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Topic: Distributive Justice
August 1, 2013 | Posted By Bruce D. White, DO, JD

Recently, The New York Times in a series of reports has alerted the world to many of the ethical difficulties in marketing drugs globally. The titles of the articles alone hint at many of the issues: “Drug Research in China Falls Under a Cloud; “Glaxo Says Executives May Have Broken Chinese Law; “For Global Drug Manufacturers, China Becomes a Perilous Market.

Moreover, phrases used contextually in the articles are even more alarming: “Glaxo’s problems may go beyond the sales practices that are currently at the center of a bribery and corruption scandal”; “the company fired the head of research and development in China after discovering that an article he helped write in the journal Nature Medicine contained misrepresented data”; “[research] supervisors did not always ensure that the work done there was of high quality”; “auditors came across six [animal] studies whose results had not been reported, even though early trials in humans were already underway”; “auditors found that Glaxo employees failed to record whether the [human subject] research participants had signed new consent forms”; “Glaxo said that employees were properly monitored trials but that they were not adequately documenting their work”; “[Glaxo] used travel agencies to funnel illegal payments to doctors and government officials to bolster drug sales.”

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.

June 27, 2013 | Posted By Marleen Eijkholt, PhD

Sarah is a 10-y old girl with cystic fibrosis who, until recently, was in desperate need of a lung transplant. The doctors had estimated that Sarah would only have a couple more weeks to live without a transplant. Recent news headlines reported about her quest for this transplant, the success of the operation and, over the weekend, they issued the happy news about her regaining consciousness. Most of this news paralleled comments about the battle to revise the legislation, and underscored antagonism towards policy or policy makers (lawyers and ethicists), as if hindering good medicine. 

In this post I would like to comment on this antagonism, and propose that the policy makers did quite a good job in Sarah’s case. I propose that we need a symbiotic relation between medicine and policy makers. As a clinical ethicist with a background in law, I feel a lot of fear for ‘lawyers’, and prejudice against the idea that law, ethics and medicine can go together. In this post, I seek to outline how they can go together, and how Sarah’s case provides an opportunity for partnership. I must note here, however, that this issue is a minor one given the terrible ordeal of all the involved individuals.

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.

June 4, 2013 | Posted By Bruce White, DO, JD

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.

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 4, 2013 | Posted By Bruce D. White, DO, JD

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.

February 4, 2013 | Posted By Bruce White, DO, JD

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.

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.

December 12, 2012 | Posted By Wayne Shelton, PhD

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.

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.

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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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