From Nation, page 15, issue 372, June 16, 2008
Translated by Zuo Maohong
Original article:[Chinese]

Six lives lost in a week at the same hospital in east China's Jiangxi province following treatment with human immunoglobulin (PH4) infusions alarmed health authorities and sparked an ongoing investigation. Meanwhile, the cause remains uncertain.

On the night of May 22, when Wu Hongying and her then-hospitalized husband Wan Guoming saw a crowd gathering at the entrance of the hospital ward.  

"My husband, Wan, squeezed through the crowd to the front for a better view. He reemerged to tell me that the patient in there was surely dying.

"He told me the doctor was trying to revive the guy's heartbeat, but the patient seemed to have lost consciousness, his face purplish and eyes wide open," Wu recalled two weeks after the incident.

Only much later did Wu learn that this patient was the first victim who succumbed to infusion of human immunoglobulin (PH4), proteins that function as antibodies, in the Second Affiliated Hospital of Nanchang University (SAHNU), a top-grade hospital in east China's Jiangxi province.

The victim, 26-year-old Chen Haiying, was originally receiving treatment for viral meningitis in the hospital.

Never had Wu suspected that her husband, Wan – one of the onlookers that day – would become the fifth victim. Five days after seeing Chen turning purplish, Wan too died abruptly during a PH4 infusion.

Treatment Using PH4
Wan was admitted to SAHNU for the fifth treatment for his lymphoma on May 4. Three days after admission, preliminary diagnosis indicated Guillain-Barre Syndrome (GBS) as the cause for the numbness in Wan's face.

According to his medical records, PH4 was used immediately after the diagnosis. After three days of treatment – six bottles of PH4 per day – Wan's family members found it effective. "The numbness in the face had eased. It (PH4) was a bit expensive at 386 yuan a bottle, but we didn't mind as long as it worked," they said.

Despite that, Wan still felt numbness in his limbs, and was again diagnosed as caused by GBS. The doctor in-charge, Yu Li, then prescribed the same treatment of a PH4 infusion.

On May 27, as per the doctor's advice, Wan started with an infusion of dexamethason, an anti-inflammatory, and omeprazole, a drug that protects the stomach, before proceeding to PH4 – which a 5%, 2.5 grams/bottle, batch no. 2007514, manufactured by Jiangxi Boya Biopharmaceutical.

Wan and his family members had no doubt over the medication, as he had been fine with the PH4 – all from the same batch number and specification – he received earlier between May 8 and 10.

Wu recalled the day things went awry – infusion of other drugs started at 5pm, and PH4 started around 7pm. By the time her husband received the third bottle of PH4, it was already 9pm.
 
"By then, Wan felt something was amiss. He noticed that the drips were moving slowly, but he said he was feeling normal. The doctor on duty was sent for. He adjusted the speed of dripping, told us "no problem" and left," Wu recounted.

However, Wu said that after the doctor left, Wan found that the drippings were slowed to the point of almost stopping, and he had started to complain of stuffiness and heart burn.

"I saw his face turning pale. He also complained of a stomachache. I was scared. I screamed for the doctor. But doctor Yu Li, who was in-charged of Wan's case, had left, and a young doctor on night shift came," Wu continued.

She added the nurse on shift followed, and by then Wan's face turned from pale to purple. His whole body twitched, and he lost bowel control. The nurse turned on the vital signs monitor and found all the indexes were dropping rapidly.

The doctor began performing CPR (cardiopulmonary resuscitation) in an attempt to revive Wan's heartbeat, and asked the son to place oxygen mask on Wan to help him breath.  

"He twitched for about two minutes. His whole body turned purple. He didn't even close his eyes. The vital signs monitor showed his heart had stopped beating. The doctor then announced "the patient has died," recalled Wan's sister.

"Problematic medication" was the first thing Wu and her family suspected. They thus demanded an autopsy and for the hospital to seal up the remaining drips prescribed for Wan as well as his medical records.

Wu said doctor told her that Wan had experienced a sudden death, who assured her there had been other such cases with tumor patients.

But Wan was not the last victim. The next day, a leukemia patient from Lichuan, Jiangxi, who had only been diagnosed as having "mild symptoms", also died suddenly during an infusion of PH4.

The hospital claimed in a notice later that "except the sixth victim, all other patients who had passed away were originally suffering from severe illnesses.

This statement was immediately met with disagreement from the families of the deceased, who argued that "a severe illness doesn't mean it's critical."

Who Should be Responsible?
How could the medication kill six people within seven days if it was a qualified product, purchased legally and used properly? What went wrong? Who should be responsible?

On the morning of June 3, the hospital spokesperson Yu Feng told the EO, "we are a sanjia (the top rank of hospital in China) hospital. Both our diagnosis and treatment are well-grounded. We firmly believe that the hospital did nothing wrong in this case."

According to a source in the hospital, specialists of various medical branches were called in after the serial deaths. They reached a consensus that the hospital had made the right prescription, but the medicine itself, which was manufactured by Boya, might be responsible for the deaths.

In the early stage of the controversy, Boya chose not to respond. When this reporter got hold of its general manager Xu Jianxin's mobile phone number and made the call, the answer from the other end was: "you have called the wrong number" and hung up quickly. Several more phone calls made later were not picked up.

On June 2, however, the company issued a statement on its website, listing detailed records of distribution and use of its PH4 products. It also posted notice of storage and recall of the products.

The company emphasized that among the 3,192 bottles of PH4 from the same batch and had been used in hospitals throughout China, only those in SAHNU had caused abnormal reactions from patients.

The statement also stressed that the "real cause", which was enlarged and in bold typeface, was currently under investigation by the authorities.

"Boya is a legal company. Its products have been distributed in the market for over a decade, and nothing has ever happened.

"Now there's only one hospital which has problem with the medicine. Why didn't this happen to other hospitals? This means that at least there's nothing wrong with the manufacturing process," the company's sales manager claimed.

A salesman of the company also told the EO that it was preparing for a market listing, and thus was extra careful with product's quality.

Being the only blood product manufacturer in Jiangxi, it had a yearly production of several hundred million, he said. As the government has become stricter with blood products in recent years, there has been a shortage in such products, which created an opportunity for Boya to list, he added.

"This is a critical time for the company's listing. Who would dare slack off in the manufacturing process?" he said.

Other Possible Sources of Mishap
If both the hospital and the manufacturer were innocent, then the problem might have lied in the intermediary processes, which involved two parts—the dealer, Jiangxi Huachen Pharmaceutical Technologies, and the hospital's medicine storage.

When this reporter arrived at Huachen, which was located in the new development zone of the capital city Nanchang, on the afternoon of June 4, three police cars were parked in front of the office building, and several men were seen walking out of a store house.

The company's president Li Shaohua declined to answer this reporter's queries, but stressed: "We have been through the province tendering process to become a medical supplier. Both our storage and transportation are qualified. We are now under investigation. You'll know the truth once the [investigation's] findings are out."

One pharmaceutical dealer in Nanchang, however, raised doubts over Huachen's capacity, as the company was not a large one.

"SAHNU is a top-ranking hospital in the entire province. Why would it choose to buy medicine from such a company? Besides, if a small company managed to purchase large volumes of blood products, which are in short supply at present, it means it has powerful connections," said the dealer.  

Another manager of Jiangxi's biggest pharmaceutical dealer, Nanhua, claimed that despite his company's scale, it still faced difficulties in keeping a steady supply of human albumin and PH4. He added: "We have ceased supplying the latter."

This reporter called SAHNU's pharmacy department director known as Lu, who hung up without comment.

Industry veteran Hu Pinfu said that supply chains for blood products were complicated, and proper cold storage was important.

"The transportation [of the PH4 involved in this case] was only limited within Nanchang. It was a short distance, so there couldn't be big problems during transportation," he said.

Another possibility was the hospital's medicine storehouse. The EO learned that the hospital purchased 500 bottles of PH4 produced by Boya on May 6, and transported them into the store house the same day after assessment by a purchaser and a storage-keeper.

Before entering the storehouse, the two checked the product's qualification and its immunoglobulin certificate issued by the State Food and Drug Administration, and things appeared to be in order.

The medicine was then stored in two refrigerators in the storehouse, as blood products should be kept in low temperatures between two and eight degrees Centigrade. When needed, the medicine would be transported to the hospital's pharmacy, where there were also refrigerators.

"The eight refrigerators in the pharmacy are all numbered. Every day, there's a group leader checking on the temperature to make sure it is below eight degrees Centigrade. There's a daily record of this, which is available for inquiry at any time," said one staffer at the pharmacy.

"It's a short period of time between when a doctor gives a prescription of blood products to the time the medicine is fetched and used," said a nurse. "There's a refrigerator in each department. If the doctor prescribed two bottles or more at one time, then the unused ones will also be stored in the refrigerators of each department," she added.

On June 12, about two weeks after drug regulators launched an investigation into the case, this reporter contacted related government bodies and was told that data collected for the case were still being analyzed.