Category: Law

Immigration sentences to ponder

“I would never have been able to arrive at my destination without my smartphone,” he added. “I get stressed out when the battery even starts to get low.”

That is from Osama Aljasem, a 32-year-old music teacher from Deir al-Zour in Syria, who took a boat to Greece, walked to Belgrade, and hopes to continue to parts further north and west:

In this modern migration, smartphone maps, global positioning apps, social media and WhatsApp have become essential tools.

Recommended.  And yes, disintermediation is kicking in:

“Right now the traffickers are losing business because people are going alone, thanks to Facebook,” said Mohamed Haj Ali, 38, who works with the Adventist Development and Relief Agency in Belgrade, Serbia’s capital — a major stopover for migrants.

Facebook groups are used to pass along GPS coordinates and the prices charged by the traffickers have fallen in half.

Is it time to regulate personal trainers?

Can you guess my answer to that question?  But it does seem to be coming:

After decades of unregulated existence in all 50 states, the booming field of personal trainers is braced for a wave of scrutiny that is expected to transform the industry and could make or break some of the biggest fitness companies in the country.

The new regulations, being written by and for the nation’s capital city, will create a registry of all personal trainers in the District only. But they are expected to become a model that winners and losers in the fight believe will be replicated elsewhere.

The credit or blame, as you may care to describe it, goes to the Affordable Care Act:

A variety of workplace wellness programs and preventive health-care initiatives called for in the law could soon translate into rivers of billable hours for those with credentials to keep American waistlines in check.

And that means the race is on to be eligible for those credentials…

I believe the excess bureaucratization of the ACA is just beginning to show all of its implications…

The story is by Aaron C. Davis.  And the article is sad throughout:

“We all have heard anecdotal reports of injuries, sexual misconduct and misrepresentation of titles by persons claiming to be competent in that area,” Simpson testified before a D.C. Council committee. She called the lack of any registration or licensure of personal trainers “a nationwide failure.”

Well, that is one “failure” we seem to be on the verge of remedying…

How would America evolve under open borders?

Nathan Smith has a very thoughtful speculative essay on that topic. Here is one interesting bit of many:

I would tentatively envision the US experience under open borders as resembling the British and Roman cases, inasmuch as the protocols and ideals of the US polity, as well as its merely ethnic characteristics, would persist in attenuated form, but governing a much larger population would necessitate improvisational and sometimes authoritarian expedients that would cumulatively transform the polity into something quite different, even as it claimed descent from the historic constitutional polity of the United States as we know it. The illusion of continuity would deceive the subjects of the new polity, native-born and immigrant, to a considerable extent, though on the other hand there would be a good deal of lamentation and triumphalism, and only after several generations would historians be able to look back and assess the bewildering transformation in a sober, balanced way.

Certain American ideals would die of their own increasing impracticality, e.g., “equality of opportunity,” the social safety net, one person, one vote, or non-discrimination in employment. Americans might continue to feel that these ideals were right long after they had ceased to be practiced, as the Romans seemed to feel that Rome ought to be governed by its Senate long after real governance had passed to the emperors. I don’t see how public schools could adapt to a far larger and more diverse student body.

In sum:

I think the most wild-eyed predictions of the open borders optimists will come true, and to spare, but I think a lot of the forebodings of the grimmest open border pessimists will also prove more than justified.

The article is interesting throughout, do read the whole thing.

From the comments — on suicide

Switzerland tolerates assisted suicide since 1942 and there are very interesting numbers. A) From 1995 to 2009, assisted suicide cases have grown but the total number of suicides keeps constant. B) Assisted suicide in 2009 accounted for approx 30% of all suicides. C) Women chose assisted suicide more than men, but men use firearms more than women to commit suicide. D) Peak assisted suicide is between 75 and 84 years old. It seems that people that cross the 80+ years old line are not affected by painful or exhausting diseases thus they choose to life until it ends naturally E) Peak suicide is between 45-54 years old, midlife crisis is real, F) Overall suicide rates for women kept constant even if assisted suicide rates increase. G) Overall suicide rates for men are going down and assisted suicide goes up.

http://www.bfs.admin.ch/bfs/portal/en/index/news/publikationen.html?publicationID=4732

The overall suicide rate in Netherlands between 1999 and 2013 has been between 8.3 and 11 per 100K habitats. The lowest rate was just before the crisis. http://www.cbs.nl/nl-NL/menu/themas/gezondheid-welzijn/publicaties/artikelen/archief/2015/4320-suicide-in-noord-holland-noord-en-nederland1999-2013.htm

The WaPo article would lose its killer headline if the total suicide rate is considered when assessing the “exponential” increase of assisted suicide. This seems like another case of double standards. When someone blows their brains with a gun we have to respect the decision and comfort the family, when someone opens the valve of sodium thiopental with their hand…..it’s just wrong.

That is from Axa.

The culture that is Dutch fact of the day

In 2013, euthanasia accounted for one of every 28 deaths in the Netherlands, three times the rate of 2002. In the Dutch-speaking part of Belgium, one of every 22 deaths was due to euthanasia in 2013, a 142 percent increase since 2007. Belgium has legalized euthanasia for children under 12, though only for terminal physical illness; no child has yet been put to death.

That is from Charles Lane.

Germany fact of the day, will support for immigration collapse?

Berlin has said it expects to receive a record 800,000 asylum seekers this year, more than the entire EU combined in 2014, laying bare the scale of the biggest refugee crisis to face the continent since the second world war.

Whether you consider this “good news” depends on what you are comparing it to.  Most of all, we would prefer a situation where not so many people wanted asylum.  In the meantime, my fear is that this immigration will not proceed in an orderly manner, and the backlash against immigration will grow stronger yet.  I do not expect 2017 to resemble 2015; “unorthodox arrivals” to Europe were three times higher this July than last and at some point that process will be stopped, no matter what our moral judgment of the situation.

Note this:

Interior minister Thomas de Maizière warned that the Schengen zone, which allows passport-free travel across much of mainland Europe, could not be maintained unless EU states agreed to share asylum seekers.

The Schengen agreement of course has been the best achievement of immigration policy in a long time.  But can the European Union agree on a coherent asylum policy, and furthermore one which removes some of the relative burden from Germany and the UK?  Keeping relatively free immigration does in fact require a good deal of regulation, most of all in Europe, but those same governments are not always good at regulating.

Here is some bad polling news from Sweden.   Trouble is afoot in other corners too:

Authorities in Hungary said this week they would dispatch thousands of “border hunters” to arrest migrants entering the country from Serbia.

The forces, drawn from the Hungary’s police, will patrol the 175km long border with Serbia, where soldiers and labourers are building a 4m high razor-wire fence to keep out an estimated 300,000 migrants expected to arrive in the country this year.

I think of these developments as a good illustration of why an attempt at truly, fully open borders probably would, due to backlash, result in a lower level of immigration than the pro-immigration, immigration-increasing, low-skilled immigration increasing policies I favor.  But the idea of maximizing subject to a backlash constraint is unpopular in libertarian circles, let me tell you, including at GMU lunch table.  Nonetheless we are learning, I am sorry to say, that the backlash constraint is more binding than many of us had thought.

This all remains an under-reported story in many American newspapers,  Even with Donald Trump still leading in the polls, it is not understood what a prominent role images of Calais are playing in British national debate.  I don’t see all this as leading to anything good.

There are an estimated 250 paternoster lifts (Personenumlaufaufzüge) still in use in Germany

The culture and polity that is Germany:

Officials in Stuttgart were among the loudest protesters against the labour minister Andrea Nahles’ new workplace safety regulations, which stated that the lifts could only be used by employees trained in paternoster riding.

“It took the heart out of this place when our paternoster was brought to a halt, and it slowed down our work considerably,” said Wolfgang Wölfle, Stuttgart’s deputy mayor, who vociferously fought the ban and called for the reinstatement of the town hall’s lift, which has been running since 1956.

“They suit the German character very well. I’m too impatient to wait for a conventional lift and the best thing about a paternoster is that you can hop on and off it as you please. You can also communicate with people between floors when they’re riding on one. I see colleagues flirt in them all the time,” he added, celebrating its reopening at a recent town hall party to which hundreds of members of the public were invited.

…In officialese the lifts are referred to as Personenumlaufaufzüge – people circulation lifts – while a popular bureaucrats’ nickname for them is Beamtenbagger or “civil servant excavator”. The name paternoster – Latin for “our father” – is a reference to one of the prayers said by Catholics using rosary beads, which are meditatively passed through the hand, just as the cabins are in perpetual motion around the shaft.

There is more here, with excellent videos of paternoster riding, all via Michelle Dawson.  By the way, it has been against the law to build new paternosters since 1974.

New Jersey facts of the day

Erik Eckholm reports:

I was startled by these calculations for New Jersey, for example: Cutting in half the number of people sent to prison for drug crimes would reduce the prison population at the end of 2021 by only 3 percent. By contrast, cutting the effective sentences, or time actually served, for violent offenders by just 15 percent would reduce the number of inmates in 2021 by 7 percent — more than twice as much, but still hardly the revolution many reformers seek.

New Jersey could reduce its prison population by 25 percent by 2021. But to do it, it would have to take the politically fraught step of cutting in half the effective sentences for violent offenders.

In other words, the real debate over how to deal with criminals has hardly begun.

The low-hanging fruit on this issue seems to be in Kentucky, Missouri, and Texas most of all.  But keep in mind another point: to the extent prison overcrowding eases, many judges will be giving longer sentences to many of the more violent offenders.

FDA approval at what price?

There is plenty of debate over whether the FDA should be looser or tougher with new drug approval, but I rarely hear the question posed as “approval at what price?”

One option would be to approve relatively strong and safe drugs at full Medicare and Medicaid reimbursement rates, if not higher.  Drugs with lesser efficacy or higher risk could be approved at lower reimbursement prices.  It is possible or perhaps even likely, of course, that private insurance companies would follow the government’s lead.

Dr. Peter Bach has promoted one version of this idea, and produced a calculator for valuing these drugs.  In essence the government would be saying to lower quality producers “yes, you can continue to try to improve this drug, but not at public expense.”

I believe proposals of this kind deserve further attention, and in general the notion of regulatory approval need not be conceived in strictly binary, yes/no terms.

FDA Loses Another Free Speech Case

WSJ: A federal court in New York delivered a setback to the Food and Drug Administration, ruling the agency can’t bar a drug company from marketing a pill for off-label use as long as the claims are truthful.

The decision by the federal district court in the Southern District of New York, is the latest of a line of such cases. It concerns the Irish company Amarin Pharma Inc. and its fish-oil-derived drug Vascepa, and it has been closely watched by the pharmaceutical industry. The company asked the court to stop the FDA from enforcing its off-label marketing ban, and the court agreed.

The ruling is important because in the last few years the FDA has extracted billions of dollars in settlements from pharmaceutical firms for engaging in what appears to be constitutionally protected speech. In fact, the courts have repeatedly ruled that FDA and Congressional restrictions on truthful and non-misleading off-label marketing are unconstitutional.

In Washington Legal Foundation v. Friedman, for example, the DC court issued an injunction preventing the FDA from prohibiting, restricting, sanctioning or otherwise seeking to limit pharmaceutical and device manufactures from disseminating information about off-label uses from peer-reviewed professional journals or textbooks. In U.S. v. Caronia the court (2nd circuit) reversed a criminal conviction and said that the FDA cannot criminalize truthful promotion of off-label uses of approved drugs. Indeed, the court in that case defended the utility of such promotion:

…prohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use “paternalistically” interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions. See Va. Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 770 (1976)

…See also Sorrell, 131 S. Ct. at 2670- 72 (“[The] fear that [physicians, sophisticated and experienced customers,] would make bad decisions if given truthful information” cannot justify content-based burdens on speech.”) (citing sources);

…Liquormart, 517 U.S. at 503 (“[B]ans against truthful, nonmisleading commercial speech . . . usually rest solely on the offensive assumption that the public will respond ‘irrationally’ to the truth. . . . The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”).

In Washington Legal Foundation v. Henney the court summed up concisely:

The First Amendment is premised upon the idea that people do not need the government’s permission to engage in truthful, nonmisleading speech about lawful activity.

(By the way, it’s this line of cases that makes me think that 23andMe has a strong first amendment case for presenting to customers information about their own DNA.)

The courts were exactly correct. Off-label uses of approved drugs are a vital part of the discovery process of modern medicine. New uses for old drugs are often discovered through serendipity and close observation in the field. Indeed, modern medicine moves faster than the FDA and it often happens that the first-line therapy is an off-label treatment. Prohibiting firms from truthfully discussing such treatments with physicians is not just unconstitutional it’s also paternalistic and harmful to patient welfare.

This case, Amarin v FDA, is especially egregious because the company wants to discuss with physicians the results of its own FDA-approved trial. Amarin has a fish-oil derived drug designed to reduce triglyceride levels and it already has approval to sell and market this drug in patients with very high levels of triglycerides. It also wanted approval to sell the drugs in patients with high (but not very high levels) and it conducted an FDA-approved trial that showed that the drug is safe and effective at reducing triglyceride levels in this set of patients.

Although the trial was successful the FDA, for reasons discussed below, refused to grant approval. Amarin isn’t disputing the refusal but they wanted to tell physicians the results of the trial and then let the physicians and their patients decide whether reducing triglyceride levels is something that they want to do given currently existing evidence about triglyceride levels and heart attacks. The FDA threatened to pursue civil and possibly criminal charges but the court has now precluded the FDA from those pursuits.

Aside from the first amendment issues, the case is also interesting as another example of how a capricious FDA can kill innovation through regulation uncertainty. (The story is similar in many respects to that told by Joseph Gulfo in Innovation Breakdown, see my review).

To wit: Amarin wanted approval to sell its drug to patients with high levels of triglycerides and they obtained a special protocol agreement (SPA) from the FDA to run a study in this population. Quoting the court:

An SPA agreement is a written agreement that a manufacturer may enter into with the FDA, which sets out the design and size parameters for clinical trials of a new drug, and the conditions under which the FDA would approve the drug. For the manufacturer, such an agreement minimizes development risk by providing regulatory predictability: Provided that the manufacturer follows the procedure set in the SPA agreement and the drug proves meets the benchmarks for effectiveness set in the agreement, the FDA must approve the drug.

The results of the study were good:

The ANCHOR study achieved each numeric objective that the SPA Agreement had set: The results showed that Vascepa produced a statistically significant decrease in triglyceride levels in persons with persistently high triglycerides, as well as in other lipid, lipoprotein, and inflammatory biomarkers.

…Because Amarin had met all requirements for approval set out in the ANCHOR SPA Agreement, Amarin anticipated that the FDA would approve Vascepa for the additional use that Amarin sought, i.e., by patients with persistently high triglycerides.

Instead of approving the drug, however, the FDA rescinded their agreement. The FDA argued that although the drug did reduce triglyceride levels it was no longer certain that reducing triglyceride levels would reduce cardiovascular events.

Can you imagine the tailspin this sent researchers at Amarin into when they learned that the drug would not be approved despite passing all the agreed upon tests? (Read Gulfo for a vivid account of his case).

Who will invest in bio-medical advances with this kind of risk? Sergei Brin said that he didn’t want to invest in health care because “It’s just a painful business to be in . . . the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs.” It’s precisely this kind of regulatory uncertainty that an SPA was meant to avoid. By rescinding their agreement, the FDA is sending the message to investors that no one is safe.

*Just Married*

That is the new and highly intelligent book by Stephen Macedo, and the subtitle is Same-Sex Couples, Monogamy & the Future of Marriage.  I balk at only one of his conclusions: he is pro-gay marriage, where I agree, but he does not believe in legal polygamy.  For instance he argues there is no polygamous orientation comparable to a same-sex orientation, rather polygamy is a preference.  He views polygamy as unstable, and also as leading to distributive injustice, with high status males reaping excess gains.  Furthermore the historical record of polygamy is often negative.  Here are relevant comments from Will Wilkinson, who (like me) is convinced by Macedo on gay marriage but not polygamy.  Is polygamy going to be such a significant practical problem that we ultimately have to in some way wield the coercive apparatus of the state if people insist on trying to practice it?  Would polygamous-equivalent contracts be not just left unenforced but also banned?  I don’t quite see how a liberal doctrine gets you there.  Furthermore, might polygamy make more sense in some eras than in others?  (“Not your grandfather’s polygamy!”)  I still wish to defend the presumption for some notion of freedom of contract.

Regulation, imperfect competition, and the U.S. abortion market

There is a newly published paper by Andrew Beauchamp:

The U.S. abortion market has grown increasingly concentrated recently, while many states tightened abortion laws. Using data on abortion providers, I estimate an equilibrium model of demand, price competition, entry and exit, to capture the effect of regulation on industry dynamics. Estimates show regulations played an important role in determining the abortion market structure and evolution. Counterfactual simulations reveal increases in demand-aimed regulation were the most important observed factor in explaining recent abortion declines. Simulating Utah’s regulatory regime nationally shows tightening abortion restrictions can increase abortions in equilibrium, mainly through tilting the competitive landscape toward low-price providers.

There are ungated versions here, and for the pointer I thank the excellent K.