A Blog by Jonathan Low


May 9, 2020

It's Not Clear Remdesivir Stops Covid-19, But the Battle Over Its Price Is On

Gilead promised to donate 1.5 million doses of the drug to the government, which was not entirely philanthropical, since the government funded significant aspects of the research.

How much Gilead will charge after those first doses are gone looks like it will be a big number. JL

Mike Masnick reports in Tech Dirt:

Orphan works designations, which give extra monopoly rights to the holders (beyond patent exclusivity), are meant for diseases that don't impact a large population. Since the ceiling to qualify for orphan drug status is 200,000, Gilead got in its application before there were 200,000 confirmed cases. Wall Street expects (it) to come in at $4,000 per patient above remdesivir’s development cost, which Gilead estimates at $1 billion.
You may recall in the early days of the pandemic, that pharma giant Gilead Sciences -- which has been accused of price gouging and (just last year!) charging exorbitant prices on drug breakthroughs developed with US taxpayer funds -- was able to sneak through an orphan works designation for its drug remdesevir for COVID-19 treatment. As we pointed out, everything about this was insane, given that orphan works designations, which give extra monopoly rights to the holders (beyond patent exclusivity), are meant for diseases that don't impact a large population. Gilead used a loophole: since the ceiling for infected people to qualify for orphan drug status is 200,000, Gilead got in its application bright and early, before there were 200,000 confirmed cases (we currently have over 1.3 million). After the story went, er... viral, Gilead agreed to drop the orphan status, realizing the bad publicity it was receiving.
After a brief dalliance with chloroquine, remdesivir has suddenly been back in demand as the new hotness of possible COVID-19 treatments. Still, a close reading of the research might give one pause. There have been multiple conflicting studies, and Gilead's own messaging has been a mess.

On April 23, 2020, news of the study’s failure began to circulate. It seems that the World Health Organization (WHO) had posted a draft report about the trial on their clinical trials database, which indicated that the scientists terminated the study prematurely due to high levels of adverse side effects.
The WHO withdrew the report, and the researchers published their results in The Lancet on April 29, 2020.
The number of people who experienced adverse side effects was roughly similar between those receiving remdesivir and those receiving a placebo. In 18 participants, the researchers stopped the drug treatment due to adverse reactions.
But then...

However, also on April 29, 2020, the National Institute of Allergy and Infectious Diseases (NIAID) announced that their NIH trial showed that remdesivir treatment led to faster recovery in hospital patients with COVID-19, compared with placebo treatment.
“Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo,” according to the press release. “Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo.”
The mortality rate in the remdesivir treatment group was 8%, compared with 11.6% in the placebo group, indicating that the drug could improve a person’s chances of survival. These data were close to achieving statistical significance.
And then...

“In addition, there is another Chinese trial, also stopped because the numbers of new patients with COVID-19 had fallen in China so they were unable to recruit, which has not yet published its data,” Prof. Evans continues. “There are other trials where remdesivir is compared with non-remdesivir treatments currently [being] done and results from some of these should appear soon.”
Gilead also put out its own press release about another clinical trial, which seems more focused on determining the optimal length of remdesivir treatment. Suffice it to say, there's still a lot of conflicting data and no clear information on whether or not remdesevir actually helps.
Still, that hasn't stopped people from trying to figure out just how much Gilead will price gouge going forward:

The Institute for Clinical and Economic Review (ICER), which assesses effectiveness of drugs to determine appropriate prices, suggested a maximum price of $4,500 per 10-day treatment course based on the preliminary evidence of how much patients benefited in a clinical trial. Consumer advocacy group Public Citizen on Monday said remdesivir should be priced at $1 per day of treatment, since “that is more than the cost of manufacturing at scale with a reasonable profit to Gilead.”
Some Wall Street investors expect Gilead to come in at $4,000 per patient or higher to make a profit above remdesivir’s development cost, which Gilead estimates at about $1 billion.
So... we've got a range of $10 to $4,500 on a treatment that we don't yet know works, and which may or may not save lives. But, given that we're in the midst of a giant debate concerning things like "reopening the economy" -- something that can really only be done if the public is not afraid of dying (or at least becoming deathly ill) -- the value to the overall economy seems much greater than whatever amount Gilead wants to charge. It seems the right thing to do -- again, if it's shown that remdesevir actually helps -- is to just hand over a bunch of money to Gilead, say "thank you very much" and get the drug distributed as widely as possible. Though, again, it should be noted that a decent chunk of the research around remdesevir was not done or paid for by Gilead, but (yet again) via public funds to public universities, which did the necessary research. The idea that it's Gilead that should get to reap massive rewards for that seems sketchy at best. But the absolute worst outcome is one in which Gilead sticks to its standard operating procedure and prices the drug in a way that millions of Americans can't afford it, and it leads to a prolonging/expanding of the pandemic.


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