50 signatures reached
To: Governor Andrew Cuomo
Repeal NYS Executive Order 202.10 Hindering Use of HCQ
Rescind the section of the Executive Order which prohibits pharmacies from dispensing Hydroxychloroquine (HCQ).
Why is this important?
This concerns Governor Andrew Cuomo’s Executive Order 202.10 dated March 7, 2020 which prohibited pharmacies from dispensing hydroxychloroquine (HCQ) “except when written as prescribed for a FDA approved indication or as part of state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted and any permitted prescription is limited to one fourteen day prescription with no refills”. 1 However, there is evidence that indicate a benefit to SAR-CoV-2 (COVID-19) patients who have been given HCQ in the early stages of the illness.
In April 20, 2020, Congressional Research Service created a document for Members and Committees of Congress which indicated that the “FDA has authorized the emergency use of two drugs: hydroxychloroquine sulfate (“hydroxylchloroquine”) and chloroquine phosphate (“chloroquine”). The agency has determined that based on the totality of scientific evidence, “it is reasonable to believe that [chloroquine] and [hydroxychloroquine] may be effective in treating COVID-19,” and that when used in accord with the conditions of the emergency use authorization (EUA), the known and potential benefits outweigh the known and potential risks of these drugs.”2 If these are called “unprecedented times” we are living, why is Governor Cuomo limiting our healthcare choices to fight against COVID-19 without hospitalization? The Trickett Wender, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 authorized the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State Law and for other purposes.3 Didn’t Governor Cuomo state “people will die” numerous times? In this document you also have stakeholders who find the use of HCQ as “anectodal and that expanding access may jeopardize research into the drug”. 4
Attached is compendium of peer-reviewed evidence indexed in the PubMed, “Sequential CQ/HCQ Research Papers and Reports”, which states “the HCQ-AZ combination, when started immediately after diagnosis, appears to be a safe and efficient treatment for COVID-19, with a mortality rate of 0.5%, in elderly patients. It avoids worsening and clears virus persistence and contagious infectivity in most cases.”5 In addition, a 2004 research paper titled “In vitro inhibition of severe acute respiratory syndrome coronavirus by chloroquine” 6, and 2005 research paper in the Virology Journal titled “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread” 7 supports that CQ does help stop the progression of SARS-CoV.
A Monroe NY physician caused some controversy, Dr. Vlamidir Zelenko, by publicizing his positive patient results on YouTube about his COVID-19 regimen using (HCQ-Zn-Azithromycin [AZ]) for only five days. These things cannot be ignored. Perhaps his results should have been documented better but aren’t these “unprecedented times”. Here is a solution, without violating HIPPA rules, when a physician electronically sends a prescription to a pharmacy on a COVID-19 positive patient, have a dataset which captures the prescription and generate a number prefix by the physician office number. Thereby, not violating HIPPA and stats can be generated. A follow-up by the physician office should be done after five days to see how the patient is doing. The follow-up must be documented in the patient electronic file that will populate the dataset.
Example of a separate dataset that can be incorporated when necessary:
SARS-CoV-2 Results
HCQ Requested by Patient
HCQ Prescibed
HCQ Waiver Form Signed
Follow Up After 5 days
Pos ☐ Neg☐
Yes ☐ No ☐
Yes☐ No☐
Yes ☐ N/A☐
Improved ☐
Required Hospitization☐
Didn't Improve ☐
Death☐
This isn’t suggesting that all COVID-19 positive patients be mandated to receive HCQ, but if the patient “wants to try” that option should not be denied. Every FDA approve drug has side effects and they are allowed to be sold with a disclosure. If litigation is a concern have the patient sign a waiver.
Based on this evidence presented a request that Governor Cuomo rescind that part of the Executive Order limiting the use of HCQ and further order administrative agencies not impose any requirements on the prescription of HCQ intended to treat the coronavirus illness that do not apply equally to all approved medications that may be used off-label for any purpose.
1State of New York from the Executive Chamber, Executive Order 202.10, March 7, 2020
2,4Congressional Research Services, “Treatment of COVID-19: Hydroxylcloroquine and Chloroquine”, https://crsreports.congress.gov, April 20, 2020
3Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, January 3, 2018
5PubMed, “Sequential CQ/HCQ Research Papers and Reports”, January to April 20, 2020
6 BBRC, “In vitro inhibition of severe acute respiratory syndrome coronavirus by chloroquine”, August 11, 2004
7Virology Journal, “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread”, July 12, 2005
In April 20, 2020, Congressional Research Service created a document for Members and Committees of Congress which indicated that the “FDA has authorized the emergency use of two drugs: hydroxychloroquine sulfate (“hydroxylchloroquine”) and chloroquine phosphate (“chloroquine”). The agency has determined that based on the totality of scientific evidence, “it is reasonable to believe that [chloroquine] and [hydroxychloroquine] may be effective in treating COVID-19,” and that when used in accord with the conditions of the emergency use authorization (EUA), the known and potential benefits outweigh the known and potential risks of these drugs.”2 If these are called “unprecedented times” we are living, why is Governor Cuomo limiting our healthcare choices to fight against COVID-19 without hospitalization? The Trickett Wender, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 authorized the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State Law and for other purposes.3 Didn’t Governor Cuomo state “people will die” numerous times? In this document you also have stakeholders who find the use of HCQ as “anectodal and that expanding access may jeopardize research into the drug”. 4
Attached is compendium of peer-reviewed evidence indexed in the PubMed, “Sequential CQ/HCQ Research Papers and Reports”, which states “the HCQ-AZ combination, when started immediately after diagnosis, appears to be a safe and efficient treatment for COVID-19, with a mortality rate of 0.5%, in elderly patients. It avoids worsening and clears virus persistence and contagious infectivity in most cases.”5 In addition, a 2004 research paper titled “In vitro inhibition of severe acute respiratory syndrome coronavirus by chloroquine” 6, and 2005 research paper in the Virology Journal titled “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread” 7 supports that CQ does help stop the progression of SARS-CoV.
A Monroe NY physician caused some controversy, Dr. Vlamidir Zelenko, by publicizing his positive patient results on YouTube about his COVID-19 regimen using (HCQ-Zn-Azithromycin [AZ]) for only five days. These things cannot be ignored. Perhaps his results should have been documented better but aren’t these “unprecedented times”. Here is a solution, without violating HIPPA rules, when a physician electronically sends a prescription to a pharmacy on a COVID-19 positive patient, have a dataset which captures the prescription and generate a number prefix by the physician office number. Thereby, not violating HIPPA and stats can be generated. A follow-up by the physician office should be done after five days to see how the patient is doing. The follow-up must be documented in the patient electronic file that will populate the dataset.
Example of a separate dataset that can be incorporated when necessary:
SARS-CoV-2 Results
HCQ Requested by Patient
HCQ Prescibed
HCQ Waiver Form Signed
Follow Up After 5 days
Pos ☐ Neg☐
Yes ☐ No ☐
Yes☐ No☐
Yes ☐ N/A☐
Improved ☐
Required Hospitization☐
Didn't Improve ☐
Death☐
This isn’t suggesting that all COVID-19 positive patients be mandated to receive HCQ, but if the patient “wants to try” that option should not be denied. Every FDA approve drug has side effects and they are allowed to be sold with a disclosure. If litigation is a concern have the patient sign a waiver.
Based on this evidence presented a request that Governor Cuomo rescind that part of the Executive Order limiting the use of HCQ and further order administrative agencies not impose any requirements on the prescription of HCQ intended to treat the coronavirus illness that do not apply equally to all approved medications that may be used off-label for any purpose.
1State of New York from the Executive Chamber, Executive Order 202.10, March 7, 2020
2,4Congressional Research Services, “Treatment of COVID-19: Hydroxylcloroquine and Chloroquine”, https://crsreports.congress.gov, April 20, 2020
3Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, January 3, 2018
5PubMed, “Sequential CQ/HCQ Research Papers and Reports”, January to April 20, 2020
6 BBRC, “In vitro inhibition of severe acute respiratory syndrome coronavirus by chloroquine”, August 11, 2004
7Virology Journal, “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread”, July 12, 2005