Journal Article10.1258/147775007781870029
Vioxx and other pharmaceutical product withdrawals: ethical issues in ensuring the integrity of drug and medical device research, development and commercialization
K L Phua,F I Achike +1 more
3
TL;DR: It is argued that the steady stream of drug recalls indicates the existence of a systemic problem and threats to the integrity of each of these processes are discussed.
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Abstract: The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of products by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems.
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Citations
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Harm to the Health of the Public Arising from Aggressive Marketing and Sales of Health-Related Products and Services: Another Aspect of Medicalization Which is a Cause for Concern?
Kai-Lit Phua
- 15 Sep 2014
TL;DR: The view is that much more attention should be paid to this aspect of medicalization as a public health threat because of questionable marketing strategies used by drug companies.
References
Relationships between authors of clinical practice guidelines and the pharmaceutical industry.
TL;DR: There appears to be considerable interaction between CPG authors and the pharmaceutical industry, and the need for appropriate disclosure of financial conflicts of interest for authors of CPGs and a formal process for discussing these conflicts prior to CPG development is highlighted.
Failing the public health--rofecoxib, Merck, and the FDA.
TL;DR: On September 30, 2004, after more than 80 million patients had taken rofecoxib and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes.
Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology
TL;DR: Findings indicate that pharmaceutical company sponsorship of economic analyses is associated with reduced likelihood of reporting unfavorable results.
Pharmaceutical Advertisements in Leading Medical Journals: Experts' Assessments
TL;DR: This study aims to assess both the accuracy of scientific data presented in print pharmaceutical advertisements and the compliance of these advertisements with current Food and Drug Administrators' regulations.
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