The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience

Peter Doshi and colleagues describe their experience trying and failing to access clinical study reports from the manufacturer of Tamiflu and challenge industry to defend their current position of RCT data secrecy.

[1]  C. Del Mar,et al.  Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children , 2014, Sao Paulo medical journal = Revista paulista de medicina.

[2]  Andreas Pott EMA’s response to articles , 2011, BMJ : British Medical Journal.

[3]  P. Gøtzsche,et al.  Opening up data at the European Medicines Agency , 2011, BMJ : British Medical Journal.

[4]  David M. Studdert,et al.  Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints , 2011, PLoS Medicine.

[5]  H. Brody,et al.  The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health , 2011, American journal of public health.

[6]  Matthew J. Thompson,et al.  Ensuring safe and effective drugs: who can do what it takes? , 2011, BMJ : British Medical Journal.

[7]  D. Eyding,et al.  Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials , 2010, BMJ : British Medical Journal.

[8]  Andreas Lundh,et al.  Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study , 2010, PLoS medicine.

[9]  D. Cohen Rosiglitazone: what went wrong? , 2010, BMJ : British Medical Journal.

[10]  B. Davies,et al.  Safety and pharmacokinetics of oseltamivir at standard and high dosages. , 2010, International journal of antimicrobial agents.

[11]  Fiona Godlee,et al.  We want raw data, now , 2009, BMJ : British Medical Journal.

[12]  James Smith Point-by-point response from Roche to BMJ questions , 2009, BMJ : British Medical Journal.

[13]  D. Cohen Complications: tracking down the data on oseltamivir , 2009, BMJ : British Medical Journal.

[14]  Tom Jefferson,et al.  Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis , 2009, BMJ : British Medical Journal.

[15]  Peter Doshi,et al.  Neuraminidase inhibitors—the story behind the Cochrane review , 2009, BMJ : British Medical Journal.

[16]  J. Abraham The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[17]  L. Kennedy Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes , 2008 .

[18]  C. Rosen The rosiglitazone story--lessons from an FDA Advisory Committee meeting. , 2007, The New England journal of medicine.

[19]  S. Nissen,et al.  Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. , 2007, The New England journal of medicine.

[20]  S. Hyman,et al.  Characteristics and Impact of Drug Detailing for Gabapentin , 2007, PLoS medicine.

[21]  Aaron S Kesselheim,et al.  Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. , 2007, Health affairs.

[22]  M. Chren,et al.  Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents , 2006, Annals of Internal Medicine.

[23]  Jeffrey M Drazen,et al.  Expression of concern: Bombardier et al., "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis," N Engl J Med 2000;343:1520-8. , 2005, The New England journal of medicine.

[24]  Richard Smith,et al.  Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies , 2005, PLoS medicine.

[25]  G. DeFriese,et al.  The New York Times , 2020, Publishing for Libraries.

[26]  Eric J Topol,et al.  Failing the public health--rofecoxib, Merck, and the FDA. , 2004, The New England journal of medicine.

[27]  J. Lenzer Pfizer pleads guilty, but drug sales continue to soar , 2004, BMJ : British Medical Journal.

[28]  Acip Prevention and control of influenza : recommendations of the Advisory Committee on Immunization Practices (ACIP) , 2004 .

[29]  P. Ward,et al.  Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. , 2003, Archives of internal medicine.

[30]  J. Lenzer Whistleblower charges drug company with deceptive practices , 2003, BMJ : British Medical Journal.

[31]  黄亚明 MedScape , 2009 .

[32]  Malbea A Lapete,et al.  Morbidity and Mortality Weekly Report Prevention and Control of Influenza Recommendations of the Advisory Committee on Immunization Practices (acip) Centers for Disease Control and Prevention Epidemiology Program Office Early Release 1 Prevention and Control of Influenza Recommendations of the Advis , 2022 .

[33]  J. Oxford,et al.  Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. , 2001, JAMA.

[34]  V Demicheli,et al.  Neuraminidase inhibitors for preventing and treating influenza in healthy adults. , 2011, The Cochrane database of systematic reviews.

[35]  Lise,et al.  Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. , 2000, The New England journal of medicine.

[36]  C. Clar,et al.  Rosiglitazone for type 2 diabetes mellitus. , 2007, The Medical letter on drugs and therapeutics.

[37]  J. Collier Science, Politics, and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation , 1995 .

[38]  M. Thobaben,et al.  Prevention and Control of Influenza , 2003, MMWR. Morbidity and mortality weekly report.

[39]  Robert M. Halperin FDA Disclosure of Safety and Effectiveness Data: A Legal and Policy Analysis , 1979 .