Tag Archives: opioids

Who Funds the Opioid Epidemic (and the Subsequent HCV Epidemic)

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

Senator Claire McCaskill (D-MO) is planning to introduce a bill into the Senate that would require drug makers to report payments that are made to nonprofit organizations and patient advocacy groups (Silverman, 2018). This is an issue that HEAL Blog, as well as the Community Access National Network’s HIV/HCV Co-Infection Watch publication, has repeatedly brought up in our reporting.

Sen. Claire McCaskill

Photo Source: The Washington Free Beacon

State and Federal lawmakers have been attempting to place prescribing and use restrictions on prescription opioid drugs for the better part of two decades. There is a natural opposition that state and Federal lawmakers face from opioid manufacturing pharmaceutical companies, such as Purdue Pharma, maker of OxyContin, the first prescription opioid drug made available and marketed to average consumers rather than for use in palliative care and severe injury. But, that’s not where the pressure on lawmakers ends.

Purdue Pharma logo

Photo Source: Purdue Pharma

Where McCaskill’s proposal comes into play goes back much further, with pharmaceutical companies creating and funding nonprofit organizations to advocate for a single issue: Pain. Pain Advocates, since the late-1980s, have been actively lobbying Congress, the U.S. Food & Drug Administration (FDA), and state legislatures to push for easier access to these powerful drugs. Every time a legislator or the FDA attempts to reign in what was once virtually unfettered access to

Opioid drugs work by binding to opioid receptors in the brain, spinal cord, and other areas of the body and reducing the sending of pain messages to the brain, thereby reducing the feeling of pain. For Pain Advocates who claim to represent patients whose levels of daily or regular pain leave them unable to function normally, these drugs have been seen as necessary for their survival. What drug manufacturers who fought for easy access to these drugs failed to mention (despite knowing from their own research) is that opioid drugs are highly addictive.

I’ve personally encountered several pain advocates whose opposition to my advocacy for opioid prescribing restrictions in the state of West Virginia has been boiled down to this line of thinking: “How am I supposed to be a functional human being without these prescriptions?” In a state like West Virginia, which has the highest rate of drug overdose deaths in the nation (52 per 100,000) and potentially the highest rate of Hepatitis C (HCV) in the nation (7.2 per 100,000), this comes across to me as them really saying, “My pain is more important than the preventable spread of disease or others’ lives.”

As the rate of new HCV infections continues to rise, in some states like WV, exponentially, is that opioid drug abuse is directly tied to this meteoric increase. In a report from the National Institutes of Health’s (NIH’s) National Institute on Drug Abuse, data indicate that the incidence of heroin initiation (beginning to use) was 19 times higher among those who reported prior nonmedical pain reliever use than among those who did not. Further, a separate study cited by the NIH found that 86% of young, urban heroin injectors had used opioid pain relievers nonmedically prior to using heroin, and that their introduction into nonmedical use was characterized by three main sources of opioids: family, friends, and personal prescriptions (National Institute on Drug Abuse, 2018).

Next week, we’ll take a deeper look at how opioid diversion from legitimate prescriptions can potentially lead to addictions that can increase the risk of acquiring Hepatitis and HIV as a result of Injection Drug Use.

References:

__________

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.

 

Advertisements

1 Comment

Filed under Uncategorized

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:

__________

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.

Leave a comment

Filed under Uncategorized

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:

__________

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.

Leave a comment

Filed under Uncategorized

amfAR Releases Opioid & Health Indicators Database

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

amfAR, The Foundation for AIDS Research, has published their latest site, “Opioid & Health Indicators Database,” which pulls together, for each state, trends over time in opioid use and related infectious disease mortality, as well as state-by-state levels of Federal funding (Melville, 2017). The site was revealed at last week’s Association of Nurses in AIDS Care (ANAC) 2017 conference by Alana Sharp, MPH, from the Foundation of AIDS Research, a private organization that focuses on the various research and databases that informs their reporting.

AmfAR logo

Photo Source: amfAR

The website pulls together various data from a variety of sources and present this data for every state in the U.S., and puts them in the context of HIV, Hepatitis C (HCV), and the opioid crisis. This unique site is one of the first to actively connect these types of data in a user-friendly manner. They also make use of the supplemental data used to compile a list of 220 counties in the U.S. most at risk of HIV and/or HCV outbreaks due to a variety of similar circumstances that include: Drug Overdose Mortality, Prescription Opioid Sales, Mental Health Services, Insurance Coverage, Urgent Care Facilities, Vehicle Availability, Education, Income, Population Density, Poverty, Race/Ethnicity, Unemployment, Urban/Rural Status, and Buprenorphine Prescription Capacity (Van Handel, et al., 2016b).

Opioids Amplifying Impacts on HIV and HCV

Photo Source: opioid.amfar.org

From the front page, users select their either the state or congressional district from one of two dropdown boxes, and receive a fresh page that provides information. For states, the first page displays information on the Most Vulnerable Counties, taken from the Van Handel report, and after a click-thru, lands on a page that lists a considerably deep level of state statistics, including demographic data, HIV and/or HCV populations, opioid use statistics, healthcare-related statistics, and treatment and prevention services information, all of which are set against national statistics (e.g. – Percentage of People without Health Insurance (2015): West Virginia – 11.5%; National – 13.0%). After the numerical presentation, you can scroll down for more in depth coverage about state opioid policies, graphs of state health trends, Federal funding from various agencies, as well as a data explorer, that provides county-by-county HIV and HCV incidence and prevalence data broken, the same data by congressional districts, and by state for comparison.

If users select their congressional district, they’re asked to provide their zip/postal code, and are provided with a district profile providing numerical data similar to the state profile, and follows with the same graphic representation of data as presented on the state level, but Congressional district-specific.

This database, one of the first of its kind, helps provide a fantastic resource for state-level advocates and policy makers for informing good policy planning and crafting. For more information, please visit amfAR’s website at the following address: http://opioid.amfar.org.

References:

  • Melville, N.A. (2017, November 08). Opioid Crisis Inflaming Hep C, HIV in Hard-Hit Communities. New York, NY: Medscape, LLC: News: Conference News. Retrieved from: https://www.medscape.com/viewarticle/888219
  • Van Handel M.M., Rose C.E., Hallisey E.J., Kolling J.L., Zibbell J.E., Lewis B., Bohm M.K., Jones C.M., Flanagan B.E., Siddiqi A.E., Iqbal K., Dent A.L., Mermin J.H., McCray E., Ward J.W., & Brooks J.T. (2016b, November 01). County-Level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections Among Persons Who Inject Drugs, United States. JAIDS Journal of Acquired Immune Deficiency Syndromes: November 1st, 2016 – Volume 73 – Issue 3 – p 323–331. doi: 10.1097/QAI.0000000000001098. Retrieved from: http://journals.lww.com/jaids/Citation/2016/11010/County_Level_Vulnerability_Assessment_for_Rapid.13.aspx
  • Van Handel M.M., Rose C.E., Hallisey E.J., Kolling J.L., Zibbell J.E., Lewis B., Bohm M.K., Jones C.M., Flanagan B.E., Siddiqi A.E., Iqbal K., Dent A.L., Mermin J.H., McCray E., Ward J.W., & Brooks J.T. (2016b, November 01). County-Level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections Among Persons Who Inject Drugs, United States – Supplemental Appendix. JAIDS Journal of Acquired Immune Deficiency Syndromes: November 1st, 2016 – Volume 73 – Issue 3 – p 323–331. doi: 10.1097/QAI.0000000000001098. Retrieved from: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/QAI/A/QAI_2016_06_29_VANHANDELM_QAIV16762_SDC1.pdf

__________

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.

Leave a comment

Filed under Uncategorized

Opioid State of Emergency Muddies the Waters

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

On July 31st, 2017, President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis put forth its recommendations for combating the opioid epidemic in the United States. It’s “first and most urgent recommendation:” “…declare a national emergency under either the Public Health Service Act or the Stafford Act” (Ingraham, 2017). The President was quick to react, promising he would do so. It only took nearly three months, but he followed through with as much forethought and careful planning as every other venture in this administration. That is to say, it did not go very well.

One of the biggest frustrations with the Trump Administration has been its members’ tendency to act with seemingly no real concern or knowledge of existing programs and systems already in place, or of any complications or repercussions their decrees and executive orders may create. Moreover, getting him to follow through on any of his promises always seems to require a Herculean effort that inevitably involves constant hounding, public comments, and eventual media shaming. Even then, after being raked over the coals, when he does act, it always seems to fall short of actually meaning or doing anything. Thus is the case with last week’s announcement of a quite limited “Public Health Emergency.”

Using the Public Health Service Act, the President declared on October 26th, 2017, a not-so-sweeping “Public Health Emergency” in an effort to combat the opioid epidemic (Johnson & Wagner, 2017). This declaration orders acting Acting-Secretary of Health and Human Services Eric Hargan to waive regulations and give states more flexibility in how they use Federal funds (Korte, 2017). It also allows the U.S. Department of Health and Human Services (DHHS) to work around what the administration calls “…bureaucratic delays and inefficiencies in the hiring process” to temporarily appoint specialists to deal with the crisis. In addition, it allows for expanded access to telemedicine services, including services involving remote prescribing of medicine commonly used for substance abuse or mental health treatment.

President Donald Trump shakes hands with New Jersey Gov. Chris Christie after signing a presidential memorandum to declare the opioid crisis a national public health emergency in the East Room of the White House, Thursday, Oct. 26, 2017, in Washington. (AP Photo/Pablo Martinez Monsivais)

Photo Source: AP Photo/Pablo Martinez Monsivais

Most troubling, the action specifically:

“…allows for shifting of resources within HIV/AIDS programs to help people eligible for those programs receive substance abuse treatment, which is important given the connection between HIV transmission and substance abuse.”

This is particularly alarming, given the fact that the programs that provide coverage for the treatment of HIV in lower-income patients – namely the Ryan White program – already allow funds to be used for outpatients substance abuse treatment and rehabilitation services under both Title I and Title II. That being the case, the inclusion of this language in last week’s declaration sparked a panic within the HIV services and advocacy communities as they attempted to parse exactly what the declaration meant, as well as which programs were at risk of having their funding reallocated for another purpose. Other HIV/AIDS programs beyond treatment coverage include prevention efforts, research, data mining, and efforts at the CDC. Are those on the chopping block, now?

Perhaps the most oft-repeated refrain of 2017 has been, “We just don’t know.” Virtually every action by the Trump administration has left every department responding to almost every question about intents, implications, or repercussions by saying, “We just don’t know.” This holds true for the public health emergency declaration:

From where is the funding for these programs going to come? “We just don’t know.” Senator Richard Blumenthal (D-CT) said the measure won’t be sufficient for most states. In Connecticut, the President’s move would free up only $57,000 in additional public health funds (Firger, 2017).

What temporary appointments can or will be made within the DHHS? “We just don’t know.” Many of the experts in these fields are either already working within the government or are working for other governments in nations where Harm Reduction is actively funded and healthcare is universally provided.

How does this declaration plan to increase access to telemedicine, and how will that access work without being connected to other recovery services? “We just don’t know.” Many of the most affected regions in the country are in areas where rehabilitation and recovery services are already sparse, and medication-assisted treatment for substance abuse is intended to be used in conjunction with those services. And, again, how will we pay for all of this? “We just don’t know.”

The President’s partial measure in announcing a public health emergency rather than a national emergency seems arbitrary to most people, but had he done the latter under the Stafford Act, that would have opened up resources that are usually reserved for natural disasters (i.e. – FEMA’s disaster relief fund) and states could have requested Federal grants for those purpose. Instead, we got an unfunded half-measure that includes some rather terrifying implications for HIV/AIDS programs, and a “Fact Sheet” about the declaration, half of which was comprised of self-congratulatory back pats instead of a detailed and specific plan for moving forward with this declaration.

Perhaps the most telling part of the aforementioned Fact Sheet was the introductory quote at the top of the page:

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place.  If they don’t start, they won’t have a problem.” – President Donald J. Trump  

Well. That certainly clears things up for everybody.

References:

 __________

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.

Leave a comment

Filed under Uncategorized

Drug Enforcement Has Never Been More Convoluted

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 case you’ve been living under a rock since the mid-1990s, the U.S. is in the midst of an opioid drug crisis. Since the 1996 approval and release of Perdue Pharma’s wildly profitable OxyContin for use among the general public, Americans have quickly become addicted to “pain relief” (Bourdet, 2012); not just any pain relief – pain relief that had, prior to the early-90s, been reserved only for the sickest, most severely in pain. Pain relief that turned out to be, despite Purdue’s legal defense arguments, highly addictive.

Fast forward twenty years and 200,000 opioid-related deaths later to 2016 and we find the passage of a new bill in Congress – S.483: Ensuring Patient Access and Effective Drug Enforcement Act of 2016.

For those who have been advocating and lobbying for harm reduction measures that limit the number of prescription opioid drugs legally allowable, the phrase “patient access” has become something of a millstone around our necks. It seems like a benign term – what could be better than ensuring that patients have access to the medications they need? – but as it relates to the “pro pain management” movement (conveniently funded by the same pharmaceutical companies who manufacture the drugs), it inevitably winds up meaning, “unlimited and unrestricted access.”

This was the case was S.483, and the House version, H.R. 471. The house version, sponsored by Rep. Tom Marino (Republican – Pennsylvania 10th District) and co-sponsored by Gus Bilirakis (Republican – Florida 12th), Marsha Blackburn (R. – Tennessee 7th), Judy Chu (Democratic – California 27th), Doug Collins (R – Georgia 9th), Ryan Costello (R. – PA 6th), and Peter Welch (D. – Vermont At Large), was crafted in collaboration with various pharmaceutical lobbying firms and organizations to compel the Drug Enforcement Agency (DEA) and the Justice Department to agree to a more industry-friendly law. That bill, once it had progressed to the Senate, became sponsored by Sen. Orrin Hatch (Republican – Utah) and co-sponsored by Bill Cassidy (R. – Louisiana), Marco Rubio (R. – Florida), David Vitter (R. – LA), and Sheldon Whitehouse (D. – RI). Sen. Hatch, himself, claims to have worked in conjunction with the DEA and Justice Department lawyers under the Obama Administration to come to an agreement on the final language of the bill (Leonard, 2017).

Drug Enforcement Agency sign

Photo Source: ABC News

Really, we need to back up a second to explain what the DEA was able to do in order to combat our nation’s prescription opioid epidemic prior to the passage of this law:

The DEA can register a controlled substance manufacturer, distributor, or dispenser if it is in the public interest after considering certain factors, including factors relevant to and consistent with the public health and safety. Additionally, the DEA was allowed to immediately suspend a registration to prevent imminent danger to the public health and safety.

The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 took aim at these specific powers by both narrowing down the definitions relevant to these powers, and by revising and expanding the required elements of an order to show cause prior to denying, revoking, or suspending a registration for a Controlled Substances Act violation.           The DEA, which had fought the bill for several years, lost the battle to members of Congress and industry lobbyists and was forced to accept a deal it did not want (Highman & Bernstein, 2017).

Essentially, in order to exact these regulatory powers upon manufacturers, distributors, and dispensers, the DEA must now demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat,” which is a much higher bar than the DEA had to meet for four decades prior to this law. This bar is also difficult to reach, because “immediate,” in legal terms, means “right now.” It can be successfully argued that eventual harm, such as abuse of the substances by those who were not prescribed the medications or later distribution down the line by patients who turn around and resell the pills to opioid addicts, is insufficient for the DEA to perform its duties as effectively as before the law.

What was once a relatively uncontroversial bill, in public awareness terms, shot to the forefront of the political dialogue last week when The Washington Post and ’60 Minutes’ released a joint investigation into the bill’s history (Highman & Bernstein) and impact, particularly focusing on the participation of Rep. Tom Marino (R-PA), then-nominee to become the Trump Administration’s next Drug Czar.

The bill’s lead sponsor in the House, Marino spent several years trying to move it through Congress while receiving nearly $92,500 in political contributions from various political action committees representing the interests of the pharmaceutical industry (Highman & Bernstein). Marino, in a House Judiciary Committee hearing, stated that the DEA was wrong to go after legitimate drug companies as if they were “illicit narcotics cartels” (Llorente, 2017). For Marino, who represents a particularly hard-hit district in PA, his participation in the bill’s passage proved so controversial it forced him to remove his name from consideration for the Drug Czar.

The Washington Post wasn’t the first news source to pillory the law. The New York Times (NYT) first put this Act on the radar in May 2016, noting that the bill curtailed the DEA’s powers to “pursue pharmacies and wholesalers that the agency believes have contributed to the epidemic” (Harris & Huetteman, 2016). The NYT report repeatedly stated the “unintended” consequences of the Act, but went largely unnoticed during a volatile presidential campaign cycle.

The reason why I put “unintended” in quotation marks is because I highly doubt that these consequences were unintentional in nature. The language of the two bills specifically uses the phrase “current law” in reference to DEA activities and includes modifications that the bills state are for the purpose of rolling back the DEA’s regulatory powers. To say that this was “unintentional” is to defy both logic and reason. What is more likely is that the bill was sold to Senators under the guise of “Ensuring Patient Access” – again, what could be better than ensuring that patients have access? Sen. Joe Manchin (D-WV) believes this to be the case:

They made it and camouflaged it so well all of us were fooled. All of us. Nobody knew!” Sen. Manchin said. “There’s no oversight now … that bill has to be retracted … has to be repealed (Cordes, 2017).

Sen. Clair McCaskill (D-MO) introduced a bill on Monday, October 16 to repeal the law, along with co-sponsors Manchin, Margaret Wood (D-NH), and Dick Durbin (D-Ill. (Chappell, 2017). Marino, in typical form for the current administration, stands by the bill and reduced criticism of the bill to “fake news”:

Given these facts and the importance of this legislation, [I] find it sad and disheartening that the news media have left behind any concept of balanced reporting and credited conspiracy theories from individuals seeking to avert blame from their own failures to address the opioid crisis that proliferated during their tenure (Roubein, 2017).

Marino’s statement, blaming disgruntled employees for problems he suggests “proliferated” during the past eight years, ignores reality. For those of us in the advocacy game, the opioid crisis has been going on for nearly twenty years, under now four separate administrations. Further, the issue of massive distribution irregularities has occurred to a degree rarely seen in the pharmaceutical world.

In Manchin’s home state of West Virginia, this problem has been longstanding. 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 the 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 (Hopkins, 2017).

Supporters of the act, including pharmaceutical lobbyists, pain management advocates, elected officials, and patients, insist that the law is doing its intended job – reigning in an “out of control” DEA that treated chain pharmacies and drug distributors like “drug cartels and other criminals’ (Harris & Huetteman). These businesses complained for years that their operations have been disrupted and profits hurt by DEA investigators who ordered immediate closures of pharmacies deemed regional destinations for addicts seeking a fix (Harris & Huetteman). Pain management advocates have argued against virtually any type of legislative or regulatory restrictions being places upon prescription opioids, insisting that the needs of chronic pain sufferers outweigh the concerns of public health and safety.

These arguments come as distributors and manufacturers have been hit with several dozen lawsuits from various cities, counties, and states accusing them of knowingly distributing highly addictive substances and demanding that they pay recompense for the resultant damage their knowing negligence has caused. Rather than go to court, these entities have largely chosen instead to settle the claims with no admission of guilt, opting to essentially pay off these municipalities. It should be noted that these settlement payments are a mere fraction of the overall profits these companies have made from prescription opioid sales.

The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 is a piece of legislation that was written with a particular worldview in mind: “America is Overregulated.” This view seems to be held by both the bills’ sponsors and its supporters. Where this bill gets it wrong is that it takes out of the hands of the DEA the power to act in the actual interests of public health and safety, raising the bar for action to unreasonable (and, some contend, unreachable) standards. It is a gift to pharmaceutical distributors and manufacturers, alike, is a definitive step backward in the fight to combat prescription opioid abuse.

References:

__________

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.

Leave a comment

Filed under Uncategorized

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:

__________

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.

Leave a comment

Filed under Uncategorized