未经批准的治疗艾滋病药物试验导致伦理质疑
患者是否获知了他们的知情同意权？（图片来源：WHO/Eric Miller）
菲律宾马拉维松巴一名医院技术员被指控进行未经批准的药物临床试验，评论家说，这一案件凸显了围绕着对患者进行研究的一系列伦理问题。
Thadeo Mac'osano是马拉维南部圣路加医院姑息治疗组的负责人，他被控在没有监督或批准的情况下独立进行化疗药物试验直到2008年9月。该临床实验的6名患者死亡，尽管还不知道他们的死是不是由这种药物引起的。
伦理学家说这个案例表明了需要对临床试验进行更全面的管理监督。
Mac'osano在向医院提交了他的试验的初步结果之后于10月被捕，他对患艾滋病和相关癌症——卡波西肉瘤——的人们进行了试验。
圣路加医院的负责人Anthony Chilembwe1月8日在法庭上作证说，Mac'osano提交报告之后，Chilembwe立即进行了调查，发现他没有得到批准，并对他进行了停职处理。
南非威特沃特斯兰德大学Steve Biko生物伦理中心的Jillian Gardner说，问题在于Mac'osano如何获得了化疗药物，以及这所医院是否没能教育病人他们拥有知情同意权。
Mac'osano面临4项指控，包括未经马拉维的药物和毒物委员会（PMPB）或国家卫生科学研究委员会（NHSRC）批准就进行临床试验；没有适当的执照就给患者提供药物；以及未经患者知情同意就进行药物试验。他对所有指控都表示不服罪。
根据PMPB的初步调查结果，Mac'osano声称已经向医学研究和伦理委员会以及卫生部的艾滋病部门提交了进行药物试验的申请。
但是PMPB的律师Ishmael Wadi说，Mac'osano所谓的申请是一封寻求财政援助以启动试验的信。
Gardner说，南非的管理机构有义务通知所有的申请者他们的申请是否被批准或拒绝，而Mac'osano的申请显然被忽略了。
这一案件也表明了需要确保为伦理委员会提供资金从而让他们正确履行使命，而且“凸显了确立体系和程序的重要性。”Gardner说。
她说“奇怪”的是Mac'osano认为他可以不经批准就进行药物试验，但是她指出他向管理机构进行申请的事实意味着他知道基本的研究责任。
所有9名证人的证词已于1月28日提供完毕。而控辩双方的律师有21天时间向法官提交材料。关于Mac'osano是否应该对试验承担责任的裁决预计于4月7日公布。
Unauthorized treatment of AIDS drugs test led to the ethical challenge
Whether the patient was informed of their rights to informed consent? (Photo source: WHO / Eric Miller)
Malawi sumba Philippines, a hospital technician was accused of conducting unauthorized clinical trials of drugs, critics argue that this case highlights around the study of patients with a series of ethical problems.
Thadeo Mac'osano is St Luke's Hospital in southern Malawi palliative care group, he was charged in the absence of supervision or approval of the independent test chemotherapy drugs until September 2008. The clinical trial of the six patients died, although they do not know the death is not caused by this drug.
Ethicists said the case demonstrates the need for a more comprehensive clinical trial management and supervision.
Mac'osano to the hospitals to submit his preliminary findings of the trial in October was arrested after he was suffering from AIDS and related cancer - Kaposi's sarcoma - the people tested.
St Luke's hospital on the 8th on Anthony Chilembwe1 in court, testified that, Mac'osano submission of the report, Chilembwe immediately conducted an investigation and found that he had not been approved, and he was suspended from their duties.
University of the Witwatersrand, South Africa Steve Biko Bioethics Center Jillian Gardner said that the problem was how to obtain a Mac'osano chemotherapy drugs, as well as whether the hospital failed to patient education they have the right to informed consent.
Mac'osano facing four charges, including without Malawi Drugs and Poisons Committee (PMPB) or the National Health Sciences Research Council (NHSRC) approval to conduct clinical trials; without proper licenses give patients drugs; as well as without informed consent of patients on the drug test. He said that all allegations pleaded not guilty.
PMPB according to preliminary findings, Mac'osano claims to have the medical research and ethics committee and the Ministry of Health's AIDS department submitted an application to carry out drug tests.
However PMPB lawyer Ishmael Wadi said, Mac'osano the so-called application is seeking a financial assistance to start the pilot's letter.
Gardner said that South Africa's regulatory bodies have an obligation to inform all applicants whether their applications have been approved or rejected, while applications Mac'osano apparently been ignored.
This case also demonstrates the need to ensure that funding for the Ethics Committee in order to enable them to correctly carry out the mission, but also "highlights the establishment of the importance of systems and procedures." Gardner said.
She said, "strange" is Mac'osano that he could not approve the drug test, but she pointed out that his application to the regulatory agencies meant that he was aware of the fact that basic research responsibilities.
All nine witnesses on January 28 to provide finished. The prosecution and defense lawyers 21 days to submit materials to the judge. About Mac'osano whether the trial should be the responsibility of ruling is expected to be announced April 7.