Tag: medicine

CHICAGO, IL – The American Medical Association (AMA), in a surprising move, has officially rescinded a previous statement against the use of Hydroxychloroquine (HCQ) in the treatment of COVID-19 patients, giving physicians the okay to return to utilizing the medication at their discretion.

Previously, the AMA had issued a statement in March that was highly critical of HCQ in regards to its use as a proposed treatment by some physicians in the early stages of COVID-19. In addition to discouraging doctors from ordering the medication in bulk for “off-label” use – HCQ is typically used to treat diseases such as malaria – they also claimed that there was no proof that it was effective in treating COVID, and that its use could be harmful in some instances.

However, on page 18 of a recent AMA memo, issued on October 30, (resolution 509, page 3) the organization officially reversed their stance on HCQ, stating that its potential for good currently may supersede the threat of any potential harmful side effects.

So, there we have it. HCQ could not be approved before the election, because President Trump had recommended it. Meanwhile, with an 8o +% reduced risk of having to be admitted to the hospital if administered with Azithromycin and Zinc as soon as testing positive or symptoms occurred, many (70000+) lives could have been saved.

It has come to my attention that the resolution, while adopted got stopped before a new and valid recommendation was issued. There are powerful interests in the AMA that want to keep things as they are rather than advance real medical science based on real results, and never admit a mistake. Meanwhile, people are dying because of lack of solid, but inexpensive medical solutions.

The recommendation is still up on their website, but should it disappear, here it is , the important part part.

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES

Resolution: 509 (November 2020)

Introduced by: Georgia

Subject:Hydroxychloroquine and Combination Therapies – Off-Label Use

Referred to:Reference Committee E

Whereas, SARS-CoV-2 is the novel coronavirus that causes COVID-19; and

2 Whereas, Three distinct stages of COVID-19 infection have been observed in some people who test positive for the disease and have variable degrees of symptoms as noted (1); and

Whereas, During the early infection phase (Stage 1), the virus multiplies inside the body and is likely to cause mild symptoms that may be confused with a common cold or flu; and

Whereas, The second phase is the pulmonary phase (Stage 2), when the Immune System becomes strongly affected by infection and leads to primarily respiratory symptoms such as persistent cough, shortness of breath and low oxygen levels. Problems with blood clotting–especially with the formation of blood clots–may be predominant in Stage 2; and

Whereas, The third hyperinflammatory phase (Stage 3), occurs when a hyperactivated immune system may cause injury to the heart, kidneys, and other organs. A “cytokine storm”–where the body attacks its own tissues–may occur in this phase; and

Whereas, There is no current Federal Drug Administration (FDA) indication for the treatment of Early Coronavirus infection, but early emergency use authorization (EUA) originally approved the use of hydroxychloroquine and then rescinded it (2); and

Whereas, The FDA limited use of convalescence plasma but now has rescinded that limitation (3); and

Whereas, Hydroxychloroquine and Chloroquine are FDA approved medications for over 50 years, and these medications are safely prescribed long-term for other indications (2); and

Whereas, AMA President, Patrice A. Harris, MD, issued the following statement: “The AMA is calling for a stop to any inappropriate prescribing and ordering of medications, including chloroquine or hydroxychloroquine, and appealing to physicians and all health care professionals to follow the highest standards of professionalism and ethics” (4); and

Whereas, The AMA, American Pharmacists Association, and American Society of Health System Pharmacists issued a joint statement on March 25, 2020 on inappropriate ordering, prescribing, or dispensing of medications to treat COVID-19 (4); and

Whereas, Some states, pharmacy boards and institutions have forbidden the use of these medications for COVID-19 infection (4, 5); and

Whereas, A proposed regimen to treat COVID-19 for Stage 1, includes 10 days of hydroxychloroquine, Azithromycin, zinc, and on occasion Vitamin D (6); and

Whereas, This regimen is not being advocated for Stage 2 and Stage 3 COVID therapy; and

Whereas, The original studies published in The Lancet and The New England Journal of Medicine(NEJM) initially citing harm due to hydroxychloroquine and chloroquine use were retracted by said journals due to dubious research methodology and incorrect conclusions (7, 8, 9); and

Whereas, AMA policy H-120.988, “Patient Access to Treatments Prescribed by Their Physicians,” supports a physician’s autonomy to prescribe medications the physician believes to be in the patient’s best interest, where the benefits outweigh risk and the patient consents; and

Whereas, Physicians have used off label medications for years and this use is supported by existing policy; and

Whereas, Data regarding harm have been limited due to poorly designed studies or studies usually in Stage 2 or later, or stopped without harm but no effect in phase 2 and hypothesis (7, 8, 9, 10, 11, 12); and

Whereas, There are many studies that indicate that the use of Hydroxychloroquine, Azithromycin is effective and front-line physicians are using the therapy where permissible (13, 14, 15); and

Whereas, The COVID-19 pandemic is a serious medical issue, people are dying, and physicians must be able to perform as sagacious prescribers; therefore be it

RESOLVED, That our American Medical Association rescind its statement calling for physicians to stop prescribing hydroxychloroquine and chloroquine until sufficient evidence becomes available to conclusively illustrate that the harm associated with use outweighs benefit early in the disease course. Implying that such treatment is inappropriate contradicts AMA Policy H-120.988, “Patient Access to Treatments Prescribed by Their Physicians,” that addresses off label prescriptions as appropriate in the judgement of the prescribing physician (Directive to Take Action); and be it further

RESOLVED, That our AMA rescind its joint statement with the American Pharmacists Association and American Society of Health System Pharmacists, and update it with a joint statement notifying patients that further studies are ongoing to clarify any potential benefit of hydroxychloroquine and combination therapies for the treatment of COVID-19 (Directive to Take Action); and be it further

RESOLVED, That our AMA reassure the patients whose physicians are prescribing 18 hydroxychloroquine and combination therapies for their early-stage COVID-19 diagnosis by issuing an updated statement clarifying our support for a physician’s ability to prescribe an FDA-approved medication for off label use, if it is in her/his best clinical judgement, with specific reference to the use of hydroxychloroquine and combination therapies for the treatment of the earliest stage of COVID-19 (Directive to Take Action); and be it further

RESOLVED, That our AMA take the actions necessary to require local pharmacies to fill valid prescriptions that are issued by physicians and consistent with AMA principles articulated in AMA Policy H-120.988, “Patient Access to Treatments Prescribed by Their Physicians,” including working with the American Pharmacists Association and American Society of Health System Pharmacists.

(Directive to Take Action) Fiscal Note: Modest – between $1,000 – $5,000

Received: 10/23/20

References:

1. Stages of COVID-19. https://emergencymedicinecases.com/covid-19-screening-diagnosis-management/

2. Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and

3. Recommendations for Investigational COVID-19 Convalescent Plasma. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma

4. “The A.M.A. is calling for a stop to any inappropriate prescribing and ordering of medications, including chloroquine or hydroxychloroquine, and appealing to physicians and all health care professionals to follow the highest standards of professionalism and ethics,” said AMA President Patrice A. Harris, MD. The American Medical Association, American Pharmacists Association, and American Society of Health System Pharmacists issued a joint statement on March 25, 2020 on inappropriate ordering, prescribing or dispensing of medications to treat COVID-19. https://www.ama-assn.org/system/files/2020-04/board-of-pharmacy-covid-19-prescribing.pdf

5. Pharmacy Practice New. Rosenthal M. Hydroxychloroquine: Where Pharmacy, Medicine and Politics Intersect, Pharmacy Practice News August 8, 2020

6. Risch H. Opinion: Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis Am J Epidemiol. 2020 May 27;kwaa093. doi: 10.1093/aje/kwaa093. Online ahead of print.

7. Piller C, Servick k. Two elite medical journals retract coronavirus papers over data integrity questions. https://www.sciencemag.org/news/2020/06/two-elite-medical-journals-retract-coronavirus-papers-over-data-integrity-questions#June 4, 2020

8. Lancet retraction website https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931180-6

9. NEJM Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI:

10.1056/NEJMoa2007621.

11. NIH halts clinical trial of hydroxychloroquine https://www.nih.gov/news-events/news-releases/nih-halts-clinical-trial-hydroxychloroquineResolution: 509 (November 2020) Page 4 of 6

12. Filippo Albani F, Fusina F , Giovannini A et al. Impact of Azithromycin and/or Hydroxychloroquine on Hospital Mortality in COVID-19. J. Clin. Med. 2020, 9, 2800; doi:10.3390/jcm9092800

13. Schwartz RA, Suskind RH DTH-9999-e13785 Azithromycin and COVID‐19Prompt Early Use at First Signs of this Infection in Adults and Children an Approach Worthy of Consideration. DTH-999-e13785 doi 10.1111/dth.13785

14. Meo SA, Klonoff DC, Akram J. Efficacy of chloroquine and hydroxychloroquine in the treatment of COVID-19 European Review for Medical and Pharmacological Sciences 2020; 24: 4539-4547

15. US ‘frontline’ doctors’ website exposes ‘criminal’ campaign by tech giants, govt agencies to block COVID med file:///C:/Users/JGoldman/Documents/Corona%20Virus/critique%20of%20HCQ/US%20%E2%80%98frontline%E2%80%99%20doctors%E2%80%99%20website%20exposes%20%E2%80%98criminal%E2%80%99%20campaign%20by%20tech%20giants,%20govt%20agencies%20to%20block%20COVID%20med%20_%20Blogs%20_%20Lifesitenews.html