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December 13, 2010 | Posted By Bruce White, DO, JD


When it comes to medical care, Americans want the best. The collective opinion of thought leaders in the field – often published by national groups as consensus expert guidelines and recommendations by seasoned, well-schooled, respected, and thus authoritative physician peers – is one the gold standards of professional practice. But, sometimes the experts, the respected authorities, get it wrong. And, the argument may be made that, as a consequence of the wrong advice – regardless of how well intentioned and widely regarded, patients may have been harmed. And when harmed, patients want someone held responsible for the perceived damages.

One example of this phenomenon has appeared in the news recently. The Los Angeles Times reported on November 24 that the “Nevada Supreme Court Upholds $58M Judgment Against Wyeth Over Hormone Drugs."  See the report here [accessed December 1, 2010].

Estrogen replacement (HRT) for menopause symptoms was recognized therapy – it was standard of care treatment – in the late 20th Century.

Attitudes towards HRT changed in 2002 following the announcement by the Women's Health Initiative of the National Institutes of Health that those receiving the treatment in the main part of their study had a larger incidence of breast cancer, heart attacks and strokes. The WHI findings were reconfirmed in a larger national study done in the UK, known as The Million Women Study. As a result of these findings, the number of women taking hormone treatment dropped precipitously. As a result of these findings, the Women's Health Initiative recommended that women with normal rather than surgical menopause should take the lowest feasible dose of HRT for the shortest possible time to avoid these risks.

Quoted from “Hormone Replacement Therapy” Wikipedia [accessed December 1, 2010], with trade names and references removed.

But should Wyeth be held responsible? True, Ayerst’s (then Wyeth’s, and now Pfizer’s) product Premarin® (conjugated estrogens, Pfizer) was marketed widely for HRT during the period of time when most estrogen prescriptions for menopause were written, but should one drug company be responsible for breast cancer, heart attack, or stroke cases for all those patients for all those years when the treatment was regarded as standard of care? And what happens the next time. See  “Report Questions Need for 2 Vitamin Supplements[accessed December 1, 2010].

1 comments | Topics: Bioethics in the Media, Pharmaceuticals

Comments

Richard R. Pesce, MD

Richard R. Pesce, MD wrote on 02/13/11 5:53 PM

Welcome to the world of medicine - that is the world of uncertainty. Certainly the standard of practice at that time, but standards shift over time. The time of the shift is not a priori knowledge we have. So should we be held accountable for the unknowable? Phronesis would suggest considered deliberation of therapies before and during implementation. Also these symptoms, though highly annoying are not life threatening and are biological. Treatment was demanded by patients and was accepted. Hopefully informed consent was obtained including the uncertainty of uncertainty. It is the best we are able to do until all knowledge is known and all therapy is confirmed as beneficial. Since that time is in the far, far future all will have to accept uncertainty and what it applies. So I do not think in this case the the pharmaceutical Company should be liable unless Information was withheld form the public, physicians and the FDA. The situation then changes.

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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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