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Frank Bernheisel: The View From Here
Frank Bernheisel
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Frank Bernheisel
Posted 02.24.14
Just Outside Washington

FRANK BERNHEISEL

Bad Drugs Equals Health Problems

Recently, I was reading the labels on the containers of the pills and other medicines that I take and have taken. Most of the vitamins, medicines (those with 'real' labels and not just the pharmacy label) say "distributed by" but not where they are made. The aspirin says "Made in Canada," and some of the supplements are labeled "Made in USA." None of the pharmaceuticals have origin labels. Is this a problem?

The New York Times has pointed out that, if you are presently taking Vitamin C, the product that has almost certainly been made in China and if you are taking aspirin, the product most certainly was made in either Thailand or China.

Many of the companies are "American" companies that moved their manufacturing out of the U.S. In the case of antibiotics, the last antibiotic plant in the United States was in Syracuse, New York, and it closed in 2004.

Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), says that eighty percent of the active pharmaceutical ingredients in drugs taken in the U.S. are actually manufactured in other countries and about forty percent of the finished drugs are coming from other countries.

China and India are major suppliers of these active pharmaceutical ingredients. Of course, drug manufacturers, wherever located, has to meet the standards and regulations of the FDA to sell drugs in the U.S.

Allen Coukell of the PEW Charitable Trusts says they have been tracking drug manufacturing and drug quality issues since 2008. PEW started this because of the contamination of a blood thinner called Heparin, which made a large number of patients very sick.

In that case, the drug was coming from China and someone in the upstream supply chain of Heparin substituted something that was not the correct active ingredient but tested like the correct active ingredient. It made its way all the way into the drug and into the U.S. supply chain and made large number of patients quite sick. The substitute was much cheaper.

Because of the concern about contaminated drugs from overseas, in 2012 Congress increased the FDA budget by $300 million to fund sending FDA inspectors to China and India. As a result, recently, the FDA banned Indian exports of generic versions of popular medicines -- including Accutane, Neurontin and Cipro -- after the regulatory agency found that they had been adulterated.

Bad drugs are clearly a health problem.

But there is also a security issue. Given that the U.S. is getting most of its drugs from China and India, particularly those that are essential for hospital operations, what happens if the supply chain is disrupted? Health care in the U.S. would stop.

How did the U.S. get into this mess?

As mentioned above, U.S. companies moved to India and China for the reason everyone understands -- cheap labor. But there is another reason -- there was no FDA. And because there was no FDA there was no regulation.

I mean really, regulation is a pain in the ass -- there is always someone looking over your shoulder and if you screw up, you have to throw out the whole batch. And you may have to clean up the factory. Man, that costs money!

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