When President Donald Trump fell ill with Covid-19 in October, he attributed an antibody drug from Regeneron that made him feel better ‘immediately’.
“I felt just as good three days ago as I do now,” he said in a video shot for the White House after leaving Walter Reed National Military Medical Center, with promising drugs from Regeneron and Eli Lilly to be available soon. are for the American. public to help stop the terrible effects of Covid-19.
The concern, as these drugs were approved by the FDA and hit the market last month, was that there wouldn’t be enough supply. They are difficult to manufacture, and Regeneron said there were only enough doses for 80,000 Americans by the end of November. Lilly has 250,000 doses available.
According to data from Johns Hopkins University, an average of more than 200,000 Americans are currently diagnosed with Covid-19. Policymakers expected to have to ration the antibodies.
But a month after their distribution, the opposite problem arises: the drugs are not used.
“We currently have a surplus of these monoclonal antibodies,” Health Secretary Alex Azar told CNBC’s Shepard Smith Tuesday night. “What’s happening is people are waiting too long to seek the treatments.”
Moncef Slaoui, chief scientific adviser to the U.S. government’s Operation Warp Speed, told CNBC on Tuesday that the federal government distributes about 65,000 doses of the antibodies to states every 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%. Reduce.
The drugs are not easy to administer. To begin with, they are given by intravenous infusion, so patients should go to health centers where this can be done. But since they are likely to be contagious, existing IV facilities, such as where patients receive 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 health care providers say they should be administered as soon as possible after diagnosis and within 10 days of the onset of symptoms. It does not recommend taking the drugs once patients are so ill that they are hospitalized.
But many patients don’t feel sick right away, so the idea of an intravenously administered drug doesn’t come to them immediately after diagnosis, Slaoui and Azar suggested.
“If you’re over 65 or at risk of serious complications or hospitalization due to co-morbidities, what have you got, and you test positive, then you should look for and get the monoclonal antibody Lilly or Regeneron,” Azar said on it. News With Shepard Smith. “” It could drastically reduce our risk of hospital admissions at a time when hospitals are very busy with people with Covid. “
But it is challenging for some health systems to set up the infrastructure to deliver these drugs. Some states use 100% of their allocation, Slaoui said. Others, such as in Georgia and Illinois, may not use, according to to former FDA Commissioner Dr. Scott Gottlieb.
The Georgian Public Health Department did not immediately respond to questions about their antibody use. A spokeswoman for the Illinois Department of Public Health said providers are not yet required to report the use of monoclonal antibodies, but that the U.S. Department of Health and Human Services will require hospitals to report the information starting Jan. 8.
“Finding the infusion centers you need is not an easy task,” Gottlieb told CNBC’s Squawk Box Wednesday morning. “Some states like Maryland have set up special sites and have done very well, and other states had not planned this.”
He also said funding is an issue.
“States on their own have few resources,” noted Gottlieb. “There is probably more that the federal government can do to hold back the states.”
Gottlieb also warned that the stunted antibody rollout is a bad precursor to the mass distribution campaign of Covid-19 vaccines that has just begun in the US.
“It could be challenging for the states to distribute the vaccines if they cannot distribute the antibodies,” Gottlieb said.
He noted that the data behind the drugs suggests that “the number it takes to keep one patient out of the hospital is … 10”. Lilly has said it will have 950,000 doses available by the end of January, Gottlieb mentioned the effects if 900,000 doses were used: “That means if all the drugs were distributed, we could avoid 90,000 hospitalizations or emergency room visits. That would be significant. to be. . “
Lilly noted that the intravenous administration of the antibody drugs “poses unique challenges for healthcare,” and said it works to address the challenges of ensuring that patients who need the drug can get it. The company is running a number of pilot programs through Operation Warp Speed, including one with CVS for home infusions, a company spokeswoman said.
Slaoui said Operation Warp Speed would help, but “I really think it’s the different centers that should usually 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’ll fix that,” Slaoui said Tuesday. But he also noted that if some states don’t figure out how to use the drugs, the federal government would send the doses to the places that could.
“If there are places they don’t use,” said Slaoui, “why send them?”
Disclosure: Scott Gottlieb is a contributor to CNBC and serves on the boards of Pfizer, genetic testing start-up Tempus and biotech company Illumina. Gottlieb is also Co-Chairman of Norwegian Cruise Line Holdings’ and Royal Caribbean’s “Healthy Sail Panel”.