Only I (and hydroxychloroquine) Can Fix It

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The comedian David Steinberg once referred to President Ronald Reagan as “the Popeil Pocket Fisherman President.” When asked to explain, Steinberg said, “it looks ok on TV but when you get it home it doesn’t work.” And now, in a far less humorous and way more tragic vein, we have the Dunning Kruger President.

In the field of psychology, the DunningKruger(DK)  effect is a cognitive bias in which people with low ability at a task overestimate their ability. It is related to the cognitive bias of illusory superiority and comes from the inability of people to recognize their lack of ability.

Need we say more? Never has it been clearer in the recent controversy that has arisen about whether to adopt the widespread use of hydroxychloroquine for the treatment of COVID19 without the benefit of a clinical trial on its safety and efficacy. “I’m not a doctor, but I have common sense’, our dear leader utters, never has common sense shown itself to be less common nor less sensical. In fact, our Scottish brethren facing their own stressors from the viral pandemic have an entire webpage dedicated to our leader’s nicknames. Perhaps the most consistent with his hydroxychloroquine trumpeting, iscockwomble”, defined by the Urban Dictionary as “(noun) A person, usually male, prone to making outrageously stupid statements and/or inappropriate behaviour while generally having a very high opinion of their own wisdom and importance..”.

CNN reported major blow up among the White House staff with non-scientists arguing with the world leader in virology, Dr. Anthony Fauci, about what constitutes evidence and proof vs. anecdote. A big pile of anecdotes does not add up to anything more than anecdotes despite how often or how loudly you say it mustering up as much illusory superiority as you can and a scotoma that you drive a Mack truck through about your own lack of ability. Nevertheless, very much unlike the disrespect given tothat womanfrom Michigan for calling out The Feds, “that man” and his sycophants and that “other man”, Peter Navarro, continue to write the forward to the updated version of Tom Nichols’ book, The Death of Expertise.

The definition of the DunningKruger effect reads like a DSM diagnostic criterion for Narcissistic Personality Disorder. Illusory superiority, no ability to recognize one’s own lack of ability.

According to the researchers for whom it is named, psychologists David Dunning and Justin Kruger, the effect is explained by the fact that the metacognitive ability to recognize deficiencies in one’s own knowledge or competence requires that one possess at least a minimum level of the same kind of knowledge or competence, which those who exhibit the effect have not attained. Because they are unaware of their deficiencies, such people generally assume that they are not deficient, in keeping with the So when one reads the description of this effect, it reads like a virtual diagnostic criterion for tendency of most people to “choose what they think is the most reasonable and optimal option.” Although not scientifically explored until the late 20th century, the phenomenon is familiar from ordinary life, and it has long been attested in common sayings—e.g., “A little knowledge is a dangerous thing”—and in observations by writers and wits through the ages—e.g., “Ignorance more frequently begets confidence than does knowledge” (Charles Darwin).

Examples of the DK effect are common in every day life. For example, seen in people who continue to insist on doing home repairs when all it does is cause more damage and higher bills when the experts are called in to fix the even bigger problem they created. But when it characterizes your leadership at a time of crisis and they are practicing medicine and epidemiology at the expense of public health that’s another story. (Hey, wasn’t Jared Kushner fixing the Middle East yesterday?)

Understanding the Facts

The U.S. Food and Drug Administration (FDA) terms use of an approved medication for an unapproved indication “off-label.”1 When medications are used off-label they are employed for treatment of a condition other than that for which they were deemed safe and effective in clinical trials. It is critical here to emphasize that when medications are approved, this occurs within the context of treatment of specific conditions. Thus, the safety profile, dosing schema, side effects, and monitoring parameters of a given medication cannot necessarily be extended to its use in all conditions.  Off-label use places patients at risk for side-effects and untoward harms and leaves them vulnerable to potential ineffectiveness.2  For these reasons, the Food, Drug and Cosmetic Act (FDCA) prohibits pharmaceutical companies from marketing or promoting their products for off-label use.3 Lawsuits have been brought against pharmaceutical companies and their representatives for promoting off-label uses of therapies as it violates the FDCA and undermines the mission of the FDA.3 Notwithstanding, that is exactly what our leadership is doing, and without the any oversight or consequences for disobeying regulation standards to which pharma companies are held by the very same government.

All of this is relatively easy to swallow when we consider off-label use of medications for conditions that are rarely fatal and have well-established, effective standards of care. The unnecessary risk of off-label use is clearly undesirable.  However, if a critically ill patient dies following treatment with an unproven medication, it creates the conundrum as to whether the disease killed the patient or the therapy.4 When facing a condition, such as COVID19, that has reached pandemic proportions and is causing significant morbidity and mortality this question is difficult to answer.  When adding off-label use of medications with significant toxicities, such as hydroxychloroquine to the mix, the question becomes nearly impossible to answer. But, without hydroxychloroquine we are left primarily with just supportive care options, so “what do we have to lose?” There is plenty to lose!

When it comes to off-label use of hydroxychloroquine the potential side-effect burden is significant, the medical monitoring required is substantial and the repercussions of supply chain deficits are staggering. In addition to common hydroxychloroquine side effects such as gastrointestinal upset (nausea, vomiting, diarrhea), headache, fatigue and weight-loss; it carries a slew of systemic risks.  Loss of color vision or total loss of vision, according to the American Academy of Ophthalmology, is a significant risk due to retinal toxicity secondary to hydroxychloroquine and chloroquine treatment. This requires baseline and routine monitoring. There is evidence supporting a progressive quality to the retinopathy which suggests that the damage begins early in the dosing regimen.5

Hydroxychloroquine also carries a risk of QTc prolongation, fatal cardiac arrhythmia (torsades de pointes), hepatitis, acute pancreatitis and neutropenia. Patients may also experience hypoglycemia, potentially fatal skin risk (Stevens-Johnson Syndrome(SJS)/toxic epidermal necrolysis), extreme muscle weakness, seizures and bleeding. Patients require baseline and ongoing bloodwork monitoring, EKGs and retinal exams at minimum.

Notably, COVID19 patients are already at increased risk for many of these conditions due to their baseline characteristics (majority elderly patients and those with cardiovascular comorbidities). Further, hepatitis and neutropenia have both been associated with COVID19 disease progression.4  This serves to muddy the waters of deciphering whether the disease or the “cure” has caused such adverse events. Although we are certain of the significant risks hydroxychloroquine poses, its efficacy in COVID19 remain uncertain.

There is one population, however, who relies on its properties as a disease-modifying antirheumatic drug (DMARD) to manage debilitating conditions such as rheumatoid arthritis, lupus and ankylosing spondylitis.  The media storm largely proclaimed by “that man” regarding hydroxychloroquine’s potential efficacy for COVID19 has resulted in unprecedented hoarding and supply chain deficits of this important therapy.6 State and federal mandates, have been put in place to protect this vulnerable population. These mandates prohibit the dispensing of hydroxychloroquine for any purpose other than its FDA approved indication unless the patient is enrolled in a legitimate clinical trial. This has launched pharmacists into the role of gatekeeper  as even medical providers have been noted to hoard these medications for themselves or their family and friends.6

All medication use relies on a tenuous balance between risk and benefit. The benefit must be proven significant improvement in health or quality of life, disease cure, prevention of disease progression, etc. in order the justify the risk inherent to ingesting exogenous substances. When no proven benefit exists, we are left only with risk. Risk, which will come to bear in the most critically ill patients as we battle the coronavirus pandemic if erroneous and incomplete medical information continues to be propagandized and proselytized.

In summary, to answer “the man’s” question “What do you have to lose?” Here’s a simple graphic you can paste to your podium to illustrate and remind you of the common hydroxychloroquine toxicities in the absence of taking it while seriously ill for any cockwombles that believe they understand the peer reviewed scientific literature. Illness and additional medications alone and combined, both increase the risk of these problems and resultant death. Essentially it summarizes risks for the following:

  1. Death from toxic epidermal necrolysis
  2. Death from heart failure
  3. Death from liver failure
  4. Death from blood disorder
  5. Permanent loss of vision (not a problem if you die)

So, if you watch the nightly briefings and you decide to take advice that sounds good on TV, remember it probably won’t work as well at home.

For more factual information, see this hydroxychloroquine fact sheet from the FDA.

As always, comments, positive or negative are welcomed with enthusiasm!!!


Author Bios

  1. Dr. Mortimer Fein doesn’t have to practice medicine – he’s good at it. He’s named after an opioid and he’s not a real doctor and he doesn’t play one on TV.
  2. Dr. Perspicuity comes to us with exceptional background in healthcare management, public safety, and eloquent writing skills. She is withholding more specifics in order to protect the innocent and to avoid the wrath of federal cockwombles bestowed upon previous truthsayers.
  3. Dr. Justin Time ironically admits to being a political cockwomble, but nevertheless has expertise in clinical drug research, pain management, and related bioethics.


References

  1. S. Food and Drug. “Understanding Unapproved Use of Approved Drugs Off-label.” 5 Feb 2018. Available from: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
  2. Sinha MS, Kesselheim AS. The next forum for unraveling FDA off-label marketing rules: State and federal legislatures. PLoS. 2018 May 8;15(5).
  3. Federal Food, Drug and Cosmetic Act of 1938. P.L. No.75-717,S52Stat.1040.
  4. Kalil AC. Treating COVID-19- Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. 24 Mar 2020. E1-2.
  5. Marmor MF, Carr RE, Easterbrook M, Farjo AA, Mieler WF. American Academy of Ophthalmology. Recommendations on screening for chloroquine and hydroxychloroquine retinopathy: A report by the American Academy of Ophthalmology. 2002;109:1377–81.
  6. Persico AL, Kwon S, Fudin J. Exercise Caution Amid the Covd-19 Pandemic. Pharmacy Times. April 2020;38-39

 

 

 

 

 

 

 

24 thoughts on “Only I (and hydroxychloroquine) Can Fix It

    1. Thanks for the factual parts of this article. I am actually impressed with other articles on the site and wish to express my appreciation for your work. I am a chronic pain sufferer since a January 2003 vehicle accident damaged my back and neck and subsequent operations were unsuccessful in relieving my pain but did remove the likelihood that my spine would be severed from a slight fall. I am interested in whether you have been successful in creating a CBD oil that lacks THC. I’d like to try it as an alternative to the opioids my PM doctor has me on now without the risk of popping positive for THC.

  1. Nicely done and done with the appropriate political perspective.
    I hope the noun, cockwomble, is used more often, and picked up by national news outlets, to describe our leader.

    1. Let’s just ignore the fact that the President has National Security clearance and studies that the military has done, and access to patents that the government decided to keep secret from all of us. He just might be privy to information that you lack. Keep political bias out of science and medical discussion and argue the merits of a possible cure and prophylactic and therapeutic medication. Also it’s worth noting that anyone going into an area with known Malaria is immediately and without question prescribed HCQ as a prophylactic against contracting the virus. On top of that HCQ is prescribed to patients with Lupus, Rumitoid Arthritis, and several other immune disorders on a lifetime basis. Let’s not forget that the side effects of HCQ are also among the permanent effects of severe cases of COVID 19 because of oxygen starvation of all organs and even ventilators can’t make the body’s lungs absorb oxygen after the damage is done by COVID 19. It only makes sense to start patients on HCQ as soon as the virus is suspected, not wait until they were already having a severe case and they are on a ventilator

  2. Great piece Dr. Fudin…. This situation happened to me at work yesterday.. This is why clinicians like myself get very scared when people. Say “just try it” or “what do you have to lose”… I have been seeing situations like this pop up and it scares me… Below is a situation that happened to me yesterday. As you know, all four of these medications may cause QT prolongation and torsades de pointes.

    Looks at suspected COVID pt chart…

    Sees med list
    -rythmol
    -citalopram
    -hydroxychloroquine
    -azithromycin

    Last Qtc recorded- 515 msec

    Me: About to fall out of my chair.

    Stuff like this happens all the time. Now just imagine patients like this are being put on added regimens of HCQ and Azithromycin,.. Luckily we called the doctor and he d/c some of these meds.. As a pharmacist, I am constantly assessing med therapy to make sure stuff like this doesn’t happen… So yes there are definitely compounded risks that can happen and this is the type of patients we often see.. Multiple comorbidities and on multiple drugs…

  3. People thinking up clever insults for a President they hate strikes me as decidedly unhelpful.
    One in five prescriptions is now off label.
    Ophthalmologists say they are rarely seeing retinal toxicity, even with long-term use of HCQ, and rheumatologists are not routinely monitoring EKGs.
    Balancing risks and benefits is what physicians do. Having bureaucrats, ivory-tower academics, and governors forbid them to use their best judgment in time of pandemic is imprudent, tyrannical, and likely lethal to thousands.
    You wouldn’t send troops into as malarious zone without protection. Are we in the equivalent, or is it an over-reaction to consider somebody taking a walk to be a deadly threat?
    The President didn’t think up HCQ + AZT all by himself. There’s been scientific literature since at least 2003. Many doctors are reporting success in the field. Yes, case reports are evidence: the only kind we’ve had for eons. New discoveries are not made by RCTs. So far, it appears from available reports that the probability of benefit is better than 93 percent. It is likely to shorten and reduce infectivity, relieve symptoms, prevent hospitalization, and prevent permanent lung damage and death.
    Not worth the risk, you say? Don’t take the drugs. Stay in your cell and hope somebody keeps working to feed you. But stop trying to force your opinions on doctors who have direct responsibility to the individual patients they serve.

    1. “You wouldn’t send troops into a military zone without protection.” Yet, anybody on the front lines of the COVID19 battle will confirm that many, if not most don’t have proper or adequate PPE, and our leader calls that fake news. Why, because it doesn’t fit an agenda? And that’s somehow okay? You are the one making it political. Our authors just stated the facts.

    2. Bravo! I would like to add that zinc is something to add to HCQ and Azithromycin because it prevents the reproduction of the virus if zinc is already in the cell being attacked.

  4. Interesting video. There is some good information here. Dr. Oz first interviews Dr. Fauci, an infectious disease expert on the White House’s coronavirus task force, and then Dr. Raoult from Universite d’Aix-Marseille where a non-randomized clinical trial was conducted. I’ll cover them in reverse since Dr. Fauci makes some helpful comments on Dr. Raoult’s study.

    In the interview, Dr. Raoult describes that “stories” of hydroxychloroquine and azithromycin being toxic are “bizarre.” He references the fact that many people take these medications every day. It’s true! They do. The catch is that the patients taking these medications every day are taking them for indications for which they are proven to be efficacious and these patients are not critically ill. They go on to discuss a study conducted at Dr. Raoult’s facility. They did not specifically mention which study they were referring to but a Pubmed search identified the following:

    Gautret P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. doi: 10.1016/j.ijantimicag.2020.105949. [Epub ahead of print]

    This 20-patient study found that patients given hydroxychloroquine had a lower viral load after 6 days of treatment than those who were untreated(either because they refused treatment or they were at a different facility). Some of the patients in the treatment group were also given azithromycin. Treatment with azithromycin was determined based on symptomatology and was not random. The authors concluded that hydroxychloroquine was effective and that its effect was reinforced by azithromycin. It is not clear how they differentiated the effect of azithromycin from hydroxychloroquine.

    A very important note regarding this combination of medications is that both individually can increase the risk of QTc interval prolongation, as seen on EKG, and torsades de pointes- a fatal cardiac arrhythmia. When multiple medications with this risk are used concomitantly there is a synergistic effect on risk. This effect is well described in the literature. A few examples of references are included below.

    Around the 2-min, 30-second mark, Dr. Oz interviews Dr. Fauci. Fauci discusses the studies conducted in France and confirms that the data is not very robust and that, although it may be possible for hydroxychloroquine to be efficacious, the evidence is not very strong. I agree with his opinion. Despite the enormous desire to find a beacon of hope in the midst of tragedy we have to resist the urge to cling, prematurely, to incomplete and inadequate information.

    O’Laughlin JP Mehta PH, Wong BC. Life Threatening Severe QTc Prolongation in Patient with Systemic Lupus Erythematosus due to Hydroxychloroquine.Case Rep Cardiol. 2016;2016:4626279. doi: 10.1155/2016/4626279. Epub 2016 Jul 12.

    Costedoat-Chalumeau N1, Hulot JS, Amoura Z, Leroux G, Lechat P, Funck-Brentano C, Piette JC. . Heart conduction disorders related to antimalarials toxicity: an analysis of electrocardiograms in 85 patients treated with hydroxychloroquine for connective tissue diseases.Rheumatology (Oxford). 2007 May;46(5):808-10. Epub 2007 Jan 3.

    Choi Y, Lim HS, Chung D Choi JG1, Yoon D. Risk Evaluation of Azithromycin-Induced QT Prolongation in Real-World Practice. Biomed Res Int. 2018 Oct 14;2018:1574806. doi: 10.1155/2018/1574806. eCollection 2018.

    1. Thx!
      Interesting note: After I posted, this was in my mailbox:- https://www.medscape.com/viewarticle/928336
      Perhaps consistent with your thoughts. Of note, another video discusses that they have extended the number to 1000 patients and will release it soon. Sure, there are cardiac events potential and they have been reported in the past. As Raoult mentions, both have billions of doses used and remain in good standing for use despite the potential AE. All of this has been complicated by both desperation and politics. Appreciate the follow up.

  5. I think it is important to differentiate treating very sick people with it – compassionately – in the absence of other interventions, where the risk benefit ratio is tilted by the urgency of trying to save a life, from a range of other situations in which the risk benefit ratio is far different. Some are likely to come away from hearing the rhetoric and thinking everyone should take it to lower their risk of getting ill even those who could and should be managing their risk through social distancing alone. Those people have a much different amount to lose and might even take unnecessary chances and risk exposure to the virus if they have what they believe to be a preventative on board. And somewhere in the middle of these poles are a range of other situations: infected and sick – but not critical – people who could and should be entered into a trial for example. A controlled trial at the time of a pandemic for such patients doesn’t need to be a placebo trial. Two active arms with potential could be compared as was done during other breakouts. Also, those with exposures who are not sick – first responders and front line workers many of whom are working with inadequate PPE, could be on a trial and again it need not be a placebo controlled trial. The risk benefit ratio is all over the map. The problem with the political rhetoric of this coming from the non-scientists is that these subtleties all across the risk spectrum get blurred and many for whom the risk benefit ratio is very unfavorable might end up harmed.

  6. My husband has taken it for 10 years for mixed connective tissue disorder without side effects and without it, he’d be in a wheelchair. If I get sick enough and the marvelous doctors have nothing to offer but Tylenol, I’ll take it in a heartbeat. Your political twist on this was below your dignity, or so I thought.

    1. Lana, I am glad to know that your husband has had success with this drug, and apparently tolerates it well. I also hope you are thoughtful enough to reflect on this post, without bias, should your dear husband be placed in a position where he is unable to obtain the drug because an unqualified person is cheerleading for it, as that would be a travesty. regardless what you think about the authors of this post, I hope that if YOU ever take this drug because of exposure to COVID19, that you don’t die or end up blind because of it, and that it helps you! It is beyond me how people are willing to overlook facts purely because of a dedicated political affiliation, or how somebody is willing to ignore all the patient advocacy this site brings in spite their own self.

  7. Interesting perspective although tainted with a political bend. Obviously the drug can be dangerous and the orange man shouldn’t be pushing so hard. That being written, those positions are contrasted by reports like this:
    https://youtu.be/44AniIdSGEU
    As “experts”, it’s be great to hear from you on where the facts from France fall short.

  8. “A big pile of anecdotes does not add up to anything more than anecdotes despite how often or how loudly you say it”

    True, but the current situation comes perilously close to what I was once told by a state regulator: “The plural of anecdote is policy.”

    Especially true when dealing with cockwombles, I suppose.

    1. Great piece Dr. Fudin…. This situation happened to me at work yesterday.. Ths is why clinicians like myself get very scared when people. Say “just try it” or “what do you have to lose”… I have been seeing situations like this pop up and it scares me… Below is a situation that happened to me yesterday

      Looks at suspected COVID pt chart

      Sees med list
      -rythmol
      -citalopram
      -hydroxychloroquine
      -azithromycin

      Last Qtc recorded- 515

      Me: About to fall out of my chair

      Stuff like this happens all the time.. Now just imagine patients like this are being put on added regimens of HCQ and Azithromycin,.. Luckily we called the doctor and he d/c some of these meds.. I am constantly assessing med therapy to make sure stuff like this doesn’t happen… So yes there are definitely compounded risks that can happen and as pharmacists this is the type of patients we usually see.. Multiple co morbidities and on multiple drugs…

  9. While serious researchers and clinicians are working around the clock to prevent and treat severe morbidity and mortality, we are also fighting the purveyor-n-chief of “self-inflicted wounds”—thanks for your well-crafted expose! Stay well, one and all.

  10. You’ve outdone yourself this time, Jeff. Outstanding article. Nice to read something full of truths these days as opposed to the lies fed to us by the “cockwombles”!

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