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Topic: Bioethics and the Law
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.

January 7, 2013 | Posted By Ricki Lewis, PhD


In 1729, Jonathan Swift of Gulliver’s Travels fame published a satirical essay called "A Modest Proposal." He suggested that a cure for poverty was for poor people to sell their children to rich people as food.

I’m borrowing Swift’s title to bring up another outrageous idea: analyzing forensic DNA databases for a genetic signature of criminality.

Is there a genetic signature for criminality? 
It’s an old and controversial question. (NHGRI)

ADAM LANZA’S DNA

Days after the Newtown shootings of December 14, 2012, headlines trumpeted the state medical examiner’s request of University of Connecticut geneticists to examine mass murderer Adam Lanza’s DNA. What exactly that might entail wasn’t announced, but celebrity docs, geneticists, and bloggers weighed in, nearly all agreeing that (1) violent tendencies are due to complex interactions of many genetic and environmental factors and (2) probing Lanza’s DNA and finding anything even suggestive of causing his crime could lead to stigmatization of individuals who share suspect genome regions with him.

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.

November 9, 2012 | Posted By Bruce White, PhD

Almost everyone now must have heard about the New England Compounding Pharmacy tragedy that has been unfolding over the past month. The Centers for Disease Control and Prevention in Atlanta (CDC) numbers the present death toll at 28 and total reported cases at 377 from 19 states. Untold thousands of patients may have been injected with contaminated medicines. The New York Times has called this situation “one of the worst public health drug disasters since the 1930s.” 

Already there are more calls for stricter regulations and controls for compounded medicines that enter interstate commerce. The New York Times reported on November 2, 2012, that Representative Edward J. Markey (D-Mass.) will be introducing a bill to oversee compounding pharmacies with wide-scale operations be regulated as “manufacturers” by the Food and Drug Administration (FDA). Calls for greater regulation of compounding pharmacies are not new; the FDA has been attempting greater control for at least the last 20 years.

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.

September 11, 2012 | Posted By Jane Jankowski, LMSW, MS

Plans are underway at some drug store chains and other discount retailers to open in-store clinics which will offer an expanded menu of low cost vaccines and basic clinic services to consumers. Vaccines for flu and pneumonia have been available at retail locations for a number of years, and have become a familiar practice at drugstore chains and other retailers particularly during autumn when the newest flu vaccines are available. A folding table and chairs, consent forms, alcohol swabs and a sharps container typically wait at the end of often long lines of people seeking these prophylactic shots. More recently, several retailers began opening in-store clinics and current estimates of existing in-store clinics hover around 1,300. The pending expansion of these clinics may bring the numbers up to over 3,000 within the next 3 years. 

The self-proclaimed low price leader, Wal-Mart, plans to open independently owned and operated in-store clinics which will treat walk-in patients seven days a week. The list of services ranges from acne care and common vaccines to flu treatment (for those who missed the Wal-Mart flu shots) and upper respiratory infections. It seems reasonable to presume that other in-store clinics are or will be similarly equipped. For the millions of Americans who have difficulty accessing primary care, this may be a tolerable solution which falls somewhere in between going to the ER for these routine healthcare issues and having a primary care physician who can provide comprehensive on-going care. As noted in a piece printed in The Detroit News, the Affordable Care Act will thrust millions of newly insured patients into the waiting rooms of medical offices clogging an already strained primary care system. Perhaps the locating clinics in popular stores is a kind of outreach for clinic owners who  have been unsuccessful in efforts to provide care to underserved populations. I am not convinced these clinics represent such altruistic intentions. This expansion of medical services raises questions about whether or not this venue truly supports the best interests of patients.

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.

August 29, 2012 | Posted By Bruce D. White, DO, JD

The July 31, 2012, issue of the Chicago Tribune carried an article entitled “Chicago-Based Accretive Health Banned from Doing Business in Minnesota for 2 Years.

Facts in the article are sketchy: (1) The Minnesota attorney general’s office began investigating possible privacy breaches when a hospital account collections company laptop was stolen two years ago. The laptop contained the names and protected health information of 23,000 patients treated at two Minnesota hospitals. (2) The company – Accretive Health – manages billing and collections for hospitals. One hospital in Minnesota accounted for 9.9% of Accretive’s first quarter revenue - $25 million out of $253.7 million.

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.

August 3, 2012 | Posted By Ricki Lewis, PhD

On Sunday morning, July 21, I faced a room of people from families with Leber congenital amaurosis (LCA), an inherited blindness caused by mutations in any of at least 18 genes. It was the final session of the Foundation for Retinal Research’s bi-annual LCA family conference, and I was there to discuss the history of gene therapy. But I zapped through that quickly, because the future is much more intriguing.

The excitement pervading the room that day was palpable, following a day of scientific updates, and not only because those with young children were soon to visit Sesame World and the sights of Philadelphia.


E
xome sequencing identified the rare mutation that causes Gavin Stevens’ hereditary blindness (Leber congenital amaurosis, or LCA). (Photo: Jennifer Stevens)

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.

August 2, 2012 | Posted By John Kaplan, PhD

It was reported in the New York Times earlier this month that GlaxoSmithKline was fined three billion (yes billion!) dollars by the feds to settle civil and criminal penalties for illegally promoting ten of its drugs. In Maythe drug firm Abbott Laboratories was fined 1.6 billion (yes billion!) dollars for illegally promoting their drug Depakote. In April Johnson & Johnson was fined 1.2 billion (yes billion!) dollars in Arkansas for marketing practices of their drug Risperdal. We can keep this short by primarily reporting fines from this year and those in the billion-plus range. I do feel the need to recall Pfizer’s 2.3 (yes billion!) dollar fine in 2009 for illegal marketing of Bextra. Taxpayers Against Fraud reports over ten billion in such settlements and civil and criminal penalties during the current fiscal year.

How can pharmaceutical companies engage in such costly activities on an ongoing basis? It turns out that what seems like a lot of money to you and me is not so much to these huge corporations. Avandia, Paxil, and Wellbutrin, just three of the ten drugs that GlaxoSmithKline was marketing this way had sales of over 25 billion (again, yes billion!) during the ten year period covered by the settlement. According to Patrick Burns, spokesman for Taxpayers Against Fraud, this “can be rationalized as the cost of doing business.” The market apparently agrees that this is a reasonable cost to do business as these fines barely registered in terms of the valuation of stock in these companies. Implicit in this conclusion is that these companies are making a purposeful decision to act in this manner and thus could be considered criminal enterprises.

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.

 

July 23, 2012 | Posted By Hayley Dittus-Doria, MPH

As the world knows, obesity has become a public health epidemic over the last several years in the United States, with over 35% of US adults falling into the obese category.  But when public health experts and lawmakers try to “do the right thing” by forcing people to engage in healthier behavior, are they going too far?

In a June 8th article on CNN.com, Harriet Washington believes that the ban on sugary drinks that New York City mayor Michael Bloomberg has proposed is the wrong way to go about encouraging healthy eating and drinking habits.  She also disagrees with “sin taxes,” stating that they often have unintended consequences.  In the sugary beverages ban proposal, restaurants, street carts, and movie theaters would not be able to sell any sugary drinks over 16 ounces.

While I don’t necessarily support an outright ban of sugary drinks, I do think that, for the most part, taxes imposed on items (such as those for tobacco and alcohol) are a great step toward  discouraging people from partaking in these unhealthy behaviors and increasing state revenue at the same time.  Many states have implemented a tax on sugary beverages in recent years, and many others have tried, but failed, for a soda tax to catch on.  Mayor Bloomberg even proposed a soda tax in 2009 for NYC, yet this proposal was eventually abandoned and never came to fruition.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

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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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