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Topic: Health Care Policy
April 11, 2014 | Posted By Wayne Shelton, PhD

In my last blog I alluded to the effect of an assumed point of view, particularly a set of ideological set of assumptions around which a community is organized, has on the way we interpret data about how we perceive risks and benefits and make decisions about a range of issues.  I was applying this perspective to public health perspectives such as the risks of gun ownership and forgoing vaccinations. In this blog, I will sketch out a theoretical approach for how humans process and understand information a bit more and conclude with some questions for my next blog about how to understand the obligations of those who are in the best positions to understand public health data, such as the better educated and healthcare workers.

We often assume that most people are capable of coming to objective and fair beliefs and reasonable decisions about various empirical topics, e.g. the effects of climate change, if only we have access to valid, scientific information.  Thus, we often further assume that the goal of having more enlightened people to make more enlightened decisions about public health issues, or for that matter political issues and most other issues of public interest, is simply a matter of bringing to bear more complete and clear knowledge for people to understand. This is the assumption that Dan Kahan (a law and psychology professor from Yale Law School) and his research team calls the “More Information Hypothesis”. However recent research shows that this hypothesis is simply not true—in fact the more information people on opposite sides of an issue get, the more divided and intractable the conflict becomes. The simple fact of making more information accessible clearly does not resolve most public issues that are connected to well-established ideological and philosophical perspectives.

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 31, 2014 | Posted By Zubin Master, PhD

I have written on this blog about the topic of stem cell tourism and the different strategies that have been proposed to stop the phenomenon. Just to provide a background on the topic from a previous blog: stem cell tourism is used to describe an internet-based direct-to-consumer advertised industry where clinics offer untested and unproven stem cell interventions as bonafide therapies to patients with a range of diseases and injuries including Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. Basically there is no scientific evidence of safety of efficacy of these modalities to offer them on a for-profit basis to patients. The term was originally coined as a form of tourism because patients traveled from countries like the U.S., U.K., Canada and Australia to clinics in countries with lax regulations, but this simply is not the case anymore. There are several clinics within highly regulated countries like U.S. that offer stem cell interventions.

Of the several strategies people have discussed, one of the first has been on the topic of providing education to patients and the public. Here, people argue that providing education on the dangers of stem cell tourism might actually sway patients to not undertake unproven stem cell interventions. As some scholars have mentioned, education might not be as effective because it depends on a “rationale actor model” where we assume that patients will behave rationally and make choices based on weighing the harms and benefits of seeking unproven treatments. More so, such an argument does not sufficiently consider the hope patients have to ameliorate their disease, reduce pain or other symptoms, and increase their quality of life. While these counterarguments are certain rational and likely to be true, there is yet no solid evidence showing whether education on stem cell tourism is effective at swaying people from traveling for unproven interventions. But even if before we go into whether education might influence a patient’s decision to travel for unproven stem cell treatments, I think we need to assess the role of patient education in medicine.

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 10, 2014 | Posted By Wayne Shelton, PhD

The case of the 13 year-old California girl, Jahi McMath, declared brain dead following a tonsillectomy has created another media frenzy. This is truly a tragic story. Apparently Jahi underwent tonsil surgery and two other procedures on December 9, 2013 to help her better manage sleep apnea. Following the surgery she was awake but shortly thereafter went into cardiac arrest and was placed on a ventilator. By December 11, physicians made a medical determination of brain death.

From the parent’s point of view, one can only imagine the shock and disbelief they have been experiencing. Their young child went to a major medical center where highly skilled physicians were going to perform what was assumed to be relatively low risk procedures. Jahi had apparently had some worries herself about not waking up following anesthesia. Like all supportive, loving parents they assured she was in good hands and no doubt reminded her of how important it was to have these procedures done in order to deal with what could be a life threatening medical condition in sleep apnea. They fully expected she would be fine and return to normal. Instead, she is on a mechanical breathing machine, which is supporting her breathing and heartbeat, and her physicians now say she’s dead.

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 19, 2013 | Posted By Wayne Shelton, PhD

There are some ominous social and political trends currently in American society on which the field of bioethics should focus more attention. In this informal and admittedly polemical blog, I would like to briefly explore a couple of them.

Governors from about half of the states, mostly from the Tea Party GOP, have invoked their constitutional right to deny healthcare coverage to individuals in their states who make less that 138% of the federal poverty level. These governors calmly claim that pragmatism, not politics, is the basis for their decision to refuse their states the opportunity to participate in the Medicaid expansion program under the Affordable Care Act (ACA). It’s just too costly and the Medicaid program is broken, so they say.

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.

November 12, 2013 | Posted By Bruce White, DO, JD

With the endorsement of the American Society for Bioethics and Humanities (ASBH) Board of Directors, and the publication of a process to confer eventually a “quality attestation” credential on successful candidates, the ASBH Quality Attestation Presidential Task Force (QAPTF) has begun apilot procedure to assess those involved in providing clinical ethics consultation services. Importantly, it’s unclear at this point if the Task Force will be looking at those who provide consultation as an individual, or as a member of a small group of consultants or as a member of a larger ethics committee.

As part of the pilot to refine the process, the QAPTF has asked those interested to submit a letter of intent. (It is not a requirement that one be an ASBH member to submit a letter of intent.) The Task Force will review the submitted letters and select a representative sample (“a cross-section of eligible candidates whose professions represent the distribution of professions among Clinical Ethics Consultants”). 

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.

October 25, 2013 | Posted By Wayne Shelton, PhD

In the summer of 2009 when the Patient Protection Affordable Care Act, also known as the Affordable Care Act (ACA) and Obamacare, was being widely discussed as a front burner political issue, I attended a town hall meeting held by my congressional representative, a moderate democrat, to listen to public comments before he decided whether or not to support the ACA. In the years following the disappointing implosion of healthcare reform during the Clinton administration, honestly, I did not expect to see the issue of healthcare reform back on the political agenda in my lifetime. So I was eager to attend and lend my support for a bill that would expand healthcare coverage for Americans and to hear my congressman respond to questions. When I arrived I was struck by the number of attendees and even more so by the large number of signs and placards with crude slogans linking ACA death panels, Nazism, killing grandma, etc. It was also striking that many of the people there were local working people who were members of the newly formed Tea Party and fierce opponents of the ACA. The negative views being expressed were passionate and urgent: Passage of the ACA would take our country down a path toward socialism, loss of freedom and government interference into the sacred domain of the physician-patient relationship.

Now that the ACA has passed both chambers of congress, signed by the president and ruled to be constitutional by the Supreme Court, there are still strong efforts by it opponents to stop its implementation. At present, the right wing of Republican Party in the house of representation has been willing to shut down our government and threaten default on our national debt unless the ACA is repealed or delayed. It is instructive to put the recent efforts to derail the ACA into historical context and see them as an extension of a century long effort, led by well-funded special interests groups to motivate American citizens through misinformation and scare tactics to vote against their own interests.

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.

October 14, 2013 | Posted By Bruce White, DO, JD

Enrollment with the new Affordable Care Act [ACA] exchanges appears to be off to a bad start. It may be that by the time the insurance exchanges and plans take effect early next year, all the glitches may be worked out. However, even at this relatively late date, many questions remain unanswered. Some of the more distressing unanswered questions relate to the availability of expensive medicines

According to The New York Times, several of the states administering exchanges have yet to release information about drug formularies or fully explain which drugs might be excluded. Of the few states that have released this kind off information, some have options that will require patients to pay as much as 50 percent of the costs of the most expensive drugs covered. Of course, there’s no guarantee that some drugs will be included at all.

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.

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.

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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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