A voice for women's health

Letter to the Health and Disability Commissioner - May 2014

15 May 2014
Anthony Hill
Health & Disability Commissioner
PO Box 11934

Dear Anthony Hill,

The Auckland Women’s Health Council (AWHC) is writing to you about the issue of enrolling unconscious patients in clinical trials. We first learned about this practice during the March meeting of the Northern A ethics committee.
The issue hit the headlines yesterday when the Herald made it front-page news after a reporter received a copy of the May issue of the AWHC’s newsletter (copy included). Since then some researchers, doctors, ethics committee chairpersons, DHB senior managers, and others have leapt to defend the practice.
Two members of the AWHC have been regularly attending meetings of the Ministry of Health ethics committees for the past six or seven years. We have become increasingly alarmed and are now extremely concerned at what has happened to patient rights in the current clinical trials environment. There are many clinical trials being undertaken which involve vulnerable patients, including infants, children, young adults with Down syndrome as well as unconscious patients.
Last night during an item on TV3’s 6 o’clock News on this issue it was stated “that only 5% of unconscious patients complain” when they regain consciousness and are told they have been enrolled in a clinical trial. This is a significant number as there will also be those who are not happy but feel too vulnerable to complain or even admit to wanting to withdraw from the trial. There are also those patients who are never told and never find out that they have been enrolled in a clinical trial. Under the media spotlight people’s memories of what was said during an ethics committee meeting tend to be quite different to what was actually said. I take accurate notes and find there are considerable discrepancies and omissions in the minutes that eventually find their way on to the MOH ethics committees website.
While consumers’ rights to make informed choices regarding their health care and inclusion in research trials are enshrined in legislation and listed in the Code of Consumers’ Rights, the current clinical trials environment means that New Zealand consumers are not always able to make informed decisions. There are now big loopholes which enable research studies to go ahead that previously may not have got ethics committee approval. For example, I have seen research studies that have been given ethics committee approval despite the fact that the clinical trial offers no benefit to the research participant, and no benefit to the general public – it is being carried out so that the drug company sponsoring the study can get their “me-to” drug onto the market. This is openly acknowledged during the meeting. It is our contention that unconscious patients should not be enrolled in clinical trials that are non-inferiority studies, or offer no benefits to either the patient or the general public, or do not meet the threshold of being in the best interests of the patient.
The DHBs and those involved in the clinical trials industry are now firmly focused on the thousands of dollars to be made from conducting clinical trials. Even the ethics committees are not focused on protecting research participants the way they were in the years following the Cartwright Inquiry.
The AWHC is therefore requesting that the Office of the Health and Disability Commissioner to investigate the issue of enrolling people in nonconsensual trials. We are also requesting you to take action to strengthen Right 7 (4) and Right 9 in order to prevent people from being enrolled in clinical trials without their knowledge or consent.
Yours sincerely,
Lynda Williams

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