New drug scare

The U.S. relies too heavily on China's drug makers, experts say

BEIJING -- The medicine cabinet in the average U.S. home is filling with drugs made in China, and some experts say that could be a prescription for trouble.

China's booming pharmaceutical industry has doubled exports to the United States in five years, undercutting competitors and making U.S. consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.

It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.

Consider this scenario:

If a major anthrax attack were to occur in the United States -- larger than the one in 2001, when five people died -- pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once U.S. stockpiles were exhausted. Those ingredients no longer are made in the West.

A Portuguese company that ramped up doxycycline production in 2001 at Washington's request said China now controlled the flow of its crucial drug component.

"If we were asked to do this again, we would be dependent on China providing us with key starting materials that are unavailable in the rest of the world," said Guy Villax, chief executive of Hovione, a fine-chemicals company based in Lisbon.

The spectacular growth of China's pharmaceutical industry coincides with equally huge problems. A kickback scandal ensnared China's State Food and Drug Administration and its chief in charges that they gave approval for bogus drugs, including a counterfeit antibiotic that killed 13 people. Wary of rising public anger, the state issued a Draconian sanction: It executed the agency chief in July.

Cases of tainted toothpaste, toys and pet food that have made global consumers wary of the "Made in China" label added urgency to a high-profile drug agency purge.

Even so, China's $65 billion pharmaceutical industry is galloping at an annual growth rate of 24 percent in the first eight months of this year. Competitors say China's drug companies not only have low-cost advantages but also get a nearly free pass from U.S. drug regulators, who hold the screws to U.S. companies -- raising their costs significantly -- but rarely inspect in China.

Calling for less finger-pointing

China says it is a reliable source of safe medicine for its own citizens and export markets. At a news conference this week, the deputy drug agency chief, Wu Zhen, called on countries to work together to ensure a safe global supply of medicines.

"To solve the drug safety problems, we need international cooperation," Wu said. "We hope to have ... more cooperation and less finger-pointing."

China dominates more than antibiotics. U.S. regulators license 714 plants in China to produce ingredients for over-the-counter, generic and prescription drugs for Americans. China has snagged a major share of the global sales of many vitamins, antibiotics, enzymes and painkillers. It makes a third of the world's acetaminophen, an over-the-counter pain medication widely sold under the brand name Tylenol.

This brings up another possible scenario:

"Just suppose you are taking some cholesterol drug, and its intermediates or active ingredients are made in China. Then there's some conflict with Taiwan. Will your drug still be available?" asked Joe Acker, the president of the Synthetic Organic Chemical Manufacturers' Association, a trade group in Washington. "The whole drug supply could be in jeopardy in these kinds of situations."