Hot Topics: Health Regulation & Law

Blog Posts (94)

August 4, 2017

The Age of Designed Babies Arrives

by Craig Klugman, Ph.D.

In the film Gattaca, a couple desiring to have a child visits their neighborhood geneticist:

Geneticist: You have specified hazel eyes, dark hair and fair skin.

August 2, 2017

Sterilization for Prisoners Is Not New and Shows That Studying History is Essential

by Craig Klugman, Ph.D.

In 1927, Supreme Court Justice Oliver Wendell Holmes ruled that Carrie Buck and her baby could be sterilized because of a perception that they were “mental defectives.” In the 20th century, 32 states had federally funded programs that sterilized “undesirable” populations.…

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 They point to the number of insurance companies that have withdrawn from the marketplaces including Ohio, where there are 20 counties with no plans available.…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.…

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Published Articles (26)

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

The Final Rule: When the Rubber Meets the Road P. Pearl O'Rourke

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Examining Provisions Related to Consent in the Revised Common Rule Jeremy Sugarman

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Rethinking the Belmont Report? Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

A Proposed Process for Reliably Updating the Common Rule Benjamin E. Berkman, David Wendler, Haley K. Sullivan & Christine Grady

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

At Last! Aye, and There's the Rub Alexander M. Capron

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box Suzanne M. Rivera, Kyle B. Brothers, R. Jean Cadigan, Heather L. Harrell, Mark A. Rothstein, Richard R. Sharp & Aaron J. Goldenberg

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

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News (199)

August 16, 2017 9:00 am

Commit to talks on patient data and public health (Nature)

Of course it was going to happen — and now it has. Last week, an international team reported the use of CRISPR–Cas9 gene-editing techniques to correct a heart-wrenching mutation in human embryos. These attempts worked several times more efficiently than previous ones had, and avoided introducing new genetic errors. Although the embryos were never destined to be used for pregnancies (and have now been destroyed), the work — carried out mainly in the United States — makes it easy to foresee practical applications to genetically alter human embryos.

August 11, 2017 9:00 am

CRISPR fixes disease gene in viable human embryos (Nature)

An international team of researchers has used CRISPR–Cas9 gene editing — a technique that allows scientists to make precise changes to genomes with relative ease — to correct a disease-causing mutation in dozens of viable human embryos. The study represents a significant improvement in efficiency and accuracy over previous efforts.

July 19, 2017 9:00 am

British baby Charlie Gard to be evaluated by US doctor (CNN Health)

Baby Charlie Gard, the 11-month-old with a rare, terminal medical condition who has been the center of an ongoing legal battle, will be evaluated by a doctor from the United States. Charlie will be examined early this week, in London, by Dr. Michio Hirano, a neurologist at New York’s Columbia University Medical Center.

July 10, 2017 9:00 am

How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA (Science)

A group led by virologist David Evans of the University of Alberta in Edmonton, Canada, says it has synthesized the horsepox virus, a relative of smallpox, from genetic pieces ordered in the mail. Horsepox is not known to harm humans—and like smallpox, researchers believe it no longer exists in nature; nor is it seen as a major agricultural threat. But the technique Evans used could be used to recreate smallpox, a horrific disease that was declared eradicated in 1980.

July 3, 2017 9:00 am

Europe's top court alarms vaccine experts (Science)

On 21 June, the European Court of Justice issued a ruling in the case of a French man who claimed his multiple sclerosis was triggered by a hepatitis vaccine. Some media stories suggested that from now on, “vaccines can be blamed for illness without scientific proof,” which alarmed vaccine advocates. But experts on liability law are divided on what the court’s decision will mean for medical product liability in Europe. Some argue that rather than dealing a blow against science or vaccines, the court sought to balance individuals’ rights against society’s interest in preventing disease; others say the ruling leaves a worrying amount of room for judges in the European Union to ignore certain kinds of scientific evidence.

June 23, 2017 9:00 am

Don’t let Europe’s open-science dream drift (Nature)

Now that the major players have agreed to the giant European Open Science Cloud, it’s time to get the project moving.

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).

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