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).
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.
- Bourdet, K. (2012, Sept 18). How Big Pharma Hooked America on Legal Heroin. Motherboard. Retrieved from: http://motherboard.vice.com/read/how-big-pharma-hooked-america-on-legal-heroin
- Chappell, B. (2017, October 17). Tom Marino, Trump’s Pick As Drug Czar, Withdraws After Damaging Opioid Report. Washington, DC: National Public Radio: The Two-Way. Retrieved from: http://www.npr.org/sections/thetwo-way/2017/10/17/558276546/tom-marino-trumps-pick-as-drug-czar-withdraws-after-damaging-opioid-report
- Cordes, N. (2017, October 16). “All of us were fooled”: Opioid report reverberates across political world. New York, NY: https://www.cbsnews.com/news/opioid-addiction-epidemic-capitol-hill-calls-for-change/
- Eyre, Eric. (2016a, December 17). Drug firms poured 780M painkillers into WV amid rise of overdoses. Charleston, WV: Charleston Gazette-Mail. Retrieved from: http://www.wvgazettemail.com/news-health/20161217/drug-firms-poured-780m-painkillers-into-wv-amid-rise-of-overdoses
- Harris, G. & Huetteman, E. (2016, May 18). Actions by Congress on Opioids Haven’t Included Limiting Them. New York, NY: The New York Times: U.S.: Politics. Retrieved from: https://www.nytimes.com/2016/05/19/us/politics/opioid-dea-addiction.html
- Highman, S. & Bernstein, L. (2017, October 15). THE DRUG INDUSTRY’S TRIUMPH OVER THE DEA. Washington, DC: The Washington Post: Investigations. Retrieved from: https://www.washingtonpost.com/graphics/2017/investigations/dea-drug-industry-congress/
- Hopkins, M. (2017, January 09). West Virginia’s Rx Crisis. Washington, DC: Community Access National Network: HEAL Blog. Retrieved from: https://communityaccessnationalnetwork.wordpress.com/2017/01/09/west-virginias-rx-crisis/
- Leonard, K. (2017, October 16). Orrin Hatch tears into Washington Post opioids report: It’s meant to derail Trump’s drug czar nominee. Washington, DC: Washington Examiner. Retrieved from: http://www.washingtonexaminer.com/orrin-hatch-tears-into-washington-post-opioids-report-its-meant-to-derail-trumps-drug-czar-nominee/article/2637699
- Llorente, E. (2017, October 17). Little-noticed law drug companies fought for: How it passed amid opioid crisis, what it does. New York, NY: Fox News. Retrieved from: http://www.foxnews.com/us/2017/10/17/little-noticed-law-drug-companies-fought-for-how-it-passed-amid-opioid-crisis-what-it-does.html
- Roubein, R. (2017, October 17). Newly controversial opioid enforcement law under fire. Washington, DC: The Hill: Policy: Healthcare. Retrieved from: http://thehill.com/policy/healthcare/355928-newly-controversial-opioid-enforcement-law-under-fire
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.