BernieHund: The Political Watchdog

February 16th, 2008 at 11:28 am

FEMA, FISA, Now FDA (Again)

» by sinde in: FDA

“F you” takes on a new meaning with government agencies.  FEMA is broken.  FISA would be obsolete if left to the administration.  And, once again FDA has failed.

In the latest incident, FDA according to the New York Times didn’t follow its own policy, costing American lives:

A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.

Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.

Four deaths and 350 “complications” from the heparin have been linked to the Chinese imported ingredients to date.

Excuses, excuses, excuses.  Supposedly, the Chinese plant that produced the ingredient made from pig intestines had not been inspected as the plants’ operation has no drug license and falls outside their regulatory requirements.  (That should have been the first clue.)

FDA’s response was, as expected.

Karen Riley, a spokeswoman for the United States Food and Drug Administration, said inspectors from that agency would be visiting the Changzhou plant soon. Ms. Riley said she could not be more specific. Earlier in the week she described her agency’s failure to inspect the plant as a “glitch.”

Maybe I’m confused, but I really thought the idea behind the FDA was to make sure we avoided “glitch” as a cause of death.

Remember Vioxx?  I’m not going to go off on another rampage about the ever lengthening list of drugs that have been pulled from the shelves.  The FDA just can’t seem to get it right.

Now, because of a “glitch” we cannot rely on the quality of the ingredients that make up our drugs.  I’m not going to bash China, although I’m tempted.  But, I will say this.  Chinese ingredients were in the dog and cat food that killed our pets.  Sorry that I bring that one up so often, but I lost my precious black cat to that “glitch”.  Lead tainted products in children’s toys caused a major furor before Christmas, again everyone claiming “glitch”, no one accepting responsibility and everyone pointing fingers.

With a history of Chinese ingredients and products killing our pets and affecting the health of our children, isn’t it reasonable to expect the FDA to notice the red flag?  What is the FDA doing? 

Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year.

Once the problem with the heparin was discovered, the FDA did rise to the occasion in the same manner as FEMA shipping toxic trailers to Tennessee.

Problems with Baxter’s heparin were first noticed late last year when four children undergoing dialysis in Missouri had severe allergic reactions minutes after being injected with the drug.

The F.D.A. then allowed Baxter to deliver heparin that it was in the midst of shipping, for fear that a total recall would lead to a shortage of the drug, but cautioned doctors to use as little of it as possible and to administer it very slowly.

The agency also suggested that doctors give steroids or antihistamines with the Baxter heparin to help prevent allergic reactions.

Once again, a government agency says to just keep on, keeping on… just slow down the process for a while and maybe it will go unnoticed.  So, FDA thinks a slow death is better than a quick one? 

If I subscribed to conspiracy theories I would probably conclude that our government agencies, FDA and FEMA, were systematically working to eliminate the need for entitlement programs, by poisoning the sick and the poor.  Without FISA in place any survivors could be whisked away, labeled as a terrorist.  But, I’m not a conspiracy theorist.  I can’t give the government credit for having the ability to pull off anything that complicated.  It would take organization, something none of our agencies seem to have.

Instead, I think the government agencies are broken, totally unable to carry out the missions they were designed for, run by inept and incapable personnel with no leadership. 

Lester Crawford, former FDA leader had his own challenges.

In October 2006, former U.S. FDA head Lester M. Crawford pleaded guilty to a conflict of interest charge and making false financial disclosures to the U.S. Senate and the Executive Branch. He was sentenced to three years probation.

Mr. Crawford was replaced by Andrew von Eschenbach, the current commissioner of the FDA.  Maybe we should now look in his closet or at his portfolio. 

“Good job, Andy!”

tags: FDA   FEMA   FISA   heparin  

You must be logged in to post a comment.

  • Subscribe, Bookmark, Share

  • Keep Up With the Candidates

  • Sign The Tear It Down Petition

    Bernie's number is 120,270.
    Tear It Down
    is asking for 500,000 to sign the Petition to Tear Down Gitmo.
  • Sponsors

  • Our Sponsors

    iPhone

    Wii

    GPS

  • We Search ---> You Save

  • Translate

  • Meta

  • Recent Posts

  • Categories

  • Archives