This is nearly a textbook example about how a news release can take mixed results from a clinical study and both highlight the promising findings while illuminating the harms and other issues, too. The only glaring omission here was any mention of the costs of treatment, which likely are considerable.
The release discusses a clinical trial of a therapy for multiple sclerosis (MS) that includes destruction of the immune system with chemotherapy and reconstitution of the immune system with previously preserved patient’s blood stem cells. The study is of 24 subjects followed from 4 to 13 years.
As the news release states, “MS affects approximately 2.3 million people around the world, causing symptoms that range from blurred vision to extreme fatigue to partial or complete paralysis.” This therapy is intended for only those with severe relapsing disease, but these are the people who become the most disabled the quickest and for whom specific MS drugs do not seem to work well.
There is no mention of the cost of this therapy. However, it is already used for treating leukemia and some other types of cancer and so the costs should be known. Because the treatment involves destruction of the immune system via chemotherapy and the use of stem cells, it is a very complex and intensive treatment requiring long hospital stays. This therapy is likely extremely expensive.
The release clearly indicates that all of the subjects showed benefits from the therapy with none of the patients requiring MS drugs, showing additional brain lesions or exhibiting a clinical relapse. It provided quantification in almost each of its bullet points on outcomes from the therapy. It also states that 40 percent of the subjects regained some of their lost function.
In the very first quote — the first quote! — the release talks about side effects. This is a huge departure from most news releases about clinical studies. It says, “This is very exciting. However, it is important to note that this therapy can have serious side effects and risks, and would only be appropriate for a small proportion of people with very active MS. People with MS who have had significant disability for a long time would likely not benefit.” So it acknowledges the risks and then goes beyond. These people will benefit. These people will not. You have to appreciate that clarity. The release also says later, “Indeed, one participant in this study died of liver failure due to the treatment and another required intensive care for liver complications. The treatment regimen was modified over the course of the study to reduce toxicity, but all participants still developed fevers, which were frequently associated with infections.”
The release explains all of the relevant details about the structure of the study, saying: “Led by Dr. Harold Atkins and Dr. Mark S. Freedman of The Ottawa Hospital and the University of Ottawa, the trial included 24 participants who were followed for up to 13 years.” By noting high up that the study was small on participants but long on duration it provides people with the right context for understanding how to weigh the evidence here.
There is no disease mongering in the release. And we like how the release took care to stratify the different levels of MS and not to talk about it as a monolithic disease. It was a good reminder for writers that people don’t experience diseases in one way and that diseases can change their character as they progress.
Very early in the release it notes who funded the study and — a rarity — how much the study cost. “The $6.47 million trial was funded by the MS Society of Canada and its affiliated Multiple Sclerosis Scientific Research Foundation. The research was also supported by The Ottawa Hospital Foundation, The Ottawa Hospital Department of Medicine and Canadian Blood Services.”
The release doesn’t mention any alternative treatments or compare how the new therapy compares with the standard treatments. The study does compare the patient volunteers’ individual outcomes before and after treatment.
The release establishes that the therapy is available at limited locations where it states, “People who are interested in this therapy should speak with their own neurologist, who can request a referral to The Ottawa Hospital MS Clinic or another major hospital with experience in this area….”
While acknowledging that the combined chemotherapy and stem cell intervention has been used previously, the release describes the novelty of this research as:
“Our study is unique in that we used a stronger cocktail of drugs to eliminate the immune system, we followed the participants for a very long time, and the majority of our participants have had significant, long-lasting responses.”
The release is cautious where it needs to be and provides the right context for readers to understand that these are promising findings but only for a small segment of the population.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
Comments (1)
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A Fisher
June 23, 2016 at 1:49 pmThe news release does not mention how the treatment, performed 13 years ago, differs from now prevailing methods. Indeed, the protocols have changed over the last 13 years to bring the mortality rate down, which is of utmost importance.
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