CDCV, Deck Chairs of the Titanic? We shall see.......

It looks as if the VC team has completely taken over Navigenics. Dana Mead of KPCB and Sue Siegel of MDV will be taking over. Mari will stay on as a Board Member.

This whole thing has me wondering........if I pitch an idea to VC, will they turn me down, only to "create" the exact same company? "Oh, we don't sign NDAs"

A lot of Entrepreneurs out there are asking the same questions.....I think they are right to ask these......Despite what they say.....

It seems Navigenics is one of those VC started companies.........and it looks as if they can't pull out.

Why? Well, this seems to be their baby.....Much like Google's baby is 23andME.

Any other sane investor would have pulled out of these companies when the regulations hit. But, now it seems as if these companies are firing their webmasters, outsourcing the work and looking to save face.

What really would hit them hard is if a new round of regulations were to get in their way.....

Many of my detractors say "If these companies die, so does personalized medicine"

I often laugh when I hear this. Is personal genomics the same as personalized medicine?

The short answer is no. The long answer is No Freakin Way!

Most of these markers don't help us at all. The only thing useful here is the social milieu which they are trying to create.

23andME seems to be doing the best job of that. However, with chat rooms filled with medical misinformation, I wonder how useful these sites will become....

The Sherpa Says: Navigenics hasn't fully turned clinical yet........They will once this move is completed and we will have another 2 clinical diagnostic companies that have an undetermined clinical utility. It takes 5 years to prove utility and I think KPCB and MDV are in for the long haul.......Maybe it is the beginning of the end and these guys are just re-arranging deck chairs. Time will tell, Vamos a Ver....

The beginning of the End? Mari leaving Navi?

Mari Baker is leaving Navigenics......

I am fairly certain of that....

Unless you can be the CEO of 2 companies at once.......

"PlayFirst Expands Management Team to Address Growing Consumer Entertainment Market; Recruits Senior Industry Veterans in CEO, CFO Positions


SAN FRANCISCO, Feb. 26 /PRNewswire/ -- PlayFirst, Inc., the award-winning entertainment company, today announced that Mari Baker, a consumer software and internet industry veteran, has been named its Chief Executive Officer. The company also announced today that Jim Wandrey has joined as Chief Financial Officer. PlayFirst, one of the leaders in casual entertainment, recruited the new leadership to address the growing market opportunity in interactive consumer entertainment."


Or maybe they're restructuring. Or maybe a major VC is pulling out???

All the best Mari. I hope your next company doesn't have a multi-million dollar open bar party for 9 days in SoHo.

-Steve

HT: BC at EG

The Sherpa is Right! DNADirect moves into the clinical space.

As if my conjectures weren't enough, it seems to me that the DTC genomics space is proving my theories to be correct. It turns out that the real value is in providing analysis of the genetic material, NOT testing itself. When you start giving interpretation, you begin to incur regulations that were not applied to those labs who are doing the tests.

It turns out, people don't like buying genetic tests online. In fact, one of the oldest DTC genetic testing company is NOW turning into a genetic counseling resource service.

According to the DNADirect site:

DNA Direct can help your physician practice or medical center meet this challenge by providing access to genetic expertise that can be seamlessly integrated into patient care.

It turns out that this was one of the things we did at Helix Health of Connecticut of CT about a year ago. We sat a CGC down in a busy IM practice and hoped that they would share and learn from each other. We also hoped it would lead to more referrals.

It didn't lead to too many more referrals, but it did bring the doctors up to some sort of speed. I think this is DNADirect's attempt to get physicians comfortable with genetics and I commend them for this. But I also know that they are in discussions with insurance providers to offer genetic counseling services for Insurers......much in the same light as my friend Heather Shappell.

Here's what I think. The DTC Companies will all evolve in some aspect towards providing professional services. Navigenics does, deCode is moving in this direction and NOW DNADirect is moving into this space. So much so that they are seeking out insurers to provide these services......In fact based on what I am reading they are looking to serve as a "dial a genetic counselor" for regular physicians in everyday practice.

I have thought about providing this service too, but you see physicians actually have a limitation that genetic counselors don't. Physicians have to be licensed in each and every state that they provide medical care......EVEN Telegentics care.....

Counselors don't. I think this is a good thing for counselors, but a bad thing for Pharmacogenomics and Common Adult Disease Genetics. Maybe, this is the out for 23andME????

Or maybe they (23andMe) will continue to deny that they are providing genetics services..........

You see, Heather had pioneered TeleGenetic Services for Cancer genetics at her company "Informed Medical Decisions"

She landed a contract with Aetna and is looking at more third party providers.....

This is a key to expanding our services. Most providers are unaware of OR improperly use genetic testing to aid health services. If you can land in every physicians office with a warm voice and some key skills, it would be very useful........rather than some discussion boards where voodoo medicine and medical misinformation is passed between patient and patient.

That being said, BRCA testing seems to be easily integrated in Internal Medicine services according to recent analysis.....so maybe doctors are starting to get at least one part of it......

What amazes me about 23andME is that a lot of their discussion boards are not proctored by healthcare providers to correct misinformation. This inevitably results in a 17 year old being scared of his prostate cancer risks and someone interjecting "Oh don't worry, more sex can help you prevent prostate cancer."

Is that really outsourcing medicine? Is that really democratizing knowledge? In my mind it is spreading misinformation under the guise of scientific authority.......

I do predict that the other DTC companies, good bad or ugly, will begin to follow Informed Medical Decisions and NOW DNADirect........which are becoming virtual extensions of things like our practice at Helix Health of Connecticut.

The Sherpa Says: Hey Dietrich, if you read this.....do you remember the "Apple Stores???" Ryan has been the leader here and it is clear......the services around the genome are the most valuable things............

23andME-"Genetic Counseling isn't Clinical Medicine"

Thanks to an amazing string of commentary on my blog, I think I get it.

Most of the 23andME users don't understand clinically what they are getting. It turns out, what they are getting is in essence unsupervised genetic counseling.

Vincent a commenter notes from my previous set of comments:

"In their actual report to customers, though, their language is much more sane.

E.g.Carrier for the 6174delT BRCA2 mutation.

Lifetime risk of breast cancer for women is increased from 13% to 85% and risk of ovarian cancer is increased from less than 2% to 23%.

May significantly increase risk of prostate cancer in men. There is also an increased risk for breast cancer in men.

That an accurate (as best as I can tell) statement of fact, and one that does not cross the line into the area of clinical diagnosis."

I then clue him into something he may not get and in fact I didn't get it until we talked about it.

SHERPA-"What you said is in their report is EXACTLY what a genetic counselor would tell their patient......."

Which prompts a reasonable conclusion by Vincent, which is absolutely incorrect. Why? Because we assume genetic counselors are autonomous units.

VINCENT-"A doctor or genetic counselor would take the conversation much further, however, and that is the key point I think. A licensed practitioner has the ability and obligation to go far beyond the purely statistical and into the truly clinical. Family history, behavioral factors, prevention options, treatment options, and so forth.

A company like 23andMe does not have that obligation, and it seems like that is part of what drives you bonkers."

He nailed it without realizing he did. When 23andME presents you this information in such a fashion, they are providing exactly how a genetic counselor would. They are probably painstakingly creating reports that are word for word what genetic counselors would deliver.

In addition, he double nails it. 23andME is providing genetic counseling while abdicating any of the clinical responsibility of putting that information out there. This is especially troublesome with highly penetrant tests, such as BRCA.

He triple nailed it by describing the argument 23andME will likely use

Our reports look like Genetic Counseling, But that's NOT Clinical Medicine/Genetics

I saw this attitude when I sat at a roundtable with Ryan Phelan of DNA Direct, Jeff Gulcher of deCode, Dietrich Stephan of Navigenics and Joanna Mountain of 23andME in San Francisco last June.

When asked "What if this genetic information changes? Who is responsible to notify customers/patients of this change?" What erupted was a slew of finger pointing at the table and Ryan Phelan saying "It would be nearly impossible to ask us to recontact customers with that change in information (rough quote)" Dietrich said "We have a subscription service that you pay for to get those updates" Mountain and Gulcher were silent.

But I grabbed the mic and said "If a physician orders a test and the results change, that physician is legally and morally obligated to report that change to you, at no cost and for the rest of the time that patient is under your care"

That is responsibilty. When I say there is a fundamental lack of willingness to accept this accountability at the highest levels, I mean it. I have seen what they have had to say, and they are left lacking.

Some may say, well 23andME is not practicing medicine. But I tell you, what they are delivering smells, looks and feels an awful lot like what any genetic counselor in any town in the United States, UNDER PHYSICIAN SUPERVISION, would be providing to PATIENTS who underwent BRCA testing.

So genetic counselors, if I haven't alienated you and you are still reading the Sherpa......Beware, 23andME is looking to replace you with reports. In addition, they are arguing that what you do isn't technically the practice of healthcare/medicine......

If you let them get away with this argument

1) Their will be a legal precedent which may ruin any argument your group has to be licensed

2) They will erode the patient trust bond with your patients

3) They will unltimately replace you and a physician will be using this service instead of consulting you.

This ball is now in NSGC's court. I hope you can do something about this, before it's too late.

The Sherpa Says: 23andMe's response "Yes our reports look like genetic counseling, but that's not clinical medicine......." Ouch.......

10 months........

Forbes April 2008


"Both 23andMe and DeCode, which has not received a warning letter from New York so far, argue that the lab testing laws don't apply because their products are not medical tests. "23andMe's services are not medical ... they are educational," argues 23andMe spokesman Paul Kranhold. "

"One worry is that people who order online gene tests could get misleading information. For example, 23andMe tests for some gene variants involved in mildly raising breast cancer risk, but not genes called BRCA1 and BRCA2 that vastly raise breast cancer risk. Harvard Medical School's Mark Daley says if you found out that you had genes that slightly reduced the risk of cancer, but didn't check for the real cancer-causing gene like BRCA1, "you get a potentially dangerously misleading answer."


What a difference 10 months makes........


I am certian testing for limited amounts of mutations is probably just as confusing.....

From 23andMe

BRCA Cancer Mutations (Selected)

Breast/Ovarian Cancer is one of the diseases that 23andMe analyzes. Our service includes the following information:

• Whether or not you are a carrier for Breast/Ovarian Cancer.
• Information on SNPs i4000377, i4000378, i4000379, markers that influence your carrier status for Breast/Ovarian Cancer.
• A look at how Breast/Ovarian Cancer works, and a list of counselors, links and support groups for BRCA Cancer Mutations (Selected) in your area.
  

Carrier for Breast?Ovarian Cancer???? What kind of language is that? One thing is for sure "Carrier for Breast/Ovarian Cancer" sounds an awful lot like genetic risk for breast cancer carrier.......otherwise known as a medical diagnosis code V84.01

It depends on what the meaning of the word "IS" is

Shameful doubletalk........

The Sherpa Says: Russ, in what world is this something worthy of your support?

I am not a man.......

As I post in the "southern command" I want to announce.....

I AM Not a Man.

I repeat.

I Am Not a Man.

I know, I have man parts.

I may have a hairy chest like a man.

I may have an X and a Y.

But I repeat, "I Am Not a Man!"

I am dead serious. I AM NOT A MAN.

In a statement to Pharmacogenomics Reporter, 23andMe stressed that offering BRCA testing does not mean the firm is moving into the medical genetic-testing space.

It sounds just as silly, doesn't it?

BRCA testing is NOT A MEDICAL GENETIC TEST.......

BRCA testing is NOT A MEDICAL GENETIC TEST......

I think Myriad will beg to differ. A whole bunch of Geneticists and Counselors would as well......Just ask Ellen Matloff CGC, Research Scientist at Yale......

"Only a doctor can provide a medical diagnosis and we report information that the current state of genetic research and our technology allows. "

Last time I checked, Genetic Counselors, Nurse Practitioners, Physicians Assistants AND Doctors report medical genetic test results,...........SO DOES 23andME! But unlike 23andME the others do so in the supervision of a licensed physician. But it doesn't change the fact that presentation of genetic testing results is making a diagnosis.

Hey Linda, have you ever heard of a V84.01 or V84.02? No? Why should we expect you to? You aren't a doctor, but your company IS PERFORMING MEDICINE everytime they tell a patient they have a BRCA mutation. In essence you are reporting that the patient is a V84.01 or V84.02.

23andME is NOT PRATICING MEDICINE

23andME is NOT PRACTICING MEDICINE

Well..........

It depends on what the meaning of the word "IS", is.

What this shows is a true lack of accountability in a lame attempt to:

"Democratize the Unlicensed practice of Medicine"

I view this act in the same light I view AIG's CEO saying everything was ok, 2 days before AIG's collapse

Or when A-Rod was asked "Have you ever used steroids, human growth hormone or performace enhancing drugs"..........."NO"

Where is the accountability today?

The Sherpa Says: Linda, Anne, Sergey, Eric....admit your mistakes, accept your regulations and become a medical testing company. Because if you don't, if you try to play a "Definition of Is" on the public, then the chain of trust between patient and testing laboratory as well as between physician and testing laboratory will likely be broken. That is a risk, healthcare cannot afford........Because of your arrogance, we may need to once again ask the law to repair our chain of trust. To practice medicine, you need that chain of trust. It is essential to medicine! And you make a mockery of it.

Why Facebook and Not 23andME?

Ok, so I am certain you are all aware of the big hulabaloo surrounding good 'ol Mark Zuckerberg and Facebooks' plans to sell user provided content to companies.........The FacebookOSphere was up in arms!!!!!

What happened? He backed down.

Here's my question? Why in the hell do you care about that Drunk Photo more than you care about the information contained in your genome. That Drunk Photo is only a snapshot of your poor decisions at 21, easily explained away. But your genome? How do you explain away an APOE e4 genotype? What about a Huntington's Genotype? Familial Hypercholesterolemia?

I hope you see where I am going. Once your information is online and once you sign a terms of service which says I'm ok, you can end up with this.

To be clear, it's your choice. "We never sell data" without customer consent, Avey says. For personal data, customers consent every time they volunteer for a drug manufacturer's research project. But 23andMe will not notify customers every time they sell genetic data; in that case, a customer's initial consent -- given when first signing up for a 23andMe test -- suffices.

Mark Zuckerberg learned the hard way when he had millions of customers. Maybe since, 23andME doesn't have that kind of user lobby yet, they won't feel the pressure. But since they are already selling customers' genetic data to any one they please, the pressure won't be felt until they have already made millions......

Oh and BTW, User provided content is granted a worldwide, non revocable license to 23andME too........(That certainly smells awfully close to ownership to me).......

With the exception of your saliva sample, 23andMe does not claim ownership of the materials you provide to 23andMe (including feedback and suggestions) or post, upload, input, or submit to the Service (collectively "Submissions"), unless otherwise specified. However, by posting, uploading, inputting, providing or submitting your submission, you are granting 23andMe, its affiliated companies, sublicensees (including but not limited to sublicensees who avail themselves of the Limited License granted in Section 6 above) and successors and assigns a nonexclusive, worldwide, royalty free, perpetual, non-revocable license to use your Submissions in connection with the operation of their Internet business, including, without limitation, the rights to: copy, distribute, transmit, publicly display, publicly perform, reproduce, edit, translate, reformat, and create derivative works from your Submissions.

Imagine if Zuckerberg had asked his Facebook fanatics to agree to this one!!!! He'd be outta business in a heartbeat.....

It's funny how the rules only apply to certain companies......

I am amazed that all of these technophiles like to verbally assault me about how I feel about 23andME, yet most of the field feels THE SAME WAY about Facebook and some stupid drunk photos or illicit pics......And both companies are saying "just TRUST us" but with Terms of Service like that, how can you???

I guess it's a case of the "A-Rods"..............more people in NYC cared about that than the Stimulus bill signing.....Sad.....

The Sherpa Says: When will people realize that selling your information shouldn't be taken so lightly. It looks like Drunk Pics mean more than SNPs......that's because of public health illiteracy. We should focus on health and physiology not sex-ology in health class.

Why 23andME? Why Now?

A few people have been asking me these questions after my recent blog post. Andrew and Daniel (Two prolific bloggers in the personalized genomics space) are both asking these questions and rightly so.

1) Why did 23andMe take such a risk? They had a nice Novelty genetic testing game working (albeit flawed). Why risk by going into truly defined medical practice?

I think this move rests on 3 assumptions

A) Most people won't buy a dunkin' donut's coffee today as they cut back costs. Why spend 399 on a vanity bobble?

Thus B

B) People pay for medical necessities still. So to sell tests, they can make it look like a medical need.

C) Most investors are looking to shorten their ROI time frame especially in this economy.

2) Why now? Why take the risk now? Aren't they risking their already set income stream by rocking the boat?

A) Have you seen the economy? The FDA isn't exactly priority number one in Washington now.

B) California is about to go bankrupt, I don't think CDPH will be focusing on these tests at this moment, leaving 23andME to force their way into medicine without being regulated.

C) If they don't make this move now, they may never have the chance again. Take a look, in 6 months the economy will be better. The FDA/CDC will have their joint Genomics department set up to police these measures AND WILL HAVE STIMULUS monies behind them to bring down the hammer...

So now is the perfect time to move...........The attention is on the Economy Stupid!!!!

The Sherpa Says: If the organized specialties such as ACMG, NSGC, ACP, CAP etc. move on this, they will be left with scratching their heads as to where their lab monies have gone? Let's face it, the clinical department is only kept around at these centers because of the profits which are brought in by the labs.....

23andMe leaves the Reservation and Goes Clinical.

As I had postulated before, in order to move towards a profitable direction the DTC companies would have to choose "Medically Relevant" or "Novelty Testing" From this recent email sent to me by a reader it is clear, 23andME is Choosing to become a clinical service, without accepting the clinical responsibility.

Hello Patient X,
There's a wealth of new information in your 23andMe account. Our scientists have recently added a number of new articles to our Personal Genome Service, including two that may be of special interest.

If you take cholesterol-lowering statin drugs, be sure to check the new article for Statin Response, which deals with rare but serious side effects that may be influenced by genetics.

And for our members who have the data> from our v2 chip, we've added important information about BRCA1 and BRCA2 -> genes with variants having a quite rare but significant correlation to breast and ovarian cancer - in BRCA Cancer Mutations (Selected).

You can read these or any of our other recently published reports here.

And check out the expanding list of topics being added by your fellow community members here. Please join the conversation!

Best Wishes,
The 23andMe Team

So there you have it! BRCA1 testing on the V2 chip from 23andMe. I never, ever, ever thought that they would lay this stake so quickly. Yes, it is clear. 23andMe wants to report, directly to the consumer BRCA1 genetic test results! It is a variant and it is being reported.

Do they have medical malpractice coverage?
Are they covered by HIPAA?
Do the have the HHS Certificate of Confidentiality?

NO.

Rest assured, I have forwarded this information on to the California Department of Public Health as well as EGAPP. People do deserve to know results of these tests, there is no doubt about that. But people also deserve to have the legal protections afforded to all others who do genetic testing through a provider. These protections include significant regulations mandated of labs as well as ordering providers.......

I said last month that we would know which way these companies will go in 6 months. Looks like it took 23andMe only 1 month.......

The Sherpa Says: Pharmacogenomics and BRCA testing is in the realm of Clinical Medicine my friend.......so shall end your punch line of "Testing for Fun" I look forward to you taking medical responsibility for your actions. I hope you do too.......

23andMe enters the Clinical Medicine Realm!!!

As I had postulated before, in order to move towards a profitable direction the DTC companies would have to choose "Medically Relevant" or "Novelty Testing" From this recent email sent to me by a reader it is clear, 23andME is Choosing to become a clinical service, without accepting the clinical responsibility.

Hello Patient X,

There's a wealth of new information in your 23andMe account. Our scientists have recently added a number of new articles to our Personal Genome Service, including two that may be of special interest.

If you take cholesterol-lowering statin drugs, be sure to check the new article for Statin Response, which deals with rare but serious side effects that may be influenced by genetics.

And for our members who have the data> from our v2 chip, we've added important information about BRCA1 and BRCA2 -> genes with variants having a quite rare but significant correlation to breast and ovarian cancer - in BRCA Cancer Mutations (Selected).

You can read these or any of our other recently published reports here.

And check out the expanding list of topics being added by your fellow community members here. Please join the conversation!

Best Wishes,

The 23andMe Team

So there you have it! BRCA1 testing on the V2 chip from 23andMe. I never, ever, ever thought that they would lay this stake so quickly. Yes, it is clear. 23andMe wants to report, directly to the consumer BRCA1 genetic test results! It is a variant and it is being reported.

Do they have medical malpractice coverage?

Are they covered by HIPAA?

Do they have the HHS Certificate of Confidentiality? They are doing research on genomics!

NO.

Rest assured, I have forwarded this information on to the California Department of Public Health as well as EGAPP. People do deserve to know results of these tests, there is no doubt about that. But people also deserve to have the legal protections afforded to all others who do genetic testing through a provider. These protections include significant regulations mandated of labs as well as ordering providers.......

I said last month that we would know which way these companies will go in 6 months. Looks like it took 23andMe only 1 month.......

The Sherpa Says: Pharmacogenomics and BRCA testing is in the realm of Clinical Medicine my friend.......so shall end your punch line of "Testing for Fun" I look forward to you taking medical responsibility for your actions. I hope you do too.......

Prasugrel saves Clopidogrel???

You gotta love it. The other day I was talking to a pharma rep, yes I do speak with them.....and they were all excited about Effient (generic name Prasugrel).

What are these medications and why was the Pharma Rep excited?

Well, you see Plavix(generic name Clopidogrel) which is one of the top 3 selling medications in the world is given to people who have had a stroke or heart attack. This medication is given to prevent another heart attack or stroke......

Also, this medication is given to people who have received stents in their coronary arteries. This is to prevent the stents from clogging up with platelets.......sort of a Drano in a pill so to speak.

It is also given to people who are having an acute heart attack.

These 2 medications are blood thinners. How do these thinners work? They block platelets, in a way similar (but not the same) as Aspirin.

Why was the Pharma Rep excited?

1) Prasugrel is just about ready to be FDA approved for use

2) Prasugrel has a study called Triton-TIMI 38 which shows it is better than Clopidogrel with outcomes

3) 2 studies just came out last month in the New England Journal of Medicine and one in the British Journal Lancet which show that up to 1 in 3 people taking Clopidogrel(Plavix) may have little to no effect from the medication and are at 300 times more risk for ANOTHER heart attack, stroke, or stent clogging by platelets.......And another one this month in the European Heart Journal!!

4) Another study came out showing that Plavix has no effect in patients who are on proton pump inhibitors. Drug Drug interactions are a big deal.....

Why is number 3 a BIG deal? Because it is a polymorphism in CYP 2C19 which reduces proper conversion of Plavix to its active form.

This IS PERSONALIZED MEDICINE!!!!!

We can test patients, avoid a medication or perhaps increase a dose according to genotype and ultimately change the risks of being a poor metabolizer......

Why am I not so HOOO RAAAHHHH for Prasugrel?

Guess what? Prasugrel ALSO requires conversion like Plavix..........it just uses another CYP enzyme.....

What's that you say? Maybe that enzyme isn't screwed up in 1 in 3 people.....

But it is at least present in 7-10% of certain populations and as high as 83% of African Americans!!! I think 83% is pretty high.....what one in three? 33%?

Well, that enzyme is CYP 3A4. Does that sound familiar to anyone? CYP 3A4 is required for some STATINs to be metabolized as well as some immunosuppressants.......Oh and as for drug, drug interactions from CYP3A4 inhibitors....

Here's the list

amiodarone, amprenavir, cannabinoids, cimetadine, clarithromycin, clotrimazole, cyclosporin, delavirdine, diltiazem, ethinylestradiol, erythromycin, fluconazole, fluoxetine, fluvoxamine, indinavir, intraconazole, ketoconazole, metronidazole, mibefradil, miconazole, nefazodone, nelfinavir, nicardipine, norfloxacin, propafol, quinine, ritonavir, saquinavir, sertraline, troleandomycin, verapamil, zafirlukast

The ones that I bolded are medications I have prescribed in the last month......

Looks like we may have a teency Weency reason to be less exuberant......

Here's what I think. The same thing that they found with Plavix, will also be the case with Prasugrel.......

Which means.......We should stop dosing medications without knowing the patient's freaking genotype.....what the hell is wrong with these knuckleheads!!!!!!

The Sherpa Says: If Lilly was wise, they would release these "trade secrets" and let us know how many of their patients in the private trials failed therapy and were CYP3A4 poor metabolizers.....Now OFF to the PMC Clinical Science Committe meeting!

Public Service Announcment

I am all for the support from this administration towards Personalized Medicine, but perhaps this may be a little too heavy handed....

From Bloomberg:

Betsy McCaugheyBloomberg Feb. 9

Feb. 9 (Bloomberg) — Republican Senators are questioning whether President Barack Obama’s stimulus bill contains the right mix of tax breaks and cash infusions to jump-start the economy.
Tragically, no one from either party is objecting to the health provisions slipped in without discussion. These provisions reflect the handiwork of Tom Daschle, until recently the nominee to head the Health and Human Services Department.
Senators should read these provisions and vote against them because they are dangerous to your health. (Page numbers refer to H.R. 1 EH, pdf version).

The bill’s health rules will affect “every individual in the United States” (445, 454, 479). Your medical treatments will be tracked electronically by a federal system. Having electronic medical records at your fingertips, easily transferred to a hospital, is beneficial. It will help avoid duplicate tests and errors.

But the bill goes further. One new bureaucracy, the National Coordinator of Health Information Technology, will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective. The goal is to reduce costs and “guide” your doctor’s decisions (442, 446). These provisions in the stimulus bill are virtually identical to what Daschle prescribed in his 2008 book, “Critical: What We Can Do About the Health-Care Crisis.” According to Daschle, doctors have to give up autonomy and “learn to operate less like solo practitioners.”

Keeping doctors informed of the newest medical findings is important, but enforcing uniformity goes too far.

New Penalties

Hospitals and doctors that are not “meaningful users” of the new system will face penalties. “Meaningful user” isn’t defined in the bill. That will be left to the HHS secretary, who will be empowered to impose “more stringent measures of meaningful use over time” (511, 518, 540-541)

What penalties will deter your doctor from going beyond the electronically delivered protocols when your condition is atypical or you need an experimental treatment? The vagueness is intentional. In his book, Daschle proposed an appointed body with vast powers to make the “tough” decisions elected politicians won’t make.

The stimulus bill does that, and calls it the Federal Coordinating Council for Comparative Effectiveness Research (190-192). The goal, Daschle’s book explained, is to slow the development and use of new medications and technologies because they are driving up costs. He praises Europeans for being more willing to accept “hopeless diagnoses” and “forgo experimental treatments,” and he chastises Americans for expecting too much from the health-care system.

Elderly Hardest Hit

Daschle says health-care reform “will not be pain free.” Seniors should be more accepting of the conditions that come with age instead of treating them. That means the elderly will bear the brunt.

Medicare now pays for treatments deemed safe and effective. The stimulus bill would change that and apply a cost- effectiveness standard set by the Federal Council (464).
The Federal Council is modeled after a U.K. board discussed in Daschle’s book. This board approves or rejects treatments using a formula that divides the cost of the treatment by the number of years the patient is likely to benefit. Treatments for younger patients are more often approved than treatments for diseases that affect the elderly, such as osteoporosis.
In 2006, a U.K. health board decreed that elderly patients with macular degeneration had to wait until they went blind in one eye before they could get a costly new drug to save the other eye. It took almost three years of public protests before the board reversed its decision.

Hidden Provisions

If the Obama administration’s economic stimulus bill passes the Senate in its current form, seniors in the U.S. will face similar rationing. Defenders of the system say that individuals benefit in younger years and sacrifice later.

The stimulus bill will affect every part of health care, from medical and nursing education, to how patients are treated and how much hospitals get paid. The bill allocates more funding for this bureaucracy than for the Army, Navy, Marines, and Air Force combined (90-92, 174-177, 181).

Hiding health legislation in a stimulus bill is intentional. Daschle supported the Clinton administration’s health-care overhaul in 1994, and attributed its failure to debate and delay. A year ago, Daschle wrote that the next president should act quickly before critics mount an opposition. “If that means attaching a health-care plan to the federal budget, so be it,” he said. “The issue is too important to be stalled by Senate protocol.”

More Scrutiny Needed

On Friday, President Obama called it “inexcusable and irresponsible” for senators to delay passing the stimulus bill. In truth, this bill needs more scrutiny.

The health-care industry is the largest employer in the U.S. It produces almost 17 percent of the nation’s gross domestic product. Yet the bill treats health care the way European governments do: as a cost problem instead of a growth industry. Imagine limiting growth and innovation in the electronics or auto industry during this downturn. This stimulus is dangerous to your health and the economy.

(Betsy McCaughey is former lieutenant governor of New York and is an adjunct senior fellow at the Hudson Institute. The opinions expressed are her own.)

To contact the writer of this column: Betsy McCaughey at Betsymross@aol.com
Last Updated: February 9, 2009 00:01 EST

The Sherpa Says: This may be Change, but I doubt 70 year old patients will not object to being denied certain services because their so called "life expectancy" does not deem them worthy of preventative care.

Don't take my Kodachrome Away!!!!

Do you remember when you had to send your film to Rochester NY or Ohio to get developed......you would stop by the store check your last name.........Nope......sorry no pictures yet!! Even the thought of keeping that little tear off tag drove me nutty!

It was exciting, but it also was a huge pain in the a$$......What if the pictures were screwed up, you would have to send your negatives back so that they could get run again.........

That being said, Kodachrome is the gold standard of photo film, but that is so 1980s. In fact, there is only one processor of Kodachrome in the entire US left other than Kodak of course......

These guys had a great economy of scale with the processing centers and in fact it made a very nice business model for a while until Kodak discontinued Kodachrome......

Well in a similar type of move Complete Genomics lifts the veil at the AGBT....

and Bloomberg took notice

"Feb. 5 (Bloomberg) -- Complete Genomics, which offers DNA analysis services to drugmakers and other companies, will begin in June to sequence human genomes for $5,000, a far cry from the $2.3 billion the first sequencing cost in 2003."

"The service will be offered to drugmakers, biotechnology companies, and academic centers, said Clifford Reid, chairman and chief executive officer of the closely held Mountain View, California-based company, in a telephone interview. It won’t be available to individuals. "

From GenomeWeb

It is currently building a production genome center in Mountain View, Calif., that is scheduled to be completed this summer. By the time of its service launch this summer, the company plans to increase the output per sequence run to 200 gigabases, and to 600 gigabases by the end of the year. Its data center will host 5,000 processors and 5 petabytes of disk space initially, which will increase to 60,000 cores and 30 petabytes of storage next year.

This certainly is an interesting model.....I will be very curious as to how long this sort of technology stays this way.......say maybe before we invent The Digital Picture equivalent of Genome Scanning......

But, then what their business model entailed made me chuckle.........

“We think this is what the pharma companies have been waiting for,” he said today in a telephone interview. “We’ll be bringing a new customer to the market that’s potentially the biggest customer for DNA sequencing.”

His point was that Complete Genomics will be targeting Pharma and that this was some new model in the game of sequencing.......

I wonder if he had spoken to any of the old time microarray sales people. You see, Affy and the like actually peddled microarrays to Pharma first, BEFORE they sold that technology to the Academic centers........

That is why we have lag time between what pharma knows and what the rest of the world knows in terms of the microarray and GWAS......

So, peddling to people who have money instead of people who beg the government for money is nothing new, nor is pharma a "New Customer to the Market"

What IS a new customer was hinted at in the GenomeWeb article........

Going forward, Complete Genomics plans to provide human genome sequencing services to large genome centers, research centers, and direct-to-consumer companies.

The Sherpa Says: I wonder if LabCorp, Kimball Genetics, Myriad Genetics et.al. are going to be happy with a company essentially destroying their market by providing a Genome Direct to Consumers at a third of the price of one of their tests????? We'll find out in June!!! See you in the Summer.

Like I said........

If you have been following me at this blog for any amount of time, you know that I have been a careful watcher of these GWAS studies, and the testing companies who sprung up after them.


I have been skeptical of most of these studies unless they have had replication and fairly large Odds Ratios or Relative Risks........why? We are looking for clinical relevance and asking what can we do with this to better our patients lives........

Personalized medicine relies on several things but these 3 are absolutely needed: Prediction, Prevention and Privacy. It is rich in fields like Cancer Genetics, PGx, Preconception Genetics.

You see Personalized medicine is not just Prediction, which these DTC companies are touting, it is therapies and action......which, these tests unfortunately are lacking in.....


Unlike Pharmacogenomics....

To put it bluntly.....based on our current knowledge of what these SNPs are and what they do,

Consumer Genomic Testing is of:

Extremely Limited Clinical Value


We saw this with 9p21.3 one of the most significant findings in this arena.


Yesterday an article was released in PLOS which I just linked to which states that case pretty effectively.

I often say, that once a discovery is made of a gene or SNP or etc.....it will require at minimum 5 years to come to clinical utility.....So how could any company sell something prior to this under the auspices of medicine???


The conclusion from the PLOS paper:


Our analyses and examples show that strong association, although very valuable for establishing etiological hypotheses, does not guarantee effective discrimination between cases and controls. The scientific community should be cautious to avoid overstating the value of association findings in terms of personalized medicine before their time.


Association is NOT causation, nor is it actionable.......


Most of this small time SNP data comes through in guess what????


Family History!!!!! (five exclamation points for Daniel)


The Sherpa Says: Family History is FREE!!!! And Soon SNP testing will be too.

Recessionary Discretion......HotCoupons4U!!

Yes,


I am a big fan of the race to the bottom. At least in the case of SNP scanning. We have seen Navigenics drop their price, deCode drops off the earth and 23andMe???? Well, in a discretionary move they show use the true value of SNP scans.....




I give you HotCoupons4U.....The 23andMe special, pay close attention...


From the website.....




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Now correct me if I am wrong, but aren't they charging 399 USD for their test......so at most 23andMe thinks that their test is worth........199 USD AT MOST!!! Oh wait, this is off their family pack.....Oh, you know the one, where Anne Wojicki says you can drug your kid with benadryl for fun....and the same one where they say collecting your child's DNA is tough with the spit kits.......

Why would they lower prices even further? Because its your genome they want....not your money!!!!!



How it works:
1. Order a kit ($399 USD) from our online store.
2. Claim your kit by the claim code, spit into the tube, and send it to the lab. (The claim code is the 12-character code on the front cover of your green Spit Kit box. )
3. CLIA-certified lab analyzes your DNA in 4-6 weeks.
4. Log in and start exploring your genome.Learn more from https://www.23andme.com/howitworks/Available discount codes for 23andme: “spit party” or "SPIT"

I would like to add:

5) Release your genome into the wild and allow 23andME to profit off your folly without HIPAA protection or a certificate of confidentiality, like the one awarded the CPMC......

The Sherpa Says: Ahh Yes, it is coming in clearer now. The cost of a SNP scan is Zero US dollars.....until we prove it has value. Add on top of that the 1000 USD Genome and we will soon see that the real commodity is the interpretation and ongoing services revolving around your genome that will matter........Just like Thomas Friedman said about the Internet.......

HT-BC at EG

What will it add???? Huh Ed?

"MDVIP doctors “are very enthused and very interested in what this is going to add clinically to their management of the patient,” MDVIP CEO Edward Goldman told Pharmacogenomics Reporter this week."

That from a report by GenomeWeb's Turna Ray yesterday. (Subscription needed...bummer)

That is a superb question to be interested in Ed.....

What will Navigenics' Annual Insight test add clinically to the care of patients?????

The short answer: We have no clue.

That being said, have doctors done things on or to patients in which they had no clue what the outcome is likely to be?

Yes, it is called medical research. What it's not, is standard of care, even more, it's not concierge care. That's for certain. The team at MDVIP should be focused on taking family histories, med-med reconciliation and med-gene interactions. They should not be trying to integrate a test which has no clinical validity.

We have been studying family history and its role in medicine for decades now......so why did they jump at this shiny bobble????

I am not certain, other than they consider this a "patch" so that they can say they are practicing personalized medicine.

Let me speak clearly to Ed Goldman. "This test is not personalized medicine" In fact it is the antithesis of that. Why? Well, you are applying a test to people who may not derive use from it, even worse you are not personalizing whether you use the test or not.......

True personalized medicine is finding a family history of heart disease, anticipating the patient's risk, getting them on a good exercise regimen, and maybe even testing CYP 2C9, 2D6 and 2C19 in anticipation of a beta blocker, warfarin and perhaps plavix......

That is what personalized medicine is ladies and gentlemen. It is hard work, and not exactly scalable, but it is what is required to carry out truly preventative medicine. Not some shiny bobble.....

IMHO, MDVIP may have sullied their name by telling patients that they don't care about what the AMA says or even that this test has no proven clinical utility.....hell, even PSA has some utility!!!!

From the article:

"Of the MDVIP physicians surveyed, more than 90 percent said that genetic risk information changed how they handled their patients and spurred them to take a more aggressive medical approach."

My point exactly, why in the hell would these test results indicate that you should manage patients more aggressively? Maybe if you have enrolled them in an experiment, and obtained informed consent, you might be able to do that.....but 9p21.3 doesn't add anything to the clinical risk profile......perhaps these 90% of doctors need a course or two in clinical genetics and biostatistics.....

What a shame, these doctors were suckered in by the razzle dazzle and now are inappropriately up-managing patients based on scientifically valid (sometimes) yet clinically invalid data......

From the article

"On the one hand, Navigenics employs state-licensed physicians and genetic counselors, but maintains in its Terms of Service that this does not constitute a doctor-patient relationship. "

Shrouded in a veil of mystery and now trying to pose as clinically valid without taking responsibility.......

Well, it is no mystery that these tests are not clinically validated, or that they even produce beneficial behavioral outcomes.......

“Our stance has always been that patients shouldn't take this information and make medical decisions on their own, that they should consult a doctor,” Navigenics’ Vanier said. “This is complex information that is often challenging for physicians.”

Is that why you picked a bunch of concierge physicians who aren't trained at all in genetics to "Beta Test" the service?

“Navigenics assumes no responsibility for any consequence relating directly or indirectly to any action or inaction you take based on our site, the services, your report, or other content,” the company says on its website. “You must evaluate and bear all risks associated with their use, including any reliance on their accuracy, completeness, or usefulness.”

Of course not, why take any responsibility for what you bring to market???

Maybe MDVIP knows this and that's why the Navigenics partnership isn't on their front page

From their site:

"The truth is, MDVIP goes far beyond the fee for access companies that are rightfully seen as Concierge Healthcare and is actually setting the new gold standard for healthcare. "

If Navigenics SNP scans without any clinically valid data are the gold standard, then get me the hell out of medicine. Maybe MDVIP, should research the subject and perhaps participate in ethical research in the field???

You would have figured these companies would have funded studies prior to forcing a non clinical test on clinicians........

The Sherpa Says: This is just another case of razzle dazzle without taking moral responsibility for ones corporate actions. Haven't we had enough corporate chicanery lately????