Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is 2 determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language to obscure; to blur or eliminate the distinctions between research and therapy, ,3 scientist and physician, and subject and patient. It was suggested that a major reason for the blurring was to lower the standards for obtaining informed consent. To prevent this, it was further suggested that it is necessary to firmly establish that the modem informed consent doctrine applies to both research and treatment.4 In this article we explore the recurrent problem of equating research and treatment, and its recurring (but misinformed) rationale-that in practice, informed consent only applies to research, and not treatment. Historically, misleading and confusing terms such as therapeutic research, experimental treatment, and invalidated treatment have been used to blur the distinction between research and treatment. Similar misleading terms are being deployed in an effort to make evidence-based medicine research (including comparative-effectiveness research) easier to do by dispensing with or watering down disclosure requirements. We agree with the great need to do more research on the safety and efficacy of currently used treatments, but strongly disagree that such research requires abandoning or diluting informed consent, or treating patients simply as passive objects for the valid purpose of improving the quality of care for all. The latest term for conflating research and treatment is standard of care research, and the leading example that illustrates the problems with employing new and confusing terms for research is a study on extremely premature infants, the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (known as the SUPPORT study and described below). 5 The (mistaken) belief that clinical practice on children does not require the informed consent of the parents explains, we think, why this seductive term, standard-of-care research, was invented. It seemed to justify, for example, not informing parents of the risks of death in each of the two possible groups to which their infant would be randomized in the SUPPORT study. Viewing research as treatment is a common mistake patients also make, so common that it has been given a name, the therapeutic misconception, or the therapeutic illusion. 6 We will suggest that in the SUPPORT study the therapeutic illusion was strongest on the part of the researchers, sponsors, Institutional Review Boards ( IRBs ), and institutions, rather than, as is usual, on the part of the patient-subjects

Global Protection and the Health Impact of Migration Interception

In the fourth article in a six-part PLoS Medicine series on Migration & Health, Zachary Steel and colleagues discuss the interception phase of migration and the specific health risks and policy needs associated with this phase

“Unusual Care”: Groupthink and Willful Blindness in the SUPPORT Study

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. Citation2013) attack the study’s methodology itself in this issue, arguing that even on its own terms SUPPORT was fatally flawed (Macklin and Natanson Citation2020). Specifically, they argue that one arm of the study (the low oxygen arm) was not followed anywhere and could not be reasonably considered “standard care,” but was rather “unusual” and therefore experimental care (Cortes-Puch et al. Citation2016; Macklin and Natanson Citation2020). They also make useful suggestions about how to prevent future mischaracterizations of “usual care.

Enhancing the Fighting Force: Medical Research on American Soldiers

During President Barack Obama\u27s first primetime press conference, reporters asked primarily about the state of the economy and terrorism. Wedged between questions on these two vital issues was a query from the Washington Post\u27s Michael Fletcher: Question: What is your reaction to Alex Rodriguez\u27s admission that he used steroids as a member of the Texas Rangers? Obama: You know, I think it\u27s depressing news.... And if you\u27re a fan of Major League Baseball, I think it - it tarnishes an entire era, to some degree. And it\u27s unfortunate, because I think there are a lot of ballplayers who played it straight. And, you know, the thing I\u27m probably most concerned about is the message it sends to our kids. What I\u27m pleased about is Major League Baseball seems to finally be taking this seriously, to recognize how big a problem this is for the sport, and that our kids hopefully are watching and saying, You know what? There are no shortcuts, that when you try to take shortcuts, you may end up tarnishing your entire career, and that your integrity\u27s not worth it. That\u27s the message I hope is communicated.1 Situating the use of steroids by baseball players on the same level as the economic meltdown in the U.S. and the war in Afghanistan may seem strange, but less than two weeks later in his weekly Op-Ed column in the Sunday New York Times, Frank Rich produced a similar list of what he saw as the major evils that were denied during the Bush administration: Steroids, torture, lies from the White House, civil war in Iraq, even recession .... ,2 As to steroid denial in particular, Rich noted, [a]nyone with eyes could have seen that Sammy Sosa and Mark McGwire resembled Macy\u27s parade balloons in their 1998 home-run derby . . . . 3 And in its February 23rd issue, the cover of the New Yorker featured a portrait of Alex Rodriguez signing autographs for young children whose arms were bloated like balloons. As we will explore in this Article, some ethicists think that the concern about drugs used for enhancement, including steroids used by baseball players to increase their strength, is misplaced, and that adult athletes should be able to use whatever enhancers they want, so long as they are not dangerous to their health.4 Putting aside for a moment the health dangers of steroids on adults-which are contested-the other two primary reasons for banning the use of performance enhancers in baseball are that they are, as President Obama noted, a form of cheating that undermines the integrity of the game, and that they encourage emulation by children. Sports has been the primary arena in which what might be termed the enhancement debate has played out, and, at least until the publication of the Mitchell report in late 2007, most of the attention focused on the Olympics and devising ways to detect cheating by athletes who were using drugs.5 In George Mitchell\u27s recounting, as well as a recent survey by the Wall Street Journal, the two teams that had the most players who used steroids were George W. Bush\u27s old team, the Texas Rangers, and the New York Yankees. 6 As Red Sox fans, we can, of course, be accused of prejudice, especially against the Yankees. So it is probably best we leave the sports debate to others. Instead, our focus in this Article is on the use of performance enhancing drugs in the arena that bracketed the Alex Rodriquez question to the president: the war against terrorism, and specifically the unasked question regarding the use of enhancement drugs by U.S. soldiers in combat

“Unusual Care”: Groupthink and Willful Blindness in the SUPPORT Study

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. Citation2013) attack the study’s methodology itself in this issue, arguing that even on its own terms SUPPORT was fatally flawed (Macklin and Natanson Citation2020). Specifically, they argue that one arm of the study (the low oxygen arm) was not followed anywhere and could not be reasonably considered “standard care,” but was rather “unusual” and therefore experimental care (Cortes-Puch et al. Citation2016; Macklin and Natanson Citation2020). They also make useful suggestions about how to prevent future mischaracterizations of “usual care.