Twenty-five people have died and 338 have been sickened from tainted steroid medication created by the New England Compounding Center in Framingham, MA. We all know that several Senators, including Scott Brown, signed a letter asking the EPA to back off from regulating this company in what appears to be a process unrelated to the tainted medication. The letter was dated July 24th. Six weeks later the owner of NECC threw a fundraiser for Senator Brown. But there’s more.
On Thursday, NPR’s Talk of the Nation dedicated their program to an in depth discussion of the Compounding Pharmacy industry and the illness suffered by patients as a result of the tainted medication. One of their guests was
Kevin Outterson, an associate professor of health law and bioethics at Boston University, editor-in-chief of the Journal of Law, Medicine and Ethics.
One of the questions that Neil Conan, the host, asked of Dr. Outterson was about regulating compounding pharmacies that ship across state lines and/or make sterile medications. Here is his response:
OUTTERSON: I’m sure that’s on the menu in Congress, you know, probably after the election, to take a good look at this and look at those choices. But lobbying also affected a lot of things that happened in the past, and so this very pharmacy in Massachusetts, NECC, the compounding pharmacy, for the exact drug that we’re talking about, there was a series of regulatory actions taken by the State Board of Pharmacy in 2002 and 2006, when Mitt Romney was governor, which decided not to file a consent decree, which would have caused a lot of scrutiny of this pharmacy.
And they pulled back, despite the investigator’s suggestion, you know, recommendation to file a consent decree, and we really don’t know much about the political lobbying effort that went on behind the scenes on that.
We also have, you know, publicly reported as well the donations from one of the owners of this pharmacy in a fundraiser not that long ago for Senator Scott Brown at one of the owner’s houses. So there’s just a lot of, you know, politics that goes into regulating an industry like this.
If Conigliaro was running fundraisers for Brown this year you have to wonder if he was doing the same thing for Romney when he was running for Governor. I hope someone is looking into this right now. The failure to regulate this specific medication despite an investigator’s recommendation to do so strikes me as negligence. The whole thing stinks to high heaven. I hope the press is on to this.
and business interests came before the interests of the unsuspecting public.
http://www.salon.com/2012/10/30/romneys_lax_regulation_fueled_meningitis_outbreak/
But in a letter dated Nov. 11, 2004, Paul Cirel, an attorney for NECC, argued that such disciplinary action would be “potentially fatal” to NECC’s business. In a footnote, he asserted, “Once disclosed, the reprimand will surely result in investigations/inquiries/investigations in those other jurisdictions. Regardless of the derivative actions taken, the attendant legal and administrative costs will be devastating.”
The letter added that instead of having the state monitor the company, NECC would be willing to “bear the burden of cost and monitoring and reporting compliance” in exchange for a non-disciplinary resolution.
The Board of Registration subsequently dropped the reprimand. Meanwhile, in 2005, NECC was the subject of another complaint. Nevertheless, the Board of Registration went forward with a Consent Agreement that was, according to Oliver, “even more advantageous to the company than was requested by NECC.”
The term of the “probation” would be one year, not three, and it was to be a non-disciplinary agreement that would not be reported to the National Association of State Boards of Pharmacy or other outside agencies.
Subsequently, in 2006, NECC was effectively permitted to monitor itself simply by assuring the board it was in compliance with all procedures. In a May 22, 2006, letter obtained by Salon, NECC co-owner Barry Cadden wrote the board a short letter saying, “I am pleased to report that the following actions have been completed” regarding several safety precautions.
“Romney was responsible for these agencies,” said Oliver, who is the lead attorney attempting to consolidate the meningitis cases. “They reported to him.” She added that under Chapter 13, Section 22 of the General Laws of Massachusetts, members of the Board of Registration in Pharmacy are appointed by the governor.