New Multiple Sclerosis Therapy Promising in Early Trial

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

It may have been understandable that costs wouldn’t be discussed at this early stage of research.  However, when the Mayo expert weighed in at the end about a comparable drug, this provided the perfect and easy opportunity for the story to include ballpark costs of drugs in this category. And a ballpark cost of the comparable drug is somewhere around $20,000.

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

Not Satisfactory

Same criticisms as in the “evidence” criterion:

What does an 89 percent drop in lesion count mean?  What is the relationship between lesion count and symptoms or eventual outcome? How does a patient relate lesion count to something meaningful in his/her life?

Relapse rates may have been a more helpful indicator, but we’re only told they were “much lower.”  How much lower?  What does that mean to patients?

And if the Mayo expert says that a competing drug has been in early trials for years – why not provide the evidence from those trials?

The headline says “promising” but the independent expert says “I see no major advantage of this drug versus that older drug. It’s not better or worse. It’s the same” and that it’s not a breakthrough.

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

Not Satisfactory

What does “appears to be safe” and “no serious adverse effects directly attributable to the drug” mean?

Here’s what the study abstract stated:  “We noted serious adverse events in two of 54 (4%; 95% CI 3·0—4·4) patients in the placebo group, one of 55 (2%; 1·3—2·3) in the 600 mg ocrelizumab group, three of 55 (5%; 4·6—6·3) in the 2000 mg group, and two of 54 (4%; 3·0—4·4) in the interferon beta-1a group.”

Why didn’t the story report this?

What side effects were seen?  Tell readers/patients and let them decide if they are serious or not.  And how did researchers know that whatever was seen was not directly attributable to the drug?

And what’s the safety record been of the drug the Mayo expert described that has a longer track record?

Insufficient information on harms.

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

Not Satisfactory

What does an 89 percent drop in lesion count mean?

Relapse rates may have been a more helpful indicator, but we’re only told they were “much lower.”  How much lower?  What does that mean to patients?

And if the Mayo expert says that a competing drug has been in early trials for years – why not provide the evidence from those trials?

All in all, the story didn’t provide a meaningful context for readers.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

We only had the Mayo expert’s broad comments comparing ocrelizumab and rituximab – but no comparative data on benefits and harms were provided.

Does the story establish the true novelty of the approach?

Not Satisfactory

This is perhaps the most glaring weakness in the story.

The headline says calls it a “new therapy.”  (It’s not a therapy until it’s proven to be one.)

The body of the story uses “new” or “novel” three times.

But then the Mayo expert says “there’s nothing novel about this at all.”

So which is it?