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With the medical industrial complex expanding rapidly this is something that should concern us. Already U.S. health expenditures are the size of France's entire economy. Canada’s health bill recently reached a tenth of the economy. Around the world medicine is seen as an "economy of the future." This expansion means a lot of money to some big companies. Similarly a lot of doctors and scientists have economic and status stakes in this medical expansion. Yet who does the consumer -- often allowing her/his body to be "worked on" -- have to rely on for protection? Bioethics. (There is also individual decision making, though this is complicated by the power society defers to the medical establishment and the medical establishment’s control over medical knowledge. Government can also play a role, however, rarely do they perceive it in their best interest to regulate (high-status) doctors or scientists.) Yet can bioethics be trusted to keep the medical industrial complex in line? Probably not considering how reliant bioethicists are on the medical industrial complex for funding. Carl Elliot, author of Better Than Well, writes “bioethicists at the University of Toronto take funding from GlaxoSmithKline, Pfizer and Merck to write editorials on bringing biotechnology to the developing world . . . the University of Chicago’s MacLean Center for Clinical Medical Ethics co-sponsored a recent conference with Pfizer, Merck and PhARMA, the pharmaceutical industry trade organization, on inequities in American health care. . . bioethicists at the University of Pennsylvania take money from Pfizer to write an article explaining why physicians should not accept gifts from companies like Pfizer. We may take industry money, bioethicists argue, but we’re not industry stooges. We’re doing God’s work.” (Ottawa Citizen, Jan 2, 2004) It appears, however, that their function within the medical industrial complex is less than holy. After the approval of the drug Xigris in 2001, the drug’s manufacturer Ely Lily became disappointed with sales of a drug it expected to be a blockbuster (1$ billion in annual sales). Xigris is extremely expensive and evidence of its efficacy inconclusive. Hospital doctors “concerned that insurance companies were reimbursing the hospitals far less than the cost of the drug,” rightfully hesitated to prescribe it. (Guardian Weekly, Feb. 19, 2004) So “in October 2002 Lilly created the ‘Values, Ethics & Rationing in Critical Care Task Force’ (VERICC) with a $1.8 million grant.” VERICC, according to its Web site, “is an independent, multi disciplinary research initiative dedicated to the study of Intensive Care Unit (ICU) rationing practices, attitudes and behavior among U.S. critical care physicians, nurses and hospital administrators.” As Raymond De Vries asks “what better way to respond to caregiver concerns about cost and efficacy then to label their unwillingness to use a drug as unethical?” (G.W., Feb. 19, 2004) We don’t yet know what VERICC will find although already VERICC refers to protein C - the generic name for Xigris -- as a “life saving medication ranking high on the 'to-be-rationed' list.” Certainly Ely Lily can expect even more for its money than that not so subtle promotion for Xigris once VERICC’s findings are published. Lily seems to be especially fond of using bioethicists when it has troubles. In 1996, “after the Wall Street Journal reported that Lily was routinely using homeless alcoholics as healthy volunteers for Phase 1 trials of new drugs” (G.W., Feb. 19 2004), Lily turned to bioethicists to help its image (The report made Lily appear unscientific since “tests for toxicity can be compromised by livers that have processed too much alcohol” and Lily appeared cheap since they paid “subjects the lowest per diem rate in the industry.”). “The company [Lily] assembled a team of bioethicists drawn from some of the most prestigious American bioethics centers to investigate the ethical issues associated with the use of homeless persons in drug testing.” The bioethicists concluded “it is not unethical or exploitative to use homeless people in phase I studies if the system of subject selection is fair, consents are well informed and bona fide, and the risks are not exceptional for the pharmaceutical industry.” (G.W. Feb. 19, 2004) While this issue is certainly tricky, doesn’t the desperate state of a homeless person make it difficult for them to give bona fide consent? That’s the logic applied to prisoners who are rarely allowed to participate in research. Ultimately Lily got what it wanted from the bioethicists. Questioning bioethics relationship with the pharmaceutical industry more generally, Carl Elliot asks “do bioethicists really want to brand themselves with Pharma? To take only one example: the pharmaceutical sponsors of the University of Pennsylvania Center bioethics and its faculty’s projects are now facing multi million dollar fraud sanctions (AstraZeneca), a Nigerian lawsuit for research abuse (Pfizer), massive class action payouts (Wyeth-Ayerst), a criminal probe into obstruction of justice (Schering Plough), an ongoing fraud lawsuit (Merck and Medco), and allegations of suppressing research data on suicide in children (GlaxoSmithKline).” (Ottawa Citizen Jan 2 2004) Not exactly the most ethical partners. It’s not just the pharmaceutical industry that uses bioethicists for direct self-serving interests. Recently the American College of Obstetricians and Gynecologists (ACOG) sought out a ruling from their bioethics committee on whether an obstetrician should “agree to a mother’s request to deliver a baby by C-section if there is no medical reason for the surgery”. (G.W. Feb. 19, 2004) The reason for the ethics review was that “in 2002, more than 25 percent of babies born here [in the U.S.] were delivered surgically. Nearly all other industrialized nations have cesarean rates between 12 and 18 percent.” (G.W. Feb. 19, 2004) ACOG’s ethics committee concluded: “the decision on whether to perform an elective cesarean delivery … will come down to a number of ethical factors including the patient’s concerns and the physicians understanding of the procedures risks and benefits. In the case of an elective cesarean delivery, if a physician believes that cesarean delivery promotes the overall health and welfare of the woman and her fetus more than does vaginal birth, then he or she is ethically justified in performing a caesarean delivery.” (G.W. Feb. 19, 2004) Sounds nice, however, the problem with the ethics committee’s review is that it should never have taken place. ACOG’s should have had its committee on obstetric practice make the decision based on medical data not its ethics committee where there is no "right" answer. While ACOG claims American women “believe that the [C-section] surgery will prevent future pelvic support or sexual dysfunction problems” the reality is that “recent evidence based guidelines developed by Britain’s National Health Service suggest that it is surgical [not vaginal] birth that is to be feared. The guidelines list a number of problems associated with the procedure, including increased risk of hemorrhage, infection, injuries to the bladder and urinary tract, and reduced fertility.” (G.W. Feb. 19, 2004) Not, “coincidentally, ACOG’s pronouncement gives physicians’ the freedom to use a procedure that is in their best interest: C- sections allow doctors to better schedule their hours in the clinic, and they are reimbursed at a higher rate than for vaginal births.” (G.W. Feb. 19, 2004) Considering its history, the hand-in-glove relationship of bioethics with the medical industrial complex is no great surprise. Contrary to popular conception, bioethics does not have its roots in outside hostility to the direction of the medical scientific community but rather from within the scientific community itself, as a tool to blunt public weariness towards technology and science. According to Tina Stevens in Bioethics in America, “Bioethics caution toward medical and scientific advances grew out of concerns first expressed by the postwar bioscientific community. Among those scientists influenced by the atomic science movement was a small but influential group of international geneticists concerned with what they believed to be a ‘biological revolution’. When the claims and fears of these geneticists became public, some intellectuals in the United States became alarmed. This alarm helped to call forth the growth of bioethics. “Genetic discoveries during the 1950s and 1960s were interpreted by their founders as unprecedented and morally challenging. The geneticists believed that the public must be made aware of their implications. Referencing the Atomic experience in their calls for interdisciplinary scrutiny of biomedical research and development, geneticists followed consciously in the footsteps of the post war ‘responsible science movement’, which had called for greater thoughtfulness about the regulation of atomic power. It was an expanded interpretation of ‘the biological revolution’ that elicited the public response and helped to provoke bioethics into existence. Although the world had been unprepared for the atomic age, it was incumbent upon scientists, geneticists believed, to prepare the world for the biological revolution, especially for its eugenic implications. Should this responsibility be ignored, geneticists would not only be morally culpable but could ultimately lose control over the course of their research as well.” Losing “control over the course of their research” was the motivating factor. As part of the anti-establishment feelings in the late 1960s there was a significant radical current within bioethics that questioned the medical scientific communities direction. However, quickly this bioethics current was either marginalized or co-opted -- through money, prestige, etc. -- into the service of the medical industrial complex’s ascendance. Questions such as "should we do it" were replaced with "how can we do it" (ethically of course). Jon Merz writes about the situation today: “Although research ethics committees are charged with decisions on such important issues, many fail in their role of protecting participants welfare and having sound judgments about risks and benefits. They rarely reject proposed research, often preferring to negotiate methods at the margins to resolve specific ethical problems.” (Lancet, Jan 3, 2004) Rarely are the values underlying the medical industrial complex challenged. Tina Stevens explains: “bioethics was a more issue-specific, technology-by-technology enterprises than historic ambivalence toward technoscientific advance. Bioethicists differed from their radical contemporaries by focusing singularly on the products of biomedicine, thus resisting claims made to larger connections between science and society.” The “preeminent concern” was and is “to come to terms with a new biology and technology.” Rarely are “power imbalances between doctor and patient or between science and society” on the bioethicists’ agenda. Likewise, Stevens writes, “when bioethicists focused on non treatment decisions in neonatal intensive care units, for example, ‘relatively little attention (is) paid to the fact that a disproportionately high number of the extremely premature, very low birth weight infants . . . are born to poor, disadvantaged mothers, many of whom are single nonwhite teenagers’.” Bioethics "reduces social problems to fit within a framework that is utilitarian, positivist, and reductionist.” In a similar vein, Leigh Turner writes “some of the favorite topics of bioethicists seem trivial compared with the important health issues facing people in the world’s poor countries and in impoverished regions in rich countries.” (British Medical Journal, Jan 17, 2004) Why aren’t more bioethicists discussing the ethics of global health inequities? For instance, “the risk of dying from maternal causes in sub Saharan Africa is 1 in 16. In Western Europe it is 1 in 4000.” (Lancet, Jan 3, 2004) Bioethicists could focus their attention on the morality of a world system that allows “500 000 girls and women [to] die every year - 99% in developing countries - from preventable conditions and injuries related to pregnancy and childbirth.” (Lancet, Jan 3, 2004) Certainly there is something unethical about a medical industrial complex that puts loads of money into Botox procedures while half a million women are dying unnecessarily. These questions, unfortunately, seem to be beyond the scope of mainstream bioethics. How ethical is that? Yves Engler recently finished his first book, Playing Left Wing from Hockey to Politics: The Making of a Student Activist. Other Articles by Yves Engler *
The Regime
of Poison
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