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 Hart's 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.

Beyond The High Prices Of Prescription Drugs: A Framework To Assess Costs, Resource Allocation, And Public Funding.

During the past century, an accumulation of laws, organizations, and policy mechanisms has led to increasing transfers of public funds to private drug manufacturers, straining budgets and enabling industry revenues beyond what markets could ordinarily sustain. Tax benefits and fee waivers subsidize industry research, while public institutions and charities help fund the creation of new products and pay for their use once they are approved. New exclusivities increase prices by delaying competition, and payment programs such as Medicare Part D help guarantee that prices will be paid no matter how high they rise. Members of the public thus pay for pharmaceuticals in more ways than is commonly recognized. This article provides a more comprehensive framework for legislators and scholars to use in assessing the total societal costs of drugs. Greater transparency is needed to clarify individual drug costs, facilitate appropriate resource allocation, and ensure that the amount of public funding is justified by the value of the drugs. Congress should direct the Government Accountability Office to study public contributions underlying the highest-cost drugs and should require periodic reporting by drug manufacturers of the direct and indirect public funding they receive.

Pharmaceuticals as a market for "lemons": Theory and practice.

Drawing on economic theory and institutional analysis, this paper reframes Akerlof's theory of how a market for lemons operates and argues that each of the many markets for lemons must be studied empirically to document how different stakeholders cope with the problems of information asymmetry, secrecy, and power. Such markets are a new field for sociological analysis. To illustrate, the paper characterizes pharmaceuticals as a multi-tier market of information asymmetry in which actors in each tier have substantial control over how much they disclose about hidden risks of harm. Such a market rewards the production and sale of "lemons." Current incentives and institutional practices reward developing a large number of barely therapeutically innovative drugs and ignoring their often hidden or understated harmful side effects. They reward designing and executing substandard, biased trials that mislead the FDA and regulators abroad to approve new drugs without clear evidence of their degree of harm. Approved drugs are likely to be "lemons" but promoted as "safe and effective." The result is substantial hospitalizations and deaths from adverse drug reactions. A "risk proliferation syndrome" of institutional practices maximizes sales, profits, and exposure to toxic side effects. An "inverse benefit law" of marketing operates as companies try to maximize sales. The probability of benefits decreases but the chances of lemons adverse events do not. The details presented here deepen understanding of how markets for lemons thrive on information asymmetry, secrecy, and power. Lessons can be applied to other markets.

Addressing Health Care Disparities: A Radical Perspective and Proposal.

This paper begins by rethinking the sociological theory that social conditions are fundamental causes of health disparities and that controlling disease ironically increases or creates them. While usually true, the radical proposal of non-profit health care and pharmaceutical development could ameliorate health disparities if a nation like Canada or a region like the EU looked to radically different but successful models such as the Drugs for Neglected Diseases initiative. It uses what could be called entrepreneurial collaboration for public health markets and inverts intellectual property to public health IP to maximize health gain instead of profits.

Policy making on data exclusivity in the European Union: from industrial interests to legal realities.

After lengthening the duration of patents to twenty years in 1984, the pharmaceutical industry has turned to data exclusivity as a major vehicle for extending market protection, even after patents expire. Such protections give companies the power to tax consumers for innovation by charging above-market prices. This article draws upon unique information to describe how key actors lengthened data exclusivity for patented drugs to postpone generic competition in the European Union (EU) just before ten new members joined it. We explore the political route and the interests of different actors to understand the process by which industrial interests are translated into legal realities in the world's largest harmonized market. Several factors influenced the outcome, including the role of the pharmaceutical unit of the Directorate General for Enterprise of the European Commission in promoting the interests of the innovative branch of the industry, the time pressure to find a viable compromise before EU enlargement, and the heterogeneous preferences of the other actors. The case illustrates the inherent tension between the desire of both health care administrators and patients for high-quality, low-cost medicines and the objective of the innovator pharmaceutical industry to find and approve new drugs that are price protected and sell them in a way that maximizes revenues.

A conservative case for universal access to health care.

Universal access to health care has historically faced strident opposition from political conservatives in the United States, although it has long been accepted by most conservatives in the rest of the industrialized world. Now, in a global economy where American business is crippled by the rising cost of market-based health care, the time may be ripe for change. The key to fostering a new mindset among American conservatives is to show why universal access fulfills many of the basic values that all conservatives hold.

Manufacturing costs of HPV vaccines for developing countries.

BACKGROUND: Nearly all of the 500,000 new cases of cervical cancer and 270,000 deaths occur in middle or lower income countries. Yet the two most prevalent HPV vaccines are unaffordable to most. Even prices to Gavi, the Vaccine Alliance, are unaffordable to graduating countries, once they lose Gavi subsidies. Merck and Glaxosmithkline (GSK) claim their prices to Gavi equal their manufacturing costs; but these costs remain undisclosed. We undertook this investigation to estimate those costs. METHODS: Searches in published and commercial literature for information about the manufacturing of these vaccines. Interviews with experts in vaccine manufacturing. FINDINGS: This detailed sensitivity analysis, based on the best available evidence, finds that after a first set of batches for affluent markets, manufacturing costs of Gardasil for developing countries range between $0.48 and $0.59 a dose, a fraction of its alleged costs of $4.50. Because volume of Cervarix is low, its per unit costs are much higher, though at comparable volumes, its costs would be similar. INTERPRETATION: Given the recovery of fixed and annual costs from sales in affluent markets, Merck's break-even price to Gavi could be $0.50-$0.60, not $4.50. These savings could support Gavi programs to strengthen delivery and increase coverage. Outside Gavi, prices to lower- and middle-income countries, with profit, could also be lowered and made available to millions more adolescents at risk. These estimates and their policy implications deserve further discussion.

Ironies of success: a new history of the American health care "system".

The context for contemporary research and policy is set through a theoretically informed history of the modern American health care system that draws on the concept of countervailing powers and Fligstein's theory of control. In this context, the papers of this special issue are then introduced.