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FDA approves first new drug for lupus in 56 years


4 Star

FDA approves first new drug for lupus in 56 years

Our Review Summary

Good caveats, including in the patient profiled, who said, "It’s a bittersweet thing for me because I have friends with lupus for whom this drug won’t work. There’s no one-size-fits-all for lupus and I’m just extremely fortunate that my lupus is mild and is helped by Benlysta."

The story should have discussed potential harms and costs.


Why This Matters

As the story explained, this was not only the first new lupus drug approved in 56 years, but it could be "a milestone that medical experts say could prompt development of other drugs that are even more effective in treating the debilitating immune system disorder."


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The cost of the drug wasn’t mentioned – a big oversight.  Other news stories pegged it at about $35,000 a year.

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


Adequate job.  The story explained: "But experts stress that Benlysta is not a miracle drug: It only worked in 35 percent of North American patients tested and was not effective for patients with the deadliest form of the disease. Additionally, it did not show positive results in African Americans, who are disproportionately affected by lupus."

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

Not Satisfactory

There was no discussion of harms.  An NPR story, by comparison, pointed out that "There are side effects, of course, and some of them are pretty serious. In clinical tests involving about 2,100 people, 11 taking Benlysta died compared with 4 getting placebo. About 6 percent of people taking Benlysta got serious infections compared with 5.2 percent on placebo."

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


The story offered an interesting historical perspective on the evidence: "The company originally tested Benlysta, known generically as belimumab, as a treatment for rheumatoid arthritis. When a mid-stage trial in lupus patients failed to meet researchers’ goals in 2006, many analysts wrote the drug off and downgraded the company’s stock. But when scientists reanalyzed the data they found that the drug helped block the antibodies that cause lupus symptoms in a subset of patients."

Does the story commit disease-mongering?


No disease mongering of lupus.

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


Two independent sources were quoted.

Does the story compare the new approach with existing alternatives?

Not Applicable

Not applicable.  With no other new drug approved for lupus in 56 years, there’s not been much to compare it with.  The story did state that some experts thought this "could prompt development of other drugs that are even more effective in treating the debilitating immune system disorder."

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


The focus of the story is FDA approval of the new drug.

Does the story establish the true novelty of the approach?


The headline explains that the FDA approved the first new drug for lupus in 56 years.


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


It’s clear the story did not rely solely on a news release.

Total Score: 7 of 9 Satisfactory


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