Pain (30 page)

Under the George H. W. Bush presidency in the late 1980s and early 1990s, the FDA began a slow shift toward remedying some of the damage wrought by deregulation. Yet market infatuations with “revolutionary” painkillers, followed by fallout from the disclosure of drug side-effects, remained common. In 1989 under Bush, for example, the FDA approved Toradol as a nonnarcotic pain reliever. Its maker, Syntex Corporation, announced that it would market the drug for the treatment of postoperative pain, a market then dominated by narcotics. Toradol's promise was simple—it was not an opioid, and numerous medical journals embraced the drug's promise over the next two years. By 1992 and 1993 (the end of Bush's term and the beginning of the Clinton administration), however, widening use of Toradol had produced significant health concerns, principally about its link to kidney damage and hemorrhages. As with Oraflex before it, Toradol sales declined. So did Syntex's stock, but the problem was not limited to Toradol. Another Syntex pain reliever, Naprosyn, once hailed as an “anti-arthritis wonder drug” in the
1970s, had come under increasing scrutiny by the FDA over the integrity of its animal testing and over the drug's safety. Both drugs were shadowed by skepticism about inflated claims, damaged by competition from new products like ibuprofen, and undermined by the 1993 expiration of their patents. The clinical reports on Toradol grew worse between 1995 and 1998, validating the drug's effectiveness while stressing the elevated dangers of gastrointestinal bleeding.
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The opening of the pain market to unbridled competition, in other words, fostered its own ironies, political struggles, and risks for consumers. Drugs like Oraflex, Syntex, and Toradol (and later Vioxx and Oxy-Contin) mixed high risk with high relief, thus adding uncertainty to the pain medicine field; eventually, their booms and busts began to turn the tables on deregulatory zeal. Yet, for industry, the imagined profits of pain were more than worth the risks of recurring scandals and litigation costs. Investors hoped that every new drug would follow the path not of Oraflex and Toradol but of Motrin (ibuprofen). Available by prescription since 1974, ibuprofen gave “competitors financial aches,” won praise as a “popular choice for easing pain and swelling of arthritis,” and was (in 1984) about to be approved for over-the-counter sales projected at $1.3 billion. The makers of Tylenol took to the courts, filing suit to forestall and even rescind the FDA's approval for over-the-counter sales. As another drug company executive noted, it was “an arrogant and unconscionable effort” to maintain their own market share.
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The desperate legal maneuver was unsuccessful.

By the mid-1990s, these cycles of success and failure raised many questions about the need for vigilance—continuing physician vigilance, FDA surveillance, consumer alertness, and sustained policing and prosecution of the aggressive industry. As in so many other areas of the Reagan revolution, the courts played a powerful and prominent role in adjudicating these pain disputes. Plaintiffs and lawsuits came in many varieties—some taking on the companies for product liability, others charging the administration with wrongdoing, and sometimes the companies themselves engaging in legal battles for market supremacy. Another front in the legal battle was over whether consumers, harmed by the products they had used, had been adequately warned of the risks. As one
Wall Street Journal
writer noted, the system of consumer information in the United States had produced an odd situation in which “the
average U.S. consumer typically receives less information on prescription drugs than the average Italian or Mexican.”
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For anyone looking to the market for relief, new forms of vigilance would become vital.

Within a decade of Reagan-era reforms, the age of deregulation had spawned a new period of pain drug lawsuits; jury awards for pain, suffering, and death; and investigations of both industry and FDA practices. In this context, Eli Lilly would be called to account for the damage Oraflex had produced, but it could also boast that “a Federal grand jury which investigated the Oraflex issue for fourteen months made no charge that Lilly withheld any information prior to U.S. approval … or that Lilly intentionally violated any law,” noting that any mistakes were totally inadvertent. In other legal settings, however, consumers wronged by pain drugs found redress. In November 1983, for example, a man whose eighty-one-year-old mother, Lola Jones, of Phoenix, Alabama, had died after taking Oraflex for a month, won a $6 million award in federal court. The plaintiff alleged that the media campaign had convinced Mrs. Jones that the drug was a cure for her arthritis. After the verdict, Jones's lawyer noted, “We're a little disappointed in the dollar figure, but we made our point. It was a good win.”
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Winning some cases by jury trial, settling others, and losing some, Eli Lilly (and other companies that played the high-stakes pain game) now also sought their own form of relief—calling for Congress to pass tort reform legislation and provide the industry with legal protections from “frivolous lawsuits.” Probusiness congressional Republicans, in another bow to the industry and the market, had found a new reform issue in the 1980s—calling for measures to limit “excessive” jury awards and to stem the tide of such lawsuits. (The industry had won a major victory in 1986 when Congress passed—and Reagan signed—the National Childhood Vaccine Injury Act, a law creating a special court to regularize awards to people claiming injury and removing the litigation threat that drug makers and vaccine manufacturers claimed was crippling the industry.)
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By the first year of George H. W. Bush's presidency, the effects of deregulation were, at best, double edged. Faster drug approvals, for example,
had won unlikely followers on the left. Writing in 1989, physician George Annas asserted that the combination of AIDS activism and deregulation “threatened to transform the U.S. Food and Drug Administration (FDA) from a consumer protection agency into a medical technology promotion agency.” But the promise of faster access to drugs was also becoming a dangerous roll of the dice for consumers. Democrats blamed deregulation for scandals in the savings-and-loan industry, and, as for the drug industry, even staff reporters for the business-friendly
Wall Street Journal
observed in 1989 that the FDA was engaging with the drug industry more as a partner than as a regulator and, as a result, “lurching from one crisis to another” and becoming party to industry malfeasance. “Three FDA employees already have pleaded guilty to taking illegal gratuities from generic-drug makers,” noted the
Journal
. “Two generics companies have admitted duping the agency with falsified data. And the FDA has found manufacturing and record-keeping problems at nearly all of the twelve generic-drug makers it has investigated so far.”
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The revelations—an indictment of deregulation—were also a shift in the liberal-conservative debate. Where the Reagan years had so powerfully vilified government as the consumer's bane, now it seemed that the character and trustworthiness of American drug firms (and their close relationship with the regulators) was endangering the health and well-being of consumers.

With lowered barriers to relief, new drug products flourished and consumption rose; but so too did a new problem: drug diversion. Although diversion is often linked to prescribing physicians, it was also a product of deregulation—a natural outgrowth, an unintended derivative, of the boom market. As early as 1990, Democratic representative Pete Stark (California) characterized pharmaceutical companies and careless physicians as no better than drug pushers, with patients as their victims. He pointed, for example, to “one New Mexico doctor who was responsible for 28 percent of all Valium prescribed to Medicaid recipients in the state” as one example of abuse.
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Other commentators noted that, with the rise of such commodities in the pain market, the diversion of prescription drugs onto the black market now arose as a major law enforcement concern. One among many concerns was the misuse of over-the-counter medications such as Sudafed (valued on the black market for its ingredient pseudoephedrine in the manufacture of methamphetamine).
Policymakers' attention turned slowly away from the primary users for whom the drug was marketed to secondhand markets—and the processes by which prescription drugs were, increasingly, being resold, repurposed, and remarketed.

In the politics of pain relief, guileful consumers (more than industry) were often blamed for skewing these pathways through which drugs traveled; to address this behavior, government surveillance was compelled to expand. Interviewed in 1994, one Connecticut enforcement official noted that “prescription drug abuse doesn't get the same attention that illegal drugs get. And yet we conservatively estimate that this accounts for 30 percent of the nation's drug abuse.” This new problem required that investigators develop new knowledge and tools, including (according to this same investigator) “how the legal distribution systems are set up, who has access to drugs, and how the records are kept at hospitals, clinics, long-term care facilities and pharmacies.” Investigators also cast a suspicious eye on professionals, needing to know more about the ways in which doctors, nurses, and pharmacists (whose rates of chemical dependence were much higher than in the general population) diverted drugs. But one of the most common ways of diverting drugs from legal distribution channels was through the phenomenon that came to be known as doctor shopping. “A patient will present to a physician difficult-to-diagnose ailments such as severe back or muscular pain that are typically treated with a pain killer. After receiving the prescription, the patient will repeat the performance for three or four more physicians.” Another surveillance concern of the 1990s became the blurred line between drug companies and drug pushers. Yet other developments also blurred these lines, most notably when California passed its medical marijuana laws in the mid-1990s and the DEA under Clinton promised harsh enforcement action against dealers as well as against “doctors who help to provide otherwise illegal drugs” to their patients.
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Unsettling the market in other ways, the avenues by which people in pain learned about prescription drugs and how they navigated the new drug economy had changed dramatically in the 1980s and 1990s with DTCA. Although it was not allowed across the board until 1996 with the Clinton administration, the direct marketing concept had emerged from Reagan-era promarket philosophy. In the 1980s, companies like Upjohn had gingerly tested the waters of DTCA by urging patients to “talk to
your doctor” about treatments for specific conditions; after a short moratorium by FDA, more liberal DTCA regulations of the early 1990s allowed full-throated advertisements. Now, the pharmaceutical industry put information about specific drugs—Claritin, Prozac, and other new products—directly before buyers in the name of consumer empowerment, provided that the ads also mentioned side effects. Savvy campaigns became a new advertising reality, unsettling doctor-patient communication as the primary way people learned about prescription drugs. Medical groups like the AMA expressed caution about the implications of turning Madison Avenue loose to sell drugs, as did politicians and public health officials.
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Was this truly the consumer empowerment free market conservatives wanted? Or was the FDA now enabling consumer exploitation as many critics feared?

News stories with titles such as “Maybe You're Sick. Maybe We Can Help,” announced the arrival of DTCA, offering an array of products (often for ailments that consumers did not know existed). This shifting balance of drug marketing and therapeutic information had sweeping implications for consumer drug use and for questions of safety and liability. The rise of limited DTCA was based on the belief that the informed consumer was an empowered consumer and that better health would stem from this trend. At the same time, however, it was also clear that DTCA exposed patients to risks. As one scholar noted, “A major concern is whether consumers actually gain correct information from advertising. Initial studies by the FDA suggested that test subjects recalled potential benefits of advertised products more often than risk information.” Another looming concern for manufacturers was whether the ads exposed the companies to liability if they were deemed, later, not to have warned consumers adequately of the risks. At the same time, the aggressive rise of DTCA spawned its own legal battles—as “manufacturers—in the face of increasing price competition—[began] taking one another to court over marketing aimed at physicians, pharmacists and other health professionals.”
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It was into this competitive and unstable market created by deregulation that OxyContin appeared. The chemically active ingredient in Oxy-Contin was not new. Instead, Purdue Pharma, the creator of the drug, had reformulated oxycodone (better known as Percodan) as a time-release capsule that would deliver relief in stages rather than all at once. Percodan
had been immensely popular as a painkiller upon its introduction in the 1950s, but its manufacturer, Endo, came under fire in the early 1960s for misrepresenting the drug's addictive properties. The result of government inquiries and industry criticism was stricter prescription-only controls and a greater reluctance to prescribe the drug.
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Percodan remained on the market, however, subject to the strict oversight that characterized the “war on drugs.” (In the 1970 Controlled Substances Act, oxycodone was classified as a Schedule 2 substance—with a high potential for abuse—alongside cocaine, morphine, and methadone.) Some three decades after Percodan's high promise had crashed to the ground, oxycodone was back; the new and repackaged time-release brand won approval from the FDA in 1998. It appeared alongside the dozens of other leading painkilling performers—Celebrex, the first Cox-2 inhibitor and painkiller for arthritis patients; Vioxx, the second Cox-2 inhibitor on the market; and many other products. OxyContin promised better, faster, time-released, controlled relief with no addictive downside; it was a free-market dream. And, because the drug appealed to those who would liberalize pain medicine and end-of-life care, it found an avid market with cancer physicians seeking to give patients reliable relief without the fear of morphine-related addiction.