Travis Manint - Advocate and Consultant Travis Manint - Advocate and Consultant

New CDC Guidance Backs DoxyPEP Amid STI Surge, Political Controversy

The United States is grappling with a surge in sexually transmitted infections (STIs), with alarming increases in syphilis, gonorrhea, and chlamydia. According to the Centers for Disease Control & Prevention (CDC), syphilis rates have risen by 80% since 2018, gonorrhea cases have increased by 11%, and chlamydia remains high despite a slight decrease. This underscores the urgent need for innovative prevention strategies. One such strategy, Doxycycline Post-Exposure Prophylaxis (DoxyPEP), has emerged as a powerful tool in the fight against STIs, but it has also become a target of politically-motivated attacks fueled by misinformation and bigotry. DoxyPEP involves taking a dose of the antibiotic doxycycline after condomless sex to prevent bacterial STIs. While studies have repeatedly demonstrated its safety and efficacy, certain politicians, most notably Florida Senator Marco Rubio, have launched a crusade against DoxyPEP, jeopardizing the health and well-being of countless people.

While Senator Rubio and others leverage misinformation to fuel a politically-motivated crusade against the CDC’s new DoxyPEP guidelines, the evidence is clear: DoxyPEP is a safe, effective, and urgently needed tool to combat the nation's skyrocketing STI rates, particularly among the LGBTQ+ community already facing systemic healthcare disparities.

DoxyPEP: Backed by Science, Embraced by Communities

Fortunately, the effectiveness of DoxyPEP isn't based on conjecture or political ideology; it's firmly rooted in scientific evidence. Numerous studies have demonstrated its remarkable ability to reduce STI rates among those most vulnerable. In the groundbreaking DoxyPEP trial, researchers observed a sustained decrease in STI incidence among participants taking DoxyPEP, even with a short-term increase in sexual partners and condomless sex acts, as reported in Infectious Disease Special Edition. Further bolstering these findings, a separate study from the University of California, San Francisco, revealed that DoxyPEP reduced the risk of chlamydia and gonorrhea by nearly 70% among participants. These findings, along with a growing body of research, make it clear that DoxyPEP is a powerful tool with the potential to significantly impact the STI epidemic.

Real-World Success

The positive impact of DoxyPEP extends beyond clinical trials and into real-world settings. In San Francisco, where public health officials have proactively implemented DoxyPEP, the results have been significant. A study by the San Francisco Department of Public Health found that among participants, overall STI incidence fell by 58% after starting DoxyPEP. Chlamydia cases dropped by 67%, and early syphilis cases decreased by 78%. These real-world outcomes highlight the potential of DoxyPEP to effectively curb STI transmission when embraced by the community.

Addressing Resistance Concerns

One of the most frequently raised concerns about DoxyPEP is its potential to contribute to antibiotic resistance. While this is a valid concern that warrants careful consideration, the evidence suggests that the benefits of DoxyPEP outweigh the risks when implemented responsibly. As the CDC states in its report, "The potential for DoxyPEP to increase antimicrobial resistance is a theoretical concern, but current data do not suggest that DoxyPEP use has resulted in substantial increases in resistance." This finding is further bolstered by a study from the University of California, San Francisco, which found no significant increase in antibiotic resistance genes among DoxyPEP users. Additionally, the CDC emphasizes that the short course of doxycycline used in DoxyPEP, coupled with ongoing monitoring for resistance trends, can help mitigate this risk. These findings should reassure policymakers and the public that DoxyPEP, when implemented responsibly as part of a comprehensive STI prevention strategy, is unlikely to exacerbate the already concerning issue of antibiotic resistance.

Community Acceptance

Not only is DoxyPEP backed by robust scientific evidence, but it has also been met with enthusiasm and acceptance from the very communities it aims to protect. When offered DoxyPEP as a prevention option, people at risk for STIs have demonstrated a strong desire to incorporate this tool into their sexual health practices. In San Francisco, for example, Dr. Hyman Scott reported that "about 39% of people ultimately decided that they wanted DoxyPEP as an STI prevention tool." This positive reception speaks volumes about the willingness of people to take charge of their sexual health and embrace new strategies for protecting themselves and their partners.

Political Roadblocks: Rubio's Disinformation Campaign

Despite the overwhelming scientific evidence and the positive response from those most impacted by STIs, DoxyPEP faces a formidable roadblock: a politically-motivated disinformation campaign spearheaded by figures like Senator Rubio. Driven by what appears to be a combination of ideological opposition and a disregard for evidence-based policymaking, Rubio has repeatedly attempted to discredit DoxyPEP and undermine its adoption.

In a press release riddled with inflammatory language, Senator Rubio proclaimed, “The CDC’s unscientific recommendation is dangerous and could lead to more antibiotic-resistant infections and deaths." This statement, however, directly contradicts the findings of the CDC itself, which clearly show that current data do not suggest that DoxyPEP use has resulted in substantial increases in resistance. Furthermore, Rubio's assertion that the CDC's recommendation is "unscientific" ignores the rigorous research and clinical trials that have consistently demonstrated DoxyPEP's safety and efficacy.

By cherry-picking statistics about antibiotic resistance without acknowledging the nuances of DoxyPEP's implementation and the evidence mitigating those risks, Rubio engages in a dangerous game of misinformation. His tactics, unfortunately, have the potential to dissuade patients from accessing a potentially life-saving prevention tool and hinder efforts to curb the STI epidemic.

Unmasking the Agenda

A closer look at Senator Rubio's record reveals a disturbing pattern of opposition to policies that benefit the LGBTQ+ community, raising serious questions about the motivations behind his crusade against DoxyPEP. His voting history, as reflected in his 0 out of 100 score on the Human Rights Campaign's Congressional Scorecard, paints a picture of an anti-LGBTQ+ agenda. From opposing marriage equality to supporting discriminatory bathroom bills, Rubio has consistently aligned himself with those who seek to marginalize and harm the LGBTQ+ community.

As HRC President Kelley Robinson aptly stated, "Throughout his career, Sen. Rubio has repeatedly put his personal beliefs ahead of the needs of his constituents, particularly LGBTQ+ Floridians." His stance on DoxyPEP, a measure that would primarily benefit men who have sex with men (MSM) and transgender women, aligns with this pattern of disregard for the well-being of the LGBTQ+ community. By framing a scientifically sound public health intervention as "dangerous" and "unscientific," Rubio perpetuates harmful stereotypes and undermines efforts to address a health crisis that disproportionately impacts LGBTQ+ people.

The Dangers of Politicized Health

The case of DoxyPEP lays bare a disturbing trend in contemporary politics: the cynical manipulation of public health for political gain. When evidence-based interventions like DoxyPEP are distorted and demonized, the consequences extend far beyond a single policy debate. Allowing political agendas to dictate public health decisions undermines trust in science, erodes support for vital programs, and ultimately puts lives at risk.

This pattern of politically-motivated attacks on healthcare is particularly pronounced when it comes to the LGBTQ+ community. Across the country, conservative lawmakers at all levels of government are pushing a discriminatory agenda that seeks to restrict access to essential healthcare services for LGBTQ+ people. From attempts to ban gender-affirming care for transgender youth to efforts to allow healthcare providers to refuse service to LGBTQ+ patients, these attacks represent a clear and present danger to the health and well-being of an already marginalized community.

Senator Rubio's crusade against DoxyPEP must be understood within this broader context. His actions are not about protecting public health; they are about scoring political points by exploiting prejudice and fear. When those in positions of power prioritize ideology over evidence and demonize vulnerable communities, the consequences can be devastating.

The Path Forward: Equity, Access, and Comprehensive Prevention

To effectively address the STI epidemic, we must move beyond the politically-motivated roadblocks erected by those who prioritize ideology over evidence. A truly effective response requires a commitment to equity, access, and comprehensive prevention strategies that center the needs of those most impacted.

It's crucial to acknowledge that STIs do not impact all communities equally. As highlighted in the U.S. Department of Health and Human Services' National Strategic Plan for addressing STIs, certain populations, including gay and bisexual men, transgender people, and young people, bear a disproportionate burden of these infections. This disparity is driven by a complex interplay of factors, including stigma, discrimination, and barriers to accessing quality healthcare. For example, in 2018, more than 50% of primary and secondary syphilis infections occurred among MSM. These disparities demand a targeted and equitable approach to STI prevention, one that prioritizes the needs of those most vulnerable and addresses the systemic factors that contribute to their increased risk.

The Urgency of Action

The urgency of the STI epidemic demands swift and decisive action. We can no longer afford to let misinformation and political maneuvering hinder the implementation of evidence-based solutions like DoxyPEP. As Dr. Jonathon Cherabie, an Infectious Disease physician, pointedly stated on Twitter, "To state that this move [DoxyPEP implementation] is 'political' when two MAJOR trials have shown how beneficial this intervention is, in the midst of a massive increase in STIs especially syphilis is disingenuous." Dr. Cherabie goes on to highlight the hypocrisy of fixating on unfounded fears of antibiotic resistance with DoxyPEP while ignoring its use for other purposes like acne and malaria prophylaxis. His words serve as a potent reminder that the opposition to DoxyPEP often stems not from legitimate scientific concerns, but from a desire to undermine the health and well-being of LGBTQ+ people. Every day that passes without readily available DoxyPEP represents missed opportunities to prevent new infections and protect the health of marginalized communities.

A Multifaceted Approach

It's important to recognize that DoxyPEP, while a powerful tool, is not a standalone solution to the STI epidemic. To truly make a lasting impact, we need a comprehensive approach that addresses the complex nature of this public health crisis.

This comprehensive strategy must prioritize:

  • Expanded Access to Testing and Treatment: Timely and affordable access to STI testing and treatment is paramount. We must remove financial and logistical barriers that prevent people from seeking care, ensuring that everyone can get tested and treated promptly and effectively.

  • Comprehensive Sexual Health Education: Accurate, inclusive, and age-appropriate sexual health education is fundamental to empowering people to make informed decisions about their sexual health. We must move away from abstinence-only approaches and embrace education that encompasses a wide range of topics, including consent, contraception, and STI prevention methods.

  • Addressing Stigma and Discrimination: Stigma surrounding STIs prevents people from seeking testing and treatment, perpetuating the cycle of transmission. We must foster open and honest conversations about sexual health, challenge harmful stereotypes, and create a more supportive and inclusive environment for those affected by STIs, especially at points of care.

  • Adequate Funding for Public Health Initiatives: Effectively combating the STI epidemic requires robust and sustained funding for public health programs. This includes resources for research, surveillance, prevention programs, and healthcare infrastructure.

Conclusion

The alarming rise of STIs in the United States demands our unwavering attention and a commitment to evidence-based solutions. Inaction is not an option; it carries the weight of preventable infections, long-term health complications, and lives needlessly impacted. DoxyPEP represents “the most exciting intervention for STI prevention in two decades,” a scientifically sound intervention with the potential to significantly curb the STI epidemic, particularly among the LGBTQ+ community. We cannot allow political maneuvering and misinformation campaigns to derail this progress.

As advocates, policymakers, and industry professionals, we have the power to turn the tide against this epidemic:

  1. Integrate DoxyPEP into Policy Agendas: For policymakers, champion legislation and funding initiatives that expand access to DoxyPEP, ensuring its inclusion in Medicaid, ADAPs, and private insurance plans. Advocate for comprehensive sexual health education and robustly funded public health programs.

  2. Harness Your Platform to Disseminate Accurate Information: Leverage your professional networks, social media platforms, and public speaking engagements to counter misinformation surrounding DoxyPEP. Share the overwhelming scientific evidence supporting its efficacy and safety, and challenge those who prioritize political agendas over public health.

  3. Advocate for FDA Approval: While the CDC has issued guidelines for DoxyPEP, it remains an off-label use of doxycycline. Advocate for the FDA to formally approve this use, which would further solidify its legitimacy, potentially expand insurance coverage, and increase confidence among healthcare providers and patients.

The fight for effective STI prevention is a fight for public health, for equity, and for the well-being of us all. Let's leverage our collective influence to ensure that DoxyPEP becomes a standard tool in our arsenal against this urgent public health crisis.

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Jen Laws & Brandon M. Macsata Jen Laws & Brandon M. Macsata

340B Hypocrisy: The Inconvenient Truth Behind Why We Need to Reform This Vital Safety Net Program

Brandon Macsata is the CEO of ADAP Advocacy. Jen Laws is the CEO of Community Access National Network.

The 340B Drug Pricing Program (“340B”) is probably one of the most transformative public health programs providing lifesaving supports and services to people living with HIV in the United States, second only to the Ryan White HIV/AIDS Program (“RWHAP”). As such, rigorous debate about the future of the program is not only healthy, but it is also paramount to its success. As patients (and patient advocates), it is our responsibility to demand accountability, transparency, and stability. There is universal agreement about the vital role 340B plays in improving access to healthcare. But for many – including ADAP Advocacy and the Community Access National Network – we contend that the program could be doing more…and better! The focus of the program should be on the patients, and not the Covered Entities, medical or service providers, or any other business enterprises making lots of money off it. That is the inconvenient truth behind why we need to reform this vital safety net program.

Section 340B of the Public Health Service Act (PHSA) is a Drug Pricing Program established by the Veterans Health Care Act of 1992. That year, Congress struck a deal with pharmaceutical manufacturers to expand access to care and medication for more patients; if pharmaceutical manufacturers wanted to be included in Medicaid’s coverage, then they’d have to offer their products to outpatient entities serving low-income patients at a discount. The idea was brilliantly simple. Drug manufacturers could have a guaranteed income from participation in the Medicaid program and Covered Entities could have guaranteed access to discounted medications. Congress set-up a payment system by way of rebates and discounts affording certain healthcare providers a way to fund much needed care to patients who could not otherwise afford it.

 “…to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” H.R. Rep. No. 102-384(II), at 12 (1992)

THAT is the legislative intent behind 340B. THAT is where some of us want to return 340B’s focus. THAT is why reform is coming!

Ironically, critics of the 340B reform movement – often motivated by self-preservation and protecting their ever-expanding budget and geographic footprint – are quick to attack the idea of the need for reforms. Sadly, they’re also quick to turn their criticism into personal attacks, including questioning the intentions, morals, and character of the people supporting reform. They charge, using Inspector Clouseau “gotcha” style rhetoric, that we’re in the “pockets” of the drug manufacturers because we accept their money to help with our patient advocacy and education (yet there is no “gotcha”, since this information is quite publicly available on our websites, annual tax returns, Guidestar, as well as frequent public commentary).

Isn’t it funny how the “gotcha” mentality cannot accept the obvious, that maybe our interests align with the drug manufacturers because it is in the best interest of patients. Drug manufacturers make products patients want and need. Ensuring funding flows in a way that expands patient access to medications does indeed benefit both patients and the drug manufacturers. It should be noted, this criticism tends to also neglect mentioning the interests of the entities challenging reform: anti-competitive consolidation among hospitals and pharmacies (leaving whole areas without services), increasing profits, paying for salaries unrelated to healthcare, and increasing administrative salaries are all excellent examples of why we’re left asking “Who is actually benefiting from this program?”

The truth of the matter is, aside from a growing list of patients, patient advocacy organizations, and drug manufacturers, there is a growing chorus calling for reform. Academia wants it (NEJM, Penn LDI, USC Schaeffer), economists want it (Nikpay, Gracia), national trade associations want it (NACHC, NTU), policy think tanks want it (CMPI, NAN), and even multiple news media outlets are suggesting it (Forbes, NYT, WSJ). Local activists are also increasingly fed-up with what they’re witnessing (Dinkins, Feldman, Winstead).

Dr. Diane Nugent, Founder & Medical Director of the Center for Inherited Blood Disorders, recently noted an opinion piece in the Times of San Diego, “A September 2022 analysis by the Community Oncology Alliance revealed that some hospitals participating in 340B price leading oncology medications nearly five times more than the price they paid. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions.”

But speaking of deep pockets, isn’t it also an inconvenient truth that the very folks fighting reform, and fighting improving the program so patients can benefit more directly from it, are the same folks financed by big hospital systems, and mega service providers abusing 340B intent?

A question often asked by advocates learning about 340B: “So, exactly how much money are we talking about here?”

Well, we don’t really know…sort of. For Federal Grantees covered under 340B, their grant contracts require accounting of 340B rebates as part of their programmatic revenues. Those revenues are required to be re-invested in the program, which generated the income. This level of transparency is pretty much a “gold standard” that other Covered Entities (less maybe hemophiliac centers) in the 340B space are required to meet. That’s part of why we, and other advocates, are calling on minimum reporting requirements for hospitals, contract pharmacies, and pharmacy benefit managers (insurers covering medications) to begin providing some data. Clearing up the murkiness, if you will. What we do know is drug manufacturers reported more than $100 BILLION in 340B-related sales last year.

That’s concerning especially because “charity care” is declining and medical debt is a growing issue for more and more patients and their families. The Affordable Care Act mandated “charity care”, or “financial assistance”, to be offered by non-profit hospitals seeking to qualify as 340B entities but did not place any definitions behind the mandate, including any “floor” of how much charity care a hospital has to offer.

Now, in all rhetoric opposing any type of transparency in 340B, hospitals tend to conflate their “uncompensated care” and “unreimbursed care” or “off-sets” for public health programs – these don’t necessarily reflect any “charity” being provided to patients. These things should be separated when considering what benefit hospitals provide a community. And under that lens, things get kind of ugly with far too many of the 340B hospitals reporting providing less than 1% of their operating costs as charity. When reviewing how much hospitals write off in bad debt, or going after patients who can’t afford care, often far exceeding those charity care levels, we’re left asking if the “non-profit” designation is really a declaration of concentrating “profits” by way of salaries to top executives rather than formal shareholders?

That bad debt shows up for patients as medical debt. And we need to be very specific here: according to the Urban Institute, some 72% of patients with medical debt owe some or all of that debt to hospitals. Meaning, what we call medical debt is really hospital debt. The situation is unarguably bad. This year alone the Los Angeles County Office of Public Health issued a report outlining for policymakers the role and responsibility hospitals have in driving medical debt and how increasing charity care might stem this problem.

As patients, and frankly as patient advocates who represent thousands like us, medical debt isn’t an issue that can be swept under the carpet. Entire communities avoid necessary care to protect their financial interests. We’ve personally watched our friends open GoFundMe accounts to cover medical expenses. We’ve helped our loved one’s cover food and light bills to not miss a medical bill. We also well recognize how negative credit reporting from medical debt can hurt people from getting rental housing or a car loan, or even simple necessities. And when thinking about how much we don’t know about what’s behind that $100 billion price tag, the fact that patients face these concerns on the regular is pretty obscene.

We do know there are plenty of good actors in the 340B space. Particularly, Federal Grantee Covered Entities, like Ryan White Clinics and AIDS Drug Assistance Programs (ADAPs). And we know they’re generally great actors because of that transparency in reporting and the oversight offered by their grant contracts. Ultimately, we’re not necessarily asking for a whole lot more than that for literally everyone else who stands to make a buck in the chain between drug manufacturers and patients. Indeed, that trust on Federal Grantees, particularly Ryan White Clinics and ADAPs, is part of why drug manufacturers restricting 340B sales held a carve out for these Federal Grantees. (To be fair and without much public fanfare, years ago, we – as in ADAP Advocacy and CANN – helped to negotiate these carve-outs as part of our advocacy. Our relationship with drug manufacturers isn’t a one-way street as detractors might try and sell you on.

$100 billion is a lot of money! Is it too much to ask, “Why aren’t patients benefiting more directly from this ever-growing healthcare program?” Facts show that 340B revenues are soaring year after year, yet against the grim backdrop of consistently declining charity care in the impoverished communities needing the most help. To make matters worse, rising medical debt is crushing families. Patients deserve better. People living with HIV who depend on the RWHAP and 340B deserve better! And that is why we need reform.

Read our policy reform suggestions here.

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