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Topic: Bioethics and the Law
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.

July 17, 2012 | Posted By Lisa Campo-Engelstein, PhD

Around 10% of all people diagnosed with cancer are in their reproductive or pre-reproductive years (under age 45). This means that, each year, approximately 133,000 women, men, and children who are diagnosed with cancer are at risk for infertility due to the very treatments (e.g. chemotherapy, radiation, and surgery) that can save their lives. Given improved survivorship rates, fertility concerns have emerged as an important quality of life issue to cancer survivors and their families. Oncofertility, a new and interdisciplinary field at the intersection of cancer and fertility, is working to address potential infertility as a result of cancer treatment. 

Although more cancer patients are being offered and are using fertility preservation technology (FTP), its cost and the lack of insurance coverage for it are often the major reasons given by oncologists for why they do not provide information on fertility preservation options to their patients. One method of ensuring people in their reproductive years or children who are diagnosed with cancer have access to and insurance coverage for FPT is to create a legal mandate requiring insurance companies to cover FTP for cancer patients. 

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.

July 2, 2012 | Posted By Wayne Shelton, PhD

The decision by the Supreme Court affirming the Patient Protection and Affordable Care Act (ACA) caused many who follow health care closely to breathe a sigh of relief. About 32 million more Americans will now have access to health care insurance. One sticking point that worried many of us was the mandate in the bill requiring everyone to purchase health care. It was frustrating this past March to hear in the oral arguments comparing a requirement for citizens to buy broccoli to a requirement to buy health care, as though both are the same type of market commodities. Many on the right, such as Judges Scalia, Thomas and Alito, expressed concerns that the mandate to require everyone to buy health care was a unconstitutional, a violation of the commerce clause; whereas, many others see health care as a basic public good, which unlike broccoli, everyone requires or will require sooner or later. Fortunately, a legal consensus was reached in the ruling, with Chief Justice John Roberts moving over into the majority in the 5-4 vote. In their ruling, the mandate was not viewed as an expansion of the commerce clause, but rather as a tax, which congress has a right to impose. Regardless of the final legal justification of the ruling, many of us are pleased that the most important piece of health care legislation since Medicare and Medicaid in 1965 is now the law of the land.

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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