The Long, Hard Climb To Increasing N95 Mask Availability

The calls to get President Trump to use the Defense Production Act to force manufacturers to make more ventilators, and more protective clothing for medical personnel (and others) have increased over time, viz.:

• Vox: 3/18, 3/23, 3/25, 3/29
• New York Times: 3/20 (1), 3/20 (2), 3/22, 3/24, 3/27, 3/31, 4/3
• Washington Post: 3/19, 3/25, 3/27 (1), 3/27 (2), 3/27 (3), 3/28, 3/31

Etc., etc., etc. It seems pretty commonplace that it's just assumed that commanding such a thing will make it so, as Sarah Silverman:

We can pump out half a million SuperBowl tee shirts for the losing team but we can’t make masks for motherfucking healthcare workers risking their lives everyday?

— Sarah Silverman (@SarahKSilverman) April 3, 2020

Of course, the obvious rejoinders to this are that

1.  The T-shirt manufacturers have a week (at least) to churn those out, and
2. N95 manufacturers (and consumers) have to deal with the FDA.

The exact reasons for commanding N95 masks to exist are, at the moment, fairly obvious:

• Demand is exceeding high thanks to the COVID-19 outbreak.
• The national reserve stockpile was largely depleted during the H1N1 outbreak of 2009 and never refilled by either the Obama or Trump administrations.
• China was the source of much of the world's N95 masks, so when they banned exports, the rest of the world was devastated.

 But as ever, it's easier said than done. The Canadians, rightly fearing today's announcement of a US export ban, have struck out on their own to manufacture a domestic N95 mask. Only trouble is, virtually the entire supply chain is beyond their grasp as well. "[I]n just over two weeks, the McMaster project quickly evolved from establishing a manufacturing method for surgical and more sophisticated N95 masks to building an entire supply chain from the bottom up."

The biggest challenge: finding the basic material to make the masks. A proper N95 mask — the kind that can filter out droplets containing viruses such as COVID-19 — requires a unique material, specifically a “meltblown, non-woven polypropelene” with narrow fibre diameters and a specific pore size.

Any company that can make the fabric — there are manufacturers in China and the U.S. — has already been flooded with phone calls. Others are operating within countries, like South Korea, that have placed specific export bans on the material.

So the core of the N95 mask needs a product that the Canadians can't make at the moment; every scrap made is already spoken for.

So in the meantime, the materials team has turned its attention to exploring whether other possible fabrics could be sourced and treated to perform as well.

That requires testing — another key bottleneck in the process. Until recently, most masks were tested in the U.S., said Preston, and some cannot be tested in Canada at all. Though McMaster sent some initial prototypes to a facility in Utah — that lab is “no longer accepting international orders,” added Selvaganapathy.

They seem to be optimistic about getting over this hump — they claim to be "very close" to getting a domestic surgical mask — but an N95 mask "will take more time". The expertise and equipment aren't easy to come by:

“What this is is a brutal education in the reality of supply chains,” [Simon Evenett, University of St. Gallen professor of international trade and economic development] said. “That’s what policymakers are getting.”

While we can expect 3M to add new capacity in addition to doubling its annual US production, and Honeywell and smaller players to expand or build out new factories, the larger of those at least have some of the necessary knowledge already on-staff. The team at McMaster University have no such experience. People like Silverman or the writers at the NYT and WaPo, who have most likely never trod a factory floor in their lives, believe in magic wands that don't exist.

Who Eats Dogs? Don't Say "Chinese A**holes" Or Facebook Censors You

So, this happened in a private Facebook group yesterday. To the question, "Who eats dogs?" I provided this response, and then the Overton window slammed shut on my keyboard:

Yes, it's now the case that Facebook has decided that discussions of Chinese eating habits — the proximate origin of the COVID-19 virus — are off-limits. This is, to put it mildly, insane. "Respectful" means we can't swear? The hell, Zuck. This is part of a general campaign Facebook appears to have started five years ago (at least) in which they decided to purge content the Chinese Communist Party wanted silenced, including video of Tibetan monks self-immolating to protest CCP repression.

CNN: Exterminators Of Hope

A few days back, I noticed a CNN "fact check" that was such an exemplar of entirely irresponsible and politicized journalism that I felt it meet to comment in this space about it. Recently, French doctors in a small-sample-size trial (n=20) summary wrote of their clinical success: "Despite its small sample size our survey shows that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin."

This amounted to excellent news, at least for those of us who like actual good news about pandemics. (There is a recent report coming from China that another small sample randomized test does not show the same results.) Meantime, the CDC noted that "[b]ased upon limited in-vitro and anecdotal data, chloroquine or hydroxychloroquine are currently recommended for treatment of hospitalized COVID-19 patients in several countries." But you would not get that story from CNN, which downplayed the work being done elsewhere:

Chloroquine has not been approved by the FDA to treat the coronavirus -- and nor has any other drug, the FDA made clear in a post-briefing statement that said "there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19." Because chloroquine has been approved for other purposes, doctors are legally allowed to prescribe it for the unapproved or "off-label" use of treating the coronavirus if they want. But its safety and effectiveness has not been proven with regard to the coronavirus. FDA Commissioner Dr. Stephen Hahn, speaking after Trump at the briefing, said that chloroquine would be tested through a "large, pragmatic clinical trial" with coronavirus patients.

Here, the FDA and CDC speak in the same generalities one does when there aren't any pandemics involved, i.e. the same kind of thinking that delayed a US COVID-19 test by nearly a month. The combination is in fact going to those sorts of clinical trials, which are expected to conclude in 2022. But for now, CNN sees fit to omit the French work from their pretend "fact check" because it goes off narrative. Anything that gives people hope is disarming a weapon against Trump, and it must therefore be minimized if not eliminated. This foolish politicization will have consequences; we have already seen one in Nevada, where Democratic governor Steve Sisolak has barred physicians from using hydroxychloroquine to treat COVID-19 anywhere but in hospitals.

Update: It's important to note that Trump's initial comments were (mostly) comparatively anodyne (emboldening mine):

"It's shown very encouraging -- very, very encouraging early results. And we're going to be able to make that drug available almost immediately. And that's where the FDA has been so great. They -- they've gone through the approval process; it's been approved. And they did it -- they took it down from many, many months to immediate. So we're going to be able to make that drug available by prescription or states," Trump said.

He added: "Normally the FDA would take a long time to approve something like that, and it's -- it was approved very, very quickly and it's now approved, by prescription."

The approval speed was irrelevant for drugs already on the market. What was not forthcoming was whether this amounted to an on-label use, which, as stated above, won't be known for two years.

From The Virology Trenches: Squandered Chances By The FDA and CDC

A pretty good story from the trenches (written by someone at a local public health agency) regarding the early days of the CDC and FDA in the COVID-19 testing saga, and their role in fumbling the tests. The transcript begins at about 1:25:20; all errors are mine. Italics are what I assume is text from the letter's author; emboldened text is my emphasis, and anything in [square brackets] is my own commentary/editorial simplification as well.

Brenner writes: "Hi, TWIV team. Long-time listener. I started in academics after a PhD and a post-doc. I went into public health. I hear in the podcast that there isn't much information on the current COVID-19, or as I prefer to call it, SARS-2-CoV test [Ed. note: CDC seems to be calling it SARS-CoV-2], so let me give you the background. ... The CDC originally came out with a real-time reverse transcription PCR RTRTPCR. It had three targets, all in the N-gene. Why the N-gene when everybody else uses Spike? Your guess is as good as mine. And she gives a link. They sent out ... they sent the test out to 99 different public health labs. Of the 99, only five could make the assay work. 94 labs ... could have the N3 probe react to something in the HSC late in the reaction, causing a late positive CT for the HSC probe two [too?]. That's getting a little dense. Basically, ... test didn't work.  They got false positives. The CDC said they were gonna replace just the N3 primer probe set, but that the other two should be good to go.
A week passed. The CDC was still working on it. Were they going to change the sequence? No one knew what the problem was. However, in situations like this, laboratories cannot just adjust a protocol. We are required by CLIA, FDA, and just about every other alphabet soup agency to do the test as it is written.

A second week passed, and in a very surprising turn of events, the [Association] of Public Health Laboratories, who work very closely with the CDC getting a myriad of assays and programs up and running, wrote a harsh letter to the FDA asking them to loosen requirements for emergency authorized testing. Days afterwards, the CDC said, you only had to use the first two N-primer probe sets. They remanufactured and sent new lots out to the labs in about a week. Basically, we never speak of the N3 primer probe again....

Update 2020-03-21: Rereading this, I came to the incredible realization that there were not two but three weeks before the test could be properly performed. Insane.

More On ICU Bed/100k Population Figures

One thing I missed in Sunday's post about ICU beds in various medical systems is that the underlying Clinicians' Biosecurity News paper says that "there are about 46,500 medical ICU beds in the United States and perhaps an equal number of other ICU beds that could be used in a crisis" (emboldening mine). (The paper was published February 27, 2020, so still hot off the presses.) If we double that figure, it means the US has 93,000 ICU beds (assuming it is possible to adequately staff each one), or

93,000 ICU beds/331M population = 28 ICU beds/100k population

This is notably better than all European countries save Germany. However, they don't say how they arrived at that figure. A 2013 summary in Current Opinion In Critical Care claims the US has from 20.0-31.7 ICU beds/100k population, pointing to a 2008 summary in Critical Care Medicine:

 It seemed more likely to me that the industry itself might have better statistics, and indeed they do: the American Hospital Association says that the US has 97,776 ICU beds, which would mean

97,776 ICU beds/331M population = 29.5 ICU beds/100k population

While impressive, it seems reasonable to subtract out the neonatal ICU beds (22,860) and pediatric ICU beds (5,131). This gives us

69,785 ICU beds/331M population = 21.1 ICU beds/100k population

Overall, very good news, considering, but still inadequate to the demands if coronavirus needs spike.

Actual Intersex People: Forgotten Pawns In The Trans Wars

I recently had cause to read something from Intersex Human Rights Australia which struck me, at least at first glance, as entirely sensible and a subtle rebuke to the trans activists who wish to define away biological sex into some kind of nonexistent spectrum (emboldening mine):

After fielding a few phone calls it is clear that many people can’t grasp our position in opposing the creation of a third sex while supporting X sex descriptors on birth certificates and passports.

To be clear, intersex is not an arbitrary third sex category, but rather a spectrum of possibilities, and nor is it an arbitrary third gender.

Even though some intersex people define their identity as intersex, this is a political statement, and not necessarily anything about their gender or preference for sex classification. Identity is not what defines intersex: intersex is contingent on innate physical bodily characteristics. Intersex is not a gender identity because it is a matter of sex. ...

We say we should have that right in the same way we have the right to remain silent on our gender identity, our sexual orientation, our race, our religion and our political affiliation. None of those things are marked on birth certificates or passports, though they are in some ways more indicative of who a person is than sex anatomy. 

This strikes me as entirely reasonable. The trans activists have tried to conflate biological intersex individuals (such as people with Kleinefelter syndrome) with people having gender dysphoria, but the former get almost no air time.

Women's Soccer And "Equal Pay": Clutching Pearls At Obvious Biological Truths

ESPN has a predictably horrified article about a motion to dismiss the frivolous US Women's National Soccer pay imbalance lawsuit, which raises important (and one would hope, obvious) points about difficulty of skill required to play in those leagues:

The motion filed on behalf of U.S. Soccer on Monday reiterated a number of objections made throughout the lawsuit. But among the most stark were repeated assertions that, regardless of any other consideration, players from the two teams do not perform equal work -- either in terms of revenue potential or the actual physical labor required.

As a result, U.S. Soccer said, women's players do not qualify for relief under the Equal Pay Act or Title VII of the 1964 Civil Rights Act.

"The overall soccer-playing ability required to compete at the senior men's national team level is materially influenced by the level of certain physical attributes," the defense motion stated at one point, "such as speed and strength, required for the job."

That followed the original motion for summary judgment, in which U.S. Soccer stated that women's players did not perform jobs requiring "equal skill, effort and responsibility under similar working conditions."

That the lawsuit got this far is really astonishing, but that these things need to be pointed out is absurd:

1. We already have pay in athletics distributed by ability, not just in the major leagues (starters generally make more money than relief pitchers) but in the overall professional leagues (MLB players make more than minor leaguers). So the principle is not, on its face, absurd, despite attorney Molly Levison's sneering at it as the product of a "Paleolithic era" mentality.
2. Female soccer players get routinely beaten by high school boys in the rare cases where they scrimmage together. This is of a piece with high school boys in track and field commonly breaking world record times by females.
3. The USWNT exists entirely because of subsidies from MLS, which in turn is driven by the male game:
   

   
   Professional soccer players are also paid by privately owned club teams. Megan Rapinoe, for example, plays for Seattle Reign FC, one of nine teams in the National Women's Soccer League (NWSL). Player's salaries in the NWSL range from about $16,000 to $46,000 annually, according to NPR. That's not a lot, and it's certainly less than even the lowest-paid players in Major League Soccer (MLS; the top North American men's pro soccer league), who earn a mandatory minimum salary of $60,000.
   
   That pay gap isn't the result of sexism. It's what the market allows. Major League Soccer teams drew an average of 21,000 fans last year, while NWSL games drew about 6,000. The TV contract MLS has with ESPN and other broadcasters generates $90 million a year. While neither league discloses revenue figures, it's a safe bet MLS earns considerably more—and, thus, its players do too.

   For women to earn what men do, it's clear they need to get butts in the seats and watching on TV. So far, that hasn't happened. (Given some of the women's teams' fans, maybe there's a reason.)
4.  Those subsidies in fact are a big reason that the US women's team has won four World Cup titles, more than the US men's team ever (zero). Only a handful of countries pay their female soccer players, and this makes a huge difference in the quality and quantity of training the players can undertake. It puts the players in the interesting position of asking for more subsidy because they already get some.

It's hard to look at this situation and wonder what self-serving snake oil the women's team attorney offered her clients. The bottom line is still the bottom line, and at least one member of the women's team understands this:

"Fans can come to games," [Seattle Reign FC player Megan] Rapinoe said. "Obviously, the national team games will be a hot ticket, but we have nine teams in the NWSL. You can go to your league games, you can support that way. You can buy players' jerseys, you can lend support in that way, you can tell your friends about it, you can become season ticket-holders."

And that's it.