» Clinical Trials & Studies Where the World Finds Bioethics Sat, 28 Nov 2015 14:27:02 +0000 en-US hourly 1 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 Cute with a Good Story: Social Media Selects Experimental Subjects Tue, 01 Apr 2014 19:20:10 +0000 by Craig Klugman, Ph.D.

For patients with a serious illness, accessing cutting edge drugs has just taken a new turn. In the past, a patient with cancer would undergo conventional treatments. If that failed, then he or she would be considered for a clinical trial of a new drug that may (or may not) have the potential to affect the disease. Entry into trials is strict with controls for potential subjects’ age, sex, type and stage of cancer, treatments already tried, and more.…

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Crowdsourcing medical decisions: Ethicists worry Josh Hardy case may set bad precedent Mon, 24 Mar 2014 18:34:20 +0000 0 The Ethics of Advertising for Health Care Services Wed, 19 Mar 2014 19:26:00 +0000 0 Saturated fat advice ‘unclear’ Mon, 17 Mar 2014 23:01:46 +0000 0 Choosing Wisely: Promising New Tests to Diagnose Alzheimer’s Disease Wed, 12 Mar 2014 00:00:55 +0000 by Craig Klugman, Ph.D.

According to an article in Nature Medicine, a new blood test appears to be accurate for diagnosing whether an individual is likely to develop Alzheimer’s disease. Although not yet available for public use, the technique may offer a faster, cheaper, easier, and less invasive method for diagnosis. The researchers looked for fats present in the blood of seniors in the subject pool who were diagnosed with Alzheimer’s disease. Five years earlier, this group, along with others, had a baseline blood draw performed.…

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One Author of a Startling Stem Cell Study Calls for Its Retraction Tue, 11 Mar 2014 18:11:23 +0000 0 Elizabeth Warren vows fight for gender equality in medical studies Tue, 11 Mar 2014 18:10:22 +0000 0 New Clues To Why Traffic Pollution Is So Bad For The Heart Mon, 10 Mar 2014 18:42:29 +0000 0 Free Birth Control Not Associated With Risky Sexual Behavior Mon, 10 Mar 2014 18:38:54 +0000 0 Tampering With Evolution? “Three Parent Embryos” Tue, 04 Mar 2014 23:14:02 +0000 by Maurice Bernstein, MD

Babies are born with  a progressive neurometabolic disorder with a general onset in infancy or childhood, often after a viral infection, but can also occur in teens and adults.  The disease is seen on MRI as dead or dying tissue within the brain and though the child appears normal at birth,  in a few months to two years of age, though earlier or later,  there is loss of basic skills and finally the child may have  heart, kidney, vision and breathing complications. …

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Smoking tied to changes in the structure of teen brains Mon, 03 Mar 2014 21:20:55 +0000 0 Women Still Left Out of Medical Research: Report Mon, 03 Mar 2014 21:08:33 +0000 0 Obesity Drops Among Young Children in U.S., Report Says Wed, 26 Feb 2014 17:51:44 +0000 0 Sitting linked to increased risk for disability, study shows Wed, 19 Feb 2014 19:19:06 +0000 0 Antioxidants including vitamin E can promote lung cancer: study Wed, 29 Jan 2014 20:25:09 +0000 0 Compounds in exhaled breath may detect early lung cancer Tue, 28 Jan 2014 22:07:33 +0000 0 Vitamin D Blog: Protection Is Futile Fri, 24 Jan 2014 19:49:29 +0000 0 Sunshine may chase the blood pressure woes away Thu, 23 Jan 2014 23:02:52 +0000 0 Quality Improvement Ethics: Lessons From the SUPPORT Study Thu, 12 Dec 2013 19:20:51 +0000 0 Informed Consent and Standard of Care: What Must Be Disclosed Thu, 12 Dec 2013 19:18:58 +0000 0