Tag Archives: Perdue Pharma

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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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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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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