Ex-workers: Company linked to meningitis outbreak had questionable practices

The deadly outbreak of meningitis has spread to 16 states and infected 271 people. Today, the death toll climbed to 21.

The outbreak has been linked to steroids made at a specialty pharmacy in Massachusetts.

According to state records, from the day the New England Compounding Center (NECC) opened in 1998 to the day it voluntary shut down, the company was inspected nine times by the state and federal regulators.

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An inspection of the facility by the Food and Drug Administration prompted a 2006 enforcement letter warning that some of their procedures could lead to "potential microbial contamination.

"Well it's clear the company made a conscious effort to disregard that warning letter because only a few years later they were engaged in the very behavior the FDA warned them about," Sheldon Bradshaw, the former chief counsel of the FDA who signed the warning letter to the NECC, said.

CBS News talked to a number of former employees who didn't want to be identified. Some praised the company's safe guards. Others told us they saw incidents were safety was sacrificed.

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One former employee told us they witnessed NECC technicians handling drug vials without hair nets or gloves. Another former employee said the company's owners debated as far back as 2009 whether NECC had crossed the line from compounding, which involves mixing approved drugs for individual prescriptions -- which is allowed -- to manufacturing, which would require more oversight.

"These large drug manufacturers who operate under the guise of traditional pharmacy compounding are clearly violating the law, and they do so because they think they can get away with it," Bradshaw said.

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The NECC is owned by businessman Greg Conigliaro and his brother-in-law Barry Cadden, a pharmacist. Together with extended family, Conigliaro operates twelve companies. Four of them, including a company that recycles foam insulation, are run from the same complex as the NECC.

CBS News asked to the NECC for comment. They responded with an email, saying that while they continue to cooperate with federal and state authorities, they specific allegations made by the former employees.

[chonder2]

As far as I know a drug "mixing" company is under no self reporting regulations just like the peanut processing industry.

Remember the number of people killed by eating contaminated PB shipped out of a Georgia facility in 2008? There was a company quality control/testing lab on-site...who found salmonila in that tanker truck load and decided to ship anyway.

There was no law that required them to report it to the FDA or stop the shipment.

I happened to see on TV the congressional hearing in 2009 on that matter.After the families testified how their loved ones died in agony from tainted peanutbutter,begging for more FDA oversite...along came Georgia,Repub. Rep Gomer Gingrey who happens to represent many peanut processing plants in GA.One of the statments Gingrey made was "Being a doctor myself,having food product test results reported to the "GOVERNMENT"= FDA, would be like making me report blood test results from my patients".

That is the truth.That hearing was filmed.

That is what the American people have to deal with

[hypnotoad72]

And, ultimately, the world.

But we keep getting told how bad regulations are for the economy...

[WitchBroom]

Interesting how the employees speak up after the fact when every one of them were part and parcel of keeping quiet despite onging safety concerns and as deviations from protocols occurred. Either people have ethics and integrity and believe in what they stand for and stand for what they believe in or they don't. Clearly these employees didn't.

[hypnotoad72]

Better late than never?

And it's interesting you blame the workers while ignoring the fact the company chose to disregard things in the first place... but you're not entirely wrong, either... when the company deliberately cuts corners and the workers (or customers) do nothing, expect nothing to happen. As we've seen government won't do anything...

Maybe if we had an economy that helped whistleblowers and made it easier for people to find work elsewhere, since we all have to live on money, people would be more inclined to do the right things BEFORE tragedy happens.

Until fundamentals in our society change, people are going to "roll with the punches", or whatever the phrase is.

Thank you for reading, and you're welcome for my adding perspective and dimension to what is not a simplistic issue.

[CuriousServant]

I wish CBS would hire a proof reader.

[hypnotoad72]

Proofreaders are cool, but as someone responding on a different article said yesterday, "proper grammar is not a sign of intellect", or something to that effect...

[jnostromo]

yet another example of corporate america and corruption...Yes, the trickle down theory will work because corporations have the best interest of the people at heart.

[hypnotoad72]

"voodoo economics" - brought to you by the VP of the person who not only implemented it, but rose taxes big-time in the 1980s and granted amnesty... while his supporters love to blame Obama for... doing the same things. :)

Actually it's :( but they won't ever "get it"...

[Lerianis4]

by newster90210 October 19, 2012 11:56 PM EDT
especially you teabaggers: taxes are going up. Period. Doesn't matter what a politician tells you for your vote."

Taxes are going up up to 10% with the on-line SALES TAX on all on-line purchases coming soon, alreadyin Californicate thanks to Amazon.com SUPPORTING the damn bill, and that's an across the board 5 to 10% price hike.
_______________

********! It's taxes that should have been paid ANYWAY due to the 'use' taxes. This is not a new taxes that will increase costs for Americans, this is a tax that they should have already been paying and were BREAKING THE LAW if they didn't.

[hypnotoad72]

With Amazon taking corporate welfare... oops, wrong topic...

http://www.forbes.com/sites/petercohan/2012/10/17/amazons-sales-tax-free-status-cost-states-8-6-billion/

Oh, not as off-topic as I had thought...

There are more interesting articles discussing amazon.com and taxes, but you are right. It is not a new tax, Amazon should have been paying like everyone else, market manipulation is what compels people to think corporations should get every free ride and handout in the book at our expense (while they devalue work and blame workers for the very things the companies are guilty of!!)...

[Lerianis4]

newster, get real. You should like a radical enviroloony here and a radical veggie nut.

The fact is that since man and animals were put on the earth and animals each it each other (man is nothing more than a higher animal) we are SUPPOSED TO ******* WELL EAT MEAT!

[FormerUSMCSergeant]

They responded with an email, saying that while they continue to cooperate with federal and state authorities, they specific allegations made by the former employees.
---
CBS doesn't even proof read the crap they put up.

[foo8259]

But it's spelt correctly even if it make no sence.

[Swift29]

And when did they close? It's in the caption under the picture: basically when this hit the fan. So at least 2 regulators' periodic inspections didn't catch them and now hundreds are sick, 21 are dead.
The answer ladies and gents is REGULATION. Re-regulate.
And the republicans want to end the FDA, gut other existing safeguards that took years of toil and effort to create. Any of you right wing nitwits listening?? Anyone wonder why there's so many outbreaks of infected food? Because the right, largely, has pushed for and gotten less inspection, less regulation, of whatever you care to name. Or defunded the agencies tasked with protecting the public. And numbskulls want to vote these morons in?? Thinking what's good for business is good for America?? That's what got us here people. The invisible hand and Ayn Rand and the rest of the horsecrap. Everybody look out for number one. Great!
Think your water is safe? The inoculation for your child? The hospital whose services you may need? The products you buy? The cars you drive? Dog food? Toothpaste? Drywall? Wake up people. If you think things are dicey now just wait. With what's going on now behind closed doors we haven't BEGUN to see what industry has in store for us. Each generation gets further and further away from the standards of behavior we took for granted when we were growing up.
Now we've got execs who put glass in babyfood for God's sake. To make a buck. No lie. I can list the unbelievable manure that goes on and few crooks get caught in my opinion. And you wonder why....
The only thing standing between some innocent tyke dying from a hamburger - maybe your tyke - is a government agency like the FDA.
I could belabor the point ad infinitum but you get the picture. Not always perfect; I dare you to find something that is, but far better than leaving things to "self regulation", we've seen how that turns out. I absolutely hate the uneducated dingbats that want to throw out the baby with the bathwater. Think we can revert to some never was utopia of perfect behavior. We have cops and traffic lights for a reason. We have to pay for those. We can argue about the cost, about getting ripped off, how to fund, but you CAN NOT argue that life would be better without the things that make up civilization.
We are the West, until recently we were the envy of the world, But now we're printing money, haven't paid for the wars, or Wall St., etc. etc. etc. but we're going to 'fix it by lowering everybody's taxes'? Get a grip, especially you teabaggers: taxes are going up. Period. Doesn't matter what a politician tells you for your vote.
I'll leave out any more political observations as I'm sick to death of "IT", the media spin selling ads and the bamboozling that infects America. We'd better understand and decide what we "need" because we can't keep dreaming we can have it all.

[moretruthnow]

Dreadful for all these people who just wanted relief for their back problems. It will be no surprise that this company was not doing things safely.