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The Academic-Industry Relationship

The Academic-Industry Relationship. The CAGE Questionnaire for Drug Company Dependence. Have you ever prescribed C elebrex TM ? Do you get A nnoyed by people who complain about drug lunches and free gifts? Is there a medication lo G o on the pen you're using right now?

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The Academic-Industry Relationship

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  1. The Academic-Industry Relationship

  2. The CAGE Questionnaire for Drug Company Dependence • Have you ever prescribed CelebrexTM? • Do you get Annoyed by people who complain about drug lunches and free gifts? • Is there a medication loGo on the pen you're using right now? • Do you drink your morning Eye-opener out of a LipitorTM coffee mug? If you answered yes to 2 or more of the above, you may be drug company-dependent.

  3. The Modified CAGE Questionnaire for Drug Company Dependence • Have you ever been involved in a clinical trial of CelebrexTM? • Do you get Annoyed when drug companies try to prevent you from publishing your results? • Do you feel guilty when someone else Ghostwrites an article and puts your name on it? • Do you drink your morning Eye-opener out of a LipitorTM coffee mug? If you answered yes to 2 or more of the above, you may be drug company-dependent.

  4. “You are again reminded that under the confidentiality clause in your contract you are expressly forbidden to impart this misinformation to your patients . . . You are formally warned against any further dissemination, verbally or by any other means, of these inaccurate and malicious opinions based on the false interpretations of data obtained while you were under contract to Messrs. Karel Vita Hudson . . .”---Letter to Dr. Lara Emrich from the law firm representing KVH. (From The Constant Gardener) Fiction

  5. “As you know, paragraph 7 of the LA-02 Contract provides that all information whether written or not, obtained or generated by you during the term of the LA-02 Contract and for a period of three years thereafter, shall be and remain secret and confidential and shall not be disclosed in any manner to any third party except with the prior written consent of Apotex. Please be aware that Apotex will take all possible steps to ensure that these obligations of confidentiality are met and will vigorously pursue all legal remedies in the event that there is any breach of these obligations.”--Excerpt from a letter dated May 24, 1996, from Dr. Michael Spino, Vice President of Scientific Affairs, Apotex Research Inc., to Dr. Nancy Olivieri. Truth

  6. Withholding research results in academic life science • Survey of 3,394 life science faculty at 50 U.S. universities. • 410 (19.8%) reported delays in publishing research results of > 6 months. JAMA 1997;277:1224

  7. Withholding research results in academic life science JAMA 1997;277:1224

  8. Withholding research results in academic genetics • Survey of 3,000 life science faculty at 100 U.S. universities • 64% responded. 1,240 geneticists • 47% of geneticists had been denied requests for information or data within the preceding 3 years. • 12% had denied others’ requests for data in the preceding 3 years. JAMA 2002;287:473

  9. Withholding research results in academic genetics Reasons for withholding information, data, or materials JAMA 2002;287:473

  10. Effects of the relationship on: • Research agenda • Research design • Research results • Research authorship (ghost writing) • Research publication (or withholding)

  11. Industry funding and results of clinical trials

  12. Scope and Impact of Financial Conflicts of Interest in Biomedical Research • Systematic review of studies on relationships between investigators and industry. • 144 studies identified in Medline and other sources. • 37 studies met inclusion criteria. JAMA 2003;289:454

  13. Scope and Impact of Financial Conflicts of Interest in Biomedical Research JAMA 2003;289:454

  14. Pharmaceutical industry sponsorship and research outcome and quality: systematic review • Systematic review of studies that compared pharmaceutical company-sponsored research to non-industry-sponsored research. • Searched Medline, Embase, Cochrane register; contacted experts. • 30 studies were included in analysis. BMJ 2003;326:1167-1170

  15. Pharmaceutical industry sponsorship and research outcome and quality: systematic review • Drug company-sponsored research was less likely to be published than research sponsored by other sources. • Drug company sponsored Pharmacoeconomic studies weremore likely to report results favoring the sponsor's productthan studies with other sponsors. • 13 of 16 studies found that clinical trials and meta-analyses sponsoredby drug companies favored the sponsor’s product. • Methodological quality of industry-sponsored studies was as good as or better than non-industry sponsored studies. BMJ 2003;326:1167-1170

  16. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect of Adverse Events? • Meta-analyses of randomized trials from a random sample of Cochrane reviews. • 25 reviews comprising 370 trials included in analysis. • Funding sources were classified as nonprofit organizations (18%), not reported (29%), both nonprofit and for-profit organizations (14%), or for-profit organizations (39%). JAMA 2003;290:921-928

  17. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect of Adverse Events? JAMA 2003;290:921-928

  18. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect of Adverse Events? JAMA 2003;290:921-928

  19. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. • 332 randomized trials published between January 1999 and June 2001. • 158 drug trials, 87 surgical trials and 87 trials of other therapies. • Industry funding declared in 122 trials (37%) CMAJ 2004;170:477

  20. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 2004;170:477

  21. Source of funding and outcome of clinical trials • 107 clinical trials published in NEJM, Ann Int Med, Am J Med, Arch Int Med in 1984. • 76 (71%) favored new therapy. • 31 (29%) favored traditional therapy. J Gen Int Med 1986;1:155

  22. Source of funding and outcome of clinical trials OR = 5.2 (95% CI, 1.7-15.5) J Gen Int Med 1986;1:155

  23. The uncertainty principle and industry-sponsored research • Reviewed all treatment studies of multiple myeloma, 1996-98. • 113 articles on 136 trials identified. • Assessed quality on scale of 0-5 (<2 = poor). • 27% of trials were commercially sponsored. Lancet 2000;356:635

  24. The uncertainty principle and industry-sponsored research Uncertainty principle (“equipoise”): The patient should be enrolled in a randomized controlled trial only if there is substantial uncertainty about which of the trial treatments would benefit a patient most. • Overall, 56% of trials favored innovative vs 44% favored standard treatment. (p=0.17) Lancet 2000;356:635

  25. The uncertainty principle and industry-sponsored research Lancet 2000;356:635 OR = 3.1 (95% CI, 1.4-7.0 )

  26. The uncertainty principle and industry-sponsored research • Mean quality scores: industry 2.94, non-industry 2.4. • Proportion of trials comparing treatment to placebo: 60% industry, 21% non-industry. Lancet 2000;356:635

  27. Evaluation of conflicts of interest in economic analyses of new drugs used in oncology • Evaluated economic analyses of 3 categories of breakthrough drugs in oncology. • 44 articles found in MEDLINE and healthSTAR searches, 1988-98. • 20/44 (45%) funded by pharmaceutical companies. JAMA 1999;282:1453

  28. Evaluation of conflicts of interest in economic analyses of new drugs used in oncology OR = 11.4 (95% CI, 1.6-100.2) JAMA 1999;282:1453

  29. Evaluation of conflicts of interest in economic analyses of new drugs used in oncology Unfavorable or neutral quantitative results JAMA 1999;282:1453 OR = 3.0 (95% CI, 0.69-12.8)

  30. Evaluation of conflicts of interest in economic analyses of new drugs used in oncology “Although other sources of funds for pharmaco-economic studies are needed, limiting the publication of pharmaceutical company-sponsored studies is probably not feasible or practical. Pharmaceutical companies provide valuable resources to many areas of academic medicine and are a primary source of funding for pharmaco-economic studies.” JAMA 1999;282:1453

  31. Evaluation of conflicts of interest in economic analyses of new drugs used in oncology Study funded by an unrestricted grant from Amgen, Inc., which “had a contractual right to review and comment on manuscripts and abstracts prior to submission.” JAMA 1999;282:1453

  32. Association between competing interests andauthors' conclusions • Randomized clinical trials published in the BMJ from January 1997 to June 2001. 159 trials. • Gathered data on authors' conclusions, competing interests, methodological quality, sample size, type of intervention, and type of control. • Competing interest: “Anything that may influence professional judgment.” BMJ, 2002:325:249

  33. Association between competing interests andauthors' conclusions 159 trials: • 65 trials competing interests declared: • 27 funding by for profit organizations. • 19 funding by both for profit and non-profits. • 19 “Other.” BMJ, 2002:325:249

  34. Most trials favored experimental intervention (higher score ) BMJ, 2002:325:249

  35. BMJ, 2002:325:249

  36. Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005 • 324 cardiovascular trials published between January 1, 2000, and July 30, 2005, in JAMA, The Lancet, and the NEJM. • 137 trials funded solely by for-profits. • 104 trials funded soley by not-for-profits. • 62 trials jointly funded • 21 no funding source cited JAMA. 2006;295:2270-2274

  37. Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005 • 49% of trials funded solely by not-for-profit favored newer treatments over standard of care. • 67.2% of trials funded solely by for-profit organizations favored newer treatments over standard of care. • 56.5% of jointly funded trials favored newer treatments. JAMA. 2006;295:2270-2274

  38. Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005 For drug trials (n=205): • For-profit: 65.5% favored new treatment. • Not-for-profit: 39.5% favored new treatment. • Jointly funded: 54.4% favored new treatment. JAMA. 2006;295:2270-2274

  39. Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005 For device trials (n=39): • For-profit: 82.4% favored new treatment. • Not-for-profit: 50% favored new treatment. • Jointly funded: 69.2% favored new treatment. JAMA. 2006;295:2270-2274

  40. Industry funding and design of clinical trials

  41. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis • All RCTs of NSAIDs in treatment of arthritis indexed in MEDLINE between 9/87 and 5/90. • 61 articles representing 69 trials met inclusion criteria. • 52 articles representing 56 trials associated with pharmaceutical manufacturer (81% of trials) . Arch Int Med 1994;154:157

  42. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis • In 27 trials (48%), the dose of manufacturer-associated drug was proportionally greater than the comparison drug. • In all 16 trials where one drug was reported superior (28% of trials), the drug was the manufacturer-associated drug. Arch Int Med 1994;154:157

  43. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis • 15 eligible trials. • 10 trials industry-sponsored, comprising 92% of patients. • 79% of control patients received oral amphotericin B. • In 3 trials (comprising 43% of patients) amphotericin results were combined with nystatin results. JAMA 1999;282:1752

  44. Journal supplements and symposia

  45. The publication of sponsored symposiums in medical journals • Selected articles from 11 journals that had published >10 symposia between 1980-1989. • 625 symposia included. • “Gold standard” 0 of 3: no misleading title, no brand name, same peer review as parent journal. NEJM 1992;327:1135

  46. The publication of sponsored symposiums in medical journals • 34/262 (13%) of articles with single drug company sponsor met “gold standard” as opposed to 66 of 89 (74%) of those with non-industry sponsors. • Sponsorship by single company associated with single drug topics, misleading titles, and use of brand names. NEJM 1992;327:1135

  47. The quality of drug studies published in symposium proceedings • Randomly selected 127 clinical drug studies from symposia included in prior study. • Quality of articles similar to parent journal. • Articles with drug company support more likely to be favorable to drug of interest than those without support. Ann Int Med 1996;124:485

  48. The quality of drug studies published in symposium proceedings OR = 10.1(95% CI, 1.6- ) Ann Int Med 1996;124:485

  49. Evaluating the quality of articles published in journal supplements compared with the quality of those published in the parent journal • All RCTs published in Am J Med, Am J Card, Am Heart J, 1990-92. • 242 eligible trials • Assessment of quality based on scoring system devised by Chalmers. • Supplements received lower score in 12 of 14 items used to assess quality (mean scores: supplements 33.6% journals 38.5% (p=.01). JAMA 1994;272:108

  50. Industry funding and the research agenda

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