Covid-19 antibody drug used to deal with President Trump doesn’t make it to Individuals
When President Donald Trump contracted Covid-19 in October, he attributed an antibody drug from Regeneron to feeling better “immediately”.
“I felt as good three days ago as I do now,” he said in a video filmed outside the White House after leaving the Walter Reed National Military Medical Center. He promised that Regeneron and Eli Lilly drugs would soon be available to the American public to stop the dire effects of Covid-19.
The concern when these drugs were approved by the FDA and launched last month was that there would not be enough supply. They’re complicated to make, and Regeneron said there were only enough doses for 80,000 Americans by the end of November. Lilly has 250,000 cans available.
According to data from Johns Hopkins University, an average of more than 200,000 Americans are currently diagnosed with Covid-19 every day. Policy makers need to ration antibody drugs.
But a month after their spread, the opposite problem has arisen: the drugs are not used.
“We currently have an excess of these monoclonal antibodies,” Health Secretary Alex Azar told CNBC’s Shepard Smith on Tuesday evening. “What happens is that people wait too long to seek treatments.”
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, told CNBC Tuesday that the federal government is distributing about 65,000 doses of the antibody drugs to states each week.
But he said only 5% to 20% of the doses are given to patients.
“It should be used a lot more,” Slaoui said in a phone interview, noting that the drugs – which are indicated for patients at high risk for severe Covid-19 – could reduce hospital admissions by 50% to 70%.
The drugs are not easy to administer. For one, they are given by intravenous infusion, so patients need to go to health centers where possible. However, because they are likely to be contagious, existing IV facilities, such as patients receiving chemotherapy, cannot be used.
Another problem is that the drugs must be given early in the course of the disease. The FDA’s guidelines for healthcare providers state that they should be given as soon as possible after diagnosis and within 10 days of symptoms appearing. It is not recommended to use the medication if patients are so sick that they will be hospitalized.
However, many patients don’t feel sick right away, so the idea of an IV-infused drug doesn’t spring to mind immediately after diagnosis, Slaoui and Azar suggested.
“If you are over 65 years of age, or at risk of serious complications or hospitalization due to comorbidities, you must seek and obtain the Lilly or Regeneron monoclonal antibody,” Azar said on the News With Shepard Smith. “It can dramatically reduce the risk of hospitalization at a time when hospitals are overcrowded with people with Covid.”
However, for some health systems it is a challenge to set up the infrastructure for the delivery of these drugs. Some states use 100% of their allotment, Slaoui said. Others, like in Georgia and Illinois, use former FDA commissioner Dr. Scott Gottlieb may not have any.
The Georgian Health Department did not immediately respond to questions about the use of antibodies. An Illinois Department of Health spokeswoman said vendors are not yet required to report monoclonal antibody use, but the U.S. Department of Health will require hospitals to report the information starting Jan. 8.
“Trying to set up the necessary infusion centers is not an easy task,” Gottlieb told CNBC’s Squawk Box on Wednesday morning. “Some states like Maryland set up special sites and did a really good job, and other states didn’t plan to.”
He also said funding is an issue.
“States are inherently resource-limited,” remarked Gottlieb. “There’s probably more the federal government can do to hold the states back.”
Gottlieb also warned that the introduction of stunted antibodies is a bad harbinger of the massive Covid-19 vaccine distribution campaign that is just beginning in the United States
“It could be a challenge for states to distribute the vaccines if they cannot distribute the antibody drugs,” said Gottlieb.
He noted that the data behind the drugs suggests that “the number of patients required for treatment to keep a patient out of the hospital is 10”. Lilly has announced that 950,000 cans will be available by the end of January. Gottlieb cited the effects of using 900,000 doses: “That is, if all the drugs were distributed, we could avoid 90,000 hospital stays or emergency rooms. That would be significant.” . “
Lilly noted that administering the antibody drugs intravenously “presents unique challenges to the health system,” and said she is working to address the challenges to ensure that patients who need the drug can receive it. The company is running a number of pilot programs through Operation Warp Speed, including one with CVS for home IV fluids, a company spokeswoman said.
Slaoui said Operation Warp Speed would help, but “I really think it’s the different centers that mostly have to do it themselves.”
“If there is a need for help that can be consolidated at the state level, of course tell us what you need and we will sort it out,” Slaoui said on Tuesday. But he also noted that the federal government would be directing doses to places where some states couldn’t figure out how to handle the drugs.
“If there are places they don’t use,” said Slaoui, “why send them?”
Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, the genetic testing startup Tempus, and the biotech company Illumina. Gottlieb is also co-chair of Norwegian Cruise Line Holdings and Royal Caribbean’s Healthy Sail Panel.