Guest Blog Contributor - A Year of Enlightenment

By: Ranier Simons, ADAP Blog Guest Contributor

This is my last blog post of 2022. It is hard to believe that a year has already passed. It does not feel like I have been a guest blog contributor for an entire year. When I was blessed with the opportunity to contribute, I was unsure of what to expect. As every writer knows, the end product is always the result of creating something from nothing. In the case of this blog, the ‘something’ is not some fanciful creative writing artistic endeavor. The ‘something’ is meant to educate, reveal, inspire action, promote, support, highlight, battle misinformation and in some cases disinformation. Writing for this blog is acceptance of the responsibility to make sure every blog is properly researched, has a purposeful message, and most importantly respects and does not waste the time of those who take the time to read it. 

Photo Source: JerryJenkins.com

I have a master’s degree in healthcare innovation, many years of science and medical education and research experience, firsthand experience as a healthcare worker, life experience as a caregiver, and I am currently a clinical operations healthcare data analyst. However, those things are not why I felt equipped to write for this blog. I felt confident to effectively contribute because I knew I was willing to dig into the jargon-filled weeds of medical journals and other scientific periodicals, scour digital sites of evidence-based discourse, and seek insight from experts in order to distill information into a format easily accessible to all. Communication goes both ways. Real communication happens when information is delivered and the recipients truly comprehend and digest what is given. Medical discourse regarding HIV/AIDS and other related healthcare issues is vast. This makes distillation very important.

My path has crossed with many people living with HIV/AIDS, some of whom have passed due to HIV/AIDS. I have been very close to a good number of them and tangentially exposed to others. Even though I have a high level of exposure to the HIV/AIDS landscape, I was not fully aware of all of the layers before this year of contributing to his blog. I learned about a few HIV/AIDS concepts and related disease etiologies of which I was not previously aware. Researching some of the posts resulted in my discovery of resources I didn’t know about. Most importantly, writing for this blog revealed to me the vastness of the global network of people working towards the eradication of HIV/AIDS on many different levels.

Photo Source: African Constituency

The most important thing I’ve gleaned as a guest blog contributor is how far we have left to go in the fight against HIV/AIDS. Because medical science has advanced to the point of treating it like a chronic disease, on the surface it seems as if the general public doesn’t view it with the same sense of urgency or danger as in the past. However, there is so much more work to be done, so many more people to reach, so many more policies to write and change, so much more research to be done, many more breakthroughs to discover, and multitudes of lives to save.

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. 

Why a Secure Drug Supply Chain Matters

By: Brandon M. Macsata, CEO, ADAP Advocacy Association
       Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

Since the start of the AIDS crisis, people living HIV (PLWHA) have looked forward to a day when medicines could allow them to live a life in which their HIV is undetectable and untransmittable (otherwise known as, “UequalsU). Today, PLWHA with access to treatment and adherent to their antiretroviral therapy are expected to live well into their 80’s. There is so much promise in the fight to end the epidemic. 

PLWHA can be confident of the security of those medications from fraudsters because they are protected by the Drug Supply Chain Security Act (DSCSA). This medication protection system, originally created in 2013, completes its rollout next year in 2023. It assigns a number to each package of medicine at time of manufacture, and that number is tracked at every change of ownership from factory to distributor to pharmacist. “Track and trace” is the name associated with this drug supply safety system.

Photo Source: Pharmaceutical Technology

Though criminals never stop trying to defraud patients and pharmacists, we know the DSCSA works because it has been tested. A pharmacist in Texas who checked the serial numbers on “too-cheap-to-be-true” HIV medicine discovered fraud and returned that medicine to the seller without dispensing it to patients. Furthermore, because these kinds of serial numbers allow very fine-grained tracking of medicine in the supply chain, no broad recalls were necessary which might have taken perfectly good medicine off the market and endangered patient access.

DSCSA has protected PLWHA and all patients in the United States, but as with any system, it needs support. There are two key places where the federal government needs to help:

• Charge people who forge DSCSA paperwork with DSCSA fraud

Criminals, such as the recent spate of HIV counterfeit criminals, have yet to be charged with criminal offenses for DSCSA fraud. In fact, to-date there is no record of anyone ever having been charged with DSCSA fraud. To protect patients there must be a deterrent to forging DSCSA paperwork, and to do that, the DOJ must ensure that this crime draws a criminal charge.

There are currently 140 defendants in the existing civil litigation brought by Gilead Sciences and Johnson and Johnson Healthcare Systems against the criminals trafficking in counterfeit and diverted HIV and Hepatitis C (HCV) medications. Not even one has drawn a criminal charge of forging DSCSA paperwork. 

The Biden Administration’s Department of Justice needs to make prosecution of criminals who violate the DSCSA a priority with resources and training.

• Do not undermine the DSCSA for political expediency

For decades it has been in vogue to suggest buying medicine from other countries to make it cheaper. However, countries suggested, like Canada, don’t have a system like DSCSA and we cannot provide this same level of safety assurance to patients and pharmacists. Regulations that intentionally break the DSCSA, like the regulations that govern bulk importation of drugs from Canada that break the DSCSA will endanger HIV, HCV, and many other categories of American patients.

The Administration’s Department of Health & Human Services needs to revoke the rules governing bulk importation until Canada has an interoperable DSCSA system to protect medicine imported.

Ensure broad understanding of DSCSA features for physicians

As the DSCSA finishes its rollout, one part of the dispenser community unlikely to get the message is physicians who administer long-acting HIV injectables. These injectables, which can control HIV with just two shots every month or two months, are an enormous innovation.

However recent history includes a few failures of physicians to understand the dangers of criminals in the supply chain, including:

• Physicians purchasing black market oncology from unlicensed sellers (including Canadian criminals) and administering in their offices it to cancer patients;
• Physicians in thirteen states who purchased black market none-sterile IUDs and implanted them in patients, resulting in horrific medical adverse events; and
• Physicians who purchase black market Botox, and administered them to patients, endangering them.

Unlike pills taken by PLWHA, which can be examined by the pharmacist and patient, injectables administered by physicians don’t necessarily have this protection. Additional steps are needed to ensure patients can participate in medication verification safety. All too often, patients never see touch the injectable, and likely never see the packaging it came in. Physicians, who are not typically trained to check pharmaceutical wholesaler licenses or verify DSCSA safety features, have repeatedly been the targets for criminals. PLWHA need to be empowered to involve themselves more in this process.

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As the DSCSA rollout proceeds, we urge the Biden Administration to resource the U.S. Food & Drug Administration (FDA) so they can prioritize education of physicians about the new security features of the DSCSA and the risks to their patients and their practice if they ignore them.

People living with HIV in the United States have witnessed significant progress in managing their condition. The advent of new medicines has greatly improved their quality of life greatly, and equally the safety of their drug supply has been enhanced by the Drug Supply Chain Security Act. It’s critical that we do everything possible to support it.

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.  

Advocacy Needed to Reduce Barriers to Accessing Long-Acting Agent Therapies

By: Ranier Simons, ADAP Blog Guest Contributor

Medical science continues to advance at a rate that outpaces healthcare policy and subsequently healthcare practices. This is especially true regarding novel lifesaving therapies and modalities for chronic diseases such as HIV/AIDS. Treatment for people living with HIV/AIDS (PLWHA) is expensive, long-term, and requires consistency in its administration to be effective. Moreover, antiretroviral medications and other related compounds are rapidly evolving. There have already been challenges to ensure equal access, for all, for established and widely used therapies. The situation is even more dire for some of the newest treatments available. That is why the ADAP Advocacy Association created its ADAP Injectables Advisory Committee. 

Photo Source: PRC

The advisory committee was a collaboration of patients, as well as representatives from pharmaceutical manufacturers, advocacy groups, healthcare providers, and pharmacy groups. In August 2022, the advisory committee released its report: HIV LONG-ACTING AGENTS: Policy Considerations for Injectable Therapies under the Ryan White HIV/AIDS Program & State AIDS Drug Assistance Programs. It was in response to the need to reduce the operational burdens and other barriers of ensuring that PLWHA dependent upon the State AIDS Drug Assistance Program (ADAP) for their care receive equal access to newly developed injectable treatments in the same manner as people who are fully insured. The report also addressed barriers experienced under private insurance.

Long-acting agents include more than just antiretroviral therapies, such as Cabenuva, which is used to treat HIV. They also include treatments such as Apretude, an injectable used as PrEP, Egrifta used to reduce visceral abdominal fat as a result of lipodystrophy, Serostim for wasting, and Trogarzo which is intravenous therapy for those with multi-drug resistant HIV infections. 

These therapies are proven to be effective. However, not only are they expensive, but they are logistically challenging for supply and administration even for those who are fully insured. The challenge is even greater for those who utilize ADAP. The report described policy considerations to improve equity of care regarding injectables. Those considerations included discussions of how to reduce provider bias in offering injectable therapy as an option, ways to expand the network of facilities where injections and intravenous therapies can be administered for ADAP recipients, and ways to utilize community level resources for peer education and advocacy. 

Photo Source: Regional Center for Infectious Disease Research

A very important section of the report involved insurance. ADAP’s have formularies just in the same manner as insurance plans. Moreover, ADAP can use private insurance for patients for medication and can now assist with paying insurance premiums for low-income patients. The report discussed ways to navigate ADAP versus Medicaid insurance coverage for injectables. There was also policy discussion of how to maintain drug formularies to ensure consistent coverage.

HIV long acting agents are powerful tools in the fight against HIV and those utilizing ADAP deserve the same equity of care and access as those who are fully insured with more robust financial means. Whether it be geographical logistical challenges, treatment education deficiencies, supply chain issues, or even provider bias; ADAP recipients have many injection therapy barriers to overcome. The work of the ADAP Injectables Advisory Committee was to define necessary policy changes as well as guide discussions on how organizations can provide more ADAP recipient patient-centered care. Click here to read the report's cover letter, executive summary, and full report.

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.