Mylan workers overrode drug quality controls

[RamboLiberal]

Source: Pittsburgh Post-Gazette

MORGANTOWN, W.Va. -- Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.

Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.

But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

The report said the practice was "pervasive," occurring on all three shifts at the plant, which makes roughly 19 billion doses of medication annually. The drugs are used to treat diabetes, high blood pressure, depression, cancer, epilepsy and other conditions.



Read more: http://www.post-gazette.com/pg/09207/986516-28.stm

[lumberjack_jeff]

1. workers on three different shifts don't override safety and quality alarms...

... without guidance, leadership and tacit approval from above.

I've seen it many times, businesses create policy which guarantees unsafe practices and poor quality, then act shocked when "they learn" that the policies they promote have the predictable effect.

[National Steel 27]

3. Precisely...

"pervasive", my ass.

Just shifting blame.

[WriteDown]

4. Many workers will do anything to avoid extra work...

If obeying the alarms caused extra hastle for workers then it can happen.

[Mopar151]

6. Bullshit on the extra work!

Extra hassle from the straw boss for being a "chicken little"? That's exactly how it happens.

Most folks, and especially the kind you hire for a pharmacuticals plant, want to do the right thing. The thing of it is (and I was an industrial supervisor for 5 years) you don't want to make the wrong way the easiest way. I'd bet that QC lost a couple pissin' contests backalong, and some other nitwit manager is showing QC who's boss.

[WriteDown]

7. Sure...

So if writing a report due an alarm causes 3 times the work, you don't think that some workers will just push a few buttons instead?

I bought a watch from a retailer 2 or 3 weeks ago and brought it to the counter. It rang up a price that seemed high to me so I told the checkout girl what I thought the price was supposed to be. She tried to change it and then the register asked for a manager. She overrode it with a keystroke or two. Unfortunately, I was the one who was wrong and she sold the watch to me for about 40$ less than it actually costs.

[1monster]

17. No. I don't. I think most workers start out wanting to do the job the best they can.

I think many workers are subverted by de facto standards and practices of companies they work for.

I sincerely hope that you went back and paid the store the $40.00 you inadvertantly misapproprated from the store.

[TheMadMonk]

11. I'll call BS on your BS.

The kind of workers hired for pharm plants are exactly the same kind as you hire for any other production line. The cheapest that can be got.

I won't say there isn't managament influence, but it would be more along the lines of firing those workers who have the poorest QC results, rather than any sort of directive (or even nugde-nudge, wink-wink understanding) that could come back to bite them on the arse.

Cheap, stupid worker can't keep his machine operating within parameters. Cheap, stupid worker saves his own arse by making the problem "go away" before anyone else notices there is a problem with his work.

Same sort of shit goes down in the processed/pre-packaged food industry as well, though mostly it works in the favour of the consumer as far as quantity is concerned (assuming a decent level of regulation/oversight) as far as the worker is concerned, it's far, far better to let overweight products go through and cost the company a cent or two, than condemning underweight products at a dollar+ per shot, and getting hauled over the coals for it.

[lumberjack_jeff]

12. No.

Just no.

It only happens when the company punishes workers for slowdowns resulting from alarms and/or tolerates/tacitly approves people ignoring them.

[WriteDown]

13. Post 11 explains it well. nt.

[Amos Moses]

19. Post 11 was taken straight from of the GOP playbook.

[WriteDown]

20. If you say so.

:shrug:

[Amos Moses]

18. They'll tell you in pre shift that it's OK to stop the line.

Then, when you do stop the line, they raise all kinds of hell for doing so. They'll give you an earful about how much money you are costing the company by stopping the line.

Most places I've worked, stoppages were usually due to worn out equipment that the company was too cheap to replace or maintain instead of lazy or irresponsible line workers.

Notice how any time a bad story like this gets out, they always blame everything on labor? It was management that gave them the override codes to begin with!

[WriteDown]

22. So they're doing an internal investigation...

on policies "they" implemented? :shrug:

Go down the thread and people in the industry address it a bit.

[Amos Moses]

25. I didn't say it was company policy.

I said someone in management gave out the codes. It doesn't necessarily mean they went and told the plant manager about it to see if it was OK to do that. :think:

If you want to play semantics then don't bother wasting my time with another reply.

[WriteDown]

27. Who says that only managers have the override codes?

It still doesn't explain the concern and investigation.

[Amos Moses]

28. You're just being willfully obtuse now.

goodbye

[WriteDown]

29. If you say so....

You sound a little beligerant.

[Amos Moses]

30. goddamn right

:headbang:

[Hannah Bell]

31. there's always someone who'll squeal - if management wants to hear it, that is.

[Locrian]

2. well...

Well we all KNOW the problem is that pesky big government regulation right? I mean, it's the perfect example of why business should be free of these things. Wouldn't be a problem except for "socialists" like Obama in control.

(sarcasm)

[Gman2]

5. I have suffered two recalls on Digitalis. Cocksuckers.

They can kill peoploe easily. The dosage of Digitalis is very thin. They were putting out double thickness tabs. And you will shortly develop digitalis intolerance, and you are FUCKED> I am going to nail these punks, if I can.

[sutz12]

8. Oh good, another free market answer to our health care crisis.

Yes, that is :sarcasm: .

[bkkyosemite]

9. "Mylan's quality assurance team had concluded that no medications were compromised,"

I believe that like I believe we are landing on Mars today.

[MannyGoldstein]

10. FWIW, Drug and Medical Device Makers Tend Not To Skirt Procedures

I'm in this industry. One of the few things that the FDA will totally bust you for is messing with your own established procedures, which is what this sounds like. Managers do actually go to jail for this, and plants and even entire companies are shut down for months or years. The only thing worse is to dissemble to the FDA - then the wrath of God will rain down on your head, and (s)he will verily smite you.

I don't know the details of what happened in this case but, generally, I wouldn't worry much about medical "stuff" being manufactured properly - although there are certainly other things to worry about, where there's much more leeway. Things like safety and efficacy of things even when they are manufactured properly. Vioxx caused 50,000 excess deaths before the FDA figured out what was going on, and it was manufactured just fine.

[Gman2]

21. I am a process engineer. The safeties were dismantled officially.

You design the system to disallow any tampering, without detection. I am responsible for many alterations to the process. You are required to do an experiment, to document it, and record the whole process. If you are ISO, you update your procedures. The management, didnt want to run afoul of the FDA. If they get in your business, it gets a lot harder to function. The management might even have given the codes, to allow their productivity to stave off the move to India, and their jobs too.

[dixiegrrrrl]

24. Sorry to contradict you, Manny, but.........

In 10 minutes browsing internet, ( Topix.net)
I found that

1. Mylan had sub-contracted to a company which lost a major lawsuit for making wrong strength digatalis drug.

2.BRUSSELS -(Dow Jones)- July 08, 2009
The European Commission Wednesday said it has opened an antitrust case against Les Laboratoires Servier and several other drug makers, suspecting they colluded to keep the generic form of a blood pressure medication off the market. The commission, the European Union's regulatory arm, said......Matrix Laboratories Ltd. (524794.BY), a subsidiary of Mylan Inc...
involved in its antitrust probe.

3. A history of revolving door between state governors and Mylan staff; Mylan is huge contributor to said governors.
Governor Manchin's daughter and now ...

July 20, 2009
CHARLESTON -- A former spokeswoman for Governor Joe Manchin now works for Mylan Incorporated.

Lara Ramsburg recently joined the Pennsylvania-based pharmaceutical firm, where Manchin's daughter Heather Bresch is an executive.
( Ramsburg worked for CNN before coming to Governor's office, btw.)
Mylan co-founder Milan Puskar is a long-time Manchin supporter.

4. And my finding, below, of cronyism between Mylan, Bresch,University.of W.Vir.

You add this stuff up and it makes a picture.


edit: spelling

[MannyGoldstein]

26. You're not Contradicting me at all.

As I wrote:

"I don't know the details of what happened in this case but, generally, I wouldn't worry much about medical "stuff" being manufactured properly" (emphasis added).

Mylan could be guilty as can be - but in general, medical manufacturing is fairly well controlled.

[dixiegrrrrl]

14. Here is their website and products. Long list, too.

You can look up a drug by brand name or generic name to see if they make it.

http://www.mylanpharms.com/product/productList.aspx

I shall be there awhile.
If they make anything we take, I will fill out form on FDA site.
Enough of those forms should get FDA moving. Hopefully.

RamboLiberal..........:yourock:

[bkkyosemite]

16. Thanks for the list I have not been feeling well and it took me two seconds to find both my drugs.

I am pi*sed to say the least.

[TrogL]

23. Aw, crap. My stuff's on the list.

I'd noticed it had stopped working and was going to ask for a blood test this week.

[hedgehog]

32. Hah! They make Levothyroxine, the generic for Synthroid.

I couldn't get stabilized on levothyroxine, but have had no trouble at all on Synthroid. My pharmacist told me the quality control on Levothyroxine just isn't there, that the actual dose varies from batch to batch.

[dixiegrrrrl]

15. Mylan Inc. executive's cronyism =unearned graduate degree .

She must be related to Palin?

Wiki has the best summary:

Heather Bresch is Executive Vice President and Chief Operating Officer of Mylan, Inc

Bresch, the daughter of West Virginia governor Joe Manchin, was a graduate student at West Virginia University until 1998.
In 2007 , the university awarded her an M.B.A.
despite her having completed only 22 of the required 48 credits.
Following release of a report commissioned by the university (and written by a panel of faculty members from WVU and other universities), the university announced in April 2008 that it would rescind Bresch's degree, and WVU's provost announced his resignation from that administrative post (he will remain on the faculty). On June 6, 2008, WVU President Michael Garrison resigned in the wake of the scandal.

The university initially stated that it had awarded the degree after correcting a "records error.
Bresch claimed in April 2008 that she had arranged with the WVU Business School to have her "work experience" substitute for the outstanding coursework- a claim reportedly denied by the then-head of the business school and rejected by the panel.

Michael Garrison, WVU President at the time, was reported to be "a family friend and former business associate of Bresch" and a former consultant and lobbyist for Mylan.

edit: I found this:
The scandal ultimately led to the resignation of former WVU President Mike Garrison and the demotions of several others at the university.