CONSENT

INFORMED CONSENT FOR OFF-LABEL TREATMENT

I am prescribing medications "off-label" for the prevention and treatment of COVID-19.

Off-label means that a drug is FDA approved for one indication and then used for another. For example, Ivermectin is approved for certain parasite infections and used off-label for scabies. Aspirin has been widely used off-label for the primary prevention of cardiovascular disease.

Off-label drugs are used every day in the US and make up more than 20% of all out patient prescriptions, BUT they are usually widely affirmed by nearly all physicians and pharmacists to be safe and have enough data backing them up to argue for their off-label use.

This is NOT the case with off-label prescribing for COVID-19. It is a highly charged subject and most doctors and pharmacists DO NOT agree with using ANY off-label drugs for COVID-19 aside from over-the-counter medications for symptom control. This is because our official standard setting bodies like the FDA, NIH, CDC and FDA have recommended against most off-label medications for COVID-19 outside of clinical trials.

You can expect many pharmacists to REFUSE to fill any or all of these medications when they know or suspect they are being used for COVID-19 prevention or treatment.

The evidence base for off-label medications in COVID-19 is overall graded moderate to poor quality depending on who you ask. Those who believe it to be of poor quality recommend further higher quality studies before deciding to use the medications in practice. Those who believe at least some of the research to be moderate quality recommend using some combination of off label medications now. There are no high quality studies (like double blind placebo controlled randomized controlled trials) yet on off-label medications for COVID-19.

Also some recommended drugs (like pravastatin) may have no studies to back up their use, only a hypothesized beneficial mechanism of action based on our understanding of how they work in the body.

The alternatives to off-label drugs for COVID-19 include vaccines, monoclonal antibodies, remdesevir, symptom management, and in some cases specific therapeutics like intubation, ECMO, steroids, etc. There are also many therapeutics in development and testing phases like oral antivirals.

IVERMECTIN (IVM):

Ivermectin is a generally safe medication and has been used in millions of people around the world for over 30 years.

There are a number of studies of poor to moderate quality that appear to suggest ivermectin works to prevent and treat COVID-19. However most qualified researchers and prominent standard setting bodies like the WHO, CDC, NIH and FDA publically state the studies are weak and of very poor quality and there is not yet enough evidence to recommend ivermectin use outside a clinical trial.

There are other prominent researchers like professor of medicine Paul Marik and intensivist Pierre Kory who consider the research to be of moderate quality and strong enough to recommend ivermectin's use right now.

The non-partisan British Ivermectin Recommendation Development Panel (BIRD) has recommended ivermectin for prevention and treatment. The FLCCC in the US recommends ivermectin for prevention and treatment. There have been some meta-analyses of 27 randomized controlled trials suggesting ivermectin decreases risk of death by more than 80%. Other meta-analyses that had different inclusion criteria for their studies suggest ivermectin does not work.

Studies may be published in the future with poor trial design that appear to discredit ivermectin. It is also possible excellent quality studies are published in the future that prove ivermectin doesn't work.

IVM SAFETY

Ivermectin has a 30 year history of safe use in humans and the side effect profile appears mild for the most part. However the past use of ivermectin does not predict the safety and side effects seen when used for COVID-19 because we are using much higher doses when treating and preventing COVID-19. For scabies and parasite infections the usual dose is one time 0.2mg/kg. For COVID-19 prevention the dose is 0.2mg/kg twice a week indefinitely. For acute treatment the recommended dose is 0.4mg/kg daily until symptoms resolve and it may be continued for 7-14 days total. These doses are MUCH higher than any used in the past. Based on my experience they are still safe and in thousands of patients I have seen no lasting or serious reactions to high dose ivermectin use, but my data is imperfect and there may have been serious or severe side effects not reported to me. I do know that in the US many patients have called poison control centers after taking higher than usual doses of ivermectin. There are many reports in hospitals of patients with elevated liver function tests after ivermectin use.

Also when used on a new disease, side effects could be different than those recorded in the past. For example, the most severe side effects of ivermectin in the past were only seen in the setting of treatment for a certain parasitic disease. The other relatively common side effect that has been seen in the past is elevated liver function tests which could indicate liver damage, reported in 2% of patients. While on ivermectin you should get liver function tests done on a monthly basis. There are also a number of other more severe side effects seen less than 1% of the time. All that being said, Tylenol and Advil use has been shown to increase the risk of heart failure and death and those are available over the counter. All medications do carry some risk that you should be aware of and in our judgement the risk is acceptable given the disease, but others including the FDA, CDC, NIH and WHO STRONGLY disagree with this assessment.

SPECIFIC WARNINGS AND PRECAUTIONS OF EACH COVID TREATMENT MEDICATION INCLUDING (for more information click here):

Adverse Reactions
Contraindications
Warnings/Precautions
Drug Interactions
Food Interactions
Reproductive Considerations
Pregnancy Considerations
Breastfeeding Considerations
Dietary Considerations
Monitoring Parameters

I have read through all of the above information and if I have questions I will ask the doctor.

I certify that I have been informed of the risks and benefits of off-label treatment for COVID-19

I consent to being evaluated via telemedicine and being treated with off-label medications that have NOT been FDA approved, are NOT on the NIH treatment guidelines, and NOT recommended by any US governmental authority.

I will review the side effects of all medications I am prescribed and immediately inform the doctor of any side effects that occur.

I agree to the following release from medical liability and malpractice claims:

I acknowledge that off-label prevention and treatment for COVID-19 and related illnesses, like Long COVID or Long Haul syndrome (AKA Presumed Post Viral Syndrome due to COVID-19), has become a highly charged and political issue and poses numerous personal and professional risks to practitioners who prescribe these alternative, unapproved treatments, and that, though presumed and believed to be safe and effective based on the best available evidence, they may in fact be harmful and could cause severe disability and even death, which can in fact occur with any and all medical treatments in some percentage of patients. Physicians involved in these negative outcomes are shielded from liability when their peers agree their treatments were warranted, but this is not the case with prevention and treatment of COVID-19 and related illnesses like Long COVID. where prescribing practitioners are acting outside the bounds of medical establishment consensus, Therefore, in order to obtain treatment that is not physician, peer, FDA, NIH or CDC-approved, but may nevertheless be beneficial, I agree to release Dr. Syed Haider and all of his associates from all medical liability and malpractice claims related to any and all care, including but not limited to preventive, acute and chronic treatments for COVID-19 and Presumed and/or Diagnosed Post Viral Syndrome due to COVID-19, AKA Long COVID or Long Haul syndrome.

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