NEJM Audio Summary - Dec ８, 2011

Excerpted Script

17'13" | "Discussing Overall Prognosis with the Very Elderly",
a perspective article by Alexander Smith, from University of California, San Francisco. Though life expectancy inexorably decreases with advancing age, we tend to avoid discussing overall prognosis with elderly patients who have no dominant terminal illness. But we may thereby undercut patients' ability to make informed choices about their future. To improve the quality of decision making for the very old, the authors believe we should radically alter the paradigm of clinician–patient communication: offering to discuss overall prognosis with very elderly patients should be the norm, not the exception. The authors suggest that clinicians should routinely offer to discuss the overall prognosis for elderly patients with a life expectancy of less than 10 years, or at least by the time a patient reaches 85 years of age. Since the harms of many health interventions are immediate whereas the benefits of preventive interventions may accrue slowly over time, clinical priorities should and do vary with life expectancy. For patients with a life expectancy of more than 10 years, cancer screening, intensive blood-pressure management, and tight control of glycated hemoglobin levels will have high priority, whereas for patients with a shorter life expectancy, priority might be given to reducing the pill burden and engaging in advance care planning.
18'48" | "Learning about the Safety of Drugs — A Half-Century of Evolution", a perspective article by J. Avorn from Brigham and Women's Hospital, Boston. Fifty years ago, a constellation of events transformed the way we think about drug safety. Frances Kelsey, a new medical review officer at the FDA, was working on her first assignment: approving a sleeping aid called Kevadon. It was widely used in Europe, and the company seeking a U.S. license expected quick approval by an agency that rarely said no to anything. But Kelsey noted that the manufacturer's animal safety data were scanty and inconclusive, the clinical evidence was superficial, and there was no assessment of long-term risk. Meanwhile, a strange epidemic was unfolding in Europe. Babies were being born in unprecedented numbers with severe limb-reduction defects, their hands or feet emerging directly from their torsos. During its years on the market, thalidomide with more than 60 different trade names is believed to have caused limb-reduction defects in more than 10,000 children worldwide. Kelsey kept thalidomide off the U.S. market, sparing Americans an epidemic of limb-reduction birth defects. Fifty years later, we are still trying to learn how best to regulate, prescribe, and monitor the use of medications in ways that maximize their benefit while reducing the likelihood and severity of adverse effects. One current example is an immunomodulatory agent that has shown great promise for treating both leprosy and multiple myeloma — thalidomide.

460 words / 200 sec = 138 wpm

今回のスクリプト抜粋の後半は、映画「典子は、今」でも有名なサリドマイド禍について。
上掲書にも詳しく解説されているが、ドイツの小児科医Lenzの警告¹によりグリュネンタール社が製品の回収するに至る。日本では、ドイツでの回収開始から294日後に回収が開始した。アメリカでは1960年9月に販売許可の申請があったがFDAの審査官フランシス・ケルシーがその安全性に疑問を抱き審査継続を行ったため、治験段階で数名の被害者を出しただけだった。1962年にケルシーはケネディ大統領から表彰されている。現在ではその血管新生抑制の作用を利用して、ハンセン病、エイズ、癌、糖尿病性網膜症などへの治療に応用されるようになってきている。
1) Lenz W. Kindliche Mißbildungen nach Medikamenten-Einnahme während der Gravidität? Dtsch Med Wochenschr 1961;86:2555-2555