Does the pharmaceutical industry influence guidelines?;Besteht ein Einfluss pharmazeutischer Unternehmen auf Leitlinien?

Deutsches Arzteblatt International

Volumn 110, Issue 35-36, 2013, Pages 575-583

  Schott, Gisela ^a   Dünnweber, Claudia ^b   Mühlbauer, Bernd ^c   Niebling, Wilhelm ^d   Pachl, Henry ^a   Ludwig, Wolf Dieter ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b KLINIKUM BREMEN MITTE   (Germany)

^c UNIVERSITY OF FREIBURG   (Germany)

^d HELIOS KLINIKUM BERLIN BUCH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EFALIZUMAB; GABAPENTIN; PRESCRIPTION DRUG;

ARTICLE; BIPOLAR DISORDER; CONFLICT OF INTEREST; DERMATOLOGIST; DRUG INDUSTRY; ECONOMIC ASPECT; EUROPEAN MEDICINES AGENCY; FINANCIAL MANAGEMENT; HEALTH CARE ORGANIZATION; HEALTH INSURANCE; HUMAN; MEDICAL INFORMATION; MIGRAINE; NEUROPATHIC PAIN; PHYSICIAN; PRACTICE GUIDELINE; PSORIASIS VULGARIS; QUALITY OF LIFE;

CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; DRUG INDUSTRY; GERMANY; GUIDELINE ADHERENCE; OUTCOME ASSESSMENT (HEALTH CARE); PERIODICALS AS TOPIC; PRACTICE GUIDELINES AS TOPIC; TRUTH DISCLOSURE;

EID: 84885229124     PISSN: 18660452     EISSN: None     Source Type: Journal    
DOI: 10.3238/arztebl.2013.0575     Document Type: Article

References (40)

1. e1. Stö hr K: Leitlinien, Richtlinien und ärztliche Haftung. In: Müller GOE, Stein T (eds): Festschrift für Günther Hirsch. Mü nchen: Verlag C. H. Beck 2011; 431-41. e2.
2. Bekelman JE, Li Y, Gross CP: Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289: 454-65.
3. e3. Bero LA, Rennie D: Influences on the quality of published drug studies. Int J Technol Assess Health Care 1996; 12: 209-37.
4. e4. Lexchin J, Bero LA, Djulbegovic B , Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326: 1167-70.
5. e5. Arzneimittelkommission der deutschen Ärzteschaft: Der Einfluss pharmazeutischer Unternehmen auf ärztliche Leitlinien-Exper-tise: www.akdae.de/Stellungnahmen/Weitere/20120123.pdf. Berlin, Januar 2012. Last accessed on 6 November 2012.
6. e6. Buchan HA, Currie KC, Lourey EJ, Duggan GR: Australian clinical practice guidelines-A national study. Med J Aust 2010; 192: 490-4.
7. e7. Papanikolaou GN, Baltogianni MS, Contopoulos-Ioannidis DG, Haidich AB, Giannakakis IA, Ioannidis JP: Reporting of conflicts of interest in guidelines of preventive an d therapeutic interventions. BMC Med Res Methodol 2001; 1: 3.
8. e8. Cosgrove L, Bursztajn HJ, Krimsky S: Developing unbiased diagnostic and treatment guidelines in psychiatry. N Engl J Med 2009; 360: 2035-6.
9. e9. Choudhry NK, Stelfox HT, Detsky AS: Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA 2002; 287: 612-7.
10. e10. Cosgrove L, Krimsky S, Vijaya raghavan M, Schneider L: Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychother Psychosom 2006; 75: 154-60.
11. e11. Holloway RG, Mooney CJ, Getchius TS, Edlund WS, Miyasaki JO: Invited article: conflicts of interest for authors of American Academy of Neurology clinical practice guidelines. Neurology 2008; 71: 57-63.
12. e 12. Mendelson TB, Meltzer M, Campbell EG, Caplan AL, Kirkpatrick JN: Conflicts of interest in cardiovascular clinical practice guidelines. Arch Intern Med 2011; 171: 577-84.
13. e13. Neuman J, Korenstein D, Ross JS, Keyhani S: Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011; 343: d56 21.
14. e14. Taylor R, Giles J: Cash interests taint drug advice. Nature 2005; 437: 1070-1.
15. e15. Kung J, Miller RR, Mackowiak PA: Failure of clinical practice guidelines to meet Institute of Medicine standards: two more decades of little, if any, progress. Arch Intern Med 2012; 172: 1628-33.
16. Schwabe U, Paffrath D (eds) : Arzneiverordnungs-Report 2010. Berlin, Heidelberg: Springer Medizin Verlag 2010.
17. e17. Pfizer Pharma GmbH: Neurontin® 100/300/400 mg Hartkapseln. Status: June 2011.
18. e18. FDA: FDA Approved Drug Products: Neurontin:/www.accessdata. fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search. Search-Drug-Name. FDA Center for Drug Evaluation and Research, Office of Communications, Division of Information Services. Last accessed on 6 November 2012.
19. e19. Abramson J: Expert report of John Abramson, MD.: http://dida.library. ucsf.edu/pdf/oxx1 8v10. Neurontin Marketing and Sales Practices Litigation, MDL #1629, Docket #04-10981; 11 August 2008. Last accessed on 6 November 2012.
20. e20. Claes C, Kulp W, Greiner W, Graf von der Schulenburg J-M, Werfel T: Deutsches Institut für Me dizinische Dokumentation und Information (DIMDI) (eds): Therapie der mittelschweren und schweren Psoriasis. Bd. 34, Schriftenreihe Health Technology Assessment (HTA). Köln: DIMDI, 2006.
21. e21. IMP24011. Phase III, rand omised, double blind, placebocontrolled, multicentre study evaluating 12 weeks subcutaneous therapy with Genentech efalizumab in patients with moderate to severe psoriasis who are candidates for systemic therapy. In: Clinical and cost effectiveness of efal izumab (Raptiva) for moderate to severe psoriasis. [Industry submission]. Feltham: Serono Ltd., 2004.
22. e22. ACD2600g. Phase IIIb, randomised, double-blind, parallel group, placebocontrolled, multicentre study evaluating 12 weeks thera py with subcutaneously administered Genentech efalizumab in adults with moderate to severe psoriasis who are candidates for systemic therapy. In: Clinical and cost effectiveness of efalizumab (Raptiva) for moderate to severe psoriasis. [Industry submission ]. Feltham: Serono Ltd., 2004.
23. e23. ACD2058g. Phase III, randomised double blind placebo-controlled study evaluating 12 weeks of therapy with XOMA1 efalizumab administered subcutaneously (SC), followed by either continued treatment f or an additional 12 weeks or re-treatment for 12 weeks following a relapse. In: Clinical and cost effectiveness of efalizumab (Raptiva) for moderate to severe psoriasis. [Industry submission]. Feltham: Serono Ltd., 2004.
24. e24. Hofelic h V: Ergebnisse zur Evaluation der S3-Leitlinie zur Therapie der Psoriasis vulgaris in Deutschland: www.diss.fu-berlin.de/diss/servlets/MCRFileNodeServlet/FUDISS-derivate-000000006571/Promotion-online.pdf. Dissertation; Klinik für Dermatologie, Venerologie und Allergologie der Medizinischen Fakultät Charité-Universitä tsmedizin Berlin, Januar 2010. Last accessed on 6 November 2012.
25. e25. Serono Europe Ltd.: Fachinformation "Raptiva®". Status: September 2004.
26. e26. EMA: Public statement on Raptiva (efalizumab): Withdrawel of the marketing authorisation in the European Union: www.ema.euro pa.eu/docs/en-GB/document-library/Public-statement/2009/11/WC500009129.pdf. London, 3 August 2009; D oc. Ref. EMEA/487107/2009. Last accessed on 6 November 2012.
27. e27. Mathew NT, Rapoport A, Saper J, Magnus L, Klapper J, Ramadan N, et al.: Efficacy of gabapentin in migraine prophylaxis. Headache 2001; 41: 119-28.
28. e28. Serpell MG: Gabapentin in neuropathic pain syndromes: a random ised, double-blind, placebo-controlled trial. Pain 2002; 99: 557- 66.
29. e29. Backonja M, Beydoun A, Edwards KR, et al.: Gabapentin for th e symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA 1998; 280: 1831-6.
30. e30. Caraceni A, Zecca E, Bonezzi C, et al.: Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol 2004; 22: 2909-17.
31. e31. Dallocchio C, Buffa C, Mazzarello P, Chiroli S: Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study. J Pain Symptom Manage 2000; 20: 280-5.
32. e32. Gorson KC, Schott C, Herman R, Ropper AH, Rand WM: Gabapentin in the treatment of painful diabetic neuropathy: a placebo controlled, double blind , crossover trial. J Neurol Neurosurg Psychiatry 1999; 66: 251-2.
33. e33. Wiffen PJ, McQuay HJ, Edwards J, Moore RA: WITHDRAWN: Gabapentin for acute and chronic pain. Cochrane Database Syst Rev 2011; Issue 3: CD005452.
34. Gottlieb AB, Gordon KB, Lebwohl MG, et al.: Extended efalizumab therapy sustains efficacy without increasing toxicity in patients with moderate to severe chronic plaque psoriasis. J Drugs Dermatol 2004; 3: 614-24.
35. Leonardi CL, Papp KA, Gordon KB, et al.: Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol 2005; 52: 425-33.
36. e36. Gordon KB, Papp KA, Hamilton TK, et al.: Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA 2003; 290: 3073-80.
37. Menter A, Kosinski M, Bresnahan BW, Papp KA, Ware JE Jr.: Impact of efa lizumab on psoriasis-specific patient-reported outcomes. Results from three randomized, placebo-controlled clinical trials of moderate to severe plaque psoriasis. J Drugs Dermatol 2004 3 27-38.
38. e38. Lebwohl M, Tyring SK, Hamilton TK, et al.: A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 2003; 349: 2004-13.
39. e39. Menter A, Gordon K, Carey W, et al.: Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol 2005; 141: 31-8.
40. e40. Papp K, Bissonnette R, Krueger JG, et al.: The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody. J Am Acad Dermatol 2001; 45: 665-74.