Re: Strange Illness For Over One Year, Please Help!

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Robert wrote: 
"Susan" <nevermind@xxxxxxxxxx> wrote in message
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Robert wrote:


It's not a high volume test. We send ours out to three states over,
thousands of miles away. There is no money there.
The people who perform and report the tests do so for their pay check.


We do

what are employers tells us to do. There are procedures approved by the 

FDA

recommendations by the CDC and others like the American Society of
Microbiology. Everything is transparent. There are hospital laboratory
inspections pertaining to the reporting of Lyme disease. You don't agree
with that then start your own laboratory and pay your employees to


report

out a single band for Western blot testing as reactive and get nailed 

and

your license pulled. You can also have legal action concerning 

inducements

for doctors by providing testing which caters to their interest in
maintaining their business instead of following accepted referenced
procedures. In short you are altering your reporting to generate


business.

The daily volume we deal with is averaging about 2500 tests per day and
only get maybe one test request for lyme's or lyme in reality Bb


serology in

about a week at most. That should make you very happy because serology 

is

useless according to you. 


I'm referring to the financial incentives of the investigators who
develop the tests, not the folks who buy the kits and perform them.

Susan 


The original investigators are often NIH research grants that are given to
university based research teams. A good example is the new test by the UCSD
group involving a new test for oxidized lipids. University based research
and government funded research is handed to private companies for specific
development. They are handed the patents by the government for production.
The government is not in the business of manufacturing pharmaceuticals or
diagnostic tests based on antibodies which are patented.
Once the kit is developed and made for clinical use then the FDA must grant
the approval based on clinical studies. The UCSD people can do the test but
is marked for research purposes only and no claims can be made upon how it
is interpreted.  The interpretation has not be evaluated. That is the whole
point of the clinical study.
Private companies are in the business to make money. All the recent
developments in technology have been because of money.
Take a poor country and see how much technological development there is. The
production of monoclonal antibodies from polyclonal antibodies have
revolutionized the industry of immunology. This is a much more sensitive and
much more specific break through. Some people that were typed as RH negative
actually type as RH positive with new monoclonal anti-D.  Monoclonal
antibodies are being used in cancer treatment.
Private companies making money is such a lame excuse. Are there rip-offs?
Yes, so you regulate, fine and put in prison those that are fraudulent or
what ever.
Next argument is that the FDA is corrupt and then the government is run by
big business and how much you love president Bush.
If you have specific concerns about a company that is saying they have a
sensitivity of 99% in detecting lyme's disease then report them to the FDA.
The ads are written for professionals who know what a comparison or
correlation study is. It might say it correlates with the western blot or
correlates with a certain definitive stage of disease or any number of
things. I don't even look at those ads.
The FDA has the option of pulling all those tests off the market if they
want to. A not well known fact is that Abbott laboratories were
manufacturing many test reagent systems that were pulled by the FDA for not
submitting complete correlation studies or incomplete studies. One test was
an automated 20 minute test for hepatitis B that was in use. It was pulled
and the FDA fined them and now we use a 2 and a half hour manual procedure.
I was pissed. The manufacturer didn't want to pursue or do the studies
because the platform or instrument was becoming obsolete. It has a new
instrument that it will be available next year.
There was a pregnancy hormone test manufactured by them also that involved a
tragic case in which a women was tested and found positive for HCG a
pregnancy hormone. She was not pregnant and so it was assumed to be a
malignancy. They took out her uterus and she still tested positive for that
hormone.
It was a false positive and she never had a malignancy.
The FDA got involved and make the manufacturer to label the results as" not
to be used as a tumor marker". That was just one case and they got involved.

If I make a mistake in carrying out the procedures incorrectly and report
out a wrong result or an error in performance and contact the manufacturer
by phone on trouble shooting as to what happened or why, the manufacturer
will write down my name and the nature of the error and the FDA will be
contacted by them. It may mean a rewriting of the package insert to
instrumentation alterations by the manufacturer to reduce errors or nothing
at all.

The FDA has and can act in what you are saying.

I have direct experience with that first hand. The clinical laboratory is
not a free for all where anyone can do anything they please. We don't
experiment with anything.





Robert, are you blissfully unaware that almost everyone in the medical investigation business is convinced that trial outcomes are being influenced by investigator's financial stakes in the products they're studying? This includes NIH staff who have decided they'd rather quit than behave ethically in this regard.

You don't get out much, do you?

Susan
.

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