Arrests made related to the 2012 fungal meningitis outbreak

[chiver78]

I can't find the original thread, if someone else does, I'll merge this into that. -chiver mod.

CBS news link

the two co-founders and 12 former employees of the New England Compounding Center have been arrested this morning, charged with a variety of crimes, including “racketeering with 25 predicate acts of second degree murder in 7 states.”

[The Captain]

Here was one of them:

notmsnmoney.proboards.com/thread/27353/15-dead-due-govt-failure

[chiver78]

thanks. merging now.

I'll link back after the press conference at 11AM as well. one of the former employees that was arrested is the wife of one co-founder. I'm completely fascinated with the breakdown of oversight on this place.....


ETA:  hmm...I think I'll pass on that link, it's in P&M.

[The Captain]

Even though it took over 2 years I'm glad to see someone is being brought to justice.

[Tennesseer]

Dec 17, 2014 9:41:47 GMT -5 chiver78 said:

thanks. merging now.

I'll link back after the press conference at 11AM as well. one of the former employees that was arrested is the wife of one co-founder. I'm completely fascinated with the breakdown of oversight on this place.....


ETA:  hmm...I think I'll pass on that link, it's in P&M.

And that thread starts out with unbiased insight.

[chiver78]

not going there, Tenn.

[The Captain]

Despite the apparent bias, it still (IMHO) brings up a valid point or two for discussion.

Just how much, and at what level, is governmental oversight appropriate in general and specifically to this industry?

[mmhmm]

The link is here in the thread for those who might be interested. After reading the linked thread, I didn't see much that would be useful here.

[chiver78]

Dec 17, 2014 9:56:59 GMT -5 The Captain said:

Despite the apparent bias, it still (IMHO) brings up a valid point or two for discussion.

Just how much, and at what level, is governmental oversight appropriate in general and specifically to this industry?

I would offer that oversight is appropriate in at least the capacity to enforce the rules that already exist in the regulation of the pharmaceutical industry. I work for a biotech company registered as a manufacturer, and the rules we have to follow would easily have caught this incident well before it happened. this is the sort of case that reads like the history of the how and why the FDA came into existence in the first place. Starting with Hyland's cough syrup (1903) and moving through various other avoidable tragedies across many aspects of the pharma world, there are regulations in place now to catch 99% of those cases throughout history - as long as the companies are following the regulations. that's where the oversight comes into play.

NECC was registered as a compounding center, not as a manufacturing facility. what happened in this case was that this company was actively manufacturing and flying under the radar because the FDA didn't realize they were doing so.

[The Captain]

Dec 17, 2014 10:13:34 GMT -5 chiver78 said:

Dec 17, 2014 9:56:59 GMT -5 The Captain said:

Despite the apparent bias, it still (IMHO) brings up a valid point or two for discussion.

Just how much, and at what level, is governmental oversight appropriate in general and specifically to this industry?

I would offer that oversight is appropriate in at least the capacity to enforce the rules that already exist in the regulation of the pharmaceutical industry. I work for a biotech company registered as a manufacturer, and the rules we have to follow would easily have caught this incident well before it happened. this is the sort of case that reads like the history of the how and why the FDA came into existence in the first place. Starting with Hyland's cough syrup (1903) and moving through various other avoidable tragedies across many aspects of the pharma world, there are regulations in place now to catch 99% of those cases throughout history - as long as the companies are following the regulations. that's where the oversight comes into play.

NECC was registered as a compounding center, not as a manufacturing facility. what happened in this case was that this company was actively manufacturing and flying under the radar because the FDA didn't realize they were doing so.

I appreciate the detail but still am a bit unclear on the nuances...what is the difference between manufacturing and compounding when it comes to medicines, and - should there be a difference in how they are regulated? (I ask because ultimately both treat medical conditions, correct?)

[chiver78]

compounding is the process where you blend recipes of already-approved product into specific doses in small batches, generally customer-specific by prescription. it has nothing to do with making those products. because the products are already approved, there is a lower level of quality control in those facilities. the meds are coming in already finished, and then being blended into a specific cocktail (for lack of a better word) under the direction of the prescribing doctor.

what was going on here is that NECC started making larger batches of these cocktails and marketing them in some way. when you do things at the scale that a compounding center should be using, the vials/mixers/etc are all small enough that everything is benchtop. since you're doing individual mixes, you don't have a set "process" that needs to be validated - checked for system integrity, repeatable results, equipment sanitization, etc. when NECC started moving to the larger batches, that's exactly what they were dealing with - large process equipment. there was zero oversight to this equipment, because they weren't supposed to have it in the first place.

IMHO, anyone that deals with consumable, topical or injectable medicines outside the package, at any point between raw material and the meds being introduced to the patient, should be held to the same oversight. it's sad that those people lost their lives over this, and I think this is going to be the next case that shapes the FDA.

[chiver78]

well, I wish I had more to report from the press conference, but a woman that was on stage (not speaking) actually fainted and required medical attention. hope she's okay.

so the people that were arrested are the co-founders (I mentioned that earlier) and senior pharmacists and managers. not only were they actively manufacturing, but they falsified prescriptions to show regulators to explain their volume of production. they also falsified cleaning records, and neglected to act to investigate test results showing bacteria in the clean rooms - a move that would earn a harsh warning, if not consent decree, when discovered - and continued to fill their vials and ship them as sterile, knowing they weren't.

don't know the breakdown of who's charged with what, but US Attorney Ortiz referred to 2nd degree murder charges under the RICO Act.

will come back with more (and hopefully a link) when they return to the press conference.

[Angel!]

Dec 17, 2014 10:17:02 GMT -5 The Captain said:

Dec 17, 2014 10:13:34 GMT -5 chiver78 said:

I would offer that oversight is appropriate in at least the capacity to enforce the rules that already exist in the regulation of the pharmaceutical industry. I work for a biotech company registered as a manufacturer, and the rules we have to follow would easily have caught this incident well before it happened. this is the sort of case that reads like the history of the how and why the FDA came into existence in the first place. Starting with Hyland's cough syrup (1903) and moving through various other avoidable tragedies across many aspects of the pharma world, there are regulations in place now to catch 99% of those cases throughout history - as long as the companies are following the regulations. that's where the oversight comes into play.

NECC was registered as a compounding center, not as a manufacturing facility. what happened in this case was that this company was actively manufacturing and flying under the radar because the FDA didn't realize they were doing so.

I appreciate the detail but still am a bit unclear on the nuances...what is the difference between manufacturing and compounding when it comes to medicines, and - should there be a difference in how they are regulated? (I ask because ultimately both treat medical conditions, correct?)

Compounding can be done in a pharmacy, a pharmacy is never going to be manufacturing.  I had to go to a compounding pharmacy (it was a walgreens, but most don't do compounding) for some medicine for DS once.  It was medication that was uncommon in liquid form & had to be mixed to the right strength for DS because he was only 1.

[The Captain]

Dec 17, 2014 12:48:07 GMT -5 Angel! said:

Dec 17, 2014 10:17:02 GMT -5 The Captain said:

I appreciate the detail but still am a bit unclear on the nuances...what is the difference between manufacturing and compounding when it comes to medicines, and - should there be a difference in how they are regulated? (I ask because ultimately both treat medical conditions, correct?)

Compounding can be done in a pharmacy, a pharmacy is never going to be manufacturing.  I had to go to a compounding pharmacy (it was a walgreens, but most don't do compounding) for some medicine for DS once.  It was medication that was uncommon in liquid form & had to be mixed to the right strength for DS because he was only 1.

I understand now.  However, given that both compounding and manufacturing produce products, the end result is consumption by humans to treat illnesses, I'm shocked that the standards and oversight are different.

[The Walk of the Penguin Mich]

Dec 17, 2014 12:53:20 GMT -5 The Captain said:

Dec 17, 2014 12:48:07 GMT -5 Angel! said:

Compounding can be done in a pharmacy, a pharmacy is never going to be manufacturing.  I had to go to a compounding pharmacy (it was a walgreens, but most don't do compounding) for some medicine for DS once.  It was medication that was uncommon in liquid form & had to be mixed to the right strength for DS because he was only 1.

I understand now.  However, given that both compounding and manufacturing produce products, the end result is consumption by humans to treat illnesses, I'm shocked that the standards and oversight are different.

Actually, it does make sense.  Manufacturing may or may not be direct human consumption, but compounding will be.  A product can leave a manufacturer sterile, manipulated by a compounding facility and negate the sterility, so it may or may not be important.  Many things can be sterilized after it has been compounded too, if the process of compounding can cause contamination.  

So a manufacturing facility has the responsibility to make sure that the product is what they claim it to be, and (if used directly for consumption) sterile.  A compounding facility needs to make sure that the product has been combined at the proper concentration, and is sterile.  They have no need to do the processes that the manufacturers use to verify that the drug is the drug that they say it is.

[chiver78]

bumping this thread with some sort of good news. NECC CEO Barry Cadden was convicted of racketeering, conspiracy and fraud charges tonight, although he was spared convictions for murder. but he will be serving jail time.  

Boston Globe article

the trial for pharmacist Glenn Chin (refresher - the guy that was arrested at Logan Airport, trying to leave the country) has yet to occur.