Mr. Chairman and Members of the Committee:

I am pleased to present the President's budget request for the National Institute of Dental and Craniofacial Research (NIDCR) for FY 2003, a sum of $374,319,000, which reflects an increase of $29,016,000 million over the comparable Fiscal Year 2002 appropriation. The NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH's second annual performance report, which compared our FY 2001 results to the goals in our FY 2001 performance plan.

IMPROVING THE NATION'S ORAL HEALTH

Over the past 50 years, our nation's investment in dental, oral, and craniofacial research has yielded tremendous advances in American public health. At this time when our nation is engaged in a war, it is interesting to reflect back to the World War II era when many patriotic, able-bodied young men were rejected from military service because they lacked the mandatory six opposing teeth to enlist in the military. In hopes of countering this public health problem, Congress established in 1948 the then National Institute of Dental Research to help eradicate dental decay and tooth loss in America.⁽¹⁾ Today, NIDCR and its partners in public health reflect with pride upon the fact that few young men and women lose teeth. In addition, 70 percent of older Americans have not lost their teeth, compared to 54 percent just 20 years ago.⁽²⁾

COMMITMENT TO REDUCING HEALTH DISPARITIES

The NIDCR's mission to improve the nation's oral health remains far from finished, however. One reason is the sobering fact that many of the nation's oral health advances have yet to adequately benefit our underserved populations. Specifically, there is a clear and compelling need to push forward and reduce the higher incidence of oral cancer, gum disease, and tooth decay among the underprivileged in our society. The NIDCR remains firmly committed to forwarding this effort and pursuing it to its rightful conclusion. As a first step, NIDCR, in collaboration with the National Center for Minority Health and Health Disparities, has funded five Centers for Research to Reduce Oral Health Disparities in Boston, New York, San Francisco, Seattle, and Detroit. Another large study has been funded to examine the underlying causes of oral health disparities in rural West Virginia. This multi-year investigation will focus on the unusually high incidence of children born in this region with cleft lip and palate. The hope is that, with inexpensive dietary interventions during pregnancy, more mothers will give birth to babies free of this socially stigmatizing, expensive-to-treat problem.

UNPRECEDENTED OPPORTUNITY FOR SCIENTIFIC DISCOVERY

The NIDCR leadership also recognizes that scientists today truly stand on the threshold of an unprecedented "Golden Age" in biology. The recent completion of the Human Genome Project, in tandem with the emergence of more powerful research technologies in the laboratory, are allowing scientists to catalogue with encyclopedic comprehensiveness the actual genes, proteins, and protein networks that power our cells. Such studies, an impossibility just a few years ago, have opened a valuable window into the genetic programs of some of the most complex developmental and disease processes involving oral and craniofacial tissues.

TMJ DISORDERS: BUILDING THE SCIENTIFIC INFRASTRUCTURE

Given the tremendous opportunity that now exists for fundamental discovery in biomedicine, NIDCR has targeted as one of its high-priority research areas for FY 2003 a group of conditions collectively known as temporomandibular joint (TMJ) disorders. These disorders affect the joint that connects the lower jaw (mandible) to the skull and the surrounding muscles that are used to chew and open the mouth. An estimated 5 to 12 percent of Americans report having pain associated with the temporomandibular joint. Studies suggest that TMJ disorders may be as much as two times more common in women than men.

By investing in this new initiative, the Institute plans to create the needed research infrastructure to allow multi-disciplinary teams of scientists to more rapidly and systematically tease out the molecular and physiological basis of these conditions. Only then can rational and targeted treatment approaches be devised to help control or alleviate the chronic pain and dysfunction that people with these conditions confront on a daily basis.

To begin building the needed research infrastructure, NIDCR plans to establish the first registry for people with TMJ disorders. The registry will help track the incidence and natural history of these conditions, a longstanding need in the field. The NIDCR also will make a concerted effort to identify biomarkers -- genes, proteins, or even protein networks -- that are adversely affected by TMJ disorders. Through this research, the Institute hopes to lay the intellectual foundation for the development of tests that generate meaningful, telltale diagnostic or prognostic information for doctors and patients. The Institute also will invest in the development of animal models that closely mimic TMJ conditions, providing an important scientific tool to test emerging hypotheses as the research progresses.

RELIEVING ACUTE AND CHRONIC PAIN

One of the great challenges today in medicine is the management of pain. Yet, because most people experience pain differently, its study can be a lot like trying to analyze multiple moving targets at once. Among the variables involved in the pain process are: age, immune function, endocrine and neural activity, genetics, stress, psychological state, gender, and even cultural background.

Despite the inherent complexity of their work, NIDCR scientists and grantees continue to make progress in understanding the dynamics of pain and how to effectively control it in dental care and for pain sufferers in general. Recently, for example, NIDCR researchers used positron emission tomography (PET) to image the brain's chemical activity while human volunteers received a stimulus mimicking the chronic pain of temporomandibular joint disorders. This marked the first time ever that scientists had non-invasively analyzed sustained pain, while also (1) simultaneously monitoring brain scans of a key neurochemical system and (2) recording the self-reported pain ratings of human participants.

The NIDCR scientists found that after experiencing pain in the jaw muscles for 20 minutes, the volunteers had a surge in the release of natural opioids, part of the brain's painkilling system, and a concomitant drop in pain and pain-related emotions. But, most significantly, the researchers discovered a major variation among volunteers in the baseline and pain-induced levels of naturally occurring opioids. Interestingly, when comparing placebo and pain-inducing conditions, the activation of the anti-pain response was dramatic in some volunteers, while in others it was much less pronounced. Those who had the greatest change tended to report the lowest experience of pain, both in its sensory and emotional aspects.

This study provides new insights into the importance of the body's natural painkiller system and the reasons why each of us experiences pain differently. The results also show how brain chemistry regulates sensory and emotional experiences. The findings may help researchers better understand prolonged pain and find more effective ways to relieve it.

LEARNING TO REGENERATE ORAL AND CRANIOFACIAL TISSUES

The physical complexity of the human head and face has captured the imagination of artists since the beginning of time. However, this exquisite complexity sometimes can be problematic for clinicians who must treat injuries, diseases, and genetic defects of the craniofacial region. A noted example is the relatively rare genetic disorder, ectodermal dysplasia (ED). Children born with ED often have malformed and missing teeth, meaning they must cope with the rigors of wearing dentures for a lifetime. Yet, if scientists could learn to trick the body into regrowing a full set of healthy teeth, the quality of life for these children would be greatly enhanced.

The NIDCR leadership believes that the opportunity now exists to discover in a more rational, systematic manner how to effectively manipulate the body's developmental signals to regenerate oral and craniofacial tissues. To help forward this potentially high-yield research, the NIDCR plans to launch an initiative to develop biomimetic, tissue engineering, and stem cell approaches to restore craniofacial tissues. Specifically, the initiative will focus on learning how to repair and regenerate teeth, gums, and the bones that support these tissues; learning how to restore salivary gland function to help people with Sjögren's syndrome; and learning to develop diagnostic and treatment strategies for temporomandibular joint repair and restoration.

REDUCING THE BURDEN OF ORAL CANCER

Most Americans have heard that early detection is often critical to beat cancer. Though this principle has been difficult to apply to some hard-to-access areas of the body, such as the pancreas and the ovaries, that is not the case for many oral cancers. Precancerous oral lesions are often visible to the eye and readily accessible for biopsy.

Yet, according to American Cancer Society estimates, 7,400 Americans will die this year--in most cases needlessly--from oral and pharyngeal cancer. That totals an estimated 74,000 Americans who will succumb to oral cancer during the decade. Thousands more will undergo multiple surgeries to remove advanced tumors and reconstruct their faces and oral cavities.

What can be done to improve this needless public health problem? The NIDCR has invested in several approaches, starting with efforts to heighten public and professional awareness of oral cancers. NIDCR has funded an initiative to assess the rate of oral cancer in five states - New York, North Carolina, Florida, Michigan, and Illinois. At the same time, this initiative will assess public and professional knowledge of oral cancer risk factors, while also documenting and evaluating the practices used to diagnose oral cancers among various health professions. Included in this research is an assessment of the important public health question: How likely is it that an American will receive an annual oral cancer examination from a healthcare provider? The data generated from this research will allow individual states to tailor intervention strategies to their specific demographic and professional needs. Already, based on the results of an earlier pilot project, Maryland has developed a targeted training program for its health professionals on how to examine patients for oral cancer and identify early, developing lesions.

Secondly, NIDCR has invested in research to develop powerful new tests for the rapid diagnosis of oral cancer. The latter is an important point because, as with all cancer sites, abnormal lesions in the oral tissues can be difficult to characterize by simply staining and looking at them under a microscope. In fact, using current diagnostic tests, it is impossible to know whether a suspicious oral lesion indeed will turn cancerous. Neither is it possible to determine whether a cancer will grow rapidly or slowly. Since current diagnostic tests cannot read the so-called "molecular signatures" of biopsied tissue--information that would greatly increase diagnostic specificity.

With the arrival of more powerful laboratory tools over the past decade, NIDCR scientists and grantees have helped to identify many molecular glitches that trigger oral cancer. In fact, the step-by-step progression model for oral cancer is among the most well developed in all of oncology. Given the tremendous potential for progress in the study of these deadly cancers, NIDCR has invested in powerful new molecular technologies that could yield improved diagnostic tests for oral cancers. Already, work is under way to develop a small computer chip--about the size of a quarter--that contains hundreds of genes associated with oral tumors and their metastasis. This chip, if validated, could offer a genetic sensor as an early warning system for a developing oral cancer.

Work also is under way to design a related diagnostic chip that doctors one day could use to detect, in a matter of minutes, the abnormal activity of the very proteins that trigger oral cancers. Such a level of molecular and diagnostic specificity has been a longstanding goal of science, and the great promise of molecular medicine is now closer at hand than ever.

With its longstanding commitment to scientific excellence, NIDCR will continue in coming years to support basic and clinical advances to improve the nation's oral health. This investment in the power of research represents not only hope for millions of Americans today, but improved health and quality of life for generations to come.

STATISTICAL REFERENCES

1. Harris Ruth R. Dental Science in a New Age. Rockville, Maryland: Montrose Press, 1989.

2. U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General, 2000, pp. 2-3.

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