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A Knee-Jerker During Pandemic? Praised As a Potential Miracle Cure, Hundreds of Trials Got Initiated Across the Globe for HCQ

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A Knee-Jerker During Pandemic? Praised As a Potential Miracle Cure, Hundreds of Trials Got Initiated Across the Globe for HCQ COVID-19 31 BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com Controversial papers in NEJM and The Lancet A kNEE-JERkER DURING pandemic? Praised as a potential miracle cure, hundreds of trials got initiated across the globe for HCQ. Scientists started trying the drugs in low and high doses; alone or combined with other drugs in patients with mild or severe disease. But this hope recently got struck by a big blow when a study came along claiming that these antimalarial drugs not only look ineffective, but are downright deadly. he absence of an effective treatment against School, US; Frank Ruschitzka fromUniversity Heart the coronavirus infection has led clinicians to Center, University Hospital Zurich, Switzerland; and Tredirect drugs that are known to be effective Dr Amit N Patel from Department of Biomedical for other medical conditions to the treatment of Engineering, University of Utah, Salt Lake City, US. COVID-19. Key among these repurposed therapeutic They used hospital records procured by an agents are the antimalarial drug chloroquine (CQ) American healthcare analytics company Surgisphere and its analogue hydroxychloroquine (HCQ), which Corporation, established in 2008 by an Indian is used for the treatment of autoimmune diseases, Sapan Desai, for their study. According to their such as systemic lupus erythematosus and findings, COVID-19 patients taking CQ or rheumatoid arthritis. HCQ were associated with an increase in Praised as a potential miracle the risk of ventricular arrhythmias and cure,hundreds of trials got initiated a greater hazard for in-hospital death across the globe for HCQ. Scientists with COVID-19. The study concluded started trying the drugs in low and that these drug regimens should high doses; alone or combined with not be used outside of clinical other drugs in patients with mild or trials and urgent confirmation severe disease. from randomised clinical trials is But this hope recently got needed. struck by a big blow when a study Hereafter, large randomized came along claiming that these trials of these drugs came to a antimalarial drugs not only look halt. It prompted even the World in effective, but are downright Health Organization (WHO) to deadly. This study, published pause HCQ clinical trials in on May 22 in the elite COVID-19 patients under journal The Lancet, its giant solidarity trial. was conducted by And then came three researchers- Dr another blow when Mandeep R Mehra questions were from Brigham and raised on the Women’s Hospital authenticity Heart and Vascular of this study. Center and For example, Harvard Medical the claim 32 COVID-19 BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com “While we all are working at a record speed which is the need of the hour, it is of paramount importance for all researchers to ensure that the principles of ethics are followed to the core.” - Dr Chirag Trivedi, President, Indian Society Clinical Research, India “The lost precious time studying potential of the drug will be hurtful, considering that in many regions, the disease has already peaked and is now declining. Trial sponsors will find it more difficult to also convince patients to participate in the studies.” - Megha Joshi, Consultant, Healthcare, Markets & Technology, India that 96032 hospitalised patients from 671 hospitals the database, and to replicate the analyses presented diagnosed with COVID-19 between December 20, in the paper. 2019, and April 14, 2020 met the inclusion criteria More eyebrows were raised when the authors for this study, seemed implausible. Gradually, the informed that Surgisphere would not transfer the study came under the scanner within the research full dataset, client contracts, and the full ISO audit community. An open letter was signed by clinicians, report to their servers for analysis as such transfer medical researchers, statisticians, and ethicists from would violate client agreements and confidentiality across the world and sent to The Lancet. requirements. Eventually, the authors retracted their “While we all are working at a record speed which paper from the journal on June 5. is the need of the hour, it is of paramount importance “The publication shifted global focus from the for all researchers to ensure that the principles of humble HCQ to other promising candidates, in the ethics are followed to the core. The clinical study lead being Gilead’s remdesivir. With remdesivir design, conduct, analysis and reporting should follow expected to be priced between $2,000 and $5,000 per well-laid standards which will ensure the integrity course, pursuing HCQ could have potentially made and credibility of the data generated in addition treatment accessible globally, sooner. The publications to the following of ethical principles. Protecting doomed to retract led many regulatory agencies to patients’ safety is always of utmost importance in any ask scientists to halt their trials evaluating HCQ. clinical study that we conduct. This is something that The retraction will push safety committees to relook we have been doing and hence, should continue doing at those studies. No doubt, there has been time lost it in the present times too”, shares Dr Chirag Trivedi, which could have been used to accelerate treatment for President, Indian Society Clinical Research, India. patients, especially in critical care. The lost precious After several concerns were raised with respect time studying potential of the drug will be hurtful, to the veracity of the data and analyses conducted considering that in many regions, the disease has by Surgisphere Corporation, the authors of the already peaked and is now declining. Trial sponsors paper apparently launched an independent third- will find it more difficult to also convince patients party peer review of Surgisphere with the consent to participate in the studies”, says Megha Joshi, of Sapan Desai to evaluate the origination of the Consultant, Healthcare, Markets & Technology, India. database elements, to confirm the completeness of Around the same time, on June 4, Dr Mandeep COVID-19 33 BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com “Changes in policies “The Trial Steering of funding agencies Committeehas to ensure data from decided that ASCOT research funded by should continue these bodies to be made recruitment and publicly available will randomising patients enhance transparency of to hydroxychloroquine research.” containing arms.” - Dr Shree Divyya, - Dr Asha Bowen, Manager Healthcare Advisory, Clinician scientist, Perth Children’s Hospital, Australia Sathguru Management Consultants, India “We have clearly advised “The trial has now moved that HCQ should be on to try and urgently taken with food, not on establish any benefits empty stomach. We have from other treatments, expanded use of HCQ to including antibiotics, frontline workers also, anti-inflammatories, considering the potential drugs used to treat HIV, benefits.” and plasma therapies.” - Prof Balram Bhargava, - Frank Hester, Director General, Indian Council of Chief Executive Officer, The Phoenix Partnership, UK Medical Research, India R Mehra and Dr Amit N Patel along with their against personal gain, vested interests, commercial co-authors Dr SreyRam Kuy from Baylor College or political influences?” mentions Dr Marcus ONG of Medicine, Texas, US and Dr Timothy D. Henry, Eng Hock, Professor & Director, Health Services and from Christ Hospital, Ohio, US and Sapan Desai Systems Research Signature Research Programme, from Surgisphere Corporation announced another Duke-NUS Medical School, Singapore. paper retraction from the New England Journal of An element of irony was later revealed by few Medicine (NEJM). This study titled ‘Cardiovascular media reports that meanwhile Desai, who according Disease, Drug Therapy, and Mortality in Covid-19’, to court records has three outstanding medical had claimed that underlying cardiovascular disease is malpractice suits against him, has written extensively associated with an increased risk of in-hospital death in the past on research misconduct. There were among Covid-19 patients. further claims that major institutions including “The recent high profile retraction of two Stanford University, which were described as controversial papers on COVID-19 by The Lancet and research partners on the Surgisphere website, said the New England Journal of Medicine raises several they were not aware of any formal relationship with pertinent issues in the field of big data in medical the company. research, and the fine balance of speed versus “While the research community is always in a maintenance of rigorous scientific review during haste for publishing their research it is critical that outbreaks and pandemics. It would seem there was they maintain integrity on the data being published. indeed deliberate fabrication and fraud committed Journals rely on the declaration signed by the authors by Surgisphere, a small Chicago-based company on data reliability and any conflict of interests that purportedly was able to collect and analyse tens stated. This current system has been unsuccessful of thousands of patient records from hundreds of in providing the required reliance on data when it is hospitals in the midst of a pandemic. It is thus timely most critical with the current pandemic caused by to revisit the ethical issues regarding the use of big, COVID-19. Hence it could be beneficial for additional ‘real-world data’ (RWD) in order to derive ‘real world checks and balances to be created to reduce such evidence’ to guide clinical care, healthcare
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