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The Trasylol Tragedy: No Reprisals for Bayer

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Sarasota, FLIf there is a lesson that could be taken from the Trasylol tragedy, it might be that drug makers who hide, avoid, or mistakenly withhold important safety data from public, or even medical consumption would face certain censure in some fashion as an inducement not to ever allow such an oversight to happen again.

That lesson, however, has either not been sufficiently learned, or there is no one with sufficient teeth to enforce it.

Heart Research"Eighteen months after Bayer AG, the makers of Trasylol, was found to have withheld from a US Food and Drug Administration (FDA) advisory panel information that could have proven damaging to the marketability of Trasylol and hasten its exit from the marketplace, the FDA had yet to respond beyond an obvious distaste for what had happened.

Dr. Dennis Mangano of the Ischemia Research and Education Foundation in San Bruno, California, the researcher who spearheaded an exhaustive examination of Trasylol only to have it shot down by the advisory panel in 2006, said in an interview last summer that if drug companies faced an automatic three-year suspension from submitting new drug applications as a consequence for the withholding of important data, such behavior would never happen again.

"The system is ridiculous," Mangano told a newspaper reporter. "It's all pro-industry. Who's protecting the patient?"

In a blistering expose published in the St. Petersburg Times this past August, facts surrounding the September 2006 FDA advisory panel meeting at which the safety and efficacy of Trasylol was being debated and Mangano's study dismissed, read like a scene out of an unhappy medical sitcom.

Certainly, no one was laughing—least of whom was Dr. Mangano, who saw fifteen years of his life shot down in flames by the panel. In a study that compared the hospital records of thousands of patients in dozens of countries, and incorporating over a million points of data, Mangano concluded that Trasylol put patients at higher risk for heart attack, stroke and renal failure.

That wasn't new. Kidney toxicity was identified as a concern as far back as 1993, when the drug was first approved.

And yet, even given the existence of far safer alternatives that were also far less expensive than Trasylol, the panel voted 18-0, it has been reported, to keep Trasylol on the market. Bayer AG presented its own findings that suggested, not surprisingly, that the benefits outweighed the risks.

One panel participant was heard to say upon the conclusion of the voting that he was pleased to see that Bayer came to the table with so much data (there was no mention of Mangano's study.)

Further, the panelist gushed, the company had made an attempt to be "overly transparent, which I find refreshing in this day and age."

Of course, it soon became clear that the company was less than transparent after all, when it was revealed days later that a prominent researcher from the Harvard School of Public Health had been hired by Bayer to conduct a study in an effort to dispute, or verify Mangano's findings. The researcher took six months to review an enormous database of 67,000 heart bypass patients (Trasylol, also known as aprotinin, helps to prevent bleeding in high-risk patients and therefore mitigates the need for transfusions).

His conclusions mirrored that of Mangano's, and Dr. Alexander Walker made sure that Bayer had the finished report in hand for the all-important panel discussion.

But it was never presented. Had it been, the outcome might have been vastly different. The Walker study would have verified Mangano's results, and served to dispute the positive data that Bayer had presented.

Bayer defended the oversight at the time by suggesting that the results were preliminary in nature, and that the giant Pharma company had mistakenly neglected to mention it.

However, inside the panel discussion, those who were there point to a lament articulated by several panel members regarding the need for more data.

"At no point," said Dr, Michael Lincoff of the Cleveland Clinic in Ohio, "did the Bayer folks say, 'It's on its way.'"

Bayer later reprimanded two employees over the affair. However, there was no formal censure from the FDA or any government body. Just over a year later, even after a subsequent FDA panel again voted to keep Trasylol on the market, a Canadian study halted early because their aprotinin patients were dying served as the final nail in the coffin for Trasylol. The mounting evidence, and public opinion was such that the manufacturer, and the FDA could ignore the warning signs no longer.

Sadly, had Bayer presented Dr. Walker's findings in September of 2006, and had the FDA advisory panel voted to remove Trasylol from the market in September 2006, instead of November of 2007, it has been reported that thousands of lives could have been saved.

Steve Findlay, a health care analyst with Consumers Union and a panel member in 2006, said Bayer's actions were "intentional and very disingenuous.

"Absolutely no one would say it was in the public interest, or the interest of people having heart surgery, for that information not to be made public."

Findlay said in the August 5th edition of the St. Petersburg Times that the incident reinforces the need for a bill pending in Congress that would give the FDA more power to require post approval drug studies.

Mangano takes that one step further, suggesting the only way to hold the drug companies accountable is to penalize them where it really hurts—in the bottom line. He proposes a ban on submitting new drug applications for three years.

"The pharmaceutical industry would straighten up in a matter of seconds because you'd be hitting them in the pocketbook," he said.

"If you don't give drug companies boundaries, they'll do anything they want. Only the end user here is the patient, and I think it's critical for the government to assume the goal of protecting patients," he said, in a statement published in the St. Petersburg Times.

Melissa Morrill's husband Sonny died soon after undergoing a routine heart operation in the fall of 2003. Days after his surgery his kidneys failed, and he had three massive heart attacks that killed him.

"Bayer knew this drug caused this sort of complication and they still kept it on the market," Morrill, a 53-year-old flight attendant for Delta, told the newspaper. "My husband was just a number, a form of income for them."

She is suing Bayer AG. The manufacturer is based in Leverkusen, Germany.



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