Pain (29 page)

In this new world, the gap between people privileged with too much relief and those coping with too little had grown. Drugstores in poor neighborhoods were loath to stock painkillers for fear of break-ins and robbery, leaving local patients traveling longer distances for medications. Increasing evidence suggested that ethnic minorities had lower access to analgesic care in hospitals as compared with whites. Meanwhile, OxyContin, which had quickly earned a reputation as “hillbilly heroin” because of its prevalent use in rural America, now gained a reputation as the prescription drug of choice among upscale abusers.
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Social disparities bedeviled caregivers in end-of-life cancer relief. While some Americans were receiving too much relief—often through criminal means—other people were suffering with few remedies in sight. Where did Limbaugh stand on this spectrum of overmedication and undertreatment? This was the political question unleashed by OxyContin and confronting liberals and conservatives alike.

For much of the century, the questions of how to regulate the marketplace for relief and whether well-being was best served by the market or by government broke along political and economic lines. At times, liberal politicians like Estes Kefauver (shocked by drug scandals, aggressive marketing, and side effects) have tilted heavily toward regulating the industry; at other times, market-oriented conservatives in the Bush, Reagan, and even Clinton years leaned toward deregulation. The question of drug regulation hinged on the question of whom to trust—whether industry's claims about pain and relief were honest or venal and whether consumers could use potent drugs appropriately.

In the eyes of the drug industry, its type of pain relief was a market good. Pain medicines were also the sector's financial lifeblood. Fast relief, a seemingly enduring American consumer ideal, was tied to such products as the blockbuster tranquilizer Miltown in the 1950s, new analgesics in the 1960s and 1970s, and a vast array of other nonopioids in the 1980s, 1990s, and through today. In the 1990s, Americans were told (as they had been in previous eras) that they didn't have time for pain and that products like Vioxx and OxyContin offered new kinds of fast-acting or long-term relief. Since the 1950s, “fast relief” has been a dominant advertising motif. Less heralded has been the accompanying parade of side effects, dependence, abuse, and other recurring regulatory, policing, and political headaches that came in the shadow of such promises. In many of these cases, early claims of superior pharmacological relief gave way to concern and reassessment, opening the door to regulatory debate; but new painkillers were always around the corner, and the cycle would begin again.

By the time that ibuprofen, the first of a new family of powerful non-steroidal anti-inflammatory arthritis and pain drugs, appeared on American drugstore shelves in the 1970s and 1980s, its success came amid a new antiregulatory business environment in which such drugs would thrive. With the election of Ronald Reagan in 1980, the decade became fertile political soil for painkillers. Deregulation in all sectors of the economy had become the new watchword. The age of consumer protection that followed the thalidomide scandal in the early 1960s was giving way
to a new era that cast the Food and Drug Administration regulatory process as squelching the market, shackling innovation, and standing in the way of true relief. In the decade that followed, pharmaceutical regulatory policies aimed to open the floodgates of innovation, cut “bureaucratic red tape” in drug approval, open television marketing to drug companies, and speed the flow of products from drug maker to consumer. But these policies raised an old question: Was the pain patient victimized more by the savvy marketing, or was the person in pain being victimized by the red tape of government regulation?

Reagan-era policies opened the doors to expedited FDA drug approval in the 1980s, but the question persisted as to whether an industry unfettered by regulation was truly a gift to consumers or a curse to the gullible. In this argument (one of many catalyzed by the conservative revolution), Reagan was on the side of business—even wondering aloud after the 1980 election whether “the 1962 [post-thalidomide] reforms that required drugs to be proven effective as well as safe should be scrapped.”
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In his 1985 State of the Union address, Reagan insisted that “we stand on the threshold of a greater ability to produce more, do more, and be more. Our economy … is getting younger and stronger; it doesn't need rest and supervision, it needs new challenge, greater freedom. And that word—freedom—is the key to the Second American Revolution we mean to bring about.” For free-market conservatives, as they came to be known, freedom meant freedom from government regulation of business, including drug companies. It also meant consumer freedom because of a faster, easier pathway for experimental drugs through FDA approval and on to the market. The administration consolidated regulatory policy under Health and Human Services secretary Richard Schweiker and shelved new rules put forward by the Carter administration for keeping close track of adverse drug reactions, defective medical devices, subpar infant formula, and so on.
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Across government, the administration limited the authority of regulatory agencies, pushed for faster drug approval, and (under pressure from AIDS activists) began to see itself as a handmaiden of the drug innovation process—helping speed much-needed relief to market rather than standing in the way.

In the wake of deregulation, drug successes and drug scandals soon followed. In Reagan's first term, the arthritis drug Oraflex became the first canary in the coal mine—a test case framing a liberal-conservative
debate on the market's virtues and its damaging effects. Market analysts saw the arthritis pain field as “ripe for a breakthrough” and predicted that the 1980s would produce a drug to attack bone loss as well as pain. At stake was the relief of 6.5 million Americans with rheumatoid arthritis and almost thirty million with osteoarthritis. As the
New York Times
reported, “Some of the growth [in the arthritis market] is attributed to the aging population. Another factor is the switch of aspirin users to prescription drugs; which cost more but can deliver the needed dosage in fewer pills and are easier on the stomach.” Industry analysts put the potential market at $700 million annually, with annual growth potential of up to 20 percent.
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To feed and nurture demand, the major drug companies, including Pfizer, Eli Lilly, and Bristol Myers, turned to senior pain specialists to learn more about the pain patient—honing in on the pain market. Who were they? Were they elderly men or middle-aged housewives? Were they stock traders, advertising executives? And what kind of pains did they suffer? Reporting on one survey, pain pioneer John Bonica described pain consumers as “people who sit around watching television most of the time … Tension headaches are very common for them.” The sedentary lifestyle associated with major industrial nations gave rise to more pain. His study also found that women experienced more pain than men and that “headaches are a malady of the middle class, affecting people mostly in the $15,000–$50,000 annual income range.”
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Pain was everywhere, but unevenly distributed. Stock traders reported feeling less pain than “average Americans,” while advertising executives and people who worked at “computer video-display terminals” reported higher than average rates of headaches.

Tailoring new products to different consumer needs, companies hoped to gain a market share against Upjohn's Motrin, the blockbuster that had previously commanded the pain market. In 1981, sales of Motrin alone had totaled $1.9 billion, with profits of $181 million for Upjohn. Eli Lilly's Oraflex was another exciting new entry in this lucrative race for pain profits and rapid relief. The product entered the market to much acclaim, but it sent the company on what one business reporter called “some wild rides up and down.” Within four months of approval by the FDA in April 1982, Oraflex became one of Lilly's most popular drugs, with sixty-four thousand prescriptions filled. Sales reached $708 million in the first half
of the year, with net income of $228 million. Some patients reported remarkable improvements in pain and mobility.
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The Expanding Market 1982 projected market share, based on $717 million total sales of prescription drugs

But with such booms came troubling busts. When a British regulatory body linked Oraflex to sixty-one deaths there and eleven deaths in the United States since its American distribution four months earlier, the story rapidly pivoted from a parable of the market's virtues to a tale of its perils. In July 1982, the company learned of reports of twelve deaths, twenty-three cases of jaundice, and reports of severe liver and kidney problems among those on the drug; that same month, it warned physicians to reduce dosages. Pressure built as consumer activist Ralph Nader's Public Citizen Health Research Group (and other groups) filed a federal suit in Washington, D.C., requesting court intervention to halt the drug's sale. HHS Secretary Schweiker (who was then at the center of the administration's battle to remove claimants from the government's Social Security disability rolls) was compelled to act. The drug, he noted, was off the market and would stay off until the FDA conducted its own assessment; by June, eight deaths in the United States apparently linked to Oraflex were being investigated. By August, Eli Lilly announced the suspension of worldwide sales of the drug, as the number of U.S. and U.K. deaths rose to seventy-two, as uncertainty over the product's safety reigned, and as stock prices fell from $60 to $53 per share.
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The unleashed pain market would be vulnerable to such swings throughout the 1980s and into the 1990s. Oraflex's misfortune was a stark turnaround for such a promising product; commentators read the story of the drug's withdrawal from the market as an early warning of the perils of Reagan-era deregulation. Eli Lilly insisted that it had done nothing wrong, but the case seemed tailor made to stand in as a referendum on Reagan-era policies. As Reagan's political focus had shifted to various efforts to speed drug approval (including allowing nontraditional DTCA), critics zeroed in on whether these policies were to blame for the Oraflex debacle. Pressured by these events, Schweiker backed away (but only slightly) from HSS's earlier proposal to speed up new drug applications “out of fear that it may have inadequately reviewed the anti-arthritis drug Oraflex.”
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Greater caution seemed warranted. Where free-market conservatives saw these up and downs (in earnings, profits, and losses) as the market doing its intended work, producing winners and losers, critics of the administration's policies saw market excesses and consumer exploitation—measuring the drug market, for example, by lives lost.

Critics of the Reagan administration pointed to another problem highlighted by the Oraflex debacle—selective prosecution by the administration of the nation's drug offenders. While the Justice Department was taking an ever-harder line against illegal drug users, it failed to hold industry executives accountable for the deaths produced by their own bad drugs. In August 1985, Eli Lilly pled guilty to misdemeanor charges in the Oraflex case, admitting that it had mislabeled the drug and had failed to inform the FDA about adverse reactions. But under a plea bargain agreement with the Justice Department, the company was fined only $25,000. A former chief medical officer (a British citizen who had since left the United States) pled no contest to similar charges, paying a $15,000 fine. Critics of the administration charged that Justice Department lawyers had recommended prosecution for three of the company's officers (who apparently knew of overseas deaths tied to Oraflex but had failed to disclose them during the U.S. approval processes), but that senior Justice officials overruled its own lawyers. As Democratic representative and chair of the House Judiciary Subcommittee on Criminal Justice John Conyers saw it, this was one of the ironies of conservative governance. Overstating the deaths, he bemoaned the fact that “on the one hand, street criminals are prosecuted to the fullest extent of the law.
On the other hand corporate officials who may be responsible for the death and injury of hundreds of thousands of people are merely slapped on the wrist.”
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As critics on the political left saw it, the Justice Department was picking winners and losers in the pain economy. For the next two decades, these ironies of policing and the pain market would multiply.

Congressional Democrats charged that the Justice Department was too lenient in its refusal to pursue a trial in the Oraflex affair, a symbol of a coddling approach to the industry as well as a reflection of the Department's fear of losing at trial (a charge Justice officials denied). Democrats in Congress continued to attack the administration on this point well into Reagan's second term, with investigations and reports accusing not only the Justice department but the FDA as well of failure to protect the public health, failure to act on known side effects, and evasion of oversight in the name of speeding overseas drugs into the U.S. market. Though this debate started with painkillers (Johnson and Johnson's Zomax met a similar fate), the story continued with other drugs, like Hoecht's antidepressant, Merital. The FDA had become a drug promotion unit more than a consumer protection agency, the argument went, and skeptical Democratic lawmakers insisted on “the agency's need to enhance the public's protection from dangerous and unproven medicines.”
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