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Topic: Drug Safety
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.