Reply To: Dr. Randy Wolcott, Southwest Regional Woundcare Center

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    The following interview excerpt was edited for brevity and clarity.

    Richard Longland: So what is the “problem” you are working on here?

    Dr. Wolcott: “…it’s the most desperate thing you’ve ever seen. Because it happened slowly, people really don’t get a full picture of what we are dealing with. But wounds are probably the window into all other biofilm diseases. Wounds are just insidious and they lull you to sleep.

    But here’s what happens: it affects many different people for lots of different reasons. Over 4 million new wounds every year, probably in the neighborhood of 8 to 10 million Americans have a chronic wound at any one time. So that’s the prevalence. It’s a big deal. And the biggest deal on that is about 50,000 people die from those wounds and that’s like Christopher Reeves. So this is a real important thing. In fact, there is an article out by Armstrong that suggests that a patient is more at risk of dying; a diabetic is more risk of dying from a diabetic foot ulcer when he presents to the clinic that if that same person had had a heart attack. So think of ER: people go running around and everybody is so excited and it’s so urgent to fix that heart. Yet, somebody gets a diabetic foot ulcer and people just cover it up for three months or a year and yet that puts that person at as much risk of dying as that heart did.

    What we see in wound care is somebody will get a wound, it will grow a little bit, it will wax and wane a little bit, then they lose a toe, then they lose a foot, then they lose their other leg, and then they lose their life. And I see that pattern over and over and over again. And you know, it’s just not something you can watch too many times and then you say, “Hey, this is a big deal”. You know, so the problem is chronic infections make people suffer, but chronic infections also make people die. And so it’s something that has to be addressed and it has to be addressed with urgency…

    Richard Longland: So maybe there are people in the public wondering, what is the importance of bacterial biofilm infections from a public policy perspective or healthcare policy?

    Dr. Wolcott: When we looked at over 2,000 articles on medical biofilms and said, what does it infect? What kind of problems does it cause for that tissue system? If it’s a sinus or heart valve, a colon or a prostate. You don’t think of a chronic sinus infection as a big deal. Yet over 100,000 sinus surgeries and almost 2,000 people die every year of that sinus surgery and you go “.” What kind of public policy do you need for that? Wounds, 50,000 die. People with chronic obstructive pulmonary disease, somewhere around 50,000 die a year. Ventilator acquired pneumonia, 67,000 die. And you add all those up and you have 500,000 people dying. But they don’t just die; they suffer from their chronic infection. They lose body parts. And then they die.

    Richard Longland: You have some impressive analytics and diagnostic capabilities that we saw earlier today. Can you talk a little bit, either specifically or generally, about the kinds of pathogens that are causing chronic infections, particularly in your patients with foot wounds?

    Dr. Wolcott: The diagnostics change the playing field. Cultures gave me a microbial reality of one bacteria, a couple bacteria and it was mainly certain kinds — Staph, it’d be Strep, it’d be Pseudomonas. Those are things I knew I had antibiotics for them. I was very comfortable with those, but it wasn’t changing the outcomes of these wounds! You know it wasn’t working.

    And so, we wanted to go and start doing biofilm diagnostics. And I assumed we would pick up some other bacteria. The very first culture I got back is the slide I show in our presentation. And it shows 63 different bacteria were in the wound that I looked at. That same wound was diagnosed with a culture, a growing culture and it showed that that person had MRSA. Well our molecular showed that he had MRSA but it was only 7% of all the bugs. And there were 62 other bacteria in there. I can’t even say the names of 30 of them. And there’s anaerobes and gram negative bacteria. And all the sudden it dawned on me. That was my epiphany: chronic infections, biofilm phenotype infections: that is the pathogen. The biofilm is a single entity…

    So now it’s a single entity and it is the pathogen. Now it’s made up of different species and that’s going to determine how we try to manage that biofilm. But it is truly the pathogen. It’s not the Staph. It’s not the Pseudomonas that’s there. It’s not the Enterococcus. It’s how they combine together to cause that infection. That chronic infection in that host. That’s what I have to attack. Now I need to know those species. I also need to know some other information on the colony defenses so that we can degrade those. So the pathogen is the biofilm whereas in the individual, the acute infection, the pathogen is the species. So you say it’s MRSA. You say it’s Pseudomonas. And you are talking about “a” pathogen. A single thing. Acute infections tend to be one organism. Biofilms tend to be polymicrobial or multiple organisms. What kind of species are we seeing? We are seeing Raoultella planticola, we are seeing things that are just so rare, there are three cases in the literature or something like that. And we see it very frequently. The problem was the cultures weren’t revealing that to us. So now there’s a whole new reality.

    Richard Longland: Perhaps there are economic gains associated with these newer technologies as well. Have you gone to any measures to try to quantify the actual monetary savings for the patient, the patient’s family, or you know the American public at large? Are there economic gains we can realize by moving to these newer treatment options?

    Dr. Wolcott: Well the answer to that is yes. And the reason I know that is that Medicare has really hammered us. Medicare wants innovation and they want less cost and everything, the problem is there system is set up that if you’re different, you’re the bad guy. You’re guilty until proven innocent. We are now proven innocent. Because we did it different. Because the old way wasn’t working. So what we did was we abandoned the culture, we went to molecular studies. Those molecular studies cost twice as much as a regular growing culture, but now it gave us more than twice as much information. It told us about the bacteria, but it told us about the fungus, it told us about the yeast, and it also gave us quantitative information and all of the sudden it was accurate!

    Now did that make a difference in outcomes? Well, we looked at groups of patients that were treated with molecular diagnostics and without molecular diagnostics and there was a 23% decrease in time to healing if we used the molecular. So, does that translate into cost savings?

    At the end of the day we said, “that’s the money we saved.” We’ll just say that’s what we saved Medicare. Just the money of those prevented amputations. Well, the average cost of molecular and doing the, getting the patient healed was somewhere around $2,500 per year and some people took up to 2 years. The most expensive person outlier was $7,600 to get their wound healed. Do you understand the difference in that? I mean, I think it ended up being about, we saved Medicare somewhere in the neighborhood of 35 to 50 times, if you just count the amputations. Not anything else. 50 times savings. Just with that.

    And that’s the reality. If you can heal the wound in situ and not take off body parts, it is so much more cost effective than starting to cut things off or replacing things. It’s just orders of magnitude more when you get into that. So healing the chronic infection in place, whether it’s a wound or a sinus, whatever the chronic infection, it’s far more cost effective than any other strategy…”