1 Boring Old Man

The word character can be used in a number of contexts. In the moral sphere, it means that a person who has been principled in the past will be principled in the future [predictable repetition]. In drama, the predictable repetitions of the characters are what drive the plot. When you say "He’s a real character," you’re referring to a person with unusual predictable repetitions. But in a psychotherapeutic context, it simply means the individual collection of predictable repetitions, no matter what the context. For a trivial example, when I write these blogs, I invariably use colors, bolds, italics to emphasize certain words. I know it’s kind of annoying, but try as I might, the habit [a predictable repetition] persists. These character traits we all have are enduring, and changing them, even if you know what they are, is a real undertaking. It’s the stuff of psychotherapy, and it’s plenty hard work. It’s not hard to identify maladaptive character traits in others. It easy to see how they account for a person’s own difficulty in negotiating life happily. But there’s nothing slightly easy about helping a person change them – the wisdom of "a leopard can’t change his spots."

New England Journal of Medicine Names Third Editor in a Year

New York Times

By LAWRENCE K. ALTMAN

May 12, 2000

…Dr. Drazen, 53, helped pioneer asthma drugs now taken by four million asthmatics worldwide. In today’s news conference, he strongly defended the need for doctors to work closely and carefully with the drug industry. He called the industry a powerful force without which basic research findings made through taxpayer grants from the National Institutes of Health could not be converted into new therapies to improve patient care and public health. Last February, after an internal investigation prompted by articles in The Los Angeles Times, The Journal found that it had violated its own rules in publishing 19 articles by Dr. Drazen and other authors with industry ties. The Journal said the articles should have been written by scientists without such connections, but its editors blamed themselves and said Dr. Drazen had disclosed his industry support.

Asked today at the news conference about that episode, Dr. Drazen said that as The Journal’s new editor in chief he would hand over all manuscripts dealing with his specialty or products made by the nine companies to deputies "and make sure that they are on the agenda at a time when I do not come to the editorial meeting." In such cases, Dr. Drazen said he wanted "The Journal to be able to judge the science that comes in, if it is good or bad, without me having anything to do with it."

"I do not want to influence things in either a positive or a negative way,” he said. ”We want the good science and good information to get out there” in The Journal, which is one of the most influential in the world. Dr. Drazen, who will leave his Harvard post, will be the Journal’s third editor in chief in less than a year. His selection follows several years of turmoil between the editors of The Journal and its owner, the Massachusetts Medical Society, concerning the society’s increasing business ventures…

Califf for the FDA

New England Journal of Medicine

by Jeffrey M. Drazen, M.D.

October 28, 2015

Robert M. Califf, M.D., has been nominated to be the next head of the Food and Drug Administration (FDA); he currently serves as Deputy Commissioner for the Office of Medical Products and Tobacco. We think his confirmation as commissioner should proceed as quickly as possible. Because the FDA oversees the safety and, in some spheres, the efficacy of products that constitute about 25% of our economy, the country needs a strong and experienced leader who can keep the FDA focused on its mission.

Since Califf was nominated to succeed Margaret Hamburg, numerous individuals and groups have endorsed his candidacy. His noted strengths include his experience in the testing of new and established drugs for efficacy; his successful career at Duke University, where he was the founding director of the Duke Clinical Research Institute, by many measures one of the premier academic research organizations in the world; and until his FDA nomination, his tenure as head of the Duke Translational Medicine Institute and professor of medicine at Duke University. Over his 30-year academic career, he has published more than 1200 peer-reviewed publications, work he has authored has been cited over 50,000 times, and his Web of Science h-index is 118. But academic output has not been his primary goal; instead, he has worked to accrue the data needed to improve patient care. Despite this laudable aim, a few concerns have been expressed about his associations with industry, and these concerns may have caused some to withhold support for his nomination.

Like Califf, we believe that our actions should be driven by data, not innuendo. Since 2005, Califf has reported, as an investigator, the outcomes of seven clinical trials sponsored solely by industry in primary publications in major general medical journals. Of these trials, four had a negative outcome [i.e., not favoring the intervention], two favored the intervention, and one, with a factorial design, had a mixed outcome. Given this performance, it is impossible to argue that Califf has a pro-industry bias. On top of this, for the past 3 years the vast majority of his funded salary came from leadership roles in the Clinical Translational Science Award from the National Institutes of Health [translational medicine], the NIH Collaboratory, the Patient-Centered Outcomes Research Network [large-scale population health research], and the Duke Center for Medicare and Medicaid Innovation [CMMI] project, which developed a model approach to health care disparities in diabetes, using geospatial mapping to deliver clinical care and social support more effectively.

Our association with Califf grows from a decade of mutual service on the Forum on Drug Discovery, Development, and Translation of the Institute of Medicine [now the National Academy of Medicine]. Through this decade of service, Califf’s primary interest was clearly in gathering and using solid information to promote the health and well-being of people suffering from disease. His aim was always to find better ways to diagnose and treat illness. He wanted well-gathered data on which to base all our clinical decisions and wanted to design and implement health systems that worked effectively to improve the outcomes of individuals and populations. Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA; we strongly endorse his nomination and urge the Senate to act favorably on it.