Diseases

NIH funds study in four states to reduce opioid related deaths by 40 percent over three years

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As part of Health and Human Services Secretary Alex Azar’s cross-cutting Department initiatives to address the opioid epidemic, the National Institutes of Health today selected four research sites for the HEALing Communities Study in four states hard hit by the opioid crisis.

This ambitious study aims to reduce overdose deaths by 40 percent over three years in selected communities by testing a set of proven prevention and treatment interventions, such as distribution of naloxone to reverse overdose and linking individuals in the criminal justice system with treatment for opioid addiction.

More than $350 million will support the multi-year study under a cooperative agreement supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The study is being carried out in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), which provides support for many of the local prevention, treatment and recovery support services to be studied.

The study is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative, a bold, trans-agency effort to speed scientific solutions to stem the national opioid crisis.

“The Trump Administration recognizes that the most important work to combat our country’s opioid crisis is happening in local communities, where governments, organizations, families, and individuals are coming together to expand access to prevention, treatment, and recovery services,” said HHS Secretary Alex Azar. “The HEALing Communities Study is an exciting, unprecedented effort to support communities in using and expanding our scientific understanding of effective interventions. It is a major new step in local and national efforts that are beginning to turn the tide on this public health crisis.”

Grant awards were issued to the University of Kentucky, Lexington; Boston Medical Center, Boston; Columbia University, New York City; and Ohio State University, Columbus, respectively. Each site is partnering with at least 15 communities to measure the impact of integrating evidence-based prevention, treatment and recovery interventions across primary care, behavioral health, justice and other settings in highly affected parts of the country.

RTI International, based in North Carolina, will serve as the study’s coordinating center, and will be responsible for data analysis, health economics research, and widespread dissemination of research findings over the course of the study. Multi-year awards are subject to the availability of funds and program priorities, among other considerations.

“As communities across America continue to suffer from the opioid crisis, a comprehensive approach is needed to help end addiction long-term,” said NIH Director Francis S. Collins, M.D., Ph.D. “By testing a suite of evidence-based interventions, not just in health care, but in schools, among first responders, and in the criminal justice system, the HEALing Communities Study will seek to reduce dramatically the number of overdose deaths in those communities, and to create a model for helping communities nationwide.”

The study will track communities as they reduce the incidence of opioid use disorder, increase the number of individuals receiving medication-based treatment for opioid use disorder, increase treatment retention beyond six months, provide recovery support services and expand the distribution of naloxone, a medication to reverse opioid overdose.

“The evidence generated through the HEALing Communities Study will help communities nationwide address the opioid crisis at the local level,” said Nora D. Volkow, M.D., director of NIDA. “By testing and evaluating interventions where they are needed the most, we hope to show how researchers, providers, and communities can come together and finally bring an end to this devastating public health crisis.”

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WHO releases first guideline on digital health interventions

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WHO on Wednesday released new recommendations on 10 ways that countries can use digital health technology, accessible via mobile phones, tablets and computers, to improve people’s health and essential services.

“Harnessing the power of digital technologies is essential for achieving universal health coverage,” says WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Ultimately, digital technologies are not ends in themselves; they are vital tools to promote health, keep the world safe, and serve the vulnerable.”

Over the past two years, WHO systematically reviewed evidence on digital technologies and consulted with experts from around the world to produce recommendations on some key ways such tools may be used for maximum impact on health systems and people’s health.

One digital intervention already having positive effects in some areas is sending reminders to pregnant women to attend antenatal care appointments and having children return for vaccinations. Other digital approaches reviewed include decision-support tools to guide health workers as they provide care; and enabling individuals and health workers to communicate and consult on health issues from across different locations.

“The use of digital technologies offers new opportunities to improve people’s health,” says Dr Soumya Swaminathan, Chief Scientist at WHO. “But the evidence also highlights challenges in the impact of some interventions.”

She adds: “If digital technologies are to be sustained and integrated into health systems, they must be able to demonstrate long-term improvements over the traditional ways of delivering health services.”

For example, the guideline points to the potential to improve stock management. Digital technologies enable health workers to communicate more efficiently on the status of commodity stocks and gaps. However, notification alone is not enough to improve commodity management; health systems also must respond and take action in a timely manner for replenishing needed commodities. 

“Digital interventions, depend heavily on the context and ensuring appropriate design,” warns Dr Garrett Mehl, WHO scientist in digital innovations and research. “This includes structural issues in the settings where they are being used, available infrastructure, the health needs they are trying to address, and the ease of use of the technology itself.”

The guideline demonstrates that health systems need to respond to the increased visibility and availability of information. People also must be assured that their own data is safe and that they are not being put at risk because they have accessed information on sensitive health topics, such as sexual and reproductive health issues.

Health workers need adequate training to boost their motivation to transition to this new way of working and need to use the technology easily. The guideline stresses the importance of providing supportive environments for training, dealing with unstable infrastructure, as well as policies to protect privacy of individuals, and governance and coordination to ensure these tools are not fragmented across the health system.

The guideline encourages policy-makers and implementers to review and adapt to these conditions if they want digital tools to drive tangible changes and provides guidance on taking privacy considerations on access to patient data.

“Digital health is not a silver bullet,” says Bernardo Mariano, WHO’s Chief Information Officer. “WHO is working to make sure it’s used as effectively as possible. This means ensuring that it adds value to the health workers and individuals using these technologies, takes into account the infrastructural limitations, and that there is proper coordination.”

The guideline also makes recommendations about telemedicine, which allows people living in remote locations to obtain health services by using mobile phones, web portals, or other digital tools. WHO points out that this is a valuable complement to face-to-face-interactions, but it cannot replace them entirely. It is also important that consultations are conducted by qualified health workers and that the privacy of individuals’ health information is maintained.

The guideline emphasizes the importance of reaching vulnerable populations, and ensuring that digital health does not endanger them in any way.

Local ophthalmologists are learning to provide specialized care to Ebola survivors in the DRC

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Knowledge gained following the 2014–16 West Africa Ebola outbreak identified a number of challenges survivors face, including reduced or blurred vision stemming from inflammation of their eyes. About 20% of survivors from that outbreak had some form of eye problem.

Muhindo, a young Ebola survior, has his eyes tested by Dr Steven Yeh
WHO/J. D. Kannah

By identifying and treating these problems early, serious consequences, including blindness, can be averted. With the Ministry of Health of the Democratic Republic of the Congo (DRC), the World Health Organization recently organized an eye clinic to check on the eye health of survivors of the current Ebola outbreak.

The clinic was held in Beni, DRC, one of the affected areas, from 25 March to 1 April. In addition, an eye clinic in Butembo, another affected area, was equipped so that they can provide this specialized care to survivors there. This is the first time in an Ebola outbreak that follow-up for eye care has happened so soon after survivors have been released from care.

Several survivors also helped with the planning and administration of the clinic. Partners in this project include Emory University, which deployed two ophthalmologists, and University of North Carolina which deployed one ophthalmologist to the project via the Global Outbreak Alert and Response Network, which is hosted by WHO.

2015 Publication of The Specimen Newspaper in Freetown, Sierra Leone

Editor’s note: Cases of poor eye sight and heart diseases, among others, were reported by some Ebola survivors in Sierra Leone. The Specimen Newspaper reported the stories to alert the authority and stakeholders about the health challenges of the survivors in post Ebola period.

This medium’s editorial policy is centered on public health issues and development and is open to ideas and publications to be published for better information dissemination. With information the readers would be able to take informed health decisions.

NIH researchers make progress toward Epstein-Barr virus vaccine

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A research team led by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has determined how several antibodies induced by Epstein-Barr virus (EBV), a herpesvirus that causes infectious mononucleosis and is associated with certain cancers, block infection of cells grown in the laboratory.


A cryo-EM image of the gH/gL/gp45 candidate vaccine constructNIAID

They then used this information to develop novel vaccine candidates that, in animals, elicited potent anti-EBV antibody responses that blocked infection of cell types involved in EBV-associated cancers.

Currently, there is no licensed vaccine for EBV. The virus is associated with certain cancers (nasopharyngeal and gastric) of epithelial cells, which form the lining of the body’s surfaces, as well as Burkitt and Hodgkin lymphomas, which are cancers of the immune system’s B cells. Worldwide, about 200,000 cases of EBV-associated cancers occur annually, resulting in 140,000 deaths.

Jeffrey I. Cohen, M.D., and Wei Bu, Ph.D., both of NIAID, led the investigation. Prior efforts to develop an EBV vaccine focused on a viral surface protein, gp350, that the virus uses to enter B cells. However, EBV infects not only B cells, but also epithelial cells that line the mouth and upper throat. These cells are usually infected after contact with saliva from an EBV-infected individual. The new research helps define the contributions of virus-neutralizing antibodies other than those directed at gp350 on B cells. Among other findings, the team determined that antibodies to viral proteins called the gH/gL complex play a major role in inhibiting EBV fusion with epithelial cells.

The scientists developed two vaccine candidates, one designed to elicit antibodies to gH/gL on epithelial cells and another that included gH/gL and another viral protein, gp42. The team tested the vaccines in a series of experiments in mice and monkeys. In both animal models, each of the experimental vaccines induced antibodies that potently inhibited epithelial cell fusion. The vaccine containing gp42 induced stronger B cell fusion inhibitory antibodies than the one containing gH/gL alone.

Unlike the gp350 candidate EBV vaccine, which protects only B cells from infection, the candidate vaccines described in the new paper elicited antibodies that could prevent EBV from fusing with both epithelial cells and B cells and thus may provide protection independent of cell type, the authors note. The team is planning to further develop one of the vaccine constructs with an eye toward human trials.

Physicians may overprescribe antibiotics to children during telemedicine visits

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Children are more likely to be overprescribed antibiotics for colds, sinus infections and sore throats during telemedicine visits than during in-person visits to primary care providers or urgent care facilities, suggests a study funded by the Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The study, conducted by Kristin Ray, M.D., of the University of Pittsburgh School of Medicine and colleagues, appears in Pediatrics.

Many companies offer visits in which patients can connect with physicians outside of their primary care practice through audio-video conferencing, often on their cell phones or personal devices. The researchers compared antibiotic prescribing practices from the billing data of 4,604 telemedicine visits, 38,408 urgent care visits, and 485,201 primary care visits for children up to 17 years old with respiratory infections. They found that children were more likely to receive prescriptions for antibiotics during telemedicine visits (52%), compared to urgent care visits (42%) and visits with primary care providers (31 percent). Clinical guidelines for antibiotic prescriptions were less likely to be followed after telemedicine visits (59%), compared to urgent care (67%) or primary care visits (78%). These clinical guidelines are intended to prevent inappropriate use of antibiotics, such as to treat viral infections for which they are ineffective, and to guide selection of the most appropriate antibiotic for bacterial infections. Inappropriate antibiotic use(link is external) increases bacterial resistance to these drugs, eventually making many infections difficult to treat.

The authors theorize that physicians providing telemedicine visits may overprescribe antibiotics because they cannot closely examine patients or perform tests, potentially limiting their ability to distinguish between bacterial and viral infections.

FDA-approved drug effectively treats rare chronic immune disorder

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Small NIH clinical trial conducted in partnership with AstraZeneca.

A drug approved to treat a severe form of asthma dramatically improved the health of people with rare chronic immune disorders called hypereosinophilic syndromes (HES) in whom other treatments were ineffective or intolerable.

Activated eosinophils in the peripheral blood of a patient with idiopathic hypereosinophilic syndrome.NIAID

This finding comes from a small clinical trial led by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted through a partnership with the global biopharmaceutical company AstraZeneca. The results were published online today in the New England Journal of Medicine.

“People living with a rare disease often have few, if any, effective treatment options,” said NIAID Director Anthony S. Fauci, M.D. “This promising treatment advance for people with hypereosinophilic syndromes is just one example of how NIH research responds to the unique medical needs of individuals with rare diseases.”

HES is caused by higher-than-normal numbers of white blood cells called eosinophils(link is external) in the blood, tissues or both. While most people have 0 to 500 eosinophils per microliter (µL) of blood, people with HES typically have more than 1,500 eosinophils/µL. The symptoms of HES vary widely from one patient to the next and can affect the heart, lungs, skin, gastrointestinal tract, central nervous system and other organ systems.

Nearly all existing therapies for HES involve drugs that are not specifically approved for treating the syndromes, have significant side effects and sometimes become less effective over time. The study reported today was only the second randomized, placebo-controlled trial — the gold standard of medical research — to test the effectiveness of a drug specifically for treating HES. The trial was led by Amy Klion, M.D., chief of the Human Eosinophil Section in the NIAID Laboratory of Parasitic Diseases.

The medication tested in this Phase 2 clinical trial is benralizumab, also known by the brand name Fasenra. It consists of an antibody that binds to a protein, called IL-5 receptor a, found on the surface of eosinophils. Scientists hypothesize that once this binding takes place, immune cells called natural killer cells approach and destroy the eosinophils.

In an earlier clinical trial, benralizumab safely improved the symptoms of people who have a form of asthma associated with an excess of eosinophils in the lungs. Subsequently, the U.S. Food and Drug Administration approved the drug for treating this condition, called severe eosinophilic asthma. AstraZeneca developed and manufactures benralizumab and provided it for the HES trial through a cooperative research and development agreement with NIAID.

The NIAID trial involved 20 people with severe forms of HES who had at least 1,000 eosinophils/µL of blood when they enrolled in the study and whose condition had been stable on other HES therapies for at least a month before enrolling. These study participants all lacked a genetic marker associated with a type of HES that responds to treatment with a different drug. All study visits took place at the NIH Clinical Center in Bethesda, Maryland.

The trial had three phases over a period of 48 weeks. At the start of the first phase, which lasted 12 weeks, study participants were assigned at random to receive either 30 mg of benralizumab or a placebo solution through an injection under the skin once every 4 weeks while continuing to take their current HES therapy. Neither the participants nor the investigators knew who was receiving the study drug or what the participants’ eosinophil counts were during this first phase.

In the second phase, which lasted from week 12 to week 24, all study participants were given 30 mg of benralizumab through an injection under the skin once every 4 weeks. Eosinophil counts were revealed beginning at week 13, and participants could taper their original HES therapy if doing so was tolerable.

During the third phase, those participants whose symptoms or eosinophil counts had improved by week 24 could continue receiving benralizumab until week 48.

At the end of the first phase, blood eosinophil levels were undetectable in nine of the 10 participants who received benralizumab and had declined by 50 percent or more in three of the 10 participants who received the placebo. While the use of an immunosuppressive drug explained why eosinophil counts declined in one of the placebo recipients, the reason for the decline in the other two placebo recipients is unknown.

After at least 12 weeks of benralizumab therapy during the first phase, second phase or both, 17 of 19 participants had undetectable levels of eosinophils in the blood and a reduction in HES-related symptoms, with few or no side effects. (One person withdrew from the study at week 6 for logistical reasons.) These beneficial responses lasted through the end of the third phase in 14 of 19 participants, (74 percent). Nine of those 14 participants (64 percent) were able to taper off other HES therapies during the third phase. The 14 participants continued taking benralizumab for another year after completing the third phase.

In addition, eosinophils were undetectable in the bone marrow of nine of the 10 participants in the treatment group in the first phase, and in the tissue of all eight participants whose tissue was tested at the end of the second phase.

A larger placebo-controlled trial of benralizumab for treating HES is needed to confirm these results, according to the study investigators.

“We are grateful for the dedication of our study participants, who gave so generously of their time and were willing to undergo numerous invasive tests to help improve treatment options for the HES community,” said Fei Li Kuang, M.D., Ph.D., lead associate investigator on the study and a clinical fellow in the Human Eosinophil Section of the NIAID Laboratory of Parasitic Diseases.

Gout treatment may help prevent obesity-related type 2 diabetes, suggests small NIH study

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The drug colchicine, used to treat the arthritic condition gout, could potentially reduce complications accompanying metabolic syndrome, a combination of high blood pressure, high blood sugar and other conditions that increase the risk of heart disease and type 2 diabetes, according to researchers at the National Institutes of Health. Their study appears in Diabetes, Endocrinology, and Metabolism.

Photo credit: WebMD

Previous studies have indicated that the system-wide inflammation that occurs in obesity plays a role in the development of type 2 diabetes. In the current study, researchers led by Jack A. Yanovski, M.D., Ph.D., of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) randomly assigned 21 study participants to received colchicine twice a day for 3 months, while 19 participants received a placebo. Colchicine suppresses a multi-protein complex called NLRP3, which triggers the inflammation seen in obesity.

Researchers looked at several measures that reflect how well insulin works in the body to clear sugar from the blood (insulin resistance). There was no difference between the two groups in insulin resistance determined by one measure of insulin use (the frequently sampled, insulin-modified intravenous glucose tolerance test). However, the colchicine group showed improvement on the Homeostatic Model Assessment of Insulin Resistance test, which also estimates how much insulin is needed to keep blood sugar at a normal level while fasting. Those in the colchicine group also scored lower on a blood test of C-reactive protein and other tests that indicate inflammation. The authors concluded that larger studies are needed to determine if colchicine could prevent the development of type 2 diabetes in people with metabolic syndrome.

The research was also supported by the Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases.