» Clinical Trials & Studies Where the World Finds Bioethics Fri, 27 Mar 2015 14:54:00 +0000 en-US hourly 1 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 What Should Be Disclosed to Research Participants? Thu, 12 Dec 2013 19:16:39 +0000 0 The SUPPORT Controversy and the Debate Over Research Within the Standard of Care Thu, 12 Dec 2013 19:03:50 +0000 0 Where Have All the Negative Results Gone? Wed, 04 Dec 2013 22:57:29 +0000 by Craig M. Klugman, PhD

This week I gave a lecture at a university in Texas on ways to teach research ethics. A question from the audience led to a conversation about the stresses and pressures that lead researchers to be involved with ethically questionable activities. I mentioned that among the pressures are to maintain and increase funding as well as to get published. This pressure manifests itself in the fact that we are more likely to publish positive results than negative.…

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Addressing Unapproved Meningitis Vaccine at Princeton Mon, 18 Nov 2013 16:16:39 +0000 by Arthur L. Caplan, PhD

Emergency doses of a meningitis vaccine not approved for use in the U.S. are likely to be on the way to Princeton University to halt a meningitis outbreak that has already sickened seven students  There are approved meningitis vaccines available, but they do not protect against Meningitis B—a strain not covered by the shots given in the U.S. and not a strain prevalent here.

Government health officials said Friday they have agreed to import Bexsero, a vaccine licensed only in Europe and Australia that does protect against meningitis B. …

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Binge and Vac: Clinical Trial for Stomach Vacuum Fri, 11 Oct 2013 06:48:02 +0000 by Craig Klugman, Ph.D.

Imagine eating a big meal. You start with the shrimp appetizer, followed by a rich and creamy clam chowder, and a Caesar salad. Your main course is a large steak with buttered mashed potatoes and finished with a big piece of German chocolate cake. You may have consumed 2,000 calories or more in one meal and most people would probably feel stuffed. But not you. Instead you take out your handy aspiration device, connect it to your reverse percutaneous endoscopic gastrostomy (PEG tube) and flip on the vacuum.…

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An Unhealthy Shutdown Thu, 10 Oct 2013 06:45:55 +0000 by Craig Klugman, PhD.

It’s week 2 of the government shutdown with no end in sight. In fact, some people are saying this is a good thing because it achieves their aim of shrinking government. Some Congressmen want the country to go off the deep end of the fiscal cliff, not believing that it would have negative repercussions for the population. The problem is that it turns out the government actually helps protect our health.

Thinking about having some meat for dinner?…

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Texas woman with cancer pressuring experimental drug maker for “compassionate” access Mon, 23 Sep 2013 19:47:12 +0000 0 New scan may diagnose Alzheimer’s as brain changes occur Fri, 20 Sep 2013 17:02:11 +0000 0