Monthly Archives: February 2017

A Disservice to Veterans and a Time to Rethink Opioid Distribution

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Data obtained by the Associated Press (AP) from the Federal government indicates that drug theft from Veterans Affairs and other Federal hospitals have jumped nearly tenfold since 2009, with 2,457 incidents of reported theft in 2016 (Associated Press, 2017). What is unsurprising to those of us living in rural and Appalachian states is that most of the drugs stolen are prescription opioids. So great is the problem that two Congressional representatives – Congressman Phil Roe (R-TN) and Senator Ron Johnson (R-WI) – have asked the Department of Veterans Affairs (V.A.) to better explain its efforts to stem drug theft and loss in light of data being made public (Yen, 2017).

Logo: U.S. Department of Veterans Affairs

Source: U.S. Department of Veterans Affairs

Opioid drugs have always been highly addictive substances, with reports of physicians and others who have easy access to them becoming addicted stretching back well into the 19th Century. That access has, over the past twenty years, become far greater in no small part due to the popularization of OxyContin and its maker, Purdue Pharma. The Connecticut-based pharmaceutical company has repeatedly faced accusations that its products and its push to make prescription opioid drugs the first choice to treat virtually any type of pain, regardless of severity, the norm in the United States. The company went to great lengths to ease access restrictions to their products and, in 2007, pleaded guilty to purposely misleading the public about the addictive nature of OxyContin, agreeing to pay $600 million in one of the largest pharmaceutical settlements in history (Lindsay, 2007). Since that time, states and cities have sued Purdue Pharma, alleging that the company put profits over citizens’ welfare (AP, 2015 & Ryan, 2017).

The recent data obtained by the AP are just another example of how addiction to prescription opioid drugs can lead otherwise upstanding and respectable members of society – those in whose hands we, as citizens, place our very lives and wellbeing – to commit felony theft in order to either satisfy their addictions or to make money off of selling these drugs to other addicts. Other relatively recent examples of opioid theft and addiction in hospitals have led to highly publicized (and costly) outbreaks of Hepatitis C in patients who were not habitual drug users, but patients under hospital care, and yet, despite the clear need to make substantive changes to our nation’s prescription opioid policies, there seems little political will to do so.

Pain advocacy groups (sometimes funded by drug manufacturers) and pharmaceutical companies have repeatedly put undue pressure on state and Federal lawmakers whenever the specter of restrictions or regulations that might restrict or reduce access to prescription opioids makes its way into statehouses. Reports have frequently been made where lawmakers have been approached, bribed, or extorted in order to block or vote against these legislative measures, even if they merely serve as Harm Reduction, rather than outright restrictions. Worse, much of the literature used in prescriber and physician education courses is written by these companies, who go to great lengths to downplay the high risks of addiction by placing the onus not upon the prescribers, physicians, or pharmacists, but upon the patients (i.e. – the patient’s body knows what’s best). The science of opioid drugs, however, contradicts these assertions.

What is frustrating about this issue is that politicians talk a big game about “solving the opioid crisis,” but they appear to be hamstrung as to what to do about the issue. Doctors, nurses, and addiction specialists have frequently presented these lawmakers with detailed, well-reasoned, and affordable plans to combat the crisis, and yet, these legislators seem more concerned about potential threats to their reelection campaigns and coffers than they do about the very real life and death addiction issues facing their constituents. It seems more important to them that Purdue Pharma and other opioid manufacturers continue to support their reelection, than it is important to help save the lives of the people they’re elected to represent.

Theft from veterans is, beyond just a sad commentary on the state of opioid addiction, unconscionable. The men and women in whose debt we all stand for defending our nation’s interests can ill afford for the drugs meant to treat them to go missing, much less for that theft to be perpetrated by those tasked with their care. At some point, lawmakers are going to have to take a stand against pharmaceutical company influence, or simply cede their seat to them, altogether. The time has come for comprehensive reform related to opioid drugs, whether or not that negatively impacts the bottom lines of these companies.

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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Hepatic in the Heartland

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The Iowa Department of Public Health (IDPH) issued, this month, the state’s most recent epidemiological profile for Hepatitis C (HCV), and that profile isn’t looking good for people under the age of 30. Between 2010 and 2015, people between the ages of 18-30 have seen a 300% increase in new HCV infections (IDPH, 2017a). New HCV infections amongst all ages saw a 48.70% increase over that same period.

For nearly thirty years, the conventional wisdom has been that HCV is a Baby Boomer disease, and that, outside of the occasional People Who Inject Drugs (PWIDs), there is really no need to screen other groups for infection. What that preconceived notion failed to account for was a resurgence in popularity of heroin as the drug of choice and the resultant increase in Injection Drug Use (IDU). Moreover, the setting of heroin use has largely shifted away from being an urban problem that impacts mostly minority communities to one that’s plaguing suburban and rural areas where access to comprehensive healthcare and recovery services lags behind the more urban settings with which the heroin addiction has historically been associated.

The IDPH report indicates that IDU accounts for 68% of all new HCV infections, and that 55% of Iowans living with HCV live in one of six counties: Polk, Linn, Scott, Woodbury, Pottawattamie, and Black Hawk. Though these counties are among the most populous in Iowa, the state is, itself, relatively rural in comparison to its neighbors. In the IDPH HCV Fact Sheets, the increase in new infections amongst younger Iowans is specifically tied to IDU, indicating that ER visits for opioid and heroin overdoses increased 253% and 2,500%, respectively (IDPH, 2017b).

Randy Mayer, Chief of the IDPH Bureau of HIV, STD, and Hepatitis puts a positive spin on the report:

“These data indicate that Iowans are getting tested and referred to treatment by their medical providers. Everyone born between 1945 and 1965 and anyone who has ever injected non-prescription drugs, even once, should be tested for hepatitis C (Bunge, 2017).”

This is the first report by the IDPH to look at incidences of HCV in Iowa, and Mayer adds that, while this is the first attempt to pull together various data from around the state, the IDPH has been watching similar reports out of Appalachia, and as such paid additional attention to people under 30 (Shotwell, 2017).

This inaugural report from the IDPH does a lot of things “right,” my personal favorite being the use of APA citation, rather than MLA, allowing for in-text citations, rather than footnotes. Writing stylistic approach aside, the report does a fantastic job of indicating which areas Iowan medical professionals need to watch and where interventions most need to be made, as well as indicating that follow-up after treatment is necessary to avoid re-infection.

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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Heroin and Hepatitis Go Hand in Hand

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Over the past year, HEAL Blog has paid a lot of attention to heroin, particularly in relation to the massive increase in heroin and prescription opioid overdoses in Appalachia, the Midwest, and the Northeast. While the purpose of HEAL – “HEAL” standing for “Hepatitis: Education, Advocacy, and Leadership” – is to specifically address issues related to Viral Hepatitis, and particularly Hepatitis C (HCV), when we cover issues related to prescription opioid abuse and heroin, we sometimes fail to connect the dots between the two topics. There is, in fact, a very high correlation between Injection Drug Use (IDU), People Who Inject Drugs (PWIDs), and the transmission of HCV: most new HCV infections in the three previously listed regions are related to IDU.

Sources of Infection for Persons with Hepatitis C

Photo Source: Pinterest

HCV and HCV-related co-morbidities (e.g. – Cirrhosis, Advanced Liver Disease) kill more Americans each year than any other infectious disease (Centers for Disease Control and Prevention, 2016). It is also one of the most expensive diseases to treat, with Direct Acting Agent (DAA) drug Wholesale Acquisition Costs (WACs) ranging between $50,000 and $100,000 for twelve weeks of treatment. This makes preventing the spread of HCV not only a matter of physical health, but one of fiscal health.

Despite pharmaceutical manufacturers’ arguments that the one-time cost of a regimen to achieve a Sustained Virologic Response (SVR – “cure”) is far cheaper than the long-term costs of other diseases, not to mention the long-term costs that arise if HCV goes untreated, state and Federal healthcare budget departments remain unconvinced. Budgeting processes generally focus on a single year, rather than accounting for multi-year spending, so arguing that long-term expenditures “cost” more hasn’t been an effective argument. Even with the clandestine pricing agreements and rebates – clandestine, because they are not made public due to “trade secrets” laws – states have yet to begin treating every HCV-infected client on their government-funded rosters. To do so would blow through entire pharmacy budgets several times over, in many states.

With PWIDs representing the highest number of new HCV infections between the ages of 18-35, state legislatures are starting to come around to the realization that the best way to avoid spending that money on expensive treatments is to put into place Harm Reduction measures that are shown to prevent the spread of blood borne illnesses. As it is very difficult and unfeasible to stop IDU, syringe exchanges can be put into place that allow PWIDs to inject using clean needles, rather than sharing them.

Syringe exchanges have, for much of the past forty years, been largely reviled by politically conservative politicians and states; many Republican politicians have repeatedly argued that state-sponsored syringe exchanges will only encourage bad behavior, serving as a tacit endorsement of IDU. Now that prescription opioid and heroin abuse has moved outside of the urban areas and into the suburban and rural areas that serve as bastions of the Conservative ideal, suddenly, these politicians are coming around to the idea.

Medical technician counting needles.

Photo Source: Daily Beast

In the past two years, several considerably conservative states have passed laws allowing syringe exchanges to be established – Indiana, North Carolina, Ohio, and Virginia, to name a few – largely in response to a relative explosion of new HIV and HCV infections related to IDU. The problems that politicians and their constituents once relegated to the big cities have come to their quiet towns, and have done so right under their noses. The lessons out of Scott County, Indiana, where nearly 200 people tested positive for HIV near the end of 2015 and into 2016, are still reverberating throughout the region, and people are starting to look at ways to prevent the spread of disease, rather than punish the behavior.

It is clear that the opioid and heroin abuse epidemic is not going away, anytime soon. Since we aren’t likely to stop currently addicted people from injecting drugs, the smartest path forward is to at least make certain they can do so safely.

References:

  • Centers for Disease Control and Prevention (CDC). (2016, May 04). Hepatitis C Kills More Americans than Any Other Infectious Disease. Atlanta, GA: Centers for Disease Control and Prevention: Newsroom Home: Press Materials: CDC Newsroom Releases. Retrieved from: https://www.cdc.gov/media/releases/2016/p0504-hepc-mortality.html

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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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Up, Up with Prices

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

If the past decade has taught us anything about pharmaceutical products, it’s that necessity is the mother of price gouging. Whenever a health crisis arises, pharmaceutical companies are quick to respond with an abundance of products at exorbitant prices. Such is the case with Kaléo, the manufacturer of an injectable form of naloxone – the lifesaving medication that can reverse opioid and heroin overdoses – Evzio.

The price Kaléo’s unique auto-injecting naloxone twin pack of Evzio has increased 552.17% from $690 in 2014, to $4,500 in 2017 (Baldrige, 2017). This vast increase is not the only one of its kind: all five pharmaceutical companies that produce naloxone products – Amphastar, Pfizer, Adapt, Kaléo, and Mylan – have increased the cost of their versions of the drug, prompting Senators Clair McCaskill (D-MO) and Susan Collins (R-ME) to pose the following question to those companies:

“At the same time this epidemic is killing tens of thousands of Americans a year, we’re seeing the price of naloxone go up by 1000% or more. Maybe there’s a great reason for the price increases, but given the heart-breaking gravity of this epidemic and the need for this drug, I think we have to demand some answers (Jacobs, 2016).”

Sen. Bill Cassidy, R-La., listens on Jan. 23 as Maine Sen. Susan Collins discusses her Affordable Care Act replacement plan.

Photo Source:J. Scott Applewhite/Associated Press

Naloxone, in and of itself, is neither expensive to manufacture, nor is it difficult to produce. Injectable versions of the drug that require hand-operated syringes cost between $20.40 and $39.60, respective to milligrams-per-milliliter and size of the vial; but even those costs have risen substantially over the past decade (Gupta, 2016).

Much like Mylan did with Epi-Pen, the epinephrine shot that counteracts allergic reactions, what Kaléo uses to justify its price increases has more to do with the delivery method, rather than the drug itself. Evzio is unique in that it utilizes both an auto-injector mechanism, and “intelligent voice guidance,” which Kaléo describes as “Simple, on-the-spot voice and visual guidance [that] helps caregivers take fast, confident action administering naloxone during an opioid emergency and reminds the user to call 911” (Kaléo, n.d.). While this product is unique in these features, certainly the cost of the auto-injector mechanism and an audio device that can be found in greeting cards do not justify a price of $2,250 per dose.

While furor over this price increase has yet to gather full steam, health departments in northern Kentucky and in Cincinnati, Ohio have avoided the sticker shock by abandoning Evzio, altogether, by switching from Kaléo’s product to Adapt Pharma’s Narcan nasal spray, which has a Wholesale Acquisition Cost (WAC) of $125 per carton for two doses (DeMio & Luthra, 2017). Both Ohio and Kentucky, along with nearby Indiana, have experienced some of the highest rates of opioid and heroin abuse in the U.S., making naloxone a relatively basic necessity for every branch of emergency services, as well as schools and businesses. Adapt’s currently available dose is 4mg is designed for use in emergency situations; the Food and Drug Administration (FDA) has recently approved a 2mg dose of Narcan, which is designed for use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts (Barrett, 2017).

It is understandable that pharmaceutical companies need to make a profit in order to continue making new products, it is both unacceptable, and unconscionable for manufacturers of lifesaving drugs to engage in intentional price gouging whenever the need for a readily available, easily produce medication is in need. Given the current uncertainty within both the healthcare and economic arenas, neither patients, nor states can or should stand for being caught up in predatory pricing practices.

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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