FDA Report Shows 49 Problems at Merck Vaccine Plant
April 30th, 2008Via: Philadelphia Enquirer:
FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The agency could go on to issue a warning letter and take other actions if its concerns are not addressed. The FDA declined repeated requests to comment.
The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted “fibers” were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by “lesser quality” supplies from a vendor, the FDA report said.
The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year.
Several experts said no single finding was horrendous but that the overall pattern was troubling. “It’s the sum of many small things that puts the whole operation in question,” said consultant Wheelwright.
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That Merck would be having problems with FDA inspectors surprised several longtime company observers.
Sammie Young, a retired FDA deputy director, inspected the West Point plant early in his career and for many years oversaw vaccine-plant inspections for the entire agency.
“There are a lot of violations there [in the report],” Young said, after reading the report. “I’m surprised.”
He said vaccine-makers were supposed to investigate vaccine lots if their use was associated with a death or a life-threatening event.
Merck failed to investigate two such cases, the FDA report said. A patient treated with the pneumococcal vaccine Pneumovax developed a half-dollar-size abscess and needed intravenous antibiotics to contain the infection. A pregnant woman who took the HPV vaccine Gardasil lost her baby, the FDA report noted. The Gardasil packaging warns against its use for pregnant women.
“I am concerned about the adverse-event reporting system,” Young said. “It looks like the people didn’t know when they were supposed to report. I find that hard to believe.”
Wheelwright, a consultant with 25 years’ experience in vaccine manufacturing, suspects that the workload could be overwhelming.
“I would not judge the plant as being out of control,” he wrote in an e-mail. “There are numerous issues where they failed to comply with their own documentation and SOP [standard operating procedure] requirements. This suggests insufficient staff. There are other instances where the validation was insufficient. This also looks to me like overwork of the available crew. Sometimes in a plant where everyone feels overburdened . . . they give up trying to do everything and just try to keep their heads above water.”
Imagine what they’d find if the FDA wasn’t massively underfunded and staffed by industry insiders…!
While I’ve been tuning out NPR more frequently lately (just cause of the cutesey stories re the campaign trail) there was some gawd-awful replay of testimony re victims of Heparin contamination.
The father of a family just about wiped out by the drug crying on the airwaves. Really heartbreaking. I remember when my sister died from mesothelioma that I was asked to testify before Congress re her death and I said no I cannot. After hearing that testimony on NPR I thought that I would have collapsed talking about this issue in front of the suits. NOTHING to stop death ever seems to be accomplished.
Of course the intrepid reporters from NPR did not replay the dilemna people in the U.S. (prior to the advent of Medicaire part D), and of people in the U.S. trying to buy drugs from Canada and how the FDA said back then, that they were worried about quality. Right. And now, whoever the drug company was that sent Heparin production to China (probably Merck) is crying deliberate contamination.
It’s never been about quality, its always about monetary.
I wonder if free thinking was allowed from China what they would have to say about the Western world descending on them as a cheap labor force? Polluting their world; tearing families apart to earning an effing buck to buy what? Cheap shit from Amerika?
No wonder the world hates the U.S. Puts lead in paint on toys. Does whatever than can do, however minaminally, to send the message, we HATE YOU!
The FDA is saying now that they are going to try to open up thousands of jobs for scientists and inspectors for OVERSEAS plants?
If people on Medicaire in the U.S. are forced to buy drugs from a list of providers, and the drugs are paid for with their dollars, shouldn’t the drugs be made in U.S. and be inspected for “U.S. quality.”
I think that only stands to reason, but NOTHING ABOUT DRUGS IN THE US makes sense (cents) anymore.
Hell to peoples health. The drug companies need to make a profit, right?
Aargh.
If the FDA opens an IG office I’ll be there. I’d relish taking hunks of meat out of these god damn drug company hogs with my teeth.