Advocacy Experience with NIP Iterative Approach to VSD Analysis & Disclosure of Preliminary VSD Findings

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1 Advocacy Experience with NIP Iterative Approach to VSD Analysis & Disclosure of Preliminary VSD Findings Sallie Bernard Executive Director, SafeMinds Presentation to The Committee on Review of NIP s Research Procedures and Data Sharing Program The Institute of Medicine October 21, 2004 Washington DC

2 Charge Provide details on our experience with NIP s iterative approach to VSD analysis and disclosure of preliminary findings. Describe how this experience might inform recommendations for an improved process going forward.

3 Advocacy Foundation SafeMinds Cure Autism Now Cochrane Consumer Coalition Learning & Developmental Disabilities Initiative NIP Thimerosal External Advisor NIP Public Participation Initiative

4 Wider Context Public goals for drug evaluation: transparency, no bias, full and timely disclosure, independent monitoring Internet listing of all post marketing studies, all clinical trials Interim & final due dates, reasons for stoppage Full reporting of protocols & addendums Full reporting of results Process for independent data & safety monitoring Independent agencies to conduct studies Pre-established guidelines for reporting ADEs Independence in expert committees Closer scrutiny of risks Doctor s should never be put in the position of prescribing medications with only partial access to what is known about the drug s effects, and patients should never be put in the position of making medical decisions based on misleading, inaccurate, or incomplete information. - Senator Edward Markey, introducing Fair Access to Clinical Trials (FACT) Act October 7, 2004 (from Washington Fax, October 13, 2004)

5 VSD Experience (1999-Present) Repeated deviations from study protocol Protocol: Phase I screening; Phase II case-control Reality: 5+ screenings, changing definitions of Phases I, II, III. Each iteration created preliminary findings. Solution: adherence to written methodology with defined reporting would eliminate preliminary results.

6 5+ Screening Phases 12/99 No substantiation that one version was more valid than the other One chosen impacted later studies Which is preliminary? Results: cohort selection 2/00 HMO A: 22,647 born from 1992 through , 309 in final cohort HMO B: 184,723 born from 1992 through ,966 in final cohort Note: provisional results - may be subject to change 6/00 7/01 11/03

7 Phases I, II, III? Original study protocol, fall 1999: Phase II is casecontrol Protocol presented to expert panel at Simpsonwood, June 2000: Phase II is now Harvard Pilgrim HMO addition

8 April 2000 Phase I, II, III? Original Phase II not viable Recommending neuropsych study instead Harvard Pilgrim addition described as uninformative June 2000 July 2000

9 Phase I, II, III? Addition (Harvard Pilgrim) not in protocol was published, definitive neuropsych study still in progress. IOM 2001

10 VSD Experience (1999-Present) No independent committee to review protocol, protocol changes, or preliminary results No written explanations of changes; no validation that change is permissible. Addition of <2 polio vaccinations as exclusion criterion Adding/subtracting children Gives appearance of subjective alterations with no external rationale. Solution: establishment of independent monitoring board would allow adherence to protocol, flexibility, clear delineation between preliminary and final results, and decision-making on risk threshhold for early release.

11 Added eligibility criterion: 2+ polio vaccinations No review of validity

12 Changes in sample size Apparently same eligibility 6/00: sample 109,993 2/00: sample 75,540

13 VSD Experience (1999-Present) Questionable independence of expert panel Unknown selection criteria or biases. Surrounded by NIP, pharma reps, vaccine health officials (40 vs 11) at 2-day retreat. Pressure to conform to group expectations. Solution: expert committees should be chosen by outside organization using predetermined, public criteria; committees should either meet publicly or away from all observers.

14 Factors impacting panel s independence The ACIP is going to depend on comments from this group in order to move forward into policy We know from many experiences in history that the pure scientist has done research because of pure science. But that pure science has resulted in splitting the atom or some other process which is completely beyond the power of the scientists who did the research to control it. And what we have here is people who have, for every best reason in the world, pursued a direction of research. But there is now the point at which the research results have to be handled - John Clemens, WHO, to Simpsonwood panel, June 2000 Lesson from Statins/Cholesterol Guidelines Expert Panel Financial conflicts aren't the only danger. ``Group think'' can set in when a panel doesn't include people who can look at the science with different views than cardiologists. Cholesterol meds highlight conflict of interest debate in medicine. Marilynn Marchione, Associated Press. October 16, 2004; ml

15 VSD Experience (1999-Present) Deviations from protocol schedules Study start and completion dates varied from protocol, without explanation. Study phases took inordinate time to complete. 4 years from launch to publication: Not a VSD complexity issue same problems with other NIP studies. Thimerosal & Neuropsych: began 2001, not complete Clarkson mouse study: began 2000, not published Solution: adherence to original schedules,openness about status, and faster completion would mitigate need for preliminary results.

16 VSD Study Schedules Phase I: Screening Original protocol: e 3/00 Actual: published 11/03 Phase II: Case/Control- Harvard Pilgrim Original protocol: e 12/01 Actual: published 11/03 Phase III: Neuropsych Original protocol: b 5/00 Actual: b 3/01, ongoing

17 (1) We learn of study via IOM submission. Meeting date is Clarkson Mouse Study (3) We learn study was presented at conference and completed. Under review at CDC since (2) We FOIA study, now at CDC. (4) Findings from study would provide useful information.

18 VSD Experience (1999-Present) Selective official release of preliminary results Davis et al abstract released at AAP convention 5/00 & to advocates, while full screening phase shown at Simpsonwood 6/00 12/99 & 2/00 screenings never shown to expert panel or IOM Insiders got more information than outsiders. AAP members vs AAP executives Pharma reps vs consumer reps Infectious disease specialists vs toxicologists Solution: pre-establish rules on who gets data access; study registry with results would level the field. Consumers and providers should have as much information as industry and healthcare insiders. Issues should be debated within the wider scientific community.

19 Selective release While expert panel along with 40 other vaccine insiders got to review June 2000 Verstraeten analysis, advocates and clinicians were handed May 2000 Davis et preliminary results. Message: no harm from thimerosal in vaccines.

20 Manufacturers invited to Simpsonwood Advocates neither invited nor told afterward, despite NIP interaction since 8/99 and as of 6/15/00 meeting with NIP Internal NIP Memo 5/00

21 VSD Experience (1999-Present) Spin on release of results Expert panel findings of weak association/no causality messaged to mean no problem to ACIP, media. Media quotes on Pediatrics VSD paper refer to conclusive evidence of safety. Pronouncements not even supported by Verstraeten himself. Spins creates urgency to obtain original data and full reports Solution: full public disclosure of protocols and results would mitigate impact of spin, allow all interested parties to assess on own.

22 Spin on results Screening designed to identify plausible relationships, not causality Yet, experts asked to rate strength of causality From original protocol NIP charge to experts

23 Spin on Results We do have a plan for discussing these data at the upcoming Advisory Committee on Immunization Practices on June 21 and June 22. At that time, CDC plans to make a public release of this information So we are asking people who have [done] a great job protecting this information up until now, to continue to do that until the time of the ACIP meeting. So basically consider this embargoed information. That would help all of us to use the machinery that we have in place for considering these data and for arriving at our policy recommendations. - Roger Bernier, NIP, to Simpsonwood participants, June 2000 Study clears Vaccines Containing Mercury USA Today, Associated Press CDC Says Vaccines Are Safe The Seattle Times The bottom line is and has always been the same: an association between thimerosal and neurological outcomes could neither be confirmed nor refuted, and therefore, more study is required. Tom Verstraeten, letter to Pediatrics following VSD publication

24 VSD Experience (1999-Present) Bias of Investigators NIP has an inherent COI as promoters of vaccination and as watchdogs for safety $1 billion+ vs. <$30 million NIP investigations of itself heightens suspicion, increases need to obtain all data, all iterations. Solution: independent agency outside of CDC should be responsible for vaccine safety oversight.

25 Removal of Vaccine Safety Oversight from NIP Remove vaccine risk assessment and vaccine safety oversight responsibilities from CDC and FDA and place them in a separate federal agency, with accountability to the general public, including parent groups. Blaxill MF, Fisher BL. From Safety Last to Children First. Submission to The CDC Blue Ribbon Panel on Vaccine Safety. September 10, [Vaccine safety monitoring] should be completely removed from CDC s jurisdiction. The CDC is too conflicted to oversee this function. Congressman Dave Weldon, MD, speech at Autism One Conference, Chicago, May 29, The time has come to separate postlicensure vaccine safety assessment from vaccine risk management as recommended by the National Research Council of the National Academy of Sciences. Salmon DA, Moulton LH, Halsey NA. Enhancing Public Confidence in Vaccines Through Independent Oversight of Postlicensure Vaccine Safety. AJPH. 2004; June 94(6):

26 VSD Experience (1999-Present) Final outcome Despite best efforts of NIP to modify methodology without oversight, to tightly control release of results, and to message the findings to allay public fears Parents are extremely skeptical about NIP and about the national vaccine program. Environment is adversarial. Solution: the truth cannot be controlled; injured groups will not be quiet. The vaccine program is based on trust. Broken trust causes public skepticism, honesty restores it. Full transparency and independence are the handmaidens of honesty.

27 Summary of Solutions to the Preliminary Data Problem Establish registry of NIP vaccine safety studies. Post protocols, schedules, changes to both, and reasons. Hew to timely schedules that reflect urgency. Require independent monitoring panels involved in all steps. Post interim and final results for all to see. Assign safety evaluation to another agency.

28 If it is there for all to see then how much better it will be.

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