Tuesday, December 14, 2010

Unapproved therapeutic AIDS drugs test result in ethical questions

[/]: Philippines Malawi song she hospital technicians accused of unapproved drugs in clinical trials, critics said, this case highlights around the study of patients with a range of ethical issues.

Thadeo Macosano is southern St. Luke's Hospital palliative care group, he was accused in the absence of oversight or approval to chemotherapy drugs test independent until September 2008. The clinical trials of 6 patients died, despite not knowing their death was not caused by this drug.

Ethicists say this case illustrates the need for clinical trials more comprehensive management oversight.

Macosano in the hospital submitted his preliminary results of the test in October after the arrest, he was suffering from AIDS and cancer-associated Kaposi Sarcoma: a test of the people.

St. Luke's Hospital in charge of Anthony Chilembwe1, testified that in court, to submit a report after Macosano Chilembwe immediately investigated and found that he had not been ratified, and he was suspended from duty.

South Africa Witwatersrand University Steve Biko Bioethics Centre Jillian Gardner said that the problem is how to get the Macosano chemotherapy drugs, and the hospital is not education patients they have informed consent.

Macosano face 4 allegations, including drug without the Malawi and Poisons Board (PMPB) or National Health Sciences Research Council (NHSRC) approved the conduct of clinical trials; no appropriate licences give patients with drugs; and without the informed consent of patients on drug test. He is on all the accused pleaded not guilty.

According to preliminary findings PMPB, Macosano claimed to have to medical research and Ethics Committee and the Ministry of Health's AIDS authorities submitted an application for drug testing.

However Ishmael Wadi PMPB lawyer said that the so-called Macosano application is a letter seeking financial assistance to start a test letter.

Gardner said that South Africa's management bodies are obliged to inform all applicants whose application has been approved or rejected, and an apparently Macosano ignored.

This case also indicates the need to ensure that provided funding for the Ethics Committee so that they properly fulfil their mission, and the "highlighted the establishment of systems and procedures. "Gardner said.

She said it was "weird" Macosano think he can carry out without the approval of the drug test, but she pointed out that his application to the management bodies of fact means that he knows the basic research responsibilities.

All 9 witnesses were provided on 28 January. While the prosecution counsel have 21 days to submit materials to the judge. About whether you should test Macosano liable ruling is expected to be released on 7 April.

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