It's Not Even Clear If Remdesivir Stops COVID-19, And Already We're Debating How Much It Can Price Gouge

from the pharma-madness dept

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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Filed Under: covid-19, drug pricing, monopoly rents, patents, pricing, remdesevir
Companies: gilead sciences


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  • icon
    That Anonymous Coward (profile), 8 May 2020 @ 12:14pm

    'MERIKA!
    For the corporations,
    by the corporations,
    give us your cash or die!

    link to this | view in chronology ]

    • identicon
      Anonymous Coward, 8 May 2020 @ 1:22pm

      Re:

      give us your cash or die!

      Shouldn't that be:
      give us your cash and die.

      link to this | view in chronology ]

      • icon
        Scary Devil Monastery (profile), 11 May 2020 @ 4:09am

        Re: Re:

        "give us your cash and die."

        Not really. You are expected to linger on and keep paying. Actually dying is the unintended side effect of the corporation in question misjudging the extent to which you could be made to pay.

        link to this | view in chronology ]

  • icon
    Ceyarrecks (profile), 8 May 2020 @ 12:23pm

    Purposefully Forgetting Something?

    soooo, is this the part where a fool and their money are soon parted? Last I checked, a two month(60 day) at 20k/day supply of vitD3 costs a whooping,... $10.00 tops. Reminder: vit D, vit C, zinc combo is already, well proven, in countless places around the world, to be effective against not only CV19, but regular flu.

    link to this | view in chronology ]

  • icon
    PaulT (profile), 8 May 2020 @ 12:24pm

    I'd add to that: if the drug does work as claimed, it only claims for people who are seriously ill from the disease. So, it'll be the people worst affected by the disease, after catching it from being sent out as cannon fodder to "reopen the economy", who are will be faced with the bills. But, at least lives and costs aren't being saved via "socialism"...

    "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."

    This is always the case. Basic medical research is not profitable, so it's done by the public sector. It's only when applications are found for that research that these companies get interested, and even then often only if there's a US market for the end result, since nobody else lets them get away with marketing their product to consumers, let alone get away with charging like this.

    link to this | view in chronology ]

  • identicon
    Anonymous Coward, 8 May 2020 @ 12:56pm

    That stuff can help if the proper treatment and population are used. Most victims won't benefit from it though.

    link to this | view in chronology ]

  • icon
    Anonymous Anonymous Coward (profile), 8 May 2020 @ 2:04pm

    Still waiting for a cure and/or vaccine

    I was under the impression that remdesevir aided in recovery, in at least some cases. I have not heard that it prevents, cures, or that it is effective in all cases.

    While it may be prescribed out of an abundance of caution by medical personnel who are pestered by patients to do so, and that may increase demand, the increase in demand will not be because it is a miracle cure for or vaccine against Covid-19. The increase in demand will be because of rumor and innuendo.

    link to this | view in chronology ]

  • identicon
    David, 9 May 2020 @ 2:02am

    Well, duh.

    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.

    So? The U.S. political and economical system is based on the free market, being able to sell and buy what you want (including politicians) for those who have the means, at the price the market will bear. It has operated at the "survival of the richest" maxim for the longest time.

    This is quite literally a case of "live by capitalism, die by capitalism". It may be worth pointing out that the wealth distribution in the U.S. is to a significant degree hereditary, and even things like getting an education are becoming privileges of historically entitled classes.

    Basically it's "money is what keeps the world from going round", providing some well-desired stability.

    In that vein, giving less prosperous people a few more reasons to die is just business as usual.

    link to this | view in chronology ]

    • icon
      Mike Masnick (profile), 10 May 2020 @ 10:18pm

      Re: Well, duh.

      So? The U.S. political and economical system is based on the free market, being able to sell and buy what you want (including politicians) for those who have the means, at the price the market will bear. It has operated at the "survival of the richest" maxim for the longest time.

      Please explain to me how a government granted monopoly is part of "free market" and "being able to sell and buy what you want."

      Wouldn't a true "free market" allow for others to make their own competing products, leading to the price of the drug to fall to the marginal cost?

      Why do people always take ridiculous ideas that have nothing to do with a free market and insist that those are examples of how the free market works?

      link to this | view in chronology ]

      • icon
        Scary Devil Monastery (profile), 11 May 2020 @ 4:18am

        Re: Re: Well, duh.

        "Why do people always take ridiculous ideas that have nothing to do with a free market and insist that those are examples of how the free market works?"

        Because quite a lot of people assume that the US is the ideological heart of the free market concept and must naturally be the primary example of how a free market is supposed to operate.

        As long as you just keep assuming instead of looking properly there's no need to reevaluate that perspective. Then you take a closer look and cognitive dissonance sets in.

        link to this | view in chronology ]


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