BOSTON Oct 10 Ameridose LLC, a private company
that mixes drugs for hospitals nationwide, sought on Wednesday
to distance itself from the firm at the center of a deadly U.S.
outbreak of fungal meningitis, even though the two pharmacies
have common owners.
Both companies are owned by Gregory Conigliaro, an engineer
who invented a way to turn plastic into pot-hole filler, and his
brother-in-law, Barry Cadden, a pharmacist in charge of pharmacy
operations at the New England Compounding Center, which
distributed thousands of vials of a contaminated steroid that
has been implicated in 12 deaths.
Both firms mix, dilute and prepare drugs into formulations
not typically available through pharmaceutical manufacturers.
O'Neill and Associates, a public relations firm hired by
Ameridose, confirmed the shared ownership in an emailed
The statement said Cadden is president and pharmacist in
charge at NECC and Conigliaro is an officer and minority
shareholder who is not involved in its pharmacy operations.
Conigliaro is executive vice president of Ameridose, while
Cadden is a minority shareholder who is not involved in any of
its operations the firm said.
"Ameridose is a separate entity from New England Compounding
Center, with distinct operational management," said O'Neill in
its statement. "We have separate production facilities, separate
processes and operate at separate locations in different
Conigliaro's sister Lisa is married to Cadden.
In early 2011, Ameridose moved out of its Framingham,
Massachusetts facility - which was near NECC's operations - and
into a new, 70,000-square-foot building in nearby Westborough to
accommodate its growing operations.
Sophia Pasedis, head of regulatory affairs at Ameridose,
said Cadden had nothing to do with operations at Ameridose.
"He never came to any functions at Ameridose, he never made
any decisions, and was not involved in any discussions," she
Conigliaro, on the other hand, is at Ameridose on a regular
basis, she said, mainly overseeing the facilities.
"Greg is a wonderful man and a good human being," she said.
"He would never hurt a soul."
Pasedis sits on the Massachusetts Board of Registration in
Pharmacy, which is responsible for the licensing and monitoring
of pharmacists in the state. She said she recuses herself from
any discussions involving Ameridose or NECC.
Officials at NECC did not respond to multiple calls seeking
Medical Sales Management, a company whose board includes
Cadden and Conigliaro, provides human resources, accounting and
information technology services.
It has provided services to both NECC and Ameridose,
according to federal court filings.
Compounding pharmacies such as NECC are permitted to make
small amounts of medications based on specific prescriptions for
State and federal regulators are investigating how thousands
of vials of preservative-free methylprednisolone acetate were
shipped to healthcare facilities in multiple states and infected
124 people across 10 states, killing 12, according to the
Centers for Disease Control and Prevention.
At the insistence of the Massachusetts Department of Public
Health, NECC, which had come to the attention of state and
federal regulators following complaints going back to 2002,
surrendered its license and recalled all products distributed
from the facility in the wake of the meningitis outbreak.
Cadden's own personal pharmacist license is subject to a
restriction preventing him from practicing, at least for now,
according to public records, though more details were not
In 2004, the U.S. Food and Drug Administration and the
Massachusetts Board of Pharmacy inspected NECC and in 2006 the
FDA issued a warning letter, taking NECC to task for opening
sterile products and repackaging them in a way that could damage
human health. It said it was particularly concerned about NECC's
splitting of the cancer drug Avastin into multiple doses to be
used to treat an eye condition.
"Microbes could cause endophthalmitis, which has a high
probability for significant vision loss," the agency said in its
warning letter. "The absence of control over storage, and delays
before use after repackaging, only exacerbate these concerns."
Erica Jefferson, a spokeswoman for the U.S. Food and Drug
Administration, declined to say whether the agency had followed
up on the warning letter or if it had checked to see if the
company had mended its ways. She said the 2006 letter was
unrelated to the current meningitis situation but that an
investigation is ongoing.
The FDA also warned NECC in 2006 that it was against the law
for it to sell compounded drugs without first receiving a
prescription for an individually identified patient.
"Your firm has reportedly also told physicians' offices that
using a staff member's name on the prescription would suffice,"
the letter said.
NECC did not respond though its public relations firm to
questions asking whether it had rectified the problems
identified by the FDA six years ago. The Massachusetts
Department of Health also did not respond to questions about
whether it followed up on complaints made against NECC and
reflected in the FDA's warning letter.
In a statement, Dr. Madeleine Biondolillo, Director of the
department's Bureau of Healthcare Safety and Quality, said that
it "reacted swiftly to this serious situation, and took
immediate steps to close NECC through the voluntary surrender of
its operating license."
Neither the FDA nor the state department of health would say
whether they will investigate Ameridose, though Biondolillo in
her statement said the investigation around the meningitis
outbreak will include all issues, "including corporate
IN BUSINESS WITH BROTHER-IN-LAW
Ameridose was formed in February 2006 and has built itself
into one of the country's leading providers of prefilled
syringes and premixed intravenous and epidural pain medications.
Recent clients have included Kern Medical Center in Bakersfield,
California, which this year renewed a deal for up to $1 million,
public records show. It has also won contracts with the U.S.
Department of Veterans Affairs and the U.S. Army Medical
"There are no other sources known that would provide
products to support our patients," the Army said in a July 2012
contract disclosure notice.
Still, Ameridose has not been problem-free. In 2008 it
recalled 155 injectable doses of the narcotic painkiller
fentanyl because of concerns they were too potent, FDA records
show. And it fought a battle with Irving, Texas-based Novation
LLC, which purchases products on behalf of a network of clients
using its group purchasing power to negotiate discounts.
The two recently settled a lawsuit in which Ameridose
claimed it had been slandered by Novation spreading word that
Ameridose's quality control standards were subpar, according to
documents filed in U.S. District Court in Massachusetts.
Novation said in a statement that while it "vigorously
disputed each and every claim made in the lawsuit" the parties
ultimately agreed to settle. It declined to say why. In a joint
statement on Ameridose's website the companies said they have
entered into an expanded contract for Ameridose to deliver
compounding and mixing services to Novation member hospitals.
"Novation is confident that Ameridose delivers quality
products and services to member hospitals," the statement said.
Novation said it had reached out to Ameridose "in light of
recent developments" and was assured that Ameridose and NECC "do
not share any products or facilities, and that no NECC products
are in the Ameridose pipeline."
In June, Ameridose won a contract to compound and repackage
drugs for Brentwood, Tennessee-based HealthTrust Purchasing
Group LP, a consortium of hospitals and surgery centers with
combined annual purchasing volume of more than $20 billion and
whose owners include hospital giant HCA Holdings Inc.
"The regulatory agencies have not raised concerns about
Ameridose," said HealthTrust spokeswoman Andrea Mitchell. "There
is no indication that their products are anything but safe."
(Reporting by Toni Clarke; Editing by Martin Howell and David