Drugs produced by the New England Compounding Center were not put through the minimum procedures required to ensure sterility and were shipped to customers before the pharmacy’s own safety tests were completed, a state health official said Tuesday in announcing preliminary results of an inspection of the pharmacy at the heart of the national meningitis outbreak.
Investigators who visited the pharmacy in recent weeks found dirty lab equipment, a leaking boiler near the pharmacy’s “clean room,” and records that showed the pharmacy failed to properly maintain important sterilization tools, Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said during a State House press conference Tuesday afternoon.
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How is it possible that an Agency responsibile for ensuring the health of the state's residents is unable to recognize that "minimum procedures required to ensure sterility" were absent during their auditing survey?
And why are they allowed to operate such a business two doors down from a DUMP??!?!?!? That would seem to be the first rule change needed...
This is so big why haven't more heads at the State been fired ? This is the same agency that allowed thousands of criminals to be released due to falsified lab tests. Why hasn't the head of the Dept of Health been fired. What is patrick allowing this individual to stay on the job? This type of operation is unacceptable and has resulted in deaths and more deaths from released criminals.
If not mistaken, I believe that a guy named John Auerbach was the state's public health department chief, and he resigned last month as a scandal was breaking.
John Auerbach fell on his sword due to the fiasco at the Jamaica Plain Lab.
This entire scandal involving 300+ sickened people and 23 dead folks who allegedly were given a prescription drug made by New England Compounding Center is tragic, apparently illegal, and seems to result from apparent greed-driven violation of sound pharmaceutical practices. But it also stems from the oversight, or lack thereof, of the Gov. Deval Patrick administration's Health Department. Patrick is trying to imittate Joe Biden's and Barry Obama's handling of the Benghazi consulate episode in his efforts to suddenly and priggishly assert his outrage at NECC. State regulators' searches of NECC work spaces in Framingham have found fouled lab gear and even records that the company kept, indicating that "the pharmacy failed to properly maintain important sterilization tools", the Globe says. But note, these findings by the Health Department inspectors were found AFTER the scandal broke and upwards of a dozen people were already dead of the menengitis outbreak linked to the NECC supplied drug. Is the state trying to convince somebody that these disgusting cleanliness practices in the company's laboratories occurred only since the last state inspection? And when was that event? Did the state send inspectors into NECC (and other compounding companies'_ facilities regularly? And if so, how often? The federal Food and Drug Adminstration, for unclear reasons, was given little or no oversight of this pharmaceutical compounding segment of the medicine supply industry. That left it up to the states, with guys like Patrick in charge. Supposedly state budget concerns led Patrick and his two legislative allies, Rep. DeLeo and state Sen. Murray, to cut Health Department budgets, apparently leading to lax or laxer regulatory oversight of such facilities as the labs of NECC. Sure, Patrick can do his self-righteous outrage act. But let's see if he hikes off to Colorado or Florida to primp for his good bud, Barry, while the NECC scandal drags on, with perhaps a few more deaths that can almost certainly be linked to Massachusetts' regulation of one segment of the health industry.
TIME TO CLEAN HOUSE AT DPH:
The 'regulatory branch' of DPH is an administration with a conspicuously bad track record demonstrating lack of knowledge.
The state is a bureacracy. Health care is a science, which mean the success of their Mission is dependent upon Administration (at the top) understanding and having the knowledge to function as Administrators.
We are observing what happens when the top layer of Administration is unable to question and correct the poor functionin at lower levels.
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HOW can it be that the DPH regulatory administration are inept and unable to understand the principles of health?
Many people wonder why there are so many infections within hospitals and following surgery and now this catastrophic spread of infections due to medications made in our state.
Look up stream . . . this is an administration with a conspicuously bad track record demonstrating lack of knowledge.
When was the number of state inspectors for the facilities cut? Was it during Romney's term as governor? He believes in less government oversight.