Direct from consumers: A survey of 1,048 customers of three DTC personal genomic testing companies about motivations, attitudes, and responses to testing Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, March 8-9, 2011 Dave Kaufman, Ph.D. Genetics and Public Policy Center Johns Hopkins University, Washington, DC Work funded by NHGRI Grant 1R1HG

Several valid concerns about DTC Testing Validity & utility Risks and benefits are not well understood Misleading or unwarranted claims May lead to purchase for the wrong reasons Consumers may be unable to interpret data What will people do with it? Empirical data being collected

DTC consumers’ perspectives Survey of customers of 3 companies 23andMe ($429-$499), Navigenics ($999), deCODEme ($800-$2000) Randomly sampled & contacted by companies 2-8 months after receiving results Online survey, 20 minutes, $10 January - May ,163 of 3,167 invited responded (37%) 1,048 (90%) qualified

Aims of the survey Who is purchasing the tests? Why? What are their overall reactions? Interpretation and understanding What are they doing with the information?

Limitations Cross-sectional survey: no follow-up over time No data on individuals’ specific genes or risks Data from all three companies analyzed in aggregate

DTC Customers (%) US population 18+ (%) Age Women4651 Household Income $0-59, $60,000-84, $85, , $125, Education Attained 0-12 Years years College46 Postgraduate549 Race/Ethnic Group White non-Hispanic8765 Asian/PI (non-Hispanic)54 Black non-Hispanic112 Hispanic315 AI/AN (non-Hispanic)0.51 Other non-Hispanic3.52 Demographics

REASONS FOR TESTING

42% were interested in specific health conditions the company tests for

33% were interested in part because first-degree relative(s) “have been diagnosed with one of the medical conditions included in the service”

How important were the following when you were deciding whether or not to use the company service?

REACTIONS TO TESTING

Satisfaction “How satisfied were you with the [23andMe/deCODEme/Navigenics] service?” Very Satisfied Very Dissatisfied (0.5) Dissatisfied (1.5) Neither

Satisfaction across demographic groups (% who were satisfied or very satisfied)

Overall reactions to the services I satisfied my curiosity I feel there is nothing I can do to change my health risks I have relief from uncertainty about some aspects of my health Agree89% Disagree11% Agree8% Disagree92% Agree49% Disagree51%

Clarity and value of the reports Agree88% Disagree12% Agree38% Disagree62% Agree84% Disagree16% 92% 54% % who were satisfied Reports were easy to understand Felt value of the data was worth the cost Conclusions were too vague

INTERPRETING RESULTS

What participants felt they learned Yes58% No42% Did you learn anything that you could use to improve your health that you did not already know? 96% 76% % who were satisfied

Interpreting the data Participants were shown two hypothetical test results, using the exact format their company utilizes in its reports, and asked to interpret them

Interpreting the data Mary: 25% risk of diabetes Population risk: 30% Mike: 11% risk of colorectal cancer Population risk : 6% “Based on the information above, which answer best describes how Mary’s/Mike’s risk of [disease] compares to the average person’s risk?” MaryMike More likely to get disease 594 Less likely to get disease 903 Has the same risk 42 I don’t know 21

Mary’s diabetes - % with incorrect answer in green Mike’s Colorectal Cancer - % with incorrect in

What do people do based on the data? 28% discussed results with a healthcare prof. Including: 20% with primary health care providers 1% contacted a genetic counselor 19% with other health care professionals 9% followed up with additional laboratory tests

16% changed medication or supplement regimens based on data 10% changed dietary supplements 3% changed OTC medicines 4% changed Rx, in consult with doctor 0.4% changed Rx, without consulting doctor Among those changing one or more regimens, 54% shared results w/ h.c. provider

Behavioral changes as a result -at one point in time! 34% more careful about diet 0.1%less careful 65%the same 14% exercise more 31% “more determined to exercise” nobody exercises less or is less determined

Conclusions Demographics of early DTC customers skewed Curiosity about what might ail you highly valued Satisfaction high, though not among those who found reports difficult

Conclusions Some of what companies try to communicate is understood Whether information given is accurate or valid is a different question Measureable issues with interpretation suggest reports can be improved Behavioral changes observed – could be positive or negative, transient or lasting – Are not the same as outcomes Longitudinal studies w/richer data needed

Thanks to Juli Murphy Kim Kreger Joan Scott Gail Javitt Kathy Hudson Stephanie Devaney Robert Green Sara Katsanis Survey Participants Amy DuRoss Brenna Sweeney Joanna Mountain Amy Keifer Jeffrey Gulcher Jónheiður Ísleifsdóttir Knowledge Networks NIH Navigenics GPPC/JHU 23andMe deCODEme Duke Boston U. Work funded by NHGRI Grant 1R1HG