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Presidential Council Offers Uniquely American Take on Lowering Drug 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

Within the office of the President exists the Council of Economic Advisors (CEA) – a group of three advisors who, due to their unique training and expertise, are deemed qualified to analyze and interpret economic developments and advise the President of matters within that scope. The council consists of a chairman and two additional members, only the first of which must be confirmed by the Senate. The CEA, this month, released a White Paper (a government or authoritative report giving information or proposals on an issue) related to the topic of reducing prescription drug prices, and I have to say, as a patient advocate and someone who is pretty knowledgeable about prescription drugs and pricing, their response is entirely American in its analysis.

When it comes to pharmaceutical and biopharmaceutical drugs, Americans pay the highest prices in the world. The CEA report says that’s because the U.S. is paying the “market price” for drugs. Other developed countries who have the dreaded “single-payer” healthcare disease of which Republicans and Libertarians are so derisive institute government controls on pricing, forcing the poor, defenseless pharmaceutical giants (whose profits are measured in the billions) to comply with those controls in order to gain access to the market. The solution, the paper concludes, is to reduce “free-riding” abroad.

Did you get that? The key to reducing drug prices for Americans is to force other countries’ citizens to pay more for their drugs. Yes – rather than look at the American model of healthcare delivery and pricing (which virtually any person who’s ever looked at an itemized bill can attest is completely jacked), the CEA instead all but openly states, “Well, those other countries are just doing it wrong! Those silly Socialists and their insistence that healthcare be affordable just don’t know what they’re missing!”

The paper, which can be found here, contains lots of uniquely American concepts: the “Free Market” should dictate drug prices; because the rest of the world doesn’t have a Free Market, drug prices are artificially high; Medicaid and Medicare should stop requiring “best prices” and rebate minimums; we need more Pharmacy Benefit Mangers (PBMs) to enhance competition; make innovation more attractive through incentives.

Report Cover for the "Reforming Biopharmaceutical Pricing at Home and Abroad"

Photo Source: The Council of Economic Advisors

These “solutions,” while certainly things that could reduce the cost of pharmaceutical products, rely almost entirely upon the cooperation of private companies whose main incentives are profits – profits that are already obscene. Moreover, Americans pay for 70% of patented biopharmaceutical profits, despite being only 34% of the Organization for Economic Co-Operations and Development (OECD) market. So, rather than look at our own system and say, “Jesus – we’ve got to follow the leads of these other, healthier countries,” the solutions provided by the CEA instead insist that we not only double-down on our Free Market Madness, but that we attempt to force smarter countries to comply with our lunacy.

Obviously, this is my take on the issue, which is informed by my experience as a healthcare consumer for life (thanks, AIDS) and as someone who has closely tracked pharmaceutical development and pricing for the past five years. While virtually every other developed nation in the world, and even developing nations, pay reasonable prices for pharmaceutical products, Americans get screwed, all in the name of the “Free Market.”

How is it that America went from the government developing some of the most effective vaccines and medicines in the entire world from the 1950s through the 1970s, and then, we just handed over the reins to private companies, while funding at least half of their R&D costs, only to have the drugs sold back to us at exponentially higher prices?

The answer isn’t that other countries are doing it wrong; it’s that we are idiots, when it comes to healthcare, and before long, we’re either going to be completely priced out of the market, or intelligent people will ditch our hackneyed healthcare system, and join the rest of the Modern World and go with Universal Healthcare.

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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Class Action Correctional Malpractice

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

Inmates in Oklahoma prisons must have advanced liver disease before they become eligible for treatment for Hepatitis C (HCV). This means that their livers must manifest significant scarring before they’re even allowed to receive the curative treatment that will prevent further damage (Botkin, 2018).

A class action lawsuit has been filed in the state of California alleging that doctors within the prison system have denied them treatment because their liver disease isn’t advanced enough, that their disease is too advanced, and/or the drugs are too expensive (Locke, 2018).

A class action lawsuit in Missouri alleges that only five out of thousands of Missouri inmates have received treatment for HCV, desite between 10-15% of the incarcerated population being infected with HCV (Margolies & Smith, 2017).

Idaho says that nearly 1/3 of its prisoners have HCV, and it needs $3M to treat them (Boone, 2018). An inmate diagnosed with HCV while in a Mississippi prison has filed a suit alleging they’ve refused him treatment on at least nine separate occasions (Wolfe, 2018).

Inmate looking out window with bars on it

Photo Source: thedenverchannel.com

Each of these instances is indicative of a few major points: (1.) We have a growing number of prisoners within our justice system who are infected with HCV; (2.) Prison systems and/or state Departments of Corrections (DOCs) are refusing or delaying treatment; (3.) This is unconstitutional.

In last week’s HEAL Blog (“Cruel and Unusual” Neglect in Prisons), we introduced the concept of “deliberate indifference,” a measure introduced by Estelle v. Gamble (1976). This week, there’s another take – does being literally unable to afford the cost of treating inmates qualify as deliberate indifference?

The answer to that question really depends on the judge who hears the case. In 2017, U.S. District Court Judge Mark Walker in Tallahassee, Florida ruled in favor of three inmates who filed a class action lawsuit against the state of Florida, requiring the state to treat a significant portion of its 98,000 inmates (total population; not HCV-infected population) for HCV (Klas, 2017). Similarly, in Pennsylvania, a U.S. District Court Judge Robert D. Mariani ruled in favor of Mumia Abu-Jamal, an inmate who gained notoriety for his shooting of an officer who had stopped his younger brother in a traffic stop (Mayberry, 2017). Both Federal judges found that prisons are required to provide treatment for HCV, regardless of the cost.

Make no mistake, however – these rulings are few and far between; the primary issue is that it’s difficult to prove “deliberate indifference” without detailed and voluminous documentation. Even then, the measure is specifically designed to be difficult to prove (as are all burdens of proof). And the primary reason why prisons refuse or delay treatment has little to do with indifference, so much as the cost. HCV Direct-Acting Antivirals are prohibitively expensive for regular consumers; prisons, however, have even less wiggle room, as they are largely unable to negotiate on drug prices.

Where we are, at the moment, seems to be a holding point: until the drugs to treat HCV get exponentially cheaper to purchase (right now, the least expensive 8-week treatment regimen – Mavyret (AbbVie) – goes for $26,400, roughly 1/3 the cost of the cheapest drug in 2013), prison systems are unlikely to make any substantive efforts to treat HCV-infected inmate. Moreover, until the Federal government requires states to both screen and treat inmates for infectious diseases, it’s likely that HCV will continue to spread among inmates and the general population.

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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“Cruel and Unusual” Neglect in Prisons

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

HEAL Blog has long been banging the drum of patient healthcare access in incarcerated populations. Under Estelle v. Gamble (1976), the U.S. Supreme Court found that denying medical treatment is unconstitutional under the 8th Amendment’s “cruel and unusual punishment” clause, and established the criteria under which prisoners must file suit – “deliberate indifferent.” This essentially means that, if a patient needs medical attention, this cannot be denied, and that, if medical staff deems treatment necessary and orders it, that order must be honored, and that treatment order cannot be countermanded. Additionally, neither security staff, nor internal bureaucracies can hinder said treatment order in any way, and treatment decisions must be made based on medical need, rather than on convenience or the needs for security (Schoenly, n.d.). Estelle v. Gamble basically made inmates the only Americans for whom healthcare is a Constitutional right.

Gavel next to stethoscope

Photo Source: CorrectionalNurse.net

This argument has been successfully made as it relates to HIV, and more recently Hepatitis C (HCV), as numerous courts have ruled in favor of plaintiffs for whom HCV treatment has been denied. Courts have repeatedly rule that, regardless of the costs associated with treatment, prisons are required by the Constitution to provide Direct-Acting Antiviral (DAA) HCV drugs to inmates. Unfortunately for the states, this has the potential to explode correctional pharmacy budgets – a valid concern that, nonetheless, runs counter to case law. In order to avoid having to pay for treatment, many prisons actively avoid the Federally mandated HIV/HCV screenings required in Federal prisons by making state-level inmate screening “on request.”

When conducting research on state screening requirements, an official from the Kentucky Department of Corrections (KDOC) informed me that the state does NOT require inmates to be screened for either HIV or HCV during the intake process or on a regular basis. This is troubling, as Kentucky has the 3rd highest rate of HCV in the U.S. – 2.7 per 100,000 (Centers for Disease Control and Prevention, 2017). Kentucky also has the 10th highest rate of Opioid Overdose Deaths, having seen a 12% increase to a rate of 23.6 per 100,000 in 2016 (Kaiser Family Foundation, 2017).

Many, if not most, of those opioid drug-related death are a result of Injection Drug Use (IDU), the leading cause of new HCV infections in the U.S. With the high rate of arrest for illicit prescription opioid and heroin IDU comes a marked increase in the number of inmates living with HIV and HCV acquired via IDU. Incarceration settings are, perhaps, the best location for the U.S. to begin actively eradicating the HCV epidemic, but cost concerns make that an unlikely occurrence. Further complicating the issue is that prisons, jails, and youth correctional facilities do not have the same price bargaining powers enjoyed by Medicaid, Ryan White (AIDS Drug Assistance Programs – ADAP), and private insurers, meaning that prisons often pay the highest prices for HCV DAAs and other prescription drugs. This must change, if the U.S. hopes to adequately approach eradicating HCV.

Next week, HEAL Blog will take a look at some recent HCV-related issues in the U.S. correctional system.

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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United Kingdom to Attempt Ambitious HCV Plan

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

In 2016, the World Health Organization (WHO) set for the globe an ambitious plan for the elimination of both Hepatitis B (HBV) and Hepatitis C (HCV) by 2030 (WHO, 2016). In fact, most of the developed First World nations are on track to achieving this goal – the U.S., of course, being the sole lagging nation – while other developing nations – China, Russia, India, and some 5 dozen other countries – have virtually no chance of achieving that goal given existing policies (Connor Roche, 2017). The United Kingdom’s (UK’s) National Health Service (NHS) has developed a far more ambitious goal – the elimination of HCV in the UK by 2025.

NHS sign in foreground, with Big Ben in the background

In order to accomplish this goal, the NHS will be launching the single largest medicines procurement it has ever undertaken in an effort to further drive down the cost of HCV Direct-Acting Antivirals (DAAs). Reporting from Pharmaphorum Connect suggests that NHS is currently paying around £10,000 (≈$14249.30) for a single patient, far lower than the list price that averages £35,000 (≈$49872.55), which is about on par with what certain American programs for lower-income individuals are paying (Staines, 2018).

NHS England currently enjoys a “No Cure, No Fee” payment model with pharmaceutical companies, meaning that if Sustained Virologic Response (SVR) is not achieved using a DAA drug, the manufacturer will refund the cost of the regimen (Alcorn, 2018). This payment model has allowed NHS to save tens-of-thousands of pounds (GBP) per patient, particularly with those who were unable to achieve SVR with a first round of DAAs. The ability to re-treat patients without additional costs is an invaluable tool in limited the high cost of treatment – one that should be replicated, here in the U.S.

To meet the WHO goal of elimination by 2030, the NHS would have to treat and cure 10,000 patients per year; to meet the new NHS elimination goal of 2025, that number would have to increase to 16,000-17,000 per year (Alcorn). That increase may, however, prove unachievable unless rates of diagnosis increase, and the Polaris Observatory warns that without such diagnosis increases, the number of patients being treated could drop to just 5,000 per year (Alcorn).

While the goal is laudable, without cooperation between the NHS and pharmaceutical companies (or an exponential increase in NHS funding specifically for HCV, which is unlikely given the current political climate), it is more likely that NHS will have to fall back on attempting to meet the WHO goal of 2030.

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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Are Hepatitis C “intentional exposure” Criminalization Laws on the Horizon?

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

One of my favorite things about growing up in the 1980s/90s was hearing all about how “…this guy spit on someone, and it turned out…he had HIV.”

Inevitably, the “guy” they were talking about was supposedly arrested and charged with a felony for trying to infect someone with AIDS, and everyone would gasp in horror – how DARE someone try to spread AIDS by spitting on an innocent bystander?! If I happened to be in or around the group talking about this, I would always (not so calmly) explain to them that it is a scientific improbability that one could transmit the HIV virus by way of spit, because the concentration of the virus in spit is so low that there is almost a 0% chance that it can be transmitted outside of incredibly extreme circumstances and a concerted effort. Mind you, this was back in the late-80s/early-90s, when the AIDS panic was still in full swing. Even THEN, I wasn’t stupid enough to believe this kind of nonsense.

States that criminalize biting, spitting, or throwing of bodily fluids by people who have HIV

Little did I know, at the time, that these kinds of arrests were an actual thing. In 2017, there were 16 states that criminalize spitting, biting, and blood exposure for HIV-infected citizens (The Center for HIV Law & Policy, 2017).

I mean…

It’s 2018. These laws aren’t even based on good science!

So, because everything is awful, and America is totally known for basing their laws on good data and research, of course these fatuous laws would be extended to Hepatitis C (HCV) – one of the least effectively externally transmitted viruses.

Photo of a 27-year old man with Hepatitis C charged with spitting at Cleveland police officers.In Cleveland, OH, for example, a 27-year-old man who was drunk has been charged with First Degree Felonious Assault…for spitting on a police officer. He’s being held on $75,000 bond in the Cuyahoga County Jail, because he was drunk and spat in a police officer’s face while being put into an ambulance (Jankowski, 2018). Matthew Wenzler, the accused, has been called a “carrier” of HCV, and Cleveland Police reports state that they were “told” he is a “heroin addict.”

This isn’t even the first time Ohio has prosecuted someone for Spitting While HCV – in both State v. Price (2005) and State v. Bailey (1992), Ohio courts have upheld convictions for assault for spitting in an officer’s mouth. The neighboring state, Indiana, classifies Spitting While HCV as Class 5 or 6 felony battery…but only:

…if the accused in a rude, angry, or insolent manner places bodily fluid/waste on another person AND knew or recklessly failed to know that his or her bodily waste or fluid was infected with hepatitis [for Class 6].

…if the accused in a rude, angry, or insolent manner places bodily fluid/waste on another person AND knew or recklessly failed to know that his or her bodily waste or fluid was infected with hepatitis AND places the bodily fluid/waste on a public safety official [for Class 5] (Paukstis, 2017).

In South Dakota, a (Republican) state lawmaker has introduced legislation to make the transmission of HCV a Class 3 Felony punishable by up to 15 years in a state penitentiary and a $30,000 fine (Mercer, 2018). What makes this trouble is that this legislation is for “intentional exposure” which applies to “…transferring, donating or providing blood, tissue, organs or other infectious body parts or fluids” (Mercer). For anyone who’s paid attention over the past two years, the transplantation of HCV-infected organs has been repeatedly done, because there is now a functional cure for the disease. These organs are desperately needed at a time when the disease can be cured, and this legislation would making numerous people criminally liable for completing these procedures – the donor and anyone who approved or performed the transplant.

It should go without saying that criminalization of Viral Hepatitis (of any variety) and HIV is based not on good data or science, but upon efforts to shame and stigmatize those with the disease. It’s time for this nonsense to stop.

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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Young Adults Most at Risk of Hepatitis C Infection Via Injection Drug Use

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

Statistical analyses from around the country don’t lie: our nation’s young adults are driving the Hepatitis C (HCV) epidemic in the United States, and prescription opioids and heroin are the primary risk factor. These data, released by the U.S. Centers for Disease Control and Prevention (CDC) in December 2017, indicate that adults aged 18-39 saw a 400% increase in HCV, 817% increase in admissions for injection of prescription opioids, and a 600% increase in admissions for heroin injection (CDC, 2017). This analysis was made by compiling data from the CDC’s hepatitis surveillance system and from the Substance Abuse and Mental Health Services Administration (SAMHSA) national database that tracks admissions to substance use disorder treatment facilities in all 50 U.S. states from 2004 to 2014.

Photo of the CDC Headquarters

Source: George Mason University

The findings “…indicate a more widespread problem than previous studies have shown,” researchers led by the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) wrote (Connor Roche, 2018). The largest increases were among persons aged 18-29 and 30-39 (400% and 325%, respectively), non-Hispanic Whites, and Hispanics (Zibbell, et al, 2018). Admissions for both men and women attributed to Any Opioid Injection Drug Use (IDU) increased significantly, as did admissions for heroin IDU, and Prescription Opioid Analgesics (POA). Amontg non-Hispanic Whites, admissions for Any Opioid IDU increased 134% over the 11-year period (Zibbell).

What makes this frustrating as an advocate for both HCV and for Harm Reduction measures is the pushback from Conservative and Libertarian organizations and “think tanks” who consistently claim that there is no “opioid epidemic;” that the only real problem we have is heroin and fentanyl (Singer, 2018). The Cato Institute – one such Libertarian organization (founded as the Charles Koch Foundation in 1974) – has consistently misrepresented data about the opioid epidemic in America by focusing only on overdose statistics. Even the statistics they cite – “Digging deeper into that number shows over 20,000 of those deaths were due to the powerful drug fentanyl, more than 15,000 were caused by heroin, and roughly 14,500 were caused by prescription opioids” – come with some caveat that portends to excuse their galling lack of accuracy.

The purpose of the Cato Institute and Mr. Singer’s positions is to attempt to persuade “rational” people that prescription opioids aren’t the real problem, and any efforts to restrict or regulate the dosages, supply days, or “well-meaning, hardworking” healthcare providers who prescribe prescription opioids is obviously absurd. Why, any rational human being would never abuse prescription opioids, and the people who do are the ones at fault; not those innocent physicians who prescribe the highly addictive substances. (/sarcasm)

Counter to the alternate reality created by Mr. Singer, where addiction to the effects of opioids just magically appears, and can’t possibly be related to prescription drugs, that isn’t how addiction works, nor do any of the surrounded data – drug abuse statistics, treatment facility admission records, and HIV/HCV infection data – support his nonsensical claim.

These findings from the CDC should be concerning to Americans. These problems are going to get far worse, before they get better, particularly if people who are addicted lose access to government-, employer-based, and/or privately-funded healthcare coverage. With the removal of the Individual Mandate from the Affordable Care Act in 2017, analysts consistently predict that chaos will ensure within the health insurance marketplaces, which will inevitably result in fewer people having access to affordable healthcare, an increase in unpaid medical and emergent care expenses, and increased prices for everyone.

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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Appalachia’s Opioid Addiction Continues Wreaking Health Havoc

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 Northern Kentucky Health Department (NKHD) has reported a 48% increase in new HIV infections in the region in 2017, with 37 new cases compared to 25 in 2016. In 18 of those 37 cases (48.6%), Injection Drug Use (IDU) was listed as a primary risk factor, compared to just 5 of the 25 cases in 2016 (20%). Further analysis of these data show that the IDU-related new infections were concentrated in just two of the region’s four counties – Campbell and Kenton (Northern Kentucky Health Department, 2018).

Whenever a jump in new HIV infections occurs in Appalachia, I say to myself, “THIS! THIS will be our teachable moment! THIS will be the one that forces [state] to take action!” And, a lot of the time, I’m partially correct. The most common refrain I hear when asking state and local healthcare officials about potential HIV outbreaks is, “We don’t want this to be another Scott County, Indiana.”

Sihe HIV outbreak in Scott County, IN in 2015 (Hopkins, 2017) that saw the county’s number of new HIV infections jump from 5 per year to 216 in two years, states all across American and even the Federal government began taking actions to prevent a similar outbreak. In 2016, Congress partially lifted the ban on Federal funding for Syringe Services Programs (SSPs) – a move once thought virtually impossible given the political climate (All Things Considered, 2016). The Scott County outbreak served as a cautionary tale in state run by Conservatives – “It’s time to get with the times.”

Two hands, with one hold a needle

Photo Source: TheBody.com

Of the 18 IDU-related HIV infections, 78% were co-infected with Hepatitis C (Monks, 2018). Increases in new cases of Hepatitis C (HCV) are often the “canary in the coal mine) that leads healthcare professionals to begin more rigorous screening for HIV, particularly in areas of the country where the incidences of prescription opioid and/or heroin abuse are particularly rampant. Unlike the heroin epidemic of the 1970s, the new opioid epidemic of the modern millennium is set in rural and suburban areas of the country. Of the 220 counties identified by the Centers for Disease Control and Prevention (CDC) as being vulnerable to HIV or HCV outbreaks, 56% are in Kentucky, Tennessee, and West Virginia – the states that rank in the top four rates of Hepatitis B and HCV infections in the U.S. (Whalen & Campo-Flores, 2018).

Across the Ohio River from the Northern Kentucky Independent District, in Cincinnati, the city saw a 40% increase in new HIV infections over 2016, with a total of 129 new infections, 28 of which (22%) were IDU-related (Whalen & Campo-Flores).

HEAL Blog will continue to monitor the situation in Northern Kentucky. After all, nobody wants to be the next Scott County, Indiana

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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