한방항암제의 세계화를 위한 전략
Strategy for Globalization of Korean Medicine Anti-Cancer Drugs
1
조회
0
다운로드
0
인용
0
참고문헌
초록
Cancer is the leading cause of death worldwide and the most important cause of death in Korea. Many researches have been conducted for developing effective and safe anti-cancer drugs worldwide. Korean government recently declared to make traditional herbal medicine globally recognized and began to invest not a small budget for developing new promising herbal anti-cancer drugs. The pur- pose of this study is to investigate the scientific evidence of current Korean herbal medicines to be able to enter the world market through the studies of NEXIA. NEXIA (Rhus verniciflua Stokes), anti- cancer drug from traditional herbal medicine in Korea, has been used by Korean medicine physician legally without Ministry of Drug and Food Safety’s formal approval through a new drug approval system. We have found the studies on the NEXIA have not enough scientific evidence on safety and effectiveness due to lack of internal validity of the studies. In order to make our traditional herbal an- ti-cancer drugs successfully enter the world market, we have to establish effective system for evaluat- ing them through the world-widely recognized system such as clinical trial system of cancer drugs run by the U.S Food and Drug Administration. It should be prerequisite to establish sound evaluation system for safety and effectiveness of Korean herbal anti-cancer drugs for developing globally accept- able Korean herbal anti-cancer drugs.
Abstract
Cancer is the leading cause of death worldwide and the most important cause of death in Korea. Many researches have been conducted for developing effective and safe anti-cancer drugs worldwide. Korean government recently declared to make traditional herbal medicine globally recognized and began to invest not a small budget for developing new promising herbal anti-cancer drugs. The pur- pose of this study is to investigate the scientific evidence of current Korean herbal medicines to be able to enter the world market through the studies of NEXIA. NEXIA (Rhus verniciflua Stokes), anti- cancer drug from traditional herbal medicine in Korea, has been used by Korean medicine physician legally without Ministry of Drug and Food Safety’s formal approval through a new drug approval system. We have found the studies on the NEXIA have not enough scientific evidence on safety and effectiveness due to lack of internal validity of the studies. In order to make our traditional herbal an- ti-cancer drugs successfully enter the world market, we have to establish effective system for evaluat- ing them through the world-widely recognized system such as clinical trial system of cancer drugs run by the U.S Food and Drug Administration. It should be prerequisite to establish sound evaluation system for safety and effectiveness of Korean herbal anti-cancer drugs for developing globally accept- able Korean herbal anti-cancer drugs.
참고문헌 (46)
- Global Burden of Disease Cancer Collaboration, "The Global Burden of Cancer 2013", JAMA Oncol, 1, pp.505~527 (2015)
- "Cancer Registration Statistics"[URL]
- "The Cancer Drug Market Just Hit $100 Billion And Could Jump 50% In Four Years"[URL]
- Hay M, "Clinical development success rates for investigational drugs", Nat Biotechnol, 32, pp.40~51 (2014)
- "식약처, ‘15년 임상시험 승인현황 및 정기점검 결과 발표"[URL]
- 민정혜, "넥시아 논란 10년에 식약처·복지부도 ‘답답’", Dailymedi, ~ (2015)
- 송성철, "넥시아 검증 나섰다 고소 당한 환자단체 대표 “무혐의”", DoctorsNews, ~ (2016)
- 송수연, "2년 넘는 법정 다툼 드디어 끝낸 한정호 교수", 청년의사, ~ (2016)
- 이석영, "의편협 “넥시아 논문은 중복출판에 해당”", DoctorsNews, ~ (2016)
- 단국대 결국 ‘넥시아’ 버렸다…융합의료센터 문닫아, "청년의사", 2016
- Tagliaferri MA, "A phase IIb trial of coix seed injection for advanced pancreatic cancer", J Clin Oncol, 31, pp.e15023~ (2013)
- Song M, "TCM approved by FDA to go further clinical trials", Xinhua News, ~ (2015)
- Shaw D, "Pharmacovigilance of herbal medicine", J Ethnopharmacol, 140, pp.513~518 (2012)
- Lee SH, "Impact of standardized Rhus verniciflua stokes extract as complementary therapy on metastatic colorectal cancer: a Korean single-center experience", Integr Cancer Ther, 8, pp.148~152 (2009)
- Lee SH, "Successful outcome of advanced pulmonary adenocarcinoma with malignant pleural effusion by the standardized rhus verniciflua stokes extract: a case study", Explore, 5, pp.242~244 (2009)
- Kim KS, "A case of recurred hepatocellular carcinoma refractory to doxorubicin after liver transplantation showing response to herbal medicine product, Rhus verniciflua Stokes extract", Integr Cancer Ther, 9, pp.100~104 (2010)
- Lee SH, "Shrinkage of gastric cancer in an elderly patient who received Rhus verniciflua Stokes extract", J Altern Complement Med, 16, pp.497~500 (2010)
- Cheon SH, "Efficacy and safety of Rhus verniciflua stokes extracts in patients with previously treated advanced non-small cell lung cancer", Forsch Komplementmed, 18, pp.77~83 (2011)
- Lee S, "Efficacy and safety of standardized allergen-removed Rhus verniciflua Stokes extract in patients with advanced or metastatic pancreatic cancer: a Korean single-center experience", Oncology, 81, pp.312~318 (2011)
- Choi W, "Impact of standardized allergen-removed rhus verniciflua stokes extract on advanced adenocarcinoma of the ampulla of vater: a case series", Evid Based Complement Alternat Med, 2013, pp.203168~ (2013)
- Lee J, "The efficacy and safety of standardized allergen-removed Rhus verniciflua extract as maintenance therapy after first-line chemotherapy in patients with advanced non-small cell lung cancer", Am J Chin Med, 41, pp.773~787 (2013)
- Delgado-Rodríguez M, "Bias", J Epidemiol Community Health, 58, pp.635~641 (2004)
- Greenhalgh T, "How to read a paper. Getting your bearings (deciding what the paper is about)", BMJ, 315, pp.243~246 (1997)
- "Phases of clinical trials"[URL]
- "The Basics of Clinical Trials"[URL]
- Ananthakrishnan R, "Design of oncology clinical trials: a review", Crit Rev Oncol Hematol, 88, pp.144~153 (2013)
- Storer BE, "Design and analysis of phase I clinical trials", Biometrics, 45, pp.925~937 (1989)
- Le Tourneau C, "Dose escalation methods in phase I cancer clinical trials", J Natl Cancer Inst, 101, pp.708~720 (2009)
- Cabrera JR, "Phase I cancer clinical trials", Neuro-Oncol Pract, 4, pp.67~72 (2017)
- Jardim DL, "Predictive value of phase I trials for safety in later trials and final approved dose: analysis of 61 approved cancer drugs", Clin Cancer Res, 20, pp.281~288 (2014)
- Jung SH, "Randomized phase II clinical trials", J Biopharm Stat, 24, pp.802~816 (2014)
- Schlesselman JJ, "Phase II clinical trials in oncology: strengths and limitations of two-stage designs", Cancer Invest, 24, pp.404~412 (2006)
- "Placebos in Cancer Clinical Trials"[URL]
- Viale PH, "Postmarketing surveillance for oncology drugs", Clin J Oncol Nurs, 12, pp.877~886 (2008)
- Spigel DR, "The value of observational cohort studies for cancer drugs", Biotechnol Healthc, 7, pp.18~24 (2010)
- "Drug Discovery and Development" (2016)[URL]
- Sullivan JW, "A pharmaceutical manufacturer’s perspective on reporting adverse drug experiences", Am J Hosp Pharm, 47, pp.1342~1345 (1990)
- "Regulatory Procedures Manual-Chapter 7 Recall Procedures"[URL]
- "Pfizer to Withdraw a Cancer Drug Mylotarg"[URL]
- Davidson NE, "AACR Cancer Progress Report 2016", Clin Cancer Res, 22(19 Supplement), pp.S1~S137 (2016)
- 정희정, "국내 한방병원의 IRB 및 임상시험 실태조사", 대한한의학회지, 31(1), pp.122~129 (2010), 대한한의학회
- 김성준, "품질관리 규제의 합리적인 대안 탐색: 한약재 제조업소를 중심으로", 한국사회와 행정연구, 26(3), pp.255~278 (2015), 서울행정학회
- 송성철, "한약 부작용으로 신장이식…법원 “2억원 배상”", Doctors-News, ~ (2017)
- "WHO Collaborating Centre for Drug Statistics Methodology"[URL]
- "Herbal supplement sales to hit $93.15 billion by 2015: Report"[URL]
- "The Global Herbal Supplements and Remedies Market Trends, Drivers & Projections" (2015)[URL]