Month: July 2019

Five congenitally deaf couples have agreed to allow their embryos to be edited by Russian biologist Denis Rebrikov, who will use CRISPR to correct the defective GJB2 genes that are responsible for their hearing loss. Since both would-be parents harbor two copies of the gene, their children would necessarily also be deaf.

So far as is known, CRISPR gene-editing of human embryos has only been done by Chinese biophysicist He Jiankui. He announced the birth in November of two girls whose genomes he had edited using CRISPR with the goal of making them immune to the HIV/AIDS virus. He was widely denounced for conducting an unethical and risky treatment. Some of the condemnations were justified: The technique’s safety is unknown and the babies’ parents likely were not provided with enough information to give truly informed consent. Despite being reproached for ethical lapses, He has reportedly been approached quietly by several fertility clinics that are interested in offering gene-editing services to their clients.

Since the hearing loss versions of the GJB2 gene are recessive, Rebrikov aims to use CRISPR to correct one version of the GJB2 genes, thus enabling the gene-edited child to hear. Earlier this month, researchers at Harvard using CRISPR successfully edited a mouse gene associated with hearing loss.

One of the chief safety concerns with CRISPR is the possibility of off-target mutations that could result in unintended harms to gene-edited babies. In other words, there is the risk of editing a gene you don’t intend to, producing results you also don’t intend. However, performing the edit at the one-cell stage enables reproductive clinicians to excise and test cells taken at a later stage of embryonic development to make sure the edit has been properly made and that no dangerous off-target mutations have occurred.

Many of He’s critics point out that there are now effective ways to treat and prevent HIV/AIDS—including a possible vaccine—without resorting to gene-editing. Similarly, it is possible to correct hearing loss through the use of a cochlear implant device. It is worth noting that, in the United States, the cochlear implant devices and associated treatments can cost up to $100,000. Although gene-editing would obviously involve additional costs, the price of one cycle of IVF treatments is around $8,000 in Russia and about $12,000 in the U.S.

Hearing loss is not a fatal disease and obviously many deaf folks live happy and fulfilling lives. So should Rebrikov be allowed to proceed with his gene-editing plans? Assuming adequate safety precautions are in place and that parents clearly understand the risks and benefits from the proposed treatments, the answer is yes.

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So the Connecticut Appellate Court held Tuesday in Doe v. Cochran, by a 4-3 vote; you can read the majority and the dissent. Courts are split on this question (and its analogs), as pp. 11-12 of the dissent note. The majority notes that its opinion is limited, though it’s not clear whether the limitations (e.g., to exclusive romantic partners)will remain tenable in future decisions:

[T]he duty that we recognize today … extends only to identifiable third parties who are engaged in an exclusive romantic relationship with a patient at the time of testing and, therefore, may foreseeably be exposed to any STD that a physician fails to diagnose or properly report. And the physician fully satisfies that third-party duty simply by treating the patient according to the prevailing standard of care and accurately informing the patient of the relevant test results. Whether there are other, broader circumstances under which a physician may be held to owe a duty of care to a nonpatient third party who foreseeably contracts an infectious disease as a result of the physician’s negligence is a question that we need not resolve today.

I think the majority is generally right: To quote the Restatement (Third) of Torts:

An actor ordinarily has a duty to exercise reasonable care when the actor’s conduct creates a risk of physical harm.

A doctor’s telling the patient that the patient has tested negative for a sexually transmitted disease creates a risk of physical harm to the patient’s sexual partners—it increases the likelihood that the patient will have sex with them, or will have sex with them without proper protection. (The STD here was herpes, which can be spread even if the man wears a condom, but apparently condom use does decrease the risk; also, herpes medication apparently reduces the risk of spreading the virus as well.) And the risk to the third party is certainly foreseeable.

If the doctor or the doctor’s employees acted unreasonably—for instance (as alleged in this case), the doctor “misread [the] lab report,” or the doctor “misinformed his staff member,” or “the staff member misinformed [the patient]”—then they should be held liable. That’s not some special new legal duty; it’s just the basic duty that all of us have to act reasonably when our actions create a risk of physical harm to others.

The Restatement does note that, “In exceptional cases, when an articulated countervailing principle or policy warrants denying or limiting liability in a particular class of cases, a court may decide that the defendant has no duty or that the ordinary duty of reasonable care requires modification.” That’s why, for instance, most courts have adopted various so-called “no-duty” or “limited-duty” rules, such as the rule in most states that a social host who serves alcohol to guests can’t be liable to third parties who are injured when the guests drive drunk. But I don’t see a basis for imposing such a limitation here.

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Want to make money giving out diet tips? In Florida, you’ll have to get a bachelor’s degree and a state license to tell people how to eat better. A federal judge has upheld the Sunshine State’s occupational licensing program that censors diet coaching by those who are not officially deemed dieticians.

The case, brought by the liberty-loving and oppressive-occupational-license-fighting lawyers of the Institute for Justice, revolved around the work of Heather Kokesch Del Castillo of Fort Walton Beach. Del Castillo was applying her training from an unaccredited online holistic health program, offering six-month coaching programs to clients for pay. But she is not a licensed dietician in Florida, and when the state found out about her work, they accused Del Castillo of practicing dietetics without a license and threatened her with hundreds of dollars in fines if she didn’t stop.

With the help of the Institute for Justice, Del Castillo fought back, arguing in court that this licensing demand violated her First Amendment rights to free speech. Unfortunately for her, Judge M. Casey Rogers of the U.S. District Court for the Northern District of Florida disagreed and tossed her case. Rogers concluded that current court precedents have determined that it’s not an unconstitutional abridgment of free speech rights to require an occupational license to earn a living talking about certain issues, “so long as any inhibition of that right is merely the incidental effect of observing an otherwise legitimate regulation.”

Rogers turned to a court ruling from Locke v. Shore, another case from Florida from 2011 in which a federal court ruled that it’s legal for the state to require that interior designers get licensed to legally practice their craft.

Lawyers from the Institute for Justice argued that subsequent court rulings have weakened Locke, particularly a Supreme Court ruling from 2018, NIFLA v. Becerra, that addressed whether California could require pregnancy centers to carry notices indicating whether or not they were licensed and, if they were licensed, requiring the centers to post notices informing women of the availability of free or low-cost services, including abortions. The Supreme Court ruled that these speech demands were unconstitutional. In the writing of the majority opinion, Justice Clarence Thomas noted, “Speech is not unprotected merely because it is uttered by ‘professionals.’ This Court has ‘been reluctant to mark off new categories of speech for diminished constitutional protection.'”

Rodgers didn’t find that argument applicable here. Florida wasn’t telling Del Castillo what she could or could not say or what she must or must not say. She could give all sorts of nutrition advice out for free. But in order to earn a living giving advice, she needed to get a license, and Florida made the case that there are valid public health reasons for having such a law. Rodgers wrote, “Notably, it is, at the very least, reasonably conceivable that the unlicensed practice of dietetics could lead to improper dietary advice from unqualified individuals, which in turn could harm the public.”

The combination of rulings creates a bit of an odd outcome. Florida can require that Del Castillo get the appropriate degree and pay the appropriate licensing fees in order to legally give out nutritional advice, but it’s not clear that they could tell her what kind of nutritional advice she could give. There might be no difference between the advice she gives now and the advice she might give with a degree and an occupational license. A diploma and a license won’t actually prevent Del Castillo from giving out “improper dietary advice.” Heaven knows the government itself often gets nutritional advice completely wrong.

Lawyers from the Institute for Justice expressed dismay at yesterday’s ruling and promised to appeal.

“The court held that talking with a person about their diet isn’t speech, it’s the ‘conduct’ of practicing dietetics,” said I.J. Attorney Ari Bargil. “The Supreme Court has squarely rejected that sort of labeling game. Giving advice on what an adult should buy at the grocery store is speech, and the First Amendment protects it.”

Read the full ruling here. Read more about efforts to try to censor “unlicensed” public health and nutrition advice here.

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“America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012 as the nation’s deadliest drug epidemic spun out of control,” The Washington Post reports, citing newly released data from the Drug Enforcement Administration (DEA). That lead and the headline above the article (“76 Billion Opioid Pills: Newly Released Federal Data Unmasks the Epidemic”) tell a simple and familiar story: Because doctors prescribed too many pain pills, people died—”nearly 100,000″ from 2006 through 2012, according to the Post, although data from the U.S. Centers for Disease Control and Prevention (CDC) indicate that the actual number for the drugs the Post is talking about was more like 68,000.

The reality is more complicated. It is clear that doctors, in many cases, did prescribe more pills than their patients ended up needing, since a lot of those pills were diverted to nonmedical use. But by counting all 76 billion as self-evidently problematic, the Post ignores the benefits of opioids for the millions of Americans who actually need them for pain relief—patients who are now suffering because of the crackdown encouraged by indignant and simplistic press coverage like this.

What is the right number of pills? The Post does not know, and neither does the DEA. But since misuse of prescription analgesics co-exists with undertreatment of pain, indiscriminate reductions in the total supply have predictably bad consequences for patients. That ham-handed approach also has driven nonmedical users toward black-market substitutes that are much more dangerous because their potency is inconsistent and unpredictable, which helps explain why the increase in opioid-related deaths accelerated in recent years even as the government succeeded in driving down opioid prescriptions.

It is also important to recognize that the “epidemic” described by the Post is not an increase in nonmedical use of opioids or even in “pain reliever use disorder.” According to data from the National Survey on Drug Use and Health, the incidence of both has been essentially flat since 2002, including the period on which the Post focuses. But the number of fatalities involving prescription analgesics has increased dramatically since 2002, part of a long-term upward trend in drug-related deaths that began in 1979—17 years before the introduction of OxyContin, which the Post fingers as the main pharmacological culprit (although it also notes that OxyContin accounts for just 3 percent of the legal opioid market).

These deaths typically do not involve legitimate pain patients who accidentally got hooked on medication their doctors prescribed for them. They generally involve people with long histories of substance abuse and psychological problems who use diverted pain medication along with other drugs. CDC data indicate that more than 90 percent of deaths involving prescription analgesics also involve other drugs, most commonly heroin and illicit fentanyl. Judging from New York City data, the actual percentage may be as high as 97 percent.

The increase in deaths seems to be caused not by a general increase in the rate of misuse but by an increase in reckless consumption, including injection, higher doses, and drug mixtures. That behavior can be understood only in the context of personal, social, and economic circumstances, including whatever factors have been driving up drug-related deaths since the late 1970s.

The Post implies that there is a straightforward relationship between opioid prescription rates and opioid-related deaths. That is not true even if you focus on deaths involving pain pills. Between 2006 and 2012, the Post says, West Virginia received the most pills per capita, and “West Virginia also had the highest opioid death rate during this period,” which was still true as of 2017, according to the CDC.

But what about the other states that rank high in pills per capita? Of the top 10 states listed by the Post, the CDC has data on deaths involving prescription analgesics for seven. In addition to West Virginia, they are Kentucky, South Carolina, Tennessee, Nevada, Oklahoma, and Oregon, and those are not the states with the highest death rates. Within this group, Kentucky had the highest rate in 2017 (10.2 per 100,000), but it was still lower than the rates in Maryland (11.5) and Utah (10.8), both of which had substantially lower prescription rates.

South Carolina’s death rate (7.1 per 100,000) was lower than the death rates not only in Maryland and Utah but also in Connecticut (7.7), the District of Columbia (8.4), Maine (7.6), New Mexico (8.5), Ohio (8.4), and Rhode Island (8.8). Again, all those states had lower opioid prescription rates, in some cases much lower. The same pattern holds true for Tennessee, Nevada, Oklahoma, and Oregon, all of which had lower death rates than states where fewer opioids were prescribed. The disparity is especially striking for Oregon, where the rate of deaths involving pain pills was just 3.5 per 100,000, lower than the rates in most states, even though Oregonians received more opioid prescriptions per capita than 29 states and D.C.

The point is not that pain pill prescriptions have nothing to do with deaths involving pain pills. But other factors are clearly at work. How does Oregon manage to have such a low death rate even though it has a relatively high prescription rate? Why do Utah and Maryland, both of which have lower prescription rates, have death rates much higher than Oregon’s? The answers to such questions could point the way to policies more nuanced and effective than the blanket demand that doctors stop prescribing so many pain pills.

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