Thread by @michaelmina_lab, This is a F*^%ing joke @US_FDA Only now, after 150,000 deaths, a [...]

This is a F*^%ing joke @US_FDA

Only now, after 150,000 deaths, a test is finally authorized for asymptomatic screening.

Worse, this offers nothing new!

Americans will still require a doctors prescription to get an asymptomatic screen!

1/n https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-screening-people-without-known-or">https://www.fda.gov/news-even...

Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without...

FDA reissued the LabCorp COVID-19 RT-PCR Test EUA for screening of asymptomatic people and to allow pooled sample testing

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-screening-people-without-known-or

@US_FDA is the gatekeeper to what tests can be performed.

The US testing program is an absolute failure and, in turn, offering no useful avenue to help curb outbreaks.

Why is this not seen as the daily f*^%ing emergency that it is!?

Many people are dying every hour

2/n

We have to rally around new ideas.

The FDA, as the gatekeeper, must take a leading role to be imaginative and think outside the box!

Or at least get people to help think outside the box.

Continuing to simply apply diagnostic tests to screening is not working.

3/

Worse, formally opening up diagnostic tests to asymptomatic screens will only further erode the already failing #COVI19 diagnostic turnaround times.

Offering pools of 5 will not help either

This is a national catastrophe and @US_FDA must consider whole different approaches

4/n

Or, alternatively, FDA can release their stranglehold over screening tests and allow other public health agencies (ie county / state) to decide what can be done

There are many ways to use screening to control outbreaks - but none can occur within the existing approved structures

Finally, my apologies for the pseudo swearing. I am just so sick of inaction and lack of imaginative change

Why do we call ourselves the most innovative nation when in a national crisis we just keep doing the exact same thing and hope it will eventually do something different.

This is one option for how to turn this around but requires thinking very differently at the FDA

https://twitter.com/profvrr/status/1283741664285200384?s=21">https://twitter.com/profvrr/s... https://twitter.com/profvrr/status/1283741664285200384">https://twitter.com/profvrr/s...

https://twitter.com/profvrr/status/1283741664285200384?s=21

And here is a link to an @nytimes OpEd we wrote about the issue

https://twitter.com/michaelmina_lab/status/1279086348310392840?s=21">https://twitter.com/michaelmi... https://twitter.com/michaelmina_lab/status/1279086348310392840">https://twitter.com/michaelmi...

https://twitter.com/michaelmina_lab/status/1279086348310392840?s=21

And an abbreviated and illustrated version of the TWIV interview that was compiled by @MedCramVideos is linked here.

https://twitter.com/michaelmina_lab/status/1285742063946956803?s=21">https://twitter.com/michaelmi... https://twitter.com/michaelmina_lab/status/1285742063946956803">https://twitter.com/michaelmi...

https://twitter.com/michaelmina_lab/status/1285742063946956803?s=21

Also here are two papers by us

One detailing more frequent cheaper tests even if lower sensitivity

https://www.medrxiv.org/content/10.1101/2020.06.22.20136309v2

and">https://www.medrxiv.org/content/1... one detailing just how much more we can get from pooling much larger groups of samples together than FDAs 5.

https://www.medrxiv.org/content/10.1101/2020.05.01.20086801v1">https://www.medrxiv.org/content/1...

Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance

The COVID-19 pandemic has created a public health crisis. Because SARS-CoV-2 can spread from individuals with pre-symptomatic, symptomatic, and asymptomatic infections, the re-opening of societies...

https://www.medrxiv.org/content/10.1101/2020.06.22.20136309v2

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