Good morning everyone. My name is Glenn Hammonds, I'm a native of Nashville, Tennessee, but I've lived in the San Francisco Bay Area since 1979, and in Oakland since 1987. It is a pleasure to be back in South San Francisco where I spent many years as a scientist at Genentech and Exelixis.
I'd like to thank CDRH Director Shuren and his staff for arranging this meeting, and for giving me the opportunity to speak on the subject of Direct To Consumer Genomics.
I am concerned, as a consumer, as a scientist, and as a citizen, at the prospect of elimination of direct to consumer testing.
As a satisfied customer of 23andMe, I would be appalled to lose access to their services, which I have enjoyed for several years, and which I have recommended to friends and family. I've also used FTDNA, and am satisfied with their testing, although I don't understand why they have to remove perfectly good data from their reports before releasing it to me.
As a scientist who's spent a good deal of time in biotech and pharma, I think it likely that restricting access to these inexpensive and powerful tests could well slow discovery and innovation. I was impressed by the list given by Don Vorhaus of the Genomic Law Report web site detailing why this might happen, including the following factors.
Reduced access to capital.
Fewer new products
Fewer entrants into the field
Increased risk of Litigation.
Reduced access to technology.
Encouraging overseas development.
As you know, students in graduate and medical school today are using DTC genomic data sets, often their own, to learn genomics in a way profoundly different from any previous generation. Some of this work is already available on line, for example the Integrome project from Stanford. Genomics will continue to transform medicine and biology for a long time. These students are the vanguard of a fully genomic aware cadre of scientists and physicians. Don't stunt their growth!
Finally, as a citizen of a nation that values personal freedom and responsibility, I know that a person is not a just a patient, a consumer of medical devices, drugs, and advice. A person's genome is the starting point for all that a person is, and contains information about the whole person. Restricting access to information and advice about that most important part of personhood itself is abhorrent, and cannot stand.
I'd like to close with a selection of opinions from other customers of 23andMe, sent to me after I made a public appeal through the web site.
"It is important that you express the unhappiness - anger if you will - that has arisen among many who feel that any attempt to regulate DTC is unnecessary and unwelcome."
"In my personal experience, I took my 23andMe results to my physician and after I explained them to him he agreed to add them to my medical record."
"The medical profession and individual citizens need education, as much education as we can can help them get, about the coming era of personal genomic medicine. Restricting the information that can be learned from DNA testing from individual consumers does not promote better medical care."
"I don't find the health and trait information on this site compelling and am much more interested in genealogy and ancestry, but I can't support the restriction of information to any user whatever their interest."
"I do NOT want the government to filter my access to information about my own genome."
"The only other way I want the government involved is to ensure that insurance companies cannot use such information to deny me coverage, and that employers can't use it to not hire me"