The Natural Orifice Surgery Consortium for Assessment and Research(R) (NOSCAR(R)), a joint effort of the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), announces the first Natural Orifice Translumenal Endoscopic Surgery(R) (NOTES(R)) multicenter human trial in the United States. Until now, NOSCAR research efforts have focused on basic research. The next phase will involve critical human trials. Continuing research commitments from industry partners Ethicon Endo-Surgery, Olympus America Inc. and Stryker Medical will provide funds to support the study in this emerging transdisciplinary therapy. The landmark study was announced at the 4th International Conference on NOTES in Boston where nearly 300 physicians and industry representatives gathered to learn the latest information about the science and technology of the medical platform.

“NOSCAR is taking a big step forward later this year with the commencement of the first NOTES multicenter human trial in the U.S. We are grateful to our partners at Ethicon Endo-Surgery, Olympus America Inc. and Stryker Medical for helping make the study possible,” said Michael L. Kochman, MD, NOSCAR Research Subcommittee co-chair.

The human studies are expected to begin later this year. NOSCAR leadership is currently finalizing the design for a prospective multicenter trial of NOTES cholecystectomy (gallbladder removal) versus conventional laparoscopic cholecystectomy. NOSCAR will be granting funds to selected institutions to conduct these trials. Institutions participating in the trial have demonstrated a strong commitment to developing the basic science that forms the foundation of NOTES and have already performed human NOTES cases under an Institutional Review Board protocol; approximately 200 patients will be enrolled in the clinical trial.

NOSCAR will make additional announcements regarding the participating institutions, study protocols and when studies will commence. ACI, a Clinical Research Organization based in Pennsylvania, has been retained to provide data collection and report preparation services for the study.

“We are delighted that the research and science to date has led us to the point where we can begin conducting human trials. The careful, responsible introduction of NOTES is our utmost concern; this study will provide the basis for such an introduction,” said Steven D. Schwaitzberg, MD, NOSCAR Research Subcommittee co-chair.

About NOSCAR

Natural Orifice Translumenal Endoscopic Surgery(R) (NOTES(R)) might represent the next major advancement in minimally invasive therapy. To address this emerging technology, a working group consisting of expert laparoscopic surgeons from SAGES and a group of expert interventional endoscopists representing ASGE have joined together as the Natural Orifice Surgery Consortium for Assessment and Research(R) (NOSCAR(R)). The growing capabilities of therapeutic flexible endoscopy have ushered in a new era in treatment of gastrointestinal conditions. Refinements in laparoscopic surgery have progressed to the point that complex surgical procedures, such as gastric bypass, can now be performed in a minimally invasive fashion. These trends have set the stage for the development of even less invasive methods to treat conditions in both the gut lumen and in the peritoneal cavity. It seems feasible that major intraperitoneal surgery may one day be performed without skin incisions. The natural orifices may provide the entry point for surgical interventions in the peritoneal cavity thereby avoiding abdominal wall incisions.

About the Society of American Gastrointestinal and Endoscopic Surgeons

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) was founded in 1981 to foster, promote, support and encourage academic, clinical and research achievement in gastrointestinal endoscopic surgery. SAGES members are general and colorectal surgeons who perform endoscopy and laparoscopy as part of their practice as well as surgical residents, fellows, and other allied health personnel. The Society has grown from fewer than 50 original members to more than 5,500 from every state and over 80 countries

About the American Society for Gastrointestinal Endoscopy

Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with nearly 11,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education.

Source: NOSCAR

An ambitious new national study that aims to follow children from conception through adulthood will miss a golden opportunity to gather data on the most underrepresented population in clinical research - pregnant women, say leading ethicists at Duke University Medical Center, Johns Hopkins and Georgetown Universities.

There’s still time, however, to make small but crucial cost-effective changes that could yield valuable information for women’s health from The National Children’s Study.

“This is an ideal chance to study women during and following pregnancy, as well as the babies they will bear,” says Anne Drapkin Lyerly, MD, an obstetrician/gynecologist and medical ethicist at Duke. She is the lead author of a paper published online by the American Journal of Public Health. It urges NCS organizers to make changes in the study’s design before it’s too late.

“The simple act of adding a few key questions on medication usage to the interviews and blood draws already scheduled can lead to a wealth of information,” says Margaret Olivia Little, director of the Kennedy Institute of Ethics, Georgetown University.

Ruth R. Faden, executive director of Johns Hopkins Berman Institute of Bioethics, added, “It makes such good sense, ethically and economically, to include a focus on pregnant women in the NCS. Just a few additional questions could make an enormous difference to the health of women, not only during pregnancy but throughout their lives.”

Although the Institute of Medicine began recommending that pregnant women be included in clinical trials 15 years ago, pregnant women remain excluded from trials for many reasons, including the ethical concerns raised when trying to strike a balance between maternal and fetal risks.

“Of course safety of medicine for a developing fetus is rightfully a concern, but it shouldn’t swamp all others,” notes Lyerly who adds there are social ramifications at play too. “When an untreated woman dies of cancer, there are obviously lifelong implications for a child facing life without a mother.”

Nearly two-thirds of the four million women who become pregnant each year take prescription medications during their pregnancy for conditions ranging from hypertension to cancer, Lyerly says. A handful of medications are approved for use during pregnancy by the FDA, and most are for gestation or birth-related issues like anesthesia and nausea. As a result, clinicians have little evidence on which to base their recommendations.

“Pregnancy changes the body in dramatic and often unpredictable ways,” says Lyerly. Previous studies show pregnancy alters liver enzymes, concentrations of sex hormones, and how quickly drugs are metabolized by and excreted from the body. The lack of data also leaves many pregnant women under-treated for conditions where treatment could outweigh some of the potential risks. For example, poorly controlled asthma can lead to dangerous pregnancy complications and fetal growth problems while major depression is associated with poor outcomes for women and neonates.

“A large, observational study in which fetuses are not put at any additional risk is a promising and ethically uncomplicated way to gather data,” says Lyerly.

That, she contends, is the design of the National Children’s Study. The goal is to follow 100,000 children, with 25 percent being enrolled prior to conception and up to 90 percent during the first trimester of pregnancy. This means researchers will be in regular contact with 90,000 women throughout their pregnancy. Based on current statistics, that could potentially mean a study population including 4,000 women with diabetes, 4,000 women with pregnancy-related hypertension, 1,000 with chronic hypertension, 12,000 with depression, 4.000 to 8,000 women with asthma and 2,700 women with thyroid disease.

Many of these women will be taking one or more medications without data to back up their doctors’ recommendations. And, that, she says, is exactly what the NCS researchers could be evaluating.

Lyerly and her colleagues recognize that changes to the NCS can only come at the price of additional funding. At a minimum, they say the study should be expanded by including the collection of additional data from already scheduled interviews and maternal chart reviews. “These data would document women’s health outcomes related to their pregnancy.”

Second, blood already being drawn from pregnant women can be used to garner information on how drugs are metabolized by the woman’s body. At the very least, it would help guide the identification of drugs that require more intensive study.

“These two efforts, at very little additional cost, would result in a rich database of knowledge that could lead to critical improvements in the care of pregnant women,” the trio states in their paper. “Not including them, in our view, would be hard to justify.”

Source:
Debbe Geiger

Duke University Medical Center

The Royal Pharmaceutical Society is backing the Guild of Healthcare Pharmacists (GHP) bid
to get the Government to review its decision on the recruitment and retention premium of
pharmacists in hospitals and PCTs.

The Pay Review Body last week recommended that band 6 and 7 pharmacists in these areas
should receive the recruitment and retention premium (RRP) from October this year, but the
Government has rejected this recommendation.

Steve Churton, Society President said; “The Society has concerns that the current staff
shortages will adversely affect patient care and that a failure to address the problem now will
only make the problem worse. We wholly support the campaign being undertaken by GHP
and Unite to get the Government to rethink its decision.

“We are aware of the work the Guild has done to find a workable solution to the recruitment
and retention of hospital and PCT pharmacists. Its findings that there is a national problem are
consistent with the Pay Review Body and its recommendation of an RRP in the short term.
We intend to raise this issue with Pharmacy Minister, Mike O’Brien at the earliest possible
opportunity.

“We are now encouraging pharmacists to write to their MP if they agree that this decision is
unfair.”

Pharmacists from all sectors are being urged to contact their Health Secretary/Minister and
local MP asking for the decision to be reviewed. There are letter templates available from the
GHP website, www.ghp.org.uk that you can add your details to and send to the appropriate
MP. A list of local MP’s can also be found via this website.

Source
Royal Pharmaceutical Society of Great Britain