» Health Regulation & Law Where the World Finds Bioethics Wed, 29 Jun 2016 12:36:26 +0000 en-US hourly 1 FDA approves first pill to treat all forms of hepatitis C Wed, 29 Jun 2016 12:36:26 +0000 0 Colorado’s Teen Marijuana Usage Dips after Legalization Wed, 22 Jun 2016 12:18:22 +0000 0 Canada Legalizes Physician-Assisted Dying Mon, 20 Jun 2016 12:53:30 +0000 0 Orlando Shooting Renews Debate Over Limits on Gay Men Donating Blood Fri, 17 Jun 2016 12:04:34 +0000 0 Reducing Tobacco Use Through Withdrawal Policies: When Should We Ban the Use of a Harmful Product? Tue, 14 Jun 2016 21:15:04 +0000 Kayhan Parsi, JD, PhD

In the first-year clinical skills course at our medical school, we offer a session on tobacco cessation. In this part of our course, we emphasize to our medical students the significant costs tobacco use incurs. The costs to health are now well documented. The financial costs are substantial as well. We teach our students that they can have a positive impact upon their patients’ health by utilizing motivational interviewing techniques and applying the 5 A’s of change (ask, advise, assess, assist, arrange).…

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Who May Die? California Patients and Doctors Wrestle With Assisted Suicide Fri, 10 Jun 2016 12:38:04 +0000 0 An ‘Added Sugar’ Label Is On The Way For Packaged Food Mon, 23 May 2016 12:10:24 +0000 0 Obamacare Rule Bans Discrimination Against Transgender Patients Mon, 16 May 2016 11:48:17 +0000 0 Euthanasia for Reasons of Mental Health Thu, 12 May 2016 21:35:40 +0000 by Craig Klugman, Ph.D.

An article in the (UK) Daily Mail this week focused on a Dutch woman who chose euthanasia “after doctors decided her post-traumatic stress and other conditions were incurable.” Under Dutch euthanasia laws, a physician can end a patient’s life with a lethal injection for mental suffering. Her life was ended last year.

Euthanasia is when a physician delivers the substance that ends a patient’s life. This is distinct from physician/doctor/provider-assisted suicide (often called aid-in-dying) where a physician makes the means to end life available (often through a prescription) but the patient must ingest the life-ending medication.…

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Massachusetts Senate approves under-21 ban on tobacco sales Fri, 29 Apr 2016 12:00:27 +0000 0 Advisers to F.D.A. Vote Against Duchenne Muscular Dystrophy Drug Tue, 26 Apr 2016 13:05:28 +0000 0 New York Hospital to Pay $2.2 Million Over Unauthorized Filming of 2 Patients Fri, 22 Apr 2016 13:52:19 +0000 0 Justin Trudeau Seeks to Legalize Assisted Suicide in Canada Fri, 15 Apr 2016 13:58:11 +0000 0 Theranos Under Fire as U.S. Threatens Crippling Sanctions Thu, 14 Apr 2016 13:33:59 +0000 0 The DEA will decide whether to change course on marijuana by July Thu, 07 Apr 2016 14:53:40 +0000 0 F.D.A. Eases Requirements on Abortion Pill Label Thu, 31 Mar 2016 12:37:58 +0000 0 FDA Takes Important Step to Increase the Development of, and Access to, Abuse-Deterrent Opioids Thu, 24 Mar 2016 16:14:47 +0000 0 FDA Now Requires ‘Black Box’ Warning on Painkillers Wed, 23 Mar 2016 19:07:26 +0000 0 Vaccination aversion has fueled measles and whooping cough outbreaks, study finds Wed, 16 Mar 2016 17:32:03 +0000 0 How a bite of pizza led to an arrest in the Grim Sleeper serial killer case Tue, 16 Feb 2016 22:00:00 +0000 0 Fetal Risks, Relative Risks, and Relatives’ Risks Mon, 01 Feb 2016 21:30:14 +0000 0 Restricting Choices of Childbearing Women Mon, 01 Feb 2016 21:27:07 +0000 0 Revised Medical Access Records Guidelines Reinforce Patient Rights Fri, 22 Jan 2016 07:18:06 +0000 by Craig Klugman, Ph.D.

A few years ago I moved cross-country for a new job. Among the many moving tasks that I had was getting copies of all my medical records so I could bring those to my new physicians. Although I am very aware of HIPAA taught it in my bioethics and health policy courses for many years, I encountered obstacles to getting these records. Some of the refusals were phrased to my benefit: “If you take them then we have to charge but if we send directly to your new doctor, then there’s no charge;” “We’ll send them to you so you don’t need to carry them” and showed up months later in forwarded mail.…

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A Suggestion To Make Prescription Medicine Behind-the-Counter Wed, 23 Dec 2015 05:57:49 +0000 by Craig Klugman, Ph.D.

I recently returned from a vacation to Central America. Besides having some adventures, I also noticed that the local towns had a large number of pharmacies—far more than would be expected of towns with small populations. When I walked into these pharmacies I saw the walls covered with boxes and bottles of medications—drugs that in the U.S. would only have been available with a doctor’s prescription. Some of them were drugs that at home were available over-the-counter in small doses but here one could purchase the prescription dose.…

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U.S. mentally ill 16 times more likely to be killed by police: study Thu, 10 Dec 2015 23:30:44 +0000 0 The Bell Tolls for Death by Neurologic Criteria: Aden Hailu Fri, 04 Dec 2015 06:42:54 +0000 by Craig Klugman, Ph.D.

A judge in Reno, Nevada this week denied a request by St. Mary’s Regional Hospital to conduct an evidentiary hearing to determine that a patient is dead. Aden Hailu was a 20-year-old student at the University of Nevada, Reno (UNR) when she was hospitalized April 1 with abdominal pain. During exploratory surgery, she had a heart attack that led to low blood pressure and lack of oxygen to the brain. Hailu never awoke. A ventilator is now maintaining her body, an IV introduces fluids and nutrients, and medications are maintaining blood pressure.…

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U.S. appeals court rules against Wisconsin abortion doctor law Tue, 24 Nov 2015 19:27:03 +0000 0 S.F. woman who sought to have embryos preserved loses legal case Thu, 19 Nov 2015 21:52:23 +0000 0 Gov. Brown’s veto of right-to-try bill Tue, 20 Oct 2015 20:09:20 +0000 by Lisa Kearns, MS, MA

The conservative press’s reaction to Gov. Jerry Brown’s veto of California’s “right-to-try” bill recently was surprising—not because of the vitriol expressed, or because the writers strongly supported the legislation, which was overwhelmingly popular in the state. What was surprising was that in their rush to criticize the Democratic governor, the veto’s opponents failed to see the harm right-to-try legislation poses for patients—providing mythical hope of a 1-in-5,000 shot at a drug that offers a very slim chance of working anyway.…

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Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest Fri, 16 Oct 2015 18:02:46 +0000 0 Michigan Catholic hospital failed to help woman with brain tumor: complaint Wed, 14 Oct 2015 21:42:44 +0000 0 State of the Armed Union Tue, 06 Oct 2015 17:57:52 +0000 by Craig Klugman, Ph.D

In the first 274 days of 2015, there were 294 mass shootings (yes, that is more than 1 per day). As a nation, there were over 39,000 gun incidents leading to 10,104 deaths and 20,544 injuries so far in 2015.

For points of comparison

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New Law in the Sunshine State: Name Your Primary Physician in Your Advance Directive Tue, 29 Sep 2015 06:32:20 +0000 by Craig Klugman, Ph.D.

This week a revision to the Florida advance directive law takes effect. The notable things in this new law are that it allows for one to appoint a health care surrogate for a minor, to have a surrogate’s authority be effective immediately, and it necessitates appointing a primary physician fro make end-of-life determinations.

The bill was passed in this spring and signed into law on June 11, 2015. It was introduced by Senator John Wood, Republican of District 41.…

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Drug Price Hikes and the Misguided Profit Imperative Fri, 25 Sep 2015 18:55:13 +0000 by Craig Klugman, Ph.D.

Headlines this past week were abuzz with news that Daraprim—a drug that has fought parasitic infections such as toxoplasmosis for 62 years—saw its price hiked by 5500%, nearly overnight. For decades Daraprim has been a front line drug available for $13.50 a table. When Turing Pharmaceuticals bought the company that makes the drug last month, the new owners raised the price to $750 per pill. Often used by HIV patients, the per year cost would be $634,500.…

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Vacation as a Bioethical Issue Fri, 11 Sep 2015 12:00:13 +0000 by Craig Klugman, Ph.D.

I have been on vacation. This is that mythical experience of leaving the everyday world, disappearing to another location, spending time learning/relaxing/experiencing/destressing, and then returning back to the real world. Unfortunately, few of us in the U.S. have jobs that offer such time and even fewer take advantage of these opportunities.

The United States has the least number of vacation days and holidays (in business-speak, “paid-time-off”) than any other industrialized nation.. U.S. law does not require employers to offer paid vacations, sick leave or holidays.…

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Don’t Miss this Opportunity to Shape Federal Policy! Thu, 10 Sep 2015 17:14:16 +0000 by Ellen Fox, MD

Yesterday, the Federal Register published a long-awaited Notice of Proposed Rulemaking to “modernize, strengthen, and make more effective” the Federal Policy for the Protection of Human Subjects known as “the Common Rule.” The proposed changes are endorsed by 16 Federal agencies, plus several others that “intend to adopt the proposed rule” through a separate rulemaking. This event is momentous for several reasons. First, there have been almost no changes to the Common Rule for over 30 years.…

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81 percent of hospitals and health insurance companies have had a data breach Fri, 04 Sep 2015 18:11:21 +0000 0 U.S. government to extend healthcare nondiscrimination law to transgender people Thu, 03 Sep 2015 19:42:21 +0000 0 Legal case tests religious hospitals’ right to deny procedures Mon, 24 Aug 2015 17:33:58 +0000 0 In graphic detail, medical journal describes ‘heavy overtones’ of sexual assault in operating room Tue, 18 Aug 2015 18:02:29 +0000 0 The Texas Advanced Directive Law: Unfinished Business Sat, 01 Aug 2015 16:56:44 +0000 0 Investigating Two Claims Against Planned Parenthood: Center of Medical Progress’s Secret Videos Mon, 27 Jul 2015 22:00:39 +0000 by Craig Klugman, Ph.D.

Before you being reading, I have a disclaimer: Growing up, my mother worked for Planned Parenthood. As a nurse, she practiced in their clinics offering well women services, counseling, and contraception. After many years, she went on to direct their clinic’s in vitro fertilization program. I also heard the word “Planned Parenthood” stated with a quick northeastern accent. Said that way, as a child, I thought the place was called “Plant Parenthood” and wondered what plants had to do with women’s health.…

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The American Psychological Association Interrogation Policy and Dr. Gerald Koocher, AAAS Fellow Wed, 15 Jul 2015 05:09:04 +0000 by Steven Miles, M.D. 

A recent 542-page report describes a damning collaboration between the American Psychological Association (APA) and the Department of Defense (DoD) and other government intelligence agencies. In essence, the APA rewrote the ethics code to allow psychologists to design and monitor interrogational torture.[i] The APA Presidential Task Force on Psychological Ethics and National Security (PENS) said that the interrogational psychologists’ client was the interrogational command and not the prisoners’ wellbeing. The aim of this policy was to authorize and shelter psychologists who devised plans that included waterboarding, sleep deprivation, food restriction, use of threatening dogs, solitary confinement, use of restraining stress positions, etc.…

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A Doctor Lied & Patients Suffered Tue, 07 Jul 2015 17:39:53 +0000 by Craig Klugman, Ph.D.

When I was graduating from college, I had a friend who was diagnosed with cancer. At least, that’s what she told her friends. She would ask to crash on a living room couch because she was scared to be alone, or ask for a ride home from work because she felt too weak to complete her full shift. Some things, however, did not add up. We were not allowed to tell her parents. She said she was getting chemo but had no side effects at all.…

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In California, Vaccination is the Law Wed, 01 Jul 2015 20:52:08 +0000 by Craig Klugman, Ph.D.

This week, California governor Jerry Brown signed Senate Bill 277. This law mandates vaccinations for all children who attend a school (public or private) in the state. The only exemption is when a physician certifies that a vaccine “is not considered safe for the child.” The big change in this new law is the removal of the “personal belief” exemption from vaccination. No longer can a religious or philosophical belief exempt a child from receiving an immunization.…

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Supreme Court Allows Use of Controversial Sedative for Lethal Injection Tue, 30 Jun 2015 19:47:52 +0000 0 At Long Last: FDA Changes the Law for Hemochromatosis Mon, 22 Jun 2015 21:19:19 +0000 by Arthur Caplan, Ph.D.

Summer in the U.S. is known for many things—time at the beach, picnics, baseball, thunderstorms, vacations and ice cream. Sadly, it is also known by hospitals as the season when blood is in short supply. Schools and businesses close making blood drives harder. Frequent donors go away leaving blood and blood products in their communities in short supply. That is why a recent hard-fought breakthrough as to who can donate blood deserves much more attention and recognition than it has received which, if Google is to be believed, to date has been exactly nothing.…

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Can An Advance Directive Ever Justify Cessation of Eating in an Alzheimer’s Patient? Wed, 17 Jun 2015 12:00:39 +0000 by Craig Klugman, Ph.D.

Margot Bentley did what end-of-life care advocates say we should all do—she completed an advance directive. She wrote hers in 1991 when she was working as a nurse and stated that she did not resuscitation, surgery, respiratory support, or nutrition and hydration.

Today she is at the center of a legal battle in Canada. At age 83, she has suffered from Alzheimer’s disease for the last 16 years. She is non-responsive. Her family wants to follow her wishes by stopping feeding and taking her home to die comfortably.…

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Financial Interventions and Living Organ Donation Research in a Learning Healthcare System Fri, 12 Jun 2015 07:40:48 +0000 by Macey L. Henderson

Living kidney donation can potentially provide a solution for the growing waitlist in the United States, which is now holding steady at over 100,000 people. Through paired donation and kidney chains living donors could realistically be the solution to providing an unlimited number of transplants to those in need throughout the world, but the number of donors has been decreasing since 2004. Why? Leading groups of transplant surgeons and professionals have called for the active pursuit of health policies which achieve financial neutrality for the donor—meaning the donor wouldn’t be any financially worse off after donation than before.…

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U.S. anti-legalization group urges more access to marijuana research Thu, 28 May 2015 15:15:44 +0000 0