Taxpayers paid to develop drug but will have no say on price
Federal government spent tens of millions on research of antiviral remdesivir
The drug that buoyed expectations for a coronavirus treatment and drew international attention for Gilead Sciences, remdesivir, started as a reject, an also-ran in the search for antiviral drugs. Its path to relevance did not begin until Robert Jordan cleared it.
A Gilead scientist at the time, Jordan convinced the company seven years ago to let him assemble a library of 1,000 castoff molecules in a search for medicines to treat emerging viruses. Many viral illnesses threaten human health but do not attract commercial interest because they lack potential for huge drug sales.
“I kept asking them, ‘Is this OK?’ ” said Jordan, who is now a vice president at a pharmaceutical startup. “These don’t represent a commercial opportunity but a public health opportunity. Gilead gave me their blessing to do this on the side.”
To make progress, Gilead needed help from U.S. taxpayers. Lots of help. Three federal health agencies were deeply involved in remdesivir’s development every step of the way, providing tens of millions of dollars of research support. Now that big government role has set up a political showdown over pricing and access.
Despite the heavy subsidies, federal agencies have not asserted patent rights to Gilead’s drug, potentially a blockbuster therapy worth billions of dollars. That means Gilead will have few constraints other than political pressure when it sets a price in coming weeks. Critics are urging the Trump administration to take a more aggressive approach.
“Without direct public investment and tax subsidies, this drug would apparently have remained in the scrap heap of unsuccessful drugs,” Rep. Lloyd Doggett, D-Texas, chairman of the House Ways and Means health subcommittee, said this month. Doggett and Rep. Rosa DeLauro, D-Conn., have asked Health and Human Services Secretary Alex Azar for a detailed financial accounting of federal support for remdesivir’s discovery and development.
The HIV-prevention advocacy group PrEP4All Collaboration, working with the Technology Law & Policy Clinic at New York University, released an analysis Monday that said the government, because it helped cull the drug from hundreds of compounds, probably has a legal right to claim it co-invented remdesivir. It contends that government scientists should have been listed as co-inventors on remdesivir patents because of their contributions. It says the Trump administration should be leveraging the government’s involvement to ensure the United States and other countries can get access at a low cost.
“Agencies can’t just punt it over the fence to a pharmaceutical company and walk away,” said James Krellenstein, a co-founder of PrEP4All. “For the federal government to just walk away from that responsibility is a dereliction of the public trust.”
Two other nonprofit watchdog groups, Knowledge Ecology International and Public Citizen, also have documented the large taxpayer-funded contributions toward the drug. Public Citizen estimates public investment at a minimum of $70 million.
“Gilead did not make this drug alone. The public helped make it, and the public has a stake,” said Peter Maybarduk, director of the access to medicines program at Public Citizen.
Gilead has acknowledged the large role of government agencies in remdesivir’s development but said the original compound was discovered by Gilead researchers years earlier and that the government has no potential patent rights to the drug. It has said it will spend up to $1 billion on remdesivir manufacturing and development in 2020 as it rapidly increases production and distribution around the world.
“We are focused on getting this treatment into the hands of as many patients as possible and making sure it is both accessible and affordable to patients in the United States and around the globe,” company spokesman Ryan McKeel said in an email. “We take that responsibility to patients and families affected by COVID-19 very seriously and we will work to make sure access is not an issue.
“Gilead researchers invented remdesivir more than a decade ago, identified its broad-spectrum antiviral activity, optimized the formulation of the product and scaled up the manufacturing process,” McKeel said. “Although government funding was used to further characterize remdesivir’s profile after its initial discovery, this did not result in the creation of the underlying intellectual property invented by Gilead.”
The story of the drug’s creation shows Gilead would not be commercializing the drug if it were not for the extensive involvement of government scientists and agencies. The industry-government partnership crossed the finish line this month when the Food and Drug Administration issued an emergency use authorization clearing remdesivir to treat hospitalized patients with COVID-19, the disease caused by the coronavirus.
Screening a huge number of chemicals for effective drugs is arduous work and often fails to produce a winner. In remdesivir’s case, government researchers narrowed the search from 1,000 compounds to the chemical that would become remdesivir, confirmed its potency in laboratory tests, tested it in monkeys and finally sponsored a pivotal clinical trial in humans.
Jordan sent Gilead’s screening library to the Centers for Disease Control and Prevention in Atlanta and to Fort Detrick in Frederick, Md., home to the U.S. Army Medical Research Institute of Infectious Diseases. Scientists at both federal facilities study dangerous viruses in high-security biocontainment labs. The National Institutes of Health and academic labs in Tennessee and North Carolina that receive NIH grants also would play key roles studying the drug in mice.
Government scientists who worked with Gilead on the drug described the heavy involvement of federal resources in the drug’s development, though they said their concern at the time was not patents but speeding treatments in the battle against dangerous diseases, especially Ebola.