April 19, 2008, Gordon Gibb (LawyersandSettlements.com)
Questions about Trasylol Since 1963
Cologne, Germany: When Bayer AG convenes its annual stockholder's meeting on April 25th in Cologne, the German group Coalition against BAYER Dangers (CBG) will be on hand to introduce countermotions to the proceedings, one of which will focus on the history, and dangers of Trasylol (known as Aprotinin).
Among other issues about which it plans to challenge Bayer AG, is an alleged violation of the rules of responsible corporate management over the most recent fiscal year. Among other issues it wants to discuss with Bayer, including the construction of waste incinerators and coal plants on Bayer sites, Bayer business activities in Burma and Bayer's alleged participation in illegal price fixing cartels, is the Trasylol debacle:
"Only after intervention by the German Federal Institute for Drugs and Medical Devices (BfArM) did BAYER stop marketing its heart surgery drug, Trasylol in November 2007," the motion states.
"Although the risks of Trasylol had been known for a long time, the management stood by the drug to the bitter end. According to physician Dr. Dennis Mangano, halting sales in good time could have saved the lives of at least 22,000 patients. Mangano showed two years ago that Trasylol causes an above average number of severe side effects such as kidney damage, heart attacks and strokes.
"Quite recently, it became known that BAYER had commissioned a study back in the 1970s that showed a risk of kidney damage. However, the results landed in a drawer. At the beginning of the 1980s, BAYER was told of the risks yet again, but continued to market Trasylol regardless of the consequences."
It should be noted that while aprotinin has been around during the timeline the CBG suggests, Bayer was not given formal approval for Trasylol from the US Food and Drug Administration (FDA) until 1993.
It should also be noted that the Canadian BART study also played a significant role in the removal of Trasylol from the market, after participants on aprotinin (Trasylol) were dying at an alarming rate, when compared with patients taking two other, older alternatives. Bayer has stated previously that it is waiting for a complete analysis of the Canadian BART data before reaching any final conclusion as to the eventual fate of Trasylol.
However, it is also known that the German health authority conveyed to Bayer, in no uncertain terms last fall, that it wanted Trasylol off the market.
The Coalition Against BAYER Dangers raises an interesting sidebar regarding Trasylol, in that aprotinin has apparently been under the microscope for awhile-and has been around even longer.
Aprotinin was first isolated from bovine (cow) parotid glands in the year 1930, and independently as 'bovine pancreatic trypsin inhibitor' derived from cow pancreas in 1936. Aprotinin was finally purified from bovine lung in 1964, and its use in major surgery is reported to have commenced in the 1960s. Aprotinin was initially used to treat acute pancreatitis, but its use soon expanded into surgical procedures where excessive bleeding was a factor.
The capacity for aprotinin to reduce bleeding during complex surgery is key; it works by slowing down fibrinolysis, a process that leads to the breakdown of blood clots. The ultimate goal by using aprotinin was to reduce the need for blood transfusions duiring surgery, and the potential for organ damagae due to hypotension, or the low blood pressure that often stems from marked blood loss.
However, reports suggest that there have been questions about aprotinin since its clinical introduction way back in 1963, together with the concern about increased risk for patients re-exposed to aprotinin via multiple surgeries. According to a study authored in 2005 under the auspices of the Department of Thoracic, Cardiac and Vascular Surgery at Tubingen University Hospital at Tubingen, Germany and the Department of Anesthesiology at the German Heart Center Munich, at Munich Germany, the risk of anaphylaxis, or severe allergic reaction, was identified as 2.8 pert cent in re-exposed patients from data collected from as far back as 1963.
As well, as documented on the CBS Newsmagazine 60 Minutes, Dr. Juergen Fischer of the Instiutute of Experimental Medicine at the Univertsity of Cologne found severe kidney damage in animals given aprotinin. That red flag was accompanied by a similiar warning that popped up after a small study in 1992 involving just 20 patients. The outcome was significant to Dr. Nicholas Kouchoukos of the Missouri Baptist Medical Center. Dr. Kouchoukos is considered one of the top heart surgeons in the country. He conducted the study, and noted that out of the 20 participants, 13 were left with problems involving kidney function.
"This was the red flag," Kouchoukos told reporter Scott Pelley. "And it appeared that it was related to the use of Trasylol."
It has since been documented that several other small studies proved to be inconclusive: some showed kidney problems and renal malfunction, whereas others did not. Critics have suggested that Bayer was reluctant to fund any study large enough to determine once and for all whether a risk to the kidney was an issue. Given this lack of conclusive evidemce as to risk, vs. Trasylol's apparent effectiveness in the reduction of bleeding, the US Food and Drug Administration gave Trasylol the seal of approval in 1993.
It has since been shown that the red flags were right all along, although thousands of lives are thought to have been lost needlessly in the process.
The CBG wants to remind Bayer of that fact, in Cologne next Friday.