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June 23, 2017

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Emails incriminate US meningitis-tied firm

BOSTON -- The drug-mixing company at the heart of a deadly U.S. meningitis outbreak solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer show.

Reuters reviewed more than a dozen emails that show the New England Compounding Center (NECC), contrary to state rules, sold drugs without requiring physicians to supply individual patient prescriptions.

The customer confirmed that NECC supplied the clinic with drugs without patient names or prescriptions.

NECC, based in Framingham, Massachusetts, distributed thousands of vials of a contaminated steroid that has put 14,000 people at risk of contracting meningitis and killed 15 people.

The emails support assertions made this week by state pharmacy regulators that the compounding firm, which was authorized to deliver products only in response to patient-specific prescriptions, had violated its license in Massachusetts.

The emails also indicate that NECC referred business to a sister company, Ameridose LLC, despite a statement by Ameridose earlier this week that the two operated separately.

Both companies mix, dilute or repackage drugs that may not be easily available through a pharmaceutical manufacturer. They are owned by Gregory Conigliaro, an engineer, and his brother-in-law, Barry Cadden, a pharmacist who was in charge of pharmacy operations at NECC until it surrendered its license in the wake of the meningitis outbreak.

"NECC's intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations during 15 years of providing hundreds of thousands of patients with vital medications," NECC said in a statement. "We are cooperating with agencies that have a policy of not commenting on pending investigations, and as part of that cooperation we are honoring that policy and not commenting on specific facts."

Ameridose has closed for 12 days pending state and federal inspections. Regulators say they have not found Ameridose's products to be compromised and they have not requested a recall. Ameridose maintains it is a separate entity from NECC with "distinct operational management."

"Although there is common ownership, the two companies operate under separate registrations and different licensure," Ameridose said on Wednesday through its public relations firm, O'Neill and Associates.

Another company, Alaunus Pharmaceutical LLC, which distributes drugs for Ameridose and also is owned by Conigliaro and Cadden, suspended its operations this week. Regulators said that among other things they would be looking at any "corporate governance" issues related to the outbreak.

'Sister company'

In an email dated July 12, NECC regional sales manager David London Barron told NewSouth NeuroSpine, a neurosurgery and pain management clinic in Mississippi, that he had reached out to "our sister company, Ameridose" in connection with a request by the clinic for an anesthetic.

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