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Stem-cell therapy feels Food and Drug Administration’s pinch

Rating

3 Star

Stem-cell therapy feels Food and Drug Administration’s pinch

Our Review Summary

The story provides some key points from both sides of the debate and some caveats. But about one third of the story reads like an advertisement for the procedure. Rather than discussing data/evidence, the story centers on the positive aspects of the unregulated and unsubstantiated approach.

 

Why This Matters

New health care interventions may offer great promise and hope to patients with debilitating diseases such as severe arthritis. But news stories on such new ideas simply must help readers evaluate evidence – and this story didn’t do that.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

We’re told the procedure costs upwards of $8,000 and is not covered by most insurance policies.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The benefits of the treatment are provided in vague terms and supported solely with anecdotes rather than data. There are many key questions an informed patient should ask about this procedure, but the story provides no evidence to answer them. A standard of evidence sets the bar. Without it, all we have are subjective claims and no context to understand the anecdotes.

In one of those anecdotes, a patient "is certain that adult stem-cell therapy could someday end joint-replacement surgery." He’s certain that it could? What exactly does that mean, besides advertising the procedure? And why did the story include a patient’s forecast about the procedure’s boundless future, presumably based on overwhelming benefits, without mentioning the lack of evidence?

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

One safety study is discussed, which found no tumors or other serious complications from the treatment. However, the story misinterprets one point about this study: it implies that all 227 subjects received MRIs, when only 45 subjects (Group 1) did.

This study’s results are presented in an inappropriate, forward-looking way. The paragraph on the study begins, "Soon, regenerative stem-cell therapies like Centeno’s may not be so cutting edge," as if the results were a smoking gun demonstrating the procedure’s long-term safety. The results are followed by Centeno’s interpretation, a favorable comparison of his procedure’s risk profile to those of other orthopedic procedures. But there’s no evidence, no comparative studies, provided to support those claims.These quotes, from the procedure’s champion, a man who has a business stake in licensing this procedure to other doctors and centers around the world, should not have been included in the article without direct counterpoint.

The story notes the potential for stem cell therapies to transmit disease, and the New England Journal of Medicine article’s support for the FDA’s requirement that researchers demonstrate safety in this regard. It fails to discuss whether that burden of proof has been met with Centeno’s procedure.

We give the story credit for discussing the need for safety data, in the context of gene therapy’s challenges, where an adverse event stymied the hype. However, we are not sure the conclusion goes far enough in saying that "more research, like Colorado State University’s stem-cell work on dogs and horses, is needed to ensure safety." What about more research in humans?

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

We don’t think the story satisfies this criterion. Apart from the question of regulatory structure, the author allows Centeno to get away with a number of claims, including the dramatic N=2 "evidence" from interviewees who experience miracles, with almost no supporting evidence. Of note, and perhaps to the FDA’s case, the procedure hasn’t been studied intensively, and thus we don’t really know how well it works in the long run or how safe it is. Substituting a few patient anecdotes for evidence is insufficient. What DO the data show?

Does the story commit disease-mongering?

Satisfactory

The article doesn’t engage in disease-mongering.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

We would have liked to have heard from a truly independent source. The balance of sources leads to a largely unchallenged view of Centeno’s procedure, and the foregone conclusion that this type of stem cell therapy will steamroll through safety studies and the FDA approval process.

A source apparently unaffiliated with Centeno is quoted, and Dennis Roop adds some important caveats that the FDA’s requirement of safety evidence is critical, in light of physicians making home-grown cultures, with allusions to the deaths that occurred during early trials of gene therapy. Roop’s quote does not directly refer to Centeno and his push for unfettered permission to sell and franchise his procedure — and that is the perspective that’s missing, with more discussion of the lack of efficacy and safety data. (Perhaps the evidence question is embedded in Centeno’s head-butting with the FDA, or perhaps it’s a debate over the more complex regulatory machinery.) And Roop’s ultimate claim for the to-be-demonstrated safety and approval of stem cell therapies is presumptuous. While unaffiliated with Centano, Roop is the director of a stem cell institute. 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There are no evidence-based comparisons to existing alternatives, only claims and anecdotes. Furthermore, it’s somewhat unfair to characterize ankle fusion as a "debilitating surgery." Of course, it’s not an ideal surgery, and patients have limitations afterwards, but its point is to improve life for people who suffer from a debilitating condition, and responses vary.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story points out that the procedure is not licensed by the FDA. Meanwhile, another company is conducting FDA-approved trials of a related technique.

Does the story establish the true novelty of the approach?

Satisfactory

The story correctly points out that others are working to develop treatments utilizing the patient’s own stem cells along a traditional regulatory path.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not appear to rely on a news release.

Total Score: 5 of 10 Satisfactory

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