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Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health

Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health. David Michaels, PhD, MPH Project on Scientific Knowledge and Public Policy George Washington University School of Public Health www.DefendingScience.org. Tobacco’s Campaign to Manufacture Doubt.

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Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health

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  1. Doubt is Their Product:How Industry’s Assault on Science Threatens Your Health David Michaels, PhD, MPH Project on Scientific Knowledge and Public Policy George Washington University School of Public Health www.DefendingScience.org

  2. Tobacco’s Campaign to Manufacture Doubt “Doubt is our product, since it is the best means of competing with the ‘body of fact’ that exists in the minds of the general public. It is also the means of establishing controversy.” -Brown & Williamson Document No. 332506, 1969

  3. Product Defense is Advocacy, Not Science

  4. The Work of Mercenary Scientists Hurts the Credibility of All Scientists October 30, 2007

  5. The Funding Effect • The close correlation between the results desired by a study’s sponsors and the results reported • Identified in studies of numerous classes of pharmaceuticals

  6. Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies Richard Smith Competing Interests: RS was an editor for the BMJ for 25 years. For the last 13 of those years, he was the editor and chief executive of the BMJ Publishing Group, responsible for the profits of not only the BMJ but of the whole group, which published some 25 other journals. He stepped down in July 2004. He is now a member of the board of the Public Library of Science, a position for which he is not paid. Citation: Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138

  7. Examples of Methods for Drug Companies to Get the Results they Want from Clinical Trials • Conduct a trial of your drug against a treatment known to be inferior. • Trial your drugs against too low a dose of a competitor drug. • Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic). • Conduct trials that are too small to show differences from competitor drugs.

  8. More Examples of Methods for Drug Companies to Get the Results they Want from Clinical Trials • Use multiple endpoints in the trial and select for publication those that give favourable results. • Do multicentre trials and select for publication results from centres that are favourable. • Conduct subgroup analyses and select for publication those that are favourable. • Present results that are most likely to impress—for example, reduction in relative rather than absolute risk.

  9. Eliminate Conflicts of Interest: “Managing” Conflict is Not Enough • Financial conflict impairs the vision of honest scientists

  10. Today’s Exercise: Consider Vioxx as a drug with unknown toxicity

  11. Whose Interpretation was Correct? • FDA approved Vioxx in May 1999 • Results of early several imperfect studies lent themselves to conflicting interpretation, with independent experts and Merck scientists in disagreement • Eventually, the truth is reached through double blind placebo trial (“gold standard”)

  12. What did the Independent Experts Say? In August 2001, JAMA publishes review of Vioxx trial by three scientists not associated with Merck: • Risk of cardiovascular event among those taking Vioxx, compared with naproxen, was 2.38 (95% confidence interval, 1.39-4.00; P = .002). Mukherjee DM, Nissen SE, Topol EJ. JAMA 2001;286:954-959.

  13. The Response of Merck’s Conflicted Scientists: “It’s the Aleve, not Vioxx” • In Oct. 2001, Merck-affiliated scientists blame Aleve: “Differences observed between rofecoxib and naproxen are likely the result of the antiplatelet effects of the latter agent.” • Dec. 2001:“ We believe that the analysis of [the independent scientists] provides no substantive support for their conclusions.” Sources: Konstam MA, Weir MR, Reicin AS, et al. Circulation 2001;104:2280-2288; Konstam MA, Demopoulos LA. Cardiovascular events and COX-2 inhibitors JAMA 2001;286:2809

  14. Cumulative Incidence of Confirmed Thrombotic Cardiovascular Events in the (Vioxx) and Placebo Groups

  15. The High Cost of Getting it Wrong September 2004: Merck withdraws Vioxx after a placebo trial shows that Vioxx increases risk of heart attacks. By then, an estimated 20 million Americans had taken the drug. FDA scientists estimate Vioxx caused between 88,000 and 140,000 heart attacks in US alone. Graham D, Campen D, Hui R, et al. The Lancet, 2005;365:475-481.

  16. Shameless Self-Promotion

  17. What needs to be done? • Eliminate Conflicts of Interest: “Managing” Conflicts is Not Enough • ban employees of product defense firms from federal science advisory committees • Full Disclosure and Publication of Conflicts • Online access to disclosed information, rather than leaving it to editorial judgment

  18. For More Information • The Project on Scientific Knowledge and Public Policy: www.DefendingScience.org • The Pump Handle Blog: http://thepumphandle.wordpress.com

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