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。更通俗地讲,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NEJMJAMA 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,很快两名外国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2021年4月15日,Anil Potti被撤回了NEJM,JAMA,Nature Medicine,PNAS 等14篇文章,同时更正了PNAS,JCO 等7篇文章。

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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2021年4月15日,Anil Potti被撤回了NEJM,JAMA,Nature Medicine,PNAS 等14篇文章,同时更正了PNAS,JCO 等7篇文章。具体撤稿及纠正的文章如下:

撤稿文章:

  1. “Gene-expression patterns predict phenotypes of immune-mediated thrombosis,” in Blood
  2. “Upregulated Oncogenic Pathways in Patients Exposed to Tobacco Smoke May Provide a Novel Approach to Lung Cancer Chemoprevention,” in CHEST
  3. “Characterizing the Clinical Relevance of an Embryonic Stem Cell Phenotype in Lung Adenocarcinoma,” in Clinical Cancer Research;
  4. Genomic and Molecular Profiling Predicts Response to Temozolomide in Melanoma, in Clinical Cancer Research;
  5. “An Integrated Genomic-Based Approach to Individualized Treatment of Patients With Advanced-Stage Ovarian Cancer” in the Journal of Clinical Oncology (JCO);
  6. Translating Genomics Into Clinical Practice: Applications in Lung Cancer,in CURRENT ONCOLOGY REPORTS;
  7. “Pharmacogenomic Strategies Provide a Rational Approach to the Treatment of Cisplatin-Resistant Patients With Advanced Cancer” also in the JCO;
  8. “Gene Expression Signatures, Clinicopathological Features, and Individualized Therapy in Breast Cancer” in the Journal of the American Medical Association (JAMA);
  9. “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;
  10. A genomic approach to identify molecular pathways associated with chemotherapy resistance,in MOLECULAR CANCER THERAPEUTICS;
  11. “Genomic signatures to guide the use of chemotherapeutics,” in Nature Medicine;
  12. “A Genomic Strategy to Refine Prognosis in Early-Stage Non–Small-Cell Lung Cancer,” in the New England Journal of Medicine (NEJM);
  13. “An Integrated Approach to the Prediction of Chemotherapeutic Response in Patients with Breast Cancer” in PLoS ONE;
  14. “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:

  1. “An integration of complementary strategies for gene-expression analysis to reveal novel therapeutic opportunities for breast cancer,” in Breast Cancer Research
  2. “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
  3. “Age-Specific Differences in Oncogenic Pathway Dysregulation and Anthracycline Sensitivity in Patients With Acute Myeloid Leukemia,” in the JCO
  4. “Young Age at Diagnosis Correlates With Worse Prognosis and Defines a Subset of Breast Cancers With Shared Patterns of Gene Expression,” in the JCO
  5. “Age-Specific Differences in Oncogenic Pathway Deregulation Seen in Human Breast Tumors,” in PLoS ONE
  6. “A genomic approach to colon cancer risk stratification yields biologic insights into therapeutic opportunities,” in PNAS
  7. “Characterizing the developmental pathways TTF-1, NKX2–8, and PAX9 in lung cancer,” in PNAS

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