Laying down the Gauntlet, Royalty Time!

After having many discussions about this. First one in 2007 with Matt Tindall and others with a host of people, you know who you are!


I am even more convinced as we are a "GIVE ME MY DAMN BIOMETRIC DATA" society. Are patients really to be expected to give up their data to Google for "The good of the cause"?


The answer: Absolutely not. 


You have heard of Google AdSense right?
Google has clients that want to advertise, Google needs data to display these ads. In the internet world, this is known as content. What does Google do for this "content"? They pay you. They cut you checks for your blog/website/etc. (i.e. data)


Well, I have a question to those "early adopters (read- suckers)" Why did you give google/etc. your genomes for baubles? 


Why? For the good of it? Because you bought into AnneW's story?


GoogleAdsense existed before 23andMe. Most of you are smart silicon valley types. Why did you not demand a Google check?


My thoughts. For every piece of biometric data you pay some company to give you, the MOMENT, yes the MOMENT they sell it to a third party, you should get yourself a royalty check.


EVERY TIME!


I wanted to give shares of my company to research subjects. But, after speaking with IRBs, this was a conflict of interest. But not if the data were sold AFTER research was done.


My advice, if you are smart and are a lawyer, give me a call. I have some ideas of what area of law you should research!


The Sherpa Says: Stop Paying someone to sell your data and make profit. Sell your data and ask for a royalty!

Family History Works in Cardiac Disease!

Thank God that Muin Khoury is blogging! I would have totally missed this!


When the CDC held a conference to evaluate Family History, they found "insufficient evidence" that this was a useful tool.


At that time I was quite dismayed about this, because I know that I have helped SAVE LIVES by integrating family history in our daily personalized medicine practice.


So I knew in my clinical heart of hearts that soon we would find "sufficient data" to prove that family history should be integrated into every encounter clinically!


Here is some of the first data and evidence that integrating family history helps clarify high risk individuals


Some of this evidence suggests that for every 5000 patients in a practice we would find an extra 200-250 patients at risk for heart disease!


From Dr Berg:


Dr Berg further states: “The complex design and analysis were meticulously planned and rigorously executed… That this study was done at all speaks to the better support for high-quality research in primary care in the United Kingdom; finding support for a study like this would be extraordinarily difficult in the United States … I look forward to further research and quality improvement evaluations documenting clinical results, and I hope that more work in this clinical domain can be done in the United States.“


I am happy that despite massive cuts in the budget Dr Khoury is all over this!


The Sherpa Says: Still much cheaper than 23andMe or Navigenics or any fly by night Direct to Consumer Genetic testing company! 


P.S. I will be hosting a panel at the Consumer Genetics Conference in June. Any ideas on who I should invite????

The case for hippocratic oath in web health services

Today I want to tell you why I think that health related applications on the internet should have not only some "Good Housekeeping Seal of Approval" but should also take an oath similar to the one I took when I graduated from medical school.


On it's face, there will likely be 3-4 camps reading this. One will automatically dismiss this as the "Web services" aren't providing diagnosis or treatment. My counter to them is that I said "similar to" the hippocratic oath I swore to. We'll call it the HippocraticWeb oath. 


The second camp of people will say "This is a fantastic idea but aren't there services like this that certify web content?" My answer to them is that this is not a certification of web content. Further, we all know those services like HONcode that certifies trustworthy information. Instead this will act as a code of ethics which the consumer of the health service will understand to mean a reputable business who has taken an oath which will work in the interests of the consumer.


The third camp will say "Shouldn't the government be doing this?" My answer is: It hasn't. And how could one government govern the world and the internet? That is foolish. Instead, the web should do as those in the professions have done. Govern themselves with codes of honor and oaths which are publicly available. And no I don't mean "Don't be evil"


I mean a certifiable oath that speaks about the actions of the business housing your health and medical data. I mean an oath that governs corporate decision making about whom to sell or share your data with. Not in a way that will make them the most money, but in a way that protects you, the person. After all, you paid to have access to your data, whether that be an LDL cholesterol, a blood pressure, a REM sleep cycle, a whole genome or what have you.


Why do we need such a code?


In my Nature Biotech piece I explain the dilemma with using web services for health purposes. Corporate interests are not designed primarily for the benefit of customers. They are primarily designed for the benefits of the corporation, whether that be 23andMe who just made a hash of an unnanounced TOS change (In this way there should be an offset to consumer.Which 23andSerge finally came around to because of public outcry)


Or it be flagrant sharing of your data without your permission through privacy leaks or hacking. (IMHO Insurers should have given millions of dollars back to members for their leaks and gaffes)


Why? Health companies have to do this already. But where does that money go? Further, how do I know that someone will do the right thing with my data when there is a breach? This Oath would allow the best of class to accept responsibility for their actions.


Don't think it doesn't happen? Check it out here. And this exempts companies like 23andMe or Livestrong.com. Why. Because they are not governed by HIPAA or HiTECH!


I am not proposing further regulation here. All I am asking for is that these businesses purporting to help us maximize our health "Man Up" so to speak and all swear an Oath, The HippocraticWeb Oath.

The HippocraticWeb Oath

I swear by that which I hold most sacred, that I will fulfill according to my ability and judgment this oath and this covenant:

I will apply reasonable measures to protect the welfare of the customers whose information I keep; I will keep in mind that this data they have granted me access to is theirs. Should I wish to own this, I will compensate the customer fairly.

I will neither use this data as means of blackmail or coercion of customer. Nor will I engage in business with a company who has or intends to.

I will not use the information in a legal proceeding unless receiving subpoena and properly notifying the customer of such request. In reasonable and fair time frame to the customer.

I will not change terms or service, business plans or custodians of data without giving proper notice to affected customers, allowing them time to air grievances prior to making the business decision.

What I may see or hear in the course of business in regard to the life of customers, which on no account one must spread abroad, I will keep myself holding such things shameful to be spoken about.

If I fulfill this oath and do not violate it, may it be granted to me to enjoy life and art, being honoured with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot inclusive of compensation to my customers.






That's it. Who would be averse to having something like this? It is a simple statement ensuring that the people who have access to your data will use it properly and compensate you if the transgress.


If you believe in what I am proposing please email me steven(dot)murphy(at)Greenwichdocs(dot)com I am currently working out how to implement this very important piece of trust into corporate ethic and standards when it comes to health and medical companies that provide health and medical services over the internet. This company should not be owned or part of any corporate consortium to "Get out in front" of this. Rather it should be a non for profit headed by a well balanced board of advisors. So, are you interested?


Warmly,

Steven A.R. Murphy MD


p.s. That 4th camp is full of people like me!

23andMe Buyer Beware, The Internet doesn't equal hippocrates

Ok, ok. I am not gonna tell you I told you so. But, I did.
Did anyone read my article in Nature Biotechnology? Did ya? 


Here is your freaking reality check. 23andME has your DNA. It has it hostage and it has your datapoints. And it can do whatever the hell it pleases. Including locking or cancelling your account.


They have enough data points for their robust database. They only need you sheep to keep paying 9 dollars per month or 108 dollars per year and 99 to start. 10 years? 1080 dollars. Even more than the first 999 USD they started with.


Well guess what? People everywhere are waking up to the charlatanism that was peddled by Silicon Valley Overlords.....


They have you, you are stuck. You have to pay FOREVER!!!!! BWAHAHAHAHAHAHAHAHAHAHAHA!!!!!!


Even if you quit, they don't care. They Pwned you. And they still do. 


So what did the Sherpa say all of those years? Huh? No, not that their health reports are bull $hi!. But I did say that. No not that I was done posting on 23andMe. Clearly I am not.


But I told you about the Master Plan!


Even if you pull out your data, they still have it. End of story. You are powerless and have been duped. I am sorry. I wish you had listened


The Sherpa Says: Buyer Beware web sites giving you tests and testing your DNA. 23andMe and its company are not  to be trusted. Sorry, but the web has not  take the hippocratic oath!

2011 Comes to a close. What we know about Personalized Medicine

I wanted to write a wrap up of what we know in the last 4 years regarding personalized medicine


1. In regards to DTC Genetics, the FDA won't shut you down if you are google. But you will have to give your test away for free to build your database


2. In regards to Pharmacogenomic testing, most doctors won't use the service despite studies showing utility that have existed for 2 years.


3. In regards to GWAS predisposition testing, it is mostly useless. It doesn't scare or heal you.......most of the time


4. Classical Cancer Genetics, Cardiogenetics, GI Genetics and preconception genetics have growing concerns as I am seeing more and more of these over the last 2 years.


5. When Whole genome or exome testing come out, we will have a mess load of data. This is an opportunity if someone can create subtractive algorithms to the "normal" data. Which may help us out....IFF we have a true "Normal Genome"


6. The Sherpa has been slow in posting, but these points are facts now.


The Sherpa Says: 4 years, a lot of hype, lots of sideways climbing. Next year will show big moves, just like 2007/2008 and we'll still be here.

Back again, 23andMe still $hits the bed with their reports

In case you haven't noticed. I dropped off the blog radar for a while. I had some growing to do of the practice and some streamlining. I read Daniel MacArthur's post with great interest this week. It describes clinical utility of 23andMe testing......

The one thing I haven't stopped doing is counselling patients on DTC Genomic reports.

Just yesterday I was consulting a very nice patient. They told me they just had to speak with a doctor because the report indicated that they were at increased risk of stomach and esophageal cancer. They had been up for several nights reading about it. Further, when brought to their PMD, the PMD smiled and didn't offer up any advice.

Well, first let me preface by saying, 23andMe's SNPs which they list 4 huge freaking stars of "CON"fidence for, on Esophageal and Stomach Cancer risk, while BTFW only ranking studies on Han Chinese. And only 2 studies at that.......

This report had this patient seriously concerned. Until of course I took a G-D Damn pedigree and found out they had ZERO, I repeat ZERO Asian ancestry/ethnicity, let alone Han Chinese....

The risk report from 23andSerge listed them as high risk. How in the world did that work?

(BTW, if you don't believe me, just ask and I will send you the time stamped pdfs, with name redacted of course)

You know why that worked? Because the brainchildren at the Google owned company forgot to put an ethnicity/ancestry filter on their reports. Instead they just felt that an asterisk would work just fine.....

Well Guess what 23andMe, you haven't changed at all. Even after the FDA got on your A$$. Your reports still are misleading and are causing undue angst.

Lucky for you, Myself and Dr Lubin are around to pick up after your mess......

Can you see why someone needs to look at and police these reports? This poor patient had serious concerns and when brought to a clinician who couldn't understand the SNP studies could end up with not needed endoscopies which would put the patient at risk. Primarily due to physician malpractice avoidance behavior?

Don't think that hasn't happened? Think Again.

The Sherpa Says: I am back again at it because clearly the millionaires with a penchant for DNA peddling and CPU coding can not get this right......Clearly a #FAIL

Non-Clinician Misinterpretation of DTC Genetic testing

Ok,

In case you haven't all figured it out. Blogs are dead. Mine is too, sorta. I have less and less time to blog as my practice explodes. But there are some things that just merit a blog post.

I am on twitter, you can follow me there @genesherpas

But now I am on the Sherpa. Yes, the blog that nearly got me on 60 Minutes and definitely won me the hearts of USA Today to be interviewed...BTW the practice got super busy after that......

Today I want to talk about something more serious.

The FDA hearings have laid the course clear. Direct To Consumer Genetic testing will be regulated.

Why?

1 part potential harm

2 parts irreverence for laws and medical regulation

3 parts flagrant misrepresentation of what genetic tests can do.......

See Kari S. Disavowal of his company's stupid tag line.......

Today on twitter Shirely Wu @shwu retweeted something that was the picked up by @dgmacarthur..... great geneticist, but not a medical geneticist........

That was:

A thoughtful and eloquent case-study petition to keep genetic testing DTC:http://bit.ly/dL3qar from @celticcurse#FDADTC

The problem?

I respect Shirley a lot, but this article is not thoughtful, nor is it eloquent.

Instead it is full of misinterpretation and IMHO an ignorance of the role of genetic testing in hereditary hemochromatosis.....

In no way is HFE genetic testing required or indicated to pick up a person with hereditary hemochromatosis.

USPSTF says the harms outweigh the risks of genetic testing for screening

There are multiple genes involved in hereditary hemochromatosis only testing HFE and thinking you are "off the hook" is stupid.....

There are also modifier genes likely too.....

In other words, perhaps the cheerleaders for DTCG are misinformed about the true utility of this type of testing. Further, if they knew the literature, perhaps they would be less angry that the FDA(who know the data BTW) want to regulate against these types of misinformed claims that could lead to misinterpretation by consumers and end up fleecing their pockets for fools gold.

Let's take this little gem from @celticcurse

"A simple genetic test is all it takes to know if hereditary hemochromatosis, the most common genetic killer in America, is in your genes."

Bull$h!t buddy.....less than 30% of HFE variant persons ever develop the disease. Do me a favor, partner with a doctor to hack your health next time please......

In case you wondered, iron studies are the key to screening. I get them in every northern european or any family history of liver disease, gonadal failure, arthritis, etc......

But, the lab heads wouldn't know that. Which is why lab heads shouldn't release discoveries into the wild......

The Sherpa Says: This retweet blog post by CelticCurse is an eloquent reason WHY DTC genetic testing should be regulated for claims and use......regulate the medical as a medical test, let the ancestry buffs do their thing sans FDA. End of story guys.....