‘Breakthrough drug’ may not mean what the public think, survey finds

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29th September 2015 12:29 - Pharmaceutical

A recent US survey has revealed that what the Food and Drug Administration refers to as a ‘breakthrough’ drug, may not necessarily mean ‘Breakthrough’ drug may not mean what the public think, survey findswhat a regular, untrained person may believe.

Researchers from the Carnegie Mellon University, Pittsburgh, found that the Food and Drug Administration uses the term frequently, for smaller advances, than many people may think, which has led to false confidence in new drugs.

Approximately 600 people were recruited to take part in the study, online through Amazon’s Mechanical Turk. The samples were asked to read one of five short descriptions of recently approved drugs for metastatic lung cancer, with the ‘breakthrough’ drug designation.

The first description only outlines the facts about the drugs, such as the size of the trial, the findings from the trial and the side effects, amongst other facts. The description did not use the term ‘breakthrough’.

The second description used the same facts but described the drug as ‘promising’ and the third description used the term ‘breakthrough’.

The fourth description included language required for the Food and Drug Administration labelling, which explained that continued approval of the drug may be subject to change on future trials, confirming its effectiveness.

The fifth description did not say that the drug’s approval may be subject to change, but that it was subject to change.

The respondents were asked to gage the medicine’s benefits, harms and strength of evidence based on the description they’d been asked to read.

Of the respondents who read the first, facts only description, 11 per cent rated the drug as ‘very’ or ‘completely’ effective. Around a quarter of those who read the second and third ‘promising’ and breakthrough’ descriptions said the same. Many of those who read the second or third description said that the evidence supporting the new medicine was strong or very strong.

Just 10 to 16 per cent of those who read the fourth and fifth, ‘subject to change’ descriptions were likely to incorrectly believe that the drug was proven to save lives, as opposed to 31 per cent of those who read the ‘breakthrough’ description.

The respondents were also asked to read two further descriptions of a drug, one included the word ‘breakthrough’ and the other did not. More than 90 per cent said that they would choose to take the ‘breakthrough’ drug to treat a life-threatening illness.

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