Chronology

Chronology

2/6/95
Letter from Kerry Bone, technical manager of Mediherb Pty. Ltd. (suppliers of the herbal formula) stating that Mediherb cannot take responsibility for the efficacy of the herbs but will "take responsibility for the quality and the safety of the herbal formula".
12/7/95
Letter from Kerry Bone providing detailed information on the dosage of individual "equivalent of dried herbs" in the formula.
19/7/95
Letter from Raymond Khoury of Kingsgrove Herbal Medicine Centre, consultant to the National Herbalists Association of Australia, the NSW Medicines Information Centre and the Therapeutic Goods Administration, and further to a request for information from the NSW Medicines Information Centre, stating that "the bottom line is that they [the herbs in the formula] are safe".
2/8/95
Letter from Kim Breheny, Research Ethics Coordinator of Eastern [now South-Eastern] Sydney Area Health Service requesting particular changes to the trial protocol and participants prior to finalizing approval.
6/9/95
Letter from Kim Brehany confirming approval for trial to proceed according to NHMRC guidelines granted by Ethics Committee, ESAHS.
6/12/95
Letter from Andrew Lloyd enclosing proposal and ethics committee form, which he had signed
14/12/95
Application for approval to conduct research received from Simon Ayland, Chief Research Officer, NSW DCS.
27/12/95
Letter to Simon Eyland enclosing application to the Department of Corrective Services Institutional Ethics Committee (DCSIEC). Urgency of application stressed.
11/1/96
Letter from JR Paget, Assistant commissioner Personnel and Education Chairperson DCSIEC. Informed of current departmental policy to only consider research application sin May and November. This due to large number of requests to undertake research. Application "to be carried forward "for consideration at extraordinary meeting. Informed that "until you receive written approval no attempt to enter departmental facilities or to contact departmental staff regarding your research should be undertaken" because of section 48a of the Prisons act 1952. N.B. meeting then postponed until April.
5/2/96
Letter from Kerry Bone stating that "the herbs in the KM1 formula are safe for women before and all during the pregnancy".
13/2/96
Letter from Assoc. Professor Andrew Lloyd, Staff Specialist Department of Infectious Diseases regarding approval of Clot Retraction Test (CRT) aspect of trial.
23/2/96
Letter to JR Paget. Acknowledgment of letter and understanding of postponement. Offer to supply any additional information if required.
8/3/96
Letter from Simon Eyland. Application to be considered at a meeting of DCSIEC April 3. States that under section 48a of the Prisons Act 1952 that "until your receive written approval no attempt to enter departmental facilities or to contact departmental staff regarding your research should be undertaken".
19/4/96
Letter from NR Smethurst, Commissioner DCS. Rejecting application based on the following objections:

concerns over the operational and practical feasibility of the project;
not necessary to undertake the study on current inmates;
that "the adverse effects of the drugs are not fully known";
concerns over project aim 'to evaluate the safety of a specific formula'.

14/6/96
Letter to NR Smethurst. Notes that safety already considered by South-Eastern Sydney Area Health Service Ethics Committee (SESAHSEC), all relevant papers attached which were seen by that EC. Noted support for operational feasibility by the Coordinator of the Lifestyles Unit at Long Bay Prison. Also notes existing Departmental policy on care of prisoners with HIV/AIDS. Letter from Dr. Don Smith of the Community HIV/AIDS Research Network attached.
31/7/96
Letter from LM Sulman, acting for the Commissioner. Following consultation with DCSIEC informed that position unchanged. Notes "in particular" that:

no justification why trial needs to be undertaken on prisoners, "unconvinced that the trial needs to involve inmates";
safety aspects of the herbal formula not satisfactorily addressed.

Notes that if the trial is successful in the wider community that the IEC would reconsider application.
14/8/96
Letter to Minister , Rt. Hon R Debus. Notes community support for the trial and some internal departmental support. Notes new argument advanced by a spokesperson for the Department to a reporter for the radio station 2SER, Ashley Crossland, that allowing inmates onto our trial would breach the Helsinki Convention. Notes Departmental policy guidelines on care for prisoners with HIV/AIDS again. Notes again the acceptance of formula's safety by SESAHS and letter addressing this issue by the manufacturer (note that in drug applications to bodies such as the Therapeutic Goods Administration that company supplied information on drug safety is usually accepted without question). States that rejection of trial is "both unnecessary and, we believe, petty". Notes that practical considerations have been "consistently and successfully addressed".
3/9/96
Letter from Minister's Secretary to Ms Sandra Nori MP acknowledging representations on our behalf.
16/9/96
Letter from Andrew Lloyd refusing support for trial application because of concerns over logistical issues "although in principle I think it would be most helpful to have the trial running in the prison".
28/9/96
Letter from Bob Debus. Agrees that "there are some issues which could be explored". Told that application to be reviewed by the next IEC.
7/11/96
Letter to Bob Debus noting that IEC now saying they will not meet until "sometime next year' and that they cannot justify holding meeting when they have no other business. Tells Debus that delays mean that "inmates living with HIV are left hanging with access denied to a treatment which may well be of tremendous help to them".
18/12/96
Letter from Bob Debus. Notes that Committee is an "expert panel" constituted to NHMRC guidelines. External members have "extensive knowledge and experience of issues relating to research undertaken in a correctional setting". States concern to ensure research is "ethical and not exploitative". Presumes that results from research in wider community available and urges this to be submitted. States that inmates in Lifestyles Unit have been consulted about taking part but shown no interest. States that inmates now released have been given contact numbers or the trial and suggests that if any are taking part in trial that they submit testimonials to IEC. Told, that Committee have been asked to "fully explain" problems so "you may have an opportunity to explain or rebut them".
20/12/96
Letter from Simon Eyland. Refers to letter to Debus 7/11/96. Restates that:

research unnecessary "to be undertaken on current inmates", "from an ethical viewpoint there is insufficient basis for involving inmates in the trial;
problems remain with safety aspects, with a lack of evidence over adverse effects;

4/1/97
Letter to Bob Debus. Notes that complaint concerning delays to IEC were not addressed in his previous letter. States that application being considered in this way "because of the nature of the therapy being trialled". Notes that inmates are on drug trials and that this information cause both safety and lack of need arguments from IEC and himself to "fall by the wayside". Points out that all treatment for HIV illness is essentially experimental. States that an application to the NSW Ombudsman will be made failing action.
25/2/97
Letter from Minister's Secretary Acknowledging our letter.
28/2/97
Letter from Leo Keliher, DCS Commissioner. Replying following instruction from Minister. DCSIE offers face-to-face meeting March 12 "to discuss your proposal".
4/3/97
Letter from Antonia Barilla, Research Officer, Research & Statistics Unit. Confirms invitation to IEC meeting.
11/3/97
Fax to Leo Keliher stating that Secretary, trial participant and board member and representative of Positive Women group will attend with Trial director, Jan Kneen-McDaid.
11/3/97
Letter from Simon Eyland. States that previous invitation from Commissioner was "a personal invitation". Told that "the Chairman of the Committee considers that it would be inappropriate to have a large representation at the meeting." 12/3/97 Meeting between Trial Director and Secretary and IEC.
13/3/97
Fax To JR Paget, Assistant Commissioner. Requests copy of minutes and tape of meeting.
13/3/97
Letter from JR Paget. Confirms that the "relevant section" of the minutes and a copy of the tape "relating specifically to those proceedings dealing with the KM1 Herbal Formula Trial" will be forwarded by Simon Eyland.
14/3/97
Letter to Paget with request for full and unedited copy of the minutes.
17/3/97
Letter from Paget stating that "you will be provided with minutes which covered your meeting with the IEC".
21/3/97
Letter to Paget referring to March 17 fax from him. Further request for minutes and tape of meeting.
2/4/97
Letter from Leo Keliher. States that Committee "remains unconvinced that concerns it has with the project have been adequately addressed". Restates that:

there is "no adequate justification as to why the herbal trial needs to be undertaken on current inmates";
"safety of the formula has not been adequately addressed. Believes that this raises "serious concerns given the Department's overriding duty of care".

Department is interested if trial prove successful in the community..
17/4/97
Letter to Paget. States that minutes and tape not yet received.
7/5/97
Neither minutes or tape yet sighted.

'Set up' for meeting

On the 25th of February I was notified by the Minister's Secretary that I would be receiving a letter inviting me to discuss my proposal with the NSW Corrections department Institutional Ethics Committee (IEC).
On the 28th of February I received a message on my answering machine from the IEC Secretary, Simon Eyland, inviting me to 'discuss my project' with the IEC March 12th.
I spoke with Mr Eyland's Secretary the following Monday. I could not speak with Mr Eyland or John Paget as they were away at a conference until the following Thursday, March 6. I therefore started my preparations for the meeting. I had to find a secretary as mine was sick. I needed someone familiar with ethics proceedings as well as research (Sonia Lawless from the AIDS Council of NSW (ACON)). Also I needed my Database Manager to explain the current practical considerations with the trial.
I received a letter from the Commissioner, Leo Keliher, March 3rd confirming my invitation to the meeting of the IEC.
I received a letter from Simon Eyland's Secretary March 4th confirming the time and location of the meeting.
On the following Monday March 10th I faxed details of my team following their confirmation of availability to the Commissioner.
March 11th I was notified by mail and fax that the invitation to the IEC was "a personal one" and that it was "not appropriate" that any members of my team attend.
March 12th I contacted Mr Eyland by phone to inform him that I am blind and require someone to take notes. This was agreed and Erica (from ACON) attended with me.

Jan Kneen-McDaid
7.5.97
(Witnessed)

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