this month at the nih: niddk forms hepatotoxicity clinical research network

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Strategic Planning Taskforce Tackles AGA Priorities A strategic planning task force or- ganized by the AGA has begun efforts aimed at clarifying the organi- zation’s priorities and developing an action plan to achieve its varied agenda. The 12-member task force convened its initial meeting June 28th, thus marking the first time in approximately 8 years that the AGA has mounted such a mission. The task force is co-chaired by AGA president Dr. Daniel K. Podolsky, pro- fessor of medicine at Harvard Univer- sity, and AGA vice president and pres- ident elect Dr. Emmet B. Keeffe, professor of medicine and chief of hepatology at Stanford University. “This task force includes members of the Governing Board and leader- ship. In addition, we have ensured that this group represents all the constituencies of the AGA, including basic research, clinical research, and practice,” Keeffe says. Consulting with the task force is Cambridge Concord Associates, which, according to Keeffe, is a firm focused primarily on strategy, orga- nization, and governance. He says the task force has already interviewed “a number of key peo- ple in the organization,” in addition to having conducted “more than 50 interviews with individuals outside the AGA, from our sister societies and from some of the larger societ- ies” including the American College of Physicians and the American Board of Internal Medicine. “We want to develop an action plan for the AGA over the short term and we want to define clearly what our priorities are for the future. As the process unfolds, we will seek input from committees and mem- bers,” he says. One priority requiring action would call for AGA to do as much as possible to ensure that the group is “on the leading edge of technologic advances or scientific advances that may affect our members,” Keeffe says. “We want to anticipate changes that may occur in these arenas.” As an example, he points to uncer- tainty about the changes that the de- velopment of virtual colonoscopy might have on the current focus on colonoscopy. “How are we going to position ourselves and our members should these changes occur?” Keeffe notes that the advances in genetic science and the implications of human genome research “may have a major impact on how we practice our specialty. For example, genetic screening, where we may be interfacing with patients before they have manifestations of disease, seek- ing to find genetic risk.” He also points to the importance of ensuring that the AGA agenda continues its new emphasis, begun under the presidency of Dr. Martin Brotman, aimed at serving the needs of international members. “And so in the end we want to develop an action plan that is going to move AGA forward and in the right direction, given all the changes that have occurred since the last stra- tegic planning effort,” Keeffe says. “We want to remain a strong group that serves all the needs of our di- verse membership.” Stories by Les Lang This Month at the NIH: NIDDK Forms Hepatotoxicity Clinical Research Network A dverse drug reactions (ADRs) are an increasingly important clinical problem in medicine. Drug- induced liver injury has been the most common type of ADR that has led to drug withdrawal or refusal of approval by the FDA. In surveys of acute liver failure in the United States, drug-induced hepatotoxicity is the single leading cause. The pre- disposition to hepatotoxicity is likely to be multifactorial, involving genes that interact with environmental fac- tors. In July 12, 2002, the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) published an RFA (DK02-033) to develop a Hepatotoxicity Clinical Research Network that will accelerate ad- vances in the understanding and pre- vention of drug, CAM, and toxin-in- duced liver toxicities. From the applications received, the NIDDK se- lected 5 interactive Clinical Centers and a Data Coordinating Center. The Clinical Centers are based at the Uni- versity of Connecticut (Dr. Herbert Bonkovsky); the University of Cali- fornia at San Francisco (Dr. Timothy Davern); the University of Indiana (Dr. Naga Chalasani); the University of Michigan, Ann Arbor (Dr. Robert Fontana); and the University of North Carolina at Chapel Hill (Dr. Paul Watkins). The Data Coordinat- ing Center is located at Duke Univer- sity (Dr. James Rochon). The pri- mary objective of the Hepatotoxicity Clinical Research Network will be to develop standardized instruments to identify and fully characterize cases of drug, CAM, and toxin-induced liver injury and controls to allow for analysis of the epidemiology and clinical spectrum of hepatotoxicity and to obtain biological samples for the study of the pathogenesis of hep- atotoxicity using biochemical, sero- logical, and genetic techniques. It is anticipated that this initiative will yield further insights into important aspects of hepatotoxicity in the United States. Stephen P. James National Institutes of Health Gastroenterology News continued 1008

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Strategic Planning TaskforceTackles AGA Priorities

A strategic planning task force or-ganized by the AGA has begun

efforts aimed at clarifying the organi-zation’s priorities and developing anaction plan to achieve its variedagenda. The 12-member task forceconvened its initial meeting June28th, thus marking the first time inapproximately 8 years that the AGAhas mounted such a mission.

The task force is co-chaired by AGApresident Dr. Daniel K. Podolsky, pro-fessor of medicine at Harvard Univer-sity, and AGA vice president and pres-ident elect Dr. Emmet B. Keeffe,professor of medicine and chief ofhepatology at Stanford University.

“This task force includes membersof the Governing Board and leader-ship. In addition, we have ensuredthat this group represents all theconstituencies of the AGA, includingbasic research, clinical research, andpractice,” Keeffe says.

Consulting with the task force isCambridge Concord Associates,which, according to Keeffe, is a firm

focused primarily on strategy, orga-nization, and governance.

He says the task force has alreadyinterviewed “a number of key peo-ple in the organization,” in additionto having conducted “more than 50interviews with individuals outsidethe AGA, from our sister societiesand from some of the larger societ-ies” including the American Collegeof Physicians and the AmericanBoard of Internal Medicine.

“We want to develop an actionplan for the AGA over the short termand we want to define clearly whatour priorities are for the future. Asthe process unfolds, we will seekinput from committees and mem-bers,” he says.

One priority requiring actionwould call for AGA to do as much aspossible to ensure that the group is“on the leading edge of technologicadvances or scientific advances thatmay affect our members,” Keeffesays. “We want to anticipate changesthat may occur in these arenas.”

As an example, he points to uncer-tainty about the changes that the de-velopment of virtual colonoscopy

might have on the current focus oncolonoscopy. “How are we going toposition ourselves and our membersshould these changes occur?”

Keeffe notes that the advances ingenetic science and the implicationsof human genome research “mayhave a major impact on how wepractice our specialty. For example,genetic screening, where we may beinterfacing with patients before theyhave manifestations of disease, seek-ing to find genetic risk.”

He also points to the importanceof ensuring that the AGA agendacontinues its new emphasis, begununder the presidency of Dr. MartinBrotman, aimed at serving the needsof international members.

“And so in the end we want todevelop an action plan that is goingto move AGA forward and in theright direction, given all the changesthat have occurred since the last stra-tegic planning effort,” Keeffe says.“We want to remain a strong groupthat serves all the needs of our di-verse membership.”

Stories by Les Lang

This Month at the NIH: NIDDKForms Hepatotoxicity ClinicalResearch Network

Adverse drug reactions (ADRs)are an increasingly important

clinical problem in medicine. Drug-induced liver injury has been themost common type of ADR that hasled to drug withdrawal or refusal ofapproval by the FDA. In surveys ofacute liver failure in the UnitedStates, drug-induced hepatotoxicityis the single leading cause. The pre-disposition to hepatotoxicity is likelyto be multifactorial, involving genesthat interact with environmental fac-tors. In July 12, 2002, the NationalInstitute of Diabetes & Digestive &Kidney Diseases (NIDDK) published

an RFA (DK02-033) to develop aHepatotoxicity Clinical ResearchNetwork that will accelerate ad-vances in the understanding and pre-vention of drug, CAM, and toxin-in-duced liver toxicities. From theapplications received, the NIDDK se-lected 5 interactive Clinical Centersand a Data Coordinating Center. TheClinical Centers are based at the Uni-versity of Connecticut (Dr. HerbertBonkovsky); the University of Cali-fornia at San Francisco (Dr. TimothyDavern); the University of Indiana(Dr. Naga Chalasani); the Universityof Michigan, Ann Arbor (Dr. RobertFontana); and the University ofNorth Carolina at Chapel Hill (Dr.Paul Watkins). The Data Coordinat-ing Center is located at Duke Univer-sity (Dr. James Rochon). The pri-

mary objective of the HepatotoxicityClinical Research Network will be todevelop standardized instruments toidentify and fully characterize casesof drug, CAM, and toxin-inducedliver injury and controls to allow foranalysis of the epidemiology andclinical spectrum of hepatotoxicityand to obtain biological samples forthe study of the pathogenesis of hep-atotoxicity using biochemical, sero-logical, and genetic techniques. It isanticipated that this initiative willyield further insights into importantaspects of hepatotoxicity in theUnited States.

Stephen P. JamesNational Institutes of Health

Gastroenterology News continued

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