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Not on gels, on cyp. Three separate occasions where I took the pain to draw at same time through Quest and LabCorp, same result EACH time for different patients (and poorer customer support when staff reached out to them to discuss...just personal experience).

Statistics are statistics, unless as stated above, lab/human error is entered into the equation at which point all is out the window.

Symptoms will ALWAYS take precedence regardless of what assay one may use (even if they are those practitioners who mistakingly fail to even monitor E levels).

Standard assay, as long as you evaluate WHERE in range and are a little more weary of very high or very low numbers, does a great job for a general classification of E levels ( low/normal /high). With economic/cost of care considerations it may make more sense to only order the sensitive (more expensive) E2 test when "things don't add up (symptoms don't correlate with numbers)" or in cases of questionable very high or very low readings on the standard assay. This seems the more practical and prudent utilization of a more specialized/expensive test and is the way I utilize it.

Dr Saya
I am not going to beat a dead horse, but IF you start ordering the Sensitive assay, you will see what I mean.

Since I order more of them from LabCorp, AND Quest, than any physician in the country, I know of what I speak.

And I certainly trust the experts at the Nichols Institute to know more about laboratory science than either you or I, when they say the Standard Estradiol is not valid for adult males.

You aren't "saving money" by ordering tests which are invalid; quite the opposite. And the wasted expense is still second to the depreciation of health care.
 
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JSayaMD

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I am afraid that is not true. Standard Estradiol is almost always much higher--sometimes much higher--than the sensitive assays. I have about 1,000 lab printouts to prove this, where they ran both types of assays.

Then this would mean either one of two things...1- your statement previously (and the statistical fact that I validated above) that mid-range on one panel is equivalent to mid-range on another panel (as long as from same population) is not true - but it IS true as we have both stated (50th percentile on one panel is equivalent to 50th percentile on another panel as long as drawn from same population, 75th percentile same as 75th percentile, so forth...this is why to compare standardized testing across different times (like the USMLE for example) they use standard deviation and percentiles to compare as opposed to using exact numbers which would not be equivalent... or 2- there is some human/lab variation or error that is interfering with the statistical RULES holding true... you stated that one can reason about this, but this is not reasoning...it's statistical rules that hold true as long as the numbers hold true.

Dr Saya
 
Then this would mean either one of two things...1- your statement previously (and the statistical fact that I validated above) that mid-range on one panel is equivalent to mid-range on another panel (as long as from same population) is not true - but it IS true as we have both stated (50th percentile on one panel is equivalent to 50th percentile on another panel as long as drawn from same population, 75th percentile same as 75th percentile, so forth...this is why to compare standardized testing across different times (like the USMLE for example) they use standard deviation and percentiles to compare as opposed to using exact numbers which would not be equivalent... or 2- there is some human/lab variation or error that is interfering with the statistical RULES holding true... you stated that one can reason about this, but this is not reasoning...it's statistical rules that hold true as long as the numbers hold true.

Dr Saya
You might want to have an expert in laboratory analysis explain this to you. I obviously am not getting anywhere.
 

JSayaMD

Guest
You might want to have an expert in laboratory analysis explain this to you. I obviously am not getting anywhere.

You might want to do same, I understand statistical measurement and analysis more than most, probably you included. I hold a dual Bachelor's degree in Biological Sciences and ECONOMICS - a majority of which deals with statistics. Unless laboratory analysis (and their resultant STATISTICAL calculation of reference range - as you pointed out) doesn't follow the universal RULES of statistics, then something doesn't fit.

What you are reporting are anecdotal reports of variations seen (in reportedly >1000 lab reports) between two lab assays, when we both already know and agree that, first of all, you cannot compare results from different assay methods directly and, secondly, based on statistical rules there is no valid reason for the difference if you are looking at PERCENTILE and LOCATION WITHIN EACH RESPECTIVE RANGE...

If you are truly seeing this, I suggest you report your findings in a study for everyone to see (including the laboratories) so that they can determine the cause of this statistical anomaly.

Dr Saya
 

JSayaMD

Guest
If the problem lies with the lab, there is either:

-human/lab measurement error
-reference range calculation error
-reference population discrepancy (ie: different assays NOT based on same reference population) - MOST likely

Dr Saya
 
The problem is the top of normal range for women is the bottom of normal range for men. Therefore, the bell curve (which rules all of laboratory medicine...and just about everything else to do with humanity LOL) lies within their range.

For laboratory testing, you want your points on the bell curve where the slope is steep, either positive or negative. Values within normal range for adult males, then, lie where the slope has plateaued.

I hope this helps.
 
You might want to do same, I understand statistical measurement and analysis more than most, probably you included. I hold a dual Bachelor's degree in Biological Sciences and ECONOMICS - a majority of which deals with statistics. Unless laboratory analysis (and their resultant STATISTICAL calculation of reference range - as you pointed out) doesn't follow the universal RULES of statistics, then something doesn't fit.

What you are reporting are anecdotal reports of variations seen (in reportedly >1000 lab reports) between two lab assays, when we both already know and agree that, first of all, you cannot compare results from different assay methods directly and, secondly, based on statistical rules there is no valid reason for the difference if you are looking at PERCENTILE and LOCATION WITHIN EACH RESPECTIVE RANGE...

If you are truly seeing this, I suggest you report your findings in a study for everyone to see (including the laboratories) so that they can determine the cause of this statistical anomaly.

Dr Saya
Please read what I have written: I did present this, to the Director of Quest Diagnostics' Nichols Institute, and that is why that paragraph appears on their laboratory printout.

You state you do not order the sensitive assay. Run a few thousand of them. You are a sharp fellow; you will see what I mean.
 

JSayaMD

Guest
The problem is the top of normal range for women is the bottom of normal range for men. Therefore, the bell curve (which rules all of laboratory medicine...and just about everything else to do with humanity LOL) lies within their range.

For laboratory testing, you want your points on the bell curve where the slope is steep, either positive or negative. Values within normal range for adult males, then, lie where the slope has plateaued.

I hope this helps.

The location on said bell curve (steeper slope) produces the enhanced SENSITIVITY of differing tests...ie: on steeper part of slope = smaller change is much more evident, on flatter part of sloop = smaller change is less evident, but tells us nothing of the accuracy or reliability of the test.

As I have said, the sensitive assay is MORE SENSITIVE (ie: on steeper slope of bell curve) and will be better if you want to know the EXACT E2 level especially at the extremes of high or low ranges (ie: is the level really 9 or is it 2 -> SENSITIVE assay will tell you, but I don't care because both are too low for my purposes...is the level really 52 or 82 -> sensitive assay will tell you better but either way it's on higher end... For clinical purposes not as much interested in the actual/precise number as I am interested in where in range (percentile) with regards to low/normal/high.

We will have to agree to disagree...

Dr Saya
 

JSayaMD

Guest
Please read what I have written: I did present this, to the Director of Quest Diagnostics' Nichols Institute, and that is why that paragraph appears on their laboratory printout.

You state you do not order the sensitive assay. Run a few thousand of them. You are a sharp fellow; you will see what I mean.

I, and I'm sure many others, would love to see the abstract of this presented data for our own review...please post or point to where it can be reviewed. Until then, I can only speak on statistics and statistical calculations/analysis facts...

I do order the sensitive assay, but as I noted, only when I feel the additional cost is justified and it is necessary when the labs don't coincide with symptoms or when I question the standard assay reading...usually in the case of the former. I have not observed the relationship between the lab results between standard assay and sensitive assay that you have quoted, but have not compared 1000's as you state...all the more reason I would like to SEE THE DATA.

Dr Saya
 
I, and I'm sure many others, would love to see the abstract of this presented data for our own review...please post or point to where it can be reviewed. Until then, I can only speak on statistics and statistical calculations/analysis facts...

I do order the sensitive assay, but as I noted, only when I feel the additional cost is justified and it is necessary when the labs don't coincide with symptoms or when I question the standard assay reading...usually in the case of the former. I have not observed the relationship between the lab results between standard assay and sensitive assay that you have quoted, but have not compared 1000's as you state...all the more reason I would like to SEE THE DATA.

Dr Saya
Please take your argument to the true experts at Quest Diagnostics. Perhaps they can get you to understand.

How many sets of labs do you need to see?
 

JSayaMD

Guest
If the data you speak of is assumed to be correct, if anything it proves that one of Quest's assays (standard or sensitive) - or more appropriately their statistical derivation of their reference ranges on said assays - is flawed... remember that "mid-range on one is equivalent to mid-range on another" ...you yourself stated that and I agree--with the important caveat that they HAVE to be based on the SAME population. IF based on the same reference population, then 50th percentile on one is equivalent to 50th percentile on other and vice versa. They should determine which assay (or reference range calculation) is producing this anomaly and not offer that test anymore or FIX the anomaly so that physician's are not stuck trying to connect the dots for something that makes no concrete statistical sense. My guess is that they are NOT using same reference population pool for calculation of reference range of the two assays, which would THEN invalidate ANY comparison between the two assays including percentiles, etc.

"How many sets of lab reports do you need to see?" ---I would like to see the data from the presentation that you made to the Nichols Institute that was apparently compelling enough to cause them to add that paragraph to their lab report. Short of that, this debate is going nowhere fast and we'll have to agree to disagree.

Dr Saya
 
If the data you speak of is assumed to be correct, if anything it proves that one of Quest's assays (standard or sensitive) - or more appropriately their statistical derivation of their reference ranges on said assays - is flawed... remember that "mid-range on one is equivalent to mid-range on another" ...you yourself stated that and I agree--with the important caveat that they HAVE to be based on the SAME population. IF based on the same reference population, then 50th percentile on one is equivalent to 50th percentile on other and vice versa. They should determine which assay (or reference range calculation) is producing this anomaly and not offer that test anymore or FIX the anomaly so that physician's are not stuck trying to connect the dots for something that makes no concrete statistical sense. My guess is that they are NOT using same reference population pool for calculation of reference range of the two assays, which would THEN invalidate ANY comparison between the two assays including percentiles, etc.

"How many sets of lab reports do you need to see?" ---I would like to see the data from the presentation that you made to the Nichols Institute that was apparently compelling enough to cause them to add that paragraph to their lab report. Short of that, this debate is going nowhere fast and we'll have to agree to disagree.

Dr Saya
There are numerous assays which are designed/tuned to a given patient population. This is but one more.

I did not make a formal presentation to Quest. My conversations with Dr. Nigel Clarke, Director of the Nichols Institute, with numerous examples of my patients' results, led them to research their own laboratory methodology, and the conclusions of experts in the field of laboratory analysis were as I have posted.

If you claim to know more than the true experts who run the largest laboratory chain in the country (if not the world), then this is going no where fast. And that certainly looks like what you are trying to do.

Frankly, this "mid-range" concept you keep referring to shows you do not grasp the underlying concepts. It doesn't even have anything to do with this conversation. That, by this thread, is limited to comparing different reference ranges at different laboratories. And an invalid result is, well, invalid. You cannot compare invalid to invalid.

Everyone knows RIA methodology is much less reliable than LC/MS. That is simply what I am stating.

Start running the enhanced sensitivity; plenty often they will also run the standard assay. Compare to patient's clinical response. I am sure you will get it, after you have seen enough of them.
 

JSayaMD

Guest
Laboratory methodology is reliant upon statistical analysis. Therefore, the top of "normal range" from one lab is the same for the top of "normal range" at another--no matter what the actual numbers.

To illustrate, guys will try to use laboratories where the top of range is a higher number, thinking they will then get more testosterone. In practice, this does not work, because they just end up at the top of range, again, anyway.

IOW, midrange on one lab is the same as midrange on another. Irrespective of the ranges.

It's a strange concept, but it's just part of getting used to walking on slippery rocks all the time, which is what it is like practicing this field of medicine.

This is where the mid-range discussion came about, posted by YOU, in THIS thread.

Indeed, this discussion is going nowhere. I will continue to order the sensitive estradiol WHEN it seems clinically necessary (on the RARE occasion when the standard assay level and symptoms are discordant), but certainly not for every patient when the standard estradiol does a satisfactory job of giving me a good idea of E levels and correlates fairly well to clinical symptoms in my practice (and saves $).

As a friend of mine (MD who is very familiar with these tests as well) probably stated best...for research LC/MS is better, for clinical (taking cost into consideration as well) RIA is more than sufficient. Until I see the data to suggest that LC/MS is better for MEN (not post-menopausal women or women being treated for breast cancer) on TRT then that position will not change.

Perhaps we can meet some time you are in the Tampa area for you to give me that informal presentation that you presented to Nigel Clarke to potentially sway my opinion...until then or I see said study above, topic is a dead-end.

Dr Saya
 
This is where the mid-range discussion came about, posted by YOU, in THIS thread.

Indeed, this discussion is going nowhere. I will continue to order the sensitive estradiol WHEN it seems clinically necessary (on the RARE occasion when the standard assay level and symptoms are discordant), but certainly not for every patient when the standard estradiol does a satisfactory job of giving me a good idea of E levels and correlates fairly well to clinical symptoms in my practice (and saves $).

As a friend of mine (MD who is very familiar with these tests as well) probably stated best...for research LC/MS is better, for clinical (taking cost into consideration as well) RIA is more than sufficient. Until I see the data to suggest that LC/MS is better for MEN (not post-menopausal women or women being treated for breast cancer) on TRT then that position will not change.

Perhaps we can meet some time you are in the Tampa area for you to give me that informal presentation that you presented to Nigel Clarke to potentially sway my opinion...until then or I see said study above, topic is a dead-end.

Dr Saya
Your "friend" knows more about this than the true experts in that field, too?

You run a cut-rate testosterone clinic, and ordering the more expensive tests would cut into your profit. I get that.

But to openly state doctors who run these assays are wasting their patients' money is not only untrue, it is much more than that.

You are making patients pay for a lab test even the lab tells you is not valid.

Didn't you start out by stating it is a waste of money to run a SHBG? No expert evaluation of sex hormone status can be achieved without it. I posted but one example to show how naive physicians get fooled without them.

After I had practiced a few years I realized what I have been talking about. You will, too, once you have as well, I am sure. I would not be able to come anywhere near the results I do with my patients if I went back to the way I did things when I was just getting started.
 
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JSayaMD

Guest
Data walks and bullsh** talks...

Has NOTHING to do with personal profit as I am on salary and make not a dollar more or dollar less regardless of what lab tests I order. Myself and, I hope, other like-minded physicians will grant their patients the CHOICE (which you do not) of whether or not they want to spend their hard earned $ on a test that is not proven to be necessary by publicly available data for men on TRT (aside from an informal DISCUSSION between yourself and Nicholls Institute... Which I beg of you to show me the data relating to that informal presentation).

No sarcasm here, I would LOVE to see your data, but will not influence my patients to give up more of their money until I'm convinced (by your data?) that the additional expense is warranted given the standard test is clinically sufficient.

NEVER did I say SHBG is not important or pertinent, I said SHBG status can be inferred by looking at total T, free T, albumin, etc thus making it less necessary to pay for that test as well.

Let me know when Quest or another lab develops a test to measure the "stickiness" of the SHBG complex you mentioned previously in this thread...I'll definitely order that one.

Dr Saya
 
Data walks and bullsh** talks...

Has NOTHING to do with personal profit as I am on salary and make not a dollar more or dollar less regardless of what lab tests I order. Myself and, I hope, other like-minded physicians will grant their patients the CHOICE (which you do not) of whether or not they want to spend their hard earned $ on a test that is not proven to be necessary by publicly available data for men on TRT (aside from an informal DISCUSSION between yourself and Nicholls Institute... Which I beg of you to show me the data relating to that informal presentation).

No sarcasm here, I would LOVE to see your data, but will not influence my patients to give up more of their money until I'm convinced (by your data?) that the additional expense is warranted given the standard test is clinically sufficient.

NEVER did I say SHBG is not important or pertinent, I said SHBG status can be inferred by looking at total T, free T, albumin, etc thus making it less necessary to pay for that test as well.

Let me know when Quest or another lab develops a test to measure the "stickiness" of the SHBG complex you mentioned previously in this thread...I'll definitely order that one.

Dr Saya
That is correct. I would be happy to show actual printouts. Or, you could talk to the Medical Director at the Nichols Institute. They can assign someone to help you understand this important concept.

I will repeat this one more time: read an actual Quest Diagnostics printout. There is your answer. Then you will be left with irrefutable evidence that you knowingly order labs which you know to be invalid. Your patients might be interested in that expensive point.

Are you saying you do not ever order labs from Quest Diagnostics? Because IF you did, you have already seen the caveat of which I write.

Can anyone come up with one? It'll be next Monday before I am back in the office. I have not ordered the incorrect standard estradiol in years. And would have to go through Lord knows how many patients to find one where the lab tech screwed up on that one, and changed my order. Maybe the Quest Diagnostics website?

Honestly, your language is not different from Paul Joyce's, of the now-defunct Palm Beach rejuvenation, when he stated, years ago, his "medical experts" had looked at my protocols, and laughed at them. We all know how that turned out. LOL

Please be careful about making statements which you obviously have no knowledge; especially ones which are defamatory. We go to great lengths to save our patient's money (avoiding your pandering here). We even go so far as to order different assays from different labs, when same is necessary. Every patient's particular situation is taken into account. Our level of service is like no other practice's. That is what it takes to have patients fly in from all fifty states, and 27 foreign countries: they want a doctor who provides expert medical care; this includes, at the very least, knowing which lab assays are valid and which are not.

I am going to assume that was not sarcasm at my observation about SHBG...an observation, BTW, Dr. Shippen and I, and numerous other top Thought Leaders, have discussed many times (as I will be doing in Las Vegas next week). I would much prefer you join in on an honest conversation about what we see at the cutting edge. You don't seem particularly interested in same . The doctors who do get the best results; AND save their patients money.

Wasted money on invalid labs does no one good.

The example I posted here shows you can not reliably assume anything about SHBG levels; those who do are the ones with the unhappy patients. This happens all the time. EVERY expert orders a SHBG, on every patient. I know that because I hang out with them. You do not. And you won't ever have a seat at that table, unless you begin honestly learning about this stuff. And, perhaps, arguing with a physician who has at least 100 times your experience, and has created medical protocols which are used by countless doctors all over the world. I'm jus' sayin....

Finally, to suggest the business you work for does not have a bottom line, and one which is influenced by costs, is ludicrous.

I hope one day you are able to gain the knowledge, and experience, to take a seat with the top Thought Leaders in our field.
 

JSayaMD

Guest
Being condescending serves no purpose other than self-promotion.

I know the statement is there on Quest lab reports and you've stated 10 times it is there as a direct result of your compelling DISCUSSION to Nichols Inst, which I would love to be presented with (as would many others...or at least the data...that would quite simply solve the dilemma).

Poke at my youth and perceived inexperience all you wish...I graduated Valedictorian of high school and college degree programs and have a GENIUS level IQ ... It's more amusing to me than anything .

Best to you, Dr John, I will cause you no more grief trying to get scientific data from you.

Saya out...
 
Your lack of knowledge and experience in this field drips from your postings. Many have already figured that out. And, trust me, potential patients do not want to go to a doctor with a closed mind. THAT is what they have gotten from conventional medical doctors already.

So does your lack of appreciation for the knowledge and experience of the true masters of this field, who were figuring this stuff out while you were still taking your college entrance exams. I'd drop the arrogance, as you are no where near the top in this field; and unless you change course, you will never get there. And, yes, I am qualified to make that judgement.

IF I had a smart-ass Resident like you, same would be leaving the building in something less than a New York minute. You should be trying to learn from those with infinitely more knowledge and experience, instead of arguing and insulting. Those with an earnest desire to improve the quality of their medical care, and some common sense, do.

OBVIOUSLY, raw intelligence is not sufficient; if it were, all those Endocrinologists at world-famous medical centers would be properly evaluating and treating estrogen, NOT relying on the bottom of "normal" range for denying TRT, offering all their patients HCG etc etc. Becoming a true healer takes much more; It is an art more than a science...but you must possess the science first.

Read a Quest lab printout: there is your science.

I have already stated I am happy to provide laboratory printouts. But I am quite sure you already possess many of them. It's right there, just below the invalid estradiol assays you STILL charge your patients for.

I can tell you--as someone who has hung out with nearly every true expert in Interventional Endocrinology, all over the world--you could not even follow a conversation regarding same. Nor have you developed the demeanor.

Gene Devine knows FAR more about TRT than you do.
 
BTW, I am not the sharpest scalpel on the tray. I brag I graduated medical school at the top of the bottom third of my class.

...but even I know that when the lab itself says a given test is not valid, I know what that means.

LOL
 
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