Ever heard of an accountant? Death Knell to Obamacare?

I am sure you all must have heard. Tom Daschle, Washington insider, former Senator bungled his taxes and ended up having to step down from his likely post as HHS Secretary and Health Czar for the White House....Many are left wondering if this dealth a death blow to Obamacare.

I have been asking myself, how can a simple guy with medical practices, some medical school debt, dependants, retirement accounts, another couple of LLCs, a successful consultancy and a college savings plan manage to get his taxes right, but a guy who got paid a zillion dollars and the tax troubles stemmed in part from failing to pay tax on his consulting income, in part from taking too many charitable dedications, and in part from use of the car service.

Hasn't he ever heard of an accountant. What about H&R block, they stand by their tax returns......maybe that would have bailed him out? Daschle should have known better

he sat on the Senate's tax-writing committee.

I mean, what self respecting politician, filled with ambition would make such a rookie mistake as not paying his taxes...............Geithner

So now like many personalized medicine believers who knew that Daschle had the connections to get this through, you must be asking yourself..........is reform dead? Is there any chance for personalized medicine in the first 100 days?

My answer is Yes.

We are already doing personalized medicine in one form or another. I plan on continuing to consult with companies and get them on board. I am building out what I like to call our Command HQ offices in Stamford Connecticut. There we will be seeing primary care patients and proving once and for all that we can not only talk the talk with consultations, but also walk the walk as a primary care team.

Yes, this model IS patient centered genomic healthcare......plain and simple. We will do our damnedest to PROVE this works in any primary care practice around the US. Zak Kohane is working on how to best integrate this into an EMR, the world is moving forward, with or without the government. Coriell is studying how It works.......

Will the government jump on board? Of course they will, President Obama will find a new candidate and the show will go on.

So who are the new horses in the race.......this November post of the WSJ blog sums up some of the candidates.....

One thing is for certain, we are doing personalized medicine right now, it's just not evenly distributed yet......it will be.

The Sherpa Says: Fear not true believers, we have merely come to a fork in the trail, not a dead end.

Fast Facts About CPMC

Ok,

So after fielding a ton of questions regarding Coriell and sending a bunch of people towards their site, I figured I should give all of you some key points about the Study

Coriell Personalized Medicine Collaborative (CPMC)

Launched by Coriell Institute for Medical Research in December 2007, the CPMC is an
evidence-based research study designed to determine the benefit of using personal
genome information in clinical decision-making.

Goals

The CPMC is a forward-looking, collaborative effort involving physicians, scientists,
ethicists, genetic counselors, information technology experts and volunteer study
participants. The goal is to better understand the impact of genome-informed medicine and
to guide its ethical, legal and responsible implementation.

The CPMC also aims to understand why people often respond differently to treatments, and
to discover presently unknown genes that elevate a person’s risk of cancer and other
complex diseases.

Key Points of Differentiation
The CPMC is unlike any other organization that supplies personal genetic information to
individuals.

▪ First, the CPMC is a research study that has been approved by an Institutional Review
Board, whose mission is to review research studies involving human subjects to ensure that
the rights of research participants are protected.

▪ Second, the CPMC is a research study that provides participants with information about
themselves. Many research studies ask for subjects to participate for the good of science
while supplying little or no information back to participants.

▪ Third, the CPMC is not returning all personal genetic information back to participants but
only variants that an external advisory board (the Informed Cohort Oversight Board) has
deemed potentially medically actionable. The actions of this board are completely transparent.

▪ Fourth, the CPMC is requiring participants to complete web-based surveys. After
establishing an account on the web portal, participants will be asked to complete a series of
questionnaires regarding their medical history, family history and lifestyle. Some of this
information will be used to customize participant genetic variant reports, by adding
information provided in the surveys (age, smoking status etc) that affects risk for a health
condition.

▪ Fifth, participants are given control of their personal genetic variant information and can
opt to allow access to their genetic result data to physicians, CPMC genetic counselors or
others.

▪ Sixth, participants in the CPMC study can opt to release their de-identified genetic and
medical history information to the biomedical research community. It is completely voluntary.

▪ Seventh, the CPMC plans to enroll individuals with cancer through their healthcare
provider as well as participants from the general public through open informed consent
sessions.

The Sherpa Says: Phase one has commenced, phase 2 will begin in April when participants will be given access to their data.....For free and they can view it forever....not just for 1 year......

Coriell Goes Live!!!

Today the Coriell Personalized Medicine Collaborative website goes live. After many months of really hard work they are ready to show everyone what a Personalized Medicine Collaborative Study looks like. I maintain, without the information to be generated by Coriell, we have absolutely no clue what the heck these DTC SNP scans are clinically worth.

I can tell you what 23andMe thinks they are worth-$399 even for study participants.....

Navigenics- 2500 USD unless being a study participant, then it's $375.......or if you only want access for a year it's $495

Coriell says-They are FREE to participants $0, unlimited genetic counseling included!!!

This is a powerful statement and I am proud to be a member of the Informed Cohort Oversight Board of this "First of Its Kind" Cohort Study!

Why is this important:

1) We don't know if people actually do anything helpful with the tests that they buy from DTC.

2) We don't know whether they have any useful additional information to add towards our risk predicition capabilities. In fact 9p21.3 when added to standard clinical factors including family history, was absolutely useless in helping us risk prognosticate for heart disease. So 23andMe is useless in this aspect.

3) These tests should never have been sold as even "pseudo-medicine" without something other than basic science to back them up. As I said in Number 2, even excellent basic science can fail clinically.

4) No One, and I mean NO ONE, should be able to sell your data to another company without your permission!!!!!

The website is fantastic and lists some significant information. Including important Privacy Information.

Certificate of Confidentiality
The Coriell Institute has been granted a Certificate of Confidentiality under a federal law (Section 301(d) of the Public Health Service Act). This means that records from the CPMC study may not be disclosed, under federal, state or local court order, without your written approval. Data that are protected by a Certificate of Confidentiality may be disclosed to the Department of Health and Human Services if required for audits of research records.

This is stronger than HIPAA and nothing like this is offered by 23andMe or Navigenics!!!

Heck, those companies aren't even considered HIPAA protected agencies. IMHO, that is a risky thing!

Even better, Coriell Collaborates with several healthcare institutions who have enrollment events.

Who is Coriell?

Here they are!

Get ready world! The team is world class and the research is the first of its kind in the world!!!

The Sherpa Says: Today marks a revolution in personal genomics, the day that the world sees this research and that it needs to be funded and carried out......AT ZERO COST to all participants!!! This is ethical research, plain and simple.

Razzle Dazzle 'Em Part Deux

I was reading Daniel's Blog and this person's comments caught my eye...

"The marketplace for genetic testing is basically an uneducated one (with the exception of people who are really excited about it)."

I think she is right. To do the education to get someone to use this test will ultimately make them not use this test...because once you can understand the implications, you could understand that these tests are of limited value.......unlike Pgx testing...

Caveat: I like the people at Navigenics. I think they have great scientists. BUT, I am extremely skeptical of any physician who is working for this company to promote tests which are not clinically validated.....

To continue...

She then goes further....


"Add to that, Navigenics also wanted to offer disease related testing (I'm leaving the question of clinical utility aside here since the only people who have thought usefully about that are the deCode folks, and apparently not the Navis, 23s, etc.)


So, they realized that to keep an uneducated customer happy while contemplating medically related information, they were going to need to make it easy for that person to pick up the phone and talk to an "expert". "


Spot on......too bad the expert is a genetic counselor who has no medical training in explaining heart disease, multiple sclerosis or anything other than cancer, prenatal issues "Family planning" or monogenic disease.......the model that they were trained for.... What would you do with a woman who had a systolic BP of 136 Elissa? Could you suggest anything?...Wouldn't it be smarter if they actually talked to doctors who understood what these tests meant and who had cared for people with these diseases???? And even with clinical utility aside, deCode has failed to prove clinical utility of their tests.....

The commenter is wrong again down here........but in an extremely correct way......

"That's what they got right. Personalized genetic testing is not about the test, which is a commodity, or the "report" which is useless to most doctors, mothers, etc., but the information, which is currently best conveyed through a person who can answer questions. And people cost a lot of money, thus the ridiculously high price."


Exactly, the cobbler issue.....but I doubt,


1. That the genetic counselor is getting paid 2000 per consult. If you subtract the costs of the test from the charge, that is what you get.....


2. That the counselor is even close to a replacement for a physician....not even close when it comes to adult disease management.......

But she is absolutely correct. It costs a lot to speak with someone, which is why VC always hated Helix Health of Connecticut's model of healthcare...Too bad for them. Patients are using it.....

Just then, she had an absolutely correct point, which is exactly what Navigenics hit square on the head......they were so right in this one way!

"Personalized genetic testing is about people getting attention they feel they need or want enough to pay for it, because they can't get it from their PCP anymore on their insurance co.'s dime."

This my dear is called concierge medicine and it is why Navigenics has partnered with the Internists and Family Practitioners of MDVIP........If not to bolster the impression that their unvalidated test IS Clinically valid (Very sneaky, guys)

But I wonder how MDVIP is doing, using these tests and charging patients for it.......since after all


1) In Navigenics Terms of Service, you can't use it for healthcare

2) Most Internists and FPs need about 6 months of genetics training to understand genetics

3) Most of the info in that report gives us no advantage clinically.


And then she nails the point home:

"Any company that can capitalize on that (regardless of whether the test is clinically useful or just hand waving) will have a market."

Have any of you watched Chicago? This is exactly what I call Razzle Dazzle 'Em.......baffle the people with bull$h!+ and they will think you are worth something.......Hell, it is how these companies were sold the Venture Capital in the first place.....

"Navigenics hit much closer to this mark than the other big 3."

I agree, hand waving and bull$h!+, precisely what this company is offering........otherwise they would have hired physicians to go over the reports with patients rather than genetic counselors....

That to me is the proof of what they feel is important........

For the millions they spent in NYC (there is no shop in SoHo) they could have had Geneticists and Internists who actually get this stuff. They could have them hired at 130k per year.....what's that? 10 Doctors who know what they're doing for a year or 20 counselors who won't tell the patients that they wasted their time on clinically useless testing?

Oh wait.......last time I checked, Navi didn't even have more than 3 counselors doing the clinical work. So if Navi is so into the clinical side, why didn't they hire enough people for the job......Nor did decode or 23andMe..

Oh wait, maybe they have? All 3 have an extensive marketing team and web development team.............. deCode , Navigenics , 23andMe
All are looking for more......

As for the commenter? She works for a company who provides services around bead technology.......


The Sherpa Says: All 3 of these companies are struggling to find themselves......as I have said before, no one knows the true value of these tests yet. Which is why they should be studied......in a rigorous, IRB approved fashion, not anecdotally........Dietrich, you should have had your team listen to me about a year ago when we spoke......I could have gotten you there quicker.........One test is called a one hit wonder....a platform.....is worth so much more.

Navigenics does market research, finally.

Thanks to Daniel for posting my comments about Navi's gaffe

Even with Francis saying he is happy with DTC, with one major caveat, that they are doing it responsibly and some unbiased party has the chance to review and rate their tests....

You would figure those who can withstand the economic downturn have a chance of mild success. But I am not so sure about the ROI here......

Example Navi: Who didn't know this was coming? I sure as hell did when I sat with their marketing team and they asked why I wasn't ordering their test....

I told them that I had patients paying less for our services for the year than for their test....Prior to that I saw their marketing survey on Gerson Lehman Group....thank for the quick cash Navi! There was the first time I saw the"scaled down test for 500 dollars"

IMHO, it was a non starter....Now for 499 and a year's access to your data......it is STILL a nonstarter.

In a short amount of time the price of these tests will be Zero Dollars.....

Those who survive this little pricewar will realize that the distribution platform matters way more than any individual test....

Too bad the 30 or so VC firms we spoke with didn't want to believe this.....now, it looks as if Amway or MarketAmerica may be a better investment after all....

But in all seriousness, these companies have a choice over the next six months...

1. Go medical with PgX and get the hell regulated out of you (No, Schmidt cannot protect 23andMe)

2. Go Novelty, with ancestry, innate traits, etc.

3. dissolve the testing and turn into a platform...

The Sherpa Says: All that glitters in this DTC space has been and will continue to be fools gold for at least the forseeable future.....No matter how many cocktail parties you throw SoHo....

Plavix, Plavix, Plavix

I just finished up giving a Yale Affiliated Hospitals Lecture to a bunch of residents on the topic of pharmacogenomics. Not to toot my own horn, but several residents came up to me and asked......"Why didn't I learn this in medical school?" Even better was the 3rd year medical students who just finished up Pharmacology last year....they said "The EXACT SAME THING".......

Ok, so here's my beef. Why in the hell aren't we teaching this in medical school. I know I have said this before......but what in the hell is going on here? We have data and not just data , but DAMN GOOD data....and instead we are still pumping JakStat pathways down the throats of our second year medical students.....

I have a very big problem here and I need it fixed. Why can't we get physicians who study PgX to teach this? It is simple really, I know many more doctors who like PgX than who like other sides of genetics.....why not let them in to teach these students????

I see no barriers other than cost of paying clinical faculty, which is always the barrier.....

That being said, even with the great Plavix data out there, we still have non believers....

An editorial in the Annals of Internal Medicine hints at it.

Entitled "Personalized genetic Prediction: Too Limited, Too Expensive, or Too Soon?"

It gives me a reason to say bull$h!t

The title is an eye catcher which most busy clinicians won't read, but instead use the title as a guide post for attitudes on this subject....Trust me, I know clinicians who did precisely that.

You see, the problem with this editorial is that it should have been titled "9p21 to predict cardiovascular risk: Too Limited, Too expensive, or Too soon?"

I love how the Annals completely makes a hash of what Personalized Medicine is!

A quote from the editorial

"As these studies show, we are still far from personalized medicine."

I guess Dr. John doesn't see pharmacogenomics as part of Personalized Medicine

Or maybe he just doesn't read the New England Journal of Medicine......

Either way.....this is not a responsible way to publish a journal and disseminate personal opinion.

I personally think it is because the ACP (American College of Physicians) does not have good advice on how best to get its body up to speed on this stuff.

But I know this is not exactly true, because they sponsor Mike Murray's Harvard course on the Genetic Basis of Adult Disease, which has one lecturer on Pharmacogenomics

So why? Why did they fail to include personalized medicine into the ACP meeting?

Why did they let this guy give the opinion that disease prediction was the only thing in personalized medicine?

Why? I have no clue. But I would love to have someone from the ACP tell me.......

Please!

The Sherpa Says: Education, Regulation and Litigation will be the drivers of this field.....Not the Data......That is a damn shame. And yes, I did go to Penn State!

Harsh on All Fronts!

I am often accused of being overly critical....whether it is of the Genetic Counselors, or the Physicians, or maybe the Scientists. I am definitely critical of DTC and even more so of the Medical Geneticists....

In fact, I praise each of these groups at such a low rate, that many think I am looking to isolate myself from the entire field.....I am not. I just point out problems in our backyards so that we can clean them up.....

I was told the other day by a senior Geneticist that what I had done to the Genetic Counselors had then questioning their roles. I had thrown academic genetic departments up in arms, trying to now figure out how to bill legally for what they are doing....

Is that such a bad thing? To make people accountable for what they do.....to help motivate them to lobby extra hard to get paid what they should. Rather than break the law and just exist?

I strategically pick issues and attack them. I know that it upsets most who read this blog when they hear shortcomings in their own fields.

The pediatric geneticist who gets mad because I say they don't know what Plavix is.....

The DTC company who I say is "playing doctor" without any of the liability.....

The PhD Geneticist who says that I devalue what they do......I don't I just think we need not hype every little discovery....

My point is not to keep picking on us.....it is to help motivate us towards change.....

So I now will give you a rare Atta Boy.

1.) DTC, thank you for putting genetics into the public eye. Your millions of dollars spent on PR has helped raise awareness of genetics. Misdirected as you may be, the public is now aware that we can do genetic tests.....

2.) Human Geneticists, thank you for your tireless hours of work to discover new genes and new functions. We would have nothing without you. I can understand why you are so proud of your work and why it often comes across over zealously in the news....Thank you for your efforts,

3.) Genetic Counselors, thank you for working so hard to keep our field alive. When geneticists abandoned cancer genetics and you picked up the torch we needed you most. You have kept us true to genetic principles and spoke out against great atrocities. In addition, you spoke against false advertising.......Thank you

4.) Adult Physicians, you have felt the burden of my wrath most......but guess what, you have done the greatest thing of all, you have carried on the traditions of medicine and kept primary care alive this long....Without your work we wouldn't even have a thought of Personalized Medicine. Working long hours for continuous pay cuts by insurers, you have fought to keep patients cared for. How could you have the time to learn genetics?

5.) Medical Geneticists, thank you for caring for patients with monogenic diseases, studying new ways to investigate and care for them. To the small batch of you teaching adult doctors genetics, thank you. To those teaching medical students, thank you. We need you now more than ever.

The Sherpa Says: Now don't let that get to your head, we have a lot of climbing to do, so eat a big breakfast and let's get going!