David Lazarus
Consumer Confidential

Is the medicine you depend on made in a place you trust?

We know too little about products so vital
March 30, 2008

Any product that endangers consumers is a bad one. But there's a difference between something you buy because you want to and something you buy because you have to.

That's what makes the current scare about Chinese-made medicine so troubling.

Batches of the blood thinner heparin were recalled worldwide last week, after at least 19 deaths and hundreds of allergic reactions were reported in the United States. The drug is commonly used to prevent clots in patients with heart trouble or during surgery.

The Food and Drug Administration found that some heparin ingredients produced in a Chinese factory had been contaminated with a man-made chemical called oversulfated chondroitin sulfate. The substance mimics the blood-thinning actions of heparin but is cheaper to produce.

It's still unclear how the chemical got into the heparin batches, but investigators aren't ruling out the possibility that a Chinese supplier tried to boost its profit by substituting the cheaper chemical for real heparin ingredients.

When parents hear that a certain toy has lead in its paint, they can choose not to buy it. But people who rely on specific drugs to keep them well may not have that choice. Moreover, they may not know where their drugs were manufactured, making informed decisions all but impossible.

Incredibly, the FDA doesn't require drug companies to disclose where prescription medicines come from. Companies are free to say as much, or as little, as they please.

The $650-billion global pharmaceutical industry clearly benefits by purchasing supplies and producing drugs in countries where costs are lower.

But all you know as a consumer is that someone in a white lab coat at the pharmacy has handed you a medication that you believe will make you better. The level of trust that surrounds this transaction is virtually unparalleled in the retail world.

Having been diagnosed with Type 1 diabetes in October, I reflect that trust every day. And I'm not alone.

About 21 million people have been diagnosed with diabetes nationwide and

246 million around the world. By 2020, the global total is expected to reach 380 million, the result of increasingly sedentary lifestyles and poor eating habits (or, as in my case, funky genes).

The glucose meter I use to test my blood sugar as often as a dozen times daily was distributed by LifeScan Inc. of Northern California, a division of Johnson & Johnson. But it was made in China -- where, exactly, I have no idea, or under what conditions.

The little strips that I insert into the glucose meter for each test come from Britain. The lancing device I use to prick my finger comes from China. The lancets are from Japan. The needles for my five daily insulin shots come from Ireland.

But what about the insulin, which I rely on to keep me alive? I use two types, a fast-acting form called NovoLog and a long-acting form called Levemir, both manufactured by Denmark's Novo Nordisk, one of three leading producers.

In fact, that's exactly what the packaging says: "Manufactured by Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark." That's the address of the company's headquarters.

But does that mean the insulin actually comes from the land of Hamlet? Not exactly.

Producing insulin in laboratories is a two-step process. First, the insulin is created in crystal form, which is more easily handled and stored. Then it's converted to liquid form in vials or pre-filled cartridges for delivery to users.

In the case of Eli Lilly & Co., insulin crystals are produced at the company's Indianapolis headquarters or a plant in Puerto Rico. Vials containing liquid insulin are produced in Indianapolis, but cartridges for insulin "pens" or pumps may be produced either at headquarters or at a plant in France.

Packages specify whether the cartridges come from the United States or France. Users thus have no idea that their medication actually may have originated in Puerto Rico.



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