Testing delays, staff shortages impede distribution of Covid treatment used by Trump

Al Weiss, 74, walked into New York City’s Mt. Sinai hospital earlier this month for a colonoscopy and walked out with a Covid-19 diagnosis.

But within days, he said, he was given Eli Lilly‘s Covid-19 monoclonal antibody treatment as part of a clinical trial investigating potential adverse reactions to the drug infusion. Within 72 hours, his mild symptoms, including fatigue and a 101 degree fever, had subsided and “I was Superman,” Weiss said in a phone interview.

“I absolutely believe it was beneficial,” he said. “It was better than sliced bread.”

Monoclonal antibody treatments like the one Weiss took and another one produced by Regeneron that was given to President Donald Trump have shown promising signs in fighting the disease if given early on in infection. But the drugs aren’t being widely used by the general public. A shortage of staff that can administer the drugs, which have to be given via IV drips, combined with delays in Covid-19 testing have limited their use, hospital administrators and public health specialists said.

There’s “a level of uncertainty” around the value of the antibody treatments, Marta Wosinska, deputy director at the Duke-Margolis Center for Health Policy, said last week at an event hosted by the National Academies of Sciences, Engineering and Medicine. The only available data on the treatments have come from small clinical trials.

The Infectious Diseases Society of America has recommended against the routine use of Eli Lilly’s treatment bamlanivimab, citing a lack of data. And the National Institutes of Health, citing “insufficient data,” said the drug “should not be considered the standard of care.”

Wosinska said this is a problem because they’re not easy treatments to administer. Hospitals need to dedicate an infusion center and staff just for Covid-19 patients to effectively dole out the drugs and keep them separate from cancer and dialysis patients. But there’s “unease from providers about whether it’s really worthwhile to be standing up a whole new system to deliver these drugs,” Wosinska said.

Many hospitals across the country are already under extreme stress, she noted, and considering the lack of data, it’s difficult for hospitals to justify investing in the treatment. Still, the drugs have demonstrated a great level of promise when used on “the right patient at the right time in the right place,” she added.

One of the key difficulties with the antibody treatments is that they appear to have the biggest benefit when given to patients early on, Wosinska said.

“We need to infuse this drug within seven days of symptoms, but patients generally don’t seek care until they’re quite ill,” she said. “We have been telling patients if you’re not really sick don’t come to the ER. Stay at home, take care of yourself, isolate. And here we actually want to capture patients really early.”

And there are logistical delays keeping patients from a quick infusion, too. Before someone even considers getting the treatment, they need to seek out Covid-19 testing and get results back, which can take a day or longer, depending on where the sample is collected.

Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said delays around testing limit the “window for infusion.”

“The first challenge is the sites infusing the drug may not be the same site performing Covid testing,” he said at the National Academies event, adding that especially in rural communities, people might struggle to go from a testing center to an infusion center. “The other thing is the challenges with testing capacity and testing turnaround time.”

Michael Wargo, vice president of emergency preparedness at HCA Healthcare, said he’s working to more closely integrate testing centers with hospital systems, so that people eligible to receive the antibody treatments can be notified shortly after diagnosis.

“We need to develop this inclusion criteria at the point of testing,” he said. “When they go in and they’re screened for risk for Covid, let’s screen them for the inclusion criteria. Let’s build that and even partner with the large laboratory systems such as Quest Diagnostics.”

On top of testing, Wargo reiterated that transportation to infusion centers is one of the biggest barriers to the use of the antibody treatments. He said HCA is experimenting with a number of initiatives to broaden access, including “reversing the process of blood donation.”

Patients eligible for the treatments would be extremely infectious, so it’s not ideal to ask them to travel on public transit to an infusion center. Wargo said HCA has considered partnering with organizations like the American Red Cross to convert their blood donation vehicles into mobile infusion centers.

Other hospital systems are looking at the possibility of conducting home infusions, Mark Jarrett, chief quality officer at Northwell Health, said. He added, however, that home infusions are extremely labor-intensive and many hospitals just don’t have the free hands right now.

“This is the perfect storm for staffing issues,” he said. “We have a surge of disease in the hospitals… We now need lots of staff for vaccination … infusion staff themselves come from the nursing pool, and therefore that is a problem.”

“This is a resource we need to get to our patients. It will ease the burden on the hospitals, but the devil’s in the details,” he added.

Awareness of the treatments is another issue, Jarrett said. Many people don’t know that if they’re high-risk and early in symptom onset, this is likely an option for them, he said.

“We’re looking into the issue of public advertising,” he said. “We were very hesitant to do that in the beginning, because we were afraid we would outstrip our supply. At this point, we really think we may gear up for that.”

However, he noted that some people are hesitant to get the treatment because it’s only been authorized by the Food and Drug Administration on an emergency basis and there’s not a ton of data to vouch for its safety and effectiveness.

Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials, echoed Jarrett’s concern that there’s a lack of awareness. He added that the public health community has been so focused on the Covid-19 vaccines, that not much effort has gone toward educating the public on monoclonal antibody treatments.

“Public health is not really in a position right now to be championing much else other than a vaccine. It’s a huge undertaking and that’s where their attention is,” he said. “But I think the problem is the antibody treatments have just gone off the radar screens.”