Remdesivir is no Covid-19 miracle cure. We do not even know yet if it saves lives, but clinical trials do show that it can shorten hospital stays, and right now it’s the only drug known to interfere with coronavirus activity in the body. Doctors everywhere rightly want to give it to severely ill patients.
Yet as coronavirus cases surge, we’re facing critical supply and distribution problems. Hospitals in hot spots like Florida and Texas report having little or no remdesivir on hand while the drug sits on shelves elsewhere. And without government action to ensure an adequate supply, we will most likely face worse shortages by September.
There are solutions to both problems that can also pave the way for the more transformative Covid-19 treatment or vaccines down the line. The federal government must step in — especially with Gilead, the pharmaceutical company that holds the key patents on remdesivir.
The problem that health care providers in hot spots face is not new. Hospitals in Massachusetts experienced a similar nightmare in early May when the federal government allocated remdesivir across the state. The distribution was uneven and opaque: While Massachusetts General Hospital (where two of us work) and several community hospitals received some doses, other neighboring safety-net hospitals got none.
To fix this, our hospital and others hacked the system, just the way mutual aid groups around America have been doing, and worked with the Massachusetts Department of Public Health to share the scarce supply equitably and logically. But we still had to make tough choices: The limited supply meant not all of our qualifying patients could get the drug.
This problem persists today. In our decentralized, profit-driven system, hospitals generally operate independently of one another, which encourages them to think first of their own bottom lines and needs. Hospitals in former hot spots are worried about giving up their federally allocated supplies, for fear that they will not get any back when cases again spike in their region.
It’s also unclear if we’re legally allowed to share our supply, and if we would get it returned without cost. We don’t know how much remdesivir to request in anticipation of a second wave, or whether such a request would further deplete the limited supply that should be available to those who urgently need it now.
But the problem isn’t insoluble. The Department of Health and Human Services can build a transparent system that ensures remdesivir quickly gets to where it does the greatest good — and can be redistributed, making sure that hospitals that share now won’t be harmed down the line for doing so. Having more available doses would also help with logistics, because hospitals’ needs are not fully predictable.
Beyond the distribution problem, we are facing a supply problems as well. Gilead Sciences, which holds the key patents on remdesivir, announced last month that it had only about 500,000 treatment courses through September — for the entire world. The company has sold almost all of it to the United States, and other countries are already experiencing serious shortages.
Gilead attributes its supply problems to the complexities of manufacturing the drug. But small-molecule drugs like remdesivir are usually pretty simple to reverse-engineer. In fact, companies in India, Bangladesh and China are already making it.
Some of those companies are licensed by Gilead, and history suggests that those deals include provisions meant to lock up all available supply. But some companies are producing remdesivir independently, and if the United States were willing to put out a competitive tender, there could be a greater supply.
Indeed, isn’t that what we usually would expect any government or any business to do if its main supplier falls short? The barrier is Gilead’s patents, which allow it to prevent others from selling the drug.
Fortunately, there is a remedy for this. Health and Human Services can offer to buy the drug from any company that can supply it (or give hospitals the right to do the same) and then pay Gilead a royalty in return. The solution, called “government patent use,” was legally codified in the two world wars to prevent price gouging and shortages, and has been used for medicines before.
Government patent use is especially appropriate now, given the risk of shortages and the government’s substantial contributions to its development (so substantial in fact that it may be entitled to co-ownership credit, though it has not asserted these rights).
Remdesivir is also, arguably, overpriced. Gilead sells it for $2,340 to $3,120 per five-day treatment, even though an independent group estimated that a fair price could be substantially lower, and generic versions are selling for about $320 per treatment.
Fixing the remdesivir supply lines would do right by hundreds of thousands of patients and help us flex the kind of muscle we will need for the next Covid-19 treatment or the next vaccine. If we can create a thousand-bed Covid hospital in a matter of days, if we can ramp up telemedicine programs overnight, if we can swiftly transform the way we live, learn and work, then surely we can tackle a remdesivir shortage too.
Amy Kapczynski (@akapczynski) is a law professor at Yale. Paul Biddinger (@pbiddinger) is the medical director for emergency preparedness at Mass General Brigham. Rochelle Walensky (@rwalensky) is the chief of the division of infectious diseases at Massachusetts General Hospital.
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Remdesivir Could Be in Short Supply. Here’s a Fix. - The New York Times
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