In news reminiscent of Merck's deceitful coverup of negative Vioxx findings, Bayer didn't disclose the dangerous and fatal side effects associated with Trasylol, even during a late September meeting between company scientists and FDA officials to discuss safety concerns.
The FDA made the inquiry after a January New England Journal of Medicine paper argued not using Trasylol (a drug given to patients before heart surgery to reduce blood loss) would actually save money, preventing some 11,000 cases of kidney failure and saving more than $1 billion in dialysis costs annually.
At that Sept. 21 meeting, the FDA voted 18-0 not to alter any safety advisories for Trasylol. Six days later, the agency learned about Bayer's deception, but only after a scientist who had conducted newer research regarding the toxic effects of Trasylol tipped off a top FDA official.
Upon hearing the news, Sen. Charles Grassley (R-Iowa), chairman of the Senate Finance Committee, nailed the FDA calling them toothless and unable to hold drug companies like Bayer accountable for the things they do and don't do. Unfortunately, that's par for the course because the FDA, as it's currently configured, only serves the interests of its real clients -- the mega-drug companies -- and not you.
That's no surprise, considering 80 percent of the FDA's resources are budgeted to approve new drugs, and only 5 percent is earmarked for drug safety.
New York Times September 30, 2006 Registration Required
Spartanburg Herald-Journal September 30, 2006
Forbes.com September 29, 2006