A number of people have been visiting dozens of hospitals in the last few years in Beijing, trying to persuade doctors to allow them to participate in clinical drug trials. They are not medical enthusiasts, but rather a group of people who make a living by becoming human experiments.
A 19-year old man, under alias, is called Zhang Ke. He has had his elbows punctured with pinpricks for more than a year and tolerates the pain because he receives payments of hundreds to thousands of yuan per trial. Although his physical exams show nothing abnormal, he always feels weak and trembles during these early autumn days.
Statistics show that every year 800 medicines receive marketing approval in China after undergoing clinical trials on human beings. The medicines can produce varied effects on healthy individuals, even though they have been approved safe after first being tested on laboratory rats, the Beijing News reported on September 26. Yet the sufferings endured by the participants during drug trials inject little nobility into this rather risky business, which nonetheless is expected to save thousands to millions of patients. "We join in the trials for nothing but money, and usually we feel ourselves no different from lab mice," said Zhang.
According to China's regulation on clinical trials ratified by the State Food and Drug Administration in 2003, the rights of participants in clinical trials should be given priority over social and scientific benefits. Before participating they should be informed of the trial drugs' risks and physical requirements.
Yet easy money makes some participants neglect their rights and sign the Informed Consent Agreement without a look, the Beijing News reported. The forms are legal clinical documents outlining inherent risks. "These forms are useless. The city has lots of people willing to make money in a fast deal. If you worry about your health, others will replace you quickly," said Zhang, who is both a smoker and alcohol drinker. He denies each of the disqualified habits when being questioned by doctors and gets into drug trials with a fake student identity card.
The shaking, vomiting and dizziness during the trials shame the people from telling their secrets and the gangster-like agents strolling between the hospitals and trial applicants shut the participants' mouths even tighter.
Most of the agents in Beijing monopolize their business by controlling a certain number of hospitals, according to the Beijing News. Beating and fighting are two ways for them to compete with rivals or negotiate bargains.
Last August, four fights caused by price arguments among agents and participants in a medical laboratory in the Haidian District shocked the industry. Doctors denied their connections with agents, but failed to explain how the clinical information was leaked.
Before a drug is put into mass production and launched onto the mass market, it has to be tested on animals and then on human beings. Drug trials on humans go through four phases. Phase I requires testing on healthy subjects and then on sick ones. Regular drug trial participants are involved in the Phase I.
According to an official from the Anhui Food & Drug Administration, in China the participants in the Phase I clinical trials can be divided into three groups, namely, students, medical practitioners and unemployed people. Among them, college students, perfectly healthy and well educated, are ideal subjects. They are the first choice for organizations doing clinical trials.
According to medical professionals, the drugs for clinical trials are mostly very safe because their effectiveness and safety have been secured during animal trials and toxicity tests. Potential random risks usually manifest as negative reactions on part of certain individuals because of special physical characteristics. So those who make a living by regularly joining in drug trials are facing random risks all the time. Moreover, relevant official regulation allows people to take part in another drug trial in no less than 3 months after the previous one. But to support themselves, those regular drug trial participants cannot wait that long. They have to get into one trial every month at least. As a consequence, this high frequency puts their health, even life at stake.
Gong Yongjun, a lawyer expert in medical disputes from Nanjing Convoy Law Firm, said that although drug trials are very safe, it is very dangerous and even ridiculous to be committed to participating in drug testing for money.
Gong and Chen Zhihua, a director from the Beijing Lawyer's Association, pointed out that China needs more better laws and regulations to protect the rights of drug trial subjects and to regulate the drug testing business. Gong said that now China has only one regulation to standardize clinical drug trials, namely the Good Clinical Practice (GCP). Unfortunately, the GCP is not a compulsory regulation and cannot be used to protect victims, he added.
Gong and Chen urged the government to intervene as a third-party force to protect the rights of clinical trial participants. Facing these young people to make a living out of endangering their health or even life, the government should not just sit and do nothing.
Gong also suggested that all responsible governmental departments should establish a database on these drug trial subjects and establish an identity checking system to make it impossible for habitual participants to regularly enroll in drug trials.
(China.org.cn by Wu Jin and Pang Li, October 5, 2007)