Speeches & Floor Statements

Opening Statement: Shark Tank: New Tests for COVID-19

Posted on May 7, 2020

As we begin our hearing today, I’d like to explain a few of the changes we have made to address the health and safety recommendations made by the Attending Physician and the Sergeant at Arms after they consulted with experts at the Department of Health and Human Services and the Centers for Disease Control and Prevention.

First, seating has been spaced out to keep individuals 6 feet apart.

Second, we have made it possible for Senators and witnesses to participate by video conference if they choose to do so.

Third, to maintain social distancing we have very limited seating, so we do not have room for members of the public to attend in person.  

However, the hearing is available to watch live on-line and a recording will be available on the Committee’s website – www.help.senate.gov.  

It is important to be clear that the hearing will be shown from gavel to gavel, in its entirety, unedited by anyone, from the moment we start until the very end when we stop.

Fourth, due to the very limited seating, representatives from the press are working as a pool to relay their observations to their colleagues.

Senators and staff present in this room have been reminded about the safety guidelines put in place based on the recommendations made by the Attending Physician.   

I would like to thank the Senate Rules Committee, the Sergeant at Arms, the press gallery, the Architect of the Capitol, the Capitol Police, and our non-partisan committee staff, Chung Shek and Evan Griffis, for all of their hard work to help keep all of us safe as we conduct these important hearings.

In April, the owners of a senior living facility gave a COVID-19 diagnostic test to 2,500 employees and residents of its 26 communities in Tennessee and Kentucky. According to owner Gary Keckley, there were “very few who tested positive.” Those who tested positive were asymptomatic and put in quarantine.

“Because of the fear we decided the only way to make sure residents didn’t have the virus was to test them,” Mr. Keckley told the Tennessean. “There is no substitute for testing everybody.”

All roads back to work and back to school lead through testing. Our country will soon be doing 2 million diagnostic tests for COVID-19 a week, an impressive number.  But to contain the disease and give confidence to Americans that it is safe to leave our homes, we will need tens of millions of tests, many more than our current technologies can produce. 

Testing is necessary to identify the small number of those with the disease and those exposed to it, so they can be quarantined, instead of quarantining the whole country. Testing will help Americans traumatized by daily reports of the virus gain the confidence to go back to work and back to school.

This hearing is about how we will find those new technologies needed to rapidly produce tens of millions of tests in one of the most ambitious scientific enterprises in recent memory, headed by one of our country’s most distinguished scientists. 

Looking ahead, I want to mention two important oversight activities by this committee: 

  1. Next Tuesday, our hearing to examine how we are dealing with this pandemic: COVID-19: Safely Getting Back to Work and Back to School. Our witnesses will be: 

   o  Dr. Anthony Fauci [Fow-chi]— Director of the        National Institute of Allergy and Infectious Diseases     at the National Institutes of Health

   o  Dr. Robert Redfield — Director of the Centers for   Disease Control and Prevention 

   o  Dr. Brett Giroir [Jer-wa] — Assistant Secretary for Health at the U.S. Department of Health and Human   Services 

   o  Dr. Stephen Hahn — Commissioner of the Food      and Drug Administration 

  1. During the next few months, the committee will also examine what our country needs to do to prepare for the next pandemic.  I believe Congress should put in place those changes in structure and funding this year, while the current crisis is still on our mind, so we will be ready for the next infectious disease threat, which will surely come.  

Over 20 years, the last three Presidents and several Congresses – including after 9/11, bird flu, Katrina, SARS, and Ebola – passed 7 laws that created the national stockpile and an assistant secretary for preparedness and response, provided incentives for the development and manufacturing of diagnostics, vaccines, and medicines, strengthened the Centers for Disease Control and Prevention, and for the last five years provided record funding for the National Institutes of Health thanks to the leadership of Sen. Blunt and Sen. Murray. I will talk more about this at our hearing next Tuesday.

In a March 1 front page story, the New York Times reported that “most experts agree, the United States is among the countries best prepared to prevent or manage such an epidemic.” But I think we would all agree that we would like to have been even better prepared for COVID-19. It is everybody’s responsibility to be sure we are ready for the next the next infectious disease threat. 

I want to place in the record a remarkable speech by former Senate Majority Leader Bill Frist, delivered in 2005, who saw very clearly then the problems we still have to deal with today. On April 13, The American Mind published Senator Frist’s essay, “A Storm for Which We Were Unprepared,” which I would also like to include in the record.

The end to this crisis will be determined by three things: tests, treatments, and vaccines.

There is promising news that treatments and therapies will be available this summer. The administration’s warp-speed pursuit of a vaccine has a goal of 100 million doses by the Fall and 300 million by January, a target much more ambitious than has ever been achieved before. And the private sector is demonstrating a capacity to turn out quickly tens of millions of serology tests — tests to determine whether you have had the disease and have antibodies that might create some immunity, at least for a time. The FDA this week is taking aggressive steps to make sure serology tests are accurate.

After a bumpy start, caused mainly by a faulty test developed at the Centers for Disease Control and Prevention, we are now conducting over 1 million diagnostic tests weekly; by mid-June, there will be 2 million to 2½ million available, according to Dr. Deborah Birx, the coordinator of the coronavirus task force. And as of yesterday, according to President Trump and Johns Hopkins, the U.S. has conducted over 7 million tests. 

On May 1 the Wall Street Journal said this: 

“The Food and Drug Administration has now approved 70 coronavirus tests—about four times more than it approved for the H1N1 flu virus in 2009. More tests per capita have been performed in New York City than in Singapore, South Korea and Australia. 

  • Hospitals and labs have performed about 1.6 million tests in the past week, according to the Covid Tracking Project….Gov. Andrew Cuomo last week said tests would be available at some 5,000 pharmacies across New York. 
  • . . .. Abbott Labs says it had shipped one million tests for its 18,000 portable machines in the field that can return results in five minutes and is manufacturing 50,000 kits a day. U.S. hospitals have more than 5,000 Cepheid [Seph–E–id] fast-testing machines, which require no special training. Some 93% of the U.S. population lives within 10 miles of a test site.
  • As testing has expanded, the choke-point now is a shortage of nose swabs and chemical reagents to process specimens. But these shortages are easing thanks to FDA flexibility and the resourcefulness of private industry. The FDA is allowing polyester swabs that are easier to make. As flu season ebbs, swab manufacturers can prioritize coronavirus tests.”  

The coronavirus task force reports that states have submitted their goals for testing for May and the administration is working to help supply media and swabs that states are not able to obtain on the commercial market.

That is impressive — but not nearly enough. To test every nursing home, and every prison, everyone in an operating room, and some entire classes and campuses and factories, teams at sports events, and to give those tests more than once, we will need millions more tests. This demand will only grow as the country goes back to work and some 100,000 public schools and more than 5,000 colleges plan to reopen this August.

There are two ways to increase our testing capacity:

   o  We should squeeze every test possible out of    current technologies. 

   o  But second, our focus today, is on the need for new testing technology.  

Throughout March and April, Senator Blunt, the chairman of the Senate Appropriations subcommittee on health, and I both had many conversations with experts across the government and the private sector, and couldn’t find anyone who believed that current technology could produce the tens of millions of tests necessary to put this virus behind us.  

So we worked to include in the most recent coronavirus legislation $1.5 billion for a competitive “shark tank”– what Dr. Collins calls the Rapid Acceleration of Diagnostics (RADx) Initiative—to utilize the capacities of government itself, in coordination with the private sector-- to pull out all the stops and fast track new technologies designed to produce tens of millions of tests by August. We allocated another $1 billion to the Biomedical Advanced Research and Development Authority (BARDA), to work with NIH to accelerate production of these tests.  

In talking to scientists across the country, there are many ideas. Some utilize CRISPR gene-editing technology. At least one allows you to use your cellphone to photograph your test swab result and send it to a doctor. Several may incorporate wearable technology. There are proposals for new antigen tests. 

The NIH only five days after the funding was signed into law announced the official start of its shark tank program to boost the most promising testing technologies. There were 400 requests for applications in the first 24 hours. And as of May 5, NIH had received 850 “expressions of interest” and 50 applications have been submitted and reviewed. 

Many of these early stage concepts won’t work, or won’t be able to be scaled up quickly, and that’s ok. Thomas Edison said he failed 10,000 times before he produced the first incandescent light bulb. We hope we don’t have that many failures. But all we need are two or three successes, or even just one.  

The first place to find these technologies is at the NIH.  

   o  Dr. Francis Collins, the director of the NIH who once led the effort to map the human genome, is here today to talk about the $1.5 billion shark tank program.    

The second place is BARDA, a division of the Department of Health and Human Services. BARDA has been working across government and the private sector to invest in multiple innovative ideas to achieve accurate, fast and easy testing capabilities and to help build new capacity. 

   o  Dr. Gary Disbrow [Dis – bro], the acting director of        BARDA, is here today to talk about BARDA’s role in scaling up new, innovative tests and how the $1      billion BARDA received from Congress can be used      to help.

Nearly 80 years ago, in 1942, President Franklin D. Roosevelt invited Sen. Kenneth McKellar of Tennessee, Chairman of the Senate Appropriations Committee, to the White House, for a private meeting.

Senator McKellar, the President said, I want you to hide $2 billion in the budget for the creation of a project to win the war.

That should be no problem, Mr. President, McKellar said.  I have just one question: Where in Tennessee will the project be built?

That $2 billion funded the Manhattan project that in record time produced two nuclear bombs that won World War II. This effort assembled perhaps the greatest number of distinguished scientists working on one project in history.

Dr. Collins’ shark tank is at least a mini Manhattan project. It doesn’t have to be in Tennessee, but Tennesseans at the Oak Ridge National Laboratory will be helping it succeed. $2.5 Billion does not go as far today as $2 Billion did in 1942, but it is a lot of money. And it is likely that at this moment more scientists are working to create solutions to COVID-19 than on any other project in the world. Their success in discovering new technologies to create simple diagnostic tests with quick results—and then safe and effective treatments and vaccines—is the only way this will end.

There is no safe path forward to combat the novel coronavirus without adequate testing.  Let us hope that out of Dr. Collins’ shark tank will emerge at least one mighty great white shark that will help us combat this disease.