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.

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.

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.

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 FDA's 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 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.

Historical and comparative reflections on the U.S. national health insurance reforms.

The 2010 US reforms addressed forms of public and private insurance designed to reinforce a delivery system that developed to maximize the autonomy of physicians and hospitals. That autonomy emphasizes fees and specialization, which led to for-profit incorporation and overtreatment. Powerful corporate lobbies have defeated previous reforms and diluted the impact of the Obama reform. It barely passed and does little to manage costs or rationalize medicine. US health care does not fit established models of welfare states and contains five different models of health care delivery. Most interesting are forms of democratically run community health centres. Selected features of the reforms are highlighted.