End of an era for Pap smears?

Read the surprising results of a large-scale cervical cancer trial conducted in India. The New York Times has the story here.  Could this DNA-based assay for HPV spell the end of annual Pap smears in developed countries, and of lower quality cervical cancer tests in resource-poor settings?  If so, it would come as a welcome relief to millions of women, and require a dramatic revision of cancer screening guidelines.   Here's media from the article:

Wide enthusiasm is developing for the new DNA test among gynecologists, patients, and public health workers.   According to Mark Schiffman of the National Cancer Institute who wrote the NEJM editorial accompanying the article, "The implications of the findings of this trial are immediate and global.  International experts in cervical cancer prevention should now adopt HPV testing."

FDA staffers vent to President

Check out this story about whistle blowing from inside FDA.  Thanks to a tip from PharmaGossip, we've learned of a letter sent by FDA insiders to President Obama on April 2, 2009. You can read the full text of the letter here. The letter was well timed to coincide with the appointment of the FDA's new commisioner, Dr. Margaret Hamburg, who many hope will inaugurate a new era of transparency and accountability at the agency.

The FDA staffers complain of a growing sense of frustration with the 'arbitrary and capricious' decision making at the upper echelons of FDA:

The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA’s decision on the Plan B drug was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” FDA’s top leaders at the Center for Drug Evaluation and Research (CDER) testified that they “didn’t have a choice, and . . . [weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree” to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was “unrebutted evidence that the FDA’s [decision] stemmed from political pressure rather than permissible health and safety concerns.” The “improper political influence” and the many “departures from its own policies” reveal that such FDA officials are incapable of ensuring integrity
and science at FDA.

They go on to report concern with the agency's culture of wrongdoing and coverup, saying 'FDA is fundamentally broken':

On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta: “Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. … America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re- establishing a proper and effectively functioning FDA is vital to the physical and economic health of the nation.”

It's unclear from my vantage point how many of these accusations are merited. But it's certain that at least some FDA employees (names blacked out in the letter, but judging from the size of the text block, appears to be 5-10 individuals) have honest concerns about the agency's current culture and future directions. We're hopeful that the coming weeks will shed more evidence about the mistakes that have been made, and how Dr. Hamburg intends to reinvent FDA with a commitment to institutional integrity.

Radio silence explained

You may have noticed sparse posting on this blog after announcing our newest Board of Directors additions in March.

Yet we've been keeping busy behind the scenes, as we've sharpened our focus on grant-writing and securing stable financing for our project. Here's a recap of some of our achievements last week:

• We submitted our first grant application to Changemakers.net (an initiative of Ashokha Foundation) and have several more applications in process. In the spirit of full transparency, you can read our grant application in its entirety here.
• We welcomed Umer Raffat, M.P.H., to Clinical Trials Wiki as our new V.P. of Finance/Strategy.
  
• We are beginning an architectural overhaul of the site, expanding our database of publicly accessible clinical trials, and centering our content display and discussion forums around scientific publications from the clinical trial literature.

As you know, we're continuing work on this site alongside our day-to-day lives. Last week I started a rotation at the Brigham's Levine Cardiac Unit, which will keep me busy through the end of April, and am spending my weekends hunting for apartments in Murray Hill. While still mysteriously finding time to write and edit our grants, Brice is traveling France on what promises to be a life-changing trip. And, inspiring the envy of overachieving multi-taskers everywhere, Gaurav is working behind the curtain on technical development after his day job at a venture capital firm.

Please continue to send us your questions or feedback about our ongoing work on the site.

James Muller, M.D., joins the Board of Directors at ClinicalTrialsWiki.org

We are honored to welcome Dr. James Muller, renowned cardiologist and one of three co-founders of an organization that won the 1985 Nobel Peace Prize, to our Board of Directors. His bio follows:

James E. Muller, M.D., was one of three American Co-founders of the International Physicians for the Prevention of Nuclear War (IPPNW) the organization awarded the 1985 Nobel Peace Prize.

Dr. Muller currently serves as CEO of InfraReDx, Inc, a company that has developed a near-infrared spectroscopy catheter for the identification of lipid-rich and presumably vulnerable coronary artery plaques.

Dr. Muller formerly served as a Professor of Medicine at the Harvard Medical School where he conducted research for over 25 years on the causes of heart attacks. In 1994, he introduced the term "vulnerable plaque" to describe those plaques likely to disrupt and cause disease onset. He co-founded InfraReDx in 1998 after a detailed search to find the optimal technology to identify lipid-rich coronary artery plaques.

Jeff Drazen, M.D., joins the Board of Directors at ClinicalTrialsWiki.org

Dr. Drazen has been a mentor and friend to us for many years in the H.S.T. program at Harvard Medical School.

We extend a warm welcome to Dr. Drazen as he joins our Board of Directors today. His full bio follows:

A specialist in pulmonology, Jeffrey M. Drazen, M.D., maintains an active research program. Dr. Drazen has published more than 300 articles on topics such as lung physiology and the mechanisms involved in asthma. In 1999, he delivered the Amberson Lecture, the major research address at the annual meeting of the American Thoracic Society. In 2000, he received the Chadwick Medal from the Massachusetts Thoracic Society for his contributions to the study of lung disease.

Dr. Drazen is the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, professor of physiology at the Harvard School of Public Health, and senior physician at the Brigham and Women’s Hospital. In 2003, he was elected as a member of the Institute of Medicine. Dr. Drazen has served on numerous committees for the National Institutes of Health: the Respiratory and Applied Physiology Study Section; the Lung Biology and Pathology Study Section; the Pulmonary Disease Advisory Council; and the National Heart, Lung, and Blood Institute Advisory Council. He currently serves as the co-chair of the Institute of Medicine Drug Forum and is a member of the advisory group to the World Health Organization International Clinical Trials Registration Platform.

Dr. Drazen joined the New England Journal of Medicine as editor-in-chief in July 2000. At the Journal, Dr. Drazen’s responsibilities include oversight of all editorial content and policies. His editorial background includes service as an associate editor or editorial board member for the Journal of Clinical Investigation, the American Journal of Respiratory Cell and Molecular Biology, and the American Journal of Medicine.

Dr. Drazen earned his bachelor’s degree and graduated summa cum laude from Tufts University. He received his medical degree from Harvard Medical School and completed his internship and residency at Peter Bent Brigham Hospital in Boston. Dr. Drazen received honorary degrees from the University of Ferrara, Italy, and the National and Kapodistrian University of Athens, Greece.

A native of Missouri, Dr. Drazen lives with his wife in Winchester, Massachusetts. They are the parents of two grown sons.

Warner Slack, M.D., joins the Board of Directors at ClinicalTrialsWiki.org

We are delighted to welcome a second distinguished clinician to our Board of Directors today, Warner Slack, M.D.

Dr. Slack brings us over 35 years of experience in health information technology. He is currently co-president of the Center for Clinical Computing and, during his medical training, helped develop one of the world's first electronic health record (EHR) systems. His full bio follows:

Dr. Slack received his bachelor's degree from Princeton University, his medical degree from Columbia University's Columbia University's College of Physicians and Surgeons, and his residency training in neurology at the University of Wisconsin. Over the past 35 years he has focused his research on the use of computers to improve communication in medicine and to empower both doctors and patients for better health care. His early work in computer-based medical interviewing at the University of Wisconsin led to the first study of patient-computer dialogue.

Over the years, he has established new computer-based approaches to the medical interview, and developed and studied programs that provide direct assistance to the patient in the management of common, important medical and psychological problems. He was an early advocate of the patient's right to participate in decisions about diagnosis and treatment.

Dr. Slack and his colleagues at the Center for Clinical Computing (CCC) and the Harvard Medical School, have developed, implemented, and studied an integrated, hospital-wide clinical computing system (the CCC system) which is used in patient care at Boston's Beth Israel Deaconess Medical Center and Brigham and Women's Hospital. Distinguishing features of the CCC system are the unparalleled intensity and extensiveness of its use by clinicians in the care of their patients and the substantial financial benefits that have been realized in conjunction with its use.

Dr. Slack is Professor of Medicine at Harvard Medical School and, with Dr. Howard L. Bleich, co-president, of the Center for Clinical Computing and co-director of the Division of Clinical Computing, Department of Medicine, Beth Israel Deaconess Medical Center.

Among his recent publications, Dr. Slack is the author of Cybermedicine: How Computing Empowers Doctors and Patients for Better Health Care (revised and updated edition, San Francisco: Jossey-Bass, 2001).

Edward Hundert, M.D., joins the Board of Directors at ClinicalTrialsWiki.org

We are delighted to welcome Dr. Edward Hundert, M.D., former President of Case Western Reserve University, to the Clinical Trials Wiki family, and as a member of our Board of Directors. His bio is below:

Dr. Hundert is an internationally known academic leader, scholar, educator, psychiatrist, and medical ethicist. Over the past 20 years, he has served as President of Case Western Reserve University, Dean of the University of Rochester School of Medicine and Dentistry, and Associate Dean for Student Affairs at Harvard Medical School. He has held professorial appointments in psychiatry, medical ethics, cognitive science, and medical humanities, and he is a leader in developing innovative institutional affiliations and curricula both in academic medical centers and across all levels of higher education.

Dr. Hundert earned his bachelor’s degree in mathematics and the history of science and medicine, summa cum laude, from Yale University, where he received Yale’s Chittenden Prize “to the graduating senior with highest standing in mathematics or the natural sciences.” He attended Oxford University as a Marshall Scholar, receiving the Batterby Prize from Hertford College for “highest first class honours in philosophy, politics and economics.” Four years later he earned the M.D. from Harvard Medical School, receiving the Sanger Prize for “excellence in psychiatric research.” He completed his psychiatric residency at McLean Hospital, a Harvard affiliate, where he served as chief resident. He has received numerous teaching, mentoring, and diversity awards, and for six consecutive years he was voted the “faculty member who did the most for the class” by Harvard Medical School graduates.

Dr. Hundert has served on many national boards, including the Association of American Universities, the American Association of Medical Colleges, and the Liaison Committee on Medical Education. He co-chaired the Institute of Medicine’s National Summit on Health Professions Education. Dr. Hundert has served as chair of the Ethics Committees of McLean Hospital and the Massachusetts Psychiatric Society, and also served as ethics column editor for the Harvard Review of Psychiatry. Dr. Hundert has written dozens of articles and chapters on a variety of topics in psychiatry, philosophy, medical ethics, and medical education, as well as two books: Philosophy, Psychiatry and Neuroscience: Three Approaches to the Mind (Oxford University Press, 1989), and Lessons from an Optical Illusion: On Nature and Nurture, Knowledge and Values (Harvard University Press, 1995).

In addition to his work in the Division of Medical Ethics, Dr. Hundert is a member of the boards of TIAA-CREF and the Rock and Roll Hall of Fame.