Reuters story on MS drug for kids even less informative than the FDA news release

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no cost data. Gilenya costs $8,210 for a 30-day supply, according to the web site drugs.com.

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

Not Satisfactory

The story stated:

In a clinical trial 86 percent of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46 percent of those who were administered another MS drug.

However, it didn’t explain how many relapses patients in either groups experienced, so readers can’t tell how much of an impact these drugs actually had.

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

Not Satisfactory

No potential harms were mentioned.

The FDA said side effects of Gilenya in pediatric trial participants were “similar to those seen in adults,” with the most common being headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.

The FDA added there are other serious risks with the drug including slowing heart rate, infections including a rare brain infection, vision problems, swelling and narrowing of the blood vessels in the brain, respiratory problems, liver injury, increased blood pressure and skin cancer, as well as potential harm to a developing fetus.

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

Not Satisfactory

The story didn’t give a sense of the strength of evidence behind this drug. For example, it didn’t tell readers what the comparison drug was in the trial, nor how many children were in the trial.

According to the FDA, the clinical trial evaluating the effectiveness of Gilenya in treating pediatric patients with MS included 214 patients aged 10 to 17 and compared it to the drug interferon beta-1a.  Novartis said it was the first clinical trial of the drug specifically designed for children and adolescents with relapsing MS.

The story also could have mentioned that it’s unclear whether the frequency of relapses will accurately predict a patient’s degree of disability years later.

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

Not Satisfactory

There were no independent sources, and the fact that Novartis funded the study to support the FDA approval isn’t mentioned.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story mentioned that Gilenya was compared with another drug, but it doesn’t go into specifics. It also doesn’t mention that corticosteroid medications can be used to reduce inflammation.

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

Not Satisfactory

The story appears to have relied solely on the news release. But it was less informative and had fewer details than the news release.