Monthly Archives: October 2017

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:

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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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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:

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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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Increase in HCV Cases Calls for Updated Screening Protocols

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

We, here at HEAL Blog, attempt to provide coverage of local outbreaks of Viral Hepatitis (VH), as well as to investigate and report them using evidence-based data to accurately characterize the issues at play. What consistently comes to the forefront of Hepatitis C (HCV) infection is the issue of Injection Drug Use (IDU) and the People Who Inject Drugs (PWID). More than any other risk factor, IDU in consistent across Hepatitis A (HAV), Hepatitis B (HBV), and HCV. According to the Centers for Disease Control and Prevention (CDC), in 2015, IDU was reported as a risk factor in 36.1% of all Acute HAV cases, ~34.3% of all Acute HBV cases, and 64.2% of all Acute HCV cases (CDC, 2017).

Hepatitis Screening

Photo Source: JAMA

In the five of the states with the highest rates of HCV – Massachusetts (MA), West Virginia (WV), Kentucky (KY), Tennessee (TN), Maine (ME), and Indiana (IN) – these data are undeniable:

And yet, none of these states have amended their HCV screening protocols to include compulsory “Opt-Out” screening in every healthcare setting. This is folly, at best, and dereliction of duty, at worst. If a state’s responsibility is to ensure the health and welfare of its citizens, it is incumbent upon them to take non-extraordinary steps to expand screening protocols. Moreover, they must begin regularly surveilling and reporting, including detailed risk-factor reporting.

If this sounds “revolutionary,” it’s simply not. Given the high rates of infection, mortality, co-morbidities, and the fact that there is a functional cure for the disease, there is simply no excuse for failing to expand testing to include compulsory “Opt-Out” screening for HCV, particularly in states where IDU is high. Is it expensive? Yes. But, again, when it comes to the health and welfare of people, sometimes short-term expenditures outweigh long-term costs of care. This is why there are grants; this is why people pay taxes.

Some of the most successful screening efforts are being conducted not in traditional healthcare settings, but at Syringe Services Programs (SSPs), which remain controversial among those who say that they promote and encourage drug use. These services are, however, vital to stemming the spread of disease. Perhaps the least successful screening efforts are conducted in incarceration settings, despite having essentially a captive demographic. These efforts are hampered, again, by cost concerns, as, if the results come back “Positive,” they are required by law to treat.

While expanding screening may be initially costly, it is the best way for us to go about eliminating HCV in the U.S.

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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Hepatitis A Outbreak Expands Throughout Southern California

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 mid-September 2017, HEAL Blog wrote about the extreme measures taken by San Diego County and city to combat a severe outbreak of Hepatitis A (HAV) among the county’s homeless, indigent, and illicit drug user populations (Hopkins, 2017). At that time, the HAV outbreak consisted of 421 confirmed cases, 292 hospitalizations, and 16 deaths. That initial outbreak, which began in November 2016, has continued to grow with 481 confirmed cases, 337 hospitalizations, and 17 deaths (Sisson, 2017). The outbreak is also spreading.

Both Santa Cruz and Los Angeles Counties have begun seeing outbreaks of HAV related to the initial outbreak in San Diego County, with 68 confirmed cases in Santa Cruz County (Health Services Agency, 2017) and 12 confirmed cases in Los Angeles County, 9 of which required hospitalization (Acute Communicable Disease Control, 2017). These cases do not include all of the reported HAV cases; only those connected to the San Diego outbreak. These cases are primary among the same populations in these counties as they were in San Diego County – homeless, indigent, and illicit drug users.

Hepatitis A Facts

Photo Source: MedChitChat.com

According to Kaiser Health News writer, Stephanie O’Neill, poor access to restrooms and sinks in homeless encampments is largely to blame for these outbreaks (O’Neill, 2017). San Diego County responded to their outbreak by installing 40 portable hand-washing stations throughout the downtown areas hardest hit by the outbreak, leaving public restrooms open overnight, and power-washing heavily soiled sections of downtown sidewalks and streets with a bleach solution in an effort to stop the spread of the virus (O’Neill).

Southern California’s HAV outbreak is being described as “unprecedented” and “the largest outbreak in the U.S. that is not related to a contaminated food product” since the U.S. first introduced a vaccine for hepatitis A in 1995 (O’Neill). This trend is unlikely to be restricted to Southern California. According to the National Law Center on Homelessness and Poverty (NLCHP), “Despite a lack of affordable housing and shelter space, many cities have chosen to criminally or civilly punish people living on the street for doing what any human being must do to survive” (NLCHP, n.d.). Additionally, the NLCHP notes that, since 2006, bans on camping city-wide have increased by 69%, bans on sleeping in public have increased by 31%, bans on sitting or lying down in public have increased 52%, bans on loitering, loafing, and vagrancy have increased 88%, and bans on living in vehicles have increased 143% (NLCHP). Furthermore, most cities in the U.S. close public restrooms at dusk, leaving homeless people with nowhere to relieve themselves.

While the intention of these bans is to move cities’ homeless populations out of the line of sight and create “safer” public spaces for homed populations, the real-life effect has resulted in creating conditions ripe for the spread of diseases like HAV. People who lack access to restroom and handwashing facilities are forced to relieve themselves in the open, creating biohazardous waste and fostering the spread of HAV to potentially anyone who comes in contact with their refuse.

It is also likely that, as more cities are hit with HAV outbreaks related to homelessness and illicit drug use, responses will vary between highly effective public health responses like those put in place by San Diego County, and highly ineffective criminalization responses that end up creating worse circumstances than they purport to fix.

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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2nd Annual HIV/HCV Monitoring Report Released

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 September 21st, 2017, the Community Access National Network (CANN) hosted the 2nd Annual National Monitoring Report on HIV/HCV Co-Infection at the Pharmaceutical Research and Manufacturers of America (PhRMA) headquarters in Washington, D.C. Presentations were delivered by yours truly, and Amanda Bowes, Manager on the Health Care Access team for the National Alliance of State and Territorial AIDS Directors (NASTAD), both of whom focused on issues of coverage for Hepatitis C (HCV) Direct Acting Antivirals (DAAs) for the 59 AIDS Drug Assistance Programs (ADAPs) and Medicaid programs, as well as information about the U.S. Department of Veteran Affairs (V.A.) and Harm Reduction measures.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

Key findings of my presentation indicate that, as of August 2017, 33 state ADAP programs offer coverage for DAAs on their ADAP formularies, an increase of six states from August 2016. Additionally, all 50 states and the District of Columbia have offered expanded coverage for DAA drugs since August 2016. In March 2016, the V.A. began offering treatment with DAAs to every eligible veteran. In terms of Harm Reduction, several states have authorized Syringe Services Programs (SSPs) in an effort to prevent the spread of HIV, Hepatitis B (HBV), and HCV since Congress ended the ban on Federal funding for Syringe Exchange Programs in January 2016.

One other key finding was that, in seven of the states with the ten highest rates of HCV infection, ADAP programs offer either no coverage for HCV drugs or offer coverage only for older, less easily tolerated treatments requiring the use of Pegylated-Interferon (PEG-INF). These states include (in order of highest HCV infection rates): WV, KY, IN, NM, AL, NC, and OH.

Key findings of Mrs. Bowes’ detailed presentation indicate that NASTAD has actively been attempting to increase HCV DAA coverage by ADAP programs in cooperation with the Health Resources and Services Administration (HRSA) while still maintaining fiscal solvency. This consultation, in June 2016, included ADAP and Viral Hepatitis (VH) program staff, Federal partners including the Centers for Medicare and Medicaid Services (CMS), U.S. Department of Health and Human Services (HHS), HRSA, and the U.S. Department of Veteran Affairs (V.A.), providers specializing in treatment for HIV/HCV co-infection, community partners, and NASTAD staff. The meeting was comprised of a panel of Federal representatives, a presentation on the best practices for ADAP HCV treatment utilization, and a discussion of the various barriers preventing ADAP programs from expanding coverage, clinical management of HIV/HCV co-infection, and policies and procedures for HCV treatment among People Living With HIV (PLWH).

Additionally, NASTAD gathering detailed information related to how ADAP programs covered the cost of HCV DAAs, finding that programs that offered Insurance Continuation (purchasing private insurance coverage for ADAP clients) and paid for the co-pays, rather than paying the full prescription cost, were able to save considerably over paying directly for the medications.

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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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