Paternalistic Ableism Voices Are A Growing Threat to Silence Patient Advocates

By:  Brandon M. Macsata, ADAP Advocacy CEO, Ranier Simons, ADAP Blog Guest Contributor, and Kalvin Pugh, ADAP Advocacy 340B Patient Advisory Committee Member

Healthcare policy is a complex issue, especially in the United States, with its fragmented system. Numerous stakeholders compete to influence the healthcare ecosystem — all with financial stakes in the game — including government agencies, pharmaceutical manufacturers, hospitals, practitioners, pharmacy benefits managers, insurance companies, pharmacies, and patients. Some of these stakeholders embrace the patient experience and encourage their involvement in the debate because they recognize that it is they, as patients, who are at the center of the healthcare ecosystem. Sadly, others have contempt for patient involvement. Their contempt leads to patients being attacked for their views, sometimes even to character assassinations, because their views align with pharmaceutical industry interests.

Photo Source: Bioethics Today

The relationship between patient advocacy and industry has and continues to evolve. For example, decades ago, at the early stages of the HIV epidemic, the relationship was adversarial. People living with HIV/AIDS (PLWHA) felt targeted and attacked by the medical establishment. Fear and stigma generated from many unknowns left PLWHA marginalized and manipulated by science and society, effectuating institutional disempowerment.

As such, the Denver Principles came to fruition. In 1983, at the Fifth Annual National Lesbian and Gay Health Conference held in Denver, Colorado, a group of people came together and drafted a manifesto (Rodriguez, 2023). The Denver Principles manifesto was a declaration of dignity and a statement reclaiming the rights to be treated humanely and non-paternalistically regarding HIV related medical treatment. Most importantly, the Denver Principles established collective PLWHA advocacy, creating a voice that the general public and medical establishment would have to listen to. 

The Denver Principles manifesto consisted of four sections: recommendations for healthcare professionals, recommendations for people with AIDS, recommendations for all people, and the rights of people with AIDS (U.S. PLHIV Caucus, n.d.). One of the poignant recommendations for health care professionals was to “Treat People with AIDS as whole people and address psychosocial issues as well as biophysical ones” (U.S. PLHIV Caucus, n.d.). One of the principles for PLWHA was to “Be included in all AIDS forums with equal credibility as other participants, to share their own experiences and knowledge” (U.S. PLHIV Caucus, n.d.). A notable right of PLWHA stated was the right “To quality medical treatment and quality social service provision without discrimination of any form, including sexual orientation, gender, diagnosis, economic status or race” (U.S. PLHIV Caucus, n.d.).

Photo Source: i-base

Although the Denver Principles were birthed through an HIV lens, the conference where they were presented contained many varied panels, including holistic medicine and alcohol and substance abuse (Rodgriguez, 2023). Many advocacy populations have used the Denver Principles as a blueprint, which is evidence of the need for patient advocacy in multiple spaces. Advocating for beneficial healthcare policy, insurance reform, disease decriminalization laws, and even medication access requires discourse with and assistance from industry. Patients need industry to effectively comprehend and act upon their needs, just as industry needs patients to survive from a business perspective, as well as to engage positively as part of the overall social compact for a healthy, functioning dynamic. One example is that the pharmaceutical industry needs to create effective medications and help ensure patients have access to the drugs because dead patients don’t take medication.

Moreover, effective financial and other resource provision partnerships with industry allow advocacy groups to fight for patients in more direct ways than industry can. Industry wants patient populations to thrive just as patients desire the infrastructure to enable them to live their best lives. When a patient's needs align with industry wants, industry financial backing does not turn patients into marketing lobbying slaves. There is no patient benefit in advocating or pushing an agenda that is not in the best interests of patient health and overall well-being. Patients are independent thinkers and are not manipulated by corporate malfeasance. Many advocacy groups that receive financial backing forthrightly communicate to their sponsors that they will never advocate for something that contradicts their beliefs, even if it may be beneficial to the corporate bottom line. 

When critics of the drug manufacturers, or even fellow advocates, attempt to denigrate the contributions of individuals or organizations that align themselves with industry partners, it is not the insult one may think. It reflects the other party's lack of imagination for what valuable collaborative partnerships can be. Other thought-leaders express an enlightened view, evidenced by extensive research done on the patient experience with industry, thereby demonstrating the mutually beneficial relationship.

Photo Source: LinkedIn | Matt Toresco

Negatively characterizing patient advocacy for “having industry ties” also demonstrates a vile attitude that patients aren’t independent-minded, well-equipped with critical thinking skills. Instead, their “gotcha” attitudes are deeply rooted in paternalistic ableism. This line of thinking, recently on display by a reporter for a faux digital “news” outlet on all things 340B-related, often leads to character assassinations of patients living with severe chronic health conditions, sometimes even life-threatening ones, for expressing their opinions. It truly matters not if these patient advocates or patient advocacy organizations accept financial sponsorships from drug manufacturers; simply agreeing with industry, in their paternalistic ableism lens, disqualifies them from expressing those opinions.

In reality, patients are educated and savvy enough to come to their own conclusions about what is best for their healthcare. Equally valid, patients come to different conclusions without being told what to think or accepting a financial sponsorship.

It may be understandable from some in the HIV space who carry with them the trauma of what happened in the 1980s, or what appears to be slow responses and delayed medication options. But today is not 1985. It is 2025, where we all face uphill uncertainty, and it’s important to reframe our thinking when the truth is that patients and industry can, and do, share common goals.

Attacking patients is paternal at best, and demeaning at worst. When entities attack patient advocacy groups with malicious intent, it is evidence that the motivations of those entities are not patient-focused. It is deliberately irresponsible when individuals or entities slander the work of effective patient advocacy groups by using feeble allegations of insignificant operational characteristics to create a narrative of impropriety. Such actions raise questions about the motivations and funding of entities engaged in this behavior.

Photo Source: ABC News - Australia

The landscape of healthcare in the United States often leaves patients feeling like helpless pawns devoured by the cogs of the machinery of a complex system. The avenues for patients to fight for themselves continue to evolve. Patient advocacy encompasses a range of efforts, from individual initiatives to partnerships and community groups. Effective advocacy requires resources such as networking connections, access to subject matter experts, education, communications, data analysis, travel, and more. These endeavors often require financial resources as well. At times, health industry entities partner with patient advocacy groups, providing the necessary funding to enable patients to advocate for decisions that affect their lives, ensuring they are made with a patient-focused lens. 

Industry money does not render patient advocacy tainted or disingenuous. Often, patient goals align with industry goals in a manner like that of patient-provider alignment. Unfortunately, entities that do not have patient well-being at the forefront of their motivations often deliberately conflate industry funding with manipulation, portraying ‘patient advocacy as industry shill’ as a misguided narrative. Simply put, they’re wrong!

[1] Rodriguez, M. (2023, July 5). Remembering the Denver Principles, 40 years later. Retrieved from https://www.thebody.com/article/hiv-denver-principles-40-years-later

[2] U.S. PLHIV Caucus. (n.d.). The Denver Principles (1983). Retrieved from https://www.hivcaucus.org/resource-links/the-denver-principles-1983

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

HIV Cure Breakthrough or Yet Another Fading Hope?

By: Ranier Simons, ADAP Blog Guest Contributor

After decades of research and scientific breakthroughs, there is still no cure for HIV. Medical science has achieved significant advancements in testing, treatment, and prevention. HIV has only been eliminated from the body six times in people who required their own immune system to be completely eradicated and replaced through allogenic stem cell transplantation due to cancer (Cairns, 2023). This type of procedure is not viable for widespread use, given its health risks and likelihood of failure. HIV’s elusive ability to mutate and hide inside immune cells is what makes it formidable. However, a recent breakthrough gives hope that the virus’s ability to hide from the body’s immune system will soon be disrupted.

Photo Source: Drug Discovery World

Modern antiretroviral treatment (ART) is successful at achieving viral suppression to undetectable levels because it interferes with HIV’s ability to replicate. However, if ART is discontinued or inconsistent, HIV can resume replication, which is why lifelong ART is necessary. Even in people with undetectable status, some of the HIV virus is able to ‘hide in plain sight’ by infecting memory T-cells, integrating its proviral DNA, and lying dormant. The function of memory T-cells is to remember previous biological infections to enable the body to swiftly react (Cairns, 2023). By hiding inside immune cells, the HIV virus lies dormant and, in essence, is unable to be seen by the immune system, thus creating what medical science describes as an HIV reservoir, available for reactivation.

Recent research conducted in Australia indicates a means to identify where the HIV reservoir hides (Lay, 2025). Scientists were able to successfully deliver messenger RNA (mRNA) into the memory T-cells to instruct the cells to show where HIV is hiding. They achieved this by using lipid nanoparticles (LNPs) to transfect the resting T-cells with the desired mRNA. Previous attempts at using LNPs failed because it is difficult to coax the memory T-cells into uptaking the genetic material. Previous LNPs would not integrate. A new type of LNP enabled the cells to accept the entrance of the mRNA material, instructing the cell to express latent HIV (Cevaal et al., 2025). This new type of HIV-specific LNP essentially makes the T-cells wake the dormant HIV from its resting state. The LNPs were able to manipulate the T-cells without killing them. The hope is that when the body can identify the hidden HIV reservoir, it can attack and eradicate the virus (Cevaal et al., 2025). 

Although in its early stages, the breakthrough is promising, as it reveals a tool to shine a light on the HIV reservoir. Many questions remain regarding the future of this line of  HIV-related LNP research. It is not clear whether it is sufficient to wake dormant, hiding HIV to ‘show’ the body where it is to allow immune defenses to go after it, or if additional cellular activity will be required. Most importantly, scientists are uncertain about the level of ‘revelation’ required. Meaning, is it necessary to destroy the entirety of the HIV reservoir to render a person functionally HIV suppressed, or just a percentage? If only a percentage is required, then how much (Cevaal et al., 2025)?

Photo Source: Drug Discovery World 

This research is also promising because it has the potential to benefit the treatment of other diseases. The development of this study’s HIV-specific LNP could lead to the development of treatments for other T cell-implicated diseases or the generation of T cell-based immunotherapies (Cevaal et al., 2025). This study is another example of how HIV research has led to scientific benefits for many other diseases, including cancer.

Eradicating HIV requires solutions that are replicable, scalable, and permanent. These types of studies are promising since they are gene-therapy related. Research into ways of editing the body's instructions to make it immune to HIV infection or generate cellular environments inhospitable to HIV could potentially be less expensive and less taxing on the body than lifetime ART. The cells used for the study were donated by HIV patients. Many years of animal testing and human trials will be necessary before this research can be applied to help people. However, it is a promising start and could also help to develop tools to identify HIV in other parts of the body besides immune cells, where the virus may be hiding.

[1] Cairns, G. (2023, December). Why is HIV hard to cure? Retrieved from https://www.aidsmap.com/about-hiv/why-hiv-hard-cure

[2] Lay, K. (2025, June 5). Breakthrough in search for HIV cure leaves researchers overwhelmed. Retrieved from https://www.theguardian.com/global-development/2025/jun/05/breakthrough-in-search-for-hiv-cure-leaves-researchers-overwhelmed

[3] Cevaal, P.M. et al. (2025) ‘Efficient mrna delivery to resting T cells to reverse HIV latency’, Retrieved from https://www.nature.com/articles/s41467-025-60001-2#citeas. Nature Communications, 16(1). doi:10.1038/s41467-025-60001-2

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Barriers Mount for Undocumented Residents Seeking Health Care

By: Ranier Simons, ADAP Blog Guest Contributor

The Trump Administration’s aggressive posture on immigration is exerting chaotic uncertainty on many aspects of the lives of undocumented residents and those without permanent citizenship. This includes health care, where recent actions could result in a public health crisis. Federal and state actions are adversely affecting health care access for affected populations, including threatening HIV-related care. Many stakeholders are speaking out about the consequences of the President’s executive order targeting federal benefits for those deemed to be living in the country illegally. There is also litigation being pursued in an attempt to mitigate present and potential harms. Adverse effects on the undocumented population’s access to healthcare are a population health problem for all.

Photo Source: BBC

In February 2025, the President issued an executive order to eliminate all federal benefits for illegal immigrants as part of his ongoing campaign deriding fiscal waste, fraud, and abuse (Samuels, 2025). The utility of the order is unclear, as noncitizens, except for refugees and in some instances of emergencies, were already ineligible for federal benefits like Supplemental Nutritional Assistance Program (SNAP) and Temporary Assistance for Needy Families (TANF) (Broder & Lessard, 2024). 

It does pose as a deterrent for anyone seeking to enter the country illegally to access assistance and benefits. The order also requests improvements to eligibility verification systems and requires people found to be improperly obtaining federal benefits to be referred to the Justice Department and Homeland Security (Samuels, 2025). Without a clear indication of what programs are being specifically targeted, the order creates instability due to uncertainty. It also potentially leads to concerns about healthcare access.

In July, in alignment with the February executive order, HHS reversed a Clinton-era interpretation of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) (HHS, 2025). This interpretation enabled individuals without permanent legal status to access specific federal benefits, such as Head Start and community health centers, including federally qualified health centers (FQHCs). The new HHS policy reversal states that undocumented individuals can no longer benefit from taxpayer-funded programs, such as FQHCs, and a list of other initiatives (HHS, 2025). 

Federal regulations require community health centers, such as FQHCs, to provide care to all residents within their service area. The HHS reversal conflicts with the federal Health Center Program as authorized in Section 330 of the Public Health Service Act (PHSA). It leaves community health facilities in an unstable position. Shawn K. Frick, CEO of the Community Health Center Association of Connecticut, stated, “The notice from the U.S. Department of Health and Human Services raises significant questions about how community health centers in Connecticut and across the country can continue to meet their legal and moral obligations” (Carlesso, 2025).

Community health centers are dedicated to providing comprehensive care for all individuals to maintain public health. Connecticut health care leaders are concerned about how the conflicting messaging could negatively impact their ability to provide quality care. Currently, they do not inquire about a person's legal immigration status. If they eventually are told they have to verify status before providing care, many residents will fall out of care. Moreover, centers are not equipped to effectively verify status, which would add to the administrative burden of community health centers. In Connecticut, providers are already reporting that patients are cancelling appointments and requesting to be changed to telehealth services to avoid physically coming into treatment out of fear of deportation (Carlesso, 2025).

Photo Source: USA Today

Connecticut practitioners are also concerned about potentially having to deny care to people receiving care under the Connecticut HUSKY for immigrants program, giving government-sponsored health benefits to undocumented persons, such as 15,600 children who are enrolled in the program (Carlesso, 2025). Preventive healthcare prevents public health from deteriorating to poorer states of health, which require more expensive intervention. Keeping people healthy is beneficial for both public health and the local and state economies. 

People who do not maintain their health issues advance to disease states that result in high emergency room utilization. Senate Minority Leader Stephen Harding, R-Brookfield, and Sen. Heather Somers, R-Groton, expressed that the U.S. Department of Health & Human Services (HHS) announcement does not ban services for undocumented residents. They feel it simply means that undocumented residents can seek care at FQHCs, but will have to pay for it completely themselves without any taxpayer-funded assistance (Carlesso, 2025). Presently, Connecticut practitioners are not denying any care nor interrogating for legal status. However, the uncertainty of future guidance is already negatively affecting the vulnerable populations in need of care. 

This month, twenty state Democratic attorneys general (AGs) and the District of Columbia sued the Trump Administration over the HHS policy change (Goldman, 2025). They argue that the administration overstepped and violated administrative law. They also emphasized the serious harm to public health and the lack of resources for programs such as homeless shelters, overdose emergency services, and more to perform eligibility verifications at the point of services (Goldman, 2025). New York Attorney General Letitia James said in a statement, "These programs work because they are open, accessible, and grounded in compassion…This is a baseless attack on some of our country's most effective and inclusive public programs, and we will not let it stand” (Goldman, 2025). 

Attempting to bar noncitizen residents from certain lifesaving care services provided through federal funding is literally a matter of life and death for people living with HIV/AIDS (PLWHA). The Ryan White HIV/AIDS Program (RWHAP) is the only means by which undocumented PLWHA are able to receive their care and antiretroviral medication. Without care, they would lose viral suppression, progress to advanced disease states, and would also be at risk for increasing transmission rates. The RWHAP does not require proof of citizenship or residency (Mercer, 2025).

However, state laws have the potential to endanger the ability of undocumented PLWHA to receive HIV care from the RWHAP. Idaho passed HB135, which required people to prove their legal status before accessing public benefits such as HIV testing, other communicable disease testing, and HIV treatment programs, both federal and non-federal. (Mercer, 2025). The ACLU of Idaho, the National Immigration Law Center, and several other parties filed a lawsuit to request a temporary restraining order (TRO) to prevent Idaho from enforcing HB135 in regard to HIV treatment. A federal judge granted the TRO, which means that, for now, noncitizen PLWHA in Idaho will not be denied their lifesaving medication and care. (Mercer, 2025). However, if the injunction is not continually extended or made permanent, or if the state legally appeals and the decision is reversed, then access could be lost. The future of lifesaving HIV care access through RWHAP for undocumented PLWHA is uncertain, with the potential conundrum of states pursuing legislation in conflict with the federal RWHAP requirements of providing care for all, regardless of legal status.

Photo Source: Georgetown Univ. McCourt School of Public Policy

People living without permanent legal status are also losing access to healthcare as a result of Medicaid rollbacks. California, Illinois, and Minnesota are reversing the Medicaid expansions that the states previously enacted, which allowed thousands of undocumented immigrants to access Medicaid coverage (Nguyen & Shastri, 2025). The changes are due to budgetary constraints coupled with looming cuts to federal Medicaid funding. California is not removing any adult immigrants from the rolls, but new enrollments will cease in 2026, and adults under 60 years of age will be required to pay a $ 30 monthly fee. Illinois will be rescinding coverage to adult immigrants without legal status aged 42 to 64, and Minnesota’s new budget cuts Medicaid coverage for all undocumented adults (Nguyen & Shastri, 2025). Children in Minnesota will remain covered, but adults will need to purchase private health insurance. Patients will lose coverage for life-sustaining and preventive care, and providers will lose revenue due to lost billing from the program.

The current administration’s targeting of healthcare access of undocumented immigrants in the name of fiscal responsibility does not generate savings, justifying the damage that will result in regard to public health. Moreover, potentially requiring community health centers to verify legal status is an expansion of federal efforts to identify undocumented individuals for the purposes of deportation. The outcome of existing lawsuits will set precedents and provide a positive or negative trajectory for the public health of undocumented residents.

[1] Broder, T., Lessard, G. (2024, May 1). Overview of Immigrant Eligibility for Federal Programs. Retrieved from https://www.nilc.org/resources/overview-immeligfedprograms/

[2] Carlesso, J. (2025, July 15).HHS ban on serving undocumented clients a ‘fundamental shift,’ CT health centers say. Retrieved from   https://ctmirror.org/2025/07/15/ct-health-centers-undocumented-immigrants/

[3] Goldman, M. (2025, July 21). States sue over citizenship curbs on Head Start, clinics. Retrieved from https://www.axios.com/2025/07/21/states-sue-trump-public-benefit

[4] Mercer, O. (2025, July 1). Federal Judge Blocks Idaho Immigration Law Affecting HIV Program Access. Retrieved from https://www.visaverge.com/immigration/federal-judge-blocks-idaho-immigration-law-affecting-hiv-program-access/

[5] Nguyen, T., Shastri, D. (2025, July 21). 3 Democrat-led states have rolled back Medicaid access for people lacking permanent legal status. Retrieved from https://apnews.com/article/medicaid-immigrants-california-illinois-minnesota-ice-f43d5681a6e9d45d274790c2eae716ee?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-8GpW2rskV94yxV8zgIxLwBJHqYTLYFuHf0Ec0s8bO1rTORv8fR7tl7vcUtRPiM_WxLN4QbolpLKXOrUaKFljag-siC6Q&_hsmi=372382415&utm_content=372382415&utm_source=hs_email

[6] Samuels, B. (2025, February 19). Trump signs order targeting any federal benefits going to those in the country illegally. Retrieved from https://thehill.com/homenews/administration/5154614-trump-order-federal-benefits/

[7] U.S. Department of Health and Human Services (HHS). (2025, July 10). Press Release: HHS Bans Illegal Aliens from Accessing its Taxpayer-Funded Programs. Retrieved fromhttps://www.hhs.gov/press-room/prwora-hhs-bans-illegal-aliens-accessing-taxpayer-funded-programs.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

Fake HIV Medicine Finds Its Way into NYC Pharmacies

By: Ranier Simons, ADAP Blog Guest Contributor

Counterfeit medication is a serious threat to public health in 2025. There have been numerous warnings issued over fake cancer drugs, fake Botox, and more recently, counterfeit GLP-1s. While obscure online pharmacies and other non-traditional sources remain easy access points for fake drugs, they are increasingly infiltrating the legitimate supply chain. On several occasions in recent years, the HIV drug supply chain has been at the center of counterfeit drug schemes, often perpetrated by nefarious actors using gay dating apps, like Grindr and Jack'd. And now, according to an alert by the Partnership for Safe Medicines, alleged fake HIV medicines have been found in a New York City pharmacy.

Photo Source: American Medical Women's Association

Gilead Sciences has been a repeat victim of counterfeit drug schemes over the past few years. In 2021, taking advantage of the COVID-19 pandemic, counterfeiters targeted Gilead’s remdesivir. The investigation revealed that a significant portion was coming from Mexico and Turkey (Gilead Sciences, n.d.). In 2022, Gilead filed a lawsuit against a ring of counterfeiters selling over 85,000 fraudulent bottles of its HIV antiretrovirals Biktarvy and Descovy (Walker & Ramey, 2022). Although Gilead has seized thousands of bottles of counterfeit drugs from unauthorized distributors and won lawsuits, the harm continues. A U.S. District court in New York recently unsealed another complaint filed by Gilead Sciences.

A patient contacted Gilead because the bottle of Biktarvy they purchased from their local pharmacy was short by eight pills. Upon investigating the bottle, Gilead discovered that the label was a high-quality fake. The lot number on the bottle was outdated, and the expiration date was falsified. The packaging was a well-done counterfeit, as it contained only a minor typo, and the print resolution of the branding was only moderately off. Alarmingly, the patient had already consumed all the pills; thus, it was impossible to know if the pills in the bottle were Biktarvy or some other substance (Gilead vs. City Plus, 2025). Notably, evidence showed that the contents were filled by the counterfeiters, not Gilead. In past counterfeit transgressions involving Gilead medications, bottles were filled with medications other than the ones intended to be in them. Taking medications not prescribed to a patient could result in adverse effects ranging from overdoses of unnecessary medications to the advancement of disease states because of non-treatment with the proper drug.

Photo Source: Partnership for Safe Medicines

The most pertinent issue of the lawsuit Gilead is filing against the pharmacy that sold the counterfeit drug is that the pharmacy’s owner and operators will not voluntarily reveal the source of the fraudulent medication (Gilead vs. City Plus, 2025). As Gilead points out in the complaint, “Any legitimate pharmacy would be horrified to learn it had dispensed counterfeit HIV medicine and would do all in its power to identify the source of the counterfeit and stop it from happening again. The Defendants here instead obstructed Gilead’s investigation and refused to provide any information about the counterfeit they sold” (Gilead vs. City Plus, 2025). The fake packaging is very sophisticated and requires expensive equipment. Thus, Gilead explains that the elaborate effort indicates a larger counterfeit manufacturing scheme. Gilead accuses the pharmacy of participating in the counterfeiting and distribution of fraudulent medications, not just Biktarvy, but also others, given the sophistication of the machinery necessary to create the fake packaging.

Gilead Sciences is poised to suffer significant monetary losses due to the sale of counterfeit medications, as well as potential damage to its brand and reputation. However, the most alarming issue is the danger to public health (Gilead vs. City Plus, 2025). Hiding the source of the counterfeit medications delays the stoppage of the flow of harmful medications into the drug supply. The investment necessary to procure the labeling and printing equipment used to create the fake Biktarvy means that other medications are likely being counterfeited on a large scale. In addition to the cessation of selling any Gilead-branded medications, whether legitimate or counterfeit, and punitive damages, Gilead Sciences demands the destruction and impounding of the pharmacy’s Gilead-branded supply. It also demands that the offending pharmacy turn over all documentation associated with the purchase and sale of Gilead-labeled medications.

Counterfeiters target expensive and widely utilized medications, other than just HIV antiretrovirals. "This is another benefit of the Drug Supply Chain Safety Act (DSCSA) for patient safety. The DSCSA created a standard way to trace medicine, and a standard way for honest pharmacies to prove their innocence," said Shabbir Imber Safdar, Executive Director of the Partnership for Safe Medicines. He added, “This standardization of documentation means that a supply chain member who has strayed from the safe supply chain cannot stall investigators for weeks hiding their crime." Popular targets are painkillers, antibiotics, and ‘lifestyle’ drugs. In April 2025, the FDA issued a warning about several hundred units of counterfeit Ozempic it had seized (Lovelace, 2025). Previously, thousands of counterfeit Ozempic 1 milligram injections had been seized by the FDA from warehouses outside of Novo Nordisk’s authorized supply chain in 2023 (Reuters, 2023). Additionally, a group of patients in Australia were harmed by fake Ozempic. The patients experienced hypoglycemia and seizures, indicating the counterfeit injections contained insulin instead of Ozempic’s semaglutide (Burger & Murray 2023). The adverse effects could have been deadly. The counterfeit injection pens had been obtained online. The European Medicines Agency (EMA) confirmed that none of the fake Ozempic had reached retail pharmacies.

Photo Source: Statista

The cost of prescription medication remains a trending topic in the news cycle as well as a financial concern for many Americans. Legislation, such as parts of the Inflation Reduction Act, in addition to pharmacy benefit manager (PBM) operations, currently places pharmacies, especially independent ones, under financial strain. This creates an environment for counterfeit drug manufacturers to find inroads to circulate fraudulent products in the legitimate supply chain. The pharmacy in the recent Gilead suit appears to be a willing participant in the fraud (Gilead vs. City Plus, 2025). Safdar adds, "if true, these allegations of dispensing counterfeit medications reveal a deep betrayal of patients and a violation of patient safety. American patients should never have to worry if they are receiving real medicine when dealing with licensed bricks and mortar pharmacies." However, given the growing sophistication of counterfeit drug production, in an attempt to stay financially sound, unknowing pharmacies could fall victim to improperly sourced products. Counterfeiters create false sourcing documentation in addition to fake products and packaging. 

The World Health Organization estimates the global counterfeit pharmaceutical market value to be between $75 billion and $200 billion (Izgi & Altunay, 2025). It is imperative for the United States to propagate policies that strengthen the drug supply chain and bolster pharmacy support. It is not hyperbole to say that counterfeit medications are a matter of life and death. They are both an international and a domestic issue, given that pharmaceuticals are global products. It would be beneficial for the Department of Justice to take an interest in the current Gilead Sciences complaint, as well as the broader issue of counterfeit pharmaceuticals.

[1] Burger, L., Murray, M. (2023, October 24). Suspected fake Ozempic puts several in hospital in Austria. Retrieved from https://www.reuters.com/world/europe/several-people-taken-hospital-austria-after-taking-suspected-fake-ozempic-2023-10-24/

[2] Gilead Sciences vs. City Plus Care Pharmacy. 2025, March 17). Case 1:25-cv-01469-RER-RML. Retrieved from https://www.safemedicines.org/wp-content/uploads/2019/09/Heal-the-World-Complaint-as-filed.pdf

[3] Izgi, G., Altunay, M. (2025, June 2). Counterfeit pharmaceuticals: innovative strategies for combatting global health threats. Retrieved from https://www.ibanet.org/counterfeit-pharmaceuticals-innovative-strategies 

[4] Lovelace, B. (2025, April14). FDA warns about fake Ozempic in U.S. supply chain. Retrieved from  https://www.nbcnews.com/health/health-news/fda-warns-fake-ozempic-us-supply-chain-rcna201184

[5] Reuters. (2023, December 22). US FDA warns about counterfeit versions of Novo's diabetes drug Ozempic. Retrieved fromhttps://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-about-counterfeit-versions-novos-diabetes-drug-ozempic-2023-12-21/

[6] Walker, J, Ramey, C. (2022, January 18). Drugmaker Gilead Alleges Counterfeiting Ring Sold Its HIV Drugs. Retrieved from https://www.wsj.com/health/pharma/drugmaker-gilead-alleges-counterfeiting-ring-sold-its-hiv-drugs-11642526471

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

CALL TO ACTION: HIV Medication Carve-Out Exemption from the Medicare Drug Price Negotiation Program

By: Marcus J. Hopkins, ADAP 340B Consultant

ADAP Advocacy has submitted public comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed guidance for the Medicare Drug Price Negotiation Program (“Negotiation Program”) established under the Inflation Reduction Act (2022):

While ADAP Advocacy’s objections to the Negotiation Program’s proposed implementation are several, our primary request is for the creation of a carve-out exemption for all medications used for the treatment of HIV/AIDS in the U.S. that would prevent these treatments from being eligible for any future Medicare price negotiations.

Photo Source: CMS

ADAP Advocacy has requested this carve-out exemption due to the serious nature of the threat facing People Living with HIV/AIDS (PLWHA), should HIV medications be selected as part of the Negotiation Program. While the HIV treatment landscape has improved significantly over the last 25 years, today only a handful of manufacturers continue to work in the HIV space, including Gilead Sciences, ViiV Healthcare, and Merck. Over the past decade, three manufacturers—Bristol Myers Squibb, AbbVie, and Johnson & Johnson—have withdrawn from the HIV space for various reasons, not least of which is the difficulty of competing in a landscape where many of the most significant innovations, including well tolerated single-pill regimens, long-acting injectable agents, and highly effective oral and injectable prophylaxis, have already occurred.

As part of this effort, ADAP Advocacy has also spearheaded a national sign-on letter seeking support from national, state, and local advocacy organizations. The letter and the signature form are available online at: https://www.adapadvocacy.org/letter-cms-hiv-carveout.php. 

The Negotiation Program essentially requires manufacturers to accept the final price after four negotiation meetings set by CMS, reject the offer, and pay a 95% excise tax on all of the medications sold to Medicare payors, or remove their products from the Medicare formularies altogether (Hammond, 2024). Because no business can feasibly accept a 95% excise tax and remain viable, manufacturers are left with the unenviable decision to either accept significant profit losses in the Medicare market or withdraw their drugs.

Photo Source: Inside Sources

The prospect of losing access to HIV medications paid for through Medicare poses a significant risk to PLWHA. Medicare is the 2nd-largest payor of HIV treatment and care in the United States, accounting for 39% of federal spending in 2020, and serving 28% of PLWHA (Dawson, et al., 2023). Additionally, 77% of PLWHA who are enrolled in Medicare first qualified for the program not because of age but because of a disability diagnosis.

Patients who lose access to HIV medications may fall out of treatment entirely, placing them at risk of dying from opportunistic infections or having their HIV mutate to develop resistance to the medications used to achieve viral suppression—when the number of actively replicating HIV cells drops below 200 copies per milliliter of blood. In addition to these primary risks, patients whose HIV is not virally suppressed, or undetectable, can pass along the virus to others. In contrast, those whose viral load is undetectable are unable to do so.

In addition to the carve-out for HIV medications, ADAP Advocacy made the following recommendations:

1. CMS should implement a standardized Market Fair Price calculation methodology that replaces the methodology outlined in section 60.3 that is clear, transparent, and made available to manufacturers at the time the Market Fair Price is determined and when the initial offer is made to manufacturers;
2. CMS should revise its definition of “selected drug” as set forth in section 30.1 to ensure limit the inclusion of multiple formulations and strengths of medications to ensure that price determinations and negotiations are made in good faith;
3. CMS should undertake an immediate patient engagement campaign prior to the implementation of the proposed guidance for the Negotiation Program to ensure that Medicare beneficiaries have a clear understanding of how the Program will directly impact them and to allow patients to provide meaningful feedback and opinions to help guide the program to better patient-centered outcomes; and
4. CMS should exclude any cost-effectiveness calculations that utilize biased and discriminatory metrics, including Quality-Adjusted Life Years and similar measures of medical intervention efficacy.

A precedent already exists for protecting vulnerable populations from the unintended consequences of changes to the healthcare ecosystem, as evidenced by Medicare’s six protected classes (6PC). In Medicare Part D, 6PC protects vulnerable seniors and low-income beneficiaries with severe and complex health conditions, while also allowing Part D insurance plans to utilize the necessary tools to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness. Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions (Johnson, 2019).

Photo Source: VAROS

Healthcare decisions for complex health conditions should be left to patients, and their doctors. For people living with HIV/AIDS, numerous factors come into play when determining the appropriate highly active anti-retroviral therapy (HAART). And now with the advent of injectable HIV therapy, such decisions take-on an entirely new dimension."

These recommendations represent the bare minimum of changes that should be made to the Negotiation Program. ADAP Advocacy asks advocacy organizations to add their names to the circulating sign-on letter, as it continues to work with legislative and administrative officials to ensure that patient voices are heard and their access to life-saving treatments is sustained.

[1] Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023, May 27). Medicare and People with HIV. KFF: HIV/AIDS. https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/

[2] Hammon, J. (2024, August 19). Price controls – bad policy, big problems. Washington, DC: Paragon Health Institute. https://paragoninstitute.org/paragon-prognosis/price-controls-bad-policy-big-problems/

[3] Inflation Reduction Act of 2022, Pub. L. No. 117-169, 136 Stat. 1818 (2022). https://www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf

[4] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.     

OPINION: The 340B Program Isn't Broken—It Was Built to Exclude Us

By: Ryan Alvey, Founder & Executive Director of the Positive Change Movement, and ADAP Advocacy 340B Patient Advisory Committee Member

I grew up gay in rural Kentucky—bullied, shamed, and told I had to pray the “sissy” away. At 17, I joined the military, thinking it would make me a man. It didn’t. What followed were years of trying to survive—through addiction, toxic relationships, and the adult film industry. Systems designed to help people struggling with life often fall short for someone like me.

In 2020, I was diagnosed with HIV. I thought it would break me. But instead, it sparked something in me—a drive to help others, to create something better, to make sure no one else felt the isolation I did. I pursued certifications. I trained. I showed up ready to lead. I believed that my lived experience was not a barrier, but an asset.

When I tried to step into leadership, the door was slammed shut. Local HIV service organizations in Kentucky weren’t interested in patients speaking up for themselves, especially not those of us living openly with HIV, eager to speak.

Fast-forward to 2025, when the ADAP Advocacy Association took a chance on me and offered me a seat on their 340B Patient Advisory Committee. I spent months digging into the 340B Drug Pricing Program, created over 30 years ago to help poor patients access lifesaving care. What I found instead was a program rife with exploitation, where profits are protected, and patients like me are left out.

So, I launched Fiscal Watchdog, a project to track the money and shed light on what these nonprofit giants would rather keep hidden. What I’ve discovered so far is infuriating. Multi-million-dollar hospital CEOs, while clinics serving marginalized people close their doors. 340B discounts meant for patients are instead generating surplus revenue, and very little is reinvested in community care. Tax-exempt organizations spend more on real estate and branding than on direct services, claiming to “empower” us. And across the board, People Living with HIV are excluded from boards, executive roles, and decision-making tables.

These organizations claim to serve us, but their filings and financial statements suggest otherwise.

Photo Source: 340B Map

This isn’t just about one organization. This is about an entire system that pretends to serve while quietly excluding. Hospitals and mega-service providers are helping patients, yes, but not to the extent that they could be helping us, because money is being spent on executive pay increases, questionable capital improvements, and sometimes, even funding ballot initiatives. How do any of these things help patients like me? I’ve seen it firsthand: people with lived experience—those in recovery, those living with HIV, those who've survived the streets—are pushed to the margins, tokenized when convenient, and discarded when they speak up.

These systems weren’t designed to empower us. They were built to contain us. However, participating in the 340B Patient Advisory Committee has allowed me to speak up and demand change. Pharmaceutical manufacturers aren’t perfect, but their calls for greater accountability and transparency seem reasonable to me, and that’s why it is time to remove any barrier that prohibits patients from seeing what is really going on.

Across Kentucky and beyond, gatekeeping in HIV services is rampant. Organizations claim to value equity, but their leadership is overwhelmingly white, cisgender, and disconnected from the communities they serve. Funding is allocated in ways that prioritize status quo institutions, rather than grassroots solutions. And when people like me speak up, we’re labeled "difficult" or "unprofessional," simply for demanding what’s right.

I’m sharing my story because I'm not the only one. Countless others—brilliant, resilient people—are kept out of leadership positions, denied jobs, or dismissed by systems meant to support us. Patients like me deserve to be at the table on issues like the 340B Program.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.    

State Payors Make Advancements in Coverage of HIV Long-Acting Injectable Treatments

By: Marcus J. Hopkins, ADAP 340B Consultant

As of June 2025, 47 state AIDS Drug Assistance Programs (ADAPs) and all state Medicaid programs offer coverage for Cabenuva (cabotegravir; rilpivirine), a long-acting injectable (LAI) for the treatment of HIV/AIDS. This represents a significant change from 2023, when ADAP Advocacy found that just 40 state ADAP and 39 state Medicaid programs offered coverage for Cabenuva.

According to the National Alliance of State and Territorial AIDS Directors (NASTAD), only four state ADAP programs—Louisiana, Missouri, South Dakota, and Texas—do not currently offer coverage for Cabenuva. However, last month the Texas Legislature approved $338 billion two-year spending plan with funds to support Long-Acting Injectables (LAIs) for the Texas AIDS Drug Assistance Program (Figure 1).

Figure 1 – Long-Acting Injectable Coverage Map – Cabenuva – ADAP Coverage by State, June 2025

In addition to 47 state ADAPs offering coverage for Cabenuva, all state Medicaid programs currently provide coverage through either their fee-for-service Medicaid program or one of their Managed Care Organizations (MCOs; Figure 2). Medicaid coverage of Cabenuva, along with coverage provided by commercial insurance plans, is more difficult to quantify, as many plans may include coverage as a medical benefit rather than a pharmacy benefit. Finding information about drugs covered as medical benefits often requires searching through dozens, if not hundreds, of plan documents.

This was the case when researching Medicaid Preferred Drug Lists (PDLs). When ADAP Advocacy was unable to find direct confirmation of coverage for Cabenuva, it relied upon Long-Acting Agent Resource Center’s Cabenuva Coverage Map, a project of the American Academy of HIV Medicine (https://hivlaa.org/map/), to provide coverage information. Coverage information for the following 11 states was gleaned using this resource: Colorado, Georgia, Indiana, Iowa, Kansas, Kentucky, Montana, Nebraska, South Carolina, South Dakota, and Wisconsin.

Figure 2 – Long-Acting Injectable Coverage Map – Cabenuva – Medicaid Coverage by State, June 2025

ADAP Advocacy, under the direction of its 13-member ADAP Long-Acting Injectables Patient Advisory Committee, first began tracking ADAP and Medicaid coverage of Cabenuva, along with other LAIs to prevent or treat HIV in 2023 (Hopkins, 2023), when it was discovered that several state Medicaid programs were offering coverage of Cabenuva—first approved for monthly treatment in 2021, with a secondary approval for bi-monthly injections in 2022 (ViiV Healthcare, 2022)—in name only, with many states placing virtually insurmountable prior authorization (PA) requirements between patients and their life-saving medications. The formulary research into drug coverage and PA requirements led ADAP Advocacy to conduct original quantitative and qualitative patient-side research on sentiments and attitudes toward long-acting agents.

Key findings from ADAP Advocacy's research include:

• The majority of respondents to the Treatment Survey (52.3%) indicated that they would prefer receiving LAI medication to treat their HIV over a daily pill-based regimen; In the Prevention Survey, the majority of respondents (71.4%) indicated they would prefer an LAI over a daily pill-based regimen to prevent HIV.
• The vast majority of respondents to the Treatment Survey (87.8%) indicated being aware of Cabenuva as an LAI to treat HIV. Of those respondents who learned about the existence of LAI medications through this survey, half (50%) reported being open to discussing them with a medical provider; Just over half of respondents to the Prevention Survey (58.4%) indicated being aware of Apretude for use as LAI PrEP. More than four out of every ten respondents (42.2%) who learned about the existence of Apretude through this survey reported being open to discussing it with a medical provider;
• A majority of respondents to the Treatment Survey (87.7%) indicated having no issues finding information about LAI medications. Of those respondents who did have trouble finding information (12.3%), most respondents had trouble finding information about insurance coverage (78.6%), prior authorization requirements (78.6%), and the cost they would have to pay to access LAIs (71.4%);
• Insurance coverage barriers impacted respondents’ ability to pursue LAIs, with more than 1 in 4 survey respondents (27%) reporting this barrier in the Treatment and Prevention surveys. In the case of PrEP, a majority of those experiencing this (66%) indicated that the barriers to access were so cumbersome that they decided Apretude was not right for them.

In addition to coverage for Cabenuva, ADAP Advocacy also found that:

• 2 state ADAP programs (MA & MN) and 40 state Medicaid programs offer coverage for Apretude as Pre-Exposure Prophylaxis (PrEP);
• 43 state ADAP and 42 state Medicaid programs provide coverage for Sunlenca as HIV salvage therapy; and,
• 50 state ADAP and 32 state Medicaid programs provide coverage for Trogarzo as HIV salvage therapy.

Coverage for LAI drugs is of ever-increasing importance for People Living with HIV/AIDS (PLWHA) as long-acting agents may help to increase medication adherence and reduce the risk of creating multi-drug-resistant strains of the HIV virus. ADAP Advocacy will continue to monitor coverage of LAIs and provide updates when significant changes are made.

[1] Hopkins, M. J. (2023, July 20). The state of long-acting injectable Medicaid coverage. Nags Head, NC: ADAP Advocacy. https://adapadvocacyassociation.blogspot.com/2023/07/the-state-of-long-acting-injectable.html

[2] ViiV Healthcare. (2022, January). ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/viiv-healthcare-announces-fda-approval-of-cabenuva-for-use-every-two-months/

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.