New "anti-nanobacterial" formulation

[dshoskes]

For people interested in "anti-nanobacterial" therapy for chronic prostatitis / chronic pelvic pain syndrome symptoms associated with prostatic stones/calcifications, Nanobac Labs has spun off the manufacture and sales to a pharmacy that does "compounding". What this means is that the triple combination of tetracycline/EDTA suppository/oral supplement can be bought under a prescription, which means that some or all of the $285 per month cost may be covered by insurance.

The information is here:

http://www.westchasepharmacy.com/pages/26/index.htm

Still no randomized placebo controlled trials, but I continue to use this in patients who have failed other therapies and the majority improve.

(disclosure: I am on the medical advisory board of nanobac labs but have no affiliation with the company that makes or distributes the products)

[londoner]

Dr. Shoskes -

I feel bound to ask, particularly given your disclosures of a potentially vested interest and of your slightly (if I may say so) vague report of your medical findings, should we presume that you have found there is a direct causal link between this broad group of symptoms and calcification?

I only ask as I seem to get conflicting medical opinions on this subject wherever I turn and sometimes find myself wishing I'd never asked or that all urologists would either agree or keep quiet about it.

[dshoskes]

Dr. Shoskes -

I feel bound to ask, particularly given your disclosures of a potentially vested interest and of your slightly (if I may say so) vague report of your medical findings, should we presume that you have found there is a direct causal link between this broad group of symptoms and calcification?

I only ask as I seem to get conflicting medical opinions on this subject wherever I turn and sometimes find myself wishing I'd never asked or that all urologists would either agree or keep quiet about it.

I have done the only clinical trial on the preparation:

J Urol. 2005 Feb;173(2):474-7. Related Articles, Links

Anti-nanobacterial therapy for men with chronic prostatitis/chronic pelvic pain syndrome and prostatic stones: preliminary experience.

Shoskes DA, Thomas KD, Gomez E.

Department of Kidney Transplantation, Cleveland Clinic Florida, Weston, Florida 33331, USA. [email protected]

PURPOSE: Category III chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a common debilitating condition of unclear etiology. Patients often have prostatic calcifications but a link to symptoms is controversial. Nanobacteria are implicated in stone formation in the urinary tract and, therefore, therapy to eliminate nanobacteria and the stones that they produce might have an impact on chronic prostatitis / chronic pelvic pain syndrome symptoms. MATERIALS AND METHODS: A total of 16 men with recalcitrant chronic prostatitis / chronic pelvic pain syndrome refractory to multiple prior therapies were treated with comET (Nanobac Life Sciences, Tampa, Florida), which consists of 500 mg tetracycline, a proprietary nutraceutical and an ethylenediaminetetraacetic acid suppository daily. The National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), transrectal ultrasound, and blood and urine tests for nanobacterial antigen were performed at the start and conclusion of 3 months of therapy. One patient was lost to followup. RESULTS: Mean NIH-CPSI total score +/- SD decreased from 25.7 +/- 1.6 to 13.7 +/- 2.0 (p <0.0001). Significant improvement was seen in each subscore domain. A total of 12 patients (80%) had at least 25% improvement on NIH-CPSI and 8 (53%) had at least 50% improvement. Nanobacterial antigen or antibody was found in 60% of serum and 40% of urine samples. In 10 patients who underwent transrectal ultrasound after therapy prostatic stones were decreased in size or resolved in 50%. CONCLUSIONS: Therapy designed to eliminate nanobacteria resulted in significant improvement in the symptoms of recalcitrant chronic prostatitis / chronic pelvic pain syndrome in the majority of men, whether due to the treatment of stone producing nanobacteria or through some other mechanism. Prospective placebo controlled trials are warranted.

[dshoskes]

Forgot to mention: there is also a paper accepted for presentation at the AUA this year on nanobacteria detected in the blood of men with prostatitis. The lead author is J Jones, a Urologist working for NASA:

Preliminary Analysis of Calcifying Particles in the Serum and Prostates of Patients with Prostatic Inflammation. Jones JA, Carlson G, Kajander O, Warmflash D, Shoskes DA, Everett M, Feeback D, Ciftcloglu N. American Urological Association Meeting, May 2006, Atlanta GA (Moderated Poster)

[rider fan]

Thank-you for posting your findings, Dr. Shoskes. Your on-going research is very much appreciated!

[webslave]

Forgot to mention: there is also a paper accepted for presentation at the AUA this year on nanobacteria detected in the blood of men with prostatitis. The lead author is J Jones, a Urologist working for NASA:

Preliminary Analysis of Calcifying Particles in the Serum and Prostates of Patients with Prostatic Inflammation. Jones JA, Carlson G, Kajander O, Warmflash D, Shoskes DA, Everett M, Feeback D, Ciftcloglu N. American Urological Association Meeting, May 2006, Atlanta GA (Moderated Poster)

Readers should note that this paper has not been published in any peer reviewed journal.

In fact, the only two published papers linking prostatitis with nanobacteria were authored by Dr Shoskes himself.

Since we must point out any possible conflicts of interest, Dr Shoskes disclosed in the past:

' medical advisory board of Nanobac Labs .... I am reimbursed for my consulting time and should therefore correctly be identified as having a financial interest ... in the company's fortunes. I do also own some of their stock "

[dshoskes]

In fact, the only two published papers linking prostatitis with nanobacteria were authored by Dr Shoskes himself.

No, there was only one paper. The second paper was a review article on nanobacteria and several urologic conditions.

Since we must point out any possible conflicts of interest, Dr Shoskes disclosed in the past:

Meaning what? In my original post, I disclosed that I'm on the MAB, which incidentally I wasn't at the time the study was done. Now that the drug selling part of the company has been spun off to another, I don't derive any benefit from sales (not that I did directly before). Incidentally, has there been an MD who has posted on this forum or any other forum that has included a financial disclosure in their post? None that I have seen.

I know some here might like to conclude that the issue of chronic prostatitis / chronic pelvic pain syndrome is completely solved, but unfortunately it is not. I now work with top notch highly experienced PT's, and amazingly enough, there are some chronic prostatitis / chronic pelvic pain syndrome patients who don't have muscle spasm/trigger points and don't get durable improvement with trigger point massage/PT/stress reduction. I have had patients who failed miserably on PT who then got better with other therapies (of which anti-nanobacterial treatment is but one). For these patients, research into treatments with novel mechanisms of action is essential, and must be cofirmed (as the Stanford/Wise-Anderson Protocol has not yet been) by placebo/sham controlled studies.

[webslave]

In fact, the only two published papers linking prostatitis with nanobacteria were authored by Dr Shoskes himself.

No, there was only one paper. The second paper was a review article on nanobacteria and several urologic conditions.

If you enter the search terms "PROSTATITIS and NANOBACTERIA" into PubMed, you'll get two papers, both of which list your name in the authors list. That's all I'm saying: the link between male pelvic pain and nanobacteria is your baby, nobody else's.

Since we must point out any possible conflicts of interest, Dr Shoskes disclosed in the past:

Meaning what? In my original post, I disclosed that I'm on the MAB, which incidentally I wasn't at the time the study was done.

No subtle or hidden meaning should be inferred. It is what it is. Any possible conflicts of interest will always be apprised to all readers of this site under these circumstances. Exactly the same issue has come up with respect to other posters in the past, and their involvement with treatments or protocols was carefully investigated too.

Now that the drug selling part of the company has been spun off to another, I don't derive any benefit from sales (not that I did directly before).

Since you raise the minutiae of this issue, let me ask:

• are you still a shareholder in Nanobac Life Sciences and/or Nanobaclabs?
• are you remunerated in money or kind for your work on their MAB?

Incidentally, has there been an MD who has posted on this forum or any other forum that has included a financial disclosure in their post? None that I have seen.

We don't usually get MDs who invest in the treatments they promote, as far as we know. You did that with quercetin, for which you faced some criticism from others (not this website), and you've done it again with this treatment.

I know some here might like to conclude that the issue of chronic prostatitis / chronic pelvic pain syndrome is completely solved, but unfortunately it is not.

The combination of stress reduction, anxiety control, trigger point treatment, gluten avoidance (in a subset) and dietary modification, along with the use of the well-known medications (Elavil/Remeron, antihistamines, alpha blockers, etc) and phytopharmaceuticals (quercetin, cernilton, palmetto etc) seems to take care of the vast majority.

I now work with top notch highly experienced PT's, and amazingly enough, there are some chronic prostatitis / chronic pelvic pain syndrome patients who don't have muscle spasm/trigger points and don't get durable improvement with trigger point massage/PT/stress reduction.

Ah! Wise and Anderson contend that there are PTs and then there are PTs, and I take their word for it. We've heard many tales here of one PT who finds nothing in the patient and the next PT who find numerous TrPs in the same patient, and gives great relief. A difficult subject is this!

I have had patients who failed miserably on PT who then got better with other therapies (of which anti-nanobacterial treatment is but one). For these patients, research into treatments with novel mechanisms of action is essential, and must be confirmed (as the Stanford/Wise-Anderson Protocol has not yet been) by placebo/sham controlled studies.

It's very difficult or impossible to design a placebo/sham blinded study for something like intrarectal massage.

The need for more research is always there. One would hope that someone else will take up the cudgels of showing the significance of nanobacteria in our condition to replicate your findings. Until then, I advise caution to the readers of this website.

[webslave]

It's also interesting to see that the "new" website launched last year by Nanobac Life Sciences is now in a state of suspension. Is this a sign of trouble for them?

Nanobac Life Sciences Launches New Website

BUSINESS WIRE - September 09, 2005

Completely Redesigned Website Features New Tools, Easy Navigation and Improved Content

TAMPA, Fla.--(BUSINESS WIRE)--Sept. 9, 2005--Nanobac Life Sciences, Inc. (OTCBB:NNBP) ("Nanobac" or "the Company") announces the launch of its new e-commerce website, http://www.nanobac.com. The new site consolidates information from three Nanobac websites and features a wide array of resources, tools and interactive features. Visitors can quickly and easily gather information about the Company's products and services as well as learn more about Calcifying Nano-Particles (CNPs), also known as "Nanobacteria".

[dshoskes]

are you still a shareholder in Nanobac Life Sciences and/or Nanobaclabs?

Yup. Makes up 0.05% of my portfolio.

are you remunerated in money or kind for your work on their MAB?

Yup, as I posted before. No quid pro quo. No benefit from sales. Total sum of 1+2 is less than I give to charity every year. Won't be sending any kids to college on it, but on the other hand when I spend time consulting for companies and giving advice on trial design, FDA submissions etc, I do expect to be paid for my time.

BTW, there are Urologists well know in the academic community who make 6 to 7 figures on their consulting efforts.

The combination of stress reduction, anxiety control, trigger point treatment, gluten avoidance (in a subset) and dietary modification, along with the use of the well-known medications (Elavil/Remeron, antihistamines, alpha blockers, etc) and phytopharmaceuticals (quercetin, cernilton, palmetto etc) seems to take care of the vast majority.

Doesn't help if you are not in that majority. More and more of the patients who travel to see me are in that category.

Ah! Wise and Anderson contend that there are PTs and then there are PTs, and I take their word for it.

I agree. The PT's I work with are the EXCELLENT PT's that have worked with Dr. Potts for years. If the experience required to do the technique properly is more than my PT's have, then this technique will never gain wide usage.

It's very difficult or impossible to design a placebo/sham blinded study for something like intrarectal massage.

Not true. There is at least one such trial that I am aware of currently under design which (if all goes well) would start later this year.

[dshoskes]

It's also interesting to see that the "new" website launched last year by Nanobac Life Sciences is now in a state of suspension. Is this a sign of trouble for them?

I have no idea what their financial situation is beyond published records, but if they did end up being in trouble, what a great message to the business community that investment in prostatitis research is a financial dead end?

Does the prostatitis community want to support or criticize companies that finance research in their condition?

BTW, it's budget time at the NIH. An excellent time to let your representatives know that government funding for chronic prostatitis / chronic pelvic pain syndrome research is also important.

[webslave]

It's also interesting to see that the "new" website launched last year by Nanobac Life Sciences is now in a state of suspension. Is this a sign of trouble for them?

I have no idea what their financial situation is beyond published records, but if they did end up being in trouble, what a great message to the business community that investment in prostatitis research is a financial dead end?

Does the prostatitis community want to support or criticize companies that finance research in their condition?

BTW, it's budget time at the NIH. An excellent time to let your representatives know that government funding for chronic prostatitis / chronic pelvic pain syndrome research is also important.

I certainly agree with the last point you make.

As for Nanobaclabs, I would hope that their product would be successful in the marketplace if it is indeed useful.

[londoner]

I agree that new research and investigation should be carried out until all sufferers can find some solution to their pain and discomfort.

While an initial application of the Nanobaclabs treatment had no apparent effect on my own prostatic calcification, I would like to see more studies into this form of intervention. And preferably with a sample greater than 16 volunteers.

I find it hard to understand how the presence of hard, abrasive objects in an organ so sensitive as the prostate (which is designed to spasm) could NOT have a negative effect - yet urologists whom I have respected have said to me they think this is not the case. To me, nanobacteria aside, it's an unresolved issue.

[rider fan]

While I am extremely grateful for the work that Dr. Wise has done and agree that so much of chronic prostatitis / chronic pelvic pain syndrome is neuro-muscular in nature, I believe that Dr. Shoskes is correct in saying that research needs to be done and supported in other areas as well.

I can understand the caution on Webslave's part about pointing out the remuneration issues, but I do believe that Dr. Shoskes is one of the Uro's who is on 'our side'.

[james-d]

I would like to thank Dr. Shoskes for his continuing efforts in this overlooked field.

Remember - you neverknow what is going to be of help until it is researched - and having lived in pain and now out of it - I am glad there is someone working to help keep up the cause of treatment for CP.

This is a multi-facited disease process with many possible sollutions.

I am glad for his work and his interest!

Thanks for continually trying over the years to omprove the quality of patients lives with this condition.

As all of us suferers know - most MD's can not be bothered as it is a low profit disease with a low cure rate - that is also not fatal. This makes it very uninteresting to most Drs (until they have it!)