Scientists and policy developers at the Translating ELSI, Ethical Legal Social Implications of Human Genetics Research conference have been mulling over the myriad of ethical arguments over testing and storing our kids’ DNA.
The biggest driver for the advancement of genetic testing is the ‘early detection improves outcomes’ argument and if an individual is found to be at risk of a particular disease then life-long surveillance is a remedy.
However, consider the scenario that you’ve just discovered that your 9 year old daughter has a risk of developing breast and ovarian cancer and your 6 year son is at risk of early-onset Alzheimer’s.  Where do you go for …read more

Following my recent article on ethical guidelines for informed consent in genomic studies, a group of scientists met at the Translating ESLI conference in Cleveland to debate this whole ethical argument. This issue is particularly critical for genome-wide association studies and in establishing and using large biobanks.
It was universally acknowledged that consent forms are difficult to read for participants who do not have reading skills beyond middle school or high school, for example. As a result, these paticipants may be unaware of what exactly the research could mean to them.
Laura Beskow, a researcher at Duke University’s Institute for Genome Sciences and Policy worked …read more

G&H’s INTERVIEW WITH NAVIGENICS
Navigenics approached Genetics and Health for an interview. With so much written about similar genomics companies such as 23andme, Knome, deCODE genetics, I was intrigued to learn more about this company.  In particular, Navigenics appears to be the only company within this industry genre who provides a comprehensive wellness model – a healthcare model that Opaldia, the genetic screening and health surveillance company I founded, endorsed whole-heartedly. 
I interviewed Navigenics’ Medical Director Dr Michael A Nierenberg MD, clinical professor of medicine, emeritus at Stanford University to find out what makes Navigenics stand out amongst its competition.  He was …read more

Concluding G&H’s exclusive interview with Navigenics’ Medical Director Dr Michael Nierenberg, we explore the challenges faced by Navigenics to integrate its genomic services into mainstream medicine … 

When founding my old company Opaldia, probably the single most challenging aspect of early adoption of genetic testing was physician barriers.  Mostly this was borne out of a genuine lack of understanding about the field of genetics but also concerns that testing was too much in its infancy and tests had not been subject to rigorous clinical evaluation.  Time and again the phrase ‘not undergone prospective trials’ was used as a defense against bringing genetic testing into …read more

Continuing G&H’s exclusive interview with Navigenics’ Medical Director Dr Michael Nierenberg, we explore the whole issue of privacy, insurance, GINA and ethics…..
One of the main consumer concerns is that of privacy of information, both in terms that a genetic test has been undertaken but also that the results of the test are kept private and out of the public domain.  At the time of writing, the controversial GINA (Genetic Information Non-discrimination Act) is being passed by the US Senate which will enable genetic testing information to be kept private and not be used to discriminate against an individual, particularly by the insurance industry.  …read more

In this fifth article in the series of articles originating from G&H’s exclusive interview with Navigenics’ Medical Director, Dr Michael Nierenberg, we explore the contentious issue of whole genomic testing.
Navigenics uses Affymetrix’s gene chip which is able to test around 1 million genetic markers.  However Navigenics has initially focused on 18 specific, treatable diseases which form the foundation of its designated SNP panel.  This panel will expand over time.   
I asked the question of what happened to a member’s DNA – whether it was disposed of or stored.  Dr Nierenberg explained that a member’s DNA was stored in anticipation of future …read more

It’s been quite a month for genetics and ethics!  There has been much commentary on GINA (Genetic Information Non discrimination Act) and now an influential academic group have developed an ethical framework of recommendations to encourage individuals to join whole-genome association studies.
According to a large group of genomics scholars, researchers, ethicists, and policy designers and watchers, in order to live up to its potential, whole-genome research in the future should be built upon some ETHICAL foundation that will give people the confidence and trust they will need in order to become volunteers.
The group of experts published a statement of consensus this week in PLoS …read more

Following my article on GINA (Genetic Information Nondiscrimination Act), the influential doctors’ group, the American College of Physicians (ACP), wants the GINA to become law.
The ACP does not directly address the concerns of employers or health insurance companies, but sides with the GINA supporters on individual rights to insurance protections. The ACP agrees that insurance providers should not be able to use an individual’s genetic information to deny or limit health coverage or establish eligibility, enrolment, or to set requirements. In addition, ACP said insurers should be prohibited from setting different premium rates based on an individual’s genetic information.
ACP also said it …read more

In January, The New England Journal of Medicine published an article criticizing the popularization of genetic testing by companies such as 23andme, deCode, Navigenics and Knome who doctors believe are introducing genetic testing prematurely into a commercial setting and confusing public and medics alike.  The authors of this article coined the phrase ‘recreational genomics’ for this type of testing.
While all of these companies claim that their tests should not be used as the basis for medical decisions, some physicians are concerned that customers for these tests will nevertheless begin seeking medical direction based on their results.  Doctors have been unprepared for the genetic advice they need …read more

 
Galileo’s tomb 
Over 360 years ago Galileo died living as a recluse in Italy, a convicted heretic.  His crime - he fell foul of the religious authorities of the day by arguing that the Earth revolved around the sun and not vice versa.  His theory was subsequently found to be perfectly true.
Italian researchers, led by Prof Paulo Galluzzi, want to exhume his body from the city’s Basilica of the Holy Cross, for DNA tests to find the cause of the blindness that afflicted him. They also want to confirm, through DNA profiling, whether the body that shares his grave is that of Galileo’s beloved daughter, Sister Marie Celeste.
The …read more