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Topic: Health Care Policy
May 7, 2013 | Posted By Bruce D. White, DO, JD

The FDA has banned generic availability of the original formulation of OxyContin® (Purdue Pharma LP’s brand of oral controlled-release oxycodone). OxyContin® was approved by the FDA in 1995 and was first marketed in the US in 1996. Within a very short time, OxyContin® was the most frequently prescribed brand name analgesic with annual sales in the billions of dollars. By 2005 retail purchases were six times the 1997 volume; by 2008, sales totaled $2.5 billion.

Purdue was very effective in marketing OxyContin®. The manufacturer used several “sales strategies” that have since been roundly criticized by regulators and some physicians: aggressive off-label detailing; technically misbranding the product so as to mislead prescribers and patients regarding abuse potential; applying “significant political pressure” to gain state Medicaid formulary approvals; and engaging nationally recognized pain management thought leaders which “encouraged more liberal prescribing of opioids, based on debatable evidence.” With the increased prescribing, more of the drug was available for potential diversion to illegitimate channels. Not surprisingly, the number of accidental deaths from opioid drugs – licit and illicit – have grown in just a few years into a national crisis of epidemic proportions.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

April 2, 2013 | Posted By Bruce White, DO, JD

Last week, with the publication on March 19, 2013, of the Presidential Commission’s report titled Safeguarding Children: Pediatric Medical Countermeasure Research, the Commission demonstrated its unique value to the American people. The report came as an answer to a request from the Kathleen Sebelius, Secretary of the Department of Health and Human Services. Following are the first two paragraphs from the January 6, 2012, letter sent by Secretary Sebelius to Dr. Amy Gutmann, chair of the Presidential Commission for the Study of Bioethical Issues:

The U.S. Department of Health and Human Services is responsible for developing and stockpiling safe and effective medical countermeasures to protect the nation from bioterror attacks. While it has made significant progress toward this goal for adults, the development of appropriate medical countermeasures for children lags, in part due to challenges in collecting basic dose and immunogenicity studies in pediatric populations.

On October 28, 2011, the HHS’s National Biodefense Science Board (NBSB) released its report and recommendation on the “Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP).” The NBSB debated how best to obtain scientifically valid safety and immunogenicity data about AVA PEP for children, a complex issue with ethical, scientific, medical, legal, regulatory, and administrative challenges. In its recommendation, the NBSB concludes that it would be in the best interests of children to gather safety and immunogenicity data about AVA PEP in children prior to an anthrax event, rather than during a future crisis when the vaccine may be needed. The NBSB also recommends that such data be obtained only after the ethical considerations are adequately addressed and reviewed by an appropriate body.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 25, 2013 | Posted By Marleen Eijkhjolt, PhD

This blog post solicits for your opinion, so please stick with me. 

There are two prominent sad realities in my clinical ethics fellowship. The first is that many cases deal with end-of-life issues. The second is that there are many ‘lonely’ patients, who often die in the hospital ‘alone’. The two issues combined tend to raise some unfortunate but fascinating clinical PELSI (Policy, Ethics, Legal and Social Issues). One such issue is: Who should make medical decisions at a patient’s end-of-life when this patient lacks capacity and there is no surrogate? 

In the State of New York, we have the Family Health Care Decisions Act (FHCDA) that governs many of these issues, including end-of-life decisions in absence of a surrogate. (I will explain the legislative scheme below) However, this legislation does not solve all problems, as the written word leaves leeway for different interpretations and practices. One of these problems is related to decisions to withhold or withdraw life-sustaining treatment, and can be phrased as: Who should be the second, independent concurring physician in such decisions, in cases where the patient lacks capacity and there is no surrogate?

Let me explain. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 18, 2013 | Posted By John Kaplan, PhD

Recently the University of Pennsylvania Health System in Philadelphia announced that it would no longer hire tobacco smokers. This seemed like a smart move for several reasons. There are some pretty obvious benefits for the institution including reductions in employee health care costs, reduced rates of absenteeism due to sick days, fewer employee breaks, and the more minor advantages such as fewer people smelling of smoke. There are similarly benefits to individuals who can be convinced not to smoke by such policies. A longer healthier life spared of the expense and inconvenience of procuring these dangerous and addicting instruments should be reward enough. Thus firms which ban hiring of smokers help advance the cause of providing the twenty some percent of adults who still smoke a reason to quit. Moreover health care organizations seem to be the natural groups to take the lead in instigating this sort of social progress.

This is not a new trend. Turner Broadcasting System banned the hiring of smokers in the 1980s and has maintained this policy since. Similar bans on hiring smokers have been implemented by the Cleveland Clinic, Baylor University’s Hospital and the Geisinger Clinic. It all seems to make so much sense. Nevertheless there has been a reaction. Smokers are not a protected class under federal law. Federal law permits a company to discriminate against smokers. However no less than twenty-nine states , including here in New York State, have laws outlawing bans on the hiring of those who smoke. A list is provided here. This is a testimony to the power of the tobacco lobby.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 14, 2013 | Posted By Wayne Shelton, PhD

A story last week from Bakersfield, California received an enormous amount of attention and seemed to capture the public’s imagination. The story was in both the print and electronic media as though a great injustice has been unearthed.  People were outraged that no action was taken to provide cardiopulmonary resuscitation (CPR) on an 87 year-old woman who had arrested in an independent living facility where she was a resident. The story was the rage on Facebook and other social media—people weighing in with their concerns, which again was mostly outrage and disbelief that something like this could have happened. Now that we are a week or so out from when this event happened, I thought it might be worth thinking about what happened in this story and see what lessons we can learn.

The story begins when Lorraine Bayless, the 87 year-old resident of Glendale Gardens, a Bakersfield independent living facility, collapsed and someone, presumably an employee, called 911. Apparently the employee called to report this emergency and was expecting the paramedics to respond quickly. The dispatch operator, realizing the importance of a quick response, admonished the caller to begin CPR herself, before the paramedics arrived. The caller, who identified herself as a nurse, told the dispatcher that she was not permitted by the facility to provide CPR for patients. Glendale Gardens is an independent living facility that says by law they are "not licensed to provide medical care to any of its residents." So in the cool light of calm reflection, did something wrong take place?

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

February 14, 2013 | Posted By Wayne Shelton, PhD

Medical educators over the past six decades have designed educational objectives and curricula as though it was the educational process itself that determines students’ values and their behavior as professionals, without considering the influence of the structural environment on medical trainees. From the 1950’s on, asSamuel Bloom observed in 1988, there are examples, continuing to present day, of medical schools devising curricula with the goal “…to repair what were believed to be the dehumanizing effects of scientific specialization, but with the retention of the best of science.” To achieve these goals educators drew from the social sciences and humanities, and by the 1970s, from the growing interest in medical humanism and specifically from the field of medical ethics, which now is mostly referred to as bioethics. Bloom claims these subjects, like science, have been split off from the context of how they impact medical practice and taught mostly as an intellectual activity, thus creating a dualism between theory and practice. The curriculum has been assumed on its own to be an instrument of behavioral change that follows from knowledge. The essential process of social organization is sadly lost from view and deemphasized. How can we account for this rift?

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

January 24, 2013 | Posted By Joshua Perry, JD & Jamie Prenkert, JD

Objections to flu shots among healthcare workers have garnered much recent media attention. Depending on your point of view, the objecting workers might be martyrs for their beliefs or callous villains intent on spreading preventable disease. Regardless, the ethical and legal issues need to be clarified before resorting to simplistic labels.

First, what’s the fuss all about? Healthcare workers around the nation have reportedly refused to take the flu vaccine for a number of reasons. The objections are premised upon personal autonomy or ideology (“Nobody should be able to force me to put anything into my body.”), scientific skepticism (“I don’t believe the flu shot works.”), medical fear (“I may be one who has a rare allergic reaction.”), and/or some variety of religious conviction (“God gave us a body with an immune system, and if we live healthy and pray, we won’t get sick.").

The Centers for Disease Control and Prevention (CDC) admits that the flu vaccine is not 100 percent effective, given the variety of strains floating around out there. In fact, the efficacy of this year’s shot is only about 62 percent. That is not great, but it is far better than nothing. The American Medical Association, American Nurses Association, and CDC all recommend healthcare workers be vaccinated to enhance patient safety. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

January 14, 2013 | Posted By Jane Jankowski, LMSW, MS

In the wake of the Sandy Hook Elementary tragedy and the movie theatre massacre in Colorado, accounts of mentally ill perpetrators are offered as partial explanations as to how these horrific events came to pass. The public outcry for revised gun control measures is understandable and well placed. I don’t disagree. Yet, the predictability of which firearm aficionados may also harbor a latent predisposition toward violence may be an unreasonable task for agencies tasked with licensing weapon worthy citizens, particularly when it comes to assessing someone with a history of mental illness. The paradox of a system which relies on questions about a personal history of psychiatric treatment does not mean an individual has not needed care.  If behavioral health services are not accessible or available, there would not be any record of such intervention. This does not mean that such intervention has not been suggested, desired, or otherwise indicated.  That said, a history of mental health treatment ought to not automatically suggest the applicant should be denied a right offered other citizens.  Focusing funding and effort on firearm marketplace controls may override the much needed attention on community mental health care which are lacking across the nation.  Ensuring our nation also has accessible, high quality behavioral health treatment programs will have benefits which extend far beyond the gun control debates.  Though we may never be able to fully disentangle the issues of gun rights and mental illness, perhaps we can maximize this opportunity to press our leaders into putting some real muscle, in the form of dollars, behind mental health treatment programs.  

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 27, 2012 | Posted By Bruce D. White, DO, JD

In 2012, the percentage of money spent on providing drugs to patients in the United States continued to rise (Hoffman et al., 2012). However, this is a US trend not seen in other developing countries – such as Canada – where national drug expenditure percentages are slowing year after year (CBC News, 2012). In fact, in Canada, the rate of drug cost growth for this year is the lowest of the last 15 years. 

So, why? Simply put, the American pharmaceutical industry has fueled new drug innovation worldwide for decades. Now, the pharmaceutical companies have less money for research and development and are innovating less. When they do innovate, the companies spend their R&D allocations either on “me too” (imitation) drugs, or very, very expensive drugs for which insurance reimbursement is maximized. Market forces drive both these new drug lines. But now, the R&D well is clearly drying up (Adams, 2011).

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 12, 2012 | Posted By Wayne Shelton, PhD

Recently, I attended a debate between two very informed health care professionals about whether or not our country should have a single payer health care system. Each seemed to have their own philosophical or ideological perspective about health care as a basic service in our society and it through their ideological lens that each speaker viewed health care and brought to bear the facts to support their positions. It was striking that these two very informed and thoughtful individuals often disagreed about fundamental facts pertaining to our health care system. 

For example, the opponent of a single payer system supported his claim that turning over health care to the federal government would be a failure at least in part on the assumption government is incompetent to perform this task. He claimed, as other thoughtful conservatives do, that that Medicare and Medicaid are less efficient than private health plans. If the analysis in the first link below, which is part of the Ryan Plan, is true, then perhaps there are some facts to support their case.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit ourwebsite.

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ABOUT BIOETHICS TODAY
BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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