The Alliance For Natural Health

The FDA Attacks Laboratory-Developed Testing


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.

Some people are seriously deficient in a particular nutrient; others are not. This is one of many reasons why many 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.

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.

FDA protecting Big Medicine monopolies

The FDA has been attempting to throttle innovators in the medical testing field for some time. The agency is doing this to protect the monopoly of testing giants Quest Diagnostics and LabCorp, and of course hospitals. We suspect that the pretext for all of this is to protect hospitals, which have invested heavily in medical testing and derive much revenue from it. Hospitals partner with the government in myriad ways and get all sorts of monopoly benefits from it. For example, a doctor employed by a hospital, even if outside the hospital, will often receive a much higher fee from Medicare for a particular medical procedure or service.

One attack from the FDA came in the form of a report of twenty case studies of tests that are supposedly prone to “false positive results and misdiagnoses.” The report focuses solely on diseases that respond well to natural medicine—diseases which the medical establishment has a long history of dismissing like Lyme disease, autism, fibromyalgia, heavy metal chelation, and chronic fatigue syndrome. If the FDA starts allowing some LDTs and rejecting others, especially with input from its special interest cronies, testing will be defined and standardized for all the diseases they don’t want to pay for.

LDTs are under the jurisdiction of the Centers for Medicare and Medicaid Services (CMS), yet the FDA is looking to expand its regulatory power over the field by regulating tests as medical devices—a move that members of Congress have vehemently denounced.

The future of individualized medicine

If LDTs were easily and inexpensively available to consumers, chronic diseases could be caught early and monitored like they never could before. With the speed and convenience of this testing, more individuals would be empowered to take control of their health.

For instance, a person might read an article about the importance of vitamin D in the morning and, on the spur of the moment, pop in to a nearby drug store the same afternoon to get an inexpensive vitamin D 25-OH test, thus providing a near-immediate answer to the question of their own vitamin D level. Or, rather than a hypothyroid patient going to an endocrinologist every few months to measure hormone levels, a patient can simply stop into a drug store or neighborhood testing clinic and get the routine blood work they need to manage their condition.

LDTs are not only the future of general medicine—they are the future of individualized medicine as well. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses—information cannot be gathered and analyzed otherwise.

If the FDA us successful in its takeover of LDTs, all of this medical advancement and innovation is put at serious risk.