miércoles, 10 de febrero de 2016

NIMH » Genome-Wide Study Yields Markers of Lithium Response

NIMH » Genome-Wide Study Yields Markers of Lithium Response



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Genome-Wide Study Yields Markers of Lithium Response

NIMH scientists led the International Consortium on Lithium Genetics, which discovered genes that are associated with responsiveness to the mood-stabilizing medication lithium among patients with bipolar disorder. While the finding won’t have an immediate clinical application, it is a groundbreaking demonstration of the potential for identifying genetic information that can be used to inform personalized treatment decisions.





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Jim McElroy
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Charlotte Armstrong
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Genome-Wide Study Yields Markers of Lithium Response

 • Science Update
An international consortium of scientists has identified a stretch of chromosome that is associated with responsiveness to the mood-stabilizing medication lithium among patients with bipolar disorder. While the finding won’t have an immediate clinical application, it is a groundbreaking demonstration of the potential for identifying genetic information that can be used to inform personalized treatment decisions, even in genetically complex disorders. The genes identified are also an avenue for understanding the biology of the lithium response.
People with bipolar disorder experience marked, often extreme shifts in mood and energy. The disorder affects an estimated 2.6 percent of Americans. The mood swings can severely disrupt a person’s ability to function normally; as many as 15 percent of those affected die by suicide. Lithium is a mood stabilizing medication that is a mainstay of treatment. For some patients, it is very effective, virtually eliminating the symptoms. However, about a third of patients respond incompletely, and another third not at all.
NIMH scientist Francis J. McMahon, M.D., and Thomas G. Schulze, M.D., a former NIMH fellow now at the Ludwig-Maximilians-University of Munich, Germany, led a collaboration involving 22 sites participating in the International Consortium on Lithium Genetics to conduct a genome-wide association study (GWAS) in 2563 patients with bipolar disorder. Like all psychiatric disorders, bipolar disorder is genetically complex; it is likely that many genes, with small effects individually, influence the risk of developing it. In addition, risk genes interact with environmental factors to cause the disorder, making the search for risk genes that much more difficult. These challenges mean that large numbers of patients are necessary to enable scientists to detect associations between gene regions and biological effects.
Scientists in this study scanned genomes of participating patients, testing whether any of 6 million single nucleotide polymorphisms (SNPs), pinpoint variations in DNA across the genome, were associated with a person’s response to lithium. Four SNPs in a single location on chromosome 21 met criteria for association. The region identified contains two genes for long, non-coding RNAs (lncRNAs). In addition to RNA’s role as an intermediary in the translation of genes into proteins, it is now known to have a broader variety of biologic roles, including regulating such functions as gene expression and other cell processes. The identification of these lncRNAs offers scientists targets with which to explore how these molecules shape how someone responds to lithium.
While the patient population in this study was larger than any previous focused on the genetics of the lithium response, like other GWAS studies, this one depended on patients’ recall of their treatment experience. In an effort to test these results in a way that would avoid the uncertainties of recall, the scientific team also looked for these SNPs in a separate, smaller group of (89) patients who were being treated with lithium and assessed prospectively, or as their treatment continued. The SNPs were indeed associated with poorer lithium response, adding confidence to the original finding.
The need for “biomarkers” of lithium response—and for treatment effectiveness over the range of psychiatric disorders—is great. For genetic information to be useful in the clinic for guiding treatment choices for individuals, it may be necessary to have information on a large number of genes in addition to other types of information on individuals. The identification of genetic markers is one facet of the effort to move health care towards precision medicine , an approach in which disease treatment and prevention takes into account individual variability in genes, environment, and lifestyle. The results reported here will require replication, but this study suggests that ongoing research can provide information on genes that will be of use in health care, even for disorders in which the genetics are complex, and the effects of individual genes subtle.
Grants
ZIA-MH00284311 (NIMH Intramural Research Program), CA89392, DA021237. Other NIH grants supported data and biomaterial collected in the NIMH Bipolar Disorder Genetics Initiative.
Reference

CDC Press Release: More than 3 million US women at risk for alcohol-exposed pregnancy

Press Release
                                                                           
Tuesday, February 2, 2016

(404) 639-3286

More than 3 million US women at risk for alcohol-exposed pregnancy
Sexually active women who stop using birth control should stop drinking alcohol, but most keep drinking

An estimated 3.3 million women between the ages of 15 and 44 years are at risk of exposing their developing baby to alcohol because they are drinking, sexually active, and not using birth control to prevent pregnancy, according to the latest CDC Vital Signs report released today. The report also found that 3 in 4 women who want to get pregnant as soon as possible do not stop drinking alcohol when they stop using birth control.

Alcohol use during pregnancy, even within the first few weeks and before a woman knows she is pregnant, can cause lasting physical, behavioral, and intellectual disabilities that can last for a child’s lifetime. These disabilities are known asfetal alcohol spectrum disorders (FASDs). There is no known safe amount of alcohol – even beer or wine – that is safe for a woman to drink at any stage of pregnancy.

“Alcohol can permanently harm a developing baby before a woman knows she is pregnant,” said CDC Principal DeputyDirector Anne Schuchat, M.D. “About half of all pregnancies in the United States are unplanned, and even if planned, most women won’t know they are pregnant for the first month or so, when they might still be drinking. The risk is real. Why take the chance?”

Healthcare providers should advise women who want to become pregnant to stop drinking alcohol as soon as they stop using birth control. Most women don’t know they are pregnant until they are four to six weeks into the pregnancy and could unknowingly be exposing their developing baby to alcohol. FASDs are completely preventable if a woman does not drink alcohol during pregnancy.

Greetings from the FDA Office of Minority Health [Newsletter Vol 6]



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Greetings from the FDA Office of Minority Health (OMH)
2015 was a great year and 2016 is shaping up to be even better. The OMH communications team grew--we added 5 wonderful new specialists who completely enhance our outreach efforts. We made real strides in making FDA more accessible to people like you through webinars, workshops, and public meetings, and we expanded our social media presence.
In 2016 we are working harder to make your voices heard. That's why throughout this issue you will find opportunities to attend public meetings, comment on open dockets, and even apply to a fellowship at FDA. 
These are important opportunities to make a difference in minority health--health disparities are too numerous for FDA alone to identify and impact. Your suggestions help us close the health equity gap and ensure that medical products and devices are safe and effective for everyone. 

 In this issue: 
  • FDASIA 907 PUBLIC MEETING: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
  • CONSUMER UPDATE: Who's In Clinical Trials?
  • Join the New Diverse Women in Clinical Trials Campaign
  • #ILoveMyHeart
  • American Heart Month Twitter Chat
  • FR NOTICE: Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments
  • Tobacco Fellowship Application
  • CONSUMER UPDATE: Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
  • Get Email Updates on Safety Alerts and Recalls
  • WORKSHOP RECAP: Assessing Safety and Efficacy for Diverse Populations

FDASIA 907 PUBLIC MEETING: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
FDA will host a public meeting on 2/29/2016 to solicit feedback and recommendations on the progress of FDASIA 907: the Action Plan to Improve Clinical Trials Data for Minorities, Women, and Other Demographic Subgroups. 
Date:          February 29, 2016
Time:         9 AM - 4 PM 
Location:    The Great Room at FDA White Oak
                 10903 New Hampshire Ave
                 Silver Spring, MD
More Information

CONSUMER UPDATE: Who's in Clinical Trials?
Have you ever wondered if someone like you participated in the clinical trials for a new drug? If you have, you're not alone.
That's why FDA is making demographic information from clinical trials--such as the inclusion of women and minority groups--easily available to consumers through its online Drug Trials Snapshots database.

Join the New Diverse Women in Clinical Trials Campaign
Clinical trials help to show whether a test or treatment is safe and works well. Because medical products can affect men and women differently, it is important for women to participate in clinical trials.
Last month, the FDA Office of Women's Health launched a new Diverse Women in Clinical Trials awareness campaign to educate women of all ages, racial and ethnic groups, and women with disabilities or chronic health conditions about clinical trials. The national campaign encourages diverse women to ask their healthcare providers whether a clinical trial is right for them. 
Visit FDA's Women in Clinical Trials website for tips and resources to help you talk to your family, friends and health care provider about clinical trials. 

#ILoveMyHeart

Join the #ILoveMyHeart campaign by the FDA Office of Minority Health (@FDAOMH), Salud Today (@SaludToday) and the Association of Black Cardiologists (@ABCardio1) and show us how much you love your heart!
In honor of American Heart Month this February, take a picture with a dry erase board or poster describing how you keep your heart healthy. You can also share pictures preparing healthy meals, engaging in a physical activity, taking your medication or doing any other activities that keep your heart healthy. Share your photos on Twitter with the #ILoveMyHeart hashtag and @FDAOMH Twitter handle. Every Monday we will pick the best three photos and post them on FDA's Facebook page.

American Heart Month Twitter Chat
OMH (@FDAOMH) will participate in a Twitter chat sponsored by Million Hearts (@MillionHeartsUS) and Men's Health Network (@MensHlthNetwork) in order to raise awareness of heart health among African American Men. 
Date:       February 17, 2016
Time:      3:00 PM EST

FR NOTICE: Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments
FDA will host a public meeting to solicit patient and provider perspectives on receiving medically relevant genetic test results. Specifically, FDA wants to know what information about the tests patients and providers want to know the most, the information patients need in order to understand what their results mean, and how patients and providers want to receive their results.
Date:       March 2, 2016
Time:       8 AM - 4 PM 
Location:  The Great Room at FDA White Oak
               10903 New Hampshire Ave
               Silver Spring, MD

FDA Tobacco Fellowship Applications Open Now Through March 1st
FDA is offering mid-career professionals the opportunity to spend a year as a Tobacco Regulatory Science Fellow in the Center for Tobacco Products (CTP). This is a collaborative program between CTP and the National Academy of Medicine. 
Fellows will have the chance to help develop science-based public health strategies, serve as leads for defined projects, and meet with policy leaders. Opportunities are available in the following areas within CTP: Compliance and Enforcement, Health Communication and Education, Management, Regulations, Policy, and Science.
Tobacco use heavily impacts minority consumers, so this is an important opportunitiy for mid-level professionals to help reduce health disparities in tobacco use. 

CONSUMER UPDATE: Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
If you buy imported products marketed as "dietary supplements" and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. 
According to Cariny Nunez, M.P.H., a Public Health Advisor in the Office of Minority Health at the Food and Drug Administration (FDA), "health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information."

EMAIL UPDATES: Get Email Updates on Safety Alerts and Recalls
MedWatch Safety Alerts - Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories.
FDA MedWatch is a gateway to find information about and report serious adverse events with human medical products.
Recalls, Market Withdrawals, and Safety Alerts - FDA press releases, industry press releases on FDA-related products and safety alerts concerning significant (primarily Class I) product recalls/actions.
Medical Device Recalls - Notices about Class I medical device recalls and some Class II and III recalls of interest to consumers. 

WORKSHOP RECAP: Assessing Safety and Efficacy for Diverse Populations
FDA and Johns Hopkins Center for Excellence in Regulatory Science Innovation (CERSI) hosted a one-day clinical trials workshop: "Assessing Safety and Efficacy for a Diverse Population" on December 2, 2015. This workshop utilized a multi-disciplinary approach to examine how various population-based tools can inform pre-market clinical trials as well as post-market clinical trials as well as post-marketing studies. It also included a discussion of other innovative strategies that address meaningful use of subgroup data. 

NIAID Email Alert: Notice Highlighting Interest in Zika Virus Research Areas

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Zika Virus Research Areas

For more opportunities, see the NIAID Funding Opportunities List
You can follow us on Twitter: @NIAIDFunding.

Applied Cancer Research is now accepting submissions

BioMed Central
Applied Cancer Research
Editor-in-Chief: José Vassallo (Brazil)
Submit a ManuscriptEditorial BoardAuthor InstructionsArticle Alerts
Dear Prof CERASALE MORTEO,
I am pleased to announce that submissions are now open for the open access journalApplied Cancer Research, now published by BioMed CentralThe official journal of the AC Camargo Cancer Center in Sao Paulo, Brazil, Applied Cancer Research is led by Editor-in-Chief José Vassallo and an expert Editorial Board.
About the journal
Applied Cancer Research is an open access, peer-reviewed journal focused on clinical, surgical and translational research in the field of oncology. The journal considers for publication original articles addressing genetics, pathology, diagnosis, treatment, patient care, and epidemiology.
As a multidisciplinary journal, Applied Cancer Research aims to be a forum for exchanging relevant information among researchers, health care practitioners and health policy makers, helping them enhance prevention and decrease mortality rates from malignant diseases, improve the management of patients afflicted by them and the quality of life of people during and after treatment.
About the Editor-in-Chief
José Vassallo is Professor of Oncology and consultant in Hematopathology at AC Camargo Cancer Center and Professor of Pathology at University of Campinas, Brazil. He received his PhD from University of Münster, Germany, and postdoctoral fellowships from University Toulouse III – Paul Sabatier and University of Paris VIII, both in France, as well as from the German Cancer Research Center in Heidelberg. As a researcher, his work has focused on tumoral microenvironment, tumoral immunology, molecular pathology of neoplasia, and oncovirus. Read Professor Vassallo’s publications in PubMed
Reasons to publish with us
-Expert Editorial Board
-High-quality peer review service
-Rapid publication upon acceptance
-Highest possible global visibility for your research
-Article-Processing Charges (APCs) are covered by AC Camargo Cancer Center
Keep up to date – register to get the latest articles delivered straight to your inbox.
Sincerely yours,
Todd Hummel
Editorial Director, BioMed Central

On Facebook, Ask Us About Menopause Symptoms and Complementary Health Approaches

On Facebook, Ask Us About Menopause Symptoms and Complementary Health Approaches



National Center for Complementary and Integrative Health (NCCIH)



menopause facebook

During the years around menopause, many women have hot flashes, night sweats, difficulty sleeping, or other symptoms. Some turn to natural products—like black cohosh or red clover—or mind and body practices—such as acupuncture or meditation—for relief. This month, we invite you to ask your questions about complementary health approaches for menopause symptoms in the Comments section of the Facebook post. We’ll feature one question on our Facebook page later this month with an expanded response. Ask now!

Can you help Alzheimer’s and other research by donating your brain?

e-Update from the Alzheimer's Disease Education and Referral Center, a service of the National Institute on Aging at N I H

Organ donation is a great way to help people waiting for transplants. But did you know you can also donate your brain to science? This generous donation can help researchers learn more about the brain and brain diseases—especially Alzheimer’s disease and dementia.


Spread the word about brain donation with this social media message:

Help researchers learn more about the #brain by planning to be a brain #donor. Learn more: http://1.usa.gov/1KCPZTV #DonateLife