Possible benefits but risks promoting unproven coronavirus treatments

Normally drugs are trialed and tests are peer reviewed before allowing use by the public. There’s a good reason for this. While drugs can be relieving and life saving, they can also cause major problems with unexpected side effects, and some drugs can make some illnesses worse.

We are not in normal times as the Covid-19 virus sweeps around the world and, so far, 68,000 people have died and many more have sustained lung damage and other adverse effects.

The speed with which the virus has spread around the world – it has been out of China not much more than three months – has had scientists and laboratories  racing to develop treatments and vaccines (vaccines usually take 1-2 years to develop and test before going public).

People will inevitably self-medicate, either as a hoped for prevention, treatment or cure. But what if a very prominent person promotes an unproven drug? Do the circumstances justify ignoring well established test and certification procedures? What about for future outbreaks? Just try anything that sounds like it may help?

Tricky territory.

Donald Trump publivly promoted a drug that may or may not help treat Covid-19, and may or may not make Covid worse.

Reuters exclusive: Pressed by Trump, U.S. pushed unproven coronavirus treatment guidance

In mid-March, President Donald Trump personally pressed federal health officials to make malaria drugs available to treat the novel coronavirus, though they had been untested for COVID-19, two sources told Reuters.

Shortly afterward, the federal government published highly unusual guidance informing doctors they had the option to prescribe the drugs, with key dosing information based on unattributed anecdotes rather than peer-reviewed science.

While Trump, in a series of tweets and press comments, had made his opinions on the drugs, chloroquine and hydroxychloroquine, well known, the nature of his behind-the-scenes intervention has not been previously reported. The guidance, published by the Centers for Disease Control and Prevention, has received scant notice outside medical circles.

The episode reveals how the president’s efforts could change the nature of drug oversight, a field long governed by strict rules of science and testing. Rarely, if ever, has a U.S. president lobbied regulators and health officials to focus their efforts on specific unproven drugs.

“The president is short-circuiting the process with his gut feelings,” said Jeffrey Flier, a former dean of Harvard Medical School. “We are in an emergency and we need to rely on our government to ensure that all these potential therapies are tested in the most effective and objective way.”

I normally avoid taking any drugs – or supplements or artificial vitamins – as much as possible. When I had bad toothache (an abscess) recently I had to search the house for painkillers and took some that were past their use by date by a couple of years. When my dentist prescribed antibiotics I took the full course, but I can go for a year or two without using any pills.

If I caught some new virus or disease and there were no proven treatments, I don’t know what I would do if drugs used for other things may or may not help. I would be reluctant, because I think it would be quite a risk. Self treatment based on tweets or other online advice should be viewed with a lot of suspicion. But what if a president promotes it?

In a statement to Reuters, the White House said the president had not launched a “pressure campaign” but was taking appropriate action.

“The President’s top priority is the health and safety of the American people which is why he has brought together the federal government and private sector, including doctors, scientists, and medical researchers, for an unprecedented collaboration to expedite vaccine development,” said the statement, which did not address Reuters questions about the CDC guidance.

In the past a top priority in ensuring health and safety has been extensive testing, both for effectiveness and for side effects and adverse effects.

Online anecdotes are something I would be very cautious about using to inform my treatment.

Administration supporters say the CDC document, highlighting options, makes sense at a time of medical calamity with no proven treatment. And, they note, chloroquine and hydroxychloroquine have been prescribed for years with known risks. Any potential risk to coronavirus patients, some argue, is worth taking given the health crisis.

“In a perfect situation you would never do this,” said a public health specialist who recently left government. “But if you know what the safety downside is, and the patient is ready to try it, it’s worth a try.”

Maybe, but is it really worth the risk if you have no idea if it will work?

Apart from the possibility of adverse side effects or it being detrimental to treatment of the condition it is being used to try to treat, or the risk of addiction (there’s a good reason morphine isn’t promoted for all sorts of conditions) there’s another potential problem.

Some people may choose to self-treat with the unproven drug and think that’s all they need to do. If the drug is ineffective that may delay getting treatment that will help.

And if it’s a contagious diseases like a virus, they could spread it around while they think they are treating themselves.

In a series of conversations last month, President Trump personally instructed top officials at the Centers for Disease Control, the Food and Drug Administration and the National Institutes of Health to focus on the two drugs as potential therapies, said two sources familiar with the president’s efforts.

In seeking a medical breakthrough to the global crisis, Trump had contacted Dr. Stephen Hahn, the FDA administrator, and other top health officials, questioning whether they were moving rapidly enough to make the drugs more widely available, one source said. “He was not happy because of the bureaucracy.”

There’s another potential problem. If what Trump was pushing for does turn out to be a useful treatment, what then? What if Trump decides then to reduce the bureaucracy generally for drug testing? What if Trump promotes other drugs for other illnesses?

What if he starts to tweet about quack remedies, cancer cures, dementia preventers, skin tone improvers?

There are lot of risks with Covid-19. There are a lot more risks in making drug recommendations and availability for Covid and for other conditions unrestricted open slather. Drug companies have been found in the past to cheat normal tests to make money by getting their drugs to market.

Desperate ill and dying people can do desperate things, and can be more gullible to Internet promoted remedies.

There are a lot of risks.

Trump did not raise his voice or express anger, but did emphasize the “urgency” of fast-tracking access to the drugs, the other source said. A cascade of federal action soon followed to make the drugs more available, including the federal government’s grant of emergency authorization to supply them nationwide.

Drug authorisation by President is a dodgy development, especially drug promotion by Trump, who has a history of putting business before health of the environment (and people).

An FDA spokesperson declined to discuss any push by the president or address the CDC-issued guidance. The agency, in a statement to Reuters, said it acted appropriately when, later in March, it issued an emergency order allowing the drugs to be prescribed and distributed.

“It was determined, based on the scientific evidence available, that it is reasonable to believe that the specific drugs may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus outweigh the known and potential risks,” the FDA statement said.

So will the FDA use this as a precedent and fast track more drugs and treatments? “It is reasonable to believe that the specific drugs may be effective” is a major shift from normal approval practices.

In this case what they ‘believed’ may prove to be correct and the drug may turn out to be a successful treatment.

But if bypassing normal checks and balances becomes common practice, it’s probably just a matter of time we get another thalidomide, or some adverse effect that could be worse than the benefits.

Especially if drug companies learn how to speed up their profits at the cost of safety checks.

 

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17 Comments

  1. duperez

     /  6th April 2020

    It’s America so anything could happen.

    The President says, “There’s a rumour … people are saying … good people … that ZYX works well on the virus. It’s a powerful drug, a really powerful drug, developed by our scientists, great scientists, the best I’d say. Made by one of our very good companies, a great company actually, great people, great scientists. Anyway, that’s what people are telling me, that’s what I hear. It’s going to make a big impact.”

    So some yokel doses up on ZYX. ZYX made under licence in China. Designed to deal with warts on pigs. It kills him.

    Down the line some lawyer straight out of one of those American ‘small man had wrong done to him’ movies hears about it and takes up the case. She helps the family sue the President for $317million.

    Reply
    • Pink David

       /  6th April 2020

      “So some yokel doses up on ZYX. ZYX made under licence in China. Designed to deal with warts on pigs. It kills him.”

      Have you check out the latest on this story?

      Reply
      • duperez

         /  6th April 2020

        Not on the story I’ve written but as I write I’m watching the White House conference and just heard more about “take this, what have you got to lose?” And found reference to something mentioned:
        http://theconversation.com/a-small-trial-finds-that-hydroxychloroquine-is-not-effective-for-treating-coronavirus-135484

        Reply
        • I am among a number of researchers who are concerned that this drug has been given too much of a high priority before there is enough evidence to show it is indeed effective.

          There are already other clinical studies that showed it is not effective against COVID-19 as well as several other viruses. And, more importantly, it can have dangerous side effects, as well as giving people false hope. The latter has led to widespread shortages of hydroxychloroquine for patients who need it to treat malaria, lupus and rheumatoid arthritis, the indications for which it was originally approved.

          Similar to what I suggested.

          Reply
          • Alan Wilkinson

             /  6th April 2020

            There is some evidence it is effective. There is no evidence anything else is effective. What would you do in extremis?

            Reply
            • Kitty Catkin

               /  6th April 2020

              Penicillin is effective for most people but could be fatal for me; I’d really have to be in extremis to risk it. If I was that far gone, it would be academic, anyway.

            • “Why is the governor banning it?” asked Mr. Giuliani, President Trump’s personal lawyer, on “Sunday Morning Futures.” “Everything shows that it works.”

              Giuliani is not someone I would rate to give Cuomo or Trump advice on medical treatments.

              What if Cuomo takes Giuliani’s advise over the FDA, and it turns out that hydroxychloroquine does more harm than good, and deaths occur because of it? Who would be liable, Cuomo or Giuliani?

            • Alan Wilkinson

               /  6th April 2020

              The FDA approved it. Neither would be liable.

            • Duker

               /  6th April 2020

              More nuanced than that. Its an FDA approved medicine now , the medical system allows off label prescribing anyway.
              But Doctors will have the butts sued off if there are severe side effects, as is normal in US ( thus the heavily Insured Doctors and insured patients to afford them)

              “The emergency use authorization only applies to the supply of these two drugs in the Strategic National Stockpile, the government’s storehouses of emergency medical supplies located in warehouses throughout the country.

              Hospitals would need to request access to the drugs through their states, and the medicines would only be distributed to patients who have been hospitalized and tested positive for COVID-19, but for whom a “clinical trial is not available, or participation is not feasible,” according to the FDA.”

              “The whole history of infectious disease is littered with drugs we all thought were going to be promising but turned out … not to be,”
              https://www.npr.org/sections/coronavirus-live-updates/2020/03/30/823987540/fda-oks-addition-to-stockpile-of-malaria-drugs-for-covid-19

            • Alan Wilkinson

               /  6th April 2020

              Knowing the US, it’s far more likely doctors would be sued for not prescribing it.

            • Gezza

               /  6th April 2020

              Best way for Giuliani to go in recommending it would be to get himself infected, & then take it if & when the Covid-19 symptoms really start to show.

            • Gezza

               /  7th April 2020

              Knowing the US, it’s far more likely doctors would be sued for not prescribing it.

              Lol. Yes. Great place to be a lawyer, the US. One seems to be able to sue someone’s ass if they do anything & also sue them if they do nothing.

  2. duperez

     /  6th April 2020

    Summary and comment on part of today’s conference from NY Times:

    “Trump again promotes use of hydroxychloroquine.

    At a White House coronavirus briefing Sunday, President Trump continued to push hydroxychloroquine against the advice of doctors and health experts who say its efficacy against the coronavirus is unproven.
    Mr. Trump suggested he was speaking on gut instinct, and acknowledged he had no expertise on the subject.

    “But what do I know? I’m not a doctor,” Mr. Trump said, after recommending the anti-malaria drug’s use for coronavirus patients as well as medical personnel at high risk of infection.
    Saying that the drug is “being tested now,” Mr. Trump said “there are some very strong, powerful signs” of its potential, although health experts say the data is limited and that more study of the drug’s effectiveness against the coronavirus is needed.

    “If it does work, it would be a shame we did not do it early,” Mr. Trump said, noting again that the federal government has purchased and stockpiled 29 million doses of the drug. Mr. Trump added, “We are sending them to various labs, our military, we’re sending them to the hospitals.”

    “What do you have to lose?” Mr. Trump asked, for the second day in a row.

    When a reporter asked Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, to weigh in on the question of using hydroxychloroquine, Mr. Trump stopped him from answering. As the reporter noted that Dr. Fauci was the president’s medical expert, Mr. Trump made it clear he did not want the doctor to answer.

    Dr. Megan L. Ranney, an emergency physician at Brown University in Rhode Island, said in an interview on Sunday night that she had never seen an elected official advertise a miracle cure the way Mr. Trump has done. But she took pause.

    “There are side effects to hydroxychloroquine,” Dr. Ranney said. “It causes psychiatric symptoms, cardiac problems and a host of other bad side effects.”

    Reply
    • “There are side effects to hydroxychloroquine,” Dr. Ranney said. “It causes psychiatric symptoms, cardiac problems and a host of other bad side effects.”

      From Vulnerable people

      Who is at higher risk to COVID-19
      At-risk people include:

      Those over 70: Older people often have underlying health issues, including respiratory issues that make them more vulnerable to COVID-19.

      People with medical conditions: Underlying medical conditions can make you more vulnerable to COVID-19. In particular, people with respiratory conditions, such as COPD (Chronic Obstructive Pulmonary Disease), heart conditions, high blood pressure, kidney problems and diabetes.

      So someone with an underlying heart condition taking a drug that may cause cardiac problems should, I suggest, only be done with good medical advice, not from the gut feeling advice of a President.

      Reply
  3. Ray

     /  6th April 2020

    Apparently Ivermectin has been found to be useful with the virus.
    All NZ farmers know about this stuff as it was a breakthrough second wave stock drench, very expensive when it was under patent but great stuff.
    Now used for human nit control and theoretically Covid control.
    Cockies better lock up their supplies eh.
    https://www.tvnz.co.nz/one-news/world/australian-study-finds-common-anti-parasitic-drug-kills-covid-19-cells-within-48-hours

    Reply
    • Sounds interesting, but…

      The next step is for scientists to determine the correct human dosage, to make sure the level used in vitro is safe for humans.

      “In times when we’re having a global pandemic and there isn’t an approved treatment, if we had a compound that was already available around the world then that might help people sooner,” Dr Wagstaff said.

      “Realistically it’s going to be a while before a vaccine is broadly available.”

      Before Ivermectin can be used to combat coronavirus, funding is needed to get it to pre-clinical testing and clinical trials.

      …it could be a while before we know if it is safe to use, and effective.

      Reply

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