Trump-haters are ignoring the 'settled science' about off-label use of drugs

When it comes to federal drug safety law, "orange man bad" syndrome causes those afflicted to continually send out the "SOS" call — except in their case, it means they themselves are "Stuck on Stupid."  They are like the tonearm on a vinyl record, which hits a nick and keeps playing the same bit of music over and over again.  In fact, had they undertaken a five-minute Google search — good luck with that suggestion — they would have saved the public a good deal of the sturm und drang we've all had to endure, over and over again, about hydroxychloroquine.  This is demonstrated below: they have been playing doctor all along while accusing Trump of doing so (a standard ploy of the Democrat/media crowd).

An excellent primer on the subject of off-label drug use can be found on the national Library of Medicine/NIH website.  There one can find posted a 2012 article published in "Mayo Clinic Proceedings," entitled "Ten Common Questions (and Their Answers) about Off-Label Use."

 

The article explains that, under federal law dating back more than a century, once the FDA approves a new drug for the specific illness or condition applied for, doctors may legally prescribe the medication for any other illness or condition they deem fit.  Approval for such "off-label" use is not required, because in the initial new drug application process, and approval, the FDA concluded that the drug is safe to be prescribed, notwithstanding that it might come with certain side-effects and risk to those to whom it is prescribed. 

Doctors are expected to know of those side-effects and risks, and every prescription picked up by a consumer comes with a brochure or printout explaining known side-effects and risks of the medication. Just watch TV commercials for new medications and note how in some, the risks are cited — as the law requires — including the announcement that "this medication has been known to cause death in some patients."  Nevertheless, the FDA has approved the drug for its specific use because it has concluded the benefit to those who require the medication outweigh the risks to some of them.

Off-label uses develop over time because doctors recognize from experience that patients who receive a medication for the specific condition that it was approved for gain a benefit for other conditions — in short, from anecdotal observations.  In addition, medical researchers, knowing how an approved drug works in the body, will experiment on other conditions and in that way learn that the approved medication works on other conditions and illnesses as well.

The FDA does not require a long-term, double-blind study for off-label uses, because the cost of those might be prohibitive — and the safety profile of the medication was determined on initial application, and later use by patients, meaning the primary consideration is efficacy — i.e., will the medication work for the patient whose doctor prescribes it for off-label use?  As it happens, today, nearly 20% of all prescriptions are off-label, and the FDA even issues guidance to doctors who prescribe medications for off-label uses.  Better yet, Medicare even covers off-label uses and, on occasion, subsidizes them, so doctors will prescribe certain drugs, for instance for pain relief, in lieu of other, more harmful drugs like opioids.

So why have so many pundits and media types and even some health "professionals," tried to sell the public on the idea that federal law does not allow prescriptions of, say hydroxychloroquine, unless there has been a years-long double-blind study and consequent FDA approval.  The answer to that is self-evident.  When it comes to Trump, over a century of federal drug law no longer applies — we need a whole new take on the law, because Trump posed that a specific medication might actually save people's lives.

The following excerpt from the abstract from the above mentioned Mayo article is instructive:

The term "off-label" drug use (OLDU) is used extensively in the medical literature, continuing medical education, exercises and the media. Yet we propose that many healthcare professionals share an underappreciation of its definition, prevalence, and implications.

That's a very polite, low-key way of saying an awful lot of people in the health care field, and media covering it, don't know squat about off-label use law.  Perhaps their taking a few minutes to educate themselves on the subject would be a fitting prescription.

When it comes to federal drug safety law, "orange man bad" syndrome causes those afflicted to continually send out the "SOS" call — except in their case, it means they themselves are "Stuck on Stupid."  They are like the tonearm on a vinyl record, which hits a nick and keeps playing the same bit of music over and over again.  In fact, had they undertaken a five-minute Google search — good luck with that suggestion — they would have saved the public a good deal of the sturm und drang we've all had to endure, over and over again, about hydroxychloroquine.  This is demonstrated below: they have been playing doctor all along while accusing Trump of doing so (a standard ploy of the Democrat/media crowd).

An excellent primer on the subject of off-label drug use can be found on the national Library of Medicine/NIH website.  There one can find posted a 2012 article published in "Mayo Clinic Proceedings," entitled "Ten Common Questions (and Their Answers) about Off-Label Use."

 

The article explains that, under federal law dating back more than a century, once the FDA approves a new drug for the specific illness or condition applied for, doctors may legally prescribe the medication for any other illness or condition they deem fit.  Approval for such "off-label" use is not required, because in the initial new drug application process, and approval, the FDA concluded that the drug is safe to be prescribed, notwithstanding that it might come with certain side-effects and risk to those to whom it is prescribed. 

Doctors are expected to know of those side-effects and risks, and every prescription picked up by a consumer comes with a brochure or printout explaining known side-effects and risks of the medication. Just watch TV commercials for new medications and note how in some, the risks are cited — as the law requires — including the announcement that "this medication has been known to cause death in some patients."  Nevertheless, the FDA has approved the drug for its specific use because it has concluded the benefit to those who require the medication outweigh the risks to some of them.

Off-label uses develop over time because doctors recognize from experience that patients who receive a medication for the specific condition that it was approved for gain a benefit for other conditions — in short, from anecdotal observations.  In addition, medical researchers, knowing how an approved drug works in the body, will experiment on other conditions and in that way learn that the approved medication works on other conditions and illnesses as well.

The FDA does not require a long-term, double-blind study for off-label uses, because the cost of those might be prohibitive — and the safety profile of the medication was determined on initial application, and later use by patients, meaning the primary consideration is efficacy — i.e., will the medication work for the patient whose doctor prescribes it for off-label use?  As it happens, today, nearly 20% of all prescriptions are off-label, and the FDA even issues guidance to doctors who prescribe medications for off-label uses.  Better yet, Medicare even covers off-label uses and, on occasion, subsidizes them, so doctors will prescribe certain drugs, for instance for pain relief, in lieu of other, more harmful drugs like opioids.

So why have so many pundits and media types and even some health "professionals," tried to sell the public on the idea that federal law does not allow prescriptions of, say hydroxychloroquine, unless there has been a years-long double-blind study and consequent FDA approval.  The answer to that is self-evident.  When it comes to Trump, over a century of federal drug law no longer applies — we need a whole new take on the law, because Trump posed that a specific medication might actually save people's lives.

The following excerpt from the abstract from the above mentioned Mayo article is instructive:

The term "off-label" drug use (OLDU) is used extensively in the medical literature, continuing medical education, exercises and the media. Yet we propose that many healthcare professionals share an underappreciation of its definition, prevalence, and implications.

That's a very polite, low-key way of saying an awful lot of people in the health care field, and media covering it, don't know squat about off-label use law.  Perhaps their taking a few minutes to educate themselves on the subject would be a fitting prescription.