7/5/97 

Dear Mrs Moss 

I write with a complaint which I wish to lodge regarding the denial by the Department of Corrective Services Institutional Ethics Committee [IEC] of access by NSW prisoners to the KM1 Herbal Formula Trial. 
I have attached background information regarding the trial, copies of relevant documents and a chronology of communications and events and support letters for our case. 
Our complaint about the Institutional Ethics Committee is based on the conduct of the Committee and its officers and the methods by which they have reached their decision to refuse access. 
Regarding the conduct of the IEC. Throughout our dealings with the IEC we have found them to be unsympathetic, unhelpful and, of late, obstructionist, abusive and rude. They have consistently pointed to reasons for rejecting our application which have not been explained. In particular they have not spelt out what standard is required before the Herbal Formula is considered safe and which practical considerations block the trial's approval. They have not said why they have rejected safety information tendered to them. 
They have not said why practical considerations should block the access to this trial when prison health workers have offered to do the small amount of paperwork and the formula can be supplied as drugs currently are. 
Other reasons have been voiced outside of written communication with us, in particular to the media. 
When answers to such questions have been provided, as at a face-to-face meeting, they have been improperly discounted. 
They have dealt with the application slowly, at times not explaining why delays are occurring and have provided open ended hearing dates. 
They have threatened us regarding contact with departmental staff misquoting law (the Prisons Act 1952) barring such contact. 
After finally achieving a face-to-face meeting with the committee (after strong representations to the Minister) we were faced with a hostile wall whose sole aim was not dialogue but to 'explain' why they could not approve the trial. Our request that a small group from CTI (3) with one relevant other attend this meeting was rejected, however the Committee itself brought in a number of outsiders to this meeting. (See first attachment, "'Set up' for meeting"). It was taped without our prior knowledge, and both the tape and the minutes of the meeting have yet to be supplied to us despite receiving a letter restating the rejection of the application. 
Regarding the decision making process. 
They have reached their decisions with no specialist advice from HIV/AIDS medical professionals or complementary therapies experts. 
They have also taken no regard of recent developments in the ethical considerations surrounding HIV/AIDS trials. 
They have failed to seek evidence from us which would address their concerns, particularly over the Formula's safety and regarding practical considerations. 
To directly answer the two most persistent stated concerns of the IEC: 

• Our trial has been passed by the South Eastern Sydney Area Health Service Ethics Committee. 

This committee is one of the busiest in Australia for HIV/AIDS trial protocols and could be regarded as expert in such trials. It requested numerous changes to the trial protocol and Informed Consent forms before it was passed. 
They requested safety information from the NSW Medicines Centre who contacted Raymond Khoury, a herbalist who also works with the Therapeutic Goods Administration (TGA). Khoury, a recognised herbal expert, declared them safe, supplying information about the toxicology and safety of the herbs. 
The manufacturer, Mediherb, has confirmed this view, pointing to the existing TGA approval for the four herbs of the formula for over the counter sale. We are using licensed compounds, Special Access Scheme (SAS) and other compounds are not licensed. 
The IEC has yet to explain why it has rejected our evidence of the Formula's safety and what standard of evidence it would require and why that should be any different to that required by other ECs. 
• Existing departmental policy is that prisoners should receive the same access to health care as all other persons receive. 

The ethical argument for denying access to possibly useful therapies to people with a life threatening illness is questionable and the IEC has refused to consider the existing situation with access to experimental drug therapy for prisoners with HIV/AIDS in the same ethical light. 
This would appear to be discriminatory: the application of an overt double standard. We would also argue that the prisoner must have some rights in deciding their own health care options if they are truly to have the same level of care as those outside prison, and that this must include access to experimental therapy for prisoners with life-threatening illness. 
• Prisoners with HIV/AIDS have had access to anti-viral, opportunistic infection and prophalaxis drugs through the, compassionate access schemes, SAS and trials (my emphasis) for some time now according to doctors working or who have worked for the Corrections Health Service. 

Prisons have actually operated as a centre for a previous trial into Interferon for Hepatitis C. We refer you to the letter of support by Associate Professor Andrew Lloyd. 
Application of the IEC's ethical arguments regarding access to our trial for prisoners would appear to disallow prisoner access to these new drugs, if they were applied. The IEC appears to have both a double and a different standard for complementary therapy. 
There also appears to be no understanding of the nature of current 'mainstream' therapy for HIV/AIDS. Combination therapy, where several drugs are combined, is tailored for individual circumstances and is often based, in that particular combination, on anecdotal or other evidence which have not been considered by the TGA. Current accepted practice in HIV/AIDS therapy is to prescribe without certainty that a particular combination will be safe as regards possible side-effects and other contra indications including possible resistance down the line. These prescribing decisions are based on the best available evidence.

Jan Kneen-McDaid 
KM1 Herbal Formula trial Director 
attachments  
cc: Justice Action, Bernie Coates, Dr. Don Smith, Philip Metcalf, Clover Moore MP, Sandra Nori MP, Debra Jopson, Bob Debus MP