You Know It's Bad

You know you are in for a grilling when the SACGHS says......"While we laud you for coming to participate in the conversation, part of that participation means that you may not like what you hear(More or less quoted from the webcast)"


Then in an "Interesting" Move.......

They ask "Would you be willing to sacrifice your bottom line to offer these services at say 100 USD?"

Wha???? This is such a crazy question.....This Assumes that the data they are presenting is valid, actionable and worthwhile....... All of which.....are debatable...AND that the public would want such services....

What am I talking about? I am talking about the opening of the 30 minute interrogation that was the end of the SACGHS meeting

They even asked the question "Do you have an IRB for all this 'research?'"

The response.................."We're workin on it"

Well, not really the end.....That was reserved for clean up hitter Kathy Hudson...(Whom, BTW I think is brilliant)

Her slide set covers some very key issues and the presentation did as well....

She even manages to quote Joseph Schumpeter, elegantly...

Schumpeter thought that the institution enabling the entrepreneur to purchase the resources needed to realize his or her vision was a well-developed capitalist financial system, including a whole range of institutions for granting credit.

This is very true, but what she quoted him on was this....

“process of industrial mutation that incessantly revolutionizes the economic structure from within, incessantly destroying the old one, incessantly creating a new one.

I.E. Let's destroy the Healthcare System via DTC Genetics.....Interesting....I wonder how the committee of healthcare players liked that slide? I wonder if anyone mentioned his other theory where advanced capitalism doesn't allow entrpreneurism to flourish because of regulations and the creation of a welfare state. Hmmmmm me thinks not...

When looking at the concerns, this slide explained them pretty well

Concerns About DTC Marketing
• Consumers can’t understand genetic information; it is complicated.
•Consumers vulnerable to exaggerated claims.
•Consumers may get tested without adequately considering consequences to themselves and family
•Consumers may forego standard treatments or make dietary or lifestyle changes without proven benefit
• Consumers may seek and receive unneeded and costly care

Companies may not adequately protect privacy of genetic information
•The tests that are offered may not be valid
• The laboratories that perform the tests may not be competent
• Test claims unsupported by evidence
• Inadequate protections for research participants
•No legal barrier to surreptitious testing of another

She Says the Options are

• Let the Buyer beware
• Demand transparency: information as
  the antidote
• Require third party review of accuracy
  and safety
• Take action against false claims
• Create a category of OTC LDTs
• Expand HIPAA
• Expand common rule
  

I personally think there are many more...And I am workin on that!

The Sherpa Says:

When speaking anonymously with a panelist they said...."It was surprisingly tame" When speaking anonymously with SACGHS attendees they said "This spells the end of unregulated DTC" So it sounds to me like the 2 sides may be engaged in a conversation where no one is listening to each other.......Or the may not be communicating effectively......

The Sherpa Silenced

I know that it has been a long time since my last post. During this time I have been interviewing geneticists, networking with some major league all stars in the fields of nutrigenomics, personalized medicine and pharmacogenomics. So I ask for all of your forgiveness.

First let me state that it has been a great little breather that has got me re-invigorated to keep up the work of a Gene Sherpa.

Second, let me tell you how great it is to live in an age where the work which giants in the fields of medicine and genetics can now be applied broadly to medicine. But, with that benefit comes the danger of charlatans and hucksters.

This is why we need more Gene Sherpas. I am now putting out a plea to all of those who wish to harness genetics for health and longevity, those who wish to have science behind their clinical decision making, those who have a keen business sense and the ethics to make you shudder when you see what is being sold, those who wish to learn more about the future of genetic and medicine.....please email me and we will collaborate and create wonderful things to protect our patients, friend and families from the onslaught of false claims, dummied up studies and infomercials which will soon spring up all over the place.

Lastly I would like to direct your attention to the Institute of Medicine's (IOM) Report called "Nutrigenomics and Beyond: Informing the Future-Workshop Summary" I have spent a significant amount of my time reviewing it and trying to glean what it spells out.

A little about the IOM. It was establish in 1970 to attract elite physicians and scientists to examine national policies regarding health of the public. It issues statements all the time including those on direct to consumer testing.

The report summarized states that the science is not quite there....In addition there is much hype but also much hope. Dr Fineberg, President of the IOM closes with this statement.

"IS it possible that over time we can identify what ultimately must be the common biological pathways through which all determinants of disease or health must ultimately exercise their effect?.......Is it not possible that nutrition science -bridging as it does, everything from human behaviour, cultural values, all the way through to nutrigenomics and metabolomics and so on--might not be the crossroads for such a grand unification theory for health and disease"

The Sherpa Says: Once again, Nutrigenomics is not ready for prime time, otherwise Dr Fineberg would have said "Nutrition science is the grand unification theory" Another scientist stated that "Nutrigenomics is a in a very fragile paradigm...there are very few success stories" So please, tread lightly when someone sells you a diet based on blood type, body shape, or genetics......