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"FDA clears restricted return of MS drug to market in United States"

National Post

Source: National Post

Published: 06 Jun 2022

Category: Pharmaceutical

Rating: (3 stars)

what they said (Hover the mouse cursor over underlined words for more info)

WASHINGTON (AP) - A multiple sclerosis drug pulled from the market last year because of a rare but life-threatening side-effect will return under a restricted distribution program, U.S. health officials said Monday.
The Food and Drug Administration said it will let Biogen Idec Inc. and Elan Corp. PLC resume selling Tysabri under a requirement that doctors, pharmacies and patients register with a program designed to ensure the safe use of the drug. The drug has never been approved for use in Canada.

The original article can found in the Media Doctor archives.

how did it rate? (more information)

Criteria Rating
Total Score 6 of 10
Availability of Treatment Satisfactory (?)
Novelty of Treatment Satisfactory (?)
Disease Mongering Satisfactory (?)
Treatment Options Not Satisfactory (?)
Costs of Treatment Not Satisfactory (?)
Evidence Not Satisfactory (?)
Quantification of Benefits of Treatment Not Satisfactory (?)
Harms of Treatment Satisfactory (?)
Sources of Information Satisfactory (?)
Relies on Press Release Not Applicable
Quantification of Harms of Treatment Satisfactory (?)

what we said (Hover the mouse cursor over underlined words for more info)

This is clearly an American article that does not reflect a Canadian audience's concerns. There was no mention of the current regulatory situation in Canada or the likely costs to Canadians wishing to take the drug here or in the US. Given the potential fatal risks of the drug, a timeline of the progression of MS should have been related to the possible development of PML.(progressive multifocal leukoencephalopathy).

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