You guessed it. Many tests essential to patients’ health would no longer be available. And the future of medicine seems to lie more and more in innovative, sophisticated, and custom testing—just what the FDA won’t like. Action Alert! 
Laboratory-developed tests (LDTs) are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, and companion diagnostics. LDTs are vital tools for personalized medicine because labs can even create custom diagnostic tests.
LDTs are different from other diagnostic tests in that LDTs don’t require any sort of standardized premarket controls, whereas other diagnostic tests need to demonstrate safety and effectiveness to the FDA using analytical studies; some must be taken through the full FDA approval process.
The FDA has wrestled with the question of how to regulate LDTs for many years. The agency developed a draft guidance on how they plan to increase regulation of LDTs, but it has been stalled in the Office of Management and Budget (OMB) since 2010. Currently, the FDA employs enforcement discretion to regulate LDTs because they are considered low-risk.
Now a group of senators, Ed Markey (D-MA), Elizabeth Warren (D-MA), Richard Blumenthal (D-CT), Sherrod Brown (D-OH), and natural health’s old nemesis, Dick Durbin (D-IL), wrote to OMB asking that the LDT draft guidance be released.
The senators’ letter specifically cites Lyme disease as an example of “false positive results and misdiagnosis” and asserts that the “diagnosis of Lyme disease should instead be left to tests approved by the FDA.” It also implies that LDTs should undergo premarket review.
What is at the bottom of this push for regulation? And why are the senators so concerned about Lyme disease?
Special interests (and, given our crony capitalist approach to everything, the government) want regulation because there are LDTs they don’t want to pay for, or they fear the diagnosis will lead to treatment expense! Lyme disease is a prime example, as we’ve noted in the past.
Many mainstream doctors follow a standard two-tier diagnostic protocol, requiring positive ELISA and Western Blot tests. The problem is that this protocol fails to detect up to 90% of Lyme disease cases, and cannot distinguish between acute, chronic, or resolved Lyme infections! Alternative and integrative medicine has many other diagnostic tests for Lyme, including looking at live cultures, but these are expensive, and many insurance carriers already won’t pay for alternative tests.
Looking at live cultures is especially important, because it tells you whether a Lyme treatment is working. In the case of Lyme, you need to see the pathogen in both its active and dormant state, because it often turns dormant to escape eradication. In the past, at least one live culture test we know was rejected for the usual reason of “too many false positives.” But this made no sense. The test was being used to monitor how the treatment was going; the patient’s infection was already established. In this case, a few false positives do no harm. By banning the test, the patient is left with nothing at all to show how much of the infection is actually present.
If the FDA starts allowing some LDTs and rejecting others, which do you think the FDA will approve, especially with input from its special interest cronies? The cheap but woefully ineffective ones, or the more expensive tests which are the best that science can develop? Special interests would love to standardize and define testing for all the diseases they don’t want to pay for. And they have friends in the Senate to do the dirty work for them.
The American Clinical Laboratory Association (ACLA) points out that regulation of LDTs would increase costs tremendously, making the development of new LDTs too expensive. Certain diseases and conditions for which the only testing available is an LDT may no longer be available. In their Citizen Petition, ACLA notes that many LDTs are threatened (see section IV for an extensive list of important tests that are currently available only as LDTs).
The future of medicine lies in testing, and it protects individuals from a one-size-fits-all approach to healthcare. But special interests and the government can strike it dead by inappropriately standardizing and restricting the testing for diseases. Shouldn’t healthcare decisions be made by innovative medical professionals and their patients, not by insurance companies and the federal government?
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If I tried to respond to everything of interest on the ANH-USA, I would have calluses on all of my fingertips.
I can no longer keep up with my own government, which, to me, is very sad.
Very bad idea. They will try to interfere with our best labs which can detect Lyme disease, when their’s cannot.
Repeat previous comment concerning morally bankrupt lackeys serving the evil!
For The Love of God!
Now a group of senators, Ed Markey (D-MA), Elizabeth Warren (D-MA), Richard Blumenthal (D-CN), Sherrod Brown (D-OH), and natural health’s old nemesis, Dick Durbin (D-IL), wrote to OMB asking that the LDT draft guidance be released.
These senators need to get back in their lane! Instead of posing as if they have any sense or knowledge about this. Lyme disease, and more importantly the people plagued with this illness, and false negatives from standardized testing, do not need these fools dragging the country backwards into the the dark ages. The idiocy of these people is beyond comprehension…..It is infuriating that they would attempt to do this. I could just scream.
I would Greatly appreciate the testing left up to dr’s to decide& not an entity not involved in my personal care.
Standardization is terrible because it treats every person the same, and we are all unique and therefore have unique needs. Not surprised to see Sen Markey’s name on this idiotic idea but I am surprised to see Sen Blumenthal (from my home state).
Each patient is their own medical history…putting us all into 1 category
seriously puts our health in jeopardy! Stop this!!
At least a day late in replying, but every American needs to understand that many, many tests have been set up and initially based on sick people’s blood!! This is nearly an emergency situation.
You can be low in iron (critical nutrient) yet the established window of acceptable iron levels is so wide open, it can go on like that for years, sapping energy and proper body functions.
This is already screwing up results for more subtle systems, particularly the endocrine system that is basically under attack from chemicals, pesticide residues and heavy metal toxins in our food system.
This one-size fits all medicine should not just be stopped, instead each test needs to be critically improved, so many ailments can be caught early, and not turn into that dreaded (and vary costly) slow, downward health spiral. This is already a potential trap for the patient, and a large bucket of worms standard medical practice has stepped into.
I like this petition except for a few key points. The CDC hasn’t proven that the culture test is giving false positives. The CDC based their concern on the fact that the PCR sequences from a published paper on the culture were highly similar to a laboratory strain that is not believed to be common in the U.S. The CDC completely disregarded the fact that the negative controls were all negative. They also disregarded the fact that the similar sequences were from a highly conserved region of the Borrelia genome while another set of PCR sequences from a less conserved region demonstrated the expected variation. To me, the CDC paper points to concerns that one set of the PCRs might be contaminated, not the culture. I am waiting for the Advanced Laboratories BLAST analysis and response.
The independent laboratories are governed by CLIA, which requires that labs offering proprietary tests to meet standards of accuracy, specificity, and sensitivity. My understanding is that these labs have conducted validation studies of their tests, but many have not conducted independent validation studies. Advanced Laboratories has two independent laboratories conducting validation studies of the culture, but these results haven’t been published yet.
The fact that the CDC has used this as part of their campaign to only endorse the two tier-testing through FDA approved test kits is highly suspect. I suspect that the attack on the alternative tests is nothing less than an attack anything that might confirm just how widespread chronic Lyme disease has become. Why are positive PCRs considered diagnostic for every other disease except Lyme disease? Please see Dr. Linden Hu’s discussion on the importance of PCR or DNA evidence at the end of the NIH/CDC webinar on Persistence. Dr. Hu makes a very strong case that DNA evidence supports persistent infection, based on how quickly it has been shown through numerous peer-reviewed studies, that the body quickly clears out any foreign DNA. Yet the CDC on its website actually tells physicians not to test their patients for Lyme disease using PCR technology.
Transcript:
http://www.cdc.gov/lyme/pdfs/PersistenceTranscript.pdf
Slides:
http://www.cdc.gov/lyme/pdfs/PersistenceWebinarSlides.pdf
The point that I am trying to make is that when you make statements like there have been cultures that have been rejected for “too many false positives,” but that “false positives do no harm”, you actually give strength to the very people that want all Lyme testing to be regulated by the FDA. I hope that you reconsider some of the statements that you are making before spreading the word about this petition.
I am writing this because I share many of your concerns and I would like this petition to be an effective vehicle, but I won’t sign it or share it in its present state.
One of the biggest areas of abuse for LDTs that is rarely mentioned is the commercial drug testing industry. Started by Dr. Gregory Skipper, an ex-felon who had his license revoked in Oregon and got it back by claiming spiritual recovery in 12-step spirituality introduced the EtG in 2004 with absolutely no evidence base. He pitched it to NMS lab as an LDT then convinced medical boards it was a valid sensitive and specific forensic test that could detect covert alcohol use. Introduced into the state physician health programs under the ASAM/FSPHP front group the labs were then able to claim anything they wanted. So he introduced it to the lab and then had the state PHPs contract with the lab for testing of physicians. It was then marketed to other regulatory boards, EAPs, and monitoring services. Over the next two years after hundred if not thousands of reports of positives in people who claimed they weren’t drinking reached the tipping point and lost their license, careers, children, freedom, and citizenship (God knows how many committed suicide!) and Wall Street Journal article exposed that alcohol is ubiquitous and the specificity unknown most groups abandoned it. Except those were the power differential lies fully in the hands of the tester and the tested is powerless. Any rational person would have abandoned it. Skipper just kept raising the cutoff level 100 top 250 to 500 to 1000. We now know that hand sanitizer alone can cause a level of 2000. No worries, just make a list of everything that could cause a positive test and hold the person responsible for avoiding it. He has since introduced EtS, PEth, Soberlink, proselytized SCRAM. This is all crap junk science. Then their is Dupont and the hair testing. Psychemedics. Forensic testing needs to prohibit the LDT pathway for tests used in this manner. And everyone needs to start speaking about it as we all could be affected. Just take a look at Robert Dupont’s speech before the DATIA in 2012 and you’ll see what they have planned.