I am so blown away at the desperation (def: recklessness arising from despair) of the DTC companies. Recently my iPhone has been flooded with all sorts of clinically inaccurate information designed to make people think that something miraculously has changed with DTC genomics tests.
A change so impressive that it now appears as if you can actually do something about the results.
The best is a video now on Navi's website
2 sisters on the site taking about their results......likely plants......
The transcript includes these misleading words.......
Sister 1: We both tested "High" For Colon Cancer!
Sister 1: But the Crohn's disease was "really high" on my results. Which is interesting because, I didn't know we had that disease in our family......
Sister 2: It is a disease that is 75% genetic but 25% controllable by environment and diet
Sister 1: So I am making an appointment now to go see a "Gastro Doc"
Explain this to me, how in the hell are they getting away with such a flagrant use of insinuation that they tested for the exact 75% genetic part of Crohn's.... AND who the hell says it is 75% genetic but 25% controllable?
What does that exactly mean?
Chalk another piece of false advertising claims up to the geniuses at Navi......Good job Denise.
Let me know how that call with the FTC goes......and clean up your twitters.
Inferring that you can find out your risk for colon cancer with a gene test is false as well.... I am not going to even comment on their partnership with the Toronto Clinic other than to say that this will likely be the move of these companies prior to the US regulation hammer falling.....
They (DTC Genomics) will all move to foreign markets like Canada, Asia and maybe even Africa. Because the EU and likely the US will have had enough of their false claims and shenanigans.....
This video and the tests have tricked this ASYMPTOMATIC woman into going to see a specialist, for what I don't know....I can't wait to see the GI doctor's face. Assuming of course this wasn't just a bull$h!t marketing video that wasn't real.
The Sherpa Says: Want to know about Crohn's disease? Don't think that a few genes can give you disease or that we even know how to modify the environment enough to prevent it. I know for sure that eating some carrots, onions and peppers sure as hell ain't gonna prevent it.....I hate marketing lies. And these guys do it ALL the time.
Friday, July 24, 2009
Go See a Gastro Doc
Wednesday, July 22, 2009
Genetic Variation in Different Cell lines? That's News?
Ok, So I have to get something off of my chest.
Has anyone heard of a segmental NF patient?
No?
Maybe because you have never done clinical work?
What about the fact that even Monozygotic twins have different CNVs and epigenetic changes?
That's new to you too?
Well, HOLY $H!T is this gonna rock your world.
Blood cells and cells in the Aorta have different SNPs!
Wow!
""The usual dogma is that your DNA is the same all over the place," senior author Morris Schweitzer, an endocrinologist and lipidologist with McGill University and the affiliated Lady Davis Institute for Medical Research at Montreal's Jewish General Hospital, told GenomeWeb Daily News. But, he said, his team's work suggests that isn't the case."
Who the hell taught this guy that? That's so 1990s......
Do you mean that I could have different SNPs in my spit than in my brain? Yes!
Now what about in my blood and in my sperm? Yes again!
This is the thing I love about all these simpletons out there.
Just because we have different genetic material doesn't make the research bull$H!T. The associations are there, we just may not know exactly what the hell they mean. Nor may we actually find a pathway just because of SNP tests and GWAS.......
To ascertain true disease cause we need disease tissue, plain and simple. That has been the problem whcih has plagued psychiatric and alzheimer's genetics for years.......
I can see it now "23andSergey Research Revolution" Sign up for this GWAS where we biopsy the brains of depressed people.
It wouldn't exactly meet IRB standards, which is why I think Sergey's Angels could be the only people to pull that one off........
But seriously, what I am taken a back by is the fact that all of these purported genetic experts are suprised that SNPs are different in different tissue types. In what world would that NOT be the truth?
Maybe a world that Venture Capital was pitched to, but that ain't reality and it may not even be that big a deal.
BUT, a lot of "Smart" people have been misled if they actually assumed that SNPs were stable between tissue types.....
The Sherpa Says: A little bit of clinical work would go a long way for the people in the lab.......
Monday, July 20, 2009
I'm All for Change, But this?
I hope you can get a deep understanding of how absolutely and completely worse off we will be with this complicated system. You can say, "well can't the US government track submarines underwater while also tracking missles overhead and STILL collect taxes?" They can, but this is even more complex. Listen, it would be nice to have a cheaper Not For Profit system out there to pay for care.
Remember, having access to health insurance, is NOT having access to healthcare.......
It's having access to health insurance. I don't know if anyone reads Investors Business Daily, I do and on Wednesday I read something which almost made me $h!t my pants. The House bill went public all 1018 pages of it.....
On Page 16 there is something very, very scary on it.........
From IBD (Not to be confused with Crohn's Disease)
By INVESTOR'S BUSINESS DAILY | Posted Wednesday, July 15, 2009 4:20 PM PT
Congress: It didn't take long to run into an "uh-oh" moment when reading the House's "Health care for all Americans" bill. Right there on Page 16 is a provision making individual private medical insurance illegal.
IBD Exclusive Series: Government-Run Healthcare: A Prescription For Failure
When we first saw the paragraph Tuesday, just after the 1,018-page document was released, we thought we surely must be misreading it. So we sought help from the House Ways and Means Committee.
It turns out we were right: The provision would indeed outlaw individual private coverage. Under the Orwellian header of "Protecting The Choice To Keep Current Coverage," the "Limitation On New Enrollment" section of the bill clearly states:
"Except as provided in this paragraph, the individual health insurance issuer offering such coverage does not enroll any individual in such coverage if the first effective date of coverage is on or after the first day" of the year the legislation becomes law.
So we can all keep our coverage, just as promised — with, of course, exceptions: Those who currently have private individual coverage won't be able to change it. Nor will those who leave a company to work for themselves be free to buy individual plans from private carriers.
From the beginning, opponents of the public option plan have warned that if the government gets into the business of offering subsidized health insurance coverage, the private insurance market will wither. Drawn by a public option that will be 30% to 40% cheaper than their current premiums because taxpayers will be funding it, employers will gladly scrap their private plans and go with Washington's coverage.
The nonpartisan Lewin Group estimated in April that 120 million or more Americans could lose their group coverage at work and end up in such a program. That would leave private carriers with 50 million or fewer customers. This could cause the market to, as Lewin Vice President John Sheils put it, "fizzle out altogether."
What wasn't known until now is that the bill itself will kill the market for private individual coverage by not letting any new policies be written after the public option becomes law.
The legislation is also likely to finish off health savings accounts, a goal that Democrats have had for years. They want to crush that alternative because nothing gives individuals more control over their medical care, and the government less, than HSAs.
With HSAs out of the way, a key obstacle to the left's expansion of the welfare state will be removed.
The public option won't be an option for many, but rather a mandate for buying government care. A free people should be outraged at this advance of soft tyranny.
Washington does not have the constitutional or moral authority to outlaw private markets in which parties voluntarily participate. It shouldn't be killing business opportunities, or limiting choices, or legislating major changes in Americans' lives.
It took just 16 pages of reading to find this naked attempt by the political powers to increase their reach. It's scary to think how many more breaches of liberty we'll come across in the final 1,002.
AS Jon Belushi said in Animal House
"Holy $h!t"
This is crazy. If this becomes law, it in essence will prevent you as an individual from changing plans, unless of course you go on the government plan. No more individual policies.......EVER
This may not be a big deal for someone in bad health, but for a health 40 year old who wants access to specialists without issues or waiting periods, this could soon become illegal......
The Sherpa Says: If you think that these changes will enable Personalized Medicine, think again.........Besides, the real costs in this system are drugs and hopsitals. Why bother with the providers?
Thursday, July 16, 2009
Take Stable People and Genetic Counselors
From Bob Green's Study which is being held up as:
"SEE, NO ONE FREAKS OUT WHEN THEY GET GENETIC TEST RESULTS"
A 90-minute, semiscripted group session that was led by the genetic counselor described the limitations of APOE testing, the absence of a medical benefit of such testing, and the format for communication of the risk.
All subjects later met individually with the genetic counselor for the drawing of blood samples, which were sent to Athena Diagnostics for APOE genotyping.
Subjects were then randomly assigned to receive the genotyping results (the disclosure group) or not to receive the results (the nondisclosure group).
Subjects in the nondisclosure group were individually shown two charts: one showing the incidence of Alzheimer's disease in the general population according to age and another showing the sex- and age-specific incidence of the disease among first-degree relatives of patients with Alzheimer's disease.
Subjects in the disclosure group were shown the same curves with an additional line for their genotype-specific risk . They also received their lifetime cumulative incidence risk by the age of 85 years.
Subjects were told their APOE genotype and were given written reports of their lifetime cumulative incidence risk and remaining incident risk.
None of the subjects had high anxiety or depression scores at baseline, which would have excluded them from the study.
So what you are saying is, we took away all the unstable people, then gave a 90 minutes genetic counseling session to ALL participants and everyone that got the APOEe4 genotype seemed to handle it ok.......
What a crock of Horse$h!t
This actually got published in the NEJM? Even worse, now some dumb marketing rep can say
"According to a study in the prestigious NEJM, people can handle genetic test results when you give them to them"
I am so fed up with this crap I could scream.
For a fresh breath read the editorial
But how reassured should we be that testing and disclosure would not be harmful? None of the subjects had high anxiety or depression scores at baseline, which would have excluded them from the study.
Presumably, subjects who agreed to participate were sufficiently indifferent to the potential test results to accept randomization and thus are not representative of those who have a strong perceived need to know or need not to know. It seems possible that some subjects were unable to interpret the data.
Despite the rhetoric of a new patient-centered, evidence-based society, we remain largely innumerate and poorly equipped to comprehend statistical probabilities.
The Sherpa Says: Another study of hype! Take Stable People and Genetic Counselors, present data over 90 minutes and whaddya get. No big deal. Just like this study.
TruValue is coming. Valuation of GMG......
Valuation, it is a fickle beast. I love this post from AskTheVC.com
Valuation – especially for early stage companies – falls in the category of “more art than science.” While buyout investors who are acquiring companies with meaningful cash flow streams love their multi-sheet Excel models with 37 pivot tables, most early stage VCs can do valuations on a napkin (or – if they are good at simple math (e.g. addition and subtraction) – in their head.) In the early stages three things drive valuation: (a) ownership dynamics, (b) market terms, and (c) competitive deal dynamics.
Remember Again - this is art - there is no scientific way to really value three guys and a powerpoint slide or a web service with 10,000 subscribers of which 250 are active (although no one can prove that only 250 are active.)
Which brings me to my next point. How do you value a service which has an undisclosed amount of users, immense governmental regulation, and a company who is moving to offer the service for free?
The Art would say, unless you are going to sell the data to someone AND have that contract in hand......it is pretty much B.S.
I am surprised Pathway launched simply because of this reason.
Which makes me wonder, do these companies have contracts to sell YOUR genetic data? Did they disclose to you who they have contracts with?
Which also makes me wonder about this whole research revolution. What's so revolutionary about it? Maybe how they don't use independent reviewers to approve the research and monitor the safety of the participants? Aside from Nazi Germany and Tuskegee, that is pretty much a revolutionary concept....
One thing is for certain, the company which says takes us seriously as we charge you 2500 USD for Gornish has seen the light.
Take their recent Twitter posts
"Navigenics Health Compass: $499 until August 31st. Take control of your health. Use promotion code COMPASS-LTO-26225 http://bit.ly/11FvS2
and
New price on genetic testing http://bit.ly/oRsLF
So one has to be asking yourself, when market segmentation doesn't work and Big Blimps don't work and Celebrity endorsement doesn't work and super cool bubble conferences don't work what is the value of this and how does the public view it? The value or perceived value must be on the users themselves OR their data..........
I personally wouldn't pay any amount of money to give a single drop of spit to these companies UNLESS I could profit from their companies and the data they sell. Maybe after the companies offer free testing, they will next try to give you dividends for the investment of DNA?
It could happen. Why? 1 year ago asked attorneys about doing this grand Genome Phenome Metabolome study and if we could give people who participate shares in the company....... The lawyers freaked out. Which is precisely why it sounds just like the thing 23andSergey would do.....and in the end Navi would follow in their footsteps........ Just like they are doing now.
I have been asked why I dislike these companies and distrust them.
1. They give geneticists and genomics a bad name by hyping inaccuracy
2. They are screwing with the public perception of genetics and personalized medicine
3. The infer clinical value and don't offer it
4. They purposely avoid regulations put in place to protect people
5. They have given absolutely NOTHING back to the field of genetics or medicine
6. They are doing "research" on human subjects without protecting them
I could go on and on here, but I will save it for now.....
I like to close with a great quote, edited for Genomics purposes.
"The Silicon Valley is a system, Neo. That system is our enemy. But when you're inside, you look around, what do you see? Businessmen, Marketers, Hyped Scientists, Programmers. The very minds of the people we are trying to save. But until we do, these people are still a part of that system and that makes them our enemy. You have to understand, most of these people are not ready to be unplugged. And many of them are so inured, so hopelessly dependent on the system, that they will fight to protect it."
Have an idea, hype it, put it on Oprah, and hope the hell the sheep buy it........ I have a bad feeling about this. The public is awakening from the slumber here and it is likely that the usual VC stunts are not working......... Uh....Oh........Genomics for free, at a price.
The Sherpa Says: All the tricks the matrix pulls, all of the bamboozling, Ahh Gornish Helfn.
Wednesday, July 15, 2009
Pathway Genomics IS a lab. Not an algorithm.
Today an article came out in BioIT world about Pathway Genomics. (Sounds Eerily like Amway)
With a tagline like, "Your Future, Only Better" I thought that maybe they were like Vanilla Sky or some Total Recall like service. I could only guess how in the world they could offer a better future through a SNP scan.....
Yes another DTC Genomics/SNPscan Company in the game. Hopefully they will accept regulations and not try to manipulate the laws. I hope that they act responsibly with the data and samples. I hope that they will be transparent and honest.
FROM Bio-IT
"In common with other consumer genomics firms, Becker oversees an editorial team to review criteria from the latest peer-reviewed genome association studies. That team includes Victoria Magnuson, who trained with Francis Collins and John Todd and is an expert in type 2 diabetes genetics. “We are putting together a white paper that will eventually be on our website that describes our criteria,” said Becker. “We’ve tried to be pretty conservative as to what is acceptable, validated research versus preliminary research markers.”
Mostly, I hope that they put people with clinical experience into positions of management and decision making. Because if they don't, they will be making the same mistakes as 23andSergey.
Fast follower? Probably. But is fast what is needed here? No, I would say slow and methodical is the best way to be in this business. Which is why DeCodeMe may ultimately win in the end. That is unless they go off the deep end and push clinical tests from recent discoveries without validation......
Oh wait, they already did that........
So to Pathway I say, good luck. My guess is that your tests will cost 75.95 USD very, very, very soon.
The Sherpa Says: Your future, Only better. Damn, I am glad you are around Pathway (Sounds eerily like Amway) because I have no ability to make my own future better without you.
HT Dan V.
Tuesday, July 14, 2009
Why SB482 is bust. I am amazed by smart people.
If any of you were on the receiving end of my email blast, bear with me. I have a few points to make this morning. A coupla weeks ago, June 24th to be precise.......23andSergey reposted a tweet which really got my attention......
The original tweet was "@23andMe BTW, you saved me $25 for a CF test - used my and spouse's 23 results instead. Thx!"
The user is a really super smart CEO of a company.
After Daniel MacArthur and I protested, 23andSergey pulled down the post........Normally not a big deal, but then came a tweet for me which really had me even further convinced of some issues with DTC
"@hh Really, how so? Our fertility doc says "either of you been tested as a carrier of CF?", yes, both know status via our @23andme."
Do they really know?
No. Truth be told, the delta508 mutation is not exactly the gold standard for carrier screening.....and what the hell? Carrier screening? Isn't that medicine?
Which brings me right down to it........State Bill 482 in essence says that these DTC genomics companies aren't really doing testing. They are only applying a mathematical algorithm to determine risk...........
Could you please tell me what algorithm is used to say you are or you are not a delta508 carrier in the CFTR gene?
Here's another question.
What algorithm are you using to tell people whether or not they have Ashkenazi Jewish Founder Mutations in BRCA genes?
The answer is, they are speaking out of both sides of their mouth. These companies are intellectually dishonest and are looking to pull a fast one here.......and their lack of care for customer or patient safety and health is amazing.
When they pulled that CF retweet, did they post a tweet which says "23andSergey services are not to be used for medicine, and carrier screening is part of medicine"
The short answer.
No.
The long answer, why turn away a customer base who is inferring that it can be used?
I was quoted at the bottom of a San Jose Mercury News article the other day I am an Internist BTW.......
But my point is this, in the world of scandal in politics and lack of transparency, shouldn't we be asking why a company who wants to do this research revolution but won't have an IRB, a company who wants to "Be regulated" buyt by their own rules, a company who has deep ties to a company whose bailiwick is data mining and archiving, a company who performs medical type tests and infers that they can be used as such (despite the fine print)......shouldn't they be held to some sort of standard here?
Are we in the field of genetics so desperate for attention that we let these companies slide in their own laws and their own rules? Do all ships really rise with the tide? We need to ask ourselves here, is this sort of quick shiftiness and legal manipulation ok for the field of genetics?
What sort of trust does it inspire to know that the laws regulating companies were written by the companies. Less than 10% of all congressmen and senators were ever doctors (for my curious detractors).
Why does the medical field come under fire? Lack of trust. Do we really want another chink in our armour?
Does the entire field of genetics and its amazing discoveries want in its midst a company who is willing to manipulate data, lawmakers and ethics to survive?
What does that say about the field? How desperate are we?
What does accepting them say about us?????
