Regulation-Induced Drug Shortage Update

Monday, January 22, 2018

Almost exactly two years ago, I ran across Derek Lowe's explanation of the government's role in causing high prices for or shortages of some off-patent drugs. A recent story in the New York Times -- about hospitals manufacturing their own drugs -- reminded me of his explanation of how perverse regulatory incentives were distorting this market. Unsurprisingly, and as I hoped he might, the pharma blogger weighed in soon after the Gray Lady:

Without government meddling in the economy, cronyism such as his wouldn't be possible. (Image via Wikipedia)
... if you're going to start your own generic manufacturing effort, you have to get in line for the FDA to review your application to sell the compound(s). And that's one of the logjams -- one that will not be fixed by jamming another log into it. The article, though, mixes several problems together. You have the not-enough-players-making-cheap-drugs problem (which can happen through several means, regulatory approval not least among them), and you also have the only-one-manufacturer-eat-my-dust problem, which also takes many forms.

In some cases of the latter, you have old, off-patent, formerly cheap compounds where one supplier has been granted market exclusivity (and the ability to raise prices and drive everyone else out of the market). How does this happen? Deliberately by design of the FDA: there are incentives to bring older drugs into the modern regulatory framework, and if you do the tests needed, you get a very, very nice reward. Too nice, from my point of view, but that's how the law is written. In other one-manufacturer cases, people have bought up the only supplier of a small drug and then taken it into "restricted distribution", which basically keeps any other potential competitor from running the comparison trials needed to even get in line at the FDA to sell the drug, too. That's the Martin Shkreli playbook (although he's not the only one), and it also takes advantage of FDA regulations about how and why distribution of a drug can be so restricted. Want to change these? Change the law. [emphasis in original]
Lowe mentions that eliminating the "logjam" is a high priority of the current head of the FDA, and that is potentially good news in the short term.

But I cannot agree more with Lowe's last sentence, although I know I would take it much farther than he would. We must ultimately abolish the FDA, devolving whatever legitimate functions it performs either to legitimate governmental agencies or to non-governmental watchdog groups (depending on whether these are the business of the government) and altogether ending its innovation-killing, health-threatening stranglehold on the drug market. The FDA prevents desperate patients from trying new drugs even when they have nothing to lose, slows down or stops the introduction of even less speculative or cutting-edge drugs, and, as we see again here, threatens the availability of familiar drugs.

-- CAV

Friday Hodgepodge

Friday, January 19, 2018

Four News Items

1. An article in the Weekly Standard suggests at least a partial answer to the question, "Why are Iranians protesting now?"

Protests in Tehran. (Image via Wikipedia)
Obama, who has made a number of political pronouncements since leaving the White House a year ago, has said nothing about the unrest in Iran. It's a repeat of his performance as president in 2009, when the Green Movement sprung up to protest what appeared to be the fraudulent reelection of the president, Mahmoud Ahmadinejad. The regime violently quashed the demonstrations, killing at least 110 people and jailing 10,000 in the course of nine months, but Obama remained silent, much to the disappointment of the protesters, who chanted a rhyme in Farsi, "Obama, Obama, are you with them or with us?" His retirement has not gone unnoticed in Iran.

"There is also one big difference now compared with 2009 -- the Obama policy of appeasement of the Iranian regime has finished," says Shabnam Madadzadeh, a 30-year-old human-rights activist who fled Iran just over a year ago, after spending five years in prison. "Obama always helped the regime when it was in trouble. Now the regime no longer has this asset, and this has its impact on the people in the street, to realize that the international community is on their side and is not siding with the regime."
This article is also worth reading for its perspective on the nature of the revolution: Iranians "have realized that they will not be able to live normal decent lives and the economic situation will not get better for as long as the mullahs are in power," according to an Iranian expatriate who is helping organize protests.

2. Abha Bhattarai of the Washington Post describes "5 Ways the Future of Retail Is Already Here." Most interesting to me is the first, digital price displays that could allow stores to change prices quickly.
If a particular store is down to two bottles of tomato sauce, for example, a manager could raise prices until the next shipment arrives. Or, Fessenden said, "if we have a lot of cereal, we could decide to do a flash sale."
The option to pay more for an item low in stock would beat the pants off of simply having to do without. Walmart, are you listening?

There could be a downside for shoppers on a budget, though. There needs to be some warning if prices are going to go up.

3. And speaking of prices that rise by the hour, cautionary tales for anti-capitalist Americans continue to pour out of Venezuela. Here's a vignette about hyperinflation from another one:
Hyperinflation is disorienting. Five or six years ago, the 500 bolivars on the floor [of a store that had just been looted] would've bought you a meal for two with wine at the best restaurant in Caracas. As late as early last year, they would've bought you at least a cup of coffee. At the end of 2016, they still bought you a cup of café con leche, at least. Today, they buy you essentially nothing ... well, except for 132 gallons of the world's most extravagantly subsidized gasoline.
Anyone who wants socialism, thinking it will improve his life, should read this article for a start.

4. Theocrats in Florida are borrowing a page from paternalistic Democrats in their silly crusade against pornography:
Florida could declare pornography a public health risk that needs education, research and policy changes to protect Floridians, according to a resolution overwhelmingly approved by a House committee Thursday.
What's next? Warning labels? "The contents of this magazine are known to the state of Florida to cause blindness."

-- CAV

Does Dumb on Trade Trump Random Deregulation?

Thursday, January 18, 2018

In the grand scheme of things, that is a rhetorical question, of course. It is bad for a rational animal to either act on incorrect principles or to do so without explicit regard to any. Hallucinations -- or blindness? No thanks.

That said, there is an article by NPR titled "Turning Soybeans Into Fuel Is Costing Us Billions," that is at once somewhat amusing and, with some effort, also somewhat instructive. Aside from needing "Regulation Mandating" at the start of the title, the piece offers many interesting tidbits on the byzantine economics of the government-created, artificial market for biodiesel made from soybean oil:

Trump's stand on imports is wrong, and he should let the market decide whether these belong in fuel tanks. (Image via Pixabay.)
The story, however, is more complicated than it seems. For one thing, that boom in Argentine biodiesel exports is over, at least for now. Last summer, the United States accused Argentina of subsidizing its biodiesel producers and "dumping" cheap biodiesel on the world market. In retaliation, the U.S. imposed hefty taxes on all biodiesel from Argentina. Overnight, those imports ceased. Americans now will have to rely on biodiesel produced here in the U.S. — which also is more expensive. (In a way, Argentina was doing the U.S. a favor, helping it satisfy its biodiesel demands more cheaply.) [link omitted]
Note that Trump's general -- but unprincipled -- animus against regulation harms America here. His desire to regulate international trade, which he sees as a zero-sum game, is making an existing regulation he should get rid of more expensive to Americans. At the same time, I disagree with NPR: While calling Argentine subsidies a "favor" is understandable, you could also view this with the same lens as "enabling" our indulgence in environmental regulations, much like an indulgent parent might shield a child from the consequences of bad choices. Considered in this way, blocking these imports -- wrong because international trade shouldn't be interfered with in this way -- has the potentially happy consequence of helping Americans see just how wasteful biodiesel mandates are. Except that with the President's unprincipled approach to deregulation, it is anybody's guess whether he'll work to get renewable fuel standards off the books. I'm betting not.

That said, I note with some amusement that the article teaches that the cost of making this particular biofuel is significantly more expensive than making diesel the old-fashioned way -- even though soy oil is a waste product of the soy meal industry, in which China is a major player.

-- CAV

Solved ... Already (And Better)

Wednesday, January 17, 2018

Continuing yesterday's theme of working without distraction, I'll toss out a couple of pieces on RSS I encountered in the recent past. The first argues that RSS is a better way to keep up with news than Facebook and Twitter, for any number of reasons, such as signal-to-noise ratio. Here's that author's take on Twitter, in the form of an answer to a hypothetical question:

The wheel: Fine to customize, folly to reinvent. (Image via Wikipedia)
Wonderful! With Twitter, people can keep up with updates interspersed with cat photos, stolen jokes, retweeted jokes and celebrities' political opinions! Subscribers to multiple sites can enjoy the user-friendliness of having them all mushed up together, or having to laboriously visit each outlet's page to see new updates they missed in the firehose of minutiae!
His take on Facebook is somewhat similar.

The author of the second piece focuses more on the benefits he derives from using RSS:
... I like to work in focused bursts. If I'm deep into writing a book or a legal client project. I basically ignore everything else. I close my mail application, tell my phone service to take my calls, and I definitely don't open Twitter. When I finish the job, I can then go back to the Internet. I'll check in on Twitter, but I won't be able to get my news from it. That only works if you go into Twitter much more frequently than I do. That's why RSS is such a great solution for me. If a few days go by, I can open RSS and go through my carefully curated list of websites and get caught back up with the world.
Perhaps there are apps that can filter/save Twitter/Facebook feeds to make them less cluttered/more amenable to scheduling one's reading around one's schedule (rather than the other way around), but that would ... just make them more like RSS feeds.

As the first author notes:
Yes, the technology is dated, but it remains the best at what it does and isn't closed source or tied to some Silicon Valley company. It still works, is widely supported and does what it does better than any alternative that's come out since. Sometimes, newer isn't better. Sometimes the problem has already been solved. No blog or news website should be too new or too minimal to support RSS. [bold added]
Amen. A nice problem that comes with our era of constant and rapid innovation is that the shiny new things can cause us to forget about (or never learn the merits of) the tried and true. One should keep this in mind when choosing tools, as I have discussed before.

-- CAV

Talking About Slack, to Talk Less With It

Tuesday, January 16, 2018

Recently, comparing notes about our respective telecommuting gigs with my sister-in-law made me very glad that I use Slack exactly zero percent of the time. It also reminded me of an article I encountered about the stress caused by telecommuting, much of which comes from the way many, if not most telecommuters end up feeling pressured to misuse it:

Ideas? She won't have too many working in an open office -- or its online equivalent. (Photo by on Unsplash.)
When working remotely as a developer, the chat (usually Slack or Hipchat) quickly becomes your lifeline to the company: that is the way most people will try to contact you. And to me, being responsive on the chat accomplishes the same as being on time at work in an office: it gives an image of reliability. It also implies that if you do not really want to give the impression that you are taking a lot of breaks, you might finding yourself checking your notifications a lot while taking lunch for example, while if people had seen you working the whole morning, or if I was just talking with colleagues at that point, you would not feel the need to be so responsive. I actually often realized that other colleagues working remotely were criticized because they were not answering very quickly on the chat.

A part of the problem is that on a chat, people do not see you physically, so they cannot really estimate if you are at a good moment to be interrupted. So, you are interrupted a lot, and if you are a bit like me, you feel forced to answer quickly. So, you interrupt your work a lot. And in case you do not know it: interruptions are loathed by programmers, since it is really bad for their productivity as it breaks their focus. [bold added]
I am not a software developer, but I don't see how I could be very effective if I had to try to work this way.

Fortunately, Cal Newport, author of Deep Work offers a way out of this practice, namely by bringing it up with one's boss:
  1. Explain the concepts of deep and shallow work, noting, of course, that both are important.
  2. Ask what ratio of deep to shallow work hours you should be aiming for in your job.
  3. Then promise to measure and report back regularly. (Most bosses will be interested to gain these extra data points.)
Newport reports that the person he advised to do this very quickly got his boss on board with the idea of letting him concentrate for a decent amount of time twice a day. "Just ask Tom. But not between 9 to 11 or 2 to 4, because he'll be too busy creating valuable things to answer." Incidentally, Newport also indicates that this strategy is useful for other workplace practices that evolve more out of thoughtlessness and inertia than active hostility to the ability to concentrate.

-- CAV

Google and Political Fantasies About Technology

Monday, January 15, 2018

Google has just told us a lot more about itself than it has about any of the conservative news organizations whose claims its new "fact-checking" "feature" can or will.

"Google's New 'Fact-Checker' Is Partisan Garbage," argues David Harsanyi over at The Federalist. After demonstrating an interesting tendency for the new "feature" to scrutinize only conservative sites, and sometimes effectively put words in their mouths, Harsanyi summarizes:

It's the facts that he wants, and he knows he will still have legwork to do after he gets them. (Image via Wikipedia.)
[I]f this is the standard for corrections and dissuading people from visiting a site, what possible reason could there be for left-wing sites that regularly make arguable or false assertions about economics, history, science, and politics, like Vox and ThinkProgress and many others, to be spared from this fact-checking? It's one thing for us to read publications through filters. We do it all the time. But it's another for a search engine to manipulate perceptions about those sites -- and only conservative ones -- before people even read them. [format edits]
This reminds me of a couple of things.

First, it brought me back to my undergraduate days, way back in the late eighties, when I was contemplating a course of independent study centering around Ayn Rand's fiction. One of the first things one of my potential "advisers" uttered upon hearing the name, "Ayn Rand," was "Isn't she a fascist?" So, brand-new technology, same old, bullying left. Yes, Google's participation in this farce does expose them as sympathetic to leftists. But it also shows us that leftists imagine that they can use technology to keep people from discovering differing opinions on their own. Fortunately, they aren't a government, with the ability to censor the likes of David Harsanyi, so all they can do is psychologically project their own second-hand way of reaching opinions onto others and "help" them by means of smearing dissidents. Despite lip service to "facts", the left sees technology as a means of disseminating and enforcing an orthodoxy, rather than of helping people form solid opinions based on independently verifiable facts.

Second, this way the left sees technology as an aid to its cause reminds me of a somewhat similar fantasy I have observed on the right: If the left sees ideas as important (even if they implicitly admit they can't defend their own with facts), many on the right see them as irrelevant. All we need is the easy access to "facts on the ground" that high tech makes available, and freedom will burst forth throughout the world:
Here's another counterexample to the notion that technology -- unaided by an improvement in a society's intellectual climate -- can effect meaningful social change. [Glenn] Reynolds notes that Philippine President Joseph Estrada was brought down by a text-messaging flash mob. He fails to mention that this flash mob gathered in exactly the same place the old-fashioned mob that overthrew Ferdinand Marcos 15 years before had gathered. I dare say that unless the people of the Philippines make fundamental cultural and political changes, some other corrupt president will probably have to be overthrown later on. What difference does it make that a president can be overthrown if he never gets replaced by anything better? [bold added]
See also their current leader, the "Arab spring", and possibly also Iran. And see also scores of free-market economists who scratch their heads at how socialist regimes keep popping up despite a century of failure by socialism -- which they have documented for almost as long -- to bring anything but misery and death, much less prosperity.

Leftists think ideas are important, but can't defend their ideas. They see technology as a way to do their reeducation more effectively. Too many on the right think ideas are unimportant, that people want prosperity enough that simple exposure to facts will obviate the difficulty of having to convince them of anything in the fight for freedom. They see technology as the magic pill that will make everyone in favor of their version of freedom once the facts are out. Both sides are wrong. Opinions can and should be based on facts, and facts don't force people to act in a certain way. Technology doesn't obviate the need to think about opinions or the need to guide one's actions based on sound ones.

-- CAV

Friday Four

Friday, January 05, 2018

Four Things

Belated happy New Year's wishes come with this post, as I begin the second half of my annual blogging hiatus. Expect me back here on the fifteenth.

1. Richard E. Ralston, Executive Director of Americans for Free Choice in Medicine, debunks commentary from the left regarding the repeal of the ACA personal mandate:

We have been told ceaselessly and repeatedly that the end of the mandate means 13 million people will have their health insurance taken away. That is an Orwellian way of saying that 13 million people will not be forced, fined, or taxed to buy insurance that they do not want. Allowing people to choose to obtain their own insurance (or not) is intolerable to politicians who believe they know what is best for citizens. Eliminating the coercive mandate is instead a restoration of freedom for those 13 million people.
Also, Ralston calls the repeal "poetic justice," given the ... creative ... way that part of the law was saved from being ruled unconstitutional by the Supreme Court.

2. Some are calling "raw water" the "New Anti-Vax," while others are complaining that natural selection won't work fast enough on the buyers:
Members are taking up the unrefined drink due to both concern for the quality of tap water and the perceived benefits of drinking water in a natural state. Raw water enthusiasts are wary of the potential for contaminants in municipal water, such as traces of unfilterable pharmaceuticals and lead from plumbing. Some are concerned by harmless additives in tap water, such as disinfectants and fluoride, which effectively reduces tooth decay. Moreover, many believe that drinking "living" water that's organically laden with minerals, bacteria, and other "natural" compounds has health benefits, such as boosting "energy" and "peacefulness."
Lots of people are warning enthusiasts about the numerous hazards of drinking untreated water of which they are apparently not wary, but I can see such warnings falling on mostly deaf ears.

To ignore the huge swath of common knowledge about untreated water -- but grant credence to conspiracy theories, such as those about fluoridation requires such a degree of evasion and magical thinking that one could credibly say, "To the raw water skeptic, no warning is necessary; to the customer, none is possible." I can almost hear some hippie saying, "That's just propaganda, man," as he rushes to the water closet a few days after swilling some of this.

3. Thanks to Gallium OS, a lighweight Linux distribution, I have finally have a new "netbook" to replace the one that died when I moved to Baltimore.

The new netbook, during a break.
I'd been using a full-sized laptop for my mobile computing ever since, and it's a fine computer, but I missed the convenience of the tiny, light form factor. Unfortunately, Chromebooks -- similarly-sized laptops running the dumbed-down, web-centric Chrome-OS -- had killed off the netbook. Chrome is inadequate for my needs, but I heard about people installing Linux on Chromebooks and looked into it. I now own a Samsung Chromebook 3 that runs Gallium. As much as I liked my netbook, I'd forgotten how convenient it was, and what a perfect (at least for me) writing platform it was.

I never expected a $200.00 semi-nostalgic Christmas indulgence to be quite so liberating.

4. NPR recently put out an interesting piece on the small Chinese community in the Mississippi Delta:
"The Chinese face with a Southern accent throws people off," Jean Maskas chimes in. "I was at my daughter's school, and we'd taken some friends out to eat, and they all said, 'I just can't get used to talking to your mother! It's like an identity theft!'" The others chuckle knowingly.

Quon says the more she's traveled, the more she's come to realize how unique this Mississippi Chinese community is.

"We are all connected," she says. "The other states are not like that, truly. We knew Chinese from Memphis to Vicksburg."
The Chinese presence in the rural Delta is declining as a younger generation, encouraged by their parents, seeks opportunities elsewhere.

-- CAV


Today: (1) Fixed formatting glitch. (2) Edited caption.