Saturday, January 22, 2011

Expanded article - A New Approach to the Problem of Antibiotic Resistance


by Susanne Lewis

Hospital-acquired infections, (HAIs), have become far too prevalent across the nation. The statistics are grim. Ten million patients will get an infection in a health care institution over the next five years and half a million of them will die. Many people fear going to the hospital because that is where the most virulent antibiotic-resistant microbes are encountered. A vast study conducted several years ago found that about half of the patients in ICU wards around the world are battling some kind of acquired infection. This study looked at data from 1,265 ICU units in 75 countries. The longer the patients stayed in the ICU, the greater the risk of becoming infected—from a 32% chance for patients staying one day or less to a 70% chance for patients staying more than seven days. These patients were more than twice as likely to die than non-infected patients. This problem accounts for about 40% of total ICU health care costs. There is a great need for new approaches to be developed to cope with resistant superbugs. Appropriately, our age is described as being on the cusp of the “post-antibiotic era.”

Microbes in the community are also becoming resistant. Superbugs are on everyone’s mind. MRSA, multi-drug resistant staph aureus, has taken a terrible toll, and continues to proliferate, generating a wide range of afflictions. At this point four million people have MRSA on the skin or in the nostrils, and that is a very conservative estimate. New strains of resistant staph are continuing to show up, especially in livestock. It has been dubbed “the perfect pathogen.” But it has competition for that title. Pseudomonas Aeruginosa, C. Diff, actinobacter, e. coli and many others are developing super strains. One woman, who was infected in a wound care clinic where she had been referred for post-operative care, became colonized by three different superbugs—MRSA, pseudomonas and actinobacter. Five years later she still has an open wound in her abdomen where mesh to repair hernia had been inserted. She is on maintenance doses of very strong antibiotics and running out of options.

After 60 years of reliance on antibiotics, we are slowly descending into an iatrogenic nightmare that has already reached epidemic proportions and seems to be heading in the direction of a pandemic of global proportions. How has this happened? We all know about the over-use of antibiotics as a causative factor. But that only accelerated the problem, it did not cause it. To understand the cause, we need to understand the nature of antibiotics themselves.

Bacteria naturally produce their own antibiotics as a means of controlling competing bacteria for nutritional resources. In other words, they engage in a kind of “chemical warfare” against each other. Medical science simply learned to isolate the antibiotics directly from the microbes, and then to synthetically produce them. But microbes that produce antibiotics themselves have the ability to withstand them, at least potentially. This is one of their primary survival strategies, built into their DNA. And antibiotic resistance can be transmitted from one species to another via plasmids. So, in the long run, medical science can never win out against microbes with antibiotics because it is trying to fight them on their own turf with their own weapon. And superbugs are here to call our bluff.

In The Coming Plague, Laurie Garrett writes:

…the use of antibiotics in colonies of bacteria in which even 1% of the organisms were genetically resistant could have tragic results. The antibiotics would kill off the 99% of the bacteria that were susceptible, leaving a vast nutrient-filled Petri dish free of competitors for the surviving resistant bacteria. Like weeds that suddenly invaded an untended open field, the resistant bacteria rapidly multiplied and spread out.”
At this point, we struggle with infections nearly impossible to treat as a direct result of the use of antibiotics—not just staph but pneumonia, strep, dysentery, even resistant strains of tuberculosis and gonorrhea. The list is getting long.
The problem is further exacerbated by the widespread use of antiseptics, antibacterials and disinfectants, such as BSK (benzalkonium chloride), CHG (chlorhexidine gluconate), povidone iodine, dilute bleach, triclosan, and more. Unfortunately, microbes are able to develop resistance to these chemicals in the same way they develop resistance to antibiotics. A recent study showed microbes resistant to BSK could withstand concentrations of BSK up to 400 times greater than non-mutated strains. More importantly, these same microbes also developed resistance to ciprofloxacin, even though they had never been exposed to the drug. The conclusion is that these chemicals proliferate antibiotic resistance. In addition to this, some people are allergic to certain antibacterials, such as CHG, the severest reaction documented being anaphylactic shock. Some health care professionals are against the use of well known antiseptics in wound treatment because of the proven cytotoxicity in dermal and epidermal cells.

Antibiotic toxicity is also becoming a serious issue. Antibiotics have been shown to be chondrotoxic, damaging the body’s cartilage; neurotoxic, carcinogenic, toxic to the retina, nephrotoxic, and more. In fact, antibiotics are the principle cause of drug-associated nephropathy. The FDA was compelled to put out a black-box warning on Cipro as well as Gentamicin, for tendon rupture, ototoxicity and renal damage. A black box warning is the strongest form of warning issued by the FDA about a drug, the step taken just short of removing the drug from the market. A 2008 study conducted by the CDC revealed more than 140,000 incidences of bad reactions to antibiotics which resulted in visits to the Emergency Room each year in the US. Far more reactions go unreported, so there’s really no way of telling what the actual figure is.

It is not mere speculation that prolonged and repeated exposure to antibiotics induces cancer. A 2008 two-year study of three million people who were tracked for six years, concluded those who had taken two to five prescriptions during that two year period had a 27% increase in cancers compared to those who took none. Those who took six or more prescriptions had a 37% increase in cancers. This study was published in the International Journal of Cancer. And a National Cancer Institute study found that the number of breast cancers doubled among women who took more than 25 antibiotic prescriptions over 17 years—usually for recurrent urinary tract infections and acne. This study was published in the Journal of American Medical Association.

Antibiotics tend to have a down-regulating effect on the immune system, some even interfering with lymphocyte blastogensis. Macrobid (nitrofurantoin), often used for urinary tract infections, is one of many implicated here. Destruction of intestinal microflora is also a contributing factor. A repetitive cycle of illness and dependency on repeated use of antibiotics results. People repeatedly treated with antibiotics have far more infections than those not treated this way, especially children with recurring ear infections. Studies have clearly demonstrated that long-term use of antibiotics does indeed suppress the immune system. This is in part due to the fact that antibiotics do not reinforce the immune system but rather replace one of its functions—the destruction of bacteria. This causes that arm of the immune system to weaken. Thus re-infection is easily succumbed to. Combine this syndrome with the problem of virulent resistant strains of microbes and you have a recipe for disaster.

A paradigm shift is greatly needed in order to devise new approaches to the problems of infectious disease. One important idea is to shift emphasis from attacking the microbe at the expense of the immune system, to attacking the microbe in a way that enhances the immune system. There are many approaches. One is to use recombinant electrolyzed salt water which is laden with free-floating electrically charged oxygen ions with traces of hypochlorous acid--an antimicrobial solution that mimics the way neutrophils work to eradicate infection through what is known as oxidative burst. During oxidative burst, also known as respiratory burst, or phagocytosis, white blood cells surround the pathogen and release hypochlorous acid and reactive oxygen to burst through the cell wall of the pathogen, annihilating it, (lysis). This does not harm mammalian tissue, because its cells are tightly bound together in a matrix that cannot be affected by oxidative burst. Working in tandem with the immune system, this solution, dubbed nSOS, or pH neutral superoxidized solution, is highly effective against a very broad spectrum of pathogens, including abx resistant bacteria, viruses, fungi and spores. It is neither acidic nor alkaline, but has a neutral pH of between 6.2 and 7.8, depending on the formula. It is an entirely new class of antiseptic.

In an article entitled, “The Science Behind Stable, Super-Oxidized Water,” Dr. Andres A. Gutierrez describes what he calls “the dawn of a new solution.”  Tests have documented in-vitro antimicrobial activity of an astonishing thoroughness. Toxicology studies are cited that confirm nSOS is neither genotoxic nor cytotoxic. Worldwide approvals have been coming steadily forth for about eight years, in Europe, Canada, United States, Mexico, Russia, China, Middle Eastern countries, India, and more. It has been used in such a wide variety of applications as to be bewildering—everything from cleaning and treating cuts and scrapes to treating periodontal disease to mediastinal irrigation after open heart surgery. It has also been used to treat peritonitis and abscesses of the abdominal cavity, as well as bladder infections, urethritis, cystitis, ear infections, acne, and much much more. The list of potential uses is long indeed. Much of this is being done in an off-label capacity, pending clearance by regulatory agencies. But approvals are coming steadily through each year.

The use of nSOS as a treatment for infection as well as a preventative to keep infection from occurring, is gradually being recognized by the medical community as a very promising alternative to over-reliance on antibiotics. It is being used in wound care clinics, limb salvage clinics, diabetic foot clinics, and burn clinics, with wonderful results. Much of the research to date has been with diabetic foot ulcers. These wounds are particularly difficult to treat and often result in amputation, which is known to significantly shorten the lifespan of many undergoing this procedure. Non healing diabetic wounds are highly vulnerable to opportunistic infections, which are more and more frequently turning out to be  MDROs—multi drug resistant organisms, or superbugs. Treatment with neutral superoxidized water has been highly effective with these kinds of wounds, reducing bacterial load, enhancing local blood supply, promoting neovascularity and reducing inflammation.

Neutral superoxidized water is marketed in Europe, Russia and China as Dermacyn, in India as Oxum, and in the United States and Mexico as Microcyn, Puracyn, Vetericyn, Periocyn and MyClynse. It is the first neutral superoxidized water to be stable enough to make it practical for widespread use, with a shelf life of approximately two years.

One study demonstrated that Microcyn was effective in treating chronic wounds with extensive bioburden, and it discovered that local pain levels were substantially reduced when this treatment was used. And there have been a number of clinical studies comparing povidone iodine and Microcyn in wound care. They have been done in the United States, Italy, India and Mexico, to name just four. Wounds range from diabetic foot ulcers, venous stasis ulcers, pressure sores, surgical site infections and burns. Here is info on just one of those studies:

STUTTGART, Germany -- 218-patient study indicates Microcyn(TM) Technology superior in microbial load reduction, healing time, surgical dehiscence and adverse side effects as compared to povidone iodine (10%).
Oculus Innovative Sciences, Inc. announced that Dr. Luca Dalla Paola, a surgeon with the diabetic foot unit of the Abano Terme Hospital in Italy, recently presented the results of a 218-patient controlled clinical study that assessed the safety and efficacy of Microcyn(TM) Technology in treating diabetic foot ulcers as compared to povidone iodine (10%) antiseptic, which is often used as the "standard care" in treatment of open wounds.
In the study, the Microcyn(TM) Technology proved superior to the iodine relative to the reduction of the number of bacterial strains, local adverse effects, surgical dehiscence (incidence of not healing after surgery due to infection or ischemia) and healing time. The key endpoint of the study was microbial load reduction at both entry and at surgery (or follow-up). The Microcyn(TM) Technology showed a significantly improved rate of reduction of microbial load and healing time in open wounds as compared to the povidone iodine group. 88.2% of ulcers in the Microcyn(TM) group had a negative microbiological specimen versus 68.5% of ulcers in the povidone iodine group. The Microcyn(TM) group showed no local adverse effects, while the povidone iodine group experienced 18 incidences of such effects.

All studies indicated more complete wound healing, healthier appearance, absence of odor, reduction of inflammation, and greater presence of granulation tissue.  Microcyn’s well-established “safe as saline” profile assures there will be no irritation or other adverse reactions when used.

There is a lot of misinformation circulating about neutral superoxidized solution, but research clearly refutes these myths. First, nSOS is NOT dilute bleach in any way shape or form. Dakins solution is dilute bleach, and amongst enlightened wound care clinicians, it went out with the dinosaurs. Dakins solutions is damaging to mammalian tissue and is in well deserved disrepute because of this. It was used in the Vietnam war, but that was before research proved that it destroys fibroblasts, which are crucial to wound closure. When compared to dilute bleach, studies show that nSOS is actually a much more powerful antimicrobial solution of oxidants that are actually able to eliminate bleach resistant bacteria, without damaging fibroblasts in any way. Another myth circulating about nSOS is that it is only another manifestation of so-called ionized water. Medical grade nSOS is hardly the alkaline ionized water people drink thinking it will do everything from making them younger to curing cancer. Stable nSOS is made through an intricate proprietary method that requires considerable scientific sophistication to master. So far only one company has been able to do it successfully, Oculus Innovative Sciences, located in Petaluma, California.

In-vitro studies have shown nSOS to eradicate viruses as well as bacteria--poliovirus-1, rhinovirus-1A, herpes simplex viruses 1 & 2, influenza H1N1, West Nile virus, HIV, and many others. In addition to all the drawbacks I have mentioned in this article, one of the major limitations to antibiotic therapy is that antibiotics are helpless against viruses. Viruses have always been superbugs.

In an article on bacterial complications from burn wounds by Dr. Ariel Miranda Altamirano, Microcyn60, the nSOS product used in Mexico, was evaluated. He indicated that infection by superbugs in burn wounds has been steadily increasing in recent years, retarding overall wound healing, elevating the rate of graft loss and increasing mortality from sepsis. He concluded that:

As predicted from previous animal and clinical experience, the use of Oculus Microcyn60 was efficient and safe for the prevention of partial- and full-thickness burn infections in pediatric patients. Treatment with Oculus Microcyn60 reduced the microbial load in 90% of patients with partial- and full-thickness thermal injuries. Children also reported less pain during cleaning procedures. Application was easy and inexpensive. In addition, the length of hospital stay of patients treated with Oculus Microcyn60 was reduced by 50% relative to the control.  Considering that the daily hospital cost at this facility is approximately $1,800 US per patient, treatment with Oculus Microcyn60 saved the institution an average of $24,660 US per patient. The results of this study also suggest that burns treated with Oculus Microcyn60 heal with better cosmetic results and less chelation relative to the previous standard burn treatment.

Dr. David E. Allie said that infection plays a significant role in many chronic limb wounds, leading to amputation. In the United States the amputation rate has increased dramatically over the last two decades, and there is an excessively high mortality rate in the higher risk patients. “Successful rehabilitation after below-knee amputation is achieved in less than two-thirds of patients.” Statistics for above knee amputations are even worse. This is why there has been an increasing emphasis on limb salvage work. And nSOS is beginning to play a vital role in this area. In Dr. Allie’s study, limb salvage rate was 100% with Microcyn, there was a marked decrease in antibiotic use, both oral and IV, and far fewer hospitalizations were required.

It’s hard to imagine a solution that not only eliminates bioburden but reduces inflammation while delivering a healing payload of oxygen to tissue, but this is actually the case. nSOS contains more than five times the amount of oxygen as tap water, and elevated tissue oxygen levels have been measured up to 72 hours after application. Just how this works in tandem with small amounts of hypochlorous acid to promote such rapid and thorough healing is not fully understood yet. But an increasing body of evidence indicates that it does possess a special kind of healing power. A group of scientists in Japan speculated that reactive oxygen species, shown to be electron spin resonance spectra present in nSOS, triggers would healing through fibroblast migration and proliferation.

Whatever the reason, it works beautifully, and has saved a great many lives around the world. Dramatic stories abound. In one case, a seventeen year old developed necrotizing fasciitis, also known as flesh eating bacteria, after having a wisdom tooth extracted. The infection rapidly spread and he was in the ICU on a ventilator by the time his father, a surgeon who happened to be aware of the uses of nSOS, had several gallons of Microcyn overnighted to the hospital, with instructions to irrigate the wound around the clock. Within the next few days the young man made a remarkable recovery from a terrible infection that even the strongest IV antibiotics could not contain. Another case of necrotizing fasciitis  happened recently in Florida. The patient had a leg wound that had become infected with this microbe, and the progress of the infection could not be contained. The doctor was on the verge of amputating when he was advised about nSOS. He had a shipment overnighted to his hospital and began irrigations as soon as he could. The leg was saved and the family was ecstatic.

At a well known specialty wound care clinic that focuses on life-threatening wounds only, Lake Wound Care Clinic in Lakeview Oregon, Dr. Cheryl Bongiovanni uses nSOS extensively. Many patients are referred to her with surgical site infections that are wildly insensitive to just about every antibiotic in existence. She routinely saves lives and limbs by skillful use of nSOS. Her success rate is phenomenal. She says that she no longer uses hyperbaric oxygen, or saline solution, and the use of topical and systemic antibiotics has been greatly reduced in her clinic.

Microcyn, the only stabile nSOS, with a shelf life of two years, has been evaluated by the USP <51> Antimicrobial Effectiveness Test and is now designated as a Category 1 product. The log reduction numbers are spectacular. As an antiseptic, it highly versatile and unparalleled in its effectiveness. Over just the past seven years, over two million people have been treated worldwide without a single report of a serious adverse effect.

Health care professionals struggling with the enormous problem of HAIs are trying to establish higher standards of hygiene, especially hand washing technique, hoping to curb the epidemic. Though this is a good effort which will certainly help, it could never really solve the problem. It is impractical to expect extremely busy nurses and aides to be 100% thorough in hand washing as they struggle through another busy day. Somewhere along the line, they are all going to slip up. What needs to be done in addition to focusing on strict sanitation standards is to bring nSOS into our hospitals and clinics for a whole spectrum of treatment and techniques, thereby eliminating the danger of a missed hand wash.

If appropriate protocol using nSOS were to be established in our health care institutions, the outcome would be far reaching indeed. It has the capability of preventing HAIs when used as a skin prep prior to surgery, an irrigant during surgery, and as an antiseptic for post-operative care. A highly qualified reconstructive surgeon in Cabo San Lucas related that he has been using nSOS in his practice for some time, finding it to be extremely effective. He uses it instead of saline solution during his surgeries. In the future he believes that Microcyn60, the nSOS product in Mexico, will become the only product used for treatment during surgeries.

nSOS can also be used as a nasal spray, which could greatly reduce  the danger of patients bringing staph into the hospital setting. And nSOS can eliminate catheter-associated urinary tract infections, (CAUTIs), by rinsing the bladder on a daily basis. Ventilator associated pneumonia could be prevented by routinely cleansing the both ventilator tubing, stoma and even the trachea. 

Neutral super-oxidized water could be to the epidemic of HAIs what quinine was to malaria and the Salk vaccine to polio.  Unfortunately, history demonstrates that the obstacles of ignorance and oversight bias often create barriers to the timely emergence of such crucial medical breakthroughs.

Back before Pasteur, circa 1785, when hundreds of women were dying from childbirth infection, Alexander Gordon noticed that the cleaner things were in the birthing room the less a women giving birth was susceptible to infection. Though he attempted to spread the word about the need for cleanliness, he was scorned and ignored. Seventy years later Ignaz Semmelweis, aware that scores of women were still dying from what was called childbirth fever, took extensive empirical procedures to test the cleanliness element in birthing rooms, especially having doctors wash their hands just before delivering a baby. Yet though Semmelweis did his best, even using empirical evidence to prove cleanliness was essential, he was rejected, ridiculed and ignored, thus thousands of women continued to die because of such arrogant self-willed ignorance.  (Pushing Ultimates, 2006)

Let’s hope this notorious syndrome does not prevent the timely recognition and acceptance of vital new approaches to the problem of HAIs and antibiotic resistance. Far too many lives are at stake.