‘This Is a Massive Scandal’: Trump FDA Grants Drug Company Exclusive Claim on Promising Coronavirus Drug

Jerri-Lynn here. I encourage readers to look at this update from The Intercept, CORONAVIRUS TREATMENT DEVELOPED BY GILEAD SCIENCES GRANTED “RARE DISEASE” STATUS, POTENTIALLY LIMITING AFFORDABILITY.

Where are you, Joe Biden? What do you have to say about this decision, expected to give Gilead Sciences a multi-billion coronavirus windfall.

Bernie’s position is clear, as reported below.

How about it, Joe?

By Julia Conley, staff writer for Common Dreams. Originally published at Common Dreams

As healthcare providers across the U.S. desperately attempt to treat a rapidly growing number of patients with the coronavirus, a pharmaceutical company with ties to the Trump administration has been granted exclusive status for a drug it is developing to treat the illness—a potential windfall for the company that could put the medication out of reach for many Americans.

As The Intercept reported Monday, the Food and Drug Administration granted Gilead Sciences “orphan” drug status for remdesivir, one of several drugs being tested as potential treatments for the coronavirus, officially known as COVID-19. The designation is generally reserved for drugs that treat rare illnesses affecting fewer than 200,000 Americans—but companies can be eligible if the designation, as in this case of a rapidly spreading virus, is made before a disease spreads beyond that limit.

About 40,000 Americans had contracted COVID-19 when the orphan status was granted to remdesivir Monday, and the disease is spreading faster in the U.S. than in other countries. By Tuesday afternoon, more than 51,000 Americans had confirmed cases.

Having secured orphan drug status, Gilead Sciences can now profit exclusively off the drug for seven years and could block manufacturers from developing generic versions of the drug which might be more accessible to many patients. The company can set price controls on the drug as well as benefiting from grants and tax credits.

As The Intercept reported, the designation was given to a company where Joe Grogan, a member of President Donald Trump’s “coronavirus task force,” worked as a lobbyist from 2011 to 2017, often working on issues regarding drug pricing.

“This is a massive scandal,” tweeted Ryan Grim, Washington, D.C. bureau chief for The Intercept.

Sen. Bernie Sanders (I-Vt.) called the reports of profiteering by Gilead Sciences, with the support of the Trump administration, “insane and unacceptable” and demanded that treatment for the coronavirus be made free for all Americans.

The Orphan Drug Act of 1983 was passed to ensure medications for rare diseases can be developed, and was meant to benefit companies which may not recoup their research costs after their drugs are put on the market.

But as Sharon Lerner and Lee Fang reported at The Intercept, the “orphan” status is expected to create a massive windfall for Gilead.

“The special orphan designation,” they wrote, “was given to remdesivir despite hefty support by the government for the development of the drug. Gilead Sciences’ remdesivir was developed with at least $79 million in U.S. government funding.”

“The Trump Administration just gave the Gilead pharma corporation a seven-year monopoly, so they can charge patients outrageous prices for the medication we’ve already paid for,” Social Security Works tweeted.

Gilead’s rush to profit off a potentially life-saving drug in the midst of a public health and economic crisis could prove “deeply harmful” to the American people, many more of whom are expected to contract the coronavirus, said government watchdog Public Citizen.

“Remdesivir is one of relatively few medicines that may prove effective in treating COVID-19 this year,” said Peter Maybarduk, director of the group’s Access to Medicines program. “The government should be urgently concerned with its affordability for citizens. Instead, the FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and, with it, the ability to charge outrageous prices to consumers.”

“Gilead has gamed the system by rushing through its ‘rare disease’ orphan drug application,” Maybarduk added. “Its action is disingenuous and outrageous.”

The grassroots group ACT UP, which has fought for decades for equitable access to HIV-AIDS drugs and to healthcare, also expressed outrage on social media.

“This is how pharma greed kills,” the group said.

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51 comments

  1. ambrit

    The obvious best strategy to counter this action would be to nationalize Gilead. A second best strategy would be for some “wily foreign power” to mass produce the drug and give it away to whomever asks for it. Then lever the resulting actions of the Government in favour of Gilead’s profiteering to utterly destroy any “soft power” America has left in the world.
    This Administration seems to have raised the scoring of own goals to an art form.

    Reply
    1. txchick57

      China is doing that. I don’t know if they’re giving it away but they have reverse engineered GS-5734. Through various companies, they are selling it to cat owners whose cats have FIP, a formerly 100% fatal disease caused by a coronavirus. I used it on my cat and it worked FAST and miraculously. It saved her Iife. I have accumulated about 20 vials. I wonder what would happen if I showed up at the hospital with Covid 19 and my bootleg remdesivir – If they would administer it to me on request. I hope to not have to find out.

      Reply
      1. Ehab

        I totally get it that price gouging is not acceptable, but the tone of many of the comments here would indicate that Gilead should be a charity. Does Gilead deserve any compensation for the risk taking and the hard work of thousands of scientist to come up with GS-5734 and other ‘miraculous’ compounds that greatly improve human (and animal) lives? Gilead risked its own own and shareholders money to get to where they are. Unlike banks, I’m not aware of any bailout that went to Gilead. I’m aware that Gilead and every pharma-biotech player takes advantage of research provided by NIH and other tax-backed institutions. You can make the same argument of every for profit endeavor in this country as it would not be the same without fundamental public backed services such as public education and public libraries, etc. I’m not sure if that is a good argument for nationalizing Gilead. How about putting in place some regulations against price gouging!

        Reply
        1. Dwight

          28 U.S.C. § 1498 allows government use with reasonable compensation, usually set at 10% of sales, per Wikipedia. This statute may not apply because of “orphan” status, per Knowledge Economy International.

          Congress should immediately apply this statute to coronavirus drugs, and if necessary, pass law to makes sure this statute applies to drugs granted orphan status.

          Reply
        2. tucsonSteve

          “…Gilead risked its own own and shareholders money to get to where they are….”
          Plus $79 myn of US taxpayer money to fund (unknown) part of R&D of Remdesivir. I didn’t see that part in your comment above.

          My sense is that any drug company with a Rx intervention is looking at $20k/patient times several million patients — so once-in-a-hundred year opportunity. The drug companies are watching DC pass a $2 tryn bailout/support package for the US economy/corps. They are not about to sell their Rx intervention for $30/patient or whatever in this environment. Not gonna happen.

          With respect to all of you, enough with the Trump-bashing already
          Do any of you seriously think that Pelosi and Schumer and Trump and Pence and everyone in a position of power in DC and elsewhere doesn’t have Remdesivir and hydroxychloroquine supplies set aside for themselves? Bashing any one of these “leaders” is silly because they are all getting a better deal than you will ever get.

          Did you see that, on January 19, the Wuhan Institute of Virology filed a “new uses” patent for remdesivir and hydroxycholorquine in the treatment of Covid-19? They had enough research and clinical data in place over two months ago to justify the attempt to patent Gilead’s drug for this specific use. see:http://news.sciencenet.cn/htmlnews/2020/2/435384.shtm
          have google translate it.
          The Wuhan Institute of Virology is four city blocks from the outdoor food market which is suspected as the source for cv-19.

          What is the false neg and false pos rate for the pcr CV test in SKorea? Why are they testing 10k people a day in SKorea and in the US we cannot? Is the SKorea pcr test a low false pos/neg test? Or is it garbage? What are the false pos/neg rates for the pcr tests that could be made widely available quickly in the US? Why are we not being told the answers to these simple questions?
          What happened to the 3 myn hydroxychloroquine tablets that Bayer donated to the US government last week? Bayer is a serious company — was that a joke or something? Have you noticed that in the past week, the only msm articles on hydroxychloroquine have been dismissive and negative? Most of the reporting I have seen failed to distinguish between the available chloroquine compounds, a significant error in reporting.

          In other words, there are gaping holes in the facts as they are being presented to us, and the media are so busy trying to blame OrangeManBad for cv-19 that these missing facts are being completely ignored, and we just helplessly flail around and turn on one another.

          with respect

          Reply
    2. New Wafer Army

      “The obvious best strategy to counter this action would be to nationalize Gilead.” lol.

      That’s not going to happen. Now is a good time to revisit the rules of neoliberalism:

      1. Because markets.
      2. Go die.

      Reply
          1. Susan the other

            Or Nancy Pelosi pretending it’s not really nationalized medicine because that would usher in M4A: congress passed a bill making the fed gov the billable co-party on all corona treatment, “even for the uninsured”. Right Nancy, you hopeless fantasizer. Or grifter?

            Reply
        1. thoughtfulperson

          “You’re on your own!”
          —–

          True for you and me, but obviously not true for friends of the fed (and black rock) who will get unlimited trillions

          Reply
    3. Thomas P

      China is in the best position to mass produce it given their huge industry manufacturing pharmaceuticals for the rest of the world. Trump will scream, but he will meet limited international support if he tries to make a trade issue out if it. Cuba is another player who has a pharmaceutical industry and would just laugh if USA threatened retaliation given how they are already under US sanctions. US citizens are still screwed, of course.

      Reply
      1. fajensen

        The CIA will drone any such facility in Cuba for producing ‘bio-weapons’! China is not so simple though, probably the State Department will seek to sanction any country that buys any ‘cloned’ pharmaceuticals from China!

        Reply
        1. xkeyscored

          Much of the world is increasingly disgusted by the continuing sanctions on Venezuela and Iran in the midst of this crisis, as well as by the US military flying war criminals and test swabs off to the Fatherland while other nations are flying medical staff and supplies in.
          Sanctions against countries that avail themselves of ‘cloned’ drugs may result in the USA being left to its own devices, and its sick sanctions schemes finally falling apart.

          Reply
          1. fajensen

            One can hope, the world will be a better place with more diversity of ideas, IMO. Everyone marching to the same drumbeat is exactly why everything blows up in the same way and at the same time globally, which is not sustainable.

            Reply
      2. jrkrideau

        “Other pharmaceutical firms, including India-based pharmaceutical firm Cipla, are reportedly working toward a generic form of remdesivir, but patients in the U.S. could be prevented from buying generics with lower prices now that Gilead Sciences’s drug has been designated an orphan.”

        From the Intercept article.

        Reply
  2. The Rev Kev

    Actually I could see this getting worse based on how the fiasco with developing a test in the US went. Say in the next year or two a vaccine is developed in Germany or China or some other country. Having proved effective, the vaccine goes into mass production and is distributed world-wide in a coordinated effort to rid the world of Coronavirus except for the US. There something else happens.

    In order to protect the locked in profits of Gilead, the FDA does not give clearance on this cheap vaccine as it has not passed FDA protocols thus giving Gilead more time to develop their vaccine which they have not yet finished. Months pass but clearance on that vaccine is still in the works and it is forbidden to import it into the country. That is, unless you have the right connections or have the money to take a quick private jet trip to Canada or Mexico that is. Tell me this this could never happen.

    Reply
    1. xkeyscored

      Remdesivir is a potential treatment, not a vaccine. So far as I know, Gilead (was that name chosen before or after The Handmaid’s Tale was published?) has no vaccines in the pipeline.

      Reply
  3. vlade

    Trump is working hard at not getting elected.

    The US failure to deal with the virus will kill mostly Trump voters (not because they are olders, but because they are poorer in worse health).

    Those that survive will see that there was done precious little to be able to help them, and active actions were taken to profit from the disaster.

    Now, if only Dems had a good candidate who could believably lever on all of this.. No? I guess then Dems are working even harder to make sure Trump is elected.*)

    TBH, I think Sanders missed a trick here, where his focus seemed to be to use this to emphasise the M4A. M4A should use this – but first, one needs to deal with what’s there, i.e. the operational issues of lockups etc. Get tests and treatments for free to everyone for CV immediately (because that’s congresscritters would find it hard to fight and keep face), and then use that as a lever (with few strategically placed bits in the legislation) to extend it.

    When flood is running in, most people don’t care about systemic issues, but immediate response.

    *) a comparison is/was often made between Johnson and Trump. On the UK side, Tories are now waking up to the fact that any mess-ups will be used by Labour against them, and it’s gonna be worse than Brexit. Hence some are already trying to push for a government of national unity.

    Reply
    1. xkeyscored

      Sanders: “We will not tolerate profiteering.” (above)

      And what does that mean, in practice? Sanders will refuse remdesivir if offered it as treatment? Bernites will burn down Gilead? Or the US’ll be entertained with empty rhetoric while being urged to unite behind Biden or Trump and the neoliberal order, at least until the next elections?

      Reply
        1. xkeyscored

          Don’t get me wrong; I think he’s one of the best hopes in US politics.
          But “will not tolerate” sounds like vacuous hot air. A boycott, even if it happens, leaves the profiteering in place, and the only way of actually not tolerating it I can imagine would need the US military to take over production and distribution of remdesivir. Is Sanders calling on them to disobey their president? Not yet, so far as I know. I guess he and his supporters will tolerate this profiteering when it comes down to it, albeit while complaining about it.

          Reply
      1. David J.

        And what does that mean, in practice?

        It means not going down without a fight. Sanders has come under a lot of criticism lately but I suggest that his forceful advocacy of many policies, especially since the 2016 race, is an important foundation from which a lot of future policy will be crafted. It’s not happening as fast as many would like, but it’s not empty rhetoric either.

        Reply
          1. Michael Fiorillo

            That’s an absurd question with which to frame the issue: do you stop eating because injustice causes poor people to go hungry?

            No, you stay strong and healthy, so you can fight for them and yourself…

            Reply
            1. xkeyscored

              Sanders framed his statement, not me. I pointed out that it is probably absurd, and he probably will tolerate profiteering. I’d love to see him eliminate it, but he shows no concrete signs of doing so, though I do believe he’d like to.

              Reply
    2. Carolinian

      You’re assuming that Trump even knows what’s going on in his administration or the FDA. In any case this is a massive scandal and so massive that it may even finally break the back of the pharma IP scam. Expect pitchforks.

      As for the political angle, hopes that CoV will put feeble Joe in the White House could be optimistic. So far Trump’s poll rating for handling the virus is 60 percent public approval.

      Reply
    3. Craig

      >> The US failure to deal with the virus will kill mostly Trump voters (not because they are olders, but
      >>because they are poorer in worse health).

      Not necessarily true. The cities are the the most vulnerable with population density. Take them out and who knows how these big delegate states will go.

      Reply
    4. Procopius

      The US failure to deal with the virus will kill mostly Trump voters (not because they are olders, but because they are poorer in worse health).

      I really should restrain myself, because I can’t find a link, but shortly after the 2016 election I read that the median Trump voter had an annual income of $70,000. That’s well over median U.S. family income, and it means half of Trump voters made more than that. The MSM have harped on the idea that Trump voters are “white nationalist and racist working class voters without a college degree,” but that’s misleading. I infer that it’s intentionally misleading, but I am not a mind reader.

      Reply
    5. thoughtfulperson

      The US failure to deal with the virus will kill mostly Trump voters (not because they are olders, but because they are poorer in worse health).
      ———–

      Not the way viruses work. Note large outbreaks in closely packed cities in the US (ex. New York). US cities are heavily democrat leaning, suburbs and rural areas are repub.

      Also, will only possibly affect the Nov election in the “battle ground” states like MI, WI, due to electoral college system.

      Reply
  4. Ignacio

    Insane? Malign? Stupid? Execrable?
    Out of words here. I will watch the greed/fear index today because this is 99% greed.

    Reply
  5. Mickey Hickey

    The American system of government was carefully designed to be easily gamed. It started with the grade B movie actor Ronald Reagan mouthing “I am from the government and I am here to help you.”. Today as the MIC quakes in its boots at the prospect of Covid-19 disrupting its gravy train and the Pharmaceutical Companies see improved prospects to profit from catastrophe you can rest assured that lobbying is at fever pitch. As in most countries buying politicians is perfectly legal in America.

    Reply
  6. oaf

    …Perhaps those with the C-virus will be deemed terrorist threats, subject to neutralization as a matter of National Security…

    Reply
  7. TomDority

    Well – the defense appropriations act should be invoked as the war has already been publicly declared.
    Then don’t lift that act for this drug.
    Maybe
    Nah – it would seem impossible for a captured congress to nix a give away like that.

    Reply
  8. xkeyscored

    MIKE ELK, mike.elk@gmail.com, @MikeElk
    Elk is the senior labor reporter at Payday Report and correspondent for Business Insider.

    He said today: “People should not discount the possibility of a general strike by workers now. I was covering the lead up to the West Virginia teachers strikes in 2018 and that took people by surprise. It inspired strikes across the nation.

    “Now, you are seeing strikes of bus drivers in Birmingham and poultry workers in Georgia. Workers are mobilizing and this could inspire a massive strike wave.

    “And you have a clear precedent for this. After the 1918 influenza pandemic, you had the 1919 general strike. (See recent piece in The Nation.)

    “It’s dawning on more people how critical their labor is and how little these corporations care about them. The veneer of we’re-going-to-take-care-of-you has dropped away.

    “Health care workers are having their lives endangered by corporate moves. (See piece in The Intercept: “Kaiser Permanente Threatened to Fire Nurses Treating Covid-19 Patients for Wearing Their Own Masks, Unions Say.)

    “The lack of sick days is endangering workers and everyone. Nashville is set to have an enormous outbreak of COVID-19. It’s huge tourist center with many services workers without paid sick days.

    “We’re talking about possibly 20 to 30 percent unemployment. That will lead employers to be even more callous.

    “Meanwhile, Boeing has $15 billion in the bank and is set to get a bailout.

    “Nissan has worked to hinder its workers in Alabama from unionizing and now the company is forcing them to work and risk their lives.”

    http://accuracy.org/release/generalstrike/

    Reply
    1. John Rose

      Nashville has the lowest number of repirators per population in the country.
      A “reform” of their health care system let to the death of my best friend some years ago.

      Reply
  9. rob

    Gilead?
    like when 15 years ago…
    the bush administration granting them profits…
    Donald rumsfeld was on on the board….. became chairman in 1997
    Made millions , like when the company was selling “tamiflu”
    Amazing how some things never change…
    yet we are always hearing some news like it is “new”

    Reply
  10. barrisj

    Let us remember that Gilead is trying to repurpose for off-label use what is essentially an antiviral developed against Ebola and Marburg viral disease. Its safety profile has been established for the latter two applications, and the Company has now launched two Phase III studies for a 5-day and 10-day dosing regime against Covid-19. If any positive data emerges, under controlled clinical settings, no doubt there will be pressure upon the FDA – no less from tRump himself – for a “fast-track” approval for the drug, given the exigencies of the moment. Then comes the question of pricing, and how reimbursements will be handled. In the current climate, amidst a raging pandemic, if the drug proves efficacious and is approved, the federal government should take the lead and negotiate the treatment costs with Gilead, as granting them a monopoly patent does not grant them monopoly pricing. Although there have been countless of examples in the past few years where drug manufacturers, having a monopoly position in a particular drug, quickly pivoted to abusive and extortionate price scheduling for their products. I would think that the public-health aspects of the coronavirus pandemic would prevail over any “market-pricing” stance in this case. Remdesivir is not a “biopharmaceutical”, but a synthetic drug produced using published organic synthesis methods, so the Company would hardly jeopardize the “orphan drug” status by abusive pricing if other production sources can be put into play under any of the emergency contingencies available to government. What was given can be taken back.

    Reply
  11. Aloha

    It seems to be Christmas morning for all of the grifters in powerful positions!!! My head is spinning as I research some of the $ that will be GIVEN to billionaires and trillionaires in the next couple of months while only US citizens who filed taxes in 2018, income for single up to 75k and couples 150K, may receive up to 1200. and 2400. respectively if they are lucky, also $500. for ea child. On the bill passed it doesn’t give help to others but each state will have money for programs to help the homeless, poorest, etc. But wait, if you are a small business you might qualify for a LOAN (with free interest for a year) so that you can pay your employees until this thing blows over!!! That is good news…not. What a pathetic country this is.
    Just a reminder that Alex Azar is the US Secretary of Health and Human Services who’s job it is to have our best interests in a health crisis! Azar began working for Eli Lilly in 2007, a big pharma and was President from 2012-2017. He was also on the board of Biotechnology Innovation, a large pharmaceutical lobby group in DC. If you recall he spiked the price of insulin by 2000% and god only knows what he is up to today to help us.
    I see in the news that trump is stating that he is the “war president” ….aren’t they all? Today it is with a heavy heart that I feel like we are the enemy target along with Iran, Venezuela, Syria, etc. He states that “The US economy is more important than it’s citizens and in a couple of months, hopefully by Easter, he expects to see large crowds going to CHURCH not to mention BACK TO WORK!!!!
    I wonder if I will live long enough to see if that happens? Hawaii is one of the states whose governor doesn’t think that we should be on emergency lock down. A week ago we were told that there were test kits avail. and to go to a drive through clinic if feeling sick. People by the thousands showed up with Dr. referrals but only 250 kits were sent to the Big Island. The CV19 is going to hit the islands like a tsunami in a week or two and it is going to be really ugly. The senior population is going to disappear.

    Reply
  12. robert L goodwin

    I am not at all convinced that the FDA is under Trumps control in any way. But the corporatist actions of a federal agency never surprise me.

    Reply

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