陈一文：向国家癌症中心赵方辉博士质问“宫颈癌疫苗”相关9问题

赵方辉博士撰写国外发表文章承认:“赵方辉为参与在中国评价Gardasil（默克公司HPV疫苗）以及Cervarix（葛兰素史克公司HPV疫苗）的临床试验获得了补偿”。赵方辉博士，教授，博士研究生导师。中国医学科学院肿瘤医院流行病学研究室副主任，协和特聘教授。现工作于国家癌症中心，现担任美国NIH Fogarty和 Fulbright项目中国站点的指导老师。赵方辉博士显然实际上成为在中国有专业职位在中国推销默克公司与葛兰素-史克公司HPV疫苗的推销商。赵方辉博士是在国外发表论文《人乳头状瘤病毒HPV-16/18 AS04-添加辅佐剂疫苗在18-25岁中国妇女中的疗效、免疫原性和安全性：一项随机对照试验的结果》的“通讯作者”。本文对赵方辉博士这篇论文中的9项声明提出质问，揭露赵方辉博士的论文竭力向中国女童与少女推销葛兰素-史克HPV疫苗时不惜采用一系列科学欺诈手段。本文获得资深学者指导，特此致谢。如果赵方辉博士与论文的合作作者不同意本文提出的九个问题的话，请公开提出你们论据公开辩论。

　　Zhao Fang-hui, PhD, published a paper abroad admitting: “F.-H. Z. participates in and receives compensation for clinical trials to evaluate both Gardasil (Merck) and Cervarix (GSK) in China”. Fang-Hui Zhao M.D., Ph.D, vice Director of Dept. of Cancer Epidemiology, Cancer Institute/ Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CICAMS). At present she works at National Cancer Center, and is also a primary mentor for NIH Fogarty and Fulbright Scholars in China. Zhao in fact is a HPV vaccine salesperson of Merck and GSK with a professorial rank in China. Zhao is the corresponding author of the published article entitled “Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18–25 years: Results from a randomized controlled trial” published by Int. J. Cancer 2014 (Article). This open letter seriously questions 9 statements contained in Zhao's above referenced Article, revealing that Zhao has adopted a series of scientific frauds to promote sales of GSK’s HPV vaccine Cervarix for massive vaccination of Chinese girls. IfZhao and her co-authors do not agree with the nine issues raised, they must present their arguments openly for a public debate because the contents of the Article have been used for Cervarix vaccine approval decision in China which will have far-reaching impacts on the health, safety and welfare of the Chinese citizens.

向国家癌症中心赵方辉博士质问在中国为推销葛兰素-史克公司“预防宫颈癌疫苗”希瑞适不惜科学欺诈有关的9个问题

Nine questions to Zhao Fang-hui, PhD, National Cancer Center, usingscientific fraud to promote sales of GSK HPV vaccineCervarixin China

　　陈一文顾问 (生物化学灾害防灾减灾研究者)

　　Advisor Chen I-wan

　　(Biochem-disaster prevention and mitigation researcher)

　　2016-10-04

　　【注：文章最后附录赵方辉博士详细介绍。】

　　(Note: Appendix at the end provides details of Zhao.)

　　尊敬的赵方辉博士：

　　Dear Prof. Zhao:

　　葛兰素-史克公司(GSK)2016年7月18日宣布人乳头瘤病毒(HPV)希瑞适疫苗在中国获得批准帮助女性预防宫颈癌。GSK宣布希瑞适在中国注册用于9到25岁女性的接种，采用3剂免疫接种程序，并有望在明年年初正式上市。GSK声称在中国开展了长达6年对6000多名受试者分别接种希瑞适疫苗或Al (OH)3对照的临床试验。

　　GSK announced on 18 July, 2016 that the human papillomavirus (HPV) vaccine, Cervarix™, has been approved in China to help protect women from cervical cancer. The announcement stated that Cervarix is registered in China for use in girls and women aged 9-25 years with a 3 dose schedule and that a clinical trial conducted in China, involving more than 6000 subjects who received Cervarix or (Al (OH)3 control and were followed for up to 6 years.

　　文献搜索揭示您，赵方辉博士，是题目为《人乳头状瘤病毒HPV-16/18 AS04-添加辅佐剂疫苗在18-25岁中国妇女中的疗效、免疫原性和安全性：一项随机对照试验的结果》论文的“通讯作者”。这篇论文2014年发表在《国际癌症杂志》(2014; 135:2612–2622)。

　　A literature search revealed that you, Fang-Hui Zhao, are the corresponding author of an article entitled “Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18–25 years: Results from a randomized controlled trial” (the Article) which was published in Int. J. Cancer 2014; 135:2612–2622.

　　该项由GSK公司及其对疫苗赞助临床试验的结果用于支持GSK公司希瑞适申请在中国上市销售获得批准，因此我必须对您这篇论文中的若干声明提出质问：

　　Since the results of this clinical trial sponsored by GlaxoSmithKline Vaccines were used to support GSK’s application for approval of Cervarix to be marketed in China, I would like to ask you to answer a few questions pertaining to the statements made in the Article.

Statement 1: “Enrolment started in October 2008 and the last visit for the event-triggered analysis was in April 2011.The trial was carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) and the International Conference on Harmonisation Good Clinical Practice guidelines….. Written informed consent was obtained from each participant prior to the performance of any study-specific procedures.”

声明1：报名始于2008年10月，对事件触发分析的最后一次访问日期为2011年4月。临床试验按照《世界医学协会道德规范》(《赫尔辛基宣言》)与《协调好的临床实践国际会议》进行……在任何研究特定程序之前从每个参与者获得书面知情同意书。

Question:Were the Chinese women enrolled for the clinical trial informed that there are vaccine adverse events associated with receiving HPV vaccines or aluminum placebo injections, such as syncope, dizziness, nausea, headache, hypersensitivity reactions, urticaria, venous thromboembolic events, autoimmune disorders, GuillainBarre´syndrome, transverse myelitis, pancreatitis, motor neuron disease, and even deaths, according to a U.S. CDC report by Slade et al [1]?

　　问题：参与临床试验中国女性是否被告知接种HPV疫苗或铝成分安慰剂注射与疫苗不良事件相关，例如晕厥、头晕、恶心、头痛、过敏反应、荨麻疹、静脉血栓栓塞事件、自身免疫性疾病、吉兰-巴雷综合征、横向脊髓炎、胰腺炎、运动神经元疾病,甚至死亡，如美国疾控中心Slade et al.所报告 [1]

Statement 2:“Healthy Chinese women aged 18–25 years at the time of first vaccination were enrolled at four sites in Jiangsu Province (Binhai, Jintan, Lianshui and Xuzhou CDCs).”

声明2：“第一次疫苗接种时，在江苏省四个地方(滨海、金坛、涟水和徐州疾控中心)招募了中国18-25岁健康女性参加。”

Question:Were the Chinese women enrolled for the clinical trial informed that HPV vaccination might be associated with a higher rate of deaths in Asian women than in other races as reported by a U.S. FDA review [2]?

　　问题：参与临床试验的这些中国女性是否被告知：美国食品药品管理署(FDA)的一项审查揭示亚洲裔女性与HPV疫苗接种相关的死亡率比任何其他种族女性与HPV疫苗接种相关的死亡率都更高[2]?

Statement 3:“Women were randomized 1:1 to receive HPV-16/18 AS04-adjuvanted vaccine or aluminum hydroxide as a control.”

声明3：“女性随机以1:1比例接种HPV-16/18 AS04-加辅佐剂疫苗或者作为对照物的氢氧化铝。”

Question:What was the exact formulation of the aluminum hydroxide control? Why was an inert placebo (such as saline) not used, as recommended by the WHO expert panel [3]? Using an active immune-stimulating compound of aluminum hydroxide as control may mask the vaccine-related adverse events in statistics (Table 4).

　　问题：氢氧化铝对照物的确切配方是什么?为什么不使用惰性安慰剂(如生理盐水)，如世界卫生组织专家组推荐的那样[3]?使用活性免疫刺激氢氧化铝成分作为对照物会掩盖统计数据(表4)中的疫苗相关不良反应。

Statement 4:Healthy Chinese women aged 18–25 years at the time of first vaccination were enrolled at four sites in Jiangsu Province (Binhai, Jintan, Lianshui and Xuzhou CDCs).

声明4：“第一次疫苗接种时，在江苏省四个地方(滨海、金坛、涟水和徐州疾控中心)招募了中国18-25岁健康女性参加。”

Question:Since healthy girls aged 9-17 were excluded in the clinical trial, would you recommend that Cervarix™ be approved to be used in the young women in China for the age group of 18-25 only? PUMC professor of gynecologic oncology谭先杰 has openly stated as a rule 疫苗建议接种年龄是指疫苗在做临床实验期间选择的人群标准 [4]. Why is this principle not applied in HPV vaccination practice?

　　问题：年龄9-17岁健康女性既然被排除在临床试验外，赵方辉博士是否推荐获得批准的GSK公司HPV疫苗希瑞适仅用于18-25岁年龄段女性?北京协和医院妇科肿瘤谭先杰主任医师公开强调，作为规则，疫苗建议接种年龄是指疫苗在做临床实验期间选择的人群标准[4]。HPV疫苗接种实践为什么不使用这个原则?

Statement 5:Cervical and biopsy samples were tested for DNA from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) using SPF10 PCR-DEIA-LiPA25 version 1 (manufactured by Labo Biomedial Product, Rijswijk, the Netherlands based on licensed Innogenetics technology). HPV positive samples were also tested using HPV-16 and HPV-18 type-specific polymerase chain reaction (PCR).13

声明5：使用SPF10 PCR-DEIA-LiPA25版本1(由荷兰Rijswijk市Labo Biomedial Product公司基于授权的Innogenetics公司技术制造)，对宫颈活检样本检测DNA来自14个高危人乳头状瘤病毒类型(16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)。HPV阳性样品还使用HPV-16与HPV-18特定类型聚合酶链反应(PCR)进行测试。13

Question:There are many DNA sequence variations to the L1 gene within the genotype of HPV-18 or HPV-16 which ultimately determines the amino acid composition of the major capsid protein of a virion. The DNA methods described were designed for detection and genotyping of HPV genotypes prevalent in the Netherlands. Do you know if these methods developed for the residents in the Netherlands can detect all HPV 16 and HPV 18 variants prevalent in China?

问题：在HPV-18或HPV-16基因型内, L1基因有许多DNA序列变异型，它们最终决定病毒粒子主要衣壳蛋白的氨基酸组成。论文描述的DNA方法用于检测和基因分型在荷兰流行HPV基因型。赵方辉博士是否知道为荷兰居民开发的这些方法能否检测到在中国流行的所有HPV-16与HPV-18序列变异型?

Statement 6:Detection of HPV DNA in the tissue biopsies was regarded as associated with the lesion.

声明6：检测到组织切片中的人乳头状瘤病毒DNA被认为与病变有关。

Question:How many tissue biopsies in the clinical trial have been performed? Where are the results? Why detection of HPV DNA was regarded as associated with the lesion (in fact, there are many HPV infections which are known to be not associated with a lesion)?

　　问题：临床试验中做了多少个组织切片?论文中，结果在哪里?为什么检测到组织切片中的人乳头状瘤病毒DNA被认为与病变有关(事实上，有许多人乳头状瘤病毒感染已知与瘤病变无关)?

Statement 7:In the ATP-E, for initially HPV DNA and seronegative subjects, high VE was shown for the primary endpoint of HPV-16/18 associated 6-month PI and/or histopathologically confirmed CIN1+ (94.2% [62.7, 99.9]) (Table 2).

声明7：在ATP-E中，对最初HPV DNA与血清反应阴性受试者，高VE显示了与6个月PI和和/或组织病理学证实(1级宫颈上皮内瘤变)CIN1+相关的HPV-16/18主要终点(94.2% [62.7, 99.9])(表2)。

Question:Why histopathologically confirmed CIN1+ was chosen as a primary endpoint for the clinical trial in China whereas all other clinical trials quoted in the Article and the U.S. HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting Document [5] show that CIN2+ has been used internationally as the histopathological endpoint?

问题：论文中引用的所有其他临床试验以及美国HPV四价疫苗2006年5月18日VRBPAC会议文件[5]都表明国际上用(2级宫颈上皮内瘤变)CIN2+作为组织病理学终点，为什么赵方辉博士的论文将CIN1+选择作为在中国进行的临床试验主要终点?

　　Since CIN1+ was used in China as the primary endpoint, the statement of your paper cannot be true?

　　赵方辉博士的论文中在中国将CIN1+作为主要终点，因此你们论文中的下述论断不可能真实：

　　“Our results are in line with observations from the global PATRICIA trial, which evaluated the efficacy of the HPV-16/18 AS04-adjuvanted vaccine in women aged 15–25 years from a broad range of nationalities and ethnicities.6,7In PATRICIA, high VE was shown against 6-month and 12-month PI and CIN2+, associated with HPV-16/18.6,7 In a 4-year end-of-study analysis of PATRICIA high VE was also shown against CIN2+ and CIN3+ irrespective of HPV type in the lesion29 and consistent cross-protective efficacy was shown against HPV-31, -33, -45 and -51.30”

　　“我们的结果与全球性PATRICIA临床试验的观察相符，后者评价了HPV-16/18 AS04-加辅佐剂疫苗在广范围不同民族和种族15-25岁女性中的有效性。6,7在PATRICIA临床试验中，对6个月与12个月 PI与瘤样病变CIN2+显示了高VE。6,7在4年结束的PATRICIA研究分析中，病变中无论哪种HPV类型，对瘤样病变CIN2+与(3级宫颈上皮内瘤变)CIN3+ 都表明了高VE29 以及对HPV-31，-33, -45 与 -51显示了一致性的横向保护性有效性。30”

　　Would you like to clarify and correct this statement to openly inform the Chinese citizens?

　　赵方辉博士是否愿意对您的上述声明进行解释与改正并且公开告知中国民众?

Statement 8:PI is a reliably determined and objective clinical marker, independent of HPV type multiplicity, which shows good predictive value to CIN3 and cervical cancer.22–28

声明8：PI是一种可靠与客观的临床标记物，独立于人乳头状瘤病毒类型的多样性，对CIN3与宫颈癌表明了良好的可预测性价值。22–28

Question:In this statement, the authors of the Article used HPV persistent infection (PI) as a surrogate for “good predictive value” to CIN3 and cervical cancer”, citing several reports published from 2000 to 2008 to support such an argument.

问题：在上述声明中，赵方辉博士用人乳头状瘤病毒(HPV)持续感染(PI)作为对瘤样病变CIN3与宫颈癌具“良好预测性价值”的替代物，引用了2000-2008年期间数个报告来支持这一论点。

　　However, in the studies carried out in Costa Rica where the HPV tests and HPV vaccine trials were first initiated, it has been demonstrated that certain genetic makeups of the patients are important determinants for persistence of HPV infections and for progression to CIN3 or cervical cancer.

　　然而，在首次启动HPV试验与HPV疫苗临床试验哥斯达黎加的研究中，演示某些病人的遗传结构是确定持续HPV感染以及进一步进展到(3级宫颈上皮内瘤变)CIN3或者宫颈癌的重要决定因素。

　　Among these native residents of Costa Rica, a SNP in the Fanconi anemia complementation group A gene (FANCA) (G501S) was found to be associated with increased risk of CIN3 or cancer. A SNP in the innate immune gene IRF3 (S427T) was found to be associated with increased risk for HPV persistence.

　　在哥斯达黎加这些当地居民中，发现Fanconi贫血互补群A基因(FANCA) (G501S)中的一个单核苷酸多态性(SNP)与(3级宫颈上皮内瘤变)CIN3或者宫颈癌风险增高相关。先天免疫基因IRF3 (S427T)中的一个SNP被发现与HPV持续感染风险增加相关。

　　You and your co-authors should have known these findings because these findings were presented in part at the 24th International Papillomavirus Conference and Clinical Workshop in Beijing, China, 3–9 November 2007. [6].

　　赵方辉博士与论文其他合作作者应当了解这些发现，因为这些发现已经在2007年11月3-9日在北京举行的《第24届人乳头状瘤病毒(HPV)国际会议与临床研讨会》上報告了[6]。

　　This same group of researchers subsequently reported that there are two important transition steps in the natural history of cervical cancer, namely the viral persistence and progression to precancer/cancer step, respectively.

　　这相同组研究者们，接后报告了宫颈癌自然史中有两个重要的过度步骤，分别称之为病毒性持续与进展到癌前/癌症步骤。

　　Of the regions/genes found to be important, the association was primarily with HPV persistence for GTF2H4 and SULF1. IFNG and the epidermodysplasia verruciformis (EV)-associated genes (TMC6-EVER1 and TMC8-EVER2) were primarily associated with progression to CIN3/cancer [7].

　　发现区域/基因方面对此很重要的是，GTF2H4和SULF1与HPV持久性主要相关。IFNG以及疣状表皮发育不良(EV)相关的基因与进展到CIN3/癌症主要相关。

　　Do you have independent clinical trial data to show HPV persistent infection which is known to be capable of self-regressing [8] can be used indeed as a surrogate with good predictive value to CIN3 and cervical cancer in the population studied in China?

　　赵方辉博士是否有独立的临床试验数据表明具有自行缓解能力[8]的人乳头状瘤病毒(HPV)持续感染，在中国的人口研究中确实是(3级宫颈上皮内瘤变)CIN3与宫颈癌有良好预测价值的替代物?

　　Or do you have laboratory data to show that the genetic makeups of the Chinese women studied in the clinical trial have the same gene determinants associated with HPV persistence and the same gene determinants associated with progression to CIN3/cancer as the natives living in Guanacaste, Costa Rica?

　　或者，赵方辉博士是否与实验室数据表明临床试验中研究的中国女性的遗传结构，与哥斯达黎加Guanacaste地方居住的当地居民具有的与HPV持久性相关的相同遗传结构以及与他们进展到CIN3/癌症相关的相同基因重要决定因素?

　　Since both HPV viral persistence and cellular pathology progression are known to self-regress until the disease progression in rare cases reaches the point-of-no-return to malignancy [8] and since the genetic makeups associated with viral persistence and disease progression of the studied subjects enrolled in the clinical trial in China are not known or not known to be comparable, selection of the frequently self-regressing CIN1 changes and persistent HPV infection as the surrogate endpoint for efficacy evaluation of a vaccine claimed to be capable of preventing cervical cancer is a case of borderline scientific fraud.

　　由于人乳头状瘤病毒(HPV)病毒性持久以及细胞病理学进展皆已知在稀有情况下进展到恶性肿瘤无法返回点前具有自行减缓性 [8]，以及因为在中国参与临床试验研究的女性对象与病毒性持久与疾病进展相关的遗传结构已知或不知是否具有可比较性，选择经常自行减缓的(1级宫颈上皮内瘤变)CIN1病变以及持久HPV感染作为评价声称预防宫颈癌能力疫苗有效性替代性终点是临界性科学欺诈。

Statement 9:F. Zhu, F. Zhao, Y. Hu received support for travel to meetings related to the study from the GlaxoSmithKline group of companies.

声明9：论文声称 “F. Zhu，F. Zhao， Y. Hu接受了葛兰素-史克集团公司与该项研究出席会议相关旅差费用资助”。

【注：F. Zhu(Feng-Cai Zhu=朱凤才，江苏省疾控中心)、F. Zhao (Fang-hui Zhao=赵方辉博士), Y. Hu(Yue-mei Hu=胡月梅，江苏省疾控中心)。】

Question:Is this statement a half-truth? You have declared in an Editorial with P. E. Castle that “F.-H. Z. participates in and receives compensation for clinical trials to evaluate both Gardasil (Merck) and Cervarix (GSK) in China” when you both advocated using public funding for mass vaccination of children to prevent cervical cancer [9].So you are in fact a HPV vaccine salesperson of Merck and GSK with a professorial rank in China.

问题：这一声明是否半真半假？赵方辉博士与P. E. Castle共同提倡使用公共资金对中国女童进行大规模疫苗接种时，他们共同撰写的一个杂志社论中宣布：“赵方辉为参与在中国评价Gardasil(默克公司HPV疫苗)以及Cervarix(葛兰素史克公司HPV疫苗)的临床试验获得了补偿”。所以赵方辉博士实际上成为在中国有专业职位#FormatStrongID_72#在中国推销默克公司与葛兰素-史克公司HPV疫苗的推销商。

References

参考文献：

　　[1] Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009;302:750-7.

　　[2] “Clinical Review of Biologics License Application Supplement STN# 125126/773 – mid-adult women indication for GARDASIL” by Jeffrey N. Roberts, M.D.

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM251763.pdf

　　[3] Rid A, Saxena A, Baqui AH, Bhan A, Bines J, Bouesseau MC, Caplan A, Colgrove J, Dhai A, Gomez-Diaz R, Green SK, Kang G, Lagos R, Loh P, London AJ, Mulholland K, Neels P, Pitisuttithum P, Sarr SC, Selgelid M, Sheehan M, Smith PG. Placebo use in vaccine trials: recommendations of a WHO expert panel. Vaccine 2014; 32:4708-12.

　　[4] 谭先杰：宫颈癌疫苗来了也别想一劳永逸

http://health.huanqiu.com/people/2016-07/9242817_2.html

　　[5] HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

　　[6] Wang SS, Bratti MC, Rodriguez AC, Herrero R, Burk RD, et al. (2009) Common variants in immune and DNA repair genes and risk for human papillomavirus persistence and progression to cervical cancer. J Infect Dis 2009;199: 20–30. [Presented in part: 24th International Papillomavirus Conference and Clinical Workshop, Beijing, China, 3–9 November 2007 (abstract 340)]

　　[7] WangSS, Gonzalez P, Yu K, Porras C, Li Q, Safaeian M, Rodriguez AC, Sherman ME, Bratti C, Schiffman M, Wacholder S, Burk RD, Herrero R, Chanock SJ, Hildesheim A. Common genetic variants and risk for HPV persistence and progression to cervical cancer. PLoS One. 2010; Jan 13;5(1):e8667.

　　[8] Schiffman M, Castle PE. The promise of global cervical-cancer prevention. N Engl J Med2005;353:2101-4.

　　[9] Castle PE, Zhao FH. Population effectiveness, not efficacy, should decide who gets vaccinated against human papillomavirus via publicly funded programs. J Infect Dis. 2011;204:335-7.

　　附录：

　　Appendix:

赵方辉博士何许人也？

Dr. Zhao Fang-hui is who?

赵方辉研究员被聘任为流行病学研究室副主任

　　Fang-HuiZhao M.D., Ph.D, Vice Direcotor of Dept. of Cancer Epidemiology

http://www.cicams.ac.cn/Html/Doctors/Main/Index_645.html

　　教授，博士研究生导师。中国医学科学院肿瘤医院流行病学研究室副主任，协和特聘教授。美国NIH Fogarty/Fulbright国际交流学生和美国芝加哥大学暑期交流学生中方导师。研究方向是肿瘤的流行病学与人群防治。北京协和医学院博士毕业，现工作于国家癌症中心/中国医学科学院肿瘤医院流行病学研究室，描述流行病学与统计部门负责人，曾在美国国立癌症研究所(NCI)、国际健康合作部 (CGH) 和癌症流行病学与遗传学部(DCEG)做访问学者。现担任美国NIH Fogarty和 Fulbright项目中国站点的指导老师。

Fang-HuiZhao M.D., Ph.D,vice direcotor of Dept. of Cancer Epidemiology, CancerInstitute/Hospital, Chinese Academy of Medical Sciences & Peking UnionMedical College (CICAMS). She is also a full professor of Peking Union Medical Collegein Beijing, and the primary mentor for NIH Fogarty and Fulbright Scholars inChina. She received Medical Diploma from NormanBethune University of Medical Sciences, PhD degree in Epidemiology from PekingUnion Medical College. She has been trained for two years as a visiting scholarin Division of Cancer Prevention and Control, Center for Global Health, Division of Cancer Epidemiology& Genetics at National Cancer Institute, NationalInstitutes of Health (NCI/NIH).

主要学术兼职：亚太生殖道感染国际组织(AOGIN)研究委员会主席，中国抗癌协会(CACA)肿瘤流行病学委员会常委兼秘书长、中国优生科学协会阴道镜和宫颈病理学分会(CSCCP)常委兼副秘书长、中国医学科学院中青年医师创新联盟成员、中国医学科学院青年科学家创新联盟成员、WHO/IARC“50 for 50”未来癌症研究领导者、JGO杂志编委等大学暑期交流学生中方导师。，《Int J Cancer》、《BMC Cancer》、《中华流行病学杂志》、《中华肿瘤防治杂志》、《癌症》等杂志审稿专家，国家自然基金项目和世界癌症基金[英国]项目申请同行评议专家。

PROFESSIONALSOCIETIES：She servesas Research Committee Chair, Asia Oceania Research Organization on GenitalInfections and Neoplasia (AOGIN); Member of Epidemiology Committee, ChineseAssociation of Preventive Medicine; Member of Cancer Epidemiology Committee,Chinese Anti-Cancer Association (CACA); Member of maternal and child health industry branch of the NationalHealth Industry Enterprise Management Association; Secretary of National CervicalCancer Prevention Experts Committee, Ministry of Health, China; Secretary of ofCervical Cancer Prevention Experts Committee, Cancer Foundation of China.Invited reviews for,,, < Chinese Journal of Cancer>, < Chinese Journal of CancerPrevention & Control>,,she is also an invited reviewer for grant application to the WCRF InternationalAsian RFA Program and National Science Foundation of China.

主要研究领域：包括宫颈癌的病因、筛查(二级预防)和疫苗(一级预防)防治研究。在过去十几年的研究中，通过大规模的人群现场调查与实验室检测相结合的研究揭示我国女性人群人乳头瘤病毒(HPV感染)和各级宫颈病变的分布状况;通过人群筛查的临床试验验证和比较宫颈癌的多种筛查技术，在筛查领域的研究结果获得国际同行专家和世界卫生组织国际癌症研究所(WHO/IARC)的高度赞扬和认可;国内率先开展HPV疫苗预防宫颈癌的III期临床试验以及相关疫苗人群应用的调查研究，研究结果为确定中国女性人群接种HPV 疫苗的有效性、安全性及其接种适宜年龄，分析疫苗在中国推广应用的潜在障碍及探索可能的解决办法提供参考依据;开展的有关宫颈筛查和疫苗等方面的卫生经济学研究有助于未来有关宫颈癌防治的政策制定。

ResearchInterests:Over the past 15 years she has beeninvolved in a serial research in cervical cancer prevention including A)Etiology and epidemiologic research on human papillomavirus (HPV) and cervicalcancer; B) Clinical trials on cervicalcancer screening technologies and research on strategies; C)C. Cost-effectiveness and healtheconomic analysis of strategies on cervical cancer screening; D) HPV Vaccineclinical trial and vaccines implementation studies. Her research findings havegreat scientific and practical significances for cervical cancer epidemiology,etiology and prevention in China.

主持和承担的科研项目：包括国家科技支撑课题、卫生行业专项课题、国家863课题、国家自然基金项目、中央高校共建项目、比尔盖茨基金国际项目等。研究成果：发表论文和著作100余篇，包括《LancetOncology》，《JNatl Cancer Inst》和《IntJ cancer》等国际高影响因子的文章。其中多篇文章被评为国家癌症中心优秀论文一等奖、中国医学科学院北京协和医学院优秀论文奖。

PROJECTS& PUBLICATIONS：She has received a dozen of researchgrants including the National Science Fund for Excellent YoungScholars; the National High-tech R&D Program of China (863Program); the National Key Technology Research and Development Program of Chinaduring the 11th Five-Year Plan; and a grant from Bill and Melinda GatesFoundation as well. She has published more than 100 peer reviewed articles,monographs and book chapters in Chinese and English, with 38 articles in recent5 years as first or corresponding authors, and 21 SCI articles, some of thempublished on the Journals of,andwith high impact factors.

荣获奖励：曾荣获教育部和国务院学位委员会授予的全国百篇优秀博士学位论文、国家自然基金优秀青年科学基金获得者、首届北京高校青年教师优秀教学科研成果、中国医学科学院北京协和医学院“优秀青年科技工作者”;并多次获得国家省部级的科学技术和科学研究成果奖：北京市科学技术二等奖、三等奖;教育部高等学校科学研究优秀成果二等奖;中国抗癌协会科学奖二等奖;中华预防医学会科学技术奖二等奖;华夏医学科技奖三等奖。

AWARDS & HONORS：She has the honor of national excellentdoctorial dissertation, and also won several national scientific awards andinternational Scholarship awards including the Science and Technology AdvancedAwards of Ministry of Education and Beijing Municipal Government; HigherEducation Institutions Awards for Excellent Young Teachers; Chinese medicalscience and Technology Award; Science and technology award of ChinesePreventive Medicine Association, etc.

　　参考资料：

　　美国FDA公布“宫颈癌疫苗”临床试验报告与毒理学报告

　　毕井泉局长、书记为首的国家食品药品监督管理局领导班子为什么拒绝公布

　　微博：http://weibo.com/1269923485/E9WM432v2

　　博文：http://blog.sina.com.cn/s/blog_4bb17e9d0102wtev.html

　　外媒：全国启动"宫颈癌疫苗"前中国拒绝公布临床试验报告

　　微博：http://weibo.com/1269923485/Eb6hNf1Em

　　博文：http://blog.sina.com.cn/s/blog_4bb17e9d0102wtrp.html

　　华人病理学家李善恒致习近平主席、李克强总理的公开信：建议推迟实施对中国儿童年轻女性接种HPV疫苗

　　微博：http://weibo.com/1269923485/E466JAuji

　　博文：http://blog.sina.com.cn/s/blog_4bb17e9d0102wqsb.html

　　微博(英文)：http://weibo.com/1269923485/E46BqAYHM