August is

Overdose Awareness Month

August is Overdose Awareness Month, capped by International Overdose Awareness Day, which takes place annually on August 31st.

Overdose Awareness Month is the time to raise awareness of substance use disorders, combat the stigma that is attached to those disorders, promote treatment and celebrate recovery, and strengthen efforts to prevent overdose deaths. 

August 31st marks Overdose Awareness Day, a global event to acknowledge the grief felt by families and friends and remember those who have died or had a permanent injury due to a drug overdose.

Overdose Awareness Month spreads the message that overdose death is preventable.

What can we do to support Overdose Awareness?

• Encourage participation in Overdose Awareness events.
• Share information about the issue of fatal and non-fatal overdose.
• Send the message to current and former people who use drugs that they are valued.
• Stimulate discussion about overdose prevention and drug policy.
• Provide basic information on the range of available support services.
• Inform those around you about the risk of overdose.

We can all take action to address the overdose epidemic and enhance our support for individuals facing substance use disorder so that we can save lives.

Find more information and resources HERE and HERE. ❤

NOTICE TO SITES:

SHARE WITH YOUR PATIENTS

Your patients and caregivers are invited to attend this talk on Securing SSDI, SSI, Medicare, etc. benefits.

This is an opportunity to learn more about navigating the benefit system for a loved one living with SMI. Please join NSSC for a talk, “Securing Federal and State Benefits for a Loved One on the Psychosis Spectrum.”

Speaker: Heidi Brelsford, Founder of Schizophrenia & Schizoaffective Society

Thursday, September 5th, 2024 @ 4:00 PM Pacific | 7:00 PM Eastern

Heidi will share the ups and downs of successfully going through the application processes for SSDI and Medicare, SSI, Medicaid, Medicaid Waiver, Extra Help Fund, and SNAP for her adult loved one with Schizoaffective. She will touch on what it takes to get approved, age as a factor, benefits' limits, ABLE accounts, and her experience making the most of medical benefits from the past 9 years. Q&A session will follow immediately afterward.

Registration is required: https://lnkd.in/gDGTkzwT

National Immunization Awareness Month (NIAM) is an annual observance held in August to highlight the importance of routine vaccination for people of all ages. 

Many patients are looking for reassurance from their provider that vaccines are safe and effective. A strong, clear recommendation is usually enough, but others may need more information. Listening to their concerns and answering their questions can help them feel confident in choosing to get a vaccine.

Practical strategies for successful conversations

Here are some strategies you can use during NIAM to remind your patients and caregivers to stay up to date on routine vaccinations:

• Talk to your patients and caregivers about any missed vaccines and assess vaccination status at every visit.
• Use plain language when addressing concerns about vaccine safety.
• Practice the SHARE approach to help patients make informed decisions about vaccination.
• Show your practice’s support of vaccination throughout the month by displaying NIAM graphics on your website and on social media.

Find more information on how you can support National Immunization Awareness Month HERE. Check out THIS PAGE for amazing information on the history of vaccines.

Housing Tops List of Things Caregivers Want to Learn More About   

S&PAA surveyed their caregiver community to better understand what they most wanted to learn more about with regard to caring for someone with schizophrenia. Caregivers were asked what their priorities were across several categories: 

• The “human understanding” (Schizophrenia “101,” anosognosia, communication strategies, crisis preparation & management). 
• Medical issues (hospitals, navigating treatment systems). 
• Housing needs (housing options and homelessness). 
• The criminal justice system (police, assisted outpatient treatment [AOT], courts). 
• Support frameworks (Disability [SSI/SSDI], insurance (Medicaid/Medicare), HIPAA, legal and estate planning). 

By a wide margin, housing was named as the most important issue those surveyed want to learn more about. Housing also was a key topic of discussion at S&PAA's recent SPRING Summit, and as a result, will be included as a significant part the SPRING Roadmap to Recovery. 

For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court overruled that long-standing precedent in Loper Bright Enterprises v. Raimondo, Case.

“Judges are not experts in the field and are not part of either political branch of government,” Justice John Paul Stevens wrote in 1984, explaining why they should play a limited role.

But the current high court, with a 6-3 conservative majority, has been increasingly skeptical of the powers of federal agencies. Justices Samuel Alito, Neil Gorsuch, Brett Kavanaugh and Clarence Thomas all had questioned the Chevron decision. They were in Friday’s majority, along with Justice Amy Coney Barrett.

Justice Elena Kagan, though, said that in getting rid of Chevron “gives courts control over matters they know nothing about.” She read a summary of her dissent aloud in the courtroom to emphasize her disagreement with the majority.

Justices Ketanji Brown Jackson and Sonia Sotomayor joined Kagan in dissent.

The decision brings sweeping change to a corner of the regulatory universe. Previously, courts deferred to federal agencies’ deep expertise to interpret legal gray areas. The court’s new ruling wrests that power back. This deep-in-the-weeds decision applies to all the federal agencies that make decisions affecting our health, including the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Environmental Protection Agency, and more.

To understand the scope of the problem, consider the language in the Federal Food, Drug & Cosmetic Act that lays out the agency’s standards for approving a drug. The law requires a company to offer “substantial evidence” in the form of “adequate and well-controlled” studies, conducted by “experts qualified by scientific training and experience to evaluate the effectiveness of the drug.”

“It’s just dripping with ambiguity,” says Holly Fernandez Lynch, a professor of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine. “What’s an adequate trial? What’s a well-controlled trial? What’s an expert?”

Even more fundamental, what counts as a “disease” or a “drug”? The ambiguity of those words could be used to evade the FDA’s purview. For example, anti-abortion groups already argue that pregnancy is not a disease, so the FDA shouldn’t have oversight of medicines used for abortion or even birth control. Already, vaping manufactures see an opening to challenge the agency’s crackdown on flavored e-cigarettes.

References:

• Health Care Is About to Get Even More Litigious
• The Supreme Court Just Gave Itself a Lot More Power
• FDA’s lab developed test rule could be first check on agency’s power post-Chevron 
• Experts: Chevron deference ruling could impact recent FDA regulations

Research Ambassador Douglas Meron

The following is excerpted from a piece Douglas wrote on his journey to find community. It goes hand-in-hand with his Toastmaster's talk and can be read in full here.

The rate of loneliness is skyrocketing in the United States. People who live with mental health challenges are extremely familiar with loneliness. I live with schizoaffective disorder and often felt that I would have great difficulty being involved in social groups due to my symptoms and tendency to isolate. Some of the best advice I received was not to wait to feel better to do things but to do things to feel better. About ten months ago, I moved out from my ARF (Assisted Residential Facility) into an independent living situation (renting a room in a condo). I moved into a new area where I knew few people. A quote comes to mind: “Your life does not get better by chance; it gets better by change.”

While I was a resident at Hummingbird ARF, I worked ten hours each week as a peer specialist. Maintaining my job would be the foundation of my new life. As a peer specialist, I could help other residents and maintain my relationships with the Crestwood staff, a family-like environment.

Finding my place in the community was the next challenge. I found these in several places including the First Unitarian Universalist Church of San Diego, a Toastmasters public speaking group that I participate in weekly, my local Trader Joe’s Supermarket, my local NAMI, and a senior citizen group that meets at my local bagel shop. Although I am not a senior, the group has welcomed me with open arms. I find that there is a strong connection between seniors and those living with a mental health challenge.  I also participate in a Writer’s Group on Zoom, a weekly movie night at the city library, and a laughter yoga group in Balboa Park.

Community is vital. It provides emotional support, prevents isolation, gives practical assistance, peer support, and social interaction. It empowers me to manage my mental health challenges. I have friends and acquaintances from a variety of sources. I can break down barriers and crush the stigma of living with a mental health condition. After having so many setbacks, I am now living the life of my dreams.

The study of women's health is crucial in medical research, revealing unique needs and advancing personalized medicine. Historically, research has focused on men, leaving gaps in understanding female-specific issues. Efforts to address this bias have increased, with bodies like the FDA mandating the inclusion of women in clinical trials. Female-centric studies are essential for conditions like postpartum depression and menopause symptoms, which significantly impact women's lives.

Segal Trials’ established the Women’s Health and General Medicine site to address these disparities through dedicated research. Led by Dr. Steven Chavoustie, the facility offers continued health care support while participating in a trial, early access to investigational medications and devices, and comprehensive diagnostic options. For studies like those on sexually transmitted infections, there are provisions for fast-tracked partner treatment, ensuring holistic care.

Through the dedicated efforts of researchers and the participation of women in clinical trials, we move closer to a future where medical care is truly personalized, considering the unique needs of all patients. As an industry, we continue to uncover the nuances of gender differences in health and lay the groundwork for innovations that benefit not just women, but all of humanity.

Read the full blog post on Segal Trials' site here.

Boehringer said that it plans to put more resources behind its key late-stage pipeline assets as it continues to work towards a target of 25 new drug launches through 2030. One of these is iclepertin, which was recently given Breakthrough Therapy Designation, is an investigational asset and a GlyT1 inhibitor that targets the brain biology linked with the cognitive symptoms associated with schizophrenia (CIAS). Iclepertin has been shown to provide benefits for cognitive impairment in schizophrenia and other mental health conditions.

BioXcel Therapeutics announced positive topline results from post-marketing requirement study evaluating PRN Treatment of IGALMI™ (dexmedetomidine) sublingual film for agitation associated with bipolar disorders or schizophrenia. The study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose). The results support the Phase 3 SERENITY and TRANQUILITY programs.

J&J has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval of esketamine (Spravato) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). This would the first and only monotherapy for adults with TRD. Spravato was FDA approved in 2019 as an to be used along with an antidepressant for adults with TRD, and subsequently to be used along with an antidepressant in adults with depression from major depressive disorder with suicidal thoughts.

Bionomics initiated patient screening for the Phase 3 AFFIRM-1 trial evaluating the safety and efficacy of BNC210 for the acute, as-needed treatment of social anxiety disorder (SAD). Apart from SAD, BNC210 is said to have demonstrated potential in lowering anxiety levels in general anxiety disorder, reducing the intensity of all symptoms in post-traumatic stress disorder, and panic symptoms in panic episodes that are pharmacologically caused.

Delix Therapeutics is planning to initiate Phase Ib and Phase II studies to evaluate patients with major depression investigating its lead neuroplastogen candidate, DLX-001. DLX-001 is a neuroplastogen designed to promote neuroplasticity without giving rise to the deleterious attributes of first- and second-generation psychedelics. “With many psychoactive drugs, you’re talking about the concentrations that you’re able to maintain, continuously engaging the receptor for some period of time. We think that this [DLX-001] has a Cmax-driven effect, meaning that it’s about flipping the switch on the receptor so that downstream effects can then occur,” said Delix CMO Dr. Aaron Koenig.

HHS to Fund New US Rural Medical Residency Programs. More than $11 million will go toward launching residency programs in rural communities throughout the country, the US Department of Health and Human Services said in a statement announcing the Health Resources and Services Administration (HRSA) investment. Currently, only about 2% of medical residency training happens in rural areas.

Mining clues from a library of brain tissue samples, Cerevance' lead candidate in Parkinson’s is expected later this year and could tee up an IPO. Cerevance, a UK-based biotech leveraging a large collection of brain samples to develop therapies for CNS diseases. They are advancing CVN424 into phase 3 testing as an adjunctive therapy, targeting GPR6, a G-protein coupled receptor. The company’s pipeline also includes an earlier-stage drug aimed at multiple psychiatric conditions, including schizophrenia.

The Centers for Medicare and Medicaid Services (CMS) proposed CPT payment codes for some digital therapeutics products for the first time, potentially paving a pathway toward widespread reimbursement for the nascent industry. The codes were included in CMS’s 2025 Medicare Physician Fee Schedule (PFS) proposed rule, which was released on July 10 and applies only to digital therapeutics that support treatment for specific mental health conditions.

Related, you may recall from July's newsletter: Clinical Trials of Prescription Digital Therapeutics for Schizophrenia, written by Haig Goenjian, MD of CenExel CNS, provides an update on recent advances and learnings from ongoing studies. The article includes a table of current FDA-approved prescription DTx products and a promising DTx in development for schizophrenia (CT-155).

Heterogeneity in Antidepressant Treatment and Major Depressive Disorder Outcomes Among Clinicians. The study posed the question: To what extent do differences in clinician setting explain variability in major depression treatments and outcomes? Findings from the cohort study derived from electronic health record data, antidepressant prescribing patterns and outcomes varied significantly between prescriber groups. Clinician clusters were significantly associated with clinical outcomes.

An FTC report says PBMs have ‘outsized influence’ over drug prices. On July 9th, the FTC published an interim report as part of an ongoing investigation, which began in 2022, into drug affordability and access, raising concerns that PBMs have “significant influence” over which drugs are made available to patients and that the companies are setting increasingly higher prices. The FTC is preparing a lawsuit against the three largest PBMs regarding “business practices related to rebates brokered with drug manufacturers.” These three PBMs made about $1.6 billion in excess revenue on two cancer drugs in less than three years, according to the report. (continued in 2nd paragraph)

The report also shows that the three largest PBMs—CVS Health’s CVS Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s OptumRx—manage 79% of prescription drug claims for about 270 million people. Including the next three largest intermediaries—Humana Pharmacy Solutions, MedImpact, and Prime Therapeutics—the top six PBMs manage 94% of all prescription drug claims in the country. “PBMs oversee these critical decisions about access to and affordability of life-saving medications, without transparency or accountability to the public,” the report read.

The Senate overwhelmingly passed legislation that is designed to protect children from dangerous online content, pushing forward with what would be the first major effort by Congress in decades to hold tech companies more accountable for the harm that they cause. The bill, which passed 91-3, has been pushed by parents of children who died by suicide after online bullying or have otherwise been harmed by online content. It would force companies to take reasonable steps to prevent harm on online platforms frequently used by minors, requiring them to exercise “duty of care” and ensure that they generally default to the safest settings possible.

This Is Literally Your Brain on Drugs: A small new study shows reactions in the brain in people who were given psilocybin in a controlled setting. The image, as it happens, comes from dozens of brain scans produced by researchers at Washington University School of Medicine in St. Louis who gave psilocybin, the compound in “magic mushrooms,” to participants in a study before sending them into a functional M.R.I. scanner. The scans, published Wednesday in the journal Nature, offer a rare glimpse into the wild neural storm associated with mind-altering drugs. Researchers say they could provide a potential road map for understanding how psychedelic compounds like psilocybin, LSD and MDMA can lead to lasting relief from depression, anxiety and other mental health disorders.

How do placebos ease pain? Mouse brain study offers clues: the discovery of a brain circuit involved in the pain-relieving effect of placebos could lead to new treatments. In a study published today in Nature, neuroscientists traced the parts of the brain that were activated in mice conditioned to expect pain relief, mimicking how humans experience the placebo effect when given a pill with no active ingredients. They were surprised to see activity in the cerebellum and brainstem — parts of the brain that are typically associated with movement and coordination, rather than pain perception. “We had no real insight into how [the placebo effect] was happening and if it was a real phenomenon,” says Clifford Woolf, a neuroscientist at the University of Harvard in Boston, Massachusetts. “I think this has helped us identify, indeed it is a real phenomenon.” The findings might eventually lead to new ways to treat pain, says study co-author Grégory Scherrer, a neurobiologist at the University of North Carolina at Chapel Hill. “We might have a completely novel type of drug.”

People USA CEO, Steve Miccio; Chief Operating Officer, Kimberly Wing, LCSW; and Chief Strategy & Development Officer, Himali Gandhi participated in the Crisis Now III in Amsterdam last month.

This was the third year for the global summit focusing on Urgent & Emergency Care. This summit focused on the continued learning to advance behavioral health crisis services for the betterment of society and to deliver care to those in need across the globe.

Advocacy Spotlight:

National Shattering Silence Coalition (NSSC)

We are very pleased to introduce the National Shattering Silence Coalition, a nonprofit advocacy organization that serves the 22 million people living with and dying far too young from serious brain disorders, commonly known as serious mental illness.

NSSC's mission is to raise awareness and advocate for solutions to the suffering faced by those affected by Serious Mental Illness/Serious Brain Disorders through education, outreach, and grassroots reform. They do this by amplifying the voices of those with SMI/SBDs and their loved ones through life stories, professional and peer talks, sharing resources, and media; addressing the treatment of those with SMI/SBDs by collaborating with community stakeholders (police, EMTs, treatment providers, and crisis intervention) through educational awareness; and advocating for change in federal and state laws to improve quality of life and the way those with SMI/SBDs are treated in our nation's social services, healthcare, and criminal justice system.

Check out the NSSC's Still Here video, as well as their website for more information! ❤

DBSA’s Roots in Peer Support

As DBSA approaches 40 years of providing hope, help, support, and education to those living with mood disorders and their loved ones, we are reflecting on our deep roots in peer support. While our country faces a dire shortage of accessible and affordable mental health care and services, we see peer support as a vital solution to bridging the gap and helping peers to find community, find wellness, and find hope.

While we believe wholeheartedly in the tangible benefits of peer support, research also underscores the profound impact of peer support on mental well-being, including increasing individuals’ sense of hope, happiness, control, self-esteem, community, and decreasing levels of depression and psychosis.

Peer support among individuals living with mood disorders has been shown to:

• Reduce hospitalization rates
• Reduce days spent in inpatient care
• Reduce the overall cost of mental health services
• Increase the use of outpatient services
• Increase quality of life outcomes
• Increase engagement rates
• Increase whole health

As the evidence mounts, affirming the efficacy of peer support across diverse demographics, the importance of this paradigm becomes increasingly evident. Peer support isn’t merely a concept; it’s a lifeline, offering sanctuary amidst the storm and guiding individuals to community, wellness, and hope.

Learn more about DBSA at DBSAlliance.org.

Resources:

https://www.madinamerica.com/2012/06/13316/

https://www.mhanational.org/sites/default/files/Evidence for Peer Support May 2019.pdf

Please join Rural Minds and the National Grange for the Rural Mental Health Connections Webinar on the Impact of the Inflation Reduction Act (IRA) on New Treatments for Mental Illnesses.

This 45-minute webinar will explain the IRA drug price-setting provisions and discuss its negative impact on access to mental health treatments for patients in rural America and what you can do to prevent this unintended consequence.

2024 American Neurological Association Annual Meeting (ANA2024) will be held from September 14-17, in Orlando, FL. The ANA’s 149th Annual Meeting will convene the nation's top academic neurologists and neuroscientists. The Meeting will feature six main symposia, which highlight groundbreaking conceptual and therapeutic advances in a variety of neurologic disease states, as well as interactive lunch workshops, special interest group sessions, and poster sessions.

MHACon 2024 will be held Sept 19-21 in Washington D.C. and online. At this year's conference, explore ways to DISRUPT systemic barriers, REFORM harmful practices that prevent progress, and TRANSFORM the current landscape, ensuring everyone has equitable opportunity for optimal mental health and well-being.

The APA's 2024 Mental Health Services Conference is taking place in Baltimore, MD, Sept. 26-28. The 2024 Mental Health Services Conference will bring psychiatrists and other mental health professionals together to collaborate on practical advice to influence systems-level change for their patients. Connect and collaborate across the mental health services team and find practical ways to integrate new research and treatment strategies into clinical practice; identify barriers to care, including health service delivery issues, recognize and improve mental health disparities in the community, and more.

ANA2024 will be held Sept 14 – 17 in Orlando, FL. The Annual Meeting has been designed to foster discussions among investigators in academia, industry, and foundations toward the common goal of furthering translational science. As usual, it will include professional development workshops offering daily sessions designed for early career, mid-career, and residency directors.

The Global Site Solutions Summit will be held from Sept. 27-29 in Hollywood, FL. The Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best practices and ideas while developing strategic partnerships through ideation sessions, workshops, and focus groups. Whether your priority is networking with sponsors and CROs or learning best practices built for research sites, the Summit will provide a valuable experience for your business.

Neuroscience 2024 will be held Oct. 5-8 in Chicago. Each year, scientists from around the world congregate to discover new ideas, share their research, and experience the best the field has to offer. Attend so you can: present research, network with scientists, attend session and events, and browse the exhibit hall. Join the nearly half a million neuroscientists from around the world who have propelled their careers by presenting an abstract at an SfN annual meeting — the premier global neuroscience event.

Save the date!

The American Brain Coalition Annual Membership Meeting is being held on Monday, October 7^th in conjunction with Neuroscience 2024 at Hyatt Regency McCormick Place in Chicago, Ill. Further details to come.

SWP'24 Conference is being held at Yale University October 18-20! This hybrid event has virtual and in-person ticket options. Students With Psychosis is proud to partner with Mindmap and The Women's Mental Health Conference at Yale to make this event possible. Join us for a conference of learning, community-building, and celebrating what people living with psychosis can achieve when given the proper resources and support. Meet industry leads, renowned authors, social media influencers, mental health advocates, researchers, fellow SWP students, and their families as we hear from different viewpoints coming together to formulate new ideas for an insightful discussion. To learn more about Students With Psychosis, visit www.sws.ngo.

Psych Congress is the nation's conference on practical psychopharmacology and a community of passionate mental health clinicians. The 37th annual Psych Congress will be in Boston from Oct. 29 - Nov. 2. This year, the Schizophrenia & Psychosis Action Alliance (SPAA) is partnering with Psych Congress to bring two special sessions: A Primer on Negative Symptoms and Cognitive Impairment in Schizophrenia and a session on Long-Acting Injectable Anti-psychotics. Members of the SPAA community can use code SPAA for a $50 discount on registration. Find more info here.

The National Federation of Families National Conference is Nov. 7-9 in Orlando, FL. NFF brings together families, parents, community leaders, providers, partners, and legislators at the Annual Conference and work to leverage our lived experience and learned solutions for the support and advancement of families whose children – of any age – experience mental health and/or substance use challenges. For more information on the 2024 NFF Annual Conference, click HERE.

CNS Summit will be held Nov. 10-13 in Boston. The meeting was founded in 2009 by leaders in the life sciences as a community to advance the work of life sciences companies with a focus on innovation, collaboration and technology.

Reignite Your Team’s Passion with a Spark of Positivity!

Feeling like your staff’s energy levels are dipping? We get it - sometimes it’s hard to stay enthusiastic about work when daydreams of lounging by the pool take over. But don’t worry, we’ve got a game-changing tip for you!

In David Burkus’ insightful video, ‘How to Love Your Job Again’, he shares some fantastic ways to bring the joy back to work and leave those blah feelings behind.

Burkus’ first golden nugget of advice is all about connecting with your customers—in our case, that means connecting with patients living with mental illness. It's what he calls ‘pro-social motivation’ and it's about seeing the bigger picture and understanding that your work truly makes a difference in someone’s life. When you realize that what you do has a meaningful impact, it’s easier to feel inspired and energized.

Here at The STARR Coalition, we’re all about helping you and your team tap into that positive vibe. We’ve got some amazing tools and connections to make it happen!

Check out our Auditory Hallucination Simulation. It’s an eye-opening empathy exercise that gives participants a glimpse of what it's like to live with this common symptom of schizophrenia. Trust us, it’s a powerful way to reignite a sense of purpose.

Want to take it up a notch? We can organize a lunch-and-learn session with someone who’s living with schizophrenia, depression, PTSD, or anxiety. Our patient Research Ambassadors are ready to share their stories and help your staff connect with someone living with mental illness... someone that isn't your patient, so the dynamic is a little different.

If your team seems to be in a bit of a slump, reach out to us. We’re here to help bring back the passion and enthusiasm for the incredible work you do.

Here's to a more engaged and inspired workplace!