Upholding Our Ethical, Moral, and Bipartisan Commitment to HIV/AIDS
"Where your treasure is, there your heart will be also."
These words from Jesus found in Matthew 6:21 resonate profoundly as we examine the current legislative actions on HIV/AIDS funding in the U.S. Congress. It is hard to imagine forty years into the epidemic that we’d be witnessing a systemic attack on numerous HIV-related programs, especially ones with proven track records of success. The House L-HHS Appropriations Bill (H.R. 5894), proposing a staggering $767 million in cuts to domestic HIV programs, starkly contradicts the values of compassion and faith professed by certain lawmakers. These cuts, detailed by the AIDS Budget and Appropriations Coalition (ABAC), threaten to dismantle decades of public health progress, disproportionately impacting marginalized communities, minorities, and the LGBTQIA+ community. The appropriations bill is only the tip of the iceberg.
The irony of these legislative actions is both profound and deeply troubling. Lawmakers, often vocal about their 'pro-life' stance, are endorsing policies that will cause significant harm to millions of Americans dependent on HIV services. This bill represents more than just fiscal adjustments; it's a direct attack on the services and supports afforded to people living with HIV (PLWH), reflecting a worldview that stigmatizes and punishes rather than supports and heals. This approach starkly betrays the bipartisan legacy of the HIV/AIDS fight, which brought together the ideological opposites of the late Senators Orrin Hatch (R-UT) and Edward Kennedy (D-MA).
The bill's proposed eliminations include funding for the bipartisan Trump-era Ending the HIV Epidemic Initiative, the Ryan White HIV/AIDS Program, and the Community Health Centers Program. Alarmingly, it suggests completely eliminating Part F of the Ryan White HIV/AIDS Program (RWHAP), which supports critical components like Dental Programs and AIDS Education and Training Centers. Additionally, the bill proposes a 53% cut in the Minority HIV/AIDS Fund and the total elimination of Minority AIDS Initiative funding within the Substance Abuse and Mental Health Services Administration.
But the attack isn’t exclusive to domestic programs combating HIV/AIDS.
The stalemate over the reauthorization of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), as highlighted in a recent POLITICO article, further exemplifies the moral failure of the Freedom Caucus – which is driving most of the vitroil behind these proposed cuts. Disputes over abortion and a blatantly bigoted reluctance to aid Africa have jeopardized the most successful global health initiatives of our time.
“I’m disappointed,” Rep. Michael McCaul (R-Texas) told POLITICO. “Honestly, I was looking forward to marking up a five-year reauthorization, and now I’m in this abortion debate.” Additionally, he said, “a lot of the Freedom Caucus guys would not want to give aid to Africa.”
Jen Laws (he/him/his), President & CEO of the Community Access National Network (CANN), poignantly captures this duplicity in a tweet: “HIV is a bipartisan issue and always has been. May those who wish to insert their culture war politics onto this historical space enjoy their moral rot for as long as the spotlight lasts because the sense of power certainly won't.”
We stand at a critical crossroads, not merely facing a policy challenge but a profound moral crisis. The battle against HIV/AIDS reflects our societal values of empathy, compassion, and collective responsibility. The proposed cuts and the deadlock over PEPFAR reauthorization challenge the very foundations of equity and justice, calling for a decisive response to maintain the fragile progress made in HIV/AIDS care and prevention. These cuts are not distant policy changes; they are immediate threats to lives and well-being, demanding our urgent attention and action.
Critical Juncture
RWHAP and PEPFAR stand at a critical juncture, pivotal to the global and domestic response to HIV/AIDS. The Ryan White Program, a testament to America's commitment to combating HIV/AIDS, is under threat from the proposed House L-HHS Appropriations Bill (H.R. 5894), which includes significant funding cuts. Concurrently, PEPFAR, a global beacon in the fight against HIV/AIDS and the largest commitment by any nation to address a single disease, faces legislative hurdles that could impede its future effectiveness.
The Ryan White Program has been a cornerstone in achieving a 90% viral suppression rate among its clients, as reported by the Health Resources and Services Administration (HRSA). PEPFAR, on the other hand, has been instrumental in saving 25 million lives and supporting over 5 million infants born HIV-free, providing antiretroviral treatment to over 20 million people across 55 countries. This program has played a crucial role in significantly reducing new HIV infections worldwide.
The potential funding cuts under H.R. 5894 pose a severe risk to the Ryan White Program's continued success in the United States, especially in light of the 12% decline in new HIV infections from 2017 to 2021. The reauthorization stalemate of PEPFAR underscores the moral failure of certain lawmakers, who, despite their 'pro-life' claims, are obstructing a program that has been a lifeline for millions globally.
Comprehensive Strategy is Key
The achievements made over the last four decades in the fight against HIV/AIDS underline the necessity of a comprehensive strategy. The increase in PrEP prescriptions in the United States and the high rate of viral suppression achieved through treatment as prevention exemplify the effectiveness of a holistic approach, encompassing treatment, prevention, care, and support services. It is crucial that policymakers and the public recognize the importance of these programs and advocate for their continued support, ensuring the progress in combating HIV/AIDS is not only maintained but also advanced. Time is of the essence to embrace and implement a comprehensive HIV/AIDS strategy that goes beyond mere treatment to encompass prevention, care, and support.
Challenging Extremism and Fostering Advocacy
The battle against H.R. 5894 transcends mere policy disagreements. It represents a stand against a form of political extremism that poses a grave threat to marginalized populations, including people living with HIV/AIDS. These proposed cuts, in stark contrast to the proclaimed pro-life stance of the very lawmakers pushing them, unveil a troubling hypocrisy reminiscent of the words of Jesus in Matthew 23:27-28: "Woe to you, teachers of the law and Pharisees, you hypocrites! You are like whitewashed tombs, which look beautiful on the outside but on the inside are full of the bones of the dead and everything unclean."
Just as Jesus admonished the outwardly righteous but inwardly corrupt, these policies, under the guise of fiscal prudence, risk causing significant harm to the most vulnerable, particularly PLWH, minorities, and the LGBTQIA+ community. The stark contrast between the proclaimed values and the actual legislative actions of these lawmakers echoes the biblical warning against such duplicity. The time to stand against this political extremism is now. We cannot afford to be bystanders as these policies threaten to unravel decades of progress.
A Resounding Call to Action:
This critical juncture calls for a united, nonpartisan response from all who value public health, health equity, and human dignity. Health and human dignity are not political weapons to be wielded in service of talking points when lives hang in the balance. We urge individuals and organizations across the political spectrum to join the Southern AIDS Coalition in their efforts to push back against these cuts by signing their letter. Your voice and actions are crucial in shaping the future of HIV/AIDS policy and ensuring our continued progress towards Ending The Epidemic.
There are easy to use tools to contact your congressional representation in Congress. Not sure of your congressional district or who your member of the U.S. House of Representatives is? This service will assist you by matching your ZIP code to your congressional district, with links to your member's website and contact page. Or complete this online form to find your two U.S. Senators.
Now is the time to reaffirm our bipartisan commitment to fighting HIV/AIDS. This battle is not just about preserving past achievements; it is about resolutely advancing our collective efforts against HIV/AIDS. Your involvement is not just beneficial; it is essential. By standing together, regardless of political affiliation, we can overcome these challenges and continue our journey towards a world free from HIV/AIDS. Act now, for this fight is about life, justice, and human dignity. Your voice and action are indispensable in this crucial hour.
The Congenital Syphilis Crisis
At the turn of the century, the United States was nearing elimination of syphilis. However, in the 23 years since then, congenital syphilis has alarmingly resurfaced, revealing significant vulnerabilities in our healthcare system. Highlighted by a newly released Centers for Disease Control and Prevention (CDC) report, syphilis’ resurgence is a critical public health concern demanding immediate and comprehensive action.
The Escalating Crisis
Since 2017, recent CDC data indicates a dramatic 75% increase in syphilis cases in the United States, with congenital syphilis cases tripling in the same timeframe. In 2020, 2,148 newborns were affected, a jump from 1,870 in 2019. This worrying trend extends globally, as a Lancet study corroborates, and the World Health Organization (WHO) estimates nearly 1 million annual congenital syphilis cases worldwide. These cases often result in severe outcomes, including stillbirths, neonatal deaths, and lifelong health complications.
The surge in congenital syphilis necessitates a critical examination of its root causes, including inadequate prenatal care, healthcare access barriers, and insufficient sexual education.
Integrated Response to Syphilis Resurgence
The re-emergence of syphilis is deeply rooted in social and healthcare dynamics and exacerbated by the COVID-19 pandemic. This situation calls for an integrated response from the medical community and society as a whole, addressing both the underlying factors and the immediate challenges.
The CDC has identified significant disparities in syphilis rates among Native American, Native Hawaiian, Pacific Islander, and Black populations. These disparities are linked to broader social determinants of health, which have been further strained by the COVID-19 pandemic, as noted by the American Journal of Public Health. The pandemic's impact on healthcare services has led to increased sexually transmitted infection (STI) rates, including syphilis, due to reduced healthcare access.
Challenges and Care in Syphilis Prevention and Treatment
The medical community, including the Health Resources and Services Administration (HRSA) and dermatologists as discussed in JAMA Dermatology, plays a crucial role in addressing the syphilis epidemic. Their efforts are key to bridging healthcare access gaps and tackling systemic challenges. However, these initiatives are hindered by significant hurdles, such as medical resource shortages, emphasizing the need for a sustained, integrated approach to this public health crisis.
A major challenge is the shortage of Bicillin L-A, the primary treatment antibiotic, as highlighted by The New York Times. This shortage, caused by increased demand and manufacturing constraints, poses a significant risk, especially for pregnant women and birthing persons, and necessitates alternative strategies and early intervention to prevent mother-to-child transmission.
Coordinated Multi-sector Response
Recognizing these challenges, the medical community, led by organizations like the National Association of County and City Health Officials (NACCHO), is advocating for a coordinated response. This approach involves:
Rapid Testing and Treatment: Prioritizing rapid syphilis testing for pregnant women and birthing persons, especially in underserved areas, to prevent congenital syphilis.
Educational Campaigns: Launching culturally sensitive educational campaigns about prenatal care and regular syphilis testing during pregnancy.
Enhanced Prenatal Care Access: Expanding access to quality prenatal care, integrating routine syphilis testing into prenatal check-ups, and ensuring affordable treatment options.
Policy and Funding Support: Advocating for increased funding and policy support to enhance resources for syphilis testing, treatment, and prenatal care services.
Community Engagement and Education
To effectively combat the resurgence of syphilis, a multifaceted community engagement and education strategy is essential. This approach should encompass:
Integrated Awareness Initiatives: Implement targeted campaigns across diverse platforms to educate on syphilis risks, prevention, and treatment. These should be inclusive, culturally sensitive, and utilize local media, social platforms, and community events for maximum reach and impact.
Collaborative Community Leadership and Healthcare Partnerships: Engage community leaders, influencers, and healthcare providers in a collaborative effort. This includes disseminating information, advocating for prevention and treatment, and organizing educational workshops and seminars. These partnerships are vital for credibility and creating effective referral systems for medical consultation or treatment.
Enhanced Comprehensive Sex Education: Strengthen sex education programs in schools and community centers, covering all aspects of sexual health. This should include STI prevention, contraception, and healthy relationships, tailored to be culturally sensitive and inclusive.
Active Community Involvement and Feedback: Encourage community feedback and involvement in the planning and implementation of syphilis education and prevention programs. This ensures the initiatives are relevant, effective, and address specific community needs.
The Role of Sex Education in Preventing Congenital Syphilis
Comprehensive sex education is a pivotal element in combating congenital syphilis. This education equips people with essential knowledge and tools for informed decisions about sexual health, playing a critical role in STI prevention, including syphilis.
Key Insights and Evidence:
Gap in Education and Its Consequences: Reports from sources like NPR and the Texas Tribune highlight the link between the rise in congenital syphilis and inadequate sex education. This gap, which is especially pronounced in resource-limited areas, leaves many, particularly adolescents and young adults, vulnerable due to a lack of essential sexual health knowledge.
Societal and Cultural Barriers: Cultural stigmas and taboos, as discussed in BBC Future, often impede the implementation of comprehensive sex education, leading to misinformation and increased STI risks.
Supporting Data for Comprehensive Education:
◦ The American College of Obstetricians and Gynecologists (ACOG) and studies in the Journal of Adolescent Health underscore the effectiveness of comprehensive sex education in reducing risky behaviors and STI rates.
◦ Research from PubMed Central and the Guttmacher Institute links inadequate sex education to higher STI and unintended pregnancy rates, advocating for inclusive and comprehensive programs.
Importance of Cultural Sensitivity: Studies emphasize the need for culturally sensitive and inclusive sex education, which has been shown to positively impact sexual behavior and contraception use among adolescents.
Policy, Public Health, and Community Approach to Syphilis
The fight against the syphilis epidemic necessitates a unified approach, combining policy initiatives, public health strategies, and community involvement. Central to this effort is the Pasteur Act, reintroduced in Congress to foster antibiotic research and development, a critical step in combating drug-resistant pathogens and diseases like syphilis. This act also highlights the need for equitable access to treatments, particularly for marginalized communities disproportionately affected by congenital syphilis.
Focused Policy and Public Health Efforts:
Support for the Pasteur Act: Advocacy for this act is crucial to stimulate antibiotic innovation and ensure the availability of new treatments for those in need, particularly in underprivileged communities.
Increased Funding for Public Health Campaigns: Investing more in public health campaigns is essential to educate high-risk communities about syphilis prevention and treatment.
Strengthening Healthcare Systems: There's a pressing need to enhance healthcare infrastructure, especially in areas lacking adequate medical resources, to manage the rising cases of congenital syphilis.
Ensuring Equitable Healthcare Access: Policies should aim to provide universal access to quality healthcare, including STI testing and treatment, with a focus on reaching marginalized groups.
Community and Healthcare Provider Engagement:
Healthcare Providers' Role: Emphasizing prenatal care and routine syphilis testing for pregnant women and birthing persons during every patient encounter is critical to prevent the transmission of syphilis to newborns.
Community Involvement: Supporting comprehensive sex education and advocating for the destigmatization of sexual health are essential. Communities and individuals should be encouraged to practice regular testing and safe sex.
This collective effort, integrating medical, educational, and policy measures, is vital to significantly reduce the incidence of congenital syphilis. By working together, we can protect future generations and address the broader aspects of this public health challenge.
For more information, the CDC's congenital syphilis fact sheet provides detailed insights into prevention strategies and the impact of the disease.
Unveiling Disparities: OIG Report on HIV Care in Medicaid
A recent report by the U.S. Department of Health & Human Services’ (HHS) Office of Inspector General (OIG) unveiled a startling revelation: one in four Medicaid enrollees with HIV may not have received critical services in 2021. At a time when healthcare systems worldwide were grappling with the COVID-19 pandemic, these findings highlight the compounded struggles faced by People Living with HIV (PLWH) in accessing essential care.
Beyond safeguarding the health of PLWH, viral suppression plays a pivotal role in curbing HIV transmission, a critical metric in the public health effort to end HIV. In alignment with HHS guidelines, achieving consistent viral suppression necessitates three foundational elements: routine medical consultations, ongoing viral load assessments, and unwavering commitment to ART regimens.
Unveiling the Care Gaps
The OIG's analysis reveals pressing challenges within our system:
Out of the 265,493 Medicaid enrollees diagnosed with HIV, a startling 27% were missing evidence of receiving at least one of the pivotal services last year.
10% were missing evidence of medical visits, and 11% were missing evidence of an ART prescription, raising concerns around disease progression and higher incidence of AIDS diagnosis, increased risk of transmitting the virus, and developing antiviral resistance.
The most pronounced gap? Viral load tests. A staggering 23% of enrollees lacked evidence of even a single viral load test in 2021. This absence not only impedes clinicians from making informed decisions but also hampers our collective ability to monitor and respond to the evolving nature of the HIV epidemic.
Perhaps most concerning is the fact that more than 11,000 of these enrollees didn't have evidence of availing any of the three critical services. This is not just a statistic; it's a reflection of real individuals, facing amplified health risks due to system inadequacies.
Jen Laws, CANN's President and CEO, poignantly remarked, "Medicaid represents the greatest public program coverage of PLWH. It also represents the greatest public program coverage of people at risk of acquiring HIV. Medicaid compliance and efficacy is critical to Ending the HIV Epidemic and this report has identified gaps where states have failed to meet their obligations to Medicaid beneficiaries and where CMS has failed to ensure compliance. We must do better if we are going to reach our public health goals."
The report underscores stark disparities in care access between Medicaid-only and dual-eligible enrollees (those with both Medicaid and Medicare). Specifically, Medicaid-only enrollees were three times more likely to lack evidence of any of the three critical services compared to dual-eligible enrollees, with 6% of Medicaid-only enrollees missing out, as opposed to just 2% of the dual-eligible group. Such disparities might stem from various factors, including Medicare's higher fee-for-service rates and the observed long-standing adherence patterns among older adults who have had HIV for prolonged periods.
State-wide Disparities: A Complex Landscape
The disparities in HIV care access across states offer both a grim reality check and a clarion call for systemic reform. Drawing from the OIG report, certain states, notably Arizona, Arkansas, the District of Columbia, and Utah, have alarmingly high proportions of Medicaid-only enrollees without evidence of at least one of the three critical services. For instance, Utah stands out with a staggering 87% of such enrollees missing out on essential care. These aren't just numbers; they represent real individuals grappling with a system that's failing them.
Conversely, some states demonstrate better compliance and efficacy in delivering HIV care, which suggests potential models or strategies that could be emulated across the board. However, the stark variability across states points to the undeniable influence of state-specific policies, the quality of local HIV care infrastructures, and broader challenges associated with healthcare access.
State agencies clearly have much work ahead. These disparities not only indicate potential inefficiencies or gaps in policy implementation but also suggest a pressing need for introspection and reform at the state level. Coupled with challenges in the broader Medicaid system, there's a compelling case for a comprehensive overhaul.
The onus is on both state agencies and the Centers for Medicare & Medicaid Services (CMS) to rise to the occasion. The disparities, as evidenced in the report, necessitate a deep dive to understand the underlying causes. Is it a matter of policy misalignment, funding constraints, administrative challenges, or a combination thereof?
For instance, the significant variation in care access among dual-eligible enrollees, ranging from 9% to 53% across states, speaks volumes about the discrepancies in policy implementation and oversight. It's vital to pinpoint these issues, develop tailored interventions, and ensure that every Medicaid enrollee, irrespective of their state, receives the essential services they need.
The Pandemic's Shadow
The COVID-19 pandemic exerted immense pressure on healthcare systems, with profound implications for HIV care. The OIG report highlights the challenges faced by Medicaid enrollees with HIV during the COVID-19 pandemic. A significant finding from the report is the notable deficiency in viral load tests among these enrollees. This underscores the need for healthcare systems to effectively manage and prioritize essential services, even amidst broader healthcare crises. The report serves as a reminder of the importance of consistent and uninterrupted care for conditions like HIV, even when healthcare systems face external pressures.
Steering Towards a Brighter Future
Addressing the glaring disparities laid out in the OIG report goes beyond mere policy recalibration; it challenges our collective resolve to uphold equitable healthcare. In the shadow of the pandemic's aftermath, it's imperative that essential services for PLWH are not just nominally available but are genuinely accessible.
The OIG report's findings don't merely spotlight discrepancies; they highlight systemic lapses. States have fallen short in fulfilling their obligations to Medicaid beneficiaries, and the CMS has not adequately ensured compliance.
To translate this call to action into meaningful change, it's essential to:
Strengthen state-level accountability frameworks to ensure Medicaid obligations are met comprehensively, particularly among states utilizing Managed Care Organizations – ensuring those contracted for-profit insurance companies are meeting their contractual obligations to states. The tools for accountability already exist within these contracts, they merely must be used.
Bolster CMS oversight mechanisms, driving proactive interventions that hold states to account and rectify compliance lapses.
Engage in continuous dialogue with stakeholders, including healthcare providers and beneficiaries, to identify and remedy bottlenecks in care access.
The findings from the OIG report serve as a stark reminder of the work ahead. As Jen Laws aptly states, "We must do better." HIV advocates should consider assessing our engagement with their state Medicaid programs and look for opportunities to act, akin to our engagement Ryan White programs. With concerted efforts, policy reforms, and collective commitment, we can bridge the gaps and ensure comprehensive care for all PLWH.
DEA Appears Open to Tele-Script for Certain Controlled Substances
On August 7th, the Drug Enforcement Agency (DEA) issued a notice of meeting regarding telemedicine prescription of certain controlled substances (Schedule II only). The meeting(s) will be conducted as “listening sessions”, conducted Tuesday, September 12th, and Wednesday, September 13th from 9 a.m. to 5:30 p.m. at the DEA Headquarters (located at 700 Army Navy Drive, Arlington, VA). Participants must pre-register using this link, before or on August 21st. In-person requests will be granted via lottery and the sessions will be live-streamed. Similarly, those wishing to provide limited oral presentation, either in-person or via live-stream must also fill out the form. Again, these will be selected by DEA personnel based upon quality of summary of presentation. Presentations may be made by anyone with an interest in and expertise in the subject matter. The DEA has asked for feedback on the following questions:
If telemedicine prescribing of schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
Should telemedicine prescribing of schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of schedule II medications should be permitted in the absence of an in-person medical evaluation? If it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
If practitioners are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
If pharmacies are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
The listening sessions come as a direct result of the DEA receiving truly unprecedented responses to proposed rules published in March, in anticipation of the end of the COVID-19 public health emergency, and, thus, the DEA’s telemedicine waiver issued at the beginning of the COVID-19 pandemic. In all, the DEA received almost 40,000 comments across the proposed rules with much focus on the General Telemedicine proposed rule. We covered the content of those rules (and why they were a step backward as written) in March. In particular, we expressed concern over returning to pre-pandemic limitations on telemedicine when the pandemic-related waiver did not prove any spike in diversion and did, indeed, improve access to medication assisted substance use treatment for many patients. Along similar lines, because testosterone is considered a controlled substance, such a return at the height of bias-driven, state-based legislation limiting access to certain gender affirming care would have a disproportionately harmful impact among transgender men and undermine President Biden’s commitment to combat these hateful efforts.
The relationship between the DEA and harm reduction advocates has been long and fraught. Many harm reduction advocates criticize the role of law enforcement’s actions, particularly that law enforcement agency, working against best practices in public health, even those best practices recognized by federal public health agencies. For example, a couple of weeks ago, we highlighted the Substance Abuse Mental Health Administration’s document (currently open to public comment) aimed at formalizing certain policy positions, entitled Harm Reduction Framework. Nowhere in the “framework” is the conflict with law enforcement positions addressed.
Putting more pressure still on the DEA’s absolute refusal to meet its commitment from 2009 to introduce meaningful telemedicine rules (in response to passage of the Ryan Haight Online Pharmacy Consumer Protection Act) is the fact that the stimulant medication shortage is at its worst. Things are so bad the U.S Food and Drug Administration (FDA) and DEA issued a joint letter on August 1st to further detail actions being taken to address the shortage and consumer struggles. The problem with the letter is it is largely bypasses the responsibility the DEA has in the current situation. Leaning into a claim that manufacturers haven’t filled their annual quota limits in production and pointing fingers at an increase in legitimate prescription of stimulants to manage conditions like attention deficit hyperactivity disorder (ADHD), the letter fails to recognize that the DEA also places extraordinary limits and scrutiny on pharmacies dispensing stimulant medications. Known as “drug diversion”, the idea behind monitoring pharmacies has some merit when viewed under the lens that pharmacies have a responsibility to limit index events like those “pill mills” associated with the opioid epidemic. However, the DEA doesn’t take responsibility for pharmacy raids or strict enforcement against prescribing providers working to keep patients from turning to street supplies by providing legitimate prescriptions.
For the DEA to be a meaningful partner in combatting both illicit and harmful drug use and overdoses and help to address drug shortages, limiting harmful diversion, the agency needs to consider a dramatic shift from an “all drugs are bad, and the people who use them are bad” mindset. There needs to be a thoughtful “medium, wherein stakeholders other than law enforcement can engage in distinguishing best practices in supply chain security and harm reduction and readily identifying criminals taking advantage of patients seeking care by any means they can achieve it – including illegal and illicit channels.
Patient advocates outside of harm reduction and substance use disorder focuses and the industry stakeholders who serve these patients would do well to consider engagement in these and other opportunities to help re-shape and re-imagine the DEA’s role, ideas, and programs to better serve the public at large, better secure the supply chain and limit disruptions, and ensure patients can have ready, reliable, and modernized access to the care we need.
Feds: “Harm Reduction Framework”
On May 15th, Substance Abuse Mental Health Services Administration (SAMHSA) published a document which seeks to “…inform SAMHSA’s harm reduction activities moving forward, as well as related policies, programs, and practices,” and “to inform SAMHSA of opportunities to work with other federal, state, tribal, and local partners toward advancing harm reduction approaches, services, and programs.” The document, called the Harm Reduction Framework, specifically acts as a “level setting” document in addressing substance use as a public health issue.
While the document includes reach within the Office of National Drug Control Policy (ONDCP) and other agencies, like the Centers for Disease Control and Prevention (CDC), it does not have any “mission control” or enforceable policy influence with the Drug Enforcement Agency (DEA) or other law enforcement, which has been a central tool in federal, state, and local government responses to drug use and the opioid epidemic. Indeed, “law enforcement” only shows up once in the document’s contents and once more in the document’s references list. Arguably, whereas the document serves well as a “level setting” opportunity between various stakeholders, which claims to include “law enforcement” personnel, this effort is admirable but will lack “teeth” due to harm reduction as a programmatic idea from a public health lens when law enforcement remains a contraindicated method of response.
SAMHSA has also asked for specific feedback on the framework by way of a public comment form, indicating an effort more to formalize the framework's ideas as a policy stance.
The form follows the flow of the document with the first question seeking general and overall feedback. The second question asks for feedback on the document’s introduction and review of the working group, why the document exists, and historical recognition of how harm reduction has operated in response to substance use. This should be relatively uncontroversial for most respondents. The majority of feedback may seek to clarify or otherwise add details which lengthen the document, if adopted, but will not necessarily impact the substance of this section. The only area which might become “sticky” is the inclusion of “sex work” among “behaviors” associated with substance use and among those who might benefit from harm reduction programming.
The next four questions seek feedback on the core chaptered content pf the document as follows:
“Pillars” of harm reduction
“Supporting Principles”
“Core Practices”
“Community-Based Harm Reduction Programs” (CBHRP)
The document’s Pillars are outlined to include:
Guided by people who use drugs (PWUD) and with lived experience of drug use (this might also include family members, intimate partners, friends, and so forth of PWUD)
The inherent value of people
Commits to deep community building and engagement
Promotes equity, rights, and reparative social justice
Offers low-barrier access and non-coercive support
Focuses on any positive change as defined by the person
Supporting Principles include:
Respecting autonomy
Practicing acceptance and hospitality
Providing support
Connecting family (biological and chosen)
Provides many pathways to wellbeing across the continuum of health and social care
Values practice based evidence and on-the-ground experiences
Cultivates relationships
Assists and not directs
Promotes safety
Engages first
Prioritizes listening
Works toward systems change
Core Practice Areas” include:
Safer practices
Safer settings
Safer access to healthcare
Safer transitions to care
Sustainable workforce and field
Sustainable infrastructure
The final segment focuses on a brief description of CBHRPs, up to and including research projects used to explore innovation and efficacy of particular programs.
This section is noted with an asterisk “as permitted by law” – a nod toward the issue of law enforcement as a primary response tool to substance use and the limitations of SAMHSA as a result.
Advocates should anticipate some funding and program initiatives to reflect the general ideas around this framework or any final product around this framework. However, those barriers as a result of law enforcement and politicized attitudes will remain a barrier and perhaps present challenges for implementing novel programs. Strategically, much like SAMHSA’s drug court grants, the agency should consider how to leverage supportive funding incentives for states and municipalities to involve themselves in any resulting programming.
The public comment period is open until August 14th.
House Appropriations Mark-Up Alarms HIV Advocates
On July 14th, the U.S House of Representatives Committee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) issued its fiscal year (FY) 2024 appropriations mark-up (Editor’s Note: the mark-up hearing can be viewed here). The bill passed out of committee on a party line vote, with Republicans voting in favor and Democrats voting against. The party split reflects what Democrats have framed as bad faith undermining of agreements on spending levels made in May’s debt limit ceiling deal and include policy provisions geared toward stoking a “culture” war. While the leading issue is incredibly steep cuts to public health programs, including entirely eliminating funding for the previous administration’s Ending the HIV Epidemic initiative (which the Biden Administration wished to continue), the policy riders at issue would also undermine best practices for achieving our public health goals by limiting the types of care, education, and support services communities accessing HIV services might be able to access.
Brass tax, Committee proposed:
Ending the HIV Epidemic eliminated (-$524M)
Ryan White HIV/AIDS Program reduced (-$74M, eliminates dental coverage and AIDS Education Training Centers [AETCs], as included in Part F)
Minority AIDS Initiative reduced (-$32M)
Substance Abuse Mental Services Administration – MAI eliminated (-$117M)
Flat funding for the Centers for Disease Control and Prevention’s HIV and HCV prevention programs
Flat funding for other parts of the Ryan White HIV/AIDS Program, particularly for AIDS Drug Assistance Programs (ADAPs)
Non-HIV related cuts seek to further defund public education and the National Institutes of Health and eliminate Title X and Teen Pregnancy Prevention Programs, the federal work-study program, among other things.
HIV advocates across the country decried the bill, including but not limited to The AIDS Institute, HIV + Hepatitis Institute, AIDS United, the National Association of State and Territorial AIDS Directors (NASTAD), and the National Minority AIDS Council. Southern AIDS Coalition (SAC) has organized a letter for individual advocates and organizations to sign-on. The letter is addressed to Senators Tammy Baldwin and Shelly Moore Capito. Astute observers already recognize this appropriation will not survive the Senate as drafted by the House.
Earlier this year, HIV media outlet The Body called these efforts out for what they are and by title “HIV is Being Swept Up in the Anti-Woke Agenda”. Mandisa Moore-ONeal, Executive Director of the Center for HIV Law and Policy (CHLP), drew a direct link between behavior seen earlier this year in Tennessee as a forebearer of federal moves, “Can’t help but think back to all those…who dismissed us when we said to notice these state funding cuts and to start moving against them but told us again and again ‘It’s just the South’.” The Centers for Disease Control & Prevention’s landing page for regional analysis on HIV identifies that 51% of new HIV diagnoses are among Southerners.
Politically, Southern states are often dismissed by politicians (and advocates) not from here because some of the country’s most conservative strategies are developed in the South. However, the racial diversity of the South is also the reason progressive advocates need to focus on the region. That same diversity is precisely why the nation’s civil rights battles started here and why the forefront of combatting the domestic HIV epidemic, be it advocacy, services, or policy, must be focused here.
The Community Access National Network has already joined our colleagues in signing-on and condemning these cuts which, if enacted would not only bring a halt toward our progress in combatting HIV and other public health concerns, but would signal a dramatic step back and make our goals impossible to achieve. The House’s appropriation amounts and the policy riders included are not only mean-spirited, political jockeying of resources the most vulnerable communities in the country rely upon, they are staggeringly dangerous.
MPOX Resurgence Points to Potential Trouble Ahead
Earlier this year, as part of Community Access National Network’s (CANN’s) Monkeypox (now MPOX, previously MPV) Response and Monitoring Project, this blog cautioned against premature declarations of “victory”, urged a recognition of the likelihood MPOX would become endemic to the United States, and relayed anecdotal reports of new MPOX infections, both breakthrough and naive. CANN’s concerns were and remain centered on insufficient vaccine coverage and screening among highly marginalized, highly affected communities. Very specifically, due to anecdotal reports relayed to CANN in January 2023, heightened concern exists regarding provider knowledge, willingness to screen when presented with symptoms, and willingness of public health agencies to take community reports at face-value, rather than paternalistically denying the potential or possibility of new outbreaks or breakthrough cases.
Since then, a study out of France has identified a new cluster of MPOX cases, of which most had some level of previous vaccination, with more than half having had a “complete” vaccination cycle (several potential situation are qualified as “complete”, including a combination of childhood smallpox vaccination and “3rd generation” vaccination in 2022 as part of the 2022 MPOX outbreak). Of these, none were associated with a specific event – which indicates independent exposure among a social-sexual network and not an “index” event.
Similarly, a recent report from Howard Brown Health indicates there is a resurgence of MPOX virus cases in the Chicago area since April 17, 2023. Since April 17th, seven new cases have been identified in the area, representing a departure from the three months prior, when just one case of MPOX was identified in the area, and the highest case rate since November 2022. Patient data related to these cases have not been made available.
This increase in cases in the Chicago area is concerning, particularly as the city is about to see an influx of tourists for this year’s International Mr. Leather (IML) contest from May 25-29, 2023. The event brings in thousands of LGBTQ+ people from across the world for a variety of contest events, parties, and social gatherings where the populations most at risk of contracting MPOX—Black, Indigenous, and other People of Color (BIPOC) Same Gender Loving, Gay, and Men who have Sex with other Men (SGMSM) and Persons Living with HIV/AIDS (PLWHA)—will be in close contact with one another in crowded spaces often wearing little clothing, actively engaging in social-sexual environments, or otherwise increasing their sexual partners, often time anonymously, which will increase their possibility of being exposed to MPOX. To be clear, sexual activity in these spaces should be celebrated and effective interventions should be designed around how to empower fulfilling sexual activity while reducing risk of exposure.
After IML, Chicago will begin its 2023 Pride month, with the festivities to continue through the month of June—another prime opportunity for MPOX to spread from person to person.
In addition to the pressing concerns related to potential infections, this serves as an excellent example of why we should not be quick to call an end to public health emergencies. From almost the beginning of the 2022 MPOX outbreak, it was a disease that disproportionately impacted minority and underserved patient populations—those who were least likely to have access to or feel comfortable and safe seeking healthcare services that would lead to the identification, diagnosis, and treatment of MPOX, much less receive prophylactic vaccinations to reduce the risk of transmission.
Any time we call an end to a public health emergency where the disease primarily impacts underserved populations, we run the risk of de-prioritizing physician awareness of the disease. This is particularly true with MPOX, with which physicians outside of the infectious disease space were largely unfamiliar. Additionally, although vaccine supplies were increased by dividing the single subcutaneous dose into a two-dose intradermal delivery system, vaccine supplies were initially highly limited. Moreover, Black patients were the least likely to receive vaccination against MPOX, meaning that a priority population is still unprotected again a potential resurgence of the disease.
Another concern related to the spread of MPOX relates to the efficacy afforded by the vaccine over time. Few data are available about the continued protection of the MPOX vaccine, largely because this was one of the first use cases of the vaccine in a real-time setting with an adjusted dosing mechanism. If there are concerns about the efficacy waning, local health officials and event coordinators should make efforts to secure and provide vaccination services on-site at these very public, sex-positive events, and at a full single dose, rather than a two-dose series. While those vaccines may not provide immediate protection, they could serve as a prophylaxis against infection and transmission.
Ending public health emergencies almost always poses the risk of shifting attention away from populations where a disease may continue to flourish largely unchecked. We must remain vigilant and keep easily transmissible diseases at the front of our minds when providing services to those most at risk.
Advocates should remain engaged with their local communities, encourage ready responses from public health entities, and those same entities (contracted providers and state and community health departments) should be held accountable for being responsive, creative, and careful as community members and advocates identify potential cases and outbreaks.
New STI Surveillance Report – It’s Not Good
In late 2021, ProPublica profiled the efforts of a local public health worker, Mai Yang, Mai Yang, as she sought to track down a pregnant client recently screened for syphilis Yang was urgent in the need to find this client and get her curative treatment, three uncomfortable injections of penicillin, completed at least 30 days before giving birth. Congenital syphilis is a killer with a near 40% chance of a newborn dying or being stillborn. Beyond death, congenital syphilis risks a range of difficulties, from disabling deformities to cognitive dysfunction. COVID-19 impacts were readily felt throughout the story as Yang’s client, Angelica, struggled with housing, a language barrier required an interpreter, and, eventually, the clinic Yang sought to link Angelica to was not able to accommodate a walk-in appointment, despite Yang having gotten assurances they could.
Last week, the Centers for Disease Control and Prevention (CDC) released its annual sexually transmitted infection (STI) surveillance report for the year 2021, and the news, while not surprising in retrospect, is not good. Both syphilis and congenital syphilis cases rose about 32%, compared to 2020. 2020, on its own saw a moderate rise in both syphilis and congenital syphilis. However, the CDC notes 2020 as the most affected year in STI surveillance with a marked decreases in screening activities in much of 2020 and higher than previous baseline diagnoses throughout much 2021 (mostly around the 150% level but a massive spike well above 200% around November 2021 – or about the time of ProPublica’s report being published).
Gonorrhea and chlamydia cases rose, though not as dramatically. Herpes, despite being a prevalent STI, is not a reportable illness and thus not tracked in the annual report.
This marks the eight consecutive year of increasing STI diagnosis, as noted by the National Coalition of STD Directors and Association of State and Territorial Health Officials. The situation is dire, going forward. Public health offices across the country are expecting to see an exodus of staff in the next 5 years. Between low pay and poor benefits relative to the private sector and displeasure with supervisors (which may be attributed to a lack of flexibility befitting the modern world or political pressures exerted at the appointment level), young and even well-established professionals are planning on leaving this space. And none of that necessarily reflects struggles with private partners or contracted clinics, which are equally struggling with securing funding and meeting ever increasing demands to do more with less.
In the ProPublica article, former CDC Director Dr. Tom Frieden reflected on how the United States has a terrible tendency to go through “a deadly cycle of panic and neglect”. And the same might be considered here. When President Biden announced in May of 2021 that his administration would be working to secure funding for “tens of thousands” of jobs to respond to COVID-19 and support local public health officials, there was an implication those dollars (secured in the American rescue Plan) would also fund positions that had been left to atrophy or were usurped by COVID-19 activities – most notably, disease intervention specialists. But COVID-19 is winding down, in so far as the Biden Administration seems prepared to invest much in the way of workforce dollars, and that promise made in 2021, was supposed to extend through 2026. If comments from federal legislators last year were any indication, there’s not much hope yet in this Congress choosing to ensure funding is secured to help these programs meet their goals.
In a recent interview, U.S Food and Drug Administration (FDA) Commissioner Dr. Robert Califf said “misinformation” was a leading cause of a decline United States life expectancy. And while that may one element of the issue, an abject failure to appropriately fund, stay competitive with the private market, and retain the talent needed to execute public health programs is core and central to this issue. The latest STI surveillance report shows us this plainly. Technology can only do so much in terms of outreach and extending capacity – in order to meet the demands of public health, the human element must be sufficiently supported.
Advocates would do well to take the long-view of their work. It is critically necessary to support existing public health programming and to address disparities being laid bare by annual surveillance data in order to reach an equitable health dynamic in this country – health justice. We cannot get there without supporting public health entities, shielding them from the politicalization of their mission work, and ensuring they’re appropriately appreciated for the life-saving work they do. We cannot represent patients when we don’t know who they are. We must participate with our partners in elevating the STI crisis for what it is – a public health emergency.
A Pox in the Hen House: A Timeline of the MPV Outbreak and Topline Numbers
The first Monkeypox (MPV) diagnosis in the United States was reported on May 17th, 2022, though testing data indicate that the first test that returned a positive result was administered on May 10th. By July 3rd, 2022, there were over 1,500 reported cases in the United States.
By early July 2022, white Americans accounted for 47.6% of MPV diagnoses. But by July 24th, 2022, with 7,266 cumulative MPV diagnoses, Black Americans for the first time accounted for most positive diagnoses—32.6%—in the Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report (MMWR) Week 30. For all but 8 out of the following 28 weeks (ending in MMRW Week 5, 2023), Black Americans accounted for the highest percentage of positive test results. White Americans accounted for the majority of weekly positive diagnoses in only 7 weeks in that same period of time. On August 9th, 2022, the U.S. government declared MPV a Public Health Emergency (PHE). As of February 15th, 2023, there have been a total of 30,193 identified MPV diagnoses and 38 confirmed deaths as a result of MPV.
On May 22nd, 2022, the first JYNNEOS vaccines were administered as prophylaxis against MPV in the United States. Initial supplies of the MPV vaccine were low, however, and the U.S. Food and Drug Administration (FDA), to increase the available supply, issued an Emergency Use Authorization (EUA) on August 9th, 2022, allowing healthcare providers to administer the vaccine in a two-dose series using intradermal administration based on findings from a 2015 study that evaluated the efficacy of intradermal compared to subcutaneous vaccine administration. The total number of vaccines administered in a single week peaked in the week of August 7th – August 14th, 2022, with 108,895 total vaccines administered. By September 10th, 2022, the number of weekly second doses administered outstripped the number of first doses for the first time. This trend continued until the week ending on January 28th, 2023. The number of weekly vaccine administrations dropped precipitously in the week ending on October 1st, 2022. As of February 28th, 2023, a total of 1,196,047 doses of the MPV vaccine have been administered.
Access to and administration of the MPV JYNNEOS vaccine in the United States appear to have been highly correlated to race. In both First- and Second-Dose administration phases, white Americans were the most likely to be vaccinated, with 46.4% of first doses and 50.3% of second doses being administered to white Americans. White Americans received 47.9% of all vaccines administered. Despite the fact that Black Americans represented the highest percentage of diagnoses in the United States—33.7%—just 11.3% of first doses and 10.7% of second doses were administered to Black Americans, receiving just 11.1% of all vaccines administered. Among Hispanic Americans—who accounted for 29.6% of all MPV diagnoses in the United States.—just 20.7% of first doses, 19.6% of second doses, and 20.3% of total doses were administered to this population.
The first doses of TPOXX (tecovirimat) for the treatment of severe MPV disease were prescribed on May 28th, 2022. TPOXX administration is primarily reserved for patients with severe symptoms of the disease, who are immunocompromised, or who have other concurrent conditions that may present complications. As of January 25th, 2023, 6,832 patients were prescribed or treated with TPOXX.
On November 28th, 2022, the World Health Organization (WHO), to address racist and stigmatizing language associated with MPV recommended a global name change for the virus to “MPOX.” (Disclaimer: CANN continues to use “MPV” for its current project merely for the purpose of consistency in report language, but will begin using “MPOX” upon conclusion of the project)
On December 3rd, 2022, the U.S. government announced that it would not be renewing the PHE for MPV. The PHE officially expired on January 31st, 2023.
The Lessons We Applied, the Ones We Learned, and the Ones We Failed to Heed
One of the most successfully applied lessons was the implementation and utilization of existing testing, vaccination, and surveillance systems that were created in response to the COVID-19 outbreak.
Of the 57 reporting U.S. jurisdictions, 31 utilized their existing disease response, reporting, and tracking infrastructures to deploy in-depth disease MPV surveillance for the majority of the outbreak. The surveillance staff and protocols developed during the COVID-19 pandemic quickly pivoted to include MPV in their work, expanding their disease reporting and dashboards to include MPV case counts and demographics to better track the outbreak. Existing vaccine infrastructures including, but not limited to, staffing, scheduling systems, and drive-through delivery spots, were adapted, expanded, or repurposed to incorporate MPV vaccine supplies and dose administration.
Several jurisdictions truly set standards in their reporting, including the states of California, Colorado, Georgia, Kentucky, Massachusetts, Michigan, and New York City (which is reported separately from New York state). They provided excellent MPV diagnosis demographic breakdowns that included age groups, racial/ethnic minority categories, and gender reporting that included trans, non-binary, and other gender expression categories. These data helped to direct responses and better measure equitable outreach, education, and access to treatment and vaccines to the most affected communities.
To hear state and federal public health officials tell it, the U.S. response to the MPV outbreak has been a masterclass in how to effectively respond to and control an epidemic of a highly infectious disease. We’ve heard about how successful and swift the response to the outbreak was and, for a certain segment of the population, that may be true.
For many white, cisgender men who have sex with men (MSM), the outbreak has been little more than a month-long inconvenience; a blip that barely pinged their radars. The other side of that story, however, lies in the marginalized demographic groups.
For all of the successfully deployed public health systems, the truth is that MPV has been almost exclusively a disease that impacts the “others” in our society. From the beginning of the response, LGBTQ+ patients reported facing stigmatizing, discriminatory, and/or outright racist attitudes and behaviors on the part of medical professionals and administrative staff, particularly those seeking services outside of urban settings.
The unfortunate truth of healthcare provision is that every disease that is primarily acquired via sexual transmission comes with its own set of social, moral, and medical stigmata. In areas where self-reported levels of religiosity are high, patients seeking care often encounter negative behaviors and reactions from healthcare workers and administrative staff both inside and outside of the STD/STI/HIV spaces. While the Health Insurance Portability and Accountability Act (HIPAA) is supposed to protect patients, the reality on the ground is that healthcare workers can be woefully loose-lipped when it comes to sinking the social ships of the patients who live in small or close-knit communities. Moral judgments are made; stories get told; patients are admonished and made to feel ashamed—the impacts of these behaviors, both short- and long-term, can lead to patients refusing to seek testing or treatment until they feel they absolutely must, to avoid being honest with physicians about their symptoms, or to refuse to seek vaccinations or treatment services to help prevent infection or the further spread of the disease.
When it came to the delivery of MPV vaccines, the splitting of the JYNNEOS vaccine into two doses both created confusion about the efficacy of the vaccine and increased barriers to people wishing to complete the two-dose series. With any vaccine series, the fewer times patients need to schedule or show up for an appointment to receive their shots, the more likely they are to get fully vaccinated. Additionally, the decision to use intradermal vaccine administration as the delivery method—one of the more difficult delivery methods to correctly perform—resulted in reports of unsuccessful attempts at vaccinating individuals, particularly in patients with darker skin. Additional concerns, which were only marginally addressed by later guidance—and inconsistently applied across jurisdictions and providers—included discomfort and scarring, particularly among those prone to keloids. This meant that several patients—mostly Black and Brown—had to have their dose readministered at a later date creating yet another unnecessary barrier to becoming fully vaccinated.
Another factor that negatively impacted the MPV vaccine uptake was the exponential increase in self-reported hesitancy, skepticism, refusal, and beliefs in scientifically and factually inaccurate information about vaccines, in general. One of the worst consequences of the COVID-19 pandemic response was the massive influx of false information about how vaccines are developed and manufactured, what their contents are, their risks and side effects. Those challenges were compounded by misinformation, such as massive government/billionaire/Jewish/Chinese conspiracies to commit every farcical atrocity under the sun – including surreptitiously implanting microchips, giving people mutant magnetic properties, sterilization…you name it, some shadowy organization was allegedly doing it.
Despite these falsehoods being easily disproven within seconds, for many people the burden of proof has never been on the people making the false claims to prove their theories, but on the “experts” to disprove what the neighbor’s cousin’s sister’s oldest great-grand-nephew said about how the vaccine caused him to go blind.
Beyond those haphazardly manufactured and too easily consumed lies about vaccines, Black and Brown communities have historically legitimate reasons to distrust the government and medical authorities. Decades of actual and well-documented surreptitious sterilization, non-consensual experimentation, and abuse at the hands of systemically racist medical establishments have resulted in a generational and almost endemic distrust of public health measures, treatments, and authorities in minority communities. Efforts to combat generational hesitancy, avoidance, and distrust are slow-going, taking decades of work to undo or repair the harm that has been done to those communities. Add on top of that steady and relatively unchallenged social, digital, and visual media streams churning out anti-vax conspiracy theories, and that process becomes all the more difficult.
In Black and Hispanic men, as well as in communities of Persons Living With HIV/AIDS (PLWHA), MPV was largely allowed to run rampant, in no small part because of ineffective, lacking, or wholly absent educational, outreach, and vaccination strategies designed to reach those communities. While the work done by Drs. Demetre Daskalakis and David Holland in the Atlanta region and in a handful of other major cities was both highly effective and admirable, reality is that their campaign of taking education, testing, and vaccination drives into large-scale venues, gay cruises, fetish events, and sex clubs simply wasn’t scaled and replicated at the levels needed to truly reach those most in need of services.
One of the lessons that we need to learn from the MPV outbreak is that we need to do a much better job of delivering healthcare services outside of traditional settings and offering healthcare services outside of traditional office hours.
We already know that rural, minority, and LGBTQ+ populations face critical healthcare staffing and service provision shortfalls. The closure of rural clinics and hospitals, as well as healthcare providers who served primarily minority and/or lower-income patient populations, has exacerbated the negative outcomes and barriers that exist in areas with underfunded, little, or non-existent healthcare infrastructures. While the growth of COVID-19-related pop-up services and locations provided hope for improvement, the truth is that those investments were never designed to be long-term, nor were those investments or their implementation welcomed in more conservative parts of the country.
If we want to effectively serve underserved populations, we must think and act outside of the standalone brick-and-mortar healthcare paradigm. The MPV outbreak has shown us that we need to significantly increase local, state, and federal investments in mobile, pop-up, and telehealth healthcare delivery methods and models to meet people where they are. We also need to invest in more community-based providers, service models, and interventions. We need more public-private collaboration design – like the New York City Health Department partnering with the Sisters of Perpetual Indulgence for generating a community experiences feedback system.
Many of the most innovative and successful STD/STI/MPV interventions don’t require patients to come into a standard physical location to access testing, vaccination, and treatment services. They are set up in sex clubs and bars; they show up at concerts, parties, and other big events; they offer services in churches in communities where faith plays an important role in the lives of their patients; they build trust in, develop relationships with, and take mobile units into encampments of people experiencing homelessness. Essentially, they go out and meet patients where they are and when they’re available. A pox in the hen house has taught us one very valuable lesson: we need to fix these barriers sooner rather than later.
When MPV Became An STI
There comes a time, in the progression of any outbreak, where classifications change as we grow to understand more about the disease; a time when people—those who are living with the disease, those who have recovered, those who have never come in contact, and those who encounter the disease in a professional capacity—decide that we’re no longer in the midst of an “outbreak,” but that it has either ended or become endemic. This is where we appear to be with the Monkeypox (MPV) outbreak in the United States.
Since the beginning of the MPV outbreak in the United States, the overwhelming majority of cases have been transmitted via sexual contact (Centers for Disease Control and Prevention, 2022), primarily among men (CDC, 2023), particularly among Men who have Sex with Men (MSM) (Spicknall, et al., 2022), and disproportionately among Black Americans (CDC, 2023). The Community Access National Network (CANN) has been actively tracking reporting of MPV since September of 2022, and in that time, we have witnessed a troubling pattern emerging: the celebration of a “successful” control and suppression of a disease outbreak when the disease actually risks becoming endemic.
When we say that a disease has become endemic, it means that the disease is a constant presence in a certain population within a specific geographic region. In this case, we mean that MPV has relatively rapidly transitioned from a highly concerning outbreak to one that is being treated as a sexually transmitted infection (STI) similar to syphilis—one that is likely going to just “be around” no matter what we do. In the MSM communities that have been overwhelmingly impacted by MPV, members of those communities have already started treating it as such:
“We know it is how we are getting it, we just don’t know what to do about it because, based on lesion location alone, for example, a condom would not have prevented some of these exposures.”
This comment from an HIV activist and advocate living in New York City’s Hell’s Kitchen was related to me during a conversation about anecdotal reporting of disease outbreaks in the area.
“I know of at least a dozen men in the last couple of weeks who are experiencing minor infections despite being vaccinated or previously infected, and this week, I have seen several sex workers in the streets around here who are clearly experiencing full-blown infections, implying no vaccination.”
These statements raise several concerns, not the least of which is the availability of vaccine supplies and the distribution of said vaccine among priority populations. Additional concerns include what, if anything, can be done to curb the spread of MPV among MSM populations when vaccine supplies are unable to keep up with the demand if the virus is, in fact, becoming endemic. Will we simply decide, as a nation, that it’s just something we have to live with and move on with our lives?
One of the unfortunate truths about the availability and distribution of the MPV vaccine is that the populations who were the most disproportionately impacted by the virus were some of the least likely to receive the vaccine. As of January 19th, 2023, 48.3% of vaccines administered have been administered to White residents, despite the fact that just 22.4% of MPV cases have occurred in White residents. Comparatively, 34.7% of MPV cases have been identified in Hispanic residents, with just 23.4% of vaccines going to that population, and 27.4% of MPV cases have been identified in Black residents, with just 12.8% of vaccines going to that population.
Essentially, vaccination outreach efforts have simply not been sufficient to reach the populations most heavily impacted by the disease. While many factors may contribute to this outcome, the primary factor is that Black and Hispanic Americans simply do not have access to or receive the quantity and quality of care that White Americans enjoy—a fact that has been widely discussed but poorly addressed since the early 2000s (Collins, et al., 2002). From the quality of the facilities and services to the availability of service providers, White Americans are more likely to have access to not just more healthcare services but better services that meet their needs, whereas Black and Brown Americans are made to deal with longer wait times, under-resourced and understaffed facilities, and often lower quality care.
While there certainly have been efforts to reach into Black and Brown communities to deliver the same quantity and quality of healthcare services, healthcare workers come up against cultural barriers, including having to confront the generations of discrimination, mistreatment, and neglect that Black and Brown Americans have faced from healthcare professionals that make those populations less likely to seek healthcare services and trust providers.
These are the same barriers that people working in the HIV and STD/STI fields face when trying to provide services, and we still struggle to overcome those barriers today, although progress is being made, particularly when healthcare services are provided by members of those communities whom they know and trust. The same logic can and should apply to the delivery of vaccines, but the sad reality is that vaccine hesitancy and refusal continue to be high in Black and Brown communities (Maurer, Harris, & Uscher-Pines, 2014).
Beyond racial disparities, further concerns exist around barriers that impact the general MSM, Transgender, and Queer populations. One such barrier is the lack of culturally competent, sex-positive, and queer-centric care provision, even in areas as diverse as Hell’s Kitchen:
“A number of my friends, as well as myself, if I’m being honest, have reported that their physicians are both unaware that reinfection with MPV is possible and that infections can still occur in people who have been fully vaccinated, and as a result of their knowledge gap are refusing to test MPV lesions.” my friend continued. “There is a paucity of physicians who understand that LGBTQ+ people are going to continue to be sexually active, and this lack of cultural competence leads to our critical healthcare needs going unaddressed.”
What many Americans, and sadly many physicians and healthcare providers, fail to recognize is that healthcare is rarely a “one-size-fits-all” provision model. When we talk about diversity in patient populations, we’re should be talking about more than just racial diversity; we need to include sex and gender diversity, sexual orientation diversity, religious diversity, age diversity, and income diversity. Every patient, whether or not they are aware of them, is impacted by a wide variety of experiences related to their race, age, sex, gender, sexual orientation, and religious beliefs, and those experiences inform when, why, and how they access healthcare services. When providers are not aware of and responsive to those experiences—something that is truly difficult, particularly in areas where the patient-to-physician ratios are astronomically high—the quality of the services being provided suffers.
One way to approach this would be the better (and potentially mandated) incorporation and provision of STD/STI testing, prevention, and care in general practice settings. This would help to normalize the testing, identification, and treatment of STD/STIs in the general population and make seeking services for them less stigmatizing.
Another opportunity that is rarely explored is the provision of STI testing and vaccination services in sex-based venues, such as sex clubs, bath houses, and other venues where intimate contact between individuals is likely to occur. While some physicians—most notably Drs. David Holland and Demetre Daskalakis—have been actively pushing for and engaging in this type of health intervention, it is still a relatively rare type of intervention outside of large urban areas. Moreover, providing these types of services requires additional training for staff, particularly around situational and cultural awareness, as well as developing best practices for interacting with people in these types of settings without negatively impacting the atmosphere and customer bases of those settings.
If we are ever going to eradicate MPV in the United States, we are going to have to do a significantly better job of getting vaccine supplies to those most likely to be impacted and do a better job of overcoming the cultural and hesitancy barriers that exist in those communities. It also means that we have to do a better job of educating the MSM community about the virus and how it’s spread and doing so in a way that is both sex-positive and doesn’t rely upon fear-based tactics to scare people into getting vaccinated or into a monastic lifestyle.
More importantly, we need to come up with a way to incorporate anecdotal reporting of localized outbreaks of MPV in communities into our responses. While the CDC and states may be taking victory laps on their “successful” MPV responses, the reality is that MPV outbreaks are still ongoing and, in many places, are doing so relatively unchecked with little awareness of the disease, its symptoms, its treatments, or how to prevent it.
While anecdotal evidence is just that—based on personal experience rather than hard data or research—we know that anecdotal evidence can be very important when it comes to identifying outbreaks early, particularly in minority and underserved communities. We need to develop a better way to incorporate those anecdotal reports into our investigations so that we can catch outbreaks early on rather than waiting until cases become widespread. Simply because official reports of cases show a decrease in new infections doesn’t mean that infections aren’t occurring in populations that are less likely to seek healthcare services.
References
Centers for Disease Control and Prevention. (2022, December 08). How It Spreads. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: National Center for Emerging and Zoonotic Infectious Diseases: Division of High-Consequence Pathogens and Pathology. https://www.cdc.gov/poxvirus/monkeypox/if-sick/transmission.html
Centers for Disease Control and Prevention. (2023, January 18). Mpox Cases by Age and Gender, Race/Ethnicity, and Symptoms. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: National Center for Emerging and Zoonotic Infectious Diseases: Division of High-Consequence Pathogens and Pathology. https://www.cdc.gov/poxvirus/monkeypox/response/2022/demographics.html
Collins, K.S., Hughes, D.L., Doty, M.M., Ives, B.L., Edwards, J.N., & Tenney, K. (2002, March). DIVERSE COMMUNITIES, COMMON CONCERNS: ASSESSING HEALTH CARE QUALITY FOR MINORITY AMERICANS. The Commonwealth Fund. https://www.commonwealthfund.org/sites/default/files/documents/___media_files_publications_fund_report_2002_mar_diverse_communities__common_concerns__assessing_health_care_quality_for_minority_americans_collins_diversecommun_523_pdf.pdf
Maurer, J., Harris, K.M., & Uscher-Pines, L. (2014). Can routine offering of influenza vaccination in office-based settings reduce racial and ethnic disparities in adult influenza vaccination? Journal of general internal medicine, 29(12), 1624–1630. https://doi.org/10.1007/s11606-014-2965-z
Spicknall, I.H., Pollock, E.D., Clay, P.A., Oster, A.M., Charniga, K., Masters, N., Nakazawa, Y.J., Rainisch, G., Gundlapalli, A.V., & Grift, T.L. (2022, September 02). Modeling the Impact of Sexual Networks in the Transmission of Monkeypox virus Among Gay, Bisexual, and Other Men Who Have Sex With Men — United States, 2022. MMWR Weekly 71(35), 1131-1135. http://dx.doi.org/10.15585/mmwr.mm7135e2
Troubling Issues with HIV and Monkeypox Co-Infection
In the process of gathering state-level data on the incidence and demographics of Monkeypox (MPV) in the United States, we have come across several reports of people who have been diagnosed with MPV being co-infected with HIV. This worrisome trend indicates the need for targeted interventions, increased testing, and better communication about MPV in both patient and provider settings.
The Community Access National Network (CANN) has launched an ambitious patient awareness campaign focused on the ongoing Monkeypox outbreak. Its ‘MPV Response Project for People Living with HIV’ seeks to gather data and issue reports covering MPV in the United States. The reports will focus on epidemiological trends, vaccine access and equity, state-level access to vaccine and antiviral supplies, HIV and MPV co-infection risk and reporting, and the latest news related to the outbreak. The project is broad in scope, and it will tackle the MPV outbreak in a way that is both data-focused and patient-centric. This month’s blog will focus on the disparities faced by people living with HIV/AIDS (PLWHA) and MPV.
Data from the European Union, United Kingdom, and the United States suggest that between 28% and 51% of persons diagnosed with MPV are also living with HIV (Kuehn, 2022). According to estimates from the U.S. Department of Health and Human Services (HHS), an estimated 40% of people who have been diagnosed with MPV in the U.S. are also living with HIV (HIV [dot] gov, 2022).
These data are considerably troublesome, particularly as research is beginning to show that PLWHA are likelier to have worse manifestations of MPV, require hospitalization more frequently than persons who are not living with HIV, and are likelier to die as a result of MPV co-infection.
The underlying issue?
We simply don’t have enough localized data (or really, financial resources) to create strategic responses.
Currently, there are only three major jurisdictions in the U.S. that publicly report on HIV co-infection in MPV diagnoses—Michigan, North Carolina, and Rhode Island. This includes looking at the municipal jurisdictions that were specifically targeted for JYNNEOS vaccine supplies—Los Angeles, Chicago, New York City, and Houston—of which only Los Angeles’ reporting mentions HIV, and even then, only in relation to tecovirimat (TPOXX) prescribing data.
So, what does this mean?
Primarily, it means that we need to look at other sources in order to extrapolate co-infection data and use modeling to make educated guesses about where risks of co-infection are highest and how best to respond.
There are currently only a handful of recent studies and surveys that focus on the United States outbreak of MPV from which we can glean these data:
1. Curran, et al., published in September 2022, focused on a sample of 1,969 from eight jurisdictions:
California
Los Angeles
San Francisco
District of Columbia
Georgia
Illinois
Chicago
New York (excluding New York City)
These jurisdictions were selected because they were independently funded for HIV surveillance and because they represented areas with the highest rates of MPV infections in the United States.
Curran, et al., found that 755 patients (38%) of that sample were co-infected with HIV. Of those patients, 94% had received HIV care in the past year, and 82% were virally suppressed (Curran, et al., 2022).
2. Miller, et al., released in October 2022, looked at a significantly smaller sample size of just 57 patients who had been admitted to hospitals for severe manifestations of MPV.
Of this sample, 47 (82%) were co-infected with HIV, just four of whom (9%) were receiving antiretroviral therapy (ART) to treat their HIV prior to being diagnosed with MPV.
In terms of demographics, 68% of this sample were non-Hispanic Black Americans, which highlights disparities in HIV treatment in Black communities.
Prior to the release of this report, 12 of those patients died. MPV was listed either as the cause of death or a contributing factor in five of those deaths, six deaths remain under investigation to determine if MPV was the cause or a factor, and 1 death was deemed neither the cause nor a contributing factor (Miller, et al., 2022)
So, what can we learn from these relatively limited findings:
1. We can determine that PLWHA, particularly Men who have Sex with Men (MSM), are at higher risk of contracting MPV than their heterosexual or women peers.
From the data we have reported in previous blog posts and the reports we’ve released, MPV infection rates are highest in three primary populations:
a. MSM
b. Black Americans
c. Hispanic Americans
This should lead us to build strategies that focus on education of providers about properly identifying MPV lesions, testing, vaccination, and treatment of MPV in these communities.
An additional consideration is a lack of uniformity in gender identity reporting and data collections. As of current, while some jurisdictions are collecting gender identity data for MPV metrics (with many more getting a much better handle on the same data for HIV-related metrics), most are not. Similar to data collection and reporting in HIV prior to about 2016, MPV data does not typically distinguish between a person’s sex assigned at birth and gender identity, thus not adequately capturing data that would appropriately represent transgender communities.
In our gathering of state-level MPV reporting, we found that 22 of the 32 jurisdictions that provide gender demographic reporting either do not report on transgender patient populations, at all, or lump all non-cisgender patients into an “Other” category that fails to capture the diversity of patient populations and health outcomes between them.
Two examples of how this data delineation proves particularly relevant can be observed in the emergence of information regarding HIV prevalence among transgender women, particularly transgender women of color, and, more recently, transgender men have largely been ignored as a target population, likely because of stereotypes and assumptions as to the types of sexual activity transgender men might engage in and because transgender men are less likely to access care (Demmons, 2019). A recent study conducted by AIDS United highlighted how deeply flawed some of those assumptions are, with 35% of the transgender men responding to the survey with a self-reported HIV-positive status (AIDS United, 2022).
Further consideration should also be given to persons experiencing or at risk of experiencing homelessness. Miller, et al., found that 23% of the admitted patients were experiencing homelessness, which is likely indicative of a growing outbreak among a key population: PLWHA who may be housing insecure.
2. We don’t know what we don’t know.
One of the largest concerns, here, is that a majority of providers in the United States simply aren’t familiar enough with MPV to identify the disease consistently and correctly. Since the beginning of the epidemic, physicians have struggled to do so, with many misdiagnosing MPV as other diseases or infections, such as herpes or syphilis (Doucleff, 2022). This is because both of those sexually transmitted infections may manifest as skin lesions, similar to MPV. Misdiagnosis can lead to both the provision of ineffective treatments and result in the unchecked spread of MPV. This highlights the need for better provider education about MPV, its manifestations, and how to correctly differentiate between various diseases.
Additionally, while both Curran and Miller provide reporting on HIV co-infection in persons diagnosed with MPV, none of the listed jurisdictions from which they selected their sample groups provide public-facing reporting on HIV co-infection.
In the three jurisdictions we found with this reporting—Michigan, North Carolina, and Rhode Island—48.6% of MPV patients were co-infected in Michigan, 51.6% in North Carolina, and 27.7% in Rhode Island.
These findings fall relatively neatly into the HIV.gov reporting that 28% - 52% of MPV patients are likely to be co-infected with HIV.
However, these numbers could potentially be higher, particularly in major cities, such as Los Angeles, San Francisco, Chicago, New York, DC, Atlanta, and other areas that have higher populations of PLWHA and more areas and venues where PLWHA tend to congregate (e.g., bars, restaurants, sex clubs, steam rooms, et cetera).
3. Although overall diagnoses of MPV have fallen precipitously since August 2022, there is a significant risk of MPV becoming endemic in MSM, LGBTQ, and PLWHA populations.
This will require the development and wider distribution of better MPV-specific vaccines, better MPV-specific treatments, and better education and health communication about MPV and its transmissibility.
There seems to be a prevailing belief that the United States has weathered the worst of MPV. With declining positivity rates, there are some in the public health community who have decided that resources and attention would be better spent elsewhere—specifically, they’re looking at the tridemic of COVID-19, influenza, and respiratory syncytial virus (RSV) that is leaving hospitals once again scrambling for ICU beds. More accurately, it may be said that jurisdictions either cannot or will not expand the existing resources and personnel to allow for the continued surveillance of MPV. This essentially relegates the work of focusing on, addressing, and frankly caring about MPV to those working in HIV and infectious disease spaces.
Already, we are seeing this trend in data reporting: the state of Texas has removed MPV data entirely from its data dashboard, replacing it with Multisystem Inflammatory Syndrome in Children (MIS-C). This is indicative that a lack of financial and human resources, or the lack of political will or interest to increase those resources, will force state departments of health to reduce reporting on MPV in favor of diseases that impact populations they deem “more important” than MSM, Black, and Hispanic populations.
This, again, raises the concern that MPV will become a virus that is all but forgotten by the general public and general practitioners, as those who face the greatest impacts are already marginalized populations. The disparities faced by those bearing the brunt of MPV mirror those in new HIV diagnoses; it is incumbent upon us to respond evaluate and respond to those trends accordingly.
References
AIDS United. (2022, November). CHANGING THE GAME: Visibility of Trans Men in the South. Washington, DC: AIDS United: News and Resources. https://aidsunited.org/wp-content/uploads/2022/11/ChangingTheGame-FinalReport.pdf
Curran, K.G., Eberly, K., Russell, O.O., et al. (2022, September 09). HIV and Sexually Transmitted Infections Among Persons with Monkeypox — Eight U.S. Jurisdictions, May 17–July 22, 2022. MMWR Weekly 71(36), 1141-1147. http://dx.doi.org/10.15585/mmwr.mm7136a1
Demmons, S. (2019, July 10. Why are trans men invisible in HIV prevention & care? San Francisco, CA: San Francisco AIDS Foundation: Our Voices. https://www.sfaf.org/collections/beta/why-are-trans-men-invisible-in-hiv-prevention-care/
Doucleff, M. (2022, June 06). Monkeypox cases are going undetected or misdiagnosed. Washington, DC: National Public Radio: All Things Considered. https://www.npr.org/2022/06/06/1103372564/monkeypox-cases-are-going-undetected-or-misdiagnosed
HIV [dot] gov. (2022, November 30). mpox and People with HIV. Washington, DC: United States Department of Health and Human Services: Office of Infectious Disease and HIV/AIDS Policy: HIV.gov. https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/monkeypox
Kuehn, B. M. (2022, September 27). Interim Guidance for Monkeypox Among Patients With HIV. JAMA 328(12), 1173-1174. https://doi.org/10.1001/jama.2022.14727
Miller, M J., Cash-Goldwasser, S., Marx, G.E., Schrodt, C.A., Kimball, A., Padgett, K., Noe, R.S., McCormick, D.W., et. al. (2022, October 26). Severe Monkeypox in Hospitalized Patients — United States, August 10–October 10, 2022. MMWR ePub. http://dx.doi.org/10.15585/mmwr.mm7144e1
Advancing Access Through Place Based Care
Repeatedly over the years, I’ve asked funders to consider investing in (sponsoring) various sexual-social events. Often these events are already tapped into local clinic networks or community service organizations and, historically, these organizations are not “large” by any stretch of the imagination. If we look at one of the most influential (and sometimes notorious) examples, The Sisters of Perpetual Indulgence, the raucous, often raunchy members of the organization’s chapters are deeply, deeply tied into any given community’s needs. From providing street “ministry” by giving food to houseless persons to giving out condoms, education, and, in the case of the Las Vegas chapter, providing a community-based AIDS drug assistance program for people needing more assistance than the state program offers, the Sisters aren’t known for being…conservative. And they’re not alone.
Indeed, in nearly every large city (and often even smaller cities) across the country, there is some kind of sexual fraternity which gathers at leather bars, bathhouses, and large events, like International Mr. Leather or International Ms. Leather. These events are explicitly sexual in nature. But they’re also where these communities we seek to serve gather and often with intentional efforts are welcoming and involving people who live at layered intersections of marginalization; Onyx, for example, aims to meet the social needs of queer men of color. And all of these organizations and events and the clinics that find ways to serve these events could well stand to use additional financial support.
Every time that ask has come up, I’ve been told it might be “too edgy” to place a well-known brand in sponsorship. The Ryan White CARE Act explicitly forbids federal grant dollars from “promoting homosexual behavior” – necessarily prohibiting any financial support of these spaces which operate as centralized gathering of an audience and only allowing service providers to show up. But those sponsor dollars are what makes it possible for service organizations – be they clinics or these fraternal organizations – to show up and engage in the most effective place-based outreach and care. In November, Time published the opinion piece, We Need to Bring Sexual Health Care to Places Where People Have Sex. The piece highlights the effectiveness of place-based, going to the source, outreach, education, and vaccination in response to the mpox outbreak that’s wrapped its fingers around the globe. Across the country, health departments and federally funded clinics have quietly been working in these spaces for decades. Dr. Demetre Daskalakis, the director of the Center for Disease Control and Prevention’s (CDC’s) HIV Prevention Program, is reasonably well credited for ending a meningitis outbreak in New York City by providing vaccines on location at bath houses – where people have sex.
HIV and Hepatitis C do not thrive in “neat” and “clean” and “conservative” environments. Rather these viruses thrive where people are getting their own needs met and that includes where people are getting their sexual needs met and their coping needs met (drug use is, at its core, a coping mechanism). And interventions to curb the transmission and detrimental effects of these viruses thrive when communities come together.
Just as we need to extend funding supports that incentivize churches to host testing and education events in order to address stigma, we also need to fund the entities, communities, formal and informal, and places where communities gather. Leaning into culture, as opposed to avoiding it, ensuring existing communities thrive, meeting people where they’re at, and funding where advocacy goes to celebrate is something we need more of. Advocacy needs our funders, of all stripes, to not be afraid of being labeled “sex-positive” and to show up for us and our communities in the places we already exist.
Nevada Adds New Syringe Exchange Vending Machines, Building on Success
Just before the holiday, the Southern Nevada Health District (SNHD) announced it would be showcasing a newly added harm reduction vending machine to the located at the main SNHD health center on Decatur Boulevard in Las Vegas. In a year where other some jurisdictions are seeing local and state legislators push back against harm reduction programs of all sorts, the Las Vegas health entity has chosen to invest in successes already achieved and expand their vending machine program.
In 2017, Nevada became the first state in the country to offer syringe exchange services via vending machine, after the legislature passed a harm reduction measure allowing the state to fund these efforts, known as HB 410. Nevada’s syringe change program is operated by Trac-B Exchange out of a store front and the entity was one of three in which the program launched as a pilot. Sometimes called “public health” vending machines when numerous types of self-administered care supplies are offered, kits in the machine include syringes, tourniquets, a disposal container, first aid supplies, safe sex supplies, naloxone (the opioid overdose reversal medication), pregnancy tests, and hygiene kits. Health officials also highlighted how these kits might be used for “street” hormone replacement therapy, or when a transgender person is not engaged in traditional care but is still acquiring hormone medications (commentary also addressed bodybuilders for similar activities). The machines do not require cash to operate, rather a person seeking to use the machine is required to fill out a form and will receive a code and card. Identifying information is not required to receive access to the vending machines. Advocates and program operators have cited how the machines save public dollars by reducing the labor burden and keeping more people engaged in care.
In 2017, Las Vegas had at least 5,800 active injection-drug users and program staff have cited the success of the pilot as to part of why the newest vending machine was added. With nearly ten percent of Nevada’s new HIV diagnoses being attributed to illicit syringe use and the well-studied benefits to reducing Hepatitis C transmissions, SNHD’s newest addition seeks to engage a broader range of the public as the kits offered are more expansive in meeting care needs. Since the 2017 pilot launch in Nevada, other jurisdictions have considered beginning their own programs (not without opposition). Ohio, for example, launched a vending project in early 2021 (in part to reduce the risks associated with in-person care during a wave of high COVID-19 transmission), making it the second state to offer this type of access program. Those machines included “smoking” kits and their safe consumption kits also include fentanyl testing strips as options. Since the launch, more than 1300 items have been dispensed and almost 600 overdoses have been reversed in the community the vending machine serves.
Research released in June of 2022 found the anonymous nature of the vending machine programs was critical for many people using them. Researchers established a baseline of foot traffic for the machines by setting up a camera (which would identify consumers), afterwards setting up near the machine to offer services and information. While some consumers engaged with peers they recognized, many chose not to and the researchers had good indication at least a few potential consumers avoided the machine they might otherwise use because of the researchers’ presence. In an interview as part of the study, one person admitted to avoiding getting supplies they needed because of police presence near the vending machine. This presents a difficult-to-balance issue in working to ensure people using the machines are actively linked to care they need. Potential solutions include offering a QR code on the machine, reliance on drug using and former drug using peers to staff tables, information inserts in each kit, and possibly having a table staffed at regularly posted times so that consumers could chose to engage when and how they’d like. However, the issue of police presence as a deterrent to seeking care will remain a barrier and has been problematic for other syringe exchange programs across the country. Because law enforcement activity appears to be a significant barrier to engaging in harm reduction services, specifically syringe exchange programs or in reporting overdoses (the limitations of Good Samaritan laws vary by state, often with carve outs for drug users reporting a need for help for a friend), legislatures could address the conflict by passing laws which carve out certain enforcement, but prosecutors and police department leadership need to “buy-in” as well. Reducing uniformed patrol around these areas or committing to not prosecute people seeking harm reduction services and products via vending machines would go a long way to reducing law enforcement engagement with patient populations, increasing trust with affected communities (with both law enforcement and care provider entities), and increasing engagement with these critically necessary, life-saving programs.
State-Level Monkeypox Surveillance Highlights State-Level Disparities
The Community Access National Network (CANN) launched an ambitious patient awareness campaign focused on the ongoing Monkeypox (MPV) outbreak. Its ‘MPV Response Project for People Living with HIV’ seeks to gather data and issue reports covering MPV in the United States. The reports will focus on epidemiological trends, vaccine access and equity, state-level access to vaccine and antiviral supplies, HIV and MPV co-infection risk and reporting, and the latest news related to the outbreak. The project is broad in scope, and it will tackle the MPV outbreak in a way that is both data-focused and patient-centric. This month’s blog will focus on the demographic disparities of the MPV outbreak, in general, and how those disparities vary at the state level.
The Centers for Disease Control and Prevention (CDC) has been providing considerably detailed data about MPV since the beginning of the outbreak in the U.S. in May 2022. From its MPV data portal, users can get a surprisingly robust amount of national-level data, one of the most striking of which is that Black Americans account for roughly 44% of all new MPV diagnoses across the U.S. (CDC, 2022).
As part of this MPV Response Project, CANN has decided to dig deeper by attempting to gather and analyze state-level epidemiological reporting where it exists. Our experience with state-level surveillance has shown that, while every state has some sort of surveillance system in place, no two systems are created equally. That is to say, while some states provide robust surveillance and reporting, other states—particularly those located in the American South and rural West—do not. More to the point, they likely cannot, as a result of underfunded and understaffed departments.
With this established, here is what we found:
As of October 28th, 2022:
28 states (AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, NJ, NM, NY, NC, RI, SC, TX, VA, WA, & WI) and the District of Columbia provide detailed demographic reporting on Monkeypox virus incidence on state-run websites. Both DE and FL omit race demographics from their reporting.
13 states (HI, ID, IA, KS, ME, MT, ND, OH, OR, SD, TN, UT, & WY) provide case counts, but no demographic breakdowns on state-run websites.
9 states (AK, AZ, MO, NE, NH, OK, PA, VT, & WV) and Puerto Rico report data directly to the CDC with no reporting on state-run websites.
1 state (NV) currently has a reporting dashboard under construction
It was heartening to see that roughly half of the jurisdictions in the U.S. (when including the U.S. territories) provided relatively thorough demographic reporting. This is likely because the data dashboard systems for reporting real-time disease surveillance were already purchased and in place as a result of tracking implemented to report COVID-19 data. 28 states provide some level of demographic reporting, and almost all of those states provide reporting on race.
There are still, however, significant gaps in these data. For example, Florida—one of the most racially diverse states in the U.S.—provides no demographics broken down by race; only by age. This lack of reporting presents a significant barrier to advocates, providers, and legislators because it homogenizes the results. If we are unable to see which populations are disproportionately impacted by MPV—or any disease, for that matter—then how are we to deliver data-driven public health interventions?
An additional issue exists with states’ decisions on how and where they account for Hispanic populations. While some states include “Hispanic” as a separate race category, others treat it as an “Ethnicity” that overlaps multiple race categories. While the latter classification is technically correct—there are Black and White persons who are also Hispanic—this creates a data issue that makes comparing data across states difficult.
In the states with state-level demographic reporting, Black Americans account for a majority of new MPV diagnoses in eleven states (AL, AR, GA, LA, MD, MI, MS, NC, SC, TN, & VA). Of those states, nine are located in the American South, all of which rank in the top ten states with the highest number of Black residents as a percentage of their states’ populations. As an example, in Alabama, Black Americans constitute 26.5% of the state’s population but account for 71% of MPV diagnoses (Alabama NEDSS Base System, 2022). Similarly, in Georgia, Black Americans constitute 32% of the state’s population but account for 77% of MPV diagnoses (Georgia Department of Public Health, 2022).
This is not the case, however, in every jurisdiction. In California, New Jersey, and New York state, Hispanic Americans represent the majority of new MPV diagnoses, as well as in New York City, which is counted as a separate jurisdiction from New York state. Additionally, in Colorado and Massachusetts, while Hispanic Americans do not account for the majority of new diagnoses, they do account for a significantly greater percentage of diagnoses than Black Americans living in those states. In Colorado, Hispanic Americans constitute for 22% of the state’s population but account for 34.8% of MPV diagnoses (Colorado Department of Public Health, 2022). Similarly, in Massachusetts, Hispanic Americans constitute 12.8% of the state’s population but account for 31% of MPV diagnoses (Massachusetts Department of Public Health, 2022).
Unfortunately, in the United States, case surveillance is set at the state level, with each state determining what diseases they track, how they track them, and how they report them. This system, while protected under the 10th Amendment, is more of a liability than an asset. By leaving these decisions in the hands of states, they are infinitely more subject to political machinations by anti-science legislators than were these decisions to be placed under the purview of the Department of Health and Human Services.
Further complicating the inefficiency of our nation’s myriad surveillance systems is that state departments of epidemiology and surveillance must be adequately funded to perform these duties—a feat that, at least at the state level, is becoming less likely given the political makeup of their legislatures. One of the unfortunate impacts of the COVID-19 pandemic’s stellar state-level reporting was that certain political factions have determined that disease surveillance is political, rather than factual; that the science is not to be trusted, because the science is “biased.”
An example of this occurred in West Virginia, in 2021, when state and local legislators, in a public hearing, informed Dr. Demetre Daskalakis, then Director of the Division of HIV/AIDS Prevention at the CDC, that they did not believe him when told that West Virginia’s outbreak of HIV among Persons Who Inject Drugs was worse than in New York City (Peace, 2021). In response to his assertion, the Kanawha County Commission demanded that Senator Joe Manchin submit a congressional inquiry with the CDC to question the validity of his statements (Raby, 2021). This was not an isolated incident; state legislators in Conservative-run states have consistently disregarded and even demonized basic scientific data reporting as if it were a conspiracy against them.
As a result of this increased, and yet paradoxically incurious, scrutiny of disease surveillance, some states are choosing to decrease or drastically cut funding to those departments. And the stark reality is that this trend is likely to get worse before competent heads prevail. In response to what members of one political party have consistently referred to as “government overreach,” at least 20 Conservative-run states used their 2021 legislative sessions to enact new laws that “…preclude the use of proven public health measures or more broadly constrain the authority of state and local health officials, and governors, in a public health crisis” (Vestal, 2021). This means that, even with targeted federal funds, state departments of health and local health officials may be constrained in what they can legally do at the state level. Worse still, many of those state legislators have created committees designed to identify “misspending”—a thinly veiled code for “work we find objectionable”—and to slash budgets to ensure that the “overreach” cannot be implemented, again.
What patients, providers, and advocates can do is reach out to their state and federal legislators to advocate for greater funding specifically for surveillance, and to request that those funds come with stipulations for how they can and cannot be used and when they must be disbursed, so that states do not allow those funds to languish in interest-bearing accounts rather than spending those funds. Additionally, readers can reach out to their states’ departments of health to request that they improve the availability or make available demographic data that are broken down into useful categories that can be turned into direct action to address any disparities these data may identify.
The quest to improve the quality of our data is going to require both federal standard setting and the funds to implement them. Let’s make it happen.
References
Alabama NEDSS Base System. (2022, November 01). What You Need to Know About Monkeypox in Alabama. Alabama Department of Public Health. https://tableau.adph.state.al.us/views/MPXFINALusingextractallsheets/MPXPublic?%3Adisplay_count=n&%3Aembed=y&%3AisGuestRedirectFromVizportal=y&%3Aorigin=viz_share_link&%3AshowAppBanner=false&%3AshowVizHome=n
Centers for Disease Control and Prevention. (2022, October 26). Monkeypox Cases by Age and Gender, Race/Ethnicity, and Symptom. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: Poxvirus: Monkeypox. https://www.cdc.gov/poxvirus/monkeypox/response/2022/demographics.html
Colorado Department of Public Health. (2022, October 26). Colorado Monkeypox Data. Colorado Department of Public Health: Diseases A to Z: Monkeypox. https://cdphe.colorado.gov/diseases-a-to-z/monkeypox
Georgia Department of Public Health. (2022, October 26). Georgia Monkeypox Situational Report – October 26, 2022. Georgia Department of Public Health: GA Monkeypox Outbreak Cases and Vaccination. https://dph.georgia.gov/document/document/mpx-situational-report-october-26-2022/download
Massachusetts Department of Public Health. (2022, October 27). Monkeypox Cases and People Vaccinated by Age, Sex and Race/Ethnicity. Massachusetts Department of Public Health: Bureau of Infectious Disease and Laboratory Sciences: Monkeypox. https://www.mass.gov/doc/weekly-report-monkeypox-cases-and-people-vaccinated-october-27-2022/download
Peace, L. (2021, February 11). The CDC says Kanawha County’s HIV outbreak is the most concerning in the United States. Mountain State Spotlight. https://mountainstatespotlight.org/2021/02/11/the-cdc-says-kanawha-countys-hiv-outbreak-is-the-most-concerning-in-the-united-states/
Raby, J. (2021, April 06). CDC inquiry sought on HIV outbreak in Kanawha County. The Parkersburg News & Sentinel. https://www.newsandsentinel.com/news/local-news/2021/04/cdc-inquiry-sought-on-hiv-outbreak-in-kanawha-county/
Vestal, C. (2021, July 29). New State Laws Hamstring Public Health Officials. The Pew Charitable Trusts. https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/07/29/new-state-laws-hamstring-public-health-officials
Criminal Counterfeits Threaten Patient Safety
In February 2021, a patient in New York City opened a sealed bottle of the HIV drug Biktarvy, took his pill, and found that he couldn’t walk or speak. The medicine in the bottle was actually Seroquel, an antipsychotic that can cause dangerous sedation and poses additional risks for patients with high blood pressure, diabetes, or low white blood counts. This patient’s experience reflects a worrying uptick in financial fraud, counterfeiting and drug diversion in the HIV medicine world since 2019. Read on to learn about recent court cases that shed light on the problem, and it threatens HIV patients.
Forged documents helped sell tens of thousands of bottles of questionable HIV meds
Between February and April 2021, at least eight different patients found Seroquel, the wrong HIV treatment or, in one case, over-the-counter painkillers, in what appeared to be factory-sealed bottles of Biktarvy or Descovy. The Janssen Pharmaceutical Companies had warned about a similar issue in December 2020, when bottles labeled Symtuza turned out to contain Seroquel or Prezcobix, a different Janssen HIV treatment which contains half of Symtuza’s active ingredients, and won’t, by itself, control a patient’s viral load.
After investigating, Gilead Sciences and Janssen filed lawsuits against more than 70 defendants, including licensed distributors and pharmacies, who allegedly sold unsafe versions of HIV drugs acquired in nefarious ways. They used a variety of methods to get perfect looking bottles, including buying them at the street level from HIV patients who needed money. According to court papers and investigative journalists, the medicine the alleged criminals sold was unsafe: some bottles contained the wrong pills altogether, some were no longer factory-sterile because they had been opened and resealed, and all of them came with forged documentation. According to Gilead, the ring made hundreds of millions of dollars by putting more than 85,000 fake bottles of its products on pharmacy shelves over a two-year period.
Florida HIV prevention medicine assistance program bilked of $68MM
In May, Gilead Sciences settled a lawsuit it filed in November 2020 to stop a scam run by 58 Florida-based clinics, pharmacies, labs and affiliated individuals. According to Gilead’s complaint, the defendants hired van drivers who visited sites like soup kitchens, public libraries, bus terminals, and churches to offer homeless and low-income people money to sign up to receive PrEP, which helps prevent HIV infection, through the program, regardless of whether PrEP was an appropriate treatment for them. Sometimes, after patients received the medicine they had never wanted, the drivers bought it back so that it could be resold into the black market. More than $68M of assistance was diverted from patients who actually needed help paying for their medicine and the scheme provided an avenue for more mishandled, secondhand and potentially expired medicines to reach patients.
Another $230MM in black market HIV drugs slipped into U.S. pharmacies
In June, the Justice Department (DOJ) indicted a Miami man for his alleged role in distributing $230 million in HIV drugs he had acquired illegally. According to the DOJ, he and his co-conspirators established licensed wholesale drug distributors in four states and used them, with false documentation, to sell the medicines at a discount to other co-conspirators running distribution companies in Mississippi, Maryland, and New York. Ultimately, those treatments reached pharmacies, and patients across the country.
We’re likely to hear more about rings like this; according to the Wall Street Journal, the Department of Justice launched a criminal investigation that involves products from at least 12 drugmakers.
Resold and diverted drugs threaten patients
Patients in the early years of the HIV/AIDS epidemic pooled resources to share medicines with those who could not access new treatments. No one could ensure that those drugs were safe and effective, but community action was critical, and it saved many lives. These days, regulated, safely manufactured HIV medicines are available through public and private insurance and through assistance programs. By steadily controlling viral loads, these drugs help people live long, healthy lives.
These medications only work, however, if patients take the right pills with the right ingredients all the time—and there’s no way to ensure that that’s happening if black market drug rings are breaking into the drug supply. In these cases, vast networks of drug diverters and counterfeiters are enriching themselves while endangering the lives of people living with HIV/AIDS, and they must be stopped.
The scale of these crimes—committed in the last three years— is staggering. The last major drug counterfeiting charge was pegged at around US$80mm, and just this year we’ve had three cases, each one of them around that size or larger. While law enforcement and brand protection attorneys are actively using every last civil and criminal option to protect patients, patients can also take steps to protect themselves using the tips in HIV survivor Brandon Macsata’s recent PSA about counterfeits. PSM urges all HIV patients to take two minutes to learn how to stay safer.
Of Pride and Prejudice: Biden Administration Combats State Discriminatory Actions
Fairly regularly, our CANN Blog tends to highlight impacts of various public health actions as they relate to LGBTQIA+ populations because these communities are disproportionately impacted by a variety of social determinants of health as found in the 2015 United States Transgender Survey, conducted and published by the National Center for Transgender Equality (NCTE). It’s important to note, NCTE will be launching data gathering efforts later this year to provide updated data. Public health programs have long been leveraged to either help or harm (often via neglect of data pointing toward broader protections and specific programming) trans and non-binary people, depending on the ideological lean of the administration issuing regulations and rules, both on the federal and state levels.
2022 has been particularly challenging for transgender youth. We’ve witnessed state legislatures and governors through administrative agencies have sought to limit access to gender-affirming care. There remains deep community concern, despite some governors vetoing sports and health care related bills, judges regularly ruling against these actions, a lack of clear political support, and commitments from the Biden Administration to defend the rights of transgender people. These actions, however, aren’t just limited to transgender youth. Florida, for example, is currently proposing a rule that would prohibit the state’s Medicaid program from covering gender-affirming care for anyone, again, despite similar rules and laws having been struck down as recently as November 2021. (Editor’s Note: Florida’s rule, by the way, is open to public comment through July 8th.) Advocates for equitable access to care in public health programs and concerned on issues of health equity should readily take the time to comment. Public comment on state and federal rulemaking is a key element for policy engagement and can sometimes be used to reflect bad faith efforts on the part of these regulatory agencies, as was seen when Kentucky’s Medicaid work requirement waiver was initially squashed for failing to adequately address concerns raised in public comments.
In response to these moves, the Biden Administration has issued new executive orders including directing various agencies to assess more appropriate data gathering of sexual orientation and gender identity (SOGI) data of people participating in federally funded programs. Additionally, Biden has directed federal agencies to review existing data for information on when LGBTQIA+ youth and parents are separated from their families in child welfare matters, and issue rules to both define discrimination and protect LGBTQIA+ people from discrimination in federally funded programs. Indeed, on June 23rd, the U.S. Department of Education released a proposed rule that would extend certain protections for transgender students and seeks to further protect sexual assault and harassment victims in educational settings. An additional rule is expected later this year which would provide guidance on integrating transgender youth into school sports. We’re also still awaiting – any day now – the U.S. Department of Health and Human Services issue a new proposed rule regarding the Affordable Care Act’s non-discrimination provision known as Section 1557. The Trump Administration sought to narrowly define these protections in 2020, but it was blocked shortly after the U.S. Supreme Court issued its decision in Bostock v. Clayton County when a federal judge ruled against the Trump Administration after noted health clinic Whitman Walker sued to stop the discriminatory rule from going into effect.
These state efforts are aimed at finding “carve outs” to the precedents and rules protecting transgender people from stigma, violence, and discrimination merely as a political tactic. But just because this population is being used as a political football, doesn’t mean there aren’t severe public health consequences, some which may reach beyond the issue of gender identity. “Trans health is the canary in the coal mine,” a long-time advocate, Riley Johnson, said to me when discussing Florida’s effort to limit access to gender affirming care in its Medicaid program. “Once they can redefine ‘medically necessary’ to mean whatever they want it to mean, despite standards of care, every legitimate medical association, and decades of data, who’s to say they don’t decide to re-define ‘medical necessity’ for people living with HIV or STIs or hepatitis C, and return us to the days of moralistic ‘you did this to yourself’ or ‘it’s a choice’.” Johnson continued, “It’s real easy to look at substance users and decide their care doesn’t matter when we’re looking for reasons to justify the cruelty of denying people life-saving care.”
Johnson is correct in highlighting how bias-driven rulemaking affecting public health programs turns into a slippery slope. Experienced advocates should be mindful of intersecting issues of public health and encourage those budding advocates to take advantage of these…interesting times to build their knowledge, engage in policy development and evaluation processes, and invest in strengthening the public health advocate pipeline.
ADAP Advocacy Association Resumes Fireside Chat Retreats
The Community Access National Network (CANN) celebrated the return of ADAP Advocacy Association’s (aaa+) “Fireside Chat” retreats after a two and a half years pause, due to the COVID-19 pandemic. CANN has regularly participated in the Fireside Chats since their inception and enjoys a robust partnership with our sister organization aaa+. The event, held in Wilmington, NC, featured 23 stakeholders, including patients, advocates, and manufacturer representatives and discussed the issues of “utilization management”, the status of Ending the HIV Epidemic (EHE) plans and activities in the South, and the overall impact of the COVID-19 pandemic on public health.
Recognizing current COVID-19 transmission and community level trends, aaa+ developed a robust self-administered testing protocol, wherein participants tested prior to travel, upon arrival, and after returning to their home areas. aaa+ provided rapid self-test kits to each of the attendees. The idea here is important to note, in part, because a chain of transmission was indeed interrupted when one planned attendee reported a reactive test result from their test upon arrival, despite having had a nonreactive test result from their pre-travel test the day before. As a result, the person affected did not actually attend any sessions and appropriately self-isolated. Other attendees expressed gratitude for the reduction of risk, respect of their health and the health of attendee household members, and wished the person affected a speedy recovery. Truly, gathering safely can be done and done well, as demonstrated by aaa+’s efforts here.
Prevention Access Campaign’s United States Executive Director, Murray Penner, presented the issue of payer “utilization management” affecting people living with HIV and AIDS (PLWHA), with respect to broad issues of health care and specific to AIDS Drug Assistance Programs (ADAPs). Opening commentary reminded the audience that utilization management practices affecting health other than HIV also affects access to care for PLWHA and, in some cases, where care or coverage is denied may also result in a patient disengaging from their HIV-specific care. Conversation also discussed utilization management affecting access to pre-exposure prophylaxis for the prevention of HIV (PrEP), in the context of generic antiretroviral (ARV) products, barriers to accessing new products, as a benefit of reducing unnecessary medical tests and preventing contraindicated care. Patients and advocates readily shared how utilization management being a barrier to care is not an “outlier” situation in which patients being denied medically necessary care only occurs in “rare” occasions, rather this is a frequent occurrence with these payer practices routinely and regularly require additional administrative burdens to be met and sometimes requiring circumstances contraindicated by the Food and Drug Administration’s (FDA) approved indications for products or services. Advocates pushed back against the idea “you just want the latest drug like you want the latest iPhone” by emphasizing how the fight against HIV will not be won by having disparities in access maintained along lines of who can afford the most “elite” health care plans. Discussing how advocates can leverage state planning bodies and the role public payers could play in directing managed care organizations to reduce barriers to care as presented under utilization management practices, attendees envisioned robust yet protective access to care aimed at addressing issues of health equity and the critical role of payers in Ending the HIV Epidemic. Attendees also suggested evaluating utilization management practices under a lens of the Affordable Care Act’s rules against “discriminatory plan design”.
A lovely networking lunch followed the first discussion and attendees got the chance to bond with others they had yet to meet or reconnect with those they haven’t seen in a while. Honestly, the amount of respect and joy had during the lunch filled the room, with discussion of other areas of interest and even raucous laughter could be heard from the hallway. The energy generated from the first discussion was readily palpable.
The second discussion, lead by Community Education Group’s Director of Regional and National Policy, Lee Storrow, lead the second discussion on the status of Ending the HIV Epidemic in the South. In providing context for the update, advocates discussed their hopes and expectations when EHE had been announced under the Trump administration. While much energy had been generated, and that in and of itself is exceptionally valuable in the context of the 40-year fight against HIV, the “significant resources” advocates expected have not materialized and the addition of yet another plan has further complicated already layered reporting burdens for service providers funded under Ryan White and other HIV related initiatives and governmental funding streams. One attendee remarked “we’ve been doing the same thing for 30 years and the last 10 haven’t progressed, it’s time to do something different.” As a response, discussion moved to develop planning and programming to include the lens of “economic empowerment” of PLWHA by way of employment opportunities generated from these programs being targeted to recruiting staff from affected patient populations and served zip codes. Another attendee discussed how such an opportunity elevated her own professional experience and helped ensure her program better reflected the demographics of affected communities – ensuring better engagement and more effective outreach in her area. Attendees discussed the idea behind EHE as a “moon shot” but really seems to be hindered by the lack of cohesive systems communication across public health programs, in particular with data sharing between Medicaid and Ryan White funded programs in various states. This highlighted opportunities and barriers, manifesting in strategic planning on what cohesive data sharing might look like in an ideal. The session ended with conversation regarding “gatekeeping” among certain advocate circles when it comes to accessing institutional and governmental power and a certain lack of transparency as to exact “who” decision makers are due to bureaucratic processes, with the final note being “where is the red tape and who has scissors?”
The first day of planned discussion was capped with a dinner in which attendees continued to share with one another personal and professional details and ideas, making plans to socialize, discussing advocacy development opportunities, upcoming concerns regarding court ruling, legislation, and regulation, and programmatic planning within each other’s specific entities. The theme being “how can we help each other succeed?”
The second day of discussion held the final topic, COVID-19 impacts on public health, facilitated by CANN’s chief executive officer, Jen Laws (me). I opened the conversation by sharing the goal of the conversation being to “define” the impacts of COVID-19 on public health infrastructure and programs. Attendees were asked to share one “good” thing to come out of our collective response to the cOVID-19 pandemic and one “bad” thing (or “something we would like to go away”). Many attendees celebrated the innovation of flexibilities offered by various temporary governmental regulation and the “forced modernization” of health care in many situations – namely, telehealth. These flexibilities, including the continuous coverage requirement for Medicaid programs under the public health emergency declaration, are threatened to end as the public health emergency winds down and advocates attend the Fireside Chat expressed a certain foreboding of returning to “normal”. Specific highlights were given to the downside of relying on telehealth, especially for rural communities lacking the necessary infrastructure to make health care accessible – particularly in hospital deserts. Attendees reflected on the data “blindness” of the current moment, noting the Centers for Disease Control and Prevention’s (CDC) 2020 HIV surveillance report lack of completeness compared to previous years. “Bill Arnold reminded me frequently that the AIDS crisis is still just around the corner. We can’t blink,” I shared with the group to many nods as concerns for patients who dropped out of care weighed on the moment. Moving the discussion forward, attendees identified methods of advocate development and influencing state and federal power by more readily engaging manufacturers in their efforts to prioritize patient voices and experiences. The necessity to recognize the state of advocacy as needing re-development and investment was apparent and the note the event ended on, as attendees reflected the impacts of the COVID-19 pandemic on the public health and advocacy workforce.
While much discussion was had throughout the Fireside Chat, much more was committed to following the event. As with many in-person events, as opposed to virtual events, the quality of the experience was not absent on anyone there. It felt good to be in the physical presence of one another. We sought and gained inspiration and enthusiasm and we do so with clear cognizance of COVID-19 as a risk. If advocates and our partners can continue to similar efforts that both keep us safe and connected, the future (not without its challenges) is bright, equity-focused, empathic, and patient-driven.
Misinformation: An Ever-Growing Public Health Threat
Author’s note: For good reasons, the terms “misinformation” (those ideas which are slightly distorted) and “disinformation” (ideas which are contrary or contradictory to actual fact) are distinct. However, for the purposes of public messaging, these terms are often interchangeable so as to not collide with natural defense mechanisms of an audience. Similarly, for this blog, the terms will be used interchangeably.
There’s no two ways about the issue of health misinformation – politely, a term to describe conspiracy theories which range from moderately frustrating and lacking factual evidence to downright deadly. On the issue of public health measures and mutual community investment into one another’s health outcomes, the issue grows exorbitantly.
Before we move forward – the issue of gun violence is both a public health issue and a humanitarian one. Like abortion and gender affirming care, the issue of gun violence is not an area of expertise I possess and the analyses provided in these blogs are specific to policies and programs affecting HIV, HCV, and substance misuse. However, we cannot move on without directly addressing the role misinformation is playing right now as families grieve the loss of their children as a result of another school shooting. Within mere hours after the shooting made national news and before even the full count of children murdered had yet become clear, misinformation, driven by conspiracy and bias regarding the shooter’s identity was already proliferating across social media. Indeed, the idea which falsely linked multiple transgender women to the shooting was touted by Representative Paul Gosar. These actions have already resulted in a trans woman being assaulted in Texas.
This isn’t new. The problem of misinformation around COVID-19 had already grown so significant by the time President Biden named a Surgeon General, one of Dr. Vivek Murthy’s first acts as Surgeon general for this administration was to issue an advisory warning of the personal and public health dangers of misinformation. In addition to the issue brief accompanying the advisory, the Surgeon General’s office now maintains an information page for various stakeholders, including individuals. Yet and still, even two years into this pandemic, where incredible feats of science – like producing a viable vaccine within twelve months of an initial outbreak – have occurred, people so well-regarded as to be elected to federal and state offices are either outright shouting flagrant falsehoods or calmly suggesting COVID-19 vaccines cause AIDS, like Senator Ron Johnson did earlier this month. The seed of doubt and big bad scary things are the things of nightmares and in the absence of easy to access, easy to understand, and static answers, there are people willing to consider these nonsensical leaps as valid possibilities.
None of this is new for folks navigating HIV misinformation or stigma. The problem of misinformation around HIV isn’t some far off issue that we don’t need to concern ourselves with domestically, indeed it thrives today in the backyards of “every day Americans”. The most pernicious idea being “HIV is over” seconded only by the moralizing ideas around “who” gets HIV – that such a diagnosis is somehow a justified punishment from “God” rather than the end result of a negligent society so infected with layered biases as to not acknowledge that racism (not race), misogyny, homophobia, ablism, and every other moral and ethical rot has driven those most in need to also be those most at risk. Hate and misinformation so often leaves “disproportionately impacted communities” so “vulnerable” the Centers for Disease Control and Prevention (CDC) has a whole segment of their website and millions of dollars in programming aimed at reducing HIV stigma.
Part of the issue lies with a lack of digital literacy, an undying effort for fragile egos to leverage fear and their own ignorance for pitiful power grabs, and a near tangible disgust lobbed in response to casual conversation going just a bit sideways – tribalism at its best, as it were. Misinformation and conspiracy theories thrive when people are afraid and looking for answers that are easy to grasp and never change and the idea that things would never change once investigated is, at its roots, anti-science. The nature of science is to explore and challenge assumptions, test theories, and change our ideas based on the results. Regardless of what one thinks of themselves, reading an article about a study or even ten articles about a dozen studies isn’t “research” – it’s not even a literature review – and the fact that we as a society cannot come to agree on what defines a “fact” or “research” or release a desire to exclaim “expertise” in an effort to save an ego is deadly.
I’m a giant fan of librarians, the last great defenders of knowledge at every turn in history, and the attacks on their profession are as dangerous, in general, as they are to public health, in specific. Ultimately, librarians are the ones who end up teaching us how to navigate conflicting information and maintain the humility that is necessary to fight this moment – no question is dumb, asking for help is a super power, and being able to admit when you’re wrong is next to Godliness.
As state capitols across the country grapple with the likes of Robert Kennedy Jr. showing up exploit people’s fears, it is the duty of advocates across all issues to urge our political leaders to not indulge in conspiracy and misinformation, to show some kindness to our audiences who are coming from a very reasonable sense of being afraid of what it might mean if COVID-19 really is with us forever, and work to find that common ground we all proclaim to fight for:
We all want the same things for ourselves and our families; a safe place to call home, a good job that pays the bills, and a sense of happiness and peace. In the meantime, those with the power to influence policy also need to be advocating for meaningful funding in both public health and public education.
Community Roundtable Defines the Shape of Public Health Advocacy Amid COVID-19
Last week, Community Access National Network (CANN) hosted its annual Community Roundtable event, like last year, focused on the impacts of COVID-19 on public health programs and patient advocacy around HIV, viral hepatitis, and substance use disorder. CANN’s President & CEO (your’s truly) was joined by Kaiser Family Foundation’s (KFF) Director of LGBTQ Policy, Lindsey Dawson, and Georgetown University’s Katie Keith. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmaceutical companies, and federally or state funded service providers. The virtual event was sponsored by ADAP Advocacy Association, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and ViiV Healthcare.
I welcomed attendees, noting my own professional admiration for both Lindsey and Katie, as experts leading in education on policy issues and data analysis around issues affecting communities highly impacted by HIV, viral hepatitis, and substance use disorder. Prior to co-presenters introducing themselves, audience members were reminded both KFF and Georgetown University are both non-partisan, education entities. The impetus and aims of this year’s event in including these astounding co-presenters was to help define the ecosystem of public health affecting programs particularly serving patient communities CANN serves.
Lindsey’s presentation offered a “potpourri” of relevant data regarding AIDS Drug Assistance Programs and Ryan White Funding stagnating, tele-PrEP, the federal Ending the HIV Epidemic (EHE) initiative, Medicaid programs, and LGBTQ people’s health outcomes (especially mental health) throughout the pandemic thus far. Reviewing previously published KFF data and briefs, Lindsey reminded attendees that federal appropriations for HIV programs have largely stagnated for more than a decade and, when adjusted for inflation, have fallen. Despite the federal EHE initiative, seeking to jump start the country’s stagnating HIV progress, does not meet the funding requests of advocates. Large doubt remains as to exactly how much can be done with how little has yet to be given. For good reason, the audience was asked to consider if the existing roadmap is the “right” roadmap and what EHE might need to look like in the coming years in order to meet the goals of the initiative. Lindsey reminded attendees that 36% of PLWH live in Medicaid non-expansion states, including Georgia (which just last week shut down a proposal to expand the state’s Medicaid program to PLWH under a waiver). Moving onto a particular point with regard to access to care, tele-PrEP program successes (and weaknesses) could be attributed to flexibilities which have been the direct result of early policy answers to COVID-19. These flexibilities are among policies patient and provider communities stand to lose when the public health emergency comes to an end, unless legislators take action. Wrapping up her presentation, Lindsey drew attention to the health outcomes affecting a highly impacted patient population, LGBTQ people. Data from KFF showed LGBTQ people were more likely have received a COVID-19 vaccination series, more likely to consider COVID-19 vaccination a duty to community and others in an effort to help keep healthy, and more likely to have experienced negative mental health outcomes as a result of the pandemic.
I followed Lindsey’s presentation discussing the landscape of patient advocacy in the age of COVID. Recognizing COVID-19, despite any sentiment of the public at large, is not “over”. Considerations regarding in-person attendance to events, meetings, and travel are still in flex. Also recognizing the political landscape has significantly soured relative to “public health” in general, even if not to HIV, viral hepatitis, and substance use programs specifically, and that dramatically impacts both court rulings and legislators’ willingness to consider the crucial role “legacy” public health programs play in maintaining the health of the nation. Cautioning against potential neglect, rather than support (so much for the “heroes” of the early epidemic), I reminded audiences of the power of in-person events and the need to weigh precautions and monitoring of COVID transmission metrics when planning in-person events, regardless of how big or small they may be. Further on, the presentation focused on the structure of effective advocacy via storytelling, personalizing experiences, providing supporting data to make those personal experiences tangible among a constituency, defining an “ask” by knowing the mechanisms of action (re: actionable policy), and readily recognizing the powers, humanity, and limits of an advocate’s audience.
The final presentations, provided by, Katie Keith, reviewed historical and anticipated policy changes, including those relative to the Affordable Care Act (ACA) – specifically, the family glitch and section 1557 – and those as a result of early COVID-19 legislation, much of which is quickly coming to the end of their legislatively defined program periods, either by specified date or by way of ending the federally declared public health emergency. Katie reviewed how the Biden administration approached some of these issues upon transition to power, having already met 8 of the policy requests of advocates, have yet to meet 4 of those requests, and at least 1 request was “in progress” with potential for administrative resolution any day now (section 1557 final rule re-write, specifically defining the edges of the ACA’s non-discrimination protections. Katie also briefly discussed how the Dobbs (abortion) ruling may impact domestic public health programs, urged attendees to watch Kelley v. Becerra, and urged advocates to closely watch the 2022 midterm elections as legislators have an unbridled ability to impact public health programs.
Panelists wrapped up by reminding attendees they and their organizations remain a readily available resource. The slide deck can be downloaded here.
Biden’s State of the Union: Bold Promises on Public Health
On March 1st, President Biden delivered his first State of the Union Address to both chambers of Congress and the American people at large. Amid a slew of foreign and domestic policy proclamations, particular attention should be afforded to the statements and commitments made about addressing the COVID-19 pandemic and public health, more broadly. Championing the landmark legislation that was the American Rescue Plan, the President laid out how the legislation’s programming reduced food pantry lines, increased employment, and how expansion of the Affordable Care Act’s subsidies resulted in lower insurance premiums for many Americans. In addressing the COVID-19 pandemic, Biden also recognized a sobering outcome that will shake the nation: within the next few weeks, the United States’ official COVID death toll will surpass one million people. Though the President misstated the moment in that those empty seats at dinner tables will be more than a million; on average each COVID death has impacted 9 other people, including orphaning children across the country. Biden then shifted the address, citing the Centers for Disease Control and Prevention’s recent announcement of adjust masking guidelines and metrics of risk, trying to signal a much-needed political win in the fight against COVID. However, immediately following these statements, the President also focused on providing the country with another round of free at-home COVID-19 tests and implementing a tactic already well-known in the HIV space: test-to-treat, with added bonus of the program following the COVID vaccine model and having no out-of-pocket expense for patients.
The program ideals outlined in the days that followed found some confusion, need for clarity, and even some professional association bickering. Public health professionals who have long advocated for more robust responses to the pandemic took to news outlets to vent their frustrations and the American Medical Association drew derision on social media for their statement discouraging pharmacists prescription and provision of COVID antivirals. Pharmacists have long been a target for HIV advocates, especially in terms of increasing pre-exposure prophylaxis (PrEP) access and decreasing test to treat initiation delays. Wouldn’t it be nice if this COVID program provided a model outside of vaccination in which pharmacists could also serve a more robust role in facilitating seamless treatment and prevention? The meaningful hiccups the administration and advocates should keep a close eye on in this regard is the labor shortage of pharmacists, closing of more rural locations for chain pharmacies, and any developments around anti-competitive practices of pharmacy benefit managers (PBMs) associated with pharmacies. Consequences of these will extend beyond immediate COVID programming and ideal HIV programming.
The President also made statements referring to medication costs and price controls and needing to make sure more Americans could afford their care. However, details were lacking and if any recent effort is indicative, singularly focusing on manufacturer list prices won’t address patient costs or get much anywhere. Buyer beware, some proposals in the apparently sunk Build Back better legislation would also cut provider compensation in public payer programs, a dire consequence as the nation struggles with health care staffing shortages. Those shortages should be noted in detail because the American Rescue Plan provided funding meant to supplement the financial demands of staffing a pandemic and there’s good reason to suspect administrators, rather than providers, enjoyed the fruits of that labor. Further, most Americans experience their out-of-pocket costs of care due to the benefit design of their insurer (and PBM), not the manufacturer list price. Indeed, the Biden Administration appears to eb as insurer friendly as the Obama admin. To impact the costs facing patients more meaningfully at the pharmacy counter and other burdens in accessing medication, the Biden administration should focus more on developing patient protections via the regulatory process, limiting the aggressive utilization management (or deny-first coverage) policies, increasing formulary restrictions, and discriminatory plan design. Some of the tools for doing so already exist, but the federal government has yet to curb the tactics of payers in avoiding their responsibilities under the ACA’s medical-loss-ratio rules or ensure payers are not inappropriately applying cost-sharing for qualifying preventative medications and services.
The President also became the first to mention “harm reduction” in a State of the Union Address. Urging Congress to pass the Mainstreaming Addiction Treatment Act (MAT Act), President Biden is seeking to fulfill his commitments to address the opioid epidemic and move toward modernizing domestic drug policy. In a sign of acknowledgment of the scope and size of substance use epidemic in the country, Biden endorsed recovery programs and recognized the more than 23 million people struggling with addiction in the country. Immediately following the MAT Act mention, the President moved on to address of a lesser defined but equally important need in encouraging commitment to a robust set of policy ideals aimed at meeting the mental health needs of the country.
All these good things can easily be outweighed by what wasn’t mentioned. President Biden did not mention any interest in extending another round of stimulus payments, despite the program resulting in one of the largest reductions in poverty in US history. And while there was focus on rebuilding the nation’s health care staffing, no mention was afforded to rebuilding the nation’s public health infrastructure. Meanwhile, we’ve known for quite some time poverty as a notable association with HIV and decreasing poverty also decreases HIV risks and prevalence, data remains in the decline with regard to HIV and STI screenings, Hepatitis C rates are still on the rise, and inconsistencies in PrEP usage during the height of initial COVID waves likely foretells a more diverse at-risk community. Even the government’s own HIV.gov webpage dedicated to the State of the Union fails to mention any HIV or HCV specific programming efforts associated with the address.
While there’s much to celebrate about the President’s COVID goals, advocates should be cautious about projecting those goals onto other public health efforts. Afterall, COVID proved we could provide more up to date reporting than the 2 year delays we typically see in HIV and HCV surveillance, but we haven’t. COVID-related telemedicine expansion was welcomed by patients across the nation but Congress is poised to claw back those gains. For many of us, while the state of the union is improving coming out of the Omicron wave of the COVID-19 pandemic, much work remains. Including reminding this administration that it is empowered to protect patients, access to and affordability of care, an obligation to invest in public health programs beyond COVID and has committed to advancing efforts to End the HIV Epidemic.