By: James Gao
At a public forum for college students hosted at the White House last week, Trump-appointed “opioid czar” Kellyanne Conway offered her own solution to the most dangerous drug epidemic in American history: more fast food. “You folks are reading the labels, they won’t put any sugar in their body, they won’t eat carbs anymore, and they’re very, very fastidious about what goes into their body,” Conway moped to the crowd of millennials. “And then you buy a street drug for $5 or $10, it’s laced with fentanyl and that’s it.
“So my advice is, eat the ice cream, have the French fry, don’t buy the street drug — believe me, it all works out,” she added, demonstrating once again the superior intellect and nuance that has kept her position as Counselor to the President safe amidst unending personnel shake-ups in the Trump White House. At the very least, she has anecdotal evidence to support her position — President Trump subsists himself on a diet of McDonalds and Diet Coke, and he’s never been addicted to opioids, of course.
The government is certainly complicit in giving unhelpful advice to its eleven million citizens who suffer from opioid addictions, but it must also answer to a much more serious charge: causing the opioid crisis in the first place. With decisive, well-informed government action, the proliferation of painkillers could have been nipped in the bud decades ago. However, misleading marketing, unbridled lobbying, and a hesitancy to reform allowed the opioid industry to thrive in America and spiral into an uncontrollable epidemic — and now, ordinary citizens are paying the price.
While the severity of the opioid crisis has only reached the wider public in the past few years, America’s culture of painkiller abuse truly emerged in 1996, with the initial release of Purdue Pharma’s oxycodone-based OxyContin drug. Before then, powerful opioids had only been used in cases of severe pains, such as cancer. However, marketed as “less abusable” than other similar painkillers on the market, Purdue encouraged the usage of OxyContin prescriptions to treat pains both severe and moderate. They incentivized major advocacy groups like the American Pain Society and the Joint Commission to label “Pain as the Fifth Vital Sign”, aimed at addressing the underassessment of pain symptoms in hospitals across the country. It persuaded sufferers to seek treatment for moderate and chronic pains in the form of prescription medication. Although pain is an inherently subjective phenomenon — one that cannot be measured in the same way heart rate and blood pressure are — a pain rating scale was created and touted as an important indicator of bodily health. As such, if patients rated their pain highly, doctors had no choice but to treat their pain as they would the diagnosis of a severe condition, even without any clinical measurements to support their prescriptions. The American Federation of Medical Boards expanded upon this painkiller-pushing, declaring the undertreatment of pain a punishable offense and reassuring doctors that “in the course of treatment, large doses of opioids were acceptable.” Hoping to appease advocacy groups and suffering patients alike, they began to overprescribe pain medication; when they did so, they looked towards the drug that they had been told was the safest and most effective: OxyContin.
Targeting inexperienced doctors, Purdue goaded state medical boards and groups like the Joint Commission to provide more and more narcotics access to patients. Their advertising campaign was relentless: executives handed out free OxyContin-branded golf balls and bucket hats to hospitals, referred to top drug marketers as the “Royal Court of OxyContin” and launched a sweeping TV ad series featuring groups of young adults who proudly gave testimony for the drug’s effectiveness and safety. “There’s no question that our best, strongest pain medicines are the opioids,” one Purdue commercial boasted. “They don’t wear out. They go on working. They do not have serious medical side effects, and they should be used much more than they are right now for patients in pain.” The company spent $4.6 million on advertising in 2001 alone, more than six times the amount they had spent just five years earlier. In the end, they were extremely successful: the total number of opioid prescriptions in the United States shot up from 76 million in 1991 to 259 million in 2015 — enough for a bottle of painkillers for every adult living in the country.
The problem, as it turned out, was that the aggressive marketing campaign Purdue had embarked on relied entirely on unsubstantiated claims and violations of federal law. Their assertion that the drug was “less abusable” than other drugs turned out to be unsupported by any clinical evidence, and the basis for their “low addiction rate” argument turned out to be a single medical study on hospitalized patients (who could not take the pills home) that had never been peer-reviewed. Ultimately, Purdue had recklessly and carelessly promoted heavy opioid prescriptions using exaggerated and falsified evidence, misleading tens of thousands of doctors and patients about the true danger their drug posed.
A government crackdown on Purdue’s shady advertising could have stopped the company in their tracks right then and there, but the Food and Drug Administration (FDA) failed to take the necessary regulatory action to hold the company accountable. The federal government grants the FDA immense powers to oversee the release of new drugs into the market, but the agency’s powers have been crippled into nonexistence by excessive privatization. As a result of the Prescription Drug User Fee Act of 1992, private pharmaceutical companies began to provide over half of the FDA’s annual budget, and drug manufacturers no longer questioned if their drug would be approved, only when. The FDA, now a fundamentally broken system, continues to sacrifice consumer protections for the benefit of “Big Pharma”.
The FDA’s first opioid misstep began with the approval of the falsified claim - “Delayed absorption as provided by OxyContin tablets is believed to reduce the abuse liability of a drug” - that appeared on the label of OxyContin bottles in 1996 during the drug’s initial release. “A label is a long and detailed document that includes information about who the drug is for, how it should be used, side effects and clinical studies. Every prescription drug has one. And every sentence is meticulously negotiated between a drug company and the FDA,” Caitlin Esch writes for Marketplace in December 2017. Yet the FDA had permitted the company to promote their drug using unverified information for nearly five years before an internal review in 2001 forced Purdue to remove the statement from its advertising.
Furthermore, they approved narcotics Zohydro and Opana on the basis that they address chronic pain — despite the fact that, to this day, no clinical studies have proven that opioids are a better treatment for these types of pains than other less addictive drugs. Kathleen Frydl, the author of the 2013 book The Drug Wars in America, writes, “To call the FDA “missing in action” on the opioid crisis would be charitable. It is closer to the truth to say that the agency launched and continues to abet it.” The FDA should have undertaken a deeper investigation into the effects of opioids after their initial label blunder over two decades ago. Instead, they have done nothing but turn a blind eye to the growing epidemic, allowing safety and security to fall to the wayward as the pharmaceutical industry tightens its grip on the agency.
In 2007, Purdue Pharma finally faced fines over their initial false advertising, amounting to around $600 million in fines for the infamous “reduced abuse liability” claim, some of the largest ever paid by a drug company for misbranding charges and a significant symbolic victory against the painkiller industry. But Purdue’s trial was too little, too late. The fines Purdue had to pay were minor in comparison to the huge profits that the company was bringing in; in 2012, they reported profits of $2.8 billion solely from OxyContin sales. The company continued operating without significant repercussions, and millions of Americans continued to get treatment from their addictive painkillers. In addition, Frydl notes that the format of the trial itself represented a regulatory failure in its own right: “Most of the criminal and civil prosecution of drug companies for “misbranding” has come at the hands of U.S. Attorneys and whistleblowers, even though the law that defines the violation...falls well within the purview of the FDA. Aggressive in opioid approvals, the FDA has been lethargic in responding to the consequences,” she concludes.
The FDA is not the only federal agency to failed the American public in taking comprehensive action against the opioid industry. The Drug Enforcement Agency (DEA) has failed to utilize one of the most powerful tools it has to thwart drug epidemics: quotas. The DEA regularly imposes production quotas on drugs to limit the manufacturing of those it deems dangerous. Yet, despite the clear risk that unfettered oxycodone and hydrocodone production poses to the general public, the DEA has yet to take action against the opioid industry, and painkiller production has increased 39-fold since 1991. As the author of the 2015 book American Pain John Temple puts it, “either Americans are in 39 times more pain than they were twenty years ago, or something else is wrong.”
Unsurprisingly, something is wrong with the way the DEA functions, a product of targeted lobbying by the pharmaceutical industry. In the past ten years, lobbyists have spent over $880 million opposing drug regulations at the federal and state levels, nearly eight times as much as the equally controversial gun lobby has spent during the same time period. Pharmaceutical companies regularly back legislation aimed at crippling the DEA’s regulatory power and have found themselves allies in Republican leaders in both the Senate and the House of Representatives. Representative Tom Marino (R-PA) was once in consideration for the position of “drug czar” in the Trump administration before his ties to the pharmaceutical industry became clear. In 2016, he sponsored a bill that would “essentially make it impossible for the DEA to seize suspicious shipments” from drug distribution companies, who often oversupplied corrupt “pill mill” practices and pharmacies with opioids for the purposes of distributing them illegally for profit. Utah Senator Orrin Hatch convinced the Senate to pass the bill, which the drug lobby had spent $1.5 million on attempting to pass. Hatch himself saw $177,000 of that money; Marino received $100,000. The lobby also emerged victorious when Congress failed the Ryan Creedon Act of 2011, requiring physicians receive basic training on the risks of opioid prescriptions, and again in 2015 when $200,000 stuffed into the pocket of House Oversight and Government Reform Committee Chair Jason Chaffetz was able to convince him to stop the CDC from reducing opioid prescriptions for chronic pain — even though (as previously mentioned) there remains no evidence to support the idea that opioids are better at treating chronic pain than other less addictive painkillers.
Joseph T. Rannazzisi, who served as the former head of the DEA’s Office of Diversion before he was forced out of the agency in 2015, explained to the Washington Post that lobbying groups had inserted enforcement-soft and pharmaceutical-friendly executives into high-ranking positions in the DEA. They then used their position of power to shut down investigations into suspicious drug distributions. Similarly to the FDA, the DEA lost its clout to “Big Pharma” infiltration and lobbying that shuttered the agency’s role in opioid abuse regulation and enforcement.
The battle against opioid addiction also runs into problems at the state level, where small organizations, often founded by parents who have lost their children to painkiller overdoses, lead battles for opioid reform in state legislatures. Although the anti-pharmaceutical lobby raises over $4 million yearly, it is too small to pose a threat to larger companies, whose huge sums of money and lobbying prowess have killed dozens of narcotics-regulating bills nationwide. Their most powerful tool in doing so has been a series of nonprofit groups, collectively known as the Pain Care Forum (PCF), who contribute to the election of pro-pharmaceutical candidates in various state offices. Headed by none other than Purdue Pharma’s chief lobbyist, the group spent $24 million over nine years to support more than seven thousand state-level legislative candidates across the country, installing pharma-friendly elected officials into mayoral offices and state legislatures in all fifty states. The PCF hosts high-ranking state and federal officials regularly at monthly gatherings; resultantly, they have seen huge successes at the state level, such as requirements that some opioids be covered under health insurance policies in Maine. With only smaller, less well-funded groups championing opioid restrictions in state capitals, passing comprehensive painkiller regulations proves just as difficult statewide as it has on the national level — if not more so.
Effectively identifying pharmaceutical lobbying can prove even more difficult when they can disguise their intentions using advocacy groups that appear to have no connection to the painkiller industry. Oftentimes, lobbyists can find themselves unlikely allies in doctors’ groups like the American Medical Association that advocate for physician autonomy, the belief that there should be no restrictions on a doctor’s ability to prescribe. Other unexpected parties include American Cancer Society, seeking to ensure that no cancer patients have restrictions placed on their opioid access, and pain advocacy groups like the International Pain Foundation. These organizations, along with a multitude of others, receive large donations from painkiller manufacturers, a fact that state legislators are often unaware of. As such, they often push those lawmakers for opioid access on their donor company’s behalf, a form of indirect lobbying that hides the direct influence of the original drug companies.
Finally, the government realized the error in its ways last year and began encouraging doctors all across the country to limit their opioid prescriptions, intending to limit overdose deaths. But their actions actually had the opposite effect. When painkiller-addicted Americans found it harder and harder to gain access to opioids legally, they turned to pill mills and other black markets that have continued to thrive while the DEA willingly looks in the opposite direction. In other cases, limited access to opioids only meant that addicts turned to more potent opiates, like heroin and fentanyl. Studies indicate that painkiller abusers are forty times more likely to begin using heroin than the general public, and while legal opioid overdose rates have slowed, heroin and fentanyl overdose rates continue to rise. The federal government’s move to finally clamp down on rampant opioid abuse after years of willful ignorance was poorly planned. It failed to solve the problem of overdose and abuse in America — in fact, it only exacerbated it.
In February of 2018, Purdue Pharma announced that it would finally stop advertising OxyContin to doctors — but as Maine doctor Noah Nesin complains to NPR, “They’re about twenty years too late.” Now, opioid companies are switching their advertising message to one of unity and support, trying to repaint themselves as crucial partners with the American public in the fight against opioid abuse. But to many American families who have lost loved ones to drug addictions, the pharmaceutical companies’ words come off as hollow PR initiatives: how sorry can you truly be for causing a crisis that has earned you tens of billions of dollars? Purdue’s new marketing initiatives are merely emotionless apologies, attempts to save face when they would not save lives.
Otherwise, Purdue faces legal challenges very similar to the one it settled in 2007. Hundreds of lawsuits have been filed against the company in recent months, including thirteen states like Ohio, whose case Emily Pan covered for the Ridge Political Review just last year. They all repeat similar arguments: that doctors and patients had been misled about the safety of OxyContin and that the pharmaceutical industry, too, was liable for the epidemic that plagued America. Yet there remains no indication that these suits will be settled any differently than they were nearly eleven years ago: with a heartfelt apology and millions in damages. Purdue continues to act as if throwing money at the problem - even just a small fraction of its OxyContin profits - will absolve them of responsibility in causing this deadly crisis. It doesn’t.
In the meantime, however, the cycle of special interest lobbying and pharmaceutical profit-gleaning continues, this time marketed around the opioid epidemic. Rather than science-backed remedies to ending opioid addiction, like medication-assisted treatment, drug companies have their own proposal: more opioids. They’ve suggested a new type of pill - an abuse-deterrent formulation, or an ADF - that is harder to snort or inject, marketing it as a safer alternative to opiates already on the market. And while ADFs are an important step in the right direction, the Center for Public Integrity notes that “it’s also a multibillion-dollar sales opportunity, offering drugmakers the potential to wipe out lower-cost generic competitors and lock in sales of their higher-priced versions, which cost many times more than conventional pills.” Meanwhile, Dr. Caleb Alexander, who works for John Hopkins’ Center for Drug Safety and Effectiveness, fears that “that they’ll contribute to a perception that there is a safe opioid, and there’s no such thing as a fully safe opioid.” But whether or not ADFs are the best choice for resolving the painkiller epidemic is irrelevant, because drug companies are pushing them anyways. The pharmaceutical lobby has returned in full force, recruiting unknowing parents of overdose victims to fight for the passage of ADF-mandating bills — and essentially, guaranteeing them huge profits. There is no doubt that ADFs are soon to become a reality in America, simply because drug companies have willed it so. Even now, these manufacturers are more concerned about their own interests than they are those of the American public.
There are certain realities that the government and drug companies alike are still unwilling to recognize: opioids aren’t needed for chronic pain, they aren’t “less abusable” than other painkillers that were previously on the market, and all of our tools to promote these truths have been crippled by corruption at the cost of the public interest. Any insistence otherwise is nothing but a falsehood perpetuated by pharmaceutical lobbyists. A failure to reckon with these facts led to the worst drug epidemic that America has ever seen. As a result, tens of thousands of innocent Americans continue to die to narcotic overdoses each year, and government officials do nothing but perpetuate a system that has failed them.
It takes a strong leader in a position of authority to stand up to the massive pharmaceutical industry that has continually sacrificed progress for the sake of profit.
It takes a powerful person to speak up on the behalf of ordinary Americans to fix regulatory agencies that have been broken for decades.
Or maybe - who knows? - it just takes one french fry.