With the new 2016 law, more than four decades of DEA practice was changed, now greatly limiting its capacity to protect the public interest against what has become an epidemic of crisis proportions. The power of industry, lobbyists, and campaign donations has been demonstrated once again, together with the complicit roles of legislators.
by JOHN GEYMAN, MD
(BUZZFLASH AT TRUTHOUT) – In recent days, after six months of excellent investigative reporting, The Washington Post and CBS 60 Minutes, have jointly brought to our attention a very important expose of the back story behind the growing, unprecedented public health crisis in the U. S.—our opioid epidemic. More than 90 Americans die every day from opioid drug overdoses. These overdoses have already killed some 200,000 (more than three times the number of U. S. military deaths in the Vietnam War), overdose deaths continue to rise, and there is no end in sight. Here we have two goals: (1) to better understand how this crisis has come about and continues to increase; and (2) to outline some of the lessons we can already draw from this experience.
What’s behind this increasing crisis that is still uncontrolled?
Drug overdose deaths used to be rare, but are now the leading cause of accidental death in this country, more than peak annual deaths caused by motor vehicle accidents, guns and HIV infection. Opioids are drugs that stimulate the brain’s opioid receptors, including hydrocodone and oxycodone (the most commonly prescribed opioids), heroin, and in just recent years, fentanyl. Prescribed opioids can be essential for short-term use after surgery or accidents and for palliative care in terminal conditions. But they are often abused for chronic pain and can lead to patients becoming addicted to them.
The use of prescribed opioids, such as hydrocodone and oxycodone, has soared over the last 20 years, stimulated by a multifaceted campaign underwritten by the pharmaceutical industry. Physicians, their professional societies, and hospitals were being told that long-term use of opioids for chronic pain would benefit patients with little risk of addiction. As their use increased, so did rates of addiction and overdose deaths. We are now at a point where opioid use per capita in this country is much higher than in other developed nations. In 2015, about 2 million Americans suffered from substance abuse disorders related to prescribed opioids, more than three times the number of heroin users. The Centers for Disease Control and Prevention estimate that the “economic burden” of prescription opioid misuse alone in the U. S. costs more than $78 billion a year, including the costs of health care, lost productivity, addiction treatment, and criminal justice involvement.
Initially, under the leadership of Joseph Rannazzisi, head of the Office of Diversion Control, the Drug Enforcement Agency (DEA) stood tall in enforcement actions against wholesale drug distributors, some of them massive multinational corporations, that were shipping huge volumes of prescription opioids to targeted corrupt physicians and pharmacists engaged in a very lucrative black market. One example between 2007 and 2012 were the shipments from a mid-size Ohio-based drug distributor, Miami-Linken, of 20 million doses of oxycodone and hydrocodone to pharmacies in West Virginia, 11 million of which ended up in one county, Mingo, with a population of just 25,000. During that same time period, wholesalers collectively shipped 780 million opioid pills to West Virginia, 433 doses for every man, woman, and child in the state.
Under the Controlled Substances Act of 1970, companies were required to report unusually large or suspicious orders of narcotics. On the basis that such shipments constituted “an imminent danger to the community,” the DEA brought at least 17 cases against 13 drug distributors from the mid-2000s on, assessing almost $425 million in fines over a decade. This, however, was a drop in the bucket compared to hundreds of billions of dollars in annual revenue to these companies.
Then the powerful backlash from industry began to neutralize the DEA and change the law that allowed the DEA its authority to control this illicit drug trade. At least 56 DEA and Justice officials were recruited by the pharmaceutical industry, including attorneys who switched sides and knew all the tricks of avoiding prosecution by the government. Political action committees representing the pharmaceutical industry contributed more than $1.5 million to 23 legislators who sponsored or co-sponsored new bills to weaken the DEA’s oversight role. The resulting bill, disingenuously called The Ensuring Patient Access and Effective Drug Enforcement Act, spearheaded by Rep. Tom Marino (R-PA) in the House, was passed in 2016 by unanimous consent in both chambers of Congress. The bill raised the bar for enforcement to a higher standard—“a substantial likelihood of an imminent threat.” Since then, with the new law making it almost impossible for the DEA to freeze suspicious shipments of hundreds of millions of opioid pills from wholesalers, the number of enforcement actions by the DEA against drug wholesalers has dropped precipitously.
Joe Rannazzisi was forced out of the DEA in 2015, and now serves as a consultant to a team of lawyers suing the opioid industry. State attorney generals in 41 states have banded together to investigate the industry, while hundreds of counties, cities and towns are also suing the industry.
Incredibly, despite Tom Marino’s successful legislative efforts to derail the DEA’s authority to regulate narcotic drug wholesalers in the public interest, President Trump nominated him to become the nation’s next drug czar as head of the Office of National Drug Control Policy, but he just withdrew his name after his role in defanging the DEA was exposed by The Washington Post and CBS 60 Minutes. Now, after the bill has been shown for what it is, members of Congress on both sides of the aisle are embarrassed by what they let sail through their chambers without a single countering vote.
What lessons can we draw from this still uncontrolled crisis?
With the new 2016 law, more than four decades of DEA practice was changed, now greatly limiting its capacity to protect the public interest against what has become an epidemic of crisis proportions. The power of industry, lobbyists, and campaign donations has been demonstrated once again, together with the complicit roles of legislators. After leading the charge for more than ten years against the dangerous practices of opioid drug wholesalers, Tom Rannazzisi has observed
This is an industry that’s out of control. If they don’t follow the law in drug supply, and diversion occurs, people die. That’s just it, people die. [and what they’re also saying is] . . . The heck with your compliance. We’ll just get the law changed. (Ibid, The Washington Post, CBS 60 Minutes.)
We can draw several conclusions about this story of obvious greed and corruption which found complicity among our legislators to undermine necessary regulation by the DEA of what has become a largely preventable public health crisis, still un-contained, that kills more than 90 people every day: (1) we need more regulation, not less; (2) there is a wide disconnect between the GOP and Trump policies and the public interest; (3) the revolving door between government, lobbying and industry, including attorneys on both sides, acts against the common good; (4) the opioid crisis confirms the vital importance of investigative journalism; and (5) we need more sunlight in accounting for the flow of money in today’s politics and government at all levels.
The second point needs further emphasis, since this is just one more example of how our democratic process is being corrupted every day by greed, often below the radar, throughout our profit-driven medical-industrial complex. As two other major examples, we see this kind of disconnect in the ongoing successful campaigns waged by the inefficient and wasteful private health insurance industry to perpetuate its dominance over financing health care, while the pharmaceutical industry continues to block negotiated drug prices and importation of drugs from other countries. Hopefully, while investigative reporters uncover the back stories of these disconnects, as was so well done by The Washington Post and CBS 60 Minutes in this instance, the better off the public will be and the more trust can be developed in government oversight of industry.
Reprinted with permission
John Geyman, M.D. is the author of Common Sense about Health Care Reform in America (2017), and Crisis in U.S. Health Care: Corporate Power vs. The Common Good (2017). Visit: http://www.johngeymanmd.org/