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: