Combined T4/T3 Therapy: Placebo or Tomato?

In 1984, JAMA published an article entitled “The Tomato Effect. Rejection of highly efficacious therapies.”¹⁷ This article describes how highly effective therapies are abandoned due to paradigm shifts in the way physicians think about health and disease. One example discussed in the article was how cochicine, a highly efficacious therapy for gout, ceased to be used because it no longer fit into the belief system of medieval medicine (instead the physicians of the day chose to use leeches, purges, and cathartics). Colchicine was “lost” until rediscovered, 500 years after it had fallen out of favor.

What makes “tomatoes” more damaging than “placebos” is that they are more difficult to detect. If a placebo therapy is thought to “work”, it will be tried again and again. With repetitive use, we can quickly see that this therapy really doesn’t work well at all, and is eventually abandoned (George Washington died when his physicians used multiple courses of blood letting in their attempts to treat his Strep Throat. Thankfully, we do not routinely use leeches or blood letting anymore.) But what do we do with tomatoes? Therapies that are thought “not to work” are simply not tried again (at least not for a long time). It can take many years (or centuries) before someone considers that the paradigm that caused the rejection of this therapy was indeed false, and that the therapy does indeed work.

COULD COMBINATION T4/T3 THERAPY BE A TOMATO?

One reason to suspect that combination T4/T3 therapy is indeed a “tomato” is based the concept I laid out above, namely that tailoring thyroid hormone therapy to normalize laboratory tests such as the TSH may not be the best approach to normalizing patient symptoms. Treating the wrong thing (the TSH versus the actual patient) can mislead the most well-intentioned of investigators. What if T4 is better at normalizing the TSH, but combination T4/T3 therapy is better at normalizing symptoms? What if the process of keeping the TSH “within normal limits” makes combination T4/T3 therapy less effective? It will be difficult to answer these as long as physicians hold onto the paradigm that the TSH test is infallible.

Another source of error could be the use of global statistical analysis in these and other studies. The prevalence of overt hypothyroidism is 0.5% of the United States equaling 15 million persons.¹⁸ In addition there are many more persons with subclinical hypothyroidism who remain undiagnosed (9.5% or 28.5 million persons).¹⁹ Though the studies by Walsh and Sawka attempted to power their studies to detect subtle changes between groups, a sample size of 101 patients (Walsh) or 33 patients (Sawka) may not have been large enough to generalize to all subgroups of thyroid patients. The human genome project has started to produce research showing that unique genetic pleomorphisms make one person more susceptible to a disease than another. Likewise, these variations in the genetic code make one patient more likely to respond to one therapy than another therapy. Attempting to generalize a population of 40 million persons to less than a hundred test subjects causes individual differences to be obscured in the statistical analysis.

A more concerting explanation of how the tomato effect could gain influence in the treatment of hypothyroidism with thyroid hormone replacement therapy is based upon an editorial published in the journal Lancet.²⁰ Pharmaceutical companies influence medical decisions in a way that encourages the use of newer patentable therapies at the expense of older (but perhaps equally effective and less expensive) therapies. “It begins on the first day of medical school and lasts through to retirement … It starts slowly and insidiously, like an addiction, and can end up influencing the very nature of medical decision-making and practice … Attempts to influence the judgment of doctors by commercial interests serving the medical industrial complex are nothing if not thorough.”

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