Whoah! I never thought that my blog would generate such response! I received over 100 emails today. Guess what. In a near 50/50 split they were pro or anti regulation. Some were so nasty and hate filled I began to question why I was even blogging about this. Luckily, none threatened my pets or family! They even asked me whose side I was on. I think I have been pretty clear on this one. I am on the side of safe and effective personalized medicine. That's the only side to be on. I am FOR the Genomic Medicine revolution. I am against anything that will hinder its' development. Some of these fly by night companies have been doing just that for years now!
So I must sit back and look over the landscape. I knew this is where we were headed. Maybe we need a refresher course in history to understand why it did not start with 23andME, they were merely the straw that broke the camel's back.
1994
-Scientists isolate BRCA-1 Including my new friend Ken Offit
-The Human Genome Project is in year 1
-The UN Draft articles stating:
Article 17 (Tests predictive of genetic disease)
Tests which are predictive of genetic diseases or that may identify a genetic
predisposition to a disease may only be performed for health purposes or for scientific
research linked to health purposes.
Article 17 (Tests predictive of genetic disease)
Tests which are predictive of genetic diseases or that may identify a genetic
predisposition to a disease may only be performed for health purposes or for scientific
research linked to health purposes.
-The LA Times asks "Can We Know Too Much?"
-O.J. Simpson trial involved Genetic Testing
The results? Genetic testing is risky....
1995
-Enter Francis Collins Testimony to Senate Including him not endorsing BRCA testing YET! Awaiting further study validation!!!
-GINA is introduced in congress by Louise Slaughter, she heard what Francis had to say. Further validating the risks in genetic testing.
1996
-The New England Journal of Medicine validates the risks of genetic testing
Worried patients, encouraged by overly optimistic claims by researchers, biotechnology companies, and the media, may want to have genetic tests performed whose validity has not been established.
Truly Prescient!
1997
-NY Times exposes doctors shortcomings in interpreting Genetic Tests! Unfortunately, little has changed.
-GATTACA Debuts! 4.3 million dollar weekend. The review? Older children with a taste for science fiction should find it intriguing.
Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.”
1998
-President creates SACGT, The Secretary's Advisory Committee on Genetic Testing (Let the regs begin!!!)
So I am done doing blow by blow....
2001
-American College of Obstetrics and Gynecology endorses CF carrier screening for all pregnant women. Making carrier screening "Standard Medical Care"
2002
-First Insurer to encourage coverage for genetic testing, AETNA. Too bad they don't pay for the counseling (Yet)
-Despite all GI doctors taking family history only 30% knew there was genetic testing for Lynch Syndrome....sad
2003
-Ryan Phelan enters the field, with DNA Direct
2004
-EU met and issued 25 recommendations regarding genetic testing INCLUDING Rec 8
the appropriate medical environment for providing information prior to
testing and relevant post-test counselling be in place prior to offering such
screening
the appropriate medical environment for providing information prior to
testing and relevant post-test counselling be in place prior to offering such
screening
2005
-HFE testing for iron overload is doubted in NEJM. ONLY 20-30% of those with HFE genes develop Hemochromatosis. Genes aren't everything!
-Pew Trusts calls on stronger regulation by CMS. CLIA Complies
2006
-Kathy Hudson's group accuse the Federal Government of Neglect in regulations. Their back is now offically against the wall.
Ok, Maybe Not Done with Blow by Blow......
Who in their right mind would open genetic testing companies in this environment?
2008
-The following bogus DTC tests are available: Hair Loss, Sexual Mate, Bipolar Disorder I won't go on.
-NYS investigates and warns the "Big 3"
-CA sends cease and desist letters
Failure to regulate your own industry only gets you governmental regulation. Failure to investigate the past dooms you to the mistakes made in the past. I am still blown away about the lack of consideration for what the government can do and will do.
The Sherpa Says:
Since I got my a$$ kicked by some of my wonderful readers. I reassert. I am on the side of the Genomic Medicine Revolution. In the most ethical, responsible and effective way possible. End Of Story. I am about "Do What's Right!" My father taught me that a long time ago. Now you just saw what I see. That'll be 20k please ;)
5 comments:
have you read the studies that show people basically return to baseline psychological levels and that no lasting psychological harm is inflicted upon learning genetic testing results? You might want to do a quick pubmed search.
That was a lot of historical research to still miss the point that times-they-are-a-changin'! Too bad you clearly have not even considered the opposing view.
I would like to see that "50/50" split broken down by those with a vested interest in establishing a medical oligarchy.
Informed,
I am certainly aware of the date where a trained health professional provides this data to a patient and that they do return to a prepared and wel adjusted state. I am not aware of this data in DTC testing. Could you point me in that direction?
-Steve
Eco,
They said the same thing with "Free Love". But look at the HIV and STD ravages that caused. Just because times change doesn't mean we should throw out the baby with the bath water!
-Steve
The mistake you're making, Steve, is to lump the kind of genetic profiling which is only available today with modern next-gen sequencing technology with the old, and I agree occasionally shady, DTC genetic testing for various real or imagined ailments. Yes, both services involve DNA, but that's about it.
Genetic screening a la 23andme, is done just because some people think it would be cool to have a file containing your DNA sequence. It's not the same as self-diagnosing yourself with some disorder via DTC genetic tests.
Do you agree there's a difference?
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