FDA'S DTC Task

Is the FDA "anti-genetics," or just wading into new territory on consumer genomics?

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The general population has

The general population has been trained to expect that a genetic test is precise and yields actionable results, so companies must assume whatever information is returned from packaged test kits will be taken seriously. The nuances and limitations of "recreational" testing kits are not well understood outside the scientific community. The general population does not distinguish between the kinds of genetic testing because they are not yet familiar with the process.

We have not yet provided an educational, supportive, ethical infrastructure to support a genome testing program. Everyone who wants their genetic information should be able to get it. But it would be irresponsible and cruel to hand over anything but correct data in a format that can be understood by a non-geneticist. The general public is not familiar with caveats about the influence of environmental factors and stress on genetic material. Who will provide the genetic counselors to those whose genes reveal markers for a potentially serious disease? One thing we can do immediately is offer foundational genetic information to high school science teachers. Making terminology familiar now, will make genetic findings easier to understand for the next generation.

The FDA seems to be acting cautiously and thoughtfully about genetic testing. Now that science is ready to offer information that could be seen as predictive in relation to physical and mental well being, those who receive the results need to understand just what a test does and does not confirm.

The unanswered questions are not easy ones: What testing should be offered without symptoms and should potentially worrisome indicators be shared with patients? Should tests for currently incurable diseases be done? Should data be released to the subject through a professional counselor? What is the best way to handle the results when there is a minor involved? Ethical issues should be openly debated by professionals with public input. Such a forum will focus us on the benefits as well as the challenges that are certain to accompany the expanding use of genetic testing in medicine.

23andMe is not alone in

23andMe is not alone in making unsubstantiated claims -and paying the piper as a result. The Federal Trade Commission recently charged two companies with deceptive advertising relating to the companies' claims to produce personalized healthcare products based on the person's genome.

As Dr. White rightly states, the genomic evidence simply doesn't exist to support anything approaching disease prediction generally or to prescribe treatments. In pharma, the "Genomics Bubble" (as in "housing bubble') is recognized by both science and investors alike.

Dr. Eric Lander, head of the Broad Institute among other occupations, recently stated that we're half-way through a likely 70-year journey in learning how genomic information might contribute to healthcare and medicine.

Consumer ignorance is not the issue. Collective ignorance is simply a fact.

I found out about my alpha 1

I found out about my alpha 1 antitrypsin status via 23andme, they noted I was sz and I do have 50% activity. I also have little reason to doubt their assessment of my risks for several major and common conditions in my case. I'm glad I got in before the FDA stepped in, though I understand their issues.

You can use the service to get a snp array and then upload to Promethease or a similar service, but most people are not going to know about this.

My current insurance explicitly does not cover most genetic testing, and I currently do not have 4K to spare for whole exome that would answer additional questions more definitivelly, even though the adult genetic service recommended it.