Mass. moves to revoke license of firm tied to meningitis outbreak

BOSTONMassachusetts state officials say they found unclean conditions including visible black specks of fungus in steroids made by a pharmacy linked to a deadly outbreak of meningitis.

Gov. Deval Patrick said Tuesday the state has moved to revoke the license of the New England Compounding Center and three pharmacists. The state also said it is launching a criminal investigation into the company that is identified as the source of a 17-state meningitis outbreak.

State officials say a preliminary investigation found drugs were sent out before tests results on their sterility could be returned. They also said the company operated as a drug manufacturer by producing drugs for broader use, rather than filling out specific prescriptions for specific doctors, which is all its license allowed.

CBS Evening News medical correspondent Dr. Jon LaPook reports a lack of basic laboratory standards at the specialty pharmacy as revealed by the investigation. He notes the lab had dirty floor mats, a leaky boiler, did not adequately sterilize medications, and did not properly test its laboratory equipment.

Nearly 310 people have been sickened nationwide and 23 have died. All had received contaminated steroid injections, mostly for back pain. Four of the cases may be fungal joint infections from patients who received shots in the knees, hips, and shoulders, the Centers for Disease Control and Prevention said Tuesday.

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The company says it's cooperating with investigators.

Federal health officials matched the shots produced by the company to the outbreak after finding a deadly fungus in more than 50 unopened vials there but have not said how the shots were contaminated.

The fungus, called Exserohilum rostratum, is common in the environment but has never before been identified as a cause of meningitis, according to the CDC.

The contaminated lots of methylprednisolone acetate were sent to 76 facilities in 23 states. Federal officials estimated up to 14,000 patients may have received the injections -- 97 percent of those patients have been contacted, the CDC said.

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A congressional committee on Monday sought a decade's worth of records from the company as new state documents detailed problems an outside firm hired to do an assessment found there in 2006.

The state documents obtained by CBS News say investigators in 2006 found inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the New England Compounding Center. The problems were corrected that year, and a state inspection in May 2011 as the company prepared to update its facilities found no such issues.

• FDA confirms Mass. firm's link to meningitis outbreak
• Meningitis-linked pharmacy has history of problems, documents show
• Ex-workers: Company linked to meningitis outbreak had questionable practices

In a letter sent Monday to a lawyer for NECC, the House Committee on Energy and Commerce seeks nearly 10 years of documents about safety and quality issues at the company. It indicates 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 center by FDA and the Massachusetts Board of Registration in Pharmacy.

In January 2006, based on several complaints, the company signed with state regulators a consent agreement in which it agreed to a full inspection of its drug compounding practices by investigators.

The company's encounters with regulators have been reported since the outbreak began, but state pharmacy board documents released Monday offer a new level of detail. They show the inspection by Illinois-based Pharmaceutical Systems Inc. found "significant gaps" in procedures and a lack of required documentation at the NECC facility in Framingham, just west of Boston.

NECC spokesman Andrew Paven said he hadn't seen the committee's letter but the company continues to cooperate with the ongoing investigation.

"NECC 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," he said by email.

NECC attorney Paul Cirel told CBS News in a statement Tuesday evening, "It has always been the company's practice to provide the Board with full and complete access to its facility and its records. As is standard practice in the health care industry, the Board had numerous opportunities, including as recently as last summer, to make first-hand observations of the NECC's facilities and operations."

"Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company's operations," Cirel said. "NECC's transparency in dealing with the Board since inception in 1998 demonstrates its good faith intention to operate in compliance with the requirements of its license. Furthermore, the company's intention and best efforts at compliance are equally applicable in every other state in which it has been licensed."

[lloydbest1]

ADSch says:
"We've become accustomed to incidents like this happening in China. Perhaps the US should take a lesson from the Chinese, and put those people responsible in front of a firing squad. That includes the inspectors and their managers. Maybe that's what it will take to re-instill some ethics in business practices."

'Fraid not. Low and mid level business managers are still being shot in China for crimes like this as I write this rebuttal. It's kind of like telling your child to wear his(her) seat belt and pointing out gristly examples of what can happen if you don't. The response is almost always, "But it'll never happen to ME."
Those who are enough twisted to engage in unethical business practises are almost always believers that they are cleverer than the regulators trying to catch them out and that they will get away with their misdeeds...."It'll never happen to ME." It's almost like a game with them.
In this case a game with deadly consequences.
Criminal charges need to be filed for sure but I also think the laws pertaining to the LLC need to be reformed. If the owners and managers of these unethical firms have to part with their personal assets, as part of the penalty process, whenever their firms are caught with their fingers in the cookie jar, so to speak, then I think that will have as much of a positive effect as stringing the lot of 'em up against a wall and turning them all into hardware cloth.

[Kalameredith]

There are regulations and laws that require the state to have inspectors go to these facilities. Where were they and why aren't they being perp walked as well. Secondly this is a componding company which means it was in the business of making generic drugs. Obama has been pushing generic drugs so should we blame him as well.

[marine1957]

"Mass. moves to revoke license of firm tied to meningitis outbreak"
What has taken so long for this move against that company? It's about time!
I wonder if all the shortcuts were being made so that the CEO could get paid $50,000,000 a year...

[askagain]

The lab may have been filthy and the workers may have been sloppy. Nowhere in the article does it say the lab didn't cooperate with authorities or that authorities thought the lab should be shut down prior to this. You can have a thousand regulations that are meaningless without enforcing them. Certainly Massachusetts or the Federal government could have shut down this lab with existing regulations. And to blame Romney is as far fetched as it gets. What makes you think he ever heard of this company? And, using the same far fetched argument, why not blame Obama because he is President while this incident happened. Get real people.

[Larnan5]

Romney has called the FDA an "attack on free enterprise" and the Ryan budget considers the agency "discretionary." Ryan has voted against a stronger FDA six times and given the chance, he would slash its budget drastically.

[nancy_naive]

NECC? New England Confectionary Company? Love the waffers.

[IPonUall2]

The operation is a success, but the patient died.

[IPonUall2]

This just is another feather in the cap of the "we don't need stinking regulation" mentality.

I feel our living standards has been in decline since I was a child.
While there are many things in today's world we didn't have in the past, I feel that in those days, with older tech, we as a people had it better.
I believe much of it is a direct result of the infighting of our society as the melting pot of democracy under attack.
It is also as much the external pressure brought on by our American corporations moving out to countries that don't have the standards we have come to expect here.
The Republicans have since Reagan been a party to much our our decline.
They have been throwing the bible at you and waving the flag of patriotism to pull the wool over American eyes.

[VA_Jill]

And this is what you get with no regulation. Apparently this is what Republicans WANT.

[nancy_naive]

Jill,
When several 1000 lay dead, then the market pressures will cause the company to change its name and open a new business in a new location.
Free Market Forever...

[cntrygirl3]

This is what the republicans want to do all across the country, remove those profit killing regulations, after all it costs money to wash the floor and sterilize equipment cut these cost you raise profits. Just think about it remove regulations from meat packing and seafood, and don't inspect fruits and vegetables or eggs. Make sure your insurance is paid up this is just a taste of what is ahead.