Y. Tony Yang

Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section

Background:Since the 1990s, nationwide rates of vaginal birth after cesarean section (VBAC) have decreased sharply and rates of cesarean section have increased sharply. Both trends are consistent with clinical behavior aimed at reducing obstetricians’ exposure to malpractice litigation. Objective:To estimate the effects of malpractice pressure on rates of VBAC and cesarean section. Research Design, Subjects, Measures:We used state-level longitudinal mixed-effects regression models to examine data from the Natality Detail File on births in the United States (1991–2003). Malpractice pressure was measured by liability insurance premiums and tort reforms. Outcome measures were rates of VBAC, cesarean section, and primary cesarean section. Results:Malpractice premiums were positively associated with rates of cesarean section (&bgr; = 0.15, P = 0.02) and primary cesarean section (&bgr; = 0.16, P = 0.009), and negatively associated with VBAC rates (&bgr; = −0.35, P = 0.01). These estimates imply that a

Sociodemographic Predictors of Vaccination Exemptions on the Basis of Personal Belief in California

10,000 decrease in premiums for obstetrician-gynecologists would be associated with an increase of 0.35 percentage points (1.45%) in the VBAC rate and decreases of 0.15 and 0.16 percentage points (0.7% and 1.18%) in the rates of cesarean section and primary cesarean section, respectively; this would correspond to approximately 1600 more VBACs, 6000 fewer cesarean sections, and 3600 fewer primary cesarean sections nationwide in 2003. Two types of tort reform—caps on noneconomic damages and pretrial screening panels—were associated with lower rates of cesarean section and higher rates of VBAC. Conclusions:The liability environment influences choice of delivery method in obstetrics. The effects are not large, but reduced litigation pressure would likely lead to decreases in the total number cesarean sections and total delivery costs.

Legislative Prescriptions for Controlling Nonmedical Vaccine Exemptions

OBJECTIVES We examined the variability in the percentage of students with personal belief exemptions (PBEs) from mandatory vaccinations in California schools and communities according to income, education, race, and school characteristics. METHODS We used spatial lag models to analyze 2007-2013 PBE data from the California Department of Public Health. The analyses included school- and regional-level models, and separately examined the percentage of students with exemptions in 2013 and the change in percentages over time. RESULTS The percentage of students with PBEs doubled from 2007 to 2013, from 1.54% to 3.06%. Across all models, higher median household income and higher percentage of White race in the population, but not educational attainment, significantly predicted higher percentages of students with PBEs in 2013. Higher income, White population, and private school type significantly predicted greater increases in exemptions from 2007 to 2013, whereas higher educational attainment was associated with smaller increases. CONCLUSIONS Personal belief exemptions are more common in areas with a higher percentage of White race and higher income.

Obesity and Health System Reform: Private vs. Public Responsibility

This Viewpoint discusses types of exemptions from required vaccines and recent legislation to control numbers of nonmedical vaccine exemptions.

Maternity care and liability: pressing problems, substantive solutions.

Obesity is a particularly vexing public health challenge, since it not only underlies much disease and health spending but also largely stems from repeated personal behavioral choices. The newly enacted comprehensive health reform law contains a number of provisions to address obesity. For example, insurance companies are required to provide coverage for preventive-health services, which include obesity screening and nutritional counseling. In addition, employers will soon be able to offer premium discounts to workers who participate in wellness programs that emphasize behavioral choices. These policies presume that government intervention to reduce obesity is necessary and justified. Some people, however, argue that individuals have a compelling interest to pursue their own health and happiness as they see fit, and therefore any government intervention in these areas is an unwarranted intrusion into privacy and ones freedom to eat, drink, and exercise as much or as little as one wants. This paper clarifies the overlapping individual, employer, and social interest in each persons health generally to avoid obesity and its myriad costs in particular. The paper also explores recent evidence on the impact of government interventions on obesity through case studies on food labeling and employer-based anti-obesity interventions. Our analysis suggests a positive role for government intervention to reduce and prevent obesity. At the same time, we discuss criteria that can be used to draw lines between government, employer, and individual responsibility for health, and to derive principles that should guide and limit government interventions on obesity as health reforms various elements (e.g., exchanges, insurance market reforms) are implemented in the coming years.

Generic oncology drugs: are they all safe?

BACKGROUND This paper summarizes a new report presenting the best available research about the impact of the liability environment on maternity care, and policy options for improving this environment. Improved understanding of these matters can help to transcend polarized discourse and guide policy intervention. METHODS We used a best available evidence approach and drew on more recent empirical legal studies and health services research about maternity care and liability when available, and considered other studies when unavailable. FINDINGS The best available research does not support a series of widely held beliefs about maternity care and liability, including the economic impact of liability insurance premiums on maternity care clinicians, the existence of extensive defensive maternity care practice, and the impact of limiting the size of awards for non-economic damages in a malpractice lawsuit. In the practice of an average maternity caregiver, negligent injury of mothers and newborns seems to occur more frequently than any claim and far more frequently than a payout or trial. Many important gaps in knowledge relating to maternity care and liability remain. Some improvement strategies are likely to be more effective than others. CONCLUSIONS Empirical research does not support many widely held beliefs about maternity care and liability. The liability system does not currently serve well childbearing women and newborns, maternity care clinicians, or those who pay for maternity care. A number of promising strategies might lead to a higher functioning liability system, whereas others are unlikely to contribute to needed improvements.

Measles Outbreak as a Catalyst for Stricter Vaccine Exemption Legislation

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval.

“Right-to-Try” Legislation: Progress or Peril?

Following a multistate measles outbreak that began in Disneyland, California legislators responded to the outbreak by passing legislation repealing exemptions for philosophical and religious beliefs.1 Although the legislation retains medical exemptions, it makes California the largest state to have such strict childhood vaccination requirements, joining only West Virginia and Mississippi. Beginning in the 2016-2017 school year, children whose parents refuse vaccination and are unable to secure a medical exemption must be homeschooled.1 School-aged children who currently claim a nonmedical exemption can maintain it until the time they enter kindergarten or seventh grade, the state’s 2 vaccine checkpoints.1 The law applies to both public and private schools, as well as day care facilities.1

Why Physicians Should Oppose Assisted Suicide

Since 2014, state legislators have increased their efforts to find a way for terminally ill patients to gain legal access to experimental drugs not yet approvedbytheU.S.FoodandDrugAdministration(FDA).AsofJune1, 2015,40statesandtheDistrictofColumbiahadexaminedorwillexamine this burgeoning issue with bills that have already been filed and 18 signed so-called “Right-to-Try” laws (Table 1). Patients who are terminally ill and who are facing less than 1 year of life expectancy are willing to take greater risks and endure a higher danger of potential adverse effects than other patients, including taking experimental drugs with unknown risk-benefit ratios. For patients who have exhausted existing pharmacotherapy options, there are two conventional ways to access potentially life-prolonging investigational drugs: join a clinical trial if they are well enough to meet rigorous entry criteria or apply for FDA’s “compassionate use” exception. Although the FDA accepted 5,816 of the 5,849 expanded access applications it received in the last 4 years, some argue that the FDA approval process for allowing expanded access to experimental drugs has been slow and cumbersome. Besides, many of the delays in the process occur before submission to FDA when the drug sponsor is deciding whether or not to provide the drug in question. Although the compassionate use of investigational drugs has been a contentious issue, public debate has centered on whether the gain in providing the terminally ill with a slim chance at prolonging life is worth endangering a process designed to ensure the public health and the development of safe, effective medicines.

Change in Medical Exemptions From Immunization in California After Elimination of Personal Belief Exemptions

Is physician-assisted suicide ever justifiable? —No. “Physician assisted suicide is fundamentally inconsistent with the physicians professional role,” according to a long-standing position of the American Medical Association.1 That we are debating this question of whether physician-assisted suicide (or “physicianassisted death”) is ever justifiable shows how far medicine has shifted toward redefining the role of physician. If the medical profession accepts physician-assisted suicide, it will be declaring decisively that “physicians” are mere providers of services, to be guided only by the desires of the individual patient, the will of the state or other third parties, and what the law allows. The idea of medicine as a profession, which embodies a shared commitment to care for persons who are sick and debilitated so as to restore their health, will quickly fade into memory. Those made vulnerable by sickness and debility, to whom physicians owe their solidarity as physicians, will have much less reason to entrust themselves to physicians’ care. For centuries, physicians have worked to preserve the health of persons with terminal illness, respecting patients’ authority to refuse any treatment recommended. Often, physicians can do no more than preserve only small measures of health—such as the patient’s capacity to rest, eat, or have a bowel movement—or relieve those insults to health caused by pain or other distressing symptoms. To patients who are concerned that