Reuters doesn’t dig deep enough into FDA’s approval of ‘new’ Parkinson’s drug Gocovri
Rating
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
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.
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?
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.
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?
Satisfactory
There was no disease-mongering.
Not Satisfactory
Outside sources not connected to the study would have been a great addition to the story, but there were none.
Satisfactory
The story mentions that deep brain stimulation is a treatment option for those with severe symptoms.
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.”
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?
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
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like