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“I also want to get what I have. And I’ll do it for free, “Trump promised the audience in a video he posted on Twitter.” It’s a reliable drug, “he said. But the reality is a bit more complicated.
These drugs are really promising and can serve as a bridge to the vaccine. According to small-scale studies, both Regeneron and Lilly have applied for urgent authorization, and the Food and Drug Administration is clearly under pressure to say “yes.” But the president overstates both its benefits and its likely affordability.
What’s more, your fuss and rush to use antibodies will make it harder to get the most out of them.
Antibodies are not a miracle cure responsible for the president’s cure. As my Bloomberg Opinion colleague Faye Flam wrote this week, Trump has received so many other drugs, including the antiviral remdesivir and the powerful steroid dexamethasone, that it is impossible to say what actually worked. And summarizing the conclusions only from the president’s experience would be irresponsible.
We know that the drugs developed by Regeneron and Lilly reduce the amount of virus in the patient’s body at an early stage of the disease. There is evidence that this means milder symptoms and fewer hospitalizations. However, these preliminary findings are based on a limited number of patients who received different doses.
There are so many unanswered questions that it is unclear whether the FDA should allow the widespread use of these drugs. To date, the data we have obtained is from patients with a mild enough form of the disease to be treated outside of the hospital.
Researchers are now testing the drug in more seriously ill hospitalized people and as a short-term vaccine for people at high risk of infection. Prophylactic use looks particularly promising, as it may require lower doses of antibodies. The lower the dose, the more people can be treated.
These important tests can be canceled or delayed if the drug is released early. Fewer people will want to take part in studies where they can be given a non-working placebo when a real drug is already available, and patients who really need it may not use their limited supply.
We currently have 50,000 therapeutic doses of Regeneron; the company expects the doses to be available to 300,000 patients in the coming months. Lilly hopes to have 100,000 therapeutic doses this month and a full million by the end of the year. However, there will only be 50,000 doses of the most promising combination.
(Let’s recall the context: the US reports nearly 40,000 new cases of Covid-19 every day – at that rate, we can expect 1.2 million infected people in the next month alone.)
The president’s promise of wide drug availability will be difficult to deliver. The same goes for his claim that the antibodies will be completely free. Initial doses of Regeneron will be free to patients, as taxpayers have already lost $ 450 million under the Operation Warp Speed contract.
However, there is no pricing clarity for subsequent doses. Lilly has not signed any agreements and it is unclear how they will price their drugs; they certainly will not be free unless the government intervenes.
With the release of new and stricter FDA guidelines, it appears that we will not receive the vaccine until Election Day, so D. Trump appears to be trying to fill the gap with these therapies. Urgency means that some patients will receive treatment sooner, but in the long term, most will only lose.
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