Views: FDA and WHO Puppet of The Lancet, NEJM and such journals? The case of HCQ in COVID19

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by Anonymous Writer

Hydroxychloroquine (HCQ/CQ) is the first drug that was accepted by global scientific community as a possible treatment for COVID-19. Soon after many countries started to stockpile the drug and India in this situation distributed it to many countries. This is because India is biggest manufacturer in world and supplies it on cheaper price. One more drug Remedesvir was also proposed as cure but could not do well in clinical trials, however the case of HCQ is different because it could not get chance to complete the trial properly due to regulatory hurdles from time to time on the impressions of some journals. Let’s see the chronology of decision making and more we will discuss under conclusion.

On March 12, 2020 at 9:47am one TWITTER POST was written as “It was only with the Chinese experts’ encouragement that we agreed to perform a coronavirus test, James Cai said. When it came back positive, they recommended he be treated with the antimalarial medicine chloroquine and the HIV drug Kaletra. “Chinese experts suggest to treat with medicine to slow the virus first. Don’t wait,” he said. “Definitely I would not be here today [without them].” https://nypost.com/2020/03/12/new-jersey-patient-james-cai-recovering-from-coronavirus/

On March 14, 2020, one more post was tweeted by one self declared researcher suggesting HCQ as effective treatment and uploaded one google document (which is inaccessible now) to support the facts.

Todaro’s tweet identified Rigano as being affiliated with Johns Hopkins; Rigano’s LinkedIn profile says different. On further enquiries by WIRED, Johns Hopkins did not return a request for comment; a spokesperson for Stanford Medical School emails: “Stanford Medicine, including SPARK, wasn’t involved in the creation of the Google document, and we’ve requested that the author remove all references to us. In addition, Gregory Rigano is not an advisor with Stanford School of Medicine and no one at Stanford was involved in the study. In separate statement, Janet Diaz, head of clinical care for the World Health Organization Emergencies Program said “For chloroquine, there is no proof that that is an effective treatment at this time,”. “We recommend that therapeutics be tested under ethically approved clinical trials to show efficacy and safety.”
https://www.wired.com/story/an-old-malaria-drug-may-fight-covid-19-and-silicon-valleys-into-it/

On 16 Mar 2020, University of Queensland Centre for Clinical Research Director David Paterson told news.com.au that the two drugs, which were used in test tubes, stopped coronavirus in its tracks and a clinical trial on humans was ready to begin. One of the two medications is an HIV drug, and the other is an anti-malaria drug called chloroquine.
https://www.livemint.com/news/world/coronavirus-update-australian-researchers-claim-2-existing-drugs-could-cure-covid-19-11584369580246.html

On March 19, 2020, the researchers announced about a study on 30 confirmed COVID-19 patients in France whose results were published in the International Journal of Antimicrobial Agents. According to researchers, the study has found early evidence that the combination of hydroxychloroquine, a popular anti-malaria drug known under the trade name Plaqenuil, and antibiotic azithromycin (aka Zithromax or Azithrocin) could be especially effective in treating the COVID-19 coronavirus and reducing the duration of the virus in patients.
https://techcrunch.com/2020/03/19/french-study-finds-anti-malarial-and-antibiotic-combo-could-reduce-covid-19-duration/

On March 19, 2020, U.S. Food and Drug Administration Commissioner Stephen Hahn addressed the ongoing work of the agency in terms of its work on potential treatments and vaccines for the COVID-19 coronavirus. Despite a claim early in Thursday’s White House briefing on the pandemic by President Donald Trump that one proposed treatment, anti-malarial chloroquine, had already been approved by the FDA for COVID-19 treatment, Hahn said that in fact the agency is currently looking at widespread clinical trials of the drug, but it is not yet approved for that use. Another potential treatment which has shown signs of possible positive effect, remdesivir, was also cited by Trump as being very “near” approval for use by the FDA. Hahn also highlighted another experimental treatment possibility that the FDA is investigating: Using plasma derived from blood taken from coronavirus patients who have recovered, and injecting that into other patients in an attempt to potentially jump start their own immune response.

“In the short term, we’re looking at drugs that are already approved for other indications,” Dr. Hahn said.
It’s not a clinical study, however, and that means there are still a lot of unknowns when it comes to its use that just can’t be learned or asserted based on scattered, individual instances of compassionate care treatment.

“As the Commissioner of FDA and the president mentioned, we’re trying to strike a balance between making something with the potential of an effect available to the American people, at the same time that we do it under the auspices of a protocol that would give us information to determine if it’s truly safe and truly effective,” explained National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci during a press conference.
https://techcrunch.com/2020/03/19/fda-testing-coronavirus-treatments-including-chloroquine-plasma-from-recovered-covid-19-patients/

At this point FDA did not approve the HCQ drug but was favoring it.

According to ‘WHO – Landscape analysis of therapeutics’ of 21st March 2020, Chloroquine an antimalarial agent which is a heme polymerase inhibitor for Malaria can be prescribed as prophylaxis and treatment. The Prophylaxis dose can be 500 mg chloroquine phosphate once per week. For treatment 2.5 g chloroquine phosphate over 3 days either as oral or injectable was suggested. https://www.who.int/blueprint/priority-diseases/key action/Table_of_therapeutics_Appendix_17022020.pdf?ua=1

On March 23 2020, in India, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxychloroquine as a preventive medication for high-risk population. According to the advisory, it should be given to high risk population — asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases. According to the advisory, the drug has to be given only on the prescription of a registered medical practitioner.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/indias-covid-task-force-recommends-hydroxychloroquine-for-high-risk-patients-with-strict-riders/articleshow/74774540.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

This article of March 25 described that the National Health Commission of the People’s Republic of China published their recommendation mid-February, suggesting to treat patients with 500mg chloroquine phosphate (300mg for CQ) twice per day, for a maximum of 10 days. In Italy, the L. Spallanzani National Institute for the Infectious Disease published their recommendations for treatment on the 17th of March, which included the provision of 400mg of HCQ per day or 500mg CQ per day, in combination with another antiviral agent. However the article published limitation too of these studies which supported HCQ. https://www.cebm.net/covid-19/chloroquine-and-hydroxychloroquine-current-evidence-for-their-effectiveness-in-treating-covid-19/

In a March 28 letter leading to the FDA’s emergency USE authorization of hydroxychloroquine and chloroquine for COVID-19, agency chief scientist Denise Hinton noted that, “based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate were recommended for treatment of hospitalized COVID-19 patients in several countries.” This was the first time when HCQ was recommended by WHO.
https://www.usnews.com/news/health-news/articles/2020-03-31/fda-approves-malaria-drugs-to-treat-covid-19-despite-little-proof-they-work

After two months, on May 25, WHO announced it had temporarily suspended its trial of the drug HCQ over safety concerns. The announcement came days after a study published in medical journal The Lancet on 22nd May which found that hospitalized Covid-19 patients treated with hydroxychloroquine had a higher risk of death than those who didn’t take it. The study found that both drugs can produce potentially serious side effects, particularly heart arrhythmia. (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext(RETRACTED)

The Lancet study was subjected to an expression of concern on June 2 , and finally retracted on June 4. At the same time another study (https://www.nejm.org/doi/full/10.1056/NEJMoa2007621) from another reputed Journal NEJM retracted on various grounds. Both these retractions with some others raised again the questions over the scientific integrity and Journals’ working in such emergent pandemic times, as these are the two most reputed journals of health sciences and they have published important research without any verification of the content.

Based on the results of these two research papers, WHO on May 25 2020 announced the temporary suspension of clinical trials of hydroxychloriquine as a potential treatment for COVID-19. “The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data was under review by the Data Safety Monitoring Board,” Tedros said. https://time.com/5842264/hydroxychloroquine-testing-who/

However as we discussed already this Lancet study was challenged on June 2 and so the decision of FDA and WHO to continue the HCQ trial. On June 3, the WHO again resumed the study looking into whether the malaria drug hydroxychloroquine could be effective in treating COVID-19. Dr. Tedros, Director-General of the WHO, said in a press briefing on June 3 that the agency’s board reviewed the data concerning heart risks and found “no reasons to modify the trial.” https://time.com/5847664/who-hydroxychloroquine-covid-19/

It is to note that on May 30, CSIR, India chief criticizes HCQ trial suspension by quoting The Lancet’s study ‘sloppy’ and thus was one of the whistleblower. Shekhar Mande, Anurag Agrawal, physician and Director, Institute of Genomics and Integrative Biology as well as Rajeeva Karandikar, Director, Chennai Mathematical Institute, signed a letter and said the World Health Organization’s decision to suspend trials of the drug was a “knee-jerk” reaction. “The observational data is sloppy, and the statistics underlying them is faulty. There is no doubt that it will not stand the test of time. You can’t compare apples with oranges,” Mr. Mande told The Hindu. https://www.thehindu.com/sci-tech/health/coronavirus-csir-chief-flays-hcq-trial-suspension/article31712065.ece

On June 15, 2020 FDA updated their website as, “Based on ongoing analysis and emerging scientific data, FDA revoked the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible. This determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery. This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19. As a result, we determined that the legal criteria for the EUA are no longer met. Please refer to the Revocation of the EUA Letter and FAQs on the Revocation of the EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate for more information”. https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

 

Conclusion

From the above points it is observed that the HCQ was proposed through social media then became widely accepted by various clinical studies around the world. We cannot ignore that COVID-19 is emergent and fast changing situation but from March 12 to June 14 the decision over HCQ was accepted and rejected several times just because someone is saying something while FDA and WHO scientists could not get the time to verify the facts by themselves before going to further conclusion. First time HCQ was accepted because of several reports from different trials but was rejected just because Lancet published a heart attack story of bogus trial. But when this Lancet story was unsurfaced, FDA and WHO once again gain trust and start advocating HCQ. Lastly ,without any further solid basis they rejected HCQ trials again. So the facts raises the questions over the working of world’s reputed organizations like WHO, FDA etc. and publishing platforms like The Lancet, NEJM etc. when they have the best and sufficient staff for every task. The work which was done by whistleblowers why not came into attention of these reputed organizations and it’s most reputed staff is a matter of concern for future situations like COVID19 pandemic.

Note: Views are personal of Author’s.

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