A man with ALS participates in a fundraiser for research in New York City.
This story describes a small Phase 2 safety-focused trial of stem cell injections to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The trial involving 15 patients tested whether the stem cell injections, previously performed in low doses at Emory University, would be safe in progressively larger doses administered at multiple medical centers. The study was published in the journal Neurology.
There isn’t much news here; the question remains open as to whether stem cells could be a safe and effective therapy for ALS. Nothing from these studies suggest that this treatment may slow or reverse progression of ALS. Given that, the story did a good job outlining the harms and risks from the procedure, and it included quotes from independent experts. But it is another example of how stem cell therapies get news coverage, even when the research is still preliminary.
ALS is a rapidly progressive, fatal disease that attacks the nerve cells that control muscles. It’s relatively rare, with 3.9 cases in every 100,000 Americans, according to the National Institutes of Health. Most people with ALS die from respiratory failure, usually within 3 to 5 years from the onset of symptoms, according to the NIH, though about 10 percent of those with ALS survive for 10 or more years. There is no cure, though the drug riluzole can prolong survival.
Converting patients’ stem cells into healthy motor neurons is one ongoing research pathway for a possible treatment. The concept of replacing these dying spinal nerve cells with new ones seems intuitively appealing, but it is unknown whether this could slow the progression or ideally reverse it.
There’s no mention of how much this procedure costs. Though this is still in its earliest stages, one could simply mention this issue, as it’s likely to be very expensive.
Since this was primarily a safety study, there are no measurable benefits to quantify, and the story lets us know with this statement: “Unfortunately, the procedure provided no benefit to patients.”
We’ll count this as sufficient for a Satisfactory rating.
However, we encourage journalists to think twice about giving air time to early-phase trials, especially for stem cells. In many cases, there isn’t a lot to report yet, since benefits haven’t been established in any meaningful way. Better to wait until bigger trials are conducted, which was even implied with this ending quote in the story:
“We are just now getting started with testing our hypotheses about using stem cells as therapeutics,” Glass said. “We do not know if these treatments will work, and it will take time to test these therapies in a systematic and safe way.”
The story provided a lot of detail on the harms noted in the study, earning it a Satisfactory rating in this criterion, albeit with caveats.
Certainly, the bar for safety may be lower for ALS than for other diseases, but we think the story misleads by calling the treatment “generally safe.” As the story explains, two of the 15 patients developed “severe complications,” including partial paralysis and “incapacitating pain.” More detail is warranted here. In fact, the 15 patients in the study experienced a total of 81 adverse events that researchers said were probably or definitely related to the treatment, mainly surgery. While most of these were not serious, they may have reduced the quality of life at least temporarily for patients who probably have little time left to live. In addition, these patients spent several days in a hospital going through an uncomfortable procedure.
The story doesn’t explain much about how the study was performed nor its specific findings. But there are other details that help readers assess the status of the evidence.
For example, the story says “no unusual acceleration of disease occurred” and “the study wasn’t designed to measure effectiveness of the treatment.” And it ends with this quote: “Importantly, people should understand that, at least for neurological diseases like ALS, we are just now getting started with testing our hypotheses about using stem cells as therapeutics,” Glass said. “We do not know if these treatments will work, and it will take time to test these therapies in a systematic and safe way.”
The story does not engage in disease mongering. In fact, it explains that ALS is rare.
The story includes quotes from two people who are not involved in the research. However, it does not mention that the study was partly funded by Neuralstem, a biopharmaceutical company focused on stem cell technology. In addition, study authors have numerous financial ties that weren’t disclosed.
The story mentions that there are no effective treatments available.
The story quotes a lead researcher saying, “we are just now getting started with testing our hypotheses about using stem cells as therapeutics. … We do not know if these treatments will work, and it will take time to test these therapies in a systematic and safe way.”
The story sufficiently provides context on past studies in this area to help readers understand where this research fits into the big picture.
The story does not appear to rely on a news release.
Systematic, Criteria-Driven
I miss @HealthNewsRevu popping up in my feed. Loved seeing this one today.
https://www.healthnewsreview.org/2021/06/zombie-health-care-news/
#healthcare #journalism #ethics #conflictofinterest
Puleeeeease... this 'game changer' weight loss drug causes more nausea and vomiting than a placebo. Some game, some change. My friend Gary would spank you for using the eighth word medical reporters should never, ever use. @garyschwitzer @thackerpd
https://www.healthnewsreview.org/toolkit/just-journalists-writing-tips-case-studies/7-words-and-more-you-shouldnt-use-in-medical-news/ https://twitter.com/OttawaCitizen/status/1361426796126830597
A scary @statnews Op-Ed warns that govt attempts to rein in Pharma may cut off access to "life-changing" drugs.
It takes @garyschwitzer to let us know: the author spent 10 years as Pfizer's public-policy chief. https://twitter.com/garyschwitzer/status/1360325022578053123
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like