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

[Ginny Dudek]

The CDC video was distressing to watch. Clearly, the man saw many providers, who should have tested his calcium levels, before sending him to a lyme specialist. Because of poor insurance coverage for Lyme, head CTs are very uncommon.

For every person misdiagnosed with Lyme, there are many like me who go undiagnosed with Lyme and co-infections. I have an underlying immune deficiency, and don't create enough antibodies to have a CDC positive test, so if I saw an ID MD as they recommend, I'd be dead by now.

I'm getting better with antibiotic treatment by a Lyme Literate MD!

 

[Cort]

The CDC video was distressing to watch. Clearly, the man saw many providers, who should have tested his calcium levels, before sending him to a lyme specialist. Because of poor insurance coverage for Lyme, head CTs are very uncommon.

For every person misdiagnosed with Lyme, there are many like me who go undiagnosed with Lyme and co-infections. I have an underlying immune deficiency, and don't create enough antibodies to have a CDC positive test, so if I saw an ID MD as they recommend, I'd be dead by now.

I'm getting better with antibiotic treatment by a Lyme Literate MD!

Glad to hear it Ginny, Thanks for sharing that. Please let us know how it goes.

 

[Ginny Dudek]

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.

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Reply from Ginny Dudek
From the CDC website: see final paragraph ... 30,000 cases reported, 300,000 estimated cases per year, so 270,000 are undiagnosed every year. There is no denying that there is an epidemic in America.
http://www.cdc.gov/lyme/stats/humanCases.html

Each year, approximately 30,000 cases of Lyme disease are reported to CDC by state health departments and the District of Columbia. However, this number does not reflect every case of Lyme disease that is diagnosed in the United States every year.
Surveillance systems provide vital information but they do not capture every illness. Because only a fraction of illnesses are reported, researchers need to estimate the total burden of illness to set public health goals, allocate resources, and measure the economic impact of disease. CDC uses the best data available and makes reasonable adjustments—based on related data, previous study results, and common assumptions—to account for missing pieces of information.
To improve public health, CDC wants to know how many people are actually diagnosed with Lyme disease each year and for this reason has conducted two studies:

• Project 1 (Lyme Disease Testing by Large Commercial Laboratories in the United States) estimated the number of people who tested positive for Lyme disease based on data obtained from a survey of clinical laboratories. Researchers estimated that 288,000 (range 240,000–444,000) infections occur among patients for whom a laboratory specimen was submitted in 2008.
• Project 2 (Incidence of Clinician-Diagnosed Lyme Disease, United States, 2005–2010) estimated the number of people diagnosed with Lyme disease based on medical claims information from a large insurance database. In this study, researchers estimated that 329,000 (range 296,000–376,000) cases of Lyme disease occur annually in the United States.

Results of these studies suggest that the number of people diagnosed with Lyme disease each year in the United States is around 300,000. Notably, these estimates do not affect our understanding of the geographic distribution of Lyme disease. Lyme disease cases are concentrated in the Northeast and upper Midwest, with 14 states accounting for over 96% of cases reported to CDC. The results obtained using the new estimation methods mirror the geographic distribution of cases that is shown by national surveillance.

 

[Ginny Dudek]

Glad to hear it Ginny, Thanks for sharing that. Please let us know how it goes.

I sure wish there was good research on Lyme. I was misdiagnosed with Lymphoma, then CFS and Fibro. 5-10% of Lymies have low IgM, for which there is no treatment. We seem to be the subclass that benefit from long term antibiotics.

 

[Issie]

And while we are on the subject of Lyme, here are a few more things to muddy the water. I have been found to have a mold/fungal issue. I was exposed for over a year and that’s when I crashed from being “mostly good” to not. They also think there may be some heavy metal issues.

I’m still in the learning phase of testing and treatment. But I’m starting to feel better. There is a test that you can do online that shows results to biotoxin illness. The guy who created this test has suffered with these things too.

https://vcstest.com/

Surprisingly, many people with unexplained illness may have mold and heavy metal issues. And it’s not unusual, I’m learning, for there to be environmental sensitivity (allergies).

Here is another interview with Dr Courtney Craig, interviewing Damien. (Another guy, who has been recovering from mold.) They talk about biotoxins and Brian's test.

http://www.drcourtneycraig.com/blog/spoonie-radio-ep-02-damien-blenkinsopp

The health quest continues.

Issie

 

[Katherine Autry]

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

The Lyme community is scorned and attacked just like the CFS/ME community. Mutual support is in order.