精準醫療(Precision Medicine,PM)是一種醫療模型,可根據個人患者的具體情況制定醫療決策,治療,實踐或產品,從而提出醫療保健的個性化要求。更通俗的講,精準醫療是一種將個人基因、環境與生活習慣差異考慮在內的疾病預防與處置的新興方法。
在2006年,杜克大學Anil Potti的團隊在國際頂級醫學期刊新英格蘭醫學雜誌NEJM,JAMA 及Nature Medicine 等雜誌上發表了幾篇論文,報道某些基因表達特徵預示了患者對化學療法的反應,這也算是精準醫療的萌芽。但是,很快兩名外部生物統計學家就對該研究提出了擔憂。
2010年,杜克大學(Duke)決定讓Anil Potti休假,並根據他的工作暫停了三項臨床試驗。 幾個月後,Potti辭職了。後來,Potti的眾多頂級研究成果都被撤回,杜克大學在臨床試驗中面臨患者提起的訴訟,這直接導致杜克大學捲入了學術不端的漩渦。
2015年,根據杜克大學的調查和ORI的審查,官方得出結論,Anil Potti在資助申請,提交的手稿和9篇研究論文中包含了虛假的研究數據。 除其他問題外,Potti更篡改了數據集,以使藥物反應預測變量看起來更準確。
到2019年10月14日,Anil Potti撤回了NEJM,JAMA,Nature Medicine,PNAS等11篇文章,同時更正了PNAS,JCO等9篇文章。
2006年,Anil Potti的團隊在國際頂級醫學期刊新英格蘭醫學雜誌NEJM及Nature Medicine等雜誌上發表了幾篇論文,報道某些基因表達特徵預示了患者對化學療法的反應,但是很快兩名外部生物統計學家很快就對該研究提出了擔憂。
2010年,杜克(Duke)決定讓Anil Potti休假,並根據他的工作暫停了三項臨床試驗。 幾個月後,Potti辭職了。後來,Potti的許多論文都被撤回,杜克大學在臨床試驗中面臨患者提起的訴訟,這直接導致杜克大學捲入了學術不端的漩渦。
2015年,根據杜克大學的調查和ORI的審查,官方得出結論,Anil Potti在資助申請,提交的手稿和9篇研究論文中包含了虛假的研究數據。 除其他問題外,Potti更篡改了數據集,以使藥物反應預測變量看起來更準確。具體操作如下:
- 臨床試驗僅招募了4名患者,而且對於達沙替尼的治療都不應答,但是在Anil Potti的研究結果報告中指出:33名患者中有6名對達沙替尼呈陽性反應;
- Anil Potti更改了數據集,以提高治療反應的預測指標的準確性:在提交給臨床癌症研究的手稿中,Anil Potti逆轉了133名受試者中24名阿黴素預測因子的反應者狀態;並更改了89個樣本中46個的癌症復發表型;
到2019年10月14日,Anil Potti撤回了NEJM,JAMA,Nature Medicine,PNAS等11篇文章,同時更正了PNAS,JCO等9篇文章。具體撤稿及糾正的文章如下:
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)
糾正文章:
- 「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
參考信息:
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