Human Subject: An Investigational Memoir

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19. Uncovered

“Il y a bien longtemps que l'on dit et que l'on répète que les médecins physiologistes les plus savants sont les plus mauvais médecins et qu'ils sont les plus embarrassés quand il faut agir au lit du malade.

My main reason for seeking care in an experimental setting was that I no longer had access to good, low-cost health care. With 50 million uninsured people in the U.S., I thought that surely there would be many others using this source of free medical care. To my surprise, there seemed to be very little official acknowledgement of such a trend.

In a survey of oncology and cardiology patients conducted about 10 years ago, only 11 percent of respondents who were undergoing experimental treatment chose “Best way to pay for treatment” as a major factor in their decision to participate. About the same proportion (12 percent) of the total number interviewed were uninsured; it’s possible that these people were heavily represented among those who were in it for the money, although this correlation was not tested. The reasons cited most often were purely altruistic: helping others and advancing medical science. Of course these were mainly older people, who are likely to have Medicare coverage and who are stereotypically more generous than the spoiled younger generations. (Sugarman et al., 1998)

In a study designed to find out whether people from ethnic minorities are less willing to enroll in biomedical studies, the researchers found very little difference between the willingness of minorities (mostly African-American and Hispanic) and non-Hispanic whites to participate in research. (Wendler et al., 2006) The authors don’t even mention the insurance issue, but it seems likely that any cultural or sociological reasons for not participating in research may be balanced by desperation: African-Americans and Hispanics are the least likely to be insured. According to a 2006 report by the Commonwealth Fund, 62 percent of 19- to 64-year-old Hispanic adults in the United States were uninsured at some point in 2005; the rate was even higher for low-income Hispanics. During that same period, one-third of working-age African Americans were uninsured or had a gap in coverage. “Only” 20 percent of working-age whites were uninsured. (Doty & Holmgren, 2006)

I found a couple of Web sites where providers of social services or health care were suggesting to their low-income clients that volunteering as a research subject was a way to get free medical care. Also, JAMA has a Patient Page on their Web site that says, “By participating in a research study, you may receive free medical care and laboratory studies as well as receive treatments that may possibly prove beneficial before they are offered to others.” But many IRBs and ethics committees instruct researchers to refrain from making promises of free medical treatment, and consent forms often explicitly state that no free medical care will be provided.

So it seems that there’s a perpetual battle between those, on the one hand, who earnestly insist that research participation is no substitute for health care and those, on the other two hands, who want the uninsured to know about this alternative health-care delivery method, either for the subjects’ own benefit or as an inducement to contribute to generalizable knowledge.

Then there are the clinical trials (usually in cancer research) that require patients to pay some or all of the treatment costs. Researchers in those studies tell prospective subjects that their insurance plan may cover the costs. Since 2000, Medicare has paid for most costs of experimental treatment, and a growing number of states are requiring insurers to pay for routine care received as part of a clinical trial. But most insurers won’t pay for treatments that are considered experimental.

Anyone who’s done time as a hospital patient knows that the costs can add up quickly, and, as a 2004 Wall Street Journal article revealed, uninsured patients frequently get charged many times what government and private health plans pay. An uninsured man paid $29,500 for a 21-hour hospital stay; Medicaid would have paid $6,000 for the same overnight stay. With the charges for physician services and ambulance, the total billed amount was nearly $40,000. (Lagnado, 2004)

Some of the charges that show up on hospital bills make the Pentagon’s deals with defense contractors look like blue-light specials at Kmart. The WSJ article found that the uninsured patient was charged more than five times the list price for some supplies and more than six times the Medicaid charge for the doctor’s services. Then there are the stories about people being charged up to $129 for a “disposable mucous recovery system,” i.e., a box of tissues (Davidson, 2004), or $15 for “thermal therapy,” i.e., a bag of ice. Even if these stories are exaggerated—or completely fabricated—it’s clear that people without public or private health insurance are pretty much disqualified from any clinical trial that requires cost-sharing by participants.

The medical insurance I had through my ex-to-be was bad, but the dental coverage was abysmal. So I was pleased one day to see a flier recruiting patients for the dental licensing exam.

I emailed Lily, the student who had posted the flier. She called and explained that she needed two types of teeth for the exam: (1) ones with a particular kind of cavity to fill and (2) ones that need a lot of cleaning. I doubted whether my teeth would meet either of those criteria, but I made an appointment to be evaluated.

Another student actually did the evaluation. She told me that, with the licensing exam just two weeks away, she and Lily were getting desperate for patients. Fortunately they had the dirty-teeth requirement covered, so now they just needed some tooth decay. Unfortunately she didn’t find any on the X-rays she took of my mouth. I felt bad about letting them down, but the student seemed genuinely happy to discover that my teeth were healthy. Or maybe she just hid her disappointment well.

Dental licensing exams are a source of controversy on many levels. First there are the competing and overlapping examining boards centered in different regions of the country. Some states accept more than one exam, and some accept parts of some exams. The American Dental Association advocates for a single, national exam, but the American Dental Education Association supports the existence of multiple examining agencies, with states accepting all results.

Another topic hotly debated among dentists and their examiners is whether there’s a need to use human subjects, or “live patients” (as opposed to cadavers, I guess), in licensure exams. In 2000 the ADA passed a resolution calling for the use of human subjects to be phased out by 2005. The American Association of Dental Examiners struck back with a position statement that refuted the notion that technological means could substitute for live patients by 2005. They also disagreed with those who say that having students perform procedures on a human being constitutes a barbaric form of human experimentation. Citing the years of training that the students have had, the writers state: “To classify these individuals as barbarians is unjust and does a tremendous disservice to the educational process.” “The time may come,” the statement concludes, “as technology evolves, when clinical simulation utilizing a new generation of manikins and other computer based methodologies will provide a viable alternative to the use of patients in licensure examinations. The dental and dental hygiene licensing community does not believe that time has arrived, and that no mandates can alter that fact.” (American Association of Dental Examiners, 2001)

In 2005 the ADA stubbornly reaffirmed its support for elimination of human subjects. The debate continues, with much of it framed as an ethical issue. Even though this isn’t research, opponents of using live patients talk about issues like informed consent, privacy, and autonomy. And then there are the students, who resent having to scrounge up patients. One dentist wrote of recruiting street people, bribing them with pizza, and keeping them in his apartment overnight so that he could bring them to the examination site. (Curtis, 2006).

A couple of months after failing to qualify for free dental care, I bit the bullet, so to speak, and made an appointment with an actual dentist. She told me, on the basis of a new set of X-rays (I’d forgotten to bring in the ones from the dental school), that I had a cavity that needed filling. She also told me, when I asked why some people’s teeth are more sensitive to cold and pain than other people’s, that some people just have a lower pain threshold, i.e., some people are just wimps. After getting my alleged cavity filled (and after doing enough research to conclude that increased sensitivity to pain can actually have a physical basis), I found a different dentist.

As my human-subjects research was winding down, Michael Moore’s documentary Sicko began playing in theaters. In the first few minutes of the film he describes the plight of the 50 million Americans with no health insurance, but thereafter he astutely concentrates on the larger group of Americans who think they have adequate health coverage—until they need it. His interviews with current and former employees of HMOs and insurance companies reveal an unsurprising, but nonetheless troubling, pattern in which businesses make every possible effort to avoid paying for treatments.

The climactic sequence of the film begins when Moore assembles a group of people whose medical problems have not been adequately addressed (and in some cases have been exacerbated) by the care available to them. Some of these people’s illnesses and injuries can be traced to the volunteer work they did at Ground Zero after Sept. 11, 2001; their health needs have been neglected by both the government and their insurance providers. Moore takes these sick and broken people to Cuba, where they receive attentive, skilled, and mostly free medical care.

I won’t tackle the controversial aspects of the film, which include the circumstances of the Cuba trip. There are plenty of other writers willing either to extol Moore or to take him to task. Instead, what interests me in this story is the fact that all the ailing participants can be looked on as human subjects. One could argue that their experience was meant to develop some generalizable knowledge about comparative health care. Additionally, each subject had to weigh the risks and benefits of participating in the film.

Foremost among the risks was the dicey matter of flouting the U.S. ban on travel to Cuba. Supposedly Moore had sought permission under an exemption available to journalists, but it’s unclear whether the permission was granted, and it wouldn’t have extended to his human subjects anyway. The film doesn’t reveal how they actually got there, but presumably they all ran the risk of being detained by U.S. authorities. And once they arrived, neither the PI (Moore) nor the subjects knew for sure how they would be treated or if they would get proper medical care.

On top of the direct risks of participation, each subject had to consider the pros and cons of becoming a minor celebrity. Judging by the crowds that compete to appear on all manner of unscripted TV shows, it would seem that achieving stardom is every American’s dream. So it’s a good thing that Michael Moore isn’t on the faculty of a research institution. Any IRB would have required that the subjects be given code names and that they appear in the film with their faces blurred and voices altered, thus making them inaccessible to talent scouts and talk show producers.

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