Monday, October 20, 2014

FDA Approves New Abuse-Deterrent Labeling for Opioid Analgesic


The U.S. Food and Drug Administration (FDA) approved new labeling for Embeda, an opioid analgesic to treat severe pain. The new labeling includes a statement indicating that Embeda has properties that are expected to reduce oral abuse of the drug when the product is crushed.

Embeda becomes the third opioid analgesic to be approved with an abuse-deterrent label, in line with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling.

Embeda, which is manufactured by Pfizer, is a combination of morphine sulfate and naltrexone hydrochloride. These agents have competing actions on the opioid receptor; when capsules are swallowed intact, only the morphine is released, producing pain relief but creating the risk of abuse and addiction. When crushed, the naltrexone is also activated, blocking some of the euphoric effects of morphine. This reduces the risk of abuse, though not completely preventing it, for people who improperly use the drug such as by inhaling it.

Though the new labeling is approved, the FDA will require additional postmarketing studies of Embeda to further assess the effects of the abuse-deterrent features on the risk—and consequences—of abuse, particularly in regard to intravenous use. The agency is also holding a public meeting on October 30-31 in Silver Spring, Md., to further discuss the development of abuse-deterrent opioids.

To read about initiatives and recommendations for reducing opioid abuse, see the Psychiatric News article, "Caution Urged for Clinicians Who Prescribe Opioids."

Friday, October 17, 2014

Pipeline and Innovation for Psychotropic Drugs Are Limited, Study Finds


As development of drugs to treat psychiatric disorders lags behind that of drugs for other illnesses, a recent study published in Psychiatric Services in Advance sheds light on why the pipeline for psychotropic medicines is nearly empty.

Researchers from Brandeis University and Truven Health Analytics led an investigation of the current state of psychotropic drugs in the pipeline and potential barriers that may keep these drugs from reaching distribution in the United States. Sifting through industry reports, company press releases, and the National Institutes of Health clinical trials website, the researchers gathered information on phase 3 trials for drugs being developed to treat major psychiatric disorders, including alcohol use disorder, schizophrenia, and depression. All studies involved adults aged 18 or older.

The analysis showed that the pipeline for psychotropic drug development—99 clinical trials were included—is limited, with little product innovation evident. Most of the examined drugs were a combination of existing of U.S. Food and Drug Administration-approved medicines or individually approved medicines that were being tested for new indications or delivery-system approaches (such as an injectable version that is similar to an approved oral form). Only three drugs differed substantially from existing drugs.

Among the barriers that hindered development of psychotropic drugs were incentives that encourage firms to focus on incremental innovation—such as a new version with fewer associated side effects—rather than taking risk on radically new molecular approaches, the failure of animal studies to translate well to human trials, and drug-approval thresholds set by the FDA that developers and manufacturers may perceive as too high to attain.

In an interview with Psychiatric News, Alan Schatzberg, M.D., a professor of psychiatry at Stanford University and former APA president, said that the departure by pharmaceutical companies to develop innovative psychotropic medicines could result in serious problems for the field of psychiatry, especially for patients.

“There is a number of initiatives by various organizations to help with this problem, including the European College of Neuropsychopharmacology, which is working with companies to provide investigators with compounds that have been shelved, and NIMH's Research Domain Criteria [RDoC], which promotes research on specific [and new] biological targets," he said. Schatzberg emphasized that it will take a concerted effort on the parts of governmental agencies, industry, as well as APA to advocate for investment and innovative psychiatric drug development. “Silence will not be helpful to our patients,” he concluded.

To read more about psychotropic drugs in the pipeline and initiatives to steer drug development and innovation, read this month's "Med Check" in Psychiatric News.


(Image: Florianopulopulos/shutterstock.com)


Thursday, October 16, 2014

Psychiatry Appointments Often Difficult to Obtain, Study FInds


Considerable attention is being focused on the unmet need for mental health care in this country and how critical it is to improve insurance coverage so more people can enter treatment. But a new study finds that expanded insurance coverage might not be the answer, since even with insurance, treatment for mental illness can be hard to obtain.

Researchers at Maimonides Medical Center in Brooklyn, N.,Y., and Harvard Medical School examined the availability of outpatient psychiatric appointments in three large cities—Boston, Chicago, and Houston. As they reported yesterday in the study "Availability of Outpatient Care From Psychiatrists: A Simulated Patient Study in Three U.S. Cities" in Psychiatric Services in Advance, "Obtaining an outpatient appointment with a psychiatrist was difficult in the three cities we surveyed, and the appointments given were an average of one month away. Our findings add to the growing evidence that the mental health system is difficult for consumers to access. The findings are in line with national data demonstrating that two-thirds of primary care physicians cannot obtain outpatient mental health services for patients who need them."

Posing as patients, researchers called 120 numbers in each of the cities that were listed for individual in-network psychiatrists (as opposed to psychiatric clinics) in a Blue Cross/Blue Shield (BCBS) database. For each city, 40 callers each said they had either BCBS PPO insurance, Medicare, or were self-pay. Only 40% of the calls were answered in the first round of calling, and 16% of the numbers were found to be incorrect. After two rounds of calling, the callers obtained appointments with only 93 psychiatrists, or 26% of the sample. The differences between being in the BCBS PPO, Medicare, or self-pay were insignificant when it came to lining up the psychiatric appointment. There was, however, a significant difference in "success rate" for appointments among the cities, with psychiatrists in Boston least likely to offer an appointment (18%), while in Houston appointments were obtained 34% of the time. Chicago was in the middle at 25%.

The researchers concluded that "Expanding health insurance coverage through the Affordable Care Act may thus do little to change the conditions that made it difficult for us to obtain outpatient appointments with psychiatrists—or worse, expansion of coverage might further overwhelm the capacity of available services from these providers." As remedies, they suggest ways in which psychiatry might be made more attractive to medical students and urge an increase in insurance reimbursement for psychiatric care.

For more on these issues, see the Psychiatric News articles "Knocking Down the Barriers to Care" and "Shift to Population Health Called Critical to Psychiatry's Future."

(image: Anton Prado Photo/shuttterstock)

Wednesday, October 15, 2014

Breakthrough in Cultured Neural Cells With Alzheimer's Could Speed Drug Testing


Neural cells with the genes for Alzheimer’s disease (AD) were successfully grown in culture, developing the amyloid-β plaques and neurofibrillary tangles believed to be characteristic of the disease.

Researchers at the Genetics and Aging Research Unit at the Massachusetts General Institute for Neurodegenerative Disease and several other institutions have successfully grown “Alzheimer’s in a petri dish,” as the breakthrough was called in a New York Times article. The work was published in a report in the journal Nature. “We have successfully recapitulated amyloid-β and tau pathology in a single 3D human neural cell culture system,” the researchers stated.

Alzheimer’s experts say the breakthrough could dramatically speed the testing of drugs for treating AD. “This is a ground breaking study that will enable researchers to investigate the process of progression of Alzheimer’s disease and, more importantly, test large numbers of possible treatments in a relatively short order,” past APA President Dilip Jeste, M.D., (pictured above) told Psychiatric News. “Clinical trials take a long time to complete, and animal models such as those using mice or rats have uncertain applicability to the human disease. I believe these investigators’ work will open the door to study many other brain diseases too.” Jeste is a distinguished professor of psychiatry and neurosciences and the director of the Sam and Rose Stein Institute for Research on Aging at the University of California, San Diego.

“One note of caution is that we do not know to what extent plaques and tangles in a petri dish replicate the complex living brain of a person with Alzheimer’s disease,” Jeste added. “Nonetheless, this work opens a new and exciting line of research into neurodegenerative and other brain diseases.”

For more on AD research, see the Psychiatric News article, “High BDNF Levels May Offer Protection Against Alzheimer’s.” Also see the book Clinical Manual of Alzheimer Disease and Other Dementias from American Psychiatric Publishing.

Tuesday, October 14, 2014

Mental Health Response to Ebola Outbreak Still in Early Stages


As infectious disease specialists and health officials work to stem the Ebola outbreak in Africa, mental health personnel are patching together their own response to the disaster.

"The totality of the response has been quite slow, and the mental health response has even been slower,” said Benjamin Harris, M.D. (pictured above), in an email to Psychiatric News. Harris is an associate professor at Dogliotti College of Medicine in Monrovia, Liberia. He is also the only psychiatrist working in that country.

Health professionals are both overworked and exposed to the virus, said Mardia Stone, M.D., M.P.H., an advisor to the Division of Global Psychiatry at Massachusetts General Hospital and Harvard Medical School, who returned recently from the region. Their families are also a vulnerable group, fearing that these workers will catch the disease or inadvertently bring the pathogen home.

Neighboring Sierra Leone also has just one psychiatrist, but nongovernmental organizations there have been working to give some nurses and other health workers a basic understanding of mental health.

Liberia, Sierra Leone, and Guinea—where almost all of the Ebola cases have arisen—are collaborating to develop a psychosocial program that will focus on the children and widowed spouses of Ebola victims, said Harris.

Halting the spread of virus is the first priority of public-health personnel, but the psychological aftereffects of the epidemic will become even more apparent once the disease's spread is contained.

To read more in Psychiatric News about the mental health response to the Ebola epidemic, see the article "Response to Ebola Crisis Will Require Attention to MH Needs." Ebola factsheets from the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences are posted at http://www.cstsonline.org/ebola/.

(Image: Massachusetts General Hospital)

Friday, October 10, 2014

The Americas Must Continue Move to Community-Based Mental Health Services


“The [mental health] treatment gap is the great challenge we face today,” said Jorge Rodriguez, M.D., Ph.D., unit chief for Mental Health and Substance Use at the Pan American Health Organization (PAHO) in Washington.

Tearing down barriers to access to services should come as part of universal health coverage and include the integration of mental health into general health services, and not in some parallel track, said Rodriguez, recounting provisions of PAHO’s strategic plan for 2014-2019 at a symposium today at PAHO headquarters on World Mental Health Day. Meeting that challenge will require cooperation by governments, health professionals, families and consumers.

However, in 20 of the 27 countries in North and South America with psychiatric hospitals, more than 50% of the mental health budget still goes to those institutions rather than to community-based systems, he said.

“We need a new vision of research, policy, clinical services, and education,” added Eliot Sorel, M.D., a clinical professor of global health, health services management and leadership and of psychiatry and behavioral sciences at George Washington University, who helped organize the program. “Primary care physicians, pediatricians, and public-health people must be our allies. It is a shared responsibility.”

For more in Psychiatric News about international mental health, see: “WHO Report Emphasizes Need to Make Suicide Prevention a Global Priority.”

 (Image: Aaron Levin)

Thursday, October 9, 2014

Lack of Culturally Competent Care Prevents Hispanics From Seeking Care


In observance of National Hispanic Heritage Month, APA’s Diversity at Work program sponsored a "Lunch and Learn" program this week to celebrate the contributions of Hispanics and Latin Americans and highlight the importance of cultural competence when providing mental health services to Hispanic populations.

“Mental health involves more than the brain,” said the program’s guest speaker, Jane Delgado, Ph.D., M.S., a clinical psychologist and president and CEO of the National Alliance for Hispanic Health. “We really need to understand the people who we serve … and listen to them.” During an interview with Psychiatric News, Delgado, a Cuban American, said that one of the main factors that keep Hispanic Americans from accessing mental health care, as well as other health care services, is the fear of not being understood due to language barriers and the lack of cultural competence by clinicians, particularly when patients are describing their symptoms.

Delgado described one situation in which a person of Hispanic descent visited the emergency department and repeatedly said “débil” when asked to describe their symptoms. Under the assumption that the patient was trying to convey that he was seeing the devil, the health care professionals concluded that the patient's illness was related to mental illness. “ 'Débil' means ‘weak’ in Spanish,” Delgado explained to Psychiatric News. "This is one of many examples of how misunderstandings" of a patient’s ethnic background and language can affect the health care they receive.

Delgado, who advocates for minority health on Capitol Hill, also stressed the importance of increasing the number of diverse clinical trials, particularly involving mental health care. “Hispanics metabolize fat differently from the general population—making certain medications intended for diabetes more effective in this population. Certain heart medications are more effective in African Americans. … Does this [concept] hold true for psychiatric medication that we give patients? We need to know." She added that "mental health professionals must push for better and more diverse data to make the best decision for our patients."

To read more about mental health issues in Hispanic Americans, see the Psychiatric News article "For Better Mental Health Care for Latinos, Look at Neighborhoods."


Note: Join your APA colleagues in responding to questions and comments from the public and patients in this week's #YourMH @twitter chat tomorrow (Friday, October 10) from noon to 1 p.m. ET. The topic is serious mental illnesses (schizophrenia, major depression, bipolar disorder). To join, use #YourMH (stands for "Your Mental Health"), @apapsychiatric, or #MIAW14. If you haven't created a Twitter account yet, click here to do so now. Here's your chance to share your knowledge and insights.

(Image: Vabren Watts/Psychiatric News)

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