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Medicine’s Future: Will the FDA Let It Happen?


The most exciting and innovative advancement in medicine today is the field of medical testing. So why is the FDA strangling it? Action Alert!

Natural medicine is said to stand on three legs: a natural diet, nutritional supplements, and integrative treatments. But an essential fourth leg is medical testing. It’s of crucial importance to natural health.

If the FDA takes over testing and only approves the tests that the big testing labs can do (and that the insurance companies or Medicare will pay for), there is no future for integrative medicine and little future for medicine as a whole.

We have been closely monitoring the FDA’s attempts to throttle innovators in the medical testing field for some time. The latest news is that the FDA has issued a report detailing twenty case studies of supposedly inaccurate or misleading tests.

Some of the case studies in the FDA’s report include tests for Lyme disease, autism, fibromyalgia, heavy metal chelation, and chronic fatigue syndrome.

If you see a pattern here, so do we. The tests for the diseases mentioned above are often utilized by integrative physicians to identify and treat diseases which respond well to natural medicine treatments. When left in the hands of conventional medicine, these chronic illnesses require years of expensive treatment, which means that banning these tests would suit insurance companies very well. If the FDA is successful in eliminating these tests from the market, then diagnosing will be more difficult and there will be no mandate for insurance companies to cover these debilitating illnesses.

The medical establishment has long dismissed chronic Lyme disease, fibromyalgia, chronic fatigue syndrome, and many other ailments as examples of hypochondria. This is largely due to the fact that these illnesses cannot be treated by today’s drugs or surgery, which is all that conventional medicine has to offer. It is easier to blame the patient than the doctor.

Experts tell us that some of the tests covered in the FDA report are, indeed, bad tests that exaggerate their ability to give an accurate diagnosis. But this does not change the fact that what the FDA is doing is not legal—it lacks the authority to regulate laboratory-developed tests (LDTs). This responsibility belongs to the Centers for Medicare and Medicaid Services (CMS).

The agency’s lack of regulatory authority was pointed out to the FDA officials during a 2014 congressional hearing. Legislators also pointed out that the FDA was once again trying to skirt the official rulemaking process by proposing to change the regulatory scheme for LDTs through issuing guidance documents—which are not considered law but are treated by industry as the equivalent. (For more on this, check out our previous coverage of the issue). If the FDA has concerns over some inaccurate LDTs, it should notify CMS.

While some tests may have problems, that is to be expected in such a burgeoning new field. Many more LDTs are important, helpful, and extremely accurate, and need to be protected from assault by special interests working through an all-powerful federal agency. The FDA’s game here seems to be to use a few bad apples to rework the entire regulatory framework for LDTs in order to throttle innovation and protect larger, more established testing companies, insurance companies, and drug companies from competition.

We must also keep in mind that some people are seriously deficient in one particular nutrient; others are not. This is one of many reasons why food and supplement studies that try to assess the effect of nutrition on disease are often flawed. The only way to identify deficiencies is by testing. But the FDA is working to shut down progress and innovation in these tests, as we’ve seen recently with the assault on the groundbreaking work of Theranos. This is on top of Medicare’s refusal to pay for such testing.

If we care about the future of medicine, we need to stop this. There are already new tests to spot cancers long before they manifest themselves otherwise. But these tests are very expensive and neither Medicare nor insurance companies will pay for them. If they become more widely available, the price will fall. Testing can also help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases. Some doctors have gone along with the idea that prostate testing should be abandoned because it has limitations—even though better and better prostate tests are being developed all the time. The answer is not to abandon the effort!

Action Alert! Write to the FDA and tell them to stop violating the law and stop harassing innovators in the LDT field. Please send your message immediately.



Other articles in this week’s Pulse of Natural Health:

Bananas as We Know Them May Be Disappearing

Why is a Cancer-Causing Additive Banned Elsewhere in the World Still in Our Bread?

  • abinico

    A good integrative healer that is skilled in TCM (Traditional Chinese Medicine) does not need fancy labs for anything. In fact getting involved with ‘lab testing’ will over time diminish a health practitioner’s connection with natural feelings.

    • Peter R Mare

      Terry & I have been going to an O.M.D for the last 13 years as our primary health care provider. She has successfully treated us for Gout, concussion, torn miniscus, and Terry’s 24/7 pain. Traditional Chinese Medicine is the true healing medicine.

      • abinico

        Years ago I had really bad seasonal allergies – a naturopath I was seeing recommended I get acupuncture – I did and my allergies were cured on the first visit – quite incredible.

  • riverstrat .

    If this has anything to do with testing for human cures at the expense of animals, I’m not going to support it. If anyone knows, please advise…..

    • Kimberly Benedict Kuist

      This has to do with medical testing of human blood, saliva, urine, etc. for pathogens, deficiencies & toxins so that practitioners can pinpoint where the patients course of treatment needs to begin. This is not animal testing for research purposes.

      • riverstrat .

        Thank you…

  • Jon

    Time to terminate the empire, of which the FDA is a subsidiary entity.

    • Peter R Mare

      This is the reason Bernie must be the nominee.

      • No, this is the reason all the candidates must be put into a military brig where the rest of their revolving door crook friends will be.

  • clarify

    My naturopath uses a Zyto machine to run diagnostics on me. So much cheaper and faster than all the lab work traditional doctors use. It’s often also more thorough.

  • Like I said before and I will continue to say again: The U.S. runs a cancer monopoly and if you’re in the business of selling people fake cures for perpetrated sicknesses, you have to have sick people. If you want this to stop, stop paying taxes! You subsidize it! The corrupt system will never convict itself and it will never cease its atrocity until it has no choice but to.

  • Karen G Lyke

    I expect the tests in question are the straightforward assessments of nutrients & metabolites in urine, possibly blood as well. The amounts and proportions of them give a pretty reliable indication of which metabolic pathways are working effectively, which aren’t, and where (most of) the obstacles are. From there practical steps to take, which particular nutrients to add, other dietary & possible lifestyle adjustments, maybe facets of detox or digestion to give extra reinforcement to, are more evident. It’s far more scientific than the present allopathic practice of selecting a few signs & symptoms to determine a diagnosis then dispense a drug (then disappear). Metabolic testing works already; for any real healing to become widely practiced in the US*, it should be encouraged and used as routinely as the current (and quite abbreviated) blood tests. Unfortunately to do that exposes the inadequacies in our entire foodstuff production system in its current state, and that’s too much of a threat.

  • abinico

    Why? I have no issues needing attention. And I did go to a TCM doctor – the real deal – the guy didn’t even speak English – I talked to him with his nurse translating. TCM is great – everyone should see a TCM doctor just for a ‘balancing’ session.