Authors: Keith Wailoo
How should the expanding government police a society and a marketplace increasingly drawn to drug therapy? Rosie Page, herself an arthritis sufferer, had depended on tranquilizersâone of the blockbuster relievers of the 1950s, but one increasingly deemed “habit forming.” By the time she approached the government for disability support, skepticism had grownâdriven by new studies on their habit-forming potential. Tranquilizer sales were declining under withering scrutiny by Congress and regulators. A 1963 presidential advisory commission characterized them as a “psychotoxic” and fostering dependence, and agencies like the FDA sought to balance oversight with ensuring that innovative drugs produced true relief. As the age of tranquilizers waned, new products (arguably less prone to producing dependence) would emerge to fill the market void. As arthritis sufferers like Page looked to a liberal government for relief and protection, then, pain relief stood as a complex management dilemma in what Philip Rieff would characterize as a “therapeutic society.”
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DMSO became a textbook example of the promise and peril of the drug economy and of the double-edge challenge of liberal governmentâto provide aggressive, vigilant regulatory oversight while not standing in the way of valued relief. Was DMSO an exploiter of people in pain, or was this new drug the answer to their prayers? In the mid-1960s, the answer hinged on one's interests and what one thought about the therapeutic state. In February 1965, the media had first hailed DMSO as a miracle
drug in reports that often blurred the line between advertising and journalism. Reports proclaimed, “It kills pain, speeds wound healing, reduces inflammation, clears up bruises, serves as a tranquilizer, relieves certain ⦠allergies, relaxes muscles ⦠and relieves certain types of arthritis.” Under the drug's influence, people with bursitis, arthritis, burn pains, and intractable aches reported feeling better; their problems completely disappeared. If pain disability was a growing threat, here was a promising antidote.
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Within two months, even as drug maker Crown Zellerbach was expanding DMSO production to meet the growing demand, the popular press changed its tuneânow expressing the need for caution and reassessment. It may be “the nearest thing to a wonder drug the nineteen sixties have produced,” noted one author, but “more and more people are obtaining some and using it on themselves without medical supervision,” and they could be “inviting disastrous consequences worse than their present ailments.” What had been a story of a drug's triumph over pain in the market of relief now became, in some eyes, a story of government's failure in policing people and products. In Congress, congressional representative L. H. Fountain voiced his suspicion that the drug houses and their marketers had gained undue influence not only over prescribers and patients but also over regulators. The FDA had approved the drug, even as Fountain and his subcommittee questioned the drug's effectiveness and claimed that many researchers had tested the drug in a willfully illegal and dangerous fashion, endangering the lives of patients.
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What society and government seemed to needâat the FDA, at the FTC, in Congress, in medicine, and in the legal worldâwas more pain managers who could tell the difference between miracle relief and malicious exploitation, who could sort true relief from fraud. Also needed were more pain experts, better theories, stronger evidence on drug effects, and more robust methods for assessing subjective pain and relief. What made the DMSO case especially vexing were the fierce and competing subjective claimsâmany arthritis sufferers swore that the drug had brought lasting relief to their pain. Meanwhile, the fickle media continued to report on new studies showing serious side effects in laboratory animals and human deaths linked to DMSO. Perhaps, one author now speculated, the popular feel-good wonder drug was “not as wonderful as advertised.”
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FIGURE 2.1.
An advertisement touting the “miracle” of DMSO, appearing at the high point of the controversial drug's popular and medical allure.
Chicago Tribune
, May 3, 1964, B3.
Relief from the pain of arthritis careened between these political polarities in President Johnson's administrationâbetween calls for growing FDA surveillance of the shady business of relief and defensiveness from a growing government that regulation would not stand in the way of true remedies. FDA official Frances Kelsey, the heroine whose refusal to endorse thalidomide had prevented the drug from entering the American marketplace, took charge of the FDA effort to police suspicious drug claims. By mid-1966 the DMSO drug maker fell under heavy scrutiny, with Congress launching hearings investigating the drug's claims as well as the approval process. After a thorough investigation of DMSO, the
FDA decided in 1966 on a cautious “sensible resumption of controlled experimentation”âallowing researchers who understood the perils to resume testing the drug under strict controls.
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DMSO remained in therapeutic limboâit was not on the market nor available to prescribers nor was it entirely banned. Pushback from industry and researchers was inevitable; from 1966 onward regulators took a defensive posture. Some clinicians praised the drug's power as an alternative to surgery and narcotics. As one researcher noted in 1967, “I practically discarded physical therapy as treatment for acute musculo-skeletal problems, because the rehabilitation of my patients was so prompt.” DMSO was every bit the miracle that marketers promised, he said. “There was little or no necessity to prescribe narcotics and tranquilizers, since pain was promptly mitigated following topical application.”
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As an alternative to stigmatized habit-forming painkillers, DMSO had a clear if controversial appeal.
The field known as “pain management” was also in limbo, maturing in this contentious political environment; it is important, therefore, that we see the field not as a medical invention but as a social and political one. Pain management, broadly defined, would henceforth involve negotiating between these competing ideologies of relief and working with the interest groupsâphysicians, patients, soldiers, police, legislators, and so onâwith their own stakes in relief. With DMSO now out of reach and manufacturers and some lawmakers now complaining that it was a “persecuted drug,” the FDA was under pressure from patients and some legislators to reapprove the drug in full. Kelsey and others resisted. The standoff continued through the late 1960s and into the early 1970s. Advocates heralded its power to relieve. Skeptics pointed to its well-established toxicity. The DMSO controversy strengthened the hand of government, but it also encouraged opponents of regulation to portray government as the impediment to relief, not a true solution to people's pain. In their view, the drug was a victim of misunderstanding and persecutionâa casualty of an era of expanding, overcautious government.
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Government was also in therapeutic limbo, for increased regulation of such substances as DMSO, LSD, and even the birth control pill exposed the gnawing question at the heart of liberal society in the mid-1960sâin a truly “free” society, could government simultaneously protect people afflicted by pain while also being an agent of their self-determination? Was
such a balance politically possible? Even more vexing, new social movements pressured regulators as young people's embrace of LSD and marijuana as recreational rebellion and free expression posed new regulatory challenges. Alongside the political Right's distrust of government came another current: a potent libertarian strain from the political Left that also saw regulation as the enemy of freedom. Decisions like the Supreme Court's 1965
Griswold v. Connecticut
, with the court striking down the state's right to restrict married women's access to birth control, cast the government as an impediment to personal freedom. This argument gathered force not only in industry, among doctors, and youthful protesters but also among people who simply wanted their DMSO.
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That pain management should become a subspecialty in medicine owes much to the contentious questions of suffering, disability, entitlement, and relief swirling around people like Rosie Page. Tort law had long hinged on pain and suffering, but now when people claimed disabling pain or when they sued drug makers claiming to have been harmed by a painkiller's side effects, it was men like John Bonica, the Seattle pain doctor, who were called to give expert testimony about the risks, benefits, and harms. No pain specialist in this era could be merely a clinician, for their insights were crucial in legal and policy disputes over disability, personal injury, and product liability. Bonica's task expanded to include judging true and feigned pain, evaluating a drug's efficacy and its habit-forming potential, judging manufacturers' claims and their products, and helping governments to navigate these expanding problems of relief.
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Pain experts were gatekeepers to relief in a broad sense.
By the early 1960s, having put out a new edition of his authoritative textbook on pain management, Bonica was leading the anesthesiology program at the University of Washington in Seattle. By 1963, his clinic was becoming recognized nationally as a place where people in pain received a fair hearing. He was said to tackle tough problems that baffled most others specialists. Like the sociologist Kenneth Zola and many others who studied pain, he carried his own burden of painâin his case because of musculoskeletal injuries earned in his earlier days as a professional
wrestler. Bonica carried this burden with grim toughnessâas one colleague noted, “We watched him grapple with his pain every day, wrestling it to the mat whenever he had a lecture commitment or a deadline.”
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A 1963
Time
magazine profile recounted the route one tortured woman traveled to Bonica's Seattle unit. Like Rosie Page, she had been labeled “hysterical,” but in Seattle she found a measure of validation. Her problem had started after a traumatic surgery: “The operation for breast cancer appeared to have been successful, but the patient developed unbearable pain in her right arm. Some of the many doctors she consulted were convinced that her cancer must have recurredâbut they could not find it. Others blamed her pain on an emotional (“hysterical”) reactionâbut they could not help her either.”
Time
used her story to suggest that more experts should follow Bonica's model of careful deliberation. His clinic balanced an interest in anatomy with a concern for pain perception and psychology. Neither drugs nor surgery nor psychiatry alone could be the answer. Such cases stood as a “reminder that finding an effective treatment for pain can become one of the most difficult problems of medicine.” His multidisciplinary center just getting off the ground, Bonica was said to be asking questions “that many more medical men should be asking themselves.”
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Most important, it seemed that Bonica did not blame and stigmatize, and, as such, his multidisciplinary clinic became a welcome port in the storm.
In this context, the political salience of pain theory grew and tilted toward liberalization. Such a controversial field needed stabilizing theoriesânot the harshly judgmental concepts of malingering so dominant in the 1950s but new theories that were flexible enough to suit the pain challenges of the times. From the mid-1960s to the early 1970s, a new concept, gate control theory, arose to support the liberalization of the new field. Gate control reinforced many of the tendencies of the eraâsuggesting, for example, that Rosie Page, Judge John Brown, Henry Beecher, and John Bonica were right to see felt, subjective pain as true pain. The gate control theory was “riding in on the Zeitgeist,” one of its inventors, Ronald Melzack, later observed.
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But in reality the uptake of gate control owed less to a “cultural spirit” whisking ideas along and much more to the fact that the theory resonated on multiple levels with the era's legal battles, cultural critiques, pain relief practices, and liberalizing political commitments.
The revolution in theory began quietly when, in the early 1960s, Canadian-born psychologist Ronald Melzack and English physiologist Patrick Wall invented the gate control concept. Neither man had ever been involved in patient careâthey were outsiders to the medical establishment. Both were critics not only of pain medicine's dependence on surgery and drugs but also of pain science and its narrow anatomical bias. At the time, the most preferred medical explanation held to a Cartesian model of pain as something that traveled via nerve impulses to the brain. Melzack and Wall brusquely dismissed this understanding in 1961: “Pain is not a fixed response to a hurtful stimulus. Its perception is modified by our past experiences, our expectations and, more subtly by our culture ⦠Pain, we now believe, refers to a category of complex experiences, not to a single sensation produced by a specific stimulus.” They dismissed “the concept of a âpain center' in the brain” as “pure fiction.” Not only were multiple parts of the brain associated with pain perception, they argued, but other qualities of the person (mood, psychological state, history, and context) could modify those perceptions.
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