Toxic Shots Kill at Least Nine Patients

Toxic chemicals fraudulently sold as injectable medications have led to nine confirmed deaths in a Guangzhou hospital. Authorities are investigating at least another nine patient deaths that may be related to the shots.

Jiangsu businessman Wang Guiping, 40, was arrested on May 12th and later confessed to masterminding the profiteering scheme and selling the fake drug, which he had arranged to manufacture at a pharmaceutical company in Qiqihar, Heilongjiang Province. Wang contracted with the company to supply propylene glycol, an inactive ingredient in Armillarisni A medication. Instead he substituted diglycol, a toxic industrial material that can cause severe kidney, liver, and neurological damage. Wang has confessed that profit was his primary motive, as toxic diglycol is significantly cheaper than propylene glycol.

Authorities have also arrested the company’s legal representative, Yin Jiade, purchasing manager Niu Zhongren, inspections director Chen Guifen, and deputy directors Guo Xingjun and Zhuan Chuanhua.

has found that Wang paid the Jiangsu-based Taixing Chemical Plant for the right to sell chemicals under its name. Then he marketed his products in the Internet, where the low prices he offered convinced the Qiqihar pharmaceutical company’s supply manager, Niu, to purchase one ton of “medical propylene glycol.” In that first deal, Wang in fact delivered “industrial propylene glycol,” a cheaper though non-lethal chemical.
 
Industry specialists say it is standard practice for pharmaceutical companies to ask for samples of chemicals they are considering buying and run those samples through extensive laboratory tests. Companies should also ensure that the dealer has the required certification to handle the materials. But although most firms ignore those protocols, their failure to comply has so far not aroused the attention of industry regulators.

Niu did ask for Wang’s business license and certification, but Wang submitted faked copies. Niu could have found the truth if he had searched the national medical database, but he did not.

When Niu returned for a second purchase, Wang replace the industrial propylene glycol with the even cheaper diglycol to raise his profit margins further. This time, he fabricated a quality control report, which was dated two days after the delivery date. When the Taixing Chemical Plant discovered the error, it refused to allow him to use its invoices again, so Wang registered his own company. Niu received an invoice from Wang’s new company in February, although the sale was set last September.

At each of these transaction points, someone failed to catch irregularities that should have been red flags. The Qiqihar company’s failure to complete thorough quality control procedures for the materials it was using helped contribute to the deaths. But the company lacks the technical facilities and the personnel training to run those tests, so it went through the motions and hoped for the best.

“Sometimes we had to stay up all night [forging quality control records] before the inspection team came,” one employee told . Some employees said they had been assigned to change production dates on returned products so that they could be resold.
 
It is startling that a company that received its GMP (Good Manufacturing Practices) certification in 2002 was still guilty of such gross negligence, said one expert who wished to remain anonymous. The State Food and Drug Administration (SFDA) created the GMP standard to ensure manufacturing quality, and since 1999 has required companies to meet its criteria. In 2002 it delegated GMP approval to provincial authorities, and it is not clear whether the original standards are being upheld. In the three years between 1999 and 2002, about 1,000 firms passed the certification; in 2002 alone, however, nearly 5,000 firms passed, including Qiqihar pharmaceutical firm that made the fatal injections.

has found that a consulting firm named Beijing Canny Consulting and Service had helped the Qiqihar company pass its GMP certification. Until April, its office was located within the SFDA Training Center. After the fake drug incident, the Qiqihar company disappeared from the customer list on its website.

In Guangzhou, the Qiqihar company has had successful marketing initiatives. It won contracts to sell its fake drug to several local hospitals, including Sun Yat-Sen University’s Third Hospital, where the nine deaths occurred. Guangdong medical authorities have denied any irregularities in the bidding process.

China’s Pharmaceutical Management Law stipulates that the SFDA should supervise the pharmaceutical companies after they pass the official certifications. But post-approval supervision has become the weakest link in regulation. Analysts say supervisors must be held accountable if any progress is to be made.

English version by Xin Zhiming