jeff carmack, austin, writer, freelance writer, humorist, newspaper journalist, texas, humor writer, central texas jeff carmack, austin, writer, freelance writer
texas, humor writer, central texas
   
  What’s Mandarin for ‘Just say no to drugs?’
Feb. 27, 2008

If you think you’re any safer because the federal government is watching out for you, you’d better stop reading now. This one’s going to hit harder than the news about the Easter bunny.

I just saw a news story that said the Chinese factory that makes a popular blood thinner was never inspected by the Food and Drug Administration, and four people in the United States who took the drug later died.

As they say in the regulatory biz: oops!

This is kind of a big deal. Millions of people are given heparin every year during dialysis or to prevent complications from surgery. But despite these numbers, the FDA has never actually checked the Chinese plant where the active ingredient is made.

The story said that federal law does not require that foreign drug-makers be inspected. So, the same government that wants to keep you safe (or at least wants you to think it’s keeping you safe) by not letting you carry your nail clippers on an airplane, does let uninspected Chinese manufacturers send drugs into this country. So, while you might die from taking tainted pharmaceuticals, you don’t have to worry about a terrorist giving you a manicure at 50,000 feet.

This is the same government that spends a boatload of our money each year trying to convince us that illegal drugs are dangerous. I’m not saying that those are specifically good for you but, on the other hand, no one has ever died from smoking too much weed. Doing that might make you sit through an entire “Three’s Company” marathon on the Comedy Channel, or convince you that Funyums are actually edible, but it won’t kill you.

Another thing: when you’re buying your goodies in a biker bar from a dude named Spanish Eddie, you know it’s a crapshoot. But when your connection is a man in a white coat with a diploma on the wall, your expectations are somewhat higher.

The news article said that the feds inspected a plant – just not the right plant. And apparently they overlooked some pretty obvious clues that they were on the wrong track. The most glaring was when they discovered that the “pills” the factory was producing were crispy, golden-brown, and contained nonsensical messages on little slips of paper.

An FDA spokesperson said that when the company that makes the active ingredient for heparin applied for FDA approval, the agency thought the application had come from a different company with a similar name that had already been inspected. This is a bureaucratic way of saying, “They all look the same to me.”

More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous lowering of blood pressure, breathing difficulties and vomiting. I had similar symptoms just last week but I think it was a reaction to MSG.

A spokesman said that a team of inspectors has gone to China to determine whether health problems associated with the drug originated there. He said they would also take this opportunity to figure out how to get out of those weird little finger traps.

 

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