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

[Guest guest]

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

We know too little about products so vital

http://www.latimes.com/business/printedition/la-fi-

lazarus30mar30,1,2675795.column

By Lazarus

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 & . 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.

" Technically, that's correct, " said MacGregor, a Lilly

spokesman. " But we make no secret that we have a large plant there. "

There may be nothing wrong with insulin crystals from Puerto Rico.

But for anyone who has to use insulin multiple times daily, this

isn't a trivial piece of information.

Manufacturing prescription drugs accounts for a significant portion

of Puerto Rico's economy. However, some leading drug companies are

closing plants on the island because of, among other reasons, ongoing

issues with regulatory compliance.

A recent investigation by the Associated Press turned up " dozens of

examples over four years of lapses in quality control in the Puerto

Rican pharmaceutical industry. "

For its part, France's Sanofi-Aventis says its insulin crystals and

finished insulin are produced in Germany, which is cited in

promotional materials as the " country of origin. "

A spokesman for Novo Nordisk, Clements, said the company

produces its insulin crystals in Denmark. Those crystals are then

converted to liquid at various plants worldwide.

Clements said finished insulin for the U.S. market comes from FDA-

registered plants in the United States, Denmark or France. He said

FDA approval was pending for the company's facility in Brazil, which

is undergoing a $200-million expansion -- the biggest single

investment ever in Brazil's drug industry.

About 95% of the output of Novo Nordisk's Brazilian plant will be

exported around the world, the company said.

A 2000 study by the World Bank concluded that Brazil's pharmaceutical

industry suffered from " insufficient implementation and enforcement

of drug regulations which can assure that quality standards are in

place. "

" Evaluation, registration, surveillance, audits and inspections are

not being carried out as they should, " the World Bank found, adding

that " there is also a limited knowledge base among inspectors, which

indicates their need for training. "

Novo Nordisk's Clements said customers can be confident that the

company maintains high quality standards throughout the world.

" Regardless of manufacturing site, our manufacturing sites and supply

chain that supply our U.S. customers operate under FDA-approved and

Novo Nordisk standards for high quality and safety, " he said.

Last week, California regulators said they'd delay by another two

years a requirement that all prescription drugs be electronically

tracked to help prevent contamination and counterfeiting. The system

was originally slated to begin last year, but it was pushed back to

January 2009 amid protests from drug companies.

Now it won't begin until 2011 at the earliest.

A tracking system might have caught the tainted heparin before it

reached hospitals and pharmacies, thus preventing 19 deaths. It seems

outrageous that we're still waiting for such an obvious safeguard to

be put into place.

At the very least, consumers are entitled to know where their

medications come from. The FDA should require all drug companies to

clearly state on packages where a drug was manufactured or processed

and the origins of its major components.

Riley, an FDA spokeswoman, said this would be difficult.

" We have products that have active ingredients, inactive ingredients,

that are finished, that are raw, " she said. " How would you do country

of origin for all that? "

It doesn't seem so hard. In the case of Eli Lilly's insulin

cartridges, you could simply state: " Manufactured in France from

Puerto Rican components. " This would be accompanied by a Web address

where more detailed info would be available.

Such a requirement would have the dual benefit of allowing consumers

to make better decisions about the drugs they take as well as making

drug companies more accountable for their global operations and

suppliers.

It could also add value to a " Made in the USA " label. Would you pay a

dollar or two more for that peace of mind? I might.

There's no changing the worldwide nature of the drug industry. But

with lives at stake every minute of every day, the onus is on drug

companies to be completely transparent in their activities.

They aren't even close.

[Guest guest]

Very true! And the concerns about safety and manufacturing location applies not

just to prescription medications but to over-the-counter items as well. It's a

little scary. It would be great to see these same requirements applied to OTC

items too!

[Guest guest]

Would be very easy for other countries to plunk off the US....Maybe that's what

they are trying to do LOL