A Massachusetts company at the center of a deadly meningitis outbreak was selling medications to some of the largest medical groups in Minnesota even though it had no license to do so, the Star Tribune has learned.
The New England Compounding Center, which is under investigation for selling tainted steroids, has supplied a host of other drugs to the Mayo Clinic, Allina, HealthPartners and other hospitals and clinics -- many more than previously disclosed -- officials confirmed in interviews.
Only two Minnesota clinics have been tied to the meningitis outbreak, which has so far sickened 198 people and killed 15 in 13 states.
But NECC's customers were spread across Minnesota, from Waconia to Duluth, with hundreds of patients.
Now clinic officials are struggling to explain how they ended up buying medications from a "compounding pharmacy" that was mixing up its own batches of drugs and selling them across the country without federal safety oversight.
"We were led to believe that they were licensed appropriately," said Andra Van Kempen, a spokeswoman for CentraCare Health System in St. Cloud, which purchased three types of drugs from NECC. "This company presented themselves in such a way that was misleading."
Officials at NECC, which has closed, did not respond to requests for comment.
The company is under fire for putting thousands of people in danger when it produced a steroid, methylprednisolone acetate, that was contaminated with fungus that causes meningitis and stroke.
There is no evidence that any other NECC medications were unsafe, but all have been recalled as a precaution.
In Minnesota, clinics said they quickly pulled all NECC drugs off the shelves, even if they had none of the tainted steroids. "We have no reason to believe any patients were harmed," said a spokeswoman for the Mayo Clinic.
In the meantime, questions are surfacing about the company's sales practices as it went around the country marketing hundreds of drugs to hospitals and clinics even though it was not subject to the strict federal safety rules that apply to drug manufacturers.
"People just assume that someone in the U.S. wouldn't manufacture and illegally sell a product," said Stephen Schondelmeyer, a professor of pharmacy at the University of Minnesota. "They just assume that wouldn't go on. But in fact it does."
In the dark
As a compounding pharmacy, NECC was licensed only to fill individual prescriptions for individual patients, not to mass-produce drugs for sale across the country, according to federal and state officials.
But many of its customers say they simply didn't know that.
"I had no idea," said Dr. Richard Tholen, president of Minneapolis Plastic Surgery, whose clinic purchased an injectable enzyme from NECC for use in facial operations. "The first time I knew about it was when I read about it in the newspaper," he said.
When contacted by the newspaper, 11 Minnesota medical groups acknowledged that they had purchased NECC medications as recently as last month. The list includes Gillette Children's Hospital, Essentia Health and Ridgeview Hospital in Waconia.
They typically ordered drugs that were in short supply, such as medications used during heart surgery and cosmetic procedures, and a drug to treat cystic fibrosis.
Some, like St. Luke's Hospital in Duluth, said they only filled individual prescriptions, which is permitted by law.
Others acknowledged that they were buying supplies in bulk, as though from a pharmaceutical company.
"When we learned of these issues, we immediately stopped using NECC for anything at all," said David Kanihan, a spokesman for Allina.
HealthPartners bought an antacid from NECC in April during a "critical shortage," said spokesman Jeff Shelman.
Fairview, which bought two types of drugs a year ago, said NECC gave assurances that it met all national and state standards. "We verified that they had valid licensure in place for us to do business," said spokesman Ryan Davenport.
However, Cody Wiberg, head of the Minnesota Board of Pharmacy, said NECC is licensed only as a pharmacy, with no authority to act as a distributor. "We would have said, 'No you can't buy it wholesale from them,'" he said.
Dr. David Schultz, owner of the two Twin Cities clinics that bought tainted steroids, has said he, too, was unaware NECC was breaking any rules.
Some, though, say the buyers had a responsibility to find out.
"It's fair to ask whether the purchasers did anything to investigate the quality of NECC's drugs," said Fred Pritzker, a Minneapolis attorney who is representing 20 patients who got the suspect steroids.
"If NECC was producing drugs in violation of state and federal law, and medical professionals knew they were really acting as a drug company, aren't they complicit?"
Rob Leach, executive director of the Minnesota Board of Medicine, said the responsibility could rest with a clinic's medical director. But he said it's often not a doctor who does the ordering, so it's not clear who should be held responsible. "We've never had this before, so I can't say for sure," he said.
The Minnesota Board of Pharmacy maintains a registry on its website that identifies companies licensed to sell drugs in the state, said Wiberg, the executive director. It can be found at startribune.com/a1800.