Investigative Report

Hidden Danger in Production

Pharmaceutical companies in China routinely bribe regulators from the country’s top health agency to obtain approval for vaccines that have not undergone adequate testing and could seriously harm consumers, according to two former officials.

The companies also knowingly shirk adherence to quality standards during vaccine production to cut costs, putting the public at risk of medical complications arising from tainted or improperly-stored serum, the former officials told RFA’s Cantonese Service.

Chen Bingzhong, former head of the China Institute of Health Education, said the China Food and Drug Administration (CFDA)—which oversees vaccine quality—has been corrupt “for years” and that officials at the agency often endorse substandard products for a share in the huge profits generated by drug companies.

“The monitoring department cheats at key stages, so problems appear,” he said.

But Chen said the companies are also to blame because they frequently rush development of new vaccines for approval before adequate testing, knowing they can save money and time by bribing CFDA officials to sign off on their products.

“Problems in many of our new drugs happen in these two areas: [data] falsification by the production department and … by the testing department,” he said.

“The damage caused by this falsification is especially huge. Many R&D [research and development] departments are falsifying their data nowadays.”

China’s official recently cited a report by the CFDA that said 81 percent of product applications had been rejected or withdrawn by drug companies between July 2015 and Jan. 21 due to false or incomplete clinical trial data.

Typically, vaccine development is a costly process that can take years before a product is ready for marketing to the general public.

After obtaining bacteria or a seed virus, companies must explore which proteins should be used to combat a disease, design a vaccine concept, evaluate the efficacy of the vaccine in test tubes and on laboratory animals, and finally manufacture the serum at safe standards.

But sources told RFA that vaccine producers in China often skip steps in order to get their products to market.

Jiao Sufang, a journalist whose child died after receiving an inoculation for H1N1 “swine flu,” said that the seed virus for the serum was provided to vaccine production companies in early June 2009 after a patient infected during the outbreak was isolated a month earlier.

Jiao said that nine companies received approval to produce a Type A H1N1 vaccine from the government in less than three months, but the serum suddenly disappeared after medical professionals reported inoculations had led to deaths and disabilities among children.

Little Transparency

A former senior executive of the China Red Cross, who spoke to RFA using the alias Chen Jie, said that after the approval stage, drug companies regularly cut costs during production by using low-cost raw materials that can lead to high impurity levels in their vaccines.

“China has the standards and the techniques [to produce high quality vaccines]—the problem lies in the final implementation,” Chen said.

“For example, it is generally known that the egg white used to cultivate vaccine in China is substandard and causes more side effects … This is definitely not a secret in the industry.”

Chen said that while inadequate standards during production have led to serious medical complications, they are more likely to result in vaccines being ineffective.

The extent of this problem is largely unknown, however, as the government does not collect data about vaccine efficacy and says individuals who do can be tried for “revealing state secrets.”

“While weighing between profits and the incidence of side effects on the public, the state will definitely lean toward profitability because side effects have a small probability of occurring and it is more likely [that a vaccine will be] ineffective,” Chen said.

“But more importantly, you cannot test vaccines … [and] if there is any problem, there is no data,” he said.

“If the [ruling Chinese Communist Party] doesn’t collect the data, you can’t collect it either. If you do, then you break the Statistics Law.”

According to China’s National Bureau of Statistics, individuals found to be “organizing or carrying out statistical investigations without approval” are subject to prosecution.

Lack of Progress

In 2010, Wang Yu, director of China’s Center for Disease Control and Prevention, stated that the quality of domestic vaccines was substandard and “far lower than imported ones,” in part due to the “lack [of a] systematic assessment” by monitoring departments after the products went to market.

But in the six years since, a number of vaccine-related incidents have shaken the confidence of parents in China—many of whom now refuse to inoculate their children.

Earlier this year, a female medical school graduate in Shandong province was found to have sold tainted and improperly-stored vaccines to 24 provinces and cities over five years without approval.

In the wake of the scandal and other cases of tainted vaccines, many children have died or developed serious disabilities, but the matters typically remain unresolved with no one brought to justice by authorities.

Parents of victims say that their initial appeals for assistance have been ignored and that their subsequent petitions to the central government in Beijing are repeatedly met with detention and “deportation” to their hometowns by local authorities.

Many of the families have donated funds for a collective legal defense, but few lawyers have been willing to take on their cases because of pressure they face from the government.

Officials from the National Health and Family Planning Commission and the CFDA have told RFA they do not have statistics on vaccine-related deaths and disability cases in recent years, or have not responded to requests for interviews.

Reported by Wen Yuqing for RFA’s Cantonese Service. Written in English by Joshua Lipes.