Massachusetts drug firm not authorized to sell doses in bulk, Minnesota officials say.
The Massachusetts company at the center of a deadly national meningitis outbreak was not licensed as a drug wholesaler in Minnesota, raising questions about how it was able to supply hundreds of vials of a contaminated steroid to two Twin Cities clinics.
More than 800 Minnesotans have been notified over the past few days that they received potentially contaminated steroids this summer when they were treated at the clinics, Medical Advanced Pain Specialists (MAPS) and the Minnesota Surgery Center. They are the only clinics in the state known to have used the company's steroids.
Yet the company, New England Compounding Center, was registered only as a pharmacy in Minnesota -- which means it is not permitted to sell in bulk, said Cody Wiberg, executive director of the Minnesota Board of Pharmacy.
"They are not licensed as a drug wholesaler, and because of that, no one should have been buying from them as a wholesaler," he said.
Dr. David Schultz, the founder and owner of both Twin Cities clinics, said he was unaware of that rule.
"That's news to me," he said late Tuesday. He said the New England company was "well respected" and that it had assured him "that they have all the appropriate licenses in place."
The MAPS clinic had supplies of the company's steroid on hand until it was recalled two weeks ago, according to Anne Trujillo, the director of clinical operations.
Wiberg said that if the Massachusetts company was essentially acting like an unlicensed drug company -- selling medications to clinics in large quantities -- it would have violated state law and could face both civil and criminal penalties. As a pharmacy, it's only permitted to fill individual prescriptions. However, he would not say whether the pharmacy board is investigating the case.
Mixed its own compounds
Questions about the cause and scope of the outbreak continued to build Tuesday, as federal officials raised the number of confirmed cases of meningitis to 119 nationwide, including 11 deaths.
So far, three cases have been confirmed in Minnesota, all involving women in their 40s.
The contaminated drugs were produced at what is known as a compounding pharmacy, which is not under the same strict federal regulation as a pharmaceutical manufacturer.
In this case, New England Compounding mixed its own version of the steroid, methylprednisolone acetate, at its facility in Framingham, Mass., and shipped it to clinics in 23 states, according to federal officials.
Schultz said that many pain doctors preferred this type of steroid for spinal injections because it doesn't have preservatives or additives. Many doctors fear that additives, which are found in manufactured drugs, could harm patients if they get into the spinal fluid, he said.
He said his clinics have used New England's steroids in pain injections for years and "we never had an issue. Now we're all rethinking it, of course."
Last week, the company, which is now closed, recalled more than 17,000 vials of steroids after investigators discovered three lots were contaminated with fungus.
Meanwhile, Schultz said his staff has been working closely with the state Health Department to contact patients who may have been affected. "Our first and primary concern was our patients," he said.
He added that the crisis is raising many questions, particularly about whether compounding pharmacies need more oversight.
Up to now, the suppliers have insisted that "they have extremely pristine practices and facilities," he said. "For years, it seemed that it was true."
Maura Lerner • 612-673-7384