When Generic Drugs Come from China, Safety Must Be a Concern
> 2/1/2008 2:28:05 PM

China is often called "The World's Factory," a testament to the nation's position as the number one exporter of consumer goods. Everything from high-end electronics to cheap children's toys to pharmaceutical components and drugs are produced in China for cheaper than they could be produced almost anywhere else. These production efforts boost China's economy and free other countries to focus their workforce on other efforts.

Lately however, scandal has rocked China's manufacturing industry. Evidence or allegations of tainted or inferior goods have boiled over in virtually every corner of the industry. Just in the last calendar year toys slathered in lead paint, toothpaste with antifreeze components, and killer cough syrup have all been tied back to manufacturers in China.

This week though, things got a little scarier when the New York Times reported on tainted cancer drugs that had crippled as many as 200 Chinese patients. The manufacturer of this drug was revealed in the Times article to be the same that supplies all of the U.S.'s morning after pill, also known as RU-486. The FDA is responsible for overseeing the production of all drugs, wherever that production takes place, and the organization attests to the quality of the factory where RU-486 is created. Despite that however, the revelation of the tainted cancer drugs, combined with the growing list of substandard goods, raises several very important questions about the quality of medications that are either wholly or partly manufactured in China, and what consumers can do to protect themselves from harm.

The problems in the Chinese manufacturing industry are facilitated by a number of laws and pressures. First and foremost, the FDA's budget is likely too small to handle the demand of monitoring worldwide production of food and drugs that are imported to the U.S., as they have been charged with doing. The organization's leaders have sought to establish offices in U.S. overseas embassies, which would facilitate greater oversight over production in those countries. Battles with legislators over money though are not always courteous, and there is still a great deal of red tape to cut through before this is a reality.

China, meanwhile, has a Food and Drug Administration all its own that is supposed to oversee quality control to ensure that any and all food and drug exports meet the high standards set by American consumers. Unfortunately, as that bureau chief's high profile execution in July of 2007 - an attempt at appeasement more than correction of the problem - points out, the Chinese government lacks serious controls over these areas.

At the same time, businesses in China, especially those engaged in producing cheap goods, regularly subcontract production work out to smaller outfits. In many cases these outfits then subcontract out some of the production, and so on down the line, until many of the integral parts of consumer goods are being produced by companies established solely for the purpose of turning out a product on the cheap. It is in this way that we read stories of outrageous corner cutting, because when the buck is passed down the line so far, eventually there is no accountability for producing a quality product.

It is because of this practice of subcontracting that generic drugs and over the counter medications like ibuprofen are at the greatest risk of being tainted. As this U.S. New and World Report interview points out, big corporations benefit from consumer loyalty and pay dearly in the media and in the courtroom when a consumer is injured or sickened by one of their products. Generic drugs on the other hand can be produced anywhere, by anyone.

$675 million worth of the drugs consumed in the U.S. in 2006 were manufactured in China, so this is no small market. As pharmaceutical researcher and writer Joe Graedon explained to U.S. News and World Report in another interview, therapeutic failure is the biggest risk that one runs from switching to a generic drug. While Pfizer and Eli Lilly have a great deal invested in their product, and thus will work to ensure its effectiveness, there are no guarantees with generics, as retailers will usually purchase whatever suppliers can give them at the lowest price.

Graedon goes on to explain that the FDA tests roughly 1 unit of every 10 million that is sold every year. Pharmacists dispense, he said, over 3 billion prescriptions each year. And to be clear, this is not to belittle the efforts of the FDA; it is, as an organization, doing what it can to meet the many challenges that it faces, and they do catch many problems, as we saw this past summer with the Chinese toothpaste incident.

While all of this information should give generic drug purchasers and prescribers some pause, much of this must be considered in the grander picture of treatment. In almost every case, the only problem when switching to a generic will be a falloff in therapeutic value. Physicians and patients alike need to be aware of this possibility and plan accordingly. And in the rare case that a medication creates any greater reaction, discontinue it immediately and contact your physician.

Balancing out the risks of generic prescriptions and OTC treatments are the enormously reduced costs. To begin fixing that problem though, pharmaceutical companies will need to start adjusting the way they do business. There are many issues that come into play when considering whether to go with a generic or brand name prescription, but ultimately, it must be about what decision is right for each consumer. Balancing health costs and risks can be difficult, but by working with a physician and talking through the options, hopefully each person will arrive at the right choice.

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