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An analysis of common ethical justifications for compassionate use programs for experimental drugs

Overview of attention for article published in BMC Medical Ethics, October 2016
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  • In the top 25% of all research outputs scored by Altmetric
  • Good Attention Score compared to outputs of the same age (77th percentile)
  • Above-average Attention Score compared to outputs of the same age and source (61st percentile)

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11 tweeters
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2 Facebook pages

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41 Mendeley
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Title
An analysis of common ethical justifications for compassionate use programs for experimental drugs
Published in
BMC Medical Ethics, October 2016
DOI 10.1186/s12910-016-0145-x
Pubmed ID
Authors

Kasper Raus

Abstract

When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT's through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk (as they are already dying). Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy.

Twitter Demographics

The data shown below were collected from the profiles of 11 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 41 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 41 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 11 27%
Researcher 5 12%
Student > Doctoral Student 5 12%
Student > Bachelor 4 10%
Other 4 10%
Other 5 12%
Unknown 7 17%
Readers by discipline Count As %
Medicine and Dentistry 11 27%
Agricultural and Biological Sciences 6 15%
Nursing and Health Professions 4 10%
Biochemistry, Genetics and Molecular Biology 2 5%
Computer Science 2 5%
Other 6 15%
Unknown 10 24%

Attention Score in Context

This research output has an Altmetric Attention Score of 8. 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 11 April 2020.
All research outputs
#2,632,463
of 15,418,159 outputs
Outputs from BMC Medical Ethics
#296
of 677 outputs
Outputs of similar age
#67,150
of 294,925 outputs
Outputs of similar age from BMC Medical Ethics
#26
of 67 outputs
Altmetric has tracked 15,418,159 research outputs across all sources so far. Compared to these this one has done well and is in the 82nd percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 677 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.6. This one has gotten more attention than average, scoring higher than 56% 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 294,925 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 77% of its contemporaries.
We're also able to compare this research output to 67 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 61% of its contemporaries.