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FDA claims "bulk drug substances for many of Merck's vaccines were adulterated."

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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 02:33 PM
Original message
FDA claims "bulk drug substances for many of Merck's vaccines were adulterated."
http://fdanews.com/newsletter/article?issueId=11889&art...

Merck has resolved a warning letter citing GMP violations at its vaccine operations in West Point, PA, as well as supply constraint for bulk varicella, which had affectred sales of certain vaccines.

During its second-quarter earnings call last month, the company said the FDA closed out a warning letter that claimed bulk drug substances for many of Merck's vaccines were adulterated. The letter resulted from an inspection that cited 49 Form 483 observations, all but 12 of which were resolved before the letter was issued, the company said.


Wow! Only 49 observations of adulterated bulk substances! Congratulations, Merck, and keep up the great work!
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CoffeeCat Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 02:44 PM
Response to Original message
1. Definition of "adulterated."
Adulterated:
To make a product impure by adding an improper substance like drugs above safe levels set by the US Food and Drug Administration.

48 of these violations??????

Which vaccines does Merck make at its West Point location????

How long was this happening before the FDA discovered that there were "improper substances" being
loaded into our vaccines?


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beam me up scottie Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 02:47 PM
Response to Original message
2. Oh noes!!11!
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FiveGoodMen Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 03:18 PM
Response to Reply #2
5. So...not a problem, then?
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beam me up scottie Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 03:28 PM
Response to Reply #5
6. You'll have to ask Kitty.
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 02:49 PM
Response to Original message
3. So is the FDA in the pocket of big pharma or not? n/t
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 02:57 PM
Response to Reply #3
4. Not every inspector, obviously.
Edited on Fri Aug-22-08 03:02 PM by mhatrw
How predictable that you would spin this as a big win for Bush's FDA.

49 violations for adulterated substances at a single vaccine production plant and what did the FDA do about it?

They wrote Merck a letter!
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 03:32 PM
Response to Reply #4
7. Yup, they did write Merck a letter.
And Merck responded, and corrected the faults.

So is the FDA in the pocket of big pharma or not?
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 05:22 PM
Response to Reply #7
9. Because Merck stopped using 49 adulterated substances in their vaccines,
we should have a parade for the Bush's FDA?

Is this a sign that Bush's policy of corporate cooperation is working wonders?

Only in the minds of "scientology" fundies.
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 05:25 PM
Response to Reply #9
10. Never said anything about a parade. That's your red herring.
Is the FDA beholden to big pharma or not?

If it is, then why would they be forcing Merck to clean up?

You can't answer that question, so you're deflecting back by distorting my position and engaging in ad homs.

Answer the question. Is the FDA beholden to big pharma or not?
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 06:03 PM
Response to Reply #10
14. At the top, yes. In the field, not yet.
Of course, those are generalizations. Many at the FDA at all levels are trying to do their jobs. But Bush is beholden to Big Pharma and the Big Pharmafish rots from the head. Wouldn't you agree?
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 07:36 PM
Response to Reply #14
15. That makes no sense whatsoever.
If the top is so powerful, why did they let this correction happen? Don't they have the power to veto anything negative about "big pharma"?

And answer me this: will you trust the FDA when Obama is president?
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 07:53 PM
Response to Reply #15
16. Maybe. I trusted it more when Nixon was President than I have for the last 15 years.
How about you?

BTW, nobody is all powerful. That's a bizarre strawman.
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 08:05 PM
Response to Reply #16
17. "Maybe" isn't an answer.
Will you trust it or not? How about just will you trust it MORE?

And please, if the top levels of the FDA were all about covering for big pharma, they wouldn't let a little thing like a few adulterated vaccine ingredients get out at all. Thousands of Vioxx deaths, yeah, hard to cover up. But this? C'mon.
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:06 PM
Response to Reply #17
21. Merck released the data itself to explain why its earnings were less than expected.
But nice try.

Yes, I would trust Obama's FDA more. How about you?
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:24 PM
Response to Reply #21
24. Merck published this info *on* the FDA website?
http://www.fda.gov/foi/warning_letters/s6756c.htm

That's impressive! So the FDA is beholden to big pharma - they did exactly what Merck wanted, which was to publish a highly unflattering warning letter pointing out deficiencies and problems with their manufacturing process. Uhhh, yeah, that's the ticket. Quite the logic you have going there.

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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:44 PM
Response to Reply #24
25. Yeah, that was an awesome press release.
Edited on Fri Aug-22-08 11:46 PM by mhatrw
Now please link us to the FDA's impressive press conference about Merck's 49 violations.

:sarcasm: (for the sarcasm impaired)

Next.
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 10:41 AM
Response to Reply #25
30. Ah, I see.
You keep moving those goalposts. I'm sure it's frustrating to have been shown to be wrong as many times as you have.
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flyingobject Donating Member (324 posts) Send PM | Profile | Ignore Fri Aug-22-08 05:30 PM
Response to Reply #9
13. I wonder how much of that crap got injected into some young girls
and if some of the girls who got sick, were sick because of the violations Merck was cited with.
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TZ Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 08:46 PM
Response to Reply #13
20. None.
Cause the warning letter caused the recall of the bad batches. Thats how this game works.
And it had nothing to do with gardasil or do you not understand that varicella is not HPV?
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:09 PM
Response to Reply #20
22. There were 49 violations. The lack of varicella supply is a different issue entirely.
It is not clear what adulterated ingredients got into which vaccines or what was done about this.

But, of course, you have the blind faith of a fundamentalist that nothing bad could have happened.
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 06:55 PM
Response to Reply #22
34. The blind faith in big pharma/big corp is stunning
considering this is a democratic forum.

However, this is the only group at Du that exhibits such blind trust of
the big corporations.
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TZ Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 08:45 PM
Response to Reply #9
19. Boy
I like to know who you work for. When the FDA does its job its teh evul Merck! When Merck RESPONDS AND FIXES the problems its TEH BUSH IS TEH EVUL.
Do you really think no company ever got a warning letter before 2000 or fixed the problem before 2000? Oh wait I forgot! All the FDA SCIENTISTS ON THE ADVISORY PANELS HAD BRAIN TRANSPLANTS in 2000 to become Bush bots right? Career scientists on the FDA panel and yet you know MORE THAN THEM DOC! (are you gonna tell me again you are a med school doctor even though you know less virology than any college student). And I love how you make the same old wooshit arguments now that you made when I joined over a year ago.
Amazin static universe you live in Doc!
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:21 PM
Response to Reply #19
23. I never said I was a doctor. I teach medical students.
What I teach them is verbal reasoning and writing. You might consider such a course.

Bush isn't evil because the FDA busted Merck. Bush is evil because Bush is evil. Do you or do you not agree?

Concerning your straw man, I clearly said that the FDA is filled with good people trying their best to do their jobs, but that the fish is rotting from the head. Do you really wish to take up for Bush here? Maybe you are in the wrong place?

As for the "same old arguments" I am making, you are free to join the discussion at any time:

http://www.democtraticunderground.com/discuss/duboard.p...

My prediction is that you will avoid such discussion like the plague because you know that my "wooshit arguments" are unassailable.
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beam me up scottie Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:49 PM
Response to Reply #23
26. You teach verbal reasoning and writing to medical students?
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:

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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 11:57 PM
Response to Reply #26
27. Yeah, it's pretty funny. n/t
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cosmik debris Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 12:02 AM
Response to Reply #27
28. If it was true
It would be scary. But I'm not worried.
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 12:07 AM
Response to Reply #28
29. If it were true.
The subjunctive mood is required for all counter-factual or hypothetical statements.
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 06:54 PM
Response to Reply #27
33. I bet your students are smarter than what you deal with here
but then they are students.
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Aug-25-08 03:47 AM
Response to Reply #33
35. There is no battle. My students are generally extremely bright. n/t
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 06:53 PM
Response to Reply #26
32. you teach marketing and sales? Help Nigerian princes wire money?
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
:rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl: :rofl:
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Aug-23-08 06:50 PM
Response to Reply #19
31. more of the petty personal attacks
No facts, so try to harass.
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notadmblnd Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 03:35 PM
Response to Original message
8. kinda brings to mind the Viagra that had drywall ingredients in it
Reported by various media a year ago or so. The stuff was coming from China IIRC.
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 05:26 PM
Response to Original message
11. Adultery! Oh Noeess
I knew that it was all about sex.

:sarcasm:
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 05:28 PM
Response to Original message
12. Problems at the Plant: "Mercks Manufacturing Problems at Gardasil Factory May be Easing "
...
Newsinferno.com, NY - Aug 4, 2008

Not too long ago, Merck received a Food & Drug Administration (FDA) warning letter citing good manufacturing practice violations at its vaccine operations in West Point, Pennsylvania following an inspection that cited 49 Form 483 observations. Among the products made at the plant is the cervical cancer vaccine, Gardasil. During its second-quarter earnings call, Merck reported that the FDA closed out the warning letter that claimed bulk drug substances for many of Mercks vaccines were adulterated.

On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agencys normal review and approval process, Merck CEO Dick Clark said. Concerning supplements, we have at least two supplements with the FDA concerning Gardasil and they will move through the process, he said. Merck states the supplements are for expanded labeling for Gardasil and that it will respond to an FDA complete response letter for the use of the vaccine in women 2745 years of age.
...

http://www.newsinferno.com/archives/3567

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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Aug-22-08 08:12 PM
Response to Original message
18. Hey, Merck's gotta save money on ingredients, to pay the Vioxx settlements
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