This is commentary from my prior blog post and with a great Reader who always gets my thinking about my stances and opinions. Since I couldn't fit it all in the comments page I want to share it with everyone. You can see her comments Why can't google let more than 4096 characters exist on a comments string??? G-d Only Knows.
The Bold is my response
Dr. "Sherpa" - I am confused.
"Are you FOR personalized medicine or not?"
Yes I am for diagnosing and preventing disease, accurately, scientifically and medically. I am for dosing medications as guided by one's genes and environment. I am for identifying genetic risks for disease using accepted standards and even new standards that are medically valid.
"Are you happy NYS licensed Navigenics...and is no doubt on the path of doing so with other companies...or not?"
I am familiar with the lab requirements for NYS. They have met those. I am not so certain applying an algorithm on that data to interpret it is such a good thing here, especially the risk interpretation. Which can be different from other tests like this. Nevertheless, a physician can use this non-medically valid test if they want to in NYS. I am not certain many physicians would use it. The malpractice exposure they would get from these multiple non validated data points are pretty risky.....
"As a pioneer physician you must be aware that one doesn't begin with an optimal end result for an entirely NEW INDUSTRY...at the beginning of the process."
I agree, you have to break a few eggs to make an omelet. But when you are dealing with human life, a different standard begins to emerge......
"Certainly, as a physician, you are."
"So, I am confused by your posts making assertions that cross the line to outright claims of conflicts of interests and...sometimes worse...without a shred of proof."
Renata M, before you accuse me of slander, please tell me which statements you find objection to.
"Why undermine the trust/confidence in this new world in this way? "
Why should we trust before it is proven to us? And why is DTC Genomics equated with Personalized Medicine? It IS NOT PM!
Isn't that what we are seeing in the US now? People who trust inherently often end up hurt. In fact it is the skeptics like Socrates who are venerated. Unfortunately, often after they are long gone or are executed for their beliefs....
"Nor should dated links that no longer apply to the fast evolving and current business/economic climate, technologies and law(s) in differing American States and the international sector be fused - adding to the confusion for neophytes...like me...who, though we are not of your august standing...deserve better from you.
Renata,
Outdated links? I think that it was an important point you missed there. Jack LORD WAS the CEO of Navigenics. This is obviously not some deal cooked up by Vance. you just can't do that sort of thing in a month's time!
"Is it your belief that ANY executive or Board Member who has a former affiliation is actually acting in the capacity of all former posts/affiliations/occupations"
Renata, you cannot tell me you are that naive? Are you serious? Does Jack Lord have any ties or better yet, stock options? Tell me how much Eric Schmidt enjoyed being on Apple's board? Economically and for his own Company?
"- and - Navigenics Board, the State of New York Department of Health, investment banks and Proctor & Gamble are incapable and/or otherwise conflicted insofar as validating Management and future plans as detailed to the aforementioned?"
Hmmmmm, maybe you can clarify what the hell you mean here? I don't understand how the NYS DOH validates Management and future plans of Navigenics Board and their members?
"Are only physicians capable of avoiding conflicts of interests when they choose to participate in the business sector???"
No, no one is all that capable these days of avoiding conflicts of interests. That is why we declare them on CMEs we give, or in academic positions. It is this transparency that is needed. Do I own a DTC company? No. Do I make money from DTC testing? No. Would I make money off Genetic testing done in my office? No, not off the test.
"Are only physicians capable of avoiding conflicts of interests when they choose to participate in the business sector???"
No, no one is all that capable these days of avoiding conflicts of interests. That is why we declare them on CMEs we give, or in academic positions. It is this transparency that is needed. Do I own a DTC company? No. Do I make money from DTC testing? No. Would I make money off Genetic testing done in my office? No, not off the test.
"For those of us who are not physicians, bankers or biotech experts/lawyers...though your posts are always entertaining and provocative fun...confusing."
I would love to know who you are Renata M. Feel like disclosing? Maybe we could share IP addresses? Hmmmm?
"Fortunately, I try to keep up and have historical context to provide me with not only insights - but a view of where conflicts really lie."
I thought you were a neophyte? What historical context are you talking about?
"I cannot see them with Navigenics, nor with the decisions of P&G, investment banks, NYS Dept. of Health"
You have to stop lumping the NYS DOH in with these companies. The government has a strict protocol for defining conflicts of interest. Which is available to the public.
"...to validate this fine Company and its efforts to pioneer new, difficult terrain in a challenging economic climate."
I know that some of the people at Navigenics are very fine people. I agree. But Navi is hardly doing the pioneering for personalized medicine. I would say the people doing the family histories, using the PGX testing, seeing patients and applying the science are the pioneers. The people doing the research are the pioneers. The people guiding the governmental policies are pioneers.....
The people trying to make a fast buck here are the profiteers............
I am in this for the long haul Renata M........I am only 33. We have a long way to go. And my interests lie with giving the field Gravitas and a sense of Honor. That is what this field needs......not Sports cars, celebrity endorsement and open bars......
Seriously Renata M, WTF? This is personalized MEDICINE. Not Personalized SHOPPING. Not personalized GOSSIP SHOWS. not Personalized GENOMIC DISCRIMINATION.......
Personalized MEDICINE. Which is altogether separate, intertwined with, but different than personalized GENOMICS.....
"Be well."
You too Renata
End Comment String
The commenter raises a couple of really good points.
1. Just because you have a state approval does not mean what you are doing is medically sound. But people often think that is the case. Ask the chronic Lyme doctors who pump you full of antibiotics here in CT......
2. A Company Board has its own set of operating circumstances.....every one is different and boards of publicly traded companies have different rules and issues from private boards.......
3. Just like Toyota, these companies have a responsibility to get it right. Often, the first time. If they don't they need to recall until it is right.......even though this is not an accelerator issue, it will soon be a doctor using these tests.......(UGH!) issue.
4. I am sick of Personal Genomics jumping on the Personalized Medicine Brand. They are not the same. That is basically like saying a blood type is Medical Care. It could be used for medical care. It could also be used for "fun" Remember that? It could also be used to identify relatedness. It could be used to market a diet fad resulting in millions of dollars of profit...... It could also be used for god only knows.....but it is not always Medical Care......and at least Blood Types are clinically useful.
The Sherpa Says: We have to stay strong of mind here. The marketers are out to trick us into thinking DTC Genomics is NOW, Personalized Medicine! Because that is where the market is.........
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