FDA November 2008 Update On Feed Enforcement Activities To Limit The Spread Of BSE
To help prevent the establishment and amplification of Bovine Spongiform Encephalophathy (BSE) through feed in the United States, the Food and Drug Administration (FDA) implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, here called the Ruminant Feed Ban, became effective on August 4, 1997.
The following is an update on FDA enforcement activities regarding the ruminant feed ban. FDA’s Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA’s inspection database as of November 15, 2008. As of November 15, 2008, FDA had received over 66,000 inspection reports. The majority of these inspections (approximately 71%) were conducted by State feed control officials, with the remainder conducted by FDA officials.
Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment’s lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.
A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.
An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.
RENDERERS
These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient.
– Number of active firms whose initial inspection has been reported to FDA – 267
– Number of active firms handling materials prohibited from use in ruminant feed – 155 (58% of those active firms inspected)
– Of the 155 active firms handling prohibited materials, their most recent inspection revealed that:
- 0 firms (0%) were classified as OAI
- 3 firms (2.0%) were classified as VAI
LICENSED FEED MILLS
FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under the Ruminant Feed Ban.
– Number of active firms whose initial inspection has been reported to FDA – 1.075
– Number of active firms handling materials prohibited from use in ruminant feed – 494 (46% of those active firms inspected)
– Of the 494 active firms handling prohibited materials, their most recent inspection revealed that:
- 0 firms (0%) were classified as OAI
- 4 firms (0.8 %) were classified as VAI
FEED MILLS NOT LICENSED BY FDA
These feed mills are not licensed by the FDA to produce medicated feeds.
– Number of active firms whose initial inspection has been reported to FDA – 5,290
– Number of active firms handling materials prohibited from use in ruminant feed – 2,685 (51% of those active firms inspected)
– Of the 2,685 active firms handling prohibited materials, their most recent inspection revealed that:
- 0 firms (0%) were classified as OAI
- 29 firms (1.1%) were classified as VAI
PROTEIN BLENDERS
These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills.
– Number of active firms whose initial inspection has been reported to FDA – 387
– Number of active firms handling materials prohibited from use in ruminant feed – 196 (51% of those active firms inspected)
– Of the 196 active firms handling prohibited materials, their most recent inspection revealed that:
- 0 firms (0%) was classified as OAI
- 0 firms (0%) were classified as VAI
RENDERERS, FEED MILLS, AND PROTEIN BLENDERS MANUFACTURING WITH PROHIBITED MATERIAL
This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients.
– Total number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,712
– Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 506 (7.5%)
– Of the 506 active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that:
- 0 firms (0%) were classified as OAI
- 11 firms (2.2%) were classified as VAI
OTHER FIRMS INSPECTED
Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters.
– Number of active firms whose initial inspection has been reported to FDA – 21,865
– Number of active firms handling materials prohibited from use in ruminant feed – 7,295 (33% of those active firms inspected)
– Of the 7,295 active firms handling prohibited materials, their most recent inspection revealed that:
- 0 firm (0%) were classified as OAI
- 113 firms (1.5%) were classified as VAI
TOTAL FIRMS
Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below.
– Number of active firms whose initial inspection has been reported to FDA – 24,065
– Number of active firms handling materials prohibited from use in ruminant feed – 7,876 (33% of those active firms inspected)
– Of the 7,876 active firms handling prohibited materials, their most recent inspection revealed that:
- 0 firms (0%) were classified as OAI
- 121 firms (1.5%) were classified as VAI
Source
FDA, Center for Veterinary Medicine
http://www.fda.gov/cvm
Method By Which A Protein That Determines Cell Polarity Prevents Breast Cancer
In breast tissue, cells lining the breast’s ducts have a certain shape that is required to maintain both organ structure and function. All breast cancers display a loss of this characteristic organization, but very little is known about the molecules and pathways that regulate tissue structure and the role they play during cancer.
A team of scientists at Cold Spring Harbor Laboratory (CSHL) has now discovered that a protein called Scribble, originally discovered as a cell-shape regulator in fruit flies and worms, is an important regulator of breast cancer. They report that normal function of Scribble protein allows breast epithelial cells to form duct-like structures and resist cancer formation. When Scribble stops functioning, the tissue loses its shape and cancers ensue.
A new approach to understanding how cancer begins
The discovery identifies “a new paradigm for understanding how cancer initiates,” according to CSHL Professor Senthil Muthuswamy, Ph.D., who headed the team that conducted the research, published in Cell on Nov. 26. The results also constitute first steps toward identifying an entirely new class of molecules and pathways that can be targeted by anti-cancer therapies to prevent pre-cancerous lesions from turning into malignant tumors.
“Thinking about cancer as a disease that results only due to an increase in cell numbers is too simplistic,” according to Muthuswamy. He points out that proteins that control cell number and regulate cell structure are both critical in cancer development. He therefore proposes that carcinomas–cancers derived from epithelial cells in organs such as breast, ovary, prostate, lung and pancreas–should be approached as a problem of “deregulated morphogenic processes and not just as a disease of increased cell number.”
Seeing cells in three dimensions
Many studies aimed at unraveling cancer’s molecular mechanisms use cells cultured on plastic dishes as an experimental platform. “Such models have been quite satisfactory in allowing scientists to analyze mechanisms involved in cell growth” says Muthuswamy. But they don’t allow scientists to capture the three-dimensional organization of cells seen in tissue, including their polarity. A major enabler for Muthuswamy’s current work is an experimental model system that enables him to grow breast cells in three-dimensional cultures to allow them to form structures similar to those seen in breast ducts and lobules.
On Muthuswamy’s novel test bed, cells undergo morphogenesis — a growth/death cycle that expands and shapes tissue. Such cells give rise to what looks like a hollow ball of cells. The polarity protein Scribble lines the sides of each cell, lending to each a specific orientation.
What happens when Scribble is missing?
In breast epithelial cells grown in this new experimental culture system, when the Scribble protein is missing, cells were observed by Muthuswamy’s team to radically change their character and behavior. They lost their orientation — an effect one might have predicted since Scribble regulates polarity — and started to fill the hollow ball.. The team hypothesized that the filling-in of the “ball” was akin to the process, in living creatures, by which a breast epithelial tumor would form.
To test this notion, the experiment was moved from a cell-culture dish to living animals. Mouse breasts were generated using genetically engineered cells that had stopped producing the Scribble protein. In such mice, the researchers found that breast ducts were deformed and tumors typically developed after about one year’s time. This dramatic result pointed to Scribble, a cell shape regulator, as a tumor suppressor in breast epithelial cells.
The targets of tumor suppressors are usually cancer-causing genes, or oncogenes, such as Myc, which past research has shown to be overexpressed, i.e., present in abnormal quantity, in human breast cancer. Myc is known to activate pathways of both growth and death in breast epithelial cells. In fact, the only way that cancer can occur when Myc is overexpressed is if some other mechanism blocks its propensity to induce abnormal cells to commit suicide, a process called apoptosis. Muthuswamy and colleagues now identify this “other mechanism” as the loss of the Scribble protein, which thus is revealed to be a tumor suppressor protein.
Cells engineered by the CSHL team to lack Scribble and overexpress Myc not only stayed alive, but also went into a growth overdrive. The combined effect of polarity loss and Myc overactivation was the formation of unusually large and fast-growing breast epithelial tumors.
The CSHL team worked out the molecular players and specific intracellular pathway controlled by Scribble to initiate cell death. This revealed that Scribble only works as a cancer deflector when it finds itself in the right location–within the junctions between cells. Cellular disorientation occurs when mutations in the gene that orders Scribble to be produced in a cell either prevents its expression or causes it to be expressed in the wrong location within the cell. In either case, the same severe consequence ensues: cancer progression.
How Scribble gets deregulated in cancer remains a mystery. The CSHL team is now addressing the question of how the deregulated Scribble pathway can be targeted for diagnosis and treatment.
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Article adapted by Medical News Today from original press release.
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“Deregulation of Scribble promotes mammary tumorigenesis and reveals a role for cell polarity in carcinoma” appears in the November 2008 issue of Cell. The full citation is: Lixing Zhan, Avi Rosenberg, Kenneth C. Bergami, Min Yu, Zhenyu Xuan, Aron B. Jaffe, Craig Allred, and Senthil K. Muthuswamy. The paper appears online at http://www.cell.com/ on Nov 26th 2008.
Cold Spring Harbor Laboratory (CSHL) is a private, not-for-profit research and education institution at the forefront of efforts in molecular biology and genetics to generate knowledge that will yield better diagnostics and treatments for cancer, neurological diseases and other major causes of human suffering.
For more information please visit http://www.cshl.edu/.
Source: Hema Bashyam
Cold Spring Harbor Laboratory
Value Of Advanced CT Scans To Check For Clogged Arteries Supported By Study
In a development that researchers say is likely to quell concerns about the value of costly computed tomography (CT) scans to diagnose coronary artery blockages, an international team led by researchers at Johns Hopkins reports solid evidence that the newer, more powerful 64-CT scans can easily and correctly identify people with major blood vessel disease and is nearly as accurate as invasive coronary angiography.
Reporting in the New England Journal of Medicine online Nov. 26, researchers at nine medical centers say the faster, 64-CT scans were 93 percent as precise as invasive, conventional imaging, better known as cardiac catheterization and virtually 100 percent accurate in detecting people with at least one artery dangerously clogged by the buildup of cholesterol and plaque.
Comparison of CT and catheterization results also showed for the first time that they were equally useful in patients with heart attack symptoms, such as chest pain and shortness of breath, for predicting the need for cardiac bypass surgery or angioplasty to restore their blood flow. The CT scans accurately predicted 84 percent of invasive procedures performed, and catheterization predicted 82 percent. More than a quarter-million Americans undergo coronary bypass surgery each year, and another 1.2 million people undergo angioplasty.
Announcement of the latest findings was timed to coincide with the annual meeting of the Radiological Society of North America in Chicago, after initial results were reported last year at an annual meeting of cardiologists.
Senior study investigator and Johns Hopkins cardiologist João Lima, M.D., says 64-CT scans are not a substitute for catheterization, but the scans, which take between five and 10 seconds to perform, are “an alternative diagnostic tool” physicians can use to “rule in or rule out” coronary blockages when other, more indirect tests for reduced blood flow, such as cardiac stress testing, are unclear or unsafe for a particular patient.
Cardiac catheterization, which also checks the function of heart valves and muscle, takes longer, between 30 minutes and 45 minutes to perform, and requires more than an hour for recovery. Potential complications from the invasive procedure include infection, heart attack and stroke; however, these events are rare.
Lima, a professor of medicine and radiology at The Johns Hopkins University School of Medicine and its Heart and Vascular Institute, says the 64-CT scans, first introduced to the United States and tested at Hopkins in 2005, could reduce as much as one-fifth of the 1.3 million cardiac catheterizations performed each year nationwide that show no blockages.
CT scans for heart disease, although not yet covered by many private health plans, could also serve as an alternative to cardiac stress testing, which generally cannot safely be performed on the weak and elderly because the test uses hard exercise to speed up blood flow and measure heart function.
Lima says previous research had shown that older, less-powerful 16-CT scans were only a quarter to a third as precise as the newer tests, “fuelling much heated debate as to whether or not use of the technology could ever be justified.
“But our latest findings weigh heavily in favor of the more advanced 64-CT scans,” he adds, citing additional study results showing that the scans could pinpoint with 91 percent certainty the precise artery blocked. At four times the strength of the more widely available 16-CT scanner, Lima says the 64-CT scans “provided our first real view of the whole picture of what is going on in the artery, precisely where the blockage is, even if it is only a partially obstructed.”
Lead study investigator and interventional cardiologist Julie Miller, M.D., says the advanced scanners are so good that physicians can for the first time measure blockages in blood vessels as small as 1.5 millimeters in diameter. Older 16-CT scanners, she says, are best suited for looking inside bigger arteries, those greater in diameter than 2 millimeters.
Each of the 291 men and women, all over the age of 40, selected to participate in the new study were already scheduled to have cardiac catheterization to check for blocked arteries. Every participant had a 64-CT scan prior to catheterization and was then monitored through regular check-ups, starting in 2005 and set to continue through 2009, to identify who developed or did not develop any heart problems, who required subsequent bypass surgery or angioplasty, and who did not need any procedure.
Researchers found that 90 percent of the patients without any major blockages were correctly diagnosed with 64-CT scans.
The disadvantages of using 64-CT, Miller says, are radiation exposure and the rare potential in some people to have an allergic reaction or to develop kidney problems resulting from the contrast dyes injected into the body to enhance the images.
“CT technology has come a long way in the last decade,” says Miller, the leader of angiographic research and an assistant professor at Hopkins. She cites improvements that cut the average amount of radiation exposure and time required for a CT scan to less than 20 millisieverts with 16-CT scanners (which took about 12 seconds to perform), on average, to less than 15 millisieverts with 64-CT devices (at close to 6 seconds), and less than 6 millisieverts with the 320-CT (at less than a second.)
She says the cost of the newer CT scans – approximately $700 – compares favorably with that of current nuclear stress testing for reduced blood flow, in which radioactive dyes are used to detect arterial clogs, at nearly $1,000.
In cardiac catheterization, a thin tube is threaded into a blood vessel in the groin area to the heart’s arteries, where a dye is released to produce a clear X-ray image of the beating heart and its arterial blood supply. The procedure usually costs in excess of $1,500.
In CT imaging, computer-driven machinery passes X-rays through the body, producing digitized signals from multiple angles that are detected and reconstructed for a precise picture.
Miller points out that early detection of blockages is critical to preempting a heart attack, allowing time for drug therapy, angioplasty or heart bypass surgery to be used to keep arteries open. In coronary artery disease, hardened bits of fat and dead tissue, called plaque, build up along the inside wall of the blood vessels, impeding the body’s natural blood flow and leaving the narrowed opening more vulnerable to formation of blood clots.
Lima says the team’s next steps are head-to-head comparison studies using either CT or nuclear stress testing, which gauges reduced blood flow in parts of the heart to reveal clogging arteries. Included in the next analysis will be scans performed using an even more advanced scanner, the 320-CT. The latest imaging device was also tested at Johns Hopkins in 2006, and it can obtain images in less than a second, with significant reductions in radiation exposure.
According to researchers, nearly 5,000 64-CT scanners are installed worldwide, but not all of the centers are equipped to perform and read cardiac CTs. Miller notes that special training and certification are required by technicians and physicians to accurately perform, read and interpret the scanned images. The American Heart Association and the American College of Cardiology Foundation in 2005 jointly established training guidelines.
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Article adapted by Medical News Today from original press release.
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The CT scanner used in the study was an Aquilion 64 multidetector CT scanner, manufactured by Toshiba. Similar devices also are manufactured by Siemens, Phillips and General Electric.
Toshiba also provided funding support for the study, called CORE-64, short for Coronary Artery Evaluation using 64-row Multidetector Computed Tomography.
In addition to Lima and Miller, other Hopkins researchers involved in this study were Armin Zadeh, M.D.; Ilan Gottlieb, M.D.; Edward Shapiro, M.D.; Albert Lardo, Ph.D.; David Bush, M.D.; Christopher Cox, Ph.D.; and Jeffrey Brinker, M.D. Other investigators included in the international team are Carolos E. Rochitte, from the University of Sao Paolo in Brazil, and the lead recruiter of study participants; Marc Dewey, from Humbolt University in Charite, Germany; Hiroyuki Niinuma, from Iwate Medical University in Japan; Narinder Paul, from the University of Toronto in Canada; Melvin Clouse, from Beth Israel Deaconess Hospital in Boston, Mass., and a professor emeritus in radiology at Harvard University; John Hoe, from Mount Elizabeth Hospital of Singapore; and Albert de Roos, from Leiden University in the Netherlands.
For additional information, please go to: http://www.hopkinsmedicine.org/Press_releases/2007/11_05_07.html
Video clips of Lima and Miller commenting about the study can be found online at http://www.hopkinsmedicine.org.
Source: David March
Johns Hopkins Medical Institutions
Wisconsin A Leader In Pressure Ulcer Initiatives
The Wisconsin Department of Health Services announces that health care leaders from across the state have formed the Wisconsin Pressure Ulcer Coalition to help reduce pressure ulcers in Wisconsin’s health care industry, including nursing homes and hospitals. A pressure ulcer, also known as a bedsore, is a painful condition that can occur in individuals who are unable to move without assistance.
“Wisconsin continues to be an innovative leader in finding ways to help improve the quality of care of our loved ones,” said Department Secretary Karen Timberlake. “Wisconsin and New Jersey are the only states taking these types of steps – and Wisconsin is looking at the full spectrum of regulated health care facilities. These types of partnerships and collaborations are what we need to help us move forward and it’s what our citizens deserve.”
The Centers for Medicare and Medicaid Services (CMS) has set a goal to reduce the number of residents nationwide that develop pressure ulcers to eight percent. Wisconsin has performed consistently better than the federal goal with an average holding steady at approximately seven percent of nursing homes residents affected by pressure ulcers. CMS currently does not have figures for other types of health care settings. The goals of the Wisconsin Pressure Ulcer Coalition are to:
- Decrease the incidence of pressure ulcers in our health care settings
- Continue to educate caregivers and leaders about effective preventive measures
- Improve assessment when an individual is admitted to a health care facility, as well as continue to monitor appropriately
- Develop appropriate prevention strategies within 24 hours if individual identified to be at risk of developing pressure ulcers
- Improve communication between providers to provide a better continuity of care
MetaStar is the Quality Improvement Organization for Wisconsin’s health care facilities. According to Jennifer Harrison, Nursing Home Project Lead, “pressure ulcers are not just a concern for one health care setting, but an issue for all of those represented on the Coalition. This Coalition is intended to address pressure ulcer prevention across the entire continuum of care by bringing all of these players together to help facilitate communication and problem solving at many levels.”
According to CMS, pressure ulcers affect more than 1 million patients annually across the nation in both hospitals and nursing homes. The costs associated with caring for pressure ulcers exceed $1.3 billion.
Stakeholders who are currently part of the Wisconsin Pressure Coalition are:
- Wisconsin Department of Health Services
- MetaStar, Wisconsin’s Quality Improvement Organization
- American Medical Technologies
- Association for Professionals in Infection Control – Southeastern WI Chapter
- Hospice Organization Palliative Experts of Wisconsin
- The Laureate Group
- Rural Wisconsin Health Cooperative
- Specialized Medical Services, Inc.
- Wisconsin Assisted Living Association
- Wisconsin Association of Homes and Services for the Aging
- Wisconsin Health Care Association
- Wisconsin Hospital Association
- Representatives from a variety of nursing homes, home health organizations and hospitals
In June, the Department announced the Wisconsin Wound Care Initiative which trains registered nurses from across the state to become certified in the prevention and treatment of pressure ulcers. The public-private collaboration more than doubles the wound care specialists in the state.
The 224 new wound care specialists were certified through a week-long course this fall. This collaborative effort in mass training of staff is the first of its kind in the nation. The model is novel and unique, signifying Wisconsin’s commitment in continually searching for ways to improve quality of care.
The Wisconsin Wound Care Initiative was made possible by the following sponsors:
- Wisconsin Department of Health Services
- Wisconsin Health Care Association
- Wisconsin Association of Homes and Services for the Aging
- Wisconsin Directors of Nursing Council
- National Alliance of Wound Care
- West Bend Mutual Insurance
- GuideOne Insurance
- Golden Living
- Kindred Healthcare Foundation
- MetaStar
Below are some quotes from a variety of organizations regarding the Wisconsin Pressure Ulcer Coalition
American Medical Technologies
“AMT is committed to working with the state of Wisconsin and the Pressure Ulcer Coalition to significantly reduce pressure ulcers and improve the quality of life for those suffering from pressure ulcers,” said Charles Gokoo, MD, Chief Medical Officer at AMT.
HospiceCare Inc. – Rock County
“This is a great opportunity for hospices to work with healthcare providers throughout Wisconsin to improve quality of life for patients and their families, “said Jane Quinn, VP of HospiceCare Inc. – Rock County and representative of the HOPE of Wisconsin.
Wisconsin Assisted Living Association
“Assisted living providers are beginning to face the same issues of protecting skin integrity of their residents. The results of this initiative will help provide best practices for providers of all sizes and regulatory categories in order to meet the rising acuity in assisted living,” said Jim Murphy, WALA Executive Director. “WALA will help take this message to the assisted living providers statewide to increase care for our residents.”
Wisconsin Association of Homes and Services for the Aging “This collaborative effort clearly demonstrates the positive and proactive work of a diverse group of organizations that are serious about raising the bar of quality throughout our health and long term care systems. We are confident the Coalition’s work will significantly improve the lives of persons in need of ongoing care and services,” said John Sauer, WAHSA Executive Director.
Wisconsin Health Care Association
“Wisconsin is already one of the top states in the nation in successful treatment outcomes,” said Tom Moore, Executive Director of WHCA. “But this collaboration, along with the Wisconsin Wound Care Initiative launched this year, is going to take our state from good to great in preventing and treating pressure ulcers. I’m proud to partner with this coalition, which will help Wisconsin’s health care providers work individually and collectively with a common goal of improving the quality of care for patients statewide.”
Wisconsin Hospital Association
Dana Richardson, Vice President, Quality Initiatives, WHA, said, “The Coalition hopes to have 100 providers participate in the first year of the project, if funding is obtained to support that number of participants.” Funding for the Coalition will be provided in various ways. Coalition members will all contribute and participants will pay a fee, which will vary depending on the provider’s size.
Wisconsin Department of Health Services
Report Shows Approximately 420,000 Wisconsin Adults Have Diabetes
State health officials are stressing a healthier lifestyle as a new Department report shows that one in every 10 Wisconsin adults has diabetes, making the disease a major health concern.
“It’s fair to describe the spread of diabetes in Wisconsin as an epidemic-and it shows no sign of easing,” said Secretary Karen Timberlake. “Nearly 420,000 Wisconsin adults have diabetes and it’s estimated that approximately 125,000 of them don’t even know they have the disease.”
According to the Department’s 2008 Burden of Diabetes in Wisconsin report, adult prevalence of diabetes increased more than 27 percent from 329,460 to 419,870 during the past five years. According to the 2008 statistics, the state’s ethnic groups bear a disproportionate share of the burden of diabetes. The prevalence of diabetes in Wisconsin is 1.96 times higher in Hispanic/Latino Americans, 2.25 times higher in African Americans and 5.4 times higher in American Indians compared to whites.
The cost of diabetes and its serious complications is staggering. The direct (medical care) and indirect (lost workdays, restricted activity days, permanent disabilities and death) costs of diabetes in Wisconsin adults total an estimated $5.26 billion. Of the $5.26 billion, approximately:
- $3.46 billion is spent on direct medical expenditures for adults with diabetes
- $1.73 billion is spent on indirect costs for adults with diabetes
- Approximately $70.5 million is spent on directs costs for children and adolescents with diabetes.
Diabetes is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert the food we eat into energy needed for daily life. There are two types of diabetes: “Type 1″ occurs when the body has little or no insulin and therefore insulin is needed to survive. “Type 2″ occurs when the body does not make enough insulin, or it may not be able to use the insulin as it should. A person with diabetes is at an increased risk of complications, including blindness, kidney disease, amputations, and heart disease.
Most people with diabetes have Type 2. Age, being overweight or obese, and a sedentary lifestyle are three of the risk factors for developing Type 2 diabetes. A recent United Health Foundation report showed that nearly 27 percent of Wisconsin’s population is now obese, compared to 11 percent in 1990.
Timberlake noted that although Type 1 diabetes is not preventable, eating a healthy diet and being physically active can help control blood sugar, which also may prevent or delay the onset of Type 2 diabetes. “An investment in a healthier lifestyle now can improve the quality of life for all individuals, and reduce healthcare costs for society at large,” she said.
For more information about diabetes, go to http://dhs.wisconsin.gov/health/diabetes
Wisconsin Department of Health Services
Hawaii Department Of Health STD/AIDS Prevention Branch Selects Tom Sheeran To Receive Suzanne Richmond-Crum Award
The Hawai’i State Department of Health STD/AIDS Prevention Branch is pleased to honor Tom Sheeran with the 5th Annual Suzanne Richmond-Crum Award. Actively involved in the HIV/AIDS community in Hawai’i for nearly 20 years, Sheeran will be presented with the award at the World AIDS Day event on O’ahu, to be held from 7:00 – 8:30 p.m. on Monday, December 1st at St. Clement’s Church at 1515 Wilder Avenue in Honolulu. Sheeran will be present to receive his award.
“Tom Sheeran has consistently been committed to supporting all aspects of the HIV/AIDS community in Hawai’i, from being an advocate for persons with HIV/AIDS to assisting local organizations and agencies with their advocacy efforts,” said Peter Whiticar, Chief of the DOH STD/AIDS Prevention Branch. “In all of these activities, he has given of his time selflessly on behalf of persons with HIV/AIDS. Sheeran is clearly a person deserving of recognition. This award provides an opportunity to acknowledge the commitment and compassion he has demonstrated to this community for almost two decades.”
Dedicated to the memory of Suzanne Richmond-Crum, the former Director of the Hawai’i Seropositivity and Medical Management Program HSPAMM (an HIV/AIDS medical care program of the STD/AIDS Prevention Branch), the award is presented annually to an individual “for outstanding contribution in providing HIV/AIDS services in Hawai’i.” Richmond-Crum passed away in August 2004 after serving as Director of HSPAMM for more than 10 years. Those who knew her admired the pride, commitment, competence and compassion she exhibited in all aspects of her professional life.
Tom Sheeran worked in the area of HIV/AIDS in Hawai’i for approximately 20 years as an openly HIV-positive gay man. He began attending People With AIDS Coalition (PWAC) meetings in Hawai’i in 1989, and became a PWAC Board member in 1995. In 1997, as PWAC-Hawai’i President, Mr. Sheeran organized the first, and only, statewide conference for PWAs.
From 1996-2005, Sheeran was a community member of the Governor’s Committee on HIV/AIDS and in 1996 became the first openly HIV-positive member of the Board of Directors of Gregory House Programs, an agency that provides housing services statewide for people with HIV/AIDS .
Sheeran was a community member of Hawai’i CARES, the statewide HIV/AIDS care planning group, from 2000-2004, serving as Co-Chair for two years. One of his most effective roles has been as World AIDS Day Co-Chair for O’ahu since 2003.
As an advocate for persons living with HIV/AIDS (PLWHA), Sheeran lobbied for funding and bills at the Hawai’i legislature, and has helped to organize several HIV-related public service campaigns.
The public is invited to attend the World AIDS Day service on December 1st where Sheeran will be presented with the Suzanne Richmond-Crum Award.
There are many activities occurring statewide for World AIDS Day, December 1st, including other O’ahu-based events and Neighbor Island activities. For more information on all statewide World AIDS Day events, go to: http://www.worldaidsdayhawaii.org
World AIDS Day
A Potentially Universal Mechanism Of Aging Identified By Researchers
Like our current financial crisis, the aging process might also be a product of excessive deregulation.
Researchers have discovered that DNA damage decreases a cell’s ability to regulate which genes are turned on and off in particular settings. This mechanism, which applies both to fungus and to us, might represent a universal culprit for aging.
“This is the first potentially fundamental, root cause of aging that we’ve found,” says Harvard Medical School professor of pathology David Sinclair. “There may very well be others, but our finding that aging in a simple yeast cell is directly relevant to aging in mammals comes as a surprise.”
These findings appear in the November 28 issue of the journal Cell.
For some time, scientists have know that a group of genes called sirtuins are involved in the aging process. These genes, when stimulated by either the red-wine chemical resveratrol (http://web.med.harvard.edu/sites/RELEASES/html/11_1Sinclair.html) or caloric restriction (http://web.med.harvard.edu/sites/RELEASES/html/sinclair.html), appear to have a positive effect on both aging and health.
Nearly a decade ago, Sinclair and colleagues in the Massachusetts Institute of Technology lab of Leonard Guarente found that a particular sirtuin in yeast affected the aging process in two specific ways – it helped regulate gene activity in cells and repair breaks in DNA. As DNA damage accumulated over time, however, the sirtuin became too distracted to properly regulate gene activity, and as a result, characteristics of aging set in.
“For ten years, this entire phenomenon in yeast was considered to be relevant only to yeast,” says Sinclair. “But we decided to test of this same process occurs in mammals.”
Philipp Oberdoerffer, a postdoctoral scientist in Sinclair’s Harvard Medical School lab, used a sophisticated microarray platform to probe the mammalian version of the yeast sirtuin gene in mouse cells. The results in mice corroborated what Sinclair, Guarente, and colleagues had found in yeast ten years earlier.
Oberdoerffer found that a primary function of sirtuin in the mammalian system was to oversee patterns of gene expression (which genes are switch on and which are switch off). While all genes are present in all cells, only a select few need to be active at any given time. If the wrong genes are switched on, this can harm the cell. (In a kidney cell, for example, all liver genes are present, but switched off. If these genes were to become active, that could damage the kidney.) As a protective measure, sirtuins guard genes that should be off and ensure that they remain silent. To do this, they help preserve the molecular packaging – called chromatin – that shrink-wraps these genes tight and keeps them idle.
The problem for the cell, however, is that the sirtuin has another important job. When DNA is damaged by UV light or free radicals, sirtuins act as volunteer emergency responders. They leave their genomic guardian posts and aid the DNA repair mechanism at the site of damage.
During this unguarded interval, the chromatin wrapping may start to unravel, and the genes that are meant to stay silent may in fact come to life.
For the most part, sirtuins are able to return to their post and wrap the genes back in their packaging, before they cause permanent damage. As mice age, however, rates of DNA damage (typically caused by degrading mitochondria) increase. The authors found that this damage pulls sirtuins away from their posts more frequently. As a result, deregulation of gene expression becomes chronic. Chromatin unwraps in places where it shouldn’t, as sirtuin guardians work overtime putting out fires around the genome, and the unwrapped genes never return to their silent state.
In fact, many of these haplessly activated genes are directly linked with aging phenotypes. The researchers found that a number of such unregulated mouse genes were persistently active in older mice.
“We then began wondering what would happen if we put more of the sirtuin back into the mice,” says Oberdoerffer. “Our hypothesis was that with more sirtuins, DNA repair would be more efficient, and the mouse would maintain a youthful pattern gene expression into old age.”
That’s precisely what happened. Using a mouse genetically altered to model lymphoma, Oberdoerffer administered extra copies of the sirtuin gene, or fed them the sirtuin activator resveratrol, which in turn extended their mean lifespan by 24 to 46 percent.
“It is remarkable that an aging mechanism found in yeast a decade ago, in which sirtuins redistribute with damage or aging, is also applicable to mammals,” says Leonard Guarente, Novartis Professor of Biology at MIT, who is not an author on the paper. “This should lead to new approaches to protect cells against the ravages of aging by finding drugs that can stabilize this redistribution of sirtuins over time.”
Both Sinclair and Oberdoerffer agree with Guarente’s sentiment that these findings may have therapeutic relevance.
“According to this specific mechanism, while DNA damage exacerbates aging, the actual cause is not the DNA damage itself but the lack of gene regulation that results,” says Oberdoerffer. “Lots of research has shown that this particular process of regulating gene activity, otherwise known as epigenetics, can be reversed – unlike actual mutations in DNA. We see here, through a proof-of-principal demonstration, that elements of aging can be reversed.”
Recent findings by Chu-Xia Deng of the National Institute of Diabetes, Digestive and Kidney Diseases, also discovered that mice that lack sirtuin are susceptible to DNA damage and cancer, reinforcing Sinclair’s and Oberdoerffer’s data.
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Article adapted by Medical News Today from original press release.
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This research was funded by the National Institutes of Health, and the Glenn Foundation for Medical Research. David Sinclair is a consultant to Genocea, Shaklee and Sirtris, a GSK company developing sirtuin based drugs.
Written by David Cameron
Full citation:
Cell, November 28, 2008 Volume 135, Issue 6
“SIRT1 Redistribution on Chromatin Promotes Genome Stability but Alters Gene Expression during Aging”
Philipp Oberdoerffer(1), Shaday Michan(1), Michael McVay(1), Raul Mostoslavsky(2), James Vann(3), Sang-Kyu Park(3), Andrea Hartlerode(4), Judith Stegmuller(1,7), Angela Hafner(1), Patrick Loerch(1), Sarah M. Wright(5), Kevin D. Mills(5), Azad Bonni(1), Bruce A. Yankner(1), Ralph Scully(4), Tomas A. Prolla(3), Frederick W. Alt(6), and David A. Sinclair(1)
- Department of Pathology and Glenn Labs for Aging Research, Harvard Medical School, Boston, MA
- Massachusetts General Hospital Cancer Center, Boston, MA
- University of Wisconsin, Department of Genetics and Medical Genetics, Madison, WI
- Beth Israel Deaconess Medical Center, Boston, MA
- The Jackson Laboratory, Bar Harbor, ME
- Howard Hughes Medical Institute, Children’s Hospital Boston, Immune Disease Institute, and Department of Genetics, Harvard Medical School, Boston, MA
- Present address: Max Planck Institute for Experimental Medicine, 37075 Gottingen, Germany
Harvard Medical School http://hms.harvard.edu has more than 7,500 full-time faculty working in 11 academic departments located at the School’s Boston campus or in one of 47 hospital-based clinical departments at 18 Harvard-affiliated teaching hospitals and research institutes. Those affiliates include Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Cambridge Health Alliance, Children’s Hospital Boston, Dana-Farber Cancer Institute, Forsyth Institute, Harvard Pilgrim Health Care, Hebrew SeniorLife, Joslin Diabetes Center, Judge Baker Children’s Center, Immune Disease Institute, Massachusetts Eye and Ear Infirmary, Massachusetts General Hospital, McLean Hospital, Mount Auburn Hospital, Schepens Eye Research Institute, Spaulding Rehabilitation Hospital, and VA Boston Healthcare System.
Source: David Cameron
Harvard Medical School
Hawaii Public School Students Report Smoking Less
Lt. Governor James R. “Duke” Aiona, Jr. and the Hawai’i State Department of Health (DOH) Tobacco Prevention and Control Program today released a study that shows fewer youth identifying themselves as smokers. The Youth Tobacco Survey (YTS) also found fewer youth experimenting with cigarettes as well as being exposed to second-hand smoke.
“I’m very proud that more of our Hawai’i youth are making the right decision not to smoke,” said Lt. Governor Aiona. “The data demonstrates that the work of our statewide network of tobacco prevention and control partners is making a positive difference.”
The survey, administered jointly by the Department of Health and Department of Education to public school students in grades 6 – 12, is conducted every two years.
“After the dramatic reductions in youth smoking from the 2003 YTS data, we are really pleased to see that our progress continues,” said Deputy Director of Health Resources Morgan Barrett, M.D. “When we started collecting data on youth smoking in 1993, youth smoking rates for high school were 28.2 percent; now they are less than one third that number (9.7 percent).”
While the YTS results are positive, there is still concern that younger people who smoke are reporting more diverse ways to obtain cigarettes, including using the Internet. Therefore, parents need to be watchful of their children’s online activities.
Additionally, the tobacco industry is increasing the marketing of smokeless tobacco products and other tobacco products that appeal to youth. The smokeless tobacco rates among Hawai’i’s youth has slightly increased from 2005 and DOH will continue to closely monitor these rates.
Program initiatives over the past decade that represent the state’s comprehensive approach to tobacco control include: increases in the price of cigarettes; the creation and enforcement of laws preventing youth access to tobacco products; the adoption of smoke-free indoor air laws and policies on school campuses and in workplaces; conducting an aggressive youth-focused anti-tobacco media and counter-marketing campaign; improvements in school curriculum; enhanced data collection, surveillance and program evaluation; youth involvement in tobacco prevention and control; and the implementation of a smoking cessation Quitline (1-800-QUIT-NOW.)
Tobacco Fact Sheet
The Hawaii Youth Tobacco Survey is a bi-annual survey administered by the Departments of Health and Education to public school students in grades 6 – 12. In all, 1,172 students from 27 schools participated in the middle school survey and 1,211 students from 27 schools participated in the high school survey. The survey results are weighted to be representative of the public school population in Hawaii.
Results from the survey, conducted in the fall of 2007, revealed that:
- Fewer young people report experimenting with cigarettes, with the proportions ever trying cigarettes plummeting from 38.4% in 2000 to only 14.7% in 2007 among middle school students and from 63.3% in 2000 to 38.3% in 2007 among high school students.
- Fewer young people report being current smokers (those who have smoked on at least one of the past 30 days). Only 9.7% of high school students reporting current smoking (down from 24.5% in 2000) and only 4.2% of middle school students reporting current smoking (down from 12.9% in 2000).
- Fewer young people report being exposed to secondhand smoke (SHS), with only about one-third (35.5%) of middle school students reporting being exposed to SHS in a room in the past week (down from 53.7% in 2000) and 45.5% of high school students reporting SHS exposure (down from 68% in 2000).
- However, young people who smoke are reporting more diverse ways to obtain tobacco. There has been an increase in both middle and high school students reporting obtaining cigarettes from non-usual sources, including the internet.
Hawai’I Department of Health
Beware A Rapidly Emerging Healthcare-Associated Infection: Acinetobacter Baumannii
As a healthcare-associated infection, Acinetobacter baumannii is becoming a more serious influence as antibiotic resistances rates rise, and policy must encourage strict hygeine compliance and careful drug choice to prevent major outbreaks in the future, according to a Review released on November 18, the The Lancet Infectious Diseases.
According to author Professor Matthew E Falagas and Dr Drosos Karageorgopoulos, Alfa Institute of Biomedical Sciences, Athens, Greece, there are many environmental sources for Acinetobacter baumannii: soil; foods like vegetables, meat, and fish; and occasionally, the skin of healthy people. However, true infections of A. baumannii are usually only found in critically ill, hospitalized patients. Risk factors for infection include advanced age, serious co-morbidities or underlying diseases, immune suppression, major trauma or burns, invasive procedures (including indwelling catheters), support via mechanical ventilation, an extended hospital stay, and previous administration of a course of antibiotics.
Over the last three decades, new infections with A. baumannii have increased substantially, a change the authors potentially attribute to the availability of advanced medical support for critically ill patients, creating a larger vulnerably sub-population. It is also increasingly reported in the victims of war conflicts or mass destruction.
Recently, multidrug resistance in A. baumannii has been reported as 30%. While carbapenem antibiotics are usually considered standard treatment for such infection, as resistance rates rise, alternatives must be found. Most recently, sulbactam has been adopted, but this method is becoming less effective over time. Polymyxins are a promising new group which have recently surfaced in this struggle; also, minocycline and its derivative tigecycline, may have potential in this field. Ultimately, future therapies must be confirmed with further research.
Health care facilities around the world are suffering from issues related to antibiotic resistance rates in various pathogens. One well-known example of an antibiotic resistant pathogen is methicillin-resistant Staphylococcus aureus (MRSA). Due to continued interest in this public health problem, The Lancet Infectious Diseases will host a conference on healthcare-associated infections between December 11 and 12 in London, which will feature international experts in the field.
John McConnell, editor of The Lancet Infectious Diseases, notes the importance of this issues to today’s public health: “Modern medicine faces few greater challenges than that of healthcare-associated infections (HAIs). In the UK, one of the worst-affected countries in Europe, HAIs are estimated to cost the National Health Service at least £1 billion [1.5 billion USD] per year. Media attention has increased public pressure to tackle HAIs — a pressure that clinicians, researchers, and policy makers must deal with. The conference programme has been designed to combine state-of-the-art lectures with the opportunity for delegates to discuss management of HAIs with key opinion leaders.”
Current control and treatment of multidrug-resistant Acinetobacter baumannii infections
Drosos E Karageorgopoulos, Matthew E Falagas
Lancet Infect Dis 2008; 8: 751–62
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Written by Anna Sophia McKenney
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Australian Medical Students’ Association Welcomes COAG’s Investment Into Training The Future Australian Health Workforce
The Federal Government today announced a $1.1 billion health workforce package to be used to fund undergraduate clinical training in public and private hospitals and community settings, train and support clinical training supervisors, and build capital infrastructure including 45 new simulated learning centres.
The funding will also be used for the creation of a national health workforce agency to assist with workforce planning and improve coordination of clinical training across the country.
AMSA National President Michael Bonning said that the package recognised education as a cornerstone of the Australian health system, and was an important step towards ensuring a permanent solution to Australia’s medical workforce shortage.
“The number of medical, nursing and allied health students in Australia has increased significantly over the last decade,” Mr Bonning said.
“Training future doctors is not an economy of scale. For every increase in medical student numbers there must be a commensurate increase in medical school funding, the number of training positions available for junior doctors and the number of senior staff available to train them.
“This package capitalises on the recent increase in medical, nursing and allied health student numbers, and will ensure these students receive this highest quality training available,” Mr Bonning said.
“Furthermore, we hope the creation of a national health workforce agency will facilitate responsible future growth in the health workforce while ensuring maintenance of Australia’s high education and training standards,” he said.
The Federal Government is laying the foundations for a long-term solution to address the health workforce shortage, but AMSA warned that this investment should not be redirected by states.
“Training the health workforce is a shared Commonwealth-State responsibility and we call on the State governments to match this targeted investment in clinical training,” Mr Bonning said.
Australian Medical Students’ Association
