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Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Overview of attention for article published in Journal of Pharmaceutical Policy and Practice, October 2015
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About this Attention Score

  • In the top 25% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#22 of 160)
  • High Attention Score compared to outputs of the same age (86th percentile)
  • High Attention Score compared to outputs of the same age and source (90th percentile)

Mentioned by

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18 tweeters
facebook
1 Facebook page

Citations

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12 Dimensions

Readers on

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39 Mendeley
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Title
Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study
Published in
Journal of Pharmaceutical Policy and Practice, October 2015
DOI 10.1186/s40545-015-0046-2
Pubmed ID
Authors

Agnes Vitry, Tuan Nguyen, Vikky Entwistle, Elizabeth Roughead

Abstract

Withdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. We present a case study of the US Food and Drug Administration (FDA)'s decision to withdraw the indication of bevacizumab for the treatment of advanced breast cancer and include an analysis of the reactions of stakeholders with a view to identifying opportunities for improving risk management for new medicines with conditional approval or funding. We drew on a range of information sources, including FDA documents, medical journals and media reports, to describe the evidentiary basis of the FDA decisions. We analysed the reactions and perspectives of the stakeholders. In 2008 bevacizumab was granted conditional approval for treatment of advanced breast cancer by the FDA pending submission of supplementary satisfactory evidence. In 2011 the FDA decision to withdraw the indication was met with a hostile reaction from many clinicians and cancer survivors. There were different interpretations of the therapeutic value of bevacizumab with strong beliefs among cancer survivors that the medicine was effective and potential harm was manageable. High expectations of the public may have been encouraged by overly positive media reports and limited understanding by the public of the complexity of the scientific evaluation of new medicines and of the regulatory processes. Improving understanding and acceptance of approval or coverage schemes conditional to evidence development may require the development of risk management plans by regulatory and funding institutions. They may include a range of strategies such as requirements for formal patient acknowledgment of the conditional availability of the medicine, 'black-triangle' equivalent labels that identify full approval is based on pending evidence, and ongoing communication with the media, public and health professionals.

Twitter Demographics

The data shown below were collected from the profiles of 18 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 39 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Estonia 1 3%
Unknown 38 97%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 7 18%
Student > Master 7 18%
Unspecified 6 15%
Other 4 10%
Researcher 4 10%
Other 11 28%
Readers by discipline Count As %
Unspecified 10 26%
Medicine and Dentistry 10 26%
Social Sciences 5 13%
Pharmacology, Toxicology and Pharmaceutical Science 4 10%
Economics, Econometrics and Finance 3 8%
Other 7 18%

Attention Score in Context

This research output has an Altmetric Attention Score of 11. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 10 March 2018.
All research outputs
#1,273,288
of 12,622,988 outputs
Outputs from Journal of Pharmaceutical Policy and Practice
#22
of 160 outputs
Outputs of similar age
#37,058
of 275,620 outputs
Outputs of similar age from Journal of Pharmaceutical Policy and Practice
#2
of 20 outputs
Altmetric has tracked 12,622,988 research outputs across all sources so far. Compared to these this one has done well and is in the 89th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 160 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.6. This one has done well, scoring higher than 86% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 275,620 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 86% of its contemporaries.
We're also able to compare this research output to 20 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 90% of its contemporaries.