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FDA Panel Backs Novartis Drug For Treating Parkinson’s Dementia

Rating

2 Star

FDA Panel Backs Novartis Drug For Treating Parkinson’s Dementia

Our Review Summary

The story reports that an FDA advisory panel recommended an existing drug (rivastigmine) be approved for a new use – the treatment of dementia in people with Parkinson’s disease. The story adequately tells readers that the drug is not new, but is being considered for a new purpose. It doesn’t seem to exaggerate the condition (although more info might have been useful). However, several other areas could be improved, including discussion of costs, side effects, benefits, a description of the evidence upon which claims are based, and other treatment options. It would be a concern if this story leaves readers thinking there may be a good treatment option for Parkinson’s dementia that’s about to become available, when this may not be the case. It isn’t clear that this treatment even works in Parkinson’s, and if it does work, that any benefits are meaningful either in the short-run or long-run.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention any cost information for Exelon (rivastigmine).

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

Not Satisfactory

The story does not quantify any benefits. What’s more, the story doesn’t give any idea what the benefits might be or what improvemements might be expected. See comments in “Evidence” section.

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

Not Satisfactory

The story reports the panel believes the drug to be “safe” but does not describe any side effects or harms of rivastigmine. These may include nausea/upset stomach, vomitting, loss of appetite, and headaches.

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

Not Satisfactory

The story does not describe any evidence for therapeutic claims that the drug works for treating Parkinson’s Disease. Additionally, it appears the FDA panel recommended approval of this drug for Parkinson’s based solely on studies from the manufacturer. Another issue is that while this drug might provide some improvement in dementia symptoms among some people with some forms of Alzheimer’s, those improvements may be small and not all people will show improvement. It’s not known whether long-term outcomes, such as nursing home admission, is improved with the drug. It’s not clear that this drug would have the same effects in a different population (those with Parkinson’s), and if so, whether those effects would be meaningful.

Does the story commit disease-mongering?

Satisfactory

There are no obvious elements of disease mongering. The story provides simple, straight-forward descriptions of both Alzheimer’s and Parkinson’s disease, although more information might have been useful.

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

Not Satisfactory

The story does not provide any independent input about the therapeutic claims of rivastigmine for treating dementia in people with Parkinson’s.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does not mention other treatment options, such as memantine.

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

Not Satisfactory

The story fails to mention a projected date for or the next steps in obtaining FDA approval. While the FDA usually follows the advice of the advisory panel, which in this case recommended the drug’s approval for treatment of dementia associated with Parkinson’s Disease, the FDA does not have to follow the panel’s recommendation. There is no discussion of when the FDA might approve the drug for this indication.

Does the story establish the true novelty of the approach?

Satisfactory

The story tells readers that the drug is currently on the market for treatment of mild to moderate Alzheimer’s disease. In other words, the story adequately reports the drug is not new, but is being considered for a new purpose.

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

Satisfactory

There is no obvious evidence the story relies on a press release.

Total Score: 3 of 10 Satisfactory

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