Trials Data - Part IV: Essay Panic

By Matthew Holford

Matthew writes exclusively for Seroxat Sufferers.


Yes, students: it's essay time. Essays must be submitted on or before the deadline, or will not be awarded a mark! Let me know if I've missed anything. I'll have a go at writing an answer over the next week, or so (unless you want to have a go yourself, of course!).

Advanced Bromide Consumption plc is a large pharmaceutical company with a product portfolio covering a wide range of medicines, amongst other things. Advanced Bromide has had a particular product, called The Drug, on the market for some time, and it has been very successful, in terms of sales. However, The Drug has only been licensed by regulators for prescription to adults, and as such may not be marketed for use in the treatment of minors. The Company is keen to have the product licensed for children and adolescents, because it perceives that it would be a valuable medicine, and should be available to doctors to prescribe more widely. The Company carries out several licensed trials with the medicine, but finds that the results are less than had been hoped for, with The Drug failing to demonstrate efficacy satisfactorily, and, moreover, the safety of The Drug is also called into question. Within the Company, it is accepted that these trials will not support an application for licensing of The Drug to minors.

Dave is a project director for Advanced Bromide, and his job description includes responsibility for overseeing and directing to completion clinical trials for his employer. Edwina is a senior statistician at Advanced Bromide. Amongst her duties, she is required to take raw data generated by trials investigators, analyse it and render it into a meaningful format, in order to establish the success of the trial. Fatima is a medical writer, employed by Good Healthy Information, Inc., which is a company specializing in writing up trials data with a view to submission for publication. Advanced Bromide is a client of Good Healthy. Jake is a key opinion leader in one of the areas that Advanced Bromide has significant interests in, and Jake is approached by Advanced Bromide with a view to authoring a piece reporting on one of the trials of The Drug for publication, with a view to licensing The Drug. Jake agrees, along with several of his professional colleagues, who have been similarly invited.

Dave and Edwina collaborate with Fatima, who then writes the piece, although key information concerning safety is deliberately underplayed, on Dave's instructions. In fact, the summary of adverse reactions indicates that six times as many triallists taking The Drug experienced suicidality as did placebo triallists, and with significantly more of The Drug's triallists being hospitalized due to this and other serious adverse reactions. The piece is published in the name of Jake and his colleagues, wherein it is claimed that The Drug was well tolerated and efficacious.

Discuss the criminal liability, if any, of Advanced Bromide Consumption, Dave, Edwina, Fatima, Good Healthy Information and Jake and his colleagues.

Answers must be no more than 2000 words, typed in 12-point and double line spaced.

Related links:
None, it's a completely fictitious exercise.