During the Ebola virus epidemic that erupted in West Africa in 2013, Gilead worked with the Centers for Disease Control and Prevention as well as the U.S. Army Medical Research Institute for Infectious Diseases to examine the potential of one of its exploratory antiviral drugs, remdesivir, for use in this frightening outbreak. The Gilead drug was tested in a randomized controlled clinical trial along with three other antivirals, but unfortunately proved inferior to the other drugs that were tested, thus ending Gilead’s efforts to provide a treatment for Ebola.
Daniel O’Day, CEO of Gillead Sciences Inc., speaks during a meeting with President Donald Trump in … [+] the Oval Office of the White House, on May 1, 2020, in Washington, DC. (Photo by JIM WATSON / AFP) (Photo by JIM WATSON/AFP via Getty Images)
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Although it was viewed as a failed Ebola drug, when a novel coronavirus emerged in China, Gilead executives again turned to remdesivir as they had reason to believe that it could be of value for treating COVID-19. Well, unless you have been in hibernation for the last four months, you know that remdesivir can in fact be used to reduce the impact of the disease in some patients. That Gilead was able to bring this drug to patients in roughly two and a half months is stunning and is due not only to the incredible dedication of its scientists but also due to the enormous efforts of scientists at the FDA and the CDC. This is an unprecedented achievement.
Yet, within hours of remdesivir being granted an Emergency Use Approval by the FDA, critics began their attacks. One of the more egregious ones was a Tweet by Robert Reich, the Secretary of Labor under President Bill Clinton, on May 2.
“As Gilead’s stock price rises on reports of remdesivir, remember that the drug was developed with a $37.5 million grant from the federal government paid for by taxpayers.
Once again, Big Pharma is set to profit on the taxpayer’s dime.”
Well, where to start on this Tweet? First of all, when faced with this growing pandemic, people were asking (pleading?) for biopharma’s help in finding treatments and vaccines to treat coronavirus. Many companies along with Gilead have stepped up to the plate making huge, at-risk investments in both R&D and in production to literally help save the world. This came at the expense of diverting precious R&D resources to this effort. In addition, Gilead has stated publicly that it will DONATE 1.5 million doses of remdesivir, enough to treat 140,000 patients at no cost to patients for compassionate use, expanded access and then broader use. Gilead has also provided assurances that access won’t be an issue, leading industry analysts to speculate that remdesivir won’t be a revenue driver for Gilead.
But what about the $37.5 million windfall that benefited Gilead? My guess is that about that much was spend by Gilead in the remdesivir Ebola work. It is likely that Gilead will spend close to $1 billion in the remdesivir program not just in clinical trials around the world but in the production of this critical drug. But, these facts seem to be lost not just on Reich but also on other politicians. Rep. Doggett (D-Texas) and Rep. DeLauro (D-Conn.) have asked the Department of Health and Human Services to provide information into any and all funds that the government has provided to enable the remdesivir program. They too feel that taxpayers are going to be bilked. Unfortunately, these people haven’t a clue about the costs involved in drug R&D. Politicians repeatedly rail about who should benefit from research initially funded by agencies like the NIH. Yet, this early research, while very important, is just the first step in a long, arduous and costly process. It’s like running a marathon. The first mile is very important. But you still have another 25.2 miles to go – miles that become harder and more resource draining with each step. Yes, $37.5 million is a lot of money – but a bit less than $1 billion.
Ironically, the Institute for Clinical and Economic Review (ICER), the self-described independent watchdog on drug pricing for the nation, has estimated that a “cost-recovery” price for remdesivir, assuming that the drug saves lives, would be $4,400 per treatment course. I have no insights as to what Gilead is thinking of charging for remdesivir once the initial 140,000 treatments are exhausted. But I would be surprised if the price is this high especially given the comments made to date by Gilead’s CEO, Daniel O’Day.
So let’s stop portraying this important industry as being evil. Let’s be grateful that we have our first COVID-19 therapeutic and let’s hope that a number of others follow. Then let’s hope that the industry is successful in coming up with vaccines. Finally, please recognize that biopharma is our best hope in getting past this pandemic.