By several estimations, the response from St. Jude Medical (NYSE: STJ) to a prominent cardiologist critical of the company’s faulty Riata leads has been unprecedented.
St. Jude Medical launched an offensive against Dr. Robert Hauser, a senior consulting cardiologist at the Minneapolis Heart Institute, calling his study critical of the company’s recalled leads as inaccurate and riddled with errors. It even pulled Medtronic into the fray, insinuating that Hauser was biased in its favor.
Despite the heavy-handed approach, the Heart Rhythm Journal declined to acquiesce to St. Jude’s demand that the study be retracted.
The stock suffered following the public rebuke of Hauser.
And less than two weeks after going on the offensive, St. Jude Medical CEO Daniel Starks appeared to be lowering the temperature in a conference call discussing the firm’s first quarter performance.
“Let me just start by saying that very sincerely we have a lot of respect for Dr. Hauser’s contribution over the years to raising awareness about medical device safety issues. We have far more in common than not. We are both focused on patient safety. We are both focused on getting as much accurate information about medical devices’ performance to physicians as possible to help them make the best decisions about their patients. Unfortunately the Heart Rhythm Journal published the manuscript submitted by Dr. Hauser contained important errors that were not identified during the peer review process and were widely circulated and really this just put everyone in an awkward position. Keeping in mind that this information is about life-saving medical devices, it’s important for us to continue to inform patients with the most accurate information that we can and continue to inform physicians. So we are now working with the Heart Rhythm Journal to address this issue in a way that will be most helpful for patients and physicians and we think that’s important for us to do so.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Reached in Dubai, the editor-in-chief of the Heart Rhythm Journal — Dr. Douglas Zipes — said, once again, that there has been no change to the data in the Hauser manuscript, which is now published. Previously, Hauser said that he had no other comment besides that he stood behind his data and conclusions.
On Wednesday, Dr. Hauser did not respond to a call and email seeking comment.
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