This article is from the source 'guardian' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at http://www.guardian.co.uk/society/2012/oct/23/meningitis-firm-escaped-sanctions-outbreak

The article has changed 2 times. There is an RSS feed of changes available.

Version 0 Version 1
Meningitis: drug firm escaped tough sanctions before outbreak, files show Meningitis: drug firm escaped tough sanctions before outbreak, files show
(about 2 hours later)
The company linked to the deadly meningitis outbreak had repeatedly escaped harsh sanctions from health regulators in the years leading up to the scandal, raising fresh questions about oversight of the compounding pharmacy sector.The company linked to the deadly meningitis outbreak had repeatedly escaped harsh sanctions from health regulators in the years leading up to the scandal, raising fresh questions about oversight of the compounding pharmacy sector.
Problems at the New England Compounding Center in Framingham, Massachusetts stretched as far back as 1999, according to state records released amid a wave of legal action from patients who received contaminated or potentially contaminated steroid injections made by NECC.Problems at the New England Compounding Center in Framingham, Massachusetts stretched as far back as 1999, according to state records released amid a wave of legal action from patients who received contaminated or potentially contaminated steroid injections made by NECC.
One lawyer told the Guardian that information in the documents could expand the scope of the lawsuits against the company to include punitive damages.One lawyer told the Guardian that information in the documents could expand the scope of the lawsuits against the company to include punitive damages.
On Tuesday the US Centers for Disease Control updated the number of cases to 304, including one new case in Georgia, bringing the number of states affected to 17. No new deaths were reported.On Tuesday the US Centers for Disease Control updated the number of cases to 304, including one new case in Georgia, bringing the number of states affected to 17. No new deaths were reported.
Regulators stopped short of imposing the harshest sanctions available to them, such as putting the firm on a three-year probationary period and issuing a formal reprimand, even as the list of complaints continued to grow, the documents show.Regulators stopped short of imposing the harshest sanctions available to them, such as putting the firm on a three-year probationary period and issuing a formal reprimand, even as the list of complaints continued to grow, the documents show.
Released under a freedom of information request and published on the Massachusetts department of health website, the documents show a litany of complaints against the company, ranging from allegations of an NECC official handing out blank prescriptions in 1999, to inadequate documentation and inadequate process controls in 2006. Released under a freedom of information request and published on the Massachusetts department of health website, the documents show a litany of complaints against the company, ranging from allegations of an NECC official handing out blank prescriptions in 1999 to inadequate documentation and inadequate process controls in 2006.
The pharmacy board of the public health department in Massachusetts initially proposed sanctioning NECC in 2004 with three years of probation and a public reprimand, amid allegations that it violated accepted standards for compounding methylprednisolone acetate, the steroid linked to the current fungal meningitis outbreak. In 2004, the pharmacy board of the public health department in Massachusetts initially proposed sanctioning NECC with three years of probation and a public reprimand, amid allegations that the company violated accepted standards for compounding methylprednisolone acetate, the steroid linked to the current fungal meningitis outbreak.
But two years later, the board agreed to a non-disciplinary settlement. It also agreed not to report the agreement to the National Association of State Boards of Pharmacy or other outside agencies. NECC's lawyer had pleaded with the board not to issue a public reprimand because it could put the company out of business, according to Reuters.But two years later, the board agreed to a non-disciplinary settlement. It also agreed not to report the agreement to the National Association of State Boards of Pharmacy or other outside agencies. NECC's lawyer had pleaded with the board not to issue a public reprimand because it could put the company out of business, according to Reuters.
The documents reveal that, in 2006, an outside evaluation firm, Pharmacy Support Inc, was sent to NECC. In a letter to NECC, it concluded: "Although your facility has seen significant upgrades in facility design for the sterile compounding operation, there were numerous significant gaps identified during the assessment." The documents reveal that in 2006 an outside evaluation firm, Pharmacy Support Inc, was sent to NECC. In a letter to NECC, it concluded: "Although your facility has seen significant upgrades in facility design for the sterile compounding operation, there were numerous significant gaps identified during the assessment."
A follow-up letter was sent to Barry Cadden, NECC's chief pharmacist, in April 2006, by George Cayer, then president of the state pharmacy board charged with regulating the compounding industry, which praised the company's progress in responding to the inspection. The company was placed on probation for one year, but the probation was stayed as part of a consent agreement, and no fines or other punitive action were ordered. A follow-up letter was sent to Barry Cadden, NECC's chief pharmacist, in April 2006, by George Cayer, then president of the state pharmacy board charged with regulating the compounding industry. The letter praised the company's progress in responding to the inspection. The company was placed on probation for one year, but the probation was stayed as part of a consent agreement and no fines or other punitive action were ordered.
However, according to the Associated Press, a letter from the congressional committee indicates that the company received a warning letter from the FDA in December 2006.However, according to the Associated Press, a letter from the congressional committee indicates that the company received a warning letter from the FDA in December 2006.
Among the issues cited was NECC's manipulation of a sterile injectable product that led the FDA to be "especially concerned about potential microbial contamination." Among the issues cited was NECC's manipulation of a sterile injectable product that led the FDA to be "especially concerned about potential microbial contamination".
A congressional committee, which sought 10 years of documents relating to the NECC on Monday, said the company's actions "call into question whether the NECC was operating as a traditional compounding pharmacy or on a commercial scale as a drug manufacturer." A congressional committee, which sought 10 years of documents relating to the NECC on Monday, said the company's actions "call into question whether the NECC was operating as a traditional compounding pharmacy or on a commercial scale as a drug manufacturer".
Fred Pritzker, an attorney representing 40 patients across several states who have been affected by the outbreak, said that the documents could expand the scope of the lawsuits against NECC. He has filed one lawsuit already, but expects those lawsuits to be consolidated into one multi-district litigation action to be dealt with in one court.Fred Pritzker, an attorney representing 40 patients across several states who have been affected by the outbreak, said that the documents could expand the scope of the lawsuits against NECC. He has filed one lawsuit already, but expects those lawsuits to be consolidated into one multi-district litigation action to be dealt with in one court.
"This is not an isolated case," said Pritzker. "This is a pattern practice of abuse.""This is not an isolated case," said Pritzker. "This is a pattern practice of abuse."
He said: "It could expand the scope of the lawsuits to include punitive damages. The real problem is that the company is not going to have enough assets to cover all those affected. It is a very complicated mess, and it is usually the victims, the families of people who have been killed, or people who have suffered horrible injury who are left out." He said: "It could expand the scope of the lawsuits to include punitive damages. The real problem is that the company is not going to have enough assets to cover all those affected. It is a very complicated mess, and it is usually the victims, the families of people who have been killed or people who have suffered horrible injury who are left out."
NECC is widely expected to file for bankruptcy, which would lead to all legal action against it to be halted.NECC is widely expected to file for bankruptcy, which would lead to all legal action against it to be halted.
The complaints against NECC dated back from 1999 and appeared to follow the company as it expanded from the small family business owned by Cadden and his brother-in-law, Gregory Conigliaro, into the company that, in 2012, sold products in bulk to hospitals and clinics across 50 states. The complaints against NECC dated back from 1999 and appeared to follow the company as it expanded from a small family business owned by Cadden and his brother-in-law, Gregory Conigliaro, into the company that, in 2012, sold products in bulk to hospitals and clinics across 50 states.
Several investigations are already underway into NECC, which appears to have broken at least one state law, according to state authorities earlier this month, by providing the steroid to patients without prescription.Several investigations are already underway into NECC, which appears to have broken at least one state law, according to state authorities earlier this month, by providing the steroid to patients without prescription.
Compounding pharmacies such as NECC are only allowed to produce drugs based on a specific prescription written by a physician for an individual patient and are not generally allowed to solicit business or to promote products that have not been requested by physicians.Compounding pharmacies such as NECC are only allowed to produce drugs based on a specific prescription written by a physician for an individual patient and are not generally allowed to solicit business or to promote products that have not been requested by physicians.
The documents show that, in 2004, pharmacists in Iowa and Wisconsin complained to the board that NECC and Cadden were soliciting out-of-state prescriptions for office use and using a form unapproved by the Massachusetts department of public health. The same year, the board also issued another advisory letter, noting that it had received a complaint from a "concerned Texas pharmacist about products being solicited by Barry Cadden." The documents show that in 2004, pharmacists in Iowa and Wisconsin complained to the board that NECC and Cadden were soliciting out-of-state prescriptions for office use and using a form unapproved by the Massachusetts department of public health. The same year, the board also issued another advisory letter, noting that it had received a complaint from a "concerned Texas pharmacist about products being solicited by Barry Cadden".
An investigation revealed that NECC was offering an eye treatment and improperly included promotional material and terminology in the advertisements.An investigation revealed that NECC was offering an eye treatment and improperly included promotional material and terminology in the advertisements.
A complaint in 1999, a year after the pharmacy became operational, which was investigated by the complaints committee, also concerned prescriptions. The "New England Compounding Center providing a practitioner with prescription blanks" in "violation of board regulations," the documents said. A complaint in 1999, a year after the pharmacy became operational, which was investigated by the complaints committee, also concerned prescriptions. The "New England Compounding Center providing a practitioner with prescription blanks" in "violation of board regulations", the documents said.
On Monday, a congressional committee sought a decade's worth of records from the company. In a letter sent to a lawyer for NECC, the House committee on energy and commerce noted that as far back as 2002 and 2003 officials from the food and drug administration and the state conducted joint probes of the company after receiving a report about a steroid shot. Those probes preceded a 2004 joint investigation of the centre by FDA and the Massachusetts board of registration in pharmacy. On Monday, a congressional committee sought a decade's worth of records from the company. In a letter sent to a lawyer for NECC, the House committee on energy and commerce noted that as far back as 2002 and 2003 officials from the food and drug administration and the state had conducted joint probes of the company after receiving a report about a steroid shot. Those probes preceded a 2004 joint investigation of the centre by FDA and the Massachusetts board of registration in pharmacy.
In a statement on Monday, NECC said: "New England Compounding Center worked cooperatively with the Massachusetts board of registration in pharmacy to resolve to the board's satisfaction any issues brought to the company's attention."In a statement on Monday, NECC said: "New England Compounding Center worked cooperatively with the Massachusetts board of registration in pharmacy to resolve to the board's satisfaction any issues brought to the company's attention."