[COMMENTS FROM DONNA GARNER: This is a super paper because the author, who is a Nebraska resident himself, has taken the time to delve deeply into his Nebraska Attorney General Douglas J. Peterson’s supportive documentation which is full of the latest, “authentic” medical science. The AG’s report clearly proves that hydroxychloroquine and ivermectin can and should be prescribed for early use against COVID.
Now states all across the country and the general public have a factual, scientifically based source from which they can draw critical information that can save millions of lives.
The good thing is that Henry Burke has done the work for us by pointing out in his short and easy-to-understand article the most important facets of the AG’s report and has given the page numbers for corroboration. The official link to the AG’s report is included toward the top of the article.]
=========================
BY HENRY W. BURKE
In Nebraska, doctors can legally prescribe hydroxychloroquine and ivermectin without having their medical licenses revoked.
Because the Nebraska Medical Boards are accountable to the Nebraska Attorney General (AG), the Boards cannot revoke the doctors’ licenses without the Attorney General’s consent.
On October 14, 2021, Nebraska Attorney General Douglas J. Peterson issued an opinion on the prescription of ivermectin (IVM) and hydroxychloroquine (HCQ) by a licensed health care provider for the treatment of COVID-19. This opinion was written in response to a request from Dannette R. Smith, CEO of Nebraska Department of Health and Human Services (HHS). CEO Smith specifically asked if IVM and HCQ (or other “off label” medications) could be legally prescribed (after obtaining informed consent) by a health care provider for the treatment or prevention of COVID-19. (page 1)
PLEASE READ THE NEBRASKA AG’S OPINION HERE: https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf
Nebraska Attorney General Doug Peterson concluded:
“Based on available data, we do not find clear and convincing evidence that a physician who first obtains informed consent and then utilizes ivermectin or hydroxychloroquine for COVID-19 violates the UCA [Uniform Credentialing Act]. This conclusion is subject to the limits noted throughout this opinion.
Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained healthcare system.” (page 47)
The Nebraska Attorney General stated the following in the body of his opinion:
“In the end, as we explain below, we find that the available data does not justify filing disciplinary actions against physicians simply because they prescribe ivermectin or hydroxychloroquine to prevent or treat COVID-19.” (page 3)
In order to respond to the Nebraska HHS CEO in a timely manner, the Nebraska Attorney General confined the discussion to ivermectin and hydroxychloroquine only. This means the other “off label” medications were not addressed in the AG analysis. (page 3)
Because Nebraska Attorney General Doug Peterson limited his opinion to the two named medications, ivermectin and hydroxychloroquine, this article will do the same. Most of the information in this article comes from the Nebraska AG Opinion. Quotations (unless otherwise noted) and page numbers refer to the Nebraska AG Opinion. https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf
“Health care providers do not violate the standard of care when they ‘select between two reasonable approaches to…medicine.’” Physicians may utilize reasonable “investigative or unproven therapies” that reflect a reasonable approach to medicine. (page 5)
Prescribing medicines for off label use (for some purpose other than the use approved by the FDA) often falls within the standard of care. “Off-label use is legal, common, and necessary.” (page 5)
- Ivermectin (IVM)
Researchers discovered ivermectin in the 1970s. Although its first use was to treat animals for parasites, ivermectin has been used in humans since the 1980s. (page 8)
Ivermectin has a strong track record for humans. Ivermectin has long been “approved as an antiparasitic” by the World Health Organization (WHO) and the Food and Drug Administration (FDA). “The WHO has also recognized ivermectin as one of its ‘Essential Medicines.’” A review summarized the “antiviral effects of ivermectin” which were demonstrated through studies over the last 50 years! Doctors have been using ivermectin to treat humans for “rosacea, a chronic inflammatory disease.” Additionally, ivermectin has been found useful for “treating inflammatory airway diseases” in humans. (page 9)
For over three decades, Ivermectin has shown itself to be very safe in humans. The National Institutes of Health (NIH) recognize that “ivermectin has been widely used and is generally well tolerated.” The largest reported side effects include skin issues, headaches, dizziness, and nausea in humans. The number of adverse side effects is very small. There have been only 5,674 drug reactions (as reported on VigiAccess) with ivermectin out of “more than 3.7 billion doses” of ivermectin administered to humans since the 1980s (over 30 years)! Ivermectin has been used without serious adverse effects in multiple COVID-19 studies in humans. (pages 10-11)
The American Journal of Therapeutics provides this information:
“With total doses of ivermectin distributed apparently equaling one-third of the present world population, ivermectin at the usual doses (0.2–0.4 mg/kg) is considered extremely safe for use in humans. In addition to its antiparasitic activity, it has been noted to have antiviral and anti-inflammatory properties, leading to an increasing list of therapeutic indications.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248252/
***Ivermectin must be prescribed based on the patient’s weight. The usual dose is 0.2-0.4 mg/kg. For a 200-lb. human (90.7 kg), this translates to 18 mg/day (at 0.2 mg/kg) to 36 mg/day (at 0.4 mg/kg). Ivermectin for humans comes in capsule form; a typical dosage for a 200-lb. human would be three 6 mg capsules per day (18 mg/day) for 5 to 7 days.
Ivermectin has been used successfully for many years to treat animals (especially horses and cows) for parasites. The FDA has purposely tried to mislead people into thinking ivermectin is intended only for animals and not for humans. “The FDA’s most controversial statement on ivermectin came on August 21, 2021, when it posted a link on Twitter to its ‘Why You Should Not Use Ivermectin’ webpage with this message: ‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’” (page 23)
Because ivermectin is hard to purchase from pharmacies, some people are buying ivermectin from farm and veterinary supply stores. Ivermectin for animals typically comes as a liquid or paste. It is very difficult to monitor the amount of ivermectin you are getting from a liquid or paste. For this reason, medical professionals strongly urge people to avoid the animal versions of ivermectin.
Compare the safety record of ivermectin to remdesivir. Remdesivir was released for COVID treatment in 2020. In that short period of time, remdesivir has racked up 7,491 adverse drug reactions! This includes over 560 deaths, 550 serious cardiac disorders, and 475 acute kidney injuries! In spite of that poor safety record, remdesivir retains an FDA approval! (page 11)
How effective is ivermectin in treating patients for COVID? Randomized controlled trials (RCTs) are considered the gold standard in medicine, but they cannot always be used in the middle of a pandemic. One analysis (the Bryant review) focused on 24 total RCTs. This analysis showed “a 49 % reduction in mortality in favor of ivermectin.” It concluded that “the apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally!” (pages 14 and 36)
What is the federal government’s position on ivermectin? The NIH has adopted a neutral position on ivermectin for treating COVID-19 (adopted in January 2021). Other agencies within the NIH ignored NIH’s official position. On August 29, 2021, Dr. Anthony Fauci “announced that ‘there is no clinical evidence’ that ivermectin works for the prevention or treatment of COVID-19.” (page 20)
The FDA has also issued confusing messages. In March 2021, the FDA posted a webpage entitled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” There was no basis for its sweeping condemnation. Yet the FDA acknowledged on that webpage that the agency had not even “reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19.” The FDA announced that “taking a drug for an unapproved use can be very dangerous,” and “this is true of ivermectin.” This FDA statement deliberately tries to lead the public to the conclusion that ivermectin is a dangerous drug which is absolutely bogus according to medical science. (page 21)
On September 3, 2021, the FDA changed a sentence on the “Why You Should Not Use Ivermectin” webpage to say, “’If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.’” “This change implicitly acknowledges that ivermectin may be prescribed off-label for COVID-19.” (page 24)
The CDC has followed in the FDA’s footsteps of implying that ivermectin is unsafe. Yet, the CDC “supplies no data to indicate that human ivermectin in appropriate doses is harming anyone.” (page 24)
- Hydroxychloroquine (HCQ)
Hydroxychloroquine was first developed in 1946 and approved by the FDA in 1955. (Hydroxychloroquine is a less toxic derivative of a medicine named chloroquine.) Since that time, HCQ has been widely used to treat malaria. It has also been proven to be effective in treating autoimmune diseases like lupus and rheumatoid arthritis. HCQ’s success in treating these autoimmune diseases results from its anti-inflammatory and immunomodulatory effects. (page 31)
Millions of HCQ doses are prescribed annually. In just one year (2019), HCQ was prescribed over 5.4 million times! HCQ is widely accepted in the medical community and is considered safe, so safe that it is prescribed for pregnant women and children of all ages! (page 31)
Early in the pandemic, the reputation of hydroxychloroquine (HCQ) was irreparably damaged by a bogus article in a leading medical journal. On May 20, 2020, the Lancet published a paper denouncing HCQ as dangerous. Naturally, this caught the attention of doctors and medical boards across the country. There was just one problem -- the reported statistics were so flawed that researchers became concerned. After one of the authors refused to provide the analyzed data, the paper was retracted (just two weeks after its publication). Lancet’s Editor in Chief (Dr. Richard Horton) admitted that the paper was a “fabrication,” a monumental fraud.” (pages 2 and 39-41
When fraudulent information is published in a prominent medical journal, it leads to skepticism among physicians and the public. Unfortunately, the Lancet’s retraction is similar to a newspaper retraction; the damage had already been done! The Guardian declared that “given the seriousness of the topic and the consequences of the paper, this [was] one of the most consequential retractions in modern history!” (page 40)
The Nebraska AG made it clear that he is limiting the discussion of HCQ to its use as a prophylaxis (preventive) as well as for early treatment of COVID in outpatients. Thereby, the AG’s opinion excludes the use of HCQ for a late treatment in hospitalized patients. (page 41)
Is hydroxychloroquine effective in treating COVID-19? At the outset of the COVID pandemic, researchers found that:
…hydroxychloroquine “can inhibit [SARS-CoV-2] virus entry, transmission, and replication.” In addition to this “antiviral activity,” hydroxychloroquine also has “anti-inflammatory properties” that help regulate “pro inflammatory cytokines.” These characteristics – both the antiviral properties and the anti-inflammatory activity – are important countermeasures against COVID-19. (page 33)
Numerous large observational studies demonstrate that hydroxychloroquine significantly reduces the risk of hospitalization and death when administered to outpatients – as part of the early COVID treatment. (page 33)
What is the federal government’s position on HCQ? At the beginning of the COVID pandemic, the FDA stated HCQ has “a well-established profile” for malaria, lupus, and rheumatoid arthritis. The CDC stated that HCQ use was associated with minor issues such as “stomach pain, nausea, and vomiting.” The CDC’s guidance does not mention any cardiac disorders resulting from the drug. (page 32)
The FDA raised questions about hydroxychloroquine and adverse cardiac events. When scholars searched the safety literature pre-COVID, they found that people taking the medication in appropriate doses “are at very low risk of experiencing cardiac [adverse events], particularly with short term administration of the drug.” Heart issues from HCQ only occurred (infrequently) in patients who took dangerously high doses of the drug for many years on end. (page 38)
The FDA has questioned the safety and efficacy of HCQ. The FDA had earlier approved an Early Use Authorization (EUA) for hydroxychloroquine on March 28, 2020. When the FDA revoked the EUA on June 15, 2020, the FDA stated that it no longer “believes that the oral formulations of [hydroxychloroquine] may be effective in treating COVID-19.” (page 42)
Unfortunately, the FDA ignored the distinction between non-hospitalized patients and hospitalized patients. Expert doctors and epidemiologists have always supported the use of HCQ for outpatients in the early stages of COVID and never for late-stage COVID hospitalized patients. (page 42)
CONCLUSION
Can physicians prescribe ivermectin and hydroxychloroquine to treat patients for COVID? The answer is provided here:
And the U. S. Supreme Court, in an analogous context, has affirmed that “’off-label’ usage of medical devices” is an “accepted and necessary” practice. Even the FDA recognizes that off-label use is legitimate: it has said for many decades that once it approves a drug, “a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.” Expanding on that point, the FDA has explained that “health care providers generally may prescribe [a] drug for an unapproved use when they judge that it is medically appropriate for their patient.” (page 6)
In simple terms, physicians and healthcare providers can legally prescribe ivermectin and hydroxychloroquine to treat their patients for COVID!
#######
1.31.22
“Should Doctors Prescribe Ivermectin and Hydroxychloroquine for Treating COVID-19 in Patients?”
By Henry W. Burke, resident of Nebraska
[COMMENTS FROM DONNA GARNER: This is a super paper because the author, who is a Nebraska resident himself, has taken the time to delve deeply into his Nebraska Attorney General Douglas J. Peterson’s supportive documentation which is full of the latest, “authentic” medical science. The AG’s report clearly proves that hydroxychloroquine and ivermectin can and should be prescribed for early use against COVID.
Now states all across the country and the general public have a factual, scientifically based source from which they can draw critical information that can save millions of lives.
The good thing is that Henry Burke has done the work for us by pointing out in his short and easy-to-understand article the most important facets of the AG’s report and has given the page numbers for corroboration. The official link to the AG’s report is included toward the top of the article.]
=========================
BY HENRY W. BURKE
In Nebraska, doctors can legally prescribe hydroxychloroquine and ivermectin without having their medical licenses revoked.
Because the Nebraska Medical Boards are accountable to the Nebraska Attorney General (AG), the Boards cannot revoke the doctors’ licenses without the Attorney General’s consent.
On October 14, 2021, Nebraska Attorney General Douglas J. Peterson issued an opinion on the prescription of ivermectin (IVM) and hydroxychloroquine (HCQ) by a licensed health care provider for the treatment of COVID-19. This opinion was written in response to a request from Dannette R. Smith, CEO of Nebraska Department of Health and Human Services (HHS). CEO Smith specifically asked if IVM and HCQ (or other “off label” medications) could be legally prescribed (after obtaining informed consent) by a health care provider for the treatment or prevention of COVID-19. (page 1)
PLEASE READ THE NEBRASKA AG’S OPINION HERE: https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf
Nebraska Attorney General Doug Peterson concluded:
“Based on available data, we do not find clear and convincing evidence that a physician who first obtains informed consent and then utilizes ivermectin or hydroxychloroquine for COVID-19 violates the UCA [Uniform Credentialing Act]. This conclusion is subject to the limits noted throughout this opinion.
Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained healthcare system.” (page 47)
The Nebraska Attorney General stated the following in the body of his opinion:
“In the end, as we explain below, we find that the available data does not justify filing disciplinary actions against physicians simply because they prescribe ivermectin or hydroxychloroquine to prevent or treat COVID-19.” (page 3)
In order to respond to the Nebraska HHS CEO in a timely manner, the Nebraska Attorney General confined the discussion to ivermectin and hydroxychloroquine only. This means the other “off label” medications were not addressed in the AG analysis. (page 3)
Because Nebraska Attorney General Doug Peterson limited his opinion to the two named medications, ivermectin and hydroxychloroquine, this article will do the same. Most of the information in this article comes from the Nebraska AG Opinion. Quotations (unless otherwise noted) and page numbers refer to the Nebraska AG Opinion. https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf
“Health care providers do not violate the standard of care when they ‘select between two reasonable approaches to…medicine.’” Physicians may utilize reasonable “investigative or unproven therapies” that reflect a reasonable approach to medicine. (page 5)
Prescribing medicines for off label use (for some purpose other than the use approved by the FDA) often falls within the standard of care. “Off-label use is legal, common, and necessary.” (page 5)
Researchers discovered ivermectin in the 1970s. Although its first use was to treat animals for parasites, ivermectin has been used in humans since the 1980s. (page 8)
Ivermectin has a strong track record for humans. Ivermectin has long been “approved as an antiparasitic” by the World Health Organization (WHO) and the Food and Drug Administration (FDA). “The WHO has also recognized ivermectin as one of its ‘Essential Medicines.’” A review summarized the “antiviral effects of ivermectin” which were demonstrated through studies over the last 50 years! Doctors have been using ivermectin to treat humans for “rosacea, a chronic inflammatory disease.” Additionally, ivermectin has been found useful for “treating inflammatory airway diseases” in humans. (page 9)
For over three decades, Ivermectin has shown itself to be very safe in humans. The National Institutes of Health (NIH) recognize that “ivermectin has been widely used and is generally well tolerated.” The largest reported side effects include skin issues, headaches, dizziness, and nausea in humans. The number of adverse side effects is very small. There have been only 5,674 drug reactions (as reported on VigiAccess) with ivermectin out of “more than 3.7 billion doses” of ivermectin administered to humans since the 1980s (over 30 years)! Ivermectin has been used without serious adverse effects in multiple COVID-19 studies in humans. (pages 10-11)
The American Journal of Therapeutics provides this information:
“With total doses of ivermectin distributed apparently equaling one-third of the present world population, ivermectin at the usual doses (0.2–0.4 mg/kg) is considered extremely safe for use in humans. In addition to its antiparasitic activity, it has been noted to have antiviral and anti-inflammatory properties, leading to an increasing list of therapeutic indications.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248252/
***Ivermectin must be prescribed based on the patient’s weight. The usual dose is 0.2-0.4 mg/kg. For a 200-lb. human (90.7 kg), this translates to 18 mg/day (at 0.2 mg/kg) to 36 mg/day (at 0.4 mg/kg). Ivermectin for humans comes in capsule form; a typical dosage for a 200-lb. human would be three 6 mg capsules per day (18 mg/day) for 5 to 7 days.
Ivermectin has been used successfully for many years to treat animals (especially horses and cows) for parasites. The FDA has purposely tried to mislead people into thinking ivermectin is intended only for animals and not for humans. “The FDA’s most controversial statement on ivermectin came on August 21, 2021, when it posted a link on Twitter to its ‘Why You Should Not Use Ivermectin’ webpage with this message: ‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’” (page 23)
Because ivermectin is hard to purchase from pharmacies, some people are buying ivermectin from farm and veterinary supply stores. Ivermectin for animals typically comes as a liquid or paste. It is very difficult to monitor the amount of ivermectin you are getting from a liquid or paste. For this reason, medical professionals strongly urge people to avoid the animal versions of ivermectin.
Compare the safety record of ivermectin to remdesivir. Remdesivir was released for COVID treatment in 2020. In that short period of time, remdesivir has racked up 7,491 adverse drug reactions! This includes over 560 deaths, 550 serious cardiac disorders, and 475 acute kidney injuries! In spite of that poor safety record, remdesivir retains an FDA approval! (page 11)
How effective is ivermectin in treating patients for COVID? Randomized controlled trials (RCTs) are considered the gold standard in medicine, but they cannot always be used in the middle of a pandemic. One analysis (the Bryant review) focused on 24 total RCTs. This analysis showed “a 49 % reduction in mortality in favor of ivermectin.” It concluded that “the apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally!” (pages 14 and 36)
What is the federal government’s position on ivermectin? The NIH has adopted a neutral position on ivermectin for treating COVID-19 (adopted in January 2021). Other agencies within the NIH ignored NIH’s official position. On August 29, 2021, Dr. Anthony Fauci “announced that ‘there is no clinical evidence’ that ivermectin works for the prevention or treatment of COVID-19.” (page 20)
The FDA has also issued confusing messages. In March 2021, the FDA posted a webpage entitled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” There was no basis for its sweeping condemnation. Yet the FDA acknowledged on that webpage that the agency had not even “reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19.” The FDA announced that “taking a drug for an unapproved use can be very dangerous,” and “this is true of ivermectin.” This FDA statement deliberately tries to lead the public to the conclusion that ivermectin is a dangerous drug which is absolutely bogus according to medical science. (page 21)
On September 3, 2021, the FDA changed a sentence on the “Why You Should Not Use Ivermectin” webpage to say, “’If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.’” “This change implicitly acknowledges that ivermectin may be prescribed off-label for COVID-19.” (page 24)
The CDC has followed in the FDA’s footsteps of implying that ivermectin is unsafe. Yet, the CDC “supplies no data to indicate that human ivermectin in appropriate doses is harming anyone.” (page 24)
Hydroxychloroquine was first developed in 1946 and approved by the FDA in 1955. (Hydroxychloroquine is a less toxic derivative of a medicine named chloroquine.) Since that time, HCQ has been widely used to treat malaria. It has also been proven to be effective in treating autoimmune diseases like lupus and rheumatoid arthritis. HCQ’s success in treating these autoimmune diseases results from its anti-inflammatory and immunomodulatory effects. (page 31)
Millions of HCQ doses are prescribed annually. In just one year (2019), HCQ was prescribed over 5.4 million times! HCQ is widely accepted in the medical community and is considered safe, so safe that it is prescribed for pregnant women and children of all ages! (page 31)
Early in the pandemic, the reputation of hydroxychloroquine (HCQ) was irreparably damaged by a bogus article in a leading medical journal. On May 20, 2020, the Lancet published a paper denouncing HCQ as dangerous. Naturally, this caught the attention of doctors and medical boards across the country. There was just one problem -- the reported statistics were so flawed that researchers became concerned. After one of the authors refused to provide the analyzed data, the paper was retracted (just two weeks after its publication). Lancet’s Editor in Chief (Dr. Richard Horton) admitted that the paper was a “fabrication,” a monumental fraud.” (pages 2 and 39-41
When fraudulent information is published in a prominent medical journal, it leads to skepticism among physicians and the public. Unfortunately, the Lancet’s retraction is similar to a newspaper retraction; the damage had already been done! The Guardian declared that “given the seriousness of the topic and the consequences of the paper, this [was] one of the most consequential retractions in modern history!” (page 40)
The Nebraska AG made it clear that he is limiting the discussion of HCQ to its use as a prophylaxis (preventive) as well as for early treatment of COVID in outpatients. Thereby, the AG’s opinion excludes the use of HCQ for a late treatment in hospitalized patients. (page 41)
Is hydroxychloroquine effective in treating COVID-19? At the outset of the COVID pandemic, researchers found that:
…hydroxychloroquine “can inhibit [SARS-CoV-2] virus entry, transmission, and replication.” In addition to this “antiviral activity,” hydroxychloroquine also has “anti-inflammatory properties” that help regulate “pro inflammatory cytokines.” These characteristics – both the antiviral properties and the anti-inflammatory activity – are important countermeasures against COVID-19. (page 33)
Numerous large observational studies demonstrate that hydroxychloroquine significantly reduces the risk of hospitalization and death when administered to outpatients – as part of the early COVID treatment. (page 33)
What is the federal government’s position on HCQ? At the beginning of the COVID pandemic, the FDA stated HCQ has “a well-established profile” for malaria, lupus, and rheumatoid arthritis. The CDC stated that HCQ use was associated with minor issues such as “stomach pain, nausea, and vomiting.” The CDC’s guidance does not mention any cardiac disorders resulting from the drug. (page 32)
The FDA raised questions about hydroxychloroquine and adverse cardiac events. When scholars searched the safety literature pre-COVID, they found that people taking the medication in appropriate doses “are at very low risk of experiencing cardiac [adverse events], particularly with short term administration of the drug.” Heart issues from HCQ only occurred (infrequently) in patients who took dangerously high doses of the drug for many years on end. (page 38)
The FDA has questioned the safety and efficacy of HCQ. The FDA had earlier approved an Early Use Authorization (EUA) for hydroxychloroquine on March 28, 2020. When the FDA revoked the EUA on June 15, 2020, the FDA stated that it no longer “believes that the oral formulations of [hydroxychloroquine] may be effective in treating COVID-19.” (page 42)
Unfortunately, the FDA ignored the distinction between non-hospitalized patients and hospitalized patients. Expert doctors and epidemiologists have always supported the use of HCQ for outpatients in the early stages of COVID and never for late-stage COVID hospitalized patients. (page 42)
CONCLUSION
Can physicians prescribe ivermectin and hydroxychloroquine to treat patients for COVID? The answer is provided here:
And the U. S. Supreme Court, in an analogous context, has affirmed that “’off-label’ usage of medical devices” is an “accepted and necessary” practice. Even the FDA recognizes that off-label use is legitimate: it has said for many decades that once it approves a drug, “a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.” Expanding on that point, the FDA has explained that “health care providers generally may prescribe [a] drug for an unapproved use when they judge that it is medically appropriate for their patient.” (page 6)
In simple terms, physicians and healthcare providers can legally prescribe ivermectin and hydroxychloroquine to treat their patients for COVID!
#######