Monthly Archives: July 2016

Prescribing Data Paints a Sobering Picture

By: Marcus J. Hopkins

Whenever I speak to colleagues in the medical profession about my work with Hepatitis C (HCV) and coverage data, I inevitably begin citing some of the grim statistics related to the disease: recent spikes in new HCV diagnoses indicate that poorer people between the ages of 13-35 are the new face of the disease; the most effective drugs to treat the virus cost more for twelve weeks of treatment than most Americans make in a single year; that opioid prescription drug and heroin abusers are likelier than virtually any other population to contract HCV; how the disease is largely un- or under-reported, because states lack the funds to adequately monitor and track the disease.

Bar Chart

Photo Source: kngac.ac.in

That I am familiar with the topic and can speak with some authority on the matter is clear, but what I am consistently asked by physicians, specifically, is why I believe we should make testing compulsory for those who are not Baby Boomers, the conventional wisdom being that this population, because they are likelier to have received blood transfusions prior to 1990, are high on the list o potential candidates for HCV. As I try to explain that, the new face of the disease is quickly becoming Injection Drug Users (IDUs) who are younger, whiter, and poorer, I find myself met with consternation. How can I possibly think that compulsory – and potentially costly – blanket screening would produce a net positive result?

My experience comes from having lived during and through the AIDS epidemic of the 1980s and 90s. As a kid and teenager growing up during the age of Comprehensive Sex Education, the constant mantra was “Get tested, get tested, get tested.” The campaign knew that teenagers and young adults were going to have sex with one another, and getting tested was one of the best ways to prevent the spread of HIV; by knowing your status, you could protect yourself and others with whom you might come in contact. These messages were blasted all over the media, in schools, in health classes, in science classes, on television shows, on the radio, in popular music – and, for the most part, this tactic was effective. New infections have largely plateaued over the past twenty years, or so, at roughly 50k annually in the U.S. That these types of marketing and policies directed toward HCV could produce similar results is, to me, a no-brainer.

Despite our differences on testing policies, a constant refrain I hear, especially from Appalachian physicians, is one detailing the woes of opioid drug abuse. “We see more people in the ER for drug abuse-related issues, than for virtually any other reason,” a nighttime ER nurse relayed to me, while collecting a throat culture to check for flu. “How these people get ahold of so many pills is beyond me!”

I hear that, a lot – doctors and nurses who seem simply flummoxed as to how patients come by these prescription drugs, considering the high number of opioid pain relievers prescribed in WV (137.6 for every 100 West Virginians) (Centers for Disease Control and Prevention, 2014). I’m told stories about how boring and pointless are the mandatory opioid educational courses, when they’re not a part of the problem; why should they have to take them, and waste their time on something that’s not really in their wheelhouse?

This might be the biggest disconnect that I encounter – how the behaviors of medical personal and prescribing physicians as they relate to opioid prescription drugs may be driving the increase in new drug abuse-related HCV infections. When a healthcare professional focuses only on the behaviors of patients, without acknowledging that their own role in providing their patients with access to these highly addictive drugs, it is a reminder of just how vital, and yet seemingly unheeded, those mandatory opioid education courses are. Their tacit assertion that common drug dealers, and not themselves, are the crux of the problem demonstrates how badly they need those courses.

Given the high correlative relationship between prescription drug abuse (and its potential, and perhaps eventual, path to heroin) and HCV infections, one might be led to think that the best place to stem the problem would be with the providers of the vice. Of course, a one-solution course of action will never be enough to effectively, or even adequately, combat the problem; multiple angles must be attacked in order to win the war against HCV, and unless we put forth adequate funding, staffing, and physical resources to fight these battles, we will likely fail to win the war.

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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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Partisan Poison Pills for 2017

By: Marcus J. Hopkins, Blogger

Each year, the House Appropriations Committee – specifically, the Subcommittee for Labor, Health, and Human Services (LHHS) – releases a funding bill for the coming Fiscal Year (FY). In what is very likely highly partisan politics on the part of Congressional Republicans during a highly volatile election year, several hefty cuts and prohibitions were introduced into the spending bill which will likely – and in this writer’s opinion, hopefully – result in a veto from the President.

House Appropriations Chairman, Hal Rogers (R-KY), stated the following:

This is the 12th and final Appropriations bill to be considered by the Committee this year. It follows the responsible lead of the legislation before it –  investing in proven, effective programs, rolling back over‑regulation and overreach by the Administration that kills American jobs, and cutting spending to save hard‑earned taxpayer dollars.

Pill with the words, Poison Pill

Photo Source: Venitism

Anyone familiar with the coded language of politics knows that this is partisan fodder to try and bolster so-called “Conservative” bona fides during an election year, and the Republicans on this subcommittee pulled out all the stops ensuring that American families and individuals pay the price for their political pandering.

The final version of the bill, which has yet to go to the full House, contains the following (taken from the Appropriations site):

  • Centers for Disease Control and Prevention (CDC) – $90 million ($20m above 2016) to expand efforts to combat prescription drug abuse (a positive step, in HEAL Blog’s view). The bill also continues the “…longstanding prohibition against using federal funds to advocate or promote gun control,” which essentially forbids the CDC from labeling firearms and gun violence a public health crisis without risking severe cuts;
  • Substance Abuse and Mental Health Services Administration (SAMHSA) – $581 million to address opioid and heroin abuse, including $500m for a first-ever comprehensive state grant program that will address the opioid epidemic nationwide (another positive step), but “…maintains a prohibition on federal funds for the purchase of syringes or sterile needles, but allows communities with rapid increases in cases of HIV and Hepatitis to access federal funds for other activities, including substance use counseling and treatment referrals” (a halfway step that still ignores and fails to fund “proven” and “effective” harm reduction programs);
  • Health Resources and Services Administration (HRSA) – “Saves” taxpayers nearly $300m by eliminating all funding for the “controversial” Family Planning Program, a program that has existed and been funded since 1970 that provides contraceptive care to avert unintended pregnancies, screening for sexually transmitted diseases and infections, HIV testing, and cervical cancer screenings. These programs provide voluntary family planning information and services for their clients based on their ability to pay (on a sliding scale), and the stripping of these funds is likely to have a disproportionate impact upon lower income Americans and minorities;
  • Centers for Medicare and Medicaid Services (CMS) – Strips $576m in funds from FY16, and comes in a $1 billion below the President’s budget request. “The bill does not include additional funding to implement ObamaCare programs, and prohibits funds for the Center for Consumer Information and Insurance Oversight and Navigators programs,” essentially leaving consumers to fly blind in order to appease the anti-Affordable Care Act Republican party platform (which the chairman cannot even call by its proper name).

If it seems like anything is missing, you’ll notice from that there is no new funding for Viral Hepatitis, despite numerous Congressional hearings where representatives bemoaned the high prices of Hepatitis C (HCV) drugs and wrung their hands about the bleak prospect of exponential increases in new Hepatitis B (HBV) and HCV infections, largely related to the very same opioid and heroin abuse they managed to fund.

This bill, should it make it out of the House and Senate, is yet another example of the now-all-too-familiar dance of “Two Steps Forward; Three Steps Back” that has occurred for the past six years of Republican control of Congress. While some improvements are made, the vast majority of proposals tend to result in cuts that are sold as “cost saving” and sacrifice “controversial” programs (controversial only to the 1/3 or less of American constituents) that should leave taxpayers feeling like they’ve be presented with false advertising. Hopefully, some of these…unique proposals will be removed before a final bill is sent to the President for approval, but in an election year – particularly the one of the length and actual controversy we’re currently forced to endure – virtually anything can, and usually does, happen.
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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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Carolina on My Mind

By: Marcus J. Hopkins, Blogger

Every year, legislatures around the United States pass legislation that is a mixture of good and bad, and this year, North Carolina’s bill, H972, is no exception.

First and foremost, H972’s primary function is to codify into law that recordings made by law enforcement agencies are not public record, and therefore are not subject to Freedom of Information Act (FOIA) or public records requests. This portion of the bill – which makes up two-thirds of the document, itself – is the likeliest portion of the bill to head immediately to court. It is not, however, within the context of the purposes of HEAL Blog to comment either on the legality or constitutionality of this section, and we will therefore move on to the next.

For our purposes, the final two pages of the bill authorize the establishment of state-sanctioned needle exchange programs in the state of North Carolina. This is a fantastic step forward in a state hard hit by the ravages of opioid prescription drug and heroin abuse. Injection drug users (IDUs) represent an ever-increasing percentage of new HIV and Hepatitis C (HCV) infections in the United State, and syringe exchange programs as a measure of harm reduction have largely shown to be effective in preventing the spread of disease by reducing the likelihood that IDUs will share needles.

Image promoting needle exchange for IDUs

According to the Centers for Disease Control and Prevention (CDC), injection drug use accounted for a full 6% of new HIV infection in adults and adolescents in 2014. That number is likely to rise considerably for the year 2015, with the recent spate of widespread infection in rural and suburban areas in Indiana, Kentucky, Ohio, West Virginia, and Massachusetts.

Indiana’s well-publicized example of the risk of HIV and HCV exposure via injection drug use was so vast, it inspired a usually vehemently opposed conservative legislature to agree to pass emergency permission to establish state-sanctioned syringe exchange programs in the hardest hit areas of the state. Similar circumstances prompted certain areas in Kentucky and West Virginia – areas where syringe exchanges have been long needed, but never funded – to establish localized syringe exchange programs in some of the most impacted areas.

While North Carolina’s legislature should be lauded for their passage of Needle Exchange provisions, there is some concern that its inclusion in a bill designed to make secret the recordings of law enforcements agencies and the constitutional concerns that raises may prompt the governor to veto the bill. If that occurs, it is hoped that the tireless advocacy efforts of NC State Senator Stan Bingham and State Representative John Faircloth – both Republicans – will find their way back into another bill, as this issue is vitally important to preventing the further spread of HIV and HCV in North Carolina and beyond.
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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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An Almost Cleverly Named HCV Drug to Beat Them All

By: Marcus J. Hopkins, Blogger

The U.S. Food & Drug Administration (FDA) and Gilead Sciences – maker of the most commonly prescribed Hepatitis C (HCV drugs), Sovaldi and Harvoni – came out with yet another fantastic cure for Hepatitis C: Epclusa. What makes this drug a real miracle? Let’s take a look:

Epclusa is the first pan-genotypic HCV therapy, meaning that it works across HCV Genotypes 1-6. This is a potential coup for Gilead, who has faced occasional threats from other manufacturers whose drugs targeted those genotypes that neither Sovaldi, nor Harvoni (alone) addressed. The new ingredient – velpatisvir – is used in combination with the sofosbuvir (Sovaldi) from both of their earlier regimens, which one must assume is what allows it to be used across all genotypes with an average SVR (“cure”) rate of 94%. This advancement, alone, is amazing, given how difficult to treat HCV was a scant four years ago.

The second-best bit of information about Epclusa is its introductory Wholesale Acquisition Cost (WAC) of “only” $74,760 for twelve weeks of treatment.

Pill bottle of Epclusa medication for Hepatitis C

Photo Source: InfoHep.org

Gilead has become the face of congressional-, physician-, advocate-, and payer-led accusations of price gouging, with Sovaldi coming in at $84,000 and Harvoni at $94,500, and they have clearly taken the calculated risk of introducing Epclusa at almost $10k cheaper than one of its component drugs by itself. After three years of price-related bad press, there was great concern within the HCV world that their much lauded pan-genotypic drug was going to easily cost over $100k, and given the range of genotypes it’s used to treat, it stood to reason that this would be the case. Gilead, however, seems to have either learned from their miscalculation of what consumers, states, and insurers were willing to pay, or they’ve decided that the record profits they’ve enjoyed from their previous successes allowed them to offer this new drug as a significantly lower price. Either way, even before discounts and rebates, Epclusa’s price point is a net win for all parties.

My only beef with Epclusa has literally nothing to do with its efficacy or its price; rather, I’m a bit miffed at Gilead for not taking the name one step further to make it truly clever. “Epclusa” is fine, and all – the “-clusa” part clearly referencing its all-in”clus”ive pan-genotypic nature – but they really missed a golden opportunity by not placing an ‘H’ at the beginning, making it “Hepclusa,” allow for both “Hep-“ for “Hepatitis” and the ‘c’ in “-clusa” to serve a dual purpose for “Hep C.” Maybe, it’s the writer in me, but come on guys: if you’re going to be amazing, be amazing all the way.
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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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