Why Scientific Validation Matters

Part 1

Imagine you or a loved one taken ill with a bacterial infection. You seek medical advice and are confronted with numerous treatment choices that purport to cure the disease. Unfortunately, none are supported with third party empirical scientific validation. One treatment points to customer testimonials swearing that the stuff "WORKS GREAT!" Another advertises ancient shaman rituals and a secret recipe for herbal medicine passed down from generation to generation as its claim to fame.

So you invest your money and your trust trying one concoction and then another but the illness remains virulent and unfazed. Until the past century, the depressing scenario we've just painted was precisely the way medicine was dispensed throughout most of the world, including here in the United States. Fortunately, thanks to the combination of modern drugs (e.g. antibiotic chemotherapy) and the protocol of peer-reviewed published medical research, today one can be reasonably certain that if a drug is advertised to successfully treat or cure a disease it will likely do so.

In the hypothetical example we used to begin this article we were confronted with a bacterial disease and faced with a number of treatment choices, none though supported with proven third party evidence. Lots of glowing promises. No proven facts. Perhaps not surprisingly, and to the detriment of those who use them, unproven lotions and potions usually don't work. Maybe this is why they remain "unproven".

But that is not the way drug-based medicine is dispensed today. Over the course of the past century, all pharmaceutical drugs have been required to undergo a clearly defined path from laboratory bench, through various testing protocols, to the physician's prescription pad and ultimately the druggist's counter. This is fine for the pharmaceutical side of the equation.

Unfortunately though, today there are myriad natural health-related products that are clearly advertised as alternatives to the drug based options. Often, these naturally-derived compositions purport to work as well as the pharmaceuticals, but without the glaring risk of negative side effect. A quick side-track into recent history is now in order. In 1994 a law was enacted in the USA opening the door for vitamins and supplements to advertise health benefits. The idea behind this Dietary Supplement Health and Education Act (DSHEA) was to introduce safer naturally-based substances into the commercial arena with the idea of promoting health, but not necessarily replacing drug-based medicine. Another key impetus behind DSHEA was to spur basic science research to discover objectively measurable clinical benefits found in natural materials.

And to some extent, this is precisely what happened. A much greater emphasis for exploring botanically-derived and naturally educed materials has occurred in the past two decades. Exciting discoveries are made in this arena almost on a daily basis. Moreover, the potential for safer treatments, free from common negative side effects (such as found in drug-based compounds) has been a hallmark of the natural medicine armamentarium.

These are all very good things. So where's the harm?

The FDA is charged with overseeing the proper deployment of all substances ingested or applied to the body which may affect human health. For the most part, underfunded and understaffed as it is, the FDA does a remarkably efficient job. This organization is also peopled largely by caring and conscientious individuals whose overarching desire is to protect the health and well being of American consumers.

But because the agency must devote its limited resources as effectively as possible, the priority has rightly been to first target those products and entities that are clearly and obviously harmful. This means that particularly in the context of DSHEA the FDA may choose to overlook products and the purveyors of products which are probably useless for the indication advertised — as long as they don't actually cause physical harm. This FDA hall pass has been a multi-billion dollar boon to natural product companies that care only for making a fast buck. Because such companies can advertise all sorts of extravagant health giving promises with almost complete impunity.

Most consumers are not scientifically sophisticated enough to discern the difference between a cleverly scripted fallacy and the truth. And since the FDA lacks the resources to police every single product in every single health related category, the door is open for those who have no shame in promoting health products based almost entirely on unsupported claims.

For those of us though who are in the health care field to actually help people and provide objectively demonstrable benefit, we can only shake our heads sadly and sigh. Because we realize that we end up investing a great deal of time, money and effort to test our products using the same analytical methodologies required by the drug companies.

Yet, for all of our effort, we sometimes end up in worse fiscal shape than those who forgo the hard, expensive and time consuming process of validation, but instead use their fiscal resources to market market market. So, jumping into the realm of scientific fact, how is any compound, either naturally or pharmaceutically derived, actually proven to work? We'll explore this question next in Part 2 of WHY SCIENTIFIC VALIDATION MATTERS