The FDA hasn't inspected this plant since 1999.
In fact, inspections of all plants have been cut way back since 2001 and who knows what else is out there.
The Bush admin. is covering up this fact by having the FDA and CDC people lie and say there were problems in 2003.They don't want people to find out that our public health protection agency is being hobbled by this administration.
Doesn't it sound weird when they say this goes back to Clinton - well, it does, in a way, except that in the Clinton years, the FDA *was* inspecting and in the Bush years, the FDA suddenly dropped the ball.
Ok, I've been doing research and I'm not finished but I have gotten to the point that I am pretty confident.
It is my charge that the Bush Administration starved the FDA of sufficient funds from 2001-now to properly carry out their duties of inspecting physical plants like this lab and ensuring public safety.Secondly, the Bush administration allows too much industry input into public policy, thus allowing mergers like Powderject and Chiron when it should have known that this would cause too much risk.
It was *NOT*, repeat *NOT* 2003 that the FDA found problems in the Speke,, Liverpool factory - it was way, way back in 1999 and it is my charge that that plant hasn't been inspected until this October.
Some recent artcles repeating this:
http://www.medilexicon.com/medicalnews.php?newsid=14769&language=spanishAn FDA spokesperson, Karen Midhun stated that in 2003 the FDA had discovered some contaminated batches of flu vaccine which had been reprocessed. The licence does not allow reprocessing. She said Chiron told them it was sorting the
problem out. In August 2004 Chiron told the FDA another batch was contaminated, Midhun said.
http://www.healthfinder.gov/news/newsstory.asp?docID=521733 On Monday, however, USA Today reported that U.S. health regulators had identified problems at the British plant more than a year ago, in June 2003.
I can't prove the above allegation, except to say that the complete absence of ANY negative articles or news on the internet until you go back to 1999 is highly suspicious.If these 2003 problems occurred, it would have been reported in 2003 and the FDA would have issued a warning letter in 2003 and they didn't and it wasn't.
My evidence:
No negative news here or overseas in the internet anywhere for 2003 even though as a public company, Chiron would be required to publish negative news.
The FDA has a complete list of all warning letters on its Freedom of Information Act webpage
http://www.fda.gov/foi/warning.htmYou also need to know how this lab has changed names.
Sometime previous to 1999, the lab was run by GlaxoWellcome and by 1999, it was owned by Medeva.
In 1999,Medeva suffered a recall of its polio vaccines due to possibke exposure to BSE(mad cow diease) and subsequently, the FDA inspected the plant and issued the following Warning Letter:
http://www.accessdata.fda.gov/scripts/wlcfm/company_archive.cfm?FL=M 10/21/99 Medeva
As an aside, Glaxo also got another Warning Letter for a different plant of theirs in Italy for similar problems:
http://www.fda.gov/foi/warning_letters/m4208n.pdfGlaxo Wellcome, S.p.A.
Then to go back to the name changing - Medeva sold the plant to Celltech which sold it to Powderject and Chiron bought Powderject in June 2003.
However, 2001,2002, 2003, and 2004 so far do not show *any* warning letters and while I have not downloaded all pdf files to check, it looks like their overseas budget has been cut drastically. Their total number of warning letters are down dramatically too from the years 1999 and 2000 and I think that points to decreased investigations, not improved safety/cleanliness.
http://www.accessdata.fda.gov/scripts/wlcfm/company.cfm?FL=C Chiron not listed, Celtech unrelated item
http://www.accessdata.fda.gov/scripts/wlcfm/company_archive.cfm?FL=C Chiron unrelated item, Celltech unrelated item
http://www.accessdata.fda.gov/scripts/wlcfm/company.cfm?FL=P Powderject not listed
http://www.accessdata.fda.gov/scripts/wlcfm/company_archive.cfm?FL=P Powderject not listed
My contention is that if the FDA is consistent, they would have issued a warning letter last year to Chiron if there were problems last year. I am not saying there weren't problems - I am saying I don't believe the FDA did any inspections. I think they are afraid to admit that this plant, with such serious problems in 1999 was not further inspected until just now and that it took the British to shut it down.
Other links:
http://observer.guardian.co.uk/uk_news/story/0,6903,386177,00.htmlMartin Bright and Antony Barnett
Sunday October 22, 2000
http://www.express.co.uk/00/10/21/news/n0100splash.shtml http://stg.syndnet.thomsonfn.com/InvestorRelations/PubNewsStory.aspx?partner=5425&storyId=87791http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&contentId=A18190-2002Apr19¬Found=truehttp://www.signonsandiego.com/uniontrib/20041017/news_1n17flu.html