Showing posts with label pathway genomics. Show all posts
Showing posts with label pathway genomics. Show all posts

Friday, June 11, 2010

I am glad we can all put this behind us. FDA rules on DTCG.

As you now may be aware. DTCG is considered a medical diagnostic according to the FDA. I look forward working with companies who may now allow me to use their tests for medicine.


The Sherpa Says: If we work together, we can deliver the best preventative and personalized care in the world!

Saturday, May 22, 2010

Thomas Goetz has the wrong debate. FDA doesn't intend to restrict.


I think everyone in this space has been way off base as to what the problem is with FDA and Congress wanting to investigate the DTC Genomics companies.

The whole mindset is wrong.

What I hear from this debate is "
It's my data, mine, mine, mine. Gimmee, Gimmee, you can't keep me from my data Big Brother!"


From Mr Goetz's Blog
"The controversy seems to have stirred the FDA to assert its authority – and that of physicians – over any and all medical metrics."

"To me, getting access to this information is a civil rights issue. It’s our data."

This is a straw man argument that has been set up to make regulating these companies seem unseemly and an invasion of privacy.


IT IS A DEAD WRONG ARGUMENT and I will not stand for it being perpetuated anymore.

This is not about getting access to your data.

Fine, you want a whole genome, go get it!

The FDA is not asking should people be able to go out and buy this.
It is asking several other questions.

1. Is Interpretation of biometric data considered medicine?

The answer here is certainly confusing. I think it rests solely with intent.

Do you intend to tell someone something about a disease they now have based on this biometric data that you analyzed?


If the answer is yes, that is viewed legally and medically as a diagnosis.
Which ultimately I think is medicine and falls under medical regulations.


2. Is DTCG analyzing biometric data and intending to give an interpretation of that data which indicates a disease a person has?


It depends on what you define disease as.

Most legal experts defer to the International Classification of Diseases


3. Should we regulate a system which has not given indication of their quality control if they are indeed intending to provide medical diagnosis?

4. Are these methods of obtaining human samples to derive biometric data for the intent of analyzing and providing information about disease considered medical devices?


This is precisely the argument and precisely what Congress and the FDA are trying to define.

So stop acting like a bunch of little kids running around because someone took your kool aid away!


If I hear another, "It's my data" whine again I will scream.

This is not about restricting access to biometric data.

Which by the way, some states do already.


Is an EKG biometric data? What about a cholesterol?

Probably, no one is stopping you from going out and buying a machine to obtain this data yourself.


But any doctor will tell you, it is the interpretation that can vary widely. As demonstrated by the multiple interpretations that Venter et.al complained about

What they are intending to do is to prevent a third party from having NO ONE to answer to when providing interpretation of that very SAME biometric data.


The Sherpa Says: Regulation here will most definitely not stifle innovation as bad as a consumer death or class action lawsuit or lack of trust from consumers because of the aforementioned.

Thursday, May 20, 2010

How Bad Can a House Investigation be for DTC Genomics?


Ok, so you've been summoned to Congress to testify


It won't be that bad if you know what you are in for. So let's review.

1. A chart listing the conditions, diseases, consumer drug responses, and adverse reactions for which you test;

2. All policy documents, training materials, or written guidance materials regarding genetic counseling and physician consultations, including documents regarding what conditions, diseases, drug responses, or adverse reactions trigger the need for genetic counseling or physician consultation, and documents governing communications with consumers regarding individual genetic testing results;

3. All documents relating to the ability of your genetic testing products to accurately identify consumer risk, including:

a. internal and external communications regarding the accuracy of your testing;

b. documents describing how your analysis of individual test results controls for scientific factors such as age, race, gender, and geographic location;

c. third party communications validating the association between the scientific data your company uses for analyzing test results and the consumer's risk for each condition, disease, drug response, or adverse reaction as identified by the results of an individual test; and

d. documents relating to proficiency testing conducted by your clinical laboratories.

4. All documents regarding your policies for processing and use of individual DNA samples collected from consumers, including:

a. policy documents and protocols regarding collection, storage, and processing of individual DNA samples;

b. policy documents and protocols relating to protection of consumer privacy; and

c. documents regarding collected DNA sample uses other than to provide individual genetic counseling to a consumer, including documents relating to third-party use of collected DNA samples.

5. All documents regarding compliance with the Federal Food, Drug, and Cosmetic Act and
U.S. Food and Drug Administration (FDA) regulations.

And you should have that to them in about 2 weeks.

What could be so harmful?

If you know anything about the history of such investigations, they are mostly a dog and pony show that ends up in one of a few options.

1. Public Pillorying that leads to a slap on the wrist and a consumer base who doesn't trust you anymore (See Toyota)

2. A massive class action lawsuit from some enterprising attorneys who review the publicly available documents that the House requests via Freedom of Information.

3. The Congress forces you to behave like normal society rather than a bunch of radicals trying to take over the world.

4. Some clone company sees all your internal documents via a Freedom of Information Act, copies the good, removes the bad and launches in like 6 months.......

5. Someone goes to jail, perp-walk style.

Since 5 is not realistic, I think we can expect some combination of 1-4 for these companies.

The worst outcome is probably Number One here.

The consumer base already doesn't trust Google/23andSerge
Navigenics already has a distribution network, but if the physicians don't trust the test, they won't order it.
Pathway will have a bump in the road and no retail launch.

Number 2 could hurt too, especially Ms Wojiciki who could get personally named in the suit as well as investors like Dyson.

If I was the lawyer, those are the deep pockets I would be after. Navigenics is owned by P&G now and their corporate counsel will likely shield them.

Pathway has probably the least customers to be exposed to such a lawsuit, unlike 23andSerge's 30k

Number 3 stinks for the "Research Revolution, Che Style" but probably won't hurt Navigenics or Pathway.

Number 4 is a definite reality. I have already heard that scuttlebutt on the street.

So, I ask. Is getting companies to behave responsibly and acknowledge that some of what they are doing is medical testing so bad? Ryan made the move. Very smartly Ms. Phelan. I knew she would.

The Sherpa Says: This certainly is a nice distraction from Tar Balls and Toyota...

Monday, November 2, 2009

Away and now back, What did I miss???? 23andme layoffs? Selling Genomes for cheap up next!


23andSerge has layoffs, big surprise.

When Linda left, she had a tribe that left too. I am working on hiring one or 2 and will see what exactly was going on over there......Likely a huge cash bleed

GAPPNet has their first meeting, which I missed.

I will email Dr. Khoury and find out how it went.


Daniel MacArthur pointing out that 23andSerge could have bashed bad science, yet instead promoted it......No surprise there either.

It looks like 23andSerge fired the engineers and scientists.....and kept the PR and marketing wonks.......


Well, in the end it is crystal clear

It turns out the
lawyers questioned this as well as Misha.....Turns out, if you took the genome, then you probably can sell it.......better yet, if you "acquired it via firesale" you also can probably sell it and break all kinds of "terms of service"

What's important? Not having your genome sold off? What's important? Being able to be certain the person who has your information won't sell it to the highest bidder......Now do you see why it is important to have a doctor involved in this? We CAN'T sell it off. Even if we wanted to. It would be against the law......10 years in Folsom or 250,000 USD......OR BOTH!

The main problem is that a lot of people are confusing things.


What is important IS "What is important" not cocktail parties, blimps or CEO's from insurance companies

(hmmm, I wonder what
Navigenics is thinking about doing with it's company?) Maybe Humana wants Navi, to profile their patients?

The Sherpa Says: Companies are most dangerous to their customers and the public when the chips are down. They often do unthinkable and crazy things........for cheap. Anything to survive, that is the motto of the startup. Do or should they have any loyalty to you, AFTER they already have your money? No, unless legally bound.....This is yet another reason why a doctor should be involved here.

Wednesday, October 21, 2009

Excuse Me? Harvard and Navigenics? WTF?


Ok,
So I was blown away when I read this juicy little tid bit from Genome Web.

NEW YORK (GenomeWeb News) – Navigenics and Beth Israel Deaconess Medical Center in Boston announced today that they will collaborate on training physicians in personal genomic testing.

Amazing! I had spoken with Mike Murray up there a while ago and have neen involved in his training curriculum with CMEs for providers. I have always interpreted his opinion on the DTC companies to be suspect of what the hell the companies are doing.

In fact when we, Mike and I presented together at the Association of Program Directors in Internal Medicine meeting in 2008 in New Orleans I assumed that their department as well as he didn't much support DTC genomic testing.

Which is why the BID move had me puzzled, so I emailed him. But I also read further.....

As part of the program, residents will be given the opportunity to have their own genomes analyzed through Navigenics' consumer genomics services.

"We believe that genetics and genomics will be critical to the future of health care," Mark Boguski, of BIDMC's Department of Pathology and the Center for Biomedical Informatics at Harvard Medical School, said in a statement. "Training our residents on the leading genetic services and technologies will be essential to this future."

Ahh, I see. It is not the Genetics department who is involved with this. It is the pathologists, you know, the physicians who look at microscopic slides and run the clinical laboratories who are behind this.........

This Makes all the sense in the world now, non clinical geneticists teaching doctors about clinical genetics and how to use a self-avowed NONCLINICAL, NONMEDICAL test to learn medical genomics.....

What the hell is Harvard thinking? I wonder if they received a nice endowment gift from the VCs who fund Navi????

So let me get this straight, Harvard Medical School sponsored Medical Residency at Beth Israel Deaconess is using a NONCLINICALLY validated test, from a company who states that the test should NOT BE USED FOR MEDICINE, to teach MEDICAL residents. To quote the plan

"Among the specific goals of the program are fostering an understanding of issues related to the evaluation of direct-to-consumer genotyping services and familiarizing physicians with the interpretation of genomic information and its correlation with personal medical and health information."

Have they lost their minds???? Shouldn't this be something that the clinical genetics department should be teaching? I wonder if Vance received a faculty position for this horse$h!t?

The Sherpa Says: I knew that this wouldn't come from the clinical genetics side. I hope they don't have any fingerprints on this one.....But my guess is Raju is involved in this one some how.....Now Harvard is confusing what is Important.

Thursday, October 15, 2009

A few months late to the party....


This month's Internal Medicine News has Dr. Patricia Ganz on the cover.

I couldn't help but say, "Why does she look familiar???"
But then I read and remembered

"Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing."

Ahh, yes, she was at the National Academy meeting which served as the official hammer to DTC genomics....


These first intro words from the one of many articles in the
Internal Medicine News about Genomics hits home

"Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests" I have a serious question.

If these "tests" are for "fun" and not to be used for medicine, then why should it matter if doctors feel prepared to interpret these tests......


Should they not be interpreting these tests at all?

Since, after all, they are "not to be used for medicine".......


Well, unfortunately, the marketing firms and PR firms have pitched these little babies right next to other OTC medical treatments.......

Which means, the public will "Think" of these tests as medical.

And hell, why not?

Freaking 23andSergey is testing for the Ashkenazi Jewish BRCA founder mutations and placing the results right next to IBD, prostate cancer and heart disease, which BTW is right next to ear wax type.......


The biggest problem here is the confusion of "Medically important" with non medically important.......

When a consumer reviews important sounding stuff with non important sounding stuff, the non important looks more interesting, because it comes with stuff that "Can keep me from dying!!!!"
This is the problem here.

And despite what
Howard Levy of JHUMC says, I am not down with this problem continuing to exist.......we have allowed it to happen way too many times.....

My prediction is that clinicians will tune out this noise of DTC and use it as another excuse to tune out TRUE CLINICAL GENETICS......How do I know this? Because I know community physicians. They are WAYYYY different from the academic clinicians out there......


Dr Levy is incorrect in assuming that DTC will push the clinician to "Learn Genetics or Consult a geneticist"

Hell, most geneticists couldn't tell you what a heart attack and it's treatment entails these days. Unless of course they have had one. You should have seen the talk about Brugada up in New Haven, what a mess! I leave aside the IM genetics brethren here.....which are less in number than astronauts.......


And now that the team in Mountain View put out a press release about pure swill, it is all too clear to me what the hell is going on.

These guys are desperate. They need to live, or else the empowered genetics patient will die.

Or so they think.

This couldn't be further from the truth.

Genetics and Genomics is doing just fine without these boondoggles......
Do we need NYT spreads to survive and thrive? The answer: No.

Why?
1. Francis Collins is head of NIH
2. Obama proposed bills supporting Personalized Medicine
3. Major corporations are investing in useful genetic technology

4. Clinical research is progressing nicely in the PGx space

5. Clinicians like myself are organizing and practicing personalized medicine

So, I ask you "Why should we support something that distracts from the reality of genomic medicine?"


So we can have them figure out the interpretation algorithms?
Well, they have shown what a complete hash of that they made...... For seven diseases, 50% or less of the predictions of two companies agreed across five individuals

So we can get the public supporting Genetics in Medicine? I think we know that the public supports us, with or without them.......In fact they support us more WITHOUT them!!! Because what the public fears can actually legally happen especially if a company goes belly up......

So they can carry out the next level of collaborative research? Have you seen the latest joke research? No thanks, I'll stick with Coriell for now...Maybe Scripps too.......

Suffice to say, from my view point on the mountain, these guys (DTC Genomics) are actually parasites, sucking the energy from the movement. They contribute nothing but hype, which now will turn to backlash......


In conclusion, this backlash will detract more from the movement than the hype added to it.

The Sherpa Says: Why continue to support something that in the long run will damage credibility with community physicians and the public? Why?

Wednesday, September 9, 2009

Re-Reviewing the National Academies


After listening closely to Timothy Aitman of the Imperial College of London, it seems to me that the market for DTC is not in the United States.

It is in Jolly 'Ol England.


Timothy seems to be very Pro-DTC and Dr. Khoury(CDC), Dr. Ganz (UCLA) and Dr Korn (HARVARD) seem to firmly believe that regulations are needed and that they should be treated as one in the same with "Any other Clinical Laboratory that is offering similar services"


Frederick Anderson asks, "How far does this go? Does this go to the interpretation or the testing? Or Both?"

It seems to me that this panel is Pro-Regulation.

Timothy BTW is just a presenter, not a member.


My guess, National Academies will conclude that the regulation of these companies currently is not up to par. In fact, they may conclude it is an area in dire need of further regulation. What will that mean?

The business models of these companies will shift towards research focus. OR, they will start medical practices.
Which is sad that they run away from regulation as opposed to actually sacking up, taking the charge and doing it the best they can. Ah, such is the fickle problem with Venture Capital......why take that risk of regulations with other people's money. Understandable.

The Sherpa Says: I will cover the Alzheimers stuff later. It is not as exciting as you may think.....

Thursday, September 3, 2009

Some Confusion Exists


I have a great comment string going on with Daniel MacArthur over at his blog Genetic Future

I think there is some confusion going on here and I place blame on just about everyone in this space who has a mouthpiece.......

But mainly I lay blame on the marketing teams for the Direct to Consumer Genomics companies.

These companies have an interest in making you "think" that their products have some particular health relevance.

Otherwise, no one in their right mind would waste their time with these tests.......Other than the HUGE field of ancestry buffs like Blaine Bettinger J.D. (woohoo)
We need clarity here.

From Daniel- "The American College of Medical Genetics is saying "Genetic tests of individuals or families for the presence of or susceptibility to disease are medical tests."

The fine print says:

"This guideline should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen"

Meaning

"The judgement of what constitutes an inclusive test is left up to the physician"


In my opinion, there are Green tests, Yellow Tests and Red Tests. I think Ryan Phelan sized this up pretty eloquently in 2007 at a conference I spoke at with her.

Red means - Stop, does this test need analytic/clinical utility/validity? Yes, Go ahead and regulate, these are clinically validated/used clinically for a long time, tests which have a use in medicine. If this test is claiming to do so but does not, then this too should be a cause of regulation.


Yellow means - Well, this could be used but maybe hasn't yet. I think of Age Related Macular Degeneration testing. They could have clinical applicability and haven't been put to use yet. This category may also include low odds ratio common SNPs here which indicate risk FOR disease.

You should have some caution when selling/regulating these tests. The biggest problem is that with evidence evolving over time the low ORs may actually be overturned or fall into the Red category.

They key point is what the test claims to do here.

Does it claim to tell you a risk for a disease via algorithm etc.?

If yes, then it becomes a Red test.

If it says in huge disclaimers, this test DOES NOT PREDICT DISEASE RISK, in plain and clear writing on every piece of its marketing then Yellow tests stay Yellow.


Green Tests - Have absolutely nothing to do with a person's health. These tests do not need medical regulations. Ancestry could be here. Eye color/ear wax/height.

But the moment it is used for medicine or medical procedures (PGD for these things, scary but possible) it then becomes a Red test.


ACMG is talking about Red tests. It is also saying, if you as a clinician think a Yellow test is actually a Red test, then it is a Red test.

Which I agree is confusing. But ACMG is not the US or State Governments. Nor is it the UK or anywhere else's government......It is a professional organization.


My take is simple. If there is a risk for public harm, the government should protect its citizens from that harm in a reasonable manner. I emphasize, reasonable manner. What Techies in the Silicon Valley view as unreasonable regulation may very well be extremely reasonable in the view of physicians and hospitals......

There is no reason to get all crazy here. The New York Times is right, until the government or state governments step in to protect the citizens of risk,
it IS Buyer Beware when it comes to genetic tests.....

In my mind, genetic tests need to prove their worth in the field of medicine. They do this by medical science and clinical science studies.

Without these, they are useless noise.


So, should you be able to buy useless noise?

Go ahead.

But the moment the noise whispers in your ear "PSSST, I can tell you your risk for diabetes for 50 dollars" Its A$$ should be regulated.

I hope that clears things up. The problem here is that you have a company selling you noise mixed with clinically valid tests. They are the first company whose A$$ should be told to hold up and split the products.

Then you have a company selling you noise all the while "inferring" it is actually predictive and useful in medicine by getting Doctors to use it in medicine should also be regulated.


Blame Marketers and Spin Men, just like "Thank You for Smoking"

The Sherpa Says: If you apply the Red, Yellow, Green interpretation scale you will soon understand why all the confusion exists. And how that confusion can be cleared up.

Tuesday, September 1, 2009

IOM not webcast today. Why Not?

The IOM conference "Direct-to-Consumer Genetic Testing: A Cross-Academies Workshop" will not be webcast today? I wonder why not? Was it supposed to be and then submarined after Muin Khoury quoted an email I wrote him while he was presenting?

Why is there no webcast for this important conference today?

Maybe I am just a conspiracy theorist.

But I would like IOM and the National Academies to explain why the cover one day but not the second.

The second day by the way has some great topics



From the Agenda

Session 5: The Impact of DTC Genetic Tests on the Medical System

"If the medical system is no longer required to mediate genetic testing, how will the system cope with losing oversight (and reimbursement) of these services while retaining the full responsibility of caring for patients the services affect?"

Here is a little hint. Currently there is no mediation of this DTC testing, therefore you can see what is happening. Marketing hype, misinformation, inaccurate results, improper provision of the results, lack of follow up, no post services offered to BRCA mutation carriers.

Here's a mind bender, can you bill insurance legally for a ICD9 of Genetic Susceptibility to Breast Cancer from a 23andMx test for a 99245 on a HCFA form? Or is that insurance fraud?

To let these types of tests out in the wild, which we have, is only to introduce a lot of chaos which is not for the "Better" it is actually dangerous to the patient.

Now Back to the Agenda:

"Issues to Address:

Can we model the cost to the medical system of DTC genetic testing?

Reimbursement and DTC genetic testing – are insurance companies involved?
Do they have a role?

How can providers navigate DTC testing and results for patients in the clinic?

How do consumers react to DTC testing information, and what is the impact on their health behavior?"

Well, I would love to hear the explanations, but alas there is no webcast today!

Back to the Agenda

"Knowledge of DTC Genetic Testing Among the Public and Health Professionals"

I wonder if the public read the NY Times article yesterday ?

"It’s important to separate hope from hype,” Dr. Jennifer House, president of the March of Dimes, said at a recent meeting of its national communications advisory council. “Direct-to-consumer genetic testing is a buyer-beware market. Consumers need to be very, very cautious.”

Uh......haven't I been saying that for 2 years now? A little late to the sh!t party huh Dr House?

"At the moment, the reliability of most gene tests on all four criteria is questionable, Dr. Dolan said, adding that the “broad landscape of direct-to-consumer genetic testing is a slippery slope.”

You go Siobhan! Yet another one of Dr Marion's prodigies!

Yet, what Dr Khoury et.al. found is that 75% of doctors who were presented in the office with one of these DTC tests ALTERED care in some way.

What do Healthcare practitioners know about genetics? Very Little. What does the public know? Even Less. Which is why they are such an easy target to market to.

Back to the Agenda

"Cooperation or Competition – How Do Health Care and DTC Genetic Testing Coexist?"

They don't. Someone asked the guy from Pathway Genomics yesterday

"Do you think you are practicing medicine? If not, why not?"

That is the question here. Tell me Navi, 23andSergey, Pathway.........why aren't you practicing medicine?

You take a human biological sample, perform a test, run an algorithm and give a risk for disease. In what world is that not medicine?

Let me guess. "Uh we do those things, but what makes us NOT medicine is that we.....uh......
We uh...........we uh....DON'T CLAIM LEGAL RESPONSIBILITY FOR OUR ANSWERS"

The Sherpa Says: The IOM conference is going to be predictable, unless Google has dumped money into the Academies or the IOM......

Wednesday, July 29, 2009

Pharmacogenetic Indication for a Medication?

That's one way to market the newest medication to prevent stroke, heart attack or stent thrombosis.

Wha? Yes, I mean, Prasugrel otherwise known as Effient is FDA approved for use in these patients.

But one thing I was thinking is that, since the FDA put on the insert of Plavix that 2C19 testing may be useful to identify people who will not respond to Plavix (generic Clopidogrel)

Perhaps, the marketing geniuses over at Eli Lilly could use this as an FDA suggestion that these 2C19 people may be better off with Prasugrel.


Yes, it would be one of the most brilliant ways to market pharmacogenomics. I can only imagine the DTC genomics companies salivating over this "We offer the 2C19, test. Act now, save your life."
Technically, It actually could. Yes, all the stops would be pulled out and it could potentially save the DTC genomics companies.

You may be asking yourself, "The DTC companies need saving?"


Yes, they do. Face facts, Research revolution is a flop, nowhere near 1000 people per study. Funny how people don't trust google or anyone without proper research accreditation.

Navi is slashing costs and they have a CEO who is the master of running wastelands (i.e. companies where all the bad assets of a VC firm go)
DeCodeMe.....huh?
Pathway and Tru have no marketing budgets and no real scientific staff.......... Seriously here. WTF?

But, if they could get one big hit from Lilly shoving billions into this PGx marketing campaign, they could be ok. Otherwise, I am afraid, they are lost.

For Lilly it would be a huge win too. Why? Imagine being able to pull a full 1/3rd of all patients taking Plavix off and switching them to Effient/Prasugrel. They could, they really, really could.

So now that I have you attention. The big question is , when will Eli Lilly do this? My guess, in the fall.

Mark my words, they WILL DO THIS and it WILL SAVE companies like 23andSergey and Navi. If of course they offer the test. LabCorp, Genelex and Quest all offer the test now.

But here's the rub, if they offer this and say it is used to make a clinical decision, then they will be a part of the healthcare industry.........
Oops, forgot to mention that before. Survive and take regulations or Die..........

The Sherpa Says: This would be the most brilliant marketing campaign in the world, Personalized Medicine awareness would be worldwide, and Pharmacogenomics would hit the stage in a major, major way....Thanks Lilly, call me to orchestrate your campaign.....

Friday, July 24, 2009

Go See a Gastro Doc


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.

Thursday, July 16, 2009

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.