Mary Chris Jaklevic is a reporter-editor at HealthNewsReview.org. She tweets as @mcjaklevic.
Some cancer centers are misleading the public by advertising clinical trials as a way for patients to access cutting-edge treatments, two ethics professors argue in a paper published today.
Alex John London, PhD, of Carnegie Mellon University and Jonathan Kimmelman, PhD, of McGill University wrote in JAMA Oncology that “strong messages equating access to clinical trials with therapy imply that unproven drugs are already established as therapy.”
They said those messages contradict the very purpose of a clinical trial, which is to determine whether a therapy works.
Among the examples they cited:
In reality patients who participate in clinical trials seldom receive one of tomorrow’s effective therapies, London and Kimmelman wrote.
They pointed to a 2014 study showing that just over 10% of drugs in early-phase trials can be expected to eventually win FDA approval. But even that statistic is overly optimistic in estimating a patient’s chances of an effective therapy in a clinical trial because manufacturers typically test many variables in dosing, schedules and other factors in search of an effective “ensemble,” they wrote.
They also said marketing about clinical trials doesn’t indicate that patients in trials often endure procedures or extra clinic visits that lack a therapeutic purpose and sets unrealistic expectations that might discourage some patients from seeking palliative care.
Also, in some cases, extra procedures such as biopsies and sham surgeries present a risk of serious complications.
This isn’t the only area where some established medical centers have been accused of misleading marketing. We’ve also written about academic medical centers promoting unproven stem cell therapies in order to puff up their brands.
University of Minnesota bioethicist Leigh Turner, PhD, said this paper “moves that discussion out of the realm of stem cell marketing.”
While previous academic work has highlighted hyperbolic marketing claims of cancer centers, this is the first piece he’s aware of that focuses on the clinical trials as a marketing tool.
In recent years, it appears cancer providers have stepped up recruitment efforts amid a shortage of patients available to participate in research on experimental drugs.
“It points to the contradictions embedded within academic medical centers,” Turner said. “On the one hand they are tasked with conducting trials and promoting evidence-based medicine. On the other hand they operate in very competitive ways, trying to attract patients and attract people to clinical trials. Sometimes that results in misleading rhetoric.”
The paper challenges views held by the American Society of Clinical Oncology, which argued in 2014 that patients “regularly benefit” from early-stage clinical trials–also known as phase 1 trials– aimed at establishing safety.
ASCO said researchers also have gotten better in the last two decades at identifying patients who might benefit from a particular drug as well as eliminating ineffective agents early in the development process.
“With new agents that target specific abnormalities in a patient’s tumor, better tests to identify those abnormalities and more sophisticated clinical trial designs, today’s phase I trials in cancer offer patients a greater likelihood of benefit than ever before,” ASCO President Peter Paul Yu, MD, said in a 2014 news release. “Patients shouldn’t shy away from phase I trials and doctors should present these trials as options for eligible patients throughout the period of active cancer treatment, not only when all other treatment options have failed.”
Asked for a response to this paper’s concerns about cancer center marketing, ASCO released a statement from its chief medical officer, Richard Schilsky, MD, saying in part:
Communication about risks, benefits, and alternatives to treatment on a trial are key elements of the informed consent process. ASCO believes that this information needs to be presented objectively by members of the healthcare and research teams who are familiar with the patient’s goals of care and trial details. A lack of overall awareness and understanding of clinical trials is an important barrier to participation, but this needs to be done within the context of understanding the purpose of research and uncertainty of treatment benefit – particularly with novel therapies.
We reached out to five cancer providers whose marketing materials were mentioned in the paper. Only Cancer Treatment Centers of America responded with a statement from its president of medicine and science, Maurie Markman, MD.
As an organization, Cancer Treatment Centers of America will always do what is in the best interest of our patients. We are proud of our focus on research and our work to identify new treatment options supported by scientific and investigational research. We strongly believe that offering clinical trials, and any communication around these offerings, is essential to improving patient care and advancing cancer treatment for patients now and in the future.
We also tapped Janet Freeman-Daily, a blogger and patient advocate who takes the drug crizotinib as part of a clinical trial to prove its effectiveness in treating a rare form of lung cancer, ROS1 positive. The drug received accelerated approval as a treatment for that disease in 2016 based on a small Phase I safety trial. She counts herself lucky to have found a therapy that seems to be keeping the disease at bay without the side effects of chemotherapy.
Freeman-Daily, who said she has received speaking fees from pharmaceutical and genomic testing companies, agreed some cancer center marketers “don’t think about their choice of words and how that impacts patient expectations,” but she thinks there are larger issues for patients.
The medical community as a whole doesn’t do a great job of educating patients about the risks and benefits clinical trials, she said, and there’s also poor communication about the risks and benefits of approved therapies.
She also pointed to scant resources for people who have diseases with no effective therapy who are trying to find out about clinical trials.
“I think it’s actually valuable for patients to be aware of where clinical trials are available,” she said. “As more patients become involved with their care, we are looking for options, and it helps to know where they are.”
Addendum: After this blog post ran, Georgia Cancer Center emailed us a lengthy response from its associate director for clinical trials and research, Sharad Ghamande, MD.
It reads in part:
Getting a patient on a clinical trial is an intensely rigorous process requiring a dialogue that clearly includes other options and hospice. In fact, the document to sign an informed consent is often daunting with more checks and balances today than at any time before to safeguard patient well-being.
…I have been an integral part in building a clinical cancer trials infrastructure at the Georgia Cancer Center at Augusta University and take a lot of pride in it. We are one of the 12 sites nationally with an NCI minority National Cancer Institute Community Oncology Research Program (NCORP) grant and partner across Georgia with community hospitals and practices to get patients into clinical trials. … Yet in a small city such as Augusta, there are many people in town who do not know that we have an active clinical trials program. Those patients often spend time, effort and energy traveling across the country to avail of clinical trial opportunities.It is important to be transparent and honest as we all deal with issues that have significant emotional undertones, but to pronounce these efforts as advertisement is unfair to all involved in cancer care.
Also, the story was edited to clarify the approval status of the drug crizotinib.