FDA Says Some Lyme Tests are Dangerous - Will Start Regulating Them - Major Changes Expected

[Cort]

Last November the FDA stated it was going to start regulating what it calls "Laboratory Developed Tests". These are tests that are developed by and for single laboratories (often genomic firms) but have not been subjected to regulatory approval. At the time the FDA's regulation was created these tests were rare but with the development of genomic testing thousands have been developed. Many labs do subject their tests to stringent internal and/or independent testing but not all do.

That announcement was met by fierce opposition by industry and some academics.They stated the new regulations - which will likely make tests more expensive to develop - would stifle innovation and hurt patients.

• http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm

[fright]

[/fright]The FDA, however, believes some of these tests are doing more harm than good.

In some cases, due to false-positive tests, patients were told they have conditions they do not really have, causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone to false-negative results, in which patients’ life-threatening diseases went undetected. As a result, patients failed to receive effective treatments.

Lyme Disease Tests Prominently Featured

[fleft]

[/fleft]Lyme disease tests were featured front and center in a recent FDA report highlighting 20 offending lab tests. The FDA and Lyme disease labs and some Lyme physicians have been butting heads for years. In 2005 the CDC poisted an alert about the same types of tests included in this most recent report. The CDC has gone so far as to produce video's featuring patients misdiagnosed with Lyme disease who were later found to have something else. (See below).

In a report titled "Can You Trust Lyme Disease Tests?" , the New England Center for Investigative Reporting found, however, that thousands of people were being assessed for Lyme disease every year using unvalidated and inaccurate tests.

It noted that New York State - the only state that attempts to independently verify the accuracy of the tests - is not allowing seven labs to run Lyme disease tests there.

Igenex, a large Lyme disease testing lab, took several tries to get accredited in New York but finally did. According the Center report Igenex offers a Western Blot and urine tests and allows fewer bands be present for a Lyme Diagnosis than the CDC. Igenex argues that their test are fully validated and that the CDC's stricter criteria allows some cases of Lyme disease to be missed.

Common in the Northeast

The FDA asserts that a diagnosis of Lyme disease should be made based on a history of tick exposure, symptoms and two positive tests: a positive initial enzyme-linked immunosorbent assay test followed by a confirmatory Western Blot test. One FDA official stated it was very important that both tests be done.

The Western blot tests are not affected by the new oversight; the FDA has OK-ed over 80 Western Blot tests by different laboratories for Lyme.

The Western Blot test identifies IgM and IgG antibodies against several different B. burgdorferi antigens. Because the test can pick up antibodies other than the Lyme bacteria everyone will probably test positive to at last one band. The FDA requires that at least 5 of 10 bands on the IgG assay and 2 of 3 bands on the IgM assay be positive for a Lyme diagnosis.

Particularly in the northeast, Lyme is common. Doctors using FDA recommended Western Blot Tests make 300,000 new diagnoses every year. Testing is common as well. Over 3 million Western Blot tests costing over 400 million dollars are done every year.

Unvalidated Lyme Tests

The FDA apparently has little good to say about the rest of the Lyme Disease tests. It asserts that many urine, blood and culture tests for Lyme disease are not accurate and are causing harm.

"A falsely positive diagnosis of Lyme disease can lead to patients experiencing harmful side effects without clinical benefit, an increase in the risk of creating infectious organisms resistant to the antibiotics used to treat Lyme disease, and delay in the diagnosis of a patient’s true underlying condition."

The FDA came down particularly hard on urine tests. Between 50 - 70,000 urine tests for Lyme were run in 2005. It stated that an independent evaluation on healthy subjects gave false positives 50% of the time. Sometimes running the same blood sample again gave different results. It concluded that

"at least half of all test results were incorrect or uninterpretable, and that this test should not be used for Lyme disease detection."

Similar findings occur for some blood tests and a culture test. The FDA noted two couples were awarded $30 milllion in damages after they received months of antibiotic and other treatments.

[fright]

[/fright]In April 2014 the FDA concluded that false-positive results caused by laboratory contamination and the potential for misdiagnosis" made a culture test unworkable as well.

The FDA estimated that the average cost of a false-positive diagnosis was about $1,220 per patient.

[fright][/fright]Some patients who tested negative on FDA approved tests but positive on an unapproved test and then improved on antibiotics are upset. The Center for Investigative Reporting report noted that the FDA test is not particularly accurate in the early stages of the illness but is quite accurate after more time has passed. That means that patients with Lyme disease sometimes have to get quite ill before their tests are positive if testing follows the CDC's protocols.

The FDA acknowledges there are problems with the test but states that no better tests have appeared. For patients with a Lyme rash but without a positive blood test it recommends immediate antibiotic treatment.

With the FDA featuring Lyme prominently in its report expect the FDA to require Lyme labs to undergo more stringent testing and validation procedures. If they don't pass the FDA will apparently not allow them to market their tests anywhere in the U.S. If they do pass then their tests will be validated and the controversy will cease. It's about to get very interesting in wild world of Lyme testing.

• Check out Lyme Video's in our Media Section here.

CDC Video - When Lyme Disease Isn't

 

[Issie]

LabCorp and Quest does testing for Lyme and coinfections. They are both usually accepted.

One thing to keep in mind though, those of us with faulty autoimmune issues, it is thought that possibly if antibody testing is done, it may not detect it. Our immune systems tend to not pick up things that are there and therefore not destroy them. There may be false negatives as well as false positives.

These pathogens and protozoa can be visibly seen, if one knows what they are observing. There may be so many more varieties that are not known or tested for. Science is advancing, but we sometimes wish it would be faster.

Having gone back into a flare after mold/fungal exposure, my Doxy quit working after being pretty good for 2 years. Now, I'm addressing things with herbals and having more testing done on mold/fungus. It's not unusual for Lyme and coinfections to also have mold and fungal issues too. (My thyroid biopsy came back with two varieties of fungi known to cause tumors. Thankfully it wasn't cancer.) So now I'm learning about something new.

Issie

 

[VLynx]

Cort,
Please don't pass on the misinformation of the anti-chronic Lyme crowd. Igenex may have had initial difficulty passing New York's licensing board, but they have been licenses by New York for quite a while now.
I agree that bad tests should be identified, as the situation with Lyme disease is ripe for abuse by unethical or just misguided health practitioners. The disease is hard to identify, is confusable with many things, hard to diagnose, hard to treat, and worst of all, hard to know when it is cured. Desperate patients will try anything to get better.
I don't know if the FDA is going to help or hurt the situation with these regulations. What is needed is RESEARCH and VALID INFORMATION.

Here is Igenex's current New York License:

http://www.igenex.com/licenses/ny.pdf

 

[Cort]

Cort,
Please don't pass on the misinformation of the anti-chronic Lyme crowd. Igenex may have had initial difficulty passing New York's licensing board, but they have been licenses by New York for quite a while now.
I agree that bad tests should be identified, as the situation with Lyme disease is ripe for abuse by unethical or just misguided health practitioners. The disease is hard to identify, is confusable with many things, hard to diagnose, hard to treat, and worst of all, hard to know when it is cured. Desperate patients will try anything to get better.
I don't know if the FDA is going to help or hurt the situation with these regulations. What is needed is RESEARCH and VALID INFORMATION.

Here is Igenex's current New York License:

http://www.igenex.com/licenses/ny.pdf

Glad to hear that Igenex got it. My information was taken from an article in 2014. I will update it.

I think what we need are tests everyone can count on. We'll see what happens with the new testing. If the FDA requires validation; ie if it gives these labs plus/minus Lyme samples and the labs come up with the right answers then I think we'll have validation. Why something like this kind of testing wasn't done years ago I don't know.

I think that ultimately something like this - so long as it is done fairly - will impose some costs but will b good for the field.

 

[VLynx]

Thanks, Cort, BTW the 2014 article was wrong also. Igenex has been licensed by New York for many years. Below is a chronology (from Igenex) of their history of investigations and issues. As far as I can determine, the problems they had had to do with a urine antigen test that they discontinued in 2001.
I can't find any support of the oft-repeated "fact" that you quote that Igenex was rejected 3 times by the state of New York. Perhaps you could contact Igenex directly for the truth of the matter. According to their "Quality Assurance and Proficiency Information (PDF Document)" they were last inspected by the New York Department of Health in 2011.

Regarding "Igenex ... allows fewer bands be present for a Lyme Diagnosis than the CDC": Yes, when you receive your lab report of your Western Blot from Igenex, it details both Igenex's own criteria, based on what many would consider a more scientific approach, not influenced by the bizarre political history that led to the removal of highly specific bands from the criteria (partly because the defunct Lyme vaccine used these antigens), AND also tells you what the CDC and NY State consider to be a positive test. For example, the lab report says "IGENEX-IGG-RESULT NEGATIVE" and "CDC/NYS-RESULT NEGATIVE." Nowhere on the report does it say that one set of criteria is better than the other.

This is a topic fraught with misinformation, politics, anger, and exaggeration on both sides. Be sure to check your sources, and the stakes are very high. If you haven't yet, I strongly recommend reading Pamela Weintraub's book on the topic: Cure Unknown. She is an excellent and reputable science journalist whose whole family was affected by Lyme disease. Her reporting is thoughtful and, in my opinion, as unbiased as you can be when you are a patient caught in the middle of a truly insane political battle over a medical diagnosis.

Here is Igenex's chronology of inspections and such, written as a letter to a journalist in 2013:

Written response from IGENEX
From the Laboratory Director, Dr. Jyotsna
April 28, 2013
Question: Was IGeneX Inc ordered to cease Lyme testing in 2001 by a federal regulator? For what reason?
Response: Yes. There were issues with documentation, not with the tests.
Question: Did the federal Office of the Inspector General in 2001 put Igenex on a list of
noncompliant labs? And did your company pay fines totalling $48,000?
Response: Yes.
Question: In that year, was Igenex also cited for a lack of training among lab staff by Californian regulators?
Response: We are not aware of it
Question: The San Francisco Chronicle writes “In April 2000, the New York Department of
Health wrote Stephens that Igenex had failed a "proficiency challenge" involving 20 samples. The test failed to find two samples that had been "spiked" with Borrelia burgdorferi, the bacteria that cause Lyme disease. The tests incorrectly reported as positive four of 14 negative samples”. Is this statement correct? If not, what is incorrect? –
Response: Lyme urine antigen test (LUAT) – The LUAT was the 1st generation test. In 2001, we decided to discontinue the test and replaced it with Lyme dot blot assay (LDA).
Question: In 2005 did the NY State Dept Of Health open an investigation into IGeneX Inc regarding complaints of positive Lyme tests that could not be replicated elsewhere? What was the result of that investigation?
Response: NYS asked IGeneX to send the validation package for Lyme Western Blots. - On review NYS found no technical issues. They wanted IGeneX to report by CDC criteria. NYS had concerns regarding result reporting by IGeneX criteria.
CDC Criteria: 5/10 bands for IgG 918, 23,28, 30,31,34,39,41,45,58,66,93kDA) and 2/3 bands for IgM
(23.39 and 41 kDA)
IGeneX criteria: 2/6 bands for IgG and IgM (23,31, 34, 39, 41 and 93 kDA)
We were able to support scientifically our claims regarding 2 band criteria that IGeneX uses. IGeneX reports by CDC and IGeneX criteria.
Bottom line they found NO DEFICIECIES WITH OUR WESTERN BLOTS.
Question: In total, how many regulatory investigations of IGeneX has there been? What is the total amount of fines paid to state and federal regulatory authorities for non compliance and/or other licensing or validation breaches? –
Response: One in 1999-2000 and the NYS in 2005 - In both instances IGeneX was able to provide validation data for all the tests. IGeneX has only paid fines once, in 2001.
Question: The NYT writes “in each year since 2000, IGeneX had achieved scores of at least 97 percent accuracy on the Western blot and Elisa tests, well above the minimum 80 percent required by the state. But Robert Kenny, a spokesman for the (NY) State Department of Health, said the agency was not convinced that IGeneX was performing the recommended tests for the public in the same manner as it has been performing them to pass the state's proficiency review.” Is this correct? If not, what is incorrect?
IGeneX performs all PT in the same way as clinical samples. IGeneX has evidence to prove that point.

 

[Cort]

Thanks, Cort, BTW the 2014 article was wrong also. Igenex has been licensed by New York for many years. Below is a chronology (from Igenex) of their history of investigations and issues. As far as I can determine, the problems they had had to do with a urine antigen test that they discontinued in 2001.
I can't find any support of the oft-repeated "fact" that you quote that Igenex was rejected 3 times by the state of New York. Perhaps you could contact Igenex directly for the truth of the matter. According to their "Quality Assurance and Proficiency Information (PDF Document)" they were last inspected by the New York Department of Health in 2011.

Regarding "Igenex ... allows fewer bands be present for a Lyme Diagnosis than the CDC": Yes, when you receive your lab report of your Western Blot from Igenex, it details both Igenex's own criteria, based on what many would consider a more scientific approach, not influenced by the bizarre political history that led to the removal of highly specific bands from the criteria (partly because the defunct Lyme vaccine used these antigens), AND also tells you what the CDC and NY State consider to be a positive test. For example, the lab report says "IGENEX-IGG-RESULT NEGATIVE" and "CDC/NYS-RESULT NEGATIVE." Nowhere on the report does it say that one set of criteria is better than the other.

This is a topic fraught with misinformation, politics, anger, and exaggeration on both sides. Be sure to check your sources, and the stakes are very high. If you haven't yet, I strongly recommend reading Pamela Weintraub's book on the topic: Cure Unknown. She is an excellent and reputable science journalist whose whole family was affected by Lyme disease. Her reporting is thoughtful and, in my opinion, as unbiased as you can be when you are a patient caught in the middle of a truly insane political battle over a medical diagnosis.

Here is Igenex's chronology of inspections and such, written as a letter to a journalist in 2013:

Written response from IGENEX
From the Laboratory Director, Dr. Jyotsna
April 28, 2013
Question: Was IGeneX Inc ordered to cease Lyme testing in 2001 by a federal regulator? For what reason?
Response: Yes. There were issues with documentation, not with the tests.
Question: Did the federal Office of the Inspector General in 2001 put Igenex on a list of
noncompliant labs? And did your company pay fines totalling $48,000?
Response: Yes.
Question: In that year, was Igenex also cited for a lack of training among lab staff by Californian regulators?
Response: We are not aware of it
Question: The San Francisco Chronicle writes “In April 2000, the New York Department of
Health wrote Stephens that Igenex had failed a "proficiency challenge" involving 20 samples. The test failed to find two samples that had been "spiked" with Borrelia burgdorferi, the bacteria that cause Lyme disease. The tests incorrectly reported as positive four of 14 negative samples”. Is this statement correct? If not, what is incorrect? –
Response: Lyme urine antigen test (LUAT) – The LUAT was the 1st generation test. In 2001, we decided to discontinue the test and replaced it with Lyme dot blot assay (LDA).
Question: In 2005 did the NY State Dept Of Health open an investigation into IGeneX Inc regarding complaints of positive Lyme tests that could not be replicated elsewhere? What was the result of that investigation?
Response: NYS asked IGeneX to send the validation package for Lyme Western Blots. - On review NYS found no technical issues. They wanted IGeneX to report by CDC criteria. NYS had concerns regarding result reporting by IGeneX criteria.
CDC Criteria: 5/10 bands for IgG 918, 23,28, 30,31,34,39,41,45,58,66,93kDA) and 2/3 bands for IgM
(23.39 and 41 kDA)
IGeneX criteria: 2/6 bands for IgG and IgM (23,31, 34, 39, 41 and 93 kDA)
We were able to support scientifically our claims regarding 2 band criteria that IGeneX uses. IGeneX reports by CDC and IGeneX criteria.
Bottom line they found NO DEFICIECIES WITH OUR WESTERN BLOTS.
Question: In total, how many regulatory investigations of IGeneX has there been? What is the total amount of fines paid to state and federal regulatory authorities for non compliance and/or other licensing or validation breaches? –
Response: One in 1999-2000 and the NYS in 2005 - In both instances IGeneX was able to provide validation data for all the tests. IGeneX has only paid fines once, in 2001.
Question: The NYT writes “in each year since 2000, IGeneX had achieved scores of at least 97 percent accuracy on the Western blot and Elisa tests, well above the minimum 80 percent required by the state. But Robert Kenny, a spokesman for the (NY) State Department of Health, said the agency was not convinced that IGeneX was performing the recommended tests for the public in the same manner as it has been performing them to pass the state's proficiency review.” Is this correct? If not, what is incorrect?
IGeneX performs all PT in the same way as clinical samples. IGeneX has evidence to prove that point.

Thanks VLynx - it is a wild field. This is what the Center for Investigative Reporting stated

While the CDC has specific guidelines to interpret the results to identify Lyme, some labs interpret them far more liberally. IGeneX Inc., for example, a Palo Alto, Calif. lab that performs more than 20,000 Lyme tests a year, uses different interpretation criteria for the Western Blot. On its website, the lab also offers others, such as a urine test, that is not recommended by the CDC. IGeneX was rejected by New York three times for Lyme tests in the past decade for not having enough documentation to prove the tests worked. The lab did not respond to requests for comment.

I wish that all parties could get together - agree on an independent testing mechanism and see what happens...The patients would certainly benefit..

 

[Cort]

Thanks VLynx - it is a wild field. This is what the Center for Investigative Reporting stated



I wish that all parties could get together - agree on an independent testing mechanism and see what happens...The patients would certainly benefit..

Here's a good article by the NYTimes which gives the pro's and con's of both sides and includes Igenex and why they have different standards - which they argue are better.

http://www.nytimes.com/2005/08/23/health/policy/unproved-lyme-disease-tests-prompt-warnings.html

It was written in 2005 - ten years ago. Lyme testing was a mess back then and it apparently hasn't gotten much better. The FDA's new action will probably spur a lot of testing and efforts to finally validate all these tests.

I amended the blog a bit.

 

[Kristi]

Last November the FDA stated it was going to start regulating what it calls "Laboratory Developed Tests". These are tests that are developed by and for single laboratories (often genomic firms) but have not been subjected to regulatory approval. At the time the FDA's regulation was created these tests were rare but with the development of genomic testing thousands have been developed. Many labs do subject their tests to stringent internal and/or independent testing but not all do.

That announcement was met by fierce opposition by industry and some academics.They stated the new regulations - which will likely make tests more expensive to develop - would stifle innovation and hurt patients.

• http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm

[fright]View attachment 791 [/fright]The FDA, however, believes some of these tests are doing more harm than good.



Lyme Disease Tests Prominently Featured

[fleft]View attachment 793 [/fleft]Lyme disease tests were featured front and center in a recent FDA report highlighting 20 offending lab tests. The FDA and Lyme disease labs and some Lyme physicians have been butting heads for years. The CDC has gone so far as to produce video's featuring patients misdiagnosed with Lyme disease who were later found to have something else. (See below).

In a report titled "Can You Trust Lyme Disease Tests?" , the New England Center for Investigative Reporting found, however, that thousands of people were being assessed for Lyme disease every year using unvalidated and inaccurate tests.

It noted that New York State - the only state that attempts to independently verify the accuracy of the tests - is not allowing seven labs to run Lyme disease tests there.

Igenex, a large Lyme disease testing lab, took four tries to get accredited in New York but it finally did. According the Center report Igenex offers a Western Blot and urine tests and allows fewer bands be present for a Lyme Diagnosis than the CDC.

Common in the Northeast

The FDA asserts that a diagnosis of Lyme disease should be made based on a history of tick exposure, symptoms and two positive tests: a positive initial enzyme-linked immunosorbent assay test followed by a confirmatory Western Blot test. One FDA official stated it was very important that both tests be done.

The Western blot tests are not affected by the new oversight; the FDA has OK-ed over 80 Western Blot tests by different laboratories for Lyme.

The Western Blot test identifies IgM and IgG antibodies against several different B. burgdorferi antigens. Because the test can pick up antibodies other than the Lyme bacteria everyone will probably test positive to at last one band. The FDA requires that at least 5 of 10 bands on the IgG assay and 2 of 3 bands on the IgM assay be positive for a Lyme diagnosis.

Particularly in the northeast, Lyme is common. Doctors using FDA recommended Western Blot Tests make 300,000 new diagnoses every year. Testing is common as well. Over 3 million Western Blot tests costing over 400 million dollars are done every year.

Unvalidated Lyme Tests

The FDA apparently has little good to say about the rest of the Lyme Disease tests. It asserts that many urine, blood and culture tests for Lyme disease are not accurate and are causing harm.



The FDA came down particularly hard on urine tests. Between 50 - 70,000 urine tests for Lyme were run in 2005. It stated that an independent evaluation on healthy subjects gave false positives 50% of the time. Sometimes running the same blood sample again gave different results. It concluded that


Similar findings occur for some blood tests and a culture test. The FDA noted two couples were awarded $30 milllion in damages after they received months of antibiotic and other treatments.

[fright]View attachment 792 [/fright]In April 2014 the FDA concluded that false-positive results caused by laboratory contamination and the potential for misdiagnosis" made a culture test unworkable as well.

The FDA estimated that the average cost of a false-positive diagnosis was about $1,220 per patient.

[fright][/fright]Some patients who tested negative on FDA approved tests but positive on unapproved test and then improved on antibiotics are upset. The Center for Investigative Reporting report noted that the FDA test is not particularly accurate in the early stages of the illness but is quite accurate after more time has passed. The FDA acknowledges there are problems with the test but states that no better tests have appeared. For patients with a Lyme rash but without a positive blood test it recommends immediate antibiotic treatment.

With the FDA featuring Lyme prominently in its report expect the FDA to require Lyme labs to undergo stringent testing and validation procedures. If they don't pass the FDA will apparently not allow them to market their tests anywhere in the U.S. If they do pass then their tests will be validated and the controversy will cease. It's about to get very interesting in the Lyme testing world.

• Check out Lyme Video's in our Media Section here.

CDC Video - When Lyme Disease Isn't

I think this is a good thing. One dr I went to said he could "cure" ME/CFS. His solution was to test for Lyme Disease. I went along with that, even tho I had been tested, found negative, with an earlier test. I took the Igenex test and it still came back negative. He STILL wanted to treat me for Lyme disease! I haven't seen him since.

 

[Strike me lucky]

How can they tell if testing is accurate or not when all lyme testing is suppose to be inaccurate .

Who checks the FDAs testing as well as for being biased ? ??

the people who test the labs for accuracy , why dont labs use that testing.

am i missing something ? Its like they can accurately test for lyme but others cant. Im confused.

 

[Issie]

Even if you get testing and get a positive test, treatment is difficult if there is Chronic Lyme and went untreated for years. There is a lot of trial and error. It can lie dormant and then morph into another form and surface later. It is now thought, from recent seminars I've attended, that it can never really be permanently eliminated. Despite being treated for 2 years and getting better - I'm in another flare. Granted I'm dealing with more than just this. But it's something that is a constant and has to be managed with knowledge of what you are dealing with and how it lives and what to do as things change.

We do need testing and it would be great if there were less issues with positives and negatives with validity.

But I think of the Lyme literate docs that go to bat for us despite the controversy and who try to help us manage our bodies with not only RX meds but possibly alternatives when those fail. There needs to be more research and funding for this. It may affect way more people than is known. And there needs to be more test available and more education about how widespread this is. There are many finding great relief from addressing this. Our bodies are host to all sorts of bacteria, and pathogens. Some good, some bad. But these type of protozoa can wreck havoc on a person's life. It comes down to faulty autoimmune systems. If that were working properly, we could possibly keep things in check with little disorder.

Yay to the docs brave enough to keep going forward with looking for answers for us despite the boulders they have to climb over. I personally hope they don't get discouraged and continue to keep searching for more solutions. For nearly two years this has made a significant improvement in my life. And the hick-up I have right now --- I'm sure will get better. I went from being nearly dead to having a life. So those battling this, don't give up--- it can get better. You just have to find the right combinations to use.

Issie

 

[Cort]

It all seems to swirl around this question

Steve Courcier just wanted to know: did he have Lyme disease or didn't he?

This was from a 2005 article by the way....

• http://www.nytimes.com/2005/08/23/health/policy/unproved-lyme-disease-tests-prompt-warnings.html

Doctors who tested Mr. Courcier in March at the Mayo Clinic in Scottsdale, Ariz., ruled out Lyme, a tick-borne illness, as an explanation for the disabling pain and exhaustion he was suffering. Then a Texas doctor sent his blood sample to a California laboratory that indicated he did have Lyme disease. But a New York specialist who tested his blood a third time, in June, said emphatically that he did not.

"It's amazing to me that you could have this much disparity in medical test results and not have the government do something," said Mr. Courcier, 38-year-old executive with a consulting firm who lives with his wife and two young children in a Dallas suburb.

It took them ten more years to start to do something...I hope its as transparent as possible.

 

[Cort]

How can they tell if testing is accurate or not when all lyme testing is suppose to be inaccurate .

Who checks the FDAs testing as well as for being biased ? ??

the people who test the labs for accuracy , why dont labs use that testing.

am i missing something ? Its like they can accurately test for lyme but others cant. Im confused.

That's why instead of the FDA being completely in charge I wish all the parties could get together and attempt to agree on a way to straighten out the field. It's worth a try.

 

[Issie]

It all seems to swirl around this question

Steve Courcier just wanted to know: did he have Lyme disease or didn't he?

This was from a 2005 article by the way....

• http://www.nytimes.com/2005/08/23/health/policy/unproved-lyme-disease-tests-prompt-warnings.html

Doctors who tested Mr. Courcier in March at the Mayo Clinic in Scottsdale, Ariz., ruled out Lyme, a tick-borne illness, as an explanation for the disabling pain and exhaustion he was suffering. Then a Texas doctor sent his blood sample to a California laboratory that indicated he did have Lyme disease. But a New York specialist who tested his blood a third time, in June, said emphatically that he did not.

"It's amazing to me that you could have this much disparity in medical test results and not have the government do something," said Mr. Courcier, 38-year-old executive with a consulting firm who lives with his wife and two young children in a Dallas suburb.

It took them ten more years to start to do something...I hope its as transparent as possible.

I read the link you attached. It says he took the antibiotic and it made him feel worse. When you have herx reactions you DO feel worse. You think you can't take it any more. There is a lot of pain and naseau and intensity of all previous symptoms. You have to make sure you are staying on top of detox and elimination. As you kill off pathogens and release them from the blood, organs and muscle - you have to get them out of your body and not recirculate them. It could have been a herx. When these happen you have to back off on how much you take and slow down the herx. It's now believed that a herx is caused by a massive cytokine storm. Addressing inflammation is imperative. Yeah, FOR SURE, you will feel worse before you feel better. You have to realize that before going in to treatment. Pay attention to your body and take it at the level your body can handle. I'm super sensitive and use 1/4 of usual treatments - and it worked for me. I'm certain that when I get this biotoxins issue under control - I'll go back to being mostly good. I don't think I'll ever be completely well. But "mostly good", is acceptable.

Issie

 

[Gamboa]

One of the biggest issues of all the false positives is the intensive antibiotic regime that the patient then has to endure. As we are now starting to realize, messing around with the gut flora ( the intestinal microbiome) by taking antibiotics ,among other things that mess up the gut flora, can set one up for a lifetime of illness. It might end up being the actual cause for many people's ME/CFS, or at the very least, a major player.

I took antibiotics for months at a time from the age of 13 to my late 20's and have ME/CFS. I am fairly certain that Dr. Lipkin et al, and other people studying the human microbiome, will find that all the bacteria that make up our unique personal gut flora are crucial to our health. Antibiotics should only be used in cases where it is 100% certain that they are necessary. All the more need for this Lyme testing issue to be sorted out ASAP.

 

[Issie]

One of the biggest issues of all the false positives is the intensive antibiotic regime that the patient then has to endure. As we are now starting to realize, messing around with the gut flora ( the intestinal microbiome) by taking antibiotics ,among other things that mess up the gut flora, can set one up for a lifetime of illness. It might end up being the actual cause for many people's ME/CFS, or at the very least, a major player.

I took antibiotics for months at a time from the age of 13 to my late 20's and have ME/CFS. I am fairly certain that Dr. Lipkin et al, and other people studying the human microbiome, will find that all the bacteria that make up our unique personal gut flora are crucial to our health. Antibiotics should only be used in cases where it is 100% certain that they are necessary. All the more need for this Lyme testing issue to be sorted out ASAP.

I agree with you. I'm concentrating on my gut ecology right now. Switching antbiotics when the Doxy stopped working wasn't the best thing to do. The other antibiotics gave me major issues. I'm using lots of probiotic and binders at different times to eliminate things. Also using herbal instead of antibiotics. The immune system requires gut ecology to be optimal or that hinders things too.

However, I tried to do it with just herbals before and the Doxy addition helped me improve. But I was only using 3 pills a week and herbals the other time. I pulse and rotate.

Issie

 

[Darden Burns]

The history, diagnose and treatment of Lyme disease is a can of worms. I think its important to distinguish between acute symptoms of Lyme following a tick bite and "chronic" Lyme disease. Most of my friends with CFS or FMS have been diagnosed with Lyme disease at some time or another. In the long run it did not seem to make a difference - a dead end diagnosis. I was diagnosed with Lyme as well but subsequent treatments did not help my recovery. I remember Dr. Deitrich Klinghardt, one of the leading physicians in alternative health that treats Lyme saying that we all carry the bacteria and that if you look hard enough you will find it in the entire population. The difference he said is between those who carry the bugs and do not have symptoms and those that do. In my opinion the correct approach is not to fight the bugs but to improve the immune system and the overall health of the individual so that the bugs do not present a problem.

 

[Issie]

The history, diagnose and treatment of Lyme disease is a can of worms. I think its important to distinguish between acute symptoms of Lyme following a tick bite and "chronic" Lyme disease. Most of my friends with CFS or FMS have been diagnosed with Lyme disease at some time or another. In the long run it did not seem to make a difference - a dead end diagnosis. I was diagnosed with Lyme as well but subsequent treatments did not help my recovery. I remember Dr. Deitrich Klinghardt, one of the leading physicians in alternative health that treats Lyme saying that we all carry the bacteria and that if you look hard enough you will find it in the entire population. The difference he said is between those who carry the bugs and do not have symptoms and those that do. In my opinion the correct approach is not to fight the bugs but to improve the immune system and the overall health of the individual so that the bugs do not present a problem.

I agree. Since the latest thought is the organisms can probably not be completely eliminated, trying to get the immune system to working properly and keeping them in check - probably is the best approach. I'm truly of the opinion that all the illnesses we have comes down to faulty autoimmune systems and inflammation. The things we discover along the way are probably a consequence of......Maybe not a cause. But if there is a way to eliminate some of the burden, it should help.

Issie

 

[Victoria]

Where do you get your information?
"Particularly in the northeast, Lyme is common. Doctors using FDA recommended Western Blot Tests make 300,000 new diagnoses every year. Testing is common as well. Over 3 million Western Blot tests costing over 400 million dollars are done every year."

No, there are NOT 300k diagnoses a year. There is so much wrong with this article you need to pull it. Seriously, this is not fact checked.

 

[Issie]

Where do you get your information?
"Particularly in the northeast, Lyme is common. Doctors using FDA recommended Western Blot Tests make 300,000 new diagnoses every year. Testing is common as well. Over 3 million Western Blot tests costing over 400 million dollars are done every year."

No, there are NOT 300k diagnoses a year. There is so much wrong with this article you need to pull it. Seriously, this is not fact checked.

Sadly, this debate continues despite so much proof of its existence. So many people with unexplained neurological conditions that may be completely bed bound. And others dismissing it as if it's not viable. I've been dealing with a DX for over 2 years now. I know when I was bitten and had the rash. But didn't get treatment for a decade later. By then, the damage is done and there is not a lot of hope for complete recovery. Despite blood microscope, visual proof - there are some of my close fellow researchers who still poo poo the DX. They choose to believe it's not a contributing cause. I still try to get the message out for others to be tested and to treat it. If I had not found my Lyme literate doc and gotten treatment---- I honestly believe I would be dead right now.

Issie

 

[kam]

Just want to say to Cort: THANK YOU SO MUCH for all your hard work. I'm a chronic lyme victim. 20 years ago, I was diagnosed with CFS when a month of antibiotics did not erradicate all my lyme symptoms and I had a negative lyme test. (Nevermind that I lived in the woods, in NJ, with my dog, and had a bull's eye rash!) So sad it seems little has changed for the mainstream medicine.

I plan to look through all the responses as soon as I get more energy (story of my life...). Lots of good info here.

To all CFS victims - please get tested for Lyme with Igenex to be on the safe (?) side.