Hot Topics: Clinical Trials & Studies

Blog Posts (36)

September 21, 2016

FDA Approval Brought To You By Popular Demand

by Craig Klugman, Ph.D.

In a surprising move, the Food and Drug Administration approved Exondys, a drug that has not been proven to work, did not have a randomized control trial, and that recommended against  by an independent expert panel.  …

August 25, 2016

Do the EPA Exposure Studies Violate Do No Harm and Informed Consent?

by Craig Klugman, Ph.D

A government agency recruits elderly and sick patients for an important research study. In a controlled environment, subjects are exposed to airborne pollutants at levels many times higher than found in the real world.…

July 1, 2016

BioethicsTV: The Night Shift Needs More Sleep

by Craig Klugman, Ph.D.

Summer is a slow time for television and especially for the medical drama. One show that has been filling this warm weather slot is The Night Shift, a fairly uninteresting and poorly done drama.…

May 25, 2016

The Potential for Infrastructure Benefits and the Responsiveness Requirement

by David Wendler, PhD

The distribution of resources around the globe is characterized by staggering inequalities and inequities, with the result that individuals in lower income countries have greater disease burden and shorter lives than individuals in high-income countries.…

May 5, 2016

“And Death Shall Be No More”

by Craig Klugman, Ph.D.

Two years after John Donne’s death, the Holy Sonnets were published. In Sonnet 10, Donne speaks about the end of death: “Death, thou shalt die.” Although a metaphorical conceit referring to eternal life in heaven, the poem takes on new meaning in the age of regenerative medicine.…

May 4, 2016

Methodological Miasma not mental dystrophy plagues drug trials

by Arthur Caplan, Ph.D. and Bruce Levin, Ph.D.

The Wall Street Journal and many other media outlets chose to beat on the FDA for its recent decision to deny approval of eteplirsen, a treatment for Duchenne muscular dystrophy being developed by Sarepta Therapeutics.…

April 7, 2016

BioethicsTV: “Heartbeat” tackles therapeutic misconception

by Craig Klugman, Ph.D.

On episode 4 of Heartbeat, the heroine, Dr. Panttiere has received hospital funding to try an experimental cancer treatment on 5 patients.…

April 6, 2016

BIOETHICSTV: Chicago Med-BIID, post mortem egg retrieval, scope of practice and forgiveness

by Craig Klugman, Ph.D.

This week on Chicago Med brought 3 new ethical issues as well as the unsatisfying resolution to a story arc.…

February 29, 2016

A Post-Oscars “Spotlight” on Neonatal Lupus for Rare Disease Day

by Amanda Zink, J.D., M.A. and Jill P. Buyon, M.D.

As national funding decreased in recent decades, medical research suffered. Progress toward uncovering beneficial preventative and therapeutic treatments slowed for thousands of devastating conditions, affecting the health, happiness, and life expectancy of millions of Americans.…

February 25, 2016

Cleveland Clinic Performs First U.S. Uterus Transplant

by Craig Klugman, Ph.D.

Almost like Aphrodite herself, surgeons at the Cleveland Clinic this week may have given fertility to a 26-year-old woman through a 9-hour uterus transplant operation.…

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Published Articles (8)

AJOB Neuroscience: Volume 7 Issue 2 - Apr 2016

Ethics of Decoded Neurofeedback in Clinical Research, Treatment, and Moral Enhancement Eisuke Nakazawa, Keiichiro Yamamoto, Koji Tachibana, Soichiro Toda, Yoshiyuki Takimoto & Akira Akabayashi

American Journal of Bioethics: Volume 16 Issue 6 - Jun 2016

Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe

American Journal of Bioethics: Volume 16 Issue 6 - Jun 2016

The Potential for Infrastructure Benefits and the Responsiveness Requirement David Wendler

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Quality Improvement Ethics: Lessons From the SUPPORT Study Benjamin S. Wilfond

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Informed Consent and Standard of Care: What Must Be Disclosed Ruth Macklin & Lois Shepherd

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

What Should Be Disclosed to Research Participants? David Wendler

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care David Magnus

News (110)

September 14, 2016 8:00 am

How the Sugar Industry Shifted Blame to Fat (NY Times)

The sugar industry paid scientists in the 1960s to play down the link between sugar and heart disease and promote saturated fat as the culprit instead, newly released historical documents show.

August 16, 2016 8:00 am

How Big A Risk Is Acetaminophen During Pregnancy? (NPR)

One study now caught in that eddy is a report reporting behavioral problems in children born to women who took acetaminophen (popular brand name: Tylenol) during pregnancy. Evie Stergiakouli and George Davey Smith at the University of Bristol published it Monday in JAMA Pediatrics. They studied about 7,800 women and their children over the course of more than seven years.

August 3, 2016 8:00 am

Young blood antiaging trial raises questions (Science)

It was one of the most mind-bending scientific reports in 2014: Injecting old mice with the plasma portion of blood from young mice seemed to improve the elderly rodents’ memory and ability to learn. Inspired by such findings, a startup company has now launched the first clinical trial in the United States to test the antiaging benefits of young blood in relatively healthy people. But there’s a big caveat: It’s a pay-to-participate trial, a type that has raised ethical concerns before, most recently in the stem cell field.

July 28, 2016 8:17 am

Europe overhauls rules for ‘first-in-human’ trials in wake of French disaster (Science)

The European Union is beefing up protections for volunteers in phase I clinical trials in the wake of a disastrous clinical study in Rennes, France, that resulted in the death of one volunteer and the hospitalization of five others. On 21 July, the European Medicines Agency (EMA) in London announced in a “concept paper” that it wants to improve strategies to identify and reduce risks in “first-in-human” (FIH) studies on healthy volunteers. EMA is asking for input from stakeholders.

July 26, 2016 8:33 am

A New Depression Treatment Shows Promise (Time)

A new method known as behavioral activation (BA) is effective and can be cheaper than cognitive behavioral therapy.

July 25, 2016 5:04 am

The HIV Trap: A Woman's Lack Of Control (NPR)

When you’re pregnant, going to the doctors can be exciting. You get to find out if you’re having a boy or a girl. Maybe hear the baby’s heart beat. But in southern Africa, many women find out something else.

July 21, 2016 8:41 am

I.V.F. Does Not Raise Breast Cancer Risk, Study Shows (New York Tmes)

Women undergoing in vitro fertilization have long worried that the procedure could raise their risk for breast cancer.

July 18, 2016 9:23 am

Zika Data From the Lab, and Right to the Web (New York Times)

Of the hundreds of monkeys in the University of Wisconsin’s primate center, a few — including rhesus macaque 827577 — are now famous, at least among scientists tracking the Zika virus. Since February, a team led by David H. O’Connor, the chairman of the center’s global infectious diseases department, has been conducting a unique experiment in scientific transparency. The tactic may presage the evolution of new ways to respond to fast-moving epidemics.

July 11, 2016 8:09 am

Juno Halts Cancer Trial Using Gene-Altered Cells After 3 Deaths (New York Times)

Three patients in a study testing the use of genetically engineered cells as a treatment for cancer have died from swelling in the brain, dealing a setback to one of the most exciting pursuits in oncology.

July 1, 2016 8:08 am

Biden threatens funding cuts for researchers who don’t report clinical-trial data (Washington Post)

An impatient Vice President Biden threatened Wednesday to cut funding to research facilities that fail to report clinical-trial results quickly enough and took a swipe at drug companies that jack up the prices of cancer drugs.

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