The IC Underground

DALLAS – Nov. 19, 2009 – Contrary to current thinking, a condition called gastroesophageal reflux disease (GERD) might not develop as a direct result of acidic digestive juices burning the esophagus, UT Southwestern Medical Center researchers have found in an animal study.

Rather, gastroesophageal reflux spurs the esophageal cells to release chemicals called cytokines, which attract inflammatory cells to the esophagus. It is those inflammatory cells, drawn to the esophagus by cytokines, that cause the esophageal damage that is characteristic of GERD. The condition is manifested by symptoms such as heartburn and chest pain.

Research by Drs. Stuart Spechler and Rhonda Souza suggests that gastroesophageal reflux disease might actually be an immune-mediated injury rather than a direct result of acidic digestive juices burning the esophagus.
“Currently, we treat GERD by giving medications to prevent the stomach from making acid,” said Dr. Rhonda Souza, associate professor of internal medicine at UT Southwestern and lead author of the study appearing the November issue of Gastroenterology. “But if GERD is really an immune-mediated injury, maybe we should create medications that would prevent these cytokines from attracting inflammatory cells to the esophagus and starting the injury in the first place.”

In the study, researchers created GERD in rats by connecting the duodenum to the esophagus. This operation allows stomach acid and bile to enter the esophagus. Researchers were surprised to learn that esophagitis didn’t develop for a number of weeks after the operation.

“That doesn’t make sense if GERD is really the result of an acid burn, as we all were taught in medical school,” said Dr. Stuart Spechler, professor of internal medicine at UT Southwestern and senior author of the study. “Chemical injuries develop immediately. If you spill battery acid on your hand, you don’t have to wait a month to see the damage.”

About 40 percent of Americans suffer symptoms of GERD at some point, and 20 percent on a weekly basis, Dr. Souza said. Over the long term, GERD could eventually lead to esophageal cancer.

Previous studies had shown that if an animal esophagus is perfused with highly concentrated acid, esophageal damage develops quickly. In humans, however, the large majority of reflux episodes do not contain such highly concentrated acid, Dr. Souza said.

“In animal models of reflux esophagitis designed to mimic the human disease, researchers hadn’t looked at the early events in the development of esophageal injury,” Dr. Souza noted. “Most of those investigators have been interested in the long-term consequences of GERD, and we found virtually no published data about what happens later that induces gastroesophageal reflux.”

Dr. Souza, who is also a staff physician at the Dallas Veterans Affairs Medical Center and part of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern, and Dr. Spechler, chief of gastroenterology at the Dallas VA, said the method they used to produce GERD in rats is a reasonable representation of how GERD develops in humans – acidic digestive juices from the stomach surge into the esophagus.

Soon after the operation, they expected to see the death of surface cells of the esophagus, and they expected to see the injury progress later to the deeper layers. Instead, they found the opposite. Three days after the surgery, there was no damage to surface cells, but the researchers did find inflammatory cells in the deeper layers of the esophagus. Those inflammatory cells didn’t rise to the surface layer until three weeks after the initial acid exposure.

The next step for researchers is to conduct additional studies in humans.

Other UT Southwestern researchers involved in the study included Dr. Xiaofang Huo, postdoctoral researcher in internal medicine; Dr. Vivek Mittal, postgraduate trainee in internal medicine; Dr. Susanne Carmack, postgraduate trainee in pathology: Dr. Huiying Zhang, instructor of internal medicine; Dr. Robert Genta, clinical professor of pathology and internal medicine; Dr. Kathy Hormi-Carver, assistant professor of internal medicine; and Dr. Xi Zhang and Dr. Chunhua Yu, both research associates in internal medicine.

The study was supported by the Dallas VA Medical Center and the National Institutes of Health.

Visit http://www.utsouthwestern.org/digestive to learn about UT Southwestern’s clinical services for digestive disorders.

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We can’t say it enough, there are thousands of non-profit organizations desperately looking for funds. Some are legitimate, others are less so. Some send their pitches by regular mail, others by email. Some dedicate the majority of their funds for direct services (i.e. by funding research), others are top heavy and use much of that money to pay staff.

The Better Business Bureau has an excellent guide that will help you determine if the charity you would like to support is functioning in a prudent and healthy way. They ask you to evaluate how a non profit governs their organization, how they spend their money, their truthfulness and their willingness to disclose basic information to the public.

How an organization is managed is vital. We want to know if the Board of Directors is fulfilling its role and responsibiilities. Are they evaluating the performance of the organization? Are they reviewing the budget?? Are they providing performance reviews of the Executive Director?

We want to know if that board is meeting regularly (i.e. a minimum of three times a year). In some states (i.e. California), Board meetings are also required to be open to the public and organization members or donors. One simple way to check? Do they provide a calendar of board meetings on their websites.

Most of all, we want to ensure that the Board does not have a financial bias or interest in the organization. Normally and in most organizations, board members are generally volunteers. The BBB suggests that “Not more than one or 10% (whichever is greater) directly or indirectly compensated person(s) serving as voting member(s) of the board. Compensated members shall not serve as the board’s chair or treasurer.”

In addition to the governance of the group, we also want to know if they are spending our donations wisely. The BBB suggests that 65% of the budget should be directed towards program activities. Some organizations are very top heavy with 50% or more of their budget going to salaries and administrative overhead rather than programs. This is something to be aware of and to evaluate if you want to make long term donations to any group.

Last, but certainly not least, we want to make sure that this organization is functioning as transparently as possible. Conducting business behind closed doors, in my opinion, creates doubt for a publicly funded non-profit organization. We expect financial statements/annual reports to be available directly on their websites as well as their IRS form 990’s. The IRS Form 990 is the best document that you can use to evaluate an organization because it breaks down the budget indepth, provides salary figures, board members who are compensated, how much they receive etc. etc. Always remember that tax law requires that the 990 be made available to you at your request. If it is not provided, you can file a complaint with the IRS and we strongly suggest that you do so.

So, this year, as you receive yet more letters, emails, etc. asking for donations, we hope that you’ll take a moment to evaluate that organization and ask yourself if they are using your donations wisely. If not, there are plenty of other groups that may be far more deserving.

For more information on charities, please visit the National Charities Information Bureau at: http://www.give. org

To review some IRS Form 990’s related to various IC groups, please visit: http://www.guidestar.org. You’ll have to register (it’s free). To download the IRS forms, look for the “beta version” links… which give you direct access to the forms. You might find yourself surprised.

We, at the ICN, believe that your donor dollars would be the most appreciated when given directly to IC research centers, such as the University of Maryland. We offer an ICN Donation and Giving Guide that lists promising research centers and projects. http://www.ic-network.com/mgt/donations.html

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.

Imagine having an implant done. You’re told “You’ll need constant medical care.” You’re told “The Device will need to be adjusted occasionally.” And then your finances became so challenged that you’re forced to go on Medicaid or lose your insurance entirely. Can you still receive care?? Apparently not if you’ve received Interstim and you live in Florida.

One IC patient has tried contacting dozens of doctors to find atleast one who would adjust her Interstim device and they’ve all said that they don’t take her insurance, the state run Florida Medicaid program. She called the Patient Assistance Line and was told that it was her responsibility to find a doctor who would work with her insurance. Well, what is she supposed to do if NO doctors in the state who work with Interstim take Medicaid? So far, every doctor she’s contacted on the Medtronic list has said “No”… though she still has a few more to contact.

I don’t know about you but this infuriates me. If you were a candidate considering Interstim and were told “Oh yeah, if you ever lose your job and your forced to go on Medicaid … no doctor will maintain your device?” would you have it done?? Am I crazy??? Doesn’t the manufacturer have some responsibility in maintaining a diverse list of physician providers that will serve not only rich patients but also the poor??? God forbid a patient lose their insurance entirely. How can they possibly receive care for a device that requires constant care and monitoring.” Clearly, this may be a serious lapse in medical device industry.

Do you have an implant story to share?? Have you had difficulty finding someone to maintain your device?? Have you been discriminated against because you have Medicaid?? Please share your story!

Jill

The ICA announced, earlier this week, that they have produced three new mass media PSA’s on ICA that will appear in the next few months on DirecTV, America News Network Consumer Edition and the Radio Health Journal.

This is great news. We certainly need as many educational pieces as possible!

Jill O.

Urologic Diseases Cost Americans $11 Billion a Year

Bladder, prostate and other urinary tract diseases cost Americans nearly $11 billion a year, according to a new report from the National Institutes of Health. Medicare’s share exceeded $5.4 billion.

The five most expensive urologic problems — accounting for $9.1 billion — are, in descending order, urinary tract infections, kidney stones, prostate and bladder cancers and benign prostate enlargement, according to the authors of Urologic Diseases in America. The report was published online this spring and will be available in print and on CD in early May.

“This research sharply illustrates the immense burden of urologic diseases and the importance of studies to preempt disease processes and develop targeted treatments,” said Elias A. Zerhouni, M.D., NIH Director.

Five years in the making, Urologic Diseases in America stitches together a patchwork of reliable data, both new and previously published, revealing numbers of people affected, treatment patterns and economic cost.

TOP 10 DISEASES BY COST TOTAL
Infection (Women & Men) - $3.5 Billion

Kidney Stones - $2.1 Billion

Prostate Cancer - $1.3 Billion

Bladder Cancer - $1.1 Billion

BPH/Prostate Enlargement - $1.1 Billion

Urinary Incontinence - $463.1 Million

Kidney Cancer - $401.4 Million

Erectile Dysfunction - $327.6 Million

Prostatitis - $84.4 Million

Interstitial Cystitis/PBS - $65.9 Million

“The data have broad implications for quality of care and access to care and helps to inform discussions about health care and research needs,” said UDA coeditor Mark S. Litwin, M.D., M.P.H, a urologist at the David Geffen School of Medicine and School of Public Health at the University of California, Los Angeles.

Urologic Diseases in America describes more than a dozen diseases of children and adults, among them congenital abnormalities, erectile dysfunction, chronic prostatitis, interstitial cystitis, urinary incontinence and a chapter on sexually transmitted diseases, contributed by the Centers for Disease Control and Prevention. Findings include:

Medical care for nearly 12.8 million urinary tract infections in women alone costs nearly $2.5 billion annually. Adding the cost for men raises the total to $3.5 billion; Medicare’s share was $1.4 billion. Another $96.4 million was spent on 3.3 million prescriptions. More than half of all women will have an infection during their lifetimes. Reporting a trend toward using newer, and more expensive, fluoroquinolones raises concerns about increasing antibiotic resistance said UDA authors. And while only 20 percent of infections are in men, they are more often hospitalized and out of work about twice as long as women.

While hospitalizations, length of stay and the need for open surgery are declining for kidney stones, medical care still costs $2.1 billion annually, with another $4 million to $14 million spent on prescription drugs. Men are two to three times more likely than women to develop a stone, but more people of all ages and races are getting them: an estimated 5 percent of adults between 1988 and 1994, up from nearly 4 percent between 1976 and 1980. Compared to whites, African Americans and Mexican Americans have a 70 percent and 35 percent lower risk, respectively, of developing a stone.

Although data for childhood urologic diseases are scarce, urinary problems in children cost at least $75 million dollars a year. Vesicoureteral reflux, the abnormal flow of urine from the bladder up toward the kidneys, affects about 10 percent of all children and makes them prone to urinary tract infections and kidney damage. The cost of hospitalizations for reflux alone rose from $10 million in 1997 to $47 million in 2000; Southern states, defined using U.S. Census Bureau regions, saw the highest rise — 56 percent — attributable to a doubling in the number of cases.

“Our biggest challenge was finding reliable data in children,” said Christopher Saigal, M.D., M.P.H., Litwin’s coeditor at UCLA and RAND Health. “More research is needed in children.”

Urologic Diseases in America was funded by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases and developed by a team of epidemiologists, health economists, statisticians, programmers and urologists.

Learn more about urologic diseases at http://kidney.niddk.nih.gov; click on statistics to find Urologic Diseases in America. UDA books and CDs may be ordered from the National Kidney and Urologic Diseases Information Clearinghouse at 1–800–891–5390, nkudic@info.niddk.nih.gov and at www.catalog.niddk.nih.gov.

The NIDDK, a component of the NIH, conducts and supports research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information about NIDDK and its programs, see www.niddk.nih.gov.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.