Ethics. Research. Community.

Blogging Ethics

Note: blog content is not currently included in EthicShare's Search Results.

02/07/2020 - 7:10am

By Jeffrey R. Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics at University of Utah

We are at a critical crossroad in reproductive medicine.  How should science and society more broadly manage the powerful new technologies that can alter the genes of human embryos?  In a recent paper published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), I argue that banning the use of this technology editing human embryo is the right direction.

Concerns over theoretical capabilities of “designer babies” have been with us for generations.  The ability screen and test for embryos and fetuses with undesirable characteristics and forestall their birth is well-developed and familiar. But the actual ability to add, subtract or alter genes in the embryo is quite new.  The CRISPR-Cas9 technology and related technologies burst on the scene in the last decade and the ability to relatively easily and cheaply to alter human embryos is no longer science fiction.

A Chinese scientist, He Jiankui, was first out of the gate with claims of having altered the genomes of two children born in late 2018 with the intent of making them immune to HIV. The scientific community across the globe was shocked and angered.  He was subsequently convicted of criminal behavior, not of gene editing per se, but of violations of human subject regulations.

A Moratorium

What now? An international group of senior scholars recently called for a global moratorium on any attempts to create children through gene editing at least until questions of safety could be addressed.  A prior report by the US National Academy of Medicine described a number of significant hurdles that should be crossed before any attempts to create a baby. Yet the notion of a moratorium implicitly accepts a position that, once certain criteria are addressed, heritable genome editing could be ethically appropriate. The Asilomar Conference on recombinant DNA in 1975 is a famous example of scientists voluntarily establishing a moratorium on recombinant DNA technology until clear guidelines were established. But with recombinant DNA, there was no question of the enormous potential benefits of the technology.  The challenge was to address legitimate concerns about biosafety so that the benefits could be pursued with manageable risk.

A Ban

In contrast, heritable genome editing has virtually no useful or justifiable uses that cannot be achieved through existing technologies. Couples at risk of bearing a child with a genetic condition typically will be able to produce unaffected embryos that can be identified through preimplantation testing. Why try to edit the genome of an “affected” embryo when an unaffected embryo can be transferred through existing approaches?  The safety of children born following genome editing is a central concern.  Yet how will adequate safety be assessed and established without research involving hundreds if not thousands of women as egg donors? These women must be recruited as carriers for conditions deemed sufficiently severe to warrant the risks to women and the edited babies who will ostensibly benefit in the future.  Done right, this research agenda would be a monumental undertaking from the perspectives of risk/benefit to human subjects, regulatory oversight, manpower and cost considerations.

But even more concerning would be the fostering of attempts to enhance children through heritable gene editing. Once some degree of safety was established with therapeutic/preventative applications, the door would swing wide for services by scrupulous and unscrupulous providers alike to offer “designer” children.  Of course, complex traits that might be tempting to enhance, like intelligence, athletic ability, personality traits, etc. are due to complex and very poorly understood interactions between thousands of genes and environmental and random factors. Meaningful genetic enhancements of such traits may never be feasible but this would not prevent the marketing of interventions that purport to achieve such results. Implicit in this argument, but beyond the scope of this note, is a conclusion that heritable genetic enhancements of children raises serious ethical concerns including physical and psychological risks and social justice.

The justification for a ban on this application for this technology is threefold: the benefits are remarkably limited, the achievement of adequate safety would require a large allocation of a whole host of social resources, and the risks of misuse of the technology are profound.  In contrast, the benefits of somatic gene editing are extremely exciting and should be pursued vigorously.  The right path forward at this crossroad is one that truly enhances the health and welfare of children and families.

The post Time to Ban Heritable Genome Editing appeared first on Bill of Health.

02/07/2020 - 3:00am

It is one thing to write a DNR order without patient or family consent. Sometimes, that is justified when CPR will be medically ineffective. But it is another thing altogether to write the DNR order without even the knowledge of the patient or family. 

Despite the British appellate courts (in Tracey) declaring this practice illegal, it apparently continues. This week, Vivian Lloyd accuses (and here) NHS Lanarkshire of “playing God” with patients, after a Do Not Resuscitate order was placed on her mum without her knowledge.


02/07/2020 - 3:00am

It is one thing to write a DNR order without patient or family consent. Sometimes, that is justified when CPR will be medically ineffective. But it is another thing altogether to write the DNR order without even the knowledge of the patient or family. 

Despite the British appellate courts (in Tracey) declaring this practice illegal, it apparently continues. This week, Vivian Lloyd accuses (and here) NHS Lanarkshire of “playing God” with patients, after a Do Not Resuscitate order was placed on her mum without her knowledge.


02/07/2020 - 3:00am

It is one thing to write a DNR order without patient or family consent. Sometimes, that is justified when CPR will be medically ineffective. But it is another thing altogether to write the DNR order without even the knowledge of the patient or family. 

02/06/2020 - 7:41pm

Some weeks ago, a utilitarian perspective in favor of heritable genome editing was published (purchase or subscription required to read).  In it, the author, Kevin Smith of Abertay University in the United Kingdom, begins with a general defense of utilitarianism, the ethical philosophy that what is morally good is what produces the greatest good for …

Continue reading "An argument for heritable genome editing"

02/06/2020 - 7:15am

By Leslie Francis

Practice Fusion, an electronic health record (EHR) vendor, just settled with the Department of Justice to pay a $145 million fine for alleged kickbacks from an unnamed pharmaceutical company.  The DOJ contended that the company had taken kickbacks in exchange for including practice alerts to encourage physicians to prescribe opioids.  But paid-for prescription alerts were not the only practices engaged in by Practice Fusion with de-identified patient data.

Practice Fusion is an EHR vendor used by over 20,000 small office-based practices, serving more than 5 million patients.  It was acquired by AllScripts in 2018 for $100m, although just a few years earlier it supposedly had been valued by as much as $1b.  Practice Fusion initially became highly successful by marketing free EHR systems to physicians in office practices.  The systems were particularly attractive because they enabled physicians to obtain the $40,000 incentive bonus from the federal government for becoming “meaningful users” of health information technology.

Practice Fusion provided the EHRs for free because their business model was to monetize de-identified patient data for sale to pharmaceutical companies.  The pharmaceutical companies could then determine which physicians were frequent prescribers of their brand name drugs.  The companies could also determine which physicians were slipping in the frequency of the prescriptions they wrote.  Companies could then target their marketing to the physicians’ behavior.  Although the business model was ultimately unsustainable without the meaningful use incentives and the Practice Fusion EHR now markets for a small monthly fee, similar sales of de-identified patient data continue. This business model is fully legal under HIPAA, as the patient data sold are de-identified even though providers are identified.  Moreover, state efforts to rein in similar sales of prescription data de-identified as to patients but not as to providers had been struck down by the Supreme Court as a violation of the First Amendment, Sorrell v. IMS Health Inc. (2011).

In short, prescription alerts were not the only practices engaged in by Practice Fusion with the potential to significantly affect patient care.  The alleged illegality that resulted in the recent settlement was a kickback. But the monetization of physician-identifiable data remains fully legal because it is conducted with de-identified patient data. De-identification fails to protect patients against data uses that may affect their care in ways that remain under-recognized.

The post Practice Fusion: it’s data use, not de-identification, that matters appeared first on Bill of Health.

02/06/2020 - 3:00am

In late January 2020, the Department of Veterans Affairs Office of Inspector General published an inspection report criticizing the manner in which a physician obtained consent for DNR orders.

In contrast to significant other guidance, it appears that the OIG is suggesting that an "assent" approach to DNR orders is inappropriate. The OIG determined that the physician failed to engage in a "collaborative discussion with family involvement to include patients’ preferences and quality of life" and that this "likely led to the requests for a reversal of the DNR orders."

For one patient, the physician documented the following: "I told [the patient] that [cardiopulmonary resuscitation] would be of 'no help' since when [the patient] died of cancer [cardiopulmonary resuscitation] could only bring [the patient] back to die again. I told [the patient]I would write 'DNR order' unless [the patient] objected. [The patient] did not object…[family members] arrived near end of discussion and I repeated the above to them. I wrote DNR/DNI orders." The patient and family later asked other physicians to change the code status to full code. 

The OIG determined that the physician "held a strong belief based upon the ethical principles of beneficence and nonmaleficence to not provide cardiopulmonary resuscitation to patients who were terminal and had grim prognoses. The hospitalist’s documentation of the conversations held with these patients appears to be one of stark honesty regarding the current medical picture, the implication that cardiopulmonary resuscitation would not allow the patient to die in peace, and the futility of resuscitation measures."

When interviewed by the OIG, the hospitalist clearly indicated "no longer wishing to provide care that was medically ineffective, having done so in a past critical care practice. Such treatment conflicted with the hospitalist’s ethical beliefs. Rather, the hospitalist would transfer patients to other physicians for care when necessary . . . ."


02/06/2020 - 3:00am

In late January 2020, the Department of Veterans Affairs Office of Inspector General published an inspection report criticizing the manner in which a physician obtained consent for DNR orders.

For one patient, the physician documented the following: "I told [the patient] that [cardiopulmonary resuscitation] would be of 'no help' since when [the patient] died of cancer [cardiopulmonary resuscitation] could only bring [the patient] back to die again. I told [the patient]I would write 'DNR order' unless [the patient] objected. [The patient] did not object…[family members] arrived near end of discussion and I repeated the above to them. I wrote DNR/DNI orders." The patient and family later asked other physicians to change the code status to full code. ...

02/06/2020 - 3:00am

In late January 2020, the Department of Veterans Affairs Office of Inspector General published an inspection report criticizing the manner in which a physician obtained consent for DNR orders.

In contrast to significant other guidance, it appears that the OIG is suggesting that an "assent" approach to DNR orders is inappropriate. The OIG determined that the physician failed to engage in a "collaborative discussion with family involvement to include patients’ preferences and quality of life" and that this "likely led to the requests for a reversal of the DNR orders."

For one patient, the physician documented the following: "I told [the patient] that [cardiopulmonary resuscitation] would be of 'no help' since when [the patient] died of cancer [cardiopulmonary resuscitation] could only bring [the patient] back to die again. I told [the patient]I would write 'DNR order' unless [the patient] objected. [The patient] did not object…[family members] arrived near end of discussion and I repeated the above to them. I wrote DNR/DNI orders." The patient and family later asked other physicians to change the code status to full code. 

The OIG determined that the physician "held a strong belief based upon the ethical principles of beneficence and nonmaleficence to not provide cardiopulmonary resuscitation to patients who were terminal and had grim prognoses. The hospitalist’s documentation of the conversations held with these patients appears to be one of stark honesty regarding the current medical picture, the implication that cardiopulmonary resuscitation would not allow the patient to die in peace, and the futility of resuscitation measures."

When interviewed by the OIG, the hospitalist clearly indicated "no longer wishing to provide care that was medically ineffective, having done so in a past critical care practice. Such treatment conflicted with the hospitalist’s ethical beliefs. Rather, the hospitalist would transfer patients to other physicians for care when necessary . . . ."


02/06/2020 - 1:06am

by Craig Klugman, Ph.D.

The Good Doctor (Season 3; Episode 13): Making emotional decisions regarding cancer care; New Amsterdam (Season 2; Episode 12): Withdrawing ANH in PVS; Treating the Physical to Heal the Mental

The Good Doctor (Season 3; Episode 13): Making emotional decisions regarding cancer care

Reznick’s mother is dying of brain cancer. She is an artist and is unwilling to do any treatments that will affect her ability to create art. When her mother becomes unconscious and has a brain bleed, Reznick chooses a brain surgery to remove part of the brain that is bleeding rather than the full tumor removal that her mother has refused.…