"Prevnar" Whistleblower Trial

[LongIsland]

Associated Press (ap.org)
2/8/06

http://hosted.ap.org/dynamic/stories...MPLATE=DEFAULT

[CrazyRED]

"What is it we're all about here? Are we about saving lives or making money?" Livingston recalled the woman asked.

"I sort of gave what I thought was the right answer, which is we're here to save lives," Livingston said. "But then I thought, what would the corporation want me to answer, and I said, 'Well, we're here to do both.'"

Livingston says he regretted that equivocation ever since.

[mamakay]

I wonder what they were doing wrong...

[suschi]

The article posted states they couldn't keep up with the demand for the vax, but the truth was they were shut down until they could comply with the regulations,

"A Food and Drug Administration report detailed sloppy operating procedures, dirty work areas and instances of contamination at a New York plant. It also found that Wyeth's internal investigations were incomplete and took longer than expected.

The agency also found improper environmental monitoring and insects in a hallway outside a room where the vaccine was put into vials, the newspaper reported. In all, FDA inspectors reported finding 59 problems during an inspection of the plant last October." (bold emphasis mine)

http://mediresource.sympatico.ca/hea...=&news_id=4163
************************************
Part of the allegations in the suit:

Mr Livingston felt he was being retaliated against for his ongoing disclosures and recent report of GMP (Good Manufacturing Practices) noncompliance related to document control and training system procedures.

I think Mr Livingston stated they were taking short-cuts to meet the demand for the vaccine.

Pharmaceutical Plant Employee Fired After Raising Alarm Over Vaccine Production

In a federal whistleblower lawsuit, Livingston says he was fired in 2002 for raising questions about worker training on the Prevnar production line. The problems he says he saw could have meant big trouble for Wyeth, because in 2000 it paid a $30 million fine for violating FDA regulations at another plant.

http://abclocal.go.com/wtvd/news/pri...W_prevnar.html

[LongIsland]

Thanks Suchi . . .

. . . and now this begs the question: why did Wyeth recently halt production of it's Hib vaccine?

[mamakay]

Off topic, but since I ran across this earlier, I guess it kind of pertains to this.
http://www.newmediaexplorer.org/chri..._mcrearden.pdf

It really puts into perspective exactly how bad things have to be for a manufacturer to actually shut down.

[pumpkinsmama]

Thank you for posting the links, everyone. I wouldn't know about it if I hadn't read your posts. The stuff they get away with, that isn't more publicised bugs the hell out of me.

[suschi]

Originally Posted by LongIsland

Thanks Suchi . . .

. . . and now this begs the question: why did Wyeth recently halt production of it's Hib vaccine?

Well that must be a big secret, that there, I can't find any info about it!

HMMMM

[boobear]

Oh gross! But I shouldn't be surprised. Since consumers can't really touch drug companies for faulty products, there's not much incentive for the drug co to try and be responsible.

Sorry for just jumping in, I was busy researching homeschooling these past 2 years.

-Jeanne

[LongIsland]

Originally Posted by suschi

Well that must be a big secret, that there, I can't find any info about it!

HMMMM

Hmmm is right. I couldn't find anything either, other than what the CDC states on their website that HibTITER it is not currently being produced in the "delays and shortages" section. I could not find any warning letters on the FDA website.

I called Wyeth last week, but was kept on hold too long.

[girlsmamma2]

really HIB? that's interesting since that was the last vax my 3 year old dd got. she got a reaction to it, I was rereading my notes on it the other day. Several phone calls to convince dr it was a reaction to no avail. Luckily, she came back from it, but that was the last straw for me.

have to read the link now.....i'm sure it will tick me off.

[Moochie Mamma]

Interesting. I'm lucky to have found a family doc who doesn't push vax at all. His nurse asks at each visit: are you doing vax this time? If I say no, she answers "good". They only do vax if requested by the parent and don't give Prevnar at all. I'm taking Babygirl in for her 6 month WBE this week so I'm going ask what he's experienced with vax, especially that one to make him not even offer it.

[Plummeting]

Very slightly OT, but I love how they're arguing over whether or not this is covered by the whistleblower protection law, since the law only covers people who are doing it to protect FINANCIAL interests. I mean, God forbid someone should lose their job over trying to save LIVES - it's much more important that we protect people who are saving the pocketbooks of investors. If a vaccine is contaminated enough to kill a few people, that's not going to matter, because people are still going to line up for it, since it's required for school and all. WHERE the heck are our priorities anyway?