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Topic: Bioethics and the Law
June 13, 2013 | Posted By Ricki Lewis, PhD

Earlier today, my “in” box began to fill with info from everyone I’ve ever met letting me know that the Supreme Court had ruled on the Myriad case about patenting the breast cancer genes BRCA1 and BRCA2. I also received a dozen pitches from PR people offering me all manner of instant interviews with lawyers, doctors, bioethicists, and health care analysts.

No one offered me an interview with a geneticist – a person who knows something about DNA. So being such a person myself, I decided to take a look at the decision. And I found errors – starting right smack in the opening paragraph.

“Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening exons.”

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 30, 2013 | Posted By Marleen Eijkholt, PhD

One week ago, the state of Vermont passed legislation allowing Physician Assisted Suicide (PAS) in its ‘Patient Choice at End of Life’ Bill. This Bill will protect physicians from criminal liability for prescribing a medication that will hasten a patient’s death, under certain conditions and given certain safeguards. The legislative regime is relatively clear, and its comprehensible provisions can be applauded. Still some ambiguity exists overall about the distinction between PAS and euthanasia, as evidenced by the following headline: ‘Vermont Assisted Suicide Bill: Vermont Gives Euthanasia the Green Light’. The legislation itself does not necessarily do a service to clarify these terms, in its reference to active euthanasia. In this blog post, I seek to clarify some of the legislative regime in Vermont and clarify some terminology around PAS and euthanasia. 

Vermont is the third State that has legally permitted PAS, and is the first one to do so by law directly. Oregon and Washington legalized PAS respectively in 1994 (confirmed in 2006) and 2008 after referenda. Montana allowed PAS by a court judgment in 2009, but no Bill has been enacted yet. Vermont’s Bill was crafted with the Oregon legislation in mind. Its current safeguards revolve around record keeping by the physician, its requirements that a patient needs to suffer a terminal illness and have less than six months to live, as well its requirements for a the written statement of a patient (next to two oral ones), and a concurring opinion from a second physician. These safeguards were a compromise to facilitate and speed up the process of the Bill. In 2016 these safeguards will be replaced, and PAS will be governed by professional practice standards, like in other areas of medicine (Provision 5292).    

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.

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.

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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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