``````````````````````````````````````````````````````````````````

 We write with grave concern that too many are being distracted by the ardent advocacy of our Yale colleague, Dr. Harvey Risch, to promote the assertion that hydroxychloroquine (HCQ) when given with antibiotics is effective in treating COVID-19, in particular as an early therapeutic intervention for the disease. As his colleagues, we defend the right of Dr. Risch, a respected cancer epidemiologist, to voice his opinions. But he is not an expert in infectious disease epidemiology and he has not been swayed by the body of scientific evidence from rigorously conducted clinical trials, which refute the plausibility of his belief and arguments.

 

august

 Over the last few weeks, all of us have spent considerable time explaining the evidence behind HCQ research, as it applies to early and late stage COVID-19 patients to the scientific community and general public, and now are compelled to detail the evidence in this open letter.

 We are seriously alarmed for the safety of patients and the coherence and effectiveness of our national COVID-19 emergency response when misinformation about HCQ is spread and when rigorous scientific evidence and consensus produced by the community of expert researchers in infectious diseases, federal agencies and national and global health organizations are not heeded. Let us be clear: we are unanimous in our desire to see the development of therapies to treat COVID-19 and to prevent the transmission or acquisition of SARS-CoV-2. If HCQ was shown to be effective, even among subgroups of patients with COVID-19 in ongoing high quality trials, we would join our colleagues in promoting access to it for all who need it. However, the evidence thus far has been unambiguous in refuting the premise that HCQ is a potentially effective early therapy for COVID-19.

 HCQ is used for the treatment of rheumatological diseases, such as lupus and rheumatoid arthritis. However, this does not ensure that the drug will be safe in patients with COVID-19 or in widespread use to treat early illness. In fact, rigorously-conducted clinical trials have found that HCQ is not effective as an early prophylactic therapy in preventing illness due to COVID-19 in people exposed to the virus.

 Furthermore, HCQ, alone or together with the antibiotic, azithromycin, has not been shown to be effective in improving the clinical status of patients with COVID-19. Moreover, clinical trials have found that treatment with HCQ may be associated with increased risk of adverse reactions. Taken together, the scientific evidence does not support the widespread use of this drug, alone or in combination with an antibiotic, as advocated by Dr. Risch and others, unless rigorous evidence from clinical trials demonstrates otherwise.

 Finally, we point to the recent memorandum from the US Food and Drug Administration revoking the Emergency Use Authorization for HCQ that has assembled the data on the drug as of June 2020 (Food and Drug Administration Memorandum Explaining Basis for Revocation of Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate). The Infectious diseases Society of America now advises against the drug alone or in combination with azithromycin in the setting of COVID-19 except in the context of ongoing clinical studies. If these trials do show a clinical benefit for HCQ, we would revise our views on its use in the management of COVID-19.

 The disproportionate focus on treatment with HCQ, in addition to the lack of a strong scientific rationale for its use and the risk of its potentially harmful effects, has major opportunity costs. In a recent analysis of COVID-19 clinical trials, one in every six studies of treatments against SARSCoV-2 was designed to study HCQ or chloroquine. We understand the desperation of many to see an effective treatment for COVID-19 emerge that will stop the pandemic in its tracks or slow its relentless spread in the US. But investing our resources in HCQ after multiple studies have not shown it to be effective for COVID-19 has serious implications for more than just individual patients.

The continuing advocacy on behalf of HCQ distracts us from advancing the science on COVID-19 and seeking more effective interventions in a time when more than 1000 people are dying per day of this disease. There are multiple approaches to expedite the evaluation and approval of drugs for serious and life-threatening diseases in the US that have existed for decades now, but they all still rely on data from rigorous, well-conducted clinical trials to guide us. In addition, this ongoing promotion of HCQ has global implications as well, as many countries in the global South only have access to HCQ and use of HCQ is still common in this setting despite the lack of evidence and potential risks.

 

It is critical that we follow the science and where the evidence leads us on a quest to treat and prevent COVID-19. In this climate, it’s important to rely on the data above all else when making clinical or regulatory decisions.






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Information Shared by: MSViewsandNews
to and for those affected by Multiple Sclerosis
::::::::::::::::::::::::::::::::::::::;;;;;;;;;;;;;;;;;;;;;:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::


Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews
august

``````````````````````````````````````````````````````````````````

 We write with grave concern that too many are being distracted by the ardent advocacy of our Yale colleague, Dr. Harvey Risch, to promote the assertion that hydroxychloroquine (HCQ) when given with antibiotics is effective in treating COVID-19, in particular as an early therapeutic intervention for the disease. As his colleagues, we defend the right of Dr. Risch, a respected cancer epidemiologist, to voice his opinions. But he is not an expert in infectious disease epidemiology and he has not been swayed by the body of scientific evidence from rigorously conducted clinical trials, which refute the plausibility of his belief and arguments.

 

august

 Over the last few weeks, all of us have spent considerable time explaining the evidence behind HCQ research, as it applies to early and late stage COVID-19 patients to the scientific community and general public, and now are compelled to detail the evidence in this open letter.

 We are seriously alarmed for the safety of patients and the coherence and effectiveness of our national COVID-19 emergency response when misinformation about HCQ is spread and when rigorous scientific evidence and consensus produced by the community of expert researchers in infectious diseases, federal agencies and national and global health organizations are not heeded. Let us be clear: we are unanimous in our desire to see the development of therapies to treat COVID-19 and to prevent the transmission or acquisition of SARS-CoV-2. If HCQ was shown to be effective, even among subgroups of patients with COVID-19 in ongoing high quality trials, we would join our colleagues in promoting access to it for all who need it. However, the evidence thus far has been unambiguous in refuting the premise that HCQ is a potentially effective early therapy for COVID-19.

 HCQ is used for the treatment of rheumatological diseases, such as lupus and rheumatoid arthritis. However, this does not ensure that the drug will be safe in patients with COVID-19 or in widespread use to treat early illness. In fact, rigorously-conducted clinical trials have found that HCQ is not effective as an early prophylactic therapy in preventing illness due to COVID-19 in people exposed to the virus.

 Furthermore, HCQ, alone or together with the antibiotic, azithromycin, has not been shown to be effective in improving the clinical status of patients with COVID-19. Moreover, clinical trials have found that treatment with HCQ may be associated with increased risk of adverse reactions. Taken together, the scientific evidence does not support the widespread use of this drug, alone or in combination with an antibiotic, as advocated by Dr. Risch and others, unless rigorous evidence from clinical trials demonstrates otherwise.

 Finally, we point to the recent memorandum from the US Food and Drug Administration revoking the Emergency Use Authorization for HCQ that has assembled the data on the drug as of June 2020 (Food and Drug Administration Memorandum Explaining Basis for Revocation of Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate). The Infectious diseases Society of America now advises against the drug alone or in combination with azithromycin in the setting of COVID-19 except in the context of ongoing clinical studies. If these trials do show a clinical benefit for HCQ, we would revise our views on its use in the management of COVID-19.

 The disproportionate focus on treatment with HCQ, in addition to the lack of a strong scientific rationale for its use and the risk of its potentially harmful effects, has major opportunity costs. In a recent analysis of COVID-19 clinical trials, one in every six studies of treatments against SARSCoV-2 was designed to study HCQ or chloroquine. We understand the desperation of many to see an effective treatment for COVID-19 emerge that will stop the pandemic in its tracks or slow its relentless spread in the US. But investing our resources in HCQ after multiple studies have not shown it to be effective for COVID-19 has serious implications for more than just individual patients.

The continuing advocacy on behalf of HCQ distracts us from advancing the science on COVID-19 and seeking more effective interventions in a time when more than 1000 people are dying per day of this disease. There are multiple approaches to expedite the evaluation and approval of drugs for serious and life-threatening diseases in the US that have existed for decades now, but they all still rely on data from rigorous, well-conducted clinical trials to guide us. In addition, this ongoing promotion of HCQ has global implications as well, as many countries in the global South only have access to HCQ and use of HCQ is still common in this setting despite the lack of evidence and potential risks.

 

It is critical that we follow the science and where the evidence leads us on a quest to treat and prevent COVID-19. In this climate, it’s important to rely on the data above all else when making clinical or regulatory decisions.






::::::::::::::::::::::::::::::::::::::;;;;;;;;;;;;;;;;;;;;;::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Information Shared by: MSViewsandNews
to and for those affected by Multiple Sclerosis
::::::::::::::::::::::::::::::::::::::;;;;;;;;;;;;;;;;;;;;;:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::


Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews
august

Read full article on M.S. Views & News



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