精准医疗(Precision Medicine,PM)是一种医疗模型,可根据个人患者的具体情况制定医疗决策,治疗,实践或产品,从而提出医疗保健的个性化要求。更通俗的讲,精准医疗是一种将个人基因、环境与生活习惯差异考虑在内的疾病预防与处置的新兴方法。
在2006年,杜克大学Anil Potti的团队在国际顶级医学期刊新英格兰医学杂志NEJM,JAMA 及Nature Medicine 等杂志上发表了几篇论文,报道某些基因表达特征预示了患者对化学疗法的反应,这也算是精准医疗的萌芽。但是,很快两名外部生物统计学家就对该研究提出了担忧。
2010年,杜克大学(Duke)决定让Anil Potti休假,并根据他的工作暂停了三项临床试验。 几个月后,Potti辞职了。后来,Potti的众多顶级研究成果都被撤回,杜克大学在临床试验中面临患者提起的诉讼,这直接导致杜克大学卷入了学术不端的漩涡。
2015年,根据杜克大学的调查和ORI的审查,官方得出结论,Anil Potti在资助申请,提交的手稿和9篇研究论文中包含了虚假的研究数据。 除其他问题外,Potti更篡改了数据集,以使药物反应预测变量看起来更准确。
到2019年10月14日,Anil Potti撤回了NEJM,JAMA,Nature Medicine,PNAS等11篇文章,同时更正了PNAS,JCO等9篇文章。
2006年,Anil Potti的团队在国际顶级医学期刊新英格兰医学杂志NEJM及Nature Medicine等杂志上发表了几篇论文,报道某些基因表达特征预示了患者对化学疗法的反应,但是很快两名外部生物统计学家很快就对该研究提出了担忧。
2010年,杜克(Duke)决定让Anil Potti休假,并根据他的工作暂停了三项临床试验。 几个月后,Potti辞职了。后来,Potti的许多论文都被撤回,杜克大学在临床试验中面临患者提起的诉讼,这直接导致杜克大学卷入了学术不端的漩涡。
2015年,根据杜克大学的调查和ORI的审查,官方得出结论,Anil Potti在资助申请,提交的手稿和9篇研究论文中包含了虚假的研究数据。 除其他问题外,Potti更篡改了数据集,以使药物反应预测变量看起来更准确。具体操作如下:
- 临床试验仅招募了4名患者,而且对于达沙替尼的治疗都不应答,但是在Anil Potti的研究结果报告中指出:33名患者中有6名对达沙替尼呈阳性反应;
- Anil Potti更改了数据集,以提高治疗反应的预测指标的准确性:在提交给临床癌症研究的手稿中,Anil Potti逆转了133名受试者中24名阿霉素预测因子的反应者状态;并更改了89个样本中46个的癌症复发表型;
到2019年10月14日,Anil Potti撤回了NEJM,JAMA,Nature Medicine,PNAS等11篇文章,同时更正了PNAS,JCO等9篇文章。具体撤稿及纠正的文章如下:
撤稿文章:
- “Gene-expression patterns predict phenotypes of immune-mediated thrombosis,” in Blood
- “Upregulated Oncogenic Pathways in Patients Exposed to Tobacco Smoke May Provide a Novel Approach to Lung Cancer Chemoprevention,” in CHEST
- “Characterizing the Clinical Relevance of an Embryonic Stem Cell Phenotype in Lung Adenocarcinoma,” in Clinical Cancer Research
- “An Integrated Genomic-Based Approach to Individualized Treatment of Patients With Advanced-Stage Ovarian Cancer” in the Journal of Clinical Oncology (JCO)
- “Pharmacogenomic Strategies Provide a Rational Approach to the Treatment of Cisplatin-Resistant Patients With Advanced Cancer” also in the JCO
- “Gene Expression Signatures, Clinicopathological Features, and Individualized Therapy in Breast Cancer” in the Journal of the American Medical Association (JAMA)
- “Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial,” in The Lancet Oncology
- “Genomic signatures to guide the use of chemotherapeutics,” in Nature Medicine
- “A Genomic Strategy to Refine Prognosis in Early-Stage Non–Small-Cell Lung Cancer,” in the New England Journal of Medicine (NEJM)
- “An Integrated Approach to the Prediction of Chemotherapeutic Response in Patients with Breast Cancer” in PLoS ONE
- “A genomic approach to colon cancer risk stratification yields biologic insights into therapeutic opportunities” in the Proceedings of the National Academy of Sciences (PNAS)
纠正文章:
- “An integration of complementary strategies for gene-expression analysis to reveal novel therapeutic opportunities for breast cancer,” in Breast Cancer Research
- “Gene Expression Profiles of Tumor Biology Provide a Novel Approach to Prognosis and May Guide the Selection of Therapeutic Targets in Multiple Myeloma,” in the JCO
- “Age-Specific Differences in Oncogenic Pathway Dysregulation and Anthracycline Sensitivity in Patients With Acute Myeloid Leukemia,” in the JCO
- “Young Age at Diagnosis Correlates With Worse Prognosis and Defines a Subset of Breast Cancers With Shared Patterns of Gene Expression,” in the JCO
- “Age-Specific Differences in Oncogenic Pathway Deregulation Seen in Human Breast Tumors,” in PLoS ONE
- “A genomic approach to colon cancer risk stratification yields biologic insights into therapeutic opportunities,” in PNAS
- “Characterizing the developmental pathways TTF-1, NKX2–8, and PAX9 in lung cancer,” in PNAS
部分撤回:
1.“A Genomic Approach to Identify Molecular Pathways Associated with Chemotherapy Resistance,” in Molecular Cancer Therapeutics
参考信息:
https://www.sciencemag.org/news/2015/11/potti-found-guilty-research-misconduct
http://retractionwatch.com/2012/02/14/the-anil-potti-retraction-record-so-far/
http://retractionwatch.com/2012/02/10/two-mega-corrections-for-anil-potti-in-the-journal-of-clinical-oncology/#comment-10265
https://www.cbsnews.com/news/deception-at-duke-fraud-in-cancer-care/
https://ori.hhs.gov/content/case-summary-potti-anil