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Topic: Bioethics and Public Policy
December 7, 2012 | Posted By John Kaplan, PhD

Throughout history there has been persecution of scientists and physicians. In some of the most notable historic cases persecution has been lead by powerful institutions including both church and government and has resulted in prosecution, conviction and punishment.  The current prosecution of earthquake scientists underway in Italy seems to be an example of the worst sort of persecution and is indeed reminiscent of the types of unjust attacks by frustrated and wrong-headed government officials looking for scapegoats when there are none. The serious implications of this prosecution have intensified with the conviction of these scientists.

There seems to have been a great diversity in the basis for such persecution and these current events give us opportunity to review the reasons. I acknowledge the previous reviews and commentaries on this subject for having compiled much of the information.

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 6, 2012 | Posted By John Kaplan, PhD

I recently received a mass mailing from the American Association for the Advancement of Science (AAAS), an organization that I am a member of.  On the envelope was the statement: “The future of science is at stake.”This seemed pretty dire so I opened the envelope to learn more. The letter was about the possible consequences to science research and development funding as a result of the Budget Control Act of 2011. The Budget Control Act of 2011 is the result of the inability to develop a budget compromise and dictates sequestration of discretionary defense and domestic funding in the absence of such a compromise. It is the act popularly characterized as the “fiscal cliff”. While many are primarily concerned about one side of the budget or the other those who recognize the importance of research and development funding need to be concerned with both. Research and development funding will not only be hit hard by cuts to the domestic funding for budgets of the National Institutes of Health and the National Science foundation but also significant funding through the Department of Defense for biomedical research as well as aerospace and communications. Additional funding cuts to science are likely in the domestic research and development funding which is included in the NASA budget as well as the Departments of Energy and Agriculture. As suggested in the letter there is indeed much at stake. However, the fiscal cliff is not what I thought of when I saw the dire warning on the envelope. 

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.

September 18, 2012 | Posted By Lisa Campo-Engelstein, PhD

Thanks to health care reform, beginning last month women with health insurance no longer have to pay for contraception. While I fully support this legislation, I think it has unintended negative consequences for both women and men. Specifically, I am concerned that this legislation, as well as the debate surrounding it, once again conflates reproduction with women, thereby ignoring men’s reproductive responsibility and autonomy.

This legislation is based on and buttresses our current heterosexual contraceptive arrangement in which women are largely held responsible for contraception, especially in monogamous relationships where couples are more likely to depend upon long-acting, reversible contraceptives (LARCs) or sterilization rather than barrier methods. Women today actively participate in all contraceptive methods except vasectomy, which only accounts for 9% of contraception use in the U.S. Part of the reason for this is due the disparity between the number and types of female and male contraceptives: there are eleven contraceptive options for women, including various types of LARCs, and only two for men—male condoms and vasectomy—neither of which are LARCs. Monogamous couples not ready for sterilization generally don’t delegate contraceptive responsibility to men because male condoms are not well-suited to their needs: they are not nearly as effective as female LARCs (16% versus under 3% failure rate for typical use) and they can interrupt and minimize pleasure during sex.

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 7, 2012 | Posted By Bruce White, DO, JD

With the Supreme Court upholding the individual mandate of the Affordable Care Act (ACA) constitutional but rejecting the notion that the states had to expand their Medicaid program to cover a significant percentage of the populations, some inequities in health care delivery will only grow.

One might use any number of examples to illustrate identified expected unfairness. For the relatively poor Southern states – Alabama (AL), Louisiana (LA), and Mississippi (MS) – patients covered by Medicaid and the Children’s Health Insurance Program (CHIP) is significantly higher than the national average now. With the proposed ACA expansion in these three states effected by 2019, the percentage of Medicaid & CHIP-eligible populations would swell from 20% to 27% (AL), 26% to 34% (LA), and 26% to 37% (MS). In Louisiana and Mississippi, these percentages are approaching the number of persons in the state who have traditional private health insurance. [The projected numbers used here are from the Kaiser Family Foundation Website.]

Moreover with the increased numbers of patients who will have Medicaid and CHIP coverage, proportionately more practitioners will be critical in providing the care in these states. Is it realistic to think that Alabama, Louisiana, and Mississippi, will be able to grow their provider availability by 37%, 32%, and 41% in four years to meet the demand? The national average is 25.7 active physicians per 10,000 persons. Louisiana is very close to the US mean with 24.2 physicians per 10,000, but Alabama and Mississippi are will below the national average with 20.6 and 17.3 physicians per 10,000 respectfully. Is it reasonable to assume that these states will be able to multiply their physician populations to meet any increased demand?

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 5, 2012 | Posted By Bruce D. White, DO, JD

The Wednesday, June 27, issue of the Washington Post reported that the U.S. Senate passed a bill empowering the Food and Drug Administration (FDA) to collect about $6 billion over the next five years in new “user fees.” The bill passed the Senate 92 to 4 and now goes to the White House for President Obama’s signature.

The bill for the first time requires generic drug manufacturers to make payments to the FDA as part of the drug approval, manufacturing, and marketing process. “Innovator” (or what old-timers might recall as “ethical” or “brand name”) pharmaceutical manufacturers have been paying similar user fees since the passage of the Prescription Drug User Fee Act (PDUFA) of 1992. The user fees were seen as a “private industry” approach with manufacturers being required to shoulder some of the drug regulatory and safety processes costs. Generic manufacturers will contribute about $300 million annually. In return, the FDA has agreed to help speed the approval process for generics.

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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