Joy Victory is deputy managing editor of HealthNewsReview.org. She tweets as @thejoyvictory.
At this moment, only a handful of stem cell therapies have been proven safe and effective through clinical research, according to the International Society for Stem Cell Research (ISSCR).
Yet, that’s not evident from a recent Google News Search for stem cells, which pulls up 800,000+ results of varying quality, as we’ve seen in our examinations of stem cell stories on spinal cord injuries, muscular dystrophy, chronic obstructive pulmonary disease, severe combined immunodeficiency, and multiple sclerosis, among others.
This explosion of news coverage and stem cell hype is partly why, for the first time, ISSCR has added a section on communication to their guidelines for stem cell research and the development of new clinical therapies (see page 28 of the PDF).
The communication guidelines are aimed at helping researchers explicitly “recognize” and “confront” the issue of stem cell hype, writes Tim Caulfield in a recent issue of Science Magazine. Caulfield is the Canada Research Chair in Health Law and Policy and a professor in the Faculty of Law and the School of Public Health at the University of Alberta.
“There’s a gap between the public’s expectations and the actual state of science,” Caulfield told me, noting a lot of the news coverage is overly optimistic or focuses on secondary outcomes of research (a trial intended to establish the safety of a procedure is written about as if it were a trial to establish efficacy).
“And the reasons this is happening are complex. It’s not just the media’s fault–we’re trying to emphasize that in the guidelines,” he said.
But journalists for sure play a role in the process, a topic covered in a 2015 media analysis titled “Stem cell hype: Media portrayal of therapy translation,” which identified problems like overly optimistic predictions about when a therapy under study would become an actual treatment (known as “clinical translation”).
So how do we do better? Here are a few things to keep in mind:
Don’t focus on timelines, focus on the steps left in the process. The analysis mentioned above found that the majority of stem cell coverage in the U.S., Canada and the U.K. included timelines that “predicted that stem cell therapies will be available within 5 to 10 years or sooner, just around the corner, or in the near future.”
To combat this, the ISSCR guidelines ask scientists to be “accurate, circumspect and restrained” when making any sort of forward-looking statements. For journalists, Caulfield noted, the better question isn’t “how long until this treatment becomes available?” but “what hurdles remain in the research process?” This is true for any intervention, not just stem cells, as we note in our review criteria on establishing availability: “Ignore crystal ball predictions; they usually come from someone who stands to benefit.”
And this can be woven into storytelling, notes Jonathan Kimmelman, who chaired the task force that revised the ISSCR guidelines. He’s also an associate professor in biomedical ethics and experimental medicine at McGill University in Montreal.
“Tell the other stories: Examples of products that were greeted with similar excitement but failed to deliver on their medical promise,” he said. “Tell the story of how hard research is, and how much perseverence it requires, how many mirages one spots when searching for an oasis in a desert.”
Rein in sensational language, even if it’s coming from your source. Given that so much of stem cell research is in the early phase–where things like basic safety are still being established–it’s rare that any sort of big, bold statements are acceptable.
The onus is on journalists to be careful when using words like “breakthrough, paradigm shift, revolution, cure, and game-changer”–even when this language comes from scientists, peer-reviewed abstracts, studies and institutional news releases. Dig deeper, and ask why they’re using that kind of language, because the answer may not be what most people would think. Case in point: The word “breakthrough” when it comes to FDA approvals.
And also rein in glowing single-patient anecdotes that throw a story off balance. This is an issue that affects nearly all health care reporting: Patient anecdotes make for good storytelling, and one patient’s story is easier to digest than many stories. But this comes at a cost, which we just wrote about in a blog post, “The patient as public relations tool: Why readers should be wary of single-anecdote news stories.”
“By definition, medical science deals with populations, not individuals,” Kimmelman said. “So if all you have is an individual–rather than a group of patients–there are good grounds for skepticism about generalizability.”
And keep in mind how patients may affect objectivity. “Patients at press conferences can also discourage critical journalists from asking tough and uncomfortable questions about the science,” he added.
Emphasize what was really being studied–AKA, what were the study’s primary endpoints? It’s important for journalists to establish exactly what a study was primarily trying to find out (is it safe for rats?), and not be distracted by exciting secondary endpoints (did it help the rats get better?).
Again, this is true even if your source is suggesting otherwise. Or, as the ISSCR puts it: “Too often, studies reporting statistically nonsignificant primary outcomes are ‘spun’ by appealing to other findings, such as statistically significant secondary outcomes. Such reporting practices can distort medical and public interpretation of trial results.”
Understand the difference between clinical endpoints (are they relevant to a patient’s care?) and surrogate endpoints. “For example, in cancer, an example of a clinical endpoint is survival,” Kimmelman said. “An example of a surrogate is tumor response (i.e. tumor shrinkage). Positive surrogate outcomes frequently do not predict positive clinical outcomes.”
Kimmelman has specific questions journalists can ask to make sure they get solid information on endpoints:
“Right off the bat, I would ask two questions: Were the secondary endpoints (and statistical analysis plans for them) declared in a protocol BEFORE any analysis was done? And, two, are there other secondary endpoints that were tested, but not reported?” he said. “If the answers are ‘no’ and ‘yes,’ I’d interpret results very cautiously. I’d also ask how many secondary endpoints were measured. If a lot were measured, that increases the chances that one will be positive due to chance alone.”
Ask about “base rates” (aka an intervention’s track record). Base rates refer to the probability an advance will have a major impact, based on experience with similar claims, Kimmelman said.
“For example, imagine a researcher claims she can stop Parkinson’s disease in its tracks in rats, and she thinks it could be useful in human beings,” he said. “First question I’d ask is: How many agents that showed similar activity in rats have actually led to cures? Focusing on that track record–what psychologists sometimes call ‘the outside view’–can lead to a much more balanced and realistic appraisal of the clinical value of a scientific claim.”
Don’t forget to include limitations, risks, costs and harms. Analysis of news reporting on stem cell therapies revealed an overemphasis on the benefits of an intervention, Caulfield states, which paints a distorted depiction of the state of stem cell research, and contributes to the notion that the field in general is being hyped.
“Risks–if they are mentioned at all–are de-emphasized and study limitations are missing,” he said. “We see a lot of what we call the “errors of omission.”’
The other downside to omitting limitations, risks and harms is that overly positive news reports are appealing marketing tools for clinics peddling unproven or unapproved therapies, which brings us to our next point:
Read up on the problem of stem cell pseudomedicine clinics. Sometimes called “stem cell tourism” (though travel isn’t always necessary), this refers to providers offering unproven stem cell interventions, usually via web sites.
These businesses tend to market cures for both adults and children while “underplaying risks, peddling hope and attempting to stifle warnings.” The clinics may or may not offer informed consent and continuing care after treatment.
However, analysis shows journalists still write about these clinics frequently, often focusing on a family’s or person’s desperate hope for a cure. And many of the stories are increasingly slanted toward positive outcomes, using words like “promise and hope” without talking about negatives.
Resources to help you avoid these pitfalls include this ISSCR patient information article, this STAT piece on the FDA’s efforts to crack down on clinics, a NEJM report on the “Wild West” of U.S. stem cell clinics, as well as this tipsheet from stem cell scientist Paul Knoepfler.
And above all else, be skeptical.
“Be as skeptical and critical with scientists as you’d be with a government official,” Kimmelman said. Ask tough questions.”