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Biomedical subjects

Aaron S Kesselheim

Publications and source records attributed to Aaron S Kesselheim.

10 recordsLinked to original sources
PubMed2006

Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation.

OBJECTIVE: Much debate surrounds physicians who testify in controversial types of medical malpractice litigation, but little is known about them. We sought to describe characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation. METHODS: Using jury verdict reports, we identified 827 cases between 1990 and 2005 involving birth-related neurologic injury to a child. Frequent expert witnesses were defined as those associated with more than 10 cases. From the verdict reports and other public data sources, we compiled case descriptions (injury type and severity, legal outcomes) and characteristics of the frequent witnesses (age, gender, board certification, academic publication record). We analyzed these characteristics by comparing witnesses with each other (plaintiff compared with defendant) and with nationally representative data. RESULTS: Seventy-one frequent witnesses participated in 738 cases (89% of the sample), which paid 2.9 billion US dollars in compensation. Most (56 of 71) testified for one side in at least three fourths of cases, and 40% of cases were located outside the witnesses' home states. Frequent plaintiff witnesses had a higher median annual case rate than their defendant counterparts (2.9 compared with 1.9 cases, P=.002). They were also older (57.2 compared with 50.8 years, P=.007), less likely to have subspecialty board certification (38% compared with 95%, P<.001), and had fewer academic publications (5.0 compared with 53.5, P=.002). CONCLUSION: A small cadre of physicians testifies in most neurologic birth injury litigation, and witnesses tend to act consistently for one side. Plaintiff witnesses have fewer markers of expertise than defendant witnesses. These descriptive and analytical findings may reflect suboptimal expertise or bias in physician expert testimony.

Birth Injuries↗
PubMed2005

University-based science and biotechnology products: defining the boundaries of intellectual property.

The pharmaceutical and biotechnology industries have long relied on patenting as the primary means of allocating ownership and control over new discoveries. Yet, patent protection is a double-edged sword that has major implications for the future of innovation in biomedical science in the United States. Excessive "upstream" patenting of genes and molecular targets could hinder further research by creating a need for expensive and inefficient cross-licensing. However, limiting such basic science patenting could allow private entities to use the results of years of costly publicly funded research to produce and market lucrative products without compensating university- or public sector-based innovators. Academic and other nonprofit research centers would, therefore, be deprived of revenue for pursuing novel therapeutics or other seminal research work that may not be patentable. Recent court cases illustrate the inherent conflicts in allocating ownership and control of basic biomedical discoveries. Several options exist to avoid the complex problems of overlapping basic science patents while still rewarding pivotal discoveries and encouraging further innovation. These include establishing basic science patent pools and mandating arbitration arrangements that would assign credit and royalties for biotechnology innovations that depend on prior research that was performed, financed, or both in the public sector.

Academic Medical Centers↗
PubMedDate not supplied

The rise and fall of Natrecor for congestive heart failure: implications for drug policy.

Recent revelations of unexpected side effects of widely prescribed medications have raised questions about several aspects of U.S. drug policy, from initial Food and Drug Administration (FDA) approval to promotion by manufacturers and prescribing by physicians. One prominent example is nesiritide (Natrecor), a treatment for congestive heart failure. We use it as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physicians' prescribing choices can shape the risk-benefit relationship of new drugs. Based on the nesiritide experience, we suggest several ways to improve policies for drug approval, postmarketing surveillance, and drug utilization.

Advertising↗
PubMedDate not supplied

Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spending.

Rising prescription drug costs present a critical policy issue for Medicaid. Generic substitution can reduce costs, but the effects are undercut by extensions of intellectual property (IP) protection, elevated generic prices, and low substitution rates. Using Medicaid prescription data for amoxicillin/clavulanate, metformin, and omeprazole, we calculated the savings that could have been realized if generic drugs had been available and fully substituted at their lowest cost when IP protection first expired (an average delay of twenty-six months). The delay in availability, elevated prices, and slow uptake of generic alternatives for these three drugs alone cost Medicaid 1.5 billion dollars in 2000-2004.

Actuarial Analysis↗