Kathleen Sebelius, the Secretary of Health and Human Services, was recently sent a (flawed) open letter requesting greater oversight of genetic tests:
At the core of personalized medicine is advanced [genetic] diagnostic testing that improves a physician's ability to assess whether an individual patient is or is not likely to benefit from treatments for his or her disease or condition. Advanced diagnostic testing is becoming the standard of care for many diseases.
Accurate, reliable, and timely advanced diagnostics offer enormous promise, but poor quality testing can harm patients and waste scarce resources. Therefore, it is critical that regulatory oversight of these innovations (and innovators) strike the right balance between assuring patient safety and embracing policies that encourage the incorporation of rapidly advancing scientific methods and knowledge.
Sounds reasonable. We all want "accurate, reliable, and timely advanced diagnostics" for disease. So what's the problem?
The problem is that the letter makes several wrong assumptions about what these genetic tests are all about. Here are my issues:
- Notice the use of the term "patient". We shouldn't be medicalizing genes. We're not patients, we're people with unique gene variants. Genes are not something you have. They are something you are. They define you, like a fingerprint. They form the human character.
- Most genetic variations are not involved in disease. Instead, they are responsible for human diversity. There's no such thing as a "disease gene". Most genes come in different variants or flavors, and a few variants or normal genes can contribute to disease. But all genes have a normal function first.
- Genetic tests are not expensive, and they're getting even cheaper. Instead of running one lab test at a time, why not sequence your entire genome once and have it on file. Testing your most common genetic variants runs around $399 today, and a full genome scan currently runs $100,000, although this should decrease to around $1,000 in a few years.
- Genetic tests are not dangerous. You simply take some saliva or blood, and that's it. The test can't hurt you. A genetic test simply reveals an objective fact about you, specifically your unique gene variants or flavors. We're all 1% different, genetically-speaking.
It's the claim about the gene function that the letter writers are trying to control, under the guise of regulating genetic tests. The government is being urged to regulate all claims on gene function. Yet we have over 20,000 genes. Is the government going to control information on all of these? Again, most genetic diversity is not disease-related.
Why not allow anyone to make claims on what our genes do, in a great marketplace of ideas? We're smart enough to consider the source, and make our own decisions. We don't need the government intervening to block the free flow of information about ourselves.
There's also the question of fairness. Some genetic variants give you greater energy-level, intelligence, charisma, and resilience, often leading to higher pay and social status. Since most doctors already have these innate qualities, they're simply trying to keep their talents rare (and salary high), by having the government block access to genetic information by the rest of us.
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