HealthLawProf Blog

Sloppy Thinking about Genetic Therapy

As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.

Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.

But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided.

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The Ebola "Czar"

In the wake of Craig Spencer’s decision to go bowling in Brooklyn, governors of three major states—Illinois, New Jersey, and New York—have imposed new Ebola quarantine rules that are inconsistent with national public health policy, are not likely to protect Americans from Ebola, and may compromise the response to Ebola in Africa, as health care providers may find it too burdensome to volunteer where they are needed overseas. Don’t we have an Ebola czar who is supposed to ensure that our country has a coherent and coordinated response to the threat from Ebola?

Of course, the term “czar” was poorly chosen precisely because Ron Klain does not have the powers of a czar. He will oversee the federal response to Ebola, but he cannot control the Ebola policies of each state. Unfortunately, on an issue that demands a clear national policy that reflects medical understanding, public anxieties will give us something much less desirable.

[cross posted at Bill of Health and PrawfsBlawg]

Egg Freezing and Women's Decision Making

The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.

Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing.

Some women freeze their eggs because they face infertility from cancer chemotherapy; other women may not have found a life partner and want to suspend their biological clock until that time comes.

But some observers worry that with the option of egg freezing, some women will succumb to the pressures of the workplace and choose egg freezing not because they really want to but because they feel that have to. After all, if a woman can delay procreation and put in long hours at the office, why shouldn’t she do so? Employers might think that women who forgo egg freezing are not really committed to their jobs.

These concerns are legitimate, but are people too willing to invoke them? Egg freezing is not a simple procedure, nor is its success a certainty. Even if covered by insurance, women are not likely to choose egg freezing lightly. We should worry that egg freezing critics may be too ready to question the decision making capacity of women contemplating their reproductive choices.

[cross-posted at Bill of Health and PrawfsBlawg] 

Too Much Information? GM Food Labeling Mandates

As NPR reported yesterday, voters in Colorado and Oregon will decide next month whether foods with genetically-modified (GM) ingredients should be identified as such with labeling. And why not? More information usually is better, and many people care very much whether they are purchasing GM foods. Moreover, it is common for the government to protect consumers by requiring disclosures of information. Thus, sellers of securities must tell us relevant information about their companies, and sellers of food must tell us relevant information about the nutritional content of their products.

Nevertheless, there often are good reasons to reject state-mandated disclosures of information to consumers. Sometimes, the government requires the provision of inaccurate information, as when states require doctors to tell pregnant women that abortions result in a higher risk of breast cancer or suicide. At other times, the government mandates ideological speech, compelling individuals to promote the state’s viewpoint. Accordingly, the First Amendment should prevent government from requiring the disclosure of false or misleading information or of ideological messages. (For discussion of abortion and compelled speech, see this forthcoming article.)

What about GM labeling? Is this similar to requiring country-of-origin labeling for meat and produce, a policy upheld by the D.C. Circuit earlier this year? GM labeling likely will mislead more than inform. Many people harbor concerns about genetic modification that are not justified by reality. In particular, as the NPR report indicated, researchers have not found any risks to health from eating GM foods. Indeed, genetic modification can promote better health, as when crops are fortified with essential vitamins or other nutrients. For very good reasons, GM foods run throughout the food supply, whether from traditional forms of breeding or modern laboratory techniques. Thus, the American Association for the Advancement of Science has concluded that GM labeling “can only serve to mislead and falsely alarm consumers.”

[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]

Lessons About Medical Error Learned Watching I Love Lucy.

It's no secret that the night staff of a hospital are both over-worked and over-tired.   Nor is it any secret that many medical errors occur at night.  But until we look at the totality of the human factors making up medical error, we are unlikely to make significant headway in addressing it.  A review of the literature suggests that the reason isn't a lack of understanding about the factors which cause human errors, it's concern about the cost of addressing them.

The authors of a recent study in the Journal of the American Medical Association titled, Relationship Between Occurrence of Surgical Complications and Hospital Finances conclude that not only aren’t hospitals doing all they can to reduce medical errors, they actually have no financial incentives to do so.  

I'd suggest that financial incentives are behind ineffective efforts to address the issues of staff over-work and the inherent dangers of intermittent shift work.

 It's no surprise that another widely reported recent study has found that reductions in the hours medical residents work has not resulted in increased patient safety.   The study authors conclude that this is because although residents worked less hours, they did not have a reduced work load.  So, like Lucille Ball in the chocolate factory, the trying to cram more work in the same amount of time increased resident error.  

The findings of that study need to be seen in combination with the vast amount of scientific research on the increase in errors caused during night shifts.   A recent study of nurses working night shifts showed that “on average, the error rate increase 6% after the second night shift in a row, 17% after the third successive night shift and an astounding 35% higher on the fourth night shift.”  See also this and this article by the Joint Commission.  Although no one disputes the reality that human beings perform best in the day time, every hospital must be fully staffed 24 hours a day.  The information is both anecdotal and research based.   But no one seems to be listening.

 An article in Nursing World  does an excellent job of using available research to describe the scope of the problem, but implies that it can be effectively addressed by nurses proactively paying more attention to their sleep patterns.  It advises nurses working the night shift to “take control of sleep.”  In fact the NSF “recommends that nurses wear wrap around sunglasses when driving home so the body is less aware that it is daylight.”    This advice ignores the scientific reality that humans are not as effective or alert at night as they are in the day time.  Nor does it consider the human reality that medical shift workers do not have the luxury of using their days to sleep.  Like everyone else living in a diurnal world, they must cope with the tasks of family and daily living.

 Techniques like wearing dark glasses may work in making a shift to a new rhythm--like travelling to another time zone.   But given the unlikeliness of medical staff to convert to a  permanent change in their circadian rhthyms, as if they were working in a submarine (and that doesn’t work very well either)  the answer is to address the reality that humans are less effective at recognizing problems and completing complex tasks at night.   But that’s not where the problem solving is going. 

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