Hot Topics: Health Regulation & Law
This post is a response to a previous blog, “Ending Privacy As We Know It”(January 10, 2019)
by Nancy M.…
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by Craig Klugman, Ph.D.
This past weekend, I enjoyed a screening of On The Basis of Sex, a film about Ruth Bader Ginsburg’s first federal case that introduced the idea of gender equity into the law.…
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by David Casarett MD MD and Donald I. Abrams MD*
Although medical cannabis has been legalized in 33 states and the District of Columbia, it has not yet gained federal acceptance. …
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by Craig Klugman, Ph.D.
I recently received an email from a community organization which asked the following question: “Are there any ethical issues with our community health plan selling its medical records to a private company?” This is not an example of a new occurrence.…
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by Craig Klugman, Ph.D.
Federal kickback rules state that a pharmaceutical manufacturer or medical device producer cannot pay providers or patients to recommend or prescribe their products.…
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…“A group of ethicists, public health and health policy experts, healthcare providers, and lawyers has composed an open letter to President Donald J.
Updated November 28 at 8:30am EST
by Craig Klugman, Ph.D.
The film GATTACA turned 20 years old this year. The premise of that film is a society where DNA is viewed as predictive of everything: Your intelligence, physical abilities, your health, even how long you will live.…
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by Craig Klugman, Ph.D.
Since January 1, 2018 through November 15, the United States has seen 311 mass shootings that have killed 339 people and injured 1,249.…
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by Jeffrey P. Kahn, Ph.D., M.P.H. and Anna C. Mastroianni, J.D., M.P.H.
National Institutes of Health Director (NIH) Francis S. Collins and Food and Drug Administration Commissioner Scott Gottlieb recently co-authoreda New England Journal of Medicinecommentary suggesting that special oversight of gene transfer research in humans was no longer necessary.…
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by Craig Klugman, Ph.D.
My father tells the story of how when he was a child, shoe stores had boxes into which you could slide your feet, shod in potential new shoes.…
Full ArticleGenes wide open: Data sharing and the social gradient of genomic privacy
Serious Ethical Violations in Medicine: A Statistical and Ethical Analysis of 280 Cases in the United States From 2008–2016
Toward More Effective Self-Regulation in Medicine
Physician Sexual Assault: The Moral Imperative for Gender Equity in Medicine
Abusive Doctors: How the Atlanta Newspaper Exposed a System That Tolerates Sexual Misconduct by Physicians
Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies
Sunset on the RAC: When Is It Time to End Special Oversight of an Emerging Biotechnology?
Just Policy? An Ethical Analysis of Early Intervention Policy Guidance
Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff
Data and tissue research without patient consent: A qualitative study of the views of research ethics committees in New Zealand
Japan has approved a stem-cell treatment for spinal-cord injuries. The event marks the first such therapy for this kind of injury to receive government approval for sale to patients.
“This is an unprecedented revolution of science and medicine, which will open a new era of healthcare,” says oncologist Masanori Fukushima, head of the Translational Research Informatics Center, a Japanese government organization in Kobe that has been giving advice and support to the project for more than a decade.
But independent researchers warn that the approval is premature. Ten specialists in stem-cell science or spinal-cord injuries, who were approached for comment by Nature and were not involved in the work or its commercialization, say that evidence that the treatment works is insufficient. Many of them say that the approval for the therapy, which is injected intravenously, was based on a small, poorly designed clinical trial.
Full ArticleFederal regulators say they’ve identified the source of the cancer-causing impurities that have tainted millions of bottles of commonly used generic blood pressure and heart failure medications recalled by drugmakers over the last seven months.
The carcinogens are a chemical byproduct of the process used to synthesize the active ingredient in the drugs, which include valsartan, losartan and irbesartan. People who take those drugs may have been exposed to trace amounts of impurities for at least four years, after a switch in how companies manufactured the active ingredient, according to the Food and Drug Administration.
Full ArticleSome U.S. researchers knew of a Chinese scientist’s intentions to implant edited embryos but were unable to stop him. Now scientific institutions are trying to devise global safeguards.
Vaginal mesh, used to repair and improve weakened pelvic tissues, is implanted in the vaginal wall. It was initially — in 1998 — thought to be a safe and easy solution for women suffering from stress urinary incontinence.
But over time, complications were reported, including chronic inflammation, and mesh that shrinks and becomes encased in scar tissue causing pain, infection and protrusion through the vaginal wall.
Full ArticleThe flu season is going strong.
About six million to seven million people in the United States have come down with the illness so far, with half of them sick enough to have seen doctors, according to estimates released on Friday by the Centers for Disease Control and Prevention.
Some 69,000 to 84,000 ended up in the hospital during the period from Oct. 1, 2018 through Jan. 5.
Full ArticleMost Americans say it would be OK to use gene-editing technology to create babies protected against a variety of diseases — but a new poll finds they’d draw the line at changing DNA so children are born smarter, faster or taller.
A month after startling claims of the births of the world’s first gene-edited babies in China, the poll by The Associated Press-NORC Center for Public Affairs Research finds people are torn between the medical promise of a technology powerful enough to alter human heredity and concerns over whether it will be used ethically.
Full ArticleNIPT’s entry into the mainstream has raised some questions as busy health-care providers scramble to figure out how to offer it en masse to a public with varying understanding of genetic testing and little access to genetic counselors.
Full ArticleEver since scientists created the powerful gene-editing technique CRISPR, they have braced for the day when it would be used to produce a genetically altered human being. Now, the moment they feared may have come. What’s likely to happen next?
Full ArticleTheft of your personal medical information is on the rise, despite stringent privacy laws intended to safeguard it, according to a recent study in the Journal of the American Medical Association.
The breaches of electronic health records can include a vast array of personal information, including your Social Security number and medical history. The theft is the latest example of how all private data is increasingly subject to breaches, where credit card numbers, account log-ins and more end up in the wrong hands.
Full ArticleNeuroscientists have amassed more evidence for the hypothesis that sticky proteins that are a hallmark of neurodegenerative diseases can be transferred between people under particular conditions — and cause new damage in a recipient’s brain.
They stress that their research does not suggest that disorders such as Alzheimer’s disease are contagious, but it does raise concern that certain medical and surgical procedures pose a risk of transmitting such proteins between humans, which might lead to brain disease decades later.
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