Working Group Meeting Nov. 30 - Dec. 1, 2009
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Centers for Disease Control and Prevention / Century Center – Atlanta, GA
Topics, Methods and Products Subcommittee (SC) meetings were held from 8:30 – 9:30 am to finalize deliberations and presentations for the full EWG.
Welcome and Opening Statement
Al Berg welcomed the EGAPP Working Group (EWG) members to the meeting and outlined a few housekeeping items.
Al Berg also mentioned that the EWG would be getting an update on the recent GAPPNet Meeting held in October from Muin Khoury.
EGAPP Working Group members present included Al Berg, MD, MPH, Chair; Doug Campos-Outcalt, MD, MPA; James Haddow, MD; Maxine Hayes, MD, MPH; Celia Kaye, MD, PhD; Roger D. Klein, MD, JD; Kenneth Offit MD, MPH; Stephen Pauker, MD, MACP, FACC, ABMH; Margaret Piper, PhD, MPH; Sue Richards, PhD, FACMG; Joan Scott, MS, CGC (via conference call); Ora Strickland, PhD; and David L. Veenstra, PharmD, PhD
Core EGAPP Consultants present included Judy Johnson, PhD; and Glenn Palomaki, BS.
Dave Dotson reviewed the meeting agenda. The EWG was updated on key items including:
- Reports/manuscripts/reviews pipeline
- Factor V
- CYP2D6 Tamoxifen review
- Type 2 Diabetes review
- EWG recruitment
- EGAPP reviews web site
CYP2D6 Testing for Tamoxifen Treatment in Breast Cancer Review
Cecelia Bellcross presented draft key questions and analytical frameworks for the upcoming Breast Cancer treatment with Tamoxifen Evidence Review. This review will be conducted by an Evidence-based Practice Center chosen by AHRQ. The EGAPP Working Group will finalize the Key Questions and Analytic Framework for submission to AHRQ.
There are 4 target populations possible for this review. These are:
- Pre-menopausal women with cancer
- Pre-menopausal women without cancer
- Post-menopausal women with cancer
- Post-menopausal women without cancer
The EGAPP Working Group discussed endoxifen levels as a clinical outcome rather than intermediate outcomes and determined in this case endoxifen levels would be an intermediate outcome.
They also discussed the biological plausibility of tamoxifen use under these clinical scenarios.
- What is the management option for tamoxifen use if testing was conducted? Is the dose adjusted based on response? No, it is not adjusted. Data on metabolite drug levels (endoxifen) never give us a recommendation to do something, but a clinical outcome could.
- There are about 3 articles on measurement of endoxifen levels in these clinical scenarios according to Glenn Palomaki.
- Why measure genotype vs. metabolite levels?
Many articles lump poor and intermediate metabolizers together in order to get significance. Poor metabolizers do not make the endoxifen active product.
GAPPNet Meeting update
Muin Khoury gave a report form the Office of Public Health Genomics (OPHG) and the recent GAPPNet kickoff meeting.
The GAPPNet Iniative is actively underway with
- Initial paper published
- Web site in development
- Themes of the initiative include empowering research through translation continuum, linking stakeholders to information from translation research, explore synergy with GAPPNet new online journal/database and exploring new directions for EGAPP
Muin Khoury offered a special thank you to members rolling off of the EGAPP Working Group including : Maxine Hayes, Steve Teutsch, and Jeff Botkin
Marta Gwinn presented the ongoing development of Knols during the lunch and learn session. A Knol is a brief summary of the current information on a particular topic of interest to GAPPNet and EGAPP. It will be hosted as a Knol on the Google Knol web site for GAPPNet.
Some parts might need more or less input from the EWG. The EWG was concerned about the quality of the information put on these KNOLS and who might be reviewing them.
The raw materials for EGAPP would be beneficial and expand information available to the public
The Knol is a published tool for the general public and target audiences. The EWG has the EWG web site password protected page for distribution of their sensitive and internal documents.
The EWG was concerned about broken links and the process to update and add/remove links.
Glenn Palomaki presented to the EWG on the current status of the Cardiogenomic Profiling evidence review.
The review includes 29 genes or markers with outcomes of heart disease and stroke. Some of the markers have multiple variants. The review of methods and credibility of evidence for Analytic and Clinical Validity and Clinical Utility were outlined.
Al Berg charged the EWG with carrying out the objectives of each of the breakout sessions. The two breakout sessions are Cardiovascular Disease recommendation and Factor V recommendation.
CVD Breakout Report
Glenn Palomaki reported for the CVD recommendation writing breakout session.
The EWG reviewed and edited the recommendation statement. The exact wording of the recommendation was discussed.
The EWG elected to make a recommendation based on the 9p21 markers separate from the other 28 genes or markers.
The EWG voted on the recommendation statements and a unanimous 12 votes were cast in favor of the recommendation statement as it was worded.
Factor V Breakout Report
Jim Haddow reported for the Factor V recommendation writing breakout session.
The EWG discussed the possibility for issuing two recommendation statements. The first would be targeted to individuals and the second for family members. The EWG decided to include two statements in the recommendation.
The EWG voted on the first paragraph statement that addressed individuals with a unanimous (12) vote.
The EWG voted on the second paragraph statement that addressed family members with a unanimous (14) vote.
Judy Johnson reported on the Evaluation of the EGAPP Products. The focus of this first round of evaluation was on CYP450 and Depression Evidence Report and Recommendation Statement.
The surveys are still open and online for individuals to complete.
Any further types of analysis should be requested by end of December 2009, through the Translation Team lead.
The final report will be filed with CDC’s OPHG in January 2010. The final report will be released on the web site and be available to the public.
A second survey will be released at the end of February and will include Lynch Syndrome and UGT1A1 reports/recommendations.
Products SC Report
Celia Keya presented the outcomes of the Products SC breakout session. The main topic for the discussion was the results of the health marketing survey on CYP450 and depression.
The discussion was tabled for later during the presentation by Sara Bedrosian and Jen Flome
Topics SC Report
Sue Richards presented the outcomes of the Topics SC breakout session. The main topic for discussion is potential new topics.
The SC reviewed the past prioritization of topics and recommendation to the full EWG for their review.
Several new topics were identified since the last meeting.
The EWG requested summaries on the following topics:
- Markers for the risk of lung cancer and smoking
- BRAF testing for melanoma
- Age-related Macular Degeneration testing
- Scoliosis testing
- Fetal abnormalities
Methods SC Report
Steve Teutsch presented the outcomes of the Methods SC breakout session. The main topic for discussion of the use of EGAPP Methods to develop reviews and the development of methods to identify research gaps for publication.
There is potential for a world market of using our methods and model to develop reviews.
There is shaky ground if the research gaps identified are used to actually recommend research projects. It would be a good tool to identify gaps, but we should only lay out 1-2 which research gaps that might be best used. Any “prescriptions” of specific studies should be minimal.
How can EGAPP advance until medicine advances as a whole to accept evidence-based technologies?
Holding to the strict definition of clinical utility, the public feeling is the stifling of availability of tests to the consumer.
Health Message Testing – Sara Bedrosian and Jen Flome
Sara Bedrosian and Jen Flome presented the results of health message testing conducted on the translated Lynch Syndrome Product messages.
The health message testing was the result of collaboration with CDC’s Health Marketing Office. The messages were tested with a subset of questions from a pool of approximately 300 questions previously approved by the OMB.
There were no public comments.
Al Berg thanked everyone for their participation and the meeting was adjourned at 1:50pm
The next EGAPP Working Group Meeting is scheduled for Monday & Tuesday,
February 1-2, 2010 in San Diego, California.