New Clinical Treatment Guideline Outlines Recommendations to Reduce Blood Clots After Hip and Knee Replacement - AAOS

09/28/2011
New Clinical Treatment Guideline Outlines Recommendations to Reduce Blood Clots After Hip and Knee Replacement
Guideline recommends postoperative blood thinners, compression, early mobilization to prevent clots
Rosemont, IL
 
An updated clinical practice guideline released last week by the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors recommends how to reduce the likelihood of blood clots after hip or knee replacement surgery, procedures that more than 800,000 Americans undergo each year. The new guideline suggests use of preventive treatments and advises against routinely screening patients after surgery using ultrasound imaging.
 
“Hip and knee arthroplasty [joint replacement surgery] is among the most successful of procedures in terms of restoring function and minimizing pain. However, one possible complication that orthopaedic surgeons are concerned about is venous thromboembolic disease,” said Joshua Jacobs, MD, Academy second vice president, an orthopaedic surgeon at Rush University Medical Center in Chicago, who was chairman of the workgroup that developed the guideline.
 
Thromboembolic disease encompasses two conditions: deep vein thrombosis (DVT), or formation of a blood clot in a deep vein such as in the thigh or calf, and pulmonary embolism (PE). In the relatively uncommon event of a PE, pieces of a clot break free and travel through the vein to the lung, where they can lodge in an artery. PE typically causes no symptoms, however possible symptoms include shortness of breath, chest pain, light headedness or chest congestion. In very rare cases, PE can be fatal. Likewise, in many patients, DVT causes no symptoms. However, in some patients, DVT can lead to symptoms such as leg swelling and pain that can necessitate further treatment or rehospitalization. The goal of the orthopaedic surgeon is to prevent, as much as possible, the occurrence of PE and DVT following total hip and knee replacement.
 
According to the guideline, in the absence of prophylaxis, DVT occurs in about 37 percent of patients, as detected by imaging. The majority of those patients will remain asymptomatic and will require no further treatment. Recent studies in Denmark show that only 0.7 percent of hip replacement patients and 0.9 percent of knee replacement patients require hospitalization because of DVT in the first three months after surgery.
 
“After looking at all available scientific research evidence, in a rigorous fashion to minimize bias, we made recommendations that can help guide practitioners in the safest and most effective ways to prevent this potentially serious complication,” said Jacobs.
 
Among the preventive measures the experts analyzed for safety and effectiveness are mechanical compression devices, designed to improve blood flow in the legs after surgery, as well as drug therapy. Drug therapy involves anticoagulants, commonly called blood thinners, as well as aspirin, which interferes with blood clotting by acting on platelets.
 
The work group also outlined suggestions for future research to fill in the evidence gaps that were apparent through an exhaustive and systematic review of the medical literature. Further research is deemed critical to develop the optimum strategies to prevent venous thromboembolic disease in the safest and most effective manner.
 
From the evidence reviewed, the workgroup made the following recommendations for physicians treating patients before hip or knee replacement:

• Patients should stop taking antiplatelet medications (a type of anticoagulant), such as aspirin and clopidogrel (Plavix), because of the increased risk of blood loss during surgery with these drugs.
• A patient should discuss the timing of stopping any medication with his or her physician.
• A prior DVT or PE is an additional risk factor for thromboembolic disease and it is important that patients discuss any such event with his or her surgeon. There is insufficient evidence to recommend for or against routinely assessing patients for other possible risk factors.
• Patients may want to have the surgery performed under regional anesthesia, such as epidural or spinal, rather than general anesthesia. Although evidence suggests that these regional approaches do not affect the occurrence of DVT or PE, they do limit blood loss.

The workgroup also made these recommendations for care after hip or knee replacement:

• Hip and knee replacement patients should not have routine postoperative screening for thromboembolic disease with duplex ultrasonography (an ultrasound test that shows how blood moves through the arteries and veins). Screening with this test does not significantly reduce the rate of symptomatic DVT or PE or the rate of fatal PE.
• Patients should receive anticoagulant therapy (unless they have a medical reason for not being able to use these drugs, such as a bleeding disorder or active liver disease) and/or mechanical compression devices after a hip or knee replacement surgery. There is, however, insufficient evidence to recommend any particular preventive strategy or the duration of these treatments. Patients should discuss the duration and type of preventive treatment with their physician.
• After hip or knee replacement, patients should get up and walk as soon as safely possible. Although there is insufficient evidence that “early mobilization” reduces DVT rates, early mobilization is low cost, of minimal risk and consistent with current practice.

The full guideline, “Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty,” along with all supporting documentation and workgroup disclosures, is available on the AAOS website: www.aaos.org/guidelines.
More information about DVT, and its symptoms, is available at http://www.orthoinfo.org/.
# # #
Disclaimer: This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances.
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Link to the guideline
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New Clinical Treatment Guideline Outlines Recommendations to Reduce Blood Clots After Hip and Knee Replacement - AAOS

FDA Warns LASIK Providers: Stop Making False Claims: MedlinePlus

FDA Warns LASIK Providers: Stop Making False Claims

Agency giving practitioners 90 days to curtail inflated promises, missing safety info in ads

URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_117017.html
(*this news item will not be available after 12/28/2011)

Thursday, September 29, 2011

Related MedlinePlus Page

• Laser Eye Surgery

THURSDAY, Sept. 29 (HealthDay News) -- The U.S. Food and Drug Administration is once again cracking down on eye care professionals who make false safety claims and promises about the popular LASIK eye surgery.

The agency's Letter to Eye Care Professionals, issued this week, follows an earlier warning from May of 2009. In its latest salvo against deceptive, potentially harmful advertising, the FDA is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson.

"It's about the false claims and not adequately providing consumers with information about the risks associated with the procedure," she said.

LASIK, a laser cornea-shaping procedure, does come with risks. Those risks are small but can include vision loss, under- or over-correction of vision, dry eye, infection, glare, halos and or double vision.

And LASIK isn't for everyone. At this point in time, the procedure can help repair vision among people who are nearsighted, farsighted or have an astigmatism (irregular curvature of the cornea), all conditions known as refractive errors.

The FDA refrained from pointing out examples of misleading advertising by LASIK practitioners, but a 2008 guidance to eye care doctors, issued by the U.S. Federal Trade Commission (FTC), lists a few:

• Unproven claims. "A company must have a 'reasonable basis' for its claims before it runs an ad," the FTC said. "For example, the statement, 'clinical studies show that the laser used by Dr. X results in 20/20 vision 85 percent of the time,' must be supported by clinical studies to that effect for Dr. Xs patients ... Statements from satisfied customers are not sufficient to support a health or safety claim or any other claim that requires objective evaluation."
• Important omissions. Some ads tell the truth, but not the whole truth, the FTC said. For example, a LASIK ad that claimed that nearsighted people can "'throw away their eyeglasses' may be deceptive without further qualification, if, after surgery, a significant number of patients require eyeglasses for best vision, for reading, or under particular circumstances, such as for night driving," the agency said.
• Claims of complete safety. "An advertisement with express or implied representations that the procedure is 'safe,' or 'clinically proven to be safe,' for example, also should tell consumers that, like any surgery, Lasik, or other advertised refractive surgery, has risks and potential complications, and that they will be discussed during a surgical consultation prior to the procedure," the FTC said.

Eye care professionals agreed that deceptive ads must be stamped out. Speaking on behalf of the American Society of Cataract and Refractive Surgery, Dr. Eric D. Donnenfeld said the group supports the FDA's efforts.

LASIK is exceptionally safe when done by the right doctor on the right patient, stressed Donnenfeld, who is an ophthalmologist with offices throughout Long Island, NY. However, he said that "choosing the right doctor is the most important thing one can do." According to Donnenfeld, LASIK surgeons should be members of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. LASIK surgeons should also be board-certified by the American Board of Ophthalmology.

"A lot of patients make a decision based on an ad in a magazine or an audio clip on radio," Donnenfeld said.
This may not be the smartest approach, he said, because "there are a lot of very good doctors who advertise, but it doesn't mean a doctor is good because he advertises or offers group discounts."

"We have to go beyond the advertising or Groupons and have to treat [LASIK] as a surgical procedure," he said.

Not everyone is a good candidate for LASIK, either, Donnenfeld added. People with thin or irregular corneas and other eye diseases such as dry eye, glaucoma (increased pressure in the eye) or cataract (cloudy areas in the lens) might be advised against the procedure, for example.

Donnenfeld's advice for finding a good LASIK surgeon: ask your eye doctor who he or she would see for their own eyes.

But he also stressed that as LASIK technology has improved many risks have been minimized, if not eliminated. For example, "the risk of glare and halo have largely gone away," Donnenfeld said.

"Dry eye is common after LASIK and it almost always goes away after three or six months," he noted, and people who already have dry eye prior to the surgery are not candidates for LASIK.

Infection is also a risk with any surgery, Donnenfeld said, but following preoperative instructions -- including taking antibiotics -- can help reduce this risk. Another potential risk may be larger pupils.
"These should all be discussed during your consultation," he said.

SOURCES: Erica Jefferson, spokeswoman, U.S. Food and Drug Administration; Eric D. Donnenfeld, M.D., ophthalmologist, Long Island, New York; Sept. 23, 2011, FDA Letter to Eye Care Professionals, U.S. Food and Drug Administration; Oct. 2008, Marketing of Refractive Eye Care Surgery: Guidance for Eye Care Providers, U.S. Federal Trade Commission

HealthDay

Copyright (c) 2011 HealthDay. All rights reserved.

FDA Warns LASIK Providers: Stop Making False Claims: MedlinePlus
FDA Warns LASIK Providers: Stop Making False Claims: MedlinePlus

Guidances (Drugs) > Bioequivalence Recommendations for Specific Products

Bioequivalence Recommendations for Specific ProductsGuidance for Industry: Bioequivalence Recommendations for Specific Products (PDF - 81KB)1 (Issued June 2010)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf
Dissolutions Methods Database2
http://www.fda.gov/Drugs/InformationOnDrugs/ucm135742.htm

"Please submit comments for any of the guidances posted in the Bioequivalence Recommendations for Specific Products website to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments refer to the website http://www.regulations.gov3/ OR you can mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov HelpDesk at 1-877-378-5457 (toll free) for assistance regarding submissions."

Guidances (Drugs) > Bioequivalence Recommendations for Specific Products

Genome.gov | 2011 News Feature: NIH researchers achieve better understanding of skin cancer

 

NIH researchers achieve better understanding of skin cancer

By Raymond MacDougall
Associate Communications Director for Intramural Research

Micrograph of metastatic melanoma cells, left, that have invaded pancreatic tissue, right.

Melanocytes — the skin's pigments cells — are sensitive to the sun's ultraviolet radiation, which, along with chemical and other exposures, can trigger DNA damage. The genetic material that fabricates, organizes and invigorates the skin cells can undergo abnormal changes, or mutations.

Because mutations can cause faulty genetic instructions — some that control cell division and survival — affected melanocytes may start to grow and divide out of control. Such cells may spread to surrounding layers of the skin and to other parts of the body, resulting in a life-threatening cancer known as metastatic melanoma.

"Melanoma is very highly mutated and is in some cases mutated approximately on an order of magnitude higher than other cancer types," said Yardena Samuels, Ph.D., an investigator in the Cancer Genetics Branch of the National Human Genome Research Institute's (NHGRI) Division of Intramural Research. Dr. Samuels is part of a National Institutes of Health (NIH)-led team studying the genetics of melanoma and is the senior author of an article in the Sept. 25, 2011, early online issue of Nature Genetics that found that mutations in the metabotropic glutamate receptor-3 (GRM3) gene cause some cases of melanoma.

This newest melanoma-causing mutation joins a growing list of culprits. In April 2011, Nature Genetics published the team's first systematic genomic probe of melanoma. Using whole-exome sequencing, a technique that deciphers just the portions of the genome that code for proteins, the researchers identified 15 new mutations that drive cancer development and one that had previously been detected. The researchers found that one of the mutated genes, GRIN2A, is mutated in 25 percent of melanoma cases. It is located in the signaling pathway for the nerve cell messenger glutamate — the same pathway as GRM3.

In the current study, the researchers focused on mutations in the largest human gene family, G protein-coupled receptors (GPCRs). The significance of the receptors coded by GPCR genes is underscored by the fact that they are the targets of more than half of drugs approved by the U.S. Food and Drug Administration (FDA). Additionally, genes in the GPCR family regulate signal pathways for cell growth, the hallmark cellular activity in cancer.

NHGRI researchers and a colleague from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore designed and analyzed the new study, while National Cancer Institute (NCI) researchers, including Steven Rosenberg, M.D., Ph.D., chief of surgery at the NCI, and colleagues from the University of Texas MD Anderson Cancer Center in Houston and the University of Colorado Denver School of Medicine collected melanoma tumor samples.

The researchers obtained DNA from 11 melanoma tumor samples and sequenced the exon region — or protein-coding portion of the DNA sequence — that spanned the 734 GPCR genes. Mutational analysis narrowed the interest of the researchers to a group of 11 genes in the GPCR family that contained two or more mutations. The team accessed an additional 80 melanoma samples and detected that one particular gene, GRM3, had a high mutation rate in the tumor samples. Furthermore, multiple tumor samples contained the precise mutation in the very same location within the gene, an occurrence characterized as a mutational 'hot spot.' This prevalent recurrence indicates that the mutation has a selective advantage, elevating its importance as a mutation that drives the development of cancer.

To explore the function of this gene, the researchers studied melanoma cells that harbor the mutations. In an experiment that heightened the function of mutated GRM3, the researchers detected increased activity of a signal pathway called the MAP kinase pathway, already known to be involved in melanoma. A kinase is a type of protein enzyme that modifies other proteins to cause some particular cell function. The pathway includes a kinase known as MEK targeted by current melanoma drugs. While some targeted treatments have been effective, tumors become drug resistant within months of treatment. The pathway also is associated with the most highly mutated gene in melanoma, called BRAF.

The researchers performed a test to detect whether the cells with the newly identified mutation in GRM3 respond to the drug that inhibits the MEK pathway. They detected that mutated cells treated with a MEK inhibitor responded positively, dying off as they should rather than persistently replicating as cancer cells.
Further analysis showed that when the cells carry both a BRAF mutation and a GRM3 mutation, the inhibitor compound selectively killed the cells that had the GRM3 mutation. Dr. Samuels suggested that in some cases, failure of melanoma cells to respond to a MEK inhibitor might be due to those cells having a BRAF mutation but no GRM3 mutation. Dr. Samuels predicts that prospective genetic analysis will enable differentiation of melanoma into subclasses.
"Melanoma has been subdivided by pathological characteristics," she said. "With the advent of in-depth genetic analyses, it may become possible to classify melanoma by its genetic alterations. Based on our two recent studies, I predict several melanoma subclasses will be identified in the near future."
For a high resolution micrograph of metastatic melanoma, please go to http://www.genome.gov/pressDisplay.cfm?photoID=20152 and www.genome.gov/pressDisplay.cfm?photoID=20153.
Genome.gov 2011 News Feature: NIH researchers achieve better understanding of skin cancer

NIH to make a mightier mouse resource for understanding disease, September 29, 2011 News Release - National Institutes of Health (NIH)

Thursday, September 29, 2011
Genome.gov | National Human Genome Research Institute (NHGRI) - Homepage
Contacts:
Geoffrey Spencer, NHGRI: spencerg@mail.nih.gov <spencerg@mail.nih.gov>
301-402-0911
Cindy McConnell, NCRR: mcconnellc@mail.nih.gov <mcconnellc@mail.nih.gov>
301-435-0888
NIDCD Press Office:
301-496-7243
Stephanie Courchesne, OSC: stephanie.courchesne@nih.gov <stephanie.courchesne@nih.gov>
301-451-6387

NIH to make a mightier mouse resource for understanding disease
Publicly available resource will add detailed medical information about knockout mice
Over the next five years, National Institutes of Health (NIH)-funded researchers will extensively test and generate data about mice with disrupted genes to gain clues about human diseases. NIH today awarded a set of cooperative agreements totaling more than $110 million to begin the second phase of the Knockout Mouse Project (KOMP).

The results of the next stage, called the Knockout Mouse Phenotyping Project, or KOMP2, will be placed in a public database. Researchers make knockout mice by disrupting the function of individual genes across the animal’s genome.

KOMP2 is a trans-NIH and NIH Common Fund project that will work with other members of the International Knockout Mouse Phenotyping Consortium (IMPC) to generate about 5,000 strains of knockout mice that will undergo a large battery of clinical phenotype tests. A phenotype includes biological information about appearance, behavior and other measurable physical and biochemical characteristics. Such information will help reveal how all traits are affected by deleting a given gene in an individual mouse.

In the long term, the project aims to enable the research community to establish the traits associated with the function of every protein-coding gene in the mammalian genome. Such information will be valuable for the discovery of the genetic causes of human diseases and will aid efforts to identify new drug targets.

"The generation of detailed phenotypic information for each knockout mouse strain will be a boon to disease researchers who want to determine the function of genes and to improve mouse models of human disease," said NIH Director Francis S. Collins, M.D., Ph.D. "I am grateful to all of the people and programs across NIH who are supporting this effort and to our international partners who have joined us in this scientific endeavor."

In partnership with several international programs, the initial five-year phase of KOMP will reach its goal of creating knockout mouse embryonic stem cell lines for each of the approximately 21,000 protein-coding genes in the mouse genome this year. The International Knockout Mouse Consortium (IKMC) includes the Knockout Mouse Project (KOMP), U.S.A.; the European Conditional Mouse Mutagenesis Program (EUCOMM) funded by the European Commission: the Texas A&M Institute for Genomic Medicine (TIGM); and the North American Conditional Mouse Mutagenesis Project (NorCOMM) funded by Genome Canada.

"NIH is committed to making knockout mouse models more widely accessible to the biomedical research community," said James Battey, M.D., Ph.D., director of the National Institute on Deafness and Other Communication Disorders (NIDCD), who is also a co-chairman of the Trans-NIH Mouse Initiative. "Getting these valuable models into the hands of a wide range of researchers will serve to accelerate our efforts to develop new strategies for understanding and treating human disease."

During the next five years, KOMP2 will transform the knockout mouse embryonic stem (ES) cells into adult mice for 2,500 lines of well-characterized knockout mice strains, and IMPC will create about 2,500 additional knockout mouse strains. Each mouse will undergo the same standard analysis so that the results can be compared for all of the mice tested. NIH has awarded six cooperative agreements to three groups to establish production and phenotype centers for the project.

"It is going to take a great deal of scientific teamwork to assimilate phenotypic information about this knockout mouse resource, but we are confident in the team that has been assembled to accomplish the task," said National Human Genome Research Institute (NHGRI) Director Eric D. Green, M.D., Ph.D. NHGRI is involved in the planning and administration of KOMP2.

The National Center for Research Resources (NCRR) will administer the awards for the production centers, and NHGRI will administer the awards for the phenotyping centers. NCRR and NHGRI are components of the NIH.

The funded groups will all receive a total of approximately $34 million and are expected to produce and phenotype 833 strains of knockout mice each for a total of about 2,500 knockout mouse lines. Recipients of the awards are:
•Baylor College of Medicine, Houston. This center will collaborate with the Wellcome Trust Sanger Institute in Hinxton, England and the Medical Research Council (MRC) Harwell in Oxfordshire, England.
•University of California, Davis. This center will collaborate with the Toronto Center for Phenogenomics in Canada, Children’s Hospital Oakland Research Institute in California, and Charles River Laboratories in Wilmington, Mass.
•The Jackson Laboratory in Bar Harbor, Maine.
"This resource will enable many more researchers to tap into the power of knockout mice for exploring gene function, which in turn will speed our efforts to improve human health," said Louise E. Ramm, Ph.D., acting director, National Center for Research Resources.

In addition to the production and phenotype centers, NIH awarded a five-year, cooperative agreement totaling $10 million to the European Bioinformatics Institute in Hinxton, England, which will collaborate with MRC Harwell and Wellcome Trust Sanger Institute to set up a data coordination center and database to track progress of the project and to coordinate efforts between KOMP2 and IMPC researchers. In addition, this center will build an integrated Web portal that will provide researchers access to the phenotype data.

The mouse is a key mammalian system in which to produce a genomics resource because of the long history and depth of understanding of mouse genetics and the availability of the mouse genome sequence. What's more, researchers have made advances over the last several years in improving the efficiency and decreasing the cost of generating knockout mice.

Historically, researchers have generated their own lines of knockout mice to serve as models for human disease, such as heart disease or cancer. However, rather than generating a detailed and comprehensive phenotype of the mouse, they often are only interested in a handful of phenotypes. For example, a researcher interested in cardiovascular disease may only want to examine the effect of a disrupted gene on blood pressure.

This single-lab approach can be expensive and inefficient. A researcher with access to a low-cost knockout mouse that has been extensively phenotyped can focus his or her time and research budget on more in-depth research questions rather than spending it on producing a knockout mouse about which the researcher has limited information.

KOMP2 and IMPC researchers will begin by creating lines of knockout mice from embryonic stem cells produced by KOMP. The 5,000 genes that will be knocked out will be selected from nominations already submitted by the research community. Many of the selected genes will be used to study disease processes and underlying mechanisms. Others will be selected based on the genetic variations associated with the human diseases that have been uncovered by genome-wide association studies.

Statistically, about 25 percent of the mouse pups will inherit both copies of the knocked out gene, while their littermates will have only one copy and be heterozygous, or normal. The knockout mice and the healthy littermates will both undergo a battery of more than 400 phenotype measurements at multiple times during their lives. Tests will include X-ray imaging, magnetic resonance imaging (MRI), blood exams, balance tests, and urine and fecal analysis, to name a few. Both the knockout and normal phenotype data will be made available through the KOMP2 data coordination center so that researchers who acquire and study the knockout mice can compare various phenotypes.

"We want to characterize each line of mice broadly with no assumptions about what the gene is or is not doing," said IMPC Executive Director Mark Moore, Ph.D. "If you think of the function of a gene as a needle in a haystack, we’re removing the haystack so you can see what the needle does."

At the end of the initial five years of the effort, the NIH and IMPC will evaluate the usefulness of the resource to the research community. If the evaluation is a positive one, both efforts may scale up to create and phenotype a total of 12,000 more knockout mice.

Once each knockout mouse is phenotyped, researchers can obtain information on what knockout mouse lines are available and how to order them from the University of California Davis KOMP Repository.
To access the IKMC Web portal, please go to http://www.knockoutmouse.org/.

The 18 NIH institutes, centers and offices contributing to the Knockout Mouse Project are: the NIH Office of Strategic Coordination/Common Fund; NCRR; the National Eye Institute; NHGRI; the National Heart, Lung and Blood Institute; the National Institute on Aging; the National Institute of Alcohol Abuse and Alcoholism; the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIDCD; the National Institute of Dental and Craniofacial Research; the National Institute of Environmental Health Sciences; the National Institute of General Medical Sciences; the National Institute of Mental Health; the National Institute of Neurological Disorders and Stroke; the National Institute of Diabetes and Digestive and Kidney Diseases; the National Cancer Institute; and the Office of AIDS Research.

For more information on the Knockout Mouse Project, go to the NIH Knockout Mouse Project. For a fact sheet describing what knockout mice are, how they are made and what they are used for, go to Knockout Mice. To download a high-resolution photo of knockout mice, go to www.genome.gov/pressDisplay.cfm?photoID=5006. For more information on the IMPC, go to www.mousephenotype.org/index.html.

The National Center for Research Resources (NCRR), a part of NIH, provides laboratory scientists and clinical researchers with the resources and training they need to understand, detect, treat and prevent a wide range of diseases. NCRR supports all aspects of translational and clinical research, connecting researchers, patients and communities across the nation. For more information, visit http://www.ncrr.nih.gov/.

NHGRI is one of the 27 institutes and centers at NIH. The NHGRI Division of Extramural Research supports grants for research and training and career development at sites nationwide. Additional information about NHGRI can be found at http://www.genome.gov/.

The NIH Common Fund encourages collaboration and supports a series of exceptionally high impact, trans-NIH programs. Programs funded through the Common Fund are managed by the NIH Office of the Director’s Office of Strategic Coordination in partnership with the various NIH Institutes, Centers and Offices. Common Fund programs are designed to pursue major opportunities and gaps in biomedical research that the agency as a whole should address to make the biggest impact possible on the progress of medical research. Additional information about the NIH Common Fund can be found at http://commonfund.nih.gov/.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

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NIH to make a mightier mouse resource for understanding disease, September 29, 2011 News Release - National Institutes of Health (NIH)

Down syndrome consortium formed, September 29, 2011 News Release - National Institutes of Health (NIH)

For Immediate Release
Thursday, September 29, 2011 Contact:
Robert Bock or Marianne Glass Miller

NICHD - The Eunice Kennedy Shriver National Institute of Child Health and Human Development Official Home Page

bockr@mail.nih.gov <bockr@mail.nih.gov>
301-496-5133


Down syndrome consortium formed
NIH, Down syndrome groups to meet regularly for exchange of information, ideas
National Institutes of Health has joined with organizations interested in Down syndrome to form a consortium that will foster the exchange of information on biomedical and biobehavioral research on the chromosomal condition.

"The idea is to have an open channel of communication between the NIH and those organizations intimately involved with Down syndrome," said Yvonne T. Maddox, deputy director of the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the agency that will chair the new consortium. "The consortium will allow NIH to inform the Down syndrome community of advances in the field, ongoing studies, and potential avenues for future research. In turn, those who work in Down syndrome research and patient care can share their experiences and ideas for potential research opportunities with NIH."

Down syndrome most frequently results from an extra copy of chromosome 21 in the body's cells. The chance of giving birth to a baby with Down syndrome increases as women age. Infants with Down syndrome have certain characteristic physical features, such as short stature and distinctive facial features. They are also more likely to have health conditions like hearing loss, heart malformations, digestive problems, and vision disorders. Although Down syndrome is the most common cause of mild to moderate intellectual disability, the condition occasionally involves severe intellectual disability. In addition, individuals with Down syndrome age prematurely and may experience dementia, memory loss, or impaired judgment similar to that experienced by individuals with Alzheimer disease. Because of its far reaching effects on an individual’s health, Dr. Maddox explained, Down syndrome warrants a comprehensive research effort by a wide array of scientific disciplines.

"A single, comprehensive forum will make the research effort to address Down syndrome more effective, minimizing duplication of effort and capitalizing on the knowledge of those with the greatest experience in the field," Dr. Maddox said.

A focus of the consortium will be the implementation of the NIH Down syndrome research plan, which set research goals for Down syndrome, based on previous research accomplishments and the need for research in areas in which evidence is lacking. The consortium will meet two to three times a year.

Individuals with Down syndrome and family members will be represented on the consortium, which will also include the NIH Down Syndrome Working group, an internal NIH group that coordinates NIH-supported Down syndrome research, and representatives from prominent Down syndrome and pediatric organizations.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at http://www.nichd.nih.gov/.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

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Down syndrome consortium formed, September 29, 2011 News Release - National Institutes of Health (NIH)

CDC NIOSH Science Blog: Bed bugs, pesticides, and illnesses

CDC NIOSH Science Blog: Bed bugs, pesticides, and illnesses
Image courtesy of Janice Haney Carr / CDC

CDC "Just try to sleep tight. The bed bugs are back," a New York Times headline proclaimed in 2005. The article reported on a resurgence of reports about infestations of tiny Cimex lectularius in New York City. These "stealthy and fast-moving nocturnal creatures that were all but eradicated by DDT after World War II, have recently been found in hospital maternity wards, private schools and even a plastic surgeon's waiting room," the article stated.1

The New York experience is not unique. Around the world, pest control specialists have reported "10-fold, 100-fold, even 1,000-fold increases in bed bug jobs over the past five or ten years," according to pest control consultants Lawrence J. Pinto, Richard Cooper, and Sandy Kraft.2

Bed bugs have been a nuisance to humans at least as far back as ancient Greece. Although largely eradicated in the Western countries in the 1940s with the aggressive use of pesticides, notably DDT, they began to re-emerge in the mid-1990s. Entomologists and pest control specialists believe that several factors may contribute to this trend. These factors include the discontinuance of DDT in the U.S. following a 1972 ban, increased resistance to various insecticides, and an increase in international travel, which raises the chances that the tiny pests will be unknowingly packed into luggage.3

Bed bugs are not known to transmit disease, but they are a troublesome health nuisance. Their bites can cause mild to severe allergic reactions, and people living in infested homes have reported anxiety, insomnia, and systemic reactions.4 These bites don't just occur at home. Using workers' compensation (WC) claims data from California between 2000 and 2011, the California Department of Public Health identified 96 workers who were bitten by bed bugs while traveling for work. The majority of bed bug-related WC claims in California consisted of complaints of bed bug bites or rashes caused from bites; however there were several reports of physical injuries (such as strains) sustained by workers while moving furniture to look for or treat bed bugs. (More information on work-related insecticide exposures is provided below.)

For apartment owners and managers, hotels and motels, and other businesses involving the stewardship of property, a bed bug infestation can be a serious business cost in remediation expenses, public stigma, and lawsuits.5 The annoyance, economic costs, frustration and emotional agony of bed bug infestations may tempt business owners and homeowners to take extreme measures. However, a recent study by NIOSH scientists and their colleagues highlights the need to be informed and strategic in dealing with the problem, so that tackling one problem does not introduce greater health risks of another kind.

Bed bug infestations often are treated with insecticides, but insecticide resistance is a problem, and excessive use of insecticides or improper application can increase the potential for illness in humans. To better understand the problem of illness associated with bed bug-related insecticide, investigators looked for cases using the Sentinel Event Notification System for Occupational Risks (SENSOR) Pesticides program and data from the New York City Department of Health and Mental Hygiene. A total of 111 illnesses and one fatality associated with bed bug-related insecticide were identified in seven states: California, Florida, Michigan, North Carolina, New York, Texas, and Washington.

The most frequently reported health outcomes were neurologic symptoms (40%), including headache and dizziness; respiratory symptoms (40%), including upper respiratory tract pain and irritation and dyspnea; and gastrointestinal symptoms (33%), including nausea and vomiting. Most (81%) symptoms were of low severity. The individual whose death was linked to bed-bug related insecticide had a series of preexisting medical conditions and was exposed to high levels of insecticide through atypical applications.6

The most common factors contributing to illness were excessive insecticide application, failure to wash or change pesticide-treated bedding, and inadequate notification of pesticide application. The majority of insecticide exposures were to pyrethroids and/or pyrethrins, and were in toxicity category III and are considered to be slightly toxic.

Among the cases of illnesses from bed bug-related insecticide, 12% were work-related. Of these, three illnesses involved workers who applied pesticides, including two pest control operators, of whom one was a certified applicator. Four cases involved workers who were unaware of pesticide applications (e.g., two carpet cleaners who cleaned an apartment recently treated with pesticides). Two cases involved hotel workers (a maintenance worker and a manager) who were exposed when they entered a recently treated hotel room, and two cases involved emergency medical technicians who responded to a scene where they found white powder thought to be an organophosphate pesticide.

To prevent future illness from bed bug-related insecticides, NIOSH recommends educating the public about effective bed bug management including:
•nonchemical methods to control bed bugs such as:
◦heating infested rooms to 118°F (48°C) for 1 hour or cooling rooms to 3°F (-16°C) for 1 hour by professional applicators ;
◦encasing mattresses and box springs with bed bug—excluding covers;
◦vacuuming, steaming, laundering, and disposing of infested items
•methods to prevent bed bug infestation (e.g., avoiding the purchase of used mattresses and box springs),
•prudent use of effective insecticides.
Those who choose to treat their bed bug infestation with insecticides should seek the services of a certified exterminator who uses an integrated pest management approach to avoid pesticide misuse. Those applying insecticides should follow product instructions for safe and appropriate use. Insecticide labels that are easy to read and understand also can help prevent illnesses associated with bed bug control.

If individuals develop an illness from exposure to bed-bug related insecticides, they should consult their personal physician or the poison control center (1-800-222-1222) and mention that the insecticide exposure occurred while attempting to eliminate bed bugs.

If bed bugs are a problem where you live or work, be bright in your fight and don't let the bed bugs bite!
—John Howard, M.D., Naomi Hudson, Dr.P.H., M.P.H., Geoffrey Calvert, M.D., M.P.H., and F.A.C.P.
Dr. Howard is the Director of the National Institute for Occupational Safety and Health
Dr. Hudson is an Epidemic Intelligence Service Officer at NIOSH
Dr. Calvert is a Team Leader and Senior Medical Epidemiologist in the NIOSH Division of Surveillance, Hazard Evaluations, and Field Studies

References
1.Just Try to Sleep Tight. The Bed Bugs Are Back. New York Times, Nov. 27, 2005, p. A-1.
2.Pinto et al, Bed Bug Handbook: The Complete Guide to Bed Bugs and Their Control. Mechanicsville, Md.: Pinto & Associates, 2007, p. 2
3.Pinto et al, pp. 36-41; U.S. Environmental Protection Agency, Bed Bug Information.
4.Joint Statement on Bed Bug Control in the United States from the U.S. Centers for Disease Control and Prevention [CDC] and the U.S. Environmental Protection Agency [EPA]
5.The Cost of Bed Bugs, Business Week, Nov. 8, 2007.
6.Centers for Disease Control and Prevention. Acute Illnesses Associated With Insecticides Used to Control Bed Bugs - Seven States, 2003-2010. Morbidity and Mortality Weekly Report, September 23, 2011 / 60(37);1269-1274.
Posted 9/29/2011 at 11:00 am

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