Paid to be a guinea pig

By Yang Wanli ( China Daily) Risks from participating in medical trials are greater than many people imagine, reports Yang Wanli.迷你倉Dressed in a well-tailored black suit, 26-year-old Ren Tianyue walked along a street in Beijing's financial district. His neat, freshly ironed shirt and classy black-framed glasses gave him the air of a white-collar worker at a big-money enterprise.Seeing Ren like this, few people would imagine that he used to earn a living by being a guinea pig in medical trials, testing a variety of medicines from pills to treat nasal inflammation to insulin injections. The payment per trial ranged from a few hundred yuan to 8,000 yuan ($1,300), depending on the drugs involved.Ren is one of about 500,000 people in China who participate in medical trials every year. He usually took part in phase 1 trials, which can help scientists determine the best way to administer new treatments and the safe maximum dosage.China's pharmaceutical market was worth 93 billion yuan by the end of 2012, according to a report released by the Chinese Academy of Social Sciences in February. It's estimated the market will grow by 12 percent every year over the next decade.The Beijing Normal University math graduate said he was inspired to participate in the trials by a TV program he watched as a high school student."I saw a documentary on the Discovery Channel in which a participant forced himself to take a handful of pills for a medical trial. It piqued my curiosity," he said.He first attempt to become involved, at age 20, ended in failure when he was rejected because a standard pre-trial urine test indicated nicotine in his bloodstream.In 2011, Ren's application was successful and he joined a trial of a drug to treat nasitis (nasal inflammation). He freely admits that he was motivated as much by the money on offer as altruism, because at the time he was earning around 2,000 yuan a month and the lure of 2,000 yuan for just one week's "work" was too great to resist."I believe most of the products are made using similar, possibly even the same, formulas as those used in other countries for years, so they are safe," he said. "Sick people take medicine to treat diseases, and we test the medicines for them - it's a commitment. Since it's inevitable that everyone will take some form of medicine during their lifetime, it doesn't matter when you take it." However, the risks inherent in participating in medical trials are real and greater than many people imagine, because of the almost inevitable side effects. Many are temporary and disappear when the participant stops taking the medicine, but others can be long-term or permanent. Also, while some side effects appear during the testing process, others may not show until the treatment is over. Moreover, by their very nature the treatments are new, so the doctors don't always know what the side effects will be.The dose given to each subject varies; some participants are given a high dose, some are given a small amount and others receive a placebo, a treatment that contains no trace of the drug being tested. Who gets what is decided randomly, but the risks are always greater for those chosen to receive a high dose because the reaction varies from person to person.Despite being fully aware of the potential risks, thousands of men and women, blinded by the relatively large sums on offer, are happy to take every possible opportunity to "make a living" through the trials.Dirty tricks In October, a recruitment notice was posted on an online chat group called Medical Trials. The poster was looking for two people to test an anesthetic agent. The trial was to be held over just two days, but the participants were promised 5,000 yuan each, far higher than the usual payment. More than 80 people turned up at the hospital named in the notice, hoping to be selected.The Internet is awash with chat groups like Medical Trials. They don't just recruit participants for tests, but also showcase a variety of jobs offering good money for short-term work, including blood donation. Normally, each chat group has around 50 to 60 members.But the number of willing subjects always outstrips the number of jobs on offer and as a result a whole range of dirty tricks has evolved, designed to maximize the profits of the participants, some of whom even indulge in chemical deception."In order to pass the health check, smokers often add a certain liquid to their urine sample to disguise the presence of nicotine. It's even possible to get a bogus certificate of good health by underhand means," said Ren.He declined to say whether bribery is commonplace, but said it's crucial to maintain a good relationship with the "hunters" responsible for participant recruitment.The health checks and the trials are often carried out in the same hospital. In most cases, the participants are isolated in the testing center, where daily care is available, and free meals and pajamas are issued. The period of isolation varies from one day to a week and the participants are paid according to the duration of the trial and the amount of discomfort incurred."If you are well-behaved and don't haggle too much over the payment, the hunters will be willing to call on you when more tests are being held," said Ren, who participated in more than a dozen trials between 2011 and July last year, earning about 40,000 yuan in total.I儲存herent risks To clearly identify the effect of the treatment on humans, it's essential to assess the pre-test condition of the participants. In the past, college students were the target group for phase one trials because of their youth and generally good health."A few of my classmates and friends agreed to participate in the higher-risk phase one trials because the money was so good. But I think those of us with deeper medical knowledge are unwilling to take the risk," said Wu Bian, a student majoring in clinical medicine at Nanjing Medical University, who participated in two medical trials, one for herbal toothpaste, the other for herbal treatments designed to improve blood circulation."The possibility of falling foul of a sample that will make you ill or endanger your life, although very rare, still exists," he said.According to Ren, a large number of participants are poorly educated migrant workers. "Many are part-time security guards, who just want to make some extra money," he said."People involved in high-risk trials - for example, antibiotics or anti-cancer drugs - are paid more. I've heard that some people even paid their mortgages by participating in medical trials," he said. "The money they made must be at least tens of thousands." But the trials involve much more than simply staying in a comfortable room, enjoying free, nutritious food and doing nothing but sleeping. Some include regular blood tests, which might require more than 20 tubes of blood. And the participants' daily activities are confined to a limited area where they can't even access the Internet."It's like being in jail. Eight or so participants share one room," said Ren. "There's little emotional empathy between the doctors and the participants. The medical staff in the trial center knew that most of us were only doing it for the money, so they rarely showed us any respect. You could sense their scorn by the way they spoke and looked at us." Health gamble Ren's illusion that his participation was worthy of respect was shattered when he began to understand more about the background to the trials, especially when he learned that some "experienced" participants took part in two or three trials at the same time."By rights, there should be at least three months between each trial to ensure that the target is clean," said a director named Li, who works for a drug company and has overseen trials for four years.She said some participants in the second, third and fourth phases of testing already have the condition the trial drug is meant to treat and, despite the risks, hope to benefit by offering their services."By contrast, 'professional' participants are gambling with their lives just for money. The result of this deception is not only likely to harm them, but could also lead to severe losses for the pharmaceutical companies and those being treated with the drugs," Li said.Those who have participated in a large number of trials may also display an unconscious tendency to produce the sort of response they feel the doctors want, rather than an honest appraisal of the product. "They are very familiar with the procedures and may involuntarily produce a 'good' result in line with the tester's desired response," she said.Payment poser Some regular participants feel the payment on offer is not commensurate with the risks they face. The hospitals take the lion's share of the payment, often leaving participants with around 10 percent of the total amount, according to Ren."I once saw the payment details on a doctor's computer," he said. "I was told I would be paid 2,500 yuan, but the budget was 30,000." During tests on a new brand of insulin, Ren was told that the drug company provided 9,000 yuan for each participant - a huge increase on the usual payment - but he and his fellow guinea pigs received less than half the promised amount."We only got 4,000 yuan because the doctors took the rest of the money. We didn't dare complain, though. If we had, we would never have been chosen to take part in trials again." Li said the practice is an open secret in the industry, but the companies are unable to help. Hospitals naturally want to be reimbursed for the time and trouble they've taken and there is no requirement in China forcing doctors and testers to confirm payment details on the participant's contract."In Europe, the payment is written into the contract, which ensures the participants' interest," Li said. According to the regulations, drug companies are not allowed direct contact with the participants because only the hospital has that right.Lack of protection Wang Chenguang, a professor specializing in pharmaceutical law at Tsinghua University, said "professional" participants exist in most countries, but the laws and regulations in China lag far behind those overseas.He said the 1985 Drug Administration Law lacks provision for the division of responsibility among the regulatory departments."In particular, there are no specific and operational implementation rules to govern the transparency of the review and approval process, or to prevent the abuse of regulatory discretion. Also, liability insurance for clinical trials doesn't exist, neither do specific measures to protect a participant's personal information or settle disputes," he said.Contact the writer at yangwanli@chinadaily.com.cn Jiang Xueqing contributed to this story.mini storage