- Email: [email protected]
Second annual Gastrointestinal cancers symposium
continued
House Subcommittee Holds Hearing on Clinical Trial Disclosure
T
he House Committee on Energy and Commerce, and Subcommittee on Oversight and Investigations, repeatedly took both Food and Drug Administration (FDA) and pharmaceutical company officials to task for failing to fully disclose clinical trial results. At a day-long hearing in Washington, DC, September 9, 2004, panelists closely questioned FDA and drug company witnesses about whether they intended to support various proposals to create centralized registries and databases that would contain both positive and negative trial results. The hearing came a day after the International Committee of Medical Journal Editors (ICMJE) issued a call for more open reporting of clinical data. In statements published in The New England Journal of Medicine and the Journal of the American Medical Association, the ICMJE said it would bar data from trials that had not been registered— before enrolling any patients—in a registry that meets several different criteria: It “must be accessible to the public at no charge. It also must be open to all
Second Annual Gastrointestinal Cancers Symposium
F
or the second consecutive year, the American Gastroenterological Association (AGA), the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiology and Oncology (ASTRO), and the Society of Surgical Oncology (SSO) will cosponsor a 3-day, multidisciplinary symposium on gastrointestinal cancers, January 27–29, 2005 in Miami, Florida. It is estimated that more than 300 scientific abstracts will be presented. The meeting is expected to attract more than 1000
prospective registrants and managed by a not-for-profit organization” and that “there must be a mechanism to ensure the validity of the registered data, and the registry should be electronically searchable.” In addition, an acceptable registry must include at minimum the following: a unique identifying number; a statement of the intervention(s) and comparison(s) studied; the study hypothesis; definitions of outcomes; key trial dates; target number of subjects; anticipated or actual date of last follow-up; planned or actual date of closure to data entry; funding source; and contact information for the principal investigator. According to the ICMJE, www.clinicaltrials. gov, which is sponsored by the U.S. National Library of Medicine, “meets these requirements.” Rep. Diana DeGette (D-Col.) said the PhRMA registry, which would be voluntary and will be online at www. clinicaltrialresults.org beginning October 1, 2004, was “a commendable first step,” but asked how meaningful and available the data will be to physicians and patients. Rep. Henry Waxman (D-Calif.), disagreed, saying, “if it’s voluntary, it’s voluntary not to do it.”
Waxman said he and colleague Edward Markey (D-Mass.) would introduce legislation to make it mandatory to register clinical trials of drugs and biologics at an expanded www. clinicaltrials.gov. The bill would incorporate recommendations from the ICMJE and the AMA. They noted that the legislation would “respond to failures to provide information voluntarily by including strong enforcement mechanisms. Among other mechanisms, the bill will make participation in the registry a requirement for Institutional Review Board approval and will provide for civil monetary penalties for noncompliance.” In his testimony before the subcommittee, AMA Trustee Dr. Ronald M. Davis said “physicians need complete and unbiased information about the safety and effectiveness of the treatments they prescribe for their patients. A centralized clinical trials registry would improve physician and researcher access to this information.” Further details can be found at N Engl J Med 2004;351;12 and at www.ama-assn.org/ama/pub/article/ print/1615-8833.html.
physicians with an interest in gastrointestinal cancers. The “2005 Gastrointestinal Cancers Symposium: Current Status and Future Directions for Prevention and Management” will bring together leading experts on gastrointestinal cancers to present and discuss new research on prevention, screening, and treatment. The symposium will involve specialists in oncology, gastroenterology, radiology, and surgery. “Last year’s GI cancer meeting surpassed our expectations, and it’s clear that small educational meetings focused on specific cancer sites are welcome and needed in the medical
community,” said James L. Abbruzzese, MD, Chair of the Steering Committee. According to AGA, attendees will participate in didactic and abstractdriven sessions examining various types of gastrointestinal cancer, with each day focusing on a different section of the gastrointestinal tract: cancers of the esophagus and stomach; cancers of the pancreas and hepatobiliary tract; and cancers of the colon and rectum. Also scheduled are general sessions each day focusing on prevention, screening and diagnosis, multidisciplinary management, molecular targeted therapies and translational 1287
continued
research, and controversies in clinical practice, including pro versus con sessions on screening for Barrett’s esophagus, adjuvant treatment of pancreatic cancer, and adjuvant therapy for rectal cancer. Co-chairs for the symposium’s program committee are Charles
Blanke, MD, Oregon Health Sciences University, Portland, and Bruce Minsky, MD, Memorial SloanKettering Cancer Center, New York. The AGA’s GI oncology is involved with the organization of this annual meeting through Dr. Randall Burt of the University of
Utah and also, Dr. Robert Sandler of UNC-Chapel Hill, Dr. C. Richard Boland of Baylor, and Dr. Daniel Chung of Massachusetts General Hospital. For more information, including registration and housing, see www. ASCO.org.
Insulin-Producing beta-Cells Arise Via Self-Duplication
istence of adult pancreatic endocrine stem cells, which by definition, are not yet beta cells but are often suggested as a potential source of beta cells for patients with diabetes. “The regeneration of beta cells after injury has been thought to involve the differentiation of stem cells that appear to reside within the pancreatic-duct epithelium. That belief is based on immunohistochemical evidence of large numbers of single beta cells arising in and around the ducts after pancreatic injury. Rather than relying on a histologic approach, Dor and colleagues worked out a way to label, through a specific exogenous stimulus, mature beta cells and their progeny and thereby track their fate during turnover and regeneration.” Levine and Mercola point out that the new results must be reconciled with the observation that many single beta cells appear in and near pancreatic ducts after injury. “Where do these cells originate? According to the model suggested by the experiments of Dor and colleagues, they must come from preexisting beta cells. Since rodents, unlike humans, have very few isolated endocrine cells outside of islets, one explanation is that beta cells migrate from residual islets to the periductular
space and beyond to coalesce with other endocrine cells and form new islets. An alternative scenario is that rare extra-islet endocrine cells in the rodent undergo massive proliferation to form new islets, but this possibility is inconsistent with the findings of Dor et al.” The Journal authors view the new study as placing increased emphasis on promoting the replication of adult beta cells and the differentiation of beta cells from embryonic stem cells “at the expense of pursuing research into the use of adult stem cells for beta-cell replacement. As to the replication of beta cells,” they say “the challenges are substantial: human beta cells replicate less readily than those of mice, and replicating human beta cells undergo dedifferentiation and senescence in vitro. Last, but by no means least, are then ramifications of the study for federally mandated guidelines that restrict research on embryonic stem cells. This study will probably increase calls to lift those restrictions.” For additional details, see Nature 2004;429:41– 46 and N Engl J Med 2004;351:1024 –1026.
I
nsulin-producing beta-cells in the adult pancreas were thought to derive from pancreatic stem cells. But last spring, findings reported in the journal Nature by Dr. Yuval Dor and colleagues from the department of molecular and cellular biology and Howard Hughes Medical Institute at Harvard University, indicate they arise abundantly from betacells themselves, by self-duplication rather than stem-cell differentiation. In their recent overview of this research and its clinical implications, Drs. Fred Levine, MD, PhD, and Mark Mercola, PhD, of the Burnham Institute and the University of California, San Diego, write in The New England Journal of Medicine that because that source of beta-cells is limited, “so the science of producing new beta-cells has become a red-hot topic, sparking a flurry of studies into how the adult body itself generates insulin-producing cells.” The authors note that the findings of Dor and colleagues, who used a genetic lineage-marking approach to shed light on the origin of beta-cells in adult transgenic mice, countered prevailing hypotheses in the field. They say the work questions the ex-
1288
Stories by Les Lang
House Subcommittee Holds Hearing on Clinical Trial Disclosure
T
he House Committee on Energy and Commerce, and Subcommittee on Oversight and Investigations, repeatedly took both Food and Drug Administration (FDA) and pharmaceutical company officials to task for failing to fully disclose clinical trial results. At a day-long hearing in Washington, DC, September 9, 2004, panelists closely questioned FDA and drug company witnesses about whether they intended to support various proposals to create centralized registries and databases that would contain both positive and negative trial results. The hearing came a day after the International Committee of Medical Journal Editors (ICMJE) issued a call for more open reporting of clinical data. In statements published in The New England Journal of Medicine and the Journal of the American Medical Association, the ICMJE said it would bar data from trials that had not been registered— before enrolling any patients—in a registry that meets several different criteria: It “must be accessible to the public at no charge. It also must be open to all
Second Annual Gastrointestinal Cancers Symposium
F
or the second consecutive year, the American Gastroenterological Association (AGA), the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiology and Oncology (ASTRO), and the Society of Surgical Oncology (SSO) will cosponsor a 3-day, multidisciplinary symposium on gastrointestinal cancers, January 27–29, 2005 in Miami, Florida. It is estimated that more than 300 scientific abstracts will be presented. The meeting is expected to attract more than 1000
prospective registrants and managed by a not-for-profit organization” and that “there must be a mechanism to ensure the validity of the registered data, and the registry should be electronically searchable.” In addition, an acceptable registry must include at minimum the following: a unique identifying number; a statement of the intervention(s) and comparison(s) studied; the study hypothesis; definitions of outcomes; key trial dates; target number of subjects; anticipated or actual date of last follow-up; planned or actual date of closure to data entry; funding source; and contact information for the principal investigator. According to the ICMJE, www.clinicaltrials. gov, which is sponsored by the U.S. National Library of Medicine, “meets these requirements.” Rep. Diana DeGette (D-Col.) said the PhRMA registry, which would be voluntary and will be online at www. clinicaltrialresults.org beginning October 1, 2004, was “a commendable first step,” but asked how meaningful and available the data will be to physicians and patients. Rep. Henry Waxman (D-Calif.), disagreed, saying, “if it’s voluntary, it’s voluntary not to do it.”
Waxman said he and colleague Edward Markey (D-Mass.) would introduce legislation to make it mandatory to register clinical trials of drugs and biologics at an expanded www. clinicaltrials.gov. The bill would incorporate recommendations from the ICMJE and the AMA. They noted that the legislation would “respond to failures to provide information voluntarily by including strong enforcement mechanisms. Among other mechanisms, the bill will make participation in the registry a requirement for Institutional Review Board approval and will provide for civil monetary penalties for noncompliance.” In his testimony before the subcommittee, AMA Trustee Dr. Ronald M. Davis said “physicians need complete and unbiased information about the safety and effectiveness of the treatments they prescribe for their patients. A centralized clinical trials registry would improve physician and researcher access to this information.” Further details can be found at N Engl J Med 2004;351;12 and at www.ama-assn.org/ama/pub/article/ print/1615-8833.html.
physicians with an interest in gastrointestinal cancers. The “2005 Gastrointestinal Cancers Symposium: Current Status and Future Directions for Prevention and Management” will bring together leading experts on gastrointestinal cancers to present and discuss new research on prevention, screening, and treatment. The symposium will involve specialists in oncology, gastroenterology, radiology, and surgery. “Last year’s GI cancer meeting surpassed our expectations, and it’s clear that small educational meetings focused on specific cancer sites are welcome and needed in the medical
community,” said James L. Abbruzzese, MD, Chair of the Steering Committee. According to AGA, attendees will participate in didactic and abstractdriven sessions examining various types of gastrointestinal cancer, with each day focusing on a different section of the gastrointestinal tract: cancers of the esophagus and stomach; cancers of the pancreas and hepatobiliary tract; and cancers of the colon and rectum. Also scheduled are general sessions each day focusing on prevention, screening and diagnosis, multidisciplinary management, molecular targeted therapies and translational 1287
continued
research, and controversies in clinical practice, including pro versus con sessions on screening for Barrett’s esophagus, adjuvant treatment of pancreatic cancer, and adjuvant therapy for rectal cancer. Co-chairs for the symposium’s program committee are Charles
Blanke, MD, Oregon Health Sciences University, Portland, and Bruce Minsky, MD, Memorial SloanKettering Cancer Center, New York. The AGA’s GI oncology is involved with the organization of this annual meeting through Dr. Randall Burt of the University of
Utah and also, Dr. Robert Sandler of UNC-Chapel Hill, Dr. C. Richard Boland of Baylor, and Dr. Daniel Chung of Massachusetts General Hospital. For more information, including registration and housing, see www. ASCO.org.
Insulin-Producing beta-Cells Arise Via Self-Duplication
istence of adult pancreatic endocrine stem cells, which by definition, are not yet beta cells but are often suggested as a potential source of beta cells for patients with diabetes. “The regeneration of beta cells after injury has been thought to involve the differentiation of stem cells that appear to reside within the pancreatic-duct epithelium. That belief is based on immunohistochemical evidence of large numbers of single beta cells arising in and around the ducts after pancreatic injury. Rather than relying on a histologic approach, Dor and colleagues worked out a way to label, through a specific exogenous stimulus, mature beta cells and their progeny and thereby track their fate during turnover and regeneration.” Levine and Mercola point out that the new results must be reconciled with the observation that many single beta cells appear in and near pancreatic ducts after injury. “Where do these cells originate? According to the model suggested by the experiments of Dor and colleagues, they must come from preexisting beta cells. Since rodents, unlike humans, have very few isolated endocrine cells outside of islets, one explanation is that beta cells migrate from residual islets to the periductular
space and beyond to coalesce with other endocrine cells and form new islets. An alternative scenario is that rare extra-islet endocrine cells in the rodent undergo massive proliferation to form new islets, but this possibility is inconsistent with the findings of Dor et al.” The Journal authors view the new study as placing increased emphasis on promoting the replication of adult beta cells and the differentiation of beta cells from embryonic stem cells “at the expense of pursuing research into the use of adult stem cells for beta-cell replacement. As to the replication of beta cells,” they say “the challenges are substantial: human beta cells replicate less readily than those of mice, and replicating human beta cells undergo dedifferentiation and senescence in vitro. Last, but by no means least, are then ramifications of the study for federally mandated guidelines that restrict research on embryonic stem cells. This study will probably increase calls to lift those restrictions.” For additional details, see Nature 2004;429:41– 46 and N Engl J Med 2004;351:1024 –1026.
I
nsulin-producing beta-cells in the adult pancreas were thought to derive from pancreatic stem cells. But last spring, findings reported in the journal Nature by Dr. Yuval Dor and colleagues from the department of molecular and cellular biology and Howard Hughes Medical Institute at Harvard University, indicate they arise abundantly from betacells themselves, by self-duplication rather than stem-cell differentiation. In their recent overview of this research and its clinical implications, Drs. Fred Levine, MD, PhD, and Mark Mercola, PhD, of the Burnham Institute and the University of California, San Diego, write in The New England Journal of Medicine that because that source of beta-cells is limited, “so the science of producing new beta-cells has become a red-hot topic, sparking a flurry of studies into how the adult body itself generates insulin-producing cells.” The authors note that the findings of Dor and colleagues, who used a genetic lineage-marking approach to shed light on the origin of beta-cells in adult transgenic mice, countered prevailing hypotheses in the field. They say the work questions the ex-
1288
Stories by Les Lang