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

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Presentation on theme: "Drug Company Funding of Clinical Psychiatric Research Related to Outcomes Robert Kelly, MD Beth Israel Medical Center New York, New York."— Presentation transcript:

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  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  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)

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) Sponsorship type Sponsorsolanzapinerisperidone NoneNN JanssenCS LillySC Janssen + LillyMM

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 by Type of Sponsorship *= p < 0.05 **= p < 0.01 ***= p < 0.001

20 Favorable Outcomes by Type of Sponsorship *= p < 0.05 **= p < 0.01 ***= p < 0.001

21 Favorable Outcomes by Type 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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