A pharmaceutical company, Ameridose, founded by owners of the same pharmacy linked to a deadly meningitis outbreak, is recalling all of its products worldwide. Officials of the Food and Drug Administration (FDA) would not give specific details about the recall, but federal inspectors have pointed to uncleanliness and compromised sterility testing and associated procedures as probable and proximate causes of the recall.
Dr. Janet Woodcock is Director of the Center for Drug Evaluation and Research at the FDA. When asked about Ameridose’s troubles, Woodcock would only say, “We found there was not adequate assurance of sterility in their sterile products.” When pressed, she allowed that there were no known infections or outbreaks as a result of Ameridose’s operations. In fact, in a written statement, Ameridose declared that it ordered the recall on its own volition “out of an abundance of caution.” That statement reads, in pertinent part, thusly:
“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death. We are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations.”
Ameridose produces a number of injectable drugs, drugs which are used in everything from anesthesia to manipulating acid imbalances in the body during critical care. Ameridose “voluntarily” shut down for inspection last month when contaminated steroids from the New England Compounding Center (NECC) were linked to a nationwide meningitis outbreak.
As to the current state of that outbreak, the Centers for Disease Control and Prevention (CDC) has provided the following information: As of this writing, there are 386 meningitis cases throughout the United States. There have been 28 deaths in the following states: Florida (3), Indiana (3), Maryland (1), Michigan (7), North Carolina (1), Tennessee (11) and Virginia (2)
Both Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Although they are legally separate companies, Cadden was the lead pharmacist at the long since closed NECC. He also has now resigned from Ameridose.
I have earlier reported on the problems at NECC. That report may be found here: http://www.allvoices.com/contributed-new
The FDA inspectors reported the exact opposite results for both Ameridose and NECC. Dozens of infractions were noted. However, four examples should suffice and provide a “flavor” for what was going on in these drug factories:
1) Plants or trees were located within 10 feet of where drugs were being manufactured. Plants attract insects;
2) An actual live bird was found flying around a lab where drugs were being sterilized;
3) There were constant dripping, loud leaks from pipes and equipment; and,
4) Cracks in the ceiling and walls of a “clean room” used to manufacture sterile drugs were clearly seen. That particular clean room’s walls and ceiling oozed ‘‘thick residues that were orange, brown, and green’’ directly onto equipment used for sterilization.
As noted in my previous piece on this subject, these firms have lobbied Congress heavily for less “regulation” of their activities. It is probably fair to say that had Mitt Romney won the election last week, both of these companies would be back up and running full blast before Inauguration Day.