The IC Underground

NIDDK Seeks Studies in Pelvic Pain and Other Syndromes

RFA Calls for Multidisciplinary Approach to Study of Chronic Pelvic Pain

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has issued a Request for Applications (RFA) for a multidisciplinary approach to the study of chronic pelvic pain (MAPP).

The MAPP Research Network will adopt multisite, multidisciplinary, highly collaborative, novel approaches using traditional urologic and nonurologic expertise to address key questions in understanding chronic pelvic pain syndromes. This effort is expected to lead to critical new insights into the underlying causes of interstitial cystitis (IC)—also called painful bladder syndrome (PBS)—and chronic nonbacterial prostatitis (CP), or chronic pelvic pain syndrome (CPPS), as well as possible links between these conditions and comorbid disorders, which have the potential for creating future prevention and treatment strategies.

In a separate complementary effort, the NIDDK is developing new and more comprehensive research definitions and criteria for IC/PBS and CP/CPPS that will adopt the concept of systemic disease. With these new definitions and criteria, researchers hope to identify more specific and relevant patient profiles for IC/PBS and CP/CPPS.

Frustrating Conditions

IC/PBS causes recurring discomfort or pain in the bladder and surrounding pelvic region. CP/CPPS causes pain in the lower back and genital area. Urinary urgency and frequency commonly occur in both IC/PBS and CP/CPPS patients. Both conditions frustrate patients and their health care providers because so little is understood about the source of the pain. Effective treatments are equally elusive.

The NIDDK has supported a series of initiatives aimed at understanding conditions that cause chronic pelvic pain, including the
• Interstitial Cystitis Database Study
• Interstitial Cystitis Clinical Research Network
• Boston Area Community Health Survey
• Rand IC Epidemiology Study
• Chronic Prostatitis Clinical Research Network
• Chronic Prostatitis Clinical Database

The NIDDK also has funded many basic research studies focusing on the biology of the bladder and prostate in an attempt to better understand the pathological basis of urologic chronic pelvic pain conditions. Despite these efforts, much remains to be learned regarding the etiology and natural history of these diseases.

The clinical and basic research studies developed by the NIDDK and the research community have traditionally focused on the bladder and prostate as the origins of disease for IC/PBS and CP/CPPS, respectively. However, recent epidemiological studies have shown other illnesses that share chronic pain as a major symptom are often associated with these urologic conditions, including fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome. These findings suggest the possibility of a common underlying pathophysiology in chronic pain disorders that has not been adequately addressed in IC/PBS and CP/CPPS studies.

MAPP Research Network Structure and Organization

The MAPP Research Network will include up to six Discovery Sites that share the common goal of improving the understanding of the fundamental basis of disease pathophysiology and natural history—including predisposition for IC/PBS or CP/CPPS—and assessing potential relationships between IC/PBS and CP/CPPS and other chronic pelvic pain syndromes.

“The NIDDK’s MAPP Network, through its unique approach, will address many long standing questions regarding urologic chronic pelvic pain conditions and will provide an improved knowledge foundation for developing effective treatment and intervention efforts,” said Chris Mullins, Ph.D., the program’s director and the NIDDK director of Urology Basic Cell Biology Programs.

While the specific scientific interests of each Discovery Site may differ, they all must demonstrate a dedication to the study of IC/PBS or CP/CPPS as a central focus. Individual Discovery Sites will conduct multiple projects focused on the scientific priorities of the MAPP Network.

Efforts will involve both site-specific studies and highly collaborative multisite, or trans-network, studies using the combined resources and varied expertise of the MAPP Network. The MAPP Network will include two separate Core Sites that will serve as common resources:
• The Data Coordination Core (DCC) will provide expertise in the overall administration and coordination of multisite research studies and in data analysis for individual Discovery Site projects and multisite trans-network studies.
• The Tissue Analysis and Technology Core will provide tissue (biopsy, serum, and urine) collection, banking, annotation/blinding, distribution services, and histological and tissue morphology analyses. The Core also will provide genomics and proteomics analyses and generate assay platforms—such as for genomics and proteomics studies and tissue expression analyses—for multisite efforts and individual Discovery Site efforts, as needed.

In addition to providing these functions, Data Coordinating Core and Tissue Analysis and Technology Core funds will support MAPP Research Network Ancillary Projects beginning in the first year. These projects, which will be designed to enhance multisite scientific collaborative projects at two or more sites, will be developed by the MAPP Research Network Steering Committee and will be reviewed for scientific merit and feasibility by an external Scientific Advisory Committee.

The NIDDK anticipates that among those selected to serve as Discovery Site or Core Site directors and as project leaders on individual Discovery Site projects will be investigators from diverse fields and those who have not been traditionally involved in studies of urologic chronic pelvic pain, but who have expertise in relevant disciplines.

For more information, email Chris Mullins at MullinsC@extra.niddk.nih.gov.

NIH Publication No. 08–5743
March 2008

My head almost popped off this morning as I was reading the newspaper. The great cheapskates in the world (i.e. businesses trying to save money by using cheap products from China), have, yet again, put our health at risk. How, you ask???

If you haven’t been following the recall of the blood thinner Heparin (yes, Heparin is also used in rescue instills) that began several weeks ago… you should. Baxter International and the FDA began noticing significantly higher rate of side effects with a recent lot of products. Normally, they received 60 or so complaints a year… but, in just January 2008, they had 150 reported side effects….. such a significant increase that it requires much further investigation. Apparently nineteen patients have now died.

According to the Baxter press release of January 28, 2008 … adverse reactions have included: stomach pain or discomfort; nausea; vomiting; diarrhea; low blood pressure; chest pain; fast heart rate; dizziness; fainting; unresponsiveness; shortness of breath; tachycardia; drug ineffectiveness; burning sensation; redness or paleness of skin; abnormal sensation of the skin, mouth, or lips; flushing; increased sweating; decreased skin sensitivity; headache; feeling unwell; restlessness; watery eyes; throat swelling; thirst; and difficulty opening the mouth. Some of these reactions may be severe or life-threatening. Rather chilling, eh? Read on!

Today, the Washington Post reported that testing of the heparin has revealed contamination of 5% to 20% of every sample tested. The contaminant is apparently a molecule similar to heparin that normal tests used by the industry don’t detect. It was a new, more sensitive testing method which found the contaminant.

The question is… was the contaminant part of a botched production/manufacturing method or was it “intentionally added to reduce costs.” Gee, doesn’t that sound familiar?? It should. Remember the melamine debacle last year where it was discovered that some suppliers in China were adding plastic melamine to artificially raise protein levels of products to be used in pet food?? Now, can you imagine a similar circumstance for drugs that are then shipped around the world?? You should.

According to the New York Times and CNN, Baxter International gets the active ingredient for Heparin from China… specifically a manufacturing plant outside of Shanghai. Heparin is made from pig intestine. The FDA also admits that they have NEVER inspected that plant.

Baxter and FDA representatives are now scrambling for answers. Baxter Chief Medical Officer Janet Woodcock said “We don’t know how… this compound got into the heparin but we are aggressively investigating it.” Baxter has also recalled all active ingredients “sourced from China that showed signs of possible contamination.”

Yes, I must clearly state that they are still unsure of exactly what is causing the adverse events. The FDA suspects that it is the contaminant but that IS speculation at this point. I have a logical suspicion. Given the absolutely terrible water quality and sewage treatment (or lack thereof) problems in China, could this have come from the water and/or foods fed to the pigs? Clearly, additional research is needed and must come quickly before we put yet more lives in danger.

I was dismayed to learn that drug manufacturing and/or the development of drug active ingredients is a fast growing industry in China. Given their track history of environmental contamination and track record of putting cash ahead of product quality and safety, I think we’re foolish to purchase anything from China that is meant to be consumed and/or placed in our bodies.

Maybe we need new legislation that requires a disclosure of where the drugs are source from. If I could see “Some ingredients imported” or “Made in China” on the label, I wouldn’t buy the product. I’d rather buy a product made from ingredients found in the USA that supported the US farmers, employees and, most of all, complied with our much better product safety and testing standards. We do have a thriving pig industry in the USA, don’t we??

Nuff said…

Jill O.

References:

1- http://www.baxter.com/about_baxter/n…rin_multi.html
2 - http://www.cnn.com/2008/HEALTH/03/05…ant/index.html
3 - http://www.nytimes.com/2008/02/29/us/29heparin.html?hp
4 - http://www.washingtonpost.com/wp-dyn…ail/components
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Yesterday, the ICA announced by e-mail that founder & President Vicki Ratner MD has “stepped down” from her position as President of the organization. A new Executive Director, Barbara Gordon, will begin work in early March 2008.

We would like to take a moment to acknowledge Dr. Ratner who is, easily, the most recognized IC figure in the world today. She has been with the ICA for more than 25 years as its President and/or as a paid staff member. She had a tenacious drive to increase funding for IC research which, during her tenure, increased dramatically. From lobbying Congress to serving on various NIDDK committees, chairing IC conferences to working with various media outlets, she has been a pivotal figure in the IC movement. Her departure comes as a huge surprise.

In fifteen years, I rarely heard Dr. Ratner talk publicly about her IC. I find it impressive that she was able to travel so extensively and work so diligently given the challenges of having IC. She certainly deserves our accolades for being such a passionate IC advocate.

This transition comes at a challenging time. Not only is the IC international research community still debating a possible name change for IC, many researchers are now accepting the fact that IC is probably far more than a bladder disease. The latest MAPP study launched by the NIDDK is exploring how IC is related to its most common related conditions such as irritable syndrome and vulvodynia. It was also with great disappointment that we learned that the NIDDK funded clinical trial for a new IC treatment (Cellcept) was terminated just a few weeks ago due to a lack of positive results.

Pharmaceutical companies that have helped develop and fund IC outreach efforts are in transition, particularly with this difficult economy. Many see the profit potential of the IC community as limited and have moved on to other more profitable medical conditions. Others have products which, over time, have lost popularity as an IC treatment (i.e. DMSO). Luckily, some new over-the-counter supplements have created interest and excitement with a few new companies.

Similarly, the IC patient movement continues to change and diversify. No longer is the ICA the only patient organization in the USA or world. The IC Network continues our focus on needs of the IC patient, offering more than 300,000 support sessions per month in our support forum, live chats and phone support. Pure-Hope, formerly ICU Texas, is a new national non-profit focusing on both IC and pelvic pain whose strength lies in creating conferences and events. Local IC groups continue to function independently proving that they don’t need a national organization to manage them. A wide variety of international IC/PBS patient organizations now exist. Funding has become far more competitive with so many more hands reaching for a piece of the pie.

So, the question is, where will the ICA go in the coming years? Their success is clearly research and we hope that these efforts continue. We’re particularly excited about research “beyond the bladder.” If you’ve spent any time with an IC support group, it’s crystal clear that the relationship between IC and it’s related conditions must be explored in depth if we’re to uncover why and how these conditions occur simultaneously. Why do so many of us have anxiety disorder and IBS?? Why do women with IC often struggle with vulvodynia. How does IC vary between men, women, children and/or cultures?? What are the most promising new treatments under development?? For every new fact learned in a research study, it seems as if a dozen more questions emerge. The race is on and the ICA is an important part of our future.

We also hope that there will be more openness in the IC community in coming years:

• We hope that researchers with divergent and/or new viewpoints will have the opportunity to have their voices heard, particularly at the federal level.
• We hope that national and regional patient group leaders in the USA will gather together, atleast once a year, to discuss our common goals for the IC community. We have urgent issues that need attention, such as the dramatic rise of false cures on the web that are bilking patients out of thousands of dollars. The power of our collective diversity and individual organizational strengths has yet to be tapped. Collaboration, not competition, is vital to our overall success.
• We hope that more IC educational events will occur, particularly in areas that have been previously underserved, particularly the southeast.
• We hope that the youngest and newest members of the IC community will speak out on their needs, hopes and dreams and participate actively in our organizations. (Fifteen years ago, when we were new, we were laughed at for wanting to offer IC support on the web!). The door must always remain open to the next generation of our community. If that door is shut, the IC movement will lose our ability to respond, in a timely way, to the changing needs of the IC patient.

Yes, our wish list can go on endlessly but time is short today. I’d like to welcome Barbara Gordon to the IC community. She has taken on a large and complex job during what may be the most difficult period for the IC movement. We wish her success.

Jill Osborne, MA - ICN President & Founder

Age 47, Diagnosed at 32, First Symptoms at 13.