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Dubious lab tests get reprieve after FDA backs off regulatory plan

The FDA's recent announcement that it would halt efforts to effectively regulate laboratory-developed tests no doubt caused a sigh of relief among practitioners of pseudoscience, for whom such tests offer a gateway to fabricated diagnoses and quack treatments.

Laboratory-developed tests (LDTs) are designed, manufactured, and performed by a single CLIA-certified lab. While the FDA has the authority to regulate LDTs, it has exercised what is known as "enforcement discretion" in the past, meaning there was little oversight from the agency. Under the current regulatory scheme, an LDT, among other things, does not have to demonstrate clinical validity. That is, the test does not have to show that it

"consistently and accurately identifies, measures or predicts: 1) a disease or condition in an individual; or 2) characteristics related to the clinical status of the individual."

Thus, LDTs have become the perfect vehicle for pseudoscientific practitioners, like naturopathic "doctors," chiropractors, and "Lyme literate" and "integrative" physicians, who can test their patients for non-existent conditions and then proceed to "treat" them, sometimes with hundreds of dollars-worth of medically unnecessary dietary supplements. Where the practitioner lacks the legal authority to order lab tests (for example, in states where naturopaths are not licensed), he can simply tell the patient which direct-to-consumer test to order from a lab. Because bogus tests are not covered by insurance, the patient pays out of pocket, sometimes with a markup added by the practitioner.

In 2014, the FDA announced it would issue a draft regulatory framework for LDTs based on patient risk rather than whether a test was made and used by a single laboratory. The agency itself identified well-known quack tests as an area of concern (also here):

  • Incorrect diagnoses of autism – Exposed children to ineffective treatments, and potentially harmful treatments
  • Incorrect diagnoses of Lyme disease – Exposed patients to unnecessary antibiotics
  • Incorrect information about heavy metal toxicity in the body – Patients were exposed to unnecessary, and potentially harmful therapies

Oversight would include pre-market review for higher-risk LDTs, such as those used to guide treatment decisions. The vast majority of LDTs are not based on pseudoscience and there were concerns from legitimate medical groups who thought the added expense of regulation would adversely affect them. For example, a non-profit lab running rarely-used tests for university hospitals and the government was opposed to new regulations. Tellingly, though, opposition also came from dubious practitioners and their supporters, like Lymedisease.org and the Alliance for Natural Health.

The FDA's recent decision to stop work on LDT regulation, according to the FDA Law Blog, was based on current political realities and is not likely to be revived in the near future:

"FDA's announcement is unsurprising in the wake of the unexpected election results. While this announcement is framing the current status of the draft guidances as delayed, given the current political landscape, these draft guidances are dead for all intents and purposes. Republican members of Congress have been among some of the harshest critics of FDA's proposal to expand regulatory oversight of LDTs. FDA did say it would 'continue to work with stakeholders, our new administration, and Congress to get our approach right.' FDA also said, 'We plan to outline our view of an appropriate risk-based approach in the near future.' Nevertheless, with a Republican President committed to less regulation and Republican majorities in both the House and Senate, we believe FDA's efforts to issue far-reaching LDT guidance is moribund for many years."

Fortunately, the bloggers think there are other avenues the FDA can pursue to reign in LDT proliferation.

When the FDA originally announced its intent to more effectively regulate LDTs, it said

"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."

Unnecessary treatment, delay in needed treatment and inappropriate therapies are the bread-and-butter of pseudoscientific practitioners. This is just one more way the recent election benefits science denialism.


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