Almost two weeks ago, President Trump told Americans that they would do this get soon an antibody treatment he had advertised as a “cure” for the coronavirus without evidence. This weekend as the country braced for another big wave of coronavirus infections, Trump was Minister of Health promised such therapies were just around the corner.
But these statements are misleading at best. Even if the drugs turn out to be working – still a big if – there is little chance they will be widely available anytime soon. A smooth distribution of antibody treatments will depend on the same factors that have hindered the country’s response to Covid-19: quick and plentiful testing, coordination between state and federal officials, and fair access to health care.
Supply will be extremely limited at first, although the pool of patients who could benefit is huge, which raises messy questions about who should be the first to be eligible for treatment. The drugs are believed to work best on people who have recently been infected and are not yet very ill.
“It’s just a setup for all challenging about the pandemic we’ve had so far which is confusion, inequality, delays and reliance on testing, “said Dr. Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. The therapies look promising, he said, but “anything that has gone wrong makes the problems worse.”
Roughly 60,000 Americans test positive for the coronavirus every day, but Regeneron, which ran the president’s antibody treatment, has announced it will only give 50,000 doses initially. Eli Lilly, who is developing a similar product, has announced that it will initially have 100,000 cans. Regeneron will eventually have 300,000 cans, and Eli Lilly will have up to a million by the end of the year. Both companies have applied to the Food and Drug Administration for emergency approval for their products.
Administration of treatment is not as simple as handing out a bottle of pills. The therapies are given intravenously, so an infected person must go to a medical clinic or hospital.
This assumes that the distribution goes smoothly. Officials with Operation Warp Speed, the government’s efforts to get treatments and vaccines to market faster, recently told reporters that the federal government would assign states the task of allocating the starting doses of Regeneron drugs. However, these government agencies are overwhelmed with the current influx of new cases, as well as planning the distribution of coronavirus tests and future vaccines, and have not yet established detailed plans for deciding on how to assign antibody treatments to hospitals and clinics.
“We are really busy and this was not up front and center,” said Dr. Marcus Plescia, the Chief Medical Officer of the Association of State and Territorial Health Officials.
Even some company executives have acknowledged that the country may not be up to the challenge. Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron, said in a recent appeal with investors and reporters that communities would need rapid testing and contact tracing to identify the best candidates for the treatments.
“We as a society are literally trying to fly an airplane while we’re trying to build it here,” he said.
Early data on the therapies showed that they would help clear the virus in recently infected people and that they may help prevent hospital stays. In another positive sign, the F.D.A. recently approved A Regeneron Ebola treatment that uses the same technology.
Eli Lilly and Regeneron have said the antibodies could be used both to treat sick people and to prevent infections in exposed people. The treatments could act as a bridge to a vaccine and protect high-risk groups such as nursing home residents and the workers who care for them.
However, it is unclear when the F.D.A. gives the green light for emergency authorization. Regulators need to review a mountain of data and decide which groups could benefit most from it. Last week, a government-sponsored clinical trial tested Eli Lilly therapy in hospital patients was stopped for unspecified security reasonsand it won’t restart until at least October 26th.
If an emergency permit is received, the first 300,000 cans of Regeneron will go to the federal government thanks to a pre-sale agreement. These starting doses are free for Americans.
Eli Lilly hasn’t made a similar deal, but CEO David A. Ricks recently said at a press conference that “Talks are ongoing with Operation Warp Speed.”
There will likely also be questions about whether affluent or well-connected patients will be able to unfairly move to the top of the line. Few would argue that given national security concerns, the president should not be given emergency access to Regeneron’s treatment. However, it is unclear what criteria Eli Lilly used as a drug manufacturer cleared his treatment for Chris Christie, the former governor of New Jersey. (A spokeswoman for Eli Lilly declined to discuss certain cases citing patient privacy, but said the company approves such treatments on a case-by-case basis in “exceptional circumstances.”)
Dr. Douglas B. White, a medical ethicist and professor of intensive care medicine at the University of Pittsburgh Medical School, hoped the hospitals would learn the lessons they learned when another Covid-19 experimental drug, remdesivir, was initially tight was. The federal government also called on the states to take responsibility for the allocation of the drug.
Dr. White wrote guidelines passed by Pennsylvania recommending giving priority to people from economically disadvantaged communities who are at higher risk of dying from Covid-19. The same rules should apply to antibody treatments when they are in short supply, he said.
“There needs to be clear guidelines and efforts must be made to mitigate the unequal outcomes between groups in society,” he said.
Dr. Plescia, from the National Health Service Group, said he believed most states had resolved the problems they had with remdesivir. Now he said, “I think there is a distribution chain that could be adapted to this.”
Antibody treatment will present new challenges.
Eli Lilly has said that people who are older and obese are at higher risk for bad outcomes from Covid-19 and will benefit the most from treatment. Regeneron has said that people whose bodies don’t produce antibodies seem like the best candidates.
in the early trial data Released by Eli Lilly, 5.8 percent of those who received a placebo were hospitalized or visited an emergency room for Covid-19, compared to 0.9 percent of those in the group who received the antibody treatment. Figuring out who will benefit the most is a daunting challenge as most people will recover on their own.
Geoffrey Porges, a pharmaceutical analyst at investment bank SVB Leerink, said that means that 100 patients would have to be treated to prevent about five from going to the hospital. “It’s expensive and complicated, and you don’t know who the five are who would have gone to the hospital,” he said.
And since the treatments are given to newly infected people, doctors need to run the tests quickly to quickly identify patients.
In the case of Regeneron, an antibody test may also be needed to identify patients whose immune systems are not responding. Dr. Yancopoulos acknowledged that such simple and quick tests were not yet widely available, and said Regeneron was working with Roche to develop tests that could help doctors identify the right patients. In a statement Roche said it was investigating which of its tests could be helpful in triaging patients.
Mr Ricks, the executive director of Eli Lilly, said his company was considering testing obstacles when it decided to classify high-risk patients based on age and weight. “It can be used immediately in a practical clinical setting,” said Ricks at the latest investor conference.
Even after the right patients have been identified, further hurdles await. Patients need to be moved quickly to a clinic or hospital that can perform the treatment and kept separate from others who are not infected. They will need assistance from medical personnel in protective equipment who can insert an intravenous line and monitor them while the drug is being infused.
If the antibody treatments prove effective, they are expected to become more widely available early next year. Regeneron has announced that it will be able to produce around 250,000 cans per month in collaboration with Roche. Eli Lilly has announced that it will also be able to ramp up production. Another company, AstraZeneca, is also developing an antibody treatment that is already under development. and it has a deal with the federal government to deliver up to 100,000 cans by the end of December.
Meanwhile, some frontline doctors say they are looking forward to a new tool to keep people out of the hospital.
Dr. Manar Alshahrouri is an intensive care doctor in Green Bay, Wisconsin, one of the many cities in the upper Midwest where infections are on the rise. The intensive care units in the two hospitals he works in are almost full, he said. And patients newly infected with Covid-19 have little to offer to prevent them from ending up there. “We don’t currently have anything that is effective,” said Dr. Alshahrouri. “We just don’t.”
However, he warned that hope for a miracle cure should not be used as a crutch and preventive measures such as wearing masks should not be substituted.
Keeping people out of the hospital is “a great endpoint for us as clinicians, but not a substitute for far more effective measures,” he said. “When you have a flood in your basement, the answer is no longer towels. The answer is to turn off the water. “
Gina Kolata contributed to the coverage.