Hot Topics: Clinical Trials & Studies

Blog Posts (41)

November 9, 2016

Bioethics faces a rocky but navigable road

by Arthur Caplan, Ph.D.

Academic bioethics has never been popular with Republicans.  Libertarians dislike academic bioethics because it seems too elitist and anti-free market. …

November 9, 2016

President Trump & A Republican Congress: What Might It Mean?

by Craig Klugman, Ph.D.

In a 2000 episode of The Simpsons, a flash forward shows Lisa being elected the first heterosexual female U.S.…

October 28, 2016

BIOETHICS TV 10/27 – Modern miracles, body hacking, and sex trafficking

by Craig Klugman, Ph.D.

Pure Genius (Seasons 1, Episode 1)

This new TV show might be the ethicists worst nightmare. The show opens with Dr.…

October 5, 2016

Right to Try is A Snake Oil Sale to “Dismantle the FDA”

by Craig Klugman, Ph.D.

Right to Try laws have been getting a lot of press lately with California being the 32nd state to pass such a statute.…

September 30, 2016

BioethicsTV: Community Research Consent and Competing for an Infant Heart

by Craig Klugman, Ph.D.

In the fall premiere of Code Black, military trauma surgeons are visiting the hospital on an annual pilgrimage to share what they have learned treating battlefield injuries.…

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.…

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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 (121)

December 2, 2016 9:00 am

Bad hair day? ‘Uncombable hair syndrome’ traced to gene mutations (Science)

Scientists have now pinpointed the three genes that cause so-called “uncombable hair syndrome”

November 28, 2016 6:00 am

Climbing the social ladder can strengthen your immune system, monkey study suggests (Science)

Immune cells from low-ranking monkeys were less effective at fighting the infection.

November 17, 2016 9:00 am

CRISPR gene-editing tested in a person for the first time (Nature)

A Chinese group has become the first to inject a person with cells that contain genes edited using the revolutionary CRISPR–Cas9 technique.

November 16, 2016 9:00 am

Too many people are being told they have a vitamin D deficiency (Washington Post)

Doctors are warning about vitamin D again, and it’s not the “we need more” news you might expect.

November 7, 2016 8:00 am

Has a new mutation in the Ebola virus made it deadlier? (Science)

The sheer size of the Ebola epidemic that began in 2013 and engulfed West Africa is still a bit of a riddle for scientists. Previous Ebola outbreaks had never sickened more than 600 people. But the outbreak in Liberia, Sierra Leone, and Guinea infected more than 28,000 before it was finally brought under control. Part of the explanation was that the virus had suddenly surfaced in major cities, making it harder to stamp out than in the isolated rural locales where it had struck before. The countries’ poor public health infrastructure and other environmental factors played roles as well.

November 2, 2016 8:00 am

Male Birth Control Injections Found Effective, But Study Cut Short Due to Side-Effects (US News)

New research published Thursday in The Journal of Clinical Endocrinology & Metabolismshows hormonal birth control injections for men could be effective. But don’t expect to see them on the market anytime soon. The study was cut short due to side effects including depression, mood changes and libido issues – in short, side effects similar to those experienced by women who take hormone-based birth control.

October 25, 2016 8:00 am

Can Ecstasy Help Relieve Social Anxiety Epidemic Among Autistic People? (NPR)

For a long time, Daniel Au Valencia got the message that she was wrong, wrong, wrong. She stood wrong. She talked wrong. She looked at people wrong. “There’s a lot of shame around autism,” she says. “There’s a lot of being told you look weird.”

October 25, 2016 8:00 am

Eating plenty of fruit and veggies may not lessen risks tied to meat-heavy diets (Washington Post)

The researchers analyzed data on 74,645 adults, most in their late 50s or early 60s when the study began. None had a history of cardiovascular disease or cancer. Over a 16-year period, 17,909 of the participants died. The more processed and unprocessed red meat people ate regularly, the more likely they were to have died — 21 percent more likely than those who ate the least meat overall. Early death from a cardiovascular cause was 29 percent more likely among those whose regular diets included the most red meat compared with those who ate the least. Those risks did not change, regardless of whether people regularly ate a low, medium or high amount of fruits and vegetables. The researchers reported finding “no interaction” between red meat and fruit and vegetable consumption.

October 20, 2016 8:00 am

Mouse eggs made from skin cells in a dish (Nature)

In a tour de force of reproductive biology, scientists in Japan have transformed mouse skin cells into eggs in a dish, and used those eggs to birth fertile pups. The report marks the first creation of eggs entirely outside a mouse. If the process could be made to work for humans, researchers could produce artificial eggs without needing to implant immature cells into ovaries to complete their development.

October 11, 2016 8:00 am

80% of China’s clinical trial data are fraudulent, investigation finds (BMJ)

Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country’s drug regulator.  An investigation of data for 1622 new drugs submitted to China’s State Food and Drug Administration (CFDA) for registration said that 1308 of the applications should be withdrawn because they contained fabricated, flawed, or inadequate data from clinical trials.

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