A beautifully written two-part report for which we offer only a few thoughts of constructive criticism.
Some excellent reporting and writing is demonstrated in this piece. The patient stories are beautifully drawn, and the science, for the most part, is well explained. It provides a range of viewpoints on the treatments, gives cost information for the trial, and establishes the novelty of the technique.
But the story could have dug deeper into the question of what is causing the ALS that stem cells might help. And that the limited response in only 1 of 15 patients could actually be due to something other than the stem cells.
In short, we would have liked to see more about the limitations of the evidence and about the tremendous mountain that needs to be climbed before patients are likely to benefit from new treatments from ALS.
Our main constructive criticism is that the story repeatedly talks about how the stem cell technique “may provide hope” for ALS sufferers. Should such stories emphasize a frame of hope? Or simply report on the evidence and let readers decide how much hope to invest in the evidence? And the evidence on this approach so far is very limited and not particularly good. The story also could have provided more context and background about the history of failed stem cell experiments to date.
The story does talk about the cost of the trial. It says, “The company has shelled out about $2.5 million for the first phase of the trial and provided the stem cells, one of the company’s premier products.”
But the story also could have included a line something like, “this treatment is years away from consideration for routine use. If it reaches that point, it will likely be a very expensive treatment costing tens of thousands of dollars or more.”
The story says early that, “One patient showed a remarkable improvement for a while, though U-M’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that. The other 14 showed no improvement.” We’re not sure what to make of that. Later in the story it says, “This part of the trial tests safety only. By design, it doesn’t assess the efficacy of the treatment yet.” So this makes it even more confusing as to why we are being told that there should be so much hope in the air about this trial. And after that we learn that the patient who saw improvement is now in decline. We gave this one a pass, though, because the story does say repeatedly that only one patient out of 15 saw any improvement.
There is no mention of harms from the trial in the story. The story quickly dispenses with what happened to most of the people in the trial, never making it clear whether their conditions were worsened because of the trial. Instead, every time the tone of the story starts to be cautious, the next sentence stars banging the drum for stem cells again. “So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them,” the story says. “Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive, from his home overlooking a sparkling Georgian lake.”
What are the potential harms? Could this approach make a terrible situation even worse and lead to earlier death?
We’ll give the story the benefit of the doubt because it explains that the study is small, that it is “tentative and early,” and that the results have been “remarkable” in just one patient so far. And the story paraphrases the researcher’s reminder: “This part of the trial tests safety only. By design, it doesn’t assess the efficacy of the treatment yet.”
But we think the story could have included a bit of discussion about whether this scientific line of inquiry is likely to deviate from the string of stem cell failures in recent years. Instead, the story says that the technique promises to “push back the battle lines against other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s or Huntington’s.” What? Because one out of 15 patients showed short-term signs of improvement but later declined?
The story does not engage in disease mongering – far from it. It is a very thorough and thoughtful portrayal of the disease at different phases, how it affects individuals and how it affects their families. This writer must have spent an admirable amount of time trying to get to know the patients and their families, and their portraits are written with grace and wonderfully telling details.
A good range of voices is represented here. One of the best comments in the piece came from one of the patients. “It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” says Ed Tessaro. “I don’t think I have anything to lose … and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.” That idea could have led to a more nuanced and honest portrayal of clinical trials like this. The story also notes the role of “Neuralstem, a Rockville, Md.-based biomedical company that is funding the trial.” It would not have been difficult to find a more cautious or skeptical specialist for some additional balance.
The story did state:
Until there is a cure or treatment, ALS clinics like the one at U-M can only offer help for the symptoms — braces and wheelchairs for when limbs fail; occupational therapy for when patients need help dressing or opening drawers; soft diets for when they can no longer swallow, and tracheostomy tubes for when they can no longer breathe on their own.
Riluzole — better known as Rilutek — is the only drug approved by the FDA for ALS. It may extend life by a few months for some, but it doesn’t improve a person’s condition.
It would have been helpful for the story to at least touch on other experimental work in the field of ALS.
Nonetheless, we’ll give it the benefit of the doubt on this criterion.
The story explains the different phases of clinical research necessary to develop this treatment into a clinical application. It says, “Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.”
It wouldn’t hurt for a story like this to be more explicit and state that an approach like this is at least 3-5+ years from routine use, if it ever gets through the trials.
The story claims novelty right from the beginning. It says, “It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord.” It also shows how this technique would be a significant advance if successful.
This story did not rely on a news release.