• Le Dalkon Shield

    In 1970, the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Hugh J. Davis, M.D. The Dalkon Corporation had only four shareholders: the inventors Davis and Irwin Lerner,[1] their attorney Robert Cohn, and Thad J. Earl, M.D., a medical practitioner in Defiance, Ohio. In 1971, Dalkon Shield went into the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign. At its peak, about 2.8 million women used the Dalkon Shield in the U.S.

    At the time of its introduction, the Dalkon Shield was promoted as a safer alternative compared to birth control pills, which at the time were the subject of many safety concerns.[1] Initial reports in the medical literature raised questions about whether its efficacy in preventing pregnancy and expulsion rate were as good as those claimed by the manufacturer, but failed to detect the tendency of the device to cause septic abortion and other severe infections.[2]

    In June 1973, the Centers for Disease Control and Prevention (CDC) conducted a survey of 34,544 physicians with practices in gynecology or obstetrics regarding women who had been hospitalized or had died with complications related to the use of an IUD in the previous 6 months. A total of 16,994 physicians responded, yielding 3,502 unique case reports of women hospitalized in the first 6 months of 1973. Based on the survey response rate, the CDC estimated that a total of 7,900 IUD related hospitalizations occurred during this 6-month period. Based on an estimate of 3.2 million IUD users, the CDC estimated an annual device-related hospitalization rate of 5 per 1000 IUD users. The survey also provided 5 reports of device-related fatalities, with four of these related to severe infection. One of the five was associated with the Dalkon Shield. Based on these data, the CDC estimated an IUD-related fatality rate of 3 per million users per year of use, which it compared favorably to the mortality risks associated with pregnancy and other forms of contraception. Importantly, the survey showed that the Dalkon Shield was associated with an increased rate of pregnancy-associated complications leading to hospitalization.[3]

    By 1974, approximately 2.5 million women had received the Dalkon intrauterine device. In June of that year, the medical director of A.H. Robins published a letter to the editor of the British Medical Journal stating that the company was aware of an “apparent increase in the number of cases of septic abortions” including 4 fatalities, but stating that “there is no evidence of a direct cause-and-effect relationship between wearing of the Dalkon Shield and the occurrence of septicemia”. The letter recommended precautions including pregnancy tests for women who missed their period and immediate removal of the device in women who were found to be pregnant.[4] In October 1974, a series of four case reports of septic pregnancies was published in the journal Obstretics and Gynecology".[5] In 1975, the CDC published a study associating the Dalkon Shield with a higher risk of spontaneous abortion-related death compared to other IUDs.[6]

    As many as 200,000 women made claims against the A.H. Robins company, mostly related to claims associated with pelvic inflammatory disease and loss of fertility. The company eventually filed for bankruptcy. The company’s representatives argued that pelvic infections have a wide variety of causes, and that the Dalkon Shield was no more dangerous than other forms of birth control. Lawyers for the plaintiffs argued that the women they represented would be healthy and fertile today if not for the device. Scientists from the CDC stated that both arguments have merit.[7]

    Aftermath

    More than 300,000 lawsuits were filed against the A.H. Robins Company – the largest tort liability case since asbestos. The federal judge, Miles W. Lord, attracted public commentary for his judgments, impositions of personal liability, and public rebukes of the company heads.[8] The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in 1985. As a result, Robins sold the company to American Home Products (now Wyeth).[citation needed]

    In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act mandated the U. S. Food and Drug Administration, for the first time, to require testing and approval of “medical devices”, including IUDs.[citation needed]

    The Dalkon Shield became infamous for its serious design flaw: a porous, multifilament string upon which bacteria could travel into the uterus of users, leading to sepsis, injury, miscarriage, and death. Modern Intrauterine devices (IUDs) use monofilament strings, which do not pose this grave risk to users.

    https://en.wikipedia.org/wiki/Dalkon_Shield

    –—
    https://www.wired.com/2011/07/ff_iud

  • Neal Stephenson : Innovation Starvation | WIRED
    https://www.wired.com/2011/10/stephenson-innovation-starvation

    par Neil Stephenson

    Still, I worry that our inability to match the achievements of the 1960s space program might be symptomatic of a general failure of our society to get big things done. My parents and grandparents witnessed the creation of the airplane, the automobile, nuclear energy, and the computer to name only a few. Scientists and engineers who came of age during the first half of the 20th century could look forward to building things that would solve age-old problems, transform the landscape, build the economy, and provide jobs for the burgeoning middle class that was the basis for our stable democracy.

    The Deepwater Horizon oil spill of 2010 crystallized my feeling that we have lost our ability to get important things done. The OPEC oil shock was in 1973 — almost 40 years ago. It was obvious then that it was crazy for the United States to let itself be held economic hostage to the kinds of countries where oil was being produced. It led to Jimmy Carter’s proposal for the development of an enormous synthetic fuels industry on American soil. Whatever one might think of the merits of the Carter presidency or of this particular proposal, it was, at least, a serious effort to come to grips with the problem.

    The audience at Future Tense was more confident than I that science fiction [SF] had relevance — even utility — in addressing the problem.

    I heard two theories as to why:

    The Inspiration Theory. SF inspires people to choose science and engineering as careers. This much is undoubtedly true, and somewhat obvious.
    The Hieroglyph Theory. Good SF supplies a plausible, fully thought-out picture of an alternate reality in which some sort of compelling innovation has taken place. A good SF universe has a coherence and internal logic that makes sense to scientists and engineers. Examples include Isaac Asimov’s robots, Robert Heinlein’s rocket ships, and William Gibson’s cyberspace. As Jim Karkanias of Microsoft Research puts it, such icons serve as hieroglyphs — simple, recognizable symbols on whose significance everyone agrees.

    Today’s belief in ineluctable certainty is the true innovation-killer of our age. In this environment, the best an audacious manager can do is to develop small improvements to existing systems — climbing the hill, as it were, toward a local maximum, trimming fat, eking out the occasional tiny innovation — like city planners painting bicycle lanes on the streets as a gesture toward solving our energy problems. Any strategy that involves crossing a valley — accepting short-term losses to reach a higher hill in the distance — will soon be brought to a halt by the demands of a system that celebrates short-term gains and tolerates stagnation, but condemns anything else as failure. In short, a world where big stuff can never get done.

    #Science_fiction #Innovation #Neil_Stephenson