID-19 vaccines, as does CDC’s recommendation.

Emerging data have demonstrated that immunocompromised people who have low or no protection following two doses of mRNA COVID-19 vaccines may have an improved response after an additional dose of the same vaccine. There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine.

So if you got one dose of J&J and are immunocompromised then you can’t get a second dose. But if you got two doses of an mRNA (which is already more effective than one dose of J&J) and are immunocompromised then the CDC recommends a third dose. None of this makes any sense. The weasel words there ‘isn’t enough data to determine’ indicate a typical failure to think in Bayesian terms and use all the information available and a typical failure to think in terms of patient welfare and expected cost and benefits.

Notice also the illiberal default. Instead of saying ‘we don’t have data on the J&J vaccine and the immunocompromised so we are not at this time recommending or not recommending boosters but leaving this decision in the hands of patients and their physicians’ they say ‘we don’t have data and so we are forbidding patients and their physicians from making a decision using their own judgment.’

Hat tip: Pharmacist CB.

The TGA is Worse than the FDA, and the Australian Lockdown

I have been highly critical of the FDA but in Australia the FDA is almost a model to be emulated. Steven Hamilton and Richard Holden do not mince words:

At the end of 2020, as vaccines were rolling out en masse in the Northern Hemisphere, the TGA [Therapeutic Goods Administration, AT] flatly refused to issue the emergency authorisations other regulators did. As a result, the TGA didn’t approve the Pfizer vaccine until January 25, more than six weeks after the US Food and Drug Administration (FDA), itself not exactly the poster child of expeditiousness.

Similarly, the TGA didn’t approve the AstraZeneca vaccine until February 16, almost seven weeks after the UK.

In case you’re wondering “what difference does six weeks make?“, think again. Were our rollout six weeks faster, the current Sydney outbreak would likely never have exploded, saving many lives and livelihoods. In the face of an exponentially spreading virus that has become twice as infectious, six weeks is an eternity. And, indeed, nothing has changed. The TGA approved the Moderna vaccine this week, eight months after the FDA.

It approved looser cold storage requirements for the Pfizer vaccine, which would allow the vaccine to be more widely distributed and reduce wastage, on April 8, six weeks after the FDA. And it approved the Pfizer vaccine for use by 12 to 15-year-olds on July 23, more than 10 weeks after the FDA.

And then there’s the TGA’s staggering decision not to approve in-home rapid tests over reliability concerns despite their widespread approval and use overseas.

Where’s the approval of the mix-and-match vaccine regimen, used to great effect in Canada, where AstraZeneca is combined with Pfizer to expand supply and increase efficacy? Where’s the guidance for those who’ve received two doses of AstraZeneca that they’ll be able to receive a Pfizer booster later?

In the aftermath of the pandemic, when almost all of us should be fully vaccinated,there will be ample opportunity to figure out exactly who is to blame for what.

But the slow, insular, and excessively cautious advice of our medical regulatory complex, which comprehensively failed to grasp the massive consequences of delay and inaction, must be right at the top of that list.

You might be tempted to argued that the TGA can afford to take its time since COVID hasn’t been as bad in Australia as in the United States but that would be to ignore the costs of the Australian lockdown.

Article 13 of the Universal Declaration of Human Rights states that

  1. Everyone has the right to freedom of movement and residence within the borders of each state.
  2. Everyone has the right to leave any country, including his own, and to return to his country.

Australia has now violated each and every clause of this universal human right and seemingly without much debate or objection. It is deeply troubling to see people prevented from leaving or entering their own country and soldiers in the street making sure people do not travel beyond a perimeter surrounding their homes. The costs of lockdown are very high and thus so is any delay in ending these unprecedented infringements on liberty.

The American Academy of Pediatrics Tells the FDA to Speed Up and Stop Endangering Patients

The American Academy of Pediatrics has written a stunning letter to the FDA:

We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials of their COVID-19 vaccines. While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group. In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort in the post-market setting. This approach would not slow down the time to authorization of these critically needed vaccines in the 5–11-year age group.

In addition, as FDA continues to evaluate clinical trial requirements for children under 5 years, we similarly urge FDA to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group. Based on scientific data currently available on COVID-19 vaccines, as well as on 70 years of vaccinology knowledge in the pediatric population, the Academy believes that clinical trials in these children can be safely conducted with a 2-month safety follow-up for participants. Assuming that the 2-month safety data does not raise any new safety concerns and that immunogenicity data are supportive of use, we believe that this is sufficient for authorization in this and any other age group. Waiting on a 6-month follow-up will significantly hinder the ability to reduce the spread of the hyper infectious COVID-19 Delta variant among this age group, since it would add 4 additional months before an authorization decision can be considered. Based on the evidence from the over 340 million doses of COVID-19 doses administered to adults and adolescents aged 12-17,as well as among adults 18 and older, there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine administration.

In my many years of writing about the FDA, I can’t recall a single instance in which a major medical organization told the FDA to use a smaller trial and speed up the process because FDA delay was endangering the safety of their patients. Wow.

The invisible graveyard is invisible no more.

The FDA Is Still Much Too Strict

Here is just one bit from a superb post on the FDA by psychiatrist Scott Alexander at Astral Codex Ten.

I worry that people are going to come away from this with some conclusion like “wow, the FDA seemed really unprepared to handle COVID.” No. It’s not that specific. Every single thing the FDA does is like this. Every single hour of every single day the FDA does things exactly this stupid and destructive, and the only reason you never hear about the others is because they’re about some disease with a name like Schmoe’s Syndrome and a few hundred cases nationwide instead of something big and media-worthy like coronavirus. I am a doctor and sometimes I have to deal with the Schmoe’s Syndromes of the world and every [email protected]$king time there is some story about the FDA doing something exactly this awful and counterproductive.

A while back I learned about Infant Short Bowel Syndrome, a rare condition with only a few hundred cases nationwide. Babies cannot digest food effectively, but you can save their lives by using an IV line to direct nutrients directly into their veins. But you need to use the right nutrient fluid. The FDA approved an early draft of the nutrient fluid, but it didn’t have enough fish oil, which is necessary for development, so a lot of the babies still died or ended up with permanent neurological damage. Around the late 90s/early 00s, researchers figured out what was going on and recommended adding fish oil to the IV fluid. The FDA responded that they had only approved the non-fish-oil version, it would take them a while to approve the new version, and until they did that adding fish oil was illegal. A bunch of babies kept dying and getting permanent neurological damage, and everyone knew exactly how to stop it, but if anyone did the FDA would take away their licenses and shut them down. Around 2010, Boston Children’s Hospital found some loophole that let them add fish oil to their nutrient fluid on site, and infants with short bowel syndrome at that one hospital stopped dying or ending up permanently disabled, and the FDA grudgingly agreed to permit it but banned them from distributing their formulation or letting it cross state lines – so for a while if you wanted your baby not to die you had to have them spend their infancy in one specific hospital in Massachusetts. Around 2015 the FDA said that if your doctor applied for a special exemption, they would let you import the correct nutritional fluid from Europe (where, lacking the FDA, they had just added fish oil to the fluid as soon as researchers discovered it was necessary), but you were only able to apply after your baby had already sustained serious damage, and the FDA might just say no. Finally in 2018 the FDA got around to approving the corrected nutritional fluid and now babies with short bowel syndrome do fine, after twenty years of easily preventable state-mandated deaths. And it’s not just this and coronavirus, I CANNOT STRESS ENOUGH HOW TYPICAL THIS IS OF EVERYTHING THE FDA DOES ALL THE TIME.

Read the whole thing! I actually had to read it in several sessions, it’s not that long but bouts of anger interspersed with moments of laughter made me have to put it down momentarily to recover. There is a lot more in the post on reforms.

Best quick intro to my views on the FDA is this post (follow the links) and my paper on off-label prescribing.

Addendum: Scott updates the infant fish oil story and provides much more detail. He got some things wrong and the FDA as an agency ends up looking better but the broad outline about the FDA system looks right. I am leaving the post up for posterity but this specific part isn’t correct.

My Conversation with Daniel Carpenter, on regulation and also the FDA

Here is the audio, video, and transcript, I found it a very substantive and also illuminating episode.  Carpenter is very, very smart and also very well-informed historically.  Here is part of the summary:

Daniel Carpenter is one of the world’s leading experts on regulation and the foremost expert on the US Food and Drug Administration. A professor of Government at Harvard University, he’s conducted extensive research on regulation and government organizations, as well as on the development of political institutions in the United States. His latest book Democracy by Petition: Popular Politics in Transformation, details the crucial role petitions played in expanding the franchise and shaping modern America.

Here is an excerpt from the non-FDA section, much of which focuses on (non-FDA) regulation:

COWEN: What kinds of records should the Postal Service keep about itself?

CARPENTER: [laughs] Great question. There’s a whole set of things that they don’t since the Griswold decision and since the First Amendment decisions. They don’t keep as much records of what goes through the mail. They can’t prohibit things like pornography, contraception.

I guess it depends on what you mean by “itself.” I would start with the idea that basic privacy restrictions, which governed the postal system as much through norm as by law in the 19th century and early 20th century, should govern the system.

It’s a crime if I were to walk past your mailbox and open your letter. I’m committing a federal crime, but there were also norms that seals were not to be broken, things like that. I do think whichever way the Postal Service goes — and it’s quite possible that you could imagine an electronic platform for the US postal system — I think basic privacy restrictions have to be guaranteed.

Actually, in some respects, I think we need to know a fair amount about what postal workers do without, say, calling for Amazon tracking. But if we think that postal workers are misplacing ballots or not providing birth control pills or something like that, then we should probably have some way of picking up on that kind of nefarious behavior.

In the FDA section I got mad at him, the first (but not last?) time that has happened in a CWT, do read or listen to the whole section, the two of us really had at it!  Here is a tiny sliver from it:

COWEN: But shouldn’t there be a button within the FDA that can be pushed, where the FDA goes into a kind of wartime mode?

I don’t want to misrepresent Carpenter by an ill-chosen excerpt, so please do digest his full set of replies.  Recommended.

From the comments, on FDA credibility

This maybe a violation of Cowen’s second law, but my cursory examination turns up no useful hits in PubMed about FDA credibility. We have the odd op-ed, some drivel about people thinking the FDA is more credible about cigarettes when they learn that FDA regulates cigarette manufacture, and precious little else of remote utility.

Almost as though senior FDA leadership have not bothered, after over a year of pandemic to even commission a rigorous survey of which action(s) the public would view as credible. Certainly what they are doing is not coherent with any of the effective medical communication techniques I was taught nor with any of my training for dealing with public responses to calamity.

But maybe I’m wrong. Maybe somewhere the FDA dumped a couple of grand into even a Mechanical Turk survey to justify actions that will have billions in cost implications and might lead to the death of thousands of folks (particularly overseas).

I mean, the civil servants at the FDA surely are not just LARPing as pop psychologists, somewhere I’ve missed they have actual peer reviewed literature guiding any of their moves regarding communication, credibility, and risk management, right?

That is from Sure.  So what is the best piece on FDA credibility?  (Yes, I know the work of Daniel Carpenter and have a CWT with him coming out and we do address this directly.)  And what has the FDA itself done to study the issue of its own credibility?

FDA Postpones Inspections Delaying New Drugs and Creating Shortages of Old Drugs

NYTimes: The Covid-19 pandemic has forced the Food and Drug Administration to postpone hundreds of drug company inspections, creating an enormous backlog that is delaying new drug approvals and leading the industry to warn of impending shortages of existing medicines.

…In an interview, F.D.A. officials said they sharply curtailed the inspections to protect their investigators, following guidelines from the Centers for Disease Control and Prevention, which discouraged federal employees from travel during the pandemic.

But some people in both industry and public health communities say that federal drug inspections are essential, and that the agency should bypass travel restrictions by taking precautions, including wearing proper personal protective equipment.

…In interviews, F.D.A. officials denied that the dramatic drop in inspections has slowed drug approvals. But a number of drug companies, including Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb, has issued statements noting deferred F.D.A. action because of the agency’s inability to conduct inspections.

  • In October, Spectrum announced that the F.D.A. had deferred action on its application for Rolontis, a treatment for cancer patients who have a very low number of certain white blood cells, because it could not inspect the manufacturing plant the company uses in South Korea.

  • In late December, Biocon Biologics notified shareholders that the F.D.A. deferred action on its joint application with Mylan for a proposed biosimilar to Avastin, a cancer drug.

  • Bristol Myers Squibb announced in November that the F.D.A. would miss its November deadline for taking action on a lymphoma treatment, lisocabtagene maraleucel because it could not inspect a third-party Texas manufacturing plant. The agency eventually did complete its inspection and approved the drug last month.

Grocery store workers are working, meat packers are working, hell bars and restaurants are open in many parts of the country but FDA inspectors aren’t inspecting. It boggles the mind.

Let’s review. The FDA prevented private firms from offering SARS-Cov2 tests in the crucial early weeks of the pandemic, delayed the approval of vaccines, took weeks to arrange meetings to approve vaccines even as thousands died daily, failed to approve the AstraZeneca vaccine, failed to quickly approve rapid antigen tests, and failed to perform inspections necessary to keep pharmaceutical supply lines open.

I am a long-time critic of the FDA and frankly I am stunned at the devastation.

A Polite Request of the FDA

After the FDA advisory committee voted in favor of Pfizer’s EUA last Thursday–as almost everyone thought they would–the FDA had difficulty finishing the paperwork. The NYTimes reported:

People familiar with the F.D.A.’s situation say that regulators are now racing to complete a fact sheet, information for physicians and other required documents that go with the authorization.

The paperwork delay meant that the FDA was going to wait to issue the EUA until Monday. That’s when Trump called the FDA “a big, old, slow turtle” and yelled at Hahn to “Stop playing games and start saving lives!!!.” The FDA then sped up and issued the EUA on Friday. As a result, the first tranche of vaccines are being delivered today.

The advisory committee for the Moderna vaccine meets this coming Thursday. Here’s a polite request of the FDA–please have the fact sheet, information for physicians and other required documents ready to go. Thanks.

P.S. We would also be really grateful and, you know, it might save some lives if you allowed Moderna to start shipping now so the vaccine is on-site and ready to go on Friday. Please give it some thought and thanks again for your kind consideration. It’s been very stressful seeing thousands of people dying every day.

The Simple Math of FDA Delay

Two to three thousand people a day are dying from COVID. Thus anything that delays rolling out a vaccine has a very high cost in human lives. People want to deny this, perhaps because it is so horrifying. I get a lot of pushback when I say that FDA delay is deadly. Let’s dispense with a few objections. It is true, of course, that the people who are dying today can’t literally be saved by a vaccine today but they could have been saved had they been vaccinated four or five weeks ago and similarly projecting forward.

Another response that many smart people tell me is that a vaccine can’t be rolled out immediately so even under the best scenarios you couldn’t save that many people immediately. That’s true but irrelevant. Since a lot of people are getting this wrong, I want to show this in a simple model using pictures. Red is for deaths. Green is for life. Suppose two thousand people are dying from COVID a day as in panel 1. Let’s for the sake of the simple model assume that you could deliver a vaccine to everyone on Day 1. You would then save 2000 lives a day going forward for however long the pandemic would have lasted as shown in panel 2. If you delay by one day then two thousand people die who would have lived without the delay, as shown in panel 3. Pretty obvious so far.

Now assume that the vaccine can’t roll out to everyone immediately. For the sake of this simple model let’s assume that on day one you can only vaccinate half the population. By doing so you save 1000 lives on day 1 and 2000 lives every day thereafter for the length of the pandemic. That’s the fourth panel. Now suppose we delay the vaccine rollout by one day. 2000 people die on Day 1 but you save 1000 on Day 2 and 2000 on Day 3 and every day thereafter for the length of the pandemic. How many people were killed by the delay? Compare the 4th and 5th panels. 2000 exactly as before! The slow ramp up doesn’t change the number of deaths caused by delay it just spreads them out over different days. You can adjust the ramp so that it occurs over 10 days or 30 days. Doesn’t change much on the delay margin unless you delay for so long that the pandemic is close to being over.

What could matter is if delay increases the speed at which you can ramp up. I doubt that this is true. We were ready to go with millions of doses in late October (guess why?). (In fact we had a vaccine in January and millions of doses around March-April.) We won’t really be better prepared tomorrow than we are today. It’s learning by doing that matters. See the point Tyler made earlier about economic time versus calendar time.

As Tyler noted, this is hardly the final analysis but many people are not even conceptualizing the problem correctly and this is a good place to begin.

How many lives will be saved if the FDA had moved faster?

Many people are asking me this question.  I don’t mean to relitigate the question of whether the FDA should be moving faster, rather consider this an exercise in how to think about the trade-offs.  I thus am going to hold the safety and quality of the vaccine constant.

To proceed, consider the distinction between processes defined by economic time and processes defined by calendar time.  In Virginia it may snow in February but not in October, and that is defined by calendar time, not caused by local gdp.  But for many inventory processes, they do not restock until the shelf is emptied by buying customers, and that is economic time.  They don’t check to see if it is June or July.

Let us say that only economic time matters, though I will drop that assumption shortly.

Now, given how late we are in “the season,” it is easier to think about pushing the approval date back rather than moving it forward.  Let’s say that the FDA postponed the December 10 meeting to January 10.  Some number of people would die of Covid during that month — the current clip being around 2600 a day but changing — and then around Jan.10 some kind of vaccine-related health and economic recovery would move into fuller gear.

If only economic time matters, it seems the Dec.10 recovery and the Jan.10 recovery run about the same.  The net difference between the two scenarios is the lives lost in the meantime, to oversimplify say 2000 x 30 days, or 60,000 lives plus accompanying lost jobs and gdp.

I do not think that losing those lives would somehow speed the later, Jan.10-starting recovery process, and it may in some ways render it more fractious.

On top of that, the postponed recovery period likely will imply some kind of grinding uncertainty in the meantime, and possibly intertemporal substitution from some agents (like me!) who are waiting for the change to come before going to the barber. The true net costs are thus higher than what I listed two paragraphs above.

Now, how might the introduction of calendar time alter those estimates?

First, the production of complementary goods for vaccines (say freezers, but the point is more general) may be on a clock of its own, more or less on automatic pilot and requiring time.  When approval comes later, more of those complementary goods are in place, and thus the later recovery is a more powerful one.  That factor tends to lower the cost of delaying approval.

(Of course to the extent those same complementary inputs depend upon economic time, that is reason not to delay approval!  The sooner you approve, the sooner they will get working on getting those freezers in place, which of course boosts recovery power.  Supply is elastic with respect to approval, as suggested for instance by stock market reactions to approval decisions.)

Second, the seasonal effects will differ.  Ideally you want the spread of vaccines to be covering some of the more infectious and thus more difficult winter months.  February is worse than March, and so on.  Given the current clock, this is a big reason to be hurrying.

You might think of other ways calendar time could matter.  You also might think of various non-linear effects and interactions, though I am not sure whether they would make delay more or less costly.

Overall it seems to me that the costs of approval delay are likely very high.  They are not obviously overturned or minimized by citing the relevance of complementary inputs.  The import of complementary inputs might be more ruled by “economic time,” or the seasonal effects may be a stronger quantitative magnitude, again favoring faster speed of approval.

I do understand this is far from a final analysis, rather it is a starting point for conceptualizing the problem.

How badly has the FDA been lagging?

As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency’s review can be done within 24 to 48 hours without cutting any corners. They just need to work harder.

Contrary to popular belief, the FDA process is not hands-on—it does not interview vaccine trial patients or look under a microscope at the immune cells. It’s doing a statistical analysis and looking at data. For the vaccine trial, the data set is small and straightforward. If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.

The FDA also reviews manufacturing data from Pfizer on how they made the drug. But not only can that data be reviewed in a few hours, it should have been done months ago when it was available. While the FDA was waiting for Pfizer’s long-term vaccine results to come in, the agency should have anticipated this step and done it early.

The final step of the FDA review is to look at the outcomes of the study volunteers, including rates and severity of infection and side effects in the vaccine and placebo groups. Again, there is no plausible reason why this basic analysis cannot be done in 24 hours. The FDA and external scientists have a simple task: confirm or reject  the review already conducted by the trial’s independent data safety monitoring board before FDA submission.

That is from Marty Makary, who also details an ongoing history of FDA delays during the pandemic, starting with the very first Covid testing attempts from the University of Washington, which the FDA tried to nix, but continuing throughout.  And:

FDA insiders say the agency and its approximately 17,000 employees were dark for the four-day Thanksgiving holiday, including those working on the vaccine approval.

For those of us who lived through the 2008 financial crisis (agencies other than the Fed were not on the ball in response), or who have studied (and indeed practiced) the economics of bureaucracy for forty years, or who know the extensive literature on how the FDA operates, will not be surprised by a lack of urgency.  Or from the NYT:

Dr. Fauci said the politicization of the pandemic in his own country had led regulators to move a little more cautiously than the British, to avoid losing public support.

Sorry people, but I read that as “for political reasons we did not go more quickly.”

Here from Statnews journalists Matthew Herper and Nicholas Florko defend the FDA, going into considerable detail, do read it.  Here is one excerpt, in direct contradiction to some of the above:

The agency’s staff “were eating turkey sandwiches on Thanksgiving while reviewing documents,” Peter Marks, who heads the FDA center conducting the vaccine reviews, said on a Thursday webcast run by the Journal of the American Medical Association.

Additionally, members of an FDA advisory committee that will convene Thursday to review the data and issue its recommendations, have expressed no desire to meet sooner. STAT spoke to four members of the panel and all said the agency should not try to move any faster.

My view is this: if your agency is saying “usually we move five to ten times more slowly,” it is highly unlikely their current procedures are optimized for speed.  It is fast organizations that are good at moving fast, right Usain Bolt?

We’re now at the point where Covid-19 is the single leading cause of death in this nation.

The FDA Burns

If you think the FDA has been slow at approving new coronavirus tests just look at their process for approving sunscreen products.

EWG: The FDA first began working to update sunscreen regulations more than 40 years ago. In February 2019, the agency at long last issued a proposed set of final rules, but they were never adopted.

According to EWG, the Environmental Working Group, the FDA has been too slow to test old ingredients for safety and too slow to allow new ingredients on the market thus leaving us with sunscreen products which are neither as safe nor as effective as they should be. In particular, Europe has better sunscreen protection than the United States. Here’s EWG:

Americans have fewer choices and notably poorer protection than Europeans do from ultraviolet A rays in their sunscreen options. Although most U.S. sunscreens prevent sunburn effectively when used correctly, they aren’t as good as European sunscreens at preventing the more subtle skin damage produced by lower-energy UVA radiation. UVA rays have less energy and don’t burn the skin, but they can cause the skin to age, suppress the immune system and contribute to the development of melanoma.

…Between 2003 and 2010, sunscreen makers applied for FDA permission to use eight sun-filtering chemicals developed by European companies. Four of these – Tinosorb S, Tinosorb M, Mexoryl SX and Mexoryl XL – appear to be more effective than avobenzone, the most common UVA filter permitted by the FDA. The FDA’s failure to respond to these applications prompted Congress to pass the Sunscreen Innovation Act of 2014 (FDA 2014). This act requires the FDA to review new applications for sunscreen active ingredients within 300 days, but it doesn’t relax the standards companies must meet to prove new ingredients are both safe and effective.

In 2015, the FDA responded that the companies involved had not submitted enough information to prove their chemicals were, in fact, safe and effective for use (FDA 2015). The agency asked for more data, including complete study results, measurements of ingredient levels in people’s blood, and long-term studies on systemic toxicity and potential endocrine system disruption. The FDA has also proposed that all sunscreen ingredients, including those already in use, need to have adequate safety testing data.

Some information the FDA wants, such as complete copies of studies, might be easy for sunscreen makers to produce. But in other cases, the companies could take years to satisfy FDA requests. In the meantime, Americans are being shortchanged.

I first wrote about this issue in 2013 and seven years later, despite Congress passing a law in 2014, the FDA still has not acted.

My rule is very simple. I don’t think the FDA is better than the EMA so if any drug or device is approved in Europe it ought to be available for purchase in the United States with a label saying “Approved by the EMA. Not approved by the FDA.” (By the way, we do have reciprocity type agreements with Canada and New Zealand for food so this would not be unprecedented.)

Hat tip: John Thacker.

Addendum: You should actually get more sun to avoid vitamin D deficiency which is bad for a variety of reasons including, in my estimation, greater susceptibility to COVID.