Coronavirus

Doctors, Not Politicians, Ought To Decide Whether Off-Label Drug Use of Hydroxychloroquine Is Appropriate for COVID-19 Patients

The FDA lets doctors prescribe off-label drugs all the time. Now that there’s a pandemic, some governors have decided doctors can’t make those decisions for themselves.

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As he often does, President Donald Trump uttered an untruth at a March 13 White House coronavirus task force briefing. The president claimed the drugs chloroquine and hydroxychloroquine, used for decades to treat malaria and connective tissue diseases, had been approved by the Food and Drug Administration (FDA) to treat COVID-19 and could be a "game changer" in the battle to defeat the virus. 

Trump's understanding of the FDA approval process was wrong—the drugs had not yet been approved to treat COVID-19—and his declaration of the drugs' effectiveness was premature. But partisan animus toward the president ignited a firestorm of criticism from commentators and political leaders disproportionate to these inaccuracies that has in some states already prevented coronavirus patients from getting off-label drug prescriptions which might help them recover.

As a physician in clinical practice for more than 35 years, what I know about the drugs' effectiveness I got from reading the medical literature. What I've seen about hydroxychloroquine makes me cautiously optimistic. Doctors should not be prohibited from using their best clinical judgment and recommending it to patients—especially considering the fact that these drugs have been around for a long time, which means we are familiar with their risks and complications. The government should stay out of this and let clinicians practice medicine, provided they get their patients' informed consent. Patients have a fundamental right to try drugs they think may save their lives. Doctors they consult must be free to give patients their best advice, unencumbered by government overseers. 

Unfortunately, after Trump's pronouncement, the governors of Nevada, Michigan, and New York issued executive orders restricting how doctors can use hydroxychloroquine to treat patients with COVID-19. The Washington Post published disparaging remarks about the drugs' potential while The New Yorker accused Trump of "coronavirus quackery," which rested on the fact that Dr. Anthony Fauci of the coronavirus task force had stated, "the answer is no," when asked by a reporter if he can claim hydroxychloroquine is an effective treatment for COVID-19. 

I can understand Fauci's response. In fact, I would be surprised if he had responded otherwise. Administrative physicians usually don't declare drugs effective for the treatment of conditions if randomized controlled studies have not yet been done. To clinicians in the field, however, it's an entirely different matter.

The FDA allows doctors to prescribe drugs off-label all the time. Once the FDA approves a drug for use for the specific condition for which it was developed, there are no restrictions on "off-label" use, or clinicians using that drug to treat other conditions. Much of what clinicians read in the peer-reviewed scientific literature are clinical studies and case reports of off-label uses of various FDA-approved drugs to treat various conditions. Clinicians then use that information, along with their own clinical experience and judgment, and knowledge of their patients' individual risks and potential benefits, when attending to their patients. In this way, roughly one in five prescriptions written by U.S. clinicians are off-label. At the April 4 coronavirus task force briefing, FDA Commissioner Dr. Stephen Hahn said, in answer to a question about off-label prescribing, "As a doctor, we do this all the time."

In fact, many medical advances start out this way. Physicians learn of observational studies about the successful off-label use of a drug. Clinical situations develop in which it makes sense for them to see if it helps their patients. They then report their results. Enough anecdotal reports accumulate for the drug to gain acceptance for a particular off-label use. That off-label use of the drug may gain mainstream acceptance but it may take years before the FDA is convinced by randomized controlled studies to add that use to the list of approved uses on the drug label. Aspirin is a well-known example, since it had been used off-label to prevent recurrent stroke or heart attack for many years before the FDA finally approved that use.

While Trump made false statements about hydroxychloroquine and chloroquine, the fact remains that several reports from reputable quarters suggest the drugs may reduce the severity of infection.

Researchers in Marseilles, France, reported successful results with hydroxychloroquine and azithromycin in a small 20-patient sample in early March. A follow-up study with 80 patients published three weeks later showed similar promising results. Doctors in hospitals in Kansas, China, and South Korea have all reported successfully using hydroxychloroquine to treat their patients. (Other studies, out of China and France, suggest the drug might not be very useful at treating COVID-19.)

Critics fail to appreciate that medicine is both an art and a science. Clinicians must often apply imprecise scientific knowledge to variable human predicaments. The intrusion into the practice of medicine by governors and other politicians who are not trained in medicine, yet have the hubris to tell physicians how and what they may use to treat their patients, threatens the integrity of the medical profession, and indirectly imperils patients. 

This is not new. It began a few years ago when politicians started dictating, in statute, the medical management of pain. That practice continues despite admonition by the Centers for Disease Control and Prevention that politicians are misinterpreting and misapplying the CDC's own pain management guidelines. This has led to patients being undertreated for pain and doctors being afraid to properly treat them. Now governors are dictating what drugs clinicians may use to treat a viral infection. Will they next dictate what drugs should be used to treat high cholesterol? Or hypertension? Or diabetes?

As a scientifically disciplined physician, I cannot say with any degree of certainty if hydroxychloroquine or chloroquine are effective to treat COVID-19. I can only state that early observational studies show some promise. 

If I got COVID-19 and was having a rough time of it, I would ask for one of these drugs to be used on me. I wouldn't want to take the drugs if I had a mild case because the risk of an adverse drug reaction might not be outweighed by the risk of succumbing to the infection. And if I have patients suffering from a severe case of the infection, possibly even facing death, I am ethically bound to inform them of the possible benefits of the drugs, as well as the risks, and offer it to them.

I understand that doctors should study the research carefully and be cautious about recommending new treatments to patients. And patients should ask questions and practice due diligence before accepting their doctors' advice. But the decision-making process belongs to them, not to detached bureaucrats and politicians.

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  1. But how will doctors know what’s best for their patients if politicians don’t tell them?

    1. Despite the best efforts of the media, doctors are prescribing the drug. Not sure Reasons stance here.

      1. Yes what is their stance here? I dont thin an MD is listening to Trump or other bureaucrats.

  2. Well, doc, why don’t you wander down to the local cop shop and file charges against the governor for practicing medicine without a license?

    (And I have found that it is the insurance actuaries, not my doctor who determine what course of treatment I allowed to pursue.)

    1. At worst, an insurer might not cover the $20 for generic hydroxycloroquine.

    2. “Doctors, Not Politicians, Ought To Decide Whether Off-Label Drug Use of Hydroxychloroquine Is Appropriate for COVID-19 Patients”

      “As a physician in clinical practice for more than 35 years…”

      Doctor says Doctors should control our access to medicine, not us. On a “libertarian” site. Absolutely no self-awareness. He just feels fucking entitled to control our access to medicine, and whines when the government that gives him that power takes a tiny sliver of it away.

      Drop dead, Slaver.

      A silver lining of nationalized healthcare will be seeing the medical mafia lose their power to extract their government enabled rent-seeking pounds of flesh from us.

      “some governors have decided doctors can’t make those decisions for themselves”

      Doctors are making decisions “for themselves” when they decide what medicine they will allow *you* to have.

      God I hate these entitled bastards.

      “Patients have a fundamental right to try drugs they think may save their lives.”

      Where is that fundamental right when your guild decides that what I think best promotes my health isn’t “appropriate”?

      “Doctors they consult must be free…”

      Yeah. *Doctors* must be free to control *our* access to medicine.

      Get bent.

      1. “I can understand Fauci’s response. In fact, I would be surprised if he had responded otherwise. Administrative physicians usually don’t declare drugs effective for the treatment of conditions if randomized controlled studies have not yet been done. ”

        I understand it better.

        Fauci is an even more entitled hack, a regulatory hack. Nothing can be said to work w/o the say so of the Federal Death Administration. Any suggestion otherwise is a threat to their authority and power.

        Apparatchiks gonna apparat.

        The DeepState incompetence of our medical regulators have been on full display during the pandemic. But the bodies of their victims pile up every day of every year, just not live on all news channels.

      2. “A silver lining of nationalized healthcare will be seeing the medical mafia lose their power to extract their government enabled rent-seeking pounds of flesh from us.”

        So you’d rather the government do its ‘rent-seeking’ in a more direct manner? Your rambling post is damn near schizophrenic…. ‘The government enabled rent seekers steal from us! So just let the government do it directly, and eliminate choice completely.’ Some strong logic you got there buddy….

        1. Damn dude, you really missed the point.
          Do you even know what a silver lining is?

        2. “So what you’re saying is …”

          Everyone, welcome Cathy Newman to the Reason Comments Section!

      3. That’s Jeff Singer writing that. He didn’t mean for you to take it that way. Since it was doctors that the governors’ decrees were aimed at, it was the freedom of doctors that he wrote about.

        1. Yeah, he meant for us to feel sorry for the poor old medical mafia who had their entitlement to control the peasants’ healthcare taken away a tiny bit.

      4. This ^

        People like Dr. Singer are responsible for the absurdly high medical costs in the US and the fact that many people can’t get healthcare. He seems to think the crisis is a good place to argue again for the government monopolies granted to his profession.

        F.U. Dr. Singer

  3. So we SHOULDN’T ask Peter Navarro then?

    1. It depends… did it contradict trump?

  4. I hope Trump comes out strongly for Vegetables, so millions of vegan progtards starve themselves to death

    1. Beautiful.

    2. I will be using this with some minor tweaks…

    3. +1,000,000!!!!

    4. love it.

    5. You know who else loved vegetables? [Not including the Jolly Green Giant]

      1. Roberto Benigni in Night On Earth?

      2. Florida and bush?

      3. Spaniards from Pamplona? (Actually, they may be into fruits).

      4. SpinalTap?

    6. You win the internet today good sir.

    7. You win the internet today.

    8. +1

  5. quit reading after the first lie in the first paragraph it was not an untruth nor did he say it was approved for such use. Reason has become shit. if it weren’t for intelligence of several commenters here there’d be no reason to come here at all

    1. Is John alright? Hopefully his absence is because his bunker doesnt have internet access.

    2. It’s a trope that is getting old. Trump was talking about the drugs being approved … and they are. He never said they were specifically approved for treatment of COVID-19 … and they don’t need to be since off label use of prescription medications is standard practice.

      If they didn’t lie about Trump being an incompetent liar, they might come to the realization that he isn’t so bad … and that would break their brains.

    3. Thank you for the compliment. I am sure Im one of the intelligent Commenters

      1. I assumed he was talking about me.

      2. You’re certainly more intelligent than that other human hemorrhoid with a similar name.

    4. At Reason, all the decent journalism occurs in the Comments Section.

    1. Medicare 4 some. Doctor-prescribed aquarium cleaner for others.

  6. The doctor here is correct and politicians wrong. The President Trump should have left questions on treatments to Dr. Fauci and the Governors should allow doctors to treat their patients. It worth noting this is a bigger problem and politicians want to control the doctor patient relationship for treatments like medical marijuana and procedures like abortions.

    1. “procedures like abortions”

      Begging the question of whether abortion is a legitimate medical procedure.

      Lacking confidence in your position? Otherwise why not offer proof?

      1. Abortions have been a medical procedure about as long as there have been records of medicine. Todays medically induced abortions have an established record of being effective and safe. Certainly there is more evidence of these drugs safety and efficacy than there is for hydroxychloroquine for use against coronaviruses. There is nothing in medical science to suggest abortions medical or surgical are not legitimate procedures. This is the doctor’s argument in the article. Let doctors and their patients decide.

        1. “Todays medically induced abortions have an established record of being effective and safe.”

          It’s funny to observe people that hold one side of an argument while having no knowledge whatsoever of what the other side of the argument is.

          Effective and safe for who? The person that was just killed?

          1. Especially for a “moderate”.

          2. On top of that, an estimated 6-10% have medical side effects not including depression and mental health.

            1. Any medication will have side effects and that is accounted for in making the determination to use that medication. Whether that is hydroxychloroquine or a medical aboration. As for mental health effects, those can occur regardless. Note that there are significant mental effects of just a normal pregnancy including PPD. All this suggest that the decision should be between the patient and the doctor.

    2. >>Dr. Fauci

      still not impressed.

    3. “We should be slaves to the #DeepState. They know all and see all.”

  7. “Trump should have”

    “It worth noting this is a bigger problem and politicians want to control”

    You’re a politician?

  8. B-b-but… TRUMP! HERP DE DERPITY DERPY DER!

  9. But the decision-making process belongs to them, not to detached bureaucrats and politicians.

    Them meaning you, right Singer? Wrong. The decision belongs with me. The consumer.

    1. We peasants? Have power over our own lives? Oh, tut tut.

      We need our rent-seeking betters to control what we put in our bodies.

      Our Bodies, Their Choice!

  10. some governors have decided doctors can’t make those decisions for themselves.

    “WE don’t take no ‘Hypocritical Oaf’!”

  11. “As he often does, President Donald Trump uttered an untruth”

    The word “often” is linked to a CNN article. What kinds of double-bind tests did the doctor perform to check on the accuracy of this CNN article?

      1. because they look like banditos?

      2. I’ll give props to the #EnemyOfThePeople hack who said that Governor Northam wore a “black face mask”.

        Top Kek!

      3. It is when it’s Governor Northam wearing a black face mask.

  12. >>As he often does,

    leading w/this is zzzzzzz and unnecessary for the rest of the sentence.

  13. I’ll all for bashing politicians, but partisan animus against Trump is not the full story here. Part of the governors’ worry has to do with preventing panic buying of these drugs, which will make them unavailable to people who need them. Although even then I suspect letting pharmacies manage their supplies intelligently would be much more effective. But Democrats just instinctively believe they know best how people should live their lives.

    1. It is a prescription drug, so there can’t be panic buying. At least by the general public.

      Loved your presidency, BTW.

      1. Doctors are bitching because they’re being prevented from prescribing it for *their* friends and family to evade the rationing applied to everyone else in those states. Wah! Muh entitlement!

        Much like Bronx cops protested when their vested right to fix tickets for family and friends was threatened.

  14. The slow drift of what Trump said about hydroxychloroquine, and it’s effectiveness has begun at Reason. A few more days and they might be telling the whole truth (In real time, not the truth of what’s happening now and in the past, you ask too much) about the issue.

    The question is will they be ahead of the rest of the progressive media, or following it. I look forward to ENB’s links to Slate, Vox, CNN, and NYT to get a better predictor tomorrow am.

    1. A few more days and Reason will complain that Trump didn’t seize control of the US economy in January to ramp up production of chloroquine.

      Because that’s the kind of libertarian who works at Reason.

  15. How the fuck hard is it to say the democratic governors of those states. Why try to hide it. And this is not about Trump. He’s being actually somewhat libertarian in promoting drug therapy that was not approved. But yeah let’s just shit all over that, instead of idiotic democrats who cannot think past the orange veil over every decision. Reason and the far left have one goal, no matter how many people get fucked.

    1. “How the fuck hard is it to say the democratic governors of those states.”

      Both side my man, both sides.

  16. The article ends with an ambiguous reference to doctors or maybe to doctors and patients being the people who get to choose medicines.

    I appreciate that as a doctor, the author works inside a tightly-constrained world. But as a Cato senior fellow, the author also works outside those constraints in a wider thought world; and this article overlooks first principles that need to be second nature. It’s best maybe to start at the article’s beginning and unpack things from there:

    “Doctors … Ought To Decide Whether Off-Label Drug Use of Hydroxychloroquine Is Appropriate for COVID-19 Patients”

    No. Customers decide. Doctors or pharmacists can advise and doctors can provide care if people choose to buy advice or care from doctors or pharmacists.

    No person shall be deprived of liberty or property (without due process of law, i.e., except using law and procedure that is constitutional). This means that no customer shall be deprived by FDA people of the liberty to buy what he chooses. No customer shall be deprived by state regulators of liberty or property, by forcing the customer to buy services from a doctor and a pharmacist before getting medicines. And no business person shall be deprived by FDA people of the right to sell his property.

    1. “No. Customers decide. Doctors or pharmacists can advise and doctors can provide care if people choose to buy advice or care from doctors or pharmacists.”

      I believe I’ve discovered the source of any confusion you may have. Reason is no longer a libertarian publication. They are an open borders, Orange Man Bad, globalist publication, with a select few writers that still lean libertarian.

      1. Who are they? = a select few writers that still lean libertarian

        1. Stossel, Rob on 1A…there’s a third somewhere?

      2. Invasion USA is @Reason’s “core value”, any libertarian “leaning” notwithstanding.

        Common cause with “globalists of all parties”.

        Nick:
        In the 21st century, libertarians are going to have make common cause with the globalists of all parties, with the people whose core value is the right of individuals to move freely around the planet.

        Watching The Brink made me think that for all the other differences Reason has with the socialist magazine Jacobin, it may matter far more that we share a belief in open borders.

        https://reason.com/2019/04/12/steve-bannons-economic-nationalism-is-th/

        1. https://twitter.com/nickgillespie/status/1120362508446064645
          Nick: I was on @LionsofLiberty podcast w @MarcDClair, talking about why libertarians should embrace postmodernism, my early days as a cub reporter, and more. Take a listen.

        2. Anyone miss when Nick went full “No True Communist”?
          “Totalitarians professing communism killed millions of people, but this analogy is flawed. Hitler was the leader of Nazism, Stalin the leader of…Stalinism, not communism.”
          https://twitter.com/nickgillespie/status/1021180699380920320

          1. B-b-but Reason is totes not leftist!

  17. Doesn’t matter what it is, it’s Trump’s fault, apparently.

  18. I agree that use of the meds should be between the doctor and the patient after the pros and cons are explained to the patient. Now if it is a situation where the person is going to die if nothing is done and the patient or legal guardian agrees the doctor should be allowed to use any medicine available.
    In all cases the CDC should require that the doctor reports to it the results when used off-label or in the case that the patient is about to die unless something is done. This is to help to define further use of meds that has not been approved for the current usage. As for the ‘right to try’ any meds used and the benefit or harm did would also help the CDC know if it could be used or not.
    Information is of the greatest important here.

  19. Is there a single person who wouldn’t ask for this therapy if they contracted the virus? Even the whiners with TDS.

    1. Sure there are. These drugs are not innocuous, and have half lives measured in weeks to months. Once on board any problems that arise are not going away soon.

      Much depends on the severity of the illness and what pre existing conditions are present. Anyone with a significant ventricular arrhythmia would practically be suicidal to try this as anything other than a last resort.

      1. You would ask for it. Your doctor would help you determine whether you can actually safely take it.

    2. As someone prone to cardiac arrhythmia, I definitely would not ask for this therapy!

  20. This guy obviously doesn’t know the backstory. A doctor on the west side of Michigan prescribed himself 521 pills of this stuff. This set off the alarm bells as people began hoarding it, leaving those who need it without the ability to get it. No reason to have a shortage right now due to the orangeman promoting it as a miracle drug. The governor gave pharmacists the ability to red flag this type of activity. If you think a doctor abusing the system isn’t part of the problem, you need your license taken away.

  21. The FDA does not “let” doctors use drugs off label. You say that as if it is something within their purview. It is not. The FDA has no authority to stop off label use.

    1. Thank you for that. Few people understand how it really works.

      Why is this one drug is getting so much attention? Or the proposed usefulness and risk/benefit. Well some politician talked about it.

      The two white papers from one group in France with very small number of patients and poor study design. Now it is way out of proportion.

      A discussion here.

      https://www.redactionmedicale.fr/2020/03/Review_20_03_20_001%5B1%5D.pdf

      Also very preliminary review of the data.

      Really it would be be great if there were more solid evidence.

  22. Cuomo and his fellow TDS suffering Guvnas are acting like the CCP.They don’t care how many of their citizens die.

  23. I think you have your date wrong. He said it on the 19th not the 13th.

  24. “If I got COVID-19 and was having a rough time of it, I would ask for one of these drugs to be used on me.”

    If you have the time. This engineered illness skips bad and goes straight to worse.

  25. Thank you for sending the information about It. I learned a lot from it. ! I appreciate you the detail you went into it. I am grateful for the amount of time and effort you put into this helping us. Your insights and summary are beneficial.

  26. On 08 FEB 1914 the NYT ran a story alleging murder and insanity among “cocaine negroes” since being deprived of beer by prohibition –this 3 weeks after an opium ban and 7 months before the Harrison Act turned physicians into federal informers and prohibition agents. It was that or lose their permit to practice medicine. The article is suddenly strangely absent from the internet but at druglibrary.org you can find it in a jiffy. State and federal sumptuary laws nationalized individual health and planted time bombs that routinely blow up the fractional-reserve banking system. Abolishing the FDA should follow defunding the WHO, per LP platforms since 1972.

  27. These drugs have been around for decades. Their side effects are well known and understood. Therefor if the possible side effects are not of concern to you or your doctor there is no good reason no to try them.

  28. I was hospitalized Fri 3 Apr.
    Covid19 test came back positive.
    My Rx treatment includes Hydroxychloroquine, Doxycycline, Cefdinir through VA. Started 14 day home confinement 8 Apr.

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