The Interstitial Cystitis Association of America: lessons learned over the past 30 years.

Staff is the backbone of any organization. I consider myself fortunate to have worked with so many talented and gifted staff, Board Members and volunteers. They did the work that needed to be done, and if it took 7 days a week, they put in the time. We ran on a shoestring budget, and often could not afford an office. The pay was hardly commensurate with what they deserved, but they persevered. Many of us lived in different areas of the country, and those of us who had IC often worked from home. The ICA staff had numerous responsibilities: responding to phone calls and answering the mail (literally thousands of letters and calls in the course of a year); working with NIDDK on biannual co-sponsored national conferences, both scientific and patient-oriented; working with The Centers For Disease Control; congressional lobbying; running the annual ICA pilot research program; working with the media; arranging for regional patient conferences; fundraising; grant writing; working with pharmaceutical companies; keeping an updated physician registry; running weekly staff meetings, writing quarterly newsletters for both patients and physicians; attending the AUA and other related annual meetings plus dozens upon dozens of other tasks. Given the severity of the pain, few were as motivated or as effective as were the staff, board members and volunteers with IC (and several without IC) in gaining a voice in the scientific and political community.

This program began very early on in the formation of the ICA, thanks to the generous donation of one of the ICA’s Board Members. Subsequently, the ICA raised research funds each year and was able to raise enough money annually to fund three to four projects of approximately $10-15,000 each. We were very fortunate to have a benefactor, The Fishbein Family IC Research Foundation, who donated a substantial amount of research funding each year to the ICA. Their twin daughters both have IC. Every year, a Request for Applications was sent out by the ICA specifying what areas of research we were interested in pursuing. The grants were then reviewed by committee, including the ICA President and several of the ICA’s Medical Advisory Board Members, a combination of researchers and clinicians. Once the recipients were chosen, they produced preliminary data that would at least give them a chance of competing for an NIDDK grant. Without any preliminary data, there would be little if any chance of being successful. This critical program was a steppingstone to NIDDK funding. We had an exceptionally high rate of ICA funded grants that went on to receive funding by the NIDDK—over 40%.

We learned a tremendous amount from other organizations, especially from Abbey Meyers, Founder and President of the “The National Organization for Rare Disorders”. Meyers recommended that that we attend public hearings held on Capitol Hill each year. She pointed out that it was not only imperative to appear and give testimony, it was even more important to submit the testimony, since some of it was placed in the annual Congressional Report Language. This annual report explicitly stated to the National Institutes of Health (NIH) (NIDDK in our case) how the budget Congress allocated to them should be spent. The first year, IC was only mentioned in a few sentences with a recommendation to begin studying IC. Funds were specifically allocated for IC research, yet somehow they got ‘accidentally’ directed to prostate research. We learned quickly, and that never happened again. Each year, a little more about IC research was added to The Congressional Report, until we had over one-half page of coverage that stipulated what IC specific research we wanted to see undertaken. We learned that during a Republican administration, few specific criteria were given to NIDDK on how funding should be allocated towards IC as well as other urologic conditions. Congress did not want to ‘micromanage’ NIH’s budget and often recommended broad commitments for basic bladder research, which often worked to our disadvantage. However, during a Democratic administration, we could count on Congressional and NIDDK support for IC specific projects. This was immeasurably helpful to know because many times during a Republican administration, despite funding specified for IC in Report Language, the Director of NIDDK decided that the funds could be used for basic, general research on the normal bladder. Although such research was essential, the ICA wanted the funds to also cover specific areas for IC that we knew were important to finding a cause of IC, thus moving us closer to a cure. Many political battles ensued during these times. Meyers also discussed the importance of the Health and Human Services Committee with us. She emphasized the importance of visiting each committee member every time that we were in Washington D.C. in order to update them on the progress being made and to ask them to support various projects, write a letter on our behalf, etc. We had a lobbying week in the spring of each year and visited as many congresspersons as we could from the various states that patients represented. Phyllis Greenberger, CEO of the Society for Women’s Health Research, provided many opportunities for us. One of her contributions was making sure that the ICA was always included in special Congressional hearings, conferences on women’s health, and in all of the society’s annual conferences as well. Several of the ICA staff and Board met with Harry Reid (D), Senator from Nevada, very early on, and he took an interest in our story. This was long before he was the Majority Leader of the Senate. He has been our backbone of support since the beginning, and we are indeed sad to hear that he will be retiring when his term is up in 2 years. At that time, we were also able to hire a lobbyist who was phenomenal and who gathered a great deal of support on the Hill, both Democrat and Republican. We once had a dramatic standoff in Senator Reid’s office. The Director of NIDDK at the time wanted all the IC allocated funding in Congressional Report Language to go towards basic bladder research, with no funding going specifically to IC. A meeting was called by Senator Reid, and the Director of NIDDK arrived with an entourage of approximately 10-15 people at Senator Reid’s office. I arrived with two people. Senator Reid asked the Director of NIDDK to explain his position, and then asked me to explain mine. I used the example of HIV/AIDS—that you could study the basic immune system for years, but if you didn’t study the HIV virus at the same time, you would not come any closer to finding the cause or cure of HIV/AIDS. Senator Reid stood up, not wanting to waste time, and said to the Director of NIDDK, “We can do this nicely or not” and proceeded to walk out of the room. This inferred that he planned to support IC specific research, as was dictated by Congressional Report Language that year. The three of us (myself and two others) were elated, having won a major battle. Many IC specific proposals were funded by NIDDK that year. The ICA was and is extremely grateful to the Director of Urology at NIDDK during these many years including Lee Nyberg, M.D., Ph.D., now retired, and currently Dr. Chris Mullins, Ph.D., for their tremendous support, and for allowing the ICA to actively participate in all biannual national IC scientific conferences, clinical trials meetings, the Rand study, and to have a voice at other national and international meetings. I was appointed to serve on the NIDDK Advisory Council for a 4-year term. This council is responsible for reviewing all final grants recommended for approval as well as making a final decision on those grants that scored just above the critical number of points needed for approval (The lower the number, the better the score). It was quite an honor, and it gave the ICA a voice when urologists were making decisions about whether or not to fund various urological grants.

With talent, perseverance, determination and a great staff, the ICA, grew into an extraordinarily successful organization. It was an uphill battle, but the ICA put IC ‘on the map’. Patients learned from each other, reached out to urologists and other specialists, and increased awareness among these physicians. We developed a superb ICA Medical Advisory Board, insisted on epidemiological studies, began a pilot research program of our own, and worked closely with both Congress and NIDDK. Our history may provide a useful blueprint for the development of future medical nonprofit organizations.

How did we prove that a large number of people have IC and that it was not a rare disease? Epidemiology was the answer. Historically, IC was considered to be a rare post-menopausal condition in elderly women, with perhaps 45,000 estimated cases. The very first Epidemiology Study conducted on IC in the United States was published in 1988 by Dr. Philip Held and his team at the Urban Institute. NIDDK also provided some support. Critical to legitimizing the disease, Dr. Held and his team found that: For every one patient diagnosed with IC in the urologist’s office, five went undiagnosed; It took an average of 4.5 years and five doctors to achieve a correct diagnosis; IC patients scored worse than patients undergoing renal dialysis on ‘Quality of Life’ questionnaires; A total of 60% of patients reported pain with sexual intercourse, many so severe that they abstained altogether; By combining medical expenses incurred by an IC patient with lost wages because of disability, Held’s study calculated the economic impact of the disease to be as high as $1.7 billion per year. Since that time, several epidemiological studies have been published. The Rand Corporation Interstitial Cystitis Epidemiology study (RICE study) by Sandra Berry et al. , published in 2011, estimated that 3.3-7.9 million women in the U.S. have IC/PBS. The authors believe, however, that this is a substantial underestimation. “Symptom severity and impact were comparable to those of adult women with established diagnoses. However, only 9.7% of the women reported being assigned a BPS/IC diagnosis.” Berry et al. estimated that 2.7% to 6.5% of women in the United States have urinary symptoms consistent with a diagnosis of IC/BPS ( 5 ). Konkle et al. concluded that (The Rand study) “strengthen(s) the existing body of evidence which suggests that this condition is substantially burdensome, and likely underdiagnosed and undertreated in the United States.” ( 6 ). Clemens et al. evaluated data from the BACH study (Boston Area Community Health Survey) published in 2007, and concluded that between one and four million men have IC in the U.S. ( 7 ), which is much higher than previously thought. There is now no way to dispute that IC/BPS exists, with so much data to back up the numbers. These epidemiological studies confirm that there are many more men and women who have IC/BPS in the U.S. than previously thought. Although there are many more women than men who suffer from this condition, the original ratio of 9:1/female to male in the older literature may be overstated.