Out of Order: Gift horses

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?

Jan 08, 2012
Randall C Willis
Here's Johnny! Okay, actually, it's Randy. Nonetheless, I'mback.
 
A few months ago, the editor and publishers of Drug Discovery News decided to dredge upa chestnut from the past and asked if I would be interested in contributingeditorially in 2012.
 
 
I'm not sure why they asked me back—perhaps it has somethingto do with the Mayan calendar—but I'm happy to share my thoughts with all andsundry.
 
Truth be told, I've missed everyone—the ddn staff, of course, but also ddn'sreaders. I always enjoyed meeting you at conferences and hearing back fromyou when I said something particularly inflammatory. At the risk of seriouslyconcerning Amy and the gang, I look forward to being inflammatory again.
 
A few weeks back, I read an interesting editorial in one ofthe local newspapers. If I understood correctly, it seemed that the OntarioMedical Association (OMA) was asking its members not to discuss non-Westernmedicine with their patients—everything from traditional Chinese medicine (TCM)to naturopathy, homeopathy to chiropractic—whether the member's opinions werepositive or negative. The editorial was a decidedly vehement slam on thispolicy by one of the OMA's members.
 
 
From his perspective, the policy was tantamount topracticing bad medicine, and given his tone, it seemed he felt it might havebordered on Hippocratic heresy. To him, any effort to keep him from squashingany patient's interest in non-Western medical practices was the equivalent ofputting his patients directly in harm's way.
 
In fairness, I should disclaim that I have been a patient ofTCM, naturopathy and chiropractic when I have felt that Western medicine hasfailed to address my ailments, and feel that I have had success with some ofthese practices. Much like the pharmaceutical and medical practices routinelydiscussed in this news magazine, I have found these other practices largely hitand miss.
 
 
That some Ontario medical practitioners questioned the valueof non-Western practices was not surprising. That there was such venom in theresponse, however, did catch me off guard. And it got me wondering about theblack curtain that veils these methods.
 
 
A quick Google search for the phrase "outcomes-based medicine"yields results in the tens of thousands. When you look at a lot of theseresults, however, the focus is on scientific method and not, ironically, onoutcomes—which is the point of medicine, isn't it? If you think about it, doesit really matter to the patient who is seeing no benefit from a given drug ortreatment that 72 percent of patients in a clinical trial did see a benefitover the comparator? If the desired outcome is an improvement in the patient'sdisease symptoms (or even better, in his disease state), then I'd say no. Thispatient is seeing no benefit from all of those (possibly) carefully craftedclinical trials.
 
 
I'm not advocating that we totally throw caution to thewind. But I don't think we need to necessarily throw the non-Western baby outwith the non-FDA-approved bathwater. Many of these other practices have beenaround for centuries, if not millennia, and have been sufficiently effective inlarge enough patient populations to have lasted this long.
In the past, the pharmaceutical industry has figured out howto make money from tree barks and saps, citrus mold and the delicatecomplexions of milkmaids. Surely we can figure out how to take advantage ofthis untapped knowledge—and unlike most natural products research, which hasseemed to me to be founded on pure serendipity (not that I have a problem withserendipity), these areas of exploration have some real-world evidence tosupport them.
 
Given the regular, seemingly cyclical challenges thepharmaceutical industry has in coming up with the next generation ofblockbusters based on the last generation of blockbusters, or in redefiningblockbuster so that it refers to a drug that only significantly impactsleft-handed construction workers with the TBD2 allele, where is the harm inthrowing some of these tinctures and tablets into a little acetone and sloshingthem across an HPLC? Or in analyzing extracts against animal or in-vitro models of various humandiseases?
 
The only thing that's keeping these centuries of anecdotaldata from becoming evidence-based medicine is … well, evidence. Rather thandisregard all of this information because it wasn't officially sanctioned bybodies 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 bea simple question of what have the "neighbors" been doing for 400 years to dealwith a given condition.
 
 
There are no guarantees that any of this research wouldamount to anything meaningful, let alone lucrative. But then, how much of thework that is going on today comes with guarantees? Can we realistically expecta 100-percent success rate from replacing a hydroxyl with a methyl group on the3-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 oncologydrug to deal with a particularly onerous side effect?
 
 
I'm not advocating that we cease doing medicinal chemistryor adjusting the clinical practice guidelines. I'm just saying that maybe weshould stop looking these potential gift horses in the mouth. To mix mymetaphors, they may be a red herring, but herring is a good omega-3 source.
 
 
Formerly the executiveeditor of ddn, Willis has worked at both ends of the pharmaceutical industry,from basic research to marketing, and has written about biomedical science foralmost two decades.
 

Jan 08, 2012
Randall C Willis

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