Cats, charts, and politics
A friend points out this year's stats for line-of-duty deaths among police officers:
Deaths from COVID-19 nearly equal all other causes combined. And yet news reports repeatedly list police as one of the occupations most resistant to vaccination.
Policing is dangerous work, and the last thing we need is to double the number of deaths they already suffer. So please: skip your next day at the range and go get vaccinated instead. Your family will thank you.
This is a sad but inevitable development:
Taliban fighters overran three major cities in the north of Afghanistan on Sunday, the most significant territorial gains the militants have netted in a single day since the withdrawal of U.S. forces entered its final phase this year.
....The developments marked a sharp escalation in the pace of Taliban gains across Afghanistan. For months, Taliban fighters focused on taking control of districts and increasing pressure on urban areas, but that changed Friday when they overran a provincial capital for the first time since the withdrawal of foreign forces. The militants took a second city on Saturday, and by Sunday government-held territory in the north appeared to be collapsing quickly.
After 20 years of partnership with the United States, Afghanistan's central government still has virtually no real loyalty among its troops and no real fighting power. It's true that things will get harder for the Taliban when they swing south into the central part of the country, but probably only by a matter of degree. What's more, if the Taliban runs into real trouble taking Kabul and other major cities, there's a good chance that Pakistan will covertly help them out.
This is a tragedy, especially for the women of Afghanistan. I wish there were more we could do about it, but I can't think of what it could be. I'll be surprised if it takes the Taliban more than another six or nine months to fully conquer the country.
This is a three-part story of heroism, intrigue, and ultimately treachery in the world of drug approval.
PART 1
Alex Tabarrok points me this weekend to a righteous rant about the FDA from psychiatrist Scott Alexander at Astral Codex Ten. After blasting them for several COVID-related decisions, he tells us about another example of FDA folly:
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 f@$king time there is some story about the FDA doing something exactly this awful and counterproductive. A while back I learned about cholestasis in 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 one version of the nutrient fluid, but it caused some problems, especially liver damage. Drawing on European research, some scientists suggested that a version with fish oil would cause less liver damage — but the fish oil version wasn’t FDA-approved. A bunch of babies kept getting liver damage, and everyone knew 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 getting liver damage, 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 to get decent treatment for this condition 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 fish-oil nutritional fluid from Europe, but you were only able to apply after your baby was getting liver 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 damage and death. And it’s not just this and coronavirus, I CANNOT STRESS ENOUGH HOW TYPICAL THIS IS OF EVERYTHING THE FDA DOES ALL THE TIME.
PART 2
Something about this didn't seem quite right to me, so I looked around for more details. Luckily, it turns out that Kathleen Gura, who was intimately involved in this case, got an award for her work and delivered an acceptance speech that provided lots of detail about how it all happened.¹ Here are the basics:
2002: Gura had a cancer patient that was having trouble with conventional nutrition delivered via tube. She called around for ideas, and everyone gave her the same advice—the patient just has to suck it up—except for one doctor, who had recently heard about a fish-oil based lipid emulsion from Sweden called Omegaven. Gura got emergency approval from the FDA to try it and then got some shipped over. It worked great.
2002: Gura was also involved with a team looking for ways to treat infant short bowel syndrome, which causes liver failure in some patients. Everyone suspected a toxin of some kind, but Gura convinced one doctor to do some mouse trials with Omegaven. It worked, but no one believed it. "Everyone knows it's not the lipids," she was told.
2004: Gura continued her mouse studies on the side but was unable to get funding for more serious research. Even the Swedish manufacturer had no interest in sponsoring additional research. However, one day a doctor expressed interest in using Omegaven on a child who had no other options. It worked.
2005: A few more babies were treated with Omegaven and had good results. The FDA suggested Gura apply for regular (non-emergency) investigational drug approval. She did and it was approved.
2006: Even so nobody was interested in publishing her results. After a dozen rejections, her paper was eventually published in Pediatrics.
2007: Gura started up a media war to persuade the manufacturer of Omegaven to release it in the US. They didn't want to, but succumbed after getting beaten up over it.
2007-12: Gura faced considerable opposition to her ideas, partly because she had never run a double-blind study. But she continued treating a few patients each year with Omegaven, and by 2012 it was on its way to becoming standard of care used by lots of hospitals around the country on an emergency basis. In 2012 the Swedish manufacturer finally submitted a New Drug Application to the FDA, but they asked for approval of Omegaven only as a treatment for liver disease. However, thanks to FDA guidance the NDA was changed to allow Omegaven to be used as a nutritional fluid that would prevent liver disease.
2014: A team in Hong Kong published the results of a double-blind study. It had been shut down early because the Omegaven group was so obviously doing better, but it was enough to convince the FDA that a randomized, controlled trial was not necessary. The FDA would instead accept pair-matched historical controls.
2018: Omegaven gets final approval from the FDA.
PART 3
Gura's narrative is wildly different from Alexander's. She mentions problems with testing; with funding; with publications; with the Swedish company itself; and with the medical community, which didn't accept her results. But the FDA was helpful. They provided emergency IDAs. They suggested she get a regular IDA. They caught a problem with the New Drug Application that would have severely limited Omegaven's usefulness. They accepted the results of the aborted Hong Kong study. And the time it took for FDA approval was not 16 years, but six years, since the manufacturer didn't even submit an application until 2012.
After I had written all this, I went back to Alexander's site and noticed that he had added an update. Several people wanted to know more about the Omegaven affair, so he provided a link to a post he had written about it. It starts like this:
I plucked that from the anti-FDA blogosphere, where it had been floating around for a while in various incarnations. I tried to check it before publishing, but only enough to confirm the basic outline.
Indeed. After getting the questions, he did some more research and it turns out that he relied for this research on exactly the same document I did: Kathleen Gura's speech. After a long summary he says, "There still have not really been any great large-scale studies proving that Omegaven works better than older nutrient fluids, though my impression is that everyone who uses it believes it does." That's not exactly great evidence for his thesis that Omegaven was a miracle drug caught in bureaucratic FDA hell.
Then Alexander admits some specific errors in his initial story but says, "Still, I think the basic structure was right — the new fluid was better than the old fluid, this was pretty clear in terms of miraculous recoveries, and it took 14 years between the first patient saved and full FDA approval."
This is headshakingly dense. As a hit on the FDA, his post wasn't right at all—not its basic structure and not anything else about it. He even admits that although Gura criticizes plenty of other actors, the FDA isn't one of them:
The FDA, in comparison, comes out looking pretty good. They approved the first few original single-patient exemptions to import Omegaven from Europe. They (eventually, after a lot of work) approved the Investigational New Drug application that let Boston Children’s Hospital keep using it (I’m still unclear whether any other hospitals got INDs for this). They even contributed a little funding to get one small study done. It wasn’t enough, but the FDA is not primarily a funding body, actual funding bodies dropped the ball on this one, and so it’s really impressive that the FDA went above and beyond to try to move Omegaven through the pipeline. Dr. Gura seems to have been left with the impression that the FDA was one of her few allies during this fight, which I think is fair.
I mentioned in a section of my recent post, “Sympathy For The Devil”, that I think the FDA as an agency is often quite good. They’re smart, caring people, and they usually carry out their mandate well — so well that the few exceptions, like aducanumab, are highly newsworthy. I have no objection to Dr. Gura’s mostly-positive portrayal of them.
This bears no resemblance—none—to the diatribe in Part 1:
Every single hour of every single day the FDA does things exactly this stupid and destructive....I am a doctor and sometimes I have to deal with the Schmoe’s Syndromes of the world and every f@$king time there is some story about the FDA doing something exactly this awful and counterproductive.
I have no idea how you can write "they usually carry out their mandate well" in one place and then, in your main post, just go ahead and repeat your original belief—backed by an example you know is wrong—that the FDA does stupid and destructive things on practically a daily basis.
This is why I'm automatically skeptical of anything on the web that's excessively critical of the FDA. It's not that I think the FDA is above reproach. It's because of the existence of the "anti-FDA blogosphere" that Alexander mentions. There is indeed an active clique of FDA critics in the blogosphere, mostly of a libertarian bent, who are willing to accept and pass around the most egregious stories imaginable of FDA incompetence. Occasionally they're true, but most often they're very highly exaggerated, like this one. Other times they're little more than urban legends.
The FDA has plenty of problems, and their critics have performed a useful service by pushing them to improve. That said, the FDA doesn't screw up every hour of every day on practically every useful drug ever presented to them. Even taking normal human frustration into account, that's inexcusable.
¹Note that throughout the text I'm using Gura as shorthand for "Gura and other people who were involved in getting Omegaven approved."
Rome remains a mystery. In my entire week there I didn't see a single cat outside of the Largo Argentina cat sanctuary. I don't know what's happened to them all.
However, on my very last day, as I was returning from my mandatory COVID test (negativo, thank you very much), I finally ran across a pair of pet cats. They obviously belonged to the same person, and they were both meandering around the tables of a couple of local trattorias. They weren't making any trouble or begging for food, but I'm sure they didn't take any handouts amiss.
Both were friendly but oblivious. They didn't mind if I came up to pet them, but they also didn't care and would just walk away. Very Roman, I suppose.
Several of you have noted that I cleverly used my vacation as an excuse to stop posting daily COVID charts. The truth is that I never intended to keep doing that for so long, and it's a bit of a pain in the ass. What's more, these days there are so many places with this information that we hardly need one more anyway.
However, I figure that maybe I'll keep doing this once a week, using a chart copied directly from Our World In Data. This is a lot less trouble, and it's probably where you should go anyway if you want data of your own. It covers every country and has options of showing cases, deaths, and vaccinations over any timeframe you want. Here's the latest, displayed in deaths per million.
The CDC's eviction moratorium expired on July 31, and President Biden said at the time that he couldn't legally extend it. A few days later, after a bit of roughing up from progressives, he went ahead and extended it anyway, while warning that it would probably be struck down in court.
Conservatives are outraged, just as they were repeatedly outraged about lots of President Obama's executive actions that they considered illegal.
On the other hand, they remained non-outraged when President Trump, for example, tried to limit travel from Arab countries in ways that were almost certainly illegal. Nor do they seem to have any problem with states passing anti-abortion laws that are plainly unconstitutional. It's only a problem when Democrats do it.
Speaking for myself, I think Biden should have stuck to his guns and accepted the legal advice he got from his own advisors. I know that Trump rarely seemed to care about that, but I don't think we should take Trump as a role model in these things.
That said, taking actions with the intent of having them tested in court is something that presidents of both parties do fairly routinely. If Biden's extension of the eviction moratorium is prima facie illegal, then someone will take it to court and ask for an emergency injunction, which will be granted. If the case isn't that obvious, then a court might take its time. Or it might issue an injunction with a stay. Or maybe it will get an emergency bump to the Supreme Court. Who knows? The point here is that this will be tested in court, and if it's flagrantly illegal it will be stopped quickly. If it's just garden variety illegal, it will be stopped in a few weeks or months. And if it's legal—and it might be!—then it will survive court challenge.
Bottom line: this is not only not an outrage, it's not even that big a deal. The federal court system will handle it just fine.
Just for the record, everyone understands that Tucker Carlson couldn't care less about Hungary, right? Nor does he care about the policies of its quasi-autocratic prime minister, Viktor Orbán. And of course, neither does his audience, very few of whom have even heard of Orbán before this week.
Tucker's weeklong lovefest in Budapest is solely a dumber than usual effort to annoy liberals and prompt them to write earnest thumbsuckers about the conservative love for authoritarians. So how about if we don't do it? There's no chance that Hungary will become a model for the US, so we can safely ignore Carlson's latest stunt.
The American economy gained 943,000 jobs last month. The unemployment rate declined substantially to 5.4%.
The number of employed people went up by a million while the number of unemployed dropped by about 800,000. Black unemployment remained high, but dropped a full percentage point to 8.2%.
The biggest increases in employment came in the leisure industry and in government. Hourly earnings were up 5.3% on an annualized basis, but that's roughly zero after you account for inflation.
The Congressional Budget Office has released its score of the bipartisan infrastructure bill:
Enacting Senate Amendment 2137...would decrease direct spending by $110 billion, increase revenues by $50 billion, and increase discretionary spending by $415 billion. On net, the legislation would add $256 billion to projected deficits over that period.
Conservatives are shocked that it turns out the bill won't pay for itself. Meh. I say the big news is that this so-called "$1.2 trillion bill" increases discretionary spending¹ by only $305 billion. Over ten years. That represents about a 1.5% increase in federal discretionary spending.²
And we spent six months haggling over this? Seriously? It's literally peanuts.
¹Which is only about a third of the total federal budget to begin with.
²There's also an additional $196 billion in "contract authority." However, that's relatively meaningless since it doesn't specify any actual spending, which is controlled by each year's appropriation bill.
Here are the durations of every US recession since World War II:
The pandemic recession of 2020 was only two months long. What accounts for its astounding brevity?
The most likely answer is Congress. According to the NBER recession dating folks, the recession started in February. Almost instantly Congress made it clear that it took the recession seriously by passing $2.4 trillion in rescue funding that included both immediate relief (checks) as well as longer term help (expanded UI benefits). By April the recession was over.
This has never happened before. There have been past stimulus bills, to be sure, but never of the speed and magnitude that we showed last year. Nothing even close.
So this is a fascinating macroeconomic experiment. Was there something special about the coronavirus recession? Or does our response show that we could have avoided past recessions by passing huge, immediate spending bills? Economists will be arguing about this for decades.