Numerous biopharma companies are testing or working to develop drugs and vaccines. But what is a bit unusual is the number of staffers at biotech and pharma companies and health care involved as participants in studies and clinical trials.
The COVID-19 pandemic as of today, according to Johns Hopkins University, has killed 444,426 people worldwide and 116,964 in the U.S. Early on in the pandemic, biopharma companies often halted their clinical trials in non-critical indications so patients would not have to visit clinics or hospitals. Almost 600 health care workers in the U.S. have died from the disease as the result of exposure from treating patients.
Yet, biotech and pharmaceutical companies and health care institutions are on the front lines of not only fighting the disease, but working to develop vaccines and therapies against it—often in unexpected ways.
Of course, numerous biopharma companies are testing or working to develop drugs and vaccines. But what is a bit unusual is the number of staffers at biotech and pharma companies and health care involved as participants in studies and clinical trials.
The Boston Globe reported how some biotech companies, such as many employees at Tango Therapeutics, begin their day by gargling a salt solution and bringing the wash to work in a collection tube. Researchers at Tango test their samples for SARS-CoV-2 and the company then emails them the results later in the day.
In another program, almost 230 staffers at a dozen biotech companies in Cambridge and Watertown, Massachusetts are working with the Broad Institute of MIT and Harvard to be tested for the coronavirus that causes COVID-19.
Nikita Das, a researcher at Tango who participates in the study, told the Globe, “It’s definitely not something that I ever envisioned, but then again I don’t think anyone ever envisioned that pretty much the whole world would be on a lockdown because of the virus. I don’t feel sick, but there’s always that slight worry in the back of your head of, ‘What if I’m asymptomatic and potentially spreading it to other people at work?’”
Some of this is simply—if that’s not itself an oversimplification—companies testing staffers regularly for COVID-19 to ensure it doesn’t get spread around the office or laboratory. That’s akin to companies requiring temperature checks and health questionnaires, something of the “new normal” for many employers around the world.
Some of it is mandatory, while at other companies it’s voluntary. Most employers are following Centers for Disease Control and Prevention (CDC) and public health guidelines for bringing people into work—temperature checks, questionnaires, wearing a face mask, handwashing, disinfecting workspaces and social distancing measures.
Another Cambridge, Massachusetts company, Triplet Therapeutics, is leveraging technology. It ordered wearable devices similar to wristwatches from Proxxi of Vancouver, Canada. The technology vibrates if someone else with the watch comes within six feet of another.
“It’s to identify regions in our facility that may be high-contact zones and to remind employees that are close to somebody else,” said Triplet’s founder and chief executive, Nessan Bermingham.
In the Broad Institute study, participants who test positive for COVID-19 will be notified and required to quarantine. They will need two negative tests before being allowed to return to work.
If and when a vaccine against COVID-19 is developed and approved, it’s not clear if these business screenings would halt, since at least one poll suggests only half of Americans would take the vaccine. Until a vaccine is approved, distributed and widely taken, COVID-19 is likely to be a fact-of-life with regular testing, contact tracing and quarantine the most effective form of control.
In addition to these testing and tracing efforts, there are plenty of examples of health care institutions testing drugs or testing for the disease on staffers as part of clinical trials. For example, in April, Henry Ford Health System in Detroit, Michigan launched the first large-scale trial in the U.S. of hydroxychloroquine in health care workers and first responders as a preventative against COVID-19. Participation in the trial was voluntary.
Beaumont Health Research Institute, also in Michigan, launched the largest serological testing study in April as well. The serological tests detected antibodies to identify if people had been infected unknowingly or had recovered from the disease.
But that’s different than workplaces requiring testing. The CDC recently published guidelines for testing for COVID-19 in high-density critical infrastructure workplaces after a case is identified. Among the guidelines, the CDC said, “a testing strategy should only be implemented if results will lead to specific actions.” It also noted a comprehensive approach to decreasing transmission was recommended, including isolating at home, alternate housing sites, and a strategy for deciding when they can come back to work.
They also recommend different tiers of testing along with measures to supplement reducing transmission.
Workplace testing for COVID-19 also has an overlap with HIPAA Privacy Rules that can be complicated. For example, HIPAA’s requirements to safeguard protected health information (PHI) only applies to covered entities like health care plans, clearinghouses and most health care providers. But it doesn’t apply to employers in their capacity as employers. Employers, biopharma companies or otherwise, need to maintain the confidentiality of the temperature checks and any other information they gather related to COVID-19, but HIPAA doesn’t actually apply unless that information is shared with a health care plan.
Other laws, such as the Americans with Disabilities Act (ADA) may apply as well, because they can prohibit an employer from subjecting staffers to disability-related inquiries and medical examinations, except under specific circumstances. And according to the Equal Employment Opportunity Commission (EEOC), temperature checks are considered medical examinations, but the EEOC also says employers can mandate those screening measures that might indicate COVID-19. This is because EEOC’s guidance is specific to COVID-19 and related to a finding that someone with the virus or related symptoms in the workplace might pose a substantial risk of harm to others.
Whatever else, until COVID-19 is largely eradicated via widespread use of a vaccine or through herd immunity, employers, whether biopharma, health care or anything else, are likely to be implementing measures of testing for the disease as a way to prevent the spread in the workplace.
