LYMEPOLICYWONK: FDA Proposed Regulation of Lyme Tests? Take the Survey!
LymeDisease.org has launched a new survey regarding the FDA’s proposed regulation of Lyme lab tests. We need your views on this very important topic. This is extremely time sensitive so please respond quickly! We will use this information to assess patient views and to inform our meetings with the FDA. Our last survey drew over 6,000 responses and was published this year. We need your input now!
The current FDA approved tests for Lyme disease are notoriously insensitive and have been shown to miss more than 50% of Lyme disease cases. Currently, the FDA has approved 84 Lyme tests, which are produced by 28 companies. Approximately 90% of these are ELISA tests, which researchers have found to be too insensitive to be used for screening.
The Food and Drug Administration (FDA) has proposed regulating Lyme diagnostic tests. Many tests for Lyme disease used by patients are not regulated by the FDA. Instead, they are regulated through the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). This means that many Lyme diagnostic tests currently being used would need to be submitted to the FDA for approval in order to continue to be marketed. FDA approval is time consuming, costly, is not assured, and may rely on experts from the Infectious Diseases Society of America to determine whether a test should be approved.
The types of lab tests the FDA is considering regulating include the Lyme tests manufactured by IGeneX that many patients rely on for accurate diagnosis. IGeneX and other labs like them will be the hardest hit by these regulations, which would leave only the FDA approved lab tests available to patients.
The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at lbjohnson@lymedisease.org. On Twitter, follow me @lymepolicywonk.
we need tests that have proven to show more accurate then the current approved. CDC is already on the chopping block for their current handling of other diseases. If we can’t get test that even on the NIH web site have proven to be more accurate in testing results for the diseases also related to lyme then it would appear the medical community has failed us. Our government needs to back out of some of this, and allow patients to have a say in how they are treated and tested. Insurance cos need to follow suit. I agree there needs to be some regulation on how many how often and some kind of results showing the safety of such tests. Currently they allow and push for spinal taps that have not shown to be any more reliable then simple blood testing. Along with cerebral testing that is invasive and unnecessary when ct and mri will show results as well and not have the invasive side effects and such involved. Simple tests and testing methods should be utilized and documented for future advancement.
The most important question that needs an answer is: who stands to gain from inadequate testing? When you have the answer, then you understand why they want people to remain ill.
Jean,
You ask a good question, but I think the answer to your question isn’t enough. IDSA would say that “those crooked ‘Lyme Literate” Physicians benefit from the fact the tests are not good.
Many ‘Lymies’ would say “the ‘Lyme Cabal’s” ego are the primary beneficiary. And they do get funded for a lot of research, much of which is particularly bad given the lack of good tests (and whatever test biases that inadvertently exist within the test criterion).
I think it fair to say who is hurt by it, other than patients and LLMDs. The public’s trust and the government (in general) and science and medicine (in specific). The fact that so many believe there is an Ebola conspiracy (e.g. that it is super easy to catch but no one is telling us that) are very much a sign of the mishandling of AIDS (initially) and Lyme.
I believe the tipping point is here. Most people know someone that has had (or has) Lyme and know it is not easy to cure and can be devastating. Is it incompetence or fraud?
I cannot recall off-hand who said: “never attribute to malice that which can be ascribed to incompetence” but I think egos and incompetence are the problem.
I have long term chronic lymes that manifested in many ways including neurological and cardiac. I treated twice by infectious disease with oral and IV antibiotics. I did not get well until I was referred to a Lyme Specialist and was on IV antibiotics for over a year. I am also a RN. Lymes not only exists and is an epidemic, but can also be devastating if not treated appropriately with a physician that takes the time to listen and be open to the doctors that are on the frontlines and treating this disease. I believe the FDA wants to regulate the tests to bring costs down due to Obama care. This will lessen the costs of insurance if more patients do not meet the strict guidelines of the ID and the limited positive diagnosis of Lymes. A sad day to all.
Thanks so very much for organizing this survey – we all need to be filling it out!! I imagine there are a lot of other illness conditions that are going to be affected as well by the FDA threatening to regulate independent testing labs, so I hope they also are contacting those affected. Perhaps you could also find out what other illness conditions are doing about this situation and join together.
According to the FDA guidance on human papillomavirus detection and genotyping, a molecular diagnostic test based on PCR followed by DNA sequencing of the amplicon does not need to be approved because Sanger sequencing analysis is based on the laws of physics. The FDA does not approve photoelectric effect and Genbank databases. Read the paragraph extracted from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM181511.pdf
Evaluation of HPV detection in clinical dataset
We recommend that you provide an evaluation of your device’s ability to detect the HPV genotypes in your clinical dataset. One way to do this is to perform an
FDA-approved HPV test that detects the same genotypes as your test, or you may perform PCR followed by sequencing of the amplicon (PCR/Sequencing) on your clinical specimens and compare these results to the results of your device. Use of a composite HPV comparator that incorporates both FDA-approved HPV test(s) and/or PCR/Sequencing is also an option.
Please help us and others who continue and will continue to suffer everyday from tests that just weren’t accurate.
I didn’t take the survey because I am not currently diagnosed with Lyme disease I do have Fibromyalgia and other medical issues. I believe if there are accurate tests for Lyme disease or any other disease the FDA shouldn’t regulate it a prevent people from getting accurate tests. I honestly don’t have a lot of faith in the FDA right now.
I am the parent of a probable Lyme patient. Our doctor has told us that Lyme does not exist in our State. My child’s symptoms are the same as many case studies. I am having great difficulty getting help for my child and a diagnoses. I can’t fill out the survey, but would like to as a patient advocate.
Susan – It is so important that you find a ‘Lyme Literate’ MD (LLMD) to treat your child. I found one by chance here in CA (also ‘not a state where Lyme is found’ ha ha, my tick didn’t read). ILADS, the International Lyme and Associated Diseases Society, is full of Lyme Literate doctors. This website also has resources to point you to them. Good luck!
We want answers and want to be well. Why in Heaven would you sign something that stops better testing so folks can get help.
Posting for somebody who couldn’t post it herself:
I was misdiagnosed as having Multiple Sclerosis by 3 Neurologist. Two family physicians believed them. If it wasn’t for a Lyme Literate Naturopath sending my blood to IGeneX and getting a positive test result for Lyme Disease I was destined to live out the rest of my life in a wheelchair or care home. Luckily, I received treatment for Lyme. Now, I can walk and continue to work.
I have met many people who had the Elisa test and had Negative results. Then they had the IGeneX test done, with positive results for Lyme. Those that received treatment are walking and have returned to work. Others who believed in the Negative Elisa test, and did nothing more, are now in care homes wanting to die.
This flawed test has resulted in thousands of people being misdiagnosed and going untreated while this debilitating disease robs them of their life and their livelihood.
The Infectious disease doctors and microbiologists actions, of knowingly misinforming the public and Health authorities, of the failure of this test, for several decades, verges on criminal activity.
In my opinion, for the FDA to be duped by the corrupt individuals of the IDSA in determining whether a test should be approved and from which labs, paints them with the same brush.
This could only be considered criminal.
I was the 5th Veteran to receive a 100% Permanent & Total disability rating for Lyme disease I contracted in1974. It went undiagnosed until 1997 and I didn’t get rated by the VA for Lyme (with Fibromyalgia and chronic fatigue) until 2006! Four years ago a (Yale) Infectious Disease Specialist at the VA said I have “Post Lyme Syndrome” and antibiotic treatment serves no purpose (and is “dangerous”). Incredibly, because of a computer glitch only part of my medical record was available so there was no record of civilian Brain SPECT scans, blood test data, etc. My offer to go antibiotic-free for a couple of months after which I would donate a pint of blood that the M.D would then be given was refused. I now have to purchase the antibiotics my Lyme Specialist prescribes using insurance. I’m a retired senior officer. What do young enlisted men and women who are sick do if I get this poor level of treatment provided by the VA?
My daughter was pronounced “cured” from Lymes and “recurred” with no known exposure shortly thereafter her original CDC recommended treatment. As an RN I am very aware of the Lymes controversy and recommended she get a 2nd opinion from a Lymes Literate MD. Fortunately she was appropriately treated, even though insurance did not cover the second physician. I believe we need to get our gov’t and insurers on the same page as academic researchers on this topic. Our citizens need to know that this a huge problem in the USA.
I am asked to sign a lot of surveys; usually I am not given enough information to make an informed decision.
The info above says FDA regulates some testing/diagnostics, and another federal agency–CMS– regulates others. Is that true of all diseases/testing/diagnostics, or is Lyme the only one currently split between two agencies? Is there a movement to consolidate all testing of a particular disease under one agency or the other? Is this proposed rulemaking, meaning it’s posted in CFR or somewhere for public review and comment? If so, what is the comment period and url for officiall commenting? How are you planning to use this survey? Are the testing labs/techniques that most lyme people want available currently regulated by anyone? If so, by who? Does insurance only rely on FDA approved tests, or both FDA and CMS? or those and other?
I have heard or read that some of the Lyme testing techniques done at certains places uses methodolgy that produces results that can not be reproduced by others using the stated methodology. Ability to reproduce results is the bedrock of good science. So, if what I heard it true, it is a concern to me as a patient, and as a taxpayer. While I want good diagnostics for lyme, I don’t want my tax dollars paying for questionable/unscientific testing. While I don’t want lyme patients to have to resort to secret doctors, and unregulated/unsupervised drug expermentation, etc, which can hurt as much as help, I also don’t want people to feel so desperate that they have to. Which means a lot has to change.
So it MIGHT be that FDA regulation/oversight might be a good thing in the long run. I am inclined to think that would be the case–if these testing methods are approved, I don’t see how insurance could turn them down. If they aren’t, I’d want to see the science as to why. So give me enough decision to make a sound, rational decision, please.
(Sorry I don’t buy into the everyone in gov’t related to lyme is somehow crooked. I know people who worked at FDA on drug approval–they don’t have a dog in the fight, they are not being bribed or courted or swayed. They look at the science and data and test results, the comments that come in, etc and make a decision, based on the science. Yes, it can take awhile, but good science generally does. )
It is March 7, 2015 — I would like to know have any of the FDA proposed restrictions been put into force? My wife tested, through Igenex, positive for Lyme – BB – but not quite enough for CDC diagnosis. I think I need to get tested also. Is it still possible?
As far as the restrictions – testing needs to be available to all adults – government approved or not. This is a free country.
Thank you
The FDA has not made a decision about this yet.
Where is the survery?