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.

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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.

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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.

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  • Very good read and brings up important and interesting points for one to consider regarding clinical trial advertisements, ethics and science.

  • I am on a clinical trial. It was not suggested to me. I sought it out. I had a fast growing large squamous reaccuring for the 4th time on my face. This time inside. I am on keytruda. After my 5th treatment, it looks like it might be completely gone. I am thankful for keytruda giving me the opportunity to choose a different option than chemo or radiation. The rest of the ethics issues fade to non existent when I think of where I was 5 months ago and where I am today. I sought it out because I heard about it through media and wanted something that I considered had less side effects in the long run. I think I chose wisely.

  • I can see some of the points made by this “Opinion/Viewpoint” article written by the two ethics PhDs, however I cannot help resent the fact that the they did not use their expertise in a better way to make the point that clinical trials are NOT ONLY IN ACADEMIC CENTERs AND MUST NOT BE ONLY IN ACADEMIC CENTERs. I resent the fact that they did not state that National Cooperative Group Clinical Trials Network has such a high quality clinical trial design with tedious work from concept to all the way to activation of a trial with pure strict scientific guidance. They did not make the point that NCTN trials pursue only science and altruistic goals (not me too drugs). They did not differentiate, between industry, academic investigator initiated trials versus NCTN trials, They did not mention the difference between treatment trials versus quality of life CCDR prevention and so many other types of trials. They did totally ignore all the good being done by NCI-NCORP and ASCO. I wish the two authors would be mindful and thoughtful of ethics when it comes to doing the bare minimum and highlighting and bringing awareness what NCI-NCORP is trying to do in the community setting to advance science in every aspects of cancer care continuum. Their article misses the huge positive being done by NCORP contrary to the negatives they have listed. I also wish the two authors would be mindful and thoughtful of efforts of ASCO Research Community Forum in addition to criticizing ASCO policy statement of phase I trials. It is unfortunate that these two ethics educated PHDs cannot resist the temptation of making some flash news with their biased article and highlight only some bad practices while ignoring the so many great and altruistic efforts put by NCI-NCORP and ASCO. It is a huge missed opportunity that they did not mention NCI-NCORP to encourage lay community people to seek for and take advantage of real science and altruistic trials in their communitiesin their back yard not in BIG ACADEMIC CENTERS OR CTCA or other commercially highlighted ” centers” NCI-NCORP doing the right thin in the communities where 85% of cancer patients live and I wish authors could be wise enough to see this huge positive and balance their article with the NCORP fact.

  • I couldn’t disagree more. MD Anderson, and others accept patients into “experimental therapies” after they have tried the standard of care treatments. Patients who fail the standard treatments have THE RIGHT TO TRY. To restrict alternative therapy is malpractice. Many patients are alive today because they had the ability to move to alternative therapy after traditional medicine failed. What these ads express is the Center will explore all available treatment. These MD’s are succeeding daily so take your PhD in Ethics and focus it on real problems. Thank goodness for all the Centers who will utilize ALL available options available.

    • Janet
      Clinical trials are not the same as “alternative methods” they are always very short in term, they almost always have placebo arms meaning half of the people don’t actually GET the trial drug at all and no one knows who is who with what compound until the trial is over and exposed.
      It is HIGHLY possible (read 50%) that a person in a trial is NOT getting the new miraculous treatment you speak of
      Also to suggest that this is part of the “care of excellence” is crazy since MANY people actually not only do not get better but get worse as a result of the trial. This is EXPERIMENTAL medicine at its finest. YES, we mitigate the risks but this is NOT cutting edge it is “toss it on the wall and see if it sticks” care.
      I have had hundreds maybe more patients in clinical trials over the years some did poorly some did well most did OK and a few died as a result
      I actually put myself in 4 trials so far for my own cancer and the one created such runaway side effects I was hospitalized for 35 days with near death hypertension (high blood pressure) that no drug combo could treat without worsening the overall body function (the trial was ended and the drug combo is not in use)
      So PLEASE don’t equate experimental medicine with the alternative to the standard regimen. There are PLENTY of off-label uses that don’t need a clinical trial to be implemented. Trials are not for that they are for off-book compounds or for combinations so bizarre that no doc would ever “try” an off-label use of them
      We routinely use our own medical experience to use drugs off-label for our patients who have not succeeded with first or second line treatments but trials are a different breed of dog
      Dr. Dave
      H&N cancer surgery

  • Why stop at clinical trials!?
    The whole issue of advertising for medical drugs or techniques or trials is all exclusive to the USA (and New Zealand). The rest of the world has realized the pitfalls of advertising for such products/services that NEED to be properly evaluated and vetted by a professional for the actual positive vs negative risks and values and outlawed them YEARS ago.

    I for one FULLY understand the dire situation the clinical trial industry is in with MOST trials failing to even get sufficient volunteers to even begin the study let alone satisfy the FDA or the statistics to publish BUT in reality the public’s emotional response is UNACCEPTABLE to allow them to rationally decide choices and options

    DAILY we get questions about “I saw this commercial I want to try this instead of what you recommended can we do it?”
    We need stop holding the first amendment to the Constitution as more important than the health of the population

    Sure the Constitution needs to be the principle with which we operate under but giving corporation and entities individual rights of free speech is outright WRONG

    Time we ask the FDA and FTC to stop allowing PharmaCos and institutions to advertise for specific causes or products. It should be FINE to say that we offer trials in general terms (as many hospitals do not so advertising will educate and give an advantage) Having an extensive varied approach to treating what ails one is good but to state that we have a trial that is working on lung cancer or a drug that affects arthritis is pure marketing with NO support scientifically and as stated in the article might actually recruit patients who will be harmed

    BTW stating that most drugs fail at the trial phase is incorrect by the time a drug hits the clinical trial stage it is pretty well vetted as to safety and efficacy and if it fails in one will likely pass in another it is all based on the design of the parameters used to determine success
    MOST drugs DO in fact function as described in human clinical trials the ones that are miserable failures are the current drugs used for off-label purposes or stretching the value of the drug to areas it wasn’t designed to work under
    Dr. Dave
    Head and Neck Surgical Oncology

  • This is an important message, to be sure, and many of the ads are irresponsible… but the truth is more nuanced.

    Not all clinical trials are created equal. Some are using a drug that is already well established (or even FDA approved) in disease A, and the trial is now designed to see how well it works in similar disease B. These trials have a high likelihood of success. Some trials are already fairly far along and early results may already have been reported, but the drug is not yet FDA approved since that process takes time and additional safety data need to be accumulated. Other trials are earlier, based mostly on preclinical data, and the odds of success for these studies are smaller. Still other studies are completely novel, maybe even the first time inhibiting a new pathway, and these molecules may be real long shots, very low likelihood of working. These are all different scenarios and shouldn’t be conflated.

    The authors state that it is not true that “Patients who get access to drugs in trials have an advantage over patients who do not.” However, sometimes it is true. I remember when we were doing early phase studies STI-571 (which became imatinib/Gleevec) in chronic myeloid leukemia – it was clear very early on that this drug was much better than anything we had available for the disease, but the only way to get the drug for 2 years was in a clinical trial (or via compassionate use protocols, which are like one-patient studies.) The IRIS phase 3 trial had a randomization despite the fact that the drug had a >90% complete response rate in phase 1/2 compared with ~10% for the control therapy. At least the design allowed for crossover. The same thing has played out with other targeted agents.

    Clinical trials are important and many fail. But they are also critical, and often a center that has a portfolio of trials really does have more to offer the patient than the FDA approved approaches.

  • I think this brings up a good point. Sites are supposed to have all promotional material for clinical trials approved by the ethics committee – the IRB. If promotional material is not for a specific study, they might not have to submit it to the IRB. This might be a gap in “the system”.

  • This is a really well written article and brings up some excellent points. There should never be an implied promise that these experimental treatments will work when all others will fail. My understanding is that with the myriad of trials ongoing for the breadth of promising compounds in development, it is extremely difficult to recruit for the large multicenter trials necessary to bring them to patients. I agree that the efforts to enroll patients should never be misleading but how do the authors suggest patients be educated and informed about the importance of patient volunteers to discovering new and better treatments.

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