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There are very few stem-cell therapies that are currently ready for clinical application (Jezperklauzen/Getty Images/iStockphoto)
There are very few stem-cell therapies that are currently ready for clinical application (Jezperklauzen/Getty Images/iStockphoto)

Beware the hype on stem-cell breakthroughs Add to ...

Health science gets a lot of attention in the popular press. People love hearing about breakthroughs, paradigm shifts and emerging cures. The problem is, these stories are almost always misleading.

While optimistic miscalculations of the state of biomedical research may seem as if it were a harmless distraction, there is a growing body of evidence that suggests it can be the source of real social harm. It can drive unrealistic expectations, affect the public utilization of health-care resources and even shape a less-than-ideal research agenda. It can also help to legitimize the marketing of unproven therapies.

This week, the New England Journal of Medicine (NEJM) reported on three individuals who went blind after receiving an unproven stem cell treatment at a Florida clinic. The patients paid thousands of dollars for what they thought was a clinical trial on the use of stem cells to treat macular degeneration.

The primary fault, both legally and morally, for the marketing and use of unproven stem-cell therapies lies with the providers who are involved with the practice. We need national regulators (e.g., Health Canada, the U.S. Food and Drug Administration) and the bodies that oversee the relevant health-care professionals (e.g., the colleges that regulate physicians) to take a more active role – a point noted by Dr. George Daley in an essay accompanying the NEJM case report.

Indeed, it is hard to blame patients for being drawn to providers that present optimistic portrayals of benefit. We live in confusing times. It is becoming increasingly difficult to tease out the real science from the bad and the “fake health news” from a genuinely exciting scientific advance. Not only is the science twisted by multiple systemic forces – publication pressures, overenthusiastic news releases, commercial interests and media spin – misinformation is being broadcast on a growing number of communication platforms. Social media, for example, have allowed for the rapid dissemination of false promises and creation of confirmation bubbles in which like-minded believers can trade anecdotes of success. And studies have shown clinics exploit platforms such as Twitter to create buzz about and demand for unproven therapies.

For the general public, here is a good rule of thumb: Doubt every claim that suggests a significant breakthrough. Doubt everything. This may sound a tad cynical, but if you adopt this approach you will be pleasantly surprised when something actually pans out. More important, this nothing-ever-works-as-promised strategy will be correct 99 per cent of the time.

For patients seeking a treatment, be cautious of any clinic offering a therapy that seems too good to be true, because virtually every time it will be too good to be true.

Consider stem-cell research. Think of all the hype, the headlines about near-future applications and the pronouncement about revolutionary regenerative therapies. This hand waving has been going on for almost two decades. So much so that the phrase “stem cells” has morphed into cultural marker for “cutting edge.” But despite all this unrelenting, upbeat noise, there are very few stem-cell therapies that are currently ready for clinical application. Daley, who is a renowned stem-cell researcher and the current dean of Harvard Medical School, concludes there are just a handful: those used for the blood-related ailments and for the skin (epithelium) conditions. The International Society for Stem Cell Research agrees with Daley and notes “the list of diseases for which stem-cell treatments have been shown to be beneficial is still very short.”

Don’t get me wrong; I believe stem-cell research remains a fantastically promising area of science. But true medical breakthroughs are rare. Incredibly rare. In fact, if a study claims a large effect size, which is often the case in stories about breakthroughs, there is a good chance the results will be overturned by subsequent work. In a well-known 2003 analysis, it was found that out of 101 studies published between 1979 and 1983 in top science journals and framed as clinically promising interventions, only one was “used extensively for the licensed indications” (yes, about 99 per cent of the peer-reviewed predictions were wrong). The authors concluded that “even the most promising findings of basic research take a long time to translate into clinical experimentation, and adoption in clinical practice is rare.”

Yes, we need regulators to crack down on the marketing of unproven stem-cell therapies. As demonstrated by these recent reports of treatment-induced blindness, these clinics can cause serious harm. But we also need to do our best to curb the science noise that helps to legitimize the false claims made by the purveyors of stem-cell products. Scientists, clinicians, policy makers and journalists should do their best to counter misinformation in all its forms.

More good science, less science-y noise.

Timothy Caulfield is Canada Research Chair in Health Law and Policy at the University of Alberta, a Trudeau Fellow and author of Is Gwyneth Paltrow Wrong About Everything?

This story first appeared in Healthy Debate, an online publication guided by health-care professionals and patients that covers health policy and evidence-based medicine in Canada.

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