Greater transparency on clinical trial results would help reduce off-label promotion—the promotion of medicines for uses for which they have not been approved.
Looking at the US since 2004, I compiled a table of cases taken by the Department of Justice involving off-label promotion where the fines, penalties, and/or settlements came to more than $300 000—see attached. Penalties and settlements took into account the (mis)selling of the medicine to Medicare or other state funded schemes. Compensation to private healthcare providers or patients is not included.
Clearly off-label promotion is more than a temporary lapse or oversight by just a few companies.
Of the 17 companies listed, at least seven were among the top 10 companies by sales in recent years.
Of the medicines involved, at least 12 were among the top 10 selling branded medicines for one year or more.
So there was a lot of money involved, but the real damage was to the health and lives of tens of thousands of patients given the wrong medicine.
The forms of misselling were many and various—promoting medicines for children when they were only approved for adults, selling on the basis of symptoms when the same symptoms (e.g. dementia) may have many different causes, withholding publication of inconvenient trial results, citing partial results of trials that were never subject to regulatory review, mispricing etc.
In some cases the company pleaded guilty to one or more charge. In others, a settlement was agreed without any admission on the part of the company.
Doctors are sometimes justified in prescribing off label, but in these cases here the evidence for doing so was fatally corrupted.
Still, many prescribers, competitors, and even the companies’ own reps probably assumed that the companies had good evidence for the claims made. They might have known the truth sooner if the companies had had to be more transparent about their clinical trial results. In that case, indeed, the misselling might never have started in the first place.
The incidence of misselling among top companies and for top-selling medicines is something that should be taken into account by prudent regulators and legislators, yet there is very little sign of this happening. The proposals for more transparency from the European Medicines Agency and the European Parliament will partially address the issue, but it has been largely ignored by the European Commission, and indeed many national regulators.
But then, the attached table is about the US. Perhaps the same companies act very differently in the 28 member states of the European Union? Anyone care to comment?
Competing interests: I declare that that I have read and understood the BMJ Group policy on declaration of interests and I have no relevant interests to declare.
Jim Murray is a former director of BEUC, the European Consumers’ Organisation, having previously been the first director, Consumer Affairs and Fair Trade, in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently he is a member of the European Commission’s high level group on administrative burdens, and president of the European Foundation for Financial Inclusion.