Title
: The Truth About Clorpactin: An Interview with Alfred Globus, D.Sc., CEO of United-Guardian, Inc.
Date: December 2002
Moderator: Jill Osborne, M.A., IC Network Founder (jill@ic-network.com)

(Editors Note: This is one of the most difficult topics that I've covered for the IC Network because it has challenged every belief that I had about an "old school" therapy used for IC - Clorpactin. From our founding days, the goal of the ICN was to introduce patients to the many therapies used for IC as neutrally as possible. That said, I will admit that I had lost my neutrality about this therapy years ago. From the day that I was diagnosed, I had patients telling me horror stories about how painful and damaging the procedure was. Doctors that I normally networked with rarely brought it up as a treatment option. As an IC Support Group Leader, I followed the pack and passed along what I now know was poor information.

In this interview, my intent is to set the record straight with the assistance of Alfred Globus, CEO of United- Guardian, Inc. He has patiently and thoroughly explained how Clorpactin was developed, how it is safely used today throughout medicine and how, to our mutual frustration, it was used at a higher, far more painful concentration than what the company recommended. We also will address the "myths" of Clorpactin and correct many of the common errors found in literature today. The ICN is not being paid to promote Clorpactin nor did they approach us to do this lecture.)

Clorpactin® (WCS-90) solutions are commonly used throughout the medical community as a lavage or wash that, at very low concentrations, can clean wounds, sinuses, and remove the necrotic debris from massive infections. During surgical procedures (i.e. appendix rupture), it is used as an irrigant because it kills bacteria, fungi, and some viruses. Recent research studies have shown that it also has effectiveness in the treatment of oral diseases, such as canker sores, gingivitis and periodontal disease. So, how could a therapy that is safely used in the mouth and in open abdominal incisions be described as "harmful, damaging, and bleach-like" for the bladder? A look at the history of the use of clorpactin will reveal that much of the information we have today is incorrect.

Grannum Sant, MD and Dennis La Rock, in "Intravesical Therapies for Interstitial Cystitis"1 described the early use of Clorpactin® in the bladder. "The initial rationale for the use of Clorpactin in the 1950's was based on the similarity between the 'classic form' of interstitial cystitis with…tuberculosis of the bladder. Clorpactin® was used to treat bladder tuberculosis and this led to its use in interstitial cystitis based on the unsubstantiated belief that IC is caused by unidentified bacteria." Yet, even in those earliest days, pain was a consideration that the manufacturer took very seriously. Alfred Globus, CEO of United- Guardian, Inc., offered "When Clorpactin® was first used in the bladder for tuberculosis cystitis, it was done with a 0 .33% solution. However, we found that this concentration was too high because it caused profound pain. However, most patients could tolerate a 0.2% solution much more comfortably and still receive the same results after a series of 4-6 weekly instillations. Therefore, we've only recommended the 0.2% concentration for use in the bladder."

Yet, during the 1970's, the treatment protocol for IC was dramatically changed when researchers in New Zealand began using a 0.4% solution as a single instillation in combination with a hydrodistention of the bladder, rather than doing weekly instillations at 0.2%. The New Zealand protocol was significantly more painful and also required general anesthesia. Not surprisingly, this new method & approach became popular in America where doctors at leading universities began using this "more efficient" method of delivery.
Dr. Globus reiterated: "Our recommended course of treatment involved a series of office visits at 0.2% about four or five days apart, filling the bladder comfortably without over distention. In New Zealand, they deviated from this protocol by making it a single application at 0.4% with hydrodistention. It's not only the pain caused by the 0.4%, but also the act of stretching the bladder. We did not change our viewpoint. We knew that it was too painful to exceed 0.2% and we did not recommend that increase. The point is that when someone changed the technique on their own ( i.e. 0.4%) that hurt everyone. It's not just twice as difficult to tolerate, it's probably four times as painful. The square of the increase (two squared)."

Why would it be done at the higher dose than at the lower dose? Some care providers would argue that it saved the cost of several office visits. Others would say that it was as equally effective as the lower dosage. We wonder, though, if the patient experience was disregarded. Would a patient agree to have a therapy that was very painful when a much less traumatic method of using the same medication was also available? Likely not. Dr. Globus continued "When I asked one doctor how his patients reacted to the 0.4%, he said that his patients had 'handled it.' I was surprised. Why do it at the high dose, when a lower dose can be just as effective and not as painful." Thus, the legitimate stories of excruciating procedures and pain became commonplace.

Roughly around the same time, Clorpactin® also became known for causing tissue destruction and nerve damage which, according to Dr. Globus, has no basis in fact. For example, one popular IC book compares Clorpactin® and Silver Nitrate as "caustic" bladder solutions that damage the bladder surface and/or destroy the nerves in the bladder. Clorpactin and silver nitrate are not as similiar as we thought.

Question: Are Clorpactin® and silver nitrate similar?

(Dr. Globus) No, they are not similar at all. Silver nitrate is caustic. It combines with the tissue and, if it's strong enough, it will kill the tissue. Clorpactin® is not caustic. Its pH is slightly below neutral and it doesn't burn away the tissue. I personally would never allow silver nitrate to be used in my bladder if the need existed.

Question: Is Clorpactin® chemically similar to dilute chlorine bleach?

(Dr. Globus) Chlorine bleach is highly alkaline. It has a very high pH. That makes it entirely different from Clorpactin® which is just below neutral. The pH of bleach can be has high as 10 or 11. Clorpactin is about 6.6 on average. In addition, chlorine bleach has no ability to penetrate tissue, which is one of the most important actions of Clorpactin®. Clorpactin® is a powerful penetrant that can reach into crevices and fissures. Chemically, they are very different.

Question: Is there any evidence that Clorpactin® causes scarring?

(Dr. Globus) No. It should not cause scarring at 0.2%. We know it causes slight irritation to the tissue of the bladder but not permanent harm. Clorpactin® will destroy a single cell if it can surround it entirely but solid tissue is not harmed with a 0.2% solution because those cells are in a group. Healthy bladder tissue (i.e. the bladder lining) should not be destroyed when the proper strength solution is used. The bladder is a sensitive area which requires the professional to monitor the pain threshold in individual patients and adjust the procedure both in terms of dosage and strength as needed. With the exception of a recent incident that came to our attention less than one year ago, where it was alleged that Clorpactin caused damage to a bladder that was in very bad shape prior to the instillation of Clorpactin, we have no knowledge of any cases of permanent damage to the bladder. This particular case involved over distention of the bladder which, along with the use of a 0.4% solution and excessive duration of treatment, are the main causes of the negative reports that have circulated. There were also many other factors involved in this case, including the use of excessive instillation pressure and a long history of bladder problems, so it never was determined whether or not Clorpactin was responsible for the bladder damage, but it certainly did not help that the physician used procedures that we would not have recommended.

Question: Does it damage the nerves?

(Dr. Globus) Contrary to mistaken notions, Clorpactin® does not destroy nerves, for if it did, the patient would feel no pain after the procedure or at least less pain if there was only partial nerve damage.

Question: Is there any evidence that Clorpactin® would stimulate the growth of more nerves?

(Dr. Globus) I've never heard of that but it doesn't make sense. There is no evidence that this is the case and Clorpactin has been studied and used for over 45 years.

Question: Does it slough off tissue or remove the bladder wall??

(Dr. Globus) If that were the case, we would see that tissue. Instead, we see a clear fluid drain out of the bladder after the procedure. That tells us that the bladder wall remains intact.

Question: Do you consider Clorpactin® poisonous?

(Dr. Globus) A form of Clorpactin similar to WCS-90, called Kasdenol, was marketed as an oral mouthwash and gargle for 40 years. We can definitely conclude from this, from oral LD50 tests, and from toxicity work done in the United Kingdom in connection with the approval of Clorpactin in the treatment of animal mastitis, that Clorpactin is not poisonous. This is why we're doing studies right now on the use of Clorpactin® in diseases of the mouth.

There was also a study on oral canker sores (herpes). Now we're doing studies with gingivitis/periodontal disease and that looks very promising as well. The first study was excellent and we're in the process of conducting further research.

Question: Some doctors won't use Clorpactin®. Why?

(Dr. Globus) Probably because they've heard that it causes pain and they are unaware that the original studies using 0.2% were successful and not nearly as painful. I think that if more doctors were aware of the tremendous number of successful uses of Clorpactin over the past 40 years when it is used properly, that they would be much more likely to use it. Unfortunately, the many success stories are sometimes overshadowed by the relatively rare problem cases. Hopefully this article will make both physicians and their patients feel better about trying this treatment at the lower concentration, thereby enabling many more to benefit from a treatment that has helped so many people over the past 40 years.

Question: How does Clorpactin® work specifically?

(Dr. Globus) It's a combination of penetration and oxidation. Clorpactin® is a very effective wetting agent, which causes penetration. More importantly, Clorpactin is an excellent oxidizing agent. It is more powerful than hydrogen peroxide. I think it's the combination of the two effects that is doing the job. The material is capable of penetrating into the interstitial portions of the cell.

Question: Given the fact that IC is not bacterial in nature, why do you think it will help an IC patient?

(Dr. Globus) For some reason, we found that patients who did not have infection still have a positive response to the therapy. We suspect that it is adding oxygen to the tissue. It's interesting that one doctor explained to me that he starts patients off with 0.1% solution so that they became inured to it. He felt that they respond better by getting used to the material first. He then goes to a 0.2% solution on the second visit, but never higher.

Question: How many treatments at 0.2% does it take?

(Dr. Globus) It's probably five or six. It's not a particularly painful procedure. Not like 0.4% and if you start off with the lowest dose, the patient gets more used to it. But, they must NOT exceed 0.2%. We also found that if you wait too long between treatments, such as 10 days or more, you have to start at the beginning again.

Question: Has a Clorpactin® instillation ever been combined with other instillations to make a "cocktail" such as DMSO cocktail?

(Dr. Globus) It can't be for the simple reason that the Clorpactin® would oxidize the additive. It wouldn't have any activity left to help the bladder condition. One doctor suggested mixing it with antibiotics. That won't work. The full antimicrobial spectrum that is killed by the Clorpactin® makes it unnecessary to add an antibiotic even if the two were compatible. You can't add anything to Clorpactin® but water or saline.

Question: Are there any circumstances where a patient should not use Clorpactin®? Contraindications?

(Dr. Globus) It can't be absorbed into the bloodstream. It's not generally allergenic at all. If the doctor starts at the lower concentration (0.1%), he can determine the ability of the patient to tolerate it. If the patient complains that it is painful at that low concentration, they probably shouldn't have the higher doses and treatment may need to be discontinued.

Question: If a patient experiences mild discomfort what should they do?

(Dr. Globus) Analgesics such as Tylenol®, Motrin® or aspirin should easily control mild pain.

Question: Finally, can you summarize for us the proper method of using Clorpactin to treat Interstitial Cystitis?

(Dr. Globus) First, do not use a concentration higher than 0.1% for the initial treatment and 0.2% for subsequent treatments. Have the patient empty his or her bladder as completely as possible and then perform a cystoscopic examination to make sure that there are no perforations or tears in the bladder. Fill the bladder to capacity (but do not over distend) using gravity feed at a pressure not to exceed 30 cm, and allow a total dwell time of 2-3 minutes per instillation. Perform 2-3 instillations per treatment, allowing several minutes between instillations. Repeat this procedure every 4-5 days for at least 5 treatments. Improvement should be seen by the fifth treatment, but seven or eight treatments may be necessary. If a period of 10 days or more elapses between treatments, the series of treatments should begin again. If the treatment is successful the results may last from several months to as much as a year or more before treatment may have to be repeated. Mild to moderate pain is not unusual and can be treated with an OTC analgesic, but a stronger prescription analgesic may be required.

CONCLUSION -
As the founder of the ICN and as an IC Support Group leader, much of my working day is spent on the phone with patients struggling with IC flares and/or pelvic pain. Like many of you, I have also called my doctor crying for relief and I know, first hand, just how frustrating and frightening it can be. Early in my diagnosis, I asked if bladder removal could be done. My urologist thankfully said "No" and rightly so. I had not tried any of the therapies for IC at that time. Although it took patience and determination, I did find the therapy that worked for me and dramatically improved my symptoms. So, if you are an IC patient contemplating surgery, I hope that your doctor will give you similar guidance. Clorpactin is one of several therapies that may be worth exploring.

References:
1 LaRock, D, Sant G., "Intravesical Therapies for Interstitial Cystitis" Interstitial Cystitis, Lippincott-Raven Publishers 1997, p. 250

Additional reading:
The company (United-Guardian, Inc.) has a booklet which can be requested and mailed to medical care providers. This booklet is specifically for physicians.

Contact Information:
United-Guardian, Inc.
230 Marcus Blvd.
P.O. Box 18050
Hauppauge, NY 11788
Phone: (631) 273-0900
Fax: 631 273-0858
E-mail: evp@u-g.com

Alfred Globus, D.Sc. is the CEO of United-Guardian, Inc. He is a chemist and has worked in the industry for the past sixty years.


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2002, The IC Network, All Rights Reserved.
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