Tainted Drugs Tied to Maker of Abortion Pill

BEIJING — A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour’s drive away.

The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.

When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, a leading consumer advocate and frequent F.D.A. critic, said American regulators ought to be concerned because of accusations that serious health risks had been covered up there. “Every one of these plants should be immediately inspected,” he said.

The director of the Chinese F.D.A.’s drug safety control unit in Shanghai, Zhou Qun, said her agency had inspected the factory that produced mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou said, “but these two plants are in two different places and have different quality-assurance people.”

The investigation of the contaminated cancer drugs comes as China is trying to restore confidence in its tattered regulatory system. In the last two years, scores of people around the world have died after ingesting contaminated drugs and drug ingredients produced in China. Last year, China executed its top drug safety official for accepting bribes to approve drugs.

Shanghai Hualian is a division of one of China’s largest pharmaceutical companies, the Shanghai Pharmaceutical Group, which owns dozens of factories. Neither Shanghai Hualian nor its parent company would comment on the tainted medicine.

Last week, The New York Times asked the F.D.A. whether the Shanghai Pharmaceutical Group exported to the United States any drugs or pharmaceutical ingredients other than the abortion pill. But after repeated requests, the agency declined to provide that information; it did not cite a reason.

On at least two occasions in 2002, Shanghai Hualian had shipments of drugs stopped at the United States border, F.D.A. records show. One shipment was an unapproved antibiotic and the other a diuretic that had “false or misleading labeling.” Records also show that another unit of Shanghai Pharmaceutical Group has filed papers declaring its intention to sell at least five active pharmaceutical ingredients to manufacturers for sale in the United States.

One major pharmaceutical company, Pfizer, declined to buy drug ingredients from Shanghai Pharmaceutical Group because of quality-related issues, said Christopher Loder, a Pfizer spokesman. In 2006, Pfizer agreed to evaluate Shanghai Pharmaceutical Group’s “capabilities” as an ingredient supplier, but so far the company “has not met the standards required by Pfizer,” Mr. Loder said in a statement.

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Questions Republican Candidates Should Answer

by Phyllis Schlafly, December 19, 2007

Why are questions about Communist China asked only in the Democratic presidential debates? We want to know what the Republican candidates plan to do about China sending us poisoned foods and toys.

All presidential candidates should be asked what they plan to do about the fact that free trade with China means acquiescing in gross discrimination against U.S. products and jobs. The Chinese avoid a level trading field by artificially undervaluing their currency up to 40 percent, subsidizing their products, and imposing import duties against U.S. products that are ten times higher than tariffs on their products in U.S. stores.

Our free-trade negotiators routinely accept trade agreements that give other countries the right to charge higher tariffs than we charge for similar products. For example, the Chinese Chery car will face a 2.5 percent tariff when sold in the U.S., but U.S. autos entering China will be taxed at 25 percent.

Foreign countries get by with this discrimination by calling it a Value Added Tax (VAT) instead of a tariff, but it amounts to just as high a barrier against free trade. The result is that millions of American jobs have moved overseas.

All presidential candidates ought to be asked what they plan to do about China's organized theft of our intellectual property and counterfeiting of our products. Communist China is the world's top producer of illegal copies of music, movies, software, designer clothes, and medicines.

All candidates should be asked what they plan to do about China putting its billion dollars of profits from U.S. trade into military weaponry to threaten, not only Taiwan, but the United States, especially our communication satellites.

The toy advertised by Wal-Mart as the top toy of the season had to be recalled after it was discovered that children in Texas, Delaware, New Hampshire, Illinois and Utah fell sick and were hospitalized because of swallowing the toy's bead-like parts. After 4.2 million were recalled, China finally admitted that the beads in this toy, called Aqua Dots, contained a substance that can turn into the "date-rape" drug after children swallow them.

That drug, gamma-hydroxy butyrate, causes breathing problems, loss of consciousness, seizures, drowsiness, coma, and death. Aqua Dots were supposed to have been coated with a nontoxic chemical, but that chemical costs three or four times the price of the poisonous compound, so the Chinese manufacturer couldn't resist using the cheaper product.

According to the Consumer Product Safety Commission's website, 26 million toys and other products made in China have been recalled by U.S. companies since August. Even the Boy Scouts of America had to recall a million Chinese-made plastic badges that contained unsafe amounts of lead.

Chinese products for children found to contain unacceptable levels of lead include vinyl baby bibs, Thomas the Tank Engine sets, Baby Einstein Discover & Play Color Blocks, Pirates of the Caribbean medallion squeeze lights, Totally Me! Funky Room Decor Sets, Hannah Montana handbags, and Barbie doll accessories.

Australia recalled hundreds of blankets imported from China in October because they contained formaldehyde up to ten times the level permissible under international standards. The World Heath Organization has classified formaldehyde as a known human carcinogen.

Seafood from China is a potentially more dangerous import. About 80 percent of seafood consumed by Americans is imported, and the Food and Drug Administration inspects and tests only one percent.

Lab tests show that China uses antibiotics to treat fish raised in filthy waters where bacteria, viruses and parasites breed. Lab testers say that when seafood is rejected for an illegal chemical, the Chinese simply switch to another harmful chemical.

Often found in imported fish is a fungicide called malachite green, which is illegal to use in food in the U.S. because studies show it can cause cancer and birth defects.

Alabama has its own tests and rejects 50 to 60 percent of all fish imports. Alabama Commissioner of Agriculture Ron Sparks personally visited Asia to witness seafood farmed in sewage.

Chinese products are so cheap because the workers in Guangdong, where most of the Chinese toys are made, are primarily females age 17 to 25 who work an average of 16 hours a day, 6 or 7 days a week, for about $50 per month. They live in unhealthy, overcrowded dormitories, where a bed is all they have of their own.

With the 2008 Olympic games coming soon, Communist China is stepping up its censorship under the official slogan "constructing a harmonious society." Visitors who click on China's largest Internet site, called Sina.com, are greeted by two cute cartoon police figures, one male and one female, who pop up on their screens every 30 minutes.

These images link to the Communist internet police in order to report any information the government might deem illegal. It's important for Americans to realize that China is still a very Communist and anti-American country.