The US Food and Drug Administration has an exhaustive process, “to evaluate new drugs before they can be sold.” Specifically, this involves the Center for Drug Evaluation and Research (CDER). The rationale is sound and for the general good:
The center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
Note the goal is neither absolute safety nor perfect efficacy. In other words, no drug is completely safe and without side effects, nor will a drug work every time, exactly as it was designed to. The key is the risk-benefit ratio, where the benefits outweigh the risks or costs.
Otherwise, air travel, driving, and walking would be prohibited as these activities all involve some risk — but that is far outweighed by their benefits.
Drugs are approved for a specific indication, at a particular dose, and this is on the product label, which is actually the multiple folded paper, attached to the medication container with print so small no one can or wants to read it. It summarizes indications, clinical trial results, side effects, warnings, and dosages, all determined by the registration trials leading to FDA review and approval.
When drugs are used as described by the label, this is referred to as “on-label” use. Insurance companies typically pay for on-label treatment. Conversely, “Unapproved use of an approved drug is often called ‘off-label’ use.” The FDA does not object to this,
“From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”
Except for two particular FDA-approved drugs. Astute readers will know exactly what two drugs I am referring to.
Why do physicians prescribe off-label drugs?
One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. Examples include,
Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.
Given in a different way, such as when a drug is approved as a capsule, but it is given instead in an oral solution.
Given in a different dose, such as when a drug is approved at a dose of one tablet every day, but a patient is told by their healthcare provider to take two tablets every day.
Many prescription medications are approved for one indication but used for something entirely different, prescribed by a physician, ethically and legally if they believe the use of this medication in an off-label manner is in the best interests of the patient. Here are several examples.
Antihypertensive prazosin is used to also treat PTSD-related nightmares. Another antihypertensive clonidine is used for ADHD. Antipsychotic quetiapine can be prescribed for insomnia. Heart and blood pressure medicine propranolol can be taken for performance anxiety and sildenafil, also known as Viagra, can treat female sexual arousal disorder, in addition to its well-known use in men.
In my world, Avastin is the most commonly used drug for macular degeneration and diabetic retinopathy, injected directly into the eye. Avastin is approved for various types of cancer with no FDA approval for ocular use, yet it has been our go-to retina drug for over 15 years, used off-label and saving Medicare and other payers tens of billions of dollars over the years.
Do pharmacies refuse to fill prescriptions for these off-label medications? Are doctors threatened with the loss of their medical license for prescribing these drugs? Of course not.
How often does a physician prescribe a course of antibiotics for a patient with a bad cold, usually at the patient’s request, knowing that antibiotics do nothing for viral infections? Do pharmacies refuse to fill a prescription for a Z-pak for someone with a sore throat and cough? Do these physicians face the wrath of medical boards for this off-label and useless treatment? Of course not.
Over the past two years, the medical establishment and media have reversed course on off-label medications, not only dismissing them but shaming and vilifying anyone promoting their use. The two drugs in question are well known, hydroxychloroquine and ivermectin.
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Both drugs have been FDA approved for human use for decades, but the media and even the FDA choose to characterize them as animal medication or “horse paste.” This refers to the veterinary versions of these medications, ignoring human approval and use. That’s like calling corn and oats animal food just because farm animals happen to eat something humans eat as well.
Both of these drugs have shown benefit in treating, not curing, COVID. A meta-analysis of 73 ivermectin trials demonstrated, “Using the most serious outcome shows 66% [53‑76%] and 83% [74‑89%] improvement for early treatment and prophylaxis.” A similar meta-analysis of 369 hydroxychloroquine studies showed, “Early treatment consistently shows positive effects.”
These are not cures but are safe and inexpensive therapeutics that if used appropriately, recommended by a physician as an early outpatient treatment, may keep people out of the hospital and ICU. Isn’t that the goal of early COVID treatment?
So why now, almost two years into the COVID pandemic, are we not throwing everything at this virus? There is an all-out push for vaccines and boosters, yet vaccinated persons are still getting sick and dying. While vaccines reduce the chance of severe disease, they don’t eliminate it. One could say the same about the off-label therapeutics mentioned above based on multiple clinical studies.
Then why such hostility toward off-label treatments, even when the physician follows well-established precedent, making a decision for their patient after weighing the risks and benefits? And why are physicians who follow this accepted approach for off-label medications threatened with loss of employment, license, and reputation?
As a necessary disclaimer, I am not offering medical advice, only commenting on the current state of COVID treatment. All such treatment decisions should be made in consultation with your health care provider.
Is this about the money, ignoring cheap off-label therapeutics in favor of expensive anti-viral medications? Have the tentacles of big pharma reached into the FDA and other health authorities? Is this about control, forcing compliance with a government mandate, in this case, vaccination, to work, travel, shop, and participate in society?
Fortunately, there is pushback from some quarters. Wisconsin Republicans released three bills that, “Would prevent health systems and medical credentialing boards from disciplining doctors for ordering or advocating for therapies or medicine for patients that go against medical opinions held by their employers or regulators.”
But here we are, almost two years into this pandemic, with a dozen claims by President Biden to “shut down the virus” only to be setting new daily case records. At the same time, medical authorities attempt to discipline and punish doctors who dare use their clinical experience and judgment in treating their patients with off-label drugs, a standard medical practice, except when it comes to COVID.
Why is science being upended for COVID, from off-label therapeutics to natural immunity, well-established concepts now suddenly considered junk science and dismissed? Is this what we can now expect from the finest healthcare system in the world, the Orwellian politicization of medicine?