Tufts Medical Center News Headlines
Week of May 14, 2007 - May 21, 2007
The following headline stories are re-printed from the Tufts Medical Center News, Tufts Medical Center's weekly publication.
What’s Riskier: Driving In A Car Or Taking Aspirin To Prevent A Heart Attack? New Health Affairs Study By Tufts Medical Center Researchers Grapples with Medication Risk Questions
A new study by researchers at Tufts Medical Center compares mortality risks posed by several common drugs to risks related to work, transportation, and recreation. Amid growing debate about appropriate regulation of drug safety by the Food and Drug Administration, the researchers argue that both risks and benefits should be considered for medications as well as for other domains.
The study appears in the May/June issue of the journal Health Affairs, a thematic volume titled “Pursuing Medical Progress: Managing Benefits and Risks,” and received widespread media coverage.
According to the study, mortality risks posed by Vioxx to treat arthritis and Tysabri to treat multiple sclerosis —drugs that have recently received scrutiny — are comparable to or exceed the risk of dying in a car accident, working as a truck driver or rock climbing. The Tufts Medical Center researchers evaluated fatality risks for six drugs. They found that even the widespread prophylactic use of aspirin poses a fatality risk on par with the risk associated with driving a car or working as a fire fighter.
Co-authors Joshua Cohen, PhD, and Peter Neumann, ScD, argue that systematic and comprehensive evaluation of risks and benefits is crucial to making informed, transparent decisions about risks. “Helping patients, health care providers and policymakers understand the magnitude of drug risks is crucial to helping them make an informed decision when evaluating the risks and benefits of treatment,” said Neumann. The authors note in their article that comparing drug risks with other risks people confront in their daily lives aids this understanding. Cohen is a staff member and Neumann is Director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies (ICRHPS).
The survey of risks in different areas of daily life shows that people voluntarily accept a wide range of risks under various circumstances, they say. For example, motorcyclists can potentially face annual fatality risks 40 times as great as passenger car travelers, and taxi drivers face risks three times greater than the risks experienced by fire fighters. Cohen and Neumann argue that risks cannot be properly evaluated without also considering the associated benefits. They point out that some surveys of patients who take Tysabri indicate they would tolerate considerably higher risks to alleviate their multiple sclerosis symptoms.
The need for the FDA to systematically and quantitatively evaluate both the risks and benefits of drugs may soon grow. The Institute of Medicine has recommended that the FDA undertake more intensive post-market surveillance of medications. Cohen and Neumann suggest that such surveillance would likely reveal that many more drugs have serious, although relatively rare, side effects.
As a result of concerns about drug safety, the Institute of Medicine and congressional leaders have called on the FDA to more aggressively monitor safety over the life cycles of drugs and, when necessary, to impose restrictions on the way some medications are distributed.
Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org.
Tufts Medical Center Hosts ICRHPS Ninth Annual Clinical Research Symposium
Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies (ICRHPS) held its Ninth Annual Clinical Research Symposium in the Wolff Auditorium on Tuesday, May 8, and featured numerous poster and speaking presentations from throughout the Medical Center and Tufts University research communities.
The symposium was overseen by Harry Selker, MD, MSPH, Excecutive Director of ICRHPS and Program Director of the Clinical Research Training Program; David Kent, MD, MSc, Associate Program Director; and Deborah Mayer, PhD, RN, Associate Program Director for the Clinical Research Graduate Program, which is run through Tufts Medical Center’s ICRHPS and Tufts University’s Sackler School of Biomedical Sciences.
Speakers included:
· Jennifer Chow, MD
· Ritesh Dhar, MD
· Marci Drees, MD
· Essam Elysayed, MD
Speakers:
· Gary Fanjiang, MD, MBACraig Gordon, MD
· Bertrand Jaber, MD
· Christina Kwack, MD
· Alisa Muniz–Crim, MD
Poster presenters included:
· Ahsan Alam, MD
· Peter Castaldi, MD
· Emily Dulude, MD
· Michael House, MD
· Ranjani Moorthi, MD
· Lien Quach, MD, MPH
· Dena Rifkin, MD
· Nicholas Stoycheff, MD
· Thomas Wuerz, MD
· Jill Young, MD
Floating Hospital Launches Autism Research Initiatives
Autism Spectrum Disorders (ASDs) are serious developmental disabilities that affect a child’s ability to socialize, communicate, and behave in typical ways. The Centers for Disease Control recently announced that the nationwide incidence of ASDs is now 1 in 150 births, and the Autism Society of America estimates that 1.5 million Americans and their families are now affected. Care for these persons now costs at least $35 billion annually.
To better understand the causes of ASDs and to search for more effective treatments, the Floating Hospital has joined with other Boston-area medical centers as members of the Autism Consortium, a new non-profit organization that brings together autism specialists from leading research and patient care institutions.
As part of the Consortium, clinicians from the Center for Children with Special Needs (CCSN) and the Genetics/Metabolism divisions at Floating Hospital will begin a research study in June looking at the possible genetic causes of ASDs. Co-investigators for the study are Karen Miller, MD, a Developmental-Behavioral Pediatrician at the CCSN, and Laurie Demmer, Chief of the Division of Genetics.
“What is especially exciting about this study is that more than 3,000 families will be enrolled across the five participating medical centers,” said Miller. “In addition to Floating Hospital, those centers include Cambridge Health Alliance, Boston Medical Center, Massachusetts General Hospital and Children’s Hospital Boston.”
This study is the first of a two-part process. The second step, scheduled to begin in September, will involve more extensive testing to determine whether there is a correlation between family characteristics and any genetic differences, so that scientists can get a better understanding of the gene(s) involved in ASDs.
The overall mission of the studies and the Autism Consortium is to improve patient care and help families. Research has shown that early, intensive treatment and access to appropriate information improves children’s outcomes. With that goal in mind, Bernadette Murphy Bentley, Autism Care Coordinator at the CCSN, assists families in finding resources and accessing services to help their children.
To raise awareness, the CCSN also sponsored the first-ever Autism Awareness Day at Tufts Medical Center in April. In addition to the CCSN’s autism care coordinator, representatives from the Autism Consortium, the Asperger’s Association of New England, the Autism Special Education Legal Support Center, and TILL (the Boston autism support center for families) answered questions and provided information to help children with ASDs. Tufts Medical Center staff members also represented the hospital at Autism Awareness Day at the State House on Monday, April 30.
For more information about the Floating’s autism studies, please contact Beth Rosen Sheidley, Research Coordinator, at ext. 4891 or bsheidley@tufts-nemc.org.