» Health Regulation & Law Where the World Finds Bioethics Sat, 28 Nov 2015 14:27:02 +0000 en-US hourly 1 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 Inhaler ban boosts costs for people with asthma Wed, 13 May 2015 19:37:55 +0000 0 Tension between gay, religious rights plays out at top U.S. court Tue, 28 Apr 2015 21:05:01 +0000 0 Regulators may recommend testing food for glyphosate residues Mon, 20 Apr 2015 20:32:23 +0000 0 Kaci Hickox: Public Health and the Politics of Fear Wed, 01 Apr 2015 20:13:56 +0000 0 Ideology and Microbiology: Ebola, Science, and Deliberative Democracy Wed, 01 Apr 2015 20:06:36 +0000 0 A year later, no reefer madness in Colorado Wed, 01 Apr 2015 17:31:07 +0000 0 FDA to evaluate homeopathy regulatory framework Wed, 01 Apr 2015 01:19:13 +0000 0 Ban on fast-food eateries in South L.A. hasn’t cut obesity, study says Thu, 19 Mar 2015 19:59:11 +0000 0 Raise minimum age to buy cigarettes to decrease use: U.S. study Fri, 13 Mar 2015 22:34:08 +0000 0 U.S. regulators tighten requirements on reusable medical devices Thu, 12 Mar 2015 22:24:24 +0000 0 “Right to Try” Laws, Compassionate Use, and Adverse Events: A Second Cautionary Tale Wed, 11 Mar 2015 10:00:32 +0000 by Alison, Bateman-House, Ph.D., MPH

In 2014, Colorado became the first state to debate and then pass a so-called “Right to Try” law. In early 2015, there are now five states that have such laws: Colorado, Michigan, Louisiana, Arizona, and Missouri. The Utah and Virginia state legislatures have passed their own right to try laws, both of which await signature by their respective governors, and over twenty other states are actively debating right to try legislation.

These right to try state laws are based on a model bill that was circulated by the Goldwater Institute, a libertarian think tank based in Arizona.…

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Brazil passes femicide law to tackle rise in gender killings Tue, 10 Mar 2015 22:35:44 +0000 0 Drug Development, Compassionate Use, and Adverse Events: A Cautionary Tale Mon, 09 Mar 2015 00:59:23 +0000 by Alison, Bateman-House, Ph.D., MPH

In late September 2014, a man was admitted to the hospital due to vomiting, diarrhea, and fever. Suffering from a viral infection with no known cure, he was given an experimental antiviral medicine; unfortunately, he died. Maybe the experimental medicine did not work. Alternatively, maybe the man was too ill by the time the drug was administered for anything, no matter how effective, to work.

This patient’s name was Thomas Eric Duncan, and he captured media headlines as the first person to die of Ebola in the United States.…

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And the Ban Played On Tue, 03 Mar 2015 19:59:29 +0000 by Craig Klugman, Ph.D.

Have you taken the “Celibacy Challenge?” This satirical national campaign is in response to a proposal from the FDA that would amend the lifetime blood donation ban of men who have sex with men (MSM) to only a one-year ban. The hitch is that the men would have to refrain from sex with men for one year. They could have sex with women during that year, just not men.

This proposed one-year celibacy ban is in line with the rules of other nations.…

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The Social Determinants of Health: Why Should We Care? Sun, 01 Mar 2015 19:40:41 +0000 0 Mandatory Cancer Risk Warnings on Alcoholic Beverages: What Are the Ethical Issues? Sun, 01 Mar 2015 19:39:27 +0000 0 Canadian Supreme Court: Legal Assisted Suicide In a Year Mon, 09 Feb 2015 18:12:31 +0000 by Craig Klugman, Ph.D.

A year from now, all Canadians may have the right to assisted suicide. In February 6, the Canadian Supreme Court ruled “that the prohibition on physician-assisted dying is void insofar as it deprives a competent adult of such assistance where (1) the person affected clearly consents to the termination of life; and (2) the person has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.” In other words, a competent and capacitated person with a serious and unresolvable condition that creates suffering has a right to have assistance to end his or her life.…

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ACA Report Card: One Year of Obamacare and the Individual Insurance Mandate Fri, 23 Jan 2015 13:00:41 +0000 by Craig M. Klugman

The United States has passed a milestone, the first year of the Affordable Care Act’s insurance mandate. This is the requirement that all U.S. residents have health insurance whether through an employer, an organization, or via the insurance marketplaces. Opponents of the ACA (also known as “Obamacare”) feared that this act would destroy the country by decimating the economy, creating a federal government takeover of healthcare, forcing employers to drop coverage, workers quitting who no longer need their employer-based health insurance, and companies cutting workers to stay below minimum thresholds.…

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Ebola – Yes to isolation, quarantine, and travel restrictions (Part III) Wed, 21 Jan 2015 09:50:04 +0000 By Adil E. Shamoo, Ph.D. (guest blogger)

The HIV experience can be used as a learning model to understand what processes may need to be used for this Ebola epidemic. While there are differences, there is much similarity, especially in the deadliness of the virus of both diseases in the early phase of the epidemic. Both are also transmitted through contact with body fluids, and can be transmitted through sexual contact. This aspect should not be overlooked; the sex drive is very strong and frequently sexual relationships defy logic and rationality.…

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Dad Arrested for Giving Cannabis Oil to Daughter With Cancer Wed, 21 Jan 2015 00:29:14 +0000 0 Ebola – Yes to isolation, quarantine, and travel restrictions (Part II) Mon, 19 Jan 2015 11:00:58 +0000 By Adil E. Shamoo, Ph.D. (guest blogger)

Public health policy is derived from promoting public good to protect millions of people from pain and suffering; an effective policy ultimately should enhance health and happiness. The coercive powers of federal and state governments and to enforce public health policy are derived from police powers to provide safety and security to the public. The President has those powers from the plenary powers, unnamed in the constitution, but implied in those powers that protect the security of the nation.…

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Ebola – Yes to isolation, quarantine, and travel restrictions (Part I) Fri, 16 Jan 2015 11:00:44 +0000 By Adil E. Shamoo, Ph.D. (guest blogger)

In 2014, the spread of Ebola topped the headlines. While other issues have supplanted Ebola for the time being, the risk remains as the virus continues to claim victims. A viable Ebola policy that contains the spread must be put into place.

Ebola is transmitted through direct contact with body fluids, blood, and skin. Body fluid droplets remain viable for a few hours; the most infectious period is when the patient is exhibiting severe symptoms with high fever, vomiting and diarrhea.…

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Worrying about patient satisfaction only harms the patient Wed, 14 Jan 2015 11:00:52 +0000 by Craig Klugman, Ph.D.

Anyone who has been in a hospital in the last 9 years has encountered a patient satisfaction survey. This national survey provides rankings of hospitals based on how satisfied patients are with their experience. The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) “is a survey instrument and data collection methodology for measuring patients perceptions for their hospital experience.” For anyone who works in a hospital, the results of this survey can mean raises, firings, and changes of position.…

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Cassandra C: Right to refuse treatment or protecting a minor* Tue, 06 Jan 2015 06:19:24 +0000 by Craig Klugman, Ph.D.

In Connecticut, a 17-year-old girl is being kept in a hospital room under court order. She is restrained to her treatment bed when she is given chemotherapy that neither she nor her mother want. Cassandra C. is a young woman who was diagnosed with Hodgkin’s lymphoma in September 2014. She underwent surgery to remove a lymph node and then chose not to receive further treatment. She left the hospital with her mother, Jackie Fortin, to allegedly seek a second opinion, out-of-state.…

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A Plan to Cut Costs and Crime: End Hurdle to Job After Prison Mon, 10 Nov 2014 19:35:02 +0000 0 Rest in Peace Mrs. Maynard Mon, 03 Nov 2014 18:38:25 +0000 by Craig Klugman, Ph.D.

Over this past weekend, Brittany Maynard took her own life. At 29-years-old, Mrs. Maynard took her prescription for assisted suicide to end her life before her terminal brain cancer pushed her into a quality of life that she found unacceptable. She was young, articulate, and facing a very short lifespan where she would lose control of her body and mind, becoming increasingly dependent on others to complete activities of daily living.

Mrs. Maynard had stated her intention to take her life in an internet message that she sent out into the world.…

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