Tag Archives: OxyContin

National Academies Panel Recommends Rethink on Opioids

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

A new report released by the National Academies of Science, Engineering, and Medicine (NASEM) makes several pointed recommendations about the way the United States Food and Drug Administration (FDA) approaches prescription opioid drugs, a class of pain relievers that are highly addictive and serve as a potential gateway to heroin, once supplies and sources of prescription drugs run dry (NASEM, 2017a). The panel, ordered under the Obama Administration’s FDA head in 2016, spent a year looking at the burgeoning opioid and heroin epidemics in the U.S. in an effort to better address these issues at every level of government (Diep, 2017). Among these recommendations are suggested guidelines for how the FDA considers the approval, regulation, and class scheduling of prescription opioid drugs.

National Academies of Science and Engineering Medicine

Photo Source: NASEM

Throughout the 1990s and early-2000s, pain advocates and pharmaceutical companies successfully lobbied the FDA to expand the indications (approved usage) for various high-powered opioid pain relievers that had previously been reserved for major surgeries, injuries, and palliative care. Purdue Pharma, in particular, scored a big win with its groundbreaking product, OxyContin, one of the first high-powered opioids to become commercially successful. What Purdue failed to mention while they were handing out free 30-day trial coupons for doctors to give to patients was that the drug was highly addictive. By the late-1990s, however, it became abundantly clear that these drugs had a high rate of addiction.

The recommendations put forth by NASEM as the FDA to adopt a position they term “opioid exceptionalism,” where “…the FDA thinks about opioid drugs differently from other products, …taking a public health approach to drug approvals and to other decisions about postmarket (sic) surveillance” (Servick, 2017). This would require the FDA to take into account the following:

  • benefits and risks to individual patients, including pain relief, functional improvement, the impact of off-label use, incident opioid use disorder (OUD), respiratory depression, and death;
  • benefits and risks to members of a patient’s household, as well as community health and welfare, such as effects on family well-being, crime, and unemployment;
  • effects on the overall market for legal opioids and, to the extent possible, impacts on illicit opioid markets;
  • risks associated with existing and potential levels of diversion of all prescription opioids;
  • risks associated with the transition to illicit opioids (e.g., heroin), including unsafe routes of administration, injection-related harms (e.g., HIV and hepatitis C virus), and Opioid Use Disorder (OUD); and
  • specific subpopulations or geographic areas that may present distinct benefit-risk profiles (NASEM, 2017b)

These recommendations come on the heels of a June recommendation by the FDA that pharmaceutical company, Endo, voluntarily remove its product, Opana ER, from the market in response to the public health crisis it says is in part because of illicit use of the drug by Injection Drug Users (IDUs) (Mandal, 2017). Endo recently complied with that request, despite insisting that it believes the drug to be safe when used properly (Ramsey, 2017).

Opana ER (Extended Release) is a reformulation of the drug in an effort to stem abuse by patients who were crushing the drug in order to snort it. This reformulation involved coating it with a plastic coating that Endo promised would make it “abuse deterrent/resistant.” Opana abusers, however, were quick to find a way around this by melting down the drug and its the plastic coating, filtering out the plastic through mesh, and injecting the drug directly into their bloodstream, resulting in a more intense effect (McEvers, 2016). Rather than alleviate abuse, Opana ER ended up creating a deadlier epidemic, as users were sharing needles to inject the drug, fostering the spread of both HIV and Hepatitis C (HCV). Once supplies of Opana ER dried up, those users often moved directly to heroin, as it is both cheaper and more readily available.

The NASEM recommendations will no doubt result in outcry from both pain advocates and pharmaceutical companies desperate to retain profits. Should they be adopted, the U.S. may finally be able to break its near-thirty-year abusive relationship with opioid pain killers.

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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New River Valley Region Reports Sharp Rise in Hepatitis C

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 New River is 360 miles long that spans three states – North Carolina, Virginia, and West Virginia – flowing from south to north (one of only a handful of rivers in the world to do so) and serves as one of the most scenic rivers in the eastern United States. It’s known for hosting some of the best white water rafting and kayaking in the U.S., and for having the third-longest single-arch bridge in the world. Nestled along some of the most rural parts of the three states in spans, the New River Valley (NRV) region is also home to a growing Hepatitis C (HCV) epidemic.

HEAL Blog has covered the exploding rates of HCV in West Virginia many times since our inception in 2013, as well as having covered those rates in the rest of the Appalachian Mountain Region (AMR). What frustrates many advocates and healthcare workers who live and work in the NRV is that the sharp increase in new HCV infections is largely a product of pharmaceutical companies’ – and healthcare providers’ – making.

Map showing the New River Valley area

Photo Source: Snipview

During the early-1990s, Perdue Pharma using rural towns and counties in the NRV as testing grounds for OxyContin, one of the most widely prescribed opioid drugs of the late-90s and early-00s. HEAL Blog has previously reported on this issue (Cassandra in the Coal Mines), and I stand by the assessment that this region and its population have been systematically targeted by the manufacturers and wholesalers of prescription opioid drugs; wholesalers have, in fact, spent several tens-of-millions of dollars settling cases in West Virginia related to oversupplying the drugs and creating “pill mills” in the state.

There is a direct link between the opioid and heroin epidemics in this region and the vast increase in new HCV infections. In December 2016, Dr. Marissa Levine warned during a meeting of the Virginia Board of Health that the state should expect a “tidal wave” of HCV and HIV primarily related to Injection Drug Use (IDU). The state saw a 21.212% increase in new HCV infections in 2015, from 6,600 in 2014 to 8,000 in 2015 (Demeria, 2016). Dr. Levine also argued that the lack of a dedicated funding stream greatly hinders the ability of the Health Department to accurately capture and track the data accurately, an argument shared by virtually every state in the U.S.

Beyond just opioid drug injection, New River Health District Health Director, Noelle Bissell, M.D., has seen a spike in acute HCV infections (as opposed to chronic conditions) linked to tattoo parlors, the use of homemade tattoo guns at parties, and in people who report more than 10 sexual partners, as well as a trend in cases associated with IDU involving methamphetamine, and in pregnant women and women of childbearing age (SWVA Today, 2017). It should be noted, however, that the Centers for Disease Control and Prevention (CDC) specifically states that the transmission of HCV via sexual activity is “not common” (CDC, 2015). The virus is inefficiently transmitted in this manner, and while it is possible in the manner Dr. Bissell describes, much of the data provided during screening is self-reported by patients – self-reporting may lead patients to purposely omit or skew their answers in an effort to avoid embarrassment or mask other behavioral risk factors.

The rural areas along the NRV are very likely to be hit with a greater explosion of HCV and HIV, and HEAL Blog will be monitoring the situation in the coming months.

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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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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Widening HCV Epidemic in Wisconsin

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 state of Wisconsin has a Hepatitis C (HCV) problem; one that’s not going away, and is no longer affecting only the Baby Boomer birth cohort. In 2006, 2,355 new cases of HCV were reported by the state; in 2013, that number rose 12% to 2,638; between 2013 and 2015, the number of new HCV infections rose 42% to 3,745 in a span of only two years (Wisconsin Department of Health Services (WI DHS), 2016b).

While the incidence (the number of new cases) seems relatively low, relative to the population, it is important to remember that these numbers represent only the confirmed cases of HCV infection. Health officials estimate that there are roughly 90,000 people living with HCV in Wisconsin, 75% of whom have no idea they’re infected (Madden, 2017).

Wisconsin Department of Health Services

Photo Source: State of Wisconsin

More troubling than just the massive two-year-increase in new infections is the relatively new trend of new HCV infections amongst people aged 15-29. In the past ten years, reports of HCV have shifted from a single peak of middle age adults in 2006, to a distribution of two peaks in 2015 (Wisconsin Department of Health Services, 2016a). While the increased rate of HCV among older adults is likely the result of a new recommendation to screen the birth cohort, the new peak in infection rates among 15-29-year-olds is likely due to the vast increase in the abuse of prescription opioids and heroin in rural and suburban areas. Between 2011 and 2015, the rate of HCV infection in 15-29-year-olds increased from 40.4 per 100,000 people (2011) to 86.9 per 100,000 people (2015) (WI DHS, 2016b).

Not far behind them are those aged 30-49, with a rate of 74.8 per 100,000 (2015), up from 57.9 per 100,000 (2011), again, largely due to the increase in Injection Drug Use (IDU). It is estimated that 50% of People Who Inject Drugs (PWIDs) become infected with HCV within five years of injecting (WI DHS 2016b). Strong prescription opioids have been readily available via legitimate prescriptions since the mid-1990s to treat virtually any type of pain, during which time, prescription abuse has become a major issue amongst children and teens who gain access and become addicted to these drugs through either their own pain-related legitimate prescriptions, or through illegally obtaining prescriptions written for family members or friends.

While the prescription opioid addiction crisis has been endured for over twenty years, now, only recently have drug manufacturers – such as Perdue Pharma, maker of OxyContin and Opana, the two most widely abused opioid drugs in the U.S. – been called to account for both the addictive nature of their drugs and the oftentimes extraneous supply of medications being routed through local and family-owned pharmacies that often lack the same level of scrutiny and oversight needed to effectively combat over-prescribing and abuse. Wisconsin also does not current require a physical exam for patients to be prescribed opioid painkillers, nor is ID required for all opioid prescription purchases (HIV/HCV Co-Infection Watch, 2017).

Wisconsin also has no doctor shopping laws on the books – laws preventing patients from seeking prescriptions from multiple physicians – which limits the state’s ability to crack down on patients who attempt to gain prescriptions from various sources, as well as prescribers who are lax in their monitoring of patient behaviors. In conjunction with the latter, Wisconsin physicians and pharmacists are not required by the state to undergo mandatory education regarding appropriate opioid prescribing practices in order to ensure that they do not over-prescribe, and that they are prescribing opioids only for medically necessary reasons (HIV/HCV Co-Infection Watch, 2017).

While Wisconsin is certainly not experiencing HCV infection rates as high as other Midwestern and Southern states, such as Indiana, Kentucky, Ohio, Tennessee, or West Virginia, this relatively sudden increase in rates and new infections is troubling. We, here at HEAL Blog, will continue to monitor the situation as it develops.

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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West Virginia’s Rx Crisis

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 two years, HEAL Blog has paid much attention to the prescription opioid and heroin epidemic sweeping America’s suburban and rural areas, particularly in the 13-state Appalachian Mountain region. Nowhere is this truer than in those counties and states where coal mining is the predominant industry. Mining coal can be brutal work, and miners have historically led the pack in terms of health issues. From Black Lung Disease to various types of cancer related to the inhalation of coal dust and exposure to chemicals used by the mining industry, it is a long-standing reality that the hard life coal miners face to make a living will likely result in long-term illness, pain, and/or disability.

Compounding the myriad health issues related to mining coal is how physicians, pain advocates, and pharmaceutical companies have capitalized upon these issues in the pursuit profits. In the late 1990s, prescription opioid painkillers that were once reserved for only the sickest, most desperately hurting patients gained acceptance as an acceptable treatment for even the most minor injuries, and Purdue Pharma, maker of OxyContin, one of the most widely abused prescription opioid drugs, was key in ensuring that their products were made available to as many people as possible, despite knowing (and withholding information about) the highly addictive nature of these pills. Purdue even went so far as to provide physicians with tens-of-thousands of coupons offering free 30-day trials of OxyContin to give their patients. And, with its work- and lifestyle-related injuries causing their patients pain, coal mining regions quickly became a pipeline for overprescribed opioid drugs.

Purdue Pharma logo

Photo Source: Purdue Pharma

Recent investigations and lawsuits in West Virginia have revealed astonishing levels of overprescribing, abuse, and overdoses in the state. Drug shipping sales records from drug companies (which those companies fought to keep confidential) indicate that, between 2007 and 2012, 780,069,272 prescription opioid drugs were shipped into state, amounting to 433 pills for every man, woman, and child in the state of West Virginia (Eyre, 2016a). A single pharmacy in the town of Kermit, WV (population 392) received nearly 9 million hydrocodone pills in a period of two years. In Wyoming County, a mom-and-pop pharmacy in Oceana, WV received 600 times as many oxycodone pills than the corporate Rite Aid pharmacy just eight blocks away. This essentially unfettered flooding of prescription opioids into the state has resulted West Virginia having the top four counties – Wyoming, McDowell, Boone, and Mingo – in the United States for fatal overdoses related to prescription opioid drugs, with two more – Mercer and Raleigh – also in the top ten. Logan, Lincoln, Fayette, and Monroe counties sit in the top twenty counties for opioid-related fatal overdoses.

West Virginia map of opioid overdoses, by county

Photo Source: Gazette-Mail

To make matters worse, state regulations have required wholesale distributors to set up systems to identify “suspicious” orders for highly addictive narcotics, and to report those questionable orders to the state’s pharmacy board, a regulation that drug companies ignored. Between 2001 and June 2012, the pharmacy board received just two reports – both from Cardinal Health; since June 2012, 7,200 reports about suspicious orders have been faxed in to the pharmacy board. This sudden flow of reports only came after former Attorney General Darrell McGraw filed lawsuits against fourteen drug wholesalers. Despite these reports, the pharmacy board did nothing with them, even failing to investigate or forward the reports on to law enforcement authorities (Eyre, 2016b). The state recently reached a $3.5M settlement with drug wholesaler, H.D. Smith Wholesale Drug Company over its role in the problem (Associated Press, 2017).

The state has since made receiving these drugs more difficult, which has led many patients addicted to them to turn to cheaper, more readily available heroin, and as such has resulted in a sharp increase in the number of heroin-related overdoses, deaths, and disease transmissions (primarily Hepatitis B and C). The state’s first syringe exchange programs opened in the Fall of 2015, which will hopefully stem the spread of disease, but they are located only in the state’s major cities. Additionally, treatment facilities for addition are vastly overcrowded, underfunded, and unaffordable for those whose meager resources are already stretched past the point of breaking.

West Virginia continues to be a state to monitor, along with Indiana, Kentucky, Ohio, and Pennsylvania, where opioid addiction can often lead to the rampant spread of blood borne diseases that were once rare in the region. It is difficult to overstate the severity of the epidemic, and HEAL Blog will do its best to report on the situation.

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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Opioid Prescription Abuse – Data vs. Addiction

By: Marcus J. Hopkins, Blogger

Every so often, I get the opportunity to speak with the hospice nurses who provide care services for my grandfather, and when they discover the focus of my research, I consistently hear the same thing – we have a huge problem with opioid addiction, abuse, and heroin usage in the state of West Virginia. Because their jobs specifically focus on providing hospice care, they’re not too engaged with the HCV aspect of the issue, but they have horror stories about relatives, friends, and neighbors looting their patients’ supply of opioid prescription drugs (from OxyContin to morphine) and either using it themselves or selling it on the street. But, the consensus is the same – this opioid epidemic is way out of control, and there doesn’t seem to be anyone doing anything about it.

This aspect – the “doing something about…” – is, perhaps, the most contentious issue within the opioid abuse conversation: what’s going to work, what is working, and who’s going to pay for it. These questions plague not only the people on the ground dealing with the fallout from opioid abuse, but the legislators tasked with combating a burgeoning problem. Additional concerns are raised about how to best cope with the growing addiction to opioid drugs, and frankly, there are simply no easy or cheap solutions to the problem.

Photo of opioid prescription drugs and an IU needle spread across money.

Photo Source: ReinventingAging.org

Tensions are further increased when “no nonsense”-style elected officials in the vein of Maine’s Paul LePage go off the rails talking about drug pushers coming to impregnate their white girls and bringing back the guillotine to deal with them. While this type of fast and loose language plays well with a certain segment of [mostly conservative] constituents, it plays a harmful role in demonizing not the repercussions of drug abuse and addiction, but the people who are involved. This creates (and reinforces) a social stigma, which research suggests serves as an internal barrier to seeking addiction treatment.

Two of the most successful legislative harm reduction strategies are Prescription Drug Monitoring Programs (PDMPs) that collect, analyze, and monitor electronically transmitted prescribing and dispensing data and Doctor Shopping Laws that attempt to prevent patients from seeking multiple prescriptions from multiple physicians for controlled substances.

PDMPs are highly effective tools for monitoring the rate of prescriptions being issues by physicians, as well as for tracking which patients receive those medications. Unfortunately, many states with those laws do not make reporting to PDMPs mandatory, which leaves it up to the physicians and pharmacists in those states whether or not they will participate. If there is less than an optimal participation rate, the purpose of monitoring the issue is not being served.

Doctor Shopping Laws are designed to penalize patients who visit multiple doctors in order to increase their on-hand supply of controlled substances (most frequently, opioid drugs). They make it illegal for patients to procure or attempt to procure controlled substances by fraud, deceit, misrepresentation, or subterfuge, and the penalties for getting caught vary by state. But, again – these laws only work if physicians and pharmacists are participating.

Another interesting aspect in relation to those harm reduction methods is how those laws affect law abiding citizens. There are concerns that these laws create a hostile environment, in which physicians are less likely to prescribe medically necessary medications for fear of violating state law. This could potentially leave patients in the lurch when trying to obtain a prescription to for valid use as prescribed. Should those patients be unable to receive a prescription from one physician, they may run the risk of running afoul of doctor shopping laws if they go to another physician in seek of help. While these scenarios are, at this point, purely anecdotal, it raises a serious concern about access to necessary treatment methods.

Sadly, this is one of the prices we must potentially pay if we wish to legitimately attempt to conquer our nation’s issues with opioid addiction. The consequence of making these drugs more difficult to obtain is that people who legitimately need them face the same hurdles as those attempting to procure them illegally. Good policy is, however, made when there is data and research to back up the initiative, whereas bad policy is often made when we cave to arguments of Pathos – stories, inspirational quotes, and vivid, emotional appeals.
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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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