7

On Opioids

different cultures and countries take different approaches to the burdens of physical pain. Almost universally, the excruciating physical tolls of diseases like cancer and sickle-cell anemia are treated aggressively with prescription painkillers. In the United States, this sort of treatment has been extended more broadly, with the same pain medications employed for chronic pain also provided to individuals experiencing musculoskeletal injuries, dental work, and surgical recoveries.

Why have so many U.S. doctors prescribed powerful opioids to so many patients at such high doses? It is now recognized that the change in medical practice contributed to the opioid epidemic that is manifesting with tragic consequences now and, inevitably, well into the future. The dynamic of the epidemic is changing, and the proximate cause of most of the overdoses is heroin and black market fentanyl. But many individuals have been first sucked into the opioid cycle by the array of choices produced legally by some of the most successful and profitable pharmaceutical manufacturers in the United States—companies whose financial growth have been enabled by persuading physicians with a particular kind of scientific campaign.

I am not suggesting that these companies are solely responsible for the opioid crisis. Powerful social and economic factors contribute to this complex epidemic. Starting in the 1990s, the increased use of opioids for pain brought reduced suffering and welcome relief to many. But there is no question that if the prescription opioids had not been available in virtually unlimited quantities beginning in the 1990s, either taken as legally prescribed or diverted to the illicit market, this epidemic would not be nearly as extensive. Many individuals who have died by overdose would be alive today. This chapter focuses on the producers of these drugs, because the ensuing epidemic is rooted in their abuse of the science.

Human brains have a remarkable mechanism for controlling pain. When we are injured or hurt, our bodies produce their own chemical opioids, which bind to receptors in the brain and nerves, reducing (or, ideally, blocking) the pain. In many instances, this natural mechanism isn’t strong enough to handle the pain, and for centuries products made from opium, and later chemically derived morphine, have been used for pain relief. These medications work for many. With a catch, of course: Their addictive properties have been well recognized and have always been a concern.

Synthetic opioids, as well as semi-synthetic ones derived from natural opioids, were first developed in the lab a century ago. They achieved marginal medicinal use beginning in the 1960s, then widespread use in the 1990s. These days, two of the most well-known synthetics are oxycodone, the main active ingredient in the brand-name product OxyContin, and fentanyl. Fentanyl, a synthetic opioid, one of the more potent, is 50 times stronger than heroin. The term “opioids” is therefore a broad category of natural and synthetic products, all of which bind with specific receptors in the brain that block pain while also producing, to one degree or another, a euphoria that can sometimes be craved by users. Those individuals who begin to seek out opioids to the exclusion of other goals, no matter the harmful consequences in their lives, have developed an addiction.

The recent opioid epidemic dates to 1995, when Purdue Pharma, a privately owned company based in Stamford, Connecticut, introduced OxyContin, the brand-name of a new formulation of oxycodone. This new product featured a much larger dose than earlier versions of oxycodone-based pain killers like Percocet and Percodan, and also promised longer-lasting pain relief (12 hours, as opposed to just four). In order to get approval for this formulation from the Food and Drug Administration (FDA), Purdue Pharma convinced the agency that while OxyContin was more potent than earlier formulations, the “longer-acting” attribute would make this opioid less likely to cause addiction. Their logic was based on the claim that a more controlled release of oxycodone would be less likely to cause euphoria and craving than short-acting forms. In time for the medication’s launch, the FDA bought this argument—and permitted the company to claim the medication was less likely to be addictive on its label. Reality soon proved otherwise, however, and patients who became addicted soon realized the pills could be crushed and then snorted or even injected. Meanwhile, the FDA medical officer in charge of the review was hired by Purdue Pharma.¹

The drug industry, in particular Purdue with its newly obtained FDA approval, endeavored to convince physicians that pain was undertreated in our society (arguably true), that the new painkillers were a safe way to treat pain because they were virtually nonaddictive (very untrue), and they could not easily be abused (outrageously untrue).

How did they do it? The first step was finding and using material from the existing medical literature that would serve as cover for inventing a whole new world of “facts” to mask the addictive properties of the drugs they were marketing. In the early 1990s, there was very limited evidence either way as to the addictiveness of opioids prescribed. The companies found a few small studies (if you even call them studies) that appeared to say what they needed—that opioids were safe and nonaddictive—and then trumpeted the results. When we look at those “studies” now we can see their limitations in design and scope, but in these early years of extensive opioid use, at least a decade before the full-blown epidemic began, the hard numbers were not yet in evidence—tens of thousands of users had grown addicted. The presiding naiveté made it a little easier to believe, or to pretend to believe, the charade.

One key industry exhibit utilized by pharmaceutical companies was a five-sentence letter to the editor in the New England Journal of Medicine, published in 1980. It carried the title “Addiction rare in patients treated with narcotics.” This is the complete text:

Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well-documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.²

As a letter (not an actual paper), it never went through peer review—the academic process whereby other experts weigh in on a document’s claims and methods to endorse, or more often trash, its suitability for publication. In other words, citing this letter was the 1990s equivalent of citing a very thoughtful online comment. Nevertheless, it became a cornerstone of the industry’s later campaign promise that opioids carry a low risk of addiction when prescribed for chronic pain. The letter was certainly impressive. The title’s message seemed definitive; one of its authors was Hershel Jick, the respected director of the Boston Collaborative Drug Surveillance Program; and it was published in one of the nation’s most prestigious medical journals, so it saw a sizable increase in references after Purdue introduced OxyContin to the market fifteen years later.³ For the next quarter-century it would be cited hundreds of times in the medical literature and completely misrepresented in the popular press, likely with the help of Big Pharma’s PR flacks. In 2001, Time magazine even described it as a “landmark study,” assuring readers that any concerns that patients would become addicted to opioids was “basically unwarranted.”⁴ Eventually, in 2017 the editor of the journal issued an unprecedented warning that the “letter has been ‘heavily and uncritically cited’ as evidence that addiction is rare with opioid therapy” and Jick later pointed out that the letter, whose misuse he had no responsibility for, had many limitations, including that it only addressed use of opioids in inpatient hospital settings and there was no follow-up after patients were discharged.⁵

The episode with the New England Journal of Medicine’s five-sentence letter may have been the most flagrant example of the industry’s misleading physicians and regulators, but there were plenty of other examples in which the industry promoted short-term studies of people prescribed opioids for pain following surgery, burns, or some other acute event. The studies were often paid for by the opioid industry, written either by the doctors on Pharma’s payroll or industry ghostwriters.⁶ There was rarely any follow-up. It turned out to be pretty easy to make the case that these drugs were not addictive if you cherry-pick the studies and then misinterpret the findings.

It was even surprisingly easy to invent a whole new diagnosis: pseudoaddiction. The idea here was that a craving for opioids accompanied by behavior aimed at obtaining the drugs—addiction, in common understanding—was in fact driven by the still unrelieved pain for which the patient had been prescribed the opioid in the first place—pseudoaddiction. The actual term and the initial description originated with one study describing one (one!) patient. Despite the fact that there really is no hard (or even soft) evidence supporting the concept, it took off. The manufacturers sponsored publications like “Responsible Opioid Prescribing,” informing physicians that signs of pseudoaddiction (rather than true addiction) include requesting drugs by name, demanding or manipulative behavior, seeing more than one doctor to obtain opioids, and hoarding.⁷ And the best way to treat pseudoaddiction? More opioids, of course. A 2015 review of the literature unearthed a grand total of six papers challenging the concept. All were written by physicians not paid by the manufacturers.⁸ Overwhelming their well-intentioned output were hundreds of articles discussing pseudoaddiction while making no attempt whatsoever to empirically validate the concept. It was not a fair fight, and the results were predictable. The bogus, well-moneyed work overwhelmed the serious science.

Now recall the fundamental claim for OxyContin: twelve continuous hours of pain relief at a sustained, lower release is better than many competitors’ four hours, and also less enticing for problematic users who crave the quicker hit offered by the older, more immediate drugs. An investigation by the Los Angeles Times (using documents uncovered in litigation as well as studies submitted to the FDA) revealed that Purdue’s own studies found that OxyContin tablets release approximately 40 percent of their active ingredients immediately, after which release slows. As a result, the drug wears off in less than 12 hours for most patients, leaving the patient desperate for more. For some patients, it wears off in less than six hours. The result is a double hit: the underlying pain has returned, and the patient begins acute withdrawal from the medication. Together, these compel the individual to seek more medication, often at a higher dose. Evidently Purdue knew all this but continued to market the drug as effective for 12 hours, driving up usage and addiction—and profits.⁹

Certain manufacturers developed new formulations that purported to make the drugs less easy to misuse. In 2012, for example, Endo Pharmaceutical marketed Opana ER, which it claimed to be “crush-resistant” compared with its original Opana formulation. (Crush-resistant would make it unsuitable for snorting.) Promoting the drug to pharmacy benefit managers, the company failed to point out that studies it performed, but never published, showed that the new product could be ground with a coffee grinder, or just chewed to release the drug.

Along with these workarounds for those driven to use the drugs illicitly, the crush-resistant pills reconfigured the marketplace for the Endo product: injection replaced snorting among people misusing Opana. In 2015, disaster: a rural Indiana county that had never had more than five new HIV cases a year reported more than 100 new cases in less than three months, the disease spread by syringe-sharing around injection of Opana ER.¹⁰ The outbreak was finally halted when, after much delay and pleading from public health officials, then-governor Mike Pence agreed to a short term needle exchange program, limited to the county where the outbreak occurred.¹¹ Two years later—and too late—the FDA finally ordered Endo to stop selling the reformulated drug entirely, the first and only time that the agency had removed an opioid pain medication from the market due to the concerns of misuse and addiction.¹²

The evidence is simply overwhelming: opioid producers suppressed some studies, misrepresented and elevated others, claimed their drugs were neither addictive nor easily abused, and claimed that the most effective approach to addressing patient pain was to continuously increase dose of the drug. But not to worry! These drugs are not particularly addictive. You don’t believe us? Just ask our PR campaign. As demonstrated in other industries and going back to the heyday of tobacco, a company or industry’s uncertainty and misinformation campaign about a given product’s harmful impacts needs to unite questionable science with a full-court press of multi-sector public relations. The opioid producers’ three-front campaign targeting regulators, physicians, and the public followed the well-established formula perfected over the decades by Big Tobacco: Perpetrate ad-hoc “sound science” (i.e., paid-for science with beneficial conclusions) and the motivated manipulation of existing science; hire “key opinion leaders” to promote the products; invent and enrich front groups to advocate the importance of unfettered sales.

In the case of opioids, manufacturers started with physicians who specialized in pain management, likely believed that pain was undertreated in our healthcare system, and that opioids should be used more widely for that purpose. The firms then hired them as “influencers”: physicians who could attract the attention of other physicians—the ones who actually write the scripts—and advance the industry narrative in professional circles. These key opinion leaders were quite well paid for their services.

I’ve mentioned the study that helped get the ball rolling on pseudoaddiction—the one with only one subject. One of the authors of that groundbreaking paper, physician and dentist J. David Haddox, became one of Purdue Pharma’s paid speakers before becoming, eventually, the company’s vice president for health policy. Another star influencer was Russell Portenoy, a pain medicine specialist at Beth Israel Medical Center in New York. Portenoy was highly visible in the field, serving as editor in chief of the Journal of Pain and Symptom Management and editor of the journal Pain. He and his program received millions of dollars in funding from the opioid manufacturers. The gospel he preached was not just for physicians but for the public as well, and centered on destigmatizing opioid use. Appearing on Good Morning America in 2010, Portenoy asserted, “Addiction, when treating pain, is distinctly uncommon. If a person does not have a history, a personal history, of substance abuse, and does not have a history in the family of substance abuse, and does not have a very major psychiatric disorder, most doctors can feel very assured that that person is not going to become addicted.” Portenoy eventually recanted in 2012, admitting to the Wall Street Journal that he “gave innumerable lectures in the late 1980s and nineties about addiction that weren’t true.” He added, “Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well … I guess I did.”¹³

Drug makers paid out millions of dollars to physicians who would make a similar case to their peers, giving direct payments and also bringing the doctors to conferences at luxury resorts and fancy dinners where the companies could promote their products.¹⁴ Hundreds of physicians received six figure payments, and thousands of others were paid more than $25,000 each.¹⁵ This was in addition to the huge, heavily incentivized sales force (600 reps at Purdue alone) employed to meet with physicians at their offices. The system worked. The physicians prescribed larger and larger numbers of pills. The drug companies, the salespeople, the overprescribing physicians—they all got very rich.

The other key component of the opioid industry’s marketing effort were groups with names that sounded like objective, professional societies or patient-advocacy organizations. Many of these well-funded organizations were really just operatives for promoting the producers’ lies. According to the 2017 lawsuit filed by then–Ohio attorney general Mike DeWine, these groups generated treatment guidelines and programs that encouraged long-term use of opioids. They also did Pharma’s dirty work “by responding to negative articles, by advocating against regulatory changes that would limit opioid prescribing in accordance with the scientific evidence, and by conducting outreach to vulnerable patient populations.” The fancily named American Pain Foundation, for example, produced educational materials for patients, reporters, and policymakers that promoted the benefits of opioids for chronic pain and minimized the risk of addiction. It targeted pain medication for veterans and ran multimedia campaigns to inform patients of their “right” to pain treatment. The organization was so singularly dependent on the manufacturers that in 2012, when the Senate Finance Committee began an investigation into the links between it and the manufacturers, the American Pain Foundation’s board of directors (which included the aforementioned Richard Portenoy and other prominent physicians) promptly dissolved the organization.⁷

The FDA requires that drug-company advertising be truthful and labels have to be approved by the agency. However, advertising that doesn’t promote a specific product name or brand but mentions only diseases or those that mention only drugs (without linking the two) are not required to provide warning information or even to reflect the accompanying risks in a fair and balanced way. The opioid industry took full advantage of this loophole, following FDA rules when promoting their own products but broadcasting very different messages in the less specific, unbranded versions. The advertisements for Endo’s Opana ER, for example, included this FDA-approved statement: “All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.” In contrast, an Endo campaign promoting opioids in general only stated: “People who take opioids as prescribed usually do not become addicted.” ⁷

Totally legal.

In considering the origins and history of industry misinformation campaigns, the gold standard for effectiveness was designed by Hill and Knowlton, the global public relations firm that worked with cigarette companies following the cancer revelations of the 1950s.

The Sackler family, owners of Purdue Pharma, was involved in public relations, advertising, and marketing drugs long before they were manufacturing opioids. They were brilliant at advertising. In fact, their revenues from that first business had provided them the capital to purchase Purdue Pharma in the first place. The OxyContin PR campaign alone, working with a budget of $200 million, was in terms of profit one of the most successful campaigns in the history of contemporary society. At the time of the Sacklers’ Purdue acquisition, advertising and marketing had already made them multimillionaires; one drug later made them billionaires. Within a few short years of OxyContin’s introduction, annual sales reached $1 billion. By 2010, it was a $3 billion drug, even though it never represented more than a small percentage of the share of opioid prescriptions.¹⁶ According to Forbes, the Sacklers are now the nineteenth richest family in the country, wealthier than the Rockefellers. (That’s down a few places from 2015, as the campaign to limit opioid addiction has become more widespread and successful.¹⁷) Of course the wealth generated by opioids isn’t limited just to Purdue and its interests. Some of the biggest Big Pharma companies, including Johnson & Johnson (whose subsidiary Janssen Pharmaceuticals sells opioids), Teva, and Allergan, have profited from the massive growth in opioid sales.⁷

On one side of the ledger, phenomenal profits; on the other side, tragic consequences. The toll hardly needs summarizing here, beyond the cold fact that opioids have killed tens of thousands and destroyed the lives of thousands more, have decimated families and whole communities, and are responsible for the first drop in U.S. life expectancy in more than two decades. The largest killers are now illicit fentanyl and heroin, replacing the legally manufactured opioids that helped launch the epidemic. In the United States, overdoses involving opioids, licit and illicit, killed 42,000 people in 2016. That number jumped to almost 48,000 people in 2017, similar to the annual number of HIV/AIDS deaths at the height of its epidemic.¹⁸

In my seven years overseeing the U.S. Occupational Safety and Health Association (OSHA), I saw one component of the opioid epidemic up close—the relationship of workplace injuries, pain, and addiction. The stories were heartbreaking. Coal miners and construction workers, injured on the job, take pain pills in order to get back to work—and get paid again. It saddened but didn’t surprise me to see the high rates of overdoses in areas around the coal fields in West Virginia and Kentucky, knowing how the miners would do everything in their power, including self-medication, to keep working. The linkages between the opioid epidemic and work injuries were first documented by Gary Franklin, medical director of the Washington State Department of Labor and Industries, the agency that runs the state’s OSHA program. Workers are eager to get back to work, and physicians who treat injured workers, especially when the employer chooses the physician, often push injured workers off workers’ compensation (known for decades as “workman’s comp”). Franklin demonstrated that workers with back injuries who were given opioids were more likely to become addicted to the drug and ended up being disabled and out of work longer than workers not given opioids. He documented how the number of opioid-overdose deaths among injured workers in Washington shot up shortly after treatment guidelines were changed in the late 1990s to recommend the liberalized use of opioids.¹⁹ Those guidelines were strongly influenced by physicians, including Richard Portenoy, and organizations like the American Academy of Pain Medicine, one of the front groups bankrolled by drug manufacturers. It was a perfect storm: the short-term need of getting employees back to work quickly, combined with the drug industry’s false advertising that denied the addictive capacity of these powerful drugs, resulted in the addiction, disability, and subsequent overdose deaths of many workers injured on the job.

Lost amid the rightful public attention to opioid use and misuse is the enormous number of children who are for all intents and purposes orphaned by their parents’ diminished capacity for parenting, or in some cases deaths.²⁰ Before 2012, the number of children placed into the foster care system nationally was dropping each year; it has since then started to rise, with greater increases in states where more overdoses are occurring.²¹ In West Virginia, the foster care rate increased by 42 percent from 2014 to 2018.²² And whereas during the AIDS epidemic, there was a mathematical model I created that estimated the number of children who would lose their mothers to the disease (and with it, how much funding was needed to support orphaned children), no such model exists for opioids.²³ But given the large numbers of young adults dying of overdoses, I have no doubt that the number of children orphaned by opioids is already surpassing that from HIV/AIDS.

As revealed in journalist Barry Meier’s 2003 book Pain Killer, documents collected by the U.S. government in its criminal prosecution against Purdue reveal that company executives, including members of the Sackler family, were receiving numerous reports of misuse of their drug as early as 1997, less than two years after the drug hit the market (and then the streets). By 2003, seven years after OxyContin was introduced, thousands of patients who claimed they had become addicted to the drug had joined lawsuits against the manufacturer. One settled in New York for $75 million. Three years later, the Department of Justice began the first criminal case against Purdue, through which many of the documents and reports publicly available have surfaced. This was during the George W. Bush administration, and Purdue hired a team of well-connected attorneys, including former New York City mayor and soon to be Republican presidential candidate Rudy Giuliani, to try to work out a deal. According to Meier’s Pain Killer, even before criminal indictments could be issued, high-level DOJ officials pressured the prosecutors to back off and accept a plea deal. Purdue pled guilty to a felony charge of illegally misbranding OxyContin in an effort to mislead physicians and consumers into believing that the drug was less addictive and less subject to misuse.¹

Corporations can’t go to jail, but executives can. The deal with the government allowed three executives (but no members of the Sackler family) to plead guilty to misdemeanors and avoid prison; the company and its executives also agreed to pay fines totaling $634 million. That sounds like a lot, but it is still just a smidgen of the revenue that OxyContin continued to generate. The settlement did lead to some changes in warning labels and marketing policies, but physician prescribing patterns had already been set, and many patients were already dependent on the drugs, so the changes had only modest impact on either opioid sales or the devastating growth of the epidemic.

Some states also filed suits against Purdue, and these cases typically settled for relatively small sums. More importantly, the files in all of these cases were sealed, so no outside parties could see the secret documents uncovered in discovery. New cases could not build off previous cases and changes in opioid control policies that might have helped stem the epidemic were delayed. The failure to effectively corral opioid companies has led to new legal strategies to change the behavior of the manufacturers in meaningful ways (following the example of tobacco, where states sued cigarette manufacturers for the costs of providing medical care to smokers with cancer or lung disease). With the opioid manufacturers, increasing numbers of states, counties, cities, Native American tribes, and unions have filed lawsuits against Purdue, Johnson & Johnson, Teva, Endo, Allergan, as well as drug distribution firms, alleging they have driven up the costs of the medical care and social services borne by the plaintiffs. The litigation was initiated by a bipartisan group of state attorneys general and based on materials gathered through investigative subpoenas and document requests. As these suits have produced more incriminating documents, members of the Sackler family, and others who served on Purdue Pharma’s board of directors, have been sued as well.²⁴

The papers filed by the states contain a particularly damning indictment of the marketing practices of Purdue and the other manufacturers. Complaints from Kentucky, Tennessee, and Ohio, states that have been decimated by the epidemic, detail how these companies cynically marketed their products to maximize their profits, ignoring the obvious catastrophic impact of their work. They figured out what they needed to claim to get FDA approval and to convince physicians to prescribe their drugs.

By fall of 2019, the legal system was beginning to catch up with these outrages. In a historic decision, Johnson & Johnson was found by an Oklahoma judge to have helped fuel the opioid epidemic in that state and fined $465 million. That firm, Purdue Pharma, and the rest of the industry now recognize they will have to pay some price for selling a product that has caused such enormous devastation across the country, and they are inexorably moving in the direction of settling the many lawsuits they are facing.

Opioid sales and prescriptions have been dropping since 2012, but the companies are still selling far more pain-killing pills than needed. The work of Washington State’s Gary Franklin and others has helped reduce the almost automatic prescribing of opioids to injured workers who report pain. But the successful indoctrination of the medical profession by the opioid industry is hard to overcome. For example, most people don’t need narcotics to control the pain of a sprained ankle. Nevertheless, from 2011 to 2015, 25 percent of insured people who appeared at emergency rooms across the country following an ankle sprain and who had never taken opioids (and so were presumably not angling for the drugs) were given opioids.²⁵

Some legislative progress has occurred. In October 2014, the U.S. Drug Enforcement Administration tightened controls on physicians’ ability to prescribe drugs containing hydrocodone, prohibiting prescription refills. Compared with the 12 months before rescheduling, dispensed hydrocodone combination product prescriptions dropped by 22 percent.²⁶ But the epidemic had been seeded before this policy change; less access to legal products has resulted in more use of illegal products, and heroin and illicit fentanyl are less expensive than legal pills diverted to the black market.

Looking back on the origins of the opioid epidemic, it’s clear what could have been done to stop it before it was so entrenched. Certainly the FDA could have refused to agree to language on drug labels about the purported safety and effectiveness of long-acting opioids that was not supported by evidence. Academic researchers could have steered clear of funding from the industry and called out the practice of anecdotal observations misleadingly presented as studies (recall that five-sentence letter to the editor of the New England Journal of Medicine). Companies like Purdue should have sounded the alarm on misuse much faster, rather than keeping evidence of growing addiction under wraps.

Public disclosure of the enormous special-interest payments to physicians might have made the public at least somewhat skeptical of the claims of safety and effectiveness. (The United States made some progress in this area with the Affordable Care Act, also known as Obamacare, which required drug manufacturers to disclose their payments to physicians and hospitals and publish those data on the web. This could change, or cease, if the Affordable Care Act is repealed or substantially weakened.)

As of the publication of this book, the secret funding of front groups remains legal in the United States. Corporations continue to fund “AstroTurf” organizations—groups that operate under the guise of being grassroots but are actually mercenary political actors employed to convince legislators, regulators, and the public that there is real popular support for an industry’s product.

The smoking guns—the documents that tell us the truth about OxyContin and some of the other drugs, as well as the truth about outrageous and deceitful marketing campaigns—were coughed up by the drug makers in the lawsuits and federal prosecution of Purdue. Yet under the terms of these settlements, Purdue was allowed to seal the record and none of those documents were made public. We have them now, a full decade later, only because state attorneys general have initiated a new round of suits. Fear of reputational damage is a powerful motivator of good behavior; had these documents surfaced earlier, or during the actual lawsuit, it is likely that Purdue, Johnson & Johnson, and the other firms would have been compelled to voluntarily stop some of their marketing ploys, and far fewer of these lethal pills would have been sold.