Reuters doesn’t dig deep enough into FDA’s approval of ‘new’ Parkinson’s drug Gocovri

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

While raising hopes of patients, it is irresponsible to be mentioning this “new” drug, as well as its basic, generically-available ingredient, amantadine, without discussing costs to patients. The new drug is likely to be much more expensive than generic amantadine, as this STAT article reports.

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

Not Satisfactory

The only benefit information we receive is this: “With Gocovri, which targets both dyskinesia and off time, patients will be able to reclaim about 3.6 hours of their day, CEO Gregory Went said in an interview ahead of the decision.”

One wonders how the drug was tested, and how the comparator group fared. Without this information, the story is robbed of its relevance. There is little to no information to help patients understand the potential benefits. For example, how many hours had the patients in this study “lost” prior to going on this medicine? What is the impact on quality of life of this extra time? For how long do patients benefit from the drug?

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

Not Satisfactory

None of the harms related to amantadine are mentioned in this release. One has to be especially cautious of the drug’s effects on the central nervous system, including nervousness, anxiety, agitation, insomnia, difficulty in concentrating, and exacerbations of pre-existing seizure disorders.

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

Not Satisfactory

There is little information about the strength of the medical evidence to support the use of this drug in Parkinson’s patients with dyskinesia. What does the evidence show? How high-quality is the evidence? What were the limitations?

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

Not Satisfactory

Outside sources not connected to the study would have been a great addition to the story, but there were none.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story makes it clear that this is the first time this drug has been approved by the FDA for this indication. However, we wanted to know: How does this version compare to the currently available amantadine that has been used off label for this condition? Is it worth the extra cost and hassle of switching?