Joint Meeting. and the Peripheral and Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research

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1 Testimony to the Department of Health and Human Services Food and Drug Administration Joint Meeting of the Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health and the Peripheral and Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research September 6-7, 2006 Gaithersburg, MD

2 NADP appreciates the opportunity to provide its perspective to the members of the advisory committees to the Food and Drug Administration regarding the use of amalgam for dental fillings. NADP is the largest non-profit trade association focused exclusively on the dental benefits industry. Our 70 member companies cover over 111 million of the 163 million Americans with dental benefits through Dental HMO, Dental PPO, Dental Indemnity, and Discount Dental products. Our members also provide coverage under Medicaid and the Federal Employee Health Benefit Program. NADP s members include national commercial carriers as well as regional and single state companies and companies organized as Blue Cross Blue Shield and Delta carriers. The dental benefits industry relies on the scientific literature along with the experience of the dental profession in setting benefit levels for its policies. Dental directors and consultants, who are or have been practicing dentists, and broad-based dental advisory committees are key contributors of recommendations regarding dental benefits coverage for particular procedures or materials. NADP s volunteer groups that include dental directors and other professional relations staffs of dental plans indicate that amalgam is the most studied material in use today for dental fillings. The historic scientific literature from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDCP), the US Public Health Service (USPHS), and the National Institutes of Health (NIH) supports the efficacy of amalgam fillings. As well, a recent study published by The Journal of the American Medical Association which focused on different aspects of a child s health including neurobehavioral, neuropsychological (IQ), and kidney function concluded that there are no measurable adverse effects of dental amalgam fillings on children. Amalgam is also the most common material covered by dental benefits for posterior fillings since the inception of dental benefit programs in the early 60s. This is because dental amalgam is durable, resistant to wear and relatively inexpensive in relation to

3 other materials. Thus, it is the most effective material for posterior teeth where the chewing loads are highest and the area for restoration is difficult to keep dry 1. Largely for cosmetic reasons, other less stringently tested materials, such as composite resins may be covered by benefit plans in anterior teeth 2. However, the cost of these materials ranges across the county from 40% to 60% more than the cost of similar amalgam fillings. NADP recognizes that the ultimate decision on the type of filling material to use is between the patient and provider. The dental benefits industry s role is to facilitate access to care by relieving some of the cost. The Surgeon General s Report, Oral Health 2000, concluded that cost was the top barrier to accessing dental care and reported that dental benefits coverage increased the percentage of the population seeking dental care by 20%. Thus, reductions in dental benefits coverage result in reduction of dental care. The 2005 NADP Purchaser Behavior Study showed 71 percent of employers offered dental benefits, with the largest percentage (more than 90 percent) among employers with more than 1,000 employees. The 2006 NADP/DDPA Dental Benefits Report: Enrollment found that 97% of all dental benefits are provided through group policies, i.e. employers, associations, other organizations and public programs. However, rising benefit costs particularly for medical coverage are pushing more of the cost of coverage, including dental coverage, to employees. NADP member company surveys show that more than two-thirds of groups and individuals cite cost as the primary factor for selecting a particular dental benefits plan. No other factor even personal dentist participation rank as high. For this reason, expanding dental benefits with new coverage or higher annual maximums or eliminating the lowest cost treatment 1 One of the requirements for placing composite fillings is keeping the area of the restoration dry during the procedure. 2 Plans may cover composite fillings in posterior teeth as an alternate benefit at the coverage level for amalgam fillings to extend a benefit within the cost constraints of premiums collected.

4 options, such as dental amalgams, can have an adverse impact on coverage decisions and ultimately the access of consumers to dental care. Providing benefits for the lowest cost, effective treatment which includes amalgam fillings keeps costs affordable. In 2005, approximately 10% of the 21 billion in claims paid by dental benefit carriers were for fillings. These costs were roughly equally divided between amalgam and composite fillings. With the cost of composite fillings averaging 50% higher than amalgam, the elimination of amalgam as a filling material, absent reductions in coverage levels, would increase overall costs of claims for dental procedures by 2.5%, i.e. more than a half billion dollars annually. If this cost were passed onto consumers through premium increases, it would be more than the total dental premium increases of the past two years combined. With cost being the top factor in selecting dental benefits, cost increases at this level could easily reduce coverage below the 55% of the population now covered. Reductions in dental care could have a spillover impact on overall health and the costs of medical care. Emerging evidence demonstrates a connection between dental health and other systemic health conditions. A report by the Journal of Periodontology found as much as an 87% reduction of premature births in women who were less than 35 weeks pregnant and who received scaling and root planing. Pregnant women with chronic gum disease during the second trimester may be up to seven times more likely to give birth prematurely 3. Data suggests that each year, periodontal (gum) disease may be causing as many as 18% of preterm births and low birth-weight deliveries, or 135,000 U.S. births each year 4. In addition, recent research has demonstrated that gum inflammation plays a possible role in the development of pre-eclampsia, a serious condition affecting approximately 3 Journal of the American Dental Association, July 2001 "Oral Health During Pregnancy: An Analysis of Information." 4 Study by University of North Carolina, Chapel Hill, March 2003

5 5% of U.S. pregnancies. When a mother suffers from pre-eclampsia, the blood supply to her baby is reduced - impacting the baby's ability to grow and be healthy 5. There are medical implications of good oral health emerging with regard to other medical conditions as well. Diabetics tend to have more periodontal (gum) disease and diabetes can slow the healing process and lower one's resistance to infections. Moderate or severe gum disease can increase the time a diabetic's blood sugar remains high. One study showed that when diabetic patients' periodontal infections were treated, they experienced a marked improvement in the ability to manage their blood sugar 6. Further, evidence is mounting that people with periodontal disease may be at higher risk for heart disease and stroke. Bacterial by-products from the gum tissues may enter the blood stream and cause small blood clots that may contribute to the clogging of arteries. The inflammation caused by gum disease may also contribute to the buildup of fatty deposits inside heart arteries 7. A recent two-year study conducted by the International Association of Dental Research concluded that per-member, per month (PMPM) medical expenditures for diabetics and cardiovascular patients were significantly lower when treated for periodontal disease. An increasing number of dental plans are adding specific benefits for treatment of periodontal disease in patients with these conditions. Direct and indirect estimated costs for these medical conditions are substantial. According to the American Diabetes Association, in 2002 diabetes cost the U.S. an estimated $132 billion. For 2006, the American Heart Association estimates the costs of cardiovascular diseases and stroke in the U.S. at $403.1 billion. The March of Dimes reports that in 2003, hospital charges for all infants totaled $36.7 billion. Nearly half of 5 Journal of Periodontology, August Journal of the American Dental Association, October, U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes for Health, 2000.

6 that $18.1 billion was for babies with a diagnosis of prematurity or low birth weight. Hospital charges for newborns without complications averaged $1,700 that year. In contrast, hospital costs for infants born too soon or too small averaged 45 times that amount--$77,000. So the implications of reduced dental coverage and dental care have greater implications beyond the costs to the dental system. There will be impacts on the overall health and medical costs of the population. Thus, it is critical to weigh all of the evidence supporting the use of the highly tested and widely used amalgam material in any recommendations that you make to the FDA. Thank you for the opportunity to provide you with these views. If the Committees would additional information on any of the points raised in our testimony, NADP would be happy to respond. Evelyn F. Ireland, CAE Executive Director National Association of Dental Plans