The Solution

We need a new Pathway for Authorization at FDA

There are 3 primary bottlenecks in getting rapid tests authorized at FDA

None make sense biologically & remain for seemingly no reason but sheer stubbornness of FDA to not recognize this PUBLIC HEALTH EMERGENCY
🧵
1/
1) We do not allow much better data already collected in Europe to be used for immediate EUA of the very best tests in use by millions in Europe.

But We should! - many of them are better than most of ours available in the US

Could increase tests by 100’s of millions in days

2/
2) FDA requires Rapid Ag tests compared to entirely different technology, w entirely different analyte that diminishes in a very different time scale.

This causes MASSIVE slow downs and hurdles with clinical trials for EUA

Compare rapid tests to a gold standard rapid test!!

3/
3) Allow ppl who know they are positive to be allowed to participate in the clinical trials

Why!!! In an emergency does FDA force companies to go find positive people who have no idea they are positive (takes a Very long time) vs quickly recruiting positive ppl?

Must stop

4/
4) Have a testing expert advisory committee inform the small group of FDA leaders on exactly what metrics are needed of new tests whose primary purpose is public health - not medicine.

We have this for vaccines and medicines - WHY not Tests - a crucial public health tool

5/
5) STOP allowing the key person responsible for the nations test EUAs, to have recently been a top executive of 1 of the only 2 companies able to secure an EUA for most ‘21

He created the first Rapid Ag test (Quidel Sofia) that FDA gave an EUA to!

Can’t make this stuff up!

6/
Here is the article that discusses the tweet above.

propublica.org/article/heres-…

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More from @michaelmina_lab

23 Dec
This article captures so well the difficulty, persistence and personal toll it’s taken to help the US (and elsewhere) have the crucial tools we all need to keep society going through this pandemic.

Thank you
@BostonGlobe @hannaskrueger

1/

bos.gl/aA6bkfK
I can’t say I succeeded. If I had, we wouldn’t have long lines and empty shelves. I truly did everything possible and imaginable to me to try to ensure we didn’t end up right here, right now. Blind in the face of a much more infectious virus that is sweeping the globe.

2
A year ago, @hannaskrueger profiled a series of epidemiologists & public health leaders. That, in my view, was a remarkable portrayal of just how difficult the virus had been on many front line workers.

I wish I could say it got better. But 2021 was immensely more difficult

3/
Read 4 tweets
22 Dec
At what point did the science of rapid tests get lost??

FREQUENCY • ACCESSIBILITY • SPEED are most important aspects of a test for public health

Talking about tests not detecting in the 1st 24 hours of contagiousness assumes people are testing in those hours. Most don’t.

1/
Most of the time that someone is contagious is not spent in the first 24 hrs of being contagious. Obviously.

Frequent rapid testing for public health has always been about the sensitivity and EFFECTIVENESS of the testing REGIMEN.

2/
If a test fails to turn pos on d 1 but someone wasn’t using the test that day, then it doesn’t matter

It’s MORE likely ppl use a test sometime in days 2,3,4,5,6 or 7 than day 1. Public health testing also must consider the days it DOES detect - not just the days it doesn’t.

3/
Read 6 tweets
22 Dec
Here’s a frustrating secret

Today - in midst of Omicron - millions of Americans are begging for access to rapid tests, thousands dying daily.

Get this:

many manufacturers with very high quality rapid tests are begging To ship 100’s of millions of tests to US

But can’t.

1/
These are some of the largest companies in the world that make diagnostic tests.

Their rapid tests have been used the world around in this pandemic with research paper after research paper showing their benefit and quality.

But FDA has them in a holding pattern for months

2/
Why?

Bc despite tremendous amount of data from real world use in millions of ppl - FDA demands the companies check off onerous but remarkably useless check boxes designed for evaluating medical devices.

FDA formally does not recognize that public health testing exists

3/
Read 14 tweets
22 Dec
🧵

Think rapid tests don’t work w Omicron?

In last few days almost everyone I know diagnosed, found out on rapid test & same for MANY MANY others:

PCR test one day - negative.

But then used rapid test day after - BC THEY WERE EASY & ACCESSIBLE & FAST -

Positive

1/
This has never ever been about how good is a single test. Ever.

That ship sailed in Feb 2020 in my view. It’s not about the individual test

I don’t know how to be any clearer

It’s about the testing regimen!

Test once, test again, etc You don’t know when you are infected

2/
A single PCR will not help if it’s a one time thing - Even if weekly. Negative today -positive tomorrow and don’t know it

It is why we published in early 2020 about how we need to focus on serial testing over multiple days

This isn’t a static state

3/

science.org/doi/10.1126/sc…
Read 9 tweets
21 Dec
Well - it’s Finally happening!

US will make 500 million #Rapidtests available for free to Americans

@POTUS⁩ will invoke the Defense Productions Act to make this happen

STARTING in January… but note, *starting* - not all in January

1/ nytimes.com/2021/12/21/us/…
It’s a terrific start and invoking DPA is a great move - I do believe I wrote that we needed to invoke DPA over a year ago!

Though to temper expectations - there’s 350 million ppl in the US and 500 million free tests distributed over a period of months only goes so far

2/
But now the ball is rolling.

Don’t expect to be swimming in rapid tests. Do expect to be able to order them free and the WH will figure out how to keep keeping up.

This is a great start - along with putting @T_Inglesby at the helm in the White House Testing!

3/
Read 5 tweets
21 Dec
Rapid tests work!

#Rapidtests given out to people for free in the UK cut hospital stays by a third!

Ppl say - but look there is still transmission. Sure - but it doesn’t mean it wouldn’t have been worse.

A LOT of people are living today Bc of them

1/

theguardian.com/world/2021/dec…
“we found that Liverpool city region’s early rollout of community rapid testing was associated with a 32% fall in Covid-19 hospital admissions after careful matching to other parts of the country in a similar position to Liverpool but without rapid testing”

2/
“We also found that daily lateral flow testing as an alternative to quarantine for people who had been in close contact with a known infected person enabled emergency services to keep key teams such as fire crews in work, underpinning public safety.”

3/
Read 5 tweets

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