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Sun, Dec 21, 2014

KESTNER: Regulators concerned about fake drugs, and they should be

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When you pick up your next prescription, think about what you are buying. In most cases your prescription will be a generic replica of the drug that the doctor may have prescribed.

Over the past few years, consumers have been bombarded with a steady dose of messages from the insurance companies beating the drum that generics are essentially the same as the original patented formula.

My insurance company even goes so far as to print their message on the front of every single envelope they mail out, pitching the idea that we should all accept generics as if they are the same as the original.

The message has been so successfully established by the insurance industry that it may even seem somewhat irresponsibly selfish to insist on original patented formulas.

In a way, this shift toward depending on generic drugs by the insurance industry can be compared to the auto insurance company insisting that aftermarket car parts are just as good as original equipment.

In other words, when your Chevrolet is repaired after being struck by a careless driver you should be content if parts made by an unknown manufacturer, possibly in an unknown country, are used instead of parts that are made by Chevrolet.

Interestingly, when I ask people if they are OK with generic auto parts they often are very adamant that they would insist that genuine original equipment be used on their vehicle. However, when I ask the same people if they are OK with taking generic pills produced in a factory in an unknown country they seem to think that isn't happening.

Further questioning to the man on the street reveals that most people place a great deal of trust in the pharmaceutical supply chain. It seems that the insurance industry has been largely successful in the effort to establish the idea that all drugs are the same.

Recent news stories investigating cases of generic drugs being faked may be creating doubt in the minds of pharmaceutical consumers.

Think about this for a moment. When you picked up your latest prescription, what were you actually buying? It was almost certainly a deeply discounted generic product rather than the name brand.

What company made the product? In what country did it originate? What manufacturing standards were followed? Who was there to insist that shortcuts are avoided? Who tested the product to make sure it even contained the chemicals it was supposed to?

Before you reject the idea that unscrupulous manufacturers could possibly cut corners to increase their profits, or possibly to meet deadlines, recall the dozens of deaths that occurred a little more than a year ago after an American company carelessly abandoned safe manufacturing processes and allowed mold to grow in their steroid preparation that was used for spinal injections.

Who was watching then? Who tested the product before it was injected into the spines of unsuspecting patients? No one did.

People died as a result and hundreds will be left with devastating disabilities as a result of the American company's careless disregard for the importance of quality controls in manufacturing process.

Now consider that many of the drugs that will be taken today in this country are produced by companies overseas. How much harder is it for short-staffed regulators to monitor a foreign company?

Considering the intense competition for these lucrative drug contracts, is it possible that somewhere, someone may cut corners or possibly even engage in fraud to increase their profits?

Recent discoveries of numerous fake drugs originating in India have drawn extra scrutiny to that country of origin. Some of the more well known drugs involved were generic forms of Accutane, Neurontin and Cipro.

In this column in the Monday Post you'll learn what U. S. regulators are doing to protect you and what steps you should take yourself to avoid the risk of taking unsafe fake drugs.

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drugs, kestner, mark, regulators
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