Monthly Archives: April 2016

Telling Us What We’ve Already Known

By: Marcus J. Hopkins, Blogger

National Academies of Sciences, Engineering, and Medicine. 2016. Eliminating the public health problem of hepatitis B and C in the United States: Phase one report. Washington, DC: The National Academies Press.
National Academies of Sciences, Engineering, and Medicine. 2016. Eliminating the public health problem of hepatitis B and C in the United States: Phase one report. Washington, DC: The National Academies Press.

The National Academies of Sciences, Engineering, and Medicine and the National Academies Press (NAP) have released their latest report, Eliminating the Public Health Problem of Hepatitis B and C in the United States: Phase One Report, in which they detail the best, most likely, and least likely ways in which the U.S. can effectively combat the growing HCV (and HBV) epidemic(s). In their findings, they report many conclusions that we in the HCV advocacy community have known for much of this decade, and in so doing, lend credibility and quantifiable evidence that we can use to better arm ourselves against a recalcitrant, uncooperative, and undependable federal government.

For some reason, accomplishing anything in Washington takes what feels like forever. Any initiative, regardless of the size or importance, faces seemingly endless hurdles and red tape, and it always seems as if every single person and committee has to get their hands on something before it comes to any sort of vote…if it even gets through said committees to make it to the floor. Combine this with the fact that, even with one party controlling both the House and the Senate, no one can manage to get anything of national import accomplished, and it’s no wonder Americans have gotten angry and feel largely disgusted with Washington.

Outsiders – those who are neither familiar with, nor privy to the “way things work” in Washington – often find themselves baffled that seemingly common sense measures take forever to put in place, especially when it comes to matters of life and death. Furthermore, excited reports of “success” in the realm of healthcare-related efforts often leave those of us on the outside feeling a little pissed off as what seems like largely incremental changes are heralded as “momentous” and “great strides forward.” Many times, I’ve found myself wanting to respond with, “Umm…you literally just got someone to say, on the record, that HCV is a big problem, and that we should really think about addressing it. What the hell is the big deal?!” And I know I’m not alone, in this regard; people living with HIV and HCV frequently find themselves frustrated at the glacial pace and seemingly miniscule results of progress.

In reality, there are hundreds of people who work tirelessly around the clock to ensure that these “minor” changes occur, and even though it’s difficult to see when you’re in the thick of things (i.e. – living with the problem), all of these seemingly minor chinks add up to destroy the armored barriers that have long prevented the HCV community from gaining the equal footing it needs to be seriously addressed.

This report from NAP takes all of the various bits of data we’ve been collecting over the last two decades and puts them together in what amounts to a significant report that will prove instrumental in convincing some of the less recalcitrant members of Congress to begin supporting better legislative efforts to address a very life-threatening and expensive problem. Those legislators who have feigned horror at the cost of HCV DAA drugs are usually the first to join our fight, but this tool will allow us to present the myriad data points related to HCV – screening issues, data collection barriers, barriers to diagnosis and treatment, and economic burdens (both personal and state) – in the hopes that even those who view HCV as mainly the problem of drug addicts, the poor, and the unemployed to take the looming healthcare disaster seriously.

Some of the key findings of this report include:

  • Injection Drug Users (IDUs) are driving the exponential increase in new HCV infections, and are more likely to transmit HCV than other patients
  • IDUs are increasingly living in suburban and rural areas, rather than urban areas, and adapting Harm Reduction to less densely populated areas will be difficult
  • IDUs are less likely to be tested for HCV or be captured in disease surveillance data
  • Deliberate attention must be paid to the highest risk populations (lower-income Whites and Native Americans living in suburban, rural, and reservation areas) in order to effectively stop the rapid spread of HCV infections
  • An element of passive racism – doctors being hesitant to prescribe opioid drugs to African Americans and Hispanic patients – has played a unique role in lessening the impact of HCV infection upon those populations
  • The high cost of DAA drugs has driven private and public payers to largely restrict access to these drugs, requiring an unreasonable amount of hurdles and prerequisites from patients for treatment
  • Half of people with Chronic HCV are undiagnosed
  • Even though HCV is twice as common and has a higher mortality rate than HIV, far fewer resources are allocated to its prevention, testing, treatment, and research
  • Even at current prices, DAA HCV drugs are cost-effective, as the long-term costs of HCV and HCV-related health issues will prove more expensive to treat; additionally, the benefits of treatment outweigh the cost
  • Surveillance data routinely fails to capture and/or include IDU, indigent, and prison populations, the latter of which accounts for 1/3 of Chronic HCV cases in the U.S., which prison healthcare systems are neither equipped, nor funded to address
  • HCV infection, much like HIV, carries with it a stigma, which serves as a barrier to treatment

To read the report, visit http://nationalacademies.org/HMD/Reports/2016/Eliminating-the-Public-Health-Problem-of-Hepatitis-B-and-C-in-the-US.aspx.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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When the Standard of Care Isn’t Standard Procedure

By: Marcus J. Hopkins, Blogger

This past week, I has the privilege of attending the ADAP Advocacy Association’s AIDS Drugs Assistance Program (ADAP) Regional Summit in Birmingham, AL. This was the sixth such meeting since 2011, with the previous year’s meeting having been held last year in Atlanta, GA. These summits are designed to discuss issues involving state-administered ADAPs that face specific regions, and three times now, this meeting has focused on the South.

This Southern focus is no accident: of the top ten states with the highest incidence of new HIV infections in 2014, Southern states fill five of those spots — including Florida, Georgia, Louisiana, North Carolina, and Texas (Kaiser Family Foundation, 2015). In addition, these states face significant barriers – endemic poverty, geographic barriers to care, inadequate Federal and state funding for assistance programs, and endemic distrust of authority and medical professionals – that largely prevent them from providing low- or no-cost HIV treatment and medications for low-income patients.

Map of the United States, with the southern states highlighted in red

Photo Source: Dialect Blog

In addition to leading the nation in regional HIV infections, the South also leads the nation in opioid prescribing. Of the top ten states for opioid prescriptions per 100 people, nine of those spots are occupied by Southern states (Centers for Disease Control, 2014). Alabama, host of this year’s Regional ADAP Summit, currently boasts the highest rate – 142.9 opioid prescriptions per 100 people. States with higher opioid prescribing rates inevitably have more Injection Drug Users (IDUs), which bodes poorly for the burgeoning rate of new HCV infections in these states. In 2015, the CDC released a report linking the increase in new HCV infections to IDUs under the age of 30 (CDC, 2015). The prescribing data, IDU rates, and HCV infection rates combine to create a bleak omen for the South’s burgeoning co-infection crisis.

ADAPs were created to serve the healthcare needs of people living with HIV for whom primary insurance coverage was essentially impossible to find. Combine a lack of access to adequate coverage with the high cost of HIV Direct Acting Agents (DAAs), and lower-income people living with HIV faced (and continue to face) seemingly insurmountable costs of care.

ADAPs are Federally-funded through a grant process; once those funds are allocated to each state (using a formula to determine the amount of ADAP funds each state is awarded), each state is then responsible for operating their own ADAP on the state-level, resulting in a sad-but-true adage: “When you’ve seen one ADAP, you’ve seen one ADAP.” This state-level administration of the program creates a massively uneven landscape, with no one state offering the same services or formulary coverage – what’s true in Tennessee may not be true in Alabama, or Georgia, or North Carolina.

Southern ADAPs almost all fail to provide coverage for the current standard of care for HCV (Infectious Diseases Society of America, 2016), which includes only newer Direct Acting Agents (DAAs) – Sovaldi, Harvoni, Olysio, Viekira Pak, Daklinza, Technivie, and Zepatier – for treatment, as opposed to the poorly tolerate ribavirin- and Pegylated interferon-based treatment regimens. Of the seventeen states that make up the American South, only three offer coverage for one or more HCV DAAs (AR, VA, & TN), while five states – all of which have very high HCV infection rates – offer no coverage, whatsoever (FL, GA, KY, LA, & TX). The remaining states provide coverage only for last decade’s poorly tolerated treatment regimens.

These older regimens often have very high failure rates for curing HCV – achieving a Sustained Virologic Response (SVR) – largely because they are so poorly tolerated that many patients simply cannot complete the regimen before they abandon treatment. In addition to being more easily tolerate, the newer DAAs have much higher success rates in achiever SVRs. This means that patients are more likely to successfully complete their treatments in a single go, rather than repeatedly failing using older regimens. With so few Southern ADAPs providing coverage for these DAAs, clients are much more likely to remain co-infected and continue to drain precious financial resources through repeated unsuccessful treatments.

There are, however, significant costs associated with these DAAs. Each of these drugs boast some of the highest Wholesale Acquisition Costs (WACs) in the pharmaceutical industry. Zepatier, the newest DAA on the market, currently sports the lowest WAC of the pack at the comparatively low price of only $54,000 for twelve weeks of treatment. Even with negotiated pricing and rebate deals between ADAPs and drug manufacturers that may lower those costs by up to 80% off the WAC, many ADAPs, Southern or otherwise, find themselves unable to afford the cost of coverage, leaving ADAP recipients to fend for themselves in an attempt to pay for treatment.

Under the Affordable Care Act (ACA), states were asked to voluntarily expand their Medicaid programs, which would have allowed Ryan White Part B ADAP programs to shift a significant number of their clients off of their rosters and onto their states’ Medicaid programs. However, this voluntary expansion plan ended up working out exactly as expected: the states that most needed the Medicaid expansion to address their healthcare needs ended up being the states that opted not to expand their programs. Of the seventeen Southern states, only seven states have expanded their programs, only three of which (AR, KY, & LA) fall in the area commonly referred to as the “Deep South.”

In these non-expansion states, ADAPs and their clients continue to face barriers related to coverage of the HCV DAA drugs. Of the nineteen states whose legislatures (or governors, via executive order) have opted not to expand Medicaid, only five (ME, OK, SD, TN, & VA) off expanded DAA coverage, while seven (FL, GA, KY, LA, NE, TX, & UT) offer no coverage, whatsoever. The remaining seven states (AL, MS, MO, NC, SC, WI, & WY) provide the outdated, ribavirin- and Pegylated Interferon-based treatments.

Further complicating issues of coverage is that many ADAPs (including Alabama’s and Louisiana’s) have decided to pay for their clients to enroll in private insurance plans through the ACA, rather than pay directly for their care. This can be considerably problematic, because it essentially ties drug coverage to whatever plans are available and their respective formulary coverage. These formularies vary from payer to payer, and in many Southern states, options can be limited to only a handful of insurance providers; in some states, those options are essentially monopolies.

What makes these insurance formularies problematic for ADAP clients is that many plans categorically shunt many of the HIV and HCV DAA and combination therapy drugs into higher tiers that require patients to pay exponentially higher co-pays to fill prescriptions; and, again, each state’s respective ADAP determines whether or not those co-pays are paid for by ADAP funds or left up to the patient.

Anecdotally, my personal Highmark West Virginia Blue Cross/Blue Shield provider currently has an HIV formulary that does not reflect the current standard of care for HIV, covering only a single single-pill regimen (Atripla), which is no longer being actively prescribed. When I contacted Highmark to inform them that their formulary is outdated and needs to come into compliance with ACA non-discrimination requirements, I was told that I was welcome to seek coverage with another insurer. As of April 15th, 2016, I filed a complaint with the Department of Health and Human Services Office of Civil Rights to begin an investigation into the provider.

While ADAPs go a long way toward helping lower-income HIV patients afford the cost of care and treatment, co-infected clients still face significant hurdles when trying to address their HCV-related care. This situation is slowly being ameliorated, as more state ADAPs add DAAs to their respective formularies. That said, there are still myriad obstacles to overcome in order to ensure that all lower-income HIV and HIV/HCV co-infected patients receive the care they need in order to live a happy, healthy, and productive life.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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In Case of Overdose, Please Spray Naloxone

By: Marcus J. Hopkins, Blogger

For the past two weeks, HEAL Blog has covered various issues related to Harm Reduction and opioid abuse, but not much attention has been given, on our part, to what happens when using injection drugs goes awry and results in an overdose. This is where two specific Harm Reduction methods – Good Samaritan laws and expanded access to the opioid antagonist, Naloxone – come into play.

Good Samaritan laws are ones that provide legal protection to people who provide reasonable assistance to people who are, or whom they believe to be, injured, ill, in peril, or otherwise incapacitated. As it relates to drug overdoses, Good Samaritan laws allow bystanders, medical professionals, or anyone, really, to treat an overdose victim using reasonable methods – such as the application of Naloxone for opioid overdoses – without fear of being later prosecuted, should the person survive and decide, for whatever reason, to sue the person who performed the life saving measure.

Naloxone, itself, is referred to as an “opioid antagonist” – a drug medication that counteracts life-threatening depression of the central nervous system and respiratory system, allowing the overdose patient to breathe normally. It’s also a nonscheduled (i.e. – non-addictive) prescription medication (Harm Reduction Coalition, n.d.), meaning that there is no chance of becoming addicted to the drug. It can be delivered via injection into the muscle, vein, or under the skin, or, more commonly, by nasal spray. The latter application, under the product name “Narcan,” is the generally preferred method of treating overdose victims.

RESPOND to an OPIOID OVERDOSE! You can save a life! [Naloxone Kit]

Photo Source: Washington.edu

When discussing “expanding access to Naloxone,” we’re speaking of more than simply making it more readily available; we’re also discussing how it can be procured, not only by medical emergency personnel and authority figures, but by minimally trained people, which can include essentially anyone, from family members to neighbors to your local postal worker. In fact, CVS pharmacy locations have made Narcan available without a prescription (over the counter, essentially) in 22 states (Thurston, 2016), allowing virtually anyone to procure the overdose cure with minimal hassle, and minimal cost.

Cost is, of course, an issue that must be dealt with, whenever we speak of medical treatments. While Naloxone is relatively inexpensive – depending on the location, between $20-$40 a shot (and in some cases, $6/dose with rebates) – the increased and increasing demand for the drug has cause some drug manufacturers – Amphastar Pharmaceuticals, in particular – to increase their prices to meet the cost of production, raw materials, and labor. Amphastar makes the naloxone most widely used by health departments and police, and is currently the only manufacturer that makes naloxone in a dosage that can be administered nasally (All Things Considered, 2015).

Naloxone, however, is not a panacea, for all its potential live-saving benefits. While the increased availability of Naloxone does translate into more overdose victims being saved, it may not be able to keep up with the increase in opioid and heroin abuse. In Louisville, KY, for example, 40 people in the metro area have died from a drug overdose as of March 21st, 2016, whereas that number was 31 in 2016 (Mora, 2016). While these numbers will, of course, fluctuate from year to year, Jefferson County (where Louisville is located) has the highest overdose rate in the state; Kentucky, as a whole, has the third highest rate in the nation.

In addition to the concerns about increasing opioid abuse levels, areas that are hardest hit by opioid addiction (and thus require larger amounts of Naloxone) may find themselves unable to keep up with the cost of treating patients. Opioid addiction and overdose rates continue to soar in suburban and rural areas, where financial resources may already be taxed by the basic functions of governance. Rural areas, in particular, face significant issues outside of just the cost of procuring doses – reaching and delivering naloxone to far flung overdose patients requires additional resources, both in terms of human and transportation resources.

While the increased access to Naloxone and Good Samaritan laws protecting those who use it are undoubtedly a good thing, they are only two parts of the Harm Reduction stratagem. Without additional efforts, such as Doctor Shopping Laws, Mandatory Prescription Drug Monitoring Programs, and Federally- and state-funded recovery services, we will continue to struggle with the growing opioid and heroin abuse epidemic. As Louisville city councilman stated, “I don’t think we’ve seen the worst of our heroin or opioid problem; I think we’re still in an upward trajectory” (Mora).

References:

All Things Considered. (2015, September 10). Price Soars For Key Weapon Against Heroin Overdoses. National Public Radio: All Things Considered. Retrieved from: http://www.npr.org/sections/health-shots/2015/09/10/439219409/naloxone-price-soars-key-weapon-against-heroin-overdoses

Harm Reduction Coaliation. (n.d.). Understanding Naloxone. New York, NY: Harm Reduction Coalition. Retrieved from: http://harmreduction.org/issues/overdose-prevention/overview/overdose-basics/understanding-naloxone/

Mora, C. (2016, April 04). Opioid overdose deaths increase, despite naloxone prevalence. Louisville, KY: WLKY News. Retrieved from: http://www.wlky.com/news/opioid-overdose-deaths-increase-despite-naloxone-prevalence/38859616

Thurston, J. (2016, March 31). CVS locations in Vermont to sell naloxone without prescription. Colchester, VT: WPTZ New Channel 5. Retrieved from: http://www.wptz.com/news/cvs-locations-in-vermont-to-sell-naloxone-without-prescription/38762902

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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A Stick in the Arm’s Worth a Lifetime of Meds

By: Marcus J. Hopkins, Blogger

National Public Radio (NPR) has begun a new series, Embedded, wherein reporter Kelly McEvers embeds herself within various communities to find out the deeper story. In her most recent segment, The House, she embeds herself in Austin, Indiana, ones of the towns at the center of the 2015 Scott County HIV and HCV outbreak.

In this story, McEvers goes into a house and interviews a number of Injection Drug Users (IDUs), all of whom are addicted to Opana (Endo Pharmaceuicals), a relatively new prescription opioid drugs that is stronger than OxyContin (Purdue Pharmaceuticals). Opana was designed to be a time-released drug, but users quickly discovered that it could be abused by crushing the pills and snorting them, for faster, more immediately powerful effects. In 2012, Endo reformulated the drug to make it much harder to break up, but, as with all addicted people, they will find a way around that roadblock: they learned how to cook the drug down into liquid form for injection purposes.

Reflective photo from a picture window in a house.

Photo Source: Seth Herald for NPR

With state and Federal governments cracking down on the distribution of prescription opioids, addicts begin to turn to street sources – drug dealers whose sources or products may or may not be good quality. At essentially $140/pill on the street, many addicts struggle to find the money to pay for their addiction. When McEvers asked why Jeff, her first interview, didn’t just turn to heroin, because it was cheaper and easier to find, Jeff informed her that Opana is simply stronger; better; cleaner.

What McEvers discovers is that, regardless of the “abuse-deterrent” label Opana carries, it’s relatively easy to abuse. In the process of her interviews, McEvers discovers just how easy the process is, as her subject, Joy – a former nurse – demonstrates for her how to use (read: abuse) Opana. Joy says that, though she started taking the pills by mouth, in February of this year, she began injecting the drugs. As a former nurse, she doesn’t share needles, but that she carries such abject shame as a result of her drug use, it makes her want to cry.

This is one of the most difficult aspects of addiction, for many IDUs – the shame that comes along with knowing you’re risking your health and safety. Joy, specifically, expresses hope that she can escape her addiction; she’s made an appointment with a doctor who can prescribe Suboxone (Invidior, Inc.) on an outpatient basis. Suboxone is a combination of buprenorpine and naloxone, and is classified as a partial opioid and can be used to treat addiction.

Another subject, Devon, admits to sharing needles to inject Opana, as well as admitting that he did not begin using the drug legally, but because people around him were using it. When asked about the recent HIV epidemic, he says that nobody knew that there was HIV in the area. McEvers interjects that, after the AIDS epidemic of the 1980s, everyone just sort of “knew” not to share needles; Devon disagrees. He tells her that clean needles were hard to come by; that drug dealers offered clean needles, but few people wanted to pony up the extra cash for clean needles.

These admissions represent a stark reality – that, despite nearly forty years of HIV being in the news, people living in rural and suburban communities seem to labor under the belief that the problem exists in their area. Both Devon and his girlfriend, Samantha, have tested HIV-Positive, and are either too ambivalent about or too preoccupied with their addictions to seek treatment.

What’s interesting, to me, about these situations is that McEvers, when meeting the town’s lone full-time practitioner, is told that once IDUs begin using Opana (or any other injectable opioid drug), their brain chemistry changes. Once they’ve used Opana, they become dependent upon it from a biological standpoint, and asking of addicts, “Why haven’t/don’t/can’t you just quit,” is an unfair request. Expecting someone to quit opioid drugs on their own, without medicated assistance, is a monumental, timely, and potentially devastating process. Withdrawal from Opana, other prescription opioids, and heroin is truly an awful, gut wrenching process, and without that medicated assistance, both relapse and failure to successfully complete a recovery scenario become exponentially more likely.

It is this key component that is currently absent from many states’ approaches to drug addiction. Though it may be difficult to operate from a position of empathy and understanding of addiction, simply expecting IDUs and other addicts to “recover” without wraparound support services has created a culture in which it’s simply easier to give up on recovery and learn to do without certain comforts in order to maintain one’s high. In my own experience with methamphetamine, I once spent over a month in the middle of the summer in Atlanta without electricity or hot water, because it was easier that way to afford both rent and meth.

As with Joy, I felt a great sense of shame over my actions, knowing that, with having HIV, smoking meth could potentially kill me in a variety of ways, not the least of which being the compromising of my immune system. Because accelerants were.to seek treatmebtvalent or too preoccupied with their addicitionsdealers offered clean neddles drugs of choice, I never personally found the idea of opioids being “for me;” as such, I cannot even begin to imagine the grip those drugs have on their users. I can, however, use my own experiences to temper my reactions and efforts when working with prescription opioid and heroin addicts; I come to the table with a level of understand that legislators do not (or do not openly) share, though they are the ones responsible for crafting and codifying programs and legislative efforts designed to take on drug addiction.

This is why programs and services that focus on patient input – saying what actually works, for them, on the ground – rather than simple edicts handed down from inexperienced government officials with little or no first-hand knowledge of addition, are so vitally important. While there are lights at the ends of certain states’ drug addiction tunnels, we still have a long way to go with incorporating the patient voice into legislative action, and hopefully, we’ll soon be able to sport multiple programs that are proven effective, because they litstened to patients.
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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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