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FDA approves new drug to treat major depressive disorder
On Sept. 30, the U.S. Food and Drug Administration approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Six clinical studies in which adults with MDD were randomly assigned to receive Brintellix or placebo demonstrated that Brintellix is effective in treating depression, according to the FDA press release. An additional study showed Brintellix decreased the likelihood of participants becoming depressed again after treatment of their MDD episode. Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill.
Studies were conducted in the United States and other countries, and included more than 4,700 patients aged 18 to 88 years. The clinical trial program included six positive six-eight week short-term studies, one of which was a dedicated study in the elderly. Takeda and Lundbeck report that the primary efficacy measure was the mean change from baseline to endpoint in the Hamilton Depression Scale total score in two short-term studies, including the elderly study, and the Montgomery-Asberg Depression Rating Scale total score in the other studies. The most common side effects reported by participants taking Brintellix in clinical trials included nausea, constipation and vomiting.
A joint press release from Takeda and Lundbeck states that Brintellix is expected to be available to patients by the end of the year.
Brintellix and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and health care professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents and young adults ages 18 to 24 during initial treatment. Studies show adults older than 24 years of age do not appear to have an increased risk of suicidal thoughts and behavior, while adults ages 65 and older appear to have a reduced risk. The FDA advises that patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.
For more information see the FDA press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370416.htm and the Takeda and Lundbeck press release at http://www.lundbeck.com/upload/us/files/pdf/2013_Releases/BrintellixApprovalRelease.pdf.
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AAGP is currently processing renewals for 2014 membership. To continue receiving AAGP's great benefits please renew online or submit your renewal payment to: AAGP, 7910 Woodmont Ave., Suite 1050, Bethesda, MD 20814.
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Apply now for AAGP awards to be presented in Orlando in March
Nominations/applications due Nov. 1
AAGP offers several awards to recognize excellence in the field of late-life mental health care, which will be presented at the Opening Plenary Session on March 14 in conjunction with the AAGP Annual Meeting, March 14-17 in Orlando, Fla. Do you know someone deserving of that recognition? Is it you? Nominations/applications for the following awards are due Nov. 1.
For detailed information on AAGP's 2014 awards, including eligibility and the nomination/application process, visit www.AAGPonline.org/awards.
- AAGP Distinguished Scientist Award
- AAGP Barry Lebowitz Early Career Scientist Award
- AAGP Member-in-Training Research Award
- AAGP Educator of the Year Award
- AAGP Clinician of the Year Award
- AAGP Diversity Award
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Exhibit at AAGP's Annual Meeting
Are you exhibiting at AAGP's 2014 Annual Meeting? Do you know someone who should be?
Connect AAGP with friends, colleagues and companies in the field who should be active in our exhibit hall. AAGP's exhibitors gain access to over 1,100 thought leaders and decision makers who treat older adults. Help us provide members and relevant organizations with the ability to network and discuss relevant technologies, products and services in the field of geriatric mental health. Learn more at www.AAGPonline.org/exhibit or contact AAGP's Marj Vanderbilt at email@example.com.
FDA issues final decision on beta amyloid positron emission tomography in dementia and neurodegenerative disease
Last month, the Centers for Medicare & Medicaid Services issued a decision memo to state that the evidence is insufficient to conclude that the use of positron emission tomography amyloid-beta imaging is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member for Medicare beneficiaries with dementia or neurodegenerative disease, and thus PET Aβ imaging is not covered under §1862(a)(1)(A) of the Social Security Act ("the Act"). However, the CMS says, there is sufficient evidence that the use of PET Aβ imaging is promising in two scenarios: (1) to exclude Alzheimer's disease in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia; and (2) to enrich clinical trials seeking better treatments or prevention strategies for AD, by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors. CMS will cover one PET Aβ scan per patient through coverage with evidence development, under §1862(a)(1)(E) of the Act, in clinical studies that meet certain criteria. For the list of criteria, see www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=265.
New HIPAA requirements this month: AMA offers resources
The AMA has a new toolkit available at www.ama-assn.org/go/hipaa to help physicians navigate the sweeping new revisions to the federal privacy and security rules for health information that were scheduled to go into effect on Sept. 23. The Department of Health and Human Services issued a final rule last January that revises and extends required safeguards for protected health information established under the Health Insurance Portability and Accountability Act of 1996.
New mental health legislation unveiled
In response to the recent Navy Yard shootings in Washington, D.C., on Sept. 16, Rep. Tim Murphy (R-Penn.), co-chair of the Congressional Mental Health Caucus, unveiled a proposal that would boost mental health treatment options for adults and children with serious mental illness, address the gaps in mental health care, and reform federal mental health spending for services and research. Murphy, a psychologist and long-time mental health advocate, said his forthcoming legislation would increase the options available for individuals who need inpatient and outpatient treatment. He cited the fact that the number of psychiatric beds has decreased from 500,000 to 40,000 in the past 50 years.
Murphy's proposed legislation is the culmination of an effort started in January by the Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee to identify problems in the nation's mental health system. Murphy, who is chairman of that subcommittee, said he plans to introduce his bill later this fall. The legislation would complement mental health legislation that was approved by the Senate Health, Education, Labor and Pensions Committee and incorporated into a gun control package (S. 649). For details of Rep. Murphy's plan and to read his Sept. 19 speech on the floor of the House of Representatives, go to: http://murphy.house.gov/latest-news/rep-murphy-outlines-mental-health-reform-agenda/.
Earlier this year, AAGP joined with the American Psychiatric Association, the American Medical Association, and other organizations representing psychiatry to develop strategies to promote better public awareness of the complex sources of violence in the United States and to recommend ways to improve mental health care in this country. A coalition was convened under the president of APA, Dilip Jeste, MD. The coalition recognized that only 3 to 5 percent of all violent crimes are directly related to mental illness, and that people with mental illnesses are much more frequently victims, rather than perpetrators, of violence. In order to decrease the occurrences of violence, the coalition has called for the cooperation of mental health organizations, federal, state and local government agencies, the legislative and judicial branches of government, and the public to identify potentially dangerous individuals and intervene before violent acts have occurred. Jeste will join with former AAGP president Paul Kirwin, MD, and former AMA president Jeremy Lazarus, MD, in discussing mental health and violence and presenting the findings and recommendations of the coalition at a plenary session at AAGP's Annual Meeting in Orlando in March 2014.
LEAD coalition urges Congress to hold hearing on Alzheimer's disease
On Sept. 23, AAGP joined other mental health organizations in sending a letter to congressional health care leaders to request a hearing on Alzheimer's disease and related disorders this fall. Led by the Leaders Engaged on Alzheimer's Disease coalition, the letter requests that the House Energy and Commerce Committee convene a hearing on the implementation of the National Plan to Address Alzheimer's Disease to determine the plan's effectiveness at "cutting through the red tape, incentivizing innovation, fostering collaboration and seizing every opportunity" to work towards the end of Alzheimer's disease and related disorders. Established by the National Alzheimer's Project Act in January 2011, the National Plan was created with the goal of overcoming Alzheimer's disease by 2025. The LEAD coalition is a diverse organization including patient advocacy and voluntary health nonprofits, philanthropies and foundations, trade and professional associations, academic research and clinical institutions, and biotechnology and pharmaceutical companies.
House committee passes legislation to advance Medicare payment reform
On July 31, the House Energy and Commerce Committee unanimously approved bipartisan legislation addressing Medicare payment reform, fueling some progress in the long-debated attempts by Congress to fix what many in the health care and mental health fields consider a "flawed" payment model. The committee voted 51-0 to approve the Medicare Patient Access and Quality Improvement Act (H.R. 2810), bipartisan legislation that would permanently fix the Medicare payment model that is used to reimburse physicians. Under the legislation, physicians in the fee-for-service system would receive a 0.5 percent annual payment increase for the first five years. Then, beginning in 2019, physician payments would be adjusted up or down depending on how well their services met new quality guidelines.
"The July 31 vote is an important milestone, but we are all resolved to achieve reform in a fiscally responsible manner," said Rep. Fred Upton, R-Mich., in a statement. "Despite our significant progress, we will not be satisfied until the ink is dry on the president's signature."
The repeal of the flawed sustainable growth rate formula would remove the threat of a 25 percent reduction in Medicare reimbursements due to years of postponed cuts piling on top of one another. Every year, the SGR formula has required an ever-increasing level of cuts, and every year Congress has enacted a patch or fix to postpone the cut.
Other congressional committees, in addition to the House Energy and Commerce Committee, have jurisdiction over Medicare but have not released any bills as yet. The Senate Finance Committee is holding discussions on how to proceed with the SGR but they currently do not have any legislation. The House Ways and Means Committee, which also has jurisdiction over Medicare, could consider the bill approved by the Energy and Commerce Committee and could approve it or amend it.
The Energy and Commerce Committee's approval of H.R. 2810 signals that there is more progress now regarding payment reform than there has been in recent years.
AAGP is continuing to work with other physician organizations to reform the Medicare payment system on a permanent basis and is providing feedback to congressional committees and others. There needs to be a permanent solution to this problem in order to preserve Medicare beneficiaries' access to care and to provide for fair reimbursement for all practitioners under the Medicare system.
Hearing held on veterans' access to mental health services
On Sept. 17, the Subcommittee on Health of the House Veteran' Affairs Committee held a field hearing in Cincinnati to learn about how VA hospitals are meeting the mental health needs of veterans. At the hearing, entitled "Making a Difference: Shattering Barriers to Effective Mental Health Care for Veterans," lawmakers heard from witnesses representing the Cincinnati VA Medical Center, local Veterans Service Commissions and the U.S. Department of Veterans Affairs. The hearing examined the VA's approach to overcoming the mental health care challenges facing veterans and how administrators and care providers are addressing common barriers to mental health care.
"Mental health care is a serious challenge facing many of our veterans when they return home. Today's hearing provided some more insight into how we can improve the care for America's veterans," said Rep. Dan Benishek (R-Mich.), chairman of the subcommittee and a physician who worked in a VA hospital for 20 years. Witness testimony from the hearing can be found at: http://veterans.house.gov/hearing/making-a-difference-shattering-barriers-to-effective-mental-health-care-for-veterans.
AAGP believes that strengthening clinical services, research and training in geriatric mental health will enhance treatment not only for elderly veterans, but for all veterans with mental disorders. Younger veterans are at risk for complications of their mental disorders as they grow older, and they clearly stand to benefit from cross-fertilization of successful treatment approaches that are developed for older veterans with complex, interacting mental and physical problems. Delivering quality health care for all veterans — integrating both physical and mental health care — must be a top priority. AAGP has consistently urged Congress to increase support for mental health services, training and research, and to commit the resources necessary to provide our nation's veterans with access to quality, affordable, well-coordinated physical and mental health care.
PCORI awards $114.2 million in federal funding to clinical effectiveness research
On Sept. 10, the Patient-Centered Outcomes Research Institute approved 71 new awards to support patient-centered comparative clinical effectiveness research. Of the $114.2 million awarded, $17 million will support projects dealing with mental disorders, and $24 million will support projects dealing with the elderly. PCORI was established by the Affordable Care Act to examine the relative health outcomes, clinical effectiveness, and appropriateness of various medical treatments. Of specific interest is a $1 million grant to develop patient center outcomes for dementia. Fifty-two of the newly approved awards are part of PCORI's third cycle of funding announcements made under the first four of its national research priorities and were selected from among more than 440 applications. The other 19 projects were selected from among 133 applications submitted under PCORI's inaugural call for proposals focused on improving methods. While PCORI does not have authority to mandate or endorse coverage policies, the Medicare program may take PCORI's research into account when determining what to cover for its beneficiaries. The full list of awardees is found here: http://pcori.org/2013/pcori-board-approves-114-million-for-pcor/.
Welcome, new AAGP members!
Nikolay Baldzhiyski, MD
Farzana Begum, MD
Stephen James Boyd, MBchB
Joseph Carbone, MD
Peggy Chatham, MD, MHSA
Mark Fettman, MD, MMM
Andrew Spitznas, MD
Elizabeth Varghese, MD
Jose Alfredo Alvarez, MD
Elaina DellaCava, MD
Nezar Ali El-Ruwie, MD
Thomas Warren Foster, MD
Julia Ogden Lunsford, MD
Anup Mani, BS/DO
Emily Murphy, MD
Samina Raja, MD
Kim Soden, MD
Crystal White, MD
Jessica Bentzen, BFA, MSN
Jaclismar Berrios, BS
Claudine Jones, BA
Megan Sheppard, DNP
Karina Vasquez, BA
David F. Rieb, PsyD
Michelle Spurlock, BSN, MBA, MSN
Steven Russell Thorp, PhD
Deborah C. Uchalik, PhD
Remarriages add complexity to dementia caregiving
Negative relations with stepchildren can compound the burdens a wife feels while caring for her husband with Alzheimer's disease or other forms of dementia, a new study suggests.
Low testosterone associated with increased dementia risk
Renal & Urology News
Low levels of total and bioavailable testosterone may be associated with an increased risk of dementia in elderly men, according to French investigators.
From a cohort of 3,650 men aged 65 years and older, Laure Carcaillon, MD, of Inserm in Villejuif, France, and collaborators compared 105 men with incident dementia and a random sample of 413 men without dementia.
Stress in midlife linked to higher risk of Alzheimer's disease
Stress in middle age may contribute to development of Alzheimer's disease later in life, according to a Swedish study spanning almost 40 years.
Psychological stress was associated with a 21 percent greater risk of developing Alzheimer's disease, according to a study of 800 Swedish women born between 1914 and 1930 who underwent neuropsychiatric tests periodically between 1968 and 2005.
Epigenetic markers shows promise in Alzheimer's disease
Increasing evidence suggests that epigenetic regulation is associated with the pathogenesis of Alzheimer's disease and targeting it may one day lead to novel diagnostic and therapeutic strategies, research suggests.
Scientists at The School for Mental Health and Neuroscience at Maastricht University, the Netherlands, have been performing parallel studies in mice and men to investigate the role of epigenetic mechanisms in ageing and AD.
Colby Horton, Vice President of Publishing, 469.420.2601
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