BloombergBy Jef Feeley and Michelle Fay CortezFeb 25, 2014Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show. Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show. The Food and Drug Administration was reviewing the bleeding as part of a safety check spurred by results seen in adverse incident reports sent to the agency. Andreas Clemens, an executive who oversees Pradaxa, acknowledged the Ingelheim, Germany-based company shared only one of the analyses and said he couldn’t say why, according to the unsealed court filings.
“Having run an analysis in several ways, there is no good reason not to disclose all the results,” said Harlan Krumholz, a Yale University cardiologist in New Haven, Connecticut, who is leading an effort to get companies and researchers to share their findings fully. Boehringer gave the FDA the underlying data and provided an analysis using what the drugmaker considered to be the most appropriate comparison, said Marjorie Moeling, a company spokeswoman, in an e-mailed response to questions. “The company is completely confident that all of the facts will show that Boehringer Ingelheim acted appropriately and responsibly.”
A company filing this month said Boehringer faces more than 2,000 suits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder. Regulators cleared the drug, which generated $1.4 billion in 2012 sales, as the first alternative to warfarin, a product sold by Bristol-Myers Squibb Co. under the brand name Coumadin that’s been used for 50 years to avert strokes caused by blood clots. Patient lawsuits contend Boehringer knew the drug posed a deadly risk when it won FDA approval. While warfarin offers a way to counteract excessive bleeding, there’s no approved antidote available yet for those on Pradaxa. In November, the company released data from the first human study of an antidote in 145 healthy volunteers. Boehringer’s decision to provide only one analysis on Pradaxa’s use after the drug’s approval may complicate the company’s defense as it prepares to face the first trial of claims that it hid the medication’s health risks.
“It is important to resist selective presentation of results, especially when the finding depends on which analysis is done,” said Krumholz, who isn’t involved in any of the Pradaxa lawsuits, by telephone. “The fact that different analyses of the same data can yield different conclusions makes it imperative that we promote an opportunity for independent analyses through data sharing so that these issues will be out in the open”…hat tip to pharmagossip…
Back at the end of January, when I read J&J chooses Yale to review requests for clinical drug data, I wrote a placemarker… vowing to keep an eye open on what happened. I’m suspicious of these independent panels to oversee Data Transparency. And after some experience with Martin Keller at Brown [Paxil Study 329] and Joseph Biederman at Harvard [childhood bipolar disease], the Ivy League thing has lost its former glow. So when Harlan Krumholz at Yale wrote Give the Data to the People, about his Yale University Open Data Access [YODA] program being chosen as the overseer of J&J’s clinical data, I was suspicious, and said so [reassure us…] – sending my post to Dr. Krumholz himself. He was offended, and as it turned out, he had every right to be offended [a patch of blue…]. I was the one in the wrong [thus my foot-in-mouth title and picture]. He had been involved in the Vioxx story in the rightest of ways and he directly reassured me without the usual evasions about the J&J panel deal. Harlan Krumholz is a white hat guy, and I hadn’t done enough homework to know that. While I come by my distrust honestly, I’ve obviously become paranoid and went off half-cocked. Like most of us, I don’t like admitting I was wrong, but I was.
The proof will be if the American College of Cardiology jumps on this Pradaxa thing and gets to the bottom of it. Academic/Organized psychiatry has not done that through all of our exposes and scandals. They’re either silent or worse, part of the defense. I think that’s why the Pradaxa story caught my eye. I realized that my expectation was that Medicine proper would get involved in an active way. Psychiatry hasn’t done that.
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