Monthly Archives: June 2015

Cassandra in the Coal Mines

By: Marcus J. Hopkins, Blogger

A friend pointed out to me, recently, that issues of disease and health aren’t really “I told you, so” moments – that it is somewhat poor form to point out that warnings have been ignored, recommendations disregarded, and preliminary results unheeded. While I appreciate his perspective, there’s no small part of me that doesn’t sit in bemused horror that, despite the continued warnings over the past two-to-three decades from healthcare professionals, social scientists, and advocates, both HIV and Hepatitis C have reared their heads in Appalachia, and states are scrambling to catch up to an estimated 364% increase in new infections in the region (Capelle, 2015).

This was not, however, something that came without warning. The Appalachian region, recently deemed the “Painkiller Belt” (Lowes, 2012), has been grappling with opioid abuse for nearly twenty years, and few efforts to stem the tide of prescription drug abuse have been met with more than marginal success.

To trace this recent spate of infections back to its roots, we must, keeping with the theme, go back to the initial Trojan Horse – the FDA approval and release of OxyContin (Perdue Pharma) in 1996.

Image of a bottle of OxyContin

Photo Credit: StopOxy.com

Prior to the 1990s, strong opioid medications were reserved primarily for those in severe pain or those who were dying (Bourdet, 2012); at some point between the late-1980s and mid-1990s, however, physicians and “pain management specialists” had managed to lobby enough support for the FDA to approve the indication of prescription opioids for the use of chronic and/or moderate levels of pain in a way that had never been seen in the American healthcare paradigm.

When I was in high school, in the late-1990s, I remember being in a mandatory Health Education classroom when we were shown an investigative report on the aftermath of OxyContin testing in a small town in rural West Virginia. In the report, the journalist chronicled how this small town, in the grips of dealing with chronic pain related to decades spent in the coal mines, became the “Ground Zero” for pharmaceutical testing.

Residents who were experiencing moderate-to-extreme levels of pain were used as guinea pigs – where better to test your drug, than in a small, isolated market that can be easily monitored and controlled for results? – and how those tests quickly burgeoned into a town-wide epidemic of prescription drug abuse.

The reporter did their due diligence, showing a teenage boy whom, without the managed proper use of OxyContin, would be unable to lead a normal life as a result of a chronic arthritic condition that rendered him all but immobile. In juxtaposition, the journalist told the story of a parent whose teenager had raided their medicine cabinet in search of “pills,” leaving the parent without their prescribed medication and dealing with a child gone off the rails into a world of opioid abuse.

What was once a peaceful, rural town quickly devolved into a wasteland of OxyContin abuse, leaving schools dealing with addicted students, homes and businesses being robbed, and families shattered. The “easily monitored and controlled” testing ground turned out to be not so isolated, and the issue of prescription opioid abuse swept across the region with the ferocity of a forest fire.

The problem quickly spread to the surrounding areas and states, and OxyContin soon became known as “Hillbilly Heroin.” With the spread of prescription drug abuse came a wave of crime – shoplifting, petty theft, and prescription fraud – and many small towns saw their rates of theft triple (Borger, 2001).

At the heart of the issue was Purdue’s lucrative bonus system to encourance sales representatives to increase sales in their region, combined with the overt obfuscation of the addictive nature of OxyContin (Van Zee, 2009).

By 2001, OxyContin sales representatives averaged annual bonuses of $71,500, on top of the annual average sales rep salary of $55,000/year. This created an incentive for sales reps to aggressively pursue prescription increases all around the country, primarily through two methods: promoting the use of OxyContin in the “non-malignant pain market” and using sales reps to distribute coupons to be distributed to patients offering a free limited-time prescription for a 7- to 30-day supply of OxyContin. When the coupon program was ended by Purdue in 2001, rougly 34,000 coupons had been redeemed nationally (Van Zee).

Purdue’s Trojan Horse, while not solely responsible for the sharp increase in prescription drug abuse, was, perhaps, the key event to which we can point when looking for how Appalachia became the Painkiller Belt. By the time Federal, state, and local governments caught on to the emerging epidemic, it was too late to unring that bell.

Pharmaceutical companies rushed to find “less addictive” pain management solutions, creating high-dollar products whose slow-release nature helped to reduce long-term dependence, but in so doing created another “unforeseen” result – addicted patients turned away from high-dollar pills, and went, instead, to heroin.

In 2010, Purdue released a reformulated version of OxyContin that contained chemical safety nets meant to render it less easily abused – the pills no longer dissolved in water, making the drug less easy to cook and inject.

A study of 2,500 OxyContin addicts conducted from July 2009 to March 2012 found a 17% drop in OxyContin abuse; 66% of participants switched to heroin (Bourdet).

Which brings us to the present. In May 2015, the CDC reported that the rate of HCV has tripled in Kentucky, Tennessee, Virginia, and West Virginia between 2006 and 2012 (Parent Herald, 2015). The vast majority of healthcare professionals and observers point to injection drug use as the source of these new infections.

Healthcare professionals and advocates have been warning of this coming epidemic for nearly two decades, particularly in rural Coal Country – the veritable Cassandra in the Coal Mines, if you will. Those warnings have largely gone unheeded.

“There’s a sense of inevitability about it,” quoted Newsplex of University of Kentucky epidemiologist Dr. Jennifer Havens who has been tracking 503 drug users since 2008, she reveals 70 percent of her participants now have Hep C. “Some say, ‘I’m surprised it took me this long,'” she added (Parent Herald).

With this spate of new HCV infections, officials are now suddenly concerned about another coming epidemic – new HIV infections. These fears are rightly based upon the recent HIV infection epidemic in Scott County, Indiana, and healthcare advocates, organizations, and providers should be preparing plans of action to respond to this coming wave.

Sadly, I’m not holding my breath for a measured, premeditated response in these states. Stigma related to drug use (as well as sexual minorities and HIV), lack of financial resources, and political gridlock will likely leave the Painkiller Belt unprepared to deal with the ramifications of an explosion of new HIV cases. Given that many of the people who will test Positive for HIV will likely already be enrolled in Medicaid programs, I am left to wonder if they will be able to cope with a mass increase in new prescriptions, either for HCV treatments or their exponentially cheaper HIV-related counterparts.

And so, we wait…

References:

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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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California’s ADAP Expanded Coverage for HCV

By: Marcus J. Hopkins, Blogger

Every two weeks, we here at HEAL Blog try to bring our readers something both timely and topical related to the treatment landscape for people living with HIV/AIDS and Hepatitis C (HCV). Keeping with tradition, this week’s blog will focus on what many advocates for HIV/HCV co-infection consider a net “win” for patients.

It was recently announced that the state of California’s new budget would include funds to expand that state’s AIDS Drug Assistance Program (ADAP) to cover more clients co-infected with HIV/HCV.

California’s ADAP coverage for HCV has always been something of a mystery, to me – a state known for its relatively vanguard approach to healthcare coverage (particularly in its public programs for low-income residents), ADAP in California has proven a bit arcane, in the past year, in not expanding to cover newer, more effective therapies, such as Sovaldi (Gilead), Harvoni (Gilead), Olysio (Janssen), or Viekira Pak (AbbVie).

Flag of California

Photo Credit: American Images

I suppose that, all things considered – those things being a gigantic population in a state with two of the nation’s biggest “gay” cities (Los Angeles and San Francisco) and a relatively high rate of injection drug abuse – it’s shouldn’t really surprise me that their formulary doesn’t extend to coverage for those more expensive options.

That said, the existing ADAP prerequisites for HCV coverage have been notoriously difficult to meet (clients must be in very advanced stages of the disease and demonstrate a specific level of liver scarring), so much so that only 13 clients will be treated for HCV infection in 2015 under the current guidelines. Next year, the ADAP guidelines will be updated to provide coverage to all clients, regardless of their stage in the disease, resulting in 199 clients being covered for treatment.

If that number seems a bit low, one must take into account that covering those 199 clients is likely to cost the CA ADAP program $6.5 million dollars. In a state whose total ADAP expenditures are estimated to be $389 million in the next fiscal year, HCV expenditures are literally 1.7% of the budget for the program.

This raises an interesting conundrum for both HIV and co-infection advocates – because Ryan White funds are intended to treat HIV-related health issues, does co-infection with HCV fall under those auspices? This is a question that continues to create controversy in the advocacy community.

The issue of HCV coverage, as well as coverage for other health issues, has widened an existing schism in the advocacy community, essentially creating two opposing camps – those who believe that Ryan White funds should not be used to treat HCV (HIV-only) and those who believe that they should (HCV-inclusive).

HIV-only advocates – long supporters of Ryan White Part B – argue that there are still a steady number of new infections, each year, and therefore, ADAP dollars should go to cover new clients, rather than be expanded to include HCV therapies for existing clients.

HCV-inclusive advocates – also long supporters of Ryan White Part B – argue that the same issue that has led people living with HIV/AIDS to require assistance from ADAP exists if they are co-infected, and therefore, funds should be used to treat all health-related issues for clients, up to and including HCV drug therapies, as HCV can create serious health issues in people living with HIV.

It is difficult to determine which side is “right,” especially in the current coverage environment of expanding coverage to all. Regardless of which side of the argument one stands, the primary issue is funding – from where will the funds come to cover these treatments?

Further muddying the waters is the suggestion by some HCV advocates (separate from the HCV-inclusive faction) that Ryan White be reopened and altered to include coverage for HCV, whether or not potential clients are mono- or co-infected, meaning that HCV patients could apply for ADAP coverage without actually being HIV-Positive.

This suggestion raises the specter of whether or not reopening Ryan White to adjust language and update the law to reflect the current state of treatment will result in “gutting” to law, altogether, given the current political climate in Congress as it relates to healthcare funding. Advocates on both sides of the HCV argument seem to agree that doing so would result in a net “loss” for people living with HIV/AIDS, and there seems to be little appetite to test those waters.

It has been reported that numerous agencies and organizations are working together to craft what they believe would serve as a good template for updating Ryan White, but there is nothing substantive to report on those suggestions, at this time.

As someone who’s relied on ADAP in the past to cover the cost of medications, it strike me as odd that, even as keyed into current events as I am, I don’t know what’s in those suggestions, who’s suggesting what changes, or how “regular” clients (read: the people whose needs are the ones being met by Ryan White) can provide input into the process.

To be perfectly frank, despite all of the “great work” done by many of the national HIV/AIDS organizations, my confidence in their priorities has taken a rather large hit due to the relative lack of inclusion of the Patient voice in these discussions. I’m not altogether certain that, given those circumstances, having these organizations craft a new Ryan White bill is going to result in something that’s a net “win” for clients.

Whatever the future for HCV coverage is going to be, the real question always will boil down to funding. So, at this point, “Yay!” for California taking a relatively big leap for them, but with some of the highest tax revenues in the country, can’t we do a bit better than 199 clients being served?

References:

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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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