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COVID-19: The Off-Label Epidemic
Earlier I posted three posts about the various therapies being used to treat COVID-19 and the battle over hydroxychloroquine (HCL) — Day 115: COVID-19 How Are Treatments Coming?, Day 130: COVID-19 The clash in scientific worldviews, and Day 141: COVID-19 The HCQ+ Wars Continue. This week the HCQ wars continued with a video from the America’s Frontline Doctors summit in Washington DC being pulled down by YouTube, et al. They covered a lot of topics about the epidemic but the primary sin was to tout HCQ+ as a treatment for certain COVID-19 patients.
Ohio got into the story this week as well when the State of Ohio Board of Pharmacy prohibited the dispensing of HCQ even with a doctor’s prescription. The Republican governor urged that the order be rescinded, and it was, letting the doctor and the patient make health care decisions and not the pharmacist.
The reason HCQ has become a battleground at all is because of how we regulate drugs in America. The Food and Drug Administration sensibly has a mission of assuring that drugs sold in this country are safe for consumption. But more than that, FDA also sees its role as assuring the drug is efficacious for the purpose it is being prescribed. There is an overlap between these two because drugs have side effects to which different people are susceptible. Through trials the drugs not only are measured for efficacy but for the way in which a population is likely to react to side effects. Literally the FDA is asking the drug manufacturer to prove that “the cure is not worse than the disease.”
Once the trials are complete and the data is compiled, the FDA approves the drug for use in accordance with the data collected. This is known as “on label use”. The “label” being the literature that accompanies the drug describing the diseases for which the drug has been demonstrated as efficacious in treating and the known side effects and prevalence that a patient might experience.
Drug manufacturers publish information about their drugs and the mechanism employed to treat the disease. From this published information medical practitioners sometimes see opportunity to use the drug for a different disease or condition. When prescribed for this purpose, the drug is being used “off label” — that is, for a disease or condition for which no formal trial has been conducted and the measured results documented.
When you are dealing with a novel virus and resulting illness, all drugs applied start out “off label.” There have been no controlled trials and tests involving the disease before, so medical clinicians are relying on their understanding of how a particular drug works to anticipate how it will affect the disease process. So long as the documented side effects do not include death, the expectation is that the drug may or may not help, but it will not do more harm than good. Over time, evidence is gained about the efficacy of a drug for the treatment of a new disease and the FDA may eventually add that treatment to the “label.” The significance of adding a disease to the “label” (as I understand it) is that the manufacturer of the drug is authorized to actively market that drug as a treatment for that disease.
The FDA can ban drugs that it believes are demonstrably harmful. More often it “controls” drugs that represent a life risk if the use thereof is not supervised by a medical practitioner. And it authorizes “compassionate use” of drugs not yet demonstrated to be efficacious and safe pending trials when there is some level of evidence supporting its use and the need is great. That is where some drugs such as Remdesivir are now. But technically Remdesivir’s use in treating COVID-19 is also “off label” today.
Use of HCQ in treating COVID-19 is “off label.” It is a drug that has been around for a long time. Originally developed to treat malaria, it has been used for treating lupus and other auto-immune disorders. The reason HCQ is used by some physicians to treat COVID-19 is that what kills some patients is the body’s reaction to the virus rather than the virus itself. This is referred to as a cytokine storm. HCQ retards the reaction. The idea is that over time the body will fight off the virus even if you retard the body’s reaction to the virus. You add supplements such as zinc and antibiotics to help the body deal with conditions created by the virus even as it is more slowly responding to the virus.
This slow going process is why HCQ is generally not believed to be effective for those whose disease has progressed to ventilation or other critical care. There are some anecdotes about patients being a death’s door and coming back with the aid of HCQ. But that has not been at all routine, and biologic processes are both complex and individualistic so it will likely never be known whether, how, and why HCQ caused a positive result in those cases. The practice of clinicians such as the Frontline Doctors group in administering HCQ to patients just presenting symptoms or newly confirmed as infected through PCR testing makes more sense because it is modifying the body’s response early in the disease process.
The question in my mind, since all treatment of a novel virus is “off label”, why would any regulatory body ban the use of HCQ? The reason seems to be the one documented side effect of tachycardia in a few patients. Untreated tachycardia can lead to death or strokes, so clearly something you don’t want to have happen. That is why physicians should understand the health history of a patient to determine whether there are known heart conditions that make the side effect of tachycardia more likely to occur. If it was being suggested that HCQ be put into vending machines I could understand the concern. But prohibiting pharmacists from dispensing it with a doctor’s prescription and supervised use? That makes no sense.
We are in an off label epidemic. All treatments are being applied based on the understandings of how certain drugs affect different aspects of the disease process. The only clinical trial for many treatments is the outcomes recorded in the wards and clinics — they will never qualify as scientifically proved. Some people will respond well, others will not, based on individual factors that must be monitored and assessed. Some people if infected will work through the disease effectively with no medical intervention at all. Some will die no matter what treatment they get.
Is HCQ only a placebo? Maybe, but there is a lot data suggesting that even if it is a placebo, it is doing very little harm, and an awful lot of good. And it is not an expensive placebo, if it is one.
[Links to all my COVID-19 posts can be found here.]
Published in General
It comes across as “the lady doth protesteth too much.”
I’ve been sorely irritated of late because I know the Marxist point of attack is to break down the pillars of community to make dependence on the state more likely. If you can’t rely on family, church, or community, you have nowhere else to go.
The response to Covid has felt like they jumped on it as an opportunity to wreck already fragile community bonds.
It feels like any attempt to reduce the fear is being targeted and blocked.
And it feels like any information that contradicts the favored government agencies is being squelched so as not to introduce doubt among the population.
If we aren’t talking to one another, than we won’t get other information than what the gatekeepers allow us to hear.
The Powers That be do not care.
Rodin, your OP contains a huge amount of information, all of it true and all of it important. But again, the PTB do not care. After all, their main goal is to get all of us to submit, forever and ever, to their inane theory that COVID 19 is a killer virus. Even though everything science and medical researchers know about corona virus activity proves that at least during warm summer months, no one who is not elderly or immune system compromised has anything at all to worry about.
Zero hedge website had an excellent article up some weeks ago about how the one drug that did get approval from the Establishment at the government agencies was tested on one and only one person! (I am forgetting if it is remdesivir, or what not.) But the drugs success in one COVID patient paves the path for this to be a “go to” drug for the ailment.
Of course its price is many times the price of HCQ, but that is just a coincidence, right?
It’s got to be political. Somehow the government and the drug companies are working with each other. I have heard all kinds of theories about the reasons for this complicity, some more credible than others. What is not credible is banning the drug. Something smells. Unless someone has proposed putting HCQ in vending machines. . . .
Is because a vaccine will be worth 100’s of billions of dollars. A billion vaccinations at $60 each is good money. That will probably be *required* annually (as immunity fades and the virus mutates). In 16 years that $1 Trillion dollars.
Another reason is that Americans are scared and viable treatment would make them less scared. This is a giant psy-op by the DNC & MSM to take over government by scaring people. And people are very scared. We just a story on this blog about a lady that died from a simple infection, because she was too scared to visit her doctor. We have heard stories about people being maced for not wearing a mask in a park. Fear is the greatest political motivator.
Dear Rodin,
Thank you for this post. It is well written and straightforward, and it helps put this aspect of the Wuhan in perspective
I appreciate the yeoman service you have done on this topic.
Sincerely,
Tim
If I remember correctly, HCQ was demonstrated as effective in vitro against SARS-1. The same might go for Remdisiver. Back in 2005+/- we used to do science instead of politics and we found new treatments and face masks were proven to be ineffective.
Plus the major meme comprised in this epidemic (#plandemic) mimics that of the emperor wearing no clothes. You are a good considerate citizen only if you follow the news, show concern that just today, so many new cases have been detected, write letters to the editor about the inconsiderate slobs who refuse to mask up, and you are now looking to see where you can obtain the googles that Dr Fauci is recommending we all wear.
Meanwhile on my twitter feed, from a fellow COVID cynic: If the incubation period for coronavirus is 14 days, why have we been locked down for 134 days?
“If it was being suggested that HCQ be put into vending machines…”
Hmmm…
@rodin — you’ve inspired me to create mischief.
I assume all legal liability for my mischief.
The huge undertaking that Mr Zuckerberg doesn’t think too many people know about, probably because we don’t: https://www.czbiohub.org/projects/infectious-disease/
So why would the PTB, who are no longer our defense contractors and the like, but now happen to be the big social media moguls and the Bill Gates’ Syndicate, ever decide on this 20 buck a month remedy to be promoted?
“HCQ!” is a distraction that serves only the statists. I am not falling for it. If I can have restoration of what I had until this year–freedom of worship, freedom of association, freedom of movement, freedom to smile at other humans and see their smiles in response, freedom of speech, freedom to earn a living–in return for a ban on HCQ, I will take it. I’ll become a black marketeer in HCQ.
The lockdown slows the spread some, but it doesn’t stop it or reduce the number who will eventually be infected.
I’m sure some of the problem is legal.
Johnson & Johnson lost a class-action suit against them for their drug Risperdal in 2019–just last year–and the company ended up paying about $8 billion. The verdict was a surprise because the suit blamed the company for the drug’s causing the development of breasts in young teenage boys who were prescribed it. Personally, I don’t think Risperdal should be given to any teenagers, but that’s a decision to be made by a psychiatrist. Risperdal started out being considered a pretty mild antipsychotic that psychiatrists were prescribing with good results for elderly people. I’m sure that’s why the pediatric psychiatrists were interested in it.
At any rate, what is truly infuriating about this verdict is that it was an off-label use. It said right on the label that it was not to be given to children and teenagers. It was truly shocking that the claimants won.
I have been wondering if that’s what’s going on with the HCQ drug. In fact, that’s why I think it has to be an over-the-counter drug. If I were a doctor, I’d be nervous about prescribing it in this legal and mass media environment.
HCQ is safe for lupus and rheumatoid arthritis but unsafe for covid. Makes perfect sense.
h/t to @alfrench
Yes, there are some in vitro studies suggesting that the HCQ mechanism is related to the “spike protein” and its attachment to the ACE2 receptor. There are also arguments about other, intracellular, effects. The opposition seems to be 100% political.
Traditionally, a corona virus is most virulent in both contagion and in lethal powers at the beginning of its spread. It is well known that over the summer, due to warm weather and the disease having weakened, it is best to behave normally, even if doing that means some individuals will then be infected by the weakened version of the ailment.
Many researchers who are independent of The Global Medical Mafia compare this COVID 19 illness with the influenza outbreaks of 1957 and 1968. This is not to make light of severity of the situation: as a HS senior I almost died from the ’68 outbreak. But life proceeded normally. I was sick three days before the much anticipated Senior Class ski trip and blowout. Every other classmate went on this outing, and none were as affected as I was, despite my being in close contact with all these girls prior to my being confined to bed. The following summer is best remembred as The Woodstock summer. I don’t remember hearing that two thirds of the participants became seriously ill or died from the influenza that was still lurking in the environment, despite the elbow to elbow environment of the event.
Dr Bastiat’s recent article on the information he received from a medical society as to the possible 300,000 to 650,000 deaths that have occurred since the declaration of the COVID National Emergency due to suicide, lack of medical treatment, heart attacks, and strokes, increase in alcoholism, and drug use was very illuminating. These figures will be dwarfed by the coming spike of fatalities in those categories as well as a dire economic future the nation will face with further unemployment and food price increases.
@drbastiat
https://ricochet.com/784400/first-do-no-harm/
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I’d like some of our doctors to chime in on this observation: HCQ seems to be most effective if used at the earliest stages. Once the virus has reached the stage of creating hypoxia it’s more in the hands of God than in the hands of medical personnel. So it seems to me that the single worst advice you could give anyone is THE official recommendation: Stay away from your GP/Internist, take acetaminophen and go to bed and only seek medical help if you’re in respiratory distress. And all these months into the pandemic that’s still the advice. To me that’s like finding a stage 1 cancer patient and telling him to come back when you’re stage 4 and we’ll see what we can do.
not a doctor
Yesterday, a cardiologist said to Laura Ingraham that HCQ is for early ‘mild’ cases while more severe patients should consider dexamethasone (typo?)
I haven’t read the comments, but I just wanted to jump right in and say, a fine and thoughtful article @rodin. As Jack Webb used to say, “Just the facts, mam, only the facts.” If it is a placebo only and I take it while experiencing symptoms of the Chinese flu and the symptoms go away and I am tested for and, indeed, have developed antibodies, then placebo away…I don’t care. I called my Doctor yesterday to chat. In the end, I asked where he was at for treatment of COVID. He pretty much hemmed and hawed. I told him if I got sick with this tomorrow, I am taking HCQ+Zinc+Zpak. “Are you with me?” I asked. “Absolutely.” was his response. I bought this little $90 device called KardiaMobil about two months ago and have been emailing my Doctor mine and my wife’s EKG’s several times a week since then. As you say, Rodin, everything right now is off label. One may as well be proactive.
I don’t know if “elbow to elbow” is the body part I would use to describe to Woodstock experience, but, other than that, I’m with ya.
antibodies might be overrated, T-cells are more important?
I agree with your proactive approach. I have a small supply of HCQ which I purchased for my parents as a precaution. If I get sick, I will assume I have covid and take HCQ for sure.
HCQ is reportedly an ionophore which transports Mg++ through the cell membrane where the Mg inhibits viral replication.
The late manifestations are more of the “Cytokine Storm” variety which is probably best treated with steroids and, possibly, anticoagulation.
https://pubmed.ncbi.nlm.nih.gov/32283152/
Note also that Cytokine Storm is also a lethal consequence of influenza.
Statement from one of The Frontline Doctors: Simone Gold: (21:46)
“May I just interject. There is a lot of [crosstalk 00:21:49] data on this.
“Not every clinician needs to publish their data to be taken seriously. The media has not covered it. There is a ton of data. I’ve got a compendium on americasfrontlinedoctors.com, there is a compendium of all the studies that show work with hydroxychloroquine.
“The mortality rate was published in Detroit, less than a … It was July 4th weekend. They published it. Mortality by half in the critically ill patients, the patients who are getting HCQ early, it’s been estimated that one half to three quarters of those patients, wouldn’t be dead. We’re talking 70,000 to 105 … 70 to 100,000 patients would still be alive if we followed this policy. There’s plenty of published data.”
I was wondering if the Cytokine Storm did show up in regular old influenza cases. Thanks for mentioning that.
The ‘danger’ of HCQ reminds me of Ralph Nader, Ford Pinto, unsafe at any speed.
According to Milton Friedman, people in and outside of DC tested his hypothesis.
Almost all of them concluded that Nader was wrong… again
Gotta agree with you there. I’m quite sure that Woodstock is the spot where the ubiquitous “Don’t come a-knockin’ if the van is rockin” expression was created.