- BIOETHICS FORUM ESSAY
DarkCo Petroceuticals, Angelic Solar Panels, and the SUPPORT Study
Published on: September 16, 2015
Published in: Clinical Trials and Human Subjects Research
As the author of the article that claimed “vindication” for the SUPPORT study, I would like to respond to Professor Latham’s insightful interpretation of the issues in the case. Like Professor Latham, I will not discuss whether the researchers exposed patients to risks that the researchers should have known about or adequately disclosed those risks. And, of course, not being a lawyer, I defer completely to his legal expertise. For me to speculate about a law professor’s interpretation of the law would be as inappropriate as, say, law professors speculating about the best way to treat a premature baby. And I certainly do not want to make that error.
But I would like to examine his hypothetical example in order to highlight what it suggests about a common view of researchers and biomedical research. (I recognize, of course, that this is merely a hypothetical example designed to illustrate a point about legal understandings of causality and has nothing, nothing whatsoever, to do with the SUPPORT trial. And so, neither will my example.)
Latham imagines a city, Fair City, in which, like many cities, some citizens get cancer. Then, a petroceutical company, named DarkCo (again, I’m sure, without any moral implications or any suggestion that this has anything to do with the SUPPORT study) dumps a potentially carcinogenic chemical into the water. Not surprisingly, cancer rates rise. But, as Latham points out, it is difficult to assign causality and accountability to the company and its carcinogenic chemical because the standard of proof required by law is so high.
Imagine, now, a different example. Fair City, like many other cities, has some citizens who get cancer. City of Angels solar panel company believes that some of this cancer is caused by the prevailing practice in the town of using fossil fuels to heat houses. It partners with a local university to plan a randomized trial to see whether people in houses heated by solar energy have lower rates of cancer. People are randomized by neighborhoods. Prior to the study 25/1000 people developed cancer every year. In the study, one group gets a single solar panel and another group gets two such panels. The people who enroll are told there is no additional risk of cancer by being in the study. The results show that, in the group with one solar panel, the cancer rate is 20/1000 and in the group with two solar panels, the rate of cancer is 15/1000. The difference between the two groups is statistically significant. The people in the group with one solar panel clearly had a cancer rate that was 33 percent higher than the people in the group with two panels. The question is this: were the higher cancer rates caused by being in the study?
The people who were in group that received one solar panel sue the researchers because those researchers failed to warn them that they might have an increased risk of cancer as a result of being in the study.
Note the following: there clearly was a difference in cancer rates between the two arms of the study. Note also that, in both arms, the people in the study had a lower cancer rate than people who were not in the study. It may be difficult for the people in the one-solar-panel arm to convince us that they were harmed by being in the study, not because the law sets the bar too high, but because, in fact, they were not harmed.
Again, like Professor Latham, I am not offering any opinions whatsoever about the issues in the SUPPORT study. I only want to highlight that analogies have to be developed carefully and sometimes make both explicit points and implicit points. Differences in one’s response to the two hypothetical scenarios – that of Professor Latham and mine – might be influenced by one’s prior views about the morals and motivations of DarkCo petroceutical company or City of Angels solar panel company.
It may be that people’s responses to the SUPPORT study depend upon whether one views biomedical researchers as more like DarkCo or like City of Angels. Such pre-existing perceptual biases may even be enough to shape ones views of the facts.
John D. Lantos, MD, is professor of pediatrics at the University of Missouri-Kansas City and director of bioethics at Children’s Mercy Hospital. He is a Hastings Center Fellow.
Posted by Susan Gilbert at 09/16/2015 10:13:43 AM |