Changes Needed in Stem Cell Regulations

A recommendation has been made that the National Institutes of Health ethics guidelines for embryonic stem cell research be modified to better protect the rights of individuals donating egg or sperm to patients undergoing in vitro fertilization.

The recommendation is reported in the February 19, 2010 issue of Science.

Third parties frequently donate sperm and egg, or “gametes,” for patients attempting to create embryos in the in vitro fertilization clinic.

Under current practice in the United States, gamete donors sign a form giving the IVF patient unrestricted legal authority to determine how to dispose of any embryos that may be leftover following fertility treatments. Donor banks and IVF clinics are not required to brief gamete donors about the various options for disposition, which include donating the embryos for stem cell research, thereby enabling scientists to derive new human embryonic stem cell lines; discarding the embryos, or donating them to other IVF patients.

While many state, national, and international scientific committees and agencies have recommended that third-party gamete donors give official “informed consent” for stem cell research with embryos remaining after infertility treatment, the NIH did not stipulate this requirement in its guidelines issued in March 2009. As these guidelines determine which human embryonic stem cell (hESC) lines may be studied under NIH research grants -- which are expected to play a growing role in funding stem cell research -- the ethical implications are significant, says Lo, chair of the UCSF Gamete, Embryonic Stem Cell Research Committee, members of which published the Science paper.

“We urge the NIH to revise its guidelines to require that gamete donors be advised that embryos containing their sperm or egg could be used for embryonic stem cell research, before they grant dispositional authority over embryos to the IVF patient,” he says. “Because some gamete donors may not approve of embryonic stem cell research, we consider this the ethically appropriate position.”

In their paper, the team recommends a process that is less complex than the detailed “informed consent” process carried out when IVF patients donate embryos for research. They suggest the disclosure to gamete donors may be made through oral discussion or brochures before donors sign a form authorizing the IVF patient to determine the disposition of embryos.

Importantly, says Lo, the gamete donors’ instructions would not disrupt the IVF process. IVF patients would learn of a gamete donor’s restrictions in advance of selecting embryos for IVF treatment, and could select other gamete donors if not satisfied with the donors’ disposition restrictions.

The recommendation is consistent with that of the National Academy of Sciences and the International Society for Stem Cell Research says Lo, a member of the ethics committee of the ISSCR, and the co-chair of the Standards Working Group of the California Institute for Regenerative Medicine.

“It would be highly desirable to have consistency among standards and regulations,'' he says. ''If such harmonization were achieved, many university Institutional Review Boards and other research oversight bodies would likely allow NIH-eligible human embryonic stem cell lines to be used for any otherwise acceptable hESC research.”

“It’s critical that we consider all parties involved in the creation of embryos and honor their wishes,” says co-author Arnold Kriegstein, MD, PhD, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF.

“The field of human embryonic stem cell research offers enormous promise for patients suffering from devastating diseases. We want to build this field on an ethical foundation of which we can be proud.”

Exceptions to the guideline could be justified for hESC lines already in existence if there were strong scientific reasons to use the cell lines and the third-party gamete donor had granted rights to the IVF patient to determine disposition of the embryos.

At the moment, many Americans are traveling overseas for stem cell treatments because they are not available in the USA.

Researchers Develop Standard of Care for Breast Cancer Survivors with Lymphedema

Lymphedema, a chronic swelling condition that can appear after breast cancer surgery, is a risk for 1.3 million breast cancer survivors. Although lymphedema can cause lifelong swelling in the arms, back, neck and chest, there is no national standard of diagnosis or care. Now, University of Missouri researchers are leading the American Lymphedema Framework Project (ALFP), a national, multi-disciplinary collaboration to develop comprehensive guidelines for the assessment, treatment, and management of lymphedema.

“We can’t cure lymphedema today – we can only manage it,” said Jane Armer, MU nursing professor and director of the project at the MU Ellis Fischel Cancer Center. “Lymphedema is a complex, chronic condition. Currently, there are inconsistent approaches to care for lymphedema, and often the most common form of self-management is to not treat it at all.”

The ALFP, established in 2008, has two main goals: establish a best practices document with evidence-based lymphedema treatment guidelines for health practitioners, and create a minimum data set of all available lymphedema research and clinical data. The ALFP researchers plan to publish the best practices document in 2011.

“Part of why there isn’t a standard of care is the lack of reliance on current evidence by health practitioners and third party payers, which in turn causes problems with reimbursement from health insurance companies. Many people with lymphedema have to pay out-of-pocket for care,” Armer said. “There isn’t a clear, national consensus for how to diagnose lymphedema and when to start treating it. The ALFP collaborators aim to document a standard of care reflecting a consensus on best practices that will help solve these problems.”

Researchers, including those at MU, have found that the most effective method of care for lymphedema is complete decongestive physiotherapy, in which therapists use specialized lymphatic massage techniques to reduce protein-rich fluid buildup. Bandages and compression garments also help to reduce swelling.

One of Armer’s innovations at MU is measuring patients’ arms with a perometer, a machine that was first used to fit garments for swollen limbs. First implemented in a research setting at MU, the machine has a large optoelectric frame that glides over a patient’s arm, scans its image and records an estimated limb volume reading. Perometer measurement is as, or more, accurate than several previous methods to measure arm circumference and volume. The machine is now used in about 20 sites across the country.

Highlights of MU Sinclair School of Nursing research from the past 10 years reveal that there is a 40 percent higher risk of developing lymphedema in women with a body mass index (BMI) classified as overweight or obese compared to normal-weight women. The researchers also found that younger patients may have less occurrence of the condition but tend to report more symptoms, which could be a result of psychological and aging-related factors.

“In addition to our previous findings, we’re currently studying whether there are any genetic factors that increase the risk of lymphedema,” Armer said. “A pilot study now underway and a proposed multi-site research study will look at the possibility of genetic predisposition for secondary lymphedema. The results could be applied to cancer treatment in which surgery and radiation affect the lymphatic system.”

In recognition of the leadership in lymphedema research at MU, the ALFP is housed at the MU Ellis Fischel Cancer Center. Armer’s research is funded by the National Institutes of Health and is published in several journals, including the Journal of Lymphoedema; Lymphology; Lymphatic Research and Biology; and the Journal of Cancer Survivorship, and presented at conferences throughout the world. The activities of the ALFP have been funded by industry partnerships and grants from the American Cancer Society through The Longaberger Company, a direct-selling company offering home products, and the Longaberger Horizon of Hope Campaign, which provided a grant for breast cancer research and education.

The West Must Plan For Climate Change

Planners in the Intermountain West must focus on the economic savings of mitigating and adapting to climate change as they tailor federal and state efforts to suit local and regional needs, according to a new report published by the Lincoln Institute of Land Policy (www.lincolninst.edu).

Planning for Climate Change in the West, by Rebecca Carter and Susan Culp, acknowledges the critical role of local planners in confronting challenges posed by climate change. It also addresses the region’s many political, cultural, demographic, and geographic factors that can be barriers to innovation and effectiveness. The report can be downloaded at http://www.lincolninst.edu/pubs/1744_Planning-for-Climate-Change-in-the-West

“State and federal initiatives are important, but mitigation and adaptation will only happen if implemented on the ground, locally,” said Armando Carbonell, senior fellow and chairman of the Department of Planning and Urban Form at the Lincoln Institute.

“Western planners are emphasizing sustainability or economic efficiency, rather than climate change, in their decisions to manage water supplies, reduce energy consumption, increase transportation efficiency, and protect open space,” said Susan Culp, the report co-author and project manager of Western Lands and Communities, a joint venture of the Sonoran Institute and the Lincoln Institute. She cited a survey of nearly 50 government staff and elected officials in the Intermountain West indicating local skepticism that climate change was a problem in many communities. According to the research, a significant number of residents in these communities are unconvinced that climate change is human-caused and they perceive the issue as global and remote.

Planning for Climate Change in the West (http://www.lincolninst.edu/pubs/1744_Planning-for-Climate-Change-in-the-West) is the latest Policy Focus Report from the Lincoln Institute. It was released today at the New Partners for Smart Growth conference in Seattle, an annual symposium on sustainability and land use that runs Feb. 4-6 and includes presentations by Housing and Urban Development Secretary Shaun Donovan, Environmental Protection Agency Administrator Lisa Jackson, and Department of Transportation Secretary Ray LaHood. The report is available at the exhibition booth of the Lincoln Institute and Sonoran Institute and can be downloaded free online at www.lincolninst.edu.

The Intermountain West, primarily arid landscapes that include all or a portion of 11 states west of the Rocky Mountains, is in a unique position when it comes to climate change. Climate change impacts are expected to wreak particular havoc on the region, yet it remains difficult to pursue many mitigation or adaptation strategies for political and cultural reasons.

The West has been shaped by dramatic fluctuations in its water and energy resources, land use patterns, economy, and a climate known for its extremes. In the decades ahead, the hydrology of the region will become even drier, leading to drought, heat waves, diminished mountain snowpack, earlier snowmelt, catastrophic wildfires, and disruptions to natural processes and wildlife habitat.

Faced with the challenge of both adapting to these impacts, and contributing to mitigation through the reduction of greenhouse gas (GHG) emissions, planners in western communities should adopt the policy language of cost-effectiveness, the report says. An array of smart growth strategies, with an emphasis on land use and transportation policies, double as climate solutions leading to more resilient communities: building codes and standards, compact mixed-use development, transportation alternatives, distributed and renewable energy, water resource consumption and planning, preservation of open space and agriculture, and mitigation of wildfire impacts. To integrate climate-oriented policies into land use and development agendas, the report encourages planners to:

• Mobilize the political will. Focus on sustainability, economic and energy efficiency, and the co-benefits of local actions, rather than politically controversial policies and goals.

• Recognize local action and citizen participation. Coordinate state and local activities to address climate change, and use public education about climate change impacts to foster citizen participation and buy-in for local programs.

• Establish peer community networks on a regional scale. Develop peer learning networks with guidance from state climate action plans and regional initiatives to help smaller communities learn from each other.

• Identify resources and a variety of options. Refer to state climate action plans region-wide for a variety of strategies and ideas that communities can select and apply to their own needs and circumstances.

• Adapt climate science to local planning needs. Seek out current information and tools in reports, Web sites, and other resources that can help planners translate available climate science for local use, and develop a baseline level of GHGs as a first step in measuring climate strategies and results.

Local planners in the Intermountain West face both the challenge and the opportunity to ensure a sustainable future for the region, where the need to respond to potential climate change impacts is particularly urgent. This report presents a regional context and reliable data, case studies, and planner-recommended guidelines for western communities to spur local actions that can minimize those threats.