Pradaxa information deliberately withheld?

Pharmaceutical company Boehringer Ingelheim in the criticism

07/28/2014

The application of the blood thinner Pradaxa (manufacturer Boehringer Ingelheim) holds a current contribution of the „British Medical Journal“ (BMJ), in their current form, can sometimes pose significant risks to patients. Here, regular checks of the blood values ​​could significantly improve the therapy safety, the authors write and combine with the statement a reproach to the pharmaceutical company: The information, on the basis of which, among other things, the US Food and Drug Administration had determined the use of Pradaxa had been incomplete, reports „BMJ“.

In the evaluation of the stroke medication, the supposedly unnecessary monitoring of the blood values ​​played, according to the „BMJ“ an essential role, as well as the possibility to waive an individual adjustment of the dosage. In the cost-benefit assessments this has made a clear advantage over the conventional stroke drug Marcumar. The contribution in the „BMJ“ however, Boehringer Ingelheim has it „failed to provide regulators with information on the potential benefits of monitoring and dose adjustment.“

Information withheld for marketing reasons?
the „BMJ“ According to internal research conducted since 2011, Boehringer Ingelheim has been aware that regularly measuring the plasma level of the drug and adjusting the dose accordingly can reduce the likelihood of major hemorrhage by 30 to 40 percent compared to the well-controlled use of warfarin. It has also been found that the plasma level sometimes varies considerably when taking the same dose. For marketing reasons, however, the pharmaceutical manufacturer decided not to publish the results of the investigation. Internal e-mails, which became public in a legal dispute, confirm that several employees of the company here saw a conflict with the market opportunities of Pradaxa (active ingredient Dabigatran), reports the BMJ. Finally, the pharmaceutical company has decided against the announcement of the investigation results.

Discussions about monitoring the medication
In the run-up to Pradaxa's approval, the BMJ authors have been discussing medication monitoring with both the Food and Drug Administration (US) and the European Medicines Agency (EMA). However, no need for monitoring was derived from the information available and „In the end, the FDA approved Dabigatran in October 2010 for use in stroke prevention in patients with atrial fibrillation, without the need to adjust the dose for each patient“, reports that „BMJ“. The EMA was approved in August 2011.

Older patients particularly at risk
After its launch, Pradaxa quickly became a success, reaching blockbuster status by April 2012 with more than $ 1 billion in revenue. Boehringer CEO Hubertus von Baumbach said that „The introduction of Pradaxa has been among the most successful launches in the pharmaceutical industry in recent years“, reports that „BMJ“. However, with the sale of Dabigatran, the discussion about deadly bleeding, especially in the elderly, was renewed. They are already at risk of bleeding, and Boehringer Ingelheim's marketing data shows that „45 percent of Pradaxa patients over 76 years or older“ are the BMJ authors write. An FDA report of all adverse events after taking Pradaxa showed that dabigatran had 542 deaths and 2,367 reports of bleeding, while warfarin accounted for 72 deaths in the same period. Thus, fundamental doubts about the safety of therapy are appropriate and, if necessary, the guidelines for monitoring and adjusting the dosage should be corrected, the authors conclude. (Fp)