Survey: FDA Proposed Regulation of Lyme Tests

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Mon 17 Nov 2014 12:11

VM, I'm pretty sure many of the ELISA's and Western Blot tests presently on the market already enjoy FDA approval. I think the same can be said for the C6 Peptide.

RitaA
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by RitaA » Mon 17 Nov 2014 16:58

velvetmagnetta wrote:We seem to have gotten way off-topic in this thread. This original post was about the new proposed regulations the FDA wishes to impose on in vitro laboratory developed tests (IVDs) This is a test that is conceived, developed, administered, and then analyzed all in one lab.

I'm not sure why this particular criteria is so important. So, if a company uses more than one lab to accomplish all of this, its tests are subject to less regulation?

I really do like the idea of a company being required to show evidence that its tests really do what they advertise. Yet, this legislation seems particularly aimed at the many varied tests offered for Lyme disease, specifically. This legislation, though, would be more far-reaching than just affecting Lyme disease tests.

Are they sure they want to limit all tests in this way? Or is the FDA really just trying to regulate Lyme tests? We need to be careful here - if we're just trying to fulfill a vendetta against a philosophy of one particular disease, or do we want this kind of strict legislation requirement for all lab tests everywhere?

Doesn't this new criteria also exclude the 2-tiered WB/ELISA tests as well? There is not sufficient evidence that these tests can diagnose Lyme disease (as it still warns right on your copy of the test results).

It's kind of funny that in their zeal to rid the world of all other interpretations of Lyme, they have excluded their very own tests!
Thanks for getting us back on track, velvetmagnetta.

There's more information about the FDA's proposed regulation of medical testing in the link below. I have done a cut-and-paste of the entire webpage (last updated on November 5, 2014) because some details (like dates and status) are likely to change over time:

http://www.fda.gov/MedicalDevices/Produ ... 407296.htm
Laboratory Developed Tests

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.

LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes, such as a test that measures the level of sodium. Other LDTs are complex and measure or detect numerous analytes. For example, DNA variations can be detected from a blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium.

While the uses of an LDT are often the same as the uses of FDA-cleared or approved in vitro-diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market.

The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.

LDT’s are important to the continued development of personalized medicine, but it is important that in vitro diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay needed treatments, or become exposed to inappropriate therapies.

The FDA has generally not enforced premarket review and other applicable FDA requirements because LDTs were relatively simple lab tests and generally available on a limited basis. But, due to advances in technology and business models, LDTs have evolved and proliferated significantly since the FDA first obtained comprehensive authority to regulate all in vitro diagnostics as devices in 1976. Some LDTs are now more complex, have a nation-wide reach and present higher risks, such as detection of risk for breast cancer and Alzheimer’s disease, which are similar to those of other IVDs that have undergone premarket review.

The FDA has identified problems with several high-risk LDTs including: claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death. The FDA is aware of faulty LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease.

To help health care providers and patients better rely on the thousands of laboratory tests that are used every day to diagnose disease or other conditions or guide treatment and to encourage the advance of personalized medicine, on July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for LDTs based on risk to patients rather than whether they were made by a conventional manufacturer or a single laboratory. This draft oversight framework includes pre-market review for higher-risk LDTs, like those used to guide treatment decisions, including the many companion diagnostics that have entered the market as LDTs. In addition, under the draft framework, the FDA would continue to exercise enforcement discretion for low-risk LDTs and LDTs for rare diseases, among others. The framework would be phased in over many years.

Commenting on the Proposed LDT Regulatory Oversight Framework

As required by the 2012 FDA Safety and Innovation Act, on July 31, 2014 the FDA provided 60-day notice to Congress of its plan to issue draft guidance on the regulation of laboratory developed tests. At the same time, the FDA posted, for public viewing, the notification provided to Congress regarding LDTs that included the anticipated details of the draft guidances (Notification to Congress: FDA’s Laboratory Developed Tests Framework - July 31, 2014).

Following this 60-day notice, on September 30, 2014, the FDA posted both draft guidances on its website. On October 3, 2014, the FDA published notices in the Federal Register formally announcing their release and the beginning of a 120-day public comment period. This comment period will last until February 2, 2015. Electronic comments on the draft LDT framework and notification guidances should be submitted through http://www.regulations.gov. Written comments may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of the appropriate Federal Register notice for the draft guidance document (Docket No. FDA-2011-D-0360 for Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), and Docket No. FDA-2011-D-0357 for Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)).

The FDA welcomes comments on all aspects of these draft guidances, as well as on the following specific issues for the oversight framework draft guidance:

• Traditional LDTs: In Section D.5.(a) of the draft guidance, FDA has proposed continued enforcement discretion for premarket review and quality system requirements for a category of LDTs called “Traditional LDTs” based on whether the device is: 1) an LDT (designed, manufactured and used within a single laboratory); 2) manufactured and used by a health care facility laboratory (such as one located in a hospital or clinic) for a patient that is being diagnosed and/or treated at that same health care facility or within the facility’s healthcare system; 3) comprised only of components and instruments that are legally marketed for clinical use; and 4) interpreted by qualified laboratory professionals without the use of automated instrumentation or software for interpretation. FDA believes that these factors appropriately mitigate risks associated with Traditional LDTs being used on patients so that continued enforcement discretion with respect to premarket review and quality system requirements is appropriate. However, FDA is seeking public feedback as to whether the following three factors may be sufficient to appropriately mitigate risk for this category of tests and whether they may also be sufficient to support continued enforcement discretion in full (i.e., for all regulatory requirements rather than just for premarket review and quality system requirements): 1) the test is an LDT (designed, manufactured and used within a single laboratory); 2) the test makes use of only components and instruments that are legally marketed for clinical use, which have a number of regulatory controls in place, including reporting of adverse events; and 3) the test is interpreted by laboratory professionals who are appropriately qualified and trained as required by the CLIA (Clinical Laboratory Improvement Amendments) regulations (see, e.g., 42 CFR 493.1449), without the use of automated instrumentation or software for interpretation.

• LDTs Used for Rare Diseases: In Section D.5.(a) of the draft guidance, FDA has proposed continued enforcement discretion for premarket review and quality system requirements for LDTs used for rare diseases, which are those tests that meet the definition of LDT in the guidance (designed, manufactured and used within a single laboratory) and meet the definition of a Humanitarian Use Device (HUD) under 21 CFR 814.102(a)(5). With these factors, FDA has attempted to balance the need to mitigate the risks associated with these tests with their potential benefit for patients. FDA invites stakeholders to provide feedback on the suitability of these factors for LDTs for rare diseases. Further, FDA is seeking feedback on whether a factor other than the HUD definition should be considered, such as a factor based on the number of tests for a rare disease or condition that would likely (based on the prevalence of the condition) be conducted annually in the United States, and if so what the annual number of tests should be for the purpose of defining an LDT as an LDT for a rare disease. FDA also seeks feedback on whether enforcement discretion should be limited to tests that are designed, manufactured and used within a single laboratory.

• Healthcare System: In Section D.5. of the draft guidance, for the categories of tests called “Traditional LDTs” and “LDTs for Unmet Needs,” FDA has identified factors it intends to consider in continuing to exercise enforcement discretion for premarket review and quality system requirements. One such factor is whether the LDT is both manufactured and used by a healthcare facility laboratory (such as one located in a hospital or clinic) for a patient that is being diagnosed and/or treated at that same health care facility or within that facility’s healthcare system. To further clarify this factor, the guidance document explains that “healthcare system” refers to a collection of hospitals that are owned and operated by the same entity and that share access to patient care information for their patients, such as, but not limited to, drug order information, treatment and diagnosis information, and patient outcomes. While FDA invites feedback on all factors described in Section D.5. of the draft guidance, FDA specifically requests feedback on whether enforcement discretion should be limited, as proposed, to those LDTs that are both manufactured and used by a healthcare facility laboratory. FDA also invites the public to provide feedback to the Agency on which types of facilities would or would not be considered within a healthcare system, or to offer an alternative description of healthcare system for Agency consideration.

• Quality System (QS) Phase-in: In Section D.6. of the draft guidance, FDA has proposed to continue to exercise enforcement discretion with respect to QS regulation requirements, codified in 21 CFR Part 820, until a manufacturer of a given LDT submits a PMA or FDA issues a 510(k) clearance order for the LDT. Under this enforcement policy, the clinical laboratory manufacturing and using the LDT will be responsible for having a quality system in place that meets the minimum requirements codified in 21 CFR Part 820, either at the time of PMA submission (the facility that makes the device must pass an inspection as a condition of PMA approval as a matter of law (21 CFR 814.45(a)(3))), or prior to market launch for cleared devices, as applicable. FDA invites feedback on the timeframe for phase-in enforcement of QS regulation requirements. Specifically, FDA is considering whether those LDTs in the highest-risk category of devices (described in section D.5.(c)), which FDA intends to generally enforce premarket review requirements 12 months following publication of the final Framework guidance, should remain under enforcement discretion for the design control requirements (21 CFR 820.30(a-h) and (j)) of the QS regulation for up to 24 months after publication of the final guidance.

• Notification: FDA notes that some laboratory networks (i.e., more than one laboratory under the control of the same parent entity) offer the same test in multiple laboratories throughout their network. Although devices in this scenario do not meet FDA’s definition of an LDT (i.e., they are not designed, manufactured and used within a single laboratory), FDA would like feedback on whether a single notification from the laboratory network for that test is sufficient, provided that the laboratory network indicates in the notification to FDA that the test is offered at multiple sites. In addition, FDA seeks comment on whether there are certain types of LDTs for which the Agency should neither enforce requirements for registration and listing nor request notification in lieu of registration and listing.

FDA understands that members of the public may want more clarity around specific issues, such as how laboratory sponsors could interpret what elements make up a medical device, what might constitute the label or labeling for their device, whether or not unique device identifier requirements apply to LDTs, and how laboratory-physician communication about a test and its result would be viewed by FDA, among others. We invite public comment on these issues and any other issues or questions that should be addressed in the guidance, including how that issue or question should be addressed.

The agency also intends to hold a public meeting in early January 2015 to collect additional input during the comment period. When the FDA schedules the public meeting it will be announced in the Federal Register notice and on this website.

Additional Resources

•Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (PDF - 312KB)
The comment period begins Oct. 3, 2014.
•Notification of Availability for the Draft Guidance Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - September 30, 2014
•Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (PDF - 565KB)
The comment period begins Oct. 3, 2014.
•Notification of Availability for the Draft Guidance FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) - September 30, 2014
•Notification to Congress: FDA’s Laboratory Developed Tests Framework (PDF - 991KB)
•Guidance for Industry: In Vitro Companion Diagnostic Devices (July 31, 2014) (PDF - 159KB) 1737
•FDA - Personalized Medicine
•FDA News Release: FDA takes steps to help ensure the reliability of certain diagnostic tests (July 31, 2014)
•FDA Voice Blog: Curbing Risk, Not Medical Innovation, in Personalized Medicine

Webinar: Framework for Regulatory Oversight of LDTs Draft Guidance - October 23, 2014

•Recorded Webinar (WMV - 17.9MB)
•Printable Slides (PDF - 700KB)
•Transcript (PDF - 414KB)

Page Last Updated: 11/05/2014
It seems that testing for Lyme disease is just one of the FDA's many concerns at this point time.

velvetmagnetta
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by velvetmagnetta » Tue 18 Nov 2014 0:41

Than you for posting that RitaA!

Yes, it was after I read that that I began to get suspicious...

Lorima
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Lorima » Tue 18 Nov 2014 2:20

Thanks for posting this in detail, Rita.
The FDA is aware of faulty LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease.
Note how they are worried about both over- and undertreatment for heart disease; not getting effective therapies for cancer as well as being exposed to inappropriate therapies; but when it comes to the infectious diseases they are only worried about unnecessary antibiotic treatments, or unnecessary harmful treatments for LD. No concern whatever about failure to treat suspected infections promptly with antibiotics, or failure of diagnosis of LD (actually, even worse, a faulty mainstream test that incorrectly rules LD out of the differential diagnosis, even when it is present, which is what we have now.)

I'm not sure what the heart disease applications or cancer tests might be; I'd like to think that they would be just as likely to crack down on unnecessary statin prescriptions due to LDL target levels set too low, or on unnecessary breast or prostate surgery due to overscreening; but I kind of doubt it. And actually I wouldn't like that; they're just as likely to get that wrong as anything else.

The term "enforcement discretion" means that it will be completely subjective, and dependent on current expert opinion about what will harm patients. We all know, or should know by now, how that goes in the LD field.

Since I'm more interested in correcting errors in mainstream medicine, which we need to be able to trust, and this regulation shows no interest that I can see in detecting mistakes already ensconced in the mainstream, it looks pretty useless to me. I'm sure most of the people involved mean well and therefore can be said to have integrity, as Rita put it, above. What I don't know is whether they have a realistic sense of how error-ridden and uncertain current medical science is. I doubt it. Their good intentions will do nothing to prevent the harm that would come, for example, from making it impossible to get a set of IgG and IgM western blots with all bands reported, for suspected LD.
"I have to understand the world, you see."
Richard Feynman

velvetmagnetta
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by velvetmagnetta » Wed 19 Nov 2014 4:54

Hmmmm...Pretty silent on the hv808Hennnecker front.

Martian
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Martian » Mon 23 Feb 2015 21:40

Source: http://www.lymediseaseassociation.org/i ... lyme-tests
13 Jan 2015

FDA Moves to Regulate All Lyme Tests

FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under "medical devices," and "approves" or "clears" tests. Non LDTs are tests which are sold to other laboratories while LDTs are generally tests which are developed and used in one lab, commonly called specialty labs.

For the last several months, the LDA has been working a parallel track with other Lyme leaders and on its own to try to understand the implications of such a move for patient access and try to ameliorate any downsides to patients on moving Lyme test under this Guidance.

To that end, the LDA has been on 2 phone calls with FDA officials and other advocates. LDA also contacted a number of Lyme specialty labs about the issue. The LDA made a slide presentation to the FDA's public workshop on the Guidance on Jan 8-9, 2015, and had a representative available at the 2 day workshop. All presentations at the workshop to the FDA panels were limited to 4 timed minutes and had a category restriction. The LDA and LDo cooperated to present different categories since the speaking time was so limited. CLICK HERE FOR LDA SLIDES Two representatives of IGenex Labs, CA, also presented at the workshop.

The LDA also contacted the offices of Congressman Christopher Smith (NJ), House Lyme Caucus Chair, and Senator Richard Blumenthal (CT), both of whom have worked with LDA on Lyme issues before. Congressman Smith’s office held a meeting with FDA officials to discuss concerns we had raised and continues to follow-up on unsettled issues. Senator Blumenthal wrote a letter to FDA expressing concerns LDA and LDo had voiced on the guidance.

The LDA has also submitted input to the US House of Representatives Energy & Commerce Committee’s 21st Century Cures initiative, specifically “21st Century Cures – A Modernized Framework for Innovative Diagnostic Tests.” CLICK HERE FOR LDA LETTER TO ENERGY & COMMERCE COMMITTEE

Concerns the LDA has are that

1. the peer review process which will be used to categorize tests and risks could be biased. This concern is based on the prior use of "experts" in Lyme disease.

2. the process used for collecting adverse events (MAUDE) currently used by FDA for approved/cleared tests is already flawed− FDA cannot determine which test kits are being reported. Yet under the proposed Guidance, the LDTs would be dumped into the same flawed MAUDE system. That action could put the newly cleared LDTs at a disadvantage, because the LDTs put into the MAUDE system would be subject to greater scrutiny, since FDA would have the ability to more readily act upon the complaints.

3. government agencies have touted that all Lyme tests should be FDA approved, and through our analysis of FDA’s process, we discovered that FDA cannot point to any "approved" Lyme tests; they are all "cleared" which means substantially equivalent to a predicate test--to what test exactly, no one knows, since they cannot point to any original predicate test for Lyme that was not itself also based on substantial equivalence.

4. specialty lab tests will be removed from the market during the review process, citing safety reasons, which can be, e.g., too many positives.
Check source for links.

Martian
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Martian » Mon 23 Feb 2015 21:44

Source: http://lymedisease.org/research/surveys.html
The FDA wants to regulate Lyme lab tests!
Take our survey and let your voice on this be heard!

What is this about?

This survey is being conducted by LymeDisease.org to determine the views of Lyme patients regarding blood tests used to diagnose Lyme disease. The Food and Drug Administration (FDA) has proposed regulating Lyme diagnostic tests. Many tests for Lyme disease currently used by patients are not currently 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 and costly. FDA approval is not assured and may rely on experts from the Infectious Diseases Society of America to determine whether a test should be approve.

Impact on Lyme Patients

The types of lab tests the FDA are 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 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 regulatory change has been widely criticized for suppressing innovation and reducing patient access to care. The American Medical Association was among the first to raise concerns, saying it believes the regulations add an additional layer of requirements which may result in patients “losing access to timely life-saving diagnostic services and hinder advancements in the practice of medicine.”

In the lives of people with Lyme disease, this translates into fewer people being correctly diagnosed and treated.

How we will use your input

The results of the survey will be used to assess patients views on Lyme lab tests and to inform our conversations with the FDA regarding their proposed regulation of Lyme disease testing.

Actions To Take

* Take the new survey
* Read the Lyme Policy Wonk blog summary of LDo’s Quality of Life Survey published in March 2014. The full text of the peer reviewed publication is available here .
* Sign up if you would like to receive information on our surveys.
Source page was last edited: 19 January 2015. Check source for links.


Also see: http://lymedisease.org/news/lymepolicyw ... rests.html
LYMEPOLICYWONK: Whose interests is the FDA protecting? Not Lyme patients, apparently


21st August 2014

On July 31, the FDA announced it would move forward with regulations to restrict cutting edge laboratory developed tests (LDTs), which have not required FDA approval before because they are not marketed to consumers. The new regulations would change that. Why should you care?

Because LDTs include the Lyme tests manufactured by IGeneX and Advanced Laboratory Services that many patients rely on for accurate diagnosis.

(...)
Check source for full article.

WillemT
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by WillemT » Tue 24 Feb 2015 12:01

Relative Risk on his blog gives his opinion on the LDA letter. Very interesting!
Why Lyme activists groups are like the NRA

In their latest pleading to the FDA not to regulate Lyme disease tests (because it would be bad for their businesses), the activists have trotted out their standard accusations and lies. Here’s a brief tour of the latest:

Individuals with vested interests in Lyme tests – but belonging to powerful medical societies - have been very vocal in lobbying agencies and in courting the press insisting that only FDA tests be allowed, even when many of those tests have poor sensitivity and specialty labs have made test improvements that can be a great benefit to physicians and to patients.

None of the above is referenced; it’s just conspiracy-minded claims (powerful medical societies) and the standard lie that all 80+ FDA-approved Lyme tests are bad.

Historically, there has been an obsessive focus by some individuals, both within and outside of government, on false positives, while minimizing patients’ and treating physicians’ concerns with the extremely serious health consequences of false negatives.

Imagine being “obsessed” about false-positive tests for cancer or HIV or even pregnancy. This is why the FDA and real labs concern themselves with specificity and sensitivity. What these clowns really want from the FDA is a Lyme test that always returns a possible result even in the absence of real infection.

What happens when FDA is pressured by an “expert” to target specialty labs that, for example, specialize in Lyme and other tickborne diseases, or, more egregiously, to target a specific specialty lab?

Who are these “experts” targeting Igenex? The letter doesn’t name names, but offers up only the standard bit of paranoia.  This letter—indeed, this entire pleading—is about Igenex. Probably it was written in part and proofed by the owner of Igenex, who also is one of the signers of this letter.

Unfortunately, inappropriate biases also are apparent in numerous published articles regarding Lyme test sensitivity.

Again, no refs about what these “inappropriate biases” are or where these “numerous published articles” might be found. I guess we’re supposed to take them at their word.

FDA should not insert itself into the practice of medicine.

This will come as news to the FDA whose business is largely the practice of medicine through the testing, developing, regulating, and approving drugs, other biologicals, vaccines, and medical devises. I guess the Lymees would like to abolish the FDA and return to the world of poisonous foods and snake oil medicine?

Finally, there’s this:
Many physicians and patients do not understand that certain Lyme testing protocols were developed for surveillance and not diagnosis.

This is one of their favorite chants: the alleged disconnect between diagnosis and surveillance. This was thoroughly reviewed here, and I’ll just point out that from the activists’ perspective, there should be no case definition of Lyme disease; whatever any clinician decides is Lyme disease is Lyme disease, and must be reported as such, making Lyme disease the only infectious disease that can be detected but not described.

In summary, this is a letter full of nonsense and time-worn claims that simply are not true. It’s lying, which in Washington, and within the federal comment period, is called “lobbying”. And who are the signatories to this pile of aged manure? Individuals with Lyme-related businesses (e.g., Sandra K. Berenbaum), lone nuts (Carl Tuttle), nefarious Lyme quacks (Ginger Savely), a couple of online posters from LymeNet Europe (Alex Weston and Charlotte Bridge), local Lyme groups in places where there is no endemic LD (Arizona Lyme Disease Association), and at the center of this effort to keep Lyme testing unregulated, Nick Harris of Igenex, the Lyme specialty lab in California.

Like the 200 or so gun manufacturers in the US who trade in mass murder while hiding behind the lobbying cloak of the NRA, Lyme groups long ago abandoned public health and public education to become the facades behind which Lyme quacks and other Lyme-related business hide while trolling for patients and customers, and supporting efforts to weaken state licensing boards and federal regulations. In effect, groups like the LDA and LymeDisease.Org have become the bag men for medical predators.

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ChronicLyme19
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by ChronicLyme19 » Tue 24 Feb 2015 15:23

I wonder if the FDA could do a compromise with a type of grace period. Where the FDA gets what it wants by making all Lyme tests, even the old two-tiered type, go through more rigorous testing, but in the meantime while it takes a few years to get to that point allow the current tests on the market to still be used. That way you don't go through a period where you have no tests available at all, but then in the long run the tests that are passed will be more reliable.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

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LHCTom
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by LHCTom » Sun 1 Mar 2015 2:07

Lets put this absurdity in context:

The CDC recogniizes 14 tick borne diseases.

http://www.cdc.gov/ticks/diseases/

13 of them have NO FDA approved tests. Most have no test available outside a research lab. Some are far more serious.

There can be only one reason these idiots are focusing on Lyme with a standard on applied to even more serious TBDs.

Politics and bureaucracy and that stupid intentionally dishonest Barbara Johnson political lame paper on the culture

http://jcm.asm.org/content/early/2013/0 ... 3.abstract


To achive FDA approval is expensive and one has the inside track.

So far the FDA has approved a vary rigid B31 based two tiered test where manufactureres are not allowed to try and improve them but copy the FDA rules or invent a very different strategy and pay lots of money and test them against the original test causes selection bias on the test cohorts.

There are better tests than the FDA approved tests like http://cvi.asm.org/content/15/6/981.full

and so far they have only approved the 2 tiered and C6 and Pep10

Even though the C6 is as good as the 2 tiered test and probably better due to a .7% specificty caused by the CDC's failure to check if the test cohort maybe had another Borrelia species. That was not checked and now we know that Borrelia miyamotoi, B. lonestari, B. theileri, B. burgdorferi ss, B. americana, B. andersoni, B. bissettii, B. californiensis, B. carolinensis, B. kurtenbachii, and B. garinii have been found in the US and cause uhuman illness. If you look at the CDC on which they based the C6 versus 2 tiered decision, none of the cohort was checked bor these other species which certainly biased the specifity. Dum or maybe stupid.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4052829/

Table 3
Reactivity with sera from patients with other diseases or that may contain interfering antibodies or substances.
Disease condition n No. of positive sera
C6 ELISA Positive or
indeterminate
Two-tier (WCS ELISA)c
positive
Two-Tier (C6 ELISA)d
positive
WCS ELISA Positive or
indeterminate
Helicobacter pylori 20 0 1 0 3
Mycoplasma pneumoniae 38 0 0 0 6
Cytomegalovirus 20 0 0 0 4
Epstein–Barr virus 20 0 0 0 3
Human immunodeficiency virus 20 0 0 0 2
Hepatitis A 25 0 0 0 1
Hepatitis B 23 0 0 0 4
Hepatitis C 15 0 0 0 5
Influenza vaccinated 25 0 0 0 0
Antinuclear antibody + 20 0 0 0 1
Rapid plasma reagin +a 20 1 1 1 3
Lipemic 20 0 0 0 4
Icteric 20 0 0 0 0
Hemolyzeda 20 1 1 1 1
Systemic lupus erythematosus 20 0 0 0 0
Rheumatoid arthritis 20 0 0 0 1
Rheumatoid factor + 20 0 0 0 1
Total 366 2 3 2 39
Overall no. [%] of negativeb
(95% CI)
364 [99.5%] (98.0–99.9%) 363 [99.2%] (97.6–99.8%) 364 [99.5%] (98.0–99.9%) 327 [89.3%] (85.7–92.3%)

Where is the non Bb testing..... nowhere!

So I say when 50% of the other 13 TBD's have FDA approved tests, it might be reasonable to visit this issue. But until then, the politics are obvious.
The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

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