Medicating Modern America
eBook - ePub

Medicating Modern America

Prescription Drugs in History

Andrea Tone, Elizabeth Siegel Watkins

Share book
  1. 262 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Medicating Modern America

Prescription Drugs in History

Andrea Tone, Elizabeth Siegel Watkins

Book details
Book preview
Table of contents
Citations

About This Book

With Americans paying more than $200 billion each year for prescription pills, the pharmaceutical business is the most profitable in the nation. The popularity of prescription drugs in recent decades has remade the doctor/patient relationship, instituting prescription-writing and pill-taking as an integral part of medical practice and everyday life.

Medicating Modern America examines the meanings behind this pharmaceutical revolution through the interconnected histories of eight of the most influential and important drugs: antibiotics, mood stabilizers, hormone replacement therapy, oral contraceptives, tranquilizers, stimulants, statins, and Viagra. All of these drugs have been popular, profitable, influential, and controversial, and the authors take a historical approach to studying their development, prescription, and consumption. This perspective locates the histories of prescription medicines in specific cultural contexts while revealing the extent to which contemporary debates about pharmaceutical drugs echo concerns voiced by Americans in the past.

Exploring the rich and multi-faceted history of pharmaceutical drugs in the United States, Medicating Modern America unveils the untold stories behind America's pharmaceutical obsession.

Contributors include: Robert Bud, Jennifer R. Fishman, Jeremy A. Greene, David Healy, Suzanne White Junod, Ilina Singh, Andrea Tone, and Elizabeth Siegel Watkins.

Frequently asked questions

How do I cancel my subscription?
Simply head over to the account section in settings and click on “Cancel Subscription” - it’s as simple as that. After you cancel, your membership will stay active for the remainder of the time you’ve paid for. Learn more here.
Can/how do I download books?
At the moment all of our mobile-responsive ePub books are available to download via the app. Most of our PDFs are also available to download and we're working on making the final remaining ones downloadable now. Learn more here.
What is the difference between the pricing plans?
Both plans give you full access to the library and all of Perlego’s features. The only differences are the price and subscription period: With the annual plan you’ll save around 30% compared to 12 months on the monthly plan.
What is Perlego?
We are an online textbook subscription service, where you can get access to an entire online library for less than the price of a single book per month. With over 1 million books across 1000+ topics, we’ve got you covered! Learn more here.
Do you support text-to-speech?
Look out for the read-aloud symbol on your next book to see if you can listen to it. The read-aloud tool reads text aloud for you, highlighting the text as it is being read. You can pause it, speed it up and slow it down. Learn more here.
Is Medicating Modern America an online PDF/ePUB?
Yes, you can access Medicating Modern America by Andrea Tone, Elizabeth Siegel Watkins in PDF and/or ePUB format, as well as other popular books in Storia & Storia della scienza. We have over one million books available in our catalogue for you to explore.

Information

Publisher
NYU Press
Year
2007
ISBN
9780814783474
Part II

4

ORAL CONTRACEPTIVES

Women over 35 Who Smoke
A Case Study in
Risk Management and Risk Communications, 1960–1989
Suzanne White Junod
Much has been written about the history of the development, approval, and the subsequent revolutionary social and medical aspects of the oral contraceptives, or “the Pill” as it is known colloquially, in recent years.1 Extensive knowledge about the history of the Pill’s approval and scientific understanding of its pharmacological properties and physiological effects, however, do not yet seem to balance out lingering suspicions about the overall safety of the oral contraceptives (OCs). This cloud of suspicion, it can be argued, is a direct result, at least in part, of the controversial and often contradictory early communications about the risks and benefits of the OCs.
The trials and tribulations surrounding the initial regulation of this class of drugs, in fact, can largely be attributed to the unique challenges posed, not so much by the oral contraceptives themselves, but by the need to understand and communicate new and emerging knowledge concerning specific risks and risk factors to a huge and growing population of women taking oral contraceptives. While precedents for such an effort were virtually nonexistent, the efforts required were unprecedented.2 Regulators spoke about a drug whose overall risk/benefit profile was favorable and kept it on the market, but women watched the evening news which detailed seemingly contradictory information about the safety of this drug.3 Much had to be learned about how to effectively communicate risk/benefit information to consumers as deeper knowledge of both the risks and the benefits of the oral contraceptives began to emerge from large-scale epidemiological studies—studies that had not been envisioned, much less launched, prior to FDA’s approval of the first oral contraceptive, Enovid, in 1960. This chapter comprises a case study on the communication of drug risks to consumers in light of evolving knowledge about the oral contraceptives and in the context of the regulatory and administrative maturation of FDA as an institution.4
Important and lasting changes took place in the Food and Drug Administration as an institution during this period, transforming FDA from an underfunded and relatively obscure old-line government agency into a prominent and modern scientific regulatory agency.5 Changes in FDA during these critical years of transition have been characterized as a shift in priorities from what have been described as enforcement or “cop” activities into a broader regulatory framework encompassing product safety.6 Although the new framework necessitated more and better scientific expertise obtained both from within the agency as well as outside of it, it was also accompanied by a more publicly recognized role for the agency in assuring product safety.7
FDA often, during these years, confronted full-blown and emotionally charged consumer crises, rather than being subjected to sober scientific questioning about product safety issues. Unlike, for example, the headline grabbing, but relatively short-lived crises over cranberries, saccharin, cyclamate, and Red #2 that also took place during this period—crises that seemed to erupt and then achieve some kind of resolution and fade from media coverage—consumer concerns about the safety of the oral contraceptives became a recurrent media issue that must have, from the anxious consumers’ viewpoint, never seemed fully resolved.8 On the other hand, this very lack of resolution gave modern consumers their first exposure to the concept that drugs are not merely “safe” or “unsafe,” but that they have benefits that may be offset by particular risks. Meanwhile, although FDA generally met the challenges recurrently posed by new questions concerning the safety of the oral contraceptives competently and with due diligence, given the changing times and circumstances of the agency and the era, FDA was on a learning curve regarding how to best communicate risk/benefit information via the media. FDA, in short, had to learn how to respond to risk/benefit issues, not so much in an entirely new way, but in a way that acknowledged the evolving nature of medical information, especially in what would eventually be formally christened the “post-marketing” phase of drug approval.
The first oral contraceptive, Enovid, by G.D. Searle, was approved by FDA in 1960, after extensive use as a hormonal treatment for menstrual irregularities beginning in 1958.9 Although its approval was controversial, it met or exceeded the effectiveness specifications for other family planning products: it was less risky than the known risks posed by pregnancy, and it was much more effective than alternatives including the condom and the diaphragm.10
The first death reportedly associated with Enovid was that of a British woman, published in The Lancet in 1961.11 This early news, however, was almost obscured by the alarming discovery that a drug available in Europe to pregnant women, thalidomide, had caused a virtual epidemic of birth defects. Although FDA had not approved the drug for marketing in the United States, Congress acted to enact the Kefauver-Harris amendments which provided, among other provisions, for the pre-market approval of future new drugs for both safety and efficacy.12 Within months of the first report in Britain, the first fatal cases of thrombosis associated with the Pill had been reported among American women.13 On May 21, 1962, FDA notified G.D. Searle that it needed to provide full information to the medical profession regarding a growing incidence of reports of serious and even fatal thromboembolisms associated with young women taking Enovid. Commissioner Larrick, apprised of these early serious health concerns, acted to appoint an ad hoc advisory committee of medical experts outside FDA to consider the evidence and make recommendations to FDA.14 Advisory committees were a particular favorite of the Eisenhower administration and such ad hoc advisory committees were short-term, single issue committees, usually appointed by Congress, but in this case, convened by FDA itself in response to concerns about the safety of the oral contraceptives. In the August 4, 1962 issue of the British Medical Journal, the Medical Advisory Council to Britain’s Family Planning Association published an advisory opening with the statement “the long-term effects of oral contraceptives cannot be entirely predicted,” and reiterating that in their family planning clinics, oral contraceptives would be used as an “alternative” method of contraception in order that they could monitor long-term effects.15 Reporters for the Washington Star and Post and the New York Times picked up on this warning prompting Commissioner Lar-rick to make public the results of FDA’s own ad hoc committee recommendations on the same day, August 4, 1962. Although the committee determined that Enovid should remain available through doctors by prescription, Larrick noted that he had requested that Searle change its labeling to advise physicians only of “an apparent hazard in women over 35.”16 Meanwhile, all three reporters expressed healthy skepticism at the early, but admittedly alarming reports, but questioned what the standard of proof might be, in light of the recently discovered birth defects associated with the hypnotic drug thalidomide when taken during pregnancy.17
The final report of the committee was not issued until September 12, 1963. Noting that there were now 1.5 million women using oral contraceptives in the United States, the committee strongly recommended a “carefully planned and controlled prospective study” to gain more information on the reported risks.18 In the meantime, the committee found that data did not support any increased risk for women over 35, so FDA announced that Searle would be able to note in its new labeling that this reported risk was not “statistically significant.”19
In response to continuing and growing concerns about the safety of the Pill, FDA established its first permanent advisory committee in 1965, the Obstetrics and Gynecology Advisory Committee.20 Charged with the review of contraceptive products and “to find out what effect, if any, oral contraceptives had on blood clotting,” as well as to examine “the Pill’s potential to cause cancer of the breast, cervix, and endometrium,” the Advisory Committee sought to address the concerns of women’s groups who charged that the agency was not taking documented evidence seriously enough. The Advisory Committee also allowed FDA to involve experienced outside physicians and researchers in the deliberative process.
The Committee’s first meetings in November 1965 were held at FDA’s Bureau of Medicine.21 The committee concluded, as had the previous ad hoc advisory committee, that there was no need for immediate action to remove OCs from the market, but echoed concerns voiced by a World Health Organization scientific group that, like FDA, was not only concerned about the reported side effects, but about the lack of scientific data to assess them. There was early agreement on the need for a large, case control study on the relationship between oral contraceptives and blood clotting.22 Although the committee’s controversial conclusion that it had found no “adequate scientific data, at this time, to prove the pill unsafe [emphasis added] for human use,” did not fully resolve the concerns of many women and physicians, the groundwork had already been laid for studies that would more definitively study OC risks and circulatory problems.23
Rather than remove oral contraceptives from the market, FDA drew upon more traditional regulatory strengths: its control over product labeling. FDA had exercised its steadily broadening control over product labeling in creative ways, beginning with the 1906 Pure Food and Drugs Act which originally provided that drugs with any of 11 dangerous ingredients had to list them on the label and ruled that labeling in general on food and drug products was not to be “false or misleading in any particular.”24 There was a fierce fight over where to place drug advertising controls prior to passage of the 1938 Food, Drug, and Cosmetic Act. The Federal Trade Commission (FTC) was given some “cease and desist” authority essentially bifurcating regulatory authority in the field, but the courts upheld and even extended FDA’s control over labeling in the years that followed, defining it to include literature, placards, even books that accompany regulated products.25 The new 1962 Drug Amendments transferred the regulation of prescription drug advertising from FTC to FDA and required that such advertising include information on contraindications and adverse effects.26 The law’s better known provisions required drug manufacturers to show, pre-market, the safety and efficacy of the drug for its intended use, based on scientifically conducted, adequately controlled clinical trials. Finally, the new law charged FDA with reevaluating the effectiveness of drugs marketed between 1938 and 1962 that had been solely evaluated on the basis of safety alone. FDA contracted with the National Academy of Sciences/National Research Council to review the New Drug Applications (NDAs) and FDA reevaluated them under its DESI program (Drug Efficacy Study Implementation).27 Finally, the new law provided some of the first patient protection policies, including a provision requiring investigators to obtain “written consent” from patients given experimental drugs. Inasmuch as the oral contraceptives changed the relationship between many women and their doctors, the changes wrought by the Drug Amendments of 1962 upset, in several ways, the FDA’s traditional relationship with physicians. Many physicians resented FDA’s second guessing of the drugs they had available, of the presumption that they would not adequately advise their patients, and the meaning behind “written consent.” Under regulation, manufacturers were required to provide a package insert with all drugs for the physician to use in advising patients.
FDA’s experience using these new drug authorities was limited at the time officials learned of the rare, but sometimes fatal thromboembolisms potentially associated with use of the OCs. Traditionally, FDA had employed its control over product labeling to make physicians aware of serious drug side effects, relying on them, in turn, to adequately counsel their patients. Utilizing the agency’s labeling authority in conjunction with the regulations requiring package inserts, FDA published a policy concerning the “promotional labeling” of oral contraceptives in September 1967.28 If the contraceptive pack...

Table of contents