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Topic: Distributive Justice
December 19, 2013 | Posted By Wayne Shelton, PhD

There are some ominous social and political trends currently in American society on which the field of bioethics should focus more attention. In this informal and admittedly polemical blog, I would like to briefly explore a couple of them.

Governors from about half of the states, mostly from the Tea Party GOP, have invoked their constitutional right to deny healthcare coverage to individuals in their states who make less that 138% of the federal poverty level. These governors calmly claim that pragmatism, not politics, is the basis for their decision to refuse their states the opportunity to participate in the Medicaid expansion program under the Affordable Care Act (ACA). It’s just too costly and the Medicaid program is broken, so they say.

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, 2013 | Posted By Bruce White, DO, JD

A July 28, 2012 article in The New York Times by Anne Lowry and Robert Pear titled “Doctor Shortage Likely to Worsen with Health Law” was recently updated with a follow-up report about Medicaid expansion by Abby Goodnough in a piece titled “Medicaid Growth Could Aggravate Doctor Shortage.” 

Many report that there’s not enough doctors now. It may be curious and rhetorical, but why would anyone suspect that there’s not going to be doctor shortages of some degree – in the very near future – if Medicaid expands by 9 million new persons and the Affordable Care Act (ACA) adds another 30 million or so newly-insured patients to those already covered by some plan. How could this not have been anticipated? It must have been factored into the ACA equation. In the same way that legislators should have realized that some insured would not be able to “keep their coverage” once the new health law was to take effect.

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.

October 14, 2013 | Posted By Bruce White, DO, JD

Enrollment with the new Affordable Care Act [ACA] exchanges appears to be off to a bad start. It may be that by the time the insurance exchanges and plans take effect early next year, all the glitches may be worked out. However, even at this relatively late date, many questions remain unanswered. Some of the more distressing unanswered questions relate to the availability of expensive medicines

According to The New York Times, several of the states administering exchanges have yet to release information about drug formularies or fully explain which drugs might be excluded. Of the few states that have released this kind off information, some have options that will require patients to pay as much as 50 percent of the costs of the most expensive drugs covered. Of course, there’s no guarantee that some drugs will be included at all.

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 5, 2013 | Posted By Bruce D. White, DO, JD

At a conference a few days ago I sat beside a former deputy commissioner of the Food and Drug Administration (FDA). We were in a small group that was discussing the need to help interested parties in Brazil, China, and India learn more about US drug regulatory affairs and compendial science. As best I could understand, the food and drug regulatory infrastructure in China and India appears to be much the same as it was in the US around the 1930s and 1940s. However, everyone agreed that China and India have some of the best medicinal chemists, pharmaceutical formulations engineers, and pharmacy plant manufacturing and pharmacokinetics specialists in the world.

During the conversation I learned that the vast majority of the world’s commercially available antibiotic products are manufactured in China and India. This information struck me as a shock! Until then, I had been under the impression that when the last antibiotic manufacturing plant closed in the US in 2004 and the industry moved off-shore, that the companies had gone to Puerto Rico and Europe. But China and India?

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 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.

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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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