Health Canada not enforcing pharmacovigiliance with Gilead
Health Canada not enforcing pharmacovigiliance with Gilead
Remdesivir maker has submitted a total of 7 adverse event reports to Canadian pharma authority
Note — This article follows up on the remdesivir Access to Information story here
In late July 2020, following an “expedited” 6 week data review, Health Canada authorized remdesivir as an in-hospital covid treatment for ages 12 and up.
Health Canada publicly claims that its secret contract with Gilead Sciences requires the drug maker to submit reports on all serious adverse events:
In August 2022, remdesivir adverse event reports were requested under section C.01.020.1 of the Food and Drug Regulations, which requires Canadian hospitals to report serious drug events. Health Canada responded with an interim release of the 14 total reports submitted by hospitals, found here.
When asked how many reports remain, this was the response:
The third party can only be Gilead.
This means either,
Remdesivir is so safe that Gilead is aware of just 7 serious adverse events.
Keep in mind that 2 of the 14 remdesivir reports generated by Canadian hospitals were deaths, and that 53% of patients died in a remdesivir trial for ebola, leading to premature termination by data safety monitors.
Or it means…
Remdesivir is dangerous and Gilead is breaking its obligation to report serious events to Health Canada.
Gilead likewise withheld remdesivir data from the European Union (who still uses the drug on its citizens anyway).
WHO recommended against remdesivir in November 2020, but in April 2022 started promoting the drug for mild cases of covid! 🤔
Logical conclusion? Worldwide regulatory capture.
See the first remdesivir release package here
Update: Gilead’s reports are released
Keep in mind an underreporting factor for adverse reactions in general. Even though there is a “requirement” to report, there is no incentive to report and there are no penalties for non-reporting. There is the same requirement to report vaccine adverse reactions but we know that reporting in Canada appears worse than other jurisdictions like even the US and UK. Health Canada will continue the narrative of “safe and effective” with remdesivir as they are with the COVID-19 vaccines, only until there are criminal charges.