Patients and the public deserve big changes in evaluation of drugs

BMJ (Online)

Volumn 338, Issue 7698, 2009, Pages 804-805

  Garattini, Silvio ^a   Chalmers, Lain ^b  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^b Summertown Pavilion   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; RANIBIZUMAB;

DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG RESEARCH; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH PROMOTION; HUMAN; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; PUBLICATION; QUALITY OF LIFE; RETINA MACULA AGE RELATED DEGENERATION; SHORT SURVEY; UNSPECIFIED SIDE EFFECT;

BIOMEDICAL RESEARCH; DRUG EVALUATION; DRUG INDUSTRY; EUROPE; GOVERNMENT AGENCIES; HUMANS; PATIENT PARTICIPATION; PATIENT SATISFACTION; PUBLIC OPINION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 66749191537     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.b1025     Document Type: Short Survey

References (30)

1. Tallon D, Chard J, Dieppe P. Relation between agendas of the research community and the research consumer. Lancet 2000;355:2037-40.[CrossRef] [ISI][Medline]
2. Roehr B. Trial participants need to represent patients better. BMJ 2008;336:737.[Free Full Text]
3. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005;164:552-28. [CrossRef][ISI][Medline]
4. Garattini S, Bertele V. How can we regulate medicines better? BMJ 2007;335:803-5.[Free Full Text]
5. Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol 2005;105:1114-8.[ISI][Medline]
6. Chalmers I. Biomedical research: are we getting value for money? Significance 2006;3:172-5.[CrossRef]
7. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-9.[Abstract/Free Full Text]
8. Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry? Ann Oncol 2008;19:1347-53. [Abstract/Free Full Text]
9. Chan A-W, Hrdbjartsson A, Haahr M, G0tzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to publications. JAMA 2004;291:2457-65. [Abstract/Free Full Text]
10. Moynihan R, Heath I, Henry D. Selling sickness: the pharmaceutical industry and disease mongering. BMJ 2002;324:886-91.[Free Full Text]
11. Light DW. Basic research funds to discover important new drugs: who contributes how much? In: Burke MA, de Francisco A, eds. Monitoring financial flows for health research 2005: behind the global numbers. Geneva: Global Fund for Health Research, 2006:29-43.
12. Garattini S, Bertele V. Adjusting Europe's drug regulation to public health needs. Lancet 2001;358:64-7. [CrossRef][ISI][Medline]
13. Vitry A, Lexchin J, Sasich L, Dupin-Spriet T, Reed T, Garattini S, et al. Provision of information on regulatory authorities' websites. Intern Med J 2008;38:559-67.[CrossRef][ISI][Medline]
14. Herxheimer A. Relationships between the pharmaceutical industry and patients' organisations. BMJ 2003;326:1208-10.[Free Full Text]
15. Hirst J. Charities and patient groups should declare interests. BMJ 2003;326:1211.[Free Full Text]
16. Chalmers I. From optimism to disillusion about commitment to transparency in the medico-industrial complex. J R Soc Med 2006;99:337-41.[Free Full Text]
17. Association of the British Pharmaceutical Industry. ABPI best practice model for the disclosure of results and transparent information on clinical trials. London: ABPI, 2008.
18. Roberts I, Li Wan Po A, Chalmers I. Intellectual property, drug licensing, freedom of information, and public health. Lancet 1998;352:726-9.[CrossRef][ISI][Medline]
19. Groves T. Mandatory disclosure of trial results for drugs and devices. BMJ 2008;336:170.[Free Full Text]
20. Coombes R. UK government tightens rules on drug trial results after weaknesses found in safety legislation. BMJ 2008;336:576-7.[Free Full Text]
21. Vandenbroucke JP. Without new rules for industry-sponsored research, science will cease to exist. [Electronic response to Rothman KJ et al. Extra scrutiny for industry funded trials.] BMJ 2005; http://bmj.com/ cgi/eletters/331/7529/1350.
22. Riddell RW. Clinical Trials Organisation. In: Report of a symposium on clinical trials held at the Royal Society of Medicine, 25 April 1958. Pfizer.
23. Capo IV. Accordo Stato-Regioni in materia sanitaria. Art. 48: Tetto di spesa per l'assistenza farmaceutica. Gazzetta Ufficiale della Repubblica Italiana 2003 (Supplement 274, part 1):95-8.
24. Jack A. Warning over drug trial's effects on testing. Financial Times 2008 May 13.
25. Dyer O. Drug industry lobby seeks to improve its image after forced disclosures. BMJ 2008;336:850-1. [Free Full Text]
26. Burton B. Drug industry weakens US bill about disclosure of gifts. BMJ 2008;336:1268.[Free Full Text]
27. Department of Trade and Industry. The R&D scoreboard 2006: the top 800 UK & 1250 global companies by R&D investment. www.innovation.gov.uk/ rd scoreboard/downloads/2006 rd scoreboard data.pdf.
28. Jack A. Balancing big pharma's books. BMJ 2008;336:418-9.[Free Full Text]
29. CMR International. 2005 global R&D performance metrics programme: industry success rates report. London: CMR International, 2006:7.
30. Chalmers I. The scandalous failure of science to cumulate evidence scientifically. Clinical Trials 2005;2:229-231.[ISI]