Special Interests Favor S.4395, but Patients Oppose It...Here's Why

This blog post is a collaborative piece, co-written by Brandon M. Macsata, CEO of ADAP Advocacy Association, and Jen Laws, CEO of Community Access National Network.

The very first words of the Ryan White HIV/AIDS Treatment Extension Act of 2009 read, “An Act to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS.” These words reflect the true legislative intent of the Act, which is to provide life-saving care and treatment for people with HIV/AIDS (PLWHA). For over thirty years, these words have represented a contract between our government and PLWHA, reflecting a commitment to patients. The Ryan White HIV/AIDS Program (RWHAP), as the payor of last resort, has literally served as the only lifeline for hundreds of thousands of patients in some of the most marginalized communities. That is why the ADAP Advocacy Association and the Community Access National Network (CANN) have led a national advocacy campaign to thwart any effort to undermine the legislative intent.

A proposed bill, S.4395 (otherwise known as the "Ryan White PrEP Availability Act"), would, for the first time in the 32-year history of this life-saving contract, open the Act to divert programmatic funding from PLWHA to people who are not living with HIV. The legislation is not only ill-conceived, it is potentially very dangerous. The special interests behind this legislation, as well as their inside-the-beltway lobbying tactics, do not reflect the general sense of the much broader HIV patient advocacy community. 

In fact, nearly 100 national, state, and local organizations joined the ADAP Advocacy Association and Community Access National Network in submitting a sign-on letter to Congress expressing the HIV patient advocacy community's collective concerns over the legislation. The sign-on letter was sent to Chair and Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP), Chair and Ranking Member of the House Committee on Energy & Commerce (E&C), and the Co-Chairs of the Congressional HIV/AIDS Caucus. Several of these offices applauded our efforts upon acknowledging receipt of the letter.

David Pable, who has been deeply embedded in South Carolina's patient advocacy community, expressed strong sentiments against the legislation. Pable said, "For almost 20 years, Ryan White has been a lifeline for me, and it was truly the safety net that saved my life. Ryan White-funded medical care, case management, and mental healthcare services have transform my life and the lives of countless others to survive and thrive." Pable's views are shared by nearly all PLWHA who learn about the potential danger lurking behind S.4395.

Over the years, Pable had the opportunity to be involved in many planning meetings for prevention services, including the need for an adequate PrEP program with dedicated funding. According to Pable, never in any of those meetings was it discussed as a good idea to funnel funding from the Ryan White Program to pay for PrEP. "Treatment, care and prevention make up three sides of the triangle," he said. "Together they each hold up the other, but take one piece away to support the other and eventually it will all fall apart." 

S.4395 would authorize the Health Resources & Services Administration (HRSA) to divert already limited resources away from providing care and treatment for PLWHA. The legislation reads, in part, "Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV... drugs and biological products for pre-exposure prophylaxis (PrEP)... medical, laboratory, and counseling services related to such drugs and biological products...and referrals and linkages to appropriate services for the prevention of HIV."

The legislation is extremely ill-advised for numerous reasons. Amending the Ryan White Program (Pub.L. 101-381) would:

• Open-up the law, (which is currently unauthorized) and thus subject it to potentially harmful changes in a hyper-partisan political environment.

• Change the purpose of the law, in that the purpose of the Ryan White Program is serving people living with HIV/AIDS.

• Create yet another access barrier for the approximately 400,000 PLWHA who are not in care.

• Further isolate PLWHA who are already disproportionally impacted by homelessness, hunger, substance use disorder, and undiagnosed and/or untreated mental health conditions.

• Impede Ending the HIV Epidemic's efforts to both increase enrollment and expand services for low-income PLWHA, especially since discretionary funding is already limited.

Unfortunately, special interests continue to push false narratives in their efforts to shove the harmful legislation through the Congress. Probably one of the most egregious claims, “The bill’s intent and text doesn’t take money from people living with HIV.” This is false! 

Indeed, legislative language reads, “To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.” While subsection “B” of the legislation entitles the program as “voluntary” and to not allow federal grant dollars for the use of funding PrEP or PrEP services, it would allow federal grant dollars to be used for referrals – explicitly providing funding for people not living with HIV.

Photo Source: oncnursingnews.com

More concerning, special interests supporting the legislation conflate programmatic revenue as not grant dollars, as a somehow meaningful distinction. There is no difference in this distinction because each funded RWHAP recipient and subrecipient is required under current law to use their programmatic revenue to support providing services included in the grant – for people living with HIV. The design of these programs are significantly dependent on revenues generated from the 340B Drug Discount Program (340B) in order to meet the goals outlined in each of the grants. 

And that gets to the heart of the issue here. 340B's intent was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program, amid much criticism, allows federal grants funding public health programs count on 340B revenues in order to show they can operate a sustainable program.

Let's be clear: S.4395 would divert RWHAP programmatic revenues – including 340B dollars – away from providing services and supports to PLWHA who are living at or below 400% of the federal poverty level (the income threshold for qualifying as eligible for receiving RWHAP funded services). It is important to remember that more than 50% of the patients receiving care from the State AIDS Drug Assistance Program are living at or below 100% of the federal poverty level. More than 250,000 patients, or approximately one quarter of all the estimated people living with HIV in the United States are earning less than $13,000 per year. 

Kathie Hiers, President & CEO of AIDS Alabama argued, "The HIV community needs to get its act together around funding for PrEP.  We have been told by the Director of the Office of National AIDS Policy that our messaging is not cohesive. At AIDS Alabama, we understand that stable PrEP programs are absolutely necessary if we ever hope to end HIV as an epidemic. However, raiding the Ryan White Program to fund prevention is not the answer, particularly as the needs of an aging HIV-positive population continue to grow."

As it stands, gaps in care still remain for too many marginalized communities. It isn't uncommon for patients to fall out of care because they have to prioritize work, or child care, or buying food, or finding affordable housing, or finding transportation. Funding to meet the needs for these patients is already stretched way too thin and the current inflationary pressures have only made things harder for far too many PLWHA. There are tens of thousands of people living with HIV who have no roof over their heads when they try to find a safe spot to sleep tonight.

Photo Source: debralmorrison.com

Robbing Peter to pay Paul is not the solution to funding HIV prevention efforts in the United States. A better option to meet the needs of people who would benefit from PrEP, and that is additional HIV prevention funding. This approach would allow patient choice in medicines and support for ancillary services, provider education and outreach. Additionally, HIV prevention funding could be directed to communities that are most in need of prevention medicines and services, thereby providing more equitable access. This approach would also use and could strengthen the existing HIV prevention infrastructure.

One local health department official (who asked to remain anonymous) in Florida said the people behind the legislation did not understand the nuances between funding for HIV prevention and HIV treatment. We couldn't agree more!

The HIV+Hepatitis Policy Institute's Carl Schmid summarized, "It's not an issue of not wanting clinics that receive Ryan White Program funding to be engaged in PrEP, we think they are the perfect places for PrEP to be delivered. It is an issue of taking funding generated from caring and treating for people living with HIV away from the intended purpose of the Ryan White Program – to provide for people living with HIV. With so many people with HIV living longer, who are not in care or have fallen out of care, you would think that these Ryan White grantees would devote that money to people who are living with HIV, as it was intended."

With more than a decade of science to back the position that effectively treating PLWHA, ensuring viral suppression both empowers positive health outcomes for PLWHA and prevents new transmissions. One of the most startling and, frankly, concerning shifts in the public policy conversation regarding Ending the [domestic] HIV Epidemic is a move away from focusing on the needs of PLWHA in favor of PrEP. The policy issues at hand, including the necessary funding, should not be proposed as an “either/or” situation, but an “and” situation. The same things that make a person vulnerable to contracting HIV are the same things that are killing people already living with HIV. 

While the U.S. Centers for Disease Control and Prevention (CDC) 2020 Surveillance data found 70% of white PLWHA were virally suppressed, only 60% of their Black/African American peers were virally suppressed. Additionally, while the U.S. Department of Housing and Urban Development (HUD) reported a general homelessness rate across the country as about 0.2% of the population, the CDC’s 2019 data found that PLWHA among communities of color were experiencing homelessness at a rate of 11%. It cannot be understated how the power RWHAP dollars hold to address these disparities specifically affecting patients. Failing to do so not only betrays the contract at the center of the legislative intent, it perpetuates injustices levied against our peers, our family, and our community. Raiding precious dollars from this program is nothing short of consenting to the unjust neglect of our communities.

Said Murray Penner, U.S. Executive Director for Prevention Access Campaign: "The Ryan White Program is crucial for people living with HIV, providing treatment and supportive services to keep people healthy and undetectable so they will not sexually transmit HIV. With over 400,000 people living with HIV in the U.S. who are not virally suppressed, there is significant unmet need for additional services. S.4395 would move money out of the Ryan White Program, potentially leaving people without the crucial treatment and services that keep them healthy and prevent new transmissions. Ensuring that the Ryan White Program is fully funded is critical for us to improve the quality of life for people living with HIV and thus improve our country's viral suppression rate and help us end the HIV epidemic."

A cornerstone of the HIV patient advocacy community's success over the last 40 years has been its desire to come together for a common purpose, which has centered around the notion of do no harm! S.4395 and the special interests and inside-the-beltway lobbyists pushing it have failed to meet that test. Raiding Ryan White programmatic funding for PrEP would negatively impact patients. Trying to authorize or amend an already underfunded program, when there is still so much unmet need in its originally intended population, undermines the goals of the program. If we try to be everything to everyone, we will end up failing on all fronts. The powers that be in Congress have assured us that this legislation "ain't going anywhere" this year!

Assessing Cultural Competency

In the ideal, the patient-provider relationship is smooth, easy, and full of trust. The imagery providers and hospitals often use is reflective of this ideal – smiling patients, providers with the warm but professional demeanor of a teacher speaking to a student, and well-lit surroundings. This is not the experience many of us can ever recall having, even when we do have a positive relationship with our providers. In the best of circumstances, our providers don’t always have as much time as we’d like to help explain something and, in the worst, we’re left feeling angry, talked down to, concerns dismissed, and so thoroughly frustrated, we don’t want to ever see a doctor again. These experiences shape the patient experience in similar ways to consumers approaching any other retail situation. The problem is the relationship between patient trust and engagement in care is far more consequential, often doesn’t allow for much choice, and even the smallest fracture in that trust can affect an individual patient for their entire lives – for communities, it can affect the health of generations.

Kaiser Health News recently covered the issue of assessing patient experiences and satisfaction and how issues of cultural competency are not being adequately measured to identify opportunities for improving patient experiences and even potentially tackling pervasive problems like implicit bias. Of particular note, author Rae Ellen Bichell pointed toward a Health Affairs study that evaluated clinician notes for coded language. The results of the study were remarkable with provider language using a negative frame toward Black patients at 2.5 times the rate white patients were described in a negative light. Digging into the nuances of how providers train to manipulate patient responses, how survey results published by the Centers for Medicare and Medicaid Services (CMS) only publish aggregate information rather delineated information which might identify an issue of disparate experiences, and how these surveys do not ask patients questions which would assess cultural competency, Bichell puts a fine point on the need to integrate cultural competency as a measure and tool of health equity. As Dr. Oni Blackstock pointed out earlier this year (and routinely does so in a fashion that providers everywhere should take note of), language matters and reflects how providers view their patients – necessarily reflecting how providers approach their patients’ needs.

These buzz words, “health disparities” and “cultural competency”, have been around for some time, picking up steam and attention as the Biden Administration set goals to address disparities further highlighted by the COVID-19 pandemic. Clinics and hospitals tend to offer “cultural competency” trainings, reviewing the needs of particular marginalized demographics. But these trainings tend to also be cursory, quick, and do not have a functional and effective tool to measure patient experiences. Lacking a complementary assessment tool, these trainings do little more than teach providers what slurs they cannot use when describing a patient, rather than ensuring patients are receiving the quality of care they deserve – the quality of care patients need in order to remain engaged in their own care.

Indeed, a common sentiment in assessing HIV and Hepatitis C programs, especially under the frame of stagnating metrics of success, is the notion that “these patients” are just harder to reach, keep in care. So much so that when reviewing various Ending the HIV Epidemic plans, there’s a very clear focus on testing and PrEP, with retention in care as a priority falling far behind despite scientific knowledge that undetectable equals untransmittable – successful engagement in care for people living with HIV is effective prevention. This frame necessarily puts the burden on patients to be engaged without acknowledging barriers to care and the very responsibility of providers (and their government funders) to assess what providers could do differently to earn the trust of patients.

As much noise been made of providers working to be more culturally competent in care, little has been done to measure that competency from the patient perspective. Lacking that data also leaves us blind as to identifying potential problems in provider approaches. Advocates and providers would do well to consider that “patient-centered” care means the patient perspective and experiences is the most key indicator as to if a patient is actually centered in care. Successful provider-patient relationships are the key to tackling medical mistrust and a critical tool in dismantling the systems that further health disparities.

Overdose Awareness Day Requires Holistic Interventions

August 31st was recognized as International Overdose Awareness Day, with governments and entities around the world observing the annual campaign to “end overdose, remember without stigma those who have died, and acknowledge the grief of the family and friends left behind.” The campaign, starting in 2001 by sally Fin in St. Kilda, Melbourne, is used to highlight the health consequences of overdoses, provide an avenue for those who may be grieving a loved one to do so without external stigma, advocate for policy changes, and educate local communities about the issue. This year, the Biden Administration issued a proclamation, designating August 28 through September 3 as “Overdose Awareness Week” with special recognition of the day and a call to action for the country to “raise awareness of substance use disorder to combat stigmatization, to promote treatment and celebrate recovery, and to strengthen our collective efforts to prevent overdose deaths.”

The Biden Administration’s focus on the overdose crisis is largely centered on shifting the national stature of drug policy from punitive as an issue of moral character to treating substance use disorder as a health issue which mist addressed through social, structural, and medical intervention and not necessarily carceral intervention. This plan has recently been met with some push back, in large part due to the issue of stigma. Remarkably, that push back also comes amid a staggering report from the National Vital Statistics System (NVSS) that United States average life expectancy has dropped to its lowest in almost three decades – in large part due to the COVID-19 pandemic but also because of fatal drug overdoses. The report notes overdoses typically take three to six months to be appropriately assessed at the local level and those data may be delayed, underestimating the life expectancy implications of the crisis. Indeed, the cause of death which caused the second most substantial influence on average life expectancy was “unintentional injuries”, of which overdoes represent a largely significant segment.

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced awarding $79.1 million in grants to various programs aimed at addressing certain aspects of the overdose crisis, including projects targeting supporting first-responders and rural emergency medical services as a point of overdose treatment, capacity building and technical assistance to providers, residential programs, and an effort to strengthen support for medication assisted treatment. SAMHSA’s page recognizes the 30% rise in overdose deaths since 2019, racial disparities affecting Black communities and American Indian and Alaskan Native communities, and the fact of socioeconomic disparities dramatically impact overdose rates.

While not mentioned in the White House, HHS, and SAMSHA pages relative to recognizing International Overdose Awareness Day, the day is meant to also recognize the impacts of non-fatal overdoes. In particular to the issue of long-term physical health, non-fatal overdoes have deep implications as to viral Hepatitis and HIV transmission and our efforts to end those epidemics. In order to adequately address overdoses, we must recognize the syndemic nature of these issues and the systemic drivers of disparities affecting these communities. Mental health is often reflective of the socioeconomic experience of a person (and community); racism, for example, significantly but not singularly defines both the social experience and economic experience of racially marginalized people.

In recognition of International Overdose Day and the holistic needs of highly affected communities, we must consider society-wide, comprehensive interventions that treat these social ills as the causative factors they are.

Feds Launch National HIV/AIDS Strategy Implementation Plan

On August 26th, the White House Office of National AIDS Policy (ONAP) director, Harold Phillips, announced publication of the Federal Implementation Plan for the National HIV/AIDS Strategy. A “dear Colleague” letter was circulated among advocates shortly before the announcement and Mr. Phillips discussed the release of the implementation plan via recorded video, published to the federal government’s HIV.gov blog.

Significantly, the implementation plan details more than 380 action items from 10 different federal agencies and specifically adds focus issues of quality of living among people living with HIV/AIDS (PLWHA) which will be added to the Medical Monitoring Project’s data tables in 2023. Many of the action items detailed include education and outreach and coordination of efforts between affected federal agencies and state partners. Much of this work intersects with the Biden Administration’s efforts to address health equity and disparities, given the disproportionate representation of marginalized communities affected by HIV.

For most advocates, the announcement was a “mixed-bag” of good news and frustration at planning that primarily highlights assessments and monitoring where data may already exist or where advocates have already outlined more concrete steps they wish the federal government to take. For example, advocates and the federal government is well-aware that thanks to the advancements in quality of medications to treat HIV and being able to keep more patients engaged in care, the population of PLWHA is generally much older than they were in say…2000. However, our planning and supports for this aging population is not sufficiently strong. Medicare integration and coverage of support services specific to PLWHA is lacking and the federal government has had to engage in repeated enforcement actions against skilled nursing facilities and assisted living facilities, both regarding the refusal to provide services to PLWHA and the failure to have adequate services for PLWHA in the facility’s care.

The new quality of life metrics focus on issues of mental health, behavioral health support, food insecurity, unemployment, and unstable housing for PLWHA, with the last 3 items being considered “structural/subsistence” issues for patients. These items are arguably significantly intertwined and success or failure in any may implicate success or failure in all of these items.

In order for the federal government’s efforts to meaningfully move forward, these plans should be treated as a roadmap, rather than actions themselves. One of the things we are very good at in HIV is planning and processing. Where efforts tend to fall short is in implementation and in order to improve implementation, we need to identify if those failures to implement are due to lack of appropriate resources, expertise, or conflicting federal and state policies and priorities. Advocates should seek to hold our friends at ONAP and other agencies accountable to proactive action in defending the rights of PLWHA as patients and acting on appropriate integration of care for our aging colleagues and friends – both in terms of ensuring existing entities serving an aging population are aware of how to care for PLWHA and in ensuring entities serving PLWHA are adequately supported to care for an aging population.

In assessing effective uses of limited resources and the plan’s goals toward meeting these quality of life metrics, advocates and the federal government should consider how to leverage the Ryan White program as a workforce development and employment opportunity in order to help lift patients and highly affected communities out of poverty and, in so doing, addressing the other listed quality of life metrics. The 2021 (fiscal year) budget for the Ryan White program is $2.4 billion (not including AIDS Drug Assistance Programs). Those dollars, when focused on employing people living with and at risk for HIV, those who would otherwise be or are already Ryan White clients, would provide a significant opportunity to address these quality of life concerns and meaningfully put these dollars to use in the community the funds are meant to serve.

European Commission Approves Once Every 6 Month Supplemental HIV-Treatment

Last week, the European Commission (EC) approved use of Gilead Sciences’ investigational medication, lenacapavir (branded as Sunlenca), for use in treatment for people whose HIV is highly treatment resistant. Lenacapvir has been closely watched by advocates because of great anticipation regarding injectable and otherwise long-acting agents (LAAs) and because of its exceptionally long half-life in the body, providing efficacy for about 6 months from just one subcutaneous injection, providing a potential for the longest acting agent to hit the market thus far.

Lenacapavir also stands out as a first-in-class product because it works in a way that no other antiretroviral medication works. Offering a novel mechanism of action, binding the shell (capsid) surrounding viral genetic material that highjacks our own cells in HIV reproduction, capsid inhibitors will work against HIV in multiple areas of the virus’ life cycle. And because this is a tool we’ve never used before, it’s ideal for meeting the treatment needs of people living with highly resistance HIV – the virus doesn’t recognize the medication and has not yet found a way around it. Because HIV is highly adaptable, that lack of resistance may be short-lived once broad reach of the product is made available but excitement remains for a novel product, especially for people who have developed such resistance that options of effective care have diminished to near zero.

Gilead Sciences is awaiting a decision from the United States’ Food and Drug Administration (FDA) on its recently resubmitted “New Drug Application” (NDA), after the agency declined to accept the NDA due to issues with the glass vials used for the injectable form of the medication. The vial issue has since been fixed and research resumed for use of lenacapavir as a supplement to “background” treatment, first-line treatment, and as pre-exposure prophylaxis (PrEP). At the end of July, the FDA provided Gilead with a December 27, 2022 prescription drug user fee date. This is one of the final steps in an initial new drug approval. (Briefly, the Prescription Drug User Fee Act funds a massive portion of the FDA and those medications which pose potential benefit to public health may receive an expedited fee date; HIV advocates historically championed the act as a massive “win” in the early 90’s when introducing this funding scheme sped up their processes to make oncology and HIV medications more readily accessible.)

Patients who may hear about “once every 6-month treatment) should be kindly reminded lenacapavir will serve only as a supplement to other therapies – administering the medication is required to be done by a provider and patients will still need to remain adherent to their existing treatment regimen. HIV medications for treatment need between 2 and 3 different combinations of medications and PrEP only needs 1. As such, there may be a disparity in lenacapavir as PrEP and Sunlenca as treatment in terms of uptake because, while lenacapavir won’t require maintenance of other medications, Sunlenca as treatment will require patients to continue to take the oral medications that are “optimized” with Sunlenca acting almost like a “soft reset” for patients.

Operationalizing will remain an issue, especially for state ADAP Program’s that have not fully implemented access to cabotegravir, in terms of injectable medication management and for arguments that frame investing in successful patient care as something that requires a “cost consideration”. Patient advocates should be well-prepared to defend a desire to see this product come to their patients as those patients so desire it.

Despite All Evidence in Support of Harm Reduction, Stigma Drives Public Attitudes

Earlier this year, a false claim spurred outrage from commentators and politicians regarding federal grant dollars for harm reduction programs across the country. Shortly after, in April 2022, the U.S. Department of Justice (DOJ) issued guidance on how the Americans with Disability Act (ADA) provides protections for people with opioid use disorder (OUD), which may also apply broadly to people with substance use disorder (SUD). From local and national advocates to actions from the Biden Administration, as a nation, the United States is facing the greatest change in drug policy since the Nixon Administration introduced a national policy officer (“drug czar”) on the issue. Forty years after Nancy Reagan’s “Just say no” campaign and the abject failure of the D.A.R.E. (drug abuse resistance education) program, the United States’ “War on Drugs” has only succeeded in criminalizing a health status with, up until relatively recent history, with broad bipartisan support. The effort to combat the stigma sewn into the fabric of our social attitudes towards drug use and misuse is coming to a fever pitch.

Scrolling through my own social media, I can across Representative Malinda Brumfield White’s post regarding a methadone clinic opening in Bogalusa – expressing “concern” for the location. The comments were rife with assumptions as to what the clinic might “mean” for the area and opposition to its location. The animus voiced is the exact type of animus an industrious litigator might cite to prove the attitudes DOJ cited as discriminatory and might spur actions which could violate the ADA. This clinic didn’t pop up out of nowhere, Louisiana’s legislature ordered a needs assessment on the impacts of the opioid crisis in 2018 after the Governor Bobby Jindal ushered in closing of most of the clinics in the state. Subsequently, the state’s health department identified a need to establish at least 10 new harm reduction service providers, focusing on addiction treatment centers (specifically, medication assisted treatment). A request for proposals (RFP) was issued in late 2021 and signed with Behavioral Health Group (BHG) shortly thereafter. But it’s just now that the local electeds are making noise about the clinic – as the operation is getting set to open.

Meanwhile, in California, Governor Gavin Newsom is rumored to be thinking about vetoing SB57, a piece of well-supported state legislation that would allow for pilot project locations for safe consumption sites. The project would be the largest yet seen, after New York allowed for a similar project last year, and is facing tough opposition even after the bill passed out of the state’s legislature, with a concerted campaign urging Governor Newsome to veto the bill. New York expanded their project this year thanks in large part due to the success of reversing hundreds of overdoses already.

Vermont’s Governor has already vetoed a similar bill. Though, that veto also axed additional funding for multiple modalities of harm reduction, including ones already existing in Vermont, Governor Phil Scott specifically cited the safe consumption sites projects as “counterintuitive” – a statement rooted in stigma (his assertation that data did not exist to support the project is false – see previous links on New York’s success). A bill in Kentucky to initiate a pilot project didn’t even get a committee hearing this year. And Rhode Island is finally finding a way to fund safe consumption sites – by using the state’s opioid settlement dollars. Rhode Island had already passed a law allowing study of safe consumptions sites, the legislation just did not include any funding to do so and those entities interested in opening sites were hard strapped to find enough private funding to open.

In other states, advocates are playing slower “games”, taking time to further educate their legislatures and communities. In North Carolina, experts took time to both debunk the claim the Biden Administration was pushing on smoking pipes but also how those same tools would be an improvement in harm reduction offerings already existing in the state. In Massachusetts, elected representatives are supportive of safe consumption sites but elected law enforcement isn’t. Those same elected law enforcement officials are peddling stigmatizing ideas with ominous sound bites like “let’s ask people in neighborhoods where they already exist and see if they feel it’s safer.” When there’s no one there to challenge these ideas, or journalists’ follow up questions aren’t answered, the dark clouds gather around pious suburbanites as if their own families aren’t one or two degrees of separation from experiencing the damaging impacts of an unabated overdose crisis.

Decades old attitudes which moralize a health condition as a personal failing and threat to our families hasn’t worked. Indeed, overdose deaths and non-fatal morbidities are on the rise…again. Despite having the tools, decades of behavioral intervention study, and a desperate need to address this issue, we keep seeing the same approached used over and over again – stigmatize, criminalize, and isolate. Our elected officials have an obligation to both educate themselves and advocate for more effective policy. The families affected by the opioid crisis, substance use disorder, Hepatitis C, and HIV are the voters and constituents these representatives are tasked to…represent. As advocates trudge on in sharing stories, we must leverage what we know to be true. This is indeed a moral fight – it is immoral and unethical to allow people to die with a callousness of disinterest, even triumph as if those deaths are somehow “deserved”. While our lawmakers are returning home as the federal legislative session comes to a brief break, they must also take this moment to lead their constituents in making the moral choice and support comprehensive harm reduction policies and programs.

Blame Payers for Only 1:3 Patients Receiving HCV Cure

On August 9th, the Centers for Disease Control and Prevention (CDC) provided an early release of a Morbidity and Mortality Weekly Report (MMWR), detailing the massive inequity between insured patients in need of curative Hepatitis C (HCV) treatment. By evaluating the HealthVerity claims and encounters database, researchers were able to identify particular patient characteristics, including payer type (private, Medicaid, and Medicare), sex, race, and age. Of particular note, assessment included recognition of various restrictions some state Medicaid programs impose on patients.

Importantly, the CDC notes that about 2.2 million people in the United States are living with an HCV diagnosis and 14,000 people die of HCV-related conditions annually. These deaths are largely preventable thanks to the development of curative treatments through direct acting agents (DAA)s. The analysis also cites previous research finding that providing timely, curative HCV care reduces costs to payers (and their sponsors) compared to costs of denying care. This remains true even when patients experience reinfection or treatment interruptions. Essentially, a cornerstone of public health is affirmed in curing patients of HCV, patient quality of life and health, engagement in society, and the economic benefits thereof are well-served when patients have ready access to life-saving treatment. This all emphasizes why the disparities displayed in the findings of this report are unacceptable and must be addressed with urgency.

Generally, for inclusion in the analysis, patients needed to be enrolled in health insurance coverage consistently just before and during the time period used in the paper. Of the unique patient files evaluated, just under 48,000 qualified for inclusion in this analysis. Medicaid and patients with private insurance saw about the same number of HCV screenings performed, however, Medicaid patients were more than twice as likely to receive an HCV RNA test whereas Medicare patients were most likely to receive an HCV RNA test than the other two payer types with rate of HCV positivity was highest among Medicaid patients. Of Medicaid patients qualified, more patients lived in states with treatment restrictions (47%) than in states without restrictions (38.8%). Overall, patients enrolled in private care were most likely to initiate DAA treatment inside of the following year (35%) and Medicaid patients were the least likely (23%). Treatment initiation was most likely to occur within 6 months of diagnosis. Critically, there did not seem to be a massive racial disparity within a particular payer type, except those patients who selected “other” or were missing racial information in their claim. For Medicaid patients, the drop was significant (19% and 20% respectively). Patients enrolled in Medicaid in states with program restrictions were 23% less likely to initiate treatment than Medicaid patients in states without restrictions.

The authors urge some caution because the qualification for inclusion required a long period of continuous insurance enrollment and did not include uninsured, incarcerated people, or people who receive coverage through other public payers (Veterans Administration or AIDS Drug Assistance Programs). The CDC expects treatment initiation for people who experience disruption in insurance coverage are less likely to initiate curative HCV treatment, in general. And the data provided has no ability to inform the “why” behind delays in initiation or failure to initiate curative treatment.

The data did not mention how the COVID-19 pandemic may have affected claims, treatment initiation, screening and testing, or even insurance enrollment during the period of time included in the assessment.

The Center for Health Law and Policy Innovation at Harvard and the National Viral Hepatitis Roundtable issued a lengthy statement urging policymakers to take note of the report. The groups highlighted their annual report on barriers to care in state Medicaid programs, Hepatitis C: State of Medicaid Access, pointing toward to work as a guidepost for reducing barriers to care and increasing patient access. The report has recently undergone an update in metrics assessed as progress has been made on fronts regarding issues raised in previous reports. Notably, the updated metrics include an “other restrictions” category to include restrictions on treating reinfections, requirements in on medication adherence (including adherence to medications not used to treat HCV), and refusal to cover lost o stolen medications. That last piece needs note because the state of Florida is one of those (9 in total) programs which limit coverage for lost and stolen medications and these barriers, under issues of natural disasters, institute yet one more barrier to care and burden when patients can afford disruption the least – such disruptions also impact adherence, creating what can amount to an unwinnable situation for many Medicaid patients.

Significantly, the CDC’s report opens with noting that all of this is preventable. Advocates should consider pressing this report with their federal and state electeds and policymakers, emphasizing these findings represent the “best” of circumstances, in terms of coverage, and many of their constituents (and ours) do not enjoy the best circumstances.

Assessing Responses to the US Monkeypox Outbreak

On August 4th, the Biden Administration declared a Public Health Emergency (PHE) regarding the ongoing Monkeypox outbreak in the United States and other countries where the virus is not endemic. Two days prior, the White House announced a National response Team, lead by the Federal Emergency Management Agency’s (FEMA) Robert Fenton and the U.S. Centers for Disease Control and Prevention (CDC) Dr. Demetre Daskalakis.

Bob Fenton holds some notoriety at FEMA, in part, because in 2005, while helping to coordinate on-the-ground responses to Hurricane Katrina’s devastation, he warned officials in Washington, D.C. that more needed to be done to meet the needs of the moment. Dr. Demetre Daskalakis has been credited with helping to curb and end a measles outbreak in 2018 and 2019 in New York City, prior to joining the CDC, but more aptly, his extraordinary efforts in 2014 to end the meningitis outbreak by bringing vaccines to bath houses, dressing in drag, and otherwise successfully bringing care to communities and people who needed it. With these histories, there’s no wondering why the White House selected these two professionals to lead this response. And having well-qualified leaders with excellent analytical skills and histories of putting success strategies into action aren’t necessarily going to be enough.

In a protracted opinion published to The New York Times, a former U.S. Food and Drug Administration (FDA) lead, Scott Gottlieb, accurately assessed a lack of political appetite to allocate more power and funding into public health. Specifically, Gottlieb argued the CDC has failed to compel a more coordinated response from state level partners, despite a very evident need to make these kinds of investments to shore up the country’s preparedness and ability to respond to health threats. The Biden Administration has instead suggested a need to make more agencies, which may be a way of trying to get around that lack of appetite and still achieve some measure of these investments. This type of move is, as Gottlieb described, a “very Washington response”, from both the short-sightedness of the legislator-politicians tasked with serving the best interests of the country’s populous and the Biden Administration’s fumbling response. He is correct in saying monkeypox, like other viruses foreign to the United States, may well become yet another public health failure. However, Gottlieb also argued the delayed or at least slow federal response to this monkeypox outbreak showed a need for the CDC to get out of the business of preventing illnesses other than infectious diseases and leave that work to other agencies. A gentle reminder, “Prevention” is in the name of the agency and adding layers of bureaucracy will not fix the fact that existing bureaucracy just…isn’t working as fast or efficiently as we need it to in order to respond to public health emergencies.

Those politically powerful voices, like Mr. Gottlieb’s, with influence must push the conversation with their audiences, especially political leadership, to draw a line in the sand in the interests of the nation. The more any party leadership is willing or even happy to promote inflammatory, conspiracy minded, and objectively false claims, especially those around issues of public health, just to win elections, the less power our federal government will have to respond to emergencies and the less states will be willing to cooperate when cooperation is needed.

Of the notable assessments Gottlieb offers, the most meaningful are drawing a potential definition of “public health failure” as monkeypox becoming an endemic virus to the United States in which persistent but low-level of the virus continues to circulate. Another is the potential of an “ascertainment” bias, but not the one most folks discussing this issue might jump to first – regarding communication around at-risk populations – but that this outbreak may seem like it “appeared out of nowhere”. Instead, it has likely been circulating undetected for some time and misdiagnosed or assumed as some other illness among health care professionals. Given the genomic distinctions discovered shortly after the initial detection of cases in Europe and North America, there’s good evidence to support that conclusion; a conclusion that lends great concern for that definition of “public health failure” to be accurate.

On the more technical analyses regarding this outbreak, a lack of precise, effective communication and a willingness for the public to accept complex realities has plagued federal, state, and local health agencies. Arguments between well-intentioned advocates, journalists, and public health professionals on effective messaging have enveloped the discussion around Monkeypox, flooding and fueling social media speculation and concerns of misinformation. Indeed, maliciously intended politicians, like Representative (GA-R) Marjorie Taylor Greene’s repeated statements (which will not be linked here as readers can Google search these things) equating the rare Monkeypox cases being reported among children are some evidence of sexual assault being perpetuated by men who have sex with men, were among the fears voiced on these platforms in June.

Public health agencies are looking to perform a balancing act in ensuring the resources, including vaccines and treatments, are reaching the most highly affected communities, while also educating and informing the public at large when addressing a unique outbreak where clinical information on transmission risks is limited, even as data is becoming more readily available. To be clear, the current global outbreak of monkeypox is concentrated among the social-sexual networks of men who have sex with men (including transgender men). Messaging and resource allocation are two very different things and should not be treated as one in the same. And educational messaging must be carefully tailored to its intended audience in order to not perpetuate stigma and the violence that can result from stigma. Indeed, issues of stigma, violence, and even public policy already suppressed investigation around a previous monkeypox outbreak in Nigeria, which may have better prepared the world for preventing this one. As Dr. MK Titanji pointed out, part of this previous disinvestment and lack of investigation is a direct result of the fact that half of the world’s countries criminalizing homosexuality are within the African continent, some of which are the only countries in the world where monkeypox is already endemic.

Critically important, stigma and other factors which perpetuate health disparities are already finding familiar lines in the United States. The CDC’s Morbidity and Mortality Report Weekly (MMWR), published on August 5th, found that even in the limited data available, "The percentage of cases among Black persons increased from 12% (29 of 248) during May 17–July 2 to 31%." Additionally, for those cases with full profiles, 41% of cases were among MSM living with HIV. The confounding factor to consider with that high rate of HIV prevalence among monkeypox cases is thanks to robust, though certainly not perfect, public health infrastructure specifically in response to HIV, people living with HIV/AIDS (PLWHA) may be more able to readily access health care professionals who are aware and educated about this monkeypox outbreak than other populations. The press conference immediately following the declaration of public health emergency had federal officials discussing a “vaccine sparing” strategy in order to facilitate reaching more people in need. However, given this concentration of case identification among PLWHA and that the available vaccines may not be as effective for this population, there’s good reason for patients and advocates to be concerned what dose sparring may mean for the most impacted population.

As this situation develops, we’re lucky to have the expertise the White House has engaged, who have readily sought out community feedback and engagement. As an example, Harold Philips, the Director of the Office of National AIDS Policy (ONAP), has had subsequent conversations with stakeholders in HIV to discuss leveraging the HIV infrastructure in order to help address this outbreak. And there’s much left unknown, including what exactly the risk is to children who may be in close, consistent, physical contact with people who have been diagnosed with monkeypox. Advocates are already coming together from across jurisdictions in an effort to appropriately influence public policy and program designs. Our efficacy in that work and in coordinating a response based in best practices of meaningful engagement means our private industry stakeholders must also support us in this work.

Additional reading which may be beneficial: From our friends over at the Center for Disaster Philanthropy; Monkeypox Briefing, including suggestions to funders in supporting advocacy and services to address the outbreak.

Institutional Barriers Still Stand in the Way to Equity

On July 28, 2022, the World Health Organization (WHO) released new guidelines on the use of long-acting, injectable cabotegravir (branded as Apretude) as pre-exposure prophylaxis (PrEP), just ahead of the 24th International AIDS Conference (AIDS2022) in Montreal. On the same day, ViiV Healthcare announced a voluntary licensing agreement with Medicines Patent Pool in an effort to extend access to the medication to middle- and low-income countries, particularly sub-Saharan African countries.

These are very exciting developments as the innovative products (Cabenuva for the treatment of HIV and Apretude for the prevention of HIV) represented the most recent of biomedical interventions around HIV with the potential for dramatic changes for the better. Expanding options, allowing for patients to choose between a daily tablet or once-every-two-months provider administered injection, gives patients the choice to pick between highly effective regimens to suit their comfort and lifestyles. While that may sound like a sales pitch for a phone, it’s not – it’s the effort to make life-saving medications appealing and easy. Frankly, they should be.

But in the long fight to make these medications available, we should be reminded that “available” and “accessible” are two, very different things. The difference is big – so big – that it can be measured in the 4,000 new diagnoses a day and 650,000 AIDS-related illness deaths in 2021.

That gulf, the pit in your stomach reading that data, the silence at the end of the hope and joy you had reading those first two paragraphs – that’s the space between “available” and “accessible”.

In order to fully appreciate the extraordinary efforts to improve living with and life for people living with HIV, we must also fully appreciate the barriers to care patients face every day. From housing to transportation to stigma to food – clean water and food – patients have consistently been blamed by policymakers, both foreign and domestic, for failing a moment in which patients aren’t the ones with institutional power to change the circumstances of their journey to care.

A large portion of AIDS2022 is dedicated to highlighting these disparities, the specific policy mechanisms countries should consider implement* in order to create a more equitable world for all and to ultimately End the HIV Pandemic. From discussing discordances in criminal laws and public health best practices (sex work, harm reduction) to practical investments in education and health care systems to very direct conversations on how political opportunism finds readiness in villainizing people and communities highly affected by HIV, the International AIDS Conference is a dedication in love, spanning thousands of years of lived experiences and expertise. The lessons learned from the collaborative and sometimes confrontational efforts highlighted at this event are lessons we ultimately should also appreciate here, in the United States.

At home, though, the disconnect between federal authorization of innovative medical products and state-based policies to ensure access is the representation of that engulfing silence from earlier. Patients, especially low-income patients, are still struggling to realize the benefits and flexibilities of the biomedical innovations. Medicaid programs were slow to appreciate the need to cover Cabenuva and Apretude (some still don’t). A national coverage determination has not yet been made to ensure Medicare patients have access. And even if every last corner of these public payers covered these medications, private payers still maintain the power over a patient’s choice by simply refusing to pay for them – instead forcing patients to suck up whatever the payer determines is acceptable.

Of all the systemic and institutional barriers to care patients face domestically, payers remain some of the least regulated, least accountable, and most profitable – of the top 12 most profitable companies in the US, 3 are or own pharmacy benefit managers. Food, housing, transportation all take many, many layers of work to dig into. But changing what patients pay at the pharmacy counter, relieving that stress and making patients less fearful of having to choose between those necessities and their medications? That takes one layer, one set of actors, to be held accountable to everyone who pays them to stay in business – including and especially the United States government. Advocates would do well, as federal legislators prepare to go elbow deep in “drug pricing” legislation, to readily ask “lower prices for whom?” The difference in the answers can be measured as the difference between “available” and “accessible.”

*The strikethrough and italics is the author’s commentary on language used by politicized entities to urge necessary policy changes.

Jen’s Half Cents: Industry Investment in Advocacy Must Look Beyond the Next Quarter

A reoccurring theme over my career in patient advocacy has been concern over the future. The discussion takes shape in different ways, mostly with looking thoughtfully into the different aspects of what we mean by “investment” and “resources” and how we define “success” in advocacy. These words tend to float around with some ambiguousness but for the purposes of this blog (and honestly the conversation at large), we do need to define them and contextualize this language before we dig into the meat of what it means to have a robust, well-supported patient advocacy ecosystem.

I’ll get straight to the point by defining the ways we use these terms:

“Investment”
Most commonly referred to mean financial commitments but these commitments, when used strategically, are built on the backs of dynamic relationships between the people involved and the representation of our various stakeholders. To this end, while investment” is tied to dollars and checks, we must be explicit about “investing” time and energy into one another, buying into avenues of trust and plutonic connection. I mean this honestly – lots of folks don’t want to talk about their personal lives and wish to keep work and home separate. While that may have been perfectly functional in the past, it’s not any longer. We must invest in one another, in our missions and purpose, our visions and analyses, and this investment must look beyond what bills are being passed into law or tallying up dollars spent.

”Resources”
As with investment, “resources” tends to refer just this side of explicitly to money. And money does indeed make advocacy a career as opposed to a hobby. I’ll frequently remind advocates and funders that we don’t get to have the luxury of being in these rooms talking with one another without being able to have the necessity of our lights on and bellies full being assuredly met. Money buys the resource of time and child care and transportation. Money also buys the resource of talent and training; it allows us to invest in the potential of community members who wish to participate beyond their scarce off-work hours. Resources are bodies and minds seeking solutions to complex problems and exploring the topography of politics and policy.

“Success”
This one requires nuance. For many funders and even board members of advocacy organizations, “success” is also financial but the word has other, programmatic and sometimes situational definitions. “Success” can be growing the interest of a community member to become an advocate. Success can be passing a bill into law or preventing one from becoming law. Success can be the number of patients linked to care or educated as to certain aspects of care. Success can be activating a patient base on particular political or policy issues. Success can be being able to trust that new relationship and giving them a call to discuss ideas. Success, however, is always tangible.

We must acknowledge that in all the ways we have previously succeeded and are currently lacking in success are directly tied to the investment of resources in patient advocacy.

Funders Concerned About AIDS has tracked a steady decrease in HIV-related funding and decrease in diversity of funders, over the last several years. Much like the social atmosphere in the South, funders are shifting their attention to other issues of Justice or health, and away from HIV as a singular, defining issue. The idea of HIV being “exceptional” is diminishing at one of the worst possible times for this phenomenon to happen. On the cusp of success or at a time when gains are being disrupted by yet another pandemic and the politics of the day, is not the time to pull away from the exceptional nature of HIV and patient advocacy as a whole.

The late-Bill Arnold used to tell me “We can’t look away. The Crisis is always right around the corner.” This was as much a pragmatic sentiment as it was an emotional one. The nature of infectious diseases, especially HIV, is they can run quietly in the background of our lives and society for an exceptional amount of time. And if we allow that to happen, as evidenced by lacking investments and flagging resources, only to come back at the moment of crisis or emergency, then we won’t ever succeed.

Much like public health, advocacy cannot succeed without continuous investment – yes, both dollars and relationships.

Our funders must maintain a commitment to funding patient advocacy now, more than ever, because the stagnation of domestic politics won’t last forever. We will face a moment in the future where we either move forward or we slide back and there won’t be enough resources to push us forward or guard against the slide back unless those investments are something advocates can rely upon.

Improving Liver Health for People Who Inject Drugs

A recently published study in the Annals of Internal Medicine found that providing Hepatitis C treatment to people who inject drugs (PWID) showed significant improvement in liver health outcomes when provided with community-based access to care and treatment. The study, which drew its cohort from Baltimore and collected data from 2006 to 2019, found a particular value to participants in low-barrier access to care – a mainstay of harm reduction advocates.

The qualifying condition for participants was a chronic HCV diagnosis, with the majority of participants being Black, assigned male at birth, and not having an HIV diagnosis. Within the last 6 months of the participants’ lives prior to study enrollment, 54% had injected drugs and 27% were on methadone. 56% of participants also scored as having had severe, harmful, or hazardous alcohol use. The initial rate of cirrhosis was 15%, rising to 19% in 2015 and dropping dramatically in 2019 to 8%, with the rate of detectable HCV RNA reducing from 100% in 2006 to 48% in 2019. Self-reported treatment also increased from 3% to 39% across the study period. Some of the most significant findings of the study were specific to broader outcomes – those with undetectable HCV RNA were 72% less likely to develop cirrhosis and were at 46% lower risk of all-cause mortality. While 430 of the participants died across the span of the study, 394 had chronic HCV and 36 had no detectable HCV RNA. 29% of those deaths were categorized as from drugs or trauma, 41% from chronic illness, and 6% from liver disease/cirrhosis.

The study itself did not depend on distribution of treatment to patients but rather, it sought to assess how patients engaged in care in community-based settings and what accessing services through these settings means for patient health outcomes. The study’s findings aren’t particularly surprising for anyone familiar with providing services to communities which are often marginalized. Indeed, for communities and patients experiencing poverty or living in health care deserts, also coinciding with red-lined neighborhoods and thus associated with Black communities, access to “traditional” health care settings is limited or not meaningfully existent. Trust of traditional health care and even public health services is equally limited due to historical traumas, including forced sterilization, concerns for law enforcement engagement, and – perhaps most directly – due to provider bias. Community-based, low-barrier care in light of these realities and lived-experiences are simply…more welcoming.

In recognizing a sense of welcoming, observers should also recognize the sense of safety patients to these settings feel – that trust in tangible for patients. It’s also important to recognize a particular failure in federal funding focuses in entities that may claim being based in a particular community but are not necessarily required to hire providers or staff from the service area or served populations. Indeed, during a recent O’Neill Institute call, this distinction was of particular complaint. Funding is typically awarded to larger entities rather than smaller ones and holds no particular requirement for staff to be reflective of the patient population. For those larger entities, they tend to also be stuck in programming with limited creativity, are explicitly tied to specific clinical outcomes, and extraordinarily strict and onerous reporting requirements. Those requirements can and do translate into administrative barriers for patients and limit the creativity that may also translate less directly or immediately to measurable health outcomes. The complaints were broad, generally stating a need to take a more diverse approach that looked at longer-term investments into patient health through relationship building.

Those relationships are critical to the success of patients and introducing the ideas behind “harm reduction”. Another barrier to successful harm reduction can be found in particular state and federal policies which may run contrary to the best practices identified by academics and advocates. In this, the details matter. For example, most “good Samaritan” laws maintain a carve out of exception for drug dealers in reporting overdoses – even if they wanted to help, they could be prosecuted for homicide if a person dies, discouraging intervention from the course. For states with syringe exchanges (now facing conservative backlash by way of moralizing substance use rather than viewing substance use as a health condition), many still maintain paraphernalia laws which means patients engaging with syringe exchange programs can be arrested and charged either going to or coming from accessing services at syringe exchange sites.

Community Access National Network’s HIV-HCV Co-Infection Watch monitors certain state-level harm reduction measures in an effort to provide a resource to advocates and our Annual Monitoring Report discusses these nuances. Advocates know well the positive health outcomes for patient and communities when public health programs are designed with long-term investments are made and comprehensive approaches are taken. State and federal law and policy makers would do well to reconcile the conflicts between these and strive to achieve a policy environment which fosters the development of creative, safe, low-barrier care and reduces risks to people who inject drugs.

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.

The Time Has Come to Centralize HIV Services in West Virginia

My name is Marcus J. Hopkins, and I have been living with HIV since 2005. While I’m not considered a “long-term survivor” of HIV—a term deservedly ascribed to People Living with HIV/AIDS (PLWHA) since the 1980s or 1990s—my experiences receiving treatment for HIV through the Ryan White HIV/AIDS Program (RWHAP) and AIDS Drug Assistance Program (ADAP) have run an interesting gamut across five states: Georgia, Florida, Tennessee, California, and West Virginia. Across those five states, I have experienced a wide variety of HIV services provision over the course of being in HIV treatment since 2007, and can truly attest to the adage, “When you’ve seen one ADAP, you’ve seen one ADAP.”

Over the course of sixteen years of receiving services through the RWHAP and ADAP programs, several things have changed:

• Providers no longer wait until a patient receives an AIDS diagnosis to initiate HIV Antiretroviral Therapy (ART)

• Treatment regimens have largely transformed from multi-pill regimens to single-pill regimens and even long-term injections requiring once monthly or every other month injections

• The emergence of Pre-Exposure Prophylaxis (PrEP)—a once-daily pill or once-monthly or every other month injection to prevent the transmission of HIV between serodiscordant sex partners—means that the possibility of no new diagnoses is a distinct possibility within our lifetimes

• The threat of waiting lists to receive treatment and services is largely a thing of the past

• The passage of the Affordable Care Act (ACA, or “Obamacare”) allowed state ADAP programs to pay the premiums and co-pays for private insurance for eligible clients

• The passage of the ACA also allowed states to expand Medicaid in such a way that PLWHA are now automatically covered by state Medicaid programs, rather than ADAP. To date, 39 states have expanded their Medicaid programs (Kaiser Family Foundation, 2022)

And yet, despite all of these advancements, issues remain, particularly in rural parts of the country where even basic medical services are limited, much less HIV-specific services. Such is the case for my home state of West Virginia.

Since returning to West Virginia from Los Angeles in 2013, my experience with this state’s HIV services has been…fraught, at best. I can’t complain about the quality of care I’ve received, here; I can say that qualifying and recertifying for the various RWHAP parts is made extremely cumbersome.

You see, in the state of West Virginia, there is one organization that handles Ryan White Part B (basically, the ADAP program) for the entirety of the state. This entity is separate from the clinics that provide Part C and Part D services (outpatient care and the provision of medical care and support services for low-income women, children, and youths with HIV and their families, respectively). And THOSE entities are entirely separate from the Part F services, which cover education, HIV treatment projects, dental programs, and the Minority AIDS Initiative. And even THOSE entities are entirely separate from the ones that provide services for the Housing Opportunities for People with AIDS (HOPWA) program that provides various housing and utility assistance services for PLWHA.

So, let’s do a quick recap: in order to receive the full breadth of services to which most PLWHA are eligible in the state of West Virginia, one must engage with at least four separate entities. This doesn’t even address nutrition assistance, non-emergency medical transportation for visits, and other supportive services.

This is a problem.

It is a problem for patients; it a problem for providers; it is a problem for the HIV Care Continuum (United States Department of Health and Human Services, 2021); it is a problem for HIV surveillance and prevention.

As far as I can tell, this problem seems kind of unique to West Virginia. West Virginia never saw the proliferation of AIDS Service Organizations (ASOs) that most of the rest of the country saw during the 1990s and early-2000s. While the rest of the country and especially surrounding states saw an influx of new 501(c)(3) non-profit organizations and clinics step in to provide the wide swath of HIV case management, clinical, behavioral health, and supportive services, West Virginia’s services developed in inefficient siloes that left patients scrambling to figure out the veritable pantheon of providers necessary to get the services for which they are eligible.

By comparison, in the northeastern region of the state of Tennessee (still deep in Appalachia), Ryan White caseworkers went out of their way to assist with every aspect of HIV care, from enrollment in the program to clinical services to mental health services to dental services to HOPWA services to enrolling in nutrition assistance programs—they did it all. The same was true of my experiences in California and Florida.

In West Virginia, however, every aspect of seeking and qualifying for HIV services requires patients to perform an intricate and ever-changing ballet, the steps for which they are never taught. Because there are so few providers of these services, when patients experience issues, there aren’t really any other avenues to turn to for assistance.

This has become the case with one of West Virginia’s terribly mismanaged HOPWA grantees.

Again, unlike virtually every other state in the U.S., HOPWA services in West Virginia are not seated within the HIV treatment and services infrastructure, insufficient as it is, but within various organizations dealing with homelessness, such as Covenant House and the West Virginia Coalition to End Homelessness. Comparatively, in other states, referral to and enrollment in the HOPWA program is handled by ASOs, who work in concert with state housing agencies to assist with housing issues.

Over the course of the past few years, when one of West Virginia’s HOPWA service providers stopped paying housing and utility payments in a timely manner, patients had nowhere to turn without having to go through multiple channels to resolve their issues…but not even really resolve them; just lodge a complaint. Those HOPWA clients would have had to complain, first, to the very agency that failed to return their panicked calls, as they lost their housing or their electricity was cut off; instead, they had to jump through several different hoops just to find out where to go to complain—the regional office in Pittsburgh, PA, which initiated an investigation which, frankly, doesn’t do anything for those who are trying to get their rent paid or their electricity reconnected.

The time has come for the formation of not one, but several ASOs in the state of West Virginia to centralize these services. It is unconscionable that a state with a burgeoning HIV infection rate should have such a disorganized and disjointed service provision landscape. The time has come to centralize services at these ASOs, lest we continue to beat numerous dead horses and fail to serve those living with HIV.

Sources:

• Kaiser Family Foundation. (2022, April 26). Status of State Medicaid Expansion Decisions: Interactive Map. Washington, DC: Kaiser Family Foundation: Medicaid. https://www.kff.org/medicaid/issue-brief/status-of-state-medicaid-expansion-decisions-interactive-map/

• United States Department of Health and Human Services. (2021, June 21). What Is the HIV Care Continuum? Washington, DC: United States Department of Health and Human Services: HIV [dot] gov: Federal Response: Policies & Issues. https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

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.

Addressing the Intersection of HIV and Methamphetamine Use

A recent convening, hosted by the O’Neill Institute, found government representatives, service providers, and community advocates discussing methamphetamine use among gay/bisexual men, transgender women, and transgender men under the lens of exploring stigma, sexual health, and HIV. The intersectionality between HIV and Methamphetamine, commonly known as “meth”, is significantly associated with greater risk for HIV transmission and numerous co-morbidities for people living with HIV.

Attendees received updates on existing data and policy relevant to methamphetamine use. Often overshadowed by the opioid epidemic, wherein the “gaps” in epidemiological data explicitly on meth use were glaringly obvious and largely dependent on supplemental data gathered during HIV outreach activities or related to broader assessments of substance use. Similarly obvious were the reasons why these data would be challenging to gather: law enforcement. According to the Substance Abuse and Mental Health Data Archive (SAMHDA), in 2019, more than 400,000 people who use methamphetamine were arrested and booked into jail for at least one time during the previous twelve (12) months. While the convening focused on gay, bisexual, and other men who have sex with men (MSM), transgender women, and transgender men, federal data found similar rates of methamphetamine use among heterosexual men and MSM. Additionally, there was no statistical difference in methamphetamine use between heterosexual women and lesbian-identified women. There was however an increase in self-reported methamphetamine use among bisexual women. Data provided did not distinguish between cisgender and transgender people, an issue explained as participants in data gathering were not asked necessarily asked questions regarding their sexual or gender identity, rather this information was largely assumed unless a participant disclosed otherwise.

Following the data sharing, patient advocates and service providers discussed their perspectives on what to consider in assessing policy and federally funded programs. Presenters highlighted their own lived-experiences as influencing their ideas on where policies and programs have succeeded and failed – largely coming to an unspoken consensus that we must do at least something differently than we are today. One presenter stated existing funding structures tend to reward large entities which is perceived to be at the expense of small service entities, which may or may not be trusted by people who use substances. Another focused on the contrary policy priorities being voiced by the Biden Administration between supporting harm reduction and supporting law enforcement – giving an explicit voice from community advocates that law enforcement often poses a threat of harm to drug users. Presenters also pointed out the need to distinguish between recreational use, misuse, and addiction, as the stigma associated with substance use often conflates these experiences with one another, when the reality is very, very different. For my part, I shared the idea that existing funding designs associated with HIV, where substance use harm reduction is largely aligned both on issues advocacy and service provision, may perpetuate social stigma by prioritizing the experiences and work of health care providers over that of patients – especially with regard to metrics of “success”. A reworking of funding and program designs and incentives that look at addressing health disparities from a human rights lens is necessary. Envisioning Ryan White programs as workforce development and community investment programs in addition to being public health programs, recognizing the potential detriment of a consolidating provider market and the need to incentivize provider diversification, and shifting funding and goals to better reflect efforts to meet the needs of communities as those communities define them.

Lastly, presenters shared honest assessments of “on the ground” perspectives and what programs are working. With meaningful geographic and demographic diversity represented on the final panel, confirming sentiments of the previous one, presenters discussed novel (and often underfunded) approaches to ensuring affected communities are receiving high quality sexual health education, linkage to care, and low-barrier interventions for those people are seeking them. Panelists discussed the need for policy makers and funding to reinforce those novel programs which do work and to consider novel metrics to better capture these successes. From reinvestments in the Ballroom scene as a safe and empowering space of expression to the successful effort from affected Latino communities in Texas to engage with their state health department, educating health care administrators and providers on the necessity of harm reduction, these programs which originate from the priorities of communities, rather than from the dictates of statehouses are already doing more and going farther than traditional programming.

So…why don’t we have more of this?

To learn more about the initiatives of the O’Neill Institute at Georgetown University, click here.

2020 HIV Surveillance Proves Earlier COVID-19 Concerns

On May 24th, the U.S. Centers for Disease Control and Prevention (CDC) issued its much anticipated annual HIV surveillance report. The anticipation is akin to waiting for a bill in the mail, “how bad is it gonna be?” In the same vein as this sentiment is the understanding that we, as a country, made the policy decisions to underinvest in public health programs, the political calculus in response to a public health emergency, and the diversion of already too scarce personnel and infrastructure resources in HIV in the effort to address COVID-19. We’re reminded of this shifting of costs, “robbing Peter to pay Paul”, throughout the annual report, in every infographic, and in the press releases associated with the report’s announcement: “Data for 2020 should be interpreted with caution due to the impact of the COVID-19 pandemic.”

Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, 2020. HIV Surveillance Report 2021;33; retrieved online at: https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-33/index.html

The top line of the report is a marked decrease in new HIV diagnoses; where since 2016, we’ve typically seem about a 3% annual decrease in new diagnoses, 2020 gave us a 17% decrease. The aforementioned press release states the decline in new diagnoses should be “attributed to declines in testing caused by less frequent visits to health centers, reduced outreach services, and shifting of public health staff to COVID-19 response activities.” The press release went further, remarking that because COVID-19 is “still ongoing, more time and data are needed to accurately assess COVID-19’s impact on HIV” and urged those relying on these data to not provide assessment s on trends in HIV diagnoses to include 2020 data are a result. A noted difference from traditional reports, this year’s supplemental Estimated HIV Incidence and Prevalence in the U.S. will not be published.

Another finding in the report is the rate of death for people with an HIV diagnosis. While the report appropriately notes the data is “all cause” deaths among people living with HIV and those deaths should not necessarily be attributed to an HIV-related complication, the incidence of death among people living with HIV did increase in 2020 significantly. This particular data category is one the CDC notes should not be “assessed” as misinterpretation is distinctly possible, if not likely. With more than one million dead from COVID-19 in the United States, HIV will not be an outlier in seeing increased all cause mortality. However, this data should be closely watched given our aging patient population and the high correlation between COVID-19 mortality risks and age.

The report encourages viewers to access the CDC’s data tool, Atlas Plus, to review “Stage 3” (AIDS) classification and prevalence. The data table for this shows a similar marked decrease in providers classifying patients living with HIV with advanced conditions and AIDS-defining diagnoses, compared to similar years. However, that decrease should be viewed extreme caution as data on linkage to and retention in care is not yet available. As NBC’s, Benjamin Ryan reported, some providers who saw patients drop out of care during the height of COVID-19-related restrictions and are now seeing patients return to care “devastatingly ill with multiple AIDS-defining diagnoses”.

A final note on the data provided, Black gay and bisexual and other men who have sex with men, Black women, and Black transgender people remain a patient demographic hard hit by new HIV diagnoses. The South accounts for nearly half of all new diagnoses. These things are not coincidental. While expanding Medicaid in southern states would provide additional opportunities for communities to find health care coverage, a lack of Medicaid expansion does not explain these geographic and demographic disparities. It is important to always recall the vast majority of the Black people living in the United States also happen to live in southern states – ultimately, racism, while hard to “measure” in a public health context, cannot be dismissed or overcome by the limited imagination of expanding Medicaid. Medicaid expansion would well-serve southern states and provide an excellent tool but should not be considered the only tool or surest answer to the social ills inflicting harm on southern Black communities.

Supplemental reports are published throughout the year, helping to further define the contours of the domestic epidemic. We’ll be monitoring and evaluating the data from these as they’re published and encourage stakeholders to review these data, weighing how best to support public health programs aimed at addressing HIV and the health and social disparities that drive the epidemic. As always, pertinent data monitoring public health programs serving at the intersection of HIV and Hepatitis C can be found in Community Access National Network’s quarterly HIV-HCV Coinfection Watch.

In multiple previous blogs throughout 2021 and during both the 2021 and 2022 Community Roundtable events, I’ve stressed the issue of “flying blind” as a result of losing hard earned ground with regard to regular testing, linkage to care, and engagement in care. The 2020 surveillance unfortunately proves this point and, as the CDC has noted, the COVID-19 pandemic is still ongoing. I’d go further and state the disruptions caused by the COVID-19 pandemic are also still ongoing. While many public health programs are working to recover personnel shifts, some state legislatures are cutting funding for health departments. Yes, activities associated with HIV programs are generally federally funded and administrative supports necessary to hire and train sufficient personnel are tied to broader public health programming and if these jobs aren’t filled, then the jobs associated with HIV programming may well go unfilled as well. Stakeholders will need to keep an eye on the evolution of data as we begin to uncover just how much COVID-19 has cost us in HIV progress.

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.

Pediatric Hepatitis of Unknown Origin: Are Viruses to Blame?

Navigating new and especially concerning developments can be challenging in the day and age of the Internet being the foremost platform for receiving up to date information…and misinformation. Navigating emerging evidence and opinions, prioritizing what “voices” hold prominence in your own formation of ideas can be difficult. I need to emphasize, the most reliable sources of information are official sources, those associated with government and institutions of positive reputation. Even if you have personal distaste for the approach or conclusions of these entities or personalities, their base facts are indeed facts, not conflation or cherry picking. Internet literacy is a critical skill set in navigating the most expedient tool of information. These details are particularly important as medical personnel and public health professionals turn their eyes to the developing issue of pediatric patients presenting with acute hepatitis “of unknown origin”.

At the time of this writing, more than 300 cases had been identified across more than 20 countries and at least 5 children have died. None of the cases being investigated have uncovered typical hepatitis viruses. According to a Centers for Disease Control and Prevention (CDC) brief, many of the cases in the United States have found active adenovirus infections. The CDC’s brief also “ruled out” COVID-19 as a cause. In the United Kingdom however, about 20% have uncovered active SARS-CoV-2 (the virus that causes COVID-19) infections. Other potential causes are being investigated as public health officials at the WHO and across are requesting providers share case data with local health departments in order to aggregate sufficient information.

Using the official CDC Director’s Twitter account, Dr. Rachel Walensky shared recently issued guidance to providers. The responses from users claiming a variety of expertise expressed concern at the CDC’s declaration that COVID-19 is not a potential cause for these cases. For these users, and likely parents watching the issue hit various news outlets, the omission of a potential for post-COVID responses seems odd and without an explanation and clarity as to investigative processes taken, doesn’t do a whole lot for repairing already deeply damaged public trust. Indeed, all of the readily available links on the issue from the CDC’s website exclusively point toward adenovirus, undermining the nature of investigative efforts to explore multiple potential causes. In contrast, the UK’s governmental updates outline why the COVID vaccine has been ruled out: most children affected are too young to have received the shots (the CDC’s briefing does not include this statement). The United Kingdom Health Security Agency’s latest update on this issue can be found here.

Part of why COVID is suspected is because of some of the unique features of the virus. A growing body of evidence is finding “pieces” of SARS-CoV-2 in a variety of body tissue, not just the lungs or brain as has been readily covered in other reports. One of the most persistent theories being tossed around includes hepatitis (generally, inflammation of the liver) as an issue of “long COVID” or a type of “post-viral” syndrome as a result of COVID infection. Part of the reason for that leap is SARS-CoV-2 has a special propensity for causing cell-to-cell fusion, resulting in “giant” cells with multiple nuclei and allowing the virus to spread in a body in an unusual fashion, evading the immune system. An additional concern is the issue of SARS-CoV-2 “superantigens” or a pathogen that “hyper-stimulates” immune responses. In one theory, currently being investigated, the super-antigenic effects of a COVID infection are being looked at as to the potential causation of multisystem inflammatory syndrome in children (MIS-C). Indeed, the issue is of such concern researchers have submitted to the Lancet (a leading scientific journal regarding infectious disease) an article urging providers to appropriately test tissue samples beyond blood in order to rule out potential long-lasting but harder to detect impacts of a SARS-CoV-2 infection.

Regardless of particular cause, at this stage, parents concerned about their children’s health should be aware that acute hepatitis tends to present similarly to most gastrointestinal bugs; abdominal pain, fever, vomiting, and nausea are common. Jaundice of the skin and eyes and darkening of urine are very key indicators something severe is occurring and needs immediate medical attention. Parents should contact their child’s provider if their children are expressing concerning symptoms.