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Two drug companies have applied for emergency authorization for their experimental COVID-19 drugs.
Safety and effectiveness results are preliminary, doses are limited, and the FDA has no timeline for approval.
The cost of administering these drugs would come on top of the cost of buying them, and there is no comprehensive plan.
President Donald Trump is pushing hard to get an experimental COVID-19 drug into the hands of anyone who needs it.
Soon after he tested positive for the coronavirus, Trump received several drugs to treat his symptoms. The one he keeps talking about is a blend of two monoclonal antibodies that hold the promise of preventing the virus from overwhelming the body’s immune system. Two companies, Regeneron and El Lilly, are well along in developing this monoclonal cocktail, although both are still in the trial stage.
Trump pledged quick action to get other infected people free access.
"If you’re in the hospital and you’re feeling really bad, I think we’re going to work it so that you get them and you’re going to get them free, and especially if you’re a senior, we’re going to get you in there quick," Trump said in an Oct. 7 video. "We have hundreds of thousands of doses that are just about ready."
Two days later, Trump told conservative radio host Rush Limbaugh that distribution is already underway. He said he was "bugging" the Food and Drug Administration "like crazy," and "hundreds of thousands of vials are being sent to the hospitals all over the country."
That seems untrue. Regeneron said the 50,000 doses it has are still in its facilities. Another drugmaker, Eli Lilly, said it could have 50,000 by the end of October.
Both companies have asked the Food and Drug Administration to authorize emergency use before safety and effectiveness trials are completed. The agency said it has no timeline for approval.
Several steps lie between where these drugs stand today and nationwide distribution. Doctors believe this sort of treatment could help, but there is worry that Trump has pushed hopes beyond the proven strength of these drugs.
"We don’t want to create public expectations that we are on the cusp of this," said Marcus Plescia, chief medical officer with the Association of State and Territorial Health Officials. "This is a whole new class of drugs. There needs to be a little caution in how we roll these out."
Plescia and others who work with emergency medical response say many questions about safety, cost, production and distribution remain unanswered.
Drug trials go through three phases, and neither drug combination has completed the third phase. Regeneron said that in the U.S., a blend of Phase Two and Phase Three trials are underway for both out-patient and hospitalized patient use. A separate trial for preventive use in people who have been exposed to the virus is in the third phase.
Trump is one of about 1,500 people in total who have received Regeneron’s monoclonal antibodies combination. (Monoclonal simply means the antibodies were cloned.)
"I have questions about the underlying data and whether there’s enough time to do what you need to do beyond just releasing this drug," said Alta Charo, former adviser to the Food and Drug Administration and University of Wisconsin law professor. "They are still working on the dosing. They have tested high and low doses. Until you have enough data, you don't know what the best dosing should be."
Charo said Trump was "irresponsible" in pressing for quick action by the FDA.
"Regulators have to weigh the risk of approving the drug against the risk patients face from the disease," Charo said. "The pressure he puts on the FDA is counterproductive if people see this as a political decision."
Physician Amesh Adalja with the Center for Health Security at Johns Hopkins University and a specialist in emergency response also raised safety concerns.
"We still haven't seen the data on when they work and who they work on," Adalja said. "We need to know how well these drugs do that. And the time window after a positive test result in which to give them."
Trump received the drug almost immediately, along with two other drugs. That further leaves it unclear whether it was the combination that helped — and Trump still faces some risk — or the monoclonal antibody cocktail alone made the difference.
The White House press office told us that the money to pay for the drug would come from funds already approved under the CARES Act, the third and largest of the virus relief packages from Congress. We asked if there were any cost estimates and if the specific program under the CARES Act they planned to draw on was fully flexible, or if the funds came with restrictions.
We did not get more details.
Regeneron produced the drug Trump received. In July, Washington awarded it $450 million to supply it to the government. The same day of Trump’s video, Regeneron applied to the FDA for an emergency use authorization that would open the doors to broader use before completing clinical trials.
In its application, Regeneron said it had 50,000 doses on hand, and the number could rise to 300,000 within a few months.
Eli Lilly said it could have 50,000 doses of its combination package in the last quarter of 2020. It produces a solo antibody drug and could have 100,000 doses available in October.
Even if the government buys the drug and uses the military to get it out to the states, more work remains.
"We have to figure out the distribution," Adalja said. "We’re not talking about Army medics infusing this drug into patients."
Plescia, with the Association of State and Territorial Health Officials, noted that administering these drugs intravenously requires a facility, equipment and staff.
"Somebody has to pay for that," Plescia said. "Typically, that’s billed to health insurance, whether that’s government or private. To the patient, it might seem free, but depending on their plan, it might not be. And if it’s really going to be free, then the government would have to reimburse either the hospital or the insurer."
If the FDA approves emergency use, Charo said there needs to be a system in place to track what happens.
There could be side effects for certain types of patients and not for others. Reactions might not be obvious and could come weeks after treatment. Collecting that information is not trivial, Charo said.
"You have to be ready to respond if adverse events come up," Charo said.
Donald Trump, Regeneron video tweet, Oct. 7, 2020
Donald Trump, Video message on Regeneron, Oct. 7, 2020
Regeneron, Statement on REGN-COV2 Emergency Use Authorization Request, Oct. 7, 2020
Statement, press office, Regeneron, Oct. 9, 2020
Eli Lilly, Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs, Oct. 7, 2020
Email exchange, White House press office, Oct. 8, 2020
Email exchange, Office of Media Affairs, U.S. Food and Drug Administration, Oct. 9, 2020
Interview, Alta Charo, professor of law and bioethics, University of Wisconsin-Madison, Oc.t 8, 2020
Interview, Marcus Plescia, chief medical officer, Association of State and Territorial Health Officials, Oct. 9, 2020
Interview, Amesh Adalja, senior scholar, Center for Health Security, Johns Hopkins University, Oct. 8, 2020
Email exchange, Public Affairs Office, Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Oct. 9, 2020