Treatments are available to keep COVID-positive people from being hospitalized and from dying, medical authorities say. And a Kalamazoo physician is a leading promoter of those treatments in Michigan.
“We’ve had a 70 percent increase in the use of monoclonal antibodies, which is great,” says Dr. William D. Fales, of Kalamazoo. “But now’s the time, with the numbers (of COVID-19 cases) going up, that we want to try to stay as far ahead of the curve as we can and treat patients to keep them out of the hospital. That’s the big thing.”
Monoclonal antibodies are laboratory-produced proteins that Fales describes as being like guided missiles that target different parts of the virus. They bond with the coronavirus and prevent it from bonding with human cells, says Fales, who is state medical director for the Michigan Department of Health and Human Services’ Division of EMS and Trauma.
Monoclonal antibodies are being used to treat people who have tested positive for COVID-19 and are at higher risk of succumbing to the potentially deadly virus. Three treatment therapies, which have been authorized for use by the U.S. Food and Drug Administration and are administered by infusion (intravenously), have shown promising results.
State medical director for MDHHS EMS and Trauma Dr. William D. Fales is also a professor of emergency medicine at the WMU Homer Stryker M.D. School of Medicine, and EMS medical director for Kalamazoo County.
They have been credited by immunologist Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, with reducing the rate of hospitalization and death among ambulatory patients by 70 percent when they are used. They also reduce the rate of hospitalization and death by 85 percent in nursing home settings where they have been used.
“There are currently three different authorized products,” says Fales, who is also a professor of emergency medicine at the WMU Homer Stryker M.D. School of Medicine. “One we just call a mono product. It’s one kind of monoclonal antibody. The other two are combinations which are two different types of antibodies.”
Two are produced by Eli Lilly and Co. Another is produced by Regeneron. Former President Donald Trump was reported to have received the Regeneron product when he contracted the virus in October.
“When you get a vaccine and you later are exposed to the COVID virus, the vaccine will trigger the release of antibodies as part of your immune system’s response,” Fales says. “Well, in people who come down with COVID, this (monoclonal antibodies therapy) is like a way to jump-start that and get these antibodies in right away so that they can neutralize the virus and prevent it from reproducing and causing all the nasty harm of COVID.”
The veteran emergency medicine doctor says, “They’re intended to kind of act like the antibodies that are produced in our body’s immune system, in this case, to fight COVID.”
As more people venture further outdoors after months of social distancing and cases of COVID-19 spike higher, why haven’t the antibody therapies been put into greater use?
“When it first got released in November,” Fales says of the first infusion therapy, “it was understandable why a lot of doctors weren’t jumping on the bandwagon because there was very limited evidence that it was going to make a difference. And the perception was, because of the IV infusion, ‘Gee, that’s a lot of work to do.’”
Fales says the FDA approved the therapies to help address the public health emergency presented by the coronavirus, although the therapies’ effectiveness had not been rigorously tested at the time. “And if you remember back in November, COVID was already kicking our butt,” he says. “So the hospitals were filling up and maxing out.”
That was not an optimal time to ask a hospital to set up an infusion clinic. And there was not good, solid evidence that showed the therapies worked.
“Now that we’re a couple months further into it, there has been the release of different studies and data from trials that show with both the Regeneron product and the Lilly product, there’s a 70 percent reduction in hospital admissions and death in patients that were receiving the antibody against those that were in the trials that got a placebo,” says Fales, who is cutting a higher profile as he promotes the treatments.
Fales explained the generally overlooked treatment therapies last Thursday (March 25) on MSNBC. He made an appearance (remotely) on the nationally syndicated Rachel Maddow Show to call attention to them.
His appearance highlighted a program segment in which Maddow asserted that the United States has two “exit doors” to escape COVID-19. One is mass vaccinations, which includes overcoming some people’s skepticism and hesitancy to become inoculated. That is widely known and vaccinations have been heavily promoted for months. The other, which far fewer people have heard about, is the use of monoclonal antibodies, she said, “So if you get COVID, you won’t get sick and die from it.”
“This is not some snake oil thing,” Maddow said. “This is proven stuff. And these treatments are a potential exit door from the worst of the COVID nightmare. We’re just not taking it. We’re just not using these treatments as a country, broadly speaking. And that’s because people don’t know how to ask for them and get them.”
Fales agrees, saying, “We have not been coming close to effectively utilizing this therapy in Michigan or nationwide and it’s like, initially, we’ve maybe used about 20 percent of what was made available to us. Part of that is just the idea that it’s given by an intravenous infusion. That sounds complicated.”
But he says it’s not. It’s like sitting for a blood donation, “but instead of taking the blood out, they’re putting the antibodies in.” He further explains, “It can be given in as little as 16 minutes – to run the infusion in. And then they require an hour of observation afterward to make sure you don’t have a bad reaction.”
To receive therapies, a person needs a doctor’s order, Fales says. “And it’s not intended for hospitalized patients. So it’s not as much about how severe your symptoms are. It’s how much risk you’re at.”
He says it's most effective for patients with mild to moderate symptoms who don’t require hospitalization or oxygen treatments.
“What we have been trying to do, with variable success, is to get doctors to say, ‘Oh, this patient is positive but they’re also high risk,’” Fales says. In those cases he wants physicians to call those patients, explain the antibody treatment, and then make a referral. He says Borgess Medical Center is now infusing people. Bronson Healthcare has not been doing infusions but has been referring people to the Capital Infectious Disease Associates in Battle Creek, a private infusion clinic.
He says the health care facilities that have had the most success with the therapies have been those that take a very proactive stance. He says the University of Michigan Hospital in Ann Arbor, for instance, has a staff member (typically a pharmacist or a nurse) take a look at all the positive COVID-19 results from the previous day and cross-check them with medical records to identify patients who are at high risk. Those patients then get a call from staffers who are able to explain the therapies and schedule an infusion treatment that day if the patient is interested.
“We’re trying to get hospitals and health systems to go to that approach rather than wait for the lightbulb to click on the ordering doctor’s brain, who’s busy at the end of the day and they’d have to connect a bunch of dots,” Fales says. “… Some are doing it but it’s not anywhere near as many as we think could benefit.”
He says small health facilities in the Upper Peninsula jumped at the opportunity to do the infusion therapies. With very limited capacity to handle major medical cases, they were looking for ways to avoid being overrun by COVID patients.
Fales says that since December state-contracted nurses have worked with paramedics and first-responders in seven Michigan counties to use the therapies to limit the impact of outbreaks in nursing homes and other facilities. Those included a 33-patient nursing home in Wayland in January, a senior care facility in Cass County in December, and a home for veterans in Grand Rapids in December. Staff at the Friendship Village Senior Living Community in Kalamazoo used the infusion therapies themselves to help their residents in January, he says.
“When these nursing homes have an outbreak, this has become like a mass casualty incident in evolution,” he says. “And now with the antibodies, we’re able to scramble a team of state nurses partnering with local paramedics. They come in and in a matter of a couple of hours, treat 20 or 30 patients at one time with amazingly good success.”
He said he was really proud of the nursing home response to the therapies.
“The state has responded to 120 patients at seven outbreaks since December,” Fales says, “with only three hospitalizations and one death.”
A few questions and answers
QUESTION: When did the therapies become available?
“They were released in mid-November,” Fales says. “It was made available nationwide to all the states. They have changed the name on it now, but it was part of what was Operation Warp Speed. That was kind of associated with the vaccinations. But there’s a therapeutic arm to Operation Warp Speed. It was done by the pharmaceutical companies but funded by the federal government. So the antibodies are free of charge. There’s no cost to anyone for the medication. And then, hospitals and health care providers can bill insurance for the infusion cost, for infusing the medicine.”
Q: Who can get this?
“It’s high-risk patients,” Fales says. “The criterion in order to receive this is first you have to be positive for COVID. You have to be within 10 days of the onset of the symptoms. And then you have to have at least one risk factor. The risk factors are: anyone over age 65 automatically qualifies; anyone between 55 and 65 that has high blood pressure, any heart ailment, or any kind of respiratory problem like asthma or COPD, they qualify; any diabetic – an adult patient who is a diabetic qualifies; chronic kidney disease, dialysis and that, qualifies; anyone who has an immune-suppressive condition, like an organ transplant, qualifies; people on chronic steroids for whatever reason; all those different auto-immune diseases; anything that affects the immune system would qualify; or if you’re receiving immunosuppressant therapy, like chemotherapy, those qualify.” He says obesity, having a body mass index above 35, is also a qualifying factor.
Q: What is the value in getting the antibody therapy if I can quarantine myself and get vaccinated for COVID after I recover?
“Because your chance of living is 70 percent better if you get the antibodies,” Fales says, referring to people with risk factors who have contracted COVID. He also says, “The problem is when you are sick, we don’t know whether you’re going to survive it.” Of patients with risk factors, he says, “A lot of times these patients make it to Day 9, Day 10 or Day 12 and that’s when they crash.”
Q: In the fight to eradicate COVID, where does he think the United States will be a year from now?
“I’d like to think that, God willing, we’ll be at a point where we have a large percentage of the population vaccinated or having already been exposed. So we will be at a place where we can say we have COVID under control.”
He says the virus is never going to go away completely and there will probably always be periodic outbreaks. But he says, “I think it’s going to gradually get to a point where it’s under much better control.”
He says he is concerned about the impact variants of the disease may have and he worries about the rise in the number of cases in recent weeks, as young people throw social distancing rules out the window to participate in spring break gatherings.
“We’re over 6,000 cases a day,” he says of recent cases of COVID contraction in Michigan. “A month ago, we were around 800.”