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Ottawa Hospital release on MS therapy hits the right notes with clarity and cautions

MS breakthrough: Replacing diseased immune system halts progression and allows repair

Our Review Summary

multiple sclerosis tabletThis 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.

 

Why This Matters

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.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

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.

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

Satisfactory

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.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

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.”

Does the news release seem to grasp the quality of the evidence?

Satisfactory

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.

Does the news release commit disease-mongering?

Satisfactory

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.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

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.”

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

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….”

Does the news release establish the true novelty of the approach?

Satisfactory

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.”

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

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.

Total Score: 8 of 10 Satisfactory

Comments (1)

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A Fisher

June 23, 2016 at 1:49 pm

The 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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