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May 6, 2014 | Posted By Kathleen O’Connor, MSW, MBA, MS

The governor of Massachusetts placed an emergency ban on Zohydro ER (Extended Release), a Schedule II controlled substance that is hydrocodone bitartrate in extended-release capsules.  The easily crushed capsules contain 50 milligrams of pure hydrocodone, which is 10 times more that a regular Vicodin. The FDA approved the drug with a few conditions attached last December although FDA’s advisors voted 11-2 against approving the drug due to concerns about addiction. Governor Patrick does not want the drug in his state until Zogenix, the pharmaceutical company that manufactures the drug, develops an abuse-deterrent version of the drug. He believes that adequate measures are not in place to safeguard against the potential for diversion, overdose and misuse. He was not alone in his concerns.  State attorneys general urged the FDA to reconsider and Congress called a hearing and a bill was introduced by West Virginia Senator Joe Manchin to force the FDA withdraw the drug. 

Zohydro supporters view it as a very important drug to treat chronic pain in fewer doses than hydrocodone therapies that are shorter acting and contain acetaminophen.  The battle began when “Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data.  The product’s release requires post-marketing studies as part of a Risk Evaluation and Mitigation Strategy (REMS) to assess serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long term use beyond 12 weeks.”   Though Zohydro is the first drug to undergo these studies, other extended release (ER) and long acting (LA) opioid analgesics will also be studied in this manner. Practioners are recommended to limit the use of Zohydro to patients whom alternative treatment options such as non-opioid analgesics or immediate-release opioids are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.    

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 29, 2014 | Posted By Marleen Eijkholt, PhD

Earlier this month, the New York Times (NYT) reported on individuals in a minimally conscious state (MCS). Although the article headed: ‘PET Scans offer clues on Vegetative States’, its contents addressed the technologies around MCS: a ‘newly’ diagnosed state of consciousness. The paper commented that PET scans would be more beneficial than functional Magnetic Resonance Imaging (functional M.R.I.) in diagnosing this state. Around the same time, the NYT published a paper that headed: ‘Cost of treatment may influence doctors’. This paper quoted a doc saying: “There should be forces in society who should be concerned about the budget, about how many M.R.I.s we do, but they shouldn’t be functioning simultaneously as doctors,”

In this blog post I want to focus on the cost and price of consciousness. I do not only want to focus on the economic costs, but also on costs in a more holistic sense, including the psychological and emotional costs. In the end, I want to ask you: how much is consciousness worth to you?

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.bvg

April 21, 2014 | Posted By Lisa Campo-Engelstein, PhD

Abortion is a contentious issue and one that gets a lot of attention by politicians and in the media. These debates on the ethics of abortion often take place on the abstract, theoretical level and fail to account for the empirical information on who seeks out abortions and why (all of the information presented here comes from the Guttmacher Institute).

Half of all pregnancies in the United States are an intended. 40% of these unintended pregnancies end in abortion and 22% of intended pregnancies also end in abortion. Over half of all women had been using some form of contraception during the month in which they became pregnant. However, many of these women (or their partners) were incorrectly or inconsistently using contraception.  Just under half of women who had an unintentional pregnancy were not using contraception for one of the following reasons: 33% perceived themselves to be at low risk for pregnancy, 32% had concerns about contraceptive methods, 26% had unexpected sex, and 1% had been forced to have 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.

April 17, 2014 | Posted By Zubin Master, PhD

One of my areas of research focus in bioethics is known as the responsible conduct of research (RCR) (a.k.a. research integrity). Research on research integrity covers a range of different norms and practices including authorship and publication ethics, research misconduct (fabrication, falsification and plagiarism), responsible mentorship, peer review, and RCR education among others. I have written on several of these topics in our AMBI blogs.

One of the topics I am interested in chatting about today is bias in the academic setting, but even more generally in the workplace. Much about research methodology aims to reduce or eliminate bias. For example, the experimental scientific method attempts to reduce bias by having proper controls, blinding researchers, and employing statistics so that we don’t over interpret our findings. Sociologists and other qualitative researchers may declare their biases when reporting research so the reader knows where the researcher is coming from. The entire concept of declaring conflicts of interest also aim to permit others to know what potential interest(s) the researcher may have which could bias their results. Moreover, the peer review process, which academia heavily relies on, aims to reduce bias in research. Peer review is not only used in the context of evaluating research, it also evaluates academic scholars for jobs, committee memberships, awards and scholarships, and other entitlements. One recent studydone by Drs. Daniele Fanelli and John Ioannidis showed the overestimation of effect sizes in behavioral research. Here the researchers performed a meta-analysis of meta-analyses (cleverly called meta meta-analysis) and found that researchers working in the behavioral, but not biomedical, sciences tended to exaggerate effects that were not supported by the data. Most interestingly, this exaggerated effect was heightened if the research had one or more US authors. While this sort of bias in the reporting of research may at first glance seem relatively benign, it actually has significant consequences because other researchers build on the results of previously published work and accumulatively, our social policies and clinical practices are based on evidence collected from such studies. Yet bias can come in all sorts of shapes and sizes in the academic and research context, some of which I think hits more personally to individual researchers.

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 14, 2014 | Posted By Jane Jankowski, LMSW, MS

A coach is defined as a person who is tasked with teaching or training others, usually in conjunction with athletic endeavors. When this term is applied to health, we often presume the coach is a personal trainer of sorts, focusing on optimizing fitness and nutrition for those who can afford the fee for this level of personal attention. Over the last few years, however, there has been a growing movement to provide a different kind of health coaching within the medical arena for patients who have difficulty adhering to health related regimens for medication, office visits, and management of chronic medical problems. This endeavor has been found to work for many reasons, but remains in the wings of the contemporary healthcare industry.

The first time I read about the concept of community based health coaching was via Atul Gwande’s article “The Hot Spotters” published in 2011 in The New Yorker magazine included here in its entirety for interested readers. What resonated for me was the comment from one recipient who stated that the coach was effective because of the way the advice and encouragement and nudging was delivered, “Because she talks like my mother” implying that there is understanding, concern, and discipline delivered as the underlying message between coach and patient. I think most good athletic coaching is the same. While success is not measured in trophies, medals, or college scholarships when it comes to medical coaching, the potential for life changing outcomes are very real. And the opportunities for cost savings are very real as well.

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 11, 2014 | Posted By Wayne Shelton, PhD

In my last blog I alluded to the effect of an assumed point of view, particularly a set of ideological set of assumptions around which a community is organized, has on the way we interpret data about how we perceive risks and benefits and make decisions about a range of issues.  I was applying this perspective to public health perspectives such as the risks of gun ownership and forgoing vaccinations. In this blog, I will sketch out a theoretical approach for how humans process and understand information a bit more and conclude with some questions for my next blog about how to understand the obligations of those who are in the best positions to understand public health data, such as the better educated and healthcare workers.

We often assume that most people are capable of coming to objective and fair beliefs and reasonable decisions about various empirical topics, e.g. the effects of climate change, if only we have access to valid, scientific information.  Thus, we often further assume that the goal of having more enlightened people to make more enlightened decisions about public health issues, or for that matter political issues and most other issues of public interest, is simply a matter of bringing to bear more complete and clear knowledge for people to understand. This is the assumption that Dan Kahan (a law and psychology professor from Yale Law School) and his research team calls the “More Information Hypothesis”. However recent research shows that this hypothesis is simply not true—in fact the more information people on opposite sides of an issue get, the more divided and intractable the conflict becomes. The simple fact of making more information accessible clearly does not resolve most public issues that are connected to well-established ideological and philosophical perspectives.

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 3, 2014 | Posted By Bruce D. White, DO, JD

A March 24, 2014, article in the New York Times about the dangers of liquid nicotine used in e-cigarettes and the lack of Food and Drug Administration (FDA) involvement in its regulation emphasized a decades old problem.

Before 2009, Congress prohibited the FDA from regulating tobacco products as customarily marketed. When the Food, Drug, and Cosmetic Act (FDCA) was enacted in 1938, Congress specifically defined drugso as to exclude tobacco products. In effect, Congress reserved the regulation of tobacco products to itself. More than likely, Congress – understanding the economic impact of tobacco at the time – preferred to retain a direct hand. This singular control by Congress was reiterated by the US Supreme Court in FDA v. Brown & Williamson Tobacco Corp. (1990) when the FDA asserted itself and attempted to prohibit the sale of tobacco products to minors by regulation. In Brown & Williamson, the Court struck the regulation down.

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 3, 2014 | Posted By John Kaplan, PhD

The scientific and medical potential of stem cells hold so much promise that progress in this area is widely followed with intense interest. Since pluripotent stem cells are able to differentiate into any cell type they hold the promise of leading to therapies for a wide variety of diseases and disabilities which cause human suffering and end lives prematurely. This field of research and development has attracted the efforts of large numbers of the most brilliant and talented biomedical researchers in the entire world. This raises the vexing question of why some of these brilliant and talented researchers are doing some very stupid things.

It seems like only yesterday (it was actually in 2004 and 2005) that Hwang Woo-Suk a renowned Korean veterinarian and researcher published the first reports in Science Magazine of the derivation of pluripotent stem cells from human embryos and subsequently the successful cloning of human embryonic stem cells. Hwang was a national hero. However these studies were recognized in 2006 as being the result of fraud.  I remember wondering then, just as I am wondering now, how someone could risk all that they had earned by committing such blatant fraud. How could they not realize that misconduct in such important work would be discovered and punished. I do not get it.

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 31, 2014 | Posted By Zubin Master, PhD

I have written on this blog about the topic of stem cell tourism and the different strategies that have been proposed to stop the phenomenon. Just to provide a background on the topic from a previous blog: stem cell tourism is used to describe an internet-based direct-to-consumer advertised industry where clinics offer untested and unproven stem cell interventions as bonafide therapies to patients with a range of diseases and injuries including Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. Basically there is no scientific evidence of safety of efficacy of these modalities to offer them on a for-profit basis to patients. The term was originally coined as a form of tourism because patients traveled from countries like the U.S., U.K., Canada and Australia to clinics in countries with lax regulations, but this simply is not the case anymore. There are several clinics within highly regulated countries like U.S. that offer stem cell interventions.

Of the several strategies people have discussed, one of the first has been on the topic of providing education to patients and the public. Here, people argue that providing education on the dangers of stem cell tourism might actually sway patients to not undertake unproven stem cell interventions. As some scholars have mentioned, education might not be as effective because it depends on a “rationale actor model” where we assume that patients will behave rationally and make choices based on weighing the harms and benefits of seeking unproven treatments. More so, such an argument does not sufficiently consider the hope patients have to ameliorate their disease, reduce pain or other symptoms, and increase their quality of life. While these counterarguments are certain rational and likely to be true, there is yet no solid evidence showing whether education on stem cell tourism is effective at swaying people from traveling for unproven interventions. But even if before we go into whether education might influence a patient’s decision to travel for unproven stem cell treatments, I think we need to assess the role of patient education in medicine.

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 28, 2014 | Posted By Marleen Eijkholt, PhD

Amber is a 70 year old woman. She is doing poorly. She has metastasized cancer, multiple co-morbidities and a pressure ulcer. Apart from her ulcer, she has no acute care needs that condone her to the hospital. Some predict that she is likely to pass over in 3 months. With the right type of medications Amber could go home. However, the pressure ulcer medications that she needs cost about 200 dollars a day and she does not have the right type of insurance to pay for this. As a result, she is confined to a hospital bed. 

Amber has always contributed diligently to society. She worked from age 17 in a bank and paid her taxes diligently. Amber and her husband, who died 3 years ago, raised 3 children and lived in a town upstate New York. They used to take holidays on the West-Coast, where Amber has a family summer home.  This house belonged to her great grand-mother and has been in her family for 120 years. All of Amber’s family is attached to this house.

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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