01.Marketing 'put ahead of safety'
An investigation by the British Medical Journal (BMJ) has found manufacturers of the blood-thinning stroke drug Pradaxa deliberately held back information on how to use the drug safely.
The maker of the drug, Boehringer Ingelheim, a multinational headquartered in Germany, announced it will fork out US$ 650m to settle about 4000 claims in state and federal court cases in the US.
The author of the BMJ investigation, Deborah Cohen, is quoted by the ABC as saying, "The key allegation here is the company had an opportunity to make [Pradaxa] far safer and it declined that opportunity because of marketing.
"To be blunt, the company had put marketing ahead of safety."
The ABC reports Pradaxa has been linked with 280 deaths and 1400 adverse reactions such as abdominal bleeding, brain haemorrhages, strokes and heart attacks in Australia in the last five years.
But the ABC also warns: "Specialists say it is important patients do not stop taking Pradaxa, because stopping suddenly could increase the risk of stroke. People with concerns should speak with their doctor."
The drug is used for people with irregular heart rhythms, otherwise known as atrial fibrillation, which can increase the risk of stroke, and for people who have major leg surgery such as hip and knee replacements, to prevent clots.
The BMJ investigation said the drug has been recommended in the US, Europe and Canada because it doesn't require monitoring of plasma levels and adjusting of doses. In fact, the key marketing advantage the drug is supposed to have over traditionally prescribed treatments such as warfarin, is that patients don’t need to have their blood levels monitored and doses subsequently adjusted.
Safety information 'withheld'
However, the BMJ says confidential documents released during litigation in the US show the manufacturer did not share information about the potential benefits of monitoring and adjusting the dose to ensure it is working safely. It also withheld analyses that calculated how many major bleeds dose adjustment could prevent.
The BMJ reportedly found a draft of a journal article Boehringer Ingelheim were intending to publish that suggests an "optimal plasma concentration" range could be attained using blood monitoring.
But in internal emails a medical team leader said he was not happy with the conclusion about an optimal range while another official said “the publication of the article will do more harm than be useful for us”.