Compulsory Genetic Testing for Refugees: No Thanks

By Gali Katznelson

lab worker testing dna

DNA tests are not perfect and they can be vulnerable to manipulation. The UNHCR says genetic testing is an invasion of privacy. (Photo by andjic/Thinkstock)

Recent reports claim that Attorney General Jeff Sessions is considering using genetic testing to confirm the relationships of children who enter the country with adults to determine if they share a genetic relationship.

The website the Daily Caller reported that Sessions suggested in a radio interview that the government might undertake genetic testing of refugees and migrants in an effort to prevent fraud and human trafficking.

This proposal is problematic, not only because DNA testing is unreliable and vulnerable to hacking, it is also an invasion of privacy and flies in the face of guidelines from the United Nations’ refugee agency.

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What is Patient-Centered Outcomes Research? What Ethical Issues Arise in its Conduct?

By Joel Weissman

Today it is not unusual for patients to expect to be engaged in making decisions about their own health care, in consultation with their doctors. This is commonly referred to as patient-centered care, and recognizes that patients are the best source of information about their needs and preferences.

A relatively newer concept is patient involvement in research on healthcare.

Traditionally, healthcare research has focused on critical events like death or complications, or physiological data from laboratory tests. But patients may be equally (and sometimes more) concerned about harder-to-measure results like quality of life, time spent at home with their families, or the ability to return to work.

Patient-centered outcomes research (PCOR) recognizes that to better understand these kinds of issues, scientists should consult patients about the design and conduct of research. Therefore, PCOR is quickly becoming the standard.

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The Health Imperative: Reunite Migrant Children with their Parents

By Gali Katznelson

Japanese family awaits evacuation 1942

A Japanese family awaits an evacuation bus to an internment camp in 1942. Children who spent time in the camps have high incidence of trauma and health problems, studies have shown. Photo via US National Archives.

Former first lady Laura Bush published an op-ed in the Washington Post where she reminded us that today’s mass detention centers for children whose parents are accused of illegally crossing the border is a public health crisis — one we have seen before.

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Prescription Monitoring Programs: HIPAA, Cybersecurity and Privacy

By Stephen P. Wood

Privacy, especially as it relates to healthcare and protecting sensitive medical information, is an important issue. The Health Insurance Portability and Accountability Act, better know as HIPAA, is a legislative action that helps to safeguard personal medical information. This protection is afforded to individuals by the Privacy Rule, which dictates who can access an individual’s medical records, and the Security Rule, which ensures that electronic medical records are protected.

Access to someone’s healthcare records by a medical provider typically requires a direct health care-related relationship with the patient in question. For example, if you have a regular doctor, that doctor can access your medical records. Similarly, if you call your doctor’s office off-hours, the covering doctor, whom may have no prior relationship with you, may similarly access these records. The same holds true if you go to the emergency department or see a specialist. No provider should be accessing protected information however, without a medical need.

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What is the Role of the Judiciary in Tackling the Opioid Epidemic?

By Ryan J. Duplechin

The Judicial Panel on Multidistrict Litigation has centralized suits in the Northern District of Ohio.

As waves of opioid lawsuits have mounted in the federal courts, one district court was chosen to shepherd all the cases, and one judge is motivated to step up to stem the tide of the epidemic.

In the Northern District of Ohio, Judge Dan A. Polster was chosen by the Judicial Panel on Multidistrict Litigation, which centralized hundreds of suits, and created the Opioid MDL.

“The federal court is probably the least likely branch of government to try and tackle [the opioid epidemic], but candidly, the other branches of government, federal and state, have punted,” said Judge Polster during the first hearing of the MDL in January. “My objective is to do something meaningful to abate this crisis and to do it in 2018.”

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Right to Try’s Problem is Funding, not Over-Regulation

By Alex Pearlman and Jonathan Darrow

Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources differently.

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Hits and misses from the Senate HELP Committee hearing on the President’s Blueprint for lower drug prices

 

By James Love

The Senate HELP committee held a hearing on June 12 on “The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices” where Secretary Alex Azar was the sole witness.

It was a moment for the Democrats in the Senate to draw a sharp contrast with the Trump Administration on an issue voters care about: drug prices.

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Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses

By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit

A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.

Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.

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DNA Donors Must Demand Stronger Privacy Protection

By Mason Marks and Tiffany Li

An earlier version of this article was published in STAT.

The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.

DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Continue reading

Roundup: What to Read in Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

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Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight

Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted.

Such efforts hold great promise, but also raise potential challenges for ethical oversight.

How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups?

This symposium will bring together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.

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The Semantics of Health Care

By Gali Katznelson

shopping trolley with medicine

The push toward commodification of health care is a luxury not everyone has. (toons17/Thinkstock)

Recently there has been a shift in popular parlance toward referring to PCPs as primary health care providers. Not primary health care physicians or practitioners, but providers.

This change seems to have increased in popularity after the original passage of the ACA, specifically with the opening of the health insurance marketplaces.

But it was particularly jarring, as a Canadian, to become accustomed to terminology that reframes physicians as providers, and patients as consumers.

Ostensibly, this language comes from a movement to empower patients to be more engaged in their health care rather than to accept passively that the “doctor knows best.” It is an effort to shift away from health care delivery by paternalistic doctors of the past, and toward the contemporary active patients who take ownership of their health and participate in making decisions. As a result, doctors are framed as service providers who cater to the needs of their consumers.

But we must challenge this narrative.

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Hepatitis C Virus Infection: Another Consequence of the Opioid Epidemic

By Stephen P. Wood

And increase in diagnosis of the hepatitis C virus increase goes hand in hand with the opioid epidemic. (Zerbor/Thinkstock)

The opioid epidemic and the toll it is taking is on American lives has resulted in the declaration of a public health emergency by the Trump administration.

There were 42,000 deaths from suspected opioid overdose in 2016, more than in any previous year to date. These deaths illuminate the direct impact of the epidemic, but this is only the tip of the iceberg. Hepatitis C is another epidemic that goes increasingly hand-in-hand with the opioid crisis, and is likely to take a long-term toll on American lives as well. Intravenous drug use accounts for approximately 80 percent of new cases of hepatitis C virus (HCV) infection in the United States, and without intervention these numbers could continue to climb. Continue reading

Patient Safety and Emergency Room Care in the NHS

By John Tingle

UCL A&E entrance

Pedestrian entrance to the Accident and Emergency Unit at University College Hospital as viewed from the pavement on the Euston Road. (Amanda Lewis/Thinkstock)

In the UK, emergency and urgent care patients visit the A & E (Accident and Emergency) units of local hospitals (known as ERs in the U.S.) A & E service provision is the public face of the NHS. It is seen by many as the bellwether of the national health care system and the basis on which its performance is judged.

The Health and Social Care Regulator of England, the Care Quality Commission (CQC), which maintains important patient safety and health quality reviews, has recently published a report on A & E urgent care that found that the 2017-2018 winter season saw an unprecedented demand for emergency services, continuing a year-over-year increase. The number of emergency admissions has grown by 42 percent over the last 12 years, adding pressure to the NHS.

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The German Stem Cell Network Has Compiled a Sample Text for Informed Consent

By Sara Gerke

Sara Gerke speaking

GSCN Conference in Jena in September, 2017

At the General Meeting of the German Stem Cell Network (GSCN) in Jena in September 2017, Tobias Cantz and I proposed the establishment of a new GSCN strategic working group.

This new working group, known as ELSA, focuses on the ethical, legal and social aspects of the modern life sciences. ELSA aims to serve as a country-wide interdisciplinary platform for the exchange of information and for the analysis and discussion of challenges facing basic and applied stem cell research in Germany.

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State-Level Solutions to Discrimination in Organ Transplants 

By Emily Largent

organ transplant

Doctors in North Dakota perform a kidney transplant. (Photo by ndguard/Flickr)

In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.

In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.”  Ultimately, Rivera received a living donor kidney transplant from her mother.

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Beyond Disadvantage: Photos from the Petrie-Flom Annual Conference

At last week’s Petrie-Flom Center Annual Conference, “Beyond Disadvantage: Disability, Law, and Bioethics,” discussed a number of topics related to the “mere difference” vs. “bad difference” disability theory debate.

Over the course of the day, six panels of experts shared their research and views on topics ranging from health care as eugenics to epistemic injustice to organ donation.

We will have the videos of the event soon, but in the meantime, enjoy the tweets from #rethinkingdisability and some photos from throughout the day by photographer Martha Stewart.

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Amy McGuire and Natalie Ram on ‘The Week in Health Law’ Podcast

By Nicolas Terry

This week on the pod I welcome Amy McGuire, the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine and Natalie Ram, a Professor of Law at The University of Baltimore School of Law. Our conversation revolves around the arrest of the suspected Golden State Killer who was partially identified by a DNA match through a publicly accessible database. Legal topics range from the Fourth Amendment to HIPAA and the Common Rule as we discuss implications for personal privacy and major, DNA-led projects such as Precision Medicine. For background see this and this

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As opioid overdose numbers rise, so does the cost of naloxone 

naloxone overdose reversal kit

Photo via bcgovphotos/Flickr

By Stephen P. Wood

Naloxone is an opioid-receptor antagonist. In other words, it has the ability to displace an opioid from the receptor site, and essentially reverse its activity to save overdose victims. However, a significant increase in the cost of naloxone has put it out of reach of the people who need it most.

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Medical Professionals with Disabilities Workforce and their Associated Challenges

By Paulchris Okpala

person wearing medical scrubs

Do the provisions of the 2008 Americans with Disabilities Act Amendments Act (ADAAA) address challenges faced by medical professionals with disabilities (MPD)?

A 2012 report on Americans with disabilities from the US Census Bureau suggests that it is highly unlikely. There is every reason to be alarmed by the increasing number of medical professionals with disabilities who leave their jobs, or express the intention to quit employment. There is also a rapidly decreasing number of MPD who express the desire to seek employment. Could this trend be attributed to the challenges faced by the MPD in the workplace?

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