By Toni Clarke and Aaron Pressman
BOSTON (Reuters) - 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, contrary to Massachusetts regulations, 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 14 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.
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 is also 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.
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.
"Richard DeLibertis will be your contact - I have asked him to reach out to you as soon as possible to discuss your options," Barron wrote in the email.
On October 1, DeLibertis, identifying himself in an email as a regional sales manager for Ameridose, told NewSouth NeuroSpine that Ameridose did not currently have the anesthetic in stock but that it would add the clinic "to the list of those seeking the medication."
Barron did not respond to telephone or email requests for comment. DeLibertis did not respond to an emailed request for comment. O'Neill and Associates, which represents NECC and Ameridose, declined to comment on behalf of its clients.
PROMISE OF LOWER COSTS
Massachusetts prohibits pharmacies such as NECC, which create drugs that are unavailable from pharmaceutical companies, from selling medications without being in receipt of a prescription. It is not illegal, however, for health care providers to buy in bulk from licensed pharmacies, of which NECC was one.
Emails between NewSouth NeuroSpine and NECC show NECC solicited bulk orders with the promise of lower costs in return for higher ordering volume - sometimes offering competitive price quotes for drugs that had not been ordered by the physician.
In July, Barron offered in an email to supply NewSouth NeuroSpine with 50 vials per month of a steroid at a cost of $20 per vial.
"If you are using approximately 50 per month your total yearly savings, if sourced through NECC, would be $4,500," Barron said in an email.
Frank York, the chief executive of NewSouth, told Reuters the center did not order or purchase the steroid from NECC. The products it ordered, he said, included items such as a contrast agent used in X-rays that the center could not get elsewhere in the dosages it needed and were provided without prescriptions.
And while the physicians were asked by NECC to fill out a "Prescription Order Form," the form acted more as a bulk ordering form than a standard physician's prescription, York said.
In one email, Barron asked the clinic to provide NECC with a list of patients scheduled for upcoming procedures "to correspond with the medication."
"If you are ordering 75 units we will need a representation of patients that you plan to use the medication on," Barron said in the email. "If one day's schedule has close to 75 patients that will be acceptable to fulfill the order. If it is easier for you to provide a simple list of names that would be OK too."
The clinic did not provide its schedule to NECC for patient privacy reasons, according to York, who added that the clinic did not receive any of the tainted steroid implicated in the meningitis outbreak.
Even without the names or individual prescriptions, however, NECC continued to supply NewSouth, York said.
Massachusetts health officials said at a press briefing on Thursday that NECC appears to have been operating in violation of the state's compounding pharmacy licensing requirements, though they did not go into detail.
"This organization chose to apparently violate the licensing requirements under which they were allowed to operate," Madeleine Biondolillo, director of the Bureau of Health Care and Safety at the Massachusetts Department of Public Health, said on a call with reporters on Thursday.
State and federal regulators in the briefing declined to say whether they previously knew about NECC's bulk sales to entities including the U.S. Department of Veterans Affairs. They said investigations were ongoing.
Regulators were not immediately available to comment on NECC's interactions with Ameridose.
While Massachusetts conducts periodic inspections of compounding pharmacies, the state does not track the volume of medications prepared and distributed at its licensed pharmacies, Biondolillo said.
(Additional reporting by Debra Sherman in Chicago, Svea Herbst and Tim McLaughlin in Boston; Editing by Ros Krasny, Mary Milliken and Lisa Shumaker)