Hot Topics: Health Regulation & Law

Blog Posts (92)

June 20, 2017

Ethics of Transparent Pharmaceutical Pricing Laws: The Harms Do Not Outweigh the Risks

by Craig Klugman, Ph.D.

Despite campaign promises that drug prices would be lowered, the current administration and Congress seem on target for giving pharmaceutical companies more power over pricing, over keeping out competition and over expanding their monopolies.…

June 14, 2017

Trump Opioid Task Force Considers HIPAA Exception for Overdoses

by Craig Klugman, Ph.D.

Confidentiality is one of the sacrosanct principles of medicine. By keeping the secrets that patients share with health care providers, the patient trusts the provider and the provider has the information necessary to diagnose and treat.…

June 7, 2017

In Calls for Repeal Comes Opportunity for Universal Coverage

by Craig Klugman, Ph.D.

According to the conservative press, the Affordable Care Act is failing. They point to the number of insurance companies that have withdrawn from the marketplaces including Ohio, where there are 20 counties with no plans available.…

April 17, 2017

A Bioethics View of Executions in Arkansas

by Craig Klugman, Ph.D.

This week the state of Arkansas had planned to execute 8 death-row inmates in 4, back-to-back killings using lethal injection over 10 days.…

April 5, 2017

Internet Privacy and Health Portals: Why I Won’t Be Contacting My Doctor Online

by Craig Klugman, Ph.D.

Part of the Affordable Care Act was an effort to increase efficiency in sharing and storing health data through electronic health records.…

March 22, 2017

Texas Considers Letting Doctors Lie to Patients

by Craig Klugman, Ph.D.

The Texas Senate just passed a new bill (SB 25) that would shield doctors from a lawsuit if a baby is born with a disability even if the doctor knew of the concern and chose not to tell the parents.…

March 7, 2017

The Ethics of the New GOP Health Plan – Violating Justice & Solidarity

by Craig Klugman, Ph.D.

Whatever one may think of the Affordable Care Act (ACA), it began with noble intentions. The ACA was built on a philosophy of providing more people not only with access to health insurance but also with assistance to pay for it.…

February 15, 2017

The National Academy of Sciences Expands its Approval for Gene Editing

by Keisha Ray, Ph.D.

This week the National Academy of Sciences (NAS) released a report giving their support for altering heritable genes when previously the NAS only supported altering uninheritable genes.…

February 13, 2017

The Death of Aid-in-Dying in DC

by Craig Klugman, Ph.D.

I recently gave a talk to a local chapter of a national physicians’ health care group where I was talking about what end of life could look like under a single payer health care system.…

January 30, 2017

Bioethics and the Problem of Silent Neutrality in the age of Trump

by Craig Klugman, Ph.D.

One of the most contentious of all issues in bioethics has been whether as a profession, we should take a stand against issues.…

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Published Articles (20)

American Journal of Bioethics: Volume 17 Issue 6 - Jun 2017

Bringing Transparency to Medicine: Exploring Physicians' Views and Experiences of the Sunshine Act Susan Chimonas, Nicholas J. DeVito & David J. Rothman

American Journal of Bioethics: Volume 17 Issue 6 - Jun 2017

Shining Light on Conflicts of Interest Craig Klugman

AJOB Primary Research: Volume 8 Issue 2 - Apr 2017

Perspectives of IRB chairs on the informed consent process Eugene I. Kane III & Joseph J. Gallo

AJOB Primary Research: Volume 8 Issue 2 - Apr 2017

Healthy individuals' perspectives on clinical research protocols and influences on enrollment decisions Laura Weiss Roberts & Jane Paik Kim

American Journal of Bioethics: Volume 17 Issue 4 - Apr 2017

Psychiatric Genomics and Mental Health Treatment: Setting the Ethical Agenda Camillia Kong, Michael Dunn & Michael Parker

American Journal of Bioethics: Volume 17 Issue 3 - Mar 2017

The Precautionary Principle and the Tolerability of Blood Transfusion Risks Koen Kramer, Hans L. Zaaijer & Marcel F. Verweij

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Morals or markets? Regulating assisted reproductive technologies as morality or economic policies in the states Erin Heidt-Forsythe

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee Derek Gideon Tersmette & Dirk Peter Engberts

American Journal of Bioethics: Volume 16 Issue 12 - Dec 2016

Does Lack of “Genetic-Relative Family Health History” Represent a Potentially Avoidable Health Disparity for Adoptees? Thomas May, Kimberly A. Strong, Kaija L. Zusevics, Jessica Jeruzal, Michael H. Farrell, Alison LaPean Kirschner, Arthur R. Derse, James P. Evans & Harold D. Grotevant

American Journal of Bioethics: Volume 16 Issue 11 - Nov 2016

The Ethics of Organ Donor Registration Policies: Nudges and Respect for Autonomy Douglas MacKay & Alexandra Robinson

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News (193)

June 13, 2017 12:39 pm

University of Virginia student Otto Warmbier, said to be in a coma, released from North Korea (Washington Post)

University of Virginia student Otto Warmbier has been medically evacuated from North Korea in a coma after being detained for 17 months, his parents told The Washington Post on Tuesday.

May 24, 2017 9:00 am

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial (The Lancet)

The emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost.

May 23, 2017 9:00 am

U.S. flower sellers rush to destroy illegal GE petunias (Science)

The U.S. Department of Agriculture (USDA) announced today that U.S. flower distributors have begun to destroy countless petunia plants after federal scientists confirmed that they were genetically engineered (GE) to produce vivid orange, red, and purple blooms. The agency says the flowers pose no risk to the environment or to human health, but GE organisms need special permits to be sold in the United States.

May 2, 2017 9:00 am

$10 million settlement over alleged misconduct in Boston heart stem cell lab (Science)

A research misconduct investigation of a prominent stem cell lab by the Harvard University–affiliated Brigham and Women’s Hospital (BWH) in Boston has led to a massive settlement with the U.S. government over allegations of fraudulently obtained federal grants. As Retraction Watch reports, BWH and its parent health care system have agreed to pay $10 million to resolve allegations that former BWH cardiac stem cell scientist Piero Anversa and former lab members Annarosa Leri and Jan Kajstura relied on manipulated and fabricated data in grant applications submitted to the U.S. National Institutes of Health (NIH).

April 20, 2017 9:00 am

Medical robotics—Regulatory, ethical, and legal considerations for increasing levels of autonomy (Science)

The regulatory, ethical, and legal barriers imposed on medical robots necessitate careful consideration of different levels of autonomy, as well as the context for use.

April 13, 2017 9:00 am

US regulators test organs-on-chips for food safety monitoring (Nature)

The US Food and Drug Administration (FDA) has started testing whether livers-on-a-chip — miniature ‘organs’ engineered to mimic biological functions — can reliably model human reactions to food and foodborne illnesses. The experiments will help the agency to determine whether companies can substitute chip data for animal data when applying for approval of a new compound, such as a food additive, that could prove toxic. It is the first time a regulatory agency anywhere in the world has pursued organs-on-chips as an alternative to animal testing.

April 11, 2017 9:00 am

Congress and FDA nominee heap love on ‘adaptive trials’ (Science)

This week, as President Donald Trump’s nominee to head FDA, Gottlieb sat before Republican lawmakers hungry for promises of “shorter time frames” for drug and device approvals, and again expressed his zeal—repeatedly—for adaptive trial designs. If confirmed to be FDA’s head, as expected, Gottlieb suggested he’d promote wider use of the approach.

April 3, 2017 9:00 am

Donald Trump believes the solution to the opioid crisis is talk (Vox)

President Donald Trump will soon sign an executive order to tackle what he’s called the “total epidemic” of opioid abuse and addiction. The main objective of the order is to create a commission that’s tasked with publishing a report on what to do about America’s deadliest drug crisis ever.

March 31, 2017 9:00 am

Europe says University of California deserves broad patent for CRISPR (Science)

The European Patent Office (EPO) announced on 23 March its “intention to grant a patent” to the University of California (UC) for its broad-based claims about the genome-editing tool popularly known as CRISPR. UC, on behalf of several parties, has been in a pitched battle with the Broad Institute of Cambridge, Massachusetts, over CRISPR patents, and the new decision marks a sharp departure from the position of the U.S. Patent and Trademark Office (USPTO).

March 21, 2017 9:00 am

Federal advisory panels agree Opana's risks outweigh benefits (USA Today)

The new extended-release version of Endo Pharmaceuticals’ Opana may even be more dangerous than the version it replaced, according to critics including the advocacy group Public Citizen. Two Food and Drug Administration advisory panels seemed to agree, voting 18 to 8 that it presents more risks than benefits to society. Next it’s up to the FDA to decide whether to act on the panels’ advice, which it generally does. Possible actions include changes to labels, restriction of prescriptions and an outright ban.

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