Dangerous Drugs Lead to More Than One Death Sentence

Posted on July 18, 2007
by Maureen Keene

According to the New York Times, Zheng Xiaoyu, the former head of China’s equivalent of the FDA who was recently executed for accepting bribes and allowing dangerous products to enter the Chinese marketplace, started out as a reformer but succumbed to temptation and accepted money and gifts from unethical manufacturers seeking a way around safety regulations. Many of his staff have been implicated as well, and even his wife and son were involved in soliciting bribes.

Zheng Xiaoyu’s execution raises many moral questions — from a distance. For families in China whose loved ones are forever lost and whose lives are damaged because of his misdeeds, there seems to be more clarity. The New York Times reports:

While visiting relatives a year ago, Du Haipeng, 5, came down with a sore throat. Doctors prescribed a Chinese antibiotic, Xinfu. The boy’s reaction to the drug was so violent, he had to be taken to a nearby hospital.

“I remember clearly that I was shearing sheep when I got a call from my sister and her husband,” said Du Xinglong, 36, Haipeng’s father. “When I rushed to the hospital my son had already fallen into a coma.”

A week later, regulators banned Xinfu. Authorities eventually determined that the State Food and Drug Administration had granted the drug’s maker a seal of approval, even though Xinfu was not properly produced or sterilized.

The manufacturer’s license was revoked and the head of the company reportedly committed suicide. But that was too late for another child, a 6-year old girl who was given Xinfu for an infection. She fell into a coma and died within days.

In the end, at least 14 people died after taking Xinfu, and perhaps hundreds more were severely sickened. Du Haipeng woke from his coma after 22 days of emergency treatment. But he wasn’t himself. “He didn’t recognize us,” said his mother, Fu Liguang, 38. “Over the next two and a half months, he didn’t say a single word.”

Today, the boy rarely speaks. He wets his pants, and his doctors say he may have permanent brain damage.

The fact that there is such widespread corruption in China’s drug industry should give consumers in the U.S. pause since there has been a huge increase in the last few years in the quantity of drugs and drug ingredients we import from China. (The U.S. imported $42 billion in drugs and drug ingredients last year.) Like the import of individual food ingredients, there is no way for consumers to know that drug ingredients have come from abroad because no specific country of origin labeling is required. The FDA does not conduct the types of inspections in foreign facilities that it does within the U.S. and relies on the pharmaceutical companies to conduct their own safety testing. According to the Washington Post:

After the pet food scandal that triggered fears over the safety of human and animal foods imported from China, experts say medicines from that country and from India pose a similar risk of being contaminated, counterfeit or simply understrength and ineffective.

“As the manufacturing goes to China and India, the risk to human health is growing exponentially,” said Brant Zell, past chairman of the Bulk Pharmaceuticals Task Force. The group represents American drug-ingredient makers that filed a citizen’s petition with the FDA last year asking the agency to oversee foreign firms more aggressively.

“The low level there” of follow-up inspections, “combined with the huge amount of importing, greatly increases the potential that consumers will get products that have impurities or ineffective ingredients,” he said.

…

William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating.

“You have this confluence of events, with so much more product coming from abroad and fewer and fewer inspections,” Hubbard said. “This is very serious stuff, because a contaminated drug hitting the market could cause lots of injuries or worse before it got tracked down.”

He also said that the FDA inspection system is so weak that many foreign manufacturers believe they “can play games without consequences.”

While it’s hard to imagine a drug as deadly as Xinfu on the market in the U.S., it is much more plausible that drugs with improper strengths or medicines simply lacking effectiveness could get into the U.S. and go undetected since doctors and patients would probably not suspect a poor quality drug to be the culprit when a medical condition fails to improve.

Tell your representatives in Congress that you are concerned about the quality and safety of prescription and over-the-counter drugs in the U.S. today. Urge them to strengthen the FDA, require frequent mandatory inspections of overseas manufacturing facilities, and require country of origin labels for drug ingredients from outside the U.S.

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