Director, International Society of Genetic Genealogy
Wednesday, December 11, 2013
Director, International Society of Genetic Genealogy
Wednesday, September 28, 2011
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"
Monday, September 28, 2009
A "Commentary" paper that leads off with an abstract stating DTC test analysis is "uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak". This assessment is based on only one paper reference.
The introduction of the paper provides a brief description of DTC tests and asks if tests should be regulated. The Discussion section covers the current federal and state regulatory framework for genetic tests already in place including the 2008 California Dept. of Public Health's "cease and desist" letters.
The authors' opinion that the DTC companies arguments for offering tests directly to the public are "weak to indefensible" citing that while "People may indeed have a right to their genetic information, but it does not follow that we should not regulate the process to make sure that information is appropriately provided." They summarize that the second argument for public DTC is that the tests are "not really medical" and the third argument is "that patients deserve direct access to their health information without a physician intermediary." The authors state that "A physician working for a company selling tests is clearly not well situated to look after a patient's best interest".
The authors stretch to support this argument with, "To make matters more confusing, personal genomics could predict risks of very weak genetic associations while leaving out powerful predictive mutations" like in a rare form of breast cancer. But then the straw-man is revealed in their caveat, "But these are not tests offered through personal genomics services."
The authors then postulate that "California and New York states are right to create standards to protect their citizens from the risks of medical testing" which first of all, California did not create a "standard"; the California Dept. of Public Health arbitrarily sent "cease and desist" letters based on anonymous "letters of complaint". New York's law dates from 1996, and can hardly be suggested as standards created for the DTC-era since the law pre-dates it.
The authors acknowledge that physicians will need training. What the authors do not mention is what kind of impact such training will have upon the industry such as: will all physicians require training? Who will pay for the training? How long will such training take and will the DTC companies still be allowed to sell tests during this time frame? These and many more questions need answering before any legislation or standards are imposed.
Tuesday, September 8, 2009
The purpose of the document:
"promote high standards and consistency in the provision of direct-to-consumer genetic tests amongst commercial providers at an international level in order to protect the interests of people seeking genetic tests and their families. They will identify where individual companies and or national jurisdictions should have defined measures in place and the nature of those measures. " - pg 1
"The HGC is not a regulatory body. It hopes that these Principles will lead to the development of codes of practice that take account of existing regulatory structures where the need for additional regulation or legislation is revealed to be necessary."
"Other tests can also provoke anxieties, such as ancestry tests that offer fundamental information about identity and ethnicity."
Tuesday, July 7, 2009
"The House of Lords Science and Technology Committee said a code of conduct was needed to stop bogus claims being made. The report also said the tests, which predict the risk of disease later in life, needed to be more thoroughly reviewed before being marketed."The article goes on to say,
"Health firms have already started to exploit the issue by offering genetic testing, which can give people an idea of the risk they face of getting a range of diseases from heart disease to Alzheimer's. The committee said it was concerned that unproven claims were being made and that individuals were not being offered the proper support and counselling to understand and cope with the results."
Unfortunately, the article does not state or cite examples of "exploitation" and any "unproven claims". However, it does state that NHS staff need additional training to meet the "increasing demands" of people worried about their test results. Again, the article is non-specific about just what the "demands" are and where the test results were obtained.
Friday, July 3, 2009
Dr. Blaine Bettinger provides an overview and critique on the article in his blog, "The Genetic Genealogist".
The article cites the American Society of Human Genetics' recommendations on ancestry testing but injects opinion as well with statements like, "...the false assumption that contemporary groups are reliable substitutes for ancestral populations..." and "...the lack of transparency regarding the statistical methods that companies use to determine test results".
Two press releases were issued as a result of the article: "Stanford Bioethicist and Colleagues Call for Federal Regulation of Genetic Ancestry Testing" and "Tougher controls sought for DNA ancestry testing" in which the latter cites the now defunct company, AncestrybyDNA.
Thursday, January 1, 2009
Everything has a history. The history of concern by academia over Direct-to-Consumer (DTC) genetic testing dates back to at least 2004 in which it manifested itself in a published statement from the American College of Medicine Genetics.
The statement contains a mere 132 words, yet that is enough to convey their message: "Due to the complexities of genetic testing and counseling, the self-ordering of genetic tests by patients over the telephone or the Internet, and their use of genetic “home testing” kits, is potentially harmful. Potential harms include inappropriate test utilization, misinterpretation of test results, lack of necessary follow-up, and other adverse consequences."
- ASMG Policy Statement - January/February 2004 Vol. 6 No. 1
As of 2009, it is unknown if their concerns have become a reality. On the contrary, there are documented cases of patients using the tests for improving their healthcare decisions. Visit our "Success Stories" section to view such cases.