From Lisa:

Dear —— ,

I am both a mom to a Sarasota County School student, as well as a pediatric nurse practitioner in Sarasota. Since becoming aware of the seriousness of the COVID-19 pandemic, I have been working hard in both these roles to provide needed healthcare and to minimize spread. 

Policies understandably change frequently, often on a daily basis. We are watching science evolve in real time as our knowledge about this rapidly grows.

Once schools shut down in March, our office saw what was an extraordinary number of patients with respiratory illnesses immediately drop to almost none. This continued through the summer. 

I believe all of us have felt some trepidation as the decision to allow in-person schooling to resume in Florida was made. I believe we all feel the challenge of weighing the educational and emotional costs of having our children not attend in-person school, with the costs of potential increased cases and deaths by allowing them to gather together. 

Traditionally, once school resumes in the fall we begin seeing an increase in illnesses. Despite all the measures with masks and distancing and hand washing, this has proven to be the case this year as well. 

My office is providing rapid SARS-CoV-2 testing. As current evidence suggests that children in particular may have varied and less serious symptoms with this infection, and that folks may be contagious either without or before showing symptoms, our criteria to test is low. 

Fortunately, our results have mostly been negative, which is a reflection of the current lowered prevalence in this area. However, I believe that frequent testing with rapid results remains one of the cornerstones of our efforts to keep rates low. If we are able to quickly identify those who are infected, we can quarantine and contact trace to minimize spread. 

When we test patients in our office and obtain a negative result, we provide a return to school note advising of the negative test. Clearly, with a known exposure current policy calls for a 14 day quarantine, regardless of a negative test. 

We test patients and provide this note of a negative result as it seems best medical and epidemiological practice. Both to prevent spread and to let our local schools know how many students are being tested and the results of those tests, as they also work to prevent spread. 

Today the policy of the Sarasota County Schools regarding return to school with a negative test, along with no known exposure, came to my attention. I thought surely the person telling me this policy must be mistaken and so I called the School Board to confirm. 

If a student has been home ill and has either not sought medical care or not been tested, a note from a parent or a healthcare provider is sufficient to return to school once symptoms are mostly improved and they have had no fever without fever reducers for the past 24 hours. However, if a student has been tested – even if they have had no known exposure and their test is negative – they cannot return to school without clearance and a letter from the Department of Health. 

This does not make sense to me. Asking parents who have sought medical care and testing to then have to jump through this additional hoop to get their child safely back in school seems to encourage exactly the opposite of what we ought to be encouraging. It encourages not seeking testing and merely sending their student back as soon as they are feeling better, without knowing if they are infected and thus potentially still contagious. 

Regards,

From Charles:

Dear GOP Senator;

When I have written to you in the past I have tried to see both sides of an issue.  When it comes to our national response to SARS-COV-2, I can only see a needlessly failed policy.  If you disagree, please explain the graph at: https://flic.kr/p/2jo9bxq

It is a comparison of how we are doing with respect to the rest of the G8 countries.  The graph has been normalized for population differences.  I truly believe that the results are indefensible, but if you disagree, please try to convince me.

We cannot go back in time, so I am not going to dwell on what we did wrong.  Looking forward it is obvious we need more testing, a lot more.  I see that the FDA approved Quest’s COVID-19 test for ‘pooled’ samples just yesterday.  That is a step in the right direction, but it is not nearly enough.  We need Warp Speed/ACTIV to put money into really cheap and fast testing that does not require a lot of training to administer.  These tests just need to be good enough to catch those that are shedding infectious amounts of virus.  As Dr. Fauci said during a recent interview (link below) about this exact topic, “don’t let the perfect be the enemy of the good”.  According to Dr. Michael Mina (an Assistant Professor of Epidemiology at Harvard), testing often with fast turnaround is much more important than accuracy (links below).

Bottom line, we need all of Congress to get involved in pushing/funding Warp Speed/ACTIV to develop SARS-COV-2 testing that can be performed by untrained or at the very most minimally trained personal, without special equipment, with the test performed on saliva, with results in about 10 minutes and cost of $1.00.

This is not pie in the sky.  We can do this and when we do, we can safely open businesses, schools and places of worship.  We have very competent federal and university research labs that can take on a large part of the development that private enterprise may not want to.

We are at war with SARS-COV-2 and we must bring all guns to bear on the virus.  It is not acceptable to allow so many to die and for the economy to be destroyed when we can prevent it.

Thanks,

Charles

Dr. Fauci link (13 minute mark): https://www.youtube.com/watch?v=a_Vy6fgaBPE 

Dr. Mina links: https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html and (all of it is really good, but if you are in a hurry skip to the 22 minute mark) https://www.youtube.com/watch?v=kDj4Zyq3yOA

From Lisa:

Subject: Rapid, daily, inexpensive, at home, COVID-19 test exists. Solves safe school/economy
reopening
 
Hello,
 
I am one of your constituents.  Thank you for all of your hard work. 


The most pressing issue we all face today has to do with COVID-19.
 
The technology for a rapid, inexpensive, at home, spit on paper, COVID-19 test (hereinafter referred to as the “rapid test”) exists and millions of tests can easily be
manufactured and distributed.  This cheap, easy-to-use test, allows for frequent testing of a large percentage of the population and therefore, solves the problem of how to safely reopen schools and the economy.  
 
I am writing to ask you to please insist that:

  1. the FDA [or insert your country’s version of the FDA such as Health Canada]
    immediately license [use the word “authorize” instead of ‘license’ in Canada] the
    rapid test and
  2. the government immediately begin manufacturing and distributing the rapid tests.

Background

  • The rapid test can easily be taken at home. The test requires spit on paper and is simple to run. Results are given within minutes. (No blood, laboratory equipment or medical professionals are needed to run the test).
  • At $1 per test, you can take a test every day.  (Exact cost for the test will depend on a number of factors but a price this low is possible). Life could safely return to ‘normal’. 
  • For example, before going to work/school in the morning or attending a family gathering, everyone could test themselves.
  • Several companies have developed the technology for a rapid test (and it is ready to be manufactured), but they are not asking the FDA [or insert your country’s version of the FDA such as Health Canada] to license [use the word “authorize” instead of ‘license’ in Canada] the rapid test because it is less sensitive than the current nasopharyngeal swab PCR (polymerase chain reaction) test. 
  • We do not need a test as sensitive as the gold standard PCR test to stop the spread of SARS-CoV-2.  The PCR test is so sensitive that it can detect viral RNA at very low levels.  At these low levels it is unlikely that people are actually transmitting the virus to others, i.e., at low levels, the PCR test may just be detecting leftover bits of RNA (not virus). 
  • The rapid test is accurate when the virus is present at high levels, i.e., when people are transmitting the virus to others. 
  • Because the rapid test is simple enough and inexpensive enough that it can be administered daily/frequently, it can identify the majority of people while they are capable of transmitting the virus to other people. This means that people can immediately self-isolate and stop the spread of SARS-CoV-2.
  • The gold standard PCR test often fails to identify people during the short window of time (usually a few days to a week) in which they are capable of transmitting the virus to other people. This is due to the fact that the gold standard PCR test is usually only administered once due to its high cost, testing shortages, and logistics (it requires a testing location, medical professionals, and a laboratory to run). Furthermore, testing delays often mean that people who test PCR positive for SARS-CoV-2 often get the results days after they have stopped transmitting the virus to others.
  • In order to stop the spread of SARS-CoV-2, we must change our testing strategy from the current method of infrequently testing with the gold standard PCR test to the frequent use of the rapid test so we can identify and isolate people when they are actually transmitting the virus.
  • A large scale, daily/frequent, rapid test, testing strategy is very cost-effective. 
  • It’s much cheaper than a shut down.
  • Current PCR nasopharyngeal swab testing is much more expensive and requires a laboratory to complete.
  • It would eliminate the need for most contact tracing since people would be testing themselves daily so they would know if they had the virus.
  • Not everyone needs to be tested daily.  If a person is staying at home or lives in an area without (or with little) COVID-19, they may be able to test themselves less often.

A large scale, daily/frequent, rapid test, testing strategy is very cost-effective. 

  • It’s much cheaper than a shut down.
  • Current PCR nasopharyngeal swab testing is much more expensive and requires a laboratory to complete.
  • It would eliminate the need for most contact tracing since people would be testing themselves daily so they would know if they had the virus. 
  • Not everyone needs to be tested daily.  If a person is staying at home or lives in an area without (or with little) COVID-19, they may be able to test themselves less often.

To learn more about the rapid test and its benefits, listen to the interview with Dr. Michael Mina on the podcast, This Week in Virology, episode #640 (specifically minutes 22-33). This podcast was released on July 16, 2020.  (https://www.microbe.tv/twiv/twiv-640/).  Dr. Mina is Assistant Professor, Harvard T.H. Chan School of Public Health, Center for Communicable Disease Dynamics, Department of Epidemiology.  Dr. Mina cowrote, along with economist Laurence Kotlifoff (professor of economics at Boston University), an op-ed piece on this subject that was published in the New York Times on July 3, 2020.  https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html

This Week in Virology is an outstanding podcast and I highly recommend all of the episodes.  During the pandemic, they have done an excellent job of explaining issues related to COVID-19 in a manner that is accessible to both scientists and non-scientists.

If you have any questions, please feel free to contact me.  Thank you,

[Insert your name]

[Insert your address – so they know that you’re one of their constituents]

P.S. It’s not just about reopening schools and businesses.  It’s also about equity and accessibility.  Firstly, the rapid test is more accessible because it’s inexpensive and it doesn’t require access to a medical professional.  Secondly, the rapid test would also be extremely helpful to members of vulnerable populations, such as people over 70 and to people who are disabled, immunocompromised or have a non-COVID-19-related health condition.  Many of these people have been unable to receive the homecare and/or healthcare that they need during the pandemic.  

From Jocelyn:

Subject: paper strips printed with monoclonal antibodies for fast, frequent, cheap testing — we CAN open our economy, our schools safely

Dear State Epidemiologists,
This Week in Virology recently had a fascinating and helpful explanation & forum discussion with Dr. Michael Mina (Harvard School of Public Health) about how frequent and fast and inexpensive tests are more important than test sensitivity to stop the spread of SARS Cov2.  The virologists and immunologists from Columbia University, University of Michigan, DREW, etc, on the panel were blown away, and I was too (a layperson).  The technology has been available since early May but need to be scaled up quickly.  

If we can spotlight this proposal, it may get attention from the FDA, NIH and CDC and hopefully we can get governmental authorities to act.
Here is the forum discussion with Dr. Michael Mina on This Week in Virology (TWiV):https://www.microbe.tv/twiv/twiv-640/

Here’s the written opinion from Drs. Laurence Kotlikoff and Michael Mina on those points: https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html

And finally, here is the MedCram episode (viewed by many in healthcare) that provides a summary and background of the This Week In Virology forum discussion: https://www.youtube.com/watch?v=h7Sv_pS8MgQ&feature=youtu.be

If these tests become widely available and affordable, they can support to a great extent our schools’ and our states’ ability to safely re-open.

Malcolm Gladwell said this about Dr. Mina’s proposal:
“This is hands down the best and smartest and most hopeful (maddening) thing I have encountered since COVID began.  Please listen.”  (And Malcolm Gladwell links the TWiV episode #640): https://twitter.com/Gladwell/status/1284843069427388416

Dr. Seheult (co-founder of Medcram.com) closed the Medcram episode with these comments:

“What you have here, potentially, is a test like this that’s pretty cheap, that you could pick up, that you could test daily and find out whether you’re infective.  And if you were [infective], you could stay home and prevent infection to other people.  This may be a way, potentially, to get out and get kids back to school, which is obviously the ideal situation.  One of the reasons Dr. Mina points why we’re not seeing these [tests] as much is because these companies may be having a little bit of difficulty in terms of thinking how to get passed FDA approval. The FDA really wants to have some rigid standards in terms of how accurate the test is going to be.  If [the companies] are working on that, then it’s going to raise the price of these tests.  They believe that if there is a viral particle in the patient, the test should turn positive.  When in fact, the practical definition of what we’re really looking for here when we’re trying to curb an outbreak is who is infective and who is not infective.  And that may be completely different question than who has the viral particles and who doesn’t have the viral particles.  Ideally, what you want is a very cheap test that everybody can self administer, that is widely available, and that will tell you whether or not you are infective.”

I am cc’ing Dr. Michael Mina from Harvard University here, in case you have questions.

Thanks and best regards,

From Anonymous:

Dear [Town …Person, etc]
We need more testing to support reopening business, schools and places of worship. Testing needs to be local, with quality driven key metrics reported centrally to ensure appropriate surveillance and safety of the community. [insert why you are writing to day, eg: The recent case reported by local business is a good example of why we need to test, to reduce exposure risk to the community as we ramp up reopening measures.]

Rapid, inexpensive, at home testing: 

  1. The FDA approved Quest’s COVID-19 test for ‘pooled’ samples. This is a start. We need to put money into really cheap and fast testing that can be performed by the end user (at home)
  2. Tests are needed every day with rapid results just good enough to catch those that are shedding infectious amounts of virus. (links below from Dr. Michael Mina, Assistant Professor of Epidemiology at Harvard and Dr. Fauci)
  3. We have the technology to manufacture the rapid test that can easily be taken at home. The test requires spit on paper and is simple to run. Results are given within minutes. At $1 per test, you can take a test every day. (See Dr. Mina link below)
  4. University and federal research labs can front a large part of the development prior to scale up for manufacturing, which can be done by most companies printing paper. Local labs can be set up easily using equipment sourced from industry 
  5. Key standardized metrics reporting from a central source allows stable surveillance and supports local risk levels

Bottom line, we need to get involved in pushing/funding to develop SARS-COV-2 testing that can be performed by untrained, at home user with results in about 10 minutes and cost of $1.00.

We can do this, we have the technology to do this, and when we do, we can safely open businesses, schools and places of worship. It is not acceptable to allow so many to die and for the economy to be destroyed when we can prevent it.

Kind regards,
[insert Self-Identification]

Dr. Fauci link (13 minute mark): https://www.youtube.com/watch?v=a_Vy6fgaBPE 

Dr. Mina links: https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html and (all of it is really good, but if you are in a hurry skip to the 22 minute mark) https://www.youtube.com/watch?v=kDj4Zyq3yOA
https://www.medrxiv.org/content/10.1101/2020.05.01.20086801v1

Refer to the below podcast for great information on SARS-COV-2 https://www.microbe.tv/twiv/twiv-640/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+twivmp3+%28This+Week+in+Virology+-+MP3+Edition%29

From Jon:

A scientifically validated approach — frequent, rapid, cheap paper-strip testing for the SARS-CoV-2 virus — could turn the tide, help reopen schools and businesses safely, and avoid untold deaths and further economic misery.   PLEASE, Congresswoman Eshoo, read https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html !  The author, Michael Mina, is an epidemiologist, immunologist & physician @ Harvard School of Public Health & Harvard Med School (https://twitter.com/michaelmina_lab)

From age 18-65, I almost  *never* contacted my representative;  I’m determined to be heard now, because so much is at stake.  The federal bureaucracy is moving too slowly, and the pandemic is ravaging the U.S. more than any other country.  It’s a tragedy.  It’s unnecessary.  *It can be brought under control*.

FREQUENCY is far more important than sensitivity for effective testing, and is absolutely critical to enable schools to reopen safely.   Dr. Mina has shown how we can do it.  PLEASE help him be heard, and overcome roadblocks from the FDA.  I encourage your staff and you to go deeper into the details, e.g. listen to his chat with expert virologists and immunologists at https://www.microbe.tv/twiv/twiv-640/ (“This Week in Virology”, an authoritative, long-running podcast.)

I would appreciate your directing your colleagues’ attention to these ideas.  I am eager for your reaction, and for suggestions of other officials I should contact.

Thank you for your attention!

— p.s. I just called and left a message about this at your district office.

From Matt:

[Date]
Dear [local, state, federal government official or other influencer],

We need more testing to limit the damage done by SARS-CoV-2 to our economy and our lives. Testing needs to be:

  1. Frequent – given the lifecycle of COVID-19 disease and that one’s ability to infect others can occur within days of infection and often prior to the onset of symptoms, we need daily testing in order to arrest outbreaks of disease.
  2. Rapid – for daily testing to be useful, the tests need to provide rapid results. If results were available within 10-15 minutes, such a test could be used to screen workers upon entering the job site, students upon entering a school or classroom, customers upon entering a business/restaurant/bar/gym/salon, and so on.
  3. Effective – the test should identify those who can infect others. We don’t need a test that is capable of detecting the very smallest amounts of virus. Frequency of testing will soon catch those with a small amount of virus that subsequently grows to an amount large enough to infect others.
  4. Simple – testing should be as simple as swabbing a cheek, or spitting in a tube.
  5. Inexpensive – cost should not be a barrier to frequent testing. Tests should be affordable and/or subsidized soas not to burden individuals, and overall cost should be minimized so that funding can support frequent and widespread testing.

See the following items on this topic:

We can do this, the technology is available today. See: 

By trading off sensitivity for simplicity and speed at reduced cost, we can achieve a test that is effective at containing outbreaks of COVID-19. Don’t let perfect be the enemy of good. What is needed is a focused effort and funding for the development, approval, manufacture and distribution of a $1 paper-strip COVID-19 saliva test.

Best regards,

[identification of sender – helpful to identify relationship (e.g. voter/funder)]

From Howard:

Dear Sam, Leslie, and John

Thank you for continuing to raise concerns about the likely spread of CoVid with the reopening of schools.  I suggest that you look into the measures to greatly increase safety suggested by Michael Mina of Harvard’s School of Public Health.  (A good place to go is the podcast “This Week In Virology” #640 – www.microbe.tv – a bunch of senior virologists chatting about virus-related research).

In a nut-shell, Mina identifies the obvious but ignored fact that the danger arises not from those infected with CoVid, but from those infectious with CoVid (critical in stopping the spread). 

Unfortunately, the current testing regime is clinical, and focuses on identifying infection; these are expensive, slow, and complex (they must be done in labs in order to detect very low viral loads associated with being infected).  In contrast, the tests for being infectious are cheap ($1 range), fast (10 minute results), and simple (easily, accurately, and safely done in schools) because a very high viral load is needed to spread the disease.

Mina’s proposal is that tests for being infectious be given to every student and staff member at the start of every day, and that anyone testing positive for being infectious be isolated as soon as the tests showed results, breaking the chain of transmission.  The other members of the school community would thus be potentially exposed to contagion for a very short time (significantly reducing risk), contact tracing would be accurate and quick, and close monitoring (twice daily testing?) for infectiousness of those who were in close contact. 

Only those who were contagious would need to stay away from school.

Also, last week TWIV #647 discussed preliminary, but in their view credible, new research that indicates that even very young kids can carry a viral load as great as those of adults, and thus be similarly infectious.  This is at odds with earlier indications that kids younger than 10 were very unlikely to spread CoVid=19 (which they, being virologists, refer to as SARS-CoV-2).

Screening for fevers and other symptoms will do little good (people, especially children, can be contagious without any symptoms).  Deep-cleaning once a week will be next to useless (all the current research indicates that in real-life settings the virus becomes inactive within hours of landing on a surface).  These measures may falsely increase a sense of comfort without increasing safety – exactly the wrong approach, and one that is wasteful of resources that would better be deployed to decreasing transmission.  (Masks and distancing are important, but compliance will be a serious – potentially insurmountable – problem.)

Kids need to be back in school, but we mustn’t do it in a way that generates severe outbreaks that endangers both health and people’s livelihoods. 

I’m not in a position to judge the merits or practicality of Mina’s proposal, but I have come to trust the TWIV virologists.  They have been consistently aware of research well ahead of anything that I get from the press, WHO, or CDC, and they are insightful in their critiques.

If Mina’s idea is workable but needs more than 4 weeks to put in place, I can see no reason why the start of school can’t be delayed until schools are protected from becoming a hub of transmission.

Trusting that you are all well and coping with the stresses of the current mess,

Howard Goodman

PS. You might want to share Mina’s proposal with your counterparts in other high-congregation sectors that can generate clusters such as long-term care, hospitals, prisons, bars and restaurants, food-processing, and agriculture.

From Craig:

——– sample letter: ——–

We need a paradigm shift in testing to bring COVID-19 outbreaks under control. Testing must be Fast, Frequent, and Widespread (FFW).

Widespread: because people are highly contagious before they have symptoms. This is the main reason why it’s a pandemic. It’s the people who don’t have symptoms who need testing. 

Frequent: because a clear test last week doesn’t mean you’re still clear today.

Fast: because you need the results in time to act on them. If it takes a week to get the result, you’ve already been infecting people for days, or else you’ve wasted a week in isolation for no reason. This delay also makes contact tracing impossible. (Note that with Fast, Frequent, Widespread testing, you don’t even need contact tracing.)

The tests should be self-administered to be widespread and fast.

Ideally the tests we need are:

  1. self-administered
  2. by everyone
  3. daily
  4. with immediate results
  5. sensitive enough to detect contagious levels of virus

Such tests already exist but need to be supported for widespread production and use. 

These fast, frequent, widespread tests need to be allowed, developed, and supported in deployment. 

Spit in a cup, stick in a strip of reactive paper, read the results. Each person can decide each day whether they need to self isolate or they can go to work. Spot-checks could be done at the door for admission.  Since these are self-administered, they bypass anyone’s privacy concerns. At scale they should cost roughly $1/day per person, which is a tremendous bargain considering it would stop the pandemic, open the economy, and obviate contract tracing too.

P.S. For epidemic-control purposes, the tests do not need to be highly sensitive, because people are contagious only when they have a fairly high concentration of virus. The tests just need to be good enough to detect the virus at contagious levels. (In fact, with widespread daily tests, even that would not be necessary. The virus grows fast enough that a false negative on Monday will be a true positive on Tuesday. Not perfect, but far better than the current situation, where the vast majority of people have no test at all.)

References:

By Laurence J. Kotlikoff and Michael Mina

Mr. Kotlikoff is a professor of economics at Boston University and Dr. Mina is an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health.

For an audio discussion, the first hour of this podcast:

TWiV 640: Test often, fast turnaround, with Michael Mina

This Week in Virology TWiV 640: Test often, fast turnaround, with Michael Mina

July 16, 2020

Thank you very much for your consideration and support.

(name, town, and state)

From Charles:

Dear Senator;

This is my second correspondence with you about the need for point of entry SARS-CoV-2 testing.  If we want to open the country before a safe and effective vaccine is ready we must have rapid at home or point of entry testing.

WE NEED TO USE WARP SPEED AND ACTIV TO FUND DEVELOPMENT OF AT HOME ANTIGEN TESTS FOR SARS-COV-2.

After these tests have emergency approval from the FDA, we must use the Defense Procurement Act to produce and distribute them.

TESTING IS OUR ONLY WAY OUT OF THIS MESS BEFORE A SAFE AND EFFECTIVE VACCINE HAS WIDE SPREAD DISTRIBUTION.

Please get onboard with public statements and bipartisan leadership to make it happen, ASAP.

I was not impressed with your response to my first correspondence.  Please do better this time, our lives depend on it.