Drug company puts lives in danger while protecting their product

Taking the Cake

I’ve covered many cases of drug company greed and corruption over the years, but this one completely takes the cake. It really would be very hard to go lower than this.

As you might suspect, an unsafe drug is at the center of this controversy. It’s called Trasylol (manufactured by Bayer), and you’ve probably never heard of it because its use is so specific: It controls bleeding during heart operations. But for well over a decade Trasylol may have contributed to many thousands of deaths.

Bayer representatives knew this, and records show they withheld evidence from the FDA.

This deplorable case was covered on 60 Minutes a couple of weeks ago, but for those who missed it I’ll provide a simple but appalling timeline of events that illustrates how greed drives a drug company to protect product over people.

Time after time

Potential problems linked to Trasylol started showing up years before the drug was approved by the FDA.

EARLY 1980s: Dr. Juergen Fischer (director of the University of Cologne’s Institute of Experimental Medicine) tells Bayer executives he’s found evidence that Trasylol prompts severe kidney damage in animals. Dr. Fischer told 60 Minutes that he felt Bayer representatives weren’t interested in examining this troubling side effect.

1992: Heart surgeon Dr. Nicholas Kouchoukos conducts a small study in which Trasylol is given to 20 patients. Thirteen of these subjects experience some level of kidney malfunction.

1993: The FDA approves Trasylol for use during surgery on heart patients at high risk of bleeding, noting that the drug may cause kidney toxicity.

1998: The FDA approves Trasylol for use in any heart bypass operation.

2005: Sales of Trasylol reach $300 million. Sales for 2006 are projected at $750 million.

January, 26, 2006: Reality catches up with Trasylol when the New England Journal of Medicine features a study that examined more than 4,000 patients. Results showed Trasylol use doubled the risk of renal failure requiring dialysis, while also increasing risk of heart attack and stroke. The lead author of that study told 60 minutes that Trasylol use “showed a trend toward increased death in hospital.”

January 2006: The FDA issues a warning to alert doctors of the NEJM study results.

Early 2006: The FDA plans an advisory committee meeting to assess Trasylol safety. According to 60 Minutes, Bayer executives prepare for the meeting by launching a study to examine records of about 67,000 patients who had used Trasylol. Results show Trasylol increases risk of acute kidney failure and death.

September 26, 2006: With 18 yes votes and one abstention, an FDA advisory committee votes to ENDORSE the efficacy and safety of Trasylol. Bayer representatives are present at the committee meeting, but do not submit the results of the study they commissioned.

September 30, 2006: A whistleblower reveals the Bayer study results to the FDA.

November 5, 2007: When a Canadian Trasylol trial is halted, prompted by deaths among subjects taking the drug, 60 Minutes reports that “the FDA persuaded Bayer to suspend marketing temporarily, though surgeons can still use it in special cases.”

February 17, 2008: In a 60 Minutes interview, correspondent Scott Pelley asked Dennis T. Mangano, M.D. (the lead author of the January 2006 NEJM study), to estimate how many lives might have been saved if Trasylol had been taken off the market after his study was published. Dr. Mangano’s answer: 22,000.

Slight additional charge for side effects

You might think this miserable story couldn’t get any worse. But it does.

The 60 Minutes report notes that there are two other drugs that control bleeding during heart operations. Dr. Mangano states that these two drugs are just as effective as Trasylol, but with none of the adverse side effects.

And to ice the cake: Trasylol costs more than $1,000. The other two drugs cost $50. Which begs the question: Who makes the decision to use Trasylol? When your doctor prescribes Lipitor, for instance, you can go home and do some research about side effects before filling the prescription. But when you go into surgery, your doctor doesn’t suggest you use Trasylol. He administers it. Which begs question number tw Did Trasylol become a best selling drug because Bayer offered sweet perks to surgeons who chose their drug over the less expensive ones?

The FDA and Bayer both declined to discuss the Trasylol fiasco with 60 Minutes, but Bayer sent a letter stating: “Available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.”

Well, what can we really expect them to say? After all, they’ve got to do everything they can to support their legal department in what will surely be a flood of lawsuits, similar to the deluge of litigation that followed the Vioxx disaster a few years ago.

As I’ve noted in previous e-Alerts, anyone who takes a drug within the first few years after FDA approval is essentially participating in a safety trial. But instead of getting compensated to participate, they actually pay top dollar. Some pay with their lives.

“One Thousand Lives A Month” 60 Minutes, CBS News, 2/17/08, cbsnews.com
“The Risk Associated with Aprotinin in Cardiac Surgery” New England Journal of Medicine, Vol. 354, No. 4, 1/26/06, content.nejm.org
“Trasylol Pulled From Worldwide Market” Steven Reinberg, HealthDay News, 11/5/07, health.usnews.com
“Judging the Safety of Aprotinin” Dennis T. Mangano, Ph.D., M.D., Letter to the editor, New England Journal of Medicine, Vol. 355, No. 21, 11/23/06, content.nejm.org