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A. M. Flaum, R. Jager, R. Singh; Demographic Differences in FDA Drug Acceptance. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5213. doi: https://doi.org/.
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The purpose of this study was to obtain our clinic population’s understanding of FDA approval and off label use of certain drugs, namely Avastin and Leucentis. We wanted to compare our findings to those in Leeds- Bradford, UK because of the drastically different population demographics. The Chicago population surveyed was a low income/welfare supported population, whereas the UK population is middle to upper class
The study was based on a short questionnaire which was administered to patients in the retina and general ophthalmology clinic in Chicago, IL, 33 questionnaires were used with no exclusions. In Leeds-Bradford, UK, 31 questionnaires were used and none were excluded.
1.Have you heard of Avastin? US: yes:4, no: 29 UK yes:2 no:292.Have you heard of Lucentis? US yes 3, no:30UK yes 2, no:293. If yes, which one is approved by the FDA/ NICE?Doesn’t know : 33, in both US and UK4. IIf Drug A costs $35 dollars and Drug B costs $2,000 / month and they both treat the same condition, which drug do you think is likely to be better? US A:16, B: 5, DN 0, neither:12, inappropriate:2 UK A:7, B: 17, DN 5, neither: 2, Inappropriate:15.If Drug A is approved by the FDA and Drug B is not approved by the FDA, which drug do you think is more effective?US A :20, B: 5, N: 4, Blank:0 inappropriate:4UK A:16, B:5, N: 7, Blank:3, inappropriate:06.Would you be willing to have a drug given to you that is not approved at all by the FDA?US yes:6, no:27UK yes:9 no:18, Don’t know:4 7.Would you be willing to have a drug approved for veins, into the eye instead?US yes:19, no:14, don’t know: 0, Blank:2UK yes: 13,no:13 don’t know:3, Blank:
Although the sampled populations were not reflective of the "general population," but rather a selected population because of their presence in ophthalmology clinic, it was not surprising that most people had not heard of Avastin or Leucentis, nor did they know if either is approved by any regulatory bodies. The interesting finding was that 50% of people surveyed in Chicago chose the less expensive drug , or that price had nothing to do with the effectiveness of a drug. Whereas in the UK, the majority thought that the more expensive drug was better. This perhaps is due to the differences in demographics between the two populations. The Chicago population surveyed was a low income/ welfare population, while the UK group was middle to upper class. As predicted, most people would not use a drug not approved by a regulating body in either countries. Lastly, it was interesting to find that about 50 % of both populations surveyed would be willing to use an "off label" drug if their doctor recommended it. This is interesting because it is a rather common practice.
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