Regulators in 2004 proposed a formal reprimand for acompany now linked to a deadly meningitis outbreak, but they never delivered itafter the company protested the reprimand could be "fatal to thebusiness."
The sanction by the Board of Registration in Pharmacy wasincluded in a proposed consent agreement that was meant to resolve complaintsagainst the New England Compounding Center in Framingham. The complaintsincluded a failure to meet accepted standards for making the same steroidthat's been connected to the outbreak.
The agreement was among documents released this week by thestate Department of Health that provide more details about past incidents atNECC, which was shut down in the wake of the fungal meningitis outbreak thathas reached 17 states, sickening 317 people, 24 of whom have died. The outbreakhas been linked to a steroid made by the NECC and taken mainly for back pain.Compounding pharmacies like NECC custom mix solutions in doses or formsgenerally not commercially available.
The state has now moved to revoke NECC's license, but thereprimand represents a missed opportunity to crack down on the lab years beforethe current outbreak.
The proposed consent agreement, sent to owner Barry Caddenfor review in October 2004, included the reprimand and a three-yearprobationary period for the company's registration and Cadden's license.
In its response, the company's attorney wrote that theboard's dealings with the company were "a success story" and areprimand was unwarranted.
"The collateral consequences to many, if not all ofNECC's 42 other licenses (to operate in other states), would be potentiallyfatal to the business," attorney Paul Cirel wrote.
"Such a catastrophe is clearly not the intended resultof the Board's proposed reprimand, nor is it warranted in this case,"Cirel wrote. "The Board's mandate is to protect the public health safetyand welfare, not punish the licensees."
In a footnote, he wrote, "Once disclosed, the reprimandwill surely result in inquiries/investigations in those other jurisdictions.Regardless of the derivative actions taken, the attendant legal and administrativecosts will be devastating."
The case ended without disciplinary action as part of adifferent consent agreement reached with the board in 2006.
Cirel did not respond to requests for comment from TheAssociated Press.
Alec Loftus, a spokesman for the state's office of healthand human services, said the state has expanded its investigation to includehow the 2006 consent agreement was reached, including why the board neverissued the reprimand and whether that was related to the protest from thecompany.
The agreement was signed under then-Gov. Mitt Romney'sadministration, but some members from that time remain on the pharmacy board.
"All options are on the table, and no actions have beenruled out," Loftus said. "We won't be satisfied until all of thoseresponsible for these troubling events are held accountable."
He added that the state was still compiling information onhow frequently formal reprimands are given.
Loyd V. Allen Jr., editor of the International Journal ofPharmaceutical Compounding, said the proposed three years' probation indicatesthe board considered the violations very serious. He said a plea from thecompany should have been irrelevant to the board's decision.
"Whether or not it's going to be hurtful or harmful tothe business shouldn't really be the issue if patient safety is on theline," Allen said.
The pharmacy board recommended the reprimand after aninvestigation that followed a confidential report filed with a U.S. Food andDrug Administration district office in Stoneham in 2002. The report allegedthat two patients had an unspecified "adverse effect" after taking anNECC compounded Betamethasone Repository Injection, a steroid used to treatjoint pain and arthritis that's different from the one linked to the currentmeningitis outbreak.
A subsequent inspector's report, completed in March 2004after numerous interactions between the state and NECC, said a toxin had beenfound in the drug and the company couldn't produce various records about thedrug, including test results on its sterility. Similar problems have beenuncovered in a preliminary investigation of NECC prompted by the outbreak,including failure to sterilize its products long enough and inadequate testingof its sterilization equipment.
The inspector's report also noted the FDA had notified thestate pharmacy board in October 2002 about "a second incident"involving a drug the company had produced, methylprednisolone acetate, which isthe same steroid linked to the outbreak.
The report offered no details about that incident. But theFDA report to Massachusetts came three months after New York resident WilliamKoch became sick with bacterial meningitis after receiving an injection of thesame steroid, made at NECC. He died as a result in 2004 and NECC later settleda lawsuit in the case.
Some circumstantial evidence points to Koch's involvement inthe second incident. For instance, the October 2002 complaint was the only oneinvolving methylprednisolone acetate in the year he got sick, according to atimeline of complaints against NECC that was released Monday among theDepartment of Public Health documents. That complaint also originated in NewYork, where Koch lived.
The FDA said it could not give details about what it toldMassachusetts in October 2002, so it could not be definitively confirmed thatKoch was involved in the second incident.
The inspector's report said that a re-inspection of NECCshowed it had corrected its problems by 2004. But the inspector cited previousconcerns against the agency dating from 1999, and wrote: "It is thisinvestigator's opinion that a formal reprimand should be issued."
