A quick Google search for the phrase "outcomes-based medicine" yields results in the tens of thousands. When you look at a lot of these results, however, the focus is on scientific method and not, ironically, on outcomes—which is the point of medicine, isn't it? If you think about it, does it really matter to the patient who is seeing no benefit from a given drug or treatment that 72 percent of patients in a clinical trial did see a benefit over the comparator? If the desired outcome is an improvement in the patient's disease symptoms (or even better, in his disease state), then I'd say no. This patient is seeing no benefit from all of those (possibly) carefully crafted clinical trials.  

 

I'm not advocating that we totally throw caution to the wind. But I don't think we need to necessarily throw the non-Western baby out with the non-FDA-approved bathwater. Many of these other practices have been around for centuries, if not millennia, and have been sufficiently effective in large enough patient populations to have lasted this long. In the past, the pharmaceutical industry has figured out how to make money from tree barks and saps, citrus mold and the delicate complexions of milkmaids. Surely we can figure out how to take advantage of this untapped knowledge—and unlike most natural products research, which has seemed to me to be founded on pure serendipity (not that I have a problem with serendipity), these areas of exploration have some real-world evidence to support them.

 

Given the regular, seemingly cyclical challenges the pharmaceutical industry has in coming up with the next generation of blockbusters based on the last generation of blockbusters, or in redefining blockbuster so that it refers to a drug that only significantly impacts left-handed construction workers with the TBD2 allele, where is the harm in throwing some of these tinctures and tablets into a little acetone and sloshing them across an HPLC? Or in analyzing extracts against animal or in-vitro models of various human diseases?

 

The only thing that's keeping these centuries of anecdotal data from becoming evidence-based medicine is … well, evidence. Rather than disregard all of this information because it wasn't officially sanctioned by bodies like the FDA or wasn't the result of carefully designed clinical trials, maybe the first step in the screening process for potential new drugs should be a simple question of what have the "neighbors" been doing for 400 years to deal with a given condition.  

 

There are no guarantees that any of this research would amount to anything meaningful, let alone lucrative. But then, how much of the work that is going on today comes with guarantees? Can we realistically expect a 100-percent success rate from replacing a hydroxyl with a methyl group on the 3-carbon of a benzyl side chain of an antibiotic that stopped working last year? Or the co-administration of an antiemetic with a new platinum-based oncology drug to deal with a particularly onerous side effect?  

 

I'm not advocating that we cease doing medicinal chemistry or adjusting the clinical practice guidelines. I'm just saying that maybe we should stop looking these potential gift horses in the mouth. To mix my metaphors, they may be a red herring, but herring is a good omega-3 source.  

 

Formerly the executive editor of ddn, Willis has worked at both ends of the pharmaceutical industry, from basic research to marketing, and has written about biomedical science for almost two decades.