Donald W. Light

Pharmaceutical research and development: what do we get for all that money?

Data indicate that the widely touted “innovation crisis” in pharmaceuticals is a myth. The real innovation crisis, say Donald Light and Joel Lexchin, stems from current incentives that reward companies for developing large numbers of new drugs with few clinical advantages over existing ones

The changing character of the medical profession: a theoretical overview.

Technological advances in medicine have greatly enhanced the ability of physicians to treat disease and disability, but, at the same time, changes in the organization and management of health care services in the United States have imposed constraints on their autonomy. How have these changes--medical advancement and professional decline--affected the theoretical concept of the medical profession? Challenging the prevailing model of professional dominance, the concepts of deprofessionalization, corporatization, and proletarianization emphasize the effects of recent social and economic developments on the changing status of the medical profession. There is evidence, however, that what the proponents of these concepts perceive as the professions response to external forces are, in fact, the unanticipated consequences of the professions campaign for autonomy.

From Managed Competition to Managed Cooperation: Theory and Lessons from the British Experience

The United Kingdom led the world in transforming the largest single health care system from a publicly administered service to a set of interlocking contracts. Policy lessons that can be adapted by employers, nations, and other large payers are identified. These lessons are drawn from the improvements that the British made over the design of managed competition, the mistakes and problems they experienced, the underlying trends toward privatization and class discrimination, and the limitations to competition that have led the British toward managed cooperation in collaborative purchasing for the health needs of communities. Yet market reform and the rhetoric of efficiency have justified the shrinking of health services, the shift of costs to household budgets, and the use of public moneys to support private services and investors at greater expense by moving properties and services off the public ledger. In these ways, managed competition can Americanize health care and pose fundamental questions about what policy goals are really being pursued.

Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDAs prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board.

The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health

Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Harts inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.

Making the NHS more like Kaiser Permanente.

The NHS needs to break down the barriers between primary, secondary, and tertiary care The US health maintenance organisation Kaiser Permanente has been highlighted as a successful model of integrated, cost effective care. A key policy of the NHS and other health systems is to learn from this model. However, the changes being made by the English government overlook the key features that have enabled Kaiser to develop and implement its clinical and operational programmes. We examine the importance of integrating clinical governance as well as collaborative contracting in achieving integrated, patient centred services. In a highly influential article, Feachem and colleagues compared the costs and performance of the NHS with those of Kaiser Permanente in California. They concluded that Kaiser provided much better value, largely by using only a third of the acute bed days used in the NHS.1 Several serious criticisms were levelled at the methods used, but even if they are taken into account, the Kaiser system has much lower hospital admissions and shorter lengths of stay, especially for serious illnesses. Ham and colleagues carried out a more methodologically sound and detailed study of the Kaiser system.2 The data show such a much higher rate of hospital admission in the NHS for bronchitis and asthma and for angina pectoris. However, the admission rates for acute myocardial infarction, heart failure, and urinary infection were so much higher in Kaiser than the NHS that specialists in the two systems could be practising different types of medicine. Nevertheless, the overall question is how do doctors in Kaiser Permanente achieve such low rates of hospital admission and lengths of stay? Ham and colleagues point to several factors in the Kaiser system:

Life on the edge: immigrants confront the American health system

Abstract On the basis of a study of forty health care delivery institutions in Florida, California, and New Jersey, this paper examines the interaction between the immigration and health systems in the USA. We investigate barriers to care encountered by the foreign born, especially unauthorized immigrants, and the systemic contradictions between demand for their labour and the absence of an effective immigration policy. Lack of access and high costs have forced the uninsured poor into a series of coping strategies, which we describe in relation to commercial medicine. We highlight regional differences and the importance of local politics and history in shaping health care alternatives for the foreign born.

Market spiral pricing of cancer drugs

Every patient with cancer or another life-threatening disease wants the most effective treatment, but drug prices have become staggering. Twelve of the 13 new cancer drugs approved last year were priced above

Universal Health Care: Lessons From the British Experience

100,000 annually (Table 1), and a 20% copayment makes them unaffordable, even for well-insured patients. What determines the escalating prices of cancer drugs? Pharmaceutical experts often cite the high research costs and the benefit or added value of the new cancer drug. We believe that neither argument is well-founded and that pharmaceutical companies may be using a third strategy: constantly raising prices on last year’s drugs and then pricing new ones above the new market price level; this is known as the Market Spiral Pricing Strategy.

The real ethics of rationing

Britains National Health Service (NHS) was established in the wake of World War II amid a broad consensus that health care should be made available to all. Yet the British only barely succeeded in overcoming professional opposition to form the NHS out of the prewar mixture of limited national insurance, various voluntary insurance schemes, charity care, and public health services. Success stemmed from extraordinary leadership, a parliamentary system of government that gives the winning party great control, and a willingness to make major concessions to key stakeholders. As one of the basic models emulated worldwide, the NHS-in both its original form and its current restructuring-offers a number of relevant lessons for health reform in the United States.