Despite Criticism Of The FDA Review Process, New Cancer Drugs Reach Patients Sooner In The United States Than In Europe

In accounting research, the role of organizational leaders has been underrepresented. The limited research dealing with leadership issues has focused on the impact of leadership on micro activities such as performance evaluation, budget satisfaction, and audit team performance. The impact of leadership on the structure of accounting and audit systems and organizations has been ignored. This paper focuses on the impact that past Comptrollers General have had on the working and structure of one federal audit agency, the United States General Accounting Office (GAO). In addition, it also focuses on the influence of the two most recent Comptrollers General on one important audit related activity, i.e., the audit report review process. Using qualitative field research methods, this paper documents how the organizational leadership impacts its long-term audit practices and thereby influences auditing, especially in the public sector.

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Continental Divide? The Attitudes of US and Canadian Oncologists on the Costs, Cost-Effectiveness, and Health Policies Associated With New Cancer Drugs

Journal of Clinical Oncology ◽

10.1200/jco.2010.29.1625 ◽

2010 ◽

Vol 28 (27) ◽

pp. 4149-4153 ◽

Cited By ~ 50

Author(s):

Scott R. Berry ◽

Chaim M. Bell ◽

Peter A. Ubel ◽

William K. Evans ◽

Eric Nadler ◽

...

Keyword(s):

United States ◽

Health Care ◽

Cost Effectiveness ◽

Health Care Systems ◽

The United States ◽

Drug Costs ◽

Cancer Drug ◽

Cancer Drugs ◽

Care Systems ◽

Effective Treatments

Purpose Oncologists in the United States and Canada work in different health care systems, but physicians in both countries face challenges posed by the rising costs of cancer drugs. We compared their attitudes regarding the costs and cost-effectiveness of medications and related health policy. Methods Survey responses of a random sample of 1,355 United States and 238 Canadian medical oncologists (all outside of Québec) were compared. Results Response rate was 59%. More US oncologists (67% v 52%; P < .001) favor access to effective treatments regardless of cost, while more Canadians favor access to effective treatments only if they are cost-effective (75% v 58%; P < .001). Most (84% US, 80% Canadian) oncologists state that patient out-of-pocket costs influence their treatment recommendations, but less than half the respondents always or frequently discuss the costs of treatments with their patients. The majority of oncologists favor more use of cost-effectiveness data in coverage decisions (80% US, 69% Canadian; P = .004), but fewer than half the oncologists in both countries feel well equipped to use cost-effectiveness information. Majorities of oncologists favor government price controls (57% US, 68% Canadian; P = .01), but less than half favor more cost-sharing by patients (29% US, 41% Canadian; P = .004). Oncologists in both countries prefer to have physicians and nonprofit agencies determine whether drugs provide good value. Conclusion Oncologists in the United States and Canada generally have similar attitudes regarding cancer drug costs, cost-effectiveness, and associated policies, despite practicing in different health care systems. The results support providing education to help oncologists in both countries use cost-effectiveness information and discuss drug costs with their patients.

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Cancer Drugs: An International Comparison of Postlicensing Price Inflation

Journal of Oncology Practice ◽

10.1200/jop.2016.014431 ◽

2017 ◽

Vol 13 (6) ◽

pp. e538-e542 ◽

Cited By ~ 16

Author(s):

Philip Savage ◽

Sarah Mahmoud ◽

Yogin Patel ◽

Hagop Kantarjian

Keyword(s):

United States ◽

Health Care ◽

United Kingdom ◽

The United States ◽

Cancer Drug ◽

Cancer Drugs ◽

Price Inflation ◽

Drug Prices ◽

The United Kingdom ◽

Price Increases

Purpose: The cost of cancer drugs forms a rising proportion of health care budgets worldwide. A number of studies have examined international comparisons of initial cost, but there is little work on postlicensing price increases. To examine this, we compared cancer drug prices at initial sale and subsequent price inflation in the United States and United Kingdom and also reviewed relevant price control mechanisms. Methods: The 10 top-selling cancer drugs were selected, and their prices at initial launch and in 2015 were compared. Standard nondiscounted prices were obtained from the relevant annual copies of the RED BOOK and the British National Formulary. Results: At initial marketing, prices were on average 42% higher in the United States than in the United Kingdom. After licensing in the United States, all 10 drugs had price rises averaging an overall annual 8.8% (range, 1.4% to 24.1%) increase. In comparison, in the United Kingdom, six drugs had unchanged prices, two had decreased prices, and two had modest price increases. The overall annual increase in the United Kingdom was 0.24%. Conclusion: Cancer drug prices are rising substantially, both at their initial marketing price and, in the United States, at postlicensing prices. In the United Kingdom, the Pharmaceutical Price Regulation Scheme, an agreement between the government and the pharmaceutical industry, controls health care costs while allowing a return on investment and funds for research. The increasing costs of cancer drugs are approaching the limits of sustainability, and a similar government-industry agreement may allow stability for both health care provision and the pharmaceutical industry in the United States.

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How International Is Political Science? Patterns of Submission and Publication in the American Political Science Review

Political Science and Politics ◽

10.1017/s1049096518000963 ◽

2018 ◽

Vol 51 (4) ◽

pp. 789-798 ◽

Cited By ~ 1

Author(s):

Marijke Breuning ◽

Ayal Feinberg ◽

Benjamin Isaak Gross ◽

Melissa Martinez ◽

Ramesh Sharma ◽

...

Keyword(s):

United States ◽

Political Science ◽

Review Process ◽

American Political Science Review ◽

Geographic Location ◽

The United States ◽

Science Review ◽

Global North ◽

American Political Science ◽

The Impact

ABSTRACTHow international in scope is publishing in political science? Previous studies have shown that the top journals primarily publish work by scholars from the United States and, to a lesser extent, other global-north countries. However, these studies used published content and could not evaluate the impact of the review process on the relative absence of international scholars in journals. This article evaluates patterns of submission and publication by US and international scholars for the American Political Science Review—one of the most selective peer-reviewed journals in the discipline. We found that scholars from the United States and other global-north countries are published approximately in proportion to submissions but that global-south scholars fare less well. We also found that scholars affiliated with prestigious universities are overrepresented, irrespective of geographic location. The article concludes with observations about the implications of these findings for efforts to internationalize the discipline.

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Public Availability of Results of Trials Assessing Cancer Drugs in the United States

Journal of Clinical Oncology ◽

10.1200/jco.2012.46.9577 ◽

2013 ◽

Vol 31 (24) ◽

pp. 2998-3003 ◽

Cited By ~ 27

Author(s):

Thi-Anh-Hoa Nguyen ◽

Agnes Dechartres ◽

Soraya Belgherbi ◽

Philippe Ravaud

Keyword(s):

United States ◽

The United States ◽

Phase Iii ◽

Cancer Drugs ◽

Randomized Controlled ◽

Kaplan Meier ◽

Phase Iii Trials ◽

Completion Date ◽

Public Availability ◽

Over Time

Purpose To evaluate to what extent results of completed trials of cancer drugs conducted in the United States are publicly available at ClinicalTrials.gov, as required by the Food and Drug Administration Amendments Act (FDAAA), or are published in journals. Methods We searched ClinicalTrials.gov for cancer trials governed by the FDAAA: phase II to IV trials assessing drugs in the United States with a primary completion date between December 26, 2007, and May 31, 2010. For each trial, we also searched PubMed to identify the publication of results. We assessed the cumulative percentages of posted or published results over time by using the Kaplan-Meier method. Results We identified 646 trials, including 209 randomized controlled trials (RCTs). At 12 months after completion of the trials, the cumulative percentages of trials with results posted at ClinicalTrials.gov, published in journals, and available either at ClinicalTrials.gov or in journals were 9% (95% CI, 7% to 11%), 12% (95% CI, 10% to 15%), and 20% (95% CI, 17% to 23%), respectively, and for RCTs, the percentages were 12% (95% CI, 8% to 16%), 5% (95% CI, 2% to 8%), and 17% (95% CI, 12% to 22%), respectively. At 36 months, these percentages were 31% (95% CI, 28% to 35%), 35% (95% CI, 31% to 39%), and 55% (95% CI, 51% to 59%), respectively, and for RCTs, they were 38% (95% CI, 31% to 45%), 32% (95% CI, 25% to 39%), and 56% (95% CI, 48% to 62%), respectively. Public availability of phase III trials was 15% (95% CI, 7% to 23%) at 12 months, 39% (95% CI, 27% to 49%) at 24 months, and 64% (95% CI, 50% to 73%) at 36 months. Conclusion Despite the FDAAA, results for nearly half the trials of cancer drugs in the United States were not publicly available 3 years after completion of the trials.

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The Oxford Handbook of Racial and Ethnic Politics in the United States

10.1093/oxfordhb/9780199566631.001.0001 ◽

2014 ◽

Keyword(s):

United States ◽

Online Publication ◽

Review Process ◽

Ethnic Politics ◽

The United States ◽

Publication Date ◽

Print Publication ◽

Pass Through

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