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.
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 government 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
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 has acknowledged the large role of government agencies in remdesivir’s development but said that 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.
An independent organization that measures the cost-effectiveness of drugs said Gilead could be justified in charging up to $4,500 for a 10-day course of treatment for a single coronavirus patient. But advocates, citing a study by academic researchers on what it costs to make the drug, have said Gilead could break even by charging $1 per dose.
Because Gilead tackles viral targets, it has a long history of working closely with the CDC and the NIH to develop drugs for infectious diseases that other companies have shunned, especially HIV and hepatitis C. But Gilead’s pricing and intellectual property practices have drawn public and congressional criticism.
The company received negative publicity for pricing its hepatitis C drug Sovaldi at $84,000 for a 12-week course of treatment in 2013. Last year, the Department of Justice filed a lawsuit to enforce a government patent on the HIV prevention Truvada for PrEP (pre-exposure prophylaxis) after Gilead refused to recognize its legitimacy. As that court fight is being waged, Gilead continues to charge more than $20,000 a year for Truvada for PrEP. – READ MORE
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