Posted on 02/18/2024 1:59:14 PM PST by nickcarraway
— My doctor's refusal to prescribe "just-in-case" Paxlovid speaks volumes
Simborg is a retired physician and a medical informatics expert.
I'm an 83-year-old retired physician. I let my medical license expire over a decade ago and have put my medical care into the hands of very capable people paid for by Medicare -- just like most people my age. Generally, I have been happy with this arrangement and enjoy good health.
From this perspective, I can observe our healthcare system just like any other U.S. citizen. I would like to share one important observation at this time: we are now sleep-walking our response to COVID. This is true both among the general citizenry, as well as among healthcare professionals, who seem hesitant to prescribe the most effective outpatient treatment for COVID -- nirmatrelvir/ritonavir (Paxlovid) -- even for high-risk patients like myself.
Perhaps after the several frenzied years during the worst of the pandemic this is understandable. We're all sick of it -- emotionally speaking. Certainly, it is no longer killing us in the massive numbers we saw previously. But it was the third leadingopens in a new tab or window cause of death after heart disease and cancer in people over the age of 65 during the earlier years of the pandemic, and remains a serious threatopens in a new tab or window to people of my age.
Unlike heart disease and cancer, we have a vaccine that can greatly reduce the likelihood of death from COVID. Yet, according to the CDC, far less than halfopens in a new tab or window of people over age 65 have gotten the latest vaccine. Last month, on a trip to Costa Rica for vacation, I saw only a single person on each of the four flights there and back wearing a mask. It was a flight attendant with the mask loosely slung over her mouth and chin, exposing one of only two important places for the mask: her nose. Very few people wore masks in the airports and there was certainly no social distancing on the shuttle busses (or masks). Yet, the highly infective JN.1 variant was peaking in the U.S. at the time. So much for awareness and concern among my fellow citizens.
But what about the medical professionals, themselves? An incident related to that same Costa Rica trip has me concerned. Prior to the trip, I asked my primary care physician for two "just in case" medications to carry along with me: an antibiotic in case I contracted "touristaopens in a new tab or window" and nirmatrelvir/ritonavir in case I contracted COVID. My biggest concern about the latter was the air travel going there. I was bringing along COVID testing kits, but knew that if I turned positive while in Costa Rica, it would be unlikely I could get nirmatrelvir/ritonavir prescribed there during the first 5 days of symptoms.
I was aware that nirmatrelvir/ritonavir is not approved for "just in case" travel usage, even in high-risk travelers such as myself. But, as a former physician, I also know that physicians are free to prescribe medications "off-label," and I have friends who have been prescribed nirmatrelvir/ritonavir for "just in case" travel occasions. My primary care physician gave me the antibiotic but denied the nirmatrelvir/ritonavir. He said he had discussed it with his colleagues, and they all agree that if everyone prescribed nirmatrelvir/ritonavir "just in case" for travel purposes, we would develop a shortage of nirmatrelvir/ritonavir.
I was astonished by that response. How many people still travel overseas at my age? And how many of them are requesting "just in case" nirmatrelvir/ritonavir? It seems highly unlikely that giving us those prescriptions would cause a supply chain problem at Pfizer. In fact, a study found that less than 15%opens in a new tab or window of high-risk patients who actually contract COVID take the medication! The researchers determined that over 48,000 deaths could have been prevented if just half of the eligible patients in the U.S. had gotten nirmatrelvir/ritonavir during the time period of the research.
There is hardly a run on nirmatrelvir/ritonavir in this country. Our problem is underutilization of nirmatrelvir/ritonavir, not overutilization. Researchers are working to answer this questionopens in a new tab or window of why people at high risk for severe COVID-19 don't receive nirmatrelvir/ritonavir -- or any outpatient antiviral treatment -- when diagnosed with COVID.
As for my primary care physician, why would he and his colleagues decide to raise a potential public health shortage concern as a reason not to prescribe it to me? I'm sure they had no real evidence that the numbers would overwhelm the system. That was pure speculation. He readily prescribed me a "just in case" antibiotic for a minor illness easily managed without a prescription. There is already well-known evidence that we overprescribe antibiotics leading to resistant organisms. Why create a public health concern for nirmatrelvir/ritonavir? I don't think it was a lack of concern for my well-being. Rather, I think it is a lack of concern about COVID.
It reflects a general sense in the medical community -- and the public as a whole -- that COVID is no longer a major threat. The possibility of my contracting COVID, not taking nirmatrelvir/ritonavir, and dying was simply less compelling than the notion that the country might run out of the drug. Perhaps also unstated to me but in the back of his mind was the reluctance to prescribe the drug when it is not approved for this purpose. That would have been more reasonable to me, yet it still felt as though he failed to put my well-being at the top of the list.
Finally, this raises the broader question of our national approach to COVID. Why doesn't the FDA approve nirmatrelvir/ritonavir for "just in case" usage in travel for high-risk individuals? Surely it would cut into those unnecessary death statistics. We could easily monitor its impact on the supply chain and alter the age threshold for such approval if it became a problem. Why isn't there a continued public call for vaccinations? Why has COVID fallen off the cliff of public awareness?
The virus has won. We are now sleep-walking our defense.
Donald W. Simborg, MD, is a retired physician. He is also a founding member of the American College of Medical Informatics, Co-founder of HL7, former founder and CEO of two EHR companies, and former CIO of the University of California San Francisco, currently retired.
I really hope that when I am 83 that I am not trying to make the rest of the world, including prescribing doctors, to be obsessed with the possibility that I might catch something and die. If I am that worried, when I well past my life expectancy, I think I just won’t go tot Costa Rica or wherever.
This guy sounds a little Karenish.
It has always annoyed me that in a free country I cannot prescribe myself any drugs I decide I might want.
Instead I have to go to my local legal pusher and beg.
My grandfather and two of my uncles were MD’s. My dad was a medic in the US Army in Korea. I trusted the medical system because of family in the business.
NO MORE. I have been lied to way too many times that I don’t even trust my family doctor or any other doctor.
The “first do no harm” principle has been thrown out the window.
F all of them.
“And you have assholes like me that didn’t get the jab and will never get the jab for something I have been immune to since late 1969 when I almost died from the Hong Kong Flu.”
I too almost died from the Hong Kong Flu back then. Are you saying that because we had it we may be immune to Covid? I have had no vaccines and have been exposed to several people with Covid and I should have caught it but didn’t.
Why is the good doctor nervous? He is probably “vaccinated” 20 times over. It is 100% effective we’ve been told
Paxlovid is a scary drug; here’s some prescribing information from the FDA EUA PDF:
https://www.fda.gov/media/155050/download
EUA prescribing PDF has this black box warning:
“• PAXLOVID includes ritonavir, a strong CYP3A inhibitor,
which may lead to greater exposure of certain concomitant
medications, resulting in potentially severe, life threatening, or fatal events. (4, 5.1, 7)
• Prior to prescribing PAXLOVID: 1) Review all medications
taken by the patient to assess potential drug-drug
interactions with a strong CYP3A inhibitor like PAXLOVID
and 2) Determine if concomitant medications require a dose
adjustment, interruption, and/or additional monitoring. (7)
• Consider the benefit of PAXLOVID treatment in reducing
hospitalization and death, and whether the risk of potential
drug-drug interactions for an individual patient can be
appropriately managed. (5.1, 7, 14)”
and then there’s this:
“-———————————————CONTRAINDICATIONS-—————
• History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components. (4)
• Co-administration with drugs highly dependent on CYP3A for
clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. (4, 7.3)
• Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. “
and then the FDA puts this burden on prescribers:
“You or your designee must report all SERIOUS ADVERSE
EVENTS or MEDICATION ERRORS potentially related to PAXLOVID (1) by submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to Pfizer Inc. at fax number: 1-866-635-8337. (6.4) “
[me: since the majority of medications metabolize via the set of CYPA hepatic enzymes, the potential for dangerous and even fatal drug interactions with Paxlovid is enormous ... we elderly are particularly vulnerable to this situation because so many of us have to take multiple medications to stay alive ... folks, even the FDA views Paxlovid as a very dangerous drug ...]
Paxlovid is a scary drug; here’s some prescribing information from the FDA EUA PDF:
https://www.fda.gov/media/155050/download
EUA prescribing PDF has this black box warning:
“• PAXLOVID includes ritonavir, a strong CYP3A inhibitor,
which may lead to greater exposure of certain concomitant
medications, resulting in potentially severe, life threatening, or fatal events. (4, 5.1, 7)
• Prior to prescribing PAXLOVID: 1) Review all medications
taken by the patient to assess potential drug-drug
interactions with a strong CYP3A inhibitor like PAXLOVID
and 2) Determine if concomitant medications require a dose
adjustment, interruption, and/or additional monitoring. (7)
• Consider the benefit of PAXLOVID treatment in reducing
hospitalization and death, and whether the risk of potential
drug-drug interactions for an individual patient can be
appropriately managed. (5.1, 7, 14)”
and then there’s this:
“-———————————————CONTRAINDICATIONS-—————
• History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components. (4)
• Co-administration with drugs highly dependent on CYP3A for
clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. (4, 7.3)
• Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. “
and then the FDA puts this burden on prescribers:
“You or your designee must report all SERIOUS ADVERSE
EVENTS or MEDICATION ERRORS potentially related to PAXLOVID (1) by submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to Pfizer Inc. at fax number: 1-866-635-8337. (6.4) “
[my comment: since the majority of medications metabolize via the set of CYPA hepatic enzymes, the potential for dangerous and even fatal drug interactions with Paxlovid is enormous ... we elderly are particularly vulnerable to this situation because so many of us have to take multiple medications to stay alive ... folks, even the FDA views Paxlovid as a very dangerous drug ...]
Paxlovid is a scary drug; here’s some prescribing information from the FDA EUA PDF:
https://www.fda.gov/media/155050/download
EUA prescribing PDF has this black box warning:
“• PAXLOVID includes ritonavir, a strong CYP3A inhibitor,
which may lead to greater exposure of certain concomitant
medications, resulting in potentially severe, life threatening, or fatal events. (4, 5.1, 7)
• Prior to prescribing PAXLOVID: 1) Review all medications
taken by the patient to assess potential drug-drug
interactions with a strong CYP3A inhibitor like PAXLOVID
and 2) Determine if concomitant medications require a dose
adjustment, interruption, and/or additional monitoring. (7)
• Consider the benefit of PAXLOVID treatment in reducing
hospitalization and death, and whether the risk of potential
drug-drug interactions for an individual patient can be
appropriately managed. (5.1, 7, 14)”
and then there’s this:
“-———————————————CONTRAINDICATIONS-—————
• History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components. (4)
• Co-administration with drugs highly dependent on CYP3A for
clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. (4, 7.3)
• Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. “
and then the FDA puts this burden on prescribers:
“You or your designee must report all SERIOUS ADVERSE
EVENTS or MEDICATION ERRORS potentially related to PAXLOVID (1) by submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to Pfizer Inc. at fax number: 1-866-635-8337. (6.4) “
[my comment: since the majority of medications metabolize via the set of CYPA hepatic enzymes, the potential for dangerous and even fatal drug interactions with Paxlovid is enormous ... we elderly are particularly vulnerable to this situation because so many of us have to take multiple medications to stay alive ... folks, even the FDA views Paxlovid as a very dangerous drug ...]
That sounds an awful lot like an ad. /s
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