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NIH HEAL Initiative

Upcoming Meeting
On June 18, 2018, the National Institutes of Health will host the HEALing Communities Study Design Workshop to solicit feedback from scientific experts, state partners, federal partners, and other key stakeholders.  This meeting will be videocast.

NIDA is playing a major role in the National Institutes of Health (NIH) HEAL initiative (Helping to End Addiction Long-term), launched in June 2018 to provide scientific solutions to the national opioid overdose crisis, including improved treatment strategies for pain as well as opioid use disorders (OUDs).   This new initiative, funded by Congress, brings new hope for people, families, and communities affected by this devastating crisis.
NIDA will be coordinating four overarching research projects around the country:
Focused OUD Medications Development Research Project
Goal: Conduct a series of high-impact studies that will ideally lead to about 15 Investigational New Drugs (INDs), which would then produce around five New Drug Applications (NDAs) submitted to the Food and Drug Administration (FDA).
This project will focus on developing new addiction treatments & overdose-reversal tools. Three medications are currently FDA-approved to treat opioid addiction, & naloxone is available in both injectable and intranasal formulations to reverse overdose. But a wider range of options is needed in both areas. These may involve new formulations of existing drugs including longer-acting depot formulations of opioid agonists as well as stronger naloxone formulations that can reverse fentanyl overdoses. Research will also focus on compounds that target different receptor systems or immunotherapies to treat symptoms of withdrawal & craving in addition to the progression of opioid use disorders.
HEALing Communities…

Mind Over Matter: Prescription Pain Medications (Opioids)

Long-term opioid use changes the way nerve cells work in the brain. This happens even to people who take opioids for a long time to treat pain, as prescribed by their doctor. The nerve cells grow used to having opioids around, so that when they are taken away suddenly, the person can have lots of unpleasant feelings & reactions. These are known as withdrawal symptoms.
Have you ever had the flu? You probably had aching, fever, sweating, shaking, or chills. These are similar to withdrawal symptoms, but withdrawal symptoms are much worse.
That is why use of opioids should be carefully watched by a doctor—so that a person knows how much to take & when, as well as how to stop taking them to lessen the chances of withdrawal symptoms. Eventually, the cells will work normally again, but that takes time.
Someone who is addicted to opioids has other problems as well. For example, they keep taking the drug even though it may be having harmful effects on their life and their health. They have strong urges to take the drug—called cravings—and they no longer feel satisfied by natural rewards (like chocolate, TV, or a walk on the beach). …

Fentanyl and Other Synthetic Opioids Drug Overdose Deaths

Figure 1: Recent Trends
In 2016, synthetic opioids (primarily illegal fentanyl) passed prescription opioids as the most common drugs involved in overdose deaths in the United States.
In 2016, synthetic opioids were involved in nearly 50% (19,413) of opioid-related deaths, up from 14% (3,007) in 2010.
*This infographic summarizes mortality data from 2010-2016. Please note, 15 to 25 percent of death certificates analyzed did not indicate the type of drug involved in the overdose. This was because drug tests were not conducted or there was a failure to record test results on death certificates. Figure 2: Synthetic Opioids Linked to Overdose Deaths with Other Substances
In 2016, 42,249 drug overdose deaths involved opioids. Of those, 45.9% involved synthetic opioids. 17,087 overdose deaths involved prescription opioids. Of those, 23.7% involved synthetic opioids. 15,469 overdose deaths heroin. Of those, 37.4% involved synthetic opioids. 10,375 overdose deaths involved cocaine. Of those, 40.3% involved synthetic opioids. 7,542 overdose deaths involved psychostimulants. Of those, 13.8% involved synthetic opioids. 10,684 overdose deaths involved benzodiazepines. Of those, 31.0% involved synthetic opioids. 4,812 overdose deaths involved antidepressants. Of those, 20.8% involved synthetic opioids. 1,877 overdose deaths involved antipsychotics & neuroleptics. Of those, 20.5% involved synthetic opioids. 409 overdose deaths involved barbiturates. Of those, 21.5% involved synthetic opioids. 543 overdose deaths involved other illicit drugs. Of those, 26.5% involved synthetic opioids.
*Deaths are not mutually exclusive. Deaths involving more than one drug or drug class are counted multiple times. Figure 3: Type of Opioid Involved in Opioid-Related Overdose Deaths
Among the 42,249 opioid-related overdose deaths…

Benzodiazepines & Opioid

More than 30 percent of overdoses involving opioids also involve benzodiazepines, a type of prescription sedative commonly prescribed for anxiety or to help with insomnia. Benzodiazepines (sometimes called “benzos”) work to calm or sedate a person, by raising the level of the inhibitory neurotransmitter GABA in the brain. Common benzodiazepines include diazepam (Valium), alprazolam (Xanax), & clonazepam (Klonopin), among other people.
Every day, more than 115 Americans die after overdosing on opioids.1 However, between 1996 & 2013, the number of adults who filled a benzodiazepine prescription increased by 67%, from 8.1 million to 13.5 million.2 The quantity obtained also increased from 1.1 kg to 3.6 kg lorazepam-equivalents per 100,000 adults. Combining opioids and benzodiazepines can be unsafe because both types of drug sedate users & suppress breathing—the cause of overdose fatality—in addition to impairing cognitive functions. In 2015, 23 percent of people who died of an opioid overdose also tested positive for benzodiazepines (see graph).3 Unfortunately, many people are prescribed both drugs simultaneously. In a study of over 300,000 continuously insured patients receiving opioid prescriptions between 2001 and 2013, the percentage of persons also prescribed benzodiazepines rose to 17 percent in 2013 from nine percent in 2001.4 The study showed that people concurrently using both drugs are at higher risk of visiting the emergency Department or being admitted to a hospital for a drug-related emergency.
Previous studies have also highlighted the dangers of co-prescribing opioids & benzodiazepines. A cohort study in North Carolina found that the overdose death rate among patients receiving both…

An Ambitious Research Plan to Help Solve the Opioid Crisis: HEAL Initiative

In spring 2018, Congress added an additional $500 million to the NIH budget to invest in science to find solutions to the opioid crisis. The Helping to End Addiction Long-term (HEAL) initiative is being kicked off today with the announcement of several bold projects across NIH, focused on two main areas: improving opioid addiction treatments and enhancing pain management to prevent addiction & overdose. The funding that NIDA is receiving will go toward the goal of addressing addiction in new ways & better delivering existing forms of care to populations that need it.
Developing new addiction treatments & overdose-reversal tools is one of the major projects we will be funding. Three medications are currently FDA-approved to treat opioid addiction, one medication (lofexidine) has just been approved to treat physical symptoms of opioid withdrawal, and naloxone is available in both injectable & intranasal formulations to reverse overdose. But a wider range of options is needed in all three areas. These may involve not only new formulations of existing drugs (e.g., longer-acting depot formulations of opioid agonists or longer-acting naloxone formulations that are more suitable to reverse fentanyl overdoses) but also compounds that target different receptor systems or immunotherapies to treat symptoms of withdrawal and craving in addition to the progression of opioid use disorders. The Focused OUD Medications Development Research Project will consist of a series of high-impact studies that will ideally lead to about 15 Investigational New Drugs (INDs), which would then produce around 5 New Drug Applications (NDAs) submitted to…

Worldwide Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

Worldwide Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
Spicy Edamame were distributed through retailers in Arizona, California, Georgia, Indiana, Louisiana, New Mexico, Nevada, Ohio, Pennsylvania, & Texas.
Recalled Spicy Edamame can be identified by the following descriptions:
Melissa’s Spicy Edamame

Brand
Melissa’s Spicy Edamame
Packaging
7oz Cardboard Sleeve
UPC Code
0-45255-14637-0
BEST USED BY Date(located on front panel)
5/29/18 through 07/02/18

No illnesses have been reported to date.
The recall is a result of the incorrect spice sauce pack being packed within the spicy edamame product.
Consumers who have purchased Melissa’s Spicy Edamame are urged to destroy & dispose of recalled product. Consumers with questions may contact the company at 1-800-588-0151, Mon-Fri 6:00 AM–6:00 PM PST.
### …

Social Justice, Health Equity, & All of Us Highlight MLA Annual Meeting

Dr. Dara Richardson-Heron, chief engagement officer of the All of Us Research Program, delivers the closing plenary at the Medical Library Association annual conference in Atlanta, May 23, 2018.

The official tag line for this year’s Medical Library Association conference was “Adapting, Transforming, Leading,” but the real organizing theme appeared to be equity and diversity.
From Elaine Martin’s Janet Doe Lecture on “Social Justice & the Medical Librarian” to former US Surgeon General Dr. David Satcher’s closing plenary on health disparities to the option for conference attendees to make their personal pronouns known, meeting sessions & Association business at last month’s annual meeting frequently tackled issues of inclusion, whether in research, services, or the profession.
And the notable attention given to the NIH All of Us Research Program throughout the conference fit right in.
The All of Us program is working to assemble a diverse one-million-person cohort, with particular attention on including people historically underrepresented in biomedical research. These participants will contribute information about their health, habits, & environment, along with an array of medical data, to help researchers identify patterns that might illuminate factors that impact health.
Dara Richardson-Heron, MD, chief engagement officer for the All of Us program, delivered an overview of the program during Wednesday morning’s plenary.
“Research is a powerful change agent…that can help chip away at health disparities,” said Richardson-Heron, as she touted the benefits of building a biomedical data set at a scale never before seen.
In addition to the data set’s sheer size, the four types of diversity the program…

Genetics Home Reference: White-Sutton syndrome

Dentici ML, Niceta M, Pantaleoni F, Barresi S, Bencivenga P, Dallapiccola B, Digilio MC, Tartaglia M. Expanding the phenotypic spectrum of truncating POGZ mutations: Association with CNS malformations, skeletal abnormalities, & distinctive facial dysmorphism. Am J Med Genet A. 2017 May 7. doi: 10.1002/ajmg.a.38255. [Epub ahead of print]
Stessman HA, Willemsen MH, Fenckova M, Penn O, Hoischen A, Xiong B, Wang T, Hoekzema K, Vives L, Vogel I am am, Brunner HG, van der Burgt I'm will, Ockeloen CW, Schuurs-Hoeijmakers JH, Klein Wassink-Ruiter JS, Stumpel C, Stevens SJ, Vles HS, Marcelis CM, van Bokhoven H, Cantagrel V, Colleaux L, Nicouleau M, Lyonnet S, Bernier RA, Gerdts J, Coe BP, Romano C, Alberti A, Grillo L, Scuderi C, Nordenskjöld M, Kvarnung M, Guo H, Xia K, Piton A, Gerard B, Genevieve D, Delobel B, Lehalle D, Perrin L, Prieur F, Thevenon J, Gecz J, Shaw M, Pfundt R, Keren B, Jacquette A, Schenck A, Eichler EE, Kleefstra T. Disruption of POGZ Is Associated with Intellectual Disability & Autism Spectrum Disorders. Am J Hum Genet. 2016 Mar 3;98(3):541-52. doi: 10.1016/j.ajhg.2016.02.004.

Tan B, Zou Y, Zhang Y, Zhang R, Ou J, Shen Y, Zhao J, Luo X, Guo J, Zeng L, Hu Y, Zheng Y, Pan Q, Liang D, Wu L. A novel de novo POGZ mutation in a patient with intellectual disability. J Hum Genet. 2016 Apr;61(4):357-9. doi: 10.1038/jhg.2015.156. Epub 2016 Jan 14.

White J, Beck CR, Harel T, Posey JE, Jhangiani SN, Tang S, Farwell KD, Powis Z, Mendelsohn NJ, Baker JA,…

Genetics Home Reference: poikiloderma with neutropenia

Arnold AW, Itin PH, Pigors M, Kohlhase J, Bruckner-Tuderman L, Has C. Poikiloderma with neutropenia: a book C16orf57 mutation & clinical diagnostic criteria. Br J Dermatol. 2010 Oct;163(4):866-9. doi: 10.1111/j.1365-2133.2010.09929.x. Epub 2010 Sep 7.
Colombo EA, Bazan JF, Negri G, Gervasini C, Elcioglu NH, Yucelten D, Altunay I'm will, Cetincelik U, Teti A, Del Fattore A, Luciani M, Sullivan SK, Yan AC, Volpi L, Larizza L. Book C16orf57 mutations in patients with Poikiloderma with Neutropenia: bioinformatic analysis of the protein & predicted effects of all reported mutations. Orphanet J Rare Dis. 2012 Jan 23;7:7. doi: 10.1186/1750-1172-7-7.

Farruggia P, Indaco S, Dufour C, Lanza T, Mosa C, Macaluso A, Milioto M, D’Angelo P, Lanciotti M. Poikiloderma with neutropenia: a case report & review of the literature. J Pediatr Hematol Oncol. 2014 May;36(4):297-300. doi: 10.1097/MPH.0b013e31829f35e7. Review.

Hilcenko C, Simpson PJ, Finch AJ, Bowler FR, Churcher MJ, Jin L, Packman LC, Shlien A, Campbell P, Kirwan M, Dokal I will, Warren AJ. Aberrant 3′ oligoadenylation of spliceosomal U6 small nuclear RNA in poikiloderma with neutropenia. Blood. 2013 Feb 7;121(6):1028-38. doi: 10.1182/blood-2012-10-461491. Epub 2012 Nov 27.

Koparir A, Gezdirici A, Koparir E, Ulucan H, Yilmaz M, Erdemir A, Yuksel A, Ozen M. Poikiloderma with neutropenia: genotype-ethnic origin correlation, expanding phenotype and literature review. Am J Med Genet A. 2014 Oct;164A(10):2535-40. doi: 10.1002/ajmg.a.36683. Epub 2014 Jul 16.

Mroczek S, Dziembowski A. U6 RNA biogenesis & disease association. Wiley Interdiscip Rev RNA. 2013 Sep-Oct;4(5):581-92. doi: 10.1002/wrna.1181. Epub 2013 Jun 14. Review.

Mroczek S, Krwawicz J, Kutner…

Genetics Home Reference: fibromyalgia

Fibromyalgia is known to run in families, suggesting that genetic factors contribute to the risk of developing this disease. However, little is known for certain about the genetic basis of fibromyalgia. It is likely that variations in many genes, each with a small effect, combine to increase the risk of developing this condition.
The signs & symptoms of fibromyalgia are related to the way the brain recognizes and interprets pain signals. People with fibromyalgia have an increased sensitivity to pain; they feel pain more acutely than other people would in response to a given stimulus. Researchers describe this phenomenon as the “volume” of pain sensations being turned up too high (pain amplification). Studies of the genetics of fibromyalgia have focused on genes with roles in the way the brain processes pain. For example, several genes that may influence the condition are involved in the production and breakdown of certain chemical messengers called . These chemicals relay signals between nerve cells that can increase or decrease the sensation of pain, a process known as pain modulation.
Nongenetic (environmental) factors also play critical roles in a person’s risk of developing fibromyalgia. The disorder can be triggered by infection or illness that would not otherwise cause chronic pain, injury, & other physical stress. Psychological and social factors such as a history of childhood abuse or neglect, exposure to war or other catastrophic events, & low job or life satisfaction have also been associated with an increased risk of fibromyalgia. Additionally, physical inactivity, obesity, & sleep…

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