C9ORF72 Repeat Expansions in the Frontotemp... [J Alzheimers Dis. 2012] - PubMed - NCBI

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C9ORF72 Repeat Expansions in the Frontotemp... [J Alzheimers Dis. 2012] - PubMed - NCBI

J Alzheimers Dis. 2012 Dec 19. [Epub ahead of print]

C9ORF72 Repeat Expansions in the Frontotemporal Dementias Spectrum of Diseases: A Flowchart for Genetic Testing.

Le Ber I, Camuzat A, Guillot-Noel L, Hannequin D, Lacomblez L, Golfier V, Puel M, Martinaud O, Deramecourt V, Rivaud-Pechoux S, Millecamps S, Vercelletto M, Couratier P, Sellal F, Pasquier F, Salachas F, Thomas-Antérion C, Didic M, Pariente J, Seilhean D, Ruberg M, Wargon I, Blanc F, Camu W, Michel BF, Berger E, Sauvée M, Thauvin-Robinet C, Mondon K, Tournier-Lasserve E, Goizet C, Fleury M, Viennet G, Verpillat P, Meininger V, Duyckaerts C, Dubois B, Brice A.

Source

CRicm-UMRS975, Paris, France AP-HP, Hôpital de la Pitié-Salpêtrière, Centre de Référence des Démences Rares, Paris, France AP-HP, Hôpital de la Pitié-Salpêtrière, Fédération des maladies du système nerveux, Paris, France.

Abstract

Frontotemporal dementia (FTD) refers to a disease spectrum including the behavioral variant FTD (bvFTD), primary progressive aphasia (PPA), progressive supranuclear palsy/corticobasal degeneration syndrome (PSP/CBDS), and FTD with amyotrophic lateral sclerosis (FTD-ALS). A GGGGCC expansion in C9ORF72 is a major cause of FTD and ALS. C9ORF72 was analyzed in 833 bvFTD, FTD-ALS, PPA, and PSP/CBDS probands; 202 patients from 151 families carried an expansion. C9ORF72 expansions were much more frequent in the large subgroup of patients with familial FTD-ALS (65.9%) than in those with pure FTD (12.8%); they were even more frequent than in familial pure ALS, according to estimated frequencies in the literature (23-50%). The frequency of carriers in non-familial FTD-ALS (12.7%) indicates that C9ORF72 should be analyzed even when family history is negative. Mutations were detected in 6.8% of PPA patients, and in 3.2% of patients with a clinical phenotype of PSP, thus enlarging the phenotype spectrum of C9ORF72. Onset was later in C9ORF72 (57.4 years, 95%CI: 55.9-56.1) than in MAPT patients (46.8, 95%CI: 43.0-50.6; p = 0.00001) and the same as in PGRN patients (59.6 years; 95%CI: 57.6-61.7; p = 0.4). ALS was more frequent in C9ORF72 than in MAPT and PGRN patients; onset before age 50 and parkinsonism were indicative of MAPT mutations, whereas hallucinations were indicative of PGRN mutations; prioritization of genetic testing is thus possible. Penetrance was age- and gender-dependent: by age 50, 78% of male carriers were symptomatic, but only 52% of females. This can also guide genetic testing and counseling. A flowchart for genetic testing is thus proposed.

PMID:

23254636

[PubMed - as supplied by publisher]

A centralized approach to out-of-province genetic... [Clin Genet. 2012] - PubMed - NCBI

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A centralized approach to out-of-province genetic... [Clin Genet. 2012] - PubMed - NCBI

Clin Genet. 2012 Dec 17. doi: 10.1111/cge.12077. [Epub ahead of print]

A centralized approach to out-of-province genetic testing leads to cost savings: The Alberta Experience.

Lilley M, Christian S, Blumenschein P, Chan S, Somerville M.

Source

Genetic Laboratory Services, Alberta Health Services, 8-26 Medical Sciences Building, University of Alberta, Edmonton, Alberta, CANADA, T6B 0K9. Margaret.Lilley@albertahealthservices.ca.

Abstract

The Genetic Resource Centre is a centralized process for requesting genetic testing that is not available within the province (Alberta, Canada). In order to assess potential cost savings associated with this process, all applications received by the Genetic Resource Centre in 2010 were reviewed, and cost savings were recorded for statistical analysis. Seven areas of cost savings were identified:Negotiated pricing;Laboratory selection;Testing set up in province;Duplicate testing;Inappropriate testing;Sequential testing and;Testing offered within the province. The total test cost of the 615 applications submitted in 2010 without the GRC process would have been $766 783 (Canadian dollars). A total cost savings of $112 201 was achieved through the GRC, which represents 15% of the total cost of requested testing ($112 201/$766 783). This is the first study to examine areas of cost savings for genetic testing sent out -of-province. The greatest cost savings resulted from the areas of laboratory selection and negotiated pricing. A centralized process to manage out-of-province genetic test requests results in consistency in testing and significant cost savings.
© 2012 John Wiley & Sons A/S.

PMID:

23252955

[PubMed - as supplied by publisher]

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The PCORI Challenge Initiative: Connecting Ideas for Research Collaboration

The PCORI Challenge Initiative: Connecting Ideas for Research Collaboration

Developer Challenge December 20, 2012 - By Anne C. Beal, MD, MPH and Susan Sheridan MBA, MIM At PCORI, our mandate is to support research that will help patients and those who care for them make better-informed health and health care decisions. To meet this goal, we’ve made it clear that we plan to support “research done differently,” requiring, among other things, that the projects funded provide mechanisms for meaningful involvement of patients and caregivers throughout the research process.
But how might researchers who are committed to engaging in such collaborative work connect with potential patient or caregiver partners? And how might patients or caregivers interested in working with researchers, or who have research ideas they’d like to see turned into a rigorous scientific study, connect with the investigators who can help to make that a reality?
We think these questions add up to an excellent opportunity for PCORI’s first “challenge” initiative – using an “open innovation” approach to problem-solving to tap into the expertise of our patient and other stakeholder communities. The solution we are asking for is creation of a “matching system” to link patients and scientists as partners in conducting research. It could be a well-articulated conceptual model, adaptation of an existing matching protocol reimagined for the purpose outlined in this challenge, a prototype for an entirely new web-based service or app, some combination of these approaches, or something else entirely.
This challenge, which we’re launching in collaboration with Health 2.0, offers an opportunity for innovators to help PCORI pursue our commitment to “research done differently” by bringing the voice of patients, caregivers and other stakeholders clearly and fully to the research process. We believe this means having patients and caregivers serve as collaborators with researchers in such critical activities as formulating research questions, developing research materials, determining research protocols, and helping to review and disseminate study results.
PCORI requires this focus on engagement in our funding announcements, which leverage the broad research community’s expertise in proposing topics for study but stipulate that patients and other stakeholders be meaningful members of research teams. We believe that if the research we fund is to have impact on patient outcomes, it is essential to promote involvement by and consensus among key patients and stakeholders from the start in identifying the questions to be studied and agreeing they are important.  Patients and other stakeholders need to feel a sense of ownership of the research process, and embracing research is easier when its origins are transparent, traceable and reflective of your needs.
We know that what we propose in this regard is neither traditional nor simple. Although the research community has extensive experience in recruiting patients as study subjects, engaging them as meaningful “collaborators” in research is not routine. We know many researchers are interested in taking this approach but don’t necessarily know the best or most effective way to proceed. Likewise, we know many patients and caregivers are interested in working with researchers, or might have research questions they would like to see tested in a rigorous study, but are unsure of how to make the connection that will allow them to see that done. Thus, we’d like to create a matchmaking system to bring them together.
A panel of reviewers, including researchers, technologists, patients and other stakeholders, will assess the entries. The review panel will judge entries, whether conceptual models or prototypes, based on how well they address the following criteria:

• The entry’s actual or described technical capacity to efficiently and effectively connect patients and researchers, across multiple platforms and levels of complexity.
• Usability, scalability and sustainability across diverse populations with differing levels of access to, understanding of and experience with technology and health/health care information.
• Differences in the ways that patients, caregivers and researchers understand, describe and seek answers to the problems they face or the issues they’re trying to address (e.g., different terms for similar concepts, general levels of health literacy, etc.).
• Maximizing “patient-centeredness” – the submission’s ability to account for and effectively focus on and address patients’ needs – while also emphasizing and facilitating researchers’ need to emphasize the scientific rigor of any resulting collaboration.
• The particular challenges of serving “hard-to-reach” audiences, including, but not limited to, ethnic and racial minorities, rural populations, the elderly, the disabled/physically challenged and those for whom English is not their native language.

Winners will receive cash prizes and their work may be considered for additional PCORI support, depending on the outcome of the review process.
We think this will be a compelling challenge that will resonate with researchers, patients, the caregiver and advocacy communities, developers and entrepreneurs, and anyone else with a creative mind and interest in improving health and health care. Whichever of these groups describes you, we hope you’ll take up this challenge. We very much look forward to seeing what you come up with.
Anne Beal, MD, MPH, is PCORI’s Deputy Executive Director and Chief Operations Officer
Sue Sheridan, MBA, MIM is PCORI’s Director of Patient Engagement

Human Microbiome Project

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Human Microbiome Project

Program SnapshotThe Common Fund's Human Microbiome Project (HMP) aims to characterize the microbial communities found at several different sites on the human body, including nasal passages, oral cavities, skin, gastrointestinal tract, and urogenital tract, and to analyze the role of these microbes in human health and disease. HMP includes the following initiatives.

• Development of a reference set of microbial genome sequences and preliminary characterization of the human microbiome
• Elucidation of the relationship between disease and changes in the human microbiome
• Development of new technologies for computational analysis
• Development of new tools for computational analysis
• Establishment of a data analysis and coordinating center (DACC)
• Establishment of resource repositories
• Examination of the ethical, legal and social implications (ELSI) of HMP research
• Evaluation of Multi-‘omic Data in Understanding the Human Microbiome’s Role in Health and Disease

Read More...

Press Announcements > FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation

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Press Announcements > FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation

FDA NEWS RELEASE

For Immediate Release: Dec. 28, 2012
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation

The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.

“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.

Patients with prosthetic heart valves should not take Eliquis nor should patients with atrial fibrillation that is caused by a heart valve problem. These patients were not studied in clinical trial. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with Eliquis. There is no agent that can reverse the anti-coagulant effect of Eliquis.

Eliquis will be dispensed with a patient Medication Guide that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding.

Eliquis is manufactured Bristol-Myers Squibb Company of Princeton, N.J. and marketed by BMS and Pfizer Inc. of New York.

For more information:

• FDA: Approved Drugs Questions and Answers¹
• FDA: Innovation in Development of Drugs and Biological

Women's Health And Dizziness During Pregnancy

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A notable number of women experience dizziness during pregnancy. The scientific explanation for this is that, during that period, the body of a woman's body undergoes a lot of cardiovascular changes. The body is supposed to undergo self-initiating adaptive changes in its cardiovascular and nervous systems to enable normal functioning, especially in maintaining continuous supply of blood to the brain. The consequences of failure of such adaptive mechanisms include fainting and giddiness.

One of the significant changes that occur to women during gestation is an increase in the rate of heart beat. This is accompanied by increment in blood volumes by about 45%. They also undergo dilation of blood vessels, resulting in low blood pressure. A woman experiences the lowest blood pressure levels at around mid-pregnancy. This drop is only restored to normal close to the end of gestation period.

Medical experts have identified a number of ways that can help in handling dizziness. It is critical that a woman lies down if she experiences vertigo. This prevents her from suffering injury by falling. She should also stop doing any activity that may bring harm to her or others, for instance operating machinery or driving.

The basic cause of dizziness and fainting is an inadequate supply of blood to the brain. First aid measures, hence, should aim to restore this supply. One way of achieving this is by resting the victim in a horizontal position, but with the head slightly lower than the rest of the body. Where there is no space to lie, it is advisable that the victim sits, then put her head between her knees. The woman may also lie on her left side, since this increases blood flow to both the heart and the brain.

A woman's actions may increase the risk of her fainting or experiencing lightheadedness. Top on this list is a quick shift in position from either lying or sitting to standing. Blood pools around the feet and in lower legs during resting periods. The body may not be able to restore blood flow to the heart and brain upon springing from the rest position, hence resulting in dizziness. Therefore, it is advisable for pregnant women not to spring from resting positions to standing.

Blood may also pool around the feet when a person stands at the same position for prolonged periods. Expectant women are advisable to walk around after short periods of being stationary. In case this is not possible, exercising legs could also help improve blood circulation. Wearing support stockings has also been proven to improve circulation.

Pregnant woman should take note of their sleeping positions since how they sleep may increase chances of experiencing lightheadedness. A woman should not lie on their stomachs or backs during their second and third trimesters. This is because such positions cause the uterus to exert extra pressure on inferior vena cava, slowing circulation in the lower abdomen. They should lie of their left side instead.

Vasovagal syncope may also result in dizziness during pregnancy. This is a condition resulting from straining during activities such as urination or coughing, dehydration, pain or anxiety. Symptoms associated with this condition are a feeling of warmth, nausea, yawning, sweating and paleness. It is advisable to lie or sit upon experiencing such symptoms.

We're hard at work!

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This weekend, we had our quaterly meeting at the Peace Corps Office in Kigali, the capitol of Rwanda and most beautiful and cleanest city on the continent of Africa.
_______________________________________________________

Past Successes:*Creating the committee and writing the by laws*The GAD Blog and regular SOMA contributions*Having GAD represented at all Peace Corps trainings and writing lesson plans for each training *Creating the GLOW/BE Committee to support GLOW/BE Camps*Creating the GLOW/BE VAST Grant Workbook*Conducting and analyzing the results of the all volunteer GAD survey*Coordinating the field testing of the translated Life Skills Manual
Current Projects:*Creating a GAD Manual focused on project ideas for adults*Forging a partnership between Peace Corps and Ni Nyampinga magazine*Promoting and updating the GAD blog*Collecting stories from volunteers to make senior staff aware of the prevalence of sexual harassment*Working with PSN to support volunteer who experience sexual harassment by designing a yearly retreat
Future Project Ideas:*Working with PC GAD committees in other countries to create an international PC GAD forum*Making GAD resources more accessible to volunteers through an online forum*Creating ways to help volunteers celebrate International Women's Day in their communities*Creating discussion questions for volunteers to discuss monthly at their regional meetings.  Encouraging inter-regional dialogues once or twice a year to discuss GAD related issues.

mackenzie's eyes are naturally that piercing (L to R: Alma, Lucy, Mackenzie, Chinelo, Gelsey)

resident jokesters (Zach and Chinelo)

awkward candid (L to R: Zach, Joel, Tashiya, Hope, Sarah D, Sarah E.)

all good! 

pamela's happy face, very happy face :)

Gelsey gets down to business

we are serious (L to R: Joel, Pamela, Tashiya)

What's a Nun Got to do With it? by Tashiya G.

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Tashiya Gunesekera
ED2 -- Rubavu District, Western Province


My first friend in myvillage was a nun. Her name was Eleonora, a primary school teacher.She came to visit me in my temporary housing and commented that Ineeded to clean my floors more often. I felt, knowing what I knew ofRwandan culture, that she was going to be a genuine friend.
I live in small town inthe Northwest of Rwanda. I am very connected to the Catholic church,which predominates my town. I eat all my meals with the priests, andtake myself up the hill to Sunday mass every Sunday I'm at site. Thenuns live in a quaint house connected to the health clinic in town,which they run. There are two nuns from Spain named Aurelia and MariaJesus who are there as mentors and teachers for the Rwandan Nuns whowere Eleonora, Matilde, Marcelline, and Vestine. We quickly becamefriends due to the shortbread-like cookies they gave me every time Icame to visit at 530pm any weekday. As they said recently, “Tashiya,sabemos que te gusta las dolces.” (Tashiya we know that youlike the sweets.)
Throughout my time atsite, I have spent time getting to know the nuns. They helped me thattime I had a bad day and could not find any Margarine to make Mac andCheese. They listened to me complaining about all the papers I had tomark. They invited me to watch Spain trounce Italy in the Euro Cupthis year. They gave me a thermometer when I thought I was sick. Andmost importantly they helped me with my book project to get moreEnglish reading books for my school library. These books were sent totheir mailbox in Gisenyi and they carted them up the steep mountainin their car. During this time, I've had multiple opportunities toanalyze their lives.
Not being Catholic,apart from the “Sister Act”, I personally did not know much aboutnuns before I moved to this small town in Rwanda. I thought nuns weresuper religious women that gave up a life of family and love toworship God and help poor people. And, yes in some ways this is true.They do give up having a traditional family and romantic love, andthey are religious and they do help poor people. But, there is a lotmore to these nuns than that.
The nuns at my site allhave serious jobs and careers in the making. Eleonora was a primaryschool teacher, Vestine was a nurse at the health clinic, Marcellinetrains girls that are not in school in trades like sewing, andcooking, and Matilde was responsible for teaching young mothers aboutnutrition. The two Spanish nuns oversaw much of the running of theclinic and also were responsible for the running of their home.
Within my community,these nuns are considered to be influential people. They are often atsector, cell and village events. They sit with the important peoplewho thank goodness, I have finally been cleared of sitting with. (I'mfinally one with the people!) They also live in a nice house and haveaccess to a car to go to the nearest big town, Gisenyi andoccasionally Kigali. These nuns, probably due to their congregation,have serious opportunities to travel. Eleonora broke my heart whenshe said in the beginning of the second year that she was leaving togo live in Equatorial Guinea for her next mission. Mathilde moved onto the Ivory Coast. Vestine went to University in Kigali. Thisbrought in two new Nuns, Immaculee and Larisse. Immaculee is also anurse with a degree from a University in Kigali. She speaks fluentFrench, English and Spanish. Larisse is from the Democratic Republicof the Congo. Larisse is awaiting her time before she also wants tomove on to the Ivory Coast. I know that Eleonora spent two months inSpain visiting more Nuns from her order.
Many of these womencome from very poor families. Their choice to become a Nun obviouslychanged their lives. But, they are very strong women who are greatlyrespected and honored within Rwanda. They gain high levels withintheir professional fields and are supposed and encouraged withintheir communities. Even though they are not the head of the communitychurch like a Priest, they are still leaders and contributing greatlyto the societies in where they live. Do I think that all girls shouldaim to become Nuns? Not unless you get that calling because it isafter all a life where you give up a lot of comforts. But, it'sworth noticing how in a quiet way, Nuns are contributing to bridgingthe gender divide in rural communities and encouraging women tosucceed.

International Girls' Day Essay Competition Winners by Sarah D.

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Sarah DoyleEd2 - Kigali City
For International Girls' Day on October 11th, PCVs teamed up with Girl Hub, part of the Nike Foundation, to do an essay competition at some of our schools. The winners for both Kinyarwanda and English were sent along to me to select a few to go into Girl Hub's magazine, Ni Nyampinga. The magazine LOVED the essays and will be publishing excerpts from them all in the coming issue, but I thought this would be a good forum to post the English essays in their entirety. The question that we posed to the students was: "Why do you value yourself and what can you do to help develop your community?" Very often our students struggle with critical thinking, but I'm sure you'll agree, the essays below are very powerful and speak to the growing determination of young girls in Rwanda to not only study and create a future for themselves, but also to help their communities.
So now for the winners...
KABASINGA Flaviah,S6HEG, 18 years oldCollege De Rushaki,Gicumbi District, Northern ProvincePCV: Lucy Sung
Why do I value myselfand What can I do for my community?Value is somethinginside which makes one to be more important and to be useful. One can be valuedaccording to how one values herself in the society or among other people. I value myself in order to gain self respectamong others and this self respect cannot be given to me when I have not knownthe value I have. When one values herself, it will make her gain responsibilityin the community because everyone believes that she has knowledge and she iscapable of doing everything for the society. I value myself so thatI can uplift and restore the traditional culture of our community becauseculture makes all the people in the society to be unite and respective of eachother.When I value myself, Igain confidence and hope in myself to work and develop my community in order toachieve development and prosperity to the nation. The value I give to myselfmakes it easier for to plan for my future because when I get to know the valueI have, I don’t let it down but I fight to make it better even for people tohonour me. I value myself becauseam a co-creator of God so I have to make sure that God has more value thaneverything and I have to value myself so that God can be happy with me throughshowing good examples to other creatures.I value myself becauseam a coordinator of all living things in the world .I have the power andsupremacy to control and manage everything in the world.Value brings hope,peace, and love in the society that is why I value myself because when Irespect others they also respect me, which makes us equal ad makes me morevaluable.Value brings harmonyin the society because when I value myself and others, I give a good example toothers which makes the society to live happily.All I can do for mycommunity is to keep the value of our society is to respect each other andencourage them to have love, patience, and courage in what they do. For mycommunity, I can encourage them to have the spirit of the traditional cultureand nationalism in order to keep stability in the society. Encouraging people tohave confidence and to work hard in order to achieve development which canvalue our community. I can help my community to teach them what value is, whythey need it, and how they can achieve it, because value makes people to knowntheir human rights._________________________________________________________________
UWIMBABAZI Gemime, Senior 6 MCBE.S. BUGARAMA, Rusizi District, Western ProvincPCV: Jeff Monsma
I know I have value because:- I’m able to teach other girls.- I’m able to be and I will become a good leader.- I’m able to advise others.- I have the chance to study, while before girls didn’t getthat chance.- I have my self-esteem!- I know how to prevent AIDS.- I am able to fight against peer pressure.- I have the power to change the world.- I am able to create friendship between students.- I behave well- I am able to run the world, teaching women and girls abouthow theycan have self esteem, how they can fight peer pressure, andso on. AndI’ll do it because everything is possible!

BE Camp and The Male Perception

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Caitie Gibbons

Health 4

Nyagatare District

Muraho! I’d like to begin with a quick hello, and shortintroduction. My name is Caitie Gibbons, I’m one of GAD’s three new members electedin October from Health 4. Our training group arrived in Rwanda May 2012; we arethe fourth group of health volunteers, and the seventh training group total incountry. I’m thrilled to be part of the PC Rwanda GAD committee, and am greatlylooking forward to working together in the upcoming year.

Last week I participated in my first camp. It was a BE camp(Boys Excelling), a PC Rwandan youth development club focused for boys. When Ifirst heard about BE back in September I was hesitant to jump on board. Mybackground seriously lacks any boys’ education, or boys’ development work. I’vealso worked with girls so much in the past that breaching to the other sidegave me a fear-of-the-unknown type feeling.
Mulling the opportunity over, the importance of working withboys became clear to me. While the answer may be obvious to some, it took mesome time to realize this: boys’ development is as essential as girls. Afterall, how can we achieve gender equality in Rwanda (and elsewhere) if we onlyeducate the girls? Both sides need to understand the importance of empoweringtheir own gender and each other; both sides need to be equal. Without the boysunderstanding what gender equality is, and why it is important, how can weachieve it?  
With my new mindset I jumped on board with Camp BE, readyand willing to empower and educate. BE camp was an amazing experience for mefor several different reasons, but it also opened my eyes to the Rwandan maleperception.
At camp I taught a class on Relationship Building andPartnering in Gender Equality. During the class there was a list of scenariosasking boys what they would do in certain situations. The goal of thesescenarios was to open different discussions with each other on gender equality.Scenarios included: your wife gets sick and is unable to cook, clean, take careof children, what do you do? Or, you want to have sex with your girlfriend butshe does not, what do you do? Etc. I encouraged boys to think that there was noright or wrong answer. I wasn’t looking for a popcorn fluffy response on whatteacher wanted to hear. The scenario that got the most attention and appall was:your wife wants to be president someday. She is a leader in her community, andloves to lead. It is her goal and her dream in life. How do you respond to hergoal?  
The most common responses were (verbatim):
-      According to culture, it is not good. Thehusband has responsibility of taking care of family (financially).-      No you cannot support her. If she becomespresident she will have a lot of money and no respect for you (her husband).-      You can converse about culture and ask her ifshe respects the culture, if she respects culture then she will understand nowoman should be higher in the relationship then the husband.
They came from boys between the ages of fourteen and twenty-five.And yes, it broke my heart when one of my favorite students, who I brought tocamp, stood up in class and said no he would not support her, or would want hiswife to be a leader.
This is the current male perception of woman and their rolein the culture. For women to be successful, and make more money than theirhusbands is more often than not seen as having bad culture.
I tried to stay as neutral as I could during the classdiscussion. But lets be real, I went to an all girls high school that startedpumping feminism into me at age fourteen. My final plea to my students was forthem to communicate with their partners about their goals and dreams beforemarriage, and to reevaluate the relationship according to what each otherwanted from life. To have an open mind, and understanding of what their partnerswant from life. A woman is not a machine, a relationship should be equal, andrespected by both parties.
These discussions (and eye openers for myself) are why I ampassionate about gender development and support BE and GLOW (Girls Leading OurWorld) camps and clubs. So I encourage you, in whatever area you work in, andwherever you are to create and continue the discussion.   

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Multimodal Actions of Neural Stem Cells in a Mouse Model of ALS: A Meta-Analysis


Sci Transl Med 19 December 2012:
Vol. 4, Issue 165, p. 165ra164
Sci. Transl. Med. DOI: 10.1126/scitranslmed.3004579

• Research Article

Stem Cells

Multimodal Actions of Neural Stem Cells in a Mouse Model of ALS: A Meta-Analysis

1. Yang D. Teng¹,²,³,*,†,


2. Susanna C. Benn⁴,*,


3. Steven N. Kalkanis¹,⁴,


4. Jeremy M. Shefner⁵,


5. Renna C. Onario¹,²,³,


6. Bin Cheng⁶,


7. Mahesh B. Lachyankar³,


8. Michael Marconi³,⁷,


9. Jianxue Li⁷,


10. Dou Yu¹,²,


11. Inbo Han¹,²,


12. Nicholas J. Maragakis⁸,


13. Jeronia Lládo⁸,


14. Kadir Erkmen¹,³,


15. D. Eugene Redmond Jr.⁹,


16. Richard L. Sidman¹,⁷,


17. Serge Przedborski¹⁰,


18. Jeffrey D. Rothstein⁸,


19. Robert H. Brown Jr.⁴,¹¹,† and


20. Evan Y. Snyder¹,³,⁷,¹²,†

+ Author Affiliations

1. 
   ¹Departments of Neurosurgery and PM&R, Brigham & Women’s Hospital, Spaulding Rehabilitation Hospital and Harvard Medical School, Boston, MA 02115, USA.
   


2. 
   ²SCI Research, Veterans Affairs Boston Healthcare System, Boston, MA 02132, USA.
   


3. 
   ³Department of Neurology, Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115, USA.
   


4. 
   ⁴Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
   


5. 
   ⁵Department of Neurology, State University of New York, Syracuse, NY 13210, USA.
   


6. 
   ⁶Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY 10032, USA.
   


7. 
   ⁷Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.
   


8. 
   ⁸Department of Neurology, Johns Hopkins University, Baltimore, MD 21287, USA.
   


9. 
   ⁹Department of Psychiatry and Neurosurgery, Yale University School of Medicine, New Haven, CT 06520, USA.
   


10. 
    ¹⁰Movement Disorder Division, Neurological Institute, Center for Neurobiology and Behavior, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
    


11. 
    ¹¹Department of Neurology, University of Massachusetts Medical School, Worcester, MA 01655, USA.
    


12. 
    ¹²Sanford-Burnham Medical Research Institute, La Jolla, CA 92037, USA.
    

+ Author Notes

• 
  ↵* These authors contributed equally to this work.
  

1. ↵†To whom correspondence may be addressed. E-mail: esnyder@sanfordburnham.org (E.Y.S.); Robert.Brown@umassmed.edu (R.H.B.); yang_teng@hms.harvard.edu (Y.D.T.)

Abstract

Amyotrophic lateral sclerosis (ALS) is a lethal disease characterized by the unremitting degeneration of motor neurons. Multiple processes involving motor neurons and other cell types have been implicated in its pathogenesis. Neural stem cells (NSCs) perform multiple actions within the nervous system to fulfill their functions of organogenesis and homeostasis. We test the hypothesis that transplanted, undifferentiated multipotent migratory NSCs may help to ameliorate an array of pathological mechanisms in the SOD1^G93A transgenic mouse model of ALS. On the basis of a meta-analysis of 11 independent studies performed by a consortium of ALS investigators, we propose that transplanted NSCs (both mouse and human) can slow both the onset and the progression of clinical signs and prolong survival in ALS mice, particularly if regions sustaining vital functions such as respiration are rendered chimeric. The beneficial effects of transplanted NSCs seem to be mediated by a number of actions including their ability to produce trophic factors, preserve neuromuscular function, and reduce astrogliosis and inflammation. We conclude that the widespread, pleiotropic, modulatory actions exerted by transplanted NSCs may represent an accessible therapeutic application of stem cells for treating ALS and other untreatable degenerative diseases.

• Copyright © 2012, American Association for the Advancement of Science

Citation: Y. D. Teng, S. C. Benn, S. N. Kalkanis, J. M. Shefner, R. C. Onario, B. Cheng, M. B. Lachyankar, M. Marconi, J. Li, D. Yu, I. Han, N. J. Maragakis, J. Lládo, K. Erkmen, D. E. Redmond, R. L. Sidman, S. Przedborski, J. D. Rothstein, R. H. Brown, E. Y. Snyder, Multimodal Actions of Neural Stem Cells in a Mouse Model of ALS: A Meta-Analysis. Sci. Transl. Med. 4, 165ra164 (2012).


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Drug Safety and Availability > Dietary Supplement Reumofan Plus relabeled and sold as “WOW”

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Drug Safety and Availability > Dietary Supplement Reumofan Plus relabeled and sold as “WOW”

Dietary Supplement Reumofan Plus relabeled and sold as “WOW”

[12-19-2012] The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name “WOW.”  The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.  FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocrabamol (a muscle relaxant).  These ingredients have the potential to cause serious injury.
Reumofan Plus and “WOW” products are sold on various websites, including www.gonepainfree.com and www.browerent.com.  The products are manufactured by Riger Naturals S.A.  In addition to websites selling “WOW,” FDA has become aware that various websites, including www.reumofanusa.com, owned by Reumofan USA, LLC, continue to sell Reumofan Plus even after previous FDA warnings.
“These dangerous products should simply not be sold or distributed,” said Melinda Plaisier, FDA’s Acting Associate Commissioner for Regulatory Affairs.  “FDA is prepared to take aggressive enforcement action to protect consumers from these dangerous products, including seizure, injunction, and pursuit of criminal prosecution.”
Consumers currently taking or who have taken Reumofan Plus or “WOW” should immediately consult a health care professional.  Consumers should not buy or start using these products.  FDA is concerned that other distributors may also be relabeling Reumofan Plus products and selling relabeled products under other names.  Therefore, FDA advises consumers not to use any products with “Riger Naturals S.A.” printed on the bottom of the bottle, as pictured below.
FDA warned the public of the harm of Reumofan Plus on June 1, 2012, and again on August 21, 2012.  Since June, FDA has received dozens of adverse event reports, many of them serious, from consumers who used Reumofan Plus.  The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death.
The drug ingredients in Reumofan Plus and “WOW” may interact with other medications and cause serious adverse events.  Health care professionals are urged to ask their patients about the use of Reumofan Plus, “WOW,” and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids.
Additionally, health care professionals should evaluate patients who have used Reumofan Plus and/or WOW for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.
FDA has been in contact with both Brower Enterprises and Reumofan USA, LLC about voluntarily recalling the dangerous products.  At this time, neither firm has adequately alerted the public about the safety risks associated with the products.  
Reporting Injuries to FDA
Health care professionals and consumers are encouraged to report any adverse events related to Reumofan Plus products and “WOW” to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• online at www.fda.gov/Medwatch/report.htm;


• by phone at 800-FDA-1088 (800-332-1088); or,


• by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at 800-FDA-0178.

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.





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Related Information

• FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium


• FDA issues alert on Reumofan Plus


• BeSafeRx: Know Your Online Pharmacy

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1-800-332-1088

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Drug Safety and Availability > FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

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Drug Safety and Availability > FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement

[12-19-2012] The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)¹ was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.

FACTS ON PRADAXA (dabigatran etexilate mesylate)

Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with a specific condition called non-valvular atrial fibrillation (AF), a common heart rhythm abnormality that causes the upper chambers of the heart, or atria, to beat rapidly and irregularly.  Pradaxa is not indicated for patients with atrial fibrillation caused by heart valve problems.

Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.  FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves. Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication.  The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment.  Patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke.
FDA previously released a Drug Safety Communication about the risk of serious bleeding associated with the use of Pradaxa in patients with non-valvular atrial fibrillation (the population for which the drug is approved).  FDA has not changed its recommendations regarding use of Pradaxa in the population for which it is approved.

Additional Information for Patients

• If you have had a heart valve replacement and are taking Pradaxa, talk to your health care professional as soon as possible about your treatment. Do not stop using Pradaxa or other anticoagulants without guidance from your health care professional.  Stopping anticoagulants suddenly may increase your risk of blood clots or a stroke.


• Discuss any questions or concerns about Pradaxa with your health care professional.


• Report any side effects you experience to your health care professional and FDA’s MedWatch program using the information in the “Contact FDA” box at the bottom of the page.
   

Additional Information for Healthcare Professionals

• Pradaxa is approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa has not been evaluated in the treatment of atrial fibrillation caused by heart valve problems and cannot be recommended in these patients.


• Pradaxa should not be used to prevent valve thrombosis or thromboembolism (e.g., stroke, myocardial infarction, systemic embolism, prosthetic mechanical valve thrombosis, and vascular death) in patients with mechanical prosthetic heart valves.  The RE-ALIGN trial was terminated early because thromboembolic events and major bleeding were significantly more frequent in the Pradaxa treatment arm than in the warfarin treatment arm.


• The use of Pradaxa has not been evaluated in patients with bioprosthetic valves and use cannot be recommended for such patients.


• Report adverse events involving Pradaxa to FDA’s MedWatch program using the information in the “Contact FDA” box at the bottom of the page.
   

Data Summary

The safety and efficacy of Pradaxa (dabigatran) were evaluated in the European RE-ALIGN trial,¹ in which patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than 3 months prior to enrollment) were randomized either to dose-adjusted warfarin or to Pradaxa (150, 220, or 300 mg twice a day). Initial dosing of Pradaxa was determined by renal function.  In the warfarin group, the target international normalized ratio (INR) was 2 to 3 or 2.5 to 3.5, depending on the presence of risk factors and the position of the mechanical prosthetic heart valve.
RE-ALIGN was terminated early because the Pradaxa treatment arm had significantly more thromboembolic events (valve thrombosis, stroke, and myocardial infarction) and major bleeding (predominantly postoperative pericardial effusions requiring intervention for hemodynamic compromise) than did the warfarin treatment arm. These bleeding and thromboembolic events were reported in patients who were initiated on Pradaxa postoperatively within 3 days after mechanical bileaflet valve implantation and in patients whose valves had been implanted more than 3 months previously (Table 1).   
Table 1. Patients in the RE-ALIGN study with thromboembolic and/or bleeding events, as of December 10, 2012^a (includes patients who received Pradaxa or Warfarin).

	Pradaxa (n=160)*	Warfarin (n=89)*
Death	1 (0.6%)	2 (2.2%)
Stroke	8 (5.0%)	0 (0%)
Systemic embolism event (SEE)	0	0
Transient ischemic attack (TIA)	2 (1.3%)	2 (2.2%)
Valve thrombosis (VT)	4 (2.5%)	0
Myocardial infarction (MI)	3 (1.9%)	0
Composite of events: Death/stroke/SEE/TIA/VT/MI	16 (10.0%)	4 (4.5%)
Major bleeding	6 (3.8%)	1 (1.1%)
Major bleeding in pericardial location	5 (3.1%)	0
Any bleeding	36 (22.5%)	12 (13.5%)

*Because of dose up−titrations on dabigatran and switches from dabigatran to warfarin, patients can contribute events to both columns.
^aAs of December 10, 2012. the RE-ALIGN trial data is provided by Pradaxa’s manufacturer (Boehringer Ingelheim Pharmaceuticals, Inc.); therefore, the data have not undergone quality assurance procedures or verification by FDA.

References

¹ Van de Werf, F, Brueckman M, Connolly SJ, et al. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: the randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN). Am Heart J 2012; 163:931-937.e1.





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Related Information

• FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran)


• Information on Dabigatran Etexilate Mesylate (marketed as Pradaxa)

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1-800-332-1088

1-800-FDA-0178 Fax

Report a Serious Problem
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857

Bacillus cereus outbreak at Belgian day care center sickens 20 children

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Bacillus cereus bacteria grown on sheep’s blood agar Image/CDC

The FederalAgency for the Safety of the Food Chain (AFSCA) in Belgium reported lastweek an foodborne outbreak at a Borgerhout day care center which resulted in atleast 20 children suffering with the symptoms of vomiting.
Upon notification,the agency immediately conducted a thorough inspection of the establishment.Several samples of leftover food and vomit were collected. They wereimmediately sent for analysis at the Scientific Institute of Public Health.
It turned outthat Bacillus cereus was discovered in both the food and vomit samples.
No specificfood source was mentioned in the AFSCA press release.
Bacillus cereus isan aerobic, spore-forming bacterium found in the soil and the environmentworldwide. It commonly found in low levels in raw, dried and processed foods.
A wellrecognized and common cause of food poisoning worldwide,Bacilluscereus causes two types of toxins: a diarrheal type and a vomiting type.
The diarrhealtype of this food poisoning is usually associated with meats, milkand vegetables. The onset for the disease is from 8-16 hours and it lasts 12 to14 hours.
The vomitingtype of this food poisoning is due to rice, grains, cereals and otherstarchy foods.The onset is quite rapid (30 minutes to 6 hours) and usuallylasts a day or so. This type is frequently associated with outbreaks due tocooked rice held at room temperature.
This type of foodpoisoning is rarely fatal and cannot be transmitted from person to person.
Improper storage offood stuffs is the issue. Bacillus cereus spores can survive boilingand if the food, rice for example is stored at ambient temperature, the sporescan germinate into toxin producing bacteria.
Then the person eatsthe rice contaminated with the pre-formed toxin that causes the illness.
The vomiting type of toxin is also heat resistant, much like the enterotoxinthat causes Staphylococcus aureus food poisoning, and cooking willnot destroy the toxin.
To prevent B.cereus food poisoning the key is to thoroughly cook food and ifyou do not eat it immediately, hold it at 140°F or refrigerate promptly. Do notlet the food cool slowly.
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