Wiki Does treatment of COVID-19 with non-EUA drugs disqualify a hospital from receiving CARES Act or ARPA Subsidies

[jshaw8808]

I'm hearing rumors that hospitals have almost universally stuck with remdesivir to treat COVID-19, in spite of some doctors' preference for other approaches, because they fear losing subsidies if they use something else (e.g., ivermectin).

It is my understanding that the CARES Act and ARPA require hospitals and other providers to adhere to the NIH's COVID-19 treatment guidelines in order to be eligible for subsidies. Those guidelines only explicitly endorse remdesivir, due to its being the only FDA-approved treatment for COVID-19. The guidelines don't recommend for or against ivermectin, but they do recommend avoiding HCQ or azithromycin. They also recommend against using interferons or nitazoxanide outside of clinical trials. Interestingly, the Introduction to the NIH guidelines does acknowledge that "Providers can access and prescribe investigational drugs or agents that are approved or licensed for other indications through various mechanisms, including Emergency Use Authorizations (EUAs), Emergency Investigational New Drug (EIND) applications, compassionate use or expanded access programs with drug manufacturers, and/or off-label use… Finally, it is important to stress that the rated treatment recommendations in these Guidelines should not be considered mandates. The choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider."

Does anyone know if hospitals lose their CARES and ARPA subsidies if they forego remdesivir in favor of other drugs?

Thanks

 

[thomas7331]

This an interesting question for which I don't know the answer - I almost think you'd need to ask a physician and/or an attorney to know for sure. I have not heard these rumors, but would certainly take them with a grain of salt given the current environment surrounding COVID-related matters these days.

I'll put a thought out there for you to consider, though - there may actually be two issues involved here. I think there is a fine but real line between off-label use of a drug and using a drug in a way that does not meet standards of care. My impression is that the former is the use of a drug in a manner which is supported by clinical evidence but for which the drug may not yet have been approved, or in cases in which the patient is unlikely to suffer harm from adverse effects due to an already dire condition. That's a very different thing from latter, using a drug or dosage for which there is no clinical evidence of effectiveness, or for which there are known adverse effects that could harm a patient, as this could be in violation of required standards of care and even medical ethics. (I suspect Ivermectin likely falls into this category.) All drugs involve some level of risk, so using a drug that poses a risk to a patient without any known potential for benefit puts a provider into a challenging ethical position. And failure to follow standards of care can open a provider or a facility up to malpractice lawsuits, so I wouldn't be surprised if it also could result in loss of government funds.

Just my thoughts, but I'll be interested to see if anyone else responds with additional information.

 

[jshaw8808]

This an interesting question for which I don't know the answer - I almost think you'd need to ask a physician and/or an attorney to know for sure. I have not heard these rumors, but would certainly take them with a grain of salt given the current environment surrounding COVID-related matters these days.

I'll put a thought out there for you to consider, though - there may actually be two issues involved here. I think there is a fine but real line between off-label use of a drug and using a drug in a way that does not meet standards of care. My impression is that the former is the use of a drug in a manner which is supported by clinical evidence but for which the drug may not yet have been approved, or in cases in which the patient is unlikely to suffer harm from adverse effects due to an already dire condition. That's a very different thing from latter, using a drug or dosage for which there is no clinical evidence of effectiveness, or for which there are known adverse effects that could harm a patient, as this could be in violation of required standards of care and even medical ethics. (I suspect Ivermectin likely falls into this category.) All drugs involve some level of risk, so using a drug that poses a risk to a patient without any known potential for benefit puts a provider into a challenging ethical position. And failure to follow standards of care can open a provider or a facility up to malpractice lawsuits, so I wouldn't be surprised if it also could result in loss of government funds.

Just my thoughts, but I'll be interested to see if anyone else responds with additional information.

Thanks so much for the thoughtful reply, Mr. Field. What I suspect is that there may not be an explicit denial of subsidies if another drug is used, but hospitals are playing it safe, perhaps not just in the sense of qualifying for a subsidy, but to protect themselves legally, as I think you are implying. I wonder what the PREP Act, that indemnifies providers during a medical emergency, has to say about drugs.

I do disagree about ivermectin (IVM), however. From what I've heard from a number of front-line workers, remdesivir is wreaking havoc on patients' kidneys (to the point where it's been nicknamed run-death-is-near), and that from what they've seen, during the brief window when IVM was used with some frequency, patient outcomes were significantly better and there were no problems with adverse effects. It's interesting, too, that Dr. Tess Lawrie, a medical data researcher and consultant to the WHO, secretly recorded Dr. Andrew Hill, the author of a WHO meta-analysis used to discredit IVM, admitting in a Zoom call that his research was flawed, and that he was under a lot of pressure by "a very strong lobby" to downplay the effectiveness of IVM. He didn't offer up any defense when Dr. Lawrie noted that his study ignored IVM's beneficial effects in preventing infection, increasing speed to PCR negativity, reducing admissions to the ICU, and limiting the need for mechanical ventilation. I think we would be very naive to ignore the fact that cheap, effective prophylaxis or treatment using off-patent drugs would result in the loss of hundreds of billions, maybe trillions of revenues for drug companies, as well as a reduction in budgets for government agencies and medical research centers. Of course, just mentioning this will likely get this thread removed in these days of fascist censorship.

But mostly, I just want to know why hospitals in the U.S. (and almost nowhere else) are so committed to remdesivir and so hostile to alternatives. Why not let physicians exercise their personal judgement based on their experience, knowledge and intuition, as is the norm? Certainly, most people given remdesivir and thrown on a ventilator will die anyway, so why not let doctors improvise?

 

[thomas7331]

Thanks so much for the thoughtful reply, Mr. Field. What I suspect is that there may not be an explicit denial of subsidies if another drug is used, but hospitals are playing it safe, perhaps not just in the sense of qualifying for a subsidy, but to protect themselves legally, as I think you are implying. I wonder what the PREP Act, that indemnifies providers during a medical emergency, has to say about drugs.

I do disagree about ivermectin (IVM), however. From what I've heard from a number of front-line workers, remdesivir is wreaking havoc on patients' kidneys (to the point where it's been nicknamed run-death-is-near), and that from what they've seen, during the brief window when IVM was used with some frequency, patient outcomes were significantly better and there were no problems with adverse effects. It's interesting, too, that Dr. Tess Lawrie, a medical data researcher and consultant to the WHO, secretly recorded Dr. Andrew Hill, the author of a WHO meta-analysis used to discredit IVM, admitting in a Zoom call that his research was flawed, and that he was under a lot of pressure by "a very strong lobby" to downplay the effectiveness of IVM. He didn't offer up any defense when Dr. Lawrie noted that his study ignored IVM's beneficial effects in preventing infection, increasing speed to PCR negativity, reducing admissions to the ICU, and limiting the need for mechanical ventilation. I think we would be very naive to ignore the fact that cheap, effective prophylaxis or treatment using off-patent drugs would result in the loss of hundreds of billions, maybe trillions of revenues for drug companies, as well as a reduction in budgets for government agencies and medical research centers. Of course, just mentioning this will likely get this thread removed in these days of fascist censorship.

But mostly, I just want to know why hospitals in the U.S. (and almost nowhere else) are so committed to remdesivir and so hostile to alternatives. Why not let physicians exercise their personal judgement based on their experience, knowledge and intuition, as is the norm? Certainly, most people given remdesivir and thrown on a ventilator will die anyway, so why not let doctors improvise?

You're welcome jshaw8808. It's indeed a controversial area, and I think you're asking good questions but I still think these would be best addressed to a physician. I'll add a couple more of my thoughts and leave it at that.

I'd really caution against drawing any conclusions based on hearsay or sources from anyone without a physician's background, even if they do work in healthcare. Physicians can't (and shouldn't) base their treatment decisions on anecdotal evidence or on what they've 'heard' does or doesn't work. The medical professional is built upon the data and evidence from clinical research that is extensive (i.e. involving multiple studies), is held to quite rigorous standards, is peer reviewed and has demonstrated repeatable results. It's exceedingly complex and requires many years of dedicated study and practice to become proficient. Physicians do have some latitude to tailor a treatment plan to the individual needs of their patient and weigh the risks against potential benefits in a given situation. But there are limitations on this and of course, physicians can't legally or ethically experiment on patients without their consent. If a patient is harmed or otherwise suffers a negative outcome because their physician has ordered unproven therapies not supported by the research and not endorsed by the profession, or has otherwise bypassed protocols, it can constitute malpractice and/or result in the loss of a license to practice. I think facilities and professional organizations are right to be careful and strict about this - it's part of what we're paying them for. Patient outcomes cannot be good unless patient safety is also carefully protected.

I've been fortunate to have worked with a number of physicians over the course of my career who've been willing take the time to discuss their practice with me and educate me about type of decisions they face and how they go about making them, and I've gained an knowledge and respect for what they do which has also led me to understand that while no physician is perfect, an untrained person like me generally doesn't have sufficient knowledge to judge the quality of their work or second-guess these types of decisions. I would encourage you to put some of these questions to a physician - there's really no substitute for that. If you know of one you trust or with whom you have a good working relationship and who is willing to spend some time with you, I think you'd find it very helpful and informative.

 

[jshaw8808]

You're welcome jshaw8808. It's indeed a controversial area, and I think you're asking good questions but I still think these would be best addressed to a physician. I'll add a couple more of my thoughts and leave it at that.

I'd really caution against drawing any conclusions based on hearsay or sources from anyone without a physician's background, even if they do work in healthcare. Physicians can't (and shouldn't) base their treatment decisions on anecdotal evidence or on what they've 'heard' does or doesn't work. The medical professional is built upon the data and evidence from clinical research that is extensive (i.e. involving multiple studies), is held to quite rigorous standards, is peer reviewed and has demonstrated repeatable results. It's exceedingly complex and requires many years of dedicated study and practice to become proficient. Physicians do have some latitude to tailor a treatment plan to the individual needs of their patient and weigh the risks against potential benefits in a given situation. But there are limitations on this and of course, physicians can't legally or ethically experiment on patients without their consent. If a patient is harmed or otherwise suffers a negative outcome because their physician has ordered unproven therapies not supported by the research and not endorsed by the profession, or has otherwise bypassed protocols, it can constitute malpractice and/or result in the loss of a license to practice. I think facilities and professional organizations are right to be careful and strict about this - it's part of what we're paying them for. Patient outcomes cannot be good unless patient safety is also carefully protected.

I've been fortunate to have worked with a number of physicians over the course of my career who've been willing take the time to discuss their practice with me and educate me about type of decisions they face and how they go about making them, and I've gained an knowledge and respect for what they do which has also led me to understand that while no physician is perfect, an untrained person like me generally doesn't have sufficient knowledge to judge the quality of their work or second-guess these types of decisions. I would encourage you to put some of these questions to a physician - there's really no substitute for that. If you know of one you trust or with whom you have a good working relationship and who is willing to spend some time with you, I think you'd find it very helpful and informative.

Thanks for another thoughtful reply.

Regarding anecdotal evidence, what I’m talking about are the first-hand observations of front-line medical workers, including a number of doctors. These people have no career or financial interest in countering the prevailing dogma, quite the opposite. When somebody says something that is against their personal interest, I tend to take them very seriously. When a lot of them do so, and their stories are aligning, I take them even more seriously. I also think nurses are capable of recognizing a patient with normal kidney function, and one without, and connecting the dots when a pharmaceutical is involved. However, there are a number of doctors, such as Dr. Peter McCullough and Dr. John Witcher, who have stated that remdesivir is toxic and regularly shuts down kidney (and sometimes liver) function. That is, doctors are giving interviews where they're saying that they have problems with remdesivir. Do I need to have a one-on-one conversation with a doctor? I don't think so. There are also studies like this one: https://pubmed.ncbi.nlm.nih.gov/33340409/. It's also hard not to see the discrepancy between the hasty granting of an EUA for remdesivir, following skimpy trials with lackluster results and safety issues; with the rigorous scrutiny of and hostility towards, ivermectin and other repurposed drugs having long, sterling safety records and many doctors touting their effectiveness in clinical settings. Some officials, like Dr. Fauci, have claimed that drugs like ivermectin and HCQ need to be subjected to double-blinded, placebo-controlled studies before being granted EUAs for COVID. Who's going to pay for that, for off-patent drugs? Why is that needed for drugs with proven safety records? The official line is that there are no drugs that are effective for prophylaxis or early treatment of COVID; wouldn't it be better to let doctors use these drugs as they see fit, rather than simply watch patients deteriorate to the point where they require hospitalization?

Knowledge and credentials aren’t the only, or even the most important consideration in health matters; it’s political, financial and career incentives that tend to determine people’s behavior rather than knowledge. I’ve heard both nurses and doctors say that hospitals don’t want anything to do with repurposed, off-patent drugs because they don’t make any money off of them. Remdesivir, on the other hand, is lucrative, with a WAC set at $3,200; it doesn’t take too much of a percentage markup from that base to generate real money. Moreover, as the profit margins have been squeezed at medical practices, the economic model has largely shifted to a numbers game, wherein doctors see as many patients as they can in a day, spending little time with each. Doctors also have less time to do research, and the majority of physicians get most of their information about pharmaceuticals from the drug companies and their reps. For their part, medical journals are dependent on drug advertising, so they’re not likely to publish many studies or editorials favoring off-patent medications.

I’ve also heard doctors and hospital administrators say that there is a climate of intimidation and retaliation that is discouraging doctors from exercising their traditional prerogative to prescribe FDA approved drugs as they see fit. Doctors that prescribe ivermectin or HCQ face a very stark threat of losing hospital privileges or even their medical licenses. Virtually the entire medical establishment has come out against ivermectin (and a number of other repurposed drugs); the CDC, the AMA, the APhA, the ASHP, the FSMB, the ABFM, the ABP … and on and on. The whole medical establishment is beholden in one way or another to the drug industry. If some doctors are still committed to these drugs in the face of this resistance and intimidation, they must really believe in them. It’s certainly not lucrative for these doctors to take such a stance.

Beyond first-hand accounts, there are a number of high-powered meta-studies that have looked at ivermectin as a treatment for COVID-19, and concluded that’s it’s both extremely safe and very effective. Here’s one that looked at 75 studies, 54 of which were peer-reviewed, and found an overall improvement rate of 66% in early treatment, and 83% in prophylaxis: https://ivmmeta.com/.

Also, I'd rather take the advice of a doctor who is relying on the clinical experiences of his trusted colleagues, rather than one who is getting his information from drug reps, or from studies that may be cherry-picked or rigged to favor patented drugs (or discredit off-patent drugs). Recall the ludicrously fraudulent Surgisphere study that was used to discredit HCQ, and the fact that arguably the foremost medical journal in the world, The Lancet, held out for two weeks before grudgingly retracting it. If a study like that had found HCQ effective, it almost certainly would never have been published in The Lancet in the first place; but if it had, it would have been retracted faster than Dr. Fauci can jump in front of a camera.

That’s where I’m coming from.

 

[thomas7331]

Hello again jshaw8808, I appreciate your thoughts and understand where you're coming from. I certainly share some of your concerns about the influence of financial incentives on the healthcare industry. Many reports I read and things I hear these days are concerning to me as well, but I think an internet coding forum is probably not the right place for airing or debating these topics.

As my last post hopefully conveyed, my approach has been to question, but avoid drawing conclusions, from limited information about a profession on which I understand that I am not sufficiently educated nor properly qualified to pass judgment. I meant no offense in suggesting you should discuss these issues with a physician - I only hoped to share the benefit that I've gained by having physicians whose opinions I respect and trust help me to navigate through a lot of confusing and conflicting information that's out there. I try to have faith that even though there are bad actors in this field (as there are in any), the majority of people are conscientious and trying to do the right thing at a difficult time and in a very challenging profession. Wherever you decide to take this, I hope you'll go with an open mind and the best of intentions.