Re: Fungal meningitis outbreak
New allegations in deadly meningitis outbreak
The specialty pharmacy linked to a deadly meningitis outbreak
may have misled regulators and done work beyond the scope of its state license, Massachusetts Gov. Deval Patrick said Wednesday.
That pharmacy also settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.
Meanwhile,
a second pharmacy connected to the New England Compounding Center in Framingham has shut down for state and federal inspection, and was accused by a business customer this summer of failing to separate sterile and non-sterile supplies, a charge the company denies. The Framingham-based compounding center made a steroid that was used in injections for back pain that were later found to be contaminated.
More than 130 people in 11 states have been sickened. Twelve have died.
On Wednesday, Patrick told reporters that state and federal agencies "may have been misled by some of the information we were given" by the compounding center.
The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said.
"What they were doing instead is
making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license," he said.
Massachusetts U.S. Rep. Ed Markey seized on Patrick's statement and sent a letter to the U.S. Food and Drug Administration, asking if it believes it was misled by the company.
"This company
may have disregarded federal guidelines, and we need to know from the FDA whether the company misled regulatory authorities and if sanctions against the company are available or warranted," Markey said.
A company spokesman declined comment beyond a statement that company officials are focused on cooperating with the investigation. The company has shut down operations, recalled the fungus-contaminated steroid and is cooperating with investigators.
On Wednesday afternoon, the state announced that
the pharmacy Ameridose had agreed to temporarily shut down, pending inspection by state and federal regulators.
Ameridose was founded in 2006 by Greg Conigliaro and Barry Cadden,
who opened the New England Compounding Center eight years earlier.
Ameridose said in a statement that its shutdown ends Oct. 22, though the agreement with the state allows the shutdown to be extended or shortened. The step is being taken as a precaution, not because of evidence of contamination, officials said Wednesday.
Dr. Madeleine Biondolillo, director of the state's Bureau of Healthcare Safety, said there's no evidence of problems at Ameridose and the state hasn't requested a recall of any Ameridose products.
Ameridose said that, as part of the agreement,
Cadden has resigned all corporate positions with the company, where he has not had a day-to-day role.
Andrew Paven, a spokesman for both companies, said, "Ameridose is a separate entity from New England Compounding Center, with distinct operational management."
Allegations of a shot tainted with a different form of meningitis were at the heart of a lawsuit filed against the New England Compounding Center over the 2004 death. An 83-year-old man died about a year-and-a-half after receiving a shot produced by the company.
The 2004 lawsuit filed in upstate New York's Monroe County claimed that New England Compounding Center produced the shot that infected William Koch with bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83.
The lawsuit complaint said the shot was the source of Koch's meningitis, but did not explain how that determination was made.
Bacterial meningitis is contagious and much more common than the fungal meningitis involved in the current outbreak. Fungal meningitis is more difficult to catch, according to the Centers for Disease Control.
The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.
snip
A pharmacy manager at Ameridose, Sophia Pasedis, has been a member of the regulatory body, the Massachusetts Board of Registration in Pharmacy, since 2004. But the state said she has recused herself from all matters related to Ameridose and the New England Compounding Center.
Compounding pharmacies supply products that aren't commercially available,
based on an individual doctor's prescription. Some have grown into larger businesses, operating across state lines and supplying drugs to thousands of hospitals, clinics and physicians.
Biondolillo said the state has reminded Massachusetts pharmacies that
compounding can be done only in response to a patient-specific prescription. She said the state is now
requiring all compounding pharmacies to sign an affidavit that they are following all regulations.
The state has 1,100 pharmacies that can compound drugs.
snip
Read more here:
http://www.cbsnews.com/8301-204_162-57530279/new-allegations-in-deadly-meningitis-outbreak/?tag=AverageMixRelated