Note from Dan: This was such a popular and eye-opening weekend thread that I decided to recycle it today, which marks Mitt Romney’s last visit to Roanoke before the election. It truly is troubling in terms of the kind of “(de)regulation” we can look forward to if Mitt Romney is elected president. Plus, I’m very miffed nobody has commented on the clever label work I did with the vial on the left.
We learned in The Roanoke Times Friday that medicines from the tainted compounding pharmacy in Massachusetts went to far many more Virginia clinics, hospitals and surgery centers than had been previously identified.
Locally, Carilion Clinic hospitals, Lewis Gale Medical Center hospitals, and many other hospitals and independent practices and surgery centers across the state used stuff from the New England Compounding Center.
So far, only steroids from NECC used in back-pain injections have been implicated in a deadly outbreak of fungal meningitis that as of Thursday had sickened 328 and killed 24 people in 18 states, including Virginia.
But 3,000 or so other hospitals and medical clinics in Virginia and across the country also purchased other medications from NECC. Those medical facilities are now notifying hundreds of thousands of patients that they have also been exposed to medicines from the tainted-drug manufacturer.
So it’s worth asking: how did this happen? How could the state of Massachusetts have allowed such an apparently incompetent drug manufacturer to grow and expand in a manner that became so deadly for so many people?
And the answer to that question goes directly back to 2004, and the we-don’t-need-no-regulations administration of then Massachusetts Gov. Mitt Romney.
From the Associated Press:
Massachusetts regulators in 2004 proposed a formal reprimand for a company now linked to deadly meningitis outbreak, but they never delivered it after the company protested the reprimand could be “fatal to the business.”
The sanction by the Board of Registration in Pharmacy was included in a proposed consent agreement that was meant to resolve complaints against the New England Compounding Center in Framingham. The complaints included a failure to meet accepted standards for making the same steroid that’s been connected to the outbreak.
Make sure you click on that link and read the story above. Because if you do, you’ll find out that sanctions originally proposed by the Massachusetts pharmacy board would have, according to NECC, impacted the company so badly it probably would have had to shut down for good.
That would have been the best thing to have happened. But because of the Romney Administration’s neglect, 24 people are now dead and 328 others are fighting a deadly illness. And hundreds of thousands of patients at 3,000 medical facilities around this country that used NECC products are now receiving frightening letters and phone calls warning them that that they may have been given tainted medicine.
But there’s more. People were apparently getting sick and dying from meningitis related to tainted drugs manufactured by that place as early as 2002. And it was back then, during the Gov. Mitt Romney administration, that regulators found the pharmacy manufacturing operation was not keeping records regarding its sterility procedures.
The proposed consent agreement, sent to owner Barry Cadden for review in October 2004, included the reprimand and a three-year probationary period for the company’s registration and Cadden’s license.
In its response, the company’s attorney wrote that the board’s dealings with the company were “a success story” and a reprimand was unwarranted.
“The collateral consequences to many, if not all of NECC’s 42 other licenses (to operate in other states), would be potentially fatal to the business,” attorney Paul Cirel wrote.
“Such a catastrophe is clearly not the intended result of the Board’s proposed reprimand, nor is it warranted in this case,” Cirel wrote. “The Board’s mandate is to protect the public health safety and welfare, not punish the licensees.”
In a footnote, he wrote, “Once disclosed, the reprimand will surely result in inquiries/investigations in those other jurisdictions. Regardless of the derivative actions taken, the attendant legal and administrative costs will be devastating.”
The case ended without disciplinary action as part of a different consent agreement reached with the board in 2006.
Why didn’t Massachusetts do more back then, nip the problem in the bud? It’s not as if somebody back then hadn’t already died from meningitis, after having received the same steroidal injection from an NECC medicine linked to the recent outbreak. NECC paid a lot of money to settle at least one lawsuit related to such a fatality back then.
Were NECC’s owners contributors to Romney’s gubernatorial campaign? His current presidential campaign? At this point, the answers to those questions are unclear. We do know, however, that Massachusetts Sen. Scott Brown has already donated thousands the NECC owners gave him to a meningitis-related charity.
But one thing is clear: former Massachusetts Gov. Mitt Romney is now running for president. And he’s promising the same kind of cut-through-the-red-tape regulatory environment in Washington, and across this country, as he brought to Massachusetts during his single term as governor there.
That kind of “regulation” aided NECC in growing its business and expanding across to the country, to the point that one of its medicines has killed dozens and sickened hundreds. We don’t need no burdensome regulations — yeah!
And now hundred of thousands more patients are being frightened with letters and phone calls, because the Romney administration didn’t shut that place down when it could and should have.
Is that the kind of regulatory attitude we want in the White House? How many more people have to die before we realize it’s not?