Public health experts on Wednesday criticized the U.S. for securing a large supply of the only drug licensed so far to treat COVID-19.
The U.S. government announced this week that it had an agreement with Gilead Sciences to make the bulk of their production of remdesivir available to Americans for the next three months. The Department of Health and Human Services said it had secured 500,000 treatments through September, which amounts to all but 10% of production in August and September.
“To the extent possible, we want to ensure that any American patient who needs remdesivir can get it,” Health and Human Services Secretary Alex Azar said in a statement.
Ohid Yaqub, a senior lecturer at the University of Sussex, called the U.S. agreement “disappointing news.”
“It so clearly signals an unwillingness to cooperate with other countries and the chilling effect this has on international agreements about intellectual property rights,” Yaqub said in a statement
Until now, Gilead had donated the drug. That ended Tuesday and Gilead this week set the price for new shipments. In 127 poor or middle-income countries, Gilead is allowing generic makers to supply the drug at much lower prices.
In a statement Wednesday, the California-based Gilead said its agreement with the U.S. allows for unneeded supplies to be sent to other countries. The company said it is “working as quickly as possible” to enable access worldwide. But it noted that U.S. is seeing a significant rise in COVID-19 cases, while “most EU and other developed countries have reduced their levels of disease considerably.”
Early studies testing remdesivir in patients hospitalized with COVID-19 found that those who received the treatment recovered quicker than those who didn’t. It is the only drug licensed by both the U.S. and the European Union as a treatment for those with severe illness from the coronavirus.
Dr. Peter Horby, who is running a large study testing several treatments for COVID-19, told the BBC that “a stronger framework” was needed to ensure fair prices and access to key medicines for people and nations around the world. He said that as an American company, Gilead was likely under “certain political pressures locally.”
British Prime Minister Boris Johnson’s spokesman, James Slack, declined to criticize the United States for the move. He said the U.K. had a “sufficient stock” of remdesivir for patients who need it, but didn’t specify how much that was.
Thomas Senderovitz, head of the Danish Medicines Agency, told Danish broadcaster DR that the move could endanger Europeans and others down the road.
“I have never seen anything like that. That a company chooses to sell their stock to only one country. It’s very strange and quite inappropriate,” he said. “Right now we have enough to make it through the summer if the intake of patients is as it is now. If a second wave comes, we may be challenged.”
Dr. Michael Ryan, the emergencies chief of the World Health Organization, said the agency was looking into the implications of the U.S. deal for remdesivir.
“There are many people around the world who are very sick …. and we want to ensure that everybody has access to the necessary, life-saving interventions.” He said WHO was “fully committed” to working toward equitable access for such treatments.
Gilead had been developing remdesivir for years as a viral treatment, with millions in U.S. funding, before it was tried for coronavirus. The consumer group Public Citizen estimates that at least $70 million in U.S. public funding went to develop remdesivir.
On Monday, Gilead said it will charge government insurance plans in all developed countries $2,340 for a course of remdesivir and private U.S. insurers, $3,120.
Gilead has said it expects to spend more than $1 billion by year’s end on testing and manufacturing of remdesivir.
Dr. Penny Ward of King’s College London, noted that many countries have legal provisions that allow them to prohibit the exportation of drugs to other countries during an emergency.
“It is unreasonable to expect that the U.S. government should deny their population access to drugs manufactured in the USA,” she said.
Ward pointed out that another drug that may help people with severe COVID-19, the cheap steroid dexamathasone, is long off-patent and available globally.
The U.S. has the worst coronavirus outbreak in the world, with 2.6 million reported infected and 127,000 confirmed virus-related deaths, according to a tally by Johns Hopkins University. To date, COVID-19 has sickened more than 10.5 million people worldwide, killing around 512,000, according Johns Hopkins.
Numerous countries including Britain, France, Germany, Netherlands and the U.S. have struck deals with drugmakers to have millions of doses of experimental vaccines delivered before they are licensed. British politicians have said if a vaccine currently being developed by Oxford University and manufactured by AstraZeneca is proven to work, Britons will be first in line to get it.