NEW REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD (Harvard University Office of the Vice Provost for Research)

The Harvard Embryonic Stem Cell Research Oversight (the “ESCRO”) Committee, an ethics oversight committee charged with reviewing research protocols involving human embryos, human embryonic stem cells, and certain activities with non-embryonic human pluripotent stem cells, recently issued a report exploring the ethical issues related to the creation of synthetic human embryos.

Ethical committees such as the Harvard ESCRO occasionally receive inquiries to deliberate upon the ethical implications of emerging research technologies where there is no existing or established guidance to rely upon. Deliberating in these gray areas is not a simple task, but the Harvard ESCRO has developed a general framework for navigating this ethical terrain in real time. In these instances, the Harvard ESCRO generally consults with its peer oversight bodies, reviews data from the scientific and bioethical literature and from other scientists and ethicists in the field and, from time to time, convenes symposia to broaden the discussion around such emerging technologies.  Read More

Learning the lessons from patient safety errors of the past

By John Tingle

A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000  stated:

“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identified but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).

In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.

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Immigration And Health Care Under The Trump Administration

This new post by Wendy E. Parmet appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Non-citizen immigrants are the canaries in the health care coal mine. Disproportionately poor, non-white, and non-English speaking, and without access to the franchise, they are among the most vulnerable groups in the United States. Consequently, they are often the first to experience the gaps, inefficiencies, and conflicts in our health care system. Meanwhile, anti-immigrant sentiment often spills into health policy debates, as was evident in 2009 when opponents of the bill that became the Affordable Care Act (ACA) focused their opposition on the erroneous claim that it would cover undocumented immigrants. It is therefore not surprising that the first year of the Trump administration, which has focused its domestic agenda on restricting immigration and repealing the ACA, has proven especially perilous for immigrants who need health care.

As a group, immigrants tend to be healthier than the native-born population. They are also far less likely to have insurance. In 2015, for example, 18 percent of lawfully present nonelderly adult immigrants, and 42 percent of undocumented immigrants were uninsured, compared to only 11 percent of United States citizens. Immigrants’ low insurance rate is partly due to the fact that they disproportionately work in sectors of the economy in which employer-sponsored insurance is uncommon. But the law also plays a significant role. Even before the Trump administration took office, immigrants faced an array of legal barriers to obtaining health insurance. Most importantly, the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PROWRA) prohibited undocumented immigrants from accessing most federally-funded insurance programs (including Medicaid, Medicare and Children’s Health Insurance Program (CHIP)). PRWORA also barred most authorized immigrants (except refugees) from benefiting from federally-funded programs for five years after obtaining legal status. And although the ACA made it easier for many documented immigrants to gain coverage, it left PROWRA in place. The ACA also limited participation in the exchanges to immigrants who are “lawfully present,” a category that the Obama administration decided did not include the approximately 800,000 young adults who participated in the Deferred Action for Childhood Arrivals (DACA) program. […]

Read the full post here!

The New NHS Never Events Policy and Framework

By John Tingle

In tort law we have a very well-known Latin phrase, ‘Res Ipsa Loquitur’ (the thing speaks for itself). An inference of negligence can be raised by the events that occurred. In the National Health Service (NHS) in England there is a similar concept,‘the Never Event’. The Never Event concept is a USA import into the NHS and was introduced  from April 2009. The list of what is to be regarded as a Never Event has been revised over the years in the NHS and is currently set out by NHS Improvement.

Never events include, wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route and so on. Never Events are defined in NHS policy documentation as:

“…patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers.  Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.” (p.6) Read More

Will the Sun Shine All Over Canada? Making Transparent the Financial Relationships of the Medical Industry (Part 2: Towards Effective Transparency)

By Jean-Christophe Bélisle-Pipon

As detailed in Part 1, Ontario government just enacted the Health Sector Payment Transparency Act, a Canadian first in terms of transparency. The act requires that “transfers of value” (or payments), related to medical products (drugs and medical devices), between a payor and a recipient be reported to the Health Ministry. The Act gives the Ministry unprecedented powers to require, analyze, and publish such data online.

A Transformational Act?

Will this act radically transform the practices and the public knowledge that we have about the financial relations of the medical industry? The effective implementation of the regulations will tell us. However, the fact that Innovative Medicines Canada (formerly known as Rx&D, IMC is the organization representing the interests of the pharmaceutical industry in Canada, like PhRMA in the US) has concerns about the Act is a rather positive sign that this legislation might result into pro-social changes. IMC is invoking both ideological concerns (industry’s interactions with HCPs imply cooperation rather than influence) and logistical concerns (“if the threshold for payments is low, a sales representative could easily lose a receipt and forget to report it”), as well as its  own commitment to limiting undue influences. Read More

Will the Sun Shine All Over Canada? Making the Financial Relationships of the Medical Industry Transparent (Part 1: Theoretical Transparency)

By Jean-Christophe Bélisle-Pipon

While Canada is often viewed positively for its public, comprehensive, universal, and accessible health care system, not all is rosy. Canada often lags behind other countries in terms of pharmaceutical policies. Sometimes, this is advantageous (e.g., delaying the approval of a product to wait for more clinical data or real-world efficiency, so to better assess risk-benefit and determining the maximum selling price), but more often simply a problem: until recently, transparency in Canada was more a buzzword than a strong and assumed government stance.

However, a few days ago in Ontario, the omnibus Strengthening Quality and Accountability for Patients Act received royal assent, thus enacting the Health Sector Payment Transparency Act. This clearly marked the beginning of shedding light on the financial relationships and payments to health care providers and organizations made by the medical industry (pharmaceutical and medical device companies), the explicit goal being to strengthen patient trust in the health care system (including research and education activities) by allowing patients to assess whether their health care providers are subject to influence by industry and to foster more informed choice. While the United States enacted the Physician Payments Sunshine Act (PPSA) in 2010, which requires payment disclosure, this is a first in Canada.

The main provisions of the Act Read More

The Mexico City Rule and Maternal Death

By Clíodhna Ní Chéileachair

The ‘Mexico City Rule’ is a Reagan-era regulation which bars US funding to worldwide NGOs which provide counselling relating to abortion, or referrals for abortion services, or which advocate for the expansion of abortion access. The regulation is a sticking point for the two-party reality of US politics, and has been rescinded by every Democratic president since Reagan, and reinstated by each Republican president. Trump is no exception, and his administration’s approach to the policy has been exceedingly expansionist; where the policy traditionally only applied to aid tied to family planning projects, the policy now extends to all international health care aid provided by the US government, amounting to almost $9 billion every year, and covering US aid policies in the areas of family planning and reproductive health, infectious diseases, TB treatment, children’s health, nutrition, HIV/AIDS prevention, water and sanitation programs, and tropical diseases.

The effect of the policy extends past the years in which it is actively in place. Population Action International reports on a reluctance on the part of US governmental officials and non-governmental partners to enter into agreements with organizations that may be ineligible for funding in the future based on the putative reinstatement of the policy, in effect operationalizing the policy beyond the times in which it is in active effect. Beyond the expanded remit given to the policy by the Trump administration, and the temporal expansion based on likely reinstatement, the wording of the policy itself goes some way to expanding the scope of the policy beyond what might be necessary in a vacuum. The structural effect of the policy is to prevent the funding of abortion access with US aid money (an outcome which is illegal regardless through the Helms Amendment) and abortion advocacy. The policy contemplates a neat categorization of organizations such that it is possible to carve out the aspects of a healthcare organization that deal with abortion care as an aspect of reproductive health and justice. Read More

Patient Safety at the Crossroads

By John Tingle

The NHS (National Health Service) in the UK is 70 next year: it was founded on 5th July 1948 and celebrations are being planned. Clearly a lot has changed since it was founded. Our concept of wellness has changed, we go to the doctor for reasons that would never have been considered appropriate in 1948. Health today is not just about the absence of physical diseases.

What is clear is that ever since 1948 the NHS has been shortage of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against near infinite demands is no easy task. Seventy years on, it is most concerning that a vast amount of money in the NHS is now being spent on clinical negligence claims. In their latest annual report and accounts, NHS Resolution estimates the total amount for clinical negligence claims it owes is £65 Billion. Damages paid to patients rose significantly from £950.4 million to £1,083.0 million, an increase of 14%. The high cost of clinical negligence is not sustainable and something must be urgently done to reduce the number of claims against the NHS. The issues were recently considered by the National Audit Office (NAO), which found:

  • The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding.
  • Even if successful, NHS Resolution and the Department’s current actions are unlikely to stop the growth in the cost of clinical negligence claims.
  • The government lacks a coherent cross-government strategy, underpinned by policy, to support measures to tackle the rising cost of clinical negligence.

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Religion, Health, and Medicine: the Dialectic of Embedded Social Systems

The philosopher in me understands that there are universal principles in logic, mathematics, and in basic scientific tenets such as the law of gravity. Be that as it may, the historian in me recognizes that we inherit epistemologies and ways of thinking from those before us, and from our own historical and cultural contexts. Certain ideas dominate the world; and, while some are indeed universal, especially those based on science, the fact remains that a number of other concepts are only seemingly universal. The concepts of personhood, divinity, self, and even society as we tend to understand them today are largely inherited from a Western, Christian worldview. As these ideas have wrestled with philosophical inquiry throughout history, they have either been decoupled from their origins in religious thought, or they have been secularized and rationalized a la Kantian categorical imperatives or the like—and then disseminated in universities, institutions, cultures, and literatures.

On one level, to speak of the Western world as “secular” is, as the philosopher Charles Taylor notes, to say that “belief in God, or in the transcendent in any form, is contested; it is an option among many; it is therefore fragile; for some people in some milieus, it is very difficult, even ‘weird’” (Taylor: 2011, 49). But on another and much deeper level, this very possibility was only ever tenable on account of two major factors: “First, there had to develop a culture that marks a clear division between the ‘natural’ and the ‘supernatural,’ and second, it had to come to seem possible to live entirely within the natural” (Taylor, 50). This was only possible because of a unique philosophical climate that actively sought to dislodge the old form of moral order and social “embeddedness” in an attempt to establish a “purely immanent order.” Taylor’s groundbreaking work, A Secular Age argues that secularism is part of a grand narrative in the West and shows that its historical and cultural foundations are in fact thoroughly Christian and European. He pushes back against Max Weber’s secularization thesis that religion diminishes in the modern world and in the wake of increasing developments in science and technology—and instead gives a different account of what secularism might mean: one that has deep implications for morality, politics, and philosophy.

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Emergent Medical Data

By Mason Marks

In this brief essay, I describe a new type of medical information that is not protected by existing privacy laws. I call it Emergent Medical Data (EMD) because at first glance, it has no relationship to your health. Companies can derive EMD from your seemingly benign Facebook posts, a list of videos you watched on YouTube, a credit card purchase, or the contents of your e-mail. A person reading the raw data would be unaware that it conveys any health information. Machine learning algorithms must first massage the data before its health-related properties emerge.

Unlike medical information obtained by healthcare providers, which is protected by the Health Information Portability and Accountability Act (HIPAA), EMD receives little to no legal protection. A common rationale for maintaining health data privacy is that it promotes full transparency between patients and physicians. HIPAA assures patients that the sensitive conversations they have with their doctors will remain confidential. The penalties for breaching confidentiality can be steep. In 2016, the Department of Health and Human Services recorded over $20 million in fines resulting from HIPAA violations. When companies mine for EMD, they are not bound by HIPAA or subject to these penalties.

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