Healthy Skepticism Library item: 202

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Publication type: news

De Vries, R .
Buying ethics
The Guardian Weekly 2004 Feb 19

Full text:

‘Drugs companies and physicians should not wield the bioethics label to serve their own interests’ Three decades ago bioethicists entered the worlds of medicine and the life sciences, offering to help clarify and answer vexing moral questions.Today bioethicists are part of the landscape: They sit on government commissions, issuing judgments about what is morally right and wrong, and walk hospital corridors, sorting out ethical quandaries. But while most bioethicists are no doubt well-intentioned, their work is sometimes used as cover, allowing corporate conundrums to masquerade as ethical problems, often with solutions that serve corporate interests.

Consider the case of Eli Lilly and its drug Xigris. Lilly has a marketing problem: After spending nearly two decades of research and hundreds of millions of dollars to develop Xigris – a drug to treat severe sepsis – the company has been disappointed by sales.

Lilly expected the drug, which the FDA approved in 2001, to be a blockbuster: Some analysts expected sales to reach $1 billion a year.

Instead, sales for 2003 were just over $160 million. Physicians have been slow to prescribe the drug because of questions about its cost – $6,800 per dose – and its efficacy. A review of the risks and benefits of activated protein C, the generic name for Xigris, in the New England Journal of Medicine concluded in 2002 that “Although the data regarding [it] are very encouraging . . . there is not sufficient evidence at present for it to become the standard of care.”

Lilly’s response? It reframed its marketing problem as an ethical problem.

In October 2002, Lilly created the “Values, Ethics & Rationing in Critical Care Task Force” (VERICC) with a $1.8 million grant. According to the Wall Street Journal, Lilly’s strategy was based in part on a survey, conducted by a physician who is a consultant for the company, that suggested that hospital physicians were not prescribing Xigris because insurance companies were reimbursing the hospitals far less than the cost of the drug.

VERICC, according to its Web site, is “an independent, multidisciplinary research initiative dedicated to the study of Intensive Care Unit (ICU) rationing practices, attitudes and behaviors among U.S. critical care physicians, nurses and hospital administrators.”

What better way to respond to caregiver concerns about cost and efficacy than to label their unwillingness to use a drug as unethical? The task force, which has yet to publish any findings, says it will question all rationing practices. But will its view be unbiased? It not so subtly promotes Lilly’s interests by referring to protein C as a “life-saving medication ranking high on the ‘to-be-rationed’ list.”

This is not the first time that Lilly has turned to bioethics for help. In late 1996 the company faced a serious public image problem when the Wall Street Journal reported that it was routinely using homeless alcoholics as “healthy volunteers” for Phase I trials of new drugs – trials designed to test a new drug’s toxicity. The article made the company look both unscientific (tests for toxicity can be compromised by livers that have processed too much alcohol) and cheap (Lilly was reported to pay subjects the lowest per diem rate in the industry).

The company’s first response was to deny the problem, claiming that 94 percent of its healthy volunteers reported a residential address. Lilly then moved to undermine the criticism by changing the grounds on which its behavior was evaluated. The company 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.

In an article published in the Journal of Medicine and Philosophy, the bioethicists on Lilly’s team described the homeless volunteers as research subjects facing “exclusion” or “inclusion” from the drug trial, liable to “intentional” or “nonintentional coercion,” who should be offered a “multi-staged arrangement of disclosure, dialogue, and permission-giving.”

With this decidedly more abstract take on the problem, 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.”

There is some disagreement among bioethicists on this point, but many would say that the conditions under which these subjects live, and their desperation, make it all but impossible for them to offer bona fide consent, an ethical logic routinely applied to prisoners, who are excluded from most research. In the end, Lilly got what it paid for: bioethicists agreeing that it is okay to test drugs on the homeless.

Physicians have also sought refuge in bioethics in an attempt to justify self-interested practice. Consider the recent pronouncement on “voluntary cesarean section” by the American College of Obstetricians and Gynecologists (ACOG) when it faced the question: Should an obstetrician agree to a mother’s request to deliver a baby by C-section if there is no medical reason for the surgery?

The United States has one of the world’s highest rates of births by C-section. In 2002, more than 25 percent of babies born here were delivered surgically. Nearly all other industrialized nations have cesarean rates between 12 and 18 percent.

The rate of surgical birth in the United States is high for many reasons, including, ACOG says, because an increasing number of women are simply seeking to avoid vaginal delivery “in the belief that the surgery will prevent future pelvic support or sexual dysfunction problems, or for other reasons.”

These fears are largely unfounded. In fact, recent evidence-based guidelines developed by Britain’s National Health Service suggest that it is surgical 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.

What should a physician do when a woman requests unnecessary surgery? ACOG referred this medical question not to its committee on obstetric practice, but to its committee on ethics, transforming a decision that should be driven by data into one with no “right” answer.

The 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 physician’s understanding of the procedure’s risks and benefits. In the case of an elective cesarean delivery, if the 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 cesarean delivery.”

Coincidentally, ACOG’s pronouncement gives physicians the freedom to use a procedure that is in their best interest: Voluntary C-sections allow doctors to better schedule their hours in the clinic, and they are reimbursed at a higher rate than for vaginal births.

The impetus behind bioethics is a good one. But today, when the ethics label is wielded in the service of political and economic interests, bioethics is increasing the distance between caregivers and the wisdom needed to heal. As Carl Elliott, a philosopher at the Center for Bioethics at the University of Minnesota, has concluded, “If this is where American bioethics is heading, it is time to get off the train.”

Can bioethics be fixed? If bioethicists want to recover their original mission, they must understand the ways in which their field and their ideas are being used and whose interests are being protected by their ethical judgments. In doing so, they can prevent their field being used to separate wisdom from healing.