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.

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.

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.

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.

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.

There appears to be hope for America, as a society, a democracy, and a nation. On Thursday, 6/28/2012, as everyone knows, the Supreme Court upheld the constitutionality of the Affordable Care Act (ACA) by a 5–4 vote. Much was at stake, not the least of which was the possibility of affordable health care for all Americans. But beyond this extremely important outcome, the very nature of our democracy was in play, as well as the potential success or failure of the American political enterprise.

For example, lack of affordable health care for every American diminishes our national enterprise in all sectors.

There are other important considerations involved in how the attack on the ACA played out, including the continuing degradation of our use of language. For example, the Supreme Court justices are consistently characterized as “conservative” or “liberal”. This is an immediate problem, as their individual identities are subsumed in the right vs. left dichotomy. But the meanings of the epithets are also lost. To be conservative means to uphold tradition. To be liberal means to uphold progress. However when justices hold their ideologies closely, neither tradition nor progress receive a fair evaluation. As Hannah Arendt states in Between Past and Future, “the very quality of an opinion, as of a judgment, depends upon the degree of its impartiality”. Ideology is not impartial, and Supreme Court opinions have long appeared to be based on politics rather than justice. Obviously, such a state of affairs is a major problem for a democratic society.

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.

“Human speech is like a cracked kettle on which we tap crude rhythms for bears to dance to, while we long to make music that will melt the stars.” — Gustave Flaubert, Madame Bovary

“The chances of factual truth surviving the onslaught of power are very slim indeed … ” — Hannah Arendt, Between Past and Future

Although this may be more apparent than real, it seems as if the lying and the lies are increasing in frequency on the national level. Politics has long been characterized as a blood sport, but the escalation of vicious contentiousness since 2008 is unusual and extreme. Factual truth has been cast aside, casually thrown to the wind as if one were systematically ripping the petals off a roadside wildflower and tossing them into the air as so much refuse. The losers are the public, of course, the citizens who depend on the government for sound fiscal policies, welfare for those unable to care for themselves, and protection in the form of national defense.

None of this is a surprise. As Arendt states in her essay “Truth and Politics”, modern ideologies “ openly proclaim them to be political weapons and consider the whole question of truth and truthfulness irrelevant”. Further, “it may be in the nature of the political realm to deny or pervert truth of every kind”. As the nature of truth as such is limiting (in other words, it is what it is) , politicians will naturally bend the truth to fit their purposes. As citizens, we need to be on our guard and strive to identify factual truth or the lack thereof in political pronouncements. But such activity requires substantial effort. Thinking is required, as is the concomitant ability to simultaneously hold two contrasting concepts or points of view in mind. A broad education is required, as is a good facility with language. Sadly for us, most of these requirements and capabilities are now in short supply.

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.

It was bound to happen. Last week, Nature reported that a Hungarian company “certified” that a member of parliament did not haveJewish or Roma heritage. It seems we have not come very far at all from the hatreds and behaviors that led to the Nazi atrocities of the 1930s and 1940s. But, of course, 70 years is the merest blip compared to 10,000 or more years of fear of the other.

Is this a problem of science as such? Or is it a problem related to what it means to be a human being, that notorious “riddle, wrapped in a mystery, inside an enigma”? Or is this virulent distortion of scientific progress merely what can be expected when the fruits of scientific research are placed in human hands? Modern science was born, asserts Hannah Arendt in her essay The Concept of History, when attention shifted from the search after the “what” to the investigation of “how”. Historically, science was concerned with exploring the natural world. Scientists such as Aristotle categorized, catalogued, and examined phenomena. The overall goal was to improve understanding of man’s place in creation. Investigation of the “how” was activity of an entirely different sort. Now scientists began to pull things apart in attempts to understand how things work.

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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Dr. Robert Klitzman is the author of the recently released “Am I My Genes: Confronting Fate and Family Secrets in the Age of Genetic Testing”, published by Oxford University Press. He is Professor of Clinical Psychiatry and the Director of the Masters of Bioethics Program at Columbia University. Dr. Klitzman co-founded and for five years co-directed the Columbia University Center for Bioethics, and is the Director of the Ethics and Policy Core of the HIV Center.

In our wide-ranging interview, Dr. Klitzman discusses

• The impact of genetic testing on patients with Huntington’s disease, breast cancer and ovarian cancer, and alpha-1 antitrypsin deficiency
• The implications of recent genetic breakthroughs for these people and their families
• Ethical issues involved in genetic testing, including disclosing results to family and friends, disclosing results to employers and insurers, whether to have children, whether to screen embryos, and privacy concerns
• How to confront fatalism, anxiety, and despair
• How to prepare, ethically and personally, for the likelihood of readily available genetic testing in the near future

Dr. Klitzman also discusses his previous book, When Doctors Become Patients, published by Oxford University Press.

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.

Does a person have a disease or disorder? Or is the person unwell with an illness? Are the concepts of disease and illness distinct? If we have been lulled to sleep by 100 years of Cartesian diktats from the medical establishment, we may miss the point. But if our thinking is super-sharp, we may be able to detect a critical difference.

A prominent legacy of Cartesian dualism, the mind/body problem, causes a split between the “I” that I know myself to be and the physical body that the “I” inhabits. “I” am a passenger in my body. My body carries “me” around, but we are two separate entities. Thus, my body is something separate from “me” and things can happen to it, e.g., my body can become diseased.

The practice of modern medicine is based on this seemingly real separation. But if that’s all there is, much is being missed. Investigation of the illness vs. disease antinomy offers a profound opportunity for improved medical care of people as 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.