The story is about a pharmaceutical company in China that exports to many countries, including the U.S., that is at the center of a scandal involving tainted drugs after 200 leukemia patients had serious adverse events from use of one of the company's cancer 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.
Because of opposition from the anti-abortion movement, the F.D.A. 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 F.D.A. in 2000 it has been distributed in the United States by Danco Laboratories. Danco, which does not list a street address on its Web site, did not return two telephone calls seeking comment.
The headline implies that the story is primarily about the inherent danger of "the abortion pill" (RU-486). But if you actually read the article, it's actually about lax import standards, lax FDA oversight, and how the fetophile movement's influence in government has created an environment in which importation of RU-486 was the only way to get it here.
By running a story with an inflaamatory and inaccurate headline, the Times has allowed the RU-486 aspect of the story to overshadow the larger picture, which is that as the pharmaceutical industry outsources more of its manufacturing overseas, and Republican-dominated government insists that any regulation of industry is a bad thing, what we end up with is tainted drugs. The factory that produces RU-486 isn't even the same one that manufactured the tainted cancer drugs, though the quality control at one plant certainly calls the trustworthiness of all of them into question. But since the Times earns a fair amount of advertising revenue from pharmaceutical companies, it's much easier to tar the story by identifying it solely with a controversial drug than to examine the dangers posed to a society that pops pills for everything by an industry that outsources its manufacturing process to questionable players.
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