Category: Bioethics

BoH Exclusive: Sigrid Sterckx comments on the media storm following Nature’s press release on her article announcing 23andMe’s patent for a method to obtain designer babies

The Petrie-Flom Center Staff Leave a comment

[Posted on behalf of Sigrid Sterckx, as part of our collaboration with Genetics in Medicine]

Yesterday, 3 October, an article I wrote with three co-authors about a controversial US patent was published by the (Nature) journal Genetics in Medicine. The patent, granted last week to the Californian Direct-To-Consumer genetic testing company 23andMe, is entitled ‘Gamete donor selection based on genetic calculations’ (US Patent No. 8543339). It relates to a method by which prospective donors of ova and/or sperm may be selected so as to increase the likelihood of producing a human baby with characteristics desired by the prospective parents, the selection being based on a computerized comparison of the genotypic data of the egg provider with that of the sperm provider. The “phenotype of interest” prospective parents may have in mind can include, besides some disease-related traits, traits such as eye color, height, muscle development and personality characteristics. As quoted in the patent specification by way of example, prospective parents may indicate which of the three following choices they make: “I prefer a child with”: “longest expected life span”/“least expected life cost of health care”/“least expected cumulative duration of hospitalization.”

The press release issued by Nature on Monday 30 September quickly gave rise to several news reports. The company posted an announcement on its blog the next day, stating that the patent “relates to one of the tools we offer individuals as part of their genetic exploration. The tool – Family Traits Inheritance Calculator – offers an engaging way for you and your partner to see what kinds of traits your child might inherit from you”. However, anyone who looks at the patent and reads the claims will notice that this is not what the patent relates to. As mentioned above, it relates to a method to select gamete donors in order to achieve a child with the phenotype desired by the prospective parents. 23andMe admits that “the language of the patent extends beyond the calculator” but suggests that people need not be worried as: “At the time 23andMe filed the patent, there was consideration that the technology could have potential applications for fertility clinics so language specific to the fertility treatment process was included in the patent. But much has evolved in that time, including 23andMe’s strategic focus. The company never pursued the concepts discussed in the patent beyond our Family Traits Inheritance Calculator, nor do we have any plans to do so.”

Read More

Economics, Morality, and End of Life Care

The Petrie-Flom Center Staff Leave a comment

By Nathaniel Counts

Over a quarter of Medicare spending goes toward a patient’s last six months of life.  This monopolizes limited resources, both in the hospital and in the federal budget.  Much of the blame for this overspending is placed on institutional incentives or medical training for promoting aggressive end of life care, but some would also place the blame on patients or their families, arguing that this behavior is a flaw in our culture.  The argument goes that if people would learn to be less afraid of death, then they would forego this costly life extending care and die peacefully, while allowing these resources to be available for use elsewhere with greater utility.  In this argument, there is potentially a worrying conflation of moral and economic reasoning, which would be problematic if applied in other contexts.

It would be one thing to say that, given a limited pool of resources, a cost-benefit analysis indicates that end of life care is inefficient and quality-adjusted life years across the system would best be maximized if the money was spent elsewhere, and those in need of end of life care and their families will need to adjust their expectations.  But integral to the argument in the first paragraph is that this misallocated spending is the result of a moral failing, perhaps not of the individual but of the society that imbued the person with the preference for aggressive treatment, and that this failing is worth changing, not only because it will save money and make individuals more comfortable with the fact that there are no longer the resources to support end of life care, but because it will provide some moral benefit to those whose values are changed.

My curiosity is how the economic argument (that it would be a better use of resources to spend money elsewhere) informs the moral argument (that it would be better if people accepted their death).  This is peculiar to me because this type of reasoning does not show up consistently throughout health rationing: if a country decides to spend limited resources on HIV prophylactic drugs rather than HIV treatment drugs, no one would argue that it was in any way unreasonable for the HIV positive individuals to want treatment and that they should be more at peace with a terminal illness.

Read More

Art Caplan on New York State’s Mandate to Vaccinate against the Flu or Wear a Mask

acaplan Leave a comment

Art Caplan has co-authored a new article, with Nirav R. Shah, published online today by JAMA. In “Managing the Human Toll Caused by Seasonal Influenza: New York State’s Mandate to Vaccinate or Mask,” Caplan and Shah discuss New York’s new mandate that health care personnel who have not been vaccinated against the flu must wear a mask during the coming flu season.

Read More

Art Caplan: Surgery to stop autistic boy’s screams was the right decision

acaplan Leave a comment

Art Caplan has a new op-ed up at MSNBC.com:

A Wisconsin mother says that surgery helped quiet her autistic teenage son’s ceaseless screams, a decision that has attracted criticism from many, including families within the autism community. But for this particular teenager, and this particular family, it was the right choice to make. […]

Read the full article here.

The priorities in the benefit packages vs. the priorities of those who dole out the benefits

jurrutia Leave a comment

In my last post I promised I would provide details about the new piece of statutory legislation that was recently enacted by the Colombian Congress on the right to health, but first I should talk a little more about the prior jurisprudence that set the stage for it–especially since there’s so much of it. Every year, hundreds of thousands of right-to-health cases go before judges in Colombia, and some estimate that up to one out of every five Colombians has used the judicial system to gain access to health services.

By far, most of these cases are won by the plaintiff. And they should be.

Nearly 90% of the cases that involve procedures, and over 30% of the cases for medications, involve benefits that are actually already covered by the public benefit package (plan obligatorio de salud, or POS). And most of these aren’t over particularly expensive, complicated, or scarce benefits in the POS. The most frequently litigated medications are omeprazole (Prilosec) and oxygen. The most frequently litigated procedures aren’t even the procedures themselves, but specific parts of the procedures that aren’t explicitly listed in the bundle of benefits covered by the POS. For example, the POS covers colostomies, but the insurance companies systematically deny the colostomy bags. “We’ll open the hole in your flank, but it’ll be on you to figure out what to do with the excrement that’ll start oozing out. . .”

Read More

OHRP Revises Guidance on Remuneration for Human Research Subjects

srivera 2 Comments

by Suzanne M. Rivera, Ph.D.

The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation.  And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies.   Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?”  (https://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).

Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence.  It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.

That is a real paradigm shift. Read More

Improving Outcomes by Empowering Patients: The Empirical Case for Patient-Centered Care

michaelyoung Leave a comment

By Michael Young

As healthcare institutions work to meet the triple aim of reducing healthcare costs while improving quality of care and population-wide health, efforts to expand the role of patient involvement in clinical decision making have gained appreciable momentum.  Interest in increasing patient participation in clinical decision making and goal setting is premised in large part on the notion that greater patient involvement can improve health outcomes by ensuring that treatment plans align with patients’ interests, abilities and sociocultural contexts.  A recent study published in the Journal of Personality and Social Psychology adds to the growing body of empirical research supporting these efforts, suggesting that the very act of allowing patients to choose between treatment alternatives can augment the efficacy of treatment by enhancing patients’ sense of personal control.  By giving patients more opportunities to exercise autonomy at times when many are inclined to perceive their circumstances as well beyond their influence, healthcare providers can help to restore patients’ sense of self-governance and optimize patients’ perceptions of their situations and the medical care they receive.

The idea that empowering patients to choose between treatment options might itself contribute to better health outcomes invites clinicians to rethink how to approach formulating and conveying treatment plans to patients.  Whereas traditionally some clinicians might have conceptualized their roles as experts whose responsibility is to design therapeutic plans on behalf of their patients, the principle of patient-centered care encourages providers to regard patients as associates in developing shared plans to advance and sustain health.  This paradigm of care and the distinctive stance that it demands of clinicians is poetically captured by a letter penned by novelist John Steinbeck to his personal physician, in which he incisively relates “What do I want in a doctor? Perhaps more than anything else—a friend with special knowledge.”

Effectively transitioning to this horizontal model of therapeutic relationships will require careful planning and implementation.  Indeed, boosting patient involvement in clinical decision making may prove increasingly elusive as medical knowledge continues to grow exponentially complex in substance and scope.  As such, to realize the promises of patient-centered care, clinicians should work to develop concrete plans and quantifiable measures to operationalize the ideal of patient engagement within the context of day-to-day practice.  As a first step in this direction, healthcare providers might consider ways to deliver complex biomedical knowledge to patients and surrogates in ways that are more accessible, timely and actionable.  By coupling enhancements in patient education with efforts to promote patient involvement in clinical decision making, clinicians can play a pivotal role in maximizing the efficacy of healthcare innovations and delivery systems of the future.