- The Washington Times - Tuesday, June 12, 2007

BEIJING — China said yesterday it was investigating the sale of fake blood protein, a potentially dangerous and widespread practice that underscores the country’s problems with product safety.

State media reported one death from use of the counterfeits, but authorities have not said whether anyone has fallen ill.

A shortage of albumin, a blood protein that chronically ill people often lack, triggered a nationwide investigation in March into whether fakes were being sold, China Central Television said.

The report centered on an inquiry in the northeastern province of Jilin, where 59 hospitals and pharmacies were sold more than 2,000 bottles of counterfeit blood protein. It did not say what the products were made of, but said they could “make a patient’s condition worsen and could cause death.”

CCTV’s Web site showed two vials of albumin, the real product looking cloudier and more viscous than the translucent fake.

Seven out of 36 batches of albumin tested by the Jilin Food and Drug Research Institute were found to be bogus, CCTV quoted the institute’s deputy director, Xu Fei, as saying.

“There was no element of protein, so it could not perform its intended function,” Mr. Xu was quoted as saying. “They were through-and-through fakes.”

Albumin is a primary protein in human plasma that is important in maintaining blood volume. It is used to treat conditions including shock, burns, liver failure and pancreatitis, and is needed by patients undergoing heart surgery.

“The harm could be very great,” Chen Hongguo, head of the pharmaceutical section of the Jingyu County People’s Hospital in Jilin, told CCTV. Mr. Chen said the hospital bought fake protein from the Jilin Yatai Wanlian Pharmaceutical Co.

China, which has an across-the-board problem with food and drug safety, has come under growing pressure from the United States and the European Union to improve inspections of exports.

Citing a Jilin food and drug safety official, CCTV said the product cost about $1.30 to make but was sold at $38 per vial.

It said a salesman from the company has been detained. A woman who answered the telephone at the company said no managers were around and that she was “unclear” about the situation.

Jilin government officials referred all questions to the provincial Food and Drug Administration, which said there was no spokesman available to answer questions. An official at the State Food and Drug Administration confirmed the CCTV report but refused to give his name or any details.

Henk Bekedam, the World Health Organization’s representative in China, said the development shows that checks need to be in place at every level.

“Counterfeit pharmaceuticals is a systemic challenge that needs a systems-based response,” Mr. Bekedam said. “A system of accreditation is needed at every point of the supply chain.”

The official Xinhua news agency said China has regulations for blood-based medicines, and the list will be expanded next year to include albumin.

Chinese authorities have struggled with recalls after the widespread sale of fake polio vaccines, vitamins and baby formula. Such incidents threaten both public health and faith in the government’s ability to control crime and corruption and ensure safety of food and drug supplies.

Last month, the country’s former top drug regulator was sentenced to death for taking bribes to approve substandard medicines, including an antibiotic blamed for at least 10 deaths.

The China Business News said yesterday the State Food and Drug Administration had seized fake blood protein from other provinces and regions including Shanxi, Hubei, Hunan, Ningxia, Qinghai and Chongqing.

The paper said the mother of Zhu Huazheng, from the eastern province of Shandong, died after using fake albumin from Beijing Tiantan Bioproducts Co. Ltd.

A company employee was quoted as saying that no albumin had been produced since February because of a shortage of raw materials.

“Many fake-product makers have seized the chance and sold bogus blood protein under our name. We are still investigating it,” said the unidentified employee. Telephones at the company rang unanswered yesterday.