In her Sunday, June 2, 2013, New York Times article titled “The 2.7 Trillion Medical Bill”, reporter Elizabeth Rosenthal reminds us once again that with the U.S. healthcare “system,” traditional economic market forces are a myth. In example after example, from angiogram to colonoscopy to hip replacement surgery to Lipitor to everyday radiology studies, she shows how U.S. costs are three-to-four times higher than charges in other countries, and how no one can really explain why. For this reason alone, why do some continue to insist on saying that American healthcare is sustained by free market forces as if it were another “business”?

Victor R. Fuchs – in his 1986 text The Health Economy – recalled that a typical market includes: (1) many well-informed buyers and sellers, with no large group of either able to influence price; (2) buyers and sellers acting independently; and (3) free entry of new buyers and sellers. The American healthcare market departs remarkably from these competitive conditions, often as a consequence of openly debated public policy. In America, it is very difficult for patients, consumers, “to vote with their feet” as Nobel Laureate Milton Friedman oft wrote.

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.

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.

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.

Consider the following recent news articles. In one sentence, the alleged facts are that a hospital supervisor reassigned a 25-year-veteran neonatal intensive care unit nurse to “[honor] a father's request to not let black nurses treat his infant son.”

Patients and patients’ legally authorized representatives have rights in the provider-patient relationship. A number of states have codified some of these rights in statutes and regulations in ways that look like a “patient’s bill of rights.” Typical within these declarations are statements that give patients many broad choices with respect to care. Some may see this is an extension of a patient’s autonomous choices in healthcare delivery generally.

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.

A recent blog about a tragic situation in Tennessee highlights how difficult it is to create a “fair” healthcare system.

In this case, the patient is a nine-year-old severely disabled girl. She is maintained on a ventilator and feed through a tube. “She requires medicines and breathing treatments around the clock.” “She has to be suctioned every ten minutes or so to avoid suffocating on her own saliva.” She responds to family and caregivers minimally. And, she resides at home with her parents. Her father works and her mother is disabled with severe arthritis. Because family members cannot take care of her 24 hours a day, seven days a week, home health nurses provide most of the moment-to-moment care. However, home health nurses are very expensive, much more costly than if the patient were a patient in a nursing home (about $1000 a day).

The crux of the controversy between the parents and Tennessee’s Medicaid program – TennCare – is home care versus nursing home care. The parents want to keep their child at home with 24 hours nursing support, but TennCare will only pay for nursing home care in a skilled care facility.

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.

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.

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.

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.

When former President Bill Clinton spoke at the Democratic National Convention, he argued that we must put aside ideologies to “get things done.’”  The implementation of the Affordable Healthcare Act (ACA) is challenging Republican governors on exactly this point, and their responses are not uniform.  Jan Brewer, governor of Arizona outspoken critic of President Obama and the ACA, has begun planning for, and implementing the healthcare exchanges that states must create under the rules of the legislation.  States that fail to plan for exchanges will have exchanges created for them by the federal government. Six states with Republican governors have decided not to create exchanges, and may also not accept additional money from the federal government to expand Medicaid coverage along the lines set out by the ACA.

Is this just politics as usual, or is there an ethical dimension to this partisan debate?  I would argue that to fight against Obamacare to the detriment of the health of a state’s citizens—the poorest of the states citizens—is a violation of a politician’s duty to beneficence.  Uninsured patients suffer a preventable harm from the lack of access to healthcare, a harm that is now being remediated by the ACA, but only if only states will fully implement its policies.

The September 20, 2012, issue of The New England Journal of Medicine carried two Sounding Board pieces about recommendations to contain health care spending. One article is titled “A Systematic Approach to Containing Health Care Spending” was produced by nationally known health policy experts working in cooperation with the Center for American Progress.

About half of the 11 recommended solutions are not new, nor have they proven to be anything more than platitudes from the past. Among these recommendations are: (a) “accelerate use of alternatives to fee-for-service payment”; (b) “simplify administrative systems for all payers and providers”; (c) “make better use of nonphysician providers [such as nurse practitioners and physicians assistants]”; (d) “expand the Medicare ban on physician self-referrals”; and (e) “reduce the costs of defensive medicine.” Should one peruse any one of several books produced in the 1980s written by politicians and health system gurus – such as Alain C. Enthoven’s Health Plan (1980), Joseph A. Califano, Jr.’s America’s Health Care Revolution (1986), Victor R. Fuch’s The Health Economy (1986), and Rashi Fein’s Medical Care, Medical Costs (1989) – they would find the same recommendations. Also, not so curiously, all of these authors and many others agreed in spirit – in the 1980s – that health care spending “trends [then] could squeeze out critical investments in education and infrastructure, contribute to unsustainable debt levels, and constrain wage increases for the middle class.” This at a time when total health care spending was one-tenth of what it is today (health care spending in 1980 was $256 billon; health care spending in 2020 was $2.6 trillion).

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.