Friday, July 18, 2008

Dickens Meets the Drug Industry

Guinea pig photo by Flickr user Johan Larsson, used under a Creative Commons license.

In keeping with my policy of never scooping any real journalists, I want to say a few words about a commentary that appeared several weeks ago in the New England Journal of Medicine. Carl Elliott and Roberto Abadie reported in the NEJM that participants in Phase I clinical trials – the earliest tests of drugs in human subjects – amount to an exploited research underclass.

Over roughly the past decade, Elliott and Abadie write, pharmaceutical companies have begun routinely outsourcing these riskiest of trials. Private entities pay subjects to take part in trials, outside of the traditional university setting where oversight was less likely to be tainted by conflicts of interests:
Payment to subjects has escalated, creating "shadow economies" in cities throughout North America and elsewhere. In 2005, Bloomberg Markets reported that SFBC International, a contract research organization, was paying immigrants to participate in drug trials under ethically questionable conditions in a dilapidated Miami motel. A few months later, nine apparently previously healthy subjects at an SFBC subsidiary in Montreal contracted latent tuberculosis during a trial of an immunosuppressant. In 2006, six healthy subjects required intensive care in a phase 1 trial of a monoclonal antibody at a London facility run by the contract research organization Parexel.

(Source: NEJM)
Elliott and Abadie ask whether it’s ever ethical to pay research subjects to assume incalculable but potentially life-threatening risks. They argues it’s not, because the subjects will be drawn disproportionately from the very poor, who can earn more as perpetual guinea pigs. And this has three ramifications that make such payment unethical, in their accounting, which I think is spot on:
First, poor people are less likely than wealthier ones to get access to the drugs in question, if and when they are approved. Volunteers are unlikely to have full-time employment or, therefore, to have health insurance. ...

Second, the U.S. oversight system is not well equipped to monitor a highly competitive, market-based, multinational research industry. The Office for Human Research Protections has no jurisdiction over privately sponsored studies, and the Food and Drug Administration inspects only about 1% of clinical trials. ...

Third, even though the purpose of phase 1 trials is to test whether new drugs are safe, most sponsors apparently do not provide free care or treatment for subjects who are injured in these trials. In fact, no agency is even tracking injuries in phase 1 trials, much less the long-term health of people who volunteer for many trials over a period of years. A recent study commissioned by the Department of Health and Human Services showed that only 16% of academic health centers provide injured subjects with free care. None compensate injured subjects for pain and suffering or lost wages. Although no comparable data are available for private research sponsors, there is little reason to believe that private sponsors are much more generous; indeed, many include disclaimers in their consent forms indicating that subjects retain responsibility for their own medical care. ...

Sponsors call subjects' payments "compensation" to suggest that they are merely reimbursing participants for expenses and inconvenience, even as they fill studies with unemployed people who depend on trial income to make ends meet. They refer to paid subjects as "volunteers," implying that participation is a freely chosen act of altruism, whereas most subjects indicate that they take part in trials for the money. Regulators allow sponsors to use money to attract subjects but do not require them to provide the kinds of benefits that subjects would demand if they had more power. The result is what one Philadelphia trial subject describes as "a mild torture economy." "You are not being paid to do something," he explains. "You are being paid to endure."

(Source: NEJM)
I’m not especially shocked that this happens, only that it continues today and appears to be getting worse, not better. My own research on women’s experiences of childbirth is largely a story of poor women trading their most basic freedoms to get the most basic care.

An unmarried woman pregnant woman typically lost her job and often her lodgings as well. Her only option, before the advent of maternity homes, was often to seek shelter in a hospital. As obstetrics became more scientific and professionalized, guess who was used as research and teaching subjects?

These were the women who first tested new forms of anesthesia for labor. They were exposed to an auditorium full of male med students while in labor. They had to suffer multiple repeat pelvic exams conducted by the same bumbling students – an experience that must have been akin to rape, for they had signed away their right to say no upon admission.

The full story of these women is too long to tell here. Still, the similarities to today’s research “volunteers” are striking. These women had a choice, too. They could have given birth on a street corner or homeless shelter, and a few did. They could have maintained their independence as prostitutes, and some did. They could have tried to abort the pregnancy, and countless millions did.

So yes, there’s always a “choice.” It’s just that if you’re poor, all your choices may be horrible. And as the economy continues to sour, we can expect the number of “volunteers” to swell. More people will see no better alternative to “being paid to endure.”

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