Carol M. Ashton and Nelda P. Wray
- Published in print:
- 2013
- Published Online:
- September 2013
- ISBN:
- 9780199968565
- eISBN:
- 9780199346080
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199968565.003.0003
- Subject:
- Public Health and Epidemiology, Public Health
The principles of design, conduct, analysis and reporting of clinical trials, including trials conducted for regulatory purposes, are sufficiently advanced that drugs and other therapeutic ...
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The principles of design, conduct, analysis and reporting of clinical trials, including trials conducted for regulatory purposes, are sufficiently advanced that drugs and other therapeutic interventions can be put to fair tests that provide valid evidence of efficacy and safety. However, clinical research—especially research that can make a product a winner or a loser—is not a value-free human endeavor. The rosiglitazone story exemplifies how medical product manufacturers can manipulate regulatory evidence by designing trials to ensure certain answers are—or are not—obtained, how companies can try to intimidate scientists whose research yields unfavorable evidence about a product, and how ambiguous can be the evidence from clinical trials. Federally-mandated comparative effectiveness research does not generate evidence used in product regulation, but it generates evidence that has market implications. It therefore will always be at risk for the same kinds of manipulation observed in the rosiglitazone saga.Less
The principles of design, conduct, analysis and reporting of clinical trials, including trials conducted for regulatory purposes, are sufficiently advanced that drugs and other therapeutic interventions can be put to fair tests that provide valid evidence of efficacy and safety. However, clinical research—especially research that can make a product a winner or a loser—is not a value-free human endeavor. The rosiglitazone story exemplifies how medical product manufacturers can manipulate regulatory evidence by designing trials to ensure certain answers are—or are not—obtained, how companies can try to intimidate scientists whose research yields unfavorable evidence about a product, and how ambiguous can be the evidence from clinical trials. Federally-mandated comparative effectiveness research does not generate evidence used in product regulation, but it generates evidence that has market implications. It therefore will always be at risk for the same kinds of manipulation observed in the rosiglitazone saga.
Myles W. Jackson
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780262028660
- eISBN:
- 9780262327190
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262028660.003.0006
- Subject:
- History, History of Science, Technology, and Medicine
In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the ...
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In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the subject of biomedical research on chemokine receptors and is entangled in the complex political, social, and biomedical lineages of HIV/AIDS with Big Pharma playing the lead role. The gene’s genealogy has been humanized and inextricably linked to the lives of the tens of millions infected worldwide. Once again, intellectual property issues resurface. HIV/AIDS diagnostic tests and medications have been patented by Big and Small Pharma alike, and the ramifications of those patents have been felt worldwide, including India, where attempts are underway to create generic drugs, which bind to the HIV-co-receptor.Less
In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the subject of biomedical research on chemokine receptors and is entangled in the complex political, social, and biomedical lineages of HIV/AIDS with Big Pharma playing the lead role. The gene’s genealogy has been humanized and inextricably linked to the lives of the tens of millions infected worldwide. Once again, intellectual property issues resurface. HIV/AIDS diagnostic tests and medications have been patented by Big and Small Pharma alike, and the ramifications of those patents have been felt worldwide, including India, where attempts are underway to create generic drugs, which bind to the HIV-co-receptor.
