Barack Obama & the Opioid Crisis
My President’s Worst Failure
In the fall of 2001, southern Virginia’s US Attorney John Brownlee launched an investigation of Purdue Pharma, a company he believed misled government officials and medical practitioners regarding the potentially addictive nature of its opiate painkiller OxyContin. Short-staffed and without much in the way of a budget, Brownlee and his investigators lumbered along, compiling evidence and building a picture of corporate negligence and wrongdoing. Finally, on October 19, 2006, they presented defense counsel a final settlement offer: a mix of plea deals, financial penalties, and modifications in the way Purdue Pharma presented Oxycontin in its marketing efforts. Take it, Brownlee advised, or Purdue Pharma and some of its key executives would face “other things.”
On October 24, the day the settlement offer was set to expire, Brownlee received permission from the Criminal Division of the Department of Justice to “accept a plea or charge the company.”
That evening he received a phone call.
On the other end of the line was Michael Elston, chief of staff to Deputy Attorney General Paul McNulty. Elston mentioned that his boss had been contacted by Purdue’s defense counsel, and he urged Brownlee to “slow down” his negotiations, a strange request to make of a litigator who led an an effort that stretched over half a decade, accumulating greater urgency with each passing year as overdose deaths mounted. After Brownlee refused, his name appeared on a list of US Attorneys to be fired by Attorney General Gonzales eight days later.
This attempt to interfere with an imminent criminal charge is recounted in Dreamland, Sam Quinones landmark book on the opioid crisis, and it also came in for extended discussion in a Senate hearing convened in 2007 to discuss the adequacy of the terms of settlement Brownlee ultimately concluded with Purdue Pharma. But omitted from all these accounts is the name of Purdue’s defense lawyer — a person who clearly enjoyed high level access to the Department of Justice, and was willing to use it to delay a settlement that entailed not just money to be used for treatment but also oversight over how Purdue Pharma marketed its product, including how it depicted the potential dangers and benefits of its blockbuster drug Oxycontin.
The person who phoned Deputy Attorney General Paul McNulty was Mary Jo White — a fact reported in only one place, as a detail in this 2007 article in The Washington Post. A former US Attorney for the Southern District, White was by the time of Brownlee’s settlement discussion a lawyer in private practice at Debevoise & Plimpton. (Note added on March 29, 2019: Mary Jo White will represent one half of the Sackler clan, owners of the privately held Purdue Pharma, against the NY lawsuit, recently amended: https://ag.ny.gov/sites/default/files/oag_opioid_lawsuit.pdf)
In 2013, President Barack Obama nominated White to serve as chair of the Securities and Exchange Commission. Her crass political intervention in the single most devastating case of corporate fraud in the modern era did nothing to deter Obama from putting her name forward to serve as a watchdog of Wall Street, nor did it strike Senate staff vetting her for confirmation as worthy of mention.
In light of her 2006 phone call to the Department of Justice, it comes as no surprise that Mary Jo White’s stewardship of the SEC was marred by controversy. Reviewing her performance for The Intercept, financial journalist David Dayen noted “persistent delays on finalizing rules mandated by the Dodd-Frank Act,” and, owing to her extensive corporate ties, frequent recusals that left the board deadlocked 2–2. Last October, citing White’s refusal to act on rules requiring corporate spending on political activities, Senator Elizabeth Warren sent President Obama a letter requesting that he fire her immediately, in what would have been an unceremonious departure with only weeks left in her term. Obama refused.
Most telling, throughout her SEC tenure, White preached a “broken windows” philosophy of enforcement against low-level infractions that she claimed would send clear signals to Wall Street. In reality, the SEC rarely extracted admissions of guilt. One recent study from a professor at Emory found that the SEC inflated its enforcement prowess by “double and triple counts” and overstated the severity of the fines it imposed.
This pattern of pursuing the low-hanging fruit, to much fanfare but no great effect, was replicated throughout the Obama administration, a kind of “performative enforcement” approach to corporate America that placated forces in the pharmaceutical industry at a time when they should have been confronted. Still, vignettes of insiders like Mary Jo White, whose work in government falls below the radar of most Americans, do not provide an adequate account of how the Obama administration handled the exploding problem of opioids. They point only to indifference — a terrain of half-measures and neglect, normally hard to discern, but when set against a drug crisis spiraling out of control, one that is difficult to defend.
Under President Obama, a small army of executive branch “slow-walkers” served as pallbearers, knowingly or not, to the grim march of overdose deaths from commonly prescribed opioids that was already underway in years before he took office. As the body count climbed, the Brownlee-led US Attorney settlement with Purdue, as well as West Virginia’s 2004 settlement against the same company, ought to have prompted scores of decisions to reign in opioid prescribing. Instead, the opposite happened: prescribing numbers continued to grow throughout Obama’s first term, reaching a peak in 2012. Despite subsequent reductions, they remain the highest in the world.
During Obama’s time in office, licit opioid prescribing increased not only in number but also in potency. Most notable was expanded use of the powerful synthetic known as fentanyl, a drug approved only for opioid-tolerant cancer patients suffering from pain beyond the reach of traditional opioids, but one that drug makers marketed in a manner of ways, including in advertisements that pictured construction workers and others employed in similar, physically demanding jobs. Although a reduction in opioid supply was desperately needed, and close scrutiny of opioid manufacturers more than warranted, the Obama administration declined to do either.
What most exacerbated the opioid crisis was the dramatic rise in overdose deaths from heroin and heroin adulterated with illicit synthetics (fentanyl and carfentanil). While Obama was president, illicit heroin underwent an industrial transformation: market expansion, innovation, and in many places, a reconfiguration of production and distribution. Yet the path of initiation to heroin via prescription pills that fueled its resurgence went substantially unchallenged by the president. In fact, it was strengthened and fortified.
Though Obama did not start the opioid crisis, it is a blunt and brutal fact that, under his administration, drug overdose became the leading cause of death for Americans under the age of 50, and the opioid crisis became the worst drug epidemic in American history. It is an irrevocable part of his legacy as president.
Does Obama shoulder the blame for this horrible turn? A statistic without a story is only a starting point for questions, not an answer. And questions must be reasonable: despite a tendency to make extravagant claims on behalf of favored candidates, most people know that what a president can control does not equate perfectly to developments for which he is credited or blamed. Some things, like drug cartels, conspire beyond a president’s reach; others, like the disappearance of work from deindustrialized communities, span decades, indicting an entire political class. It is unfair to charge Obama with responsibility for all this, and even more so to assess the shortcomings of his administration on opioids without also weighing his pertinent and hard-won achievements.
A sensible framework is available, and the issue urgent. Surprisingly, there has been very little attempt to review the record. To me this suggests an understandable unwillingness to wrestle with hard questions while Democrats are exiled from national government.
But expulsion from power is not a moment for convenient memory and self-regard; that’s a chronicle of the lost. For the faithful, diaspora is a moment for truth-telling.
The Record
Obama’s record on opioids rests in large part on his stewardship of the parts of executive branch most involved in managing the crisis. In this regard, no institution has been more important than the Food and Drug Administration (FDA).
About 30 cents of every American dollar spent goes toward items that fall under the FDA’s purview. Despite its importance, the agency receives sustained attention only from a small corps of specialized reporters. As a result, we learn little from the news media about the FDA’s routine activities, or how these have changed over time.
For instance, most Americans would be surprised to learn that, in the two decades of the opioid crisis (commencing with the approval of Oxycontin in 1995), the agency switched its funding stream from government-only to a combination of both taxpayer dollars and money from the pharmaceutical industry. In that same period, returns on investment for pharmaceutical companies became an even more important component of the American economy, a “financialization” of Pharma that, unfortunately for investors, coincided with a time when breakthroughs in small-molecule (traditional) drugs slowed dramatically. Corporations pressed for returns looked to bio-similar, large-molecule investments for the future. To make do in the present, they launched a Hunger Games-like defense of their own patents and protected markets — and, paradoxically, they also focused on development of “me too” drugs, imitations of proven success. And in some cases, like opioids, drug companies looked to expand the clientele for existing drugs.
These changes quietly transformed the FDA. Lawmakers and special interests who regularly depict the agency as a source of obstruction worked to pressure Congress to lower the bar for drug approval and proof of clinical effectiveness. In this sense, the 1995 approval of Oxycontin, which overlooked substantial evidence against the effectiveness of Purdue’s “extended release” technology, was a harbinger of things to come, and a part of a larger culture change within the FDA itself.
As overdose deaths from prescription opioids climbed in the early aughts, the costs incurred by a culture of lax regulation became more intolerable — and more apparent. In 2004, Connecticut Attorney General Richard Blumenthal filed a citizen petition urging the FDA to place stronger warnings on OxyContin. After it languished for four years, he sued the agency in 2008 to compel action.
Suffice it to say that by the time Obama assumed office, both he and his advisors would have been apprised of the federal government’s settlement with Purdue Pharma of 2007, as well as litigation against the same company in West Virginia and still underway in Kentucky. But they showed no great concern over it. To lead what should have been regarded as a troubled agency, the president opted, in the words of The New York Times, to “sidestep a battle” that pitted the preferred candidate of the drug industry, Dr. Robert Califf, against a well-known patient advocate, Dr. Steven Nissen. Instead Obama sent Clinton-supporter and mega-donor Dr. Margaret Peggy Hamburg to the FDA. Hamburg’s experience in managing epidemics made her more suited to run the CDC than the FDA (as the Times also noted), and her appointment fueled speculation that a long-rumored division of the agency between food and drugs was in the offing.
It never came. Instead, Hamburg retained power over the drug portfolio, and one of the first high-profile decisions under her stewardship granted Purdue Pharma approval for a tamper-resistant Oxycontin reformulation before it had been tested according to guidance the FDA had itself set out. Families of Oxycontin overdose victims filed a citizen petition to record their disbelief that the FDA would show such a lenient attitude toward a drug that was “perhaps the most abused product ever approved by the FDA.”
But the willingness to believe that tamper-resistant technology was both successful on its merits and a sufficient response to the opioid crisis was the least of the FDA’s sins on the opioid crisis. In 2012, “Physicians for Responsible Opioid Prescribing” (PROP) filed a petition urging the FDA to reconsider opioid prescribing for chronic pain. The agency resolved instead to add a risk-management strategy to extended-release opioids, and asked that opioid manufacturers undertake an analysis of the safety of their own drugs. In their petition, PROP raised the fact that no scientific evidence supported the use of opioids as an effective response to pain that lasted beyond 12 weeks; opioids had simply not been shown to work in that setting. In their reply, the FDA answered that no proof existed to the contrary — or, in other words, opioids had not been shown definitively to fail.
It’s a remarkable response — and a revealing one. Historically, ever since the landmark Kefauver-Harris Amendments of 1962, the FDA has required proof of both drug safety and effectiveness. But since that time, starting with the Reagan administration, growing pharmaceutical industry influence over the FDA weakened its commitment to this so-called “precautionary principle.” By the time of the Obama administration, the idea that the industry had an affirmative obligation to demonstrate the efficacy of their drugs — not via “surrogate endpoints” or other assumptions and extrapolations, but in actual randomized clinical trials — was on the defensive. The “21st Century Cures Act,” the last major piece of legislation signed by Obama, endangered the precautionary principle as a matter of law. Now pharmaceutical companies seeking FDA sign-off on a new use for an already-approved drug can submit “real world evidence” — observational or, as Adam Gaffney described, “really bad evidence” — in lieu of randomized clinical trials. As a result, during a year when the opioid crisis fueled an astonishing drug overdose fatality count of 63,632 lives, President Obama’s final word on the FDA was to make the scenario that unleashed the worst drug epidemic in US history more likely, not less.
There were several other decisions, specific to the opioid crisis, which baffled. Most egregious was the FDA’s 2013 approval of the opioid painkiller Zohydro, despite the agency’s own advisory committee voting 11–2 against it. That same year, a study that appeared in the journal of Drug and Alcohol Dependence found that four out of five new heroin users started their opioid consumption by misusing prescription opioids. By this point, no one could feign ignorance of the damage caused by over-prescribing and over-supply — except the FDA. After receiving criticism for its Zohydro decision, which included 28 state Attorneys General calling on the FDA to rescind approval, the agency moved to minimize future censure by refusing to convene an advisory committee for deliberations on Purdue Pharma’s tamper-resistant opioids Targiniq and Hysingla, both of which were approved.
After a long stint at the FDA, Hamburg left the agency in 2015. That was not the last she heard of her legacy, however. Hamburg is married to Peter Brown, who, alongside conservative ideologue Robert Mercer, runs Renaissance Technologies, a hedge fund that held investments in healthcare throughout Hamburg’s tenure — including, according to one lawsuit, investments in the makers of Zohydro. The suit also charges Hamburg with conspiring to shield dangerous side effects from a powerful antibiotic called Levaquin. Only after Hamburg left the agency did the FDA decide to place stronger labeling on the drug; her husband’s company also holds investments in Johnson & Johnson, makers of Levaquin.
The potential for conflicts of interest under Hamburg, once-removed and owing to the investments of her spouse, became a more direct concern when Obama put forward Dr. Robert Califf — the drug industry’s preferred initial candidate to lead the FDA — to succeed her. Califf’s financial ties to the drug and medical device industry prompted Senator Bernie Sanders to place a hold on his nomination. Massachusetts Senator Markey added an additional hold based on the agency’s “willful blindness” regarding the ever-expanding opioid crisis, and dismissed the FDA’s insistence that approval of tamper resistant opioid formulations constituted some manner of adequate response to the problem. Senator Joe Manchin of West Virginia vowed to filibuster the nomination.
After securing a promise to revamp opioid warning labels and a return to convening advisory committees, Manchin and others released their hold, but voted against Califf on the floor. “The FDA needs new leadership, new focus, and a new culture,” Manchin concluded. Richard Blumenthal, who had left the Connecticut Attorney General’s office to become a US Senator, showed the long memory of a litigator when he joined the small group of his colleagues in voting “no.” “In the face of a spiraling opioid crisis,” Blumenthal told a rally of public health and law enforcement officials gathered to oppose the Califf nomination, “the FDA has utterly, abjectly failed to protect Americans.”
Meanwhile and not surprisingly, the FDA, though possessing substantial enforcement power, declined to put it to use in the opioid crisis. The two significant cases brought against opioid manufacturers for violations of the Food and Drug Act, the agency’s core statute, came from US Attorneys (led by Brownlee) and whistleblowers who came forward in federal court, not the FDA. Even smaller enforcement tasks, some explicitly within the the agency’s purview, went unaddressed. The position of director of the FDA’s Office of Criminal Investigation (OCI) was left vacant for years, after a previous director retired in scandal. Finally, in 2014, Dr. Hamburg filled the post with a director who established a track record of going after dermatologists cutting corners by purchasing foreign versions of a popular injectable drug (field agents derisively dubbed themselves “the botox police”). But he declined to pursue more weighty cases, including investigation into counterfeit opioid painkillers sold on the street and often containing dangerous doses of fentanyl. According to reports, pop legend Prince overdosed and died from a counterfeit pain pill laced with fentanyl. Even in the wake of this shocking and high-profile event, the OCI dithered. After Republican Congressman Greg Walden requested answers regarding the office’s prosecutorial priorities, the OCI director stalled until the Trump inauguration, at which point he left the FDA to work for DLA Piper law firm. According to Reuters, he will represent drug and medical device industry clients.
It has not been difficult for Donald Trump’s nominee to the FDA, Scott Gottlieb, to improve upon the shabby opioid record of the Obama years. That’s not to suggest that his response has been adequate — only that he cuts an energetic figure compared to his predecessors. In early summer of 2017, the new director requested that the makers of Opana ER voluntarily withdraw a drug connected to HIV and Hep C outbreaks. Around the same time, Gottlieb also convened an advisory panel to discuss an expanded evaluation for tamper-resistant opioids that would incorporate public health considerations; he also extended the risk training in place for extended-release opioids to immediate-release formulations. In less than a year, he has done more than Obama’s FDA commissioners combined — although it’s imperative to note, he has shown no willingness to review the effectiveness of opioid prescribing for chronic pain, as a recent report from the National Academies recommended he do (essentially the very same recommendation PROP made back in 2012). Gottlieb has also looked to hasten drug approvals by accepting less rigorous data, citing the “real world evidence” judged to be sufficient by the Obama administration.
As poorly as the FDA performed during the Obama years, another agency compiled a record that was even worse: the Department of Justice, and specifically the Drug Enforcement Administration (DEA).
Most people are unaware of the critical role the DEA plays in regulating a large share of the country’s licit drug supply, opioids included. Like its predecessor agency the Bureau of Narcotics, tasked with essentially the same set of jobs, the DEA publicizes only its attempts to control the flow of illicit drugs to the United States, an expensive undertaking that has never met with any meaningful success.
On the other hand, the DEA’s control of licit drug supply is straightforward and effective: it sets a quota for the importation and production for all Schedule I or prohibited drugs as well as all Schedule II, or tightly monitored, drugs. (That’s right: the United States government has a production quota for prohibited substances. This allows for a small number of medical experiments that take place using these drugs — mainly with marijuana — as well as other uses the government deems appropriate.) This quota system is embedded in the global system used to regulate drugs, originally formulated by the League of Nations, and revived by the United Nations in the post World War II era. Each participating country sets its import and production quota based on its own determination of medical needs, and then submits this data to the International Narcotics Control Board, a quasi-independent body charged with implementing the latest international drug convention agreed upon by the UN. All quotas must comply with the convention, and all sanctioned imports must correspond to a sanctioned export.
That this system of regulation is rarely mentioned obscures several important facts that bear upon the current drug crisis. First, for the United States, opioids are a trade. The country does not grow its own poppies to make Oxycontin or any other drug; it never has. Legal or illegal, opioids come to the United States from elsewhere, either as a raw material or ready-for-sale (or close to it).
Second, there exists a tremendous misimpression that the opioid epidemic is the first drug crisis launched and abetted by the pharmaceutical industry. Not only does contemporaneous (and intensifying) methamphetamine abuse contradict this notion, the very structuring premise of international drug conventions — that licit drugs can be diverted to illicit channels — rests on an understanding of the role Pharma plays in all kinds of illicit drug use. In fact, the League of Nations initially developed the scheme of international conventions to deal with the diversion of one painkiller in particular: heroin. The United States ultimately persuaded the United Nations to prohibit heroin, driving all of its production and distribution channels underground. But if you go back far enough, nearly every illicit drug market can trace its roots to the pharmaceutical industry. (Even hallucinogens, a drug sector with vibrant innovation now mostly detached from industry, became of interest in the modern era as the result of a discarded compound in pharmaceutical industry experiment labeled “LSD-25”.)
The discomfiting origin story behind most illicit drug use is one reason the DEA stays silent about Aggregate Production Quotas — that is, to sustain a fiction that illicit transactions can be addressed and conceptualized separately from the pharmaceutical industry. Instead, as opioid users who turn to illicit heroin in record numbers now make plain, the patterns of licit and illicit drug use have always been deeply intertwined.
Finally, cloaking the production quotas in a veil of silence mutes an important distinction between the over-prescribing and the over-supply of licit opioids. Over-prescribing can mean either providing too many pain pills for acute care (doling out a 30-day course of pills when five or seven days would suffice), or it can mean using opioid pills in ways that science has yet to vindicate (to care for lower back pain, for instance). Some physicians would likely argue that using a maximum instead of a minimum dose of opioids is also a form over over-prescribing. Taken together, all over-prescribing starts from a prescription pad.
In contrast, over-supply starts with the Aggregate Production Quotas. Over-supply makes over-prescribing possible, and it also enables large- and small-scale diversion at any point in the chain of production, from factory to warehouse; from truck trailer to pill mill. Over-supply of dangerous drugs inevitably results in diversion and public harm. The quotas, created to define licit flows for precisely these kinds of drugs, represent a global acknowledgement of this fact: for dangerous and addictive drugs, supply will find a market, and generate its own demand.
Given that, one would assume that determinations of medical need, the ostensible guiding principle of the United States APQ, would involve medical professionals assessing need based on science and experience. One would be wrong. The DEA sets Aggregate Production Quotas by suggesting amounts, usually derived from last year’s quota and consulting the prescribing levels of their registered distributors, and publishing those suggestions in the Federal Register. Drug companies provide feedback, as is their prerogative. The DEA often incorporates that feedback, or it holds an administrative hearing to air disputes. Then the final production quota is set for the year and once again published. (See “Quotas”) In practice, the current process for setting annual APQs entails nothing more than a survey of drug companies regarding how much of any given drug they’d like to produce.
When it comes to opioids or important precursor drugs, the answer to the question has been: a lot.
Belatedly, the DEA announced in October of 2016 that it would cut APQs for 2017, citing the opioid epidemic in its announcement.
But as the chart above demonstrates, the Obama administration kept APQs extraordinarily high; even the 2017 retrenchment will mainly affect reserve stockpiles that accrued during peak APQ years of 2013–2016.
In fact the only real success the Obama administration achieved on controlled substances was the 2014 decision to bump hydrocodone from Schedule III to Schedule II (“up-scheduling”), subjecting the drug to production quotas as well as tighter controls on refills. Other than that, and notwithstanding that noteworthy change, the Obama administration kept the spigot of opioid over-exposure running at full speed. That in itself represents serious culpability in the opioid crisis. Even apart from the actual amounts, it is inexplicable why the president’s team — had they been paying any sort of attention — did not revise the process for setting APQ’s to a more public health-oriented approach.
As one part of the Drug Enforcement Administration facilitated massive exposure of the American public to opioids, other officials in their agency were hindered from pursuing opioid wholesale distributors — companies that, under the law, must report suspiciously large orders of licit opioids. In practice, distributors that claimed ignorance made money as orders swelled to staggering heights.
Only recently have drug distributors faced (minor) financial penalties for inundating local communities with narcotics. Administrative foot-dragging frustrated former DEA diversion expert Joseph Rannazzisi, who was keen to pursue criminal penalties and large fines for drug distributors while he worked at the agency.
But Eric Holder’s Department of Justice saw it differently. According to the Washington Post, Rannazzisi was called to a meeting with the Deputy Attorney General in 2012, “to chastise me for going after industry.” When the Post first reported on the resistance Rannazzisi encountered, including a congressional bill passed to stymie his efforts, reporters mentioned that the lead congressman, Republican Tom Marino, cited Eric Holder’s desire to collaborate rather than confront the drug industry during hearings on his initial bill. That detail, and the actions of the Obama administration more generally, disappeared from the Post’s latest iteration of the same story, replaced by embarrassing efforts at spin by Obama-era officials who claim to be unaware of the bill’s obvious ramifications.
Contemporaneous reporting shows that to be absurd.
US Attorneys also declined to pursue significant cases against opioid manufacturers or distributors. There was every good reason to believe that the initial settlement led by Brownlee had come up short: the damage of prescription opioids only escalated, and companies continued to misrepresent their drugs, or covertly fund ostensibly neutral nonprofits to do that work for them. In the face of corporate malfeasance, Main Justice stood still — or, as Jesse Eisinger recounts in his book The Chickenshit Club: Why the Justice Department Fails to Prosecute Executives, “timidity coursed through the Holder Justice Department.” (In fact, all second generation lawsuits on the opioid crisis have come from State Attorneys General or county and city officials.)
That the Department of Justice balked while facing the worst drug epidemic in US history is shocking, but not surprising. For most of Obama’s presidency, DOJ was led by Eric Holder, a close guardian of corporate interests — so much so that journalist David Corn once dubbed him as representative of “what’s wrong with Washington [DC]”; a “poster child” for “selling out.” While in private practice in Covington and Burling in 2004, Holder represented Purdue Pharma when defending against a West Virginia lawsuit. A settlement was reached; records were sealed (only to be revealed in the blockbuster LA Times investigation of March 2016). But all along, while serving as Attorney General of the United States, Eric Holder knew exactly what Purdue Pharma did…and he did nothing.
In fact he did worse than nothing: he remained a biddable steward of corporate America. Because of Eric Holder, Obama will go down in history as a president oblivious to or complicit in the predations of financial capitalism; and the opioid crisis, the most brutal tally of its costs.
A Record of Success
Although President Obama declined to impose a public interest principle on setting drug APQs, he crafted several of note on the provision of health insurance in the United States as part of his sweeping Affordable Care Act (ACA). Of these, none proved more important to managing the opioid crisis than the instruction that mental health services, including substance use disorder (SUD) treatment, be offered and billed on par with other kinds of care furnished to a patient. (This component built upon the Mental Health Parity Act of 2008.)
So far, this remains an unattained ideal. In their interim report, Donald Trump’s Opioid Commission singled out non-enforcement of mental health parity regulations as an area of special concern. Still, the principle of parity has been enshrined both in law — which may be repealed — and as an expectation on the part of the American people when it comes to health coverage. Though far from complete, important strides have been made.
More attention has been paid to ACA-funded access to substance use disorder treatment via health insurance expansion. As is widely noted, the ACA funded Medicaid expansion in states that opted to pursue it; the legislation also encouraged states to establish health care exchanges for individuals to purchase health care or, if they declined, made access to a federal exchange available. In Ohio alone, almost a quarter million people receive access to treatment via one of these two routes. It is difficult to make the claim that many of these people would not have received either health insurance or access treatment via other means were it not for the ACA — difficult, but sadly not impossible, given the shameful state of health insurance prior to the ACA. By facilitating access to health insurance for millions, the ACA has saved lives, and not just in the context of the opioid crisis.
Medicaid’s Section 1115 waivers have been an overlooked story in the ACA and the opioid crisis. These waivers, allowing states to bypass certain Medicaid regulations in service to a special-needs population, improve efficiency, or expand coverage, predate the ACA. But Obama’s signature reform and the attendant expansion of Medicaid have prompted several states to apply the waivers to improve SUD detection, intervention, and care, an unheralded but significant transformation in treatment delivery. If Congress or the executive branch succeeds in repealing other elements of the ACA, the legacy of Section 1115 substance use disorder-focused waivers may prove to be Obama’s most enduring success in the opioid crisis.
Obama signed other pieces of legislation designed to expand SUD treatment capacity or access. For example, in July of 2016, he signed the Comprehensive Addiction and Recovery Act — a bill with a big name that did very little, given that all the money “designated” by the act relied upon the yearly appropriations process, and that Obama had asked for $1 billion in funding and received only $181 million. “This legislation includes some modest steps to address the opioid epidemic,” Obama noted during a subdued signing ceremony.
More fanfare — and much more funding — accompanied his December 2016 approval of the “21st Century Cures Act,” which secured up to a $1 billion in grants designed to target unmet needs in outreach or care. Already the first round of funding has earmarked close to half that amount for distribution. Unfortunately, as I’ve already noted, these new resources come at a steep cost to the American people. The 21st Century Cures Act further inscribes a culture of industry deregulation into the operations of the Food and Drug Administration; in this way, President Obama’s most decisive action on the opioid crisis demonstrates his total reluctance to heed one of its most important lessons.
As a matter of fact, all of these efforts by Obama to combat on the opioid crisis can be described as “end-stage,” a point considered by public health officials to be the least effective (and most expensive) to intervene. Almost all of them will result in profits for the drug industry. Companies like Indivior, makers of Suboxone, a popular form of Medication-Assisted-Treatment (MAT), stand to reap considerable gains. A small number of companies are involved in both sides of the business, producing opioid painkillers alongside opioid maintenance drugs, allowing them to make money, and make money again, regardless of the cost to the American people.
President Obama also showed himself to be inattentive and desultory at a time when urgency was required, both in a moral and a practical sense. Although Obama occasionally devoted some stern remarks to a crisis which spiraled out of control on his watch, and he directed his bored Secretary of Agriculture to form a “taskforce” on opioids when Vilsack complained of little to do, nothing much came of either. Likewise, the White House Summit on opioids held in August 2014 was probably well thought of by earnest people willing to work within Obama’s narrow parameters of reform: leave corporate profits and power untouched.
On opioids, Obama compiled a record of success in public relations and palliative remedies, and failure in the actual practice of power.
The exception to this proves the rule: in March 2016, the Center for Disease Control released opioid prescribing guidelines, a long overdue reassessment of when and how to prescribe opioids to relieve chronic pain. Later that month, in a public forum, Obama urged “consumers and families” to use the guidelines to hold opioid manufacturers “accountable.”
He said nothing of the federal government doing the same.
The Balance Sheet
Much can be said of this impoverished notion of progressive governance — one that ameliorates the effects of exploitation, but does nothing to curb its scope, or dislodge it from power. I want to make clear that here, I have exposed it to critique on its own terms, and not from the perspective of someone who considers drug prohibition to be an unmitigated failure (as I do), or who believes late stage capitalism is beyond salvaging (as most socialists do, but as someone who is not a socialist, I do not). Both provide valid leverage for critique, but would inevitably result in assailing President Obama for failing to adopt views he never espoused. That is a harsh standard to use when considering the opioid crisis as it unfolded in real time.
Instead I have offered an account based on what a reasonable person would expect from President Obama based upon his professed vision of government; the tools he had at his disposal; and the costs of the opioid crisis itself.
Those costs have only grown since Obama left office. There is little doubt that 2017 will exceed in overdose the deaths the previously record-setting year of 2016. Neither the ACA nor the “Cures Act” will effect dramatic change in this regard, nor will the recent efforts to cut back opioid prescribing produce immediate results. Deaths once driven by the greed of the pharmaceutical industry have now graduated to the even more callous greed of drug cartels, and we must await changes beyond what we can control, or beyond what can be expected in the short-term.
This bodes ill for for Barack Obama and his legion of admirers.
What follows a presidency dictates how it is remembered. Like other components of his legacy, Obama’s deficiencies on the opioid crisis have largely endured, while his accomplishments seem provisional, vulnerable to repeal. Right now, his failure shouts, while his success whimpers. Progressives can only hope that events reverse course, or that the principles embedded in his signature reforms will survive temporary reversal, only to return as emphatic and unassailable.
Even still, the Democratic Party (or any successor to it) will not collect the voting majorities needed to revive the best components of Barack Obama’s legacy unless and until they address the worst. First and foremost, that means reckoning with the foregoing account, a story of my President’s worst failure.
