Pain (32 page)

By late 2003, nearly three hundred state and federal lawsuits (including a number of class-action suits) had been launched against OxyContin and Purdue Pharma, but at least one legal commentator—in part defending the industry—argued that most were not brought by law-abiding citizens duped into addiction but by existing drug abusers who happened to find OxyContin as their new drug of choice. In this telling, OxyContin had not created addicts; rather, addicts had besmirched the reputation of a virtuous pain reliever. Who then were these people who blamed the drug for their addiction? Were they deceitful frauds? But another question in the legal debate was the identity of Purdue Pharma. Were they a legitimate company concerned about pain and offering true relief or a deceitful drug trafficker? A new theory of “negligent marketing” threw Purdue onto the defensive: it had been recognized for the first time by the courts in 1999, relating to the sale and manufacture of firearms, and now was being deployed in court against drug makers. But, as the company's
defenders argued, Purdue could not be held responsible for diversion and the pre-existing black market. One such claim in Virginia, the case of
Mc-Cauley v. Purdue Pharma
, failed precisely because the plaintiff could not prove causation. Particularly revealing of the reach of painkillers in this era was the finding in such cases that, as one legal observer noted, “it appeared that the plaintiffs were already addicted to pain medication long before their physicians first prescribed OxyContin.”
³⁶

The years 2004 and 2005 would be contentious for the painkiller market with government re-energized to fight the industry. Early in the decade, a number of state governors, regardless of politics and ideology, had begun to push back against the pharmaceutical industry's high pricing as a way to restrain ballooning Medicaid expenses. By 2001, a variety of state initiatives, ranging from laws protecting low-income residents to multistate purchasing coalitions, were driving down the price of big sellers like the antiarthritis drug Vioxx. The same year, West Virginia tried a new tactic in cost reduction when it sued Purdue Pharma to recover $30 million in costs associated with overprescribing. As with the lawsuits from individuals, the grounds were negligent marketing. In late 2004, Purdue and the state settled—with the company paying a relatively small settlement of $10 million to pay for continuing education programs for doctors, law enforcement prevention programs, and drug rehabilitation initiatives.
³⁷

The pain relief market of the 1980s and 1990s continued to work its magic, with booms followed by more spectacular busts. Just when faith in OxyContin was declining, another high-flying pain drug crashed even more dramatically than Purdue Pharma's blockbuster. This time, it was Merck, announcing that its celebrated arthritis drug Vioxx would be removed from the market following disclosures that it increased risk of heart ailments and assertions that the company had kept this information from regulators, doctors, and patients. The Vioxx story deepened the tale of fraud and deceit, pointing more directly at the heart of the industry. It soon became a parable of a new type of corporate malfeasance that imperiled the system of capitalism itself. In 2004, the Bush administration's Justice Department and the Securities and Exchange Commission (SEC) both announced investigations of Merck, with the SEC presumably concerned with whether the company had misled not only the public but also its stockholders about the safety of Vioxx.
³⁸

Lawsuits against the company followed, and, repeating the trend already established in the OxyContin cases, state governments turned their attention to Merck. Even the conservative Congress and George W. Bush White House could not avoid launching intense regulatory measures. Alongside other corporate scandals like the Enron debacle in 2001 (where the brash Texas energy company had been propped up by elaborate accounting fraud), public attention turned toward cleaning up the malfeasance that seemed pervasive in industries that had been cut loose from regulatory oversight. The maker of Vioxx's competitor drug, Celebrex, decided to press on in the face of similar allegations, electing to weather the storm of inevitable lawsuits and regulatory scrutiny. In the wake of these disclosures, large managed-care organizations like Kaiser Permanente reassessed the appeal of other pain drugs—deciding against dispensing other controversial products like Pfizer's Bextra.
³⁹

In a sense, this was the free market at work as its advocates intended, for with regulatory barriers lowered only time and widespread use would disclose the true utility of the various drugs circulating in the pain economy; in the meantime as drugs surged through the system, the market produced record profits, considerable relief, and (ironically) much pain. From 1998 to 2005, the number of serious adverse events from prescription drugs climbed from roughly thirty-five thousand to eighty-nine thousand, with oxycodone leading the way. In this light, Rush Limbaugh was lucky; he was part of a much larger group of people who were “merely” addicted. In OxyContin consumption, the United States stood far apart from any other nation. A 2008 UN report observed that 90 percent of the global consumption of pain medicines occurred in Europe and North America but that “in 2007, the United States accounted for over 99 percent of global consumption of hydrocodone and 83 percent of global consumption of oxycodone.”
⁴⁰
As with so many of the drug stories of the decade, the U.S. stood alone—not in the degree of pain in the body politic but in its unquenchable appetite for relief.

The Vioxx crash was financially spectacular—far more calamitous for Merck than OxyContin's case had been for Purdue Pharma, and it tipped the scales decidedly toward government oversight. Even so, the two busts had been similarly damaging to the public health. Facing charges in federal court from the Department of Justice, in 2007 Purdue Pharma and its former executives (the president, medical director, and
top lawyer) pleaded guilty to misleading doctors and patients when they claimed the drug was less likely to be abused than other similar drugs (such as Percocet). Purdue Pharma paid a $600 million fine, and the three executives paid a collective $34.5 million in penalties for their part in the deceit: they had known that time-release OxyContin was not safe. Later that same year (and three years after removing its own pain drug, Vioxx), Merck agreed to pay close to $5 billion dollars to settle more than twenty-five thousand lawsuits relating to its promises of relief. (Pfizer followed in 2008 with an $894 million settlement of all lawsuits relating to its withdrawn painkiller, Bextra, and arthritis drug, Celebrex.) Some industry critics believed, however, that all this action was too mild and too late. For them, the fines and legal fees paled in comparison to the profits OxyContin and Vioxx had generated—and would not be a deterrent to other flagrant market booms and busts. During the six years of alleged wrongdoing, OxyContin had generated between $1 billion and $2 billion in revenues per year for the firm; Vioxx had generated an estimated $11.2 billion in total sales between 1999 and 2004.
⁴¹

Until the middle of the decade, the FDA had exercised little postmarket influence once drugs were approved. The agency did not have much power to compel changes in advertising, and probusiness administrations saw little need for aggressive FDA oversight. The best it could do, given its mandate, was to haggle with drug companies to change drug labeling to warn physicians of a drug's downsides. Even as the OxyContin and Vioxx scandals played out, the U.S. Senate voted by a massive majority (ninety-three to one) to establish a surveillance system to track adverse effects of prescription drugs and to enhance the FDA's power to warn the public. Senator Charles Grassley (R-Iowa) turned out to be one of the fiercest critics of the industry, taking relentless aim at the complicity of academics, pain relief advocates, and government in endorsing painkillers. The FDA was in an all-too-cozy relationship with drug makers. “Public safety is at stake,” he wrote following an Institute of Medicine (IOM) report on the topic, “along with the credibility of our nation's drug-safety agency … Vioxx was like a dead canary in the coal mine, a warning that worse may yet come. Today there's no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives.”
⁴²

At the same time that the pain relief market expanded, the Iraq war produced two new twists in pain and policy—introducing into politics the question of imposing pain on others for a “greater good”(torture) and shining a spotlight on the anguish of injured soldiers and their need for relief. The rise of torture as public policy (with revelations about brutal treatment of Iraqi detainees by American soldiers at Abu Ghraib prison and administration memos outlining the use of waterboarding—simulated drowning—to extract information) was shockingly new in public debate; the administration's stance increasingly painting the Right as all too willing to inflict pain for the greater welfare of the American public. Characterizations of Bush's vice president, Dick Cheney, as the “Master of Pain” and “Vice President of Torture” for his grim defense of “harsh interrogations” and of Bush as the “King of Pain” became common media fare—for Democrats in Congress and liberals opposed to the war, and also for many Republicans who denounced the administration's positions as alien to American values.
⁴³
The second by-product of the Iraq war, thousands of soldiers in pain from injuries from improvised explosive devices, was a new but also familiar challenge in American political history. The war produced mourning about the soldier's sacrifice and the need for support at home.
⁴⁴
By the end of the decade, the Iraq experience merged back into the OxyContin era as army experts and senators voiced concern about the dramatic increase in narcotic pain-relief prescriptions for injured troops, jumping from thirty thousand a month to fifty thousand since the war began and becoming “the most abused drug in the military.”
⁴⁵

With the damage produced by the booms and busts of the pain market stretching so broadly, the embrace of drug surveillance crossed party lines. Senator Grassley called on President Bush to help support these reforms, but he also wrote scathingly to the FDA commissioner that its own personnel were disenchanted that the FDA “has lost its way and ‘sold out' to the industries it is charged to regulate.” Speaking for Democrats, Senator Edward Kennedy also called for increased market scrutiny—in the case of Vioxx, he pointed out, it took fourteen months for the FDA to get the company to change the drug's label. “Companies routinely promise to conduct studies that are never even started, much less completed,” he noted, and they encountered no penalties for doing so.
⁴⁶
Senators had
come together on the need for surveillance. They hoped that a public database of clinical trials conducted by drug companies would produce a transparency about the pain and suffering, as well as benefits, of the ongoing OxyContin era.

If Rush Limbaugh represented one face of the American problem (over-treated pain), there were also many people struggling with undertreated pain. “It is an irony of our age,” the
Washington Post
had commented in 1986, in words that rang true decades later. Cancer patients, burn victims, and accident victims were not being adequately relieved, while others were overdosing on painkillers prescribed for a growing array of chronic pains. These striking polarities in pain care came to define the American landscape, reflecting the ironies of a consumer society. For every savvy consumer like Limbaugh who craftily navigated the system to obtain pain relief, there were many others who tried and failed or who came under clinical and legal scrutiny and never obtained the relief they sought. Race, age, and economics defined this pain divide. Patients in low-income neighborhoods found that their pharmacies did not stock strong pain medicines for fear of being robbed. Meanwhile, doctors remained reluctant to prescribe pain medication for chronic disease, fearing drug dependency in patients and wary of professional accusations of fostering addiction leveled against them by medical boards and drug enforcement officials. In the case of sickle-cell disease, as one practitioner admitted, “Physicians sometimes think that patients with sickle-cell anemia and pain compatible with crisis are drug-seeking or responding to other psychosocial factors.”
⁴⁷
Such caregivers practiced medicine under a heavy cloud of suspicion and extended that cloud of suspicion to pain patients.

The pain of minorities (or urban inner-city pain, as it was often conceived) was cast in a different light than suburban pain; researchers characterized minority pain as undertreated—a portrait several studies in the 1990s solidified. In March 1994, emergency physician Knox Todd discovered a striking phenomenon in the annals of pain and relief—that all people's pains were not relieved equally. Based on a study in an emergency
room in Los Angeles, Todd determined that white patients being treated for long bone fractures (a highly painful condition) were dosed more liberally than Latino patients with similarly severe fractures. “This disparity in analgesic practice could not be explained by patient characteristics (including sex, language use, and insurance status), severity of injury, or physician characteristics (including ethnicity, sex, or specialty),” wrote the authors. Were caregivers to blame or the patients themselves? The authors could only speculate about what accounted for the gap in relief. “We postulated that the disparity in pain management might arise at two stages of the encounter between patient and physician—pain assessment and analgesic ordering.” One possibility was that physicians assess pain differently in Latinos and whites, “either because patients express pain differently or because physicians interpret such expressions differently.” Another possibility was that physicians assessed pain in the two groups similarly “but simply choose to address pain less aggressively in the former group.” The studies offered no definitive answers—only possibilities—but the clear outcome was less relief. A year later in Atlanta, the authors found similar disparities in pain relief—now across black-white ethnic lines.
⁴⁸