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• W2205085377 abstract "The Comment by Atul Luthra and Anoop Misra1Luthra A Misra A The marketing of unproven drugs for diabetes and dyslipidaemia in India.Lancet Diabetes & Endocrinol. 2015; 3: 758-760Summary Full Text Full Text PDF Scopus (8) Google Scholar has led to outcry in the media2Mukherjee R Indians face risk from unproven drugs: Lancet.Times of India (Mumbai). Sept 20, 2015; http://timesofindia.indiatimes.com/india/Indians-face-risk-from-unproven-drugs-Lancet/articleshow/49029617.cmsGoogle Scholar about diabetes drugs in India. Here, we wish to make some clarifications about hydroxychloroquine.Besides our randomised controlled trial,3Pareek A Chandurkar N Thomas N et al.Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes: a double-blind randomized comparison with pioglitazone.Current Med Res Opin. 2014; 30: 1257-1266Crossref PubMed Scopus (65) Google Scholar there have been two prospective4Quatraro A Consoli G Magno M et al.Hydroxychloroquine in decompensated, treatment-refractory noninsulin-dependent diabetes mellitus. A new job for an old drug?.Ann Intern Med. 1990; 112: 678-681Crossref PubMed Scopus (124) Google Scholar, 5Gerstein HC Thorpe KE Taylor DW et al.The effectiveness of hydroxychloroquine in patients with type 2 diabetes mellitus who are refractory to sulfonylureas—a randomized trial.Diabetes Res Clin Pract. 2002; 55: 209-219Summary Full Text Full Text PDF PubMed Scopus (119) Google Scholar studies and one retrospective6Rekedal LR Massarotti E Garg R et al.Changes in glycosylated hemoglobin after initiation of hydroxychloroquine or methotrexate treatment in diabetes patients with rheumatic diseases.Arthritis Rheum. 2010; 62: 3569-3573Crossref PubMed Scopus (77) Google Scholar study of hydroxychloroquine for the treatment of diabetes (appendix). Furthermore, hydroxychloroquine has been marketed for the past six decades for chronic disorders such as rheumatoid arthritis and lupus. Since hydroxychloroquine is not a new chemical entity, bridging clinical data (previous studies and our randomised controlled trial) was considered adequate for approval for treatment of diabetes in India. Moreover, a plethora of published work7Olsen NJ Schleich MA Karp DR Multifaceted effects of hydroxychloroquine in human disease.Semin Arthritis Rheum. 2013; 43: 264-272Summary Full Text Full Text PDF PubMed Scopus (100) Google Scholar, 8Wasko MC McClure CK Kelsey SF et al.Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial.Diabetologia. 2015; 58: 2336-2343Crossref PubMed Scopus (65) Google Scholar (prospective observational studies, pharmacodynamic studies, review articles, and case reports) is available supporting the use of hydroxychloroquine for reducing risk of development of diabetes in patients with rheumatoid arthritis and lupus. Considering the diabetes epidemic in India and the few affordable treatment options (newer drugs such as dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, insulin analogues, and glucagon-like peptide-1 agonists are costly), affordable options such as hydroxychloroquine are sorely needed.With respect to funding, much drug development worldwide is funded by pharmaceutical companies, and company employees are often listed as authors. All studies of hydroxychloroquine before ours for treatment of diabetes or risk reduction of diabetes have been funded by institutions other than the manufacturer of hydroxychloroquine, such as the US National Institutes of Health, the Medical Research Council of Canada, and University of Naples, Italy. The corresponding author of our randomised trial of hydroxychloroquine (AP)3Pareek A Chandurkar N Thomas N et al.Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes: a double-blind randomized comparison with pioglitazone.Current Med Res Opin. 2014; 30: 1257-1266Crossref PubMed Scopus (65) Google Scholar met ICMJE criteria for authorship and competing interests were declared in accordance with guidelines. Furthermore, one of the Comment authors (Misra) has himself been involved in diabetes-related drug development programmes funded by multinational pharmaceutical companies (Clinical Trial Registry of India, numbers 2009/091/000598; 2010/091/002828; CTRI/2010/091/001186 and 2010/091/001302), which we believe represents an undeclared conflict of interest.We agree with Luthra and Misra's view that long-term studies of hydroxychloroquine are required. We have planned a large phase 4 study of hydroxychloroquine in about 1000 patients with type 2 diabetes mellitus.We are employees of Ipca Laboratories; Ipca Laboratories decided to submit this Correspondence for publication. AP has four patents pending (WO 2013054345 A2, US 20120202849 A1, WO 2014141295 A2, 1454/MUM/2015) and two patents granted (US 8415360 B2, India Patent Number 256350) related to the use of hydroxychloroquine in metabolic disorders. The Comment by Atul Luthra and Anoop Misra1Luthra A Misra A The marketing of unproven drugs for diabetes and dyslipidaemia in India.Lancet Diabetes & Endocrinol. 2015; 3: 758-760Summary Full Text Full Text PDF Scopus (8) Google Scholar has led to outcry in the media2Mukherjee R Indians face risk from unproven drugs: Lancet.Times of India (Mumbai). Sept 20, 2015; http://timesofindia.indiatimes.com/india/Indians-face-risk-from-unproven-drugs-Lancet/articleshow/49029617.cmsGoogle Scholar about diabetes drugs in India. Here, we wish to make some clarifications about hydroxychloroquine. Besides our randomised controlled trial,3Pareek A Chandurkar N Thomas N et al.Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes: a double-blind randomized comparison with pioglitazone.Current Med Res Opin. 2014; 30: 1257-1266Crossref PubMed Scopus (65) Google Scholar there have been two prospective4Quatraro A Consoli G Magno M et al.Hydroxychloroquine in decompensated, treatment-refractory noninsulin-dependent diabetes mellitus. A new job for an old drug?.Ann Intern Med. 1990; 112: 678-681Crossref PubMed Scopus (124) Google Scholar, 5Gerstein HC Thorpe KE Taylor DW et al.The effectiveness of hydroxychloroquine in patients with type 2 diabetes mellitus who are refractory to sulfonylureas—a randomized trial.Diabetes Res Clin Pract. 2002; 55: 209-219Summary Full Text Full Text PDF PubMed Scopus (119) Google Scholar studies and one retrospective6Rekedal LR Massarotti E Garg R et al.Changes in glycosylated hemoglobin after initiation of hydroxychloroquine or methotrexate treatment in diabetes patients with rheumatic diseases.Arthritis Rheum. 2010; 62: 3569-3573Crossref PubMed Scopus (77) Google Scholar study of hydroxychloroquine for the treatment of diabetes (appendix). Furthermore, hydroxychloroquine has been marketed for the past six decades for chronic disorders such as rheumatoid arthritis and lupus. Since hydroxychloroquine is not a new chemical entity, bridging clinical data (previous studies and our randomised controlled trial) was considered adequate for approval for treatment of diabetes in India. Moreover, a plethora of published work7Olsen NJ Schleich MA Karp DR Multifaceted effects of hydroxychloroquine in human disease.Semin Arthritis Rheum. 2013; 43: 264-272Summary Full Text Full Text PDF PubMed Scopus (100) Google Scholar, 8Wasko MC McClure CK Kelsey SF et al.Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial.Diabetologia. 2015; 58: 2336-2343Crossref PubMed Scopus (65) Google Scholar (prospective observational studies, pharmacodynamic studies, review articles, and case reports) is available supporting the use of hydroxychloroquine for reducing risk of development of diabetes in patients with rheumatoid arthritis and lupus. Considering the diabetes epidemic in India and the few affordable treatment options (newer drugs such as dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, insulin analogues, and glucagon-like peptide-1 agonists are costly), affordable options such as hydroxychloroquine are sorely needed. With respect to funding, much drug development worldwide is funded by pharmaceutical companies, and company employees are often listed as authors. All studies of hydroxychloroquine before ours for treatment of diabetes or risk reduction of diabetes have been funded by institutions other than the manufacturer of hydroxychloroquine, such as the US National Institutes of Health, the Medical Research Council of Canada, and University of Naples, Italy. The corresponding author of our randomised trial of hydroxychloroquine (AP)3Pareek A Chandurkar N Thomas N et al.Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes: a double-blind randomized comparison with pioglitazone.Current Med Res Opin. 2014; 30: 1257-1266Crossref PubMed Scopus (65) Google Scholar met ICMJE criteria for authorship and competing interests were declared in accordance with guidelines. Furthermore, one of the Comment authors (Misra) has himself been involved in diabetes-related drug development programmes funded by multinational pharmaceutical companies (Clinical Trial Registry of India, numbers 2009/091/000598; 2010/091/002828; CTRI/2010/091/001186 and 2010/091/001302), which we believe represents an undeclared conflict of interest. We agree with Luthra and Misra's view that long-term studies of hydroxychloroquine are required. We have planned a large phase 4 study of hydroxychloroquine in about 1000 patients with type 2 diabetes mellitus. We are employees of Ipca Laboratories; Ipca Laboratories decided to submit this Correspondence for publication. AP has four patents pending (WO 2013054345 A2, US 20120202849 A1, WO 2014141295 A2, 1454/MUM/2015) and two patents granted (US 8415360 B2, India Patent Number 256350) related to the use of hydroxychloroquine in metabolic disorders. Supplementary Material Download .pdf (.1 MB) Help with pdf files Supplementary appendix Download .pdf (.1 MB) Help with pdf files Supplementary appendix The marketing of unproven drugs for diabetes and dyslipidaemia in IndiaIndia has about one sixth of the worldwide population of patients with diabetes. In 2013, the value of the therapeutics market for type 2 diabetes in Asia-Pacific countries was estimated to be US$6·5 billion, and is expected to grow at a compound annual growth rate of 7·1% between 2013 and 2020 to $10·5 billion.1 This rapid growth is due to the anticipated approval and introduction of new products such as glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and sodium glucose transporter 2 inhibitors, and the increasing prevalence of diabetes in the Asia-Pacific region, especially in India and China. Full-Text PDF Drug approvals in India – Authors' replyWe read with interest the arguments raised in response to our Comment.1 On the whole, the two letters submitted by representatives of pharmaceutical companies have failed to provide any major new information to mitigate our view that the drugs under discussion do not have robust safety (cardiovascular safety and all-cause mortality) and long-term efficacy data. The authors have mostly reiterated the known published data (few patients, short study durations) and further added anecdotal research, retrospective analysis, “unpublished data”, and data from clinical practice. Full-Text PDF" @default.
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