Riata leads study ruffles feathers at St. Jude Medical; author stands by data

UPDATE:

In response to St. Jude Medical’s request for retraction, the editor-in-chief of the Heart Rhythm Journal said that he has offered the chance for St. Jude to write a letter to the editor but is not going to retract the article.

“I’ve talked with the leadership of the Heart Rhythm Society, I’ve talked with the study author, I’ve talked with the company and I cannot simply on the basis of a company’s statement retract an article,” said Dr. Douglas Zipes, managing editor of the Heart Rhythm Journal, in a phone interview.

Zipes said that the normal process for comment on an article is to submit a letter to the editor to which a study author has a chance to respond.

“Then the letter and rebuttal are published together,” Zipes said. “The other possibility is to conduct an independent review but that will take a long time.”

 

Recently, I got an anonymous email with an attached report of a study of St. Jude Medical’s (NYSE:STJ) recalled Riata leads that had been accepted for publication in the Heart Rhythm Journal.

The study concluded that Riata, which has been hit with a Class I recall, failed at high voltages and has killed 22 people. The main reason for failure was lead abrasion and not externalized conductors, which ironically was the reason for the recall. A St. Jude Medical spokeswoman hastily responded — it was clear that the company had had no time to analyze the manuscript given my deadline pressure — that lead abrasion, one of the causes of lead failure, was a well-known fact of older generation leads. St. Jude’s newer leads — especially Durata — don’t have the same problem, she noted.

By now, you probably know that St. Jude Medical has demanded a retraction of the manuscript published online by the Heart Rhythm Journal and called it inaccurate and biased.

“Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr. [Robert] Hauser, but can find no way of analyzing the [U.S. Food and Drug Administration's] MAUDE database that reproduces the same numbers reported in the manuscript.” read the statement issued Friday. “The company has identified duplicate reports, inconsistent categorizations and failures to include all available reports.”

However, Hauser, the study’s author and senior consulting cardiologist at the Minneapolis Heart Institute, said in an interview on Monday that he has read St. Jude’s statement and is not budging from the conclusions.

“I have no other comment other than we stand by our conclusions,” he said.

In its statement, St. Jude Medical also charges that Hauser should have compared Riata and Riata ST to other recalled leads — like Medtronic’s Sprint Fidelis lead, for instance. The company appears to be insinuating that Hauser is giving Medtronic a free pass.

On Monday, I asked Hauser if he had any conflicts he would like to disclose.

“As I’ve mentioned before, I don’t have any conflicts,” he said. “I don’t own any stock, I don’t take any money and I am not on any advisory board. How could I do what I do if I had any conflicts?”

Hauser has spoken about the risks of Riata and has irked St. Jude Medical before. It will be interesting to see what the Heart Rhythm Journal decides. Stay tuned ..

 

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