China’s National Health Commission issued on Feb. 5 an order to recall a batch of human immunoglobulin for intravenous injection, for possibly being contaminated with HIV (tested Positive for anti-HIV antibodies). One baby in Jiangxi Province injected with this batch of human immunoglobulin was also tested positive for HIV antibodies. The Shanghai Medical Products Administration identified that the contaminated batch was identified as number 20180610Z, which was made by China Meheco Xinxing Pharma Co. This suspected batch consisted of 12,226 units, due to expire in 2021.
This quickly triggered another wave of public outrages for the concerns of medical product safety in China, as scandals about contaminated rabies vaccine and using expired polio vaccine products for infants were exposed in the last few months in China.
On Feb. 7, China’s National Medical Products Administration quickly released a report stating that the related human immunoglobulin product and baby blood sample were tested negative for HIV viral RNA.
However, this obviously is a typical Chinese regime’s effort to put out the fire in the public. Since the recall order was issued by a top national health authority, all related antibody or RNA tests should have been conducted and confirmed. Otherwise, it would be a total incompetence of the authorities to release a recall order without confirmation tests. On the other hand, a negative result in viral RNA testing while being positive for anti-HIV antibody could suggest that the HIV virus was not actively replicating and suppressed to a level that was not detectable by the viral RNA testing method applied. But if the product was injected into a patient with compromised immune system, the viral replication could still be activated again.
The making of human immunoglobulin involves the pooling of thousands of human plasma samples. This recent scandal of contamination with HIV in blood products again raised the public concerns on China’s HIV epidemic situation and practice in their blood product industry.
In the 1990s, the most frequent modes of HIV transmission in China were sharing the contaminated needles among injecting drug users and unsanitary practices during paid plasma collection. When local governments in some provinces treated plasma collections and sales as an important government-driven local industry, it instigated the rampant booming of illegal plasma collection centers.
Large numbers of poor rural farmers were attracted to these centers to sell their plasma for supplementing their small income. At these centers, blood from many donors was mixed after collection. Then, the pooled plasma was separated from the red blood cells, which were re-injected back into donors, so that donors can recover quickly and sell plasma much more frequently. In such a risky practice, even with one HIV-positive donor, it would infect large numbers of people on one single occasion. This resulted in a severe epidemic of HIV infections, with hundreds of thousands poor villagers contracting HIV while selling their plasma. In some disastrous “AIDS villages” in Henan Province, more than 80% of villagers were infected with HIV. It was estimated that in Henan Province alone, more than 100,000 people have died from HIV infection due to the plasma economy.
At the end of 2001, the Ministry of Health estimated that total adult HIV-positive cases were between 800,000 to 1,500,000 in China.
After public exposure of this HIV epidemic by some courageous Chinese doctors like Dr. Gao Yaojie, the Chinese government closed the notorious blood collection centers in Henan Province. In 1998, China introduced a blood donation law banning the commercial sale of blood and encouraging voluntary donation instead. It also tightened rules on plasma collection and increased blood testing.
However, driven by the enormous profits from plasma economy, the blood agents (also called “blood heads”) relocated to more remote and impoverished regions in Guangxi and Guizhou Provinces in southwest China, to seek new blood sources.
By 2006, Guizhou Province had established 25 blood collection centers, providing about 40% of plasma supply nationwide. However, unsanitary practice in these blood collection centers inevitably resulted in public health disasters again. In 2006, according to the public health data in Guizhou Province, the diseases incidence rate due to infections of HIV and Hepatitis B increased 21.36%, and the related death rate jumped up 65.38%, due to blood contamination issues. Consequently, local governments in Guizhou Province had to close all the commercial blood collection centers in 2006.
However, many of these blood centers re-opened in 2007. And these kinds of semi-official or underground blood centers had always been operating in the past, as China is still facing a severe shortage of blood due to low engagement of voluntary blood donations. In 2017, in Nanning City (in Guangxi Province) alone, the local authorities arrested three groups of blood heads with more than 800,000 cc volume of blood collected and sold.
No official investigations were conducted regarding the plasma economy and the cover-up of the HIV epidemic in Henan in the 1990s. Therefore, no officials were held accountable for this man-made disaster. Even 20 years later in 2017, there were still representatives in China People’s Congress raising the very same issue to call for an official investigation of the disaster and proper compensation for the victims. Similarly, there were no reports so far on any corporate executives or government officers being questioned or held accountable for this recent incident about tainted human immunoglobulin. There were no reports on how many units of this potentially contaminated batch of human immunoglobulin have been used and whether health authorities are tracking these people systematically.
Chinese authorities always vowed repeatedly for tighter oversight and crackdowns on companies and officials when food and drug safety scandals broke out. However, the Xinxing Pharma Co. was originally established under the China’s People’s Liberation Army (PLA), and now its largest stock holder is the state-owned public health enterprise—China Meheco Group Co Ltd. So, even though Xinxing Pharma Co. looks like a private business now, it is essentially a state-controlled enterprise. It is no wonder that they are a state-designated medical product supplier.
Imagine if the U.S. FDA establishes a health product enterprise which could become a major income source for FDA. Will the FDA provide an effective oversight over the safety of health products made by their own enterprise? When the health authorities and health industries have formed a tightly-bonded interest group, the common folks can only hope that they are getting a good health product. When the health authorities actually own the largest health enterprises in a country without free press, where is the hope then?
Dr. Xiaoxu Sean Lin is a former U.S. Army officer with expertise on infectious diseases surveillance and global public health. He was the co-founder and former executive vice president of Sound of Hope Radio Network, and hosted talk shows on China’s current affairs on New Tang Dynasty TV. Currently, he is the founder and general manager of WQER-LP Radio Station. He is also a frequent news analyst and commentator for Sound of Hope Radio Network, with a focus on global public health, national security and foreign relations related to Asian affairs.
Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times.
Xiaoxu Sean Lin
Ph.D.
Xiaoxu Sean Lin is an assistant professor in the Biomedical Science Department at Feitian College in Middletown, New York. He is also a frequent analyst and commentator for Epoch Media Group, VOA, and RFA. He is a veteran who served as a U.S. Army microbiologist and also a member of Committee on the Present Danger: China.