2009, Kansas is going Bye Bye!

Ok, So last year I closed with a joke from Francis Collins, who by the way, I predict to be the next head of the NIH....

The Joke?

"There is this woman who is married to a research geneticist......... He keeps telling her how great their sex life WILL be."

That certainly was the hype from 2008. As we finally begin to wash ourselves off from the greatest hype and over-selling ever committed in Genomics, we may be a little skeptical...Even the FDA has now jumped on the regulation bandwagon. That's ok. But please don't dismiss Personalized Medicine as dead. Trust me, We've only just begun....

To prove this works.....

First, I am proud to announce that Helix Health of Connecticut is the newest member of the Personalized Medicine Coalition. In addition, I will be serving on their Clinical Science Committee. I am excited for the meeting on Feb. 12th!

Second, I look forward to developments from Coriell. I am told that their "disruptive move" by offering patients a Genome SNP scan at no cost, shook up 23andMe, encouraged Navigenics to partner with Scripps on a "similar" study and Caused Kari to Scream with fits of four letter expletives at a recent NIH/CDC conference.....

Why at no cost as opposed to the study funded by Navigenics and Scripps, which charges participants? They feel (and rightly so) that no one should ever have to pay for research which is being implemented through them. Yes, true they are non-profit. But have you ever seen BMS, Pfizer or Novartis charge patients for drug research????? It just doesn't make sense.

Coriell is at its heart a Medical Research Institute. My hope is that Helix Health of Connecticut will learn to be the same. A patient-centered genomic healthcare instutute.

We are also looking forward to several other announcements likely to come out in the month of January.

As for the rest of the field, things are progressing nicely. Some of the barriers we have discovered are finally being ascended. See, Cue4, Generation Health and another company I had done some work with.....

But, without further ado.......

Finally, what you all have been eagerly anticipating.

The Sherpa's Predictions for 2009.

Mind you they come in 3 groups. Highly likely, Possible and Ridiculous

Highly Likely:

1. Francis Collins will become the director of the NIH and collaborate with Kari from Iceland to create a national database of genomes. This is the only way to jumpstart personalized medicine. My feeling is that Kari knows how to do this, is a friend of Francis, and Obama is likely to give him the greenlight on this, despite public sentiment....

2. We will see our first lawsuit for a pharmacogenomic cause. My colleague over at ASU, Gary Marchant says it will only take one and the flood gates will open. The lawsuit will be based on something called "Loss of Chance" doctrine. The theory goes, "did you cause the patient to lose a chance at a better health outcome?" If the answer is yes, well then you can be sued. This recently has been the case for delayed diagnoses in several states (24 to be precise). All it takes is one smart, enterprising, hungry attorney to go after this....I can see it now.

Plantiff's attorney(PA) "Doctor, who is the FDA?"

Doctor(MD): "The US Food and Drug Administration"

PA "and what do they do?"

MD: "FDA provides safety information on drugs and other FDA-regulated products, and allows for adverse event reporting."

PA: "Would you use a drug that was not approved by the FDA?"

MD: "No"

PA: "Doctor, would you mind reading this label?"

MD: "…genetic variations in the CYP2C9 and VKORC1 enzymes may influence the response of the patient to warfarin.” In the “Dosage and Administration” section, it states that lower initial doses should be considered for patients with genetic variations in CYP2C9 and VKORC1."

PA: "Doctor, what is the genotype of the defendant Mr. X?"

MD: Silence....

PA: "Doctor?"

MD: "I do not know"

PA: "Doctor, why do you not know everything you need to know about a patient PRIOR to giving this deadly rat poison"

MD: Silence

PA: "Doctor, is there evidence showing that patients with poor metabolism would need a lower dose than the one you prescribed Mr. X?"

MD: "Yes, but......"

PA: "But what doctor? Why would the FDA put something on the label if there wasn't solid evidence behind it?"

PA: "furthermore, if you knew your patient had a liver problem with metabolizing the medication, would you give the dose you gave to Mr. X?"

MD: "Well, hepatic dysfunction is (cut off by attorney)

PA: "CYP2C9 genetic mutations ARE hepatic dysfunction doctor"

I think you get where I am headed. In economic lean times, people will try anything....and this sure is like the Statue of Liberty play. It WILL score a touchdown, that's why people still run it.

3. We will see George Church's Exome project results and they will certainly confuse all of us as to what it really means. We may even see a broken ladder?

Possible:

1. We will have an X-Prize winner. If PacBio and the black box known as Complete Genomics work out, this will be ready by November 2009. Seriously.....now, to sort out what the hell it means......We need a database, someone to actually take liability (Unlike the chickeSh!^ companies today), and someone to counsel on this.....do you really think 2700 people is enough???? That is only a cool 111,533 people per provider......at 2 hours per evaluation that is only 223,066 hours of work, only 9294 days of straight work, or 25 years straight!.....give me a freakin break NSGC/ABMG/ABGC/ACMG!

2. Mr. Stoicescu sues KNOME for a 345,000 USD refund. It could happen, the oligarchs lost a ton of money last year. I am sure he could use the money back in exchange for Complete Genomics Genome evaluation.

3. Oprah will have a third hoax on her hands as she discovers her genome scan was bogus. 3 strikes and your out Oprah!

Ridiculous:

1: Mark Cuban will buy the rights to 23andMe's database. If I have at least one thing, it is tenacity.....this one will happen

2: A new technology called next-next-next-next gen sequencing will debut and have your genome done in 15 minutes. They will say the technology will be ready for prime time in 2 years.

3. The United States will fracture into 6 territories controlled by Russia, Mexico, China, Canada....I think I played this game in the 1980s.

The Sherpa Says: Happy New Year! May the new year be as good for you as it already has been for me. Here's to personalized medicine in 2009!!!!!