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New Pill for MS Shows Promise in Clinical Trial

Rating

4 Star

Categories

New Pill for MS Shows Promise in Clinical Trial

Our Review Summary

Readers are well served by information on the study’s design, the preliminary nature of the research, the industry-funding behind the work and the strength of the study’s findings. The story also took the additional step of making it clear to readers in multiple ways what type of work is left to be done before this drug becomes a strong clinical option. We wish the story had at least offered some cost information on the experimental drug’s sole competitor, that it had provided more numbers to quantify both benefits and risks, and that it had told readers that some of the information in the story came directly from a news release.

 

Why This Matters

Relapsing-remitting multiple sclerosis is one form of the disease. It is characterized by a waxing and waning of symptoms with no disease progression. Treatment has been aimed at the immune system and has included injectable drugs (interferons, glatiramer and natalizumab) as well as a newly introduced oral drug, fingolimod. None of the existing treatments are ideal and all bring a host of side effects into play. An additional oral medication as a treatment option could increase medication compliance with some patients and could prove to be the right therapy for people with specific profiles. As this story also notes, though, promising results in clinical trials are still a good distance away from an actual clinical application. We appreciate the notes of caution throughout this piece, and we wish more stories took this approach.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Multiple sclerosis is a chronic illness requiring ongoing treatment. So, cost of treatment is an important consideration. This story did not include cost information,in part because the drug in question is not on the market. Acccording to this Bloomberg story, it costs $4,000 a month, and searches on Drugstore.com and other sites back this up.

Tip:  we’ve added a new resource for journalists to help them track down costs of medical interventions.

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

Not Satisfactory
The story only presents the benefit information in relative terms, and we think this may mislead readers. The story says, “The annual rate of MS relapse was 23 percent lower in the laquinimod group compared with the placebo group. In addition, disability progression was reduced by 36 percent and brain atrophy by 33 percent compared with those getting the sham treatment.” We’d like to see these comparisons made in absolute terms, too, and, if possible, a number needed to treat would have been nice.

A general comment – not necessarily directed at this story nor at those responsible for it:  We’ve recently heard from some journalists that they can’t or won’t report on absolute risks or NNT (harms or conflicts of interests, either, for that matter) if the researcher doesn’t provide that information.  We have no patience for that stance or argument.  That’s akin to admitting that we’ll only report what we’re spoonfed.

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

Not Satisfactory

The story says, “The study found that to date, the new drug appears to be both safe and well-tolerated.” It also says, “Adverse events, including serious events, were comparable to those in the placebo group, according to the researchers. The incidence of liver enzyme elevation was higher in patients treated with laquinimod, according to Comi, but he added that the elevations were temporary, reversible and did not lead to any signs of liver problems.” (That Comi paraphrasing also appears to be lifted directly from an American Academy of Neurology news release.) We would have liked to have seen some actual numbers attached to those adverse events. This is important context for readers.

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

Satisfactory

This story provided more information about the study design and the limitations of the study than most stories we read on drug studies. Right in the lead, the story says that the findings are from “a recently completed two-year clinical trial”. Later, the story says that the “findings concern the experimental drug laquinimod, and stem from work with over 1,100 MS patients at 139 medical facilities in 24 countries.” It goes on to say, “In the two-year, double-blind Phase III trial, participants were randomly divided into two groups: those who were given a daily dose of laquinimod (0.6 milligrams) and those who were given a sugar-pill (placebo); neither the researchers nor the participants knew who received the medication or the placebo.” The story up high gives readers the first piece of information about the study’s limitations, noting that the information comes from a conference, meaning not from a peer-reviewed journal. “He is slated to present his team’s findings this week in Honolulu at the American Academy of Neurology meeting,” the story says. And just in case readers don’t understand the distinction, the story ends by saying, “Since the study is being presented at a medical meeting, it should be considered preliminary until the findings are published in a peer-reviewed journal.”

(We’ve commented on this style of caveat before.  We appreciate the intent.  But if something is preliminary, having it peer-reviewed doesn’t suddenly mean it’s not preliminary.  “Preliminary” should be used for small, early, short-term studies with unreplicated results. The peer review issue is important, but it’s a different issue, referring to the fact that peers haven’t had a good chance to scrutinize the data yet.)

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease-mongering. In fact, we would have preferred a little more information about the disease and the different drugs used to treat various aspects of the disease.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story quotes two independent experts, and makes it clear that the study was funded by the maker of the drug being studied. “The current research was funded by Teva Pharmaceuticals, the maker of laquinimod,” it says.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story includes an unchallenged comment that “oral drugs are much better than shots,” without explaining why or what sort of evidence supports this claim. It redeems itself, though, by explaining that the inability to draw clear comparisons between the experimental drug and current alternatives is one of the study’s short points. “Laquinimod was not, however, tested against currently existing treatment alternatives, the authors stressed,” the story says. “The team added that the new medication appears to tackle MS by a different type of mechanism than other available options, and apparently works by curtailing the onset of permanent tissue damage while limiting acute inflammation. Then Dr. Gary Birnbaum, director of the MS Treatment and Research Center at the Minneapolis Clinic of Neurology, provides readers with a good summation of why this new drug, while not necessarily a silver bullet, could be clinically beneficial. “And MS is probably not a single disease,” Birnbaum says. “So different medications may work better for some and not others, which is why this new drug could end up being an important addition to the armamentarium.” He adds, though, “However, we still need to have a head-to-head comparison with other drugs.”

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story explains early that the drug is currently not available and also that it is only one of many options by saying, “If the experimental medication is eventually approved for use, it would be only the second oral MS drug available to patients, alongside a number of long-standing injectable options.”

Does the story establish the true novelty of the approach?

Satisfactory

Through the use of independent experts, the story explains that this would be one more oral drug and not necessarily anything truly unique. An important discovery, potentially, but not the only game in town.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not rely solely on the news release from the American Academy of Neurology solely, but we were troubled by how closely some of the sentences in the story mirror sentences in the news release. In particular, the story may lead readers to believe that the reporter sought out and interviewed the study’s lead author, Dr. Giancarlo Comi, director of the department of neurology and the Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy. His paraphrased comments are actually from a quotation in the press release.

The press release says: “’The incidence of liver enzyme elevation was higher in laquinimod treated patients,’ said Comi. ‘However, these elevations were temporary, reversible and did not lead to any signs of liver problems.'”

Here is the story’s paraphrase: “The incidence of liver enzyme elevation was higher in patients treated with laquinimod, according to Comi, but he added that the elevations were temporary, reversible and did not lead to any signs of liver problems.

But because the story included input from independent experts, we’ll give it the benefit of the doubt on this criterion.

Total Score: 7 of 10 Satisfactory

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