* Customer said firm supplied drugs without patient
* NECC offered discounts for bulk orders
* Emails show NECC referred business to sister company
By Toni Clarke and Aaron Pressman
BOSTON, Oct 13 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
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 Oct. 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
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
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
In July, Barron offered in an email to supply NewSouth
NeuroSpine with 50 vials per month of a steroid at a cost of $20
"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
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
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,