Use of Covid antibody treatments may expand, but they're no cure
In the past 24 hours, two drug manufacturers have asked the Food and Drug Administration to issue emergency approvals for their experimental antibody therapies for Covid-19.
Currently, patients must be in clinical trials to receive these potentially useful drugs. An EEA would increase availability to patients who do not participate in such studies - as was the case with President Donald Trump.
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The announcements by drug makers Regeneron and Eli Lilly came within hours after Trump publicly asked to garner support and enthusiasm for the drugs - and label the antibodies as "cures", despite the lack of evidence to support such a claim .
The president, who received Regeneron's antibody therapy last week as part of his overall treatment for Covid-19, extolled the drug (as well as Eli Lilly's similar therapy) in video messages posted on Twitter Wednesday and Thursday.
In a video directed at seniors, Trump suggested that he could have left the hospital the day after receiving the drug.
Monoclonal antibodies are laboratory-made antibodies that are designed to mimic the body's immune response and prevent the virus from replicating.
It is impossible to know which of the numerous medications the president received in the hospital with Covid-19 helped. Doctors also gave Trump the antiviral drug remdesivir and a steroid called dexamethasone.
But in another video, the president largely rejected the other therapies, calling the Regeneron drug "incredible."
"For me it wasn't therapeutic, it just made me better," he said. "I call this a cure."
However, it has been shown that no drugs for Covid-19 are a cure for the disease. Clinical trials on the treatment of Trump are ongoing.
Dr. Anthony Fauci said there was "a reasonably good chance" that the Regeneron drug would significantly change the president's disease course. However, it is impossible to transfer a person's apparent success to the general population.
"If you only have one, you may not find that it is a cure," Fauci, director of the National Institute for Allergies and Infectious Diseases, told MSNBC's Andrea Mitchell Reports Thursday. "You need to do a clinical trial with a large number of people and compare it to either a placebo or some other intervention."
One of Regeneron's monoclonal antibody testing sites is located at UW Health in Madison, Wisconsin, where registrations for clinical trials "rose" over the past week.
"Obviously it's easier when you can talk about a study: 'This is a study looking at the same cocktail that the President was given.' Everyone knows what you're talking about, "said Dr. William Hartman, who leads the UW process.
While the surge in public interest got the study going, Hartman emphasized the importance of completing the monoclonal antibody studies.
As a doctor, "I think it will be a good drug and you want it to be available to patients when they need it," Hartman said. "But at the same time, as a researcher, you want to be able to have all the data so that the image is as clean as possible."
Last month, Lilly released partial results from a study with its monoclonal antibody drug that indicated that patients with mild to moderate illnesses might not get sick enough to be hospitalized. Regeneron reported last week that early evidence suggested its treatment appears to help mild to moderate cases of Covid-19 as well.
Dr. Todd Rice, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee, said the data is promising, but early on.
"We want to treat the patients as soon as possible," said Rice, who is not involved in the studies. But he added that there needs to be a "balance" between enough information to make sure a drug helps patients but doesn't hurt them.
"We're starting to get this data, but I think it's pretty early for us to be confident that we know what both the good and bad of these treatments are," said Rice.
If the FDA ultimately approves the Lilly or Regeneron antibody treatment for an emergency as expected, it will help doctors access the drug outside of clinical trials.
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Neither company has published complete results from large clinical trials for peer review, which are considered the standard for scientific research. However, both companies have already started making tens of thousands of cans.
Estimating 100,000 doses to be available this month, Lilly said supply could reach up to 1 million doses by the end of the year. Regeneron said it already had doses for about 50,000 patients and predicted it could produce enough to treat 300,000 people "in total over the next few months," according to a company statement.
With more than 40,000 new Covid-19 cases per day in the US, however, it is clear that the projected supply of these monoclonal antibodies will not be enough to meet demand.
"Even if monoclonal antibodies work, there won't be enough of them," said Dr. Caleb Alexander, Professor of Epidemiology and Medicine at the Johns Hopkins Bloomberg School of Public Health. "There will be a great mess for these products."
Alexander said the gaps that are sure to remain mean the nation should not abandon evidence-based public health measures to contain the spread of the coronavirus, including physical distancing, contact tracing and wearing masks.
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