A big state-owned Chinese drugmaker that exports to dozens of countries, including the US, is at the center of a nationwide scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs, The New York Times reports.

Chinese drug regulators have accused the manufacturer of a cover-up and closed the factory that produced them. In December, China’s FDA said Shanghai police began a criminal investigation and two officials, including the head of the plant, had been detained, the Times writes. The drugmaker, Shanghai Hua Lian, is the sole US supplier of the abortion pill, mifepristone, or RU-486, although the paper notes it’s not made at the same factory that produced the tainted cancer drugs.

The FDA declined to answer the paper’s questions about Shanghai Hua Lian, citing security concerns stemming from opposition to abortion. But in a statement, the agency tells the Times the plant passed an FDA inspection in May. “FDA 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.

Last October, Pharmalot wrote that a conservative group, Judicial Watch, released documents indicating the pill is made by Shanghai Hua Lian. Given concerns over meds made in China, the group was clearly trying to create controversy, beyond any ongoing moral debate. (You can view documents here; please turn to page 8 and look for NDA 20687, which was the new drug application number assigned mifepristone).

When told of Shanghai Hua Lian’s troubles, Sid Wolfe of Public Citizen tells the paper the FDA ought to be concerned because of accusations that serious health risks had been covered up. “Every one of these plants should be immediately inspected.”

The director of the Chinese FDA drug safety control unit in Shanghai, Zhou Qun, says her agency inspected the factory that produced RU-486 three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou says, “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, the Times notes. 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 drugmakers, the Shanghai Pharmaceutical Group, which owns dozens of factories, the Times goes on to report, noting that neither Shanghai Hua Lian nor its parent company would comment on the tainted medicine. Last week, the paper asked the FDA 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 without citing a reason.

On at least two occasions in 2002, Shanghai Hua Lian had shipments of drugs stopped at the US border, FDA 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 US, the Times writes.

One major drugmaker, Pfizer, declined to buy drug ingredients from Shanghai Pharmaceutical Group because of quality-related issues, says Chris 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.”

Because of opposition from the anti-abortion movement, the FDA has never publicly identified the maker of the abortion pill for the American market. The pill was first manufactured in France, and since its approval by the FDA in 2000 it has been distributed in the US by Danco Laboratories. Danco, which does not list a street address on its Web site, did not return two telephone calls seeking comment.

Problems with the cancer drugs first surfaced last summer after leukemia patients received injections of one cancer drug, methotrexate. Afterward, patients experienced leg pain and, in some cases, paralysis. At the People’s Liberation Army No. 307 Hospital in Beijing, a 26-year-old patient, Miao Yuguang, was unable to stand up five days after being injected in the spine with the drug. “We were already unlucky to have this illness,” her father, Miao Futian, said of the leukemia. “Then we ran into this fake drug.”

The authorities recalled two batches of the drug, but issued only mild warnings because the cause of the problem was unclear. Officials with Shanghai Pharmaceutical Group stood by their products, saying that drug regulators investigating the plant had found no problems. But when another cancer drug made in the same factory — cytarabin hydrochloride — also began causing adverse reactions, investigators suspected contamination.

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