Monoclonal antibodies may have helped Donald Trump recover from COVID-19, but many others aren't getting them
President Donald Trump, former New Jersey Governor Chris Christie, and former New York Mayor Rudy Giuliani all received monoclonal antibodies when they were treated for COVID-19.
And although they had risk factors like age and weight that put them at risk of really getting sick, they recovered quickly, despite Christie spending a week in intensive care.
They all attribute monoclonal antibodies.
But only a fraction of those doses have reached the people who could benefit, Minister of Health and Human Services Alex Azar said on Monday.
The reason is a mixture of science and politics with some logistical and personnel challenges.
Monoclonal antibodies mimic the natural process of the immune system, supplying it with molecules that the body normally makes to fight disease. They are specific to each disease, but have been shown to be highly effective against other conditions, including Ebola, rheumatoid arthritis, and some cancers.
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Trump was so impressed with monoclonal antibodies that he promised to make them freely available to everyone in the United States. The government has since bought and delivered more than 250,000 doses of two therapies to hospitals across the country.
However, research isn't clear that monoclonal antibodies help patients recover faster. Two key bodies recommending how doctors should treat COVID-19 patients declined to endorse monoclonal antibodies. Until then, doctors may hesitate to prescribe treatment.
"While these look promising, there isn't enough conclusive evidence to know that they have clinical benefit," said Dr. Rajesh Gandhi, an infectious disease doctor at Massachusetts General Hospital and Harvard Medical School, who sits on both guidelines.
Most hospital patients are too sick to benefit from the drugs and it is difficult to give drugs to COVID-19 patients who are not sick enough to be hospitalized, Gandhi said.
Hospitals have limited staff to deliver monoclonal antibodies as COVID-19 has filled their beds and is busy delivering their first vaccinations.
The drugs are difficult to administer and require an hour's infusion followed by one to two hours of observation. And the people in need of monoclonal antibodies are in the most contagious stage of the disease, making it difficult to dispense the drugs in facilities like cancer or dialysis centers, which usually dispense drugs by infusion.
According to a spokesman for Health and Human Services, about 20% of the 250,000 doses of monoclonal antibodies given to states have been used by last week.
U.S. President Donald Trump takes off his mask after returning to the White House from Walter Reed National Military Medical Center in Washington, DC on October 5, 2020. Trump spent three days in the hospital for coronavirus.
To improve usage, Azar says federal Operation Warp Speed has begun delivering cans to retail pharmacies with infusion centers, skilled care facilities and home infusion services.
Azar said people at high risk of serious illnesses should ask their doctors about the monoclonal antibodies as soon as they are diagnosed with COVID-19.
"We just can't have this very valuable tool on the shelves," said Azar.
Former FDA commissioner Scott Gottlieb said the only people getting monoclonal antibodies now are those like Trump and his friends who have the right doctor or know what to ask about.
"Patients already facing obstacles to good care run the risk of finding doctors and centers that are able to infuse these drugs, while patients connected to better service points can seek out those drugs," he said. "This runs the risk of widening the differences that we are already seeing in COVID results."
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When Trump received the New York-based therapy administered by Regeneron Pharmaceuticals, he was among fewer than 10 people who received the drug outside of a study with a "compassionate use" exception. Christie received treatment this way, even though the combination of the two antibodies casirivimab and imdevimab had been approved by the FDA by the time Giuliani fell ill.
A similar treatment, bamlanivimab, made by Eli Lilly and Co. of Indianapolis, Indiana, has also received an emergency approval that requires a lower standard of efficacy than the full approval.
Monoclonal antibodies were rated "very exciting" at the beginning of the COVID-19 fight
Since the earliest days of the pandemic, health officials have promised that monoclonal antibodies will transform the fight against COVID-19.
On March 2, Dr. Deborah Birx, who recently became the Coronavirus Response Coordinator for the White House's Coronavirus Task Force, spoke about combining monoclonal antibodies, therapeutics and vaccines to fight COVID at a White House meeting with pharmaceutical company executives -19. "It's very encouraging," she said.
“It's very exciting. And the speed is also very exciting,” Trump replied.
Two months later, the government announced the creation of Operation Warp Speed, a $ 10 billion government initiative to rapidly develop vaccines, therapeutics, and diagnostics to combat COVID-19.
Vaccines were developed in record time. However, Gottlieb, the former FDA commissioner, said the administration had not worked fast enough to expand monoclonal antibody manufacturing capacity.
Millions of doses could be available and in use today if the government had done so sooner, Gottlieb said. He said officials should have used government authority to get other drug companies to make these monoclonals.
Antibodies used in medicine are Y-shaped proteins that attach to problematic molecules and cells to mark them for destruction or to block their activity [3,10].
The government could also have invested in dedicated sites for the administration of monoclonals, said Gottlieb, who also sits on the board of directors at Pfizer, the pharmaceutical giant behind one of the two previously approved COVID-19 vaccines.
"Many of us, including myself, wrote back in April and May that we should try to request production capacity for biologics because we realized that the antibodies would be available sometime in the fall," said Gottlieb.
If they had started making the drugs sooner and people understood their potential, we might not be in the current situation, he said. "We just didn't do it."
Massachusetts General's Gandhi said clinical trials with monoclonal antibodies could have been faster.
"These antibodies will give us an answer relatively soon," said Gandhi. "It would have been nice if the answer had been months ago."
A difficult lesson learned during the pandemic: The US needs a better system for conducting clinical trials during an outbreak when the need for information is urgent but the studies are more difficult, Gandhi said.
Lilly, Regeneron antibodies could "save lives and prevent hospital stays"
Although the data remain limited, monoclonal antibodies generally appear safe.
"I believe these two monoclonal antibodies can save lives and prevent hospitalizations," said Moncef Slaoui, the scientific director of Operation Warp Speed, on Monday.
"They are either effective at clearing the virus and giving the patient's own immune response time to clear it all (virus remains)," he said, "and on the other hand, they are very good at lowering the viral load, which is very likely . " translate into clinical benefit, but this benefit has not been confirmed. "
In small clinical trials, both the Lilly and Regeneron antibodies - both FDA approved for emergency use - appeared to help people stay out of the hospital. Both drugs have been approved for use in out-of-hospital patients.
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Among a high-risk group of people recently diagnosed with COVID-19, approximately 10% who received a placebo needed hospital care to treat their disease, compared to only 3% of those who received Lilly's monoclonal antibody. Regeneron's results were similar.
Regeneron showed in a 275-person study published last week in the New England Journal of Medicine that its monoclonal antibodies reduced the amount of virus in people diagnosed with COVID-19, especially those with particularly high levels of the virus and in those whose bodies had not yet started to fight it.
Gandhi said it was not yet clear whether reducing a person's viral load could help a person recover faster or save their life.
And the studies were so small "that these results are difficult to rely on," said Gandhi.
Because of this, the guidelines of the Infectious Disease Society of American and the National Institutes of Health, which require practitioners to often control the care they provide, rejected the use of monoclonal antibodies, he said.
Azar complained Monday that both groups should be willing to accept less conclusive data during a global pandemic when thousands of Americans die every day.
"We were very disappointed that this incredibly important tool, which should be used more often to keep people out of the hospital, is not reaching more patients," said Azar.
Both Regeneron and Lilly are continuing their monoclonal antibody trials and hope to make more data available soon. Slaoui said Lilly is also looking into three cases where the virus appeared to mutate in order to dodge the drug, although all three study participants recovered.
Contact Karen Weintraub at firstname.lastname@example.org
US TODAY health and patient safety coverage is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide any editorial contributions.
This article originally appeared in the US TODAY: Monoclonal Antibodies: A Potential "Life Saving" Tool Against COVID-19
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