Made in (The People's Republic of) China: February 2008 Archives

By WALT BODANICH and JAKE HOOKER | The New York Times
February 16, 2008

A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China's drug regulators to make pharmaceutical products, according to records and interviews.

Because the plant, Changzhou SPL, has no drug certification, China's drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either -- a violation of its own policy -- before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.

Baxter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems -- and whether the active ingredient in the drug, derived from pig intestines, was responsible -- has not been determined.

The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close -- in which chemical companies export pharmaceutical ingredients without a Chinese drug license.

China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency's jurisdiction.

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By Ben Shpigel | The New York Times
09 February 2008

When a caterer working for the United States Olympic Committee went to a supermarket in China last year, he encountered a piece of chicken -- half of a breast -- that measured 14 inches. "Enough to feed a family of eight," said Frank Puleo, a caterer from Staten Island who has traveled to China to handle food-related issues.

"We had it tested and it was so full of steroids that we never could have given it to athletes. They all would have tested positive."

In preparing to take a delegation of more than 600 athletes to the Summer Games in Beijing this year, the U.S.O.C. faces food issues beyond steroid-laced chicken. In recent years, some foods in China have been found to be tainted with insecticides and illegal veterinary drugs, and the standards applied to meat there are lower than those in the United States, raising fears of food-borne illnesses.

In the past two years, the U.S.O.C. has tried to figure out how to avoid such dangers at the Olympics. It has made arrangements with sponsors like Kellogg's and Tyson Foods, which will ship 25,000 pounds of lean protein to China about two months before the opening ceremony, but will hire local vendors and importers to secure other foods and cooking equipment at the Games.

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Editorial | The New York Times
February 03, 2008

The F.D.A. -- and American consumers -- got another warning last week about the need for vigilant monitoring of imported drugs from the developing world, especially from China. The contamination of a drug used to treat Chinese leukemia patients should also raise alarms at multinational pharmaceutical companies that plan to outsource manufacturing to China.

There is no sign that the leukemia drug was exported to the United States. So far, some 200 people in China appear to have been paralyzed or otherwise harmed. Given the manufacturer's expanding role in the export of drugs and active ingredients around the world, the lax practices revealed could sooner or later harm patients virtually anywhere.

The case was described last week in an article by The Times's Jake Hooker and Walt Bogdanich. Shanghai Hualian, a division of a huge state-owned pharmaceutical company, produced a leukemia drug that was somehow contaminated with another cancer drug during production. When the product was injected into the patients' spinal area, it caused paralysis and other side effects.

When Chinese regulators began to investigate the cause of the adverse reactions, plant workers tried to cover up what had happened, delaying corrective action. The government has now closed the factory and detained two company officials in a criminal investigation.

The same company is the sole supplier to the United States of the abortion pill known as RU-486. That pill is made at a different factory that passed an F.D.A. inspection in May and was inspected three times in recent months by Chinese drug regulators. Still, in light of the company's current difficulties, the F.D.A. would be wise to reinspect the plant promptly to ensure that the RU-486 production facility is adhering to rigorous quality control procedures.

This incident is one more frightening reminder of why Congress and the White House need to move quickly to strengthen the F.D.A. and other regulatory agencies to ensure that they can adequately monitor foreign producers and intercept dangerous products before they can harm American consumers.

By Eijiro Ueno and Takashi Hirokawa | Bloomberg(.com)
February 01, 2008

Chinese-made dumplings containing pesticides sickened 175 Japanese in a scandal the government says may damage relations with its neighbor, which exported $56.7 billion of food to Japan last year.

``There might be a negative impact on Japan-China ties,'' Foreign Minister Masahiko Komura said at a press conference in Tokyo today. ``If both governments cooperate and take measures, the negative impact can be minimized.'' China said it's ordered a police investigation.

The dumplings, known as ``gyoza'' in Japan, are being recalled by Japan Tobacco Inc. and Maruha Corp. in the latest quality scandal involving China. Two weeks ago, China deemed a fourth-month campaign to eliminate ``non-food materials'' from produce a success, after contaminations including industrial dye in eggs and carcinogenic fungicides in fish.

``It makes you scared to buy imported food -- you worry about your kids,'' said Hiroko Date, a 38-year-old mother of two, outside a Fujimart supermarket in Tsukishima, Tokyo. ``I think the government's being slow on this. We've been hearing about other problems with things from China, like lead in toys.''

Yukio Hatoyama, the Secretary General of the opposition Democratic Party of Japan, also criticized what described as a ``slow response'' by the Japanese government.

Some Chinese food imports may be banned under Japan's food- safety regulations, Japan's health minister Yoichi Masuzoe said today in parliament.

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