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

Rating

2 Star

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Adamas Pharma secures approval for Parkinson's dyskinesia drug

Our Review Summary

One of the main drugs used to treat Parkinson’s disease, levodopa, frequently causes a disabling side effect known as dyskinesia. Drugmakers of a newly approved drug, Gocovri, claim their medication can ease this side effect.

For patients, Gocrovi may be a welcome addition. But there are a number of important unanswered questions that this story doesn’t answer. Notably, that this drug is essentially the same medication as amantadine, which has been used off label for this condition for years. Will Gocovri really be an improvement, or just an expensive version of amantadine?

 

Why This Matters

Since the basic ingredient in Gocovri, the antiviral drug amantadine, has been on the market for decades, one wonders what kind of medical advance this approval represents. Some independent perspective was needed in this story to help readers–including investors who read business news like this–make sense of the claims.

Criteria

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 commit disease-mongering?

Satisfactory

There was no disease-mongering.

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 compare the new approach with existing alternatives?

Satisfactory

The story mentions that deep brain stimulation is a treatment option for those with severe symptoms.

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

Satisfactory

The story makes this clear: “The company said the drug is expected to be available in the fourth quarter, and formally launched in January 2018.”

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?

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

Satisfactory

While it didn’t provide much beyond the drug company’s news release, it didn’t appear to rely solely on the release, as there were some statements from an interview.

Total Score: 4 of 10 Satisfactory

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