In a particularly horrifying installment of the popular CBS program “Sixty Minutes” which aired on Sunday, February 17th (directed by Solly Granatstein), the drug Trasylol 1.10, manufactured by Bayer, was exposed as a lethal cocktail for those undergoing heart surgery. The drug was prescribed for patients undergoing heart surgery, but the problem was that the drug also caused renal failure, often leading to the patient’s death.
This unfortunate side effect of the drug was noted by a Cologne doctor named Juergen Fischer, who notified Bayer, but says, onscreen, “I felt that Bayer wasn’t interested in exploring it.”
The drug was used for 14 years and was approved by the FDA in 1993 for use in cardiac transplant surgery, to stop bleeding. In 1998, Trasylol’s use was extended by the FDA to include approval for all heart surgery. However, in the CBS piece, it was revealed that FDA “approval” did not necessarily mean that the drug was safe, which, indeed, it was not. Bayer never paid to have any extensive testing of the drug done and the FDA “approval” meant only “It’s certifying that it doesn’t appear to be unsafe.”
How wrong Bayer was! The drug was used on 4 and ½ million patients over its 14 year run, one-third of those patients were Americans. Many of them died. What made their deaths even more difficult to understand and/or accept was that the FDA was warned, not once, but at least two times. Bayer and the FDA certainly dropped the ball on protecting the public, and they dropped it Big Time.
Dr. Daniel T. Mangano, who runs a non-profit agency to test drugs and make sure that they are, indeed, safe for public consumption, wrote an article that appeared in the New England Journal of Medicine in 1995 that had, as its base of study, 5,065 patients in 17 countries. The study showed that patients who were given Trasylol during surgery were at “an elevated risk of death and acute renal or kidney failure.” Independent physicians backed this up a second and a third study.
One of those physicians, who concurred with Dr. Mangano, was (Dr.) Nicholas Kukuchas, of Missouri Baptist Medical Center, who started a study in 1992 on 20 heart patients. Of the 20 patients in his small study, 65% or 13 of 20 had problems after being given Trasylol, so the study was discontinued “because the patients were dying.”
Enter Dr. Alexander Walker of Harvard, who conducted a study at Bayer’s request, which looked at the medical records of 70,000 patients given the drug and concurred that it was dangerous. It was especially irresponsible to use Trasylol 1.01 when 2 other less-expensive drugs, Cycklikapron and/or Aminocaproic acid could perform the same task (i.e., stop bleeding in cardiac surgery patients) at a cost of about $50 per shot, versus $1000 for the Trasylol 1.01, which might well cause a fatal failure of the patient’s kidneys as a side-effect to stopping the bleeding.
Witness the story of Joe Randoni, heartbreakingly portrayed onscreen. Joe was a healthy 52-year-old husband and father who went into the hospital to have a congenital heart murmur fixed by having heart valve surgery. Prior to undergoing the operation, his wife Josephine and daughter Marissa were told that the surgery had only a “5% post operative risk.” For four hours during his surgery, he was given the drug Trasylol 1.01 intravenously.
As a result of the operation, , Joe Randoni’s kidneys failed. He endured 19 operations in a period of 8 months. His gall bladder had to be removed. He was so bloated that his eyes had to be sewn shut to prevent cornea damage. Both legs had to be amputated due to poor circulation. Ten days after Joe Randoni’s surgery, the article about the dangers of Trasylol 1.01 written by Dr. Mangoni appeared in The New England Journal of Medicine entitled “The Risk Associated with Aprotinin in Cardiac Surgery.” But Dr. Mangano’s whistle-blowing article came too late to save the life of Joe Randoni.
Joe’s life was not as important as the $300 million in sales in 2005 that Bayer realized from Trasylol 1.01, nor the $750 million they projected they would make in 2006. Still, despite the deaths of trusting individuals like Joe Randoni, the company kept quiet about the perils of using Trasylol 1.01. 2006. In 2006, when high-ranking Bayer officials appeared before the FDA, they never mentioned the ongoing study with Dr. Alexander Walker of Harvard, which supported Dr. Mangano’s warnings.
Dr. Mangano wanted the FDA committee to review the data and take Trasylol off the market. For one thing, unbelievably, Bayer withheld the information that a second study (Dr. Walker’s) was backing up all of Dr. Mangano’s warnings. So another 2 years dragged by, 2 years in which approximately 1,000 lives a month were lost because doctors were using Trasylol 1.01 in their operating rooms, thinking it was ‘safe” when it wasn’t.
On September 13, 2006, Dr. Walker of Harvard told Bayer of his corroboration of Dr. Mangano’s studies, but the FDA chose to withhold that information from the FDA and, as a result, 431,000 additional patients were treated with the lethal drug during cardiac surgery and 1,000 a month died during this 2-year foot-dragging period. When Dr. William R. Hiatt, a high-ranking FDA review doctor was asked how that made him feel, he finally admitted that not telling the FDA was irresponsible and immoral. “I thought it was truly inappropriate,” he said, in the mildest terms possible.
Dr. Mangano kept blowing the whistle until, finally, Canada also conducted a study, which caused both Canada and Germany to ban the use of the drug. To me, Dr. Mangano emerges as the Ralph Nader of cardiac surgery medicine. Just as Ralph Nader warned us that a car was “unsafe at any speed,” Dr. Mangano warned physicians world-wide that use of Trasylol 1.01 was “unsafe for any cause.”
Here is Dr. Mandano’s parting comment: “Good medicine demands that you protect the patient. That’s at issue here. (You protect the patient), and not the drug, and not the profit margin.”
Thank you, Dr. Mangano.