Dissatisfaction with the U.S. health care system is widespread, but no consensus has emerged as to how to reform it. The principal methods of finance -- employer-based insurance, means-tested insurance, and Medicare -- are deeply and irreparably flawed. Policymakers confront two fundamental questions: Should reform be incremental or comprehensive? And should priority be given to reforming the financing system or to improving organization and delivery? We consider here several proposals for incremental reform and three for comprehensive reform: individual mandates with subsidies, single payer, and universal vouchers. Over the long term, reform is likely to come in response to a major war, depression, or large-scale civil unrest.

The pharmaceutical industry is facing substantial criticism from many directions, including financial barriers to access to drugs in both developed and developing countries, high profits, spending on advertising and marketing, and other issues. Underlying these criticisms are fundamental questions about the value of the current patent-based drug development system. Six major problems with the patent system are (1) recovery of research costs by patent monopoly reduces access to drugs; (2) market demand rather than health needs determines research priorities; (3) resources between research and marketing are misallocated; (4) the market for drugs has inherent market failures; (5) overall investment in drug research and development is too low, compared with profits; and (6) the existing system discriminates against US patients.

Potential solutions fall into 3 categories: change in drug pricing through either price controls or tiered pricing; change in drug industry structure through a "buy-out" pricing system or with the public sector acting as exclusive research funder; and change in development incentives through a disease burden incentive system, orphan drug approaches, or requiring new drugs to demonstrate improvement over existing products prior to US Food and Drug Administration approval. We recommend 4 complementary reforms: (1) having no requirement to test new drug products against existing products prior to approval but requiring rigorous comparative postapproval testing; (2) international tiered pricing and systematic safeguards to prevent flow-back; (3) increased government-funded research and buy-out for select conditions; and (4) targeted experiments using other approaches for health conditions in which there has been little progress and innovation over the last few decades.

Background:

Eight randomized trials have evaluated whether the prophylactic use of an implantable cardioverter-defibrillator (ICD) improves survival among patients who are at risk for sudden death due to left ventricular systolic dysfunction but who have not had a life-threatening ventricular arrhythmia. We assessed the cost-effectiveness of the ICD in the populations represented in these primary-prevention trials.

Methods:

We developed a Markov model of the cost, quality of life, survival, and incremental cost-effectiveness of the prophylactic implantation of an ICD, as compared with control therapy, among patients with survival and mortality rates similar to those in each of the clinical trials. We modeled the efficacy of the ICD as a reduction in the relative risk of death on the basis of the hazard ratios reported in the individual clinical trials.

Results:

Use of the ICD increased lifetime costs in every trial. Two trials - the Coronary Artery Bypass Graft (CABG) Patch Trial and the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) - found that the prophylactic implantation of an ICD did not reduce the risk of death and thus was both more expensive and less effective than control therapy. For the other six trials - the Multicenter Automatic Defibrillator Implantation Trial (MADIT) I, MADIT II, the Multicenter Unsustained Tachycardia Trial (MUSTT), the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)- the use of an ICD was projected to add between 1.01 and 2.99 quality-adjusted life-years (QALY) and between $68,300 and $101,500 in cost. Using base-case assumptions, we found that the cost-effectiveness of the ICD as compared with control therapy in these six populations ranged from $34,000 to $70,200 per QALY gained. Sensitivity analyses showed that this cost-effectiveness ratio would remain below $100,000 per QALY as long as the ICD reduced mortality for seven or more years.

Conclusions:

Prophylactic implantation of an ICD has a cost-effectiveness ratio below $100,000 per QALY gained in populations in which a significant device-related reduction in mortality has been demonstrated.

Hereditary hemochromatosis is a genetic disorder of iron metabolism. Diagnosis of hereditary hemochromatosis is usually based on a combination of various genetic or phenotypic criteria. Decisions regarding screening are difficult because of the variable penetrance of mutations of the HFE gene and the absence of any definitive trials addressing the benefits and risks of therapeutic phlebotomy in asymptomatic patients or those with only laboratory abnormalities. The purpose of this guideline is to increase physician awareness of hereditary hemochromatosis, particularly the variable penetrance of genetic mutations; aid in case finding; and explain the role of genetic testing. This guideline provides recommendations based on a review of evidence in the accompanying background paper by Schmitt and colleagues. The target audience for this guideline is internists and other primary care physicians. The target patient population is all persons who have a probability or susceptibility of developing hereditary hemochromatosis, including the relatives of individuals who already have the disease.

People with stigmatized illnesses often avoid seeking health care and education. The internet may be a useful health education and outreach tool for this group. This study examined patterns of internet use for health information among those with and without stigmatized illnesses.

A national survey of internet users in the USA was conducted. Respondents who self-reported a stigmatized condition - defined as anxiety, depression, herpes, or urinary incontinence - were compared to respondents who reported having at least one other chronic illness, such as cancer, heart problems, diabetes, and back pain. The analytical sample consisted of 7014 respondents. Cross-sectional associations between stigmatized illness and frequency of internet use for information about health care, use of the internet for communication about health, changes in health care utilization after internet use, and satisfaction with the internet were determined.

After controlling for a number of potential confounders, those with stigmatized illnesses were significantly more likely to have used the internet for health information, to have communicated with clinicians about their condition using the internet, and to have increased utilization of health care based on information found on the internet, than those with non-stigmatized conditions. Length of time spent online, frequency of internet use, satisfaction with health information found on the internet, and discussion of internet findings with health care providers did not significantly differ between the two groups.

Results from this survey suggest that the internet may be a valuable health communication and education tool for populations who are affected by stigmatized illnesses.

This issue of CHP/PCOR's quarterly newsletter, which covers news from the summer 2005 quarter, includes articles about:

• our new core faculty member Grant Miller, a Harvard-trained health economist with an interest in improving health in developing countries;
• a discussion with center director Alan Garber on key issues and challenges facing the Medicare program;
• the fourth meeting of the Patient Safety Consortium, a group of more than 100 U.S. hospitals taking part in CHP/PCOR research on patient safety culture;
• core faculty member Jay Bhattacharya's research on HIV patients' perceptions of their lifespan as examined through viatical settlement transactions; and
• a research project on technology coverage decisions in the U.S. vs. the U.K., undertaken by Stirling Bryan, a U.K.-based Harkness Fellow in Health Care Policy who is spending the next academic year at CHP/PCOR.

Many stakeholders agree that the current model of U.S. health care competition is not working. Costs continue to rise at double-digit rates, and quality is far from optimal. One proposal for fixing health care markets is to eliminate provider networks and encourage informed, financially responsible consumers to choose the best provider for each condition. We argue that this "solution" will lead our health care markets toward even greater fragmentation and lack of coordination in the delivery system. Instead, we need markets that encourage integrated delivery systems, with incentives for teams of professionals to provide coordinated, efficient, evidence-based care, supported by state-of-the-art information technology.