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Topic: Drug Safety
June 11, 2012 | Posted By Bruce D. White, DO, JD

Is helping the lay public better understand how to interpret health information accurately – in the face of widely disseminated misinformation – one of the pressing challenges for today’s bioethicists?

The June 6, 2012 New York Times carried an article that may illustrate this point perfectly: “Abortion Qualms on Morning-After Pill May Be Unfounded.” The article highlights how politics-driven misinformation is so difficult to counter or contradict, even with sound medical and scientific data. Apparently, for some politicians just saying that emergency contraceptives are “abortive pills” is enough to make it so. Of course, there are other recent examples of this phenomenon too, such as Michele Bachmann claiming that HPV vaccine might cause “mental retardation.”

Regardless, if nothing else, clinical ethics is all about informed consent. Informed consent – in a nutshell – is met when the physician shares with the patient information about the working diagnosis, the available intervention options and prognoses, the benefits and burdens of each option (including the possibility of no intervention at all) and the likely outcomes, and the physician and patient – using a shared-decision making model – agree on an immediate course or plan to implement.

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.

March 9, 2012 | Posted By Posted By David Lemberg, M.S., D.C.

For 500 years science has built an ever-increasing knowledge base, proceeding in fits and starts and yet moving inexorably toward improved explanations of the universe in which we live. But science has reached a crossroads. Thus society, too, is similarly positioned.

Years ago, during the Enlightenment and the subsequent Industrial Revolution, Nature as such was vast and apparently infinitely replenishable. It was inconceivable that harm was being done to the environment on a large scale.

But as Inigo Montoya remarks to Vizzini in The Princess Bride, "You keep using that word [inconceivable]. I do not think it means what you think it means."

What was inconceivable then is now, appallingly, very conceivable. The outcomes of many scientific fields of inquiry have the potential to destroy the biosphere.

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.

March 2, 2012 | Posted By Posted By David Lemberg, M.S., D.C.
Dr. Ricki Lewis The Forever Fix
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Dr. Ricki Lewis is a science writer with a Ph.D. in genetics. Her newest book, The Forever Fix: Gene Therapy and the Boy Who Saved It, a narrative nonfiction book from St. Martin’s Press, is arriving in stores on March 13.

In our wide-ranging interview, Dr. Lewis discusses

  • How gene therapy can extend a child’s life, in some cases by years
  • Issues encountered in deciding whether a child should enroll in a gene therapy trial
  • How participants should be chosen for clinical trials
  • How problems with the informed consent process initially derailed gene therapy
  • "Therapeutic misconception"
  • How gene therapy may benefit patients with Parkinson's disease and macular degeneration

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.

January 20, 2012 | Posted By Ricki Lewis, PhD

In this age of expiring drug patents and stalled pipelines, I was pleasantly surprised to find in my morning batch of news releases four reports of promising, eclectic ways to fight diverse diseases. The efforts represent the entire trajectory in drug discovery, from the most basic research to a stage 3 clinical trial. Read on!

STRATEGY: Alter the insect vector
genetically modified mosquito might sound like something from a science fiction film, but it is a powerful intervention in the horrific cycle that is malaria. George Dimopoulos and colleagues from the Johns Hopkins Malaria Research Institute altered a gene in the Anopheles mosquito in a way that ramps up its immune response against the parasite that causes malaria. The GM mosquitoes live as long as and lay as many eggs as their non-manipulated brethren. Perhaps with a few more tweaks they can take over, biting but not infecting.

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.

December 14, 2011 | Posted By Bruce D. White, DO, JD

Last week, Health and Human Services Secretary Kathleen Sebelius overruled the decision of Food and Drug Commissioner Margaret A. Hamburg to allow the wider availability of Plan B One-Step® (levonorgestrel, Teva Women’s Health, Inc.) without a prescription to all women of child-bearing age, more specifically to adolescent girls under age 17. This was the first time that a health secretary has ever publically exercised statutory authority to reverse an FDA commissioner. Moreover, Secretary Sebelius was fully supported by President Obama in this action.

However, today’s headline – “Sebelius: Decision to keep Plan B age restrictions not political” – is difficult to believe. Particularly, when Plan B decisions have almost always been political. See here and here.

It’s difficult when a career politician dismisses the professional advice of experts and claims that the decision did not involve political considerations. But what gives credence to the Secretary’s stand is: (1) her pro-choice positions as governor of Kansas, (2) the fact that she’s facing considerable opposition from well-known Democratic leaders around the country, and (3) her willingness to reconsider the issue if the manufacturers of Plan B reapply with additional data about the “significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.”

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 20, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

In 2008 prescription medications accounted for $291 billion in sales in the United States. In 2000, the drug industry employed more than 625 lobbyists (there are only 535 members of Congress). Big business. Big money. Big power. Power versus principles — this is an eternal dialectic. If power rules, we might as well shred the Belmont Report right now.

Universal ethical standards are meant to apply universally — not locally and selectively, at the whim of the more powerful agency. They are designed to protect the more vulnerable among us — us referring to the international community. And in an ethical world, standards of care should refer to the highest, not the lowest, common denominator.

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 1, 2011 | Posted By Posted By David Lemberg, M.S., D.C.
Jennifer Miller
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Jennifer Miller is the Executive Director of Bioethics International, the leading U.S. provider of person-centered bioethics programs for the healthcare, life sciences, and biotechnology sectors.

A physicist and bioethicist by training, Ms. Miller has wide-ranging interests in biomedical research and development, public health, and disaster preparedness ethics. Recently, the Susan G. Komen Foundation awarded her a grant for research and program development in biopharmaceutical ethics including nuanced questions surrounding informed consent, access, confidentiality, and conflict of interest. A powerful and effective speaker, she has been featured on CBS News and AP News and on the cover of Science Magazine’s Career section.

In our 6-30-2011 BIOETHICS TODAY conversation, Ms. Miller discusses

  • Bioethical issues in globalization of clinical research
  • The AZT 076 and Trovan cases
  • The ethics of placebo-based trials
  • Ethical relativism
  • The way forward — transparency, education, and oversight

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.

June 6, 2011 | Posted By Ricki Lewis, PhD

Early June marks the 30th anniversary of the reporting of the first AIDS cases, but it’s also an older medical anniversary – recognition that the drug diethylstilbestrol (DES) derailed development of the reproductive systems of a huge cohort of fetuses. I was one.

My mom, like millions of others, was handed “a vitamin” while pregnant with me in 1954, which in those days of medical paternalism, she never questioned. And so when I became a teenager, I began to drip, and was hauled off to the gyno. The verdict: Adenosis. The label: DES daughter. It was scary.

As an endocrine disrupter before the term was coined, DES, among other things, played havoc with the boundaries between tissues of the cervix, which prevented glands from vanishing on schedule. With the hormonal onslaught of adolescence, the errant glands went into overdrive. Fortunately, I didn’t have the otherwise rare cancer whose sudden appearance led to identifying the problem, as with AIDS. I also escaped the trademark DES small uterus, and my husband, a DES son, escaped XY-related problems. But my mom did die of breast cancer – another legacy of the “vitamin” thought to protect against pregnancy loss. And so far the DES Follow-up Study on the third generation – my three daughters – has revealed only a slight increase in ovarian cancer risk that is likely a statistical fluke awaiting larger numbers. 

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.

May 6, 2011 | Posted By Posted By David Lemberg, M.S., D.C.
Philip Ball
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Dr. Steven Nissen is Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Dr. Nissen has served as President of the American College of Cardiology and has authored or coauthored more than 350 articles and 60 book chapters.

In recent years Dr. Nissen has written extensively on drug safety. In 2001, he co-authored the first manuscript that raised concerns about the safety of Vioxx. In 2007, he authored a manuscript which demonstrated that the widely used diabetes drug Avandia increased the risk of myocardial infarction.

Dr. Nissen is also known for his role in public policy discussions, particularly in the area of drug safety. He has testified in both the Senate and House of Representatives on the need to reform the FDA.

In our 5-3-2011 BIOETHICS TODAY conversation, Dr. Nissen discusses

  • Conflicts of interest in developing cardiovascular clinical practice guidelines
  • Conflicts of interest involving financial relationships among physicians and hospitals on one hand and pharmaceutical companies and medical device companies on the other
  • Inappropriate use of new technologies, particularly referencing "Left Main Trunk Coronary Artery Dissection as a Consequence of Inaccurate Coronary Computed Tomographic Angiography", Dr. Nissen's recent article in the Archives of Internal Medicine [Arch Intern Med 171:698?, 2011]
  • The need for incorporating Bayesian decision making in the ordering of diagnostic testing
  • Medical and ethical issues related to Avandia

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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ABOUT BIOETHICS TODAY
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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