|Pradaxa is under fire again.|
Should drug company executives who are responsible for turning a drug into a financial winner also have a say over how a drug's risks are communicated to doctors and consumers, particularly a drug with fatal bleeding risks?
That is the question being raised around Boehringer Ingelheim's blockbuster blood thinner Pradaxa after a judge recently unsealed company documents that are part of litigation over the bleeding risks of Pradaxa. Some of the internal communications show that officials wanted to soften, or even kill, an internal report that suggested a small group of patients would benefit from regular blood monitoring for bleeding risks, The New York Times reports. The big selling point for Pradaxa and other new anticoagulants is that they are as effective at preventing heart attacks or strokes as the longtime standard treatment warfarin and don't require the hassle of constant blood monitoring that it does.
"In these situations, where the stakes are really high, how crazy is it that it's in the hands of people who are so conflicted?" Dr. Lisa M. Schwartz, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, told The New York Times.
And the stakes are high for Pradaxa and other new anticoagulants like Xarelto from Bayer and Johnson & Johnson ($JNJ) and Eliquis from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY). EvaluatePharma's World Preview report last year predicted that the market for anticoagulant drugs will expand by 11.5% annually through 2018, hitting $15.3 billion in sales. That makes it the fastest growing therapeutic area. Pradaxa was the first alternative approved and has been a big seller. It generated €612 million ($811 million) for the privately held German company in the first half of 2013, a jump of nearly 28%.
The research by Paul A. Reilly was recently published--but not before being circulated internally at Boehringer Ingelheim and questioned by marketing people who said it would make it harder to sell the drug. In an email to other company officials, Dr. Jutta Heinrich-Nols, who was the international project manager for Pradaxa, warned that the paper could undermine 10 years' worth of effort proving that patients taking Pradaxa didn't need to go through the hassle of regular tests, The New York Times reports. "I would like to ask you to check again whether this is really wanted," she wrote about the decision to publish the research. Dr. Andreas Clemens, who analyzed the RE-LY trial results on Pradaxa and gave advice to marketing about the drug, acknowledged that "The world is crying for this information," but said he was "not happy with the conclusion."
The disclosures come just weeks after the FDA said it had decided to take another look into the sometimes fatal bleeding risks of Pradaxa compared with warfarin. The review will be conducted by its Mini-Sentinel program, which monitors the safety of FDA-regulated medical products by assessing electronic healthcare data. As the NYT points out, Pradaxa has been linked to more than 1,000 bleeding deaths from among the 850,000 people who have been prescribed the drug. But warfarin also has bleeding risks. Pradaxa and warfarin ranked first and second on a recent list of the top 5 drugs tied to adverse events for 2012.
Boehringer Ingelheim has been steadfast in its support of the blood thinner, pointing to studies that its bleeding risks are no greater than those of warfarin. In a statement, the company told The Times that the recently unsealed documents "represent small fragments of the robust discussion and debate that is a vital component in all scientific inquiry, and in the research and development of any important medication such as Pradaxa."
- read The New York Times story