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    Multinational drug companies exploiting the lax medical trial regulations in China 3/23/2006
    A lack of legal protection and law enforcement is encouraging foreign drug companies to use Chinese patients as drug trial guinea pigs, a legal expert told Interfax.


    Wang Yue, a member of the China health law society, and director of the law cases of Medical College in Peking University, said many trial participants tend to be less well off and less inclined to scrutinize the small print.


    He said most were college students from Medical Universities, and some working staff, mainly nurses in various medical organizations. In addition, low income earners often take part, and sometimes even jobless people who earn all their income from such trials.


    "They may get RMB 50 (USD 6.25) to RMB 80 (USD 10) a day for the trial, which is about ten times less than that in western countries. And none of them are covered by the drug company's insurance if they suffer an Adverse Drug Reaction (ADR)." Wang said.


    "Nowadays, more and more overseas drug makers have chosen China as a major base for clinical trials." Wang said, "The trend is obvious. The cost is low, and at present, there are no detailed laws and regulations for compensating the victims of unsuccessful drug trials."


    Wang suggested that China should force drug makers to provide mandatory insurance for patients who participate in medical trials. He also said independent experts should be employed to ensure the fairness and safety of clinical trials.


    He made his comments in the light of the case of a 57-year-old man from Jiangsu Province, who is suing a Chinese hospital and a pharmaceutical company after his kidneys were damaged when he took part in a medical trial.


    The Nanjing man, surnamed Guo, is seeking RMB 311,000 (USD 38,875) compensation from a Xuzhou, Jiangsu, drugmaker, and a grade one Nanjing Hospital, and filed his case on March 16.


    The drug maker has applied to the court in Nanjing's Gulou district to make the hearing private in the interests of commercial confidentiality.


    The victim said he suffered unsteady blood sugar levels due to influenza last September, and was hospitalized in Nanjing. During his treatments, a doctor suggested changing the insulin he was being administered and then introduced him to a new drug as part of a clinical trial.


    Guo was informed that the new drug was just as effective as the previous one he was given and that it would be free of charge. He signed an agreement giving his consent to take part in the trial.


    But he said doctors later found he was not suitable for the trial, but carried on regardless without informing him.


    After the trial, Guo said his blood sugar levels were still not being corrected by the drug but doctors insisted on giving him a large dose of the drug until the trial was over. Guo then suffered discomfort all over his body and felt pain on both sides of his waist. Later examination found his kidney functions had been badly damaged.


    Mr Guo alleges the hospital and drug maker pursued business profit at the expense of his health.


    Vice director of clinical Pharmacology at Jiangsu Provincial Hospital of Traditional Chinese Medicine, Jiang Meng, said that hospitals, as well as departments who carry out clinical trials and have been approved by SFDA, must adhere to strict regulations.


    "Patients all have to sign an agreement with the hospital showing they know about the clinical trials." Jiang Meng said.


    But Wang Yue doubts that the patients were well enough informed about the trials.


    "Though Mr Guo signed agreement which gave some information on the trial, it would not have been balanced information. China is lagging behind in informing patients about clinical trials."


    Wang Yue has been involved in several compensation cases where patients have damaged their health during clinical trials, "but very few of them succeeded," he said.


    "Most of the patients who agreed to receive clinical trials were not well informed about the effects the trials that may have on them." Wang said.


    "I had a client come for compensation who was just informed that the drug he was tested with was new and imported from a developed country. He was misled into thinking the drug he took for free was among the most advanced drugs in its field, so he signed the agreement immediately."


    Wang said that regardless of the unbalanced information and knowledge the patients have compared with doctors, they are also greatly influenced by the authority doctors have.


    "Authority is very powerful," Wang said. He added that when patients go to hospital for treatment, they are inclined to believe everything doctors say, because they lack the equivalent knowledge and information on drugs and medical treatment for themselves.


    China has been far behind in mapping out laws on compensation for ADR and adequate laws to protect rights do not exist, says Wang.


    "A law is expected to be drafted by the end of this year," said Wang, who has been closely monitoring the situation over the past few years. "People who receive clinical trials all have to sign an agreement showing they have sufficient knowledge of the trial, according to the regulations of the SFDA, but in practice, it doesn't work so well," he added.


    Wang said he was concerned about the wording of such agreements. He said "Some language that doctors use for persuading patients to participate in clinical trials is unclear. Sometimes even they themselves don't fully understand the agreements they pass to the patients."


    He said that for clinical trials, it should be a licensed pharmacist who formulates the agreements, but the SFDA has so far not made much effort to enforce laws on licensed pharmacists.


    "The SFDA said they were going to draft the law on licensed pharmacists three years ago, but until now, the law hasn't been worked out."


    "Some of the work that doctors in China are doing has to be passed to pharmacists. Knowledge of drugs is not easy to learn, and pharmacists are responsible for giving patients the most suitable drugs to avoid ADR as much as possible," Wang said.

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