Meningitis Outbreak: The Mold and Bacteria is on The House.
Freedom from the Tyranny of Sanitation and Government Regulation!
F.D.A. Details Contamination at Pharmacy
A federal inspection of a company whose tainted pain medicine has caused one of the worst public health drug disasters since the 1930s found greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company’s own environmental limits, and an air-conditioner that was shut off nightly despite the importance of controlling temperature and humidity.
The findings, made public on Friday by the Food and Drug Administration, followed a report from Massachusetts regulators on Tuesday and offered disturbing new details in an emerging portrait of what went wrong inside the New England Compounding Center, the pharmacy at the heart of a national meningitis outbreak in which 25 people have died, 313 more have fallen ill and as many as 14,000 people are believed to have been exposed.
Instead of producing tailor-made drugs for individual patients, as the law allowed, the company turned into a major drug maker that supplied some of the most prestigious hospitals in the country, including ones affiliated with Harvard, Yale and the Mayo Clinic, all with minimal oversight from federal regulators.
Federal officials also drew attention to the company’s proximity to a recycling plant where excavators and freight trucks heaped old mattresses, plastics and other materials, generating large amounts of dust. The plant, which is owned by one of the same people as the pharmacy, has not always complied with regulations and has drawn complaints, according to records in Framingham, Mass., where the company is located.
And as the death toll continues to rise, the F.D.A.’s commissioner, Dr. Margaret Hamburg, who was appointed by President Obama, has stayed mostly silent.
Some observers said that weighing in loudly and publicly on a contentious issue was simply not Dr. Hamburg’s style. Others said that it was because the agency was preparing a criminal case and would not want to endanger that with statements construed to be prejudicial. David Kessler, a former F.D.A. commissioner, pointed to the impending presidential election and efforts to keep the outbreak from becoming a political issue.
“Everyone is closed down right now,” he said. “People are being very careful. No one wants to make a mistake.”
The inspection report offered the clearest indication yet that the fungus that contaminated the company’s vials of methylprednisolone acetate, an injectable pain medicine, may have gotten there because of the company’s own practices.
Inspectors said that 83 out of 321 vials from one of the lots linked to the meningitis outbreak that they observed contained “greenish black foreign matter” and another 17 vials had “white filamentous material.”
The report said the company had tested only one sample from that lot, and it had proved sterile. When the F.D.A. tested 50 vials from that same lot, all of them contained some microbial growth.
Experts said that perhaps the most worrisome finding was that the company’s own testing between January and September found surfaces in the clean rooms contaminated with either bacteria or mold exceeding the levels at which the company’s own procedures called for remedial measures. In some cases, there were so many bacteria or fungi in a sample that the whole testing dish was overrun with a so-called overgrowth.
“Think of a plant just growing out of control,” said Steven Lynn, director of the Office of Manufacturing and Product Quality at the F.D.A. Yet, according to the agency, there was no evidence the company took remedial actions.
“This is pretty heinous stuff,” said Lou Diorio of LDT Health Solutions, a consultant to compounding pharmacies. “This just shows a general lack of basic clean-room principles.”
Russell E. Madsen, a consultant on sterility issues to the pharmaceutical industry, said of the inspection report: “In all my time in the pharmaceutical industry, which is 45 years, I’ve never seen one this bad.”
Another problem was the company’s air-conditioning system, which employees said was switched off between 8 p.m. and 5:30 a.m. in the room where sterile drugs were made. Maintaining proper temperature and humidity is important for retarding the growth of microbes.
Mr. Lynn underscored that the findings were not a formal indictment of the company’s practices but a list of facts that would be used to inform the conclusions of its broader investigation, which began earlier this month.
The company said in a statement that it would “review this report and continue our cooperation with the F.D.A. We will follow the existing regulatory process and provide our comments to the F.D.A. after we have had adequate time for a complete review of the report.”
The recycling center, owned by Gregory Conigliaro, who also owns a stake in New England Compounding, was not initially a focus of the investigation, but has become a part of the inquiry as investigators learn more. The inspection report noted that rooftop units for the pharmacy’s air-conditioning system were located about 100 feet away from where large trucks and excavators were moving mattresses and plastics.
Over the years, neighbors have complained about dust, smells and debris that they said came from the property. In 2004, the Massachusetts Department of Environmental Protection investigated an anonymous complaint about a “gray dust plume airborne and falling like a snowstorm.”
According to documents on file with the Massachusetts Department of Environmental Protection, Conigliaro Industries recycled more than 16,000 tons of materials last year, including mattresses, furniture, batteries, asphalt roofing shingles, carpeting and plastic. To recycle a mattress, “We filet it like a fish, peel back the felt, the foam and the fabric, bale them and send them to end markets,” Mr. Conigliaro told a reporter for Waste News, an industry publication, in 2002.
New England Compounding had about 3,000 customers, and revelations about the company have shaken health care providers across the country. In Manhattan, Beth Israel Medical Center and St. Luke’s Roosevelt Hospital - former customers of New England Compounding - will “eliminate all purchased compounded drugs from our formulary as soon as possible,” according to a memo from the executive vice president of Continuum Health Partners, which runs both hospitals.
Brigham and Women’s Hospital, a Harvard affiliate in Boston, was a customer for seven or eight years, said a spokeswoman, Lori Schroth. She said Brigham and Women’s depended on New England Compounding for products that the hospital pharmacy could not easily make, or that were in short supply and not available from major manufacturers. The hospital had inspected the pharmacy “a handful” of times in the past, she said, and had never found a problem. The hospital’s own pharmacists are now working around the clock to make some of the medications formerly purchased from New England Compounding.
At Children’s National Medical Center in Washington, the hospital’s own pharmacy is compounding medications it used to buy from New England Compounding. The hospital trusted the company, said Dr. Gerard Martin, senior vice president, because it believed that federal and state regulators were making sure its products were safe.
“You believe that when a company is being regulated, they’re following good practices,” Dr. Martin said.
F.D.A. Details Contamination at Pharmacy
A federal inspection of a company whose tainted pain medicine has caused one of the worst public health drug disasters since the 1930s found greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company’s own environmental limits, and an air-conditioner that was shut off nightly despite the importance of controlling temperature and humidity.
The findings, made public on Friday by the Food and Drug Administration, followed a report from Massachusetts regulators on Tuesday and offered disturbing new details in an emerging portrait of what went wrong inside the New England Compounding Center, the pharmacy at the heart of a national meningitis outbreak in which 25 people have died, 313 more have fallen ill and as many as 14,000 people are believed to have been exposed.
Instead of producing tailor-made drugs for individual patients, as the law allowed, the company turned into a major drug maker that supplied some of the most prestigious hospitals in the country, including ones affiliated with Harvard, Yale and the Mayo Clinic, all with minimal oversight from federal regulators.
Federal officials also drew attention to the company’s proximity to a recycling plant where excavators and freight trucks heaped old mattresses, plastics and other materials, generating large amounts of dust. The plant, which is owned by one of the same people as the pharmacy, has not always complied with regulations and has drawn complaints, according to records in Framingham, Mass., where the company is located.
And as the death toll continues to rise, the F.D.A.’s commissioner, Dr. Margaret Hamburg, who was appointed by President Obama, has stayed mostly silent.
Some observers said that weighing in loudly and publicly on a contentious issue was simply not Dr. Hamburg’s style. Others said that it was because the agency was preparing a criminal case and would not want to endanger that with statements construed to be prejudicial. David Kessler, a former F.D.A. commissioner, pointed to the impending presidential election and efforts to keep the outbreak from becoming a political issue.
“Everyone is closed down right now,” he said. “People are being very careful. No one wants to make a mistake.”
The inspection report offered the clearest indication yet that the fungus that contaminated the company’s vials of methylprednisolone acetate, an injectable pain medicine, may have gotten there because of the company’s own practices.
Inspectors said that 83 out of 321 vials from one of the lots linked to the meningitis outbreak that they observed contained “greenish black foreign matter” and another 17 vials had “white filamentous material.”
The report said the company had tested only one sample from that lot, and it had proved sterile. When the F.D.A. tested 50 vials from that same lot, all of them contained some microbial growth.
Experts said that perhaps the most worrisome finding was that the company’s own testing between January and September found surfaces in the clean rooms contaminated with either bacteria or mold exceeding the levels at which the company’s own procedures called for remedial measures. In some cases, there were so many bacteria or fungi in a sample that the whole testing dish was overrun with a so-called overgrowth.
“Think of a plant just growing out of control,” said Steven Lynn, director of the Office of Manufacturing and Product Quality at the F.D.A. Yet, according to the agency, there was no evidence the company took remedial actions.
“This is pretty heinous stuff,” said Lou Diorio of LDT Health Solutions, a consultant to compounding pharmacies. “This just shows a general lack of basic clean-room principles.”
Russell E. Madsen, a consultant on sterility issues to the pharmaceutical industry, said of the inspection report: “In all my time in the pharmaceutical industry, which is 45 years, I’ve never seen one this bad.”
Another problem was the company’s air-conditioning system, which employees said was switched off between 8 p.m. and 5:30 a.m. in the room where sterile drugs were made. Maintaining proper temperature and humidity is important for retarding the growth of microbes.
Mr. Lynn underscored that the findings were not a formal indictment of the company’s practices but a list of facts that would be used to inform the conclusions of its broader investigation, which began earlier this month.
The company said in a statement that it would “review this report and continue our cooperation with the F.D.A. We will follow the existing regulatory process and provide our comments to the F.D.A. after we have had adequate time for a complete review of the report.”
The recycling center, owned by Gregory Conigliaro, who also owns a stake in New England Compounding, was not initially a focus of the investigation, but has become a part of the inquiry as investigators learn more. The inspection report noted that rooftop units for the pharmacy’s air-conditioning system were located about 100 feet away from where large trucks and excavators were moving mattresses and plastics.
Over the years, neighbors have complained about dust, smells and debris that they said came from the property. In 2004, the Massachusetts Department of Environmental Protection investigated an anonymous complaint about a “gray dust plume airborne and falling like a snowstorm.”
According to documents on file with the Massachusetts Department of Environmental Protection, Conigliaro Industries recycled more than 16,000 tons of materials last year, including mattresses, furniture, batteries, asphalt roofing shingles, carpeting and plastic. To recycle a mattress, “We filet it like a fish, peel back the felt, the foam and the fabric, bale them and send them to end markets,” Mr. Conigliaro told a reporter for Waste News, an industry publication, in 2002.
New England Compounding had about 3,000 customers, and revelations about the company have shaken health care providers across the country. In Manhattan, Beth Israel Medical Center and St. Luke’s Roosevelt Hospital - former customers of New England Compounding - will “eliminate all purchased compounded drugs from our formulary as soon as possible,” according to a memo from the executive vice president of Continuum Health Partners, which runs both hospitals.
Brigham and Women’s Hospital, a Harvard affiliate in Boston, was a customer for seven or eight years, said a spokeswoman, Lori Schroth. She said Brigham and Women’s depended on New England Compounding for products that the hospital pharmacy could not easily make, or that were in short supply and not available from major manufacturers. The hospital had inspected the pharmacy “a handful” of times in the past, she said, and had never found a problem. The hospital’s own pharmacists are now working around the clock to make some of the medications formerly purchased from New England Compounding.
At Children’s National Medical Center in Washington, the hospital’s own pharmacy is compounding medications it used to buy from New England Compounding. The hospital trusted the company, said Dr. Gerard Martin, senior vice president, because it believed that federal and state regulators were making sure its products were safe.
“You believe that when a company is being regulated, they’re following good practices,” Dr. Martin said.