Shark Tank Initiative to Combat COVID-19, Part 1: Current State of Affairs
On Thursday, May 7, the Senate Health, Education, Labor and Pensions Committee called Dr. Francis Collins – Director of the National Institutes of Health (NIH), and Dr. Gary Disbrow – Acting Director of Biomedical Advanced Research and Develpment Authority (BARDA) – to testify about the ongoing coronavirus response. Dr. Collins, once the leader of the effort to map the human genome, appeared before the Senate to discuss the $1.5 billion Shark Tank initiative. Dr. Gary Disbrow discussed BARDA’s role – working across government and the private sector to achieve accurate and fast testing capabilities. BARDA will utilize the $2.5 billion fund granted to it in an effort to accelerate the development of diagnostic tests.
In his opening statement, Committee Chairman Lamar Alexander (R-TN) noted the likelihood that at this moment, more scientists are working to create solutions for COVID-19 than on any other project in the world. Their success in delivering new technologies to create simple diagnostic tests with quick results, as well as safe and effective treatments and vaccines are the only solutions that can bring this pandemic to an end.
Unfortunately, despite the limited amount of time allotted to each senator, some chose to focus a significant amount of their time on the failures of the Trump Administration than on getting into the nitty gritty of the current, on-going efforts of the NIH and BARDA. Senator Elizabeth Warren (D-MA) stated the “need to correct for the president’s failures, including the [lack of] use of the federal government to publicly manufacture testing supplies.” Senator Maggie Hassan (D-NH) took issue with the administration’s slow response to testing and personal protective equipment needs, and noted the need to learn from this lesson to avoid the same problems in the future.
Ranking Member, Senator Patty Murray (D-WA) spent the majority of her opening statement lamenting the administration’s failed response and its narrative surrounding the pandemic. From Senator Murray’s perspective, the U.S. has already innovated faster throughput tests, at home collection tests, and point of care tests with still more in the pipeline. The problem, to her, lies not in a lack of innovation, but a lack of national leadership and a strategic plan from the White House. She compared the current situation to innovating the fastest car in the world, “it still will not get you where you’re going without a good driver and good direction.” When it comes to testing, she feels the administration has had “no map, and no one at the wheel” and stated that “failing to plan, is planning to fail.”
Senator Murray stated that the fastest, most innovative test is useless if we don’t know how many tests are required, lack supply chain capacity to manufacture needed tests and supplies, and don’t have the workforce and lab capacity to actually administer the tests. Rapidly recruiting, training and sustaining the workforce necessary for public health efforts like contact tracing, quarantine and isolation is essential, as is data surveillance with the aim of tracking COVID-19 within communities while simultaneously protecting privacy.
And even if we had enough tests, supplies and labs and workers, Senator Murray contended, they cannot have the necessary impact unless tests are distributed widely across the country. Testing must reach essential workers, underserved communities and tribes, people with disabilities, home-bound seniors, communities of color, and high risk populations. If tests don’t become available to asymptomatic people, or if the current law requiring free testing for all goes not enforced, the program recovery effort will fail.
Even meeting these requirements would be insufficient without plans to aggregate and utilize test results to combat coronavirus, as experts wouldn’t have the visibility to ensure public health drives efforts to reopen. She feels that the administration needs to look at the whole picture, make a national plan to rapidly ramp up testing and safely get people back to school, work, and normalcy. Senator Murray expects the administration to submit a strategic testing plan by May 24, addressing all questions that need answers.
All Hands on Deck
During his opening statement, Dr. Collins stated that the NIH has taken an “all hands on deck” approach in order to bring the best and most innovative scientific solutions to the diagnosis, treatment and prevention of COVID-19. He noted that upon release of the genetic sequence of SARS-CoV-2 on January 10, the NIH worked quickly to identify possible therapeutic agents and began developing a fast-track vaccine.
Within one month, the National Institute of Allergy and Infectious Disease (NIAID) had launched a clinical trial on the Gilead drug, Remdesivir, at sites across the nation and around the world. Preliminary results from the last week of April show that patients who received Remdesvir had 31 percent faster recovery time than those who received placebo. While he realizes this isn’t a home-run, he claims it as a landmark – the first rigorous demonstration of treatment efficacy for COVID-19.
On March 16 – just 63 days after receipt of the viral genome sequence for SARS-CoV-2, NIAID completed all preclinical evaluations of a vaccine candidate, and the first human patients received the vaccine in a human trial. The human trial has progressed well so far, and experts are excited to see how the timetables for full Phase 3 testing of this vaccine and others advance.
The Race for Diagnostic Solutions
Senator Mike Braun (R-IN) stated that in talking to the CEO of one of the few pharmaceutical companies headquartered in Indiana, he learned that about 40 pharmaceutical companies across the U.S. are currently working at a “break-neck pace” to develop better diagnostics. They are working toward solutions with high reliability that are quick enough for a country the size of the U.S., and are doing so in an entrepreneurial spirit at a feverish pace. In light of this information, he wanted Dr. Collins’s opinion as to whether the commonly held opinion, which he heard during this hearing as well, that the U.S. dawdling is the reason necessary solutions are not currently in place.
Dr. Collins replied that he believes an incredible amount of energy has been invested in the development of appropriate testing. He noted that at the NIH in Bethesda, he has twenty-five thousand employees, and wants to be sure they’re safe – that if they come to work, they won’t infect their coworkers. The NIH didn’t have access to easy testing for its own employees, so he asked his laboratory in the clinical center – a research hospital – to set one up in the lab. While they were able to accomplish that objective, their daily testing capacity runs in the hundreds, not in the tens of thousands. “It’s not simple to do this,” Dr. Collins explained.
The Root of the Problem
Senator Braun clarified, “So it’s not that we’ve dawdled, it’s the fact that we’ve got a country that is scaled much larger than say South Korea, and it’s gonna take a point to get the equipment in place to do it. Is that fair?” Dr. Collins agreed with Senator Braun’s assessment and stated that the solution in the U.S. relies on bringing new technologies on board on a large scale, which is the purpose of RAD-X. But it will take time. Dr. Collins explained that the U.S. has never required the sheer scale of testing needed for the COVID-19 pandemic, even testing for HIV or Hepatitis C pales in comparison to current needs. According to Dr. Collins, “We didn’t have, in the laboratory community, the kind of capacity to take on this number of tests, and all of a sudden –there it was.”
Both Dr. Collins and Dr. Disbrow agree that tests must become so accessible that the entire population can receive testing as America moves to reopen. Tests that don’t require hours or days to determine results, and are sensitive enough to flag asymptomatic individuals who don’t yet realize they’re infected, are essential. Requirements for the next generation tests include high reliability, user friendly design and ability to utilize various types of samples, including saliva. Ideally, they should integrate with mobile devices to process and transmit data seamlessly, and show results. Above all else, testing must be accessible to all Americans.