The recent controversy surrounding a relatively new blood thinner called Pradaxa (dabigatran) centers not on the drug itself, but on the safety of the drug’s message. Brought to market as a superior product to the long-standing market leader, Coumadin (warfarin), Pradaxa is touted for its ability to treat atrial fibrillation without the inconvenience of frequent blood tests and diet monitoring imposed by its predecessor. Without this claim, the drug loses a lot of its competitive advantage.
Now in its fourth year on the market, the drug is not living up to its purported promise. In fact, it seems that the claim that patients can safely use the drug without some monitoring is not just a safety risk, but can prove deadly (the drug has been linked to 1,000 deaths in 850,000 users).
In the course of a large scale multi-district litigation, a federal judge in Illinois recently unsealed company documents revealing that the company knew about potential safety issues with the prescribed usage recommendations. The documents also uncovered that internal company employees were so concerned that a research paper supporting monitoring blood tests for Pradaxa users would damage drug sales that the author was pressured to revise it, or better yet silence the report altogether (see, Study of Drug for Blood Clots Caused a Stir, Records Show – NYTimes.com).
“This may not be a onetime test and could result in a more complex message (regular monitoring), and a weaker value proposition…vs. competitors,” wrote a company employee in response to the internal report. Another employee added to the discussion that “2 years ago there was an informed decision NOT to develop this…this would go against the ‘no monitoring’ idea/claim.” The circumstances here are reminiscent of the controversies surrounding drugs like Vioxx or SSRI’s for children. In both cases, companies selectively published and interpreted data to draw positive safety conclusions on how to use the drugs. Despite the companies’ knowledge that better safety information and prescription protocol was needed, the indications for use and other warnings were not changed until enough injuries and deaths led plaintiff attorneys to initiate lawsuits. The marketing and messaging issues presented by Pradaxa are certainly not new, but they are nonetheless striking. A drug’s intended message cannot lead the science. A rich trove of case law proves that misbranding or misrepresenting a drug’s benefits, including directions for use, likely results in physical harm to the user, and financial and/or legal harm to the drug’s maker. Apparently, Boehringer Ingelheim agrees – at least in part. A company leader, Dr. Andreas Clemens, responded to the research paper about the safety of Pradaxa in an internal email uncovered by the litigation: “The world is crying for this information…” However, he finished the sentence by adding “…but the tricky part is that we have to tailor the messages smart.”
When it comes to data on drug safety and use, what exactly is the “tricky part”? Should the public’s health be left to how “smartly” a message is tailored, or should we demand that the science speak for itself?
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.