Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

详细信息    查看全文

• 作者：William M. Tierney MD ; Eric M. Meslin PhD…
• 关键词：ethics ; research ; conflict of interest ; public–private partnerships ; research support
• 刊名：Journal of General Internal Medicine
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：31
• 期：2
• 页码：228-233
• 全文大小：585 KB
• 参考文献：1. Moses H III, Matheson DHM, Cairns-Smith S, George BP, Palisch C, Dorsey R. The anatomy of medical research: US and international comparisons. JAMA. 2015;313:174–89.CrossRef PubMed
  2.National Center for Advancing Translational Sciences. Discovering new therapeutic uses for existing molecules. Available at: http://​www.​ncats.​nih.​gov/​research/​reengineering/​rescue-repurpose/​therapeutic-uses/​therapeutic-uses.​html . Accessed April 25, 2015.
  3.National Institutes of Health. Accelerating medicines partnerships. Available at: http://​www.​nih.​gov/​science/​amp/​index.​htm . Accessed April 25, 2015.
  4.National Institutes of Health. NIH launches collaborative program with industry and researchers to spur therapeutic development. Available at: http://​www.​nih.​gov/​news/​health/​may2012/​od-03.​htm . Accessed April 25, 2015.
  5.Patent and Trademark Law Amendments Act of 1980, Pub. L. No. 96–517, 94 Stat. 3015, 69331 (1980) (codified as amended at 35 U.S.C. ch. 30 (2011)).
  6.Patient Protection and Affordable Care Act, Pub. L. No. 111–148, 124 Stat. 119 (2010); Sec. 6002: Transparency Reports and Reporting of Physician Ownership or Investment Interests (codified as 42 U.S.C.A. § 1320a-7h).
  7.USInflation.org. US inflation rate calculator. Available at: http://​usinflation.​org/​us-inflation-rate-calculator/​ . Accessed July 7, 2015.
  8. Singh S, Loke YK. Drug safety assessment in clinical trials: methodological challenges and opportunities. Trials. 2012;13:138.PubMedCentral CrossRef PubMed
  9. Farwell WR, Stump TE, Wang J, Tafesse E, L’Italien G, Tierney WM. Weight gain and new onset diabetes associated with olanzapine and risperidone. J Gen Intern Med. 2004;19:1200–5.PubMedCentral CrossRef PubMed
  10. Psaty BM, Meslin EM, Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and actions: opportunities provided by a new IOM report. JAMA. 2012;307(23):2491–2.CrossRef PubMed
  11. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-industry collaboration? JAMA. 2014;311:2171–2.CrossRef PubMed
  12. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003;326:1171–3.PubMedCentral CrossRef PubMed
  13. Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MR vaccine and autism was fraudulent. BMJ. 2011;342:c7452.CrossRef PubMed
  14. Cyranoski D. Research integrity: cell-induced stress. Nature. 2014;511(7508):140–3.CrossRef PubMed
  15. Hollon T. Researchers and regulators reflect on first gene therapy death. Nat Med. 2000;6:6.CrossRef PubMed
  16. Olsen AK, Whalen MD. Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety. Drug Saf. 2009;32:805–10.CrossRef PubMed
  17. Kroenke K, Spitzer RL, Williams JBW, Löwe B. The Patient Health Questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry. 2010;32:345–59.CrossRef PubMed
  18. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–13.PubMedCentral CrossRef PubMed
  19.Web of Science. Available at: www.​isiknowledge.​com . Accessed April 25, 2015.
  20. McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31:247–63.CrossRef PubMed
  21. Newman JC, Feldman R. Copyright and open access at the bedside. N Engl J Med. 2011;365(26):2447–9.CrossRef PubMed
  22. Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess 2010;14:iii. ix-xi, 1–193.
  23. Bero L. Industry sponsorship and research outcome: a Cochrane review. JAMA Intern Med. 2013;173:580–1.CrossRef PubMed
  24. Rennie D. Thyroid storm. JAMA. 1997;277:1238–43.CrossRef PubMed
  25. Blumenthal D, Campbell EG, Anderson MS, Causino N, Louis KS. Withholding research results by academic life scientists: evidence from a national survey of faculty. JAMA. 1997;277:1224–8.CrossRef PubMed
  26. Tierney WM, Gerrity MS. Scientific discourse, corporate ghostwriting, journal policy, and public trust. J Gen Intern Med. 2005;20:550–1.PubMedCentral CrossRef PubMed
  27. Kroenke K, West SL, Swindle R, et al. Similar effectiveness of paroxetine, fluoxetine, and sertraline in primary care: a randomized trial. JAMA. 2001;286:2947–55.CrossRef PubMed
  28. Krimsky S. Do financial conflicts of interest bias research? An inquiry into the “funding effect” hypothesis. Sci Technol Hum Values. 2013;38:566–87.CrossRef
  29. Sterne JA. Why the Cochrane risk of bias tool should not include funding source as a standard item. Cochrane Database Syst Rev. 2013;12:ED000076.PubMed
  30. Carpenter WT Jr, Koenig JI, Bilbe G, Bischoff S. At issue: a model for academic/industry collaboration. Schizophr Bull. 2004;30:997–1004.CrossRef PubMed
  31. Meslin EM, Gaffney MM, Quaid KA, Schwartz PH, Pitt AR, Rager JB. Final summary report: Review of the Merck-Regenstrief partnership. Available at: http://​hdl.​handle.​net/​1805/​6044 . Accessed July 7, 2015.
  32. Rosenbaum L. Beyond moral outrage – Weighing trade-offs of COI regulation. N Engl J Med. 2015;372:2064–8.CrossRef PubMed
  33. Steinbrook R, Kassirer JP, Angell M. Justifying conflicts of interest in medical journals: a very bad idea. BMJ. 2015;350:h2942.CrossRef PubMed
  
• 作者单位：William M. Tierney MD (1) (2)
  Eric M. Meslin PhD (2) (3)
  Kurt Kroenke MD (1) (2) (4)
  
  1. Regenstrief Institute, Inc., 410 West Tenth Street Suite HS2000, Indianapolis, IN, 46202, USA
  2. Indiana University School of Medicine, Indianapolis, IN, USA
  3. Indiana University Center for Bioethics, Indianapolis, IN, USA
  4. Roudebush VA Center for Health Information and Communication, Indianapolis, IN, USA
  
• 刊物主题：Internal Medicine;
• 出版者：Springer US
• ISSN：1525-1497

文摘

Pharmaceutical and device manufacturers fund more than half of the medical research in the U.S. Research funding by for-profit companies has increased over the past 20 years, while federal funding has declined. Research funding from for-profit medical companies is seen as tainted by many academicians because of potential biases and prior misbehavior by both investigators and companies. Yet NIH is encouraging partnerships between the public and private sectors to enhance scientific discovery. There are instances, such as methods for improving drug adherence and post-marketing drug surveillance, where the interests of academician researchers and industry could be aligned. We provide examples of ethically performed industry-funded research and a set of principles and benchmarks for ethically credible academic–industry partnerships that could allow academic researchers, for-profit companies, and the public to benefit. KEY WORDS ethics, research conflict of interest public–private partnerships research support