Where the Rubbers Meet the Road on "Ending the HIV Epidemic: A Plan for America"

By: Marcus J. Hopkins, Policy Consultant

In his 2019 State of the Union Address, Donald Trump asked for a bipartisan committee to end the HIV epidemic in the United States within 10 years. Those of us who work in HIV activism and advocacy were (and still are) incredulous, given the Trump Administration’s penchant for undermining virtually every public health initiative.

Photo Source: Business Insider

A mere five months prior to his announcement, the Trump Administration (TA) put the kibosh on HIV cure research because it used fetal tissue donated by women who have legal abortion in an effort to appease faux religious liberty activists (Wadman, 2018).

Also, in 2018, the TA released plans to take $3.8 million from HIV/AIDS programs and $5.8 million from the Ryan White HIV/AIDS Program (Kopan, 2018).

Before that, Trump “fired” the reaming members of the Presidential HIV/AIDS Council (formed in 1995 by President Bill Clinton) after six members quit the council in June 2017 in response to TA’s removal of the Office of National AIDS Policy website and Trump’s failure to appoint anyone to lead the White House Office of National AIDS Policy (Thomsen, 2017).

The announcement by Trump that his administration suddenly cares about ending HIV/AIDS came as a surprise to virtually everyone amid continually piling evidence to the contrary. There has been little evidence to support the idea that the TA is concerned with much of anything other than furthering initiatives that, in virtually every other administration, would have resulted in immediate reprisal from Congress.

So, what, really, is the TA’s grand plan to elimination HIV/AIDS by 2030? Health and Human Services (HHS) Secretary, Alex Azar, revealed their proposal, “Ending the HIV Epidemic: A Plan for America,” on February 7th, 2019 (HHS, 2019):

The plan has two primary goals: 1.) Reduce new HIV infections by 75% within five years; 2.) Reduce new HIV infections by 90% within ten years.

These goals will purportedly be reached using three major areas of action: 1.) Increasing investments in geographic hotspots through our existing, effective programs, such as the Ryan White HIV/AIDS Program, as well as a new program through community health centers that will provide medicine to protect persons at highest risk from getting HIV; 2.) Using data to identify where HIV is spreading most rapidly and guide decision-making to address prevention, care and treatment needs at the local level; 3.) Providing funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment (HHS).

They plan to focus these efforts on 48 high-burden counties, Washington, DC, San Juan, Puerto Rico, and 7 states with a substantial rural burden. How, you may ask? Well, they have four key strategies: Diagnose, Treat, Protect, and Respond – diagnose early, treat rapidly and effectively, protect uninfected populations, and respond rapidly to detect and respond to emerging HIV clusters to prevent new infections.

If this plan seems overly ambitious, it’s because it is.

Realistically speaking, adequately attacking the HIV/AIDS epidemic in the U.S. with the goal of ending it within 10 years is entirely possible…if we’re willing to pony up the resources required to realize that goal. Facts are facts: ending any epidemic is going to be costly, and the Feeral Fiscal Year (FY) 2019 budget for HIV of $34.8 billion dollars isn’t going to come anywhere near close to achieving this goal.

Why? Two words: “Rural America.”

At the beginning of the AIDS epidemic in the 1980s, people who lived in rural parts of the country felt “safe” from HIV/AIDS, because it “…only affected those big city queers.” This thinking dwelled in a peculiar place in the American psyche that believed that Americans largely remained in one place for their entire lives. And then, the 1950s happened…and the 60s, and 70s. As automobiles because more affordable, more Americans left their hometowns and relocated around the country to seek better opportunities and lives. Younger generations were moving out of the hills and hallows of their youths and into…why, they could just go anywhere! With this freedom of movement came certain costs – namely, the spread of infectious diseases.

Travel has always been the enemy of contagion containment, from the earliest days of commerce and conquest when trader ships brought to Europe the deadliest plagues Earth had to offer. So, too, was the case with HIV/AIDS. The idea that a sexually transmitted disease could be contained to metropolitan areas was a quaint notion. People travel to cities; people often have sex in cities (hell, there’s a whole cable series dedicated to the topic); people come back home and bring with them any STDs/STIs they might have picked up and spread them within their local communities.

What has not consistently been the case is that easy access to travel will mean that services will reach the same rural and/or remote places as those diseases. With America’s for-profit healthcare model, healthcare providers must generate a profit in order to remain open; statistically speaking, it is highly unlikely that those providers are going to opt to open locations in the very small towns where services are most needed, because the demand either doesn’t exist, or the residents can’t afford it.

Photo Source: Gina Ferazzi / Los Angeles Times via Getty Images file

Geographic barriers to care are an immense problem for a variety of reasons:

1. Remote parts of the country are not always easily accessible throughout the year – snowfall, flooding, and even seasonal road conditions severely limit both patients’ and providers’ abilities to access and/or provide care;
2. Telemedicine services are extremely limited in many of these rural areas, because high-speed Internet services and cell phone services are either severely limited or nonexistent – it takes a lot of money to fund expanding high-speed Internet access to rural areas;
3. Distances to and from healthcare service provision can prove insurmountable for many rural Americans – it’s too costly to travel by vehicle due to gas prices and vehicle maintenance; little to no public transportation exists to take people to and from appointments; a trip to the doctor can consume literally an entire day, which means lost hours at work that cannot easily be recovered.

I know these things because I have personally experienced them. I’ve moved 43 times in my 37 years on this earth and have had HIV services in four different states – Florida, Tennessee, California, and West Virginia. Only in Ft. Lauderdale, FL was it easy for me to get to and from doctor’s appointments without spending entire days. In Tennessee, it took me literally weeks to even find out basic information about the state’s Ryan White program (which did not, in 2008, have a website). In California, though I lived in Long Beach, the nearest location where I could be treated was in Torrance, CA – a mere 15.1 miles on a map, but an hour or longer drive, each way, to get to and from appointments that would last entire days.

This brings me to my current state – West Virginia. In West Virginia, I luckily live close to one of the two Ryan White HIV/AIDS Program Medical Provider clinics. That’s right – there are only two Ryan White clinics in the state of West Virginia – one in Charleston, and one in Morgantown. By Interstate travel, these two cities are 156 miles apart, meaning that everyone in the middle and on the outskirts of the state – where Interstate travel is not always available or easy to access – may end up spending hours driving to and from appointments.

Another client at the WVU Positive Health Clinic in Morgantown, WV drives two hours each way to get to his doctor’s appointments, each of which can last up to three or four hours. For him, this means up to an eight-hour day solely dedicated to accessing HIV care and treatment, traveling along poorly maintained state routes and country roads. Luckily, he has progress well enough in his treatment to be on six-month visits, but realistically, each of these trips is a hassle. If he is sick, injured, or otherwise unable to travel, that means a missed appointment with a long waiting period before he can be seen, again.

These anecdotal evidences aren’t just true for West Virginia, but for the majority of the country. All around the U.S., patients living with HIV in rural areas spend entire days just going to their HIV doctor. And this is the crux of the problem for not only the Trump Administration, but any future administration: in order to truly eliminate HIV/AIDS in the U.S. by 2030, it’s going to require a massive increase in financial and human resources to tackle reaching rural America.

Part of the TA’s proposal focuses on states that already have high rates of HIV transmission in rural areas – Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina. These states do have high burdens of rural transmission, with 10% or more of new infections occurring in rural areas. What the current plan fails to take into account, in my opinion, is the growing risk of infection via Injection Drug Use (IDU).

IDU is already contributing to high rates of Hepatitis C (HCV) infections in places like West Virginia. In 2015, the rate of new HCV infections was 3.4 (per 100,000); in 2016, that rate increased to 5.1; in 2017, the rate increased, again, to 9.1 (WV Department of Health and Human Resources, 2018). A majority of the Hepatitis B (HBV) and HCV cases in WV reported IDU or street drug use as the primary risk of infection.

It’s not a big leap to assume that, as was the case in Scott County, Indiana, IDU will lead to increased transmission of HIV in state with a high incidence of IDU. This means that there will need to be significant increases in intervention funding in rural states, not just in the small metropolitan cities like Charleston and West Virginia, but in areas that are less easily accessible. Those interventions come neither cheaply, nor without significant public opposition.

Frankly, I don’t believe that the current administration is either willing or able to pony up the kind of cash that will be required to fund the types of interventions needed to achieve their goal. We’re not just talking about reaching rural areas, although that’s the largest roadblock; we’re talking about hiring and training thousands of new personnel, paying for treatment for lower- and middle-income individuals who cannot afford the high price of HIV Anti-Retroviral (ARV) medications, covering transportation costs for both patients and medical personnel, purchasing testing supplies, paying for confirmatory testing and blood work (the latter of which can run into the thousands-of-dollars per patient), hiring, training, and deployment case workers to ensure medication/treatment/physician adherence. The list of things that are going to be required in order to accomplish this goal is so long and so costly, that I doubt it can feasibly be accomplished.

I’m going to be pegged as a naysayer; as a cynic. In realistic terms, what we’ve seen over the past thirty years is that, on average, they type of funding that is necessary to successfully deploy this kind of ambitious plan hasn’t been put on the table for decades. Within the HIV activist/advocacy community, we have been all but terrified to reopen the Ryan White program to reauthorization, out of fear that a Republican legislature will gut the funding down to the bare bones. And honestly, that’s not a fear that is without precedent. Outside of Defense spending, Republicans, on the whole, have been loath to increase funding for anything else without drastic spending cuts elsewhere – a strategy that is both shortsighted and destructive to public health initiatives.

I’ve attended numerous conferences where statements like the following have been made:

“The primary job of big HIV organizations is to ensure that we don’t lose any of the $35 billion dollars in funding that we have.”

This quote (which is a direct quote from an Atlanta area activist/advocate) is terrifying, because it not only indicates that there is fear amongst organizations that those funds will be cut, but that we cannot – and should not – be vocal about our needs. If we make too many waves or too much noise, we risk losing funding. As a result, we cannot be ambitious or innovative in tackling the rural HIV crises we face, because to do so will risk the funds we’re already using to address the underserved needs of people in urban areas.

So, yes – when it comes to the Trump Administration’s grand plans for HIV prevention, I am skeptical that they will succeed. They haven’t even tried to produce enough staff members to work on their own initiatives; what would lead us to think that they would do so to address a problem as widespread as HIV?

References:

• Health and Human Services. (2019, February 07). What is ‘Ending the HIV Epidemic: A Plan for America’?. Washington, DC: United States Department of Health and Human Services: HIV.gov: Office of HIV/AIDS and Infectious Disease Policy: Federal Response. Retrieved from: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview
• Kopan, T. (2018, September 20). Trump admin moves $260M from cancer research, HIV/AIDS and other programs to cover custody of immigrant children costs. Atlanta, GA: CNN: Politics. Retrieved from: https://www.cnn.com/2018/09/20/politics/hhs-shifting-money-cancer-aids-immigrant-children/index.html
• Thomsen, J. (2017, June 17). Six resign from presidential HIV/AIDS council because Trump 'doesn't care'. Washginton DC: The Hill: Healthcare. Retrieved from: https://thehill.com/news-by-subject/healthcare/338296-six-resign-from-presidential-hiv-aids-council-because-trump-doesnt
• Wadman, M. (2019, December 13). Updated: NIH says cancer study also hit by fetal tissue ban. Science. Washington, DC: American Association for the Advancement of Science: Science: News. Retrieved from: https://www.sciencemag.org/news/2018/12/trump-administration-has-quietly-barred-nih-scientists-acquiring-fetal-tissue
• West Virginia Department of Health and Human Resources. (2018, July 01). Acute Hepatitis C Incidence Rate, 2007-2017. Charleston, WV: West Virginia Department of Health and Human Resources: Bureau for Public Health. Retrieved from: https://oeps.wv.gov/HCV/documents/data/acute_hcv_chart.pdf

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.

BIO's 2018 Patient & Health Advocacy Summit

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association has long prided itself on building advocacy partnerships, and thus it is fitting that our organization's leadership — including board members Wanda Brendle-Moss and Jen Laws, as well as myself — was invited to attend the Biotechnology Innovation Organization's (BIO) 2018 Patient & Health Advocacy Summit in Washington, DC. What makes the annual event useful is it assembles the advocacy community, industry partners, regulators, academia, students, and of course, patients.

Susan Stein, MPH, who serves as CEO of the E4 Health Group, shared a simple, yet powerful characterization: "Partnerships between patient advocacy organizations and industry are more important than ever."

Photo Source: FierceAdvocate

The BIO 2018 Patient & Health Advocacy Summit brought together over 200 key stakeholders for two days of programming to discuss current policy issues, share best practices, and exchange ideas. Nearly two-thirds of the attendees represented the patient advocacy community. The BIO Summit also provided an invaluable opportunity to advance partnership among stakeholders in the healthcare ecosystem. Whereas the ADAP Advocacy Association's participation represented HIV/AIDS, there were many other disease groups in attendance, such as Psoriasis, Arthritis, Muscular Dystrophy, Metachromatic Leukodystrophy, and many more.

The BIO Summit immediately addressed the 800 pound gorilla in the healthcare ecosystem with an important pre-summit workshop on best practices for engaging with industry. As the patient perspective plays a more central role in the drug development process, it is recognized that clearer conflict-of-interest policies and best practices would better serve all stakeholders. The patient voice has moved beyond simply participating in clinical trials, and as a result industry and regulators are engaging patients earlier in the process. The 21st Century Cures Act includes a commitment to patient-focused drug development ("PFDD"). It amends the Federal Food, Drug, and Cosmetic Act to require the Food & Drug Administration to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.

The timing of the BIO Summit couldn't have been planned any better with the Trump Administration's latest announcement under its blueprint for prescription drug reform. The latest proposal would set up an international pricing index in an effort to drive down prescription drug costs under Medicare Part B, which in turn, could also drive down patient out-of-pocket costs. The U.S. Department of Health & Human Services ("HHS") Secretary Alex Azar discussed the "pro patient access proposal" at the BIO Summit, only hours after it was announced.

HHS's decision to announce an Advance Notice of Proposed Rulemaking ("ANPRM") translates into the patient advocacy community having ample time to weigh-in on it. It could very well be the case that the public comment period represents one of the times where the patient advocacy community and industry view things differently, but that is a good thing.

For a policy brief on the ANPRM, please visit: https://www.hhs.gov/about/leadership/secretary/priorities/drug-prices/ipi-policy-brief/index.html.

For a fact sheet on the ANRPM, please visit: https://www.cms.gov/newsroom/fact-sheets/anprm-international-pricing-index-model-medicare-part-b-drugs.

Comments on the ANPRM will be accepted until December 31, 2018 and may be submitted electronically through the CMS e-Regulation website at: https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/eRulemaking/index.html?redirect=/eRulemaking.

The ANPRM can be downloaded at: https://www.cms.gov/sites/drupal/files/2018-10/10-25-2018%20CMS-5528-ANPRM.PDF.

Controversial History with HIV Disqualifies Robert Redfield from CDC Service

Guest Blog By: Marcus J. Hopkins, Blogger

Robert Redfield, a 66-year-old virologist and physician, has been appointed to be the head of the U.S. Centers for Disease Control and Prevention (CDC) by U.S. Health and Human Services (HHS) Secretary Alex Azar (Sun, 2018b).  Redfield has replaced the acting head of the CDC, Principal Deputy Director Anne Schuchat, after the Trump Administration’s first pick, Brenda Fitzgerald, was forced to resign because she failed to divest from her “complex financial interests” “…in a definitive time period” (Sun, 2018).

Fitzgerald’s financial interests were so “complex” that she was essentially permanently recused from participating in the agencies activities and was unable to testify before Congress on public health issues.  Appointed by Trump’s first HHS Secretary, the disgraced Tom Price, Fitzgerald repeatedly dismissed concerns about her financial interests, and yet, had to cancel each appearance before Congress because of said interests.

Under Azar, Redfield is yet another controversial pick to head up the nation’s primary health organization.  Redfield has a long and storied history of controversial positions related to HIV and public health.

Photo Source: Gay Today

Beginning with his tenure within the Defense Department, Redfield helped create a disastrous and non-confidential policy of testing all troops for HIV beginning in October 1985 (Garrett, 2018).  Troops who tested Positive for HIV often found out after their entire chain of command, and anyone found to be HIV+ was immediately barred from service.  In addition, Active Duty personnel were also tested, and if found Positive, were often subjected to mistreatment, including isolating HIV+ personnel in isolated barracks colloquially referred to as “the leper colony,” where they were treated like prisoners until they fully developed AIDS or were dishonorably discharged.  By 1989, 5 million troops were tested, and roughly 6,000 testing Positive (Garrett). 

In the 1990s, Redfield was yet again embroiled in HIV chicanery when internal memos were obtained by Public Citizen, a left-leaning non-profit organization that represents patients, citizens, and consumer rights through advocacy and policy research.  These previously unrelease memoranda demonstrated clear evidence that Redfield led a: 

…systematic pattern of data manipulation, inappropriate statistical analyses, and misleading data presentation by Army researchers in an apparent attempt to promote the usefulness of the GP160 AIDS vaccine…which [was] intended to prevent the progression of disease in persons with HIV infection (Public Citizen, 1994).

In Phases I and II studies, researchers at the Walter Reed Army Institute of Research, led by then-Chief of the Department of Retroviral Research, Robert Redfield, and were published in many scientific fora (plural for “forum”), including the New England Journal of Medicine, AIDS Research and Human Retroviruses, and at the International AIDS Conference in 1992.  The fabricated results were also twice falsely presented before hearings of the House Subcommittee on Health and Environment.

This repeated demonstration of a lack of ethics, moral fortitude, and integrity make him clearly unfit to head that nation’s leading health organization.  Dr. Peter Lurie, President of the Center for Science in the Public Interest (CSPI), goes further in his full-throated opposition to Redfield, stating that, as the head of the CDC, we would get “…a sloppy scientist with a long history of scientific misconduct and an extreme religious agenda” (Lurie, 2018).  We at ADAP Advocacy Association could not agree more with this assessment.

The Trump Administration has repeatedly displayed a unprecedented lack of integrity on several front, but perhaps its worst offenses exist with its appointments – Betsy DeVos, Scott Pruitt, Mick Mulvaney, Tom Price, Mike Pompeo, Rex Tillerson and Ryan Zinke.  Each of these appointments stands on their own in terms of their unpreparedness, lack of candor, and incompetence within their positions, rife with conflicts of interest, unacceptable levels of spending on personal travel and completely unnecessary “security upgrades,” and serving not the interests of the American public, but either the interests of corporations who have long derided the wings of government they now lead, or their own.  Robert Redfield is just the latest example of this failure to understand either the complexities of the positions to which they are appointed, or the roles of this organizations in American governance.

Enough is enough.  Redfield must, as his predecessor before him, be flushed out of the CDC before we become the laughing stock of the world.

References:

• Garrett, L. (2018, March 23). Meet Trump’s New, Homophobic Public Health Quack. Washington, DC: Foreign Policy. Retrieved from: http://foreignpolicy.com/2018/03/23/meet-trumps-new-homophobic-public-health-quack/
• Lurie, P. (2018, March 21). CSPI Urges Administration Not to Appoint Dr. Robert Redfield, with History of Scientific Misconduct, as CDC Director. Washington, DC: Center for Science in the Public Interest: News. Retrived from: https://cspinet.org/news/cspi-urges-administration-not-appoint-dr-robert-redfield-history-scientific-misconduct-cdc
• Public Citizen. (1994, June 07). Washington, DC: Public Citizen. Retrieved from: https://kaiserhealthnews.files.wordpress.com/2018/03/940607plswtowaxman.pdf
• Sun, L.H. (2018a, January 31). CDC director resigns because of conflicts over financial interests. Washington, DC: The Washington Post: News: To Your Health. Retrieved from: https://www.washingtonpost.com/news/to-your-health/wp/2018/01/31/cdc-director-resigns-because-of-conflicts-over-financial-interests/?utm_term=.24ab7b89a316 
• Sun, L.H. (2018b, March 21). Longtime AIDS researcher Robert Redfield picked to lead CDC. Washington, DC: The Washington Post: News: To Your Health. Retrieved from: https://www.washingtonpost.com/news/to-your-health/wp/2018/03/21/longtime-aids-researcher-robert-redfield-picked-to-lead-cdc/?utm_term=.3a5d8f592e61

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.

Introduce a Little Anarchy...and Everything Becomes Chaos

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In the 2008 blockbuster film, The Dark Knight, there is an infamous line by the Joker (played by the late Heath Ledger): "Introduce a little anarchy; upset the established order, and everything becomes chaos." That line by the Clown Prince of Crime pretty much sums up the last twelve months for those of us working to end the HIV/AIDS epidemic. In fact, chaotic would be an understatement.

Photo Source: The Dark Knight

The Administration's proposed budget last year was submitted to Congress late (and it will be so again this year), and it was laced with requested funding cuts to vital safety net programs. The Presidential Advisory Committee on HIV/AIDS ("PACHA") is in complete disarray between protest resignations coupled with termination of the remaining members. The Office of National AIDS Policy ("ONAP") — viewed as an important component of the White House Domestic Policy Council since 1993 — is seemingly gone. There has been no ONAP Director to coordinate the nation's response to HIV/AIDS at home, and abroad. Proposed regulations allowing healthcare professionals to deny care if it violates their "conscious" and seek to divert limited resources to organizations that refuse comprehensive strategies under the banner of religious objection. And that doesn't even scratch the surface with the countless attacks levied against the patient protections offered to people living with HIV/AIDS under the Affordable Care Act ("ACA").

On February 1st, we fired a shot across the bow at the Administration. We called on the newly minted Secretary of the U.S. Department of Health & Human Services ("HHS") to fill the vacant director position at ONAP. Now to be fair, HHS Secretary Alex Azar has no statutory authority to fill this position but he has the ear of the President who does — and that has to be worth something. Our press release is available online.

Photo Source: (AP Photo/Andrew Harnik)

It is, after all, a core responsibility of the HHS Secretary to utilize the position of influence with the President in seeking to address the public health needs of the nation. We have added our voice to the calls from numerous other advocates, legislators, and organizations that realize the vital need for this position to be filled immediately.

Since 1993 when ONAP was created the longest time period the director position remained vacant was approximately two months. It has now been twelve months since someone has led our government's response to an epidemic that has taken 35 million souls globally. It is bad public policy. It demonstrates poor leadership. And it is simply wrong!