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According to newly unsealed legal documents, Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa were anxious that an internal research paper would damage drug sales and they suggested it should be suppressed.
Key Documents Unsealed
The key documents were recently made public by Chief Judge David Herndon in Illinois who is overseeing thousands of lawsuits filed by patients, who claim that the German company Boehringer Ingelheim, failed to properly warn them about the risks of taking the drug.
Since its approval in 2010, the drug, which can cause fatal bleeding, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health. It has been prescribed to 850,000 patients, and has been linked to more than 1,000
Internal Research Paper Torpedoes Pradaxa Benefits
Many of the documents released included emails, memos and internal presentations, and a research paper which would torpedo Pradaxa’s main claim, that it does not require regular blood tests to ensure it is working.
Testing is at the heart of the controversy, because Pradaxa and two other recently approved drugs, Xarelto and Eliquis, are in a race to gain market share from warfarin, a generic drug that has been the standard treatment for preventing blood clots and strokes. Many patients regard warfarin as a nuisance because it requires frequent blood tests and careful attention to diet and other drugs.
The new drugs claim not require such monitoring, and claim to be better, at preventing strokes and blood clots in patients with a heart-rhythm disorder known as atrial fibrillation.
Internal Fight to Suppress Research Paper
The documents and the results of the research paper, written by Paul A. Reilly, an employee at the company, indicated that some patients could benefit from monitoring of their blood. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.
One company supervisor, Dr. Jutta Heinrich-Nols, wrote in an email to other employees that she could not believe the company was planning to publish research that would negate a decade’s worth of work proving that patients taking Pradaxa would not need regular tests.
Publishing the research results, she warned, could make it “extremely difficult” for the company to defend its long-held position to regulators that Pradaxa did not require testing.
Need for Blood Testing Suppressed
According to pharmaceutical experts, the documents demonstrates how much information about drug safety is in the hands of people with a financial interest in the outcome.
Dr. Reilly’s paper was published recently in the Journal of the American College of Cardiology, and although many of the conclusions in the draft version remained, references to a patient’s optimal blood-level range no longer appear in the article.
Pradaxa Side Effects
Medical experts aid the newly released documents show that drug makers and regulators had been too eager to approve such powerful drugs without more careful monitoring.
“The one-size-fits-all was a mistake for a drug with this kind of risk,” said Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices, which keeps track of safety reports submitted to the F.D.A. He rated anticoagulants — including warfarin and Pradaxa — as the most serious safety problem in 2011 and 2012. He said Pradaxa has been cited in more than 1,000 deaths reported to the agency through the end of 2012.