Tag Archives: naloxone

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.

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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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Ohio’s Opioid Nightmare Continues

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

Yet again, Ohio’s drug users and first responders are being overwhelmed by heroin laced with a stronger opioid drugs. Seven fatal overdoses occurred in one day in Cleveland on Saturday, September 24 (Kaufman, 2016). The following Tuesday saw 27 heroin overdoses in a 24-hour period in Columbus, including two fatalities. One patient had been released from the hospital after being treated for an earlier overdose just thirty minutes prior to being picked up for a second overdose; there were two such overdose victims that first responders treated twice in the same day for being overdosed (Sullivan, 2016).

With the introduction of the powerful opioids, fentanyl and carfentanil, not only those who are addicted to prescription opioid drugs and heroin face increased risks; first responders, emergency personnel, and law enforcement officers also face increased risks of being sickened by exposure to these drugs during raids and rescue situations. So great are the risks to first responders and SWAT teams that the Drug Enforcement Agency (DEA) released a warning about the dangers of handling these powerful opioids without extreme caution (Jones, 2016).

All over the state of Ohio, first responders and crime labs are taxed to the breaking point responding to opioid and heroin overdoses. Jamie Landrum, a Cincinnati police officer, is quoted: “We were literally going from one heroin overdose, and then being on that one, and hearing someone come over [the radio] and say, ‘I have no more officers left,’” Landrum said. Three more people overdosed soon after that (Harper, 2016). At one overdose scene, a patient required at least four doses of Naloxone to be revived; after the fourth dose, he was still not responding.

Beyond the primary concerns of overdose is the reality that these drugs were never meant for use in humans, and therefore, has no human testing data from which to extrapolate even the most basic information: the lethal dose per kilogram of body weight, or how long carfentanil stays in someone’s system. This makes responding to overdoses more difficult.

Naloxone rescue kit

Photo Source: Yourblogondrugs.com

What this means for local, state, and Federal governments is more: more overdoses, more Naloxone, more time spent on each call, and ultimately more money in areas already strapped for resources. And while there’s great outcry for more resources, there seems to be little appetite for holding the pharmaceutical companies that produce these opioids financially liable for the havoc their products have wreaked upon the populace.

At this point, penalties and criminal charges have been largely reserved for prescribing physicians and individual pharmacists; holding anyone higher up the food chain responsible for the opioid epidemic has proven difficult, as the industry is very active in combating any efforts to either curb prescribing habits or to hold anyone in the industry accountable. What we really need are a few brave politicians who are willing to forego the promises of the industry that supports their reelection campaigns, and who will do what’s best for their constituents.
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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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Ohio’s Opioid Addiction Forces Rethinking

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

When rescue teams arrived on the scene, they had to break out two windows in her still-running truck to get to Debra Hyde and her eight-month-old grandson. Hyde’s truck was still in “Drive” in front of a large wall of propane tanks, when rescue workers found her overdosed on heroin in the backseat of her truck.

This is at least the second time in the past month that Ohio authorities have found a grandparent or guardian overdose in a vehicle with a child. Earlier in the month, Ronda Pasek and her boyfriend were found overdosed with a child in the backseat, and she is now sentenced to a 180-day sentence for a misdemeanor charge of “child endangerment.” In both cases, the children involved were remanded to the care of child services.

Woman laying on the ground after overdosing on Heroin, with the needle on the ground nearby

Photo Source: JustThinkTwice

1,424 people died in Ohio, in 2015, as a result of drug overdoses. This has forced first responders to reconsider not only how they prepare for their jobs – Naloxone kits are essentially a “must,” these days – but, how they respond to the burgeoning epidemic that plagues their state. In Marion, OH, and across the nation, heroin has fundamentally altered the work of police and emergency-service workers. Police and paramedics are now expected to play the roles of social workers, drug-treatment specialists, and experts at connecting with kids in drug-prevention programs (as those of us who remember D.A.R.E. can attest).

Marion Police Chief, Bill Collins, told his officers to stop charging those who overdosed, while at the same time, he was making connections with religious leaders, healthcare professionals, addition treatment providers, and teachers to find ways to help better address drug addiction within his community. He followed the evidence: many addiction surveys indicate that a large number of opioid addicts became addicted to prescription pain killers after gaining access to their parents’, grandparents’, or guardians’ properly (or improperly) prescribed opioid painkillers and began using them recreationally. In addition, he noticed that many of the people who were being found overdosed had kids in local schools, which further indicated that a great place to start would be within the educational paradigm.

With these things in mind, Collins and his allies helped create the “Too Good for Drugs” campaign, that teaches age-specific strategies that students can use to resist drugs. The program won a $25,000 Ohio Department of Education grant to fund the ten-week program for 6th-12th grade students. Teachers were so passionate about the project that they volunteer to teach it. Officials are still waiting to find out if another grand to extend the program to K-5th grade students is approved.

But, beyond the fact that these functions are becoming unlisted job requirements in these fields, should law enforcement officers and other first responders be expected to fill these roles? What few people contest is that “something” needs to be done; beyond that, there’s little agreement between healthcare professionals, law enforcement organizations, and advocacy groups on exactly what that “something” is.

Do we need more treatment centers for drug addiction, both in- and out-patient? Absolutely. Do we need more qualified social workers and staffing resources to adequately address opioid and other drug addiction? Yep. Do we need to do a better job of providing these recovery and addiction services to people in more rural parts of states – areas where opioid and heroin addiction are currently hitting states hardest? There’s no doubt of that.

But, the reality is that all of these approaches, while both the “right things to do” and the best ways we currently have to address the problem, are costly and require resources that, on the state and local levels, may simply not exist. Further complicating these efforts is the seeming inability of our elected leaders at the Federal level to work together toward accomplishing mutually beneficial goals. For states currently watching their cities turn into drug dens with a body count, it really does seem like the time for them to just get it together, and get to work.
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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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Ohio Opioid Epidemic Grows As Death Toll Mounts

By: Marcus J. Hopkins, Blogger

Two weeks ago, police in East Liverpool, Ohio, made global news after posting an arrest scene photo of a four-year-old child in his car seat, while with his grandmother and her boyfriend sat in the front seats, overdosed on heroin. The image has served as both a poignant reminder of the often overlooked consequences of opioid and heroin addiction and as a point of controversy for addiction and child advocates.

Map of Ohio, showing East Liverpool

Photo Source: Google Maps

The East Liverpool police posted the photo in an effort to bring attention to the havoc that opioid and heroin abuse wreaks on not only the user, but on the lives of the people around them. Both overdose victims received doses of naloxone – a fast acting drug that reverses the effects of opioid drugs – at the scene, an act which very like saved their lives. The driver, James Acord (47), was sentenced to 360 days in jail after pleading ‘No Contest’ to charges of child endangerment and operating a vehicle under the influence. the boy’s grandmother, Rhonda Pesak (50), who was awarded custody of the child on July 25, 2016, was sentenced to 180 days in jail after withdrawing her initial ‘Not Guilty’ plea to a charge of child endangerment, and reentering a plea of ‘No Contest.’

The child has since been relocated to live with his great aunt and uncle in South Carolina. His mother initially lost custody of him in December 2012 – four-and-a-half months before he was birth – as a result of her addiction to crack. Custody had initially been awarded to his great grandparents, and custody battles for the boy have involved his birth parents, a grandmother, two great aunts, and a friend, spanning four different states. Essentially, this boy’s life has been negatively impacted by drug addictions of some sort since before he was born.

Addiction advocates have criticized the East Liverpool police for “shaming” people who use drugs; child advocates have criticized the city for failing to obscure the identity of the child, which was done after the images were posted by news agencies. East Liverpool Service-Safety Director, Brian Allen, responded with the following statement:

If we hadn’t, Rhonda Pasek would have received a slap on the wrist and that little boy would have gone back to her – that’s not going to happen now. I doubt she will see that child again (Gould & Graham, 2016).

In the five days that followed the posting of the photograph, East Liverpool, a city of only 11,000 people, saw seven more overdoses and one death from heroin. But, this is just a small vignette of a much larger portrait. On Friday, September 09, Ohio authorities reported at least 21 overdoses in a single day in Akron, OH, bringing the total number of overdose deaths, this year, to 112 in the city. At least 24 people were hospitalized for overdoses, last month, while attending a music festival in the state (Karimi, 2016). In July, along, Akron police reported more than 90 overdoses and eight deaths (Las Vegas Review-Journal, 2016).

Ohio’s recently enacted Good Samaritan law offers immunity from prosecution to people trying to get help for someone overdosing on drugs or overdose victims, themselves, who seek assistance. The law, which went into effect, this month, covers people calling 911, contacting a police officer, or taking an overdose victim to a medical facility for up to two times; upon the third time, they would become subject to prosecution. This law, sign by current Ohio Governor, John Kasich, was passed in an effort to provide those offering assistance to overdose victims some measure of protection in the face of Ohio’s clear opioid and heroin abuse epidemic.

HEAL Blog will continue covering the epidemic in the coming weeks with more information and updates as they become available.
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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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Milk, Bread, Ground Beef, and Overdose Medication

By: Marcus J. Hopkins, Blogger

The HEAL Blog has been following the issue of opioid addiction very closely, largely because Injection Drug Users (IDUs) represent a large proportion of new Hepatitis C (HCV) infections in the U.S., particularly in rural parts of the country. The Appalachian Mountain region serves as a prime example of how heroin and opioid addiction can lead to a rash of both HIV and HCV outbreaks; it also serves as excellent proving grounds for how Harm Reduction methods can help to prevent mass outbreaks, as well as save lives.

Harm Reductions measures are those that focus on preventive measures that have been shown to lessen the risk to individuals through various legal means. As they relate to opioid addiction, one of the most important measures is increased access to Naloxone, a medication that is used to block the effects of opioid drugs, such as slowed breathing and loss of consciousness. Naloxone – sold under the brand name, Narcan – is a nasal spray that is used to counteract the effects of an opioid overdose. It is currently listed on the World Health Organization’s “List of Essential Medicines,” the most important medications needed in a basic health system, and increasing ease of access without a prescription is something for which advocates have long fought.

Last week, in the city of Huntington, WV, 26 people overdosed on opioid drugs in a period of only four hours from a particularly potent batch of heroin. Of those 26 overdose cases, none of the patients died, as first responders and hospitals were quick to react, delivering a total of 12 doses of Naloxone, including the two used by Huntington police. One patient had to be revived using three doses (Struck, 2016). The remaining patients were revived using bag valve masks, a handheld device used to provide ventilation to patients who aren’t breathing. The users who overdosed ranged in age from 20 to 59, demonstrating that the opioid epidemic affects people of virtually every age range. In Cabell County, where Huntington is located, there were 440 overdoses by June of this year, 26 of which resulted in death; the state of West Virginia, itself, ranks highest in the number of overdose deaths in the U.S.

In Kentucky, the next state over and less than fifteen miles from Huntington, Kroger grocery store locations with pharmacies on site began offering Naloxone over the counter without a prescription at 96 locations, including 80 pharmacies in the Louisville Division (Warren, 2016). Kentucky currently ranks in the top five states for overdose deaths, which makes it an excellent test market for the efficacy of offering Naloxone without a prescription. That said, the Kroger locations in Ashland, KY – the city nearest Huntington, WV – does not yet offer the drug over the counter.

Naloxone rescue kit

Photo Source: Yourblogondrugs.com

When we discuss expanding Naloxone access, there are a number of ways that access can be broadened – (1.) Naloxone can be carried by first responders; (2.) Naloxone can be carried also by state employees (such as school officials); (3.) Naloxone can be sold without a prescription to anyone. WV does not currently allow the sale of Naloxone without a prescription, although WV HB 4035 seeks to do just that. Access to first responders, including police and other emergency personnel, was expanded beyond just Emergency Medical Technicians (EMTs) in May of this year, but it is unclear, yet, whether or not HB 4035 will be ratified and made into law by the end of this year. In an election year, particularly in the latter half, little of substance seems to get done.

What is important, however, is that we continue to fight to expand access to this lifesaving drug. Politics and personal peccadillos aside, saving someone’s life should never fall prey to moralizing of whether or not opioid abuse is wrong, nor should saving a life be predicated upon whether or not one agrees with the lifestyle choices of the victim. When lives are at risk, every reasonable action should be taken to ensure that those lives are saved.

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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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New Harm Reduction Focus Helps Bring Light

By: Marcus J. Hopkins, Blogger

The HIV/HCV Co-Infection Watch — published by the Community Access National Network (CANN) — recently added two new sections to its monthly report: the first focuses on the coverage offered by the Veterans Administration (VA); the second, and perhaps more involved research, focuses on Harm Reduction efforts.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

The VA section is extremely cut and dry; they recently announced that they will effectively cover all veterans who are currently eligible for benefits for HCV treatment using Direct Acting Agent (DAA) HCV therapies. The Harm Reduction section, however, requires a more nuanced approach, as each state has its own interpretation of how they implement each aspect of Harm Reduction.

For those unfamiliar with the term, “Harm Reduction” is a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use, as well as for expanding, protecting, and respecting the rights of drug users. The specifics, again, vary from state to state in their implementation, but there are overarching ideals that are used to shape these programs. In our research, we’re focusing on several very important Harm Reduction strategies:

  • Syringe Exchanges;
  • Expanded Naloxone Access;
  • Good Samaritan Laws;
  • Mandatory Prescription Drug Monitoring Programs;
  • Doctor Shopping Laws;
  • Physical Examination Requirements;
  • ID Requirements for Purchase;
  • Required/Recommended Prescriber Education; and
  • Lock-In Programs.

If this list seems exhaustive, it’s really only the tip of the iceberg. Harm Reduction strategies have a consistent track record of bringing about positive health outcomes, but little attention gets paid to them, unless there is a well-publicized health crisis – a sudden explosion of new HIV infections resulting from injection drug use, for example – that essentially forces the hand of state legislators to act. The most recent example of legislative Harm Reduction publicity came from Maine, which we covered two weeks ago, when Republican Governor Paul LePage vetoed a bill that provided expanded access to Naloxone by allowing it to be purchased from pharmacies without a prescription; his veto was quickly overturned by both Maine’s House and Senate on April 29th.

While Harm Reduction strategies have a proven record of net positive outcomes, there are always unintended consequences to any well-intentioned law. The U.S. has been in the throes of a prescription opioid addiction problem since the late 1990s, and state and federal governmental intervention is desperately needed and vitally important to help quell the ever-increasing addiction and overdose rates, HIV and HCV infection rates, and the unfortunate increase in criminal activities (such as varies classifications of theft) that tend to accompany an increase in opioid drug use. One such unintended consequence is the reduced access to prescription opioid drugs for patients whose healthcare needs truly necessitate their occasional use of a validly prescribed opioid.

I was recently asked by a very good friend if I knew of any doctors who would prescribe opioid pain relievers. This person knows the type of research I conduct, and his question stemmed from the fact that his doctor has repeatedly tried the same methods of pain relief that provide only short-term results to a chronic issue despite repeated requests to move past the less effective approach to a longer-lasting solution. My friend’s predicament is that any doctors outside of West Virginia University’s healthcare system are outside of his insurance plan’s network, which leaves him with few good options on a fixed income.

While I understand my friend’s predicament, I was unable to provide him with the answer he was seeking. What makes this problem difficult to address is that WV has one of the most vigorous legislative approaches to Harm Reduction strategies, largely because the state has been coping with a massive opioid addiction problem for at least two decades that has all but ravaged the state. It is my belief that this doctor properly using the context of WV’s opioid addiction problem to inform his overall approach to pain relief, and rightly so. For my friend, I suggested the use of a healthcare mediator or advocate during their next appointment; someone to speak on his behalf, and to try to come to a pain management approach that will allow him to better address his needs and to help the doctor understand his patient’s position – that the regimen he’s prescribing may not be the best solution for his patient.

My position, however, remains unchanged – Harm Reduction strategies are the most effective way to achieve net positive healthcare outcomes related to prescription opioid use, abuse, and addiction. While there will always be unintended consequences for some, the good of the many outweighs the complications that can arise from more stringent prescribing requirements. There is little doubt that we are facing a crisis of unprecedented scale; how we choose to deal with that, as a nation, will be of the utmost importance.

CLICK HERE to receive the monthly HIV/HCV Co-Infection Watch.
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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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Taking a LePage from an Outdated Book

By: Marcus J. Hopkins, Blogger

Naloxone does not truly save lives; it merely extends them until the next overdose,” Gov. Paul LePage (Miller, 2016).

Maine’s very own Republican Governor Paul LePage, is renown for his ability to say just the wrong thing in the absolutely worst way possible, and his above quote is an example. LePage’s comment is a part of his veto the Maine legislature’s attempt to expand the ability of pharmacies to provide naloxone – a non-habit forming drug used to counteract the effects of opioid and heroin overdoses – without the need for a prescription.

Photo of Maine Governor Paul LePage

Photo Source: Business Insider

This type of legislation is nothing unusual – roughly 30 states have similar Harm Reduction laws on the books. Maine, in fact, has already increased access to naloxone by making it readily available to emergency personnel, nurses, and other healthcare professionals, and bill LD 1547 would’ve brought Maine in line with a majority of states. The bill came about after national pharmacy, CVS, requested the bill in response to a letter from U.S. Senator Angus King (I-ME) asking the chain to expand the availability of the antidote (Mistler, 2016a). For the most part, LD 1547 enjoyed broad bi-partisan support from legislators, community members, healthcare professionals, medical associations, and public employees and servants. So well-received was the bill, that it was passed “under the hammer” – unanimously without a roll call. LePage was not one of its fans.

Maine, like most other rural areas in the U.S., is in the throes of a growing opioid and heroin abuse epidemic, and this isn’t the first time that LePage has taken a stab (pun intended) at the problem. Earlier, this year, LePage made similarly troubling comments:

“These are guys by the name D-Money, Smoothie, Shifty. These type of guys that come from Connecticut and New York. They come up here, they sell their heroin, then they go back home. Incidentally, half the time they impregnate a young, white girl before they leave. Which is the real sad thing, because then we have another issue that we have to deal with down the road” (Fuller, 2016).

The unfortunate result of this type of verbiage is that it tends to lead to further stigmatization, rather than creating any substantive solutions or net positive results. What’s sadder is that the stigma associated with opioid and heroin abuse is so pervasive in our society that those who are also unwilling or unable to read, research, or understand existing research about opioid addiction and abuse have these stereotypes of substance abusers further reinforced in their minds.

Of further concern for LePage is that his veto is likely to be overridden by Maine’s legislature. It is this author’s hope that, along with an overridden veto, the citizens of Maine are treated with a more accurate portrayal of the fight against opioid and heroin abuse and addiction; one that doesn’t portray them as “…addict[s] [with] a heroin needle in one hand and a shot of naloxone in the other.”

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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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