» Clinical Trials & Studies Where the World Finds Bioethics Tue, 28 Jun 2016 12:31:45 +0000 en-US hourly 1 First CRISPR Human Clinical Trial Gets a Green Light from the U.S. Fri, 24 Jun 2016 12:00:53 +0000 0 Hints that antibiotics, C-sections may affect baby gut bugs Thu, 16 Jun 2016 12:06:32 +0000 0 Why taking morphine, oxycodone can sometimes make pain worse Wed, 01 Jun 2016 12:00:31 +0000 0 The Potential for Infrastructure Benefits and the Responsiveness Requirement Wed, 25 May 2016 19:43:10 +0000 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. Commentators on research ethics are well aware of this concern and have searched for ways to design and conduct clinical trials to help to address it. Much of this work focuses on how to protect individuals and communities in lower income countries from exploitation.…

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Despite Pressing Need, Survey Finds Most Americans Unlikely to Enroll in Clinical Trials Wed, 25 May 2016 13:47:36 +0000 0 Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries Tue, 24 May 2016 20:25:28 +0000 0 The Potential for Infrastructure Benefits and the Responsiveness Requirement Tue, 24 May 2016 20:23:22 +0000 0 Malaria Vaccine Shows Strongest Protection Yet Wed, 11 May 2016 11:35:38 +0000 0 “And Death Shall Be No More” Thu, 05 May 2016 15:59:58 +0000 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.

Since the 1968 ad hoc Harvard committee on defining death, brain death has been defined as the “irreversible loss of all functions of the brain, including the brainstem.” If a new project is successful that definition may have to be revised or deleted.…

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Bacteria-Infected Mosquitoes Could Slow Spread of Zika Virus Thu, 05 May 2016 13:46:49 +0000 0 Methodological Miasma not mental dystrophy plagues drug trials Wed, 04 May 2016 22:07:29 +0000 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.

Actually it was the FDA’s scientific advisors not the FDA who concluded that there wasn’t sufficient evidence the drug was effective.

Still the WSJ sneered that “Here’s the gist of FDA’s objection: 12 patients are too few, and thus we don’t know if the drug helps boys walk longer or if the results are skewed.…

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Loneliness can harm your heart, study finds Wed, 20 Apr 2016 13:53:37 +0000 0 Study Backs Pancreas Cell Transplants for Severe Diabetes Tue, 19 Apr 2016 12:53:08 +0000 0 BioethicsTV: “Heartbeat” tackles therapeutic misconception Fri, 08 Apr 2016 02:32:44 +0000 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. The intervention uses laparoscopic surgery to implant radioactive pellets directly into tumors. The show presents a good debate on the values of enrolling patients because the characters discuss the hope of more time versus providing patients with comfortable quality of life at the end of life. The side-by-side contrast is quite literal as the camera shows Panttiere sitting next to her paramour, Dr.…

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BIOETHICSTV: Chicago Med-BIID, post mortem egg retrieval, scope of practice and forgiveness Wed, 06 Apr 2016 06:29:15 +0000 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.

Story 1 begins with a patient brought into the ED after trying to saw off his arm in the hardware store. The doctors are able to save it but the patient is upset. Dr. Charles, the psychiatrist, realizes the patient suffers from Body Integrity Identity Disorder (BIID) which is characterized by people feeling a part of their body is not theirs.…

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Blood Test for Concussions? Researchers Report Some Progress Tue, 29 Mar 2016 12:42:57 +0000 0 Choosing to die at home does not hasten death for patients with terminal cancer Mon, 28 Mar 2016 15:46:34 +0000 0 A Post-Oscars “Spotlight” on Neonatal Lupus for Rare Disease Day Tue, 01 Mar 2016 03:22:11 +0000 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. Young scientists trying to enter the biomedical research arena last year faced the worst funding climate in half a century, with NIH spending down 22% since 2003. December of 2015 brought a glimmer of hope, however, when Congress passed a federal spending bill that included the biggest increase in NIH funding in 12 years, an additional $2 billion that NIH Director Francis Collins says came at “just the right time to take advantage of remarkable opportunities to improve human health, powered by dramatic advances in scientific knowledge and technological innovation.”
Today might be considered “rare” because it is a Leap Day.…

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Cleveland Clinic Performs First U.S. Uterus Transplant Fri, 26 Feb 2016 00:52:52 +0000 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. The transplanted uterus was from a deceased woman. This was the first such surgery in the United States, though it has been performed previously in Sweden and Turkey. Of the 9 women in Sweden who had the procedure, 4 have given birth.

The American patient had uterine factor infertility, which result from fibroids, scarification, genetics, or not having developed a uterus.…

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French Drug Trial Disaster Leaves One Brain Dead, Five Injured Sat, 16 Jan 2016 23:21:37 +0000 0 A Bioethicist on Mars Mon, 02 Nov 2015 07:18:08 +0000 by Craig Klugman, Ph.D.

The film, The Martian, is an exciting Robinson Crusoe space adventure. Based on the book of the same name by Andrew Weir, the film stays fairly close to the original source. Astronaut Mark Watney is stranded on Mars when he is impaled by a metal rod in the middle of a sudden and violent storm. Thought dead due to a malfunction of his suit, his fellow astronauts leave him and make an emergency evacuation to return to Earth.…

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Human Subjects Research “Vulnerability” Tue, 13 Oct 2015 03:21:07 +0000 by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM). The changes being suggested are numerous (helpful summaries can be found here and here My aim is not to review those changes, but to point out a curious conceptualization of vulnerability affirmed in the NPRM.

Consider the following section (regarding conditions for IRB approval) of the original regulations:

46.111(b) – When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.…

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Your Biology is in My Technology Mon, 05 Oct 2015 22:48:12 +0000 by Craig Klugman, Ph.D.

The PBS series Open Mind has been on television for nearly 60 years. The program “is a thoughtful excursion into the world of ideas.” The December 30 episode was an interview with Dr. Maria Freire, President of the Foundation for the National Institutes of Health. The host of this show, Alexander Heffner, asked AJOB and BIOETHICS.NET to share this interview, about which he said, “it’s among our most fascinating conversations.”

The conversation is about exploring is about the intersection of biology and technology, harnessing big data to learn about human health and find cures for human disease.…

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True Confessions: Keeping up with the literature Thu, 01 Oct 2015 08:47:03 +0000 by Craig Klugman, Ph.D.

When I was a graduate student learning about the job of being an academic, my advisor gave me some good advice. He told me to teach my classes, minimize my service, write everyday, and keep up with the literature. Teaching innovative classes using technology and active learning takes more time than lectures and seminars did. I became a department chair, which automatically increased my service duties. I still write, nearly everyday. What I do not have time for is keeping up with the literature.…

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Cancer sniffing dogs to aid British doctors Fri, 28 Aug 2015 18:08:58 +0000 0 Cystic fibrosis drug offers hope to patients Mon, 18 May 2015 19:10:43 +0000 0 Cost of Compassionate Use is Simply Too High Fri, 08 May 2015 21:01:23 +0000 by Craig Klugman, Ph.D.

Johnson & Johnson’s Janssen Pharmaceutical Company announced that it has contracted with New York University’s Division of Medical Ethics to assemble an external Compassionate-Use Advisory Committee (CompAC) to examine requests for investigational new drugs (INDs) outside of clinical trials. Arthur Caplan will lead this group, which will be composed of bioethicists, physicians, and patient advocates. The goal of this group is to provide recommendations on which patients should be given compassionate use access to experimental drugs.…

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Are religious research subjects a vulnerable population? Wed, 15 Apr 2015 19:28:11 +0000 by Craig Klugman, Ph.D.

A recent study in the journal Psychology Science found that when people are thinking about God, they are more likely to state a willingness to participate in nonmoral,° risky behaviors such as skydiving, substance abuse, and speeding. To reach their conclusion, the researchers asked online participants to undertake a short writing task. Half of the participants were asked to incorporate words that reminded them of God and half did not.

The participants then took one of several scenario tests where they were asked their willingness to participate in risky behaviors.…

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Research 2.0: Rise of the Citizen-Scientist and the Death of Privacy Thu, 26 Mar 2015 07:34:05 +0000 by Craig Klugman, Ph.D.

On Monday I attended a symposium on inter-professional education. During a session on new technologies in medicine (telemedicine, wearables, and mobile devices) I brought up the question of preserving privacy. The foundation sponsoring the event replied to me, “There is no such thing as privacy. It’s dead.” For someone who works in bioethics, serves on an IRB, and was formerly a journalist, this notion is scary. Perhaps, I have simply been in denial. After all, I use a mobile phone that tracks my position, synchs with the cloud, and provides much convenience.…

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A Pill for Compassion or Misunderstood Science? Wed, 25 Mar 2015 06:36:37 +0000 by Craig Klugman, Ph.D.

For at least a decade, studies have shown that empathy and compassion decline in medical students. The response is often more curricula dedicated to ethics, humanities, communication skills, and patient contact. But what if the answer was simply medicating the students.

An article in Time magazine reported that a study from researchers at the University of California Berkeley and University of California San Francisco have found “that by manipulating a brain chemical, people can become more compassionate and act in prosocial ways to equalize differences.”

Compassion is “a sympathetic consciousness of other’s distress with a desire to alleviate it.” According to the article, the study of 35 subjects found that when taking a drug a person’s desire to alleviate inequity increased.…

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Ethics of Penile Transplants Mon, 16 Mar 2015 23:13:04 +0000 by Craig Klugman, Ph.D.

This weekend, doctors in South Africa announced a new first—a successful penis transplant. The 9-hour operation took place in December 2014. After three months of recovery, the recipient is able to urinate, achieve an erection and a sexual response. As of yet, the recipient does not have full sensation in the organ.

The recipient was 18 years old when he underwent a ritual circumcision that went wrong and left him with 1cm of the original penis.…

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Precision Medicine Has Imprecise Ethics Wed, 18 Feb 2015 06:59:03 +0000 by Craig Klugman, Ph.D.

How do physicians diagnose disease? First they go through a set of symptoms and then compile a list of differential diagnoses or what the underlying disease may be. Then the doctor performs tests to rule out some diagnoses and advance others. In essence, though, diseases are classified according to their affect on the body—their symptology. What if instead of by symptoms, diseases were classified by their molecular function? Instead of being diagnosed with Type II Diabetes one might be diagnosed by whether there is a death of beta cells (i.e.…

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Text Messaging: A Cure for Common Nonadherence? Mon, 08 Dec 2014 19:34:57 +0000 by Craig Klugman, Ph.D.

According to research studies on medication usage, nearly 22% of all e-prescriptions and 28% of new prescriptions are not filled. For heart medications among people who have experienced a heart attach, one-half to two-thirds (depending on the medication) of patients were nonadherent to a prescription regimen. Patient adherence to medication is related to the disease, side effects, how long they are treated (there is a drop off after 6-months of treatment), complexity of the regimen, severity of disease, and cost of the medication.…

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Drugmakers look to push the boundaries of old age Thu, 06 Nov 2014 21:01:41 +0000 0 Dollars to Doctors: Sun Rises on Sunshine Act’s Open Payments Database Tue, 30 Sep 2014 07:15:50 +0000 by Craig Klugman, Ph.D.

Today, Tuesday, September 29, the Centers for Medicare and Medicaid Services will release most of the Open Payments database. The public will now have access to the monetary value of gifts, marketing, and payments for clinical testing made by the pharmaceutical industry to physicians. The database is being rolled out 12 days later than planned and with one-third of the 2013 data unavailable until June 2015: There have been some glitches including mix-up of names and wrong provider and license numbers entered.…

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The Ethics of Ebola and Scarce and Experimental Drugs Thu, 07 Aug 2014 04:08:27 +0000 by: J.S. Blumenthal-Barby

Yesterday I was contacted by the L.A. Times to answer a simple question: Should we give people access to the experimental Ebola drug, ZMapp?

The Drug and Clinical Trial Phases
So, I did a little digging to try to find out some more details about the drug. From what I could find in published news reports, the drug was developed by Mapp Biopharmaceutical Inc., with support from the NIH and the Defense Threat Reduction Agency. It has been tested on 8 monkeys.…

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Schizophrenia Linked to 108 Genes Tue, 22 Jul 2014 20:29:39 +0000 0 Study finds vaccine side effects extremely rare Wed, 02 Jul 2014 19:33:25 +0000 0 Community Consultation Should Include Social Media Thu, 19 Jun 2014 06:41:24 +0000 by Nuriel Moghavem

A New York Times article published this week describes a clinical trial in Pittsburgh where incapacitated and rapidly exsanguinating gunshot victims have their blood replaced by cold saline for up to an hour in an effort to preserve neurological function and life. This trial has raised many ethical concerns, one of which is whether the community consultation conducted before and during the trial (which is required by federal guidelines) was adequate enough to inform the community about the opt-out trial and to collect extensive feedback from it.…

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Tragedy in Research History: The Children of Ireland Tue, 10 Jun 2014 19:14:40 +0000 by Craig Klugman, Ph.D.

For many people, the film Philomena was an introduction to a history of Irish babies being taken from their unwed mothers and adopted to “good” Catholic families in other countries. I put “good” in quotes because often what qualified a couple was the ability to pay. In the last week, news has come out of Ireland of a mass grave holding the remains of 796 infants buried in a septic tank on the grounds of a former “mother and baby” home in Galway.…

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Stress hormone receptors in taste buds ‘may help explain emotional eating’ Wed, 04 Jun 2014 18:01:19 +0000 0 ‘Right to Try’ laws spur debate over dying patients’ access to experimental drugs Mon, 19 May 2014 18:46:57 +0000 0 How to Succeed in Translational Science Mon, 19 May 2014 18:45:14 +0000 0 Wine compound not tied to improved health: study Mon, 12 May 2014 22:54:08 +0000 0 Why vampires stay young Fri, 09 May 2014 04:42:19 +0000 by Craig Klugman, Ph.D.

In the world of fantasy, the vampire is known for its immortality. In most incarnations, the vampire lives forever in a youthful state by feeding on the blood of humans. Now it turns out that science may have proven that the blood of the young keeps you young.

At least, if you’re a mouse. Three papers published in the last week (two in Science and one in Nature Medicine) showed that giving blood from young mice to older mice reduced many of the signs of aging.…

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Yawning alot? It’s just your body trying to regulate your brain temperature Thu, 08 May 2014 21:50:43 +0000 0 Higher Education Associated With Better Recovery From Traumatic Brain Injury Fri, 25 Apr 2014 17:53:30 +0000 0 Simple Blood Test To Spot Early Lung Cancer Getting Closer Mon, 07 Apr 2014 20:54:11 +0000 0 Breast Ca Growth Slowed by CDK4/6 Inhibitors Mon, 07 Apr 2014 20:52:29 +0000 0 Guidance published on informing study participants about findings with potential health implications Wed, 02 Apr 2014 18:17:26 +0000 0