BernieHund: The Political Watchdog

Last week the FDA and Baxter International were suggesting that when using heparin, the doctors should administer it slowly and perhaps prescribe an antihistamine for any “allergic” reaction.  That came following 4 reported deaths from the use of the drug and over 350 complaints of reactions.

Apparently, the FDA has revived itself from a perpetual coma.

Amid indications that more people may have died or been harmed after being given a brand of the blood thinner heparin, federal drug regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug.

How many deaths does it take to get someone’s attention in Washington?

Amid indications that more people may have died or been harmed after being given a brand of the blood thinner heparin, federal drug regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug.

….  The Food and Drug Administration said the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21 from 4. But it cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.

Excuse me, but wouldn’t a reasonable person have figured “those patients were already seriously ill”?  That’s why they were on the drug in the first place.  No healthy person needs a blood thinner.

Remember the “glitch” the FDA referred to last week, when attempting to rationalize their lack of oversight?

The F.D.A. admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.

Last week, the F.D.A. sent inspectors to the plant. Among the potential problems they found was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not identified.

Over the past year the Chinese manufacturers of a key ingredient in heparin have suffered a wave of diseases involving the pig intestines which is the basis of the Chinese heparin.

The Chinese heparin market has been in turmoil over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material.

As I mentioned in a previous post, with tainted pet food ingredients, lead based paint on children’s toys, and now the heparin deaths, why would we not expect anything and everything coming into our country (for any purpose whatsoever) to be inspected before leaving China and perhaps upon arrival?