Governments are frantically trying to contain and combat the coronavirus, and those efforts are important, but the world’s best hope is private innovation. Cutting-edge diagnostic tests and treatments are advancing, and government should encourage the trend.
President Trump recently ordered the Food and Drug Administration to “slash red tape like nobody’s ever done before” to make medicines approved for other illnesses available for coronavirus patients. The FDA is famously cautious, and safety is important. But drug regulators need to be more nimble during a pandemic with millions of lives at risk.
The FDA was slow to approve tests by private and public health labs, though recently it has approved a point-of-care test by small diagnostic company Cepheid that can return results in 45 minutes. In the biggest breakthrough so far, Abbott Laboratories has received approval for a test that it says can show positive results in five minutes. The company hopes to start delivering kits this week, ramping up production to 50,000 tests a day.
Purdue University biomedical engineers have created a handheld paper device similar to a home pregnancy test that can be used to test a variety of viruses and return results in 40 minutes. Some note that at-home tests could produce more false negatives, since infected individuals may make blunders. But the FDA should consider this risk against the lower cost and strain on the health-care system.
The agency should also fast-track review of a finger-prick antibody blood test by diagnostics firm Biomerica that can return results in as few as 10 minutes and can show if a person was recently infected even in the absence of symptoms. This would allow hospitals and workplaces to identify people who were infected and may have already developed resistance to the virus.
Importantly, these tests could prevent sick people—some of whom may not be infected with the coronavirus—from flooding ERs. Screening large groups would also provide a more accurate understanding of the virus’s prevalence and severity. Screening sick people only may cause the virus’s fatality rate to appear higher than it is, leading to more draconian government responses.
Academic institutions and drugmakers are also dusting off dozens of drugs to test on the novel coronavirus. A small group of French patients were given an anti-malaria treatment combined with an antibiotic used to treat upper respiratory infections with good results (see Jeff Colyer nearby). Generic manufacturers are ramping up production of the medicines for experimental use.
Gilead has begun testing its experimental antiviral drug remdesivir on more than 1,000 patients, and six trials are now underway globally. The drug wasn’t effective against Ebola, but studies on mice and monkeys show it may work better on coronaviruses. Early results from clinical trials could be available in weeks. Gilead last week said it is broadening access to the drug and ramping up production. Even apparent dead ends in drug development sometimes later yield breakthroughs.
Scientists are also looking to repurpose therapies for inflammatory conditions. Of particular interest is the rheumatoid arthritis drug Kevzara by Regeneron and Sanofi that inhibits the molecule “interleukin 6,” which is believed to cause acute respiratory inflammation in severely ill patients. The drugmakers are beginning trials in the U.S. and other hard-hit countries.
Most medicines now being taken off the shelf are already known to be safe in humans, so trials now can determine if they are effective against the coronavirus, and at what dosage and duration. Government regulators should allow adaptive trial designs that let researchers enroll more patients in beneficial treatments rather than requiring a control group to suffer.
At least a half dozen biotech firms and universities are working on antibody treatments from blood collected from recovered patients. These treatments will take more time to develop but may be more effective across a broader population. Stanford researchers are experimenting with the Crispr gene-editing tool to stop coronavirus from hijacking human cells. Gene-editing can’t currently be applied on a large scale, but doctors in the future might be able to use it to help patients who don’t respond to other treatments.
Dozens of vaccines are also being developed and tested but probably won’t be available for months if they work. The nearer-term hope is that expanded testing can slow the spread while experimental treatments relieve the symptoms and reduce the demand for scarce ventilators and ICU beds. If even some therapies now in testing help, governments may feel better about easing economic and travel restrictions.
Global commerce has allowed the coronavirus to spread faster and further. But healthy competition among drugmakers and scientists around the world is also accelerating innovation to stop the virus.