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Drug Company Funding of Clinical Psychiatric Research Related to Outcomes

Drug Company Funding of Clinical Psychiatric Research Related to Outcomes. Robert Kelly, MD Beth Israel Medical Center New York, New York. Co-authors. Lisa J. Cohen, PhD Randye J. Semple, PhD Philip Bialer, MD Alison Bodenheimer, BA Elana Neustadter, BA Arkady Barenboim, MD, PhD

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Drug Company Funding of Clinical Psychiatric Research Related to Outcomes

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  1. Drug Company Funding of Clinical Psychiatric Research Related to Outcomes Robert Kelly, MD Beth Israel Medical Center New York, New York

  2. Co-authors Lisa J. Cohen, PhD Randye J. Semple, PhD Philip Bialer, MD Alison Bodenheimer, BA Elana Neustadter, BA Arkady Barenboim, MD, PhD Igor Galynker, MD, PhD

  3. Acknowledgements Ramin Mojtabai, MD, PhD Theresa Perlis, PhD Adam Cohen, MD Katherine DuHamel, PhD Daniel Eisenberg, MD Matthew Steinfeld, BA

  4. Financial Interests I have no significant financial or other relationship with the manufacturer of any product or service I intend to discuss --Robert Kelly

  5. Focus on Conflicts of Interest • Increasing Media & Public Attention • “Spitzer Sues a Drug Maker, Saying It Hid Negative Data” • The New York Times, June 3, 2004 • “What does the eight-hundred-pound gorilla do? Anything it wants to.” • Angell, New York Review of Books, July 4, 2004 • “Worrisome Ailment In Medicine: Misleading Journal Articles” • Wall Street Journal, May 5, 2005

  6. Focus on Conflicts of Interest • Pressure on Policy-makers • Public reaction to media coverage • Political pressure to fix problems • Individual incidents raise public outcry • Resulting in need for action

  7. Evidence Limited • Anecdotes • Speculation • Studies of Funding vs Outcomes • Analyses of Methods/Reporting

  8. Previous Work of Interest-Bekelman et al. 2003 • Reviewed studies of sponsorship-outcome association • Compared new medication to placebo or medication in use. • Four studies used blinded outcome raters • Outcome: New drug favorable? • Sponsorship assessed as industry vs non-industry rather than related to drug studied.

  9. Previous Work of Interest-Heres et al. 2006 • Head-to-head comparisons of second-generation antipsychotic medications (N = 21) • Blinded outcome raters • Outcomes favored study sponsor • Analysis of Methods/Reporting • Recommendations

  10. Goals • Examine sponsorship-outcome association • Focus: Sponsorship-drug relationship • Published clinical psychiatric studies • Broad range of original/regular articles • Blinded outcome raters • Control for potential confounds • Measure extent of pharmaceutical company sponsorship • Assess how these phenomena have changed over time

  11. Selection of Articles • Original/regular articles • Four leading psychiatric journals • AGP = Archives of General Psychiatry • AJP = American Journal of Psychiatry • JCP = Journal of Clinical Psychiatry • JCPP = Journal of Clinical Psychopharmacology • Two years (N = 850) • 1992 • 2002

  12. Selection of Articles • Excluded articles • abstracts did not name any drug used in treatment (n=528) • not dealing with issues directly related to treatment (n=19) • whose abstracts mention a drug company or brand name (n=1) • previously seen by any of the reviewers (n=0) • whose sponsors could not be properly categorized (n=1) • Study sample: 301 articles mentioning 542 drugs

  13. Outcome Rating Considerations • Goal: Measure influence • Behavior • Opinion • Trained raters + guidelines • Choices • Measure (e.g., Favorable or not) • Operationalized vs. subjective • Blinded vs. unblinded • Selection criteria

  14. Outcome Rating • Two raters • Drug outcomes: Favorable vs. not favorable • Detailed rating guidelines • Subjective approach • Blind with respect to knowledge of sponsor • Only abstracts viewed • Results compared and disagreements resolved by discussion.

  15. Sponsorship Rating • Four categories: • Same company sponsorship (S) • Competing company sponsorship (C) • Mixed sponsorship (M) • Non-pharmaceutical sponsorship (N)

  16. Research Questions • Drug company sponsored studies increased? • Favorable outcomes increased? • Same company favorable outcomes > non-pharmaceutical? • Competing company favorable outcomes < non-pharmaceutical? • Mixed sponsorship outcomes different than non-pharmaceutical?

  17. Drug Company Sponsorship * = p < 0.05 ** = p < 0.01 *** = p < 0.001

  18. Favorable Outcomes * = p < 0.05 ** = p < 0.01 *** = p < 0.001

  19. Favorable Outcomes byType of Sponsorship * = p < 0.05 ** = p < 0.01 *** = p < 0.001

  20. Favorable Outcomes byType of Sponsorship * = p < 0.05 ** = p < 0.01 *** = p < 0.001

  21. Favorable Outcomes byType of Sponsorship * = p < 0.05 ** = p < 0.01 *** = p < 0.001

  22. Control for Confounds • Example: Ice cream consumption + death by drowning • Positively correlated • Ice cream eating precedes drowning • => Ice cream risk factor for drowning! • Possible confounds • Temperature • Weather • Season • Proximity to water • No significant correlation after control

  23. Possible Confounds • Year • Journal • Drug studied • Time since FDA drug approval • Diagnosis • Sample size • Study design variables • Placebo comparison • Double-blind, single-blind, open-label, or case series/chart review • Use of comparison drug • Use of non-drug comparison treatment

  24. Logistic Regression • N = 205 (1 drug/article; missing values) • TFDA related to outcome (p=0.01) • Sponsorship related to outcome (p=0.001) • Favorable outcomes for same company sponsorship • > competing company sponsorship (OR=0.07, p<0.001) • > mixed sponsorship (OR=0.14, p=0.02) • > non-pharmaceutical sponsorship (OR=0.19, p=0.004)

  25. Limitations • Potential confounds not considered • Selective funding • Selective publication • Easterbrook, Lancet 1991 • Warranted vs. unwarranted influence • Influence warranted when drug companies encourage doctors to make the right decisions.

  26. Why Sponsorship-Outcomes Relationship? • Safer, 2002; Heres, 2006 • Method Modifictions • Dosing schedules • Study endpoints • Study time frames • Measurement scales • Statistical procedures • Inclusion/exclusion criteria • Reporting Modifications • Highlighting findings favorable to sponsor • Editorializing in the abstract

  27. Restrictive Approach Drawbacks • “We desperately need new medications for substance abuse treatment, so we should encourage the pharmaceutical companies to invest.”—Petros Levounis, MD, Director of The Addiction Institute of New York • “Although scandals, real or perceived, have a short lifetime, unmet health needs persist.”—Thomas P. Stossel, MD, NEJM 2005

  28. Treatment Without Side-Effects • Registration of clinical trials • Conflict of interest transparency • Dual sponsorship encouragement • Study design/reporting modifications education • Articles • Safer, 2002 • Heres, 2006 • Lewis & Warlow, 2004 • Montori, 2004 • Newsletters • Carlat Psychiatry Report • Most important lesson: Outcomes depend on research question asked

  29. Courtroom Analogy Plaintiff & Defendant = Competing Pharmaceutical Companies Jury = General Practitioners and Psychiatrists in Clinical Practice Judge = Leading Experts

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