What has big pharma learned from the Vioxx debacle? Apparently nothing.
Well done Boehringer Ingelheim. You’ve tainted the entire industry.
OK, so you say that the information withheld from regulatory bodies about an optimal plasma concentration range for Pradaxa, and therefore the benefits of close monitoring, did not hold up when assessed in the context of the major clinical trial. Further, that the article in the BMJ1 is ‘biased’ and contains ‘innuendo’ and ‘misleading statements’. Entirely plausible, truly. So why withhold all the data on bleeding rates? They were specifically requested by the FDA. Why provide only the most favourable analysis when it would have been so easy to include all the analyses conducted with appropriate explanations and disclaimers? The information was going to a scientific body, not the general public.
Now it’s a ‘story’. And it is of no consequence that major regulatory bodies – including the TGA – have said that access to the information would have made no difference to the recommendation for listing. Now the underlying mistrust of the public towards most large institutions has been validated, because, rightly or wrongly, the sound bites that come out of this story and stick in the collective consciousness are:
- a large pharmaceutical company lied to get a drug approved and make a profit
- this drug has put patient’s lives at risks
- it must be true because in the US the company has
- been ordered to pay nearly $1m in fines for withholding information
- set aside $650m to settle approximately 4,000 lawsuits related to serious bleeding.
1. Cohen D. BMJ, 2014; 349: g4670.