Our Review Summary
The story reports the recent FDA approval of thalidomide for the treatment of multiple myeloma (or cancer of the bone marrow) with appropriate caution. The story weighs the unclear benefit and potentially serious side effects of the medication for a group of patients already undergoing chemotherapy.
The story mentions that thalidomide has been available since 1962, but it was banned worldwide for use in pregnant women, as it caused serious birth defects. It has been used “off-label” as part of the treatment for multiple myeloma. The story does mention that recent studies of the effectiveness of thalidomide in bone cancer patients are mixed: in one study the drug did not prolong patients’ lives; in another it did, but with serious side effects. However, the story does not mention what these side effects were, or if patients had to discontinue the drug as a result.
The story mentions the harms of taking thalidomide when pregnant. However, for the intended population of bone cancer patients, the greater potential harms would be blood clots in the brain or lungs, which are increased with the chemotherapy drug dexamethasone. More common side effects are not mentioned. In one of studies cited, these common side effects included fatigue, constipation, rash, sedation and peripheral neuropathy, or numbness and pain in peripheral nerves, usually in hands or feet.
There is no discussion of other treatment options for multiple myeloma, and no mention of the cost of thalidomide in addition to chemotherapy.
Overall, a good job for a 300-word breaking news story.
(We make copy-editing errors, so we know what it’s like. But it was surprising to see the drug’s name misspelled in the last paragraph of the story. This error was then duplicated in many media outlets that ran the AP story.)
Criteria
Not Satisfactory
The cost of thalidomide as part of chemotherapy treatment is not mentioned.
Not Satisfactory
No quantitative evidence of the drug’s effectiveness. The story does mention that reviews of its effectiveness in helping patients live longer are mixed: in one study the drug did not prolong patients’ lives; in another it did, but with serious side effects. The story does not mention what these side effects are, the incidence of these side effects, or if the patients had to discontinue the drug as a result.
Satisfactory
The story mention the harms of taking thalidomide when pregnant. However, for the intended treatment population of bone cancer patients, the greater potential harms would be blood clots in the brain or lungs. The incidence of these serious side effects in recent studies is not mentioned. The story does note that these serious risks are increased with the chemotherapy drug dexamethasone. More common side effects are not mentioned. In one of the studies cited, these common side effects included fatigue, constipation, rash, sedation and peripheral neuropathy (tingling and pain in the feet and hands). The story does mention that certain side effects may outweigh the benefit of the drug for some patients.
Satisfactory
There is little mention of quantitative clinical evidence, however, there is a very brief overview of the pros and cons from recent studies, as well discussion of the mixed results of the drug in combination with chemotherapy.
Satisfactory
No evidence of disease mongering. The drug is for patients with bone cancer.
Satisfactory
FDA is cited.
Not Satisfactory
The story does not mention other treatment options for multiple myeloma.
Satisfactory
The focus of the story is the recent FDA approval of thalidomide as part of a multiple myeloma (or a form of bone cancer) treatment regimen.
Satisfactory
The story mentions that thalidomide has been available since 1962 and has been used “off-label” as part of the treatment for multiple myeloma, or cancer within the bone marrow.
Satisfactory
There is no evidence this is taken directly from a press release. The story mentions the approval of the drug for bone cancer, but is cautious in reporting its efficacy as part of cancer treatment. The story is balanced.
Total Score: 7 of 10 Satisfactory
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