Friday, April 18, 2008

They Could've used the Sherpa!

So, I am glad that I have been posting on this subject for quite some time now. It seems we all have been blogging about it. Today, Blaine points out an article at Forbes, which is further proof that someone is reading the Sherpa. Matt and Bob, sorry about slamming you before....I just needed to know where your loyalties stood. I did wonder about your journalistic neutrality. But the article you write today is neutral and shows that maybe you had read about my concerns. Thank you for putting this out there!

I hope you see the power you have to hype and over-sell. I am glad that you co-authored this piece. So let's take a looksie at what is going on...From the article

Over the last six months, New York State's Department of Health has sent letters raising the specter of fines and jail time to six online gene-testing firms that offer consumers the ability to peer into their genome to assess their future risk of getting diseases such as cancer, heart disease and multiple sclerosis. Often, it turns out, the services offering these DNA deep-dives are doing so without the involvement of a doctor. That puts them on the wrong side of the law.

The Sherpa warned them of that back in 2007. In fact I worried that these authors articles may have encouraged the companies to sell and consumers to do the deep dives!

Targets in New York's letter-writing campaign include the high-profile 23andMe, in Mountain View, Calif, (run by the wife of Google (nasdaq: GOOG - news - people ) co-founder Sergey Brin) and Navigenics, of Redwood Shores, Calif., as well as their publicly traded partners Illumina (nasdaq: ILMN - news - people ) and Affymetrix (nasdaq: AFFX - news - people ). The letters say the companies cannot perform their gene scans on New York residents without a permit. Warning letters to three more online gene-scanning firms are due to go out soon, New York says.
It seems regulations are going to be enforced. How? To Whom?
I have the litmus test for these regulations. I really wish, that rather than speak ill of me at open bar cocktail parties, these companies would have sought me out to speak about how we could do this the right way. I admire all of you (corporate genomics founders) for risking and bringing this to the forefront.....But, you all did it the wrong way. You trumped geneticists, you trumped physicians, you tried to play doctor!

And now you are going to feel the heat. Even though Spitzer is not around anymore....New Yorkers do not screw around when it comes to this!

So I ask my readers..."Why didn't these companies come seek the Sherpa's path?"

I think it is because of greed. Or perhaps the arrogance that only millions of dollars and a nice spot in SF can buy you. Well...we will recover from your follies....Back in New York we already are. And by the way, You need CLIA and NYS approval to test in New York.....D'Oh..

Or perhaps some sorry legal team gave them poor advice. You should have used my team, they knew.

Complicating matters is the fact many online gene testers, including 23andMe and Navigenics, don't actually perform the scans themselves; they are simply Web portals that disclose the results of tests performed by contract labs. "There are very few federal regulations in this area," says Elliott Stein, an attorney who represents gene-tester HairDx, which just received a letter from New York. "Unfortunately for these companies, they've got to deal with the regulations in each and every state, and often that is a judgment call."

Or maybe they thought...."Hey, after all...this is only recreational"

"Frankly, it blows my mind that someone would be saying that looking at whether you are going to get multiple sclerosis is recreational," says a New York official who spoke on condition of anonymity. The official says New York is not about to shut the services down but, "we would refer them to the attorney general's office" if they continue to operate in violation of the law.

This IS the practice of medicine, your tests are diagnosing predisease. Even if they are "low penetrance" gene SNPs. All three should never have posted health related information, unless they were prepared to practice medicine.

Simple enough. Now that you have taken your lumps, please give me a call so we can move forward in the right direction. DNADirect is moving that way and we welcome that. I hope we all can evaluate the literature in a transparent way. EGAPP is working on it and so are we at DVPMP. I hope this DNA Perspectives will help as well....Navigenics is moving this way too. So please listen, transparency is key to trust. Many are going to begin to distrust if you don't stick to this....


Now your basecamp is coming after these companies too...

California health regulators are also investigating 12 complaints from the public about certain online gene testers. California won't name the targeted companies, but notes that in the state "all genetic tests must be ordered by a licensed physician." Overall, 24 states prohibit or limit so-called direct-access testing without a doctor or other medical professional's involvement, according to a 2007 survey by Johns Hopkins University's Genetics & Public Policy Center.

I had posted on this too. Hopkins delineates this very nicely!

So Corporate Genomics........the ball is in your court. I await your calls. And if you don't want to call me...I have some other interested medical geneticists who would love to help....

The Sherpa Says:

There are several solutions to all of these issues. All of them flow through licensed physicians and medical care. Trust me....I am starting to feel like Cassandra at least towards these CEOs! For the consumers, fear not. We will get physicians and other healthcare providers up to speed. I promise. Until then, call me.

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