Genetic censorship at the FDA

Your genes are something you are, not something you have.  You receive 20,500 genes from your parents, most of which come in a different variety or flavor from your neighbor's genes.  True, some gene variants lead to a disposition for a disease, like cancer or Alzheimer’s.  But it’s not easy to order a diagnostic test to know your gene variants.

Now the FDA wants to make it even harder.  They want to regulate all genetic tests, and require that any claims on gene function are backed up by peer reviewed journal articles and rigorous clinical studies.

The problem is, most gene variants have nothing to do with disease.  They are responsible for human diversity.  The FDA wants to limit access to all genetic tests, not just those with a relationship to a disease.  If you want to test your gene variants, the FDA wants you prove the function of those genes first.  They want to tie the testing of genetic variants (an objective fact about you) with the claim about the gene's function (e.g. it causes XYZ).

Since there are thousands of gene variants in the body (and the FDA can't possibly review all claims on their function), the FDA is effectively outlawing self-knowledge!  Unless you have millions of dollars to run a clinical study, the FDA won't let you take a genetic test to learn an objective fact about yourself.

It’s a clever trick.   The FDA – a government agency – wants to limit your access to… YOU.  Why?  What's wrong with using the eBay approach instead?  Allow anyone to make claims about the function of a gene variant, and allow "consumers" to rate the credibility and reliability of the source on a public website?  Why must the government attempt to censor our genetic knowledge?

Comments

[JJ]

This above is a stupid comment.

This is not about individuals having access to this science.

It is about stopping scam operators who charge hundreds of dollars for bogus results.

These people could then sell these results to insurance companines and employers with devastating results.

This is exactly what government oversight is for.