Democratic Underground Latest Greatest Lobby Journals Search Options Help Login
Google

FDA warns Merck to fix vaccine plant problems

Printer-friendly format Printer-friendly format
Printer-friendly format Email this thread to a friend
Printer-friendly format Bookmark this thread
This topic is archived.
Home » Discuss » Topic Forums » Health Donate to DU
 
Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 08:15 AM
Original message
FDA warns Merck to fix vaccine plant problems
yikes.........

http://news.yahoo.com/s/ap/20080430/ap_on_bi_ge/merck_fda

TRENTON, N.J. - The Food and Drug Administration has ordered Merck & Co. to correct numerous manufacturing deficiencies at its main vaccine plant, the latest in a string of setbacks for the drugmaker.

The agency on Wednesday released a warning letter sent to Merck's chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia.

.........................

The nine-page letter states FDA found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17.

In a separate posting on its Web site, the agency said it issued the warning letter because Merck's response to the FDA report sent after the inspections was "inadequate to address the serious deviations noted."

According to the heavily redacted warning letter, Merck officials didn't thoroughly investigate when vaccine batches inexplicably failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway.


Printer Friendly | Permalink |  | Top
mzmolly Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 09:20 AM
Response to Original message
1. Gosh, given they are so concerned about public health above profit
this is shocking news! :sarcasm:

The letter also said the plant didn't have written procedures, tests or other laboratory controls to ensure "identity, strength, quality, and purity" of products.

Now doesn't this go against everything a certain "lab tech" asserts every time this subject rears it's head? Hmmmmm, how long have they been making vaccines again?

Printer Friendly | Permalink |  | Top
 
mzmolly Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 09:22 AM
Response to Reply #1
2. dup sorry.
Edited on Thu May-01-08 09:23 AM by mzmolly

Printer Friendly | Permalink |  | Top
 
mzmolly Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 09:24 AM
Response to Original message
3. Here's another article noting 49 safety issues.
Printer Friendly | Permalink |  | Top
 
chicagomd Donating Member (437 posts) Send PM | Profile | Ignore Thu May-01-08 09:28 AM
Response to Original message
4. But, but, but...
Doesn't Merck just pay off the FDA? I thought they were all in bed together to massively defraud the American public.

It looks like the FDA is actually doing its job. Shocking.
Printer Friendly | Permalink |  | Top
 
Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 09:55 AM
Response to Reply #4
5. heh
But how long has this been going on? The people at the FDA are of two minds. One mind is to placate the pharmaceutical companies to the greatest extent possible in order to facilitate switching job positions into the more lucrative private industry. The other mind is to promote public health. There is an ebb and flow of these two forces, based on many factors. In any case, the most egregious faults are addressed eventually, especially when potential whistleblowers threaten to surface. The FDA gets their actual funding from pharmaceutical companies, which is a conflict of interest by anyone's definition.

But, of course, there are many people at the FDA, in the front lines, that are genuinely interested in our public health, and I salute them. But there are also institutional forces that seek to keep their voices as quiet as possible. It is interesting to see these two forces clash, and how that plays out.

The system has been taking some major hits lately, most likely causing the tidal force to turn more towards protecting the public.
Printer Friendly | Permalink |  | Top
 
mzmolly Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 11:15 AM
Response to Reply #5
7. Agreed IJM
we may see more of this sort of thing in the future?
Printer Friendly | Permalink |  | Top
 
mzmolly Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 11:14 AM
Response to Reply #4
6. Democrats have been working on legislation to address some of the issues
and the focus on this issue may be having an impact?
Printer Friendly | Permalink |  | Top
 
trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 11:37 AM
Response to Original message
8. Gee, why did you stop quoting where you did?
Maybe because the very next line was:
However, in the Web site posting, the FDA said it "does not believe that the issues identified will affect the safety of the vaccines" made at West Point, or their availability.


Naw, much better to take the FOX News / sensationalist angle and try to scare people. It's second nature for the evidence-based medicine-hating crowd.

Seems to me, as chicagomd pointed out, this is a nice counterexample to the constant drumbeat of "FDA in the pocket of big pharma" that's usually found in this forum. So thanks for showing there are indeed safeguards, and that the FDA has the power to correct faults.
Printer Friendly | Permalink |  | Top
 
Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 12:04 PM
Response to Reply #8
9. Because of posting limits?
Wish I could have posted the whole thing. In any case that paragraph was several below where I stopped posting.

Also, I thought scientific evidence trumped "belief." If there was contamination visible to the naked eye, I am not sure I would put my trust in "belief" that the safety of the vaccines was not affected.

The FDA certainly is threatening strong action if they are producing 100% safe and pure vaccines.
Printer Friendly | Permalink |  | Top
 
mzmolly Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 12:47 PM
Response to Reply #9
10. Yes, suddenly it's enough to "believe" in the integrity of vaccines.
So much for that science stuff huh?

Then again the blind faith is not so sudden is it? ;)

Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-01-08 05:03 PM
Response to Original message
11. great example of the fda doing it's job. nt
Printer Friendly | Permalink |  | Top
 
DU AdBot (1000+ posts) Click to send private message to this author Click to view 
this author's profile Click to add 
this author to your buddy list Click to add 
this author to your Ignore list Thu Oct 31st 2024, 06:16 PM
Response to Original message
Advertisements [?]
 Top

Home » Discuss » Topic Forums » Health Donate to DU

Powered by DCForum+ Version 1.1 Copyright 1997-2002 DCScripts.com
Software has been extensively modified by the DU administrators


Important Notices: By participating on this discussion board, visitors agree to abide by the rules outlined on our Rules page. Messages posted on the Democratic Underground Discussion Forums are the opinions of the individuals who post them, and do not necessarily represent the opinions of Democratic Underground, LLC.

Home  |  Discussion Forums  |  Journals |  Store  |  Donate

About DU  |  Contact Us  |  Privacy Policy

Got a message for Democratic Underground? Click here to send us a message.

© 2001 - 2011 Democratic Underground, LLC