What Went Wrong? Heparin Probe Highlights Challenges Of Regulating Global Drugs Market

(CHANGZHOU, China) -- On a dusty lane in east China, a small factory sitting amid strawberry and vegetable fields processes chemicals from pig guts into heparin, a commonly used blood thinner linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany.

The mysterious problems with heparin from the factory and others like it ? China's deadliest product quality scandal since Chinese cough syrup killed 93 people in Central America a year ago ? dramatically illustrate the perils of shifting drug production offshore.

With recalls of heparin products now in six countries, it is an issue that regulators are scrambling to address.

In the past month, China's drug safety agency has ordered tighter controls on heparin production. That followed a U.S. Food and Drug Administration order requiring all heparin imports to be tested. The FDA also announced plans to station eight regulators in China and hire five Chinese to work with them.

"This is just the tip of the iceberg in terms of problems with sensitive drugs," said Dr. Bryan Liang, an adviser to the Partnership for Safe Medicines, an American group working to promote drug safety. "The problem is only going to get worse as more materials come from suspect sources."

About 40 percent of pharmaceuticals and 80 percent of the chemical ingredients in drugs are imported, according to U.S. government statistics. A growing share comes from developing countries such as China, India and Mexico that are still building their own drug safety systems.

Heparin is derived from mucous wrung and washed from pig intestines and other animal organs. It has been used for decades to prevent clotting from intravenous procedures, dialysis and heart surgery.

The recent problems were traced to heparin made in China and marketed in the United States; so far, China has reported......

Not only are these drugs coming from outside the US without being scrutinized, doctors are “clueless” about the side effects. IMO, physicians today are nothing more than pill pushers.

Is Your Doctor in Denial? Survey Finds Physicians Often Dismiss Complaints About Drugs’ Side Effects
By Ishani Ganguli - Special to The Washington Post Tuesday, August 28, 2007; Page HE04
On many online message boards and Internet chat rooms, anxious patients share details about the muscle pain and memory loss they have noticed since they started taking statins to lower their cholesterol. A new study suggests these people may be seeking validation for good reason: Some of their complaints might otherwise be going unheard.
According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients’ concerns about such side effects. The study suggests this pattern of reaction goes beyond statins to other drugs. When doctors fail to recognize a patient’s symptoms as drug side effects, more than that patient’s care is put at risk. Because the doctor makes no “adverse event report” to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is. Researchers from the University of California at San Diego had been investigating the side effects of statins when they noticed the problem.”Person after person spontaneously [told] us that their doctors told them that symptoms like muscle pain couldn’t have come from the drug. We were surprised at how prevalent that experience was,” said Beatrice Golomb, associate professor of medicine and the study’s lead researcher.

How about this for sheer stupidity? American drug manufacturers are moving their drug production facilities overseas to places like China and India. So, Americans with degrees in chemistry are finding it harder to get jobs here. The American companies that are still here are hiring foreigners under the H1B visa program to fill the few jobs that are left in the U.S. My brother has two degrees in chemistry. He gets the professional journal “Chemical and Engineering News” which is reporting all of this and often has letters to the editor from angry, frustrated, unemployed American chemistry graduates.

I suggest that the companies that are selling foreign-made garbage that is killing and sickening Americans should be sued for every penny they have. Put a bunch of their top executives in jail for manslaughter. Make an example out several of them and MAYBE they’ll decide it really isn’t cost effective to outsource or to buy this stuff from Chinese manufacturers.

And then there’s the report that was on CBS news last night. Hundreds of thousands of dollars worth of drugs, paid for by American taxpayers, are being dumped down toilets in nursing homes because the patients for whom the drugs were intended have died. These drugs are still in their original containers or syringes, have never been used, and are in perfect condition. But, some government edict requires nursing home adminstrators to dispose of them; they can’t be given to anyone else. Not only is it a colossal waste of taxpayer money under the bankrupt Medicare system, but it’s polluting our water supply because the drugs can’t be filtered out of what may eventually be used for drinking water. So, you’re getting anti-cancer, anti-Alzheimer’s and who knows what other drugs into your body just because the d_____n federal and state governments have asinine policies about drug disposal. Sheer lunacy!

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