BIDIL: A RACE-TARGETED DRUG FOR BLACK AMERICAN'S ONLY
DOI:
https://doi.org/10.22159/ajpcr.2017.v10i11.20022Keywords:
Race, Black Americans, Food and Drug Administration, HF, BiDiLAbstract
 It has been noted that pharma research toward race-targeted medicine and it criticism is going on simultaneously over the past few years. Some argued that drugs specifically target to cure particular racial groups could play a vital role against racial disparities in health. While others claimed that race-targeted medicine inappropriately treats race as a biological reason for racial disparities when broader social and environmental factors may offer better descriptions. Much of this debate includes the Food and Drug Administration's approval of drug BiDil in 2005, which became the first drug to be marked for a specific racial group black Americans who suffers from heart failure (HF). This controversial drug was declared failed due to less attention of physician's as well as its high cost in market. The highlighted part of this review is that besides much criticism still this drug prescribed by majority of physicians. Moreover, BiDil is not only one which is race specific but also there are more drugs which have been claimed to have different effects in different racial or ethnic groups. Â
Downloads
References
National Institutes of Health. National Center for Health Statistics, Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities. Hyattsville, MD: National Institutes of Health; 2015. p. 107.
Priya JK, Balambigai MS, Sariga N, Sathya M, Andhuvan G. Development and validation of patient information leaflet for heart attack patients. Int J Pharm Pharm Sci 2016;8(8):381-3.
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al. Executive summary: Heart disease and stroke statistics--2012 update: A report from the American Heart Association. Circulation 2012;125(1):188-97.
Safford MM, Brown TM, Muntner PM, Durant RW, Glasser S, Halanych JH, et al. Association of race and sex with risk of incident acute coronary heart disease events. JAMA 2012;308(17):1768-74.
Riley WJ. Health disparities: Gaps in access, quality and affordability of medical care. Trans Am Clin Climatol Assoc 2012;123:167-72.
Yu JH, Goering S, Fullerton SM. Race-based medicine and justice as recognition: Exploring the phenomenon of BiDil. Camb Q Healthc Ethics 2009;18(1):57-67.
Taylor AL, Ziesche S, Yancy C, Carson P, D’Agostino R Jr, Ferdinand K, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004;351(20):2049-57.
Taylor AL, Ziesche S, Yancy CW, Carson P, Ferdinand K, Taylor M, et al. Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: Consistency across subgroups in the African-American Heart Failure Trial. Circulation 2007;115(13):1747-53.
Cole RT, Kalogeropoulos AP, Georgiopoulou VV, Gheorghiade M, Quyyumi A, Yancy C, et al. Hydralazine and isosorbide dinitrate in heart failure: Historical perspective, mechanisms, and future directions. Circulation 2011;123(21):2414-22.
Schwartz RS. Racial profiling in medical research. N Engl J Med 2001;344(18):1392-3.
Bibbins-Domingo K, Fernandez A. BiDil for heart failure in black patients: Implications of the U.S. Food and Drug Administration approval. Ann Intern Med 2007;146(1):52-6.
Kahn J, Sankar P. Being specific about race-specific medicine. Health Aff (Millwood) 2006;25(5):w375-7.
Stephanie S. Maker of Heart Drug Intended for Blacks Bases Price on Patients’ Wealth, New York Times (1923-Current File) C3; 2005.
Cooper RS, Kaufman JS, Ward R. Race and genomics. N Engl J Med 2003;348(12):1166-70.
Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, et al. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med 2003;348(12):1170-5.
Tate SK, Goldstein DB. Will tomorrow’s medicines work for everyone? Nat Genet 2004;36 11 Suppl: S34-42.
Bjornsson TD, Wagner JA, Donahue SR, Harper D, Karim A, Khouri MS, et al. A review and assessment of potential sources of ethnic differences in drug responsiveness. J Clin Pharmacol 2003;43(9):943-67.
Exner DV, Dries DL, Domanski MJ, Cohn JN. Lesser response to angiotensin-converting-enzyme inhibitor therapy in black as compared with white patients with left ventricular dysfunction. N Engl J Med 2001;344(18):1351-7.
Weir MR, Reisin E, Falkner B, Hutchinson HG, Sha L, Tuck ML. Nocturnal reduction of blood pressure and the antihypertensive response to a diuretic or angiotensin converting enzyme inhibitor in obese hypertensive patients. TROPHY Study Group. Am J Hypertens 1998;11:914-20.
Weir MR, Gray JM, Paster R, Saunders E. Differing mechanisms of action of angiotensin-converting enzyme inhibition in black and white hypertensive patients. The Trandolapril Multicenter Study Group. Hypertension 1995;26(1):124-30.
Stein CM, Lang CC, Nelson R, Brown M, Wood AJ. Vasodilation in black Americans: Attenuated nitric oxide-mediated responses. Clin Pharmacol Ther 1997;62(4):436-43.
Rosenbaum DA, Pretorius M, Gainer JV, Byrne D, Murphey LJ, Painter CA, et al. Ethnicity affects vasodilation, but not endothelial tissue plasminogen activator release, in response to bradykinin. Arterioscler Thromb Vasc Biol 2002;22(6):1023-8.
Cubeddu LX, Aranda J, Singh B, Klein M, Brachfeld J, Freis E, et al. A comparison of verapamil and propranolol for the initial treatment of hypertension. Racial differences in response. JAMA 1986;256(16):2214-21.
Efficacy of nadolol alone and combined with bendroflumethiazide and hydralazine for systemic hypertension. Am J Cardiol 1983;52(10):1230-7.
Friedman B, Gray JM, Gross S, Levit SA. United States experience with oxprenolol in hypertension. Am J Cardiol 1983;52(9):43D-8.
Beta-Blocker Evaluation of Survival Trial Investigators, Eichhorn EJ, Domanski MJ, Krause-Steinrauf H, Bristow MR, Lavori PW. A trial of the beta-blocker bucindolol in patients with advanced chronic heart failure. N Engl J Med 2001;344(22):1659-67.
Zanchi A, Maillard M, Burnier M. Recent clinical trials with omapatrilat: New developments. Curr Hypertens Rep 2003;5(4):346-52.
Cushman WC, Reda DJ, Perry HM, Williams D, Abdellatif M, Materson BJ. Regional and racial differences in response to antihypertensive medication use in a randomized controlled trial of men with hypertension in the United States. Department of Veterans Affairs Cooperative Study Group on Antihypertensive Agents. Arch Intern Med 2000;160(6):825-31.
Blann A, Hewitt J, Siddiqui F, Bareford D. Racial background is a determinant of average warfarin dose required to maintain the INR between 2.0 and 3.0. Br J Haematol 1999;107(1):207-9.
Blann A, Bareford D. Ethnic background is a determinant of average warfarin dose required to maintain the INR between 3.0 and 4.5. J Thromb Haemost 2004;2(3):525-6.
Chapman AB, Schwartz GL, Boerwinkle E, Turner ST. Predictors of antihypertensive response to a standard dose of hydrochlorothiazide for essential hypertension. Kidney Int 2002;61(3):1047-55.
Lin KM, Poland RE, Nuccio I, Matsuda K, Hathuc N, Su TP, et al. A longitudinal assessment of haloperidol doses and serum concentrations in Asian and Caucasian schizophrenic patients. Am J Psychiatry 1989;146(10):1307-11.
Jann MW, Chang WH, Davis CM, Chen TY, Deng HC, Lung FW, et al. Haloperidol and reduced haloperidol plasma levels in Chinese vs. Non-Chinese psychiatric patients. Psychiatry Res 1989;30(1):45-52.
Watkins LL, Dimsdale JE, Ziegler MG. Reduced beta 2-receptor mediated vasodilation in African Americans. Life Sci 1995;57(15):1411-6.
Cardillo C, Kilcoyne CM, Cannon RO 3rd, Panza JA. Attenuation of cyclic nucleotide-mediated smooth muscle relaxation in blacks as a cause of racial differences in vasodilator function. Circulation 1999;99(1):90-5.
Lang CC, Stein CM, Brown RM, Deegan R, Nelson R, He HB, et al. Attenuation of isoproterenol-mediated vasodilatation in blacks. N Engl J Med 1995;333(3):155-60.
Johnson JA, Burlew BS, Stiles RN. Racial differences in beta-adrenoceptor-mediated responsiveness. J Cardiovasc Pharmacol 1995;25(1):90-6.
Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, et al. Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Adv Ther 2003;20(3):149-63.
Matsuda KT, Cho MC, Lin KM, Smith MW, Young AS, Adams JA. Clozapine dosage, serum levels, efficacy, and side-effect profiles: A comparison of Korean-American and Caucasian patients. Psychopharmacol Bull 1996;32(2):253-7.
Collazo Y, Tam R, Sramek J, Herrera J. Neuroleptic dosing in Hispanic and Asian Inpatients with schizophrenia. Mt Sinai J Med 1996;63(5-6):310-3.
Zhou HH, Sheller JR, Nu H, Wood M, Wood AJ. Ethnic differences in response to morphine. Clin Pharmacol Ther 1993;54(5):507-13.
Cepeda MS, Farrar JT, Roa JH, Boston R, Meng QC, Ruiz F, et al. Ethnicity influences morphine pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 2001;70(4):351-61.
Tornatore KM, Biocevich DM, Reed K, Tousley K, Singh JP, Venuto RC. Methylprednisolone pharmacokinetics, cortisol response, and adverse effects in black and white renal transplant recipients. Transplantation 1995;59(5):729-36. 44. Muir AJ, Bornstein JD, Killenberg PG; Atlantic Coast Hepatitis Treatment Group. Peginterferon alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-Hispanic whites. N Engl J Med 2004;350(22):2265-71.
Millward MJ, Boyer MJ, Lehnert M, Clarke S, Rischin D, Goh BC, et al. Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: A phase II study in Caucasian and Asian patients. Ann Oncol 2003;14(3):449-54.
Kimball P, Elswick RK, Shiffman M. Ethnicity and cytokine production gauge response of patients with hepatitis C to interferon-alpha therapy. J Med Virol 2001;65(3):510-6.
De Maria N, Colantoni A, Idilman R, Friedlander L, Harig J, Van Thiel DH. Impaired response to high-dose interferon treatment in African-Americans with chronic hepatitis C. Hepatogastroenterology 2002;49(45):788-92.
Goran MI, Bergman RN, Cruz ML, Watanabe R. Insulin resistance and associated compensatory responses in African-American and Hispanic children. Diabetes Care 2002;25(12):2184-90.
Bhatia S, Sather HN, Heerema NA, Trigg ME, Gaynon PS, Robison LL. Racial and ethnic differences in survival of children with acute lymphoblastic leukemia. Blood 2002;100(6):1957-64.
Pollock BH, DeBaun MR, Camitta BM, Shuster JJ, Ravindranath Y, Pullen DJ, et al. Racial differences in the survival of childhood B-precursor acute lymphoblastic leukemia: A Pediatric Oncology Group Study. J Clin Oncol 2000;18(4):813-23.
Kadan-Lottick NS, Ness KK, Bhatia S, Gurney JG. Survival variability by race and ethnicity in childhood acute lymphoblastic leukemia. JAMA 2003;290(15):2008-14.
Ibrahim R. Diabetes mellitus Type II: Review of oral treatment options. Int J Pharm Pharm Sci 2010;2:21-30.
Gerich J, Raskin P, Jean-Louis L, Purkayastha D, Baron MA. PRESERVE-beta: Two-year efficacy and safety of initial combination therapy with nateglinide or glyburide plus metformin. Diabetes Care 2005;28(9):2093-9.
Rosenstock J, Zinman B, Murphy LJ, Clement SC, Moore P, Bowering CK, et al. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in Type 2 diabetes: A randomized, controlled trial. Ann Intern Med 2005;143(8):549-58.
Bailey CJ, Bagdonas A, Rubes J, McMorn SO, Donaldson J, Biswas N, et al. Rosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in Type 2 diabetes mellitus: A 24-week, multicenter, randomized, double-blind, parallel-group study. Clin Ther 2005;27(10):1548-61.
Heart Failure Society of America, Lindenfeld J, Albert NM, Boehmer JP, Collins SP, Ezekowitz JA, et al. HFSA 2010 comprehensive heart failure practice guideline. J Card Fail 2010;16(6):e1-194.
Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, et al. 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: A report of the american college of cardiology foundation/american heart association task force on practice guidelines: Develop. Circulation 2009;119:e391-479.
Mitchell JE, Ferdinand KC, Watson KE, Wenger NK, Watkins LO, Flack JM, et al. Treatment of heart failure in African Americans - A call to action. J Natl Med Assoc 2011;103(2):86-98.
Maglo KN, Rubinstein J, Huang B, Ittenbach RF. BiDil in the clinic: An interdisciplinary investigation of physicians’ prescription patterns of a race-based therapy. AJOB Empir Bioeth 2014;5(4):37-52.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
