Biologic, Pathologic, Physiologic, Lack-of-Logic: The Triumph of Science Over Common Sense in Wound Treatments Protection Status
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By Michael Miller DO, FACOS, FAPWCA


I willingly confess that I enjoy being a maverick. Of course, at age 52 with two cats, a wonderful wife of 27 years, and two daughters (this order in no way implies favoritism), that term seems to be a bit of a stretch. As a wound care clinician and scientist, I am always on the lookout to find that new innovative dressing, technique, or technology that will help my patients just a little bit more than the next guy. I believe the trade term for my type of psychosis is called “Early Adopter.” I prefer to think of myself in terms of the little kid we all knew who had to have the newest toy first.

The benefit is that my patients have the opportunity to receive the “hot new thing,” that is, as long as the science behind it seems to make sense, that it seems to be based on basic tenets of biology, pathology, and physiology, and that it is something that, based on my knowledge and experience, I feel comfortable with. Of course, not having to pay to play helps a little. To that end, my goal is to provide access to the best wound treatment there is, to those who need it, at a cost they can afford.

It has already been well-established that the vast majority of wound care practices have little to no good, solid scientific evidence, save perhaps for years and years of large-volume, anecdotal evidence. Yet, because of the obvious universally acknowledged benefits, we cling to them like Indianapolis Colts fans to their Peyton Manning jerseys.

Despite a plethora of case support, reasonable scientific support (or in the alternative, not too much condemnation), and a history of success in some well-acknowledged venue, some of these marvelous wound healing/condition-improving offerings are dragged, kicking and screaming, into oblivion, leaving a trail of improved, healing wound care patients in their wake. The question is, is hard science the only criteria acceptable for introduction, perpetuation, and utilization of technology, or was Disney’s Jiminy Cricket just a bug on drugs?

Case in point:

In the early 2000s, I learned about a drug called Cilostazol, originated in Asia. I looked at the basic science, and learned from some very smart guys the effects it possessed, mainly to make arteries bigger to improve blood flow. In the Far East, it was used to promote improved circulation for Reynaud’s, Berger’s, neuropathy, and even “Cold Extremities.”

In the US, it underwent extensive scrutiny due to its molecular configuration and the available, albeit limited, “hard science data.” Despite a strong safety profile of use, the only indication it received was for Intermittent Claudication (leg pain due to poor circulation as a result of ambulation). The black box warning it carried, regarding use in those with advanced congestive heart failure (CHF) due to potential exacerbation, was based on a perceived relationship to a prior drug that had been removed due to that untoward effect. While it was never shown to have this effect, the warning remained. Despite the strong, obvious potential benefits, its use was perceived as limited.

In my practice, however, the potential was immediately identified. Having seen far too many patients with severe peripheral artery disease (PAD) untreatable by surgery or “plasty” and more, with debilitating microvascular disease, it became (and remains) a standard therapy, especially in diabetics. Of course, there are those who have the good fortune to be afflicted with both CHF and limb threatening vascular conditions, with the highest likelihood of partial or complete limb loss. Despite that black box warning, I always found that the decision regarding use was the penultimate in pragmatic, and I relate it to my patients in that way: “You can take a pill that will help your circulation but might make your CHF worse, or you can risk the amputation surgery and die like a dog!” Would you find it hard to believe that every patient offered this choice seemed to choose the drug despite that black box warning?

For those of you who entered the practice of wound care after Jan 21, 2009, you missed meeting my good friend Panafil. While its color tended to be off-putting (for the last time, the word is gangrene not gang-GREEN!), it was an elegantly simple wound treatment with a long history of use and safety. In their zeal to protect the public, the powers that be quashed this papaya derivative (you never know how catastrophic a tropical fruit can really be until you eat one). The rationale for doing so was based on the following: this ointment was composed of Papain (criminal history noted above), Urea (a major component of sweat and pee…enough said regarding it’s toxic potential), and (are you sitting down?) Chlorophyllin Copper, a component of all green leafy vegetables, used as a deodorizing agent in many products. While each ingredient individually never reached the point of being on the TSA forbidden list, the risk of combining these three must have been too much for governmental oversight and so, a mandate for testing the safety of this witch’s brew was issued. Despite years of use with a safety record that NASA would be proud of, the inability of the manufacturer to meet mandated testing requirements resulted in its untimely demise.

As a further governmental affront to Mother Nature, the Biotherapeutic Contingent has had their larval foot soldiers continuously slighted. Despite considerable temporal and geographic support of their efficacy as potent debriding machines, the prowess of the lowly maggot continues to receive no financial homage, save for the CPT code 97602 (non-specific debridement) which my investigation showed never has achieved a definitive payment level. Moreover, no HCPCS code has been identified to give users a hand in getting the maggot products themselves reimbursed. The fruitless, textual ping-pong played between those who control the codes and those who pay for them would make even a maggot’s stomach turn.

And so, yet another wound therapy with what I perceive as having a low-risk profile and high benefit outcome is available, but only if you pay for it yourself. It seems as though the powers that be can acknowledge efficacy, they just can’t figure out if that warrants payment to improve accessibility to the masses that need it.

To close this month’s edition of Ramblings of an Itinerant Wound Care Guy, I ask the question of who should make these decisions. The current designees have a track record of missteps in both allowing problematic drugs and devices onto the market (despite extensive safety testing), while handicapping highly beneficial others. This suggests that the current decision trees may have Root Rot. I am not advocating a haphazard, random, devil-may-care attitude about the evaluation and introduction of innovative products for healthcare. Rather, I propose the opportunity in which objective findings, expert input, and subjective considerations combine to provide a balanced view of efficacy and risk. Then, and only then can we clinicians recognizing that each patient and their wounds are unique, and the effects of any given medicine need not follow the statistical predications, regardless of the standard error, and provide those under our care that which they truly desire and deserve.

As wound care specialists, we must strive to expose ourselves to the newest theories, products, and technologies with the understanding that some of them will not make the cut, while others may initially fall short but rise to succeed in later stages. If you believe that the enemy of “good” is “better,” then you are doomed to mediocrity and so is your care. Our decisions regarding how best to advance our knowledge and help our patients comes from the mandate they have given us and no one else. As Mark Twain said, “If the opposite of ‘Pro’ is ‘Con,’ then the opposite of ‘Progress’ is…”

Until next time…

About The Author
Michael Miller DO, FACOS, FAPWCA is the Founder and Medical Director of The Wound Healing Centers of Indiana and IndyLymphedema, as well as a clinical consultant, teacher, inventor, and published author.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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