Survey: FDA Proposed Regulation of Lyme Tests

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ChronicLyme19
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Survey: FDA Proposed Regulation of Lyme Tests

Post by ChronicLyme19 » Thu 23 Oct 2014 23:40

From Lymedisease.org:

LYMEPOLICYWONK: FDA Proposed Regulation of Lyme Tests? Take the Survey!

http://lymedisease.org/news/lymepolicyw ... ey-ne.html
Half of what you are taught is incorrect, but which half? What if there's another half missing?

duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Thu 23 Oct 2014 23:50

Thanks for posting.

Done. :)

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ChronicLyme19
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by ChronicLyme19 » Fri 24 Oct 2014 0:12

Part of me would be in favor of stricter Lyme testing, say if they'd only allow testing that is 95%+ specific AND 95%+ sensitive (That should get rid of the crappy two-tiered testing as well). But then my worry would be that if doctors don't have a test, that they would not treat the infection. I highly doubt most doctors would be comfortable enough just with a clinical diagnosis and treating with long term antibiotics for those of us who they still work.

So I guess realistically, I'd like to see all the testing still allowed, but them mandated like the VA law, that each test also carry a statement on the limitations of the test, whether it be low sensitivity or low specificity.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Fri 24 Oct 2014 1:25

Yes, there are problems that cut both ways.

One of the most disturbing things for me relative to this proposal was some of the Senators who were/are supposedly promoting it.

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LHCTom
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by LHCTom » Fri 24 Oct 2014 4:17

One of the most disturbing things for me relative to this proposal was some of the Senators who were/are supposedly promoting it.
Even worse.

The Johnson culture Assessment drove the CDC MMWR which was quoted by the Senators in their letter to the FDA and OMB.

http://www.markey.senate.gov/imo/media/ ... e_LDTs.pdf

Now take one more look at my analysis of the Johnson paper:

http://puurelyrandom.wordpress.com/

Its scary.
The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

nnecker
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Wed 29 Oct 2014 13:07

Here is an article by Beth Daley about Lyme tests:

https://necir.creatavist.com/lymediseasetesting

Excerpts:

"Another lab – Pharmasan Labs. Inc., in Wisconsin – has been unable to offer its test in New York in part because of validation problems. Its test, rejected by the state last year, uses a new method to detect an immune response to Lyme.
Gottfried Kellermann, founder of Pharmasan and its sister company, NeuroScience Inc., said he plans to resubmit the rejected test to New York.
“It is a very (accurate) diagnostic test,’’ said Kellermann, who defended his test as misunderstood by authorities.
Kellermann is a German national with a 1992 felony conviction for his part in a conspiracy to defraud the federal government out of $750,000 related to malaria research.
In May, the FBI raided Kellermann’s NeuroScience offices. Kellermann’s lawyer, Henry M. Helgen III said the company believes the raid to be related to Medicare billing problems from a former employee who the company successfully sued for fraud. An FBI spokesman could not confirm the reason for the raid because it is an active case."

More:

Advanced Laboratory Services Inc. outside Philadelphia, for example, says it can detect and grow the bacteria that cause Lyme, a method most Lyme researchers have never been able to reliably do. The lab has conducted more than 4,000 tests but now does less than 50 a week, according to officials there.

The facility has come under sustained criticism by scientists and regulators since its test went on the market in 2011. New York rejected it in 2012 because, the state concluded, there was no proof it worked, and inspectors who visited the facility uncovered “broad substandard” laboratory practices, including an employee not wearing protective gear and a lack of lab supervision. A federal scientist last year also published a critical study about the company’s methods, raising contamination concerns.

“The obligation of a clinical laboratory is to properly validate their test before offering it to the public for sale,’’ said Barbara Johnson, a CDC scientist who wrote the critical study and is dubious that the Advanced Laboratory Services test works.
Advanced Laboratory Services officials publicly pledged after the CDC study to respond to it and deliver outside validation studies by the end of April. The lab has still not done so. Company spokeswoman Jen Hoefner said in an e-mail that validation studies were delayed but will still be conducted. “We have ample data to discredit” the federal scientist, she wrote, “and we hope to have this information published shortly.” She also said a study related to the test’s performance will be published soon in a scientific journal.
Philip M. Tierno, a New York University Langone Medical Center clinical professor of microbiology and pathology, has spoken out in favor of the Advanced Laboratory Services test in a media account and on the lab’s website in recent months.

I have seen the culture and evidence of (the Lyme bacteria),” Tierno said in an NECIR interview.

Rejected Lyme Tests (Source: NY State Department of Health)
But the accounts did not state, nor did Tierno initially acknowledge to NECIR, that he is a former employee of Advanced Laboratory Services, at one time running its bacteriology lab. The 2012 New York state lab inspection report took special note of Tierno, saying he was “not cognizant of what strategies or analysis was used” for the Lyme detection method.
Tierno said he was newly hired at the time of the New York state inspection and that he is no longer paid by the company. After the NECIR interview, the words “outside consultant” were inserted into his identification on his comments on the lab website."

End of excerpts.

Ray Mirra (owner of ALS) has also paid fines for Medicaid fraud to NJ:

https://dspace.njstatelib.org/xmlui/bit ... sequence=1

From page 72:

State v. Ambulatory Pharmaceutical Services
& Raymond Mirra
A civil Medicaid fraud settlement with
Ambulatory Pharmaceutical Services (APS)
was entered providing for payment of
$1,300,000 to the State of New Jersey. APS
allegedly provided higher priced brand
medication, rather than generic, even when
generic medications were available.

Ray Mirra was also friendly with Philly mobsters like Nicky Scarfo and Salvatore Testa,along with hosting fund raisers for a Pa state senator who was convicted for corruption and sent to prison for 5 years.Mirra also owns other medical businesses that have been investigated for and charged with fraud.His wife has also been charged with the murder of her son and claims that Mirra was trying to kill her.

Can you see a trend developing here with these Lyme tests,duh ?

duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Wed 29 Oct 2014 13:41

The inference the reader is suppose to draw is that whereas some of these tests may not be yet proven, the current crop of tests promoted by main street Lyme labs - like the ELISA and C6 Peptide, or even the WB - are?

Problems with testing for Lyme in part characterize the persistent confusion and lack of progress that in many ways define the community. This holds true for acute testing, and late stage. And it holds true for widely accepted tests and for new tests that await validation.

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LHCTom
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by LHCTom » Wed 29 Oct 2014 19:44

Can you see a trend developing here with these Lyme tests,duh ?
The trend I see is something like a goldrush with everyone trying to get a piece of the $1/2 Billion market. I find a couple of things interesting.

If the current serological test performed anywhere near where claimed with 98% sensitivity and 97% specificity, than why are the "experts" patenting like its a goldrush? And no they are not all trying to achieve a test that only performs sooner after infection as is always the party line. These patents are not cheap and the names are a who's who of IDSA folks. The patent rush is not in agreement with party line.

The culture is considered the Gold Standard for obvious reasons. The experts claim it doesn't work well after treatment so have given up. Barbara Johnson's "laboratory Testing for Bb Infection" and almost everyone simply points to the 2005 Maria E. Aguero-Rosenfeld "Diagnosis of Lyme Disease" as the usual reference.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1195970/

But it makes reference to the culture technique going through various modifications over time citing studies from the 1980's and 1990's with no recent attempts at improvements in over a decade. It sounds like improving the culture was essentially given up over a decade ago with practical issues such as the long culture time, blood requirements exceed children and cost.

Most of the effort on Lyme testing seems focused on patentable approaches and lean toward higher and higher tech because its easy to patent successfully. Even though ALS and Sapi patented their recent attempt at an improved culture, its not easy to protect culturing variations. Of course it makes sense to find a test that is 100% sensitive and 100% specificity that is fast, cheap and works with all patients, at time during an infection and children in a clinical setting.

But given the controversy, why wouldn't everyone want to find a culture as the last line of diagnosis since it has the ability to be 100% specific. The culture when positive either by immunochemical and or DNA PCR verfification is the only technique that can give a positive unequivocal result of an active infection. Redundant DNA testing can be used to minimize any risk of contamination. Of course its not a high volume first line test since it would only be used when all other testing is equivocal. It would decide the validity of persistence or not quite easily. It would help allow the differentiation of successfully treated or not when no other test can. If the sensitivity is only 50%, then redundant cultures can help push the sensitivity higher. Once persistence is shown real or not, treatment can be based on facts rather guessing.

With all the effort and patenting of endless testing techniques, why wouldn't the NIH and CDC put some resources into designing a culture that performs better. Because they gave up in the late 90's. A great deal has been learned in microbiology in the last decade which could be applied to unculturability. Giving up when its known Borrelia does grow in a culture environment is foolish. Its because a handful of people in power in the research community have developed a dogmatic attitude and lost their imagination. That's bad science and they complain about pseudoscience - how about dead end imagination science? Just as bad.

Its rather obvious that Lyme culture design was retarded in the late 90's. The last great improvement was taking more blood. Duh, more blood more spirochetes = rocket science . The Marques xenodiagnosis is essentially a culture technique that is trying leverage mother natures strategy. The tick gut is the culture media and their saliva is a chemo-attractant and they feed for weeks. That alone says a few things about why the retarded culture media of the 90's failed. If ticks really have a chemo-attractant as Marques believes and seems a reasonable hypothesis, why not try and understand how it works and apply it in a culture environment. Wormser found doubling the blood volume increased sensitivity due to more spirochetes and letting ticks feed for weeks gives them a longer window and better blood exposure. An adult can give a pint of blood with no problems. People on dialysis for Kidney disease allow a machine to filter their entire blood supply many times. There are many obvious strategies to follow and why a spirochete becomes difficult to culture can be explored with transcriptome analysis or metabolomic analysis. There are many untapped roads of thought if only the imaginations can be turned on.

I cant help but wonder if making a better culture simply isn't going to be profitable since it should only be used for a small percentage of Lyme cases where persistence is suspected and antibiotic treatment possibly failed. The scientists who claim persistence isn't real seem to block paths that they know could expose them to being wrong. That's worse than pseudoscience. Many ill people would happily sit in a dialysis like setting with chemo-attracttants collecting spirochetes on a newly designed medium and wait 12 weeks and pay for DNA analysis. That test could save them years of suffering and expensive treatments. I'm just pointing out the culture used in research today is only marginally better and more imaginative than the one used in 1990.

Just look at what happened with the ALS/Sapi culture. Instead of getting together and cooperating with Sapi et al, the CDC performed a paper analysis that was incomplete leading to pinching off interest in a better culture and FDA regulation. The Johnson Assessment chose to find a problem they could leverage but failed to analyze what they actually found. They also didn't even examine 16S gene sequences in NCBI that contradict what they found and provide evidence the contamination occurred in the nested PR testing and not in the cultures. The Sapi team ran the afzelii and garinii test strains through 16S nested PCR and sequencing alongside the patient samples. The 16S sequences in NCBI show this. They also show the 16S sequences for the 20 patients the CDC found garinii were burgdorferi by 16S gene BLAST by 7 nucleotides. That's a lot in the 16S partial gene.

That's because the 16S nested PCR testing or sequencing in Alabama became contaminated with the TCC test afzelii and garinii so appeared to be in patient cultures. Wrong. The CDC team failed to even examine where the contamination entered the process and failed to mention any 16S sequence data in NCBI. That's questionable science. You cannot pick and choose your data and decide when to not look any deeper once you have the answer you want. So yes their was contamination in the PCR testing but not in the cultures. Once you realize that, then the Mab and Pab and controls testing plus 16S data all are consistent. It really looks bad when a journal like the JCM and all the peer reviews just overlooked the 16S data sitting in NCBI and to ask where the contamination entered and what does that mean? Marques thought she found contamination in 2 subject PCR's and didn't throw out the whole study. She threw out what sh thought was bad data. That's what scientists are supposed to do.

It really looks like the dogma is so strong its polluting the quality of the science. Oh well.

http://www.puurelyrandom.wordpress.com
Last edited by LHCTom on Wed 29 Oct 2014 23:58, edited 1 time in total.
The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

RitaA
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by RitaA » Wed 29 Oct 2014 20:14

LHCTom,

I was planning to respond to your very detailed analysis just prior to the forum being locked for maintenance.

You obviously put a lot of time and effort into writing what you did, and the information that you outlined for interested readers concerns me more than I would like to admit. To put it in a nutshell (and please forgive me for grossly oversimplifying things), the CDC's statement about possible contamination may have been partially true (as a few of us suspected) however it certainly seems as though it occurred during the analysis/test phase -- i.e. after the blood samples had been cultured -- not before or during the new culture process itself.

To put it mildly, any testing carried out at a different location -- independently and after the culture process -- should not invalidate the new culture method in and of itself. The CDC concluding what they did -- without actually consulting with the Sapi team and/or visiting their lab -- seems very unscientific and unprofessional (at best).

Whatever the motives may be for delaying/blocking any advances in an improved Lyme disease culture test, they are inexcusable.

nnecker
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Wed 29 Oct 2014 22:45

How unprofessional is it for Sapi to do business with a person who is friendly with the mob and is involved with many other shady things as well.

How unprofessional is it for Burrascano and Tienero who say they are consultants and not to admit that they are on Mirra's payroll.

How unprofessional is it for a lab to publicly promise validation studies in April and the lab still has not done so.

How unprofessional is it for a clinical laboratory not to properly validate their test before offering it to the public for sale.

To me, VERY.

Open your eyes,it's a scam.I am going to grab some popcorn and watch it go down. :lol:

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