In a promotional video, the MD Anderson Cancer Center advertises clinical trials alongside immunotherapy and proton-beam therapy as one of its many ways of “fighting cancer.” Cancer Treatment Centers of America promotes clinical trials as part of its “commitment to bringing our patients new and innovative cancer treatment options.” You may have seen billboards or heard radio spots with similar messages. But what you are actually seeing and hearing in such advertising is a betrayal of ethics and science.
There is a lot of money behind providing cancer care, and cancer treatment centers spend an estimated $173 million on advertising each year. One of the ways they compete for patients is by offering a menu of clinical trial options and suggesting that participating in such trials gives patients an edge on their care.
As we argue in a recent Viewpoint article in JAMA Oncology, such messaging is not only misleading but also undermines the very norms of science that clinical trials — and cancer centers themselves — are supposed to advance.
Some ads entice people to participate in a clinical trial by using patient testimonials that describe significant medical improvement after participating in a trial. In an MD Anderson video, a patient says, “By the end of the clinical trial, they could barely detect any cancer at all in my body.”
The fundamental reason for running clinical trials is to replace anecdote with scientific evidence. When prestigious organizations use anecdotes to encourage clinical trial participation, they lend their credibility to a practice they are trying to discourage and supplant with evidence-based medicine.
Some ads imply that because every great treatment breakthrough was first offered to patients in clinical trials, patients who enter trials get access to great breakthroughs. Such claims commit what statisticians call the inverse fallacy. Think about the logic here. It’s like saying that most people who win the lottery buy their tickets at convenience stores, so buy your lottery tickets at a convenience store so you will win the lottery.
Suggesting that trials give patients “an edge” obscures the fact that most new drugs turn out not to be superior to standard care and, in some cases, are unacceptably toxic. In addition, trials often entail more frequent visits and potentially burdensome research procedures like organ biopsies. It also hides the fact that patients in trials are often randomized to control arms that allow scientists to compare novel treatments to the standard of care. Do medical centers mean to imply that patients who are randomized to the control arm are at a disadvantage?
Before patients can enroll in a clinical trial, they must go through a process of informed consent intended to ensure they understand the nature and purpose of the study as well as the likelihood of expected benefits, burdens, and risks. Yet patients often arrive at informed-consent discussions already having decided to enroll in a trial. Ads that deploy fallacious reasoning and misrepresent the purpose of studies prey on the hopes and fears of patients, potentially subverting the integrity of informed consent. This is particularly pernicious given the history of deception and prevarication in medical research that helped give rise to bioethics.
Suggesting that trials give patients “an edge” obscures the fact that most new drugs turn out not to be superior to standard care and, in some cases, are unacceptably toxic.
Local ethics committees work hard to help patients who are navigating a labyrinth of fear, uncertainty, and hype see clinical trials for what they are: Medical experiments that play an essential role in generating evidence for the care of future patients. Messages that use emotive language to emphasize the potential for individual benefit without mentioning risks or quantifying the prospect of benefit or harm skew expectations and complicate this task.
The most insidious aspect of these ads stems from the implication that patients who get access to drugs in trials have an advantage over patients who do not. If that was true, there would be no point in running clinical trials. More importantly, this message lends the credibility of prestigious organizations to the same practice that unscrupulous clinics use to offer unproven stem cell-based treatments to patients. It also bolsters the position of movements like “right to try” that cast clinical trials as unnecessary obstacles to accessing the benefits of untested, novel treatments. In fact, a man wearing a white coat in an MD Anderson video explicitly says, “You just find yourself wishing you could treat everyone with what’s being used in the trial, right away.”
To fix this, we offer three suggestions. First, health care organizations should treat all public messaging as falling under their duty to provide reliable and accurate information to patients. To facilitate this, marketing departments or agencies should vet proposed clinical trial ads with hospital ethics committees or institutional review boards.
Second, professional societies like the American Society of Clinical Oncology or patient advocacy groups like the American Cancer Society should issue policies or guidelines on clinical trial advertising by medical centers. Such guidelines should urge that ads not undermine patient informed consent by abetting inflated expectations and misunderstandings about research.
Third, the FDA, which regulates drug ads, and the Federal Trade Commission and attorneys general, which oversee marketing practices, should consider regulating ads for clinical trials — or at least establish strict guidelines for public messages about them.
There are many valid reasons for patients to participate in clinical research, not the least of which is the desire to expand the frontiers of our understanding of cancer and our ability to treat it in the future. For some patients, even the long odds of reaping personal benefit may be enough to motivate participation.
Patients who offer their bodies to help discover tomorrow’s treatments deserve messages that are truthful, balanced, and respectful of their role in advancing science, not the hype for clinical trials that is becoming increasingly common.
Jonathan Kimmelman, Ph.D., is an associate professor at McGill University and director of its Biomedical Ethics Unit. Alex John London, Ph.D., is professor of ethics and philosophy at Carnegie Mellon University and director of its Center for Ethics and Policy.
Excellent and thoughtful article. A related piece which addresses cancer center advertising in a somewhat broader context.
Comments are closed.