Oversight of US genetic testing laboratories.
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Biomedical subjects
Publications and source records attributed to David J Kaufman.
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OBJECTIVES: The Medicare Modernization Act of 2003 calls for medication therapy management programs (MTMPs) to control anticipated growth in drug use and expenditures. In 2006, prescription drug plan sponsors, including health plans, pharmacy benefit managers, and other entities, will be required to offer MTMP services performed by pharmacists or other health professionals. The Pharmacist Review to Increase Cost Effectiveness (PRICE) Clinic in Sacramento, California, is a pharmacist-directed, multidisciplinary model that is adaptable to providing MTMP services in a managed care setting. The PRICE Clinic serves a 3-fold mission: (1) to help low-income elderly patients decrease out-of-pocket (OOP) drug expenses; (2) to ensure that patients receive clinically appropriate, cost-effective drug regimens; and (3) to improve access to needed medications. The objectives of this study were to characterize and document the number and type of PRICE clinic interventions; measure changes in generic drug use; document savings in OOP drug costs; and measure patient access to drugs that had been, or would have been, discontinued because of cost. METHODS: A noncontrolled retrospective PRICE Clinic database review was conducted for the 520 patients seen in the PRICE Clinic in calendar year 2002. Study participants were low-income elderly with multiple chronic diseases, multiple medications, and high drug costs. For each patient, researchers documented the number and type of interventions performed by pharmacists and the drug class involved in each intervention. Changes in generic drug use and OOP costs were assessed by a preanalysis and postanalysis of selected outcome variables and a comparison of results with comparable patient populations in large state and national databases. Self-report was used to examine whether patients had discontinued medications because of cost, and the PRICE Clinic database analysis examined whether interventions enabled patients to resume previously discontinued medications. RESULTS: PRICE clinic conducted 1,297 interventions among the 520 study patients in 2002, an average of 2.5 interventions per patient. The most common drug classes involved in interventions were lipid-lowering drugs, angiotensin-converting enzyme inhibitors, and asthma and allergy drugs. Generic drug use increased from 51% before PRICE clinic interventions to 56% afterward, a relative increase of 9.8% and more than 30% higher relative to the benchmark value. OOP medication expenditures decreased 68%, from dollar 185 to dollar 60 per patient per month, or dollar 1,500 per patient per year. A total of 215 patients (41%) reported that they had or would soon discontinue drugs because of cost; 186 (87%) of these patients were able to continue or resume the drug as the result of PRICE Clinic interventions. The most common interventions were pharmaceutical industry-sponsored patient assistance programs, generic substitution, and therapeutic interchange. CONCLUSION: Results from this pilot study indicate the benefits of providing pharmacist-directed services to the population targeted by MTMP services, which encompasses Medicare beneficiaries with multiple chronic diseases, multiple drugs, and high drug costs. By providing pharmacist consultation at the point of care to ensure appropriate drug use, decrease OOP expenditures, and improve access to needed drugs, the PRICE Clinic is a possible model for further development in the implementation of MTMP services.
This article is a report of the design and methods of the Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) Study. This longitudinal, population-based study was initiated to investigate the genetic determinants of cardiovascular disease and its risk factors. Between October 2000 and April 2004, this family study enrolled 1,214 Eskimos from several coastal villages in the Norton Sound region of Western Alaska. Examinations included a physical, laboratory determinations, and measures of subclinical disease. This study will generate a genome-wide scan for loci influencing cardiovascular disease-related traits. Relations between subclinical atherosclerosis and markers of inflammation will be examined using historic and newly drawn samples. The study will provide data on CVD prevalence, risk factors and the relative contribution of genetic and environmental determinants in Alaska Native peoples. Data from this study will contribute to the delivery of health-care and prevention of CVD in Alaska Eskimos and other populations.
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Between 5 and 10% of breast cancer is attributable to inherited cancer susceptibility genes. Mutations in the genes BRCA1 and BRCA2 account for two-thirds of hereditary breast cancer cases. Using segregation analysis, families of cases without BRCA1/2 mutations were studied for statistical evidence of another major breast cancer gene in a community-based sample of Jewish probands tested previously for the presence of three BRCA founder mutations. A total of 231 probands with breast cancer, who do not carry a founder mutation, reported complete data on 602 female first-degree relatives of probands over age 20; 78 of these relatives had breast cancer. Segregation analysis was used to evaluate the likelihood of various genetic and nongenetic models. Sporadic, environmental, and general Mendelian genetic models fit the family data poorly and were rejected. A Mendelian recessive model fit better than dominant and codominant models, although none of these could be rejected. Cumulative incidence curves predicted by the recessive and codominant models fit observed incidence among first-degree relatives well. The assumption of Mendelian transmission of a major recessive gene(s) is compatible with the data. The recessive model predicts that 4% of women would carry the high-risk genotype, with 85% of them developing breast cancer by age 70. There was significant heterogeneity between these families and the 114 BRCA1/2 mutation-positive families from the same study population, implying that this apparent recessive effect is not because of undetected BRCA1/2 mutations. The study adds support for a major autosomal recessive component to breast cancer susceptibility.