SENATE - Parliament of Australia

COMMONWEALTH OF AUSTRALIA

SENATE

COMMUNITY AFFAIRS REFERENCES COMMITTEE

Reference: CJD settlement offer

CANBERRA

Monday, 25 August 1997

OFFICIAL HANSARD REPORT

CANBERRA

SENATE


Members:

Senator Bishop (Chair)Senator Knowles (Deputy Chair)

Senator Forshaw Senator NealSenator Lees Senator O’BrienSenator Lightfoot Senator Synon

Participating members:

Senator Abetz Senator ColstonSenator Bob Brown Senator FaulknerSenator Bob Collins Senator Margetts

Matters referred for inquiry into and report on:

(1) The fairness of the recent settlement offered by the Commonwealth Government torecipients of human pituitary hormones, with particular reference to:

(a) whether the Government’s response to the Allars Inquiry recommendationshas been fair and adequate;

(b) whether the Government refused to make certain relevant documents relatedto the inquiry available to recipients;

(c) whether the Commonwealth’s offer to the recipients was fair and adequateand gave recipients sufficient time and information to make a consideredresponse; and

(d) whether legal aid has been unfairly denied to the recipients, placing themunder more pressure to accept the Commonwealth’s offer of settlement.

(2) Whether the Commonwealth Serum Laboratory (CSL) or CSL Ltd, the NationalHealth and Medical Research Council, the Department of Health and FamilyServices or any other Commonwealth department, agency or employee failed toadequately protect public safety in relation to the Australian Human PituitaryHormone Program.

WITNESSES

CARROLL, Mr John Joseph, Assistant Secretary, Legal Services Branch,Department of Health and Family Services, PO Box 9848, Canberra,Australian Capital Territory 2600 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

DEAN, Dr Margaret Emily, Medical Adviser, Department of Health andFamily Services, PO Box 9848, Canberra, Australian Capital Territory2600 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

HUGHES, Mr Roger John, Acting Assistant Secretary, National HealthPromotion and Protection Branch, Department of Health and FamilyServices, Bowes Street, Woden, Australian Capital Territory. . . . . . . . . . 176

KAUFMAN, Mr Graeme Roy, General Manager, Biosciences Division, formerCommonwealth Serum Laboratories Commission, 45 Poplar Road,Parkville, Victoria 3052 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

LOY, Dr John, First Assistant Secretary, Health Services DevelopmentDivision, Department of Health and Family Services, PO Box 9848,Canberra, Australian Capital Territory 2601 . . . . . . . . . . . . . . . . . . . . . 176

LUCAS, Mr Stephen Kendall, Senior Government Solicitor, AustralianGovernment Solicitor, 200 Queen Street, Melbourne Victoria . . . . . . . . . 176

McDONALD, Mr Geoffrey William, Senior Government Solicitor, AustralianGovernment Solicitor, 200 Queen Street, Melbourne, Victoria . . . . . . . . . 176

MEAD, Dr Cathy, Director, National Centre for Disease Control, Departmentof Health and Family Services, PO Box 9848, Canberra, AustralianCapital Territory 2600 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

TUOHY, Mr Peter John, Company Secretary, former Commonwealth SerumLaboratories Commission, 45 Poplar Road, Parkville, Victoria 3052 . . . . 176

WELLS, Mr Robert William, First Assistant Secretary, Office of the NationalHealth and Medical Research Council, Department of Health andFamily Services, PO Box 9848, Canberra, Australian Capital Territory2600 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

WHITWORTH, Professor Judith Ann, Chief Medical Officer, Department ofHealth and Family Services, PO Box 9848, Canberra, AustralianCapital Territory 2600 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

SENATE


CJD settlement offer

CANBERRA

Monday, 25 August 1997

Present

Senator Bishop (Chair)

Senator Forshaw Senator Lightfoot

Senator Knowles Senator Neal

Senator Lees Senator O’Brien

Participating Member

Senator Harradine

The committee met at 8.12 p.m.

Senator Bishop took the chair.

175

CA 176 SENATE—References Monday, 25 August 1997

CARROLL, Mr John Joseph, Assistant Secretary, Legal Services Branch,Department of Health and Family Services, PO Box 9848, Canberra, AustralianCapital Territory 2600

DEAN, Dr Margaret Emily, Medical Adviser, Department of Health and FamilyServices, PO Box 9848, Canberra, Australian Capital Territory 2600

HUGHES, Mr Roger John, Acting Assistant Secretary, National Health Promotionand Protection Branch, Department of Health and Family Services, Bowes Street,Woden, Australian Capital Territory

LOY, Dr John, First Assistant Secretary, Health Services Development Division,Department of Health and Family Services, PO Box 9848, Canberra, AustralianCapital Territory 2601

MEAD, Dr Cathy, Director, National Centre for Disease Control, Department ofHealth and Family Services, PO Box 9848, Canberra, Australian Capital Territory2600

WELLS, Mr Robert William, First Assistant Secretary, Office of the National Healthand Medical Research Council, Department of Health and Family Services, PO Box9848, Canberra, Australian Capital Territory 2600

WHITWORTH, Professor Judith Ann, Chief Medical Officer, Department of Healthand Family Services, PO Box 9848, Canberra, Australian Capital Territory 2600

KAUFMAN, Mr Graeme Roy, General Manager, Biosciences Division, formerCommonwealth Serum Laboratories Commission, 45 Poplar Road, Parkville, Victoria3052

TUOHY, Mr Peter John, Company Secretary, former Commonwealth SerumLaboratories Commission, 45 Poplar Road, Parkville, Victoria 3052

LUCAS, Mr Stephen Kendall, Senior Government Solicitor, Australian GovernmentSolicitor, 200 Queen Street, Melbourne Victoria

McDONALD, Mr Geoffrey William, Senior Government Solicitor, AustralianGovernment Solicitor, 200 Queen Street, Melbourne, Victoria

CHAIR —I declare open this third day of public hearings of the Senate CommunityAffairs References Committee, inquiring into matters relating to the CJD settlement offer.The committee will continue hearing evidence given on behalf of the Department ofHealth and Family Services. I welcome, and welcome back, officers and former officers ofthe Department of Health and Family Services, former officers of the CSL Commission

COMMUNITY AFFAIRS

Monday, 25 August 1997 SENATE—References CA 177

and representatives of the Australian Government Solicitor. Do you have any comments tomake at this point on the capacity in which you appear?

Mr McDonald —I am from the office of the Australian Government Solicitor. I amsolicitor for the department of health.

CHAIR —You are reminded that if, during the giving of your evidence, youconsider it may be more appropriate for the committee to hear part of your evidence inprivate session, the committee will give consideration to your request. Does anyone wishto make any opening comments before we resume questioning by the committee?

Prof. Whitworth —With your permission, I would like to table some additionalinformation for the committee.

CHAIR —What is the nature of that additional information?

Prof. Whitworth —There are seven separate items. Firstly, with respect toinformation relating to Dr Peters’s claim that deaths were from the hormone extracted byCSL, we have a letter from the Ministry of Health in New Zealand dated 20 August 1997which advises that New Zealanders had five cases of CJD following treatment with humanpituitary derived hormones. All cases have been as a result of human growth hormonetreatment and the hormone was prepared in the United States of America.

Secondly, there is a letter to Mr Stachlewski on 12 December 1994 from the thensenior adviser of the Pituitary Hormone Task Force providing information on documentsrelating to the Allars report, the task force database and other issues previously raised byhim. Thirdly, there is the request by Senator Lees for copies of the minutes of themeetings of the Human Pituitary Advisory Committee and its subcommittees. We havefolders containing the minutes of the meetings of the Human Pituitary AdvisoryCommittee, the Follicle Stimulating Hormone Subcommittee, the FractionationSubcommittee and the Human Growth Hormone Subcommittee. They are all ready fortabling. It should be noted, Chairman, that some of these minutes do contain confidentialmaterial such as names of patients and details of their treatments.

Fourthly, we have the statistics and information from the published peer reviewmedical literature on ovarian hyperstimulation and multiple pregnancies to support ourstatement that Australian figures were equal, if not better, than those anywhere in theworld. Fifthly, we have responses to specific issues raised by Dr Frank Peters in hissubmission. Next we have a response to Mr John Stachlewski regarding possible breachesof privacy and, finally, there are CSL responses to questions on notice tabled by SenatorHarradine following the previous hearings.

CHAIR —Thank you, Professor Whitworth. We will accept all of the material. Thematerial relating to names of patients and doctors, we will accept on a confidential basis.

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Prof. Whitworth —Thank you.

Senator LEES—I was going to begin by asking about the material that I hadrequested previously. It now makes it a little difficult tonight to ask questions and to relateback other material to that documentation. I think I will let my colleagues start with theformal questions.

Senator NEAL—Bearing in mind that there is obviously a fairly substantialamount of information that we will not have time to absorb this evening, perhaps thedepartment would be prepared to accept questions on notice for, say, another two days,after we have had a chance to look at that material.

Senator LEES—Just generally, looking through some of the other material thatyou have provided, there does seem to be gaps in it. Have you now tabled all thedocumentation on each of the meetings? Or have we got meetings that we simply do nothave the minutes for any longer?

Dr Loy —No, the minutes of all the meetings have been made available to thecommittee.

Senator LEES—I will have to read the documents before going back and cross-matching for further questions.

CHAIR —I will give consideration to the statement made by Senator Neal. Howbulky is that material Professor Whitworth?

Prof. Whitworth —It came in on a trolley.

CHAIR —In relation to the warnings given in 1965 by Dr Whitten about the viralcontamination of the product, is it not the case that after the warning was given that thedepartment or CSL could not assume that that virus would be eliminated from theproduct?

Mr Kaufman —I think the history of that was that, following the meeting in 1965,where I believe Mr Telford, Dr Whitten and others were present, NBSL was requested toprovide comment on the issue of viral contamination. Professor Allars in her reportconcludes that that advice was not received, or she can find no evidence of that advicebeing received from NBSL.

CHAIR —The advice was not received?

Mr Kaufman —We have no record of that advice having been received, nor couldProfessor Allars deduce from interview as to what happened to that advice.

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CHAIR —Does that mean that, because you had not received the advice, you couldnot assume that the virus had been eliminated from the product?

Mr Kaufman —I think the results on the batches that we talked about last time—we have provided further data following a request from Senator Lees—would demonstratethat in fact the virus was removed on the column: in that, we have not seen it in post-voidvolume fractions.

CHAIR —So you maintain that the virus was eliminated from the product?

Mr Kaufman —Correct.

CHAIR —Is the department or CSL aware that the Fractionation Subcommittee ofthe department conceded in 1970—I refer to minutes of the FSH on 6 November 1970—that there was no guarantee that the virus would be eliminated from the HGH and theFSH?

Mr Kaufman —I was not aware of that, Senator.

CHAIR —Are you aware of those minutes?

Mr Kaufman —No, Senator.

CHAIR —Would those minutes be in the material that has been provided thisevening?

Mr Kaufman —I believe so.

CHAIR —Perhaps the secretary could check the minutes of the FractionationSubcommittee of 6 November 1970. Is the department or CSL also aware that FSCconceded in 1970 that exclusion criteria had not been complied with in the past and that,as a result, the FSC also conceded that past batches may have been contaminated with avirus?

Mr Kaufman —I am not aware of that, Senator.

CHAIR —Is anyone else aware of that?

Dr Loy —Could you give us a reference?CHAIR —My only reference is in 1970.

Dr Loy —Again, we would have to check the minutes of the subcommitteemeeting.

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CHAIR —All right. At any stage, were any steps taken by the FSHSC and theHGHSC to monitor the health of recipients during and after treatment to determinewhether that virus had been transmitted by the pituitary hormone injections and resultingin disease?

Dr Loy —Not that we are aware of.

CHAIR —So no steps were taken that you are aware of?

Dr Loy —No, but it clearly indicates that they were closely in touch with theirtreating doctors throughout the period, particularly both FSH and HGH recipients. I amnot aware of any reports that came back to the committees of patients suffering fromhepatitis or other diseases. I am also not aware of any systematic examination of that.

CHAIR —Has the department or CSL at any time inquired of the recipients as towhether they suffered from hepatitis or liver problems during or after treatment wasadministered?

Dr Mead—Not that I am aware of.

CHAIR —Is anyone aware of anything opposed to that?

Dr Loy —No.

CHAIR —If not, why not, given that this was the basis of the FSC’s method ofdetermining the actual risks to recipients?

Dr Loy —I am not quite clear on the meaning of the latter part of your question.

CHAIR —What method would you suggest is appropriate to determine levels ofactual risk to recipients, if any?

Dr Loy —The Fractionation Subcommittee, in particular, was concerned, obviously,to see that the methods used in fractionation did not present a substantial risk of virus inthe product. I am not sure that there was then a decision to test that by going out andseeing whether cases of hepatitis occurred. I imagine people worked on the assumptionthat the measures that had been taken were sufficient to ensure that the product was notcontaminated.

Senator LEES—I want to move on from that to, particularly, hepatitis. One of thedocuments you have already provided us with is from a particular hospital board inQueensland. Basically, the board wrote to CSL and asked, in connection with thecollection of human pituitary glands, whether it could arrange a discussion with you. The

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board said that it wondered whether material from cases of viral infection, in particularhepatitis or other infectious or malignant disease, should be included. This is dated 4January 1966. I do not have the minutes of the meetings. The first minutes of meetingsthat I have are dated 1970, so I do not know what the response of the committee was.

The question from Senator Bishop involved whether there were checks forhepatitis. It was obvious in 1966 that the risk was understood. This letter goes on to say:

Would you let me know if such material is to be forwarded or not? In the meantime we will notsupply material from these cases.

This is just one of presumably hundreds and hundreds of places from where pituitaryglands were being obtained. Basically, what was happening to then monitor for the diseasethat was already known to be a risk?

Dr Loy —My understanding is the earliest exclusion criteria for collection ofglands excluded cases of hepatitis viral infection.

Senator LEES—That was only when cases were known and understood andidentified.

Dr Loy —Yes, indeed. The exclusion criteria obviously could not be used wherethere wasn’t any evidence.

Senator LEES—So the risk was known and therefore what checks were beingdone? What processes were used to actually monitor—

Dr Loy —The whole point of the fractionation process was intended to ensure thatthe product produced was not contaminated by known viruses.

Mr Kaufman —At that stage there were no definitive tests in any case forhepatitis.

Senator LEES—But surely monitoring the patients in terms of any liver problems,symptoms et cetera?

Dr Loy —You may think that that should have been done but it wasn’t.

Senator LEES—Okay.

CHAIR —Was Dr Dean aware of Dr Whitten’s 1965 warnings, and the commentsof the FSC in 1970, when she gave evidence to a Senate committee on 2 June 1997 that:

. . . the process of extracting the pituitary hormone has been found to eliminate known bacterial and

COMMUNITY AFFAIRS


viral diseases.

She further stated:

The process of extracting the pituitary hormones from the batches does eliminate the hepatitis Bvirus, so that the batch that was found to be contaminated was reprocessed and that processeliminated the hepatitis B agent . . . Theprocess eliminates the agent before it is injected into thepatient.

Dr Dean—At the time I was not aware of Dr Whitten’s statement but I was at thattime and am still convinced that there was no contamination of the material given to therecipients of the pituitary hormones. I made that decision in my own mind on the basis ofthe evidence that I have read and the evidence that has already been presented to you. Sofar, I have not seen anything which would make me change my mind.

CHAIR —You are confident in the accuracy of your previous position?

Dr Dean—I believe my statements to you were correct.

CHAIR —Thank you, Dr Dean. What tests, if any, were performed by CSL todetermine whether or not the process was successful in removing the virus?

Mr Kaufman —The issue and what you are getting around to is the question ofvalidation of processes which really, from my recollection, gained momentum in the early1980s with the promulgation of a new edition of the code. CSL had been working onvalidating processes prior to that. The effectiveness of the column was not validated. Oneof the issues in terms of validating the removal of virus is having a suitable test. Rightthrough the 1980s that test—the testing for removal infectious particles as distinct fromthe test applied for hepatitis B surface antigen as a marker—for removal of infectiousparticles was carried out in chimpanzees. That was not a test that was available to us norto many other people. In fact, there were only a couple of groups that I have seen publishdata on inoculation of chimpanzees.

CHAIR —Who carried out those tests you were referring to?

Mr Kaufman —The ones that I am aware of are a group in the US at the Centresfor Disease Control, another group in Tokyo and no doubt several others around theworld—not here.

CHAIR —CSL did not perform any tests itself?

Mr Kaufman —That is correct.

CHAIR —Did you rely solely on that published material by the institutions thatyou just referred to?

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Mr Kaufman —They did not do tests. I am not saying they did tests on columnseparations. They did tests for measuring infectivity of various materials and the use ofchemical disinfectants and heat treatment to inactivate it.

CHAIR —Is that the only material you relied on?

Mr Kaufman —They had not done that work on the column. We relied on theability of the column to separate out large particles which we knew it could do becausewe tested it with large particles but not with viruses.

CHAIR —Dr Hughes gave evidence to a Senate committee on 2 June about hisrecollection of the Allars report:

My recollection of the report is that one batch proved positive to hepatitis B on analysis—batch 120from memory. It was reprocessed and retested and was found not to test positive to hepatitis B andwas released as batch 128.

Is the department or CSL aware of the documentation in relation to batch 128 provided tothe Senate committee by Dr Peters which indicates that tests on that batch revealed that itwas positive for hepatitis?

Mr Kaufman —I am not aware of that documentation. I am aware of our testresults, which show it to be negative.

CHAIR —You are not aware of Dr Peters’ analysis?

Mr Kaufman —I have not seen Dr Peters’ analysis, no. As you are aware, thedetailed set of test results on that batch were included in the papers that went to you lastweek.

CHAIR —Is the department or CSL aware of the reasons why the Allars inquirythat found that batch 128 tested positive for hepatitis was not released?

Mr Kaufman —I do not know. I can only assume it is transcription. ProfessorAllars was provided with the full details of those batches, which would have shown that itwas issued.

Senator FORSHAW—What was that last comment?

Mr Kaufman —My understanding was that Professor Allars was provided with afull set of information on the fate of all of those batches indicating that batch 128 wasissued.

CHAIR —How would the department then explain those variations?

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Mr Kaufman —Sorry, which variations?

CHAIR —The variations in batch 128, which tested positive for hepatitis?

Mr Kaufman —It was not tested positive. It was tested negative.

CHAIR —Dr Dean, did you give evidence on 2 June that it probably was not thecase that the incubation periods of CJD could be up to 40 years in recipients of humanpituitary hormones and that in recorded cases the incubation period could have been 14 to16 years? Do you recall that evidence?

Dr Dean—As I recall the evidence, I stated that for iatrogenic disease—diseasewhich was not sporadic and which occurred by medical misadventure or some othercause—the literature supported the fact that in this situation the onset of the disease wasmuch quicker than in sporadic cases or in Kuru, which is the condition which occurs inNew Guinea natives. I also cited the fact, although the numbers are very small, that thecases that have occurred in Australia have occurred between 14 and 16 years aftertreatment.

CHAIR —So that incubation period of 14 to 16 years was for deceased Australianrecipients?

Dr Dean—I cannot remember the exact words, but certainly—

CHAIR —Would that be your position now?

Dr Dean—Certainly, that is the case, as far as I know. There are three provencases and another two cases, one being probable and one possible. They have occurredbetween 14 and 16 years after receipt of hormone.

CHAIR —Right. Is there any information available from overseas that incubationperiods of approximately 30 years have been observed, particularly in New Zealand?

Dr Dean—Certainly. I believe I mentioned at the inquiry that, in the case ofhuman growth hormone, in New Zealand there was a longer incubation period. I was notaware that it was 30 years, but that may be the case. It is certainly longer.

CHAIR —The recent possible sixth case of CJD in Australia is confirmed to haverisen from CSL’s hPG thought to have been administered in 1971-72. If that is accepted asa bona fide case, does that mean the incubation period will be something in the order of25 years?

Dr Dean—It would certainly be a long time.

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CHAIR —How long will it be before the department confirms that this is or is nota further case of CJD in a recipient? When will it be able to come to a final position?

Dr Mead—The department has not formally received any clinical information onthat possible sixth case. The information would initially go to the CJD case register andthe register would consider whether to include such a case in their register of cases. Thedepartment would also receive the information officially to consider the eligibility of theperson for access to the trust fund but, to date, we have not received any application forthat, so we have not received any clinical information. The process for consideringeligibility for the trust fund involves referring the clinical information to an independentpanel. We have established the independent panel, but we have not yet got the material torefer to them. As soon as we do, we can refer it to the panel. As soon as they haveformed their advice, we could act on it.

CHAIR —Make a decision. Is the material currently in the CJD register?

Dr Mead—I do not know whether the CJD register has received that information.

CHAIR —Who administers that?

Dr Mead—Professor Masters, who was with us last time.

CHAIR —In Melbourne?

Dr Mead—Yes.

CHAIR —Right. Does or does not the department monitor the activities of that—

Dr Mead—The register sends the department a quarterly report. We have recentlyreceived their last quarterly report. That would have been prepared prior to any knowledgeof this possible case. They would be due to send us another report in about three monthstime.

CHAIR —I see.

Senator FORSHAW—Going back to the incubation period, this may have alreadybeen put in evidence either orally or in the material, but I just want to recap. Of therecipients in Australia that we know of, what is the longest period to date you couldmeasure where the person had been receiving the hormone? What I am trying to ascertainis: do we have people who were on the program, say, 25 years ago, and there has been agap of 20 or 25 years and they are still alive, having contracted the disease? Can you giveany sort of a picture of what the outermost limit is at the moment of people who receivedthe hormone at any time and how long it has been since they started on the program and

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since they finished?

Dr Mead—That would depend on the earliest recorded time of people receivinghormone, which would be the early sixties, before the official program started.

Senator FORSHAW—Okay, those that are on the official program. Presumablyyou know or someone knows somewhere on this database, this register.

CHAIR —Sorry, we have to go. We will adjourn for 10 minutes for a division inthe Senate.

Short adjournmentSenator FORSHAW—Before the short adjournment for the division, I asked a

question and I am not sure whether you understood me. You said earlier that the knownincubation period based upon the people who died from CJD is 14 to 16 years. I am justtrying to get an idea of how long it was between the time the first known recipient of thehormone received it and the present day. Also, what are the longest and the shortestperiods of incubation known?

Dr Mead—The longest period for recipients officially on the program from thetime that the program commenced would be 1967. So that would be 30 years. Prior tothat, there was some use of hormone, some of which was manufactured at CSL and someelsewhere in other units, and that would go back at least four years prior to that. Then theprogram ceased in 1985.

Senator FORSHAW—You are talking 12 years.

Dr Mead—Yes. But an incubation period is always—

Senator FORSHAW—Maybe, it was later than 12 years if they started earlier than1985.

Dr Mead—They could have started earlier, yes. But the incubation period isalways an average. There will always be extremes at either end and an average of—

Senator FORSHAW—But at the moment, you have got only a couple of cases togo on anyway, haven’t you?

Dr Mead—Yes.

Senator FORSHAW—I am just trying to ascertain what are the outer limits, ifyou like,—

Dr Mead—From going on product from the early 1960s, it would be—

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Senator FORSHAW—Do you measure that average period from the start, or theend, or some mid point when the person was receiving the treatment? For the people forwhom you get the 14 or 16 years incubation, does the 14 years date from when they firstreceived the treatment, or when they last received the treatment?

Dr Mead—It would be from the outer limits, from the very earliest time theycould have received the treatment. But they could have received it and it could have beena shorter time.

Short adjournment

Senator HARRADINE—In the first instance, I will ask the department whetherthey are aware that the minister has revised her response to my question on notice on 14May 1997 in respect of the availability of the Allars inquiry documents?

Mr Carroll —Yes, we are aware.Senator HARRADINE—There has been a change and the Minister has had to

alter her answer to me?

Mr Carroll —Yes, Senator.Senator HARRADINE—How did that come about?

Mr Carroll —In preparing the answer to you, we received information from theAustralian government solicitor which was to the effect that when the matter wasadjourned by consent in the court on 26 May, the Australian government solicitor advisedus that the Macedone Christie Willis, the firm acting for some of the plaintiffs had advisedthe court that the matter was almost resolved, or words to that effect.

There has been correspondence between Mr Lucas from Australian governmentsolicitor and Macedone Christie Willis where—on finding the transcript—those wordswere not included and so, therefore, the answer was in error. We have corrected it.

Senator HARRADINE—Of course I am grateful that you have, but it does raiserather serious questions when a minister, in effect, gives an incorrect response to amember of parliament, particularly when the question is asked on notice. It might beappropriate to table the minister’s revised answer to my question on notice. When is thatlikely to be provided and incorporated into the proceedings of the Senate?

CHAIR —Do you wish to have that material tabled, Senator?

Senator HARRADINE—Yes.

CHAIR —We will receive that material.

Senator HARRADINE—I assume that the appropriate letter has been sent to the

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professional body concerned, that is to say the lawyers concerned, notifying them of theerror.

Mr Carroll —Yes. My understanding is that the Australian Government Solicitorwrote today confirming that there was a mistake. There has been some correspondencebetween the parties which referred to a number of matters, but it did also refer to the factthat there would be a corrected answer provided to you.

Senator HARRADINE—Thank you. Mr Chair, I wrote a letter to the committeesecretary on 21 August asking that the committee request the Commonwealth SerumLaboratories Commission and/or CSL Limited to provide the various information bytoday’s hearing. That referred to the code of good manufacturing practice for therapeuticgoods which referred, in 4.2, to ‘The master formulae and manufacturing instructions’, andit goes on. May I incorporate that letter intoHansard? Is that appropriate? If it is notappropriate, I will—

CHAIR —If you provide it, we will incorporate it at a later time. I am advised bythe committee secretary that the correspondence you refer to has been provided to thedepartment, and they are currently going through archives, which is a fairly lengthy job, toprovide the information you request—unless you can update that now.

Mr Kaufman —In the documentation the committee received this evening areresponses to Senator Harradine’s questions on the issue of code of good manufacturing, ifthe senators wish I can summarise the documentation I provided.

Senator HARRADINE—Thank you.

Mr Kaufman —The question, for members of the committee who have not seen it,related to section 4.2 of the code which requires the generation of master manufacturinginstructions, and that these are prepared by one person and approved by a competentperson delegated by management. The first document I have provided is a delegation fromthe then director, that is, the chief executive, if you like, of the CSL Commission, topeople who have approval, and that ability to approve methods of manufacture—which arethe master manufacturing documents—was vested, I think, in three people who are expertsin particular fields.

The second document I have provided is an instruction on preparation of methodsof manufacture. What it basically sets out is the information required in those methods.That document is dated, I think, July 1969, and it in fact quotes verbatim the section ofthe code referred to by Senator Harradine as a requirement for all methods ofmanufacture. Perhaps it is pertinent to remind the committee that 1969, the date of thatdocument, is 25 months before the 1971 code was promulgated. In other words, on thebasis of the draft code, CSL included those provisions in its procedures. There is a rangeof other documents covering the period that Senator Harradine inquired about.

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Senator HARRADINE—Thank you. You are down here, on the document beforeus for the public hearing, as appearing for the Department of Health and Family Services.It has down here, ‘Mr Graeme Kaufman, former officer, CSL Commission’. Could you tellthe committee in fact who you are, where you work and for whom you work?

Mr Kaufman —I currently work for CSL Limited.

CHAIR —Why are you down here as being part of the Department of Health andFamily Services if you are CSL Limited?

Dr Loy —Perhaps I could throw some light on that, Senator. CSL Limited ofcourse had no involvement in the program itself. The program was undertaken while CSLwas the CSL Commission and part of the health portfolio; therefore we took a decisionthat it was more appropriate that the officers of the former CSL Commission who weremade available by CSL Limited appear with the department because at the pertinent times,as I said, the CSL Commission was part of the portfolio—and, of course, immediatelyprior to that, part of the department.

Senator HARRADINE—Thanks. But why is Mr Kaufman here? Were youinvolved in any way at all with the program?

Mr Kaufman —I was involved—and I am just quoting here from recollection,Senator—from approximately 1976, in the bio-assays of growth hormone and FSH orHPG, and later involved in the manufacture of those hormones.

Senator HARRADINE—Is there not another person who has far greater intimateknowledge of the program than you could ever have? And why wasn’t he asked to comeby the department or by CSL or by whoever? Dr Loy, where is Dr Peter Schiff?

Dr Loy —He is obviously not here, Senator.

Senator HARRADINE—No, he is not.

Dr Loy —And I guess the decision was that Mr Kaufman, because of his particulartechnical expertise and knowledge of the fractionation process, was the most valuableperson to the committee.

Senator HARRADINE—Is it not a fact that Dr Schiff controlled all of CSL’sresearch at the relevant time and was far more intimately involved with the pituitaryhormone experiment than anyone else? Is he not currently—

Mr Kaufman —Senator, it seems to me—

Senator HARRADINE—The question was to Dr Loy. Let me get this clear: he is

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your boss, is he?

Dr Loy —Certainly not.

Senator HARRADINE—Mr Kaufman is down as Department of Health andFamily Services.

Dr Loy —As I said, Senator, we believed that a better representation of the issuewould come about if the officers of the former commission presented together with thedepartment because at the pertinent times the CSL Commission was part of the healthportfolio and regulated by the health portfolio, and that was a better representation of thecircumstance than having CSL Limited, which had no part in the program, presentingseparately. But, of course, Mr Kaufman is appearing as a former officer of thecommission, and I guess the judgment made was that his particular technical expertise wasthe most valuable to the committee.

Senator HARRADINE—But you would agree with me that Dr Schiff was in factat all relevant times more intimately involved with the pituitary hormone experiment thananyone else.

Dr Loy —Had you been a member of the relevant committee—

Senator HARRADINE—I am asking a question. Is it not the fact that he wasmore intimately involved with it than anybody here? And why is he not here? What wasthe decision? Why was he not here, or is it you are concerned that he might be askedawkward questions?

Dr Loy —Not at all. Obviously, it is within the remit of the committee to seek tohave people appear before it if they wish.

Senator HARRADINE—Sure, but we expect the department to bring forward allof the relevant people, the people with the greatest knowledge.

Dr Loy —I think Mr Kaufman’s knowledge of the fractionation process is probablysecond to none.

Senator HARRADINE—Of the whole program?

Dr Loy —Of the fractionation process.

Senator HARRADINE—Yes, I heard what you said. Of the whole program?

Dr Loy —I do not think Schiff was involved throughout the entire period and,clearly, somebody has to exercise some judgment as to how the committee is best aided to

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come to a knowledge of the issues and in that regard, the judgment was made that MrKaufman’s expertise was the most valuable.

Senator HARRADINE—In your statement, Mr Kaufman, you claim in effect thatCSL had deliberately used iso-octane, the defatting technique, to render pituitary hormonessafe with respect to infectious hepatitis B virus contamination which might have beenpresent. Doesn’t that claim really acknowledge the value of the method as a potentialinactivator of HepB virus infectivity?

Mr Kaufman —I think the words that I used inHansardwere that that wouldprovide added assurance. The primary separation technology in the Ferguson methodalways was, always has been, the gel filtration step.

Senator HARRADINE—And CSL had recognised that?

Mr Kaufman —The gel filtration part of it, yes.

Senator HARRADINE—That is not quite what I asked.

Mr Kaufman —I am sorry, Senator, I misunderstood.

Senator HARRADINE—I will go back to the question. Am I correct in sayingthat you claimed that CSL had deliberately used the iso-octane technique?

Mr Kaufman —No, Senator, I said the iso-octane step provided added assurance. Ithink this comes to the second set of questions you asked in your letter to us.

Senator HARRADINE—Yes.

Mr Kaufman —That is covered again in my response. The first question you askedwas, ‘At what stage did I recognise the potential for iso-octane as an inactivator?’ I thinkthat was the question.

Senator HARRADINE—Could lawyers representing recipients of hormones inpending legal actions against CSL and the Commonwealth and/or the employers use thefailure of CSL to utilise a very simple technique to destroy the infectivity of envelopedviruses as evidence and argument in such actions to the detriment of those entities andindividuals?

Mr Kaufman —I do not know, Senator, I am not a lawyer.

Senator HARRADINE—I see. Are you able to provide documentary evidence tosupport the claim that this iso-octane technique was just used as a sort of addedsafeguard?

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Mr Kaufman —The principal purpose of the iso-octane step was to remove fatfrom the extract.

Senator HARRADINE—You have acknowledged that the iso-octane defattingprocess CSL used to prepare pituitary extracts for fractionation will destroy the infectivityof an enveloped virus B. I have been told that validation of that process is quite simpleand that you would have been required to do that anyway, had you actually used it forinactivation for hepatitis B infectivity: is that right?

Mr Kaufman —I am going from recollection here. There was not a lot of workdone on inactivation of hepatitis B by physico-chemical means until relatively late. Thefirst time that I became aware of it was in the early 1980s, when the groups I mentionedbefore—one at CDC and one in Tokyo—succeeded in demonstrating that hepatitis B couldbe inactivated by heat and solvents. Until that stage, a lot of the published data was onretrospective studies rather than on controlled studies in chimpanzees. So, from the pointof view of the hepatitis B virus, it was not necessarily a simple process.

Senator HARRADINE—Yes, but obviously you could see that it worked?

Mr Kaufman —You could demonstrate that it worked if you had a colony ofchimpanzees and inoculated them with the inactivated material.

Senator HARRADINE—But you were aware of this before the patent was takenout in the United States, weren’t you?

Mr Kaufman —Which patent are you referring to, Senator?

Senator HARRADINE—I understand there was a patent—

Mr Kaufman —On solvent detergent extraction, with New York Blood Centre?

Senator HARRADINE—Yes, in 1994. Page 7 of the CSL submission says thatthe CSL had a virology research department and a virology technical advisory panel. WereCSL virologists consulted about the problem of hepatitis contamination in the hormones?In particular, were the virologists consulted before batch 128 was released, and if so, didthey make a written comment?

Mr Kaufman —I cannot answer that with absolute assurance, but there werecertainly virologists involved in the quality assurance area.

Senator HARRADINE—I think we touched on that before, but who can tell us?Are you saying that there were CSL virologists consulted about the problem of hepatitiscontamination in the hormones?

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Mr Kaufman —I think that is assuming that there was a problem. That really hasnot come through in the batches that were tested.

Senator HARRADINE—But you indicated that virologists were consulted.

Mr Kaufman —I said that I assume they would have been.

Senator HARRADINE—Can somebody confirm that, please?

Mr Kaufman —I would have to confirm that, Senator.

Senator HARRADINE—Can you confirm it now?

Mr Kaufman —I would have to go back and review the records.

Senator HARRADINE—Would Dr Schiff have been able to tell us straight out?

Mr Kaufman —No, he would not have.

Senator HARRADINE—Were the virologists consulted before batch 128 wasreleased? If so, did they make any written or verbal comments?

Mr Kaufman —That was, as I understood it, the issue we were just discussing. Ican get that information for you.

Senator HARRADINE—Thank you. I would like to go to what was said on page4 of the CSL submission, that at no stage did the commission distribute ‘any productknown to be contaminated with a pathogen.’ The word ‘any’ on page 4 of the submissionis underlined. Hepatitis is a pathogen, isn’t it?


Senator HARRADINE—Leaving aside the hepatitis contaminated batches, DrPeters has told the committee that CSL distributed a number of batches that were notsterile. When a batch was found not to be sterile, did the CSL identify whether thebacteria were pathogens or not?

Mr Kaufman —If a batch is non-sterile—in other words, if, when you culture it,you demonstrate the presence of organisms, whether pathogens or not—that batch is notreleased.

Senator HARRADINE—Even if they were not pathogens?

Mr Kaufman —Even if they were not pathogens.

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Senator HARRADINE—Could they cause boils or abscesses if injected into amuscle?

Mr Kaufman —The question does not arise, because—

Senator HARRADINE—No; they were not distributed.

Mr Kaufman —Once a batch is unsterile, that is it.

Senator HARRADINE—Let me get that clear. If you identify whether the bacteriawere pathogens, even if they were not pathogens, are you saying that it would not bedistributed?

Mr Kaufman —Correct. There is no question of that whatsoever.

Senator FORSHAW—What happens to those batches? Are they destroyed insome form?

Mr Kaufman —It will depend on the individual material. Sometimes it is possibleto recover them through sterile filtration. In most cases, it is not worth the effort.

Senator NEAL—What do you mean by ‘recover them’?

Mr Kaufman —Because at this stage they are a freeze-dried powder, you canredissolve them and refilter them through a filter which removes all of the organisms.

Senator FORSHAW—Which is what happened to batch 121, was it not?

Mr Kaufman —No; batch 121 was a different situation altogether.

Senator FORSHAW—But it was redissolved. I am not as scientifically qualifiedas you. I would not even start to pretend I was, but I understood that it was reprocessed.

Mr Kaufman —In batch 121, the fractions we collected initially for hPG were oflow potency. We subsequently took a later set of fractions for that batch. It was notactually reprocessed, in that sense.

Senator FORSHAW—Just on Senator Harradine’s question, do you say it was notreleased? It sounded like ‘That is it; no need to worry any more, because it could notpossibly have been released.’ Taking that a step further, what could have happened to it, ifit was not destroyed in some form?

Mr Kaufman —There will be records in the manufacturing records which show thefate of those batches: that is a requirement of the code. The records will show whether it

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was destroyed or whether it was reprocessed.Senator HARRADINE—Mr Kaufman, batch 24 was distributed, was it not?

Mr Kaufman —No, it was not, Senator.

Senator HARRADINE—It was not?

Mr Kaufman —Unfortunately, you may not have had the opportunity to gothrough the documentation that was sent to you last Friday. In fact, with thatdocumentation, I have provided the batch records from that batch, indicating that it wasreturned. I am certain about the fate of that batch because it was returned prior to the vialshaving labels put on them; and so there was never an ampoule of FSH or hPG with alabel on it ‘024’. The batch was withdrawn and returned to the producing area prior to itbeing labelled. There is no possibility—

Senator HARRADINE—It was not distributed from CSL?

Mr Kaufman —It was not distributed. Similarly, if you read the CSL returns to theFractionation Subcommittee and to the HPAC, you will find that the hPG batches skipfrom 22 to 25. There was no batch 24 ever available for issue, nor could there be, becauseit was never even labelled and so there is not even a possibility that an ampoule couldhave snuck out somehow.

Senator HARRADINE—Could you explain Mr Considine’s report on batch 128,which has been supplied to the committee? You will see that it was headed ‘PositiveHBsAg (hepatitis B surface antigen) result in hPG batch 128’. What does ‘positiveHPsAg’ mean?

Mr Kaufman —Positive, in the context of Mr Considine’s note, means that it waspositive by screening test. If you read further down through that minute, Senator, you willfind that batch 121—and this is really covering the evidence I gave last time—the firstextraction was negative and the second extraction was negative. These are screening tests,so they are open to false positives, as I explained to the committee before. Column chargewas positive on screening, void volume was negative, and all the fractions were negative.

Senator HARRADINE—Yes. It says that the column charge is positive. What isthe column charge?

Mr Kaufman —The column charge is a combination of the first extraction, whichwas negative, and the second extraction, which was also negative, filtered through a 0.45micron filter. The column charge is that solution immediately before it goes onto acolumn. So, the two components of that were negative.

Senator HARRADINE—Okay, but it says that the column charge was positive. If

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it is positive, should it ever have been put onto the column?

Mr Kaufman —The column charge test results come back after the material hasalready gone through the column, because you cannot wait for the test results.

Senator HARRADINE—On page 101 of the Allars report, it says that, in effect,hepatitis could contaminate the column line.

Mr Kaufman —Yes, Senator.

Senator HARRADINE—It can?

Mr Kaufman —Yes; but it would be washed through in the washing solutions.

Senator HARRADINE—Dr Peters attached to his submission a copy of thelaboratory report on batches 23 and 24. You have those. What is meant by ‘Gram-positivebacilli’ and ‘Gram-positive cocci’?

Mr Kaufman —‘Gram-positive’ refers to the colour produced under a Gram stain;‘cocci’ are spherical organisms, and ‘bacilli’ are rod-shaped organisms.

Senator HARRADINE—Could these have been something like streptococcus orstaphylococcus?

Mr Kaufman —They could have been, yes.

Senator HARRADINE—They could have been?

Mr Kaufman —This is in batch 24?

Senator HARRADINE—In 23 and 24.

Mr Kaufman —I have not seen 23.

Senator HARRADINE—Are these human pathogens?

Mr Kaufman —They could be, Senator; but they could be other things.

Senator HARRADINE—They could be human pathogens, but not necessarily?

Mr Kaufman —That is correct, yes.

Senator HARRADINE—Dr Peters attaches evidence that batch 24 had beendistributed. You are saying that that definitely was not the case?

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Mr Kaufman —The evidence is conclusive that batch 24 was never distributed.

Senator HARRADINE—Could I ask Mr McDonald a couple of questions. DrPeters drew the committee’s attention to a page of the Attorney-General’s submission onreference 1(c) which names three recipients. The release of the recipients’ names, ofcourse, is a very sensitive issue with many recipients. Were these recipients asked whetherthey had any objections to their names being made public?

Mr McDonald —No.

Senator HARRADINE—They were not asked, either in writing or verbally?

Mr McDonald —No, not at the time.

Senator HARRADINE—What steps have been taken to tell them and possibly tocounsel them?

Mr McDonald —I understand that following the hearing last Wednesday, membersof the CJD Support Group spoke to them, and I was advised that they had no objection.

Senator HARRADINE—You were advised by the CJD Support Group that theyhad no objection?

Mr McDonald —I was advised by two members of the CJD Support Groupfollowing the hearing last Wednesday that they had been in touch with the three peoplenamed and that they had no objection to their names being mentioned in the report. On theThursday or the Friday I wrote to them and apologised for including their names.

Senator HARRADINE—There is a court suppression order in place concerningAPQ’s identity. Are you aware of whether this suppression order has been breached and,if so, what action has been taken about the breach?

Mr McDonald —I am not aware that that suppression order has been breached atany stage.

Senator HARRADINE—I think APQ’s expenses may already have been raised.Has that been raised this evening?

CHAIR —No, it hasn’t.

Senator HARRADINE—APQ has not got her expenses yet, has she?

CHAIR —It was raised last time, Senator Harradine.

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Senator HARRADINE—I know, and I want to raise it again now. Since we werelast all together as one big, happy family, have we come to some resolution of thatparticular urgent matter? You know her circumstances.

Mr McDonald —Yes. I received a letter today from the solicitors advising me thatthe Commonwealth’s offer had been accepted.

Senator HARRADINE—Does that involve payment to the non-legal people?

Mr McDonald —It involves payment to those clients of Messrs Rennick Briggswho have accepted the Commonwealth settlement offer, and APQ.

Senator HARRADINE—But in respect of APQ, have the expenses of non-legalpeople been paid yet? If not, why not?

Mr McDonald —No, they haven’t; but then again, I have not received any claimby non-legal people for any expenses. If they are non-legal they would not have any legalexpenses.

Senator NEAL—Wouldn’t it normally be part of the expenses claimed by thesolicitors acting for the plaintiff to also seek reimbursement of expert witness costs,reports and that sort of thing?

Mr McDonald —As I say, costs with Messrs Rennick Briggs have been settled.

Senator NEAL—Yes, I understand that. But when you pay the costs of thesolicitors acting for the plaintiff, I assume that is part of the settlement, isn’t it?

Mr McDonald —In this case, yes.

Senator NEAL—You also pay the cost of preparing the case—the cost ofobtaining reports from expert witnesses.

Mr McDonald —The plaintiff’s solicitors’ costs?

Senator NEAL—No, the cost of expert witnesses. I assume there are a number ofreports, probably prepared by people in the medical profession on behalf of the plaintiff;and they would have lodged, as part of their claim for legal costs, a claim for thosemoneys as well.

Mr McDonald —They were entitled to lodge claims, andthey were taken into consideration in negotiations.

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Senator NEAL—So those expert costs were not individually listed in the claimsmade by the plaintiff’s solicitors.

Mr McDonald —I received an itemised letter with the names of various witnessesor medical experts, and that was considered in the settlement of these costs.

Senator NEAL—Was it actually paid?

Mr McDonald —A sum of money was offered to the solicitors, and those solicitorshave accepted that offer. It is a matter then for the solicitors to negotiate with their clientsand the medical advisers as to whether their claims would be accepted.

Senator NEAL—So you did not pay the full list of disbursements.

Mr McDonald —No, we did not pay the full claim as first submitted by thesolicitors. It was negotiated.

Senator NEAL—You did not pay the full claim lodged by the solicitors, but didyou pay the full list of disbursements?

Mr McDonald —No.

Senator NEAL—When you said the matter has been settled for one particularplaintiff, how many plaintiffs’ cases have actually been settled?

Mr McDonald —I believe it is 89.

Senator NEAL—Is the basis of the agreement as to the payment of costsdependent on the number of plaintiffs that settle?

Mr McDonald —Yes, it is.

Senator NEAL—Is it correct that the costs paid to the plaintiff’s solicitors are$1,200 per person who settles?

Mr McDonald —No, that is not correct.

Senator NEAL—What is correct, then?

Mr McDonald —Are you talking about each individual plaintiff’s costs?

Senator NEAL—Yes. What I am saying to you is that as part of the settlementagreement you have agreed with the plaintiff’s solicitor to pay a certain amount of costs.Is that correct?

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Mr McDonald —Yes.

Senator NEAL—How is that to be calculated?

Mr McDonald —A claim was submitted, and as a result of that claim there werenegotiations of the proffered costs and disbursements for each of the individual plaintiffs.As a result of those negotiations, a figure has been determined.

Senator NEAL—If, at this stage, an additional plaintiff decides to settle, how willyou calculate the costs payable to their solicitor?

Mr McDonald —The solicitors would render a claim for costs on our office, andwe would then look at that claim and determine whether it was fair and reasonable.

Senator NEAL—Are you saying that on every single matter that settles, you aregoing to negotiate individually the legal costs and disbursements payable?

Mr McDonald —Yes.

Senator NEAL—You did not put in place a calculation based on a number ofplaintiffs that settle.

Mr McDonald —No, you must look at each one. If we are talking about the bulkof the plaintiffs, who accepted the offer with Messrs Rennick Briggs, in the large majorityof cases the work performed on each file was very similar. You could, in fact, come upwith a figure for each of those files.

Senator NEAL—You are saying a one-up figure. But obviously if you havealready agreed on a set sum for costs and disbursements for the 87 plaintiffs that havesettled, if an additional person settles, bearing in mind as you say that a lot of the workhas overlapped, what do they receive further by way of costs and disbursements?

Mr McDonald —It would depend very much on what has occurred. For instance, ifeffectively you have had only a writ issued, the costs would be very small. If the writ hasbeen issued, you have had discovery, interrogatories and directions hearings, then it couldbe substantial. Each matter must be assessed on the legal work performed in that matter.

Senator NEAL—Yes, but except for the particular test case, as I understand it, innearly every other case the maximum amount of work that had been done was the issue ofthe statement of claim.

Mr McDonald —That is basically correct, yes. As I say, based on that I arrived ata figure for those claims which fell within that category.

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Senator NEAL—Which category? Just having issued a statement of claim?

Mr McDonald —Yes.

Senator NEAL—So, how much was that?

Mr McDonald —In round figures, $1,600.

Senator NEAL—So basically the solicitor receives $1,600. Is that by way of justcosts, or costs and disbursements?

Mr McDonald —From memory, it would be costs and disbursements.

Senator NEAL—So for basically every case except the actual test, if someonesettled, the solicitors were paid approximately $1,600 for costs and disbursements.

Mr McDonald —Approximately. That is with Messrs Rennick Briggs. One casesettled in New South Wales was more substantial because of work performed.

Senator NEAL—Which firm was that with?

Mr McDonald —Turner Freeman.

Senator NEAL—Did that matter ever proceed to a hearing?

Mr McDonald —No.

Senator NEAL—How far did it go? Just the issue of the statement of claim?

Mr McDonald —There was issue of the statement of claim, there were a numberof appearances before the Registrar, I think—I am not sure whether the correct title wasRegistrar or Master—there were investigations of documents, and a substantial number ofattendances on counsel.

Senator NEAL—How would you characterise the particular claim? I do not wantto know the individual involved, but what sort of claim was it?

Mr McDonald —It was a similar claim to Messrs Rennick Briggs in relation to aclaim for nervous shock.

Senator NEAL—Is there any distinction that has been drawn by your office inrelation to official and non-official recipients of the hormones?

Mr McDonald —Yes, there has. The scheme was offered only to those recipients

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treated under the HPAC’s program.

Senator NEAL—So this offer is not available to those who were not officiallyapproved.

Mr McDonald —That is correct, although I believe it was Senator Bishop whoasked me last time—

CHAIR —It was; we had a discussion on this.

Mr McDonald —I said I was seeking instructions on that point.

Senator NEAL—And have you received those instructions yet?

Mr McDonald —Not as yet.

Senator NEAL—When are you expecting to receive them?

Mr McDonald —I cannot put a date on that.

Senator NEAL—How long does it normally take you to receive those sorts ofinstructions? It must be very hard to run a case if you do not know what you are trying todo.

CHAIR —When is the department going to give Mr McDonald advice on thatpoint?

Senator NEAL—Maybe we can sort it out now and make it simpler.

CHAIR —Who is going to answer that? What, nobody?

Dr Loy —It is a hospital pass!

Dr Mead—That is a matter for the minister to decide and we have not had adecision on that yet.

Senator NEAL—Who is normally responsible for instructing in legal matters?Does every instruction go to the minister? Is that normal?

Mr Carroll —No. The normal thing is that the most significant matters go from theminister. The usual chain of instruction is that the particular program area, in this case it isthe public health division, send instructions through my legal services branch, and we actas the conduit through to the Attorney-General’s Department, the Australian GovernmentSolicitor.

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Senator NEAL—How does the Department of Health determine what they candeal with and give instructions on and what they have to refer to the minister?

Mr Carroll —There are no written rules about that. The basic principle is that themost significant and controversial decisions would be made by a minister. Those that areconsidered less controversial, the department just decides to do itself.

Senator NEAL—Who made the decision on this occasion that it should bereferred to the minister?

Mr Carroll —My understanding is that we are waiting for Public Health Divisionto tell us what it is that—

Senator NEAL—Who in public health, if it was someone in public health, madethe decision that this matter should be referred to the minster? Who is ‘we’? Whichindividual? I assume one person made the—

Dr Mead—The Public Health Division, and I am representing the Public HealthDivision.

Senator NEAL—But who made the decision?

Dr Mead—I did.

Senator NEAL—Okay. On what basis did you make the decision that it should bereferred to the minister? Why did you decide that it should be referred to the minister?

Dr Mead—Because some discussions took place in the department about thatbeing a significant issue of the approval process for people on the program versus noapproval for people off the program, and that the cases that had been heard that led to theoffer being made were on the basis of people on the program, not people off the program.

Senator NEAL—I did not quite understand that. Can you just repeat that?

Dr Mead—The APQ case that led to the settlement being developed was a case onthe program. To extend the settlement that had been developed on the basis of a case onthe program to a case off the program was a significant difference. So it was appropriateto seek the minister’s advice on that question.

Senator NEAL—Has the department or the section made any assessment of howmany people might be in this category of non-official recipients?

Dr Mead—I understand we have records of 188.

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Senator NEAL—When you say you have records, how have you accumulatedthose records? What steps have you taken to ascertain who are those unofficial persons?

Dr Mead—There have been a variety of ways that that information has come to usabout people who have received hormone off the program. But, as I say, we have 188 todate, but other people could come forward that can provide information.

Senator NEAL—I just want to clarify exactly what I am asking you. What stepswere taken to ascertain who that class of unofficial recipients were?

Mr Hughes—During the life of the pituitary hormone task force, a number of thetreating doctors indicated to us in correspondence that they had records of treating peoplefor which there was no human pituitary hormone advisory committee official approval.Also, a number of people who contacted the task force during its life by telephone wereable, through documents or records they had in their possession, to prove to thedepartment that they had been treated, although there was no official record in thedepartment of the treatment.

Senator NEAL—The way you have accumulated this list is by people or doctorsvolunteering that they received it. Is that correct? Is that the exhaustive method? Does thatexhaust the methods that were used?

Dr Mead—As I understand the methods that were used.

Mr Hughes—There was also some response to some of the advertising that wasused but then again it really—

Senator NEAL—That is volunteering, is it not?

Mr Hughes—Yes, that is volunteering in responding to the advertisement.

Senator NEAL—Did the department ever take the step of writing to all doctorswho received the hormones and saying, ‘Did you give it to anyone who wasn’t authorised?Who were they?’

Mr Hughes—We wrote to a number of doctors. Some responded and some didnot.

Senator NEAL—You say you wrote to some doctors. Did you write to all doctorswho were provided with the hormones?

Mr Hughes—I would have to check the records. I cannot recall whether we wroteto all the doctors, but we certainly wrote to a number.

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Senator NEAL—Did you just pick a few out and write to them or did you set outto exhaustively write to every doctor?

Mr Hughes—As far as I recall, we did not set out to write to every doctor, but Icould be wrong. I would need to check.

Senator NEAL—How long ago did that happen?

Mr Hughes—That would have been three or four years ago.

Senator NEAL—If you could take that on notice, I would appreciate it.

Senator LEES—I have two issues for now. Firstly, is a file that the ombudsmanrecently identified that related to suspected deaths within the department one of thedocuments that we have been able to have provided? I have reference in some of thepaperwork before us that the ombudsman recently identified a file within the departmentrelating to suspected deaths. What information is there within the department on possiblerelated deaths?

Dr Mead—As I understand it, of the five known cases, one is classified aspossible, but the process of checking cases or known recipients against death certificateswas done to see if more cases could be found. I do not know the details of that.

Mr Hughes—Certainly, the department went through a very exhaustive process ofchecking death certificates of people known to have been treated on the program for thepossibility of any association with CJD or a neurological disorder. That process continuedover a period of several months. That could possibly be the file you are referring to.

Senator LEES—Have you checked both ways? You have gone through all therecipients that you have been able to track down and made sure that there is nounexplained death there that could be related. But have you also checked, over recentyears, all deaths that were identified as CJD, to make sure that those people were notamongst that group Senator Neal was just asking about?

Mr Hughes—That was one of the reasons the CJD case registry was established inMelbourne. They now have a very good database for CJD deaths in Australia, fromwhatever cause. They have checked to see if any of those could have been associated withthe hormone program and have not discovered any cases.

Senator LEES—So are you confident that there are no other deaths that have beenmissed related to the human pituitary hormone program?

Mr Hughes—To the best of our ability to chase the records, Senator.

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Senator LEES—Senator Harradine asked some questions on notice earlier on andalso mention has been made during this inquiry to the Allars documents being retrieved orremoved from archives after Professor Allars put them in there. What documents wereremoved by your department?

Mr Carroll —My understanding is that, when the plaintiff’s solicitors, RennickBriggs, said that they wanted to have access to those documents for the purpose of thelitigation, we then wrote to archives and asked that they move them from Sydney toMelbourne and arrange that that be done through the Australian Government Solicitor—the separate part to the part that were conducting the litigation.

Senator LEES—Are you confident that all documents have now been accountedfor? This has been an ongoing thing through a number of submissions and references tothe fact that, indeed, there are some documents missing.

Mr Carroll —I could provide details on notice.

Senator LEES—Thank you very much. In particular, the question has beenraised—I would have to go back through all the submissions—in at least two submissionswith regard to documents actually being destroyed. Is there any evidence of permissionbeing granted or particular documentation being recommended for disposal?

Mr Carroll —I would have to take that on notice. My understanding is that somedocuments were destroyed as a result of the normal archiving schedules but that there hasbeen no action taken by this department to say that anything should happen to thedocuments at all.

Senator NEAL—What process took place with those documents that were usedduring the Allars inquiry? What happened to them after the inquiry ended?

Mr Carroll —My understanding is that they were sent by Allars’s staff toArchives.

Senator NEAL—Were they sent on the understanding that they were to be kept ina safe place should there be litigation? Is that correct?

Mr Carroll —An officer from the Allars inquiry forwarded those documents toAustralian Archives.

Senator LEES—What exactly is involved in this archives process of cleaning outfiles from time to time? What is the technical method of doing that?

Mr Carroll —In general, there are certain rules with respect to documents that areheld by the Commonwealth and there are basically different schedules for different kindsof documents which over time are destroyed. For example, there might be a rule that

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says—I do not know the exact date here—that people’s personnel records would normallybe destroyed after X years or that documents of a particular kind—

Senator LEES—Could we have the schedules that relate to the documents that weare discussing? In particular, can we have anything that gives us an idea as to the reasonfor destroying whatever it was that was destroyed?

Mr Carroll —Certainly.

Senator LEES—Perhaps most importantly there must be some records withinarchives of what was destroyed and, in particular, what particular documents were lodged.Presumably, there is somewhere a list of everything that was lodged. I have had greatdifficulty going through a lot of the evidence to exactly work out what it is that is nowavailable. I do not think anyone really knows. Did Professor Allars or her staff lodge anoverview of everything that they were putting into archives?

Mr Carroll —There are some documents which I think are called ‘packing sheets’,which give an idea as to the kinds of documents—

Senator LEES—Could we check back against the packing sheets to see what waspacked in and then look at what was actually packed out—or unpacked—so that we canlook at what was destroyed and look at the destruction schedules or the—

Mr Carroll —Yes. To the extent that any documents were destroyed I can get backto you and let you know, as best we can, what the story is there.

Senator NEAL—Are you aware that any documents were destroyed?

Mr Carroll —I am not personally aware. My understanding is that some documentshad been destroyed, but I would have to take—

Senator NEAL—How did you understand it?

Mr Carroll —I was told by my officers.

Senator NEAL—By whom?

Mr Carroll —If it would assist the senators, we have here Mr Lucas, who is theAustralian Government Solicitor officer who has been handling matters to do with thesedocuments. If it would be helpful to you, we could ask him to give some evidence toexplain this.

Senator LEES—In a moment that would be great. I am looking not just at theAllars documents but also at other documents relating to this particular issue that may

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have been archived at any stage. I am even looking for any documents that may have beenarchived early, perhaps by CSL, who know where they have come from. There must berecords in the system that show any documentation relating to the human pituitaryhormone program.

Can you undertake on notice a wider search to see if there are any other documentsrelevant to the human pituitary hormone program that were lodged? If there were, whereare they now? Are there indeed any there? Are they still there? If there were some, wherehave they gone?

Mr Carroll —My understanding from Mr McDonald is that he has sworn anaffidavit in some litigation which sets out the documents in files.

Mr McDonald —Senator, as a result of preparing the matter of APQ in Victoria,on discovery, we are required to provide what is called an affidavit of documents, whichis sworn by both CSL in this case and the department. In that affidavit there is a sectionwhich details documents which, in this case, have been destroyed and the reasons why.

Senator NEAL—But you would only have to include them if you knew that theyexisted. How long have you been involved in the matter?

Mr McDonald —Well, that is correct, Senator.

Senator NEAL—I mean you personally. I am not suggesting that this is the casebut, as an example, if the department had known there were documents that previouslyexisted but they had not informed you, you would, of course, not include them.

Mr McDonald —No, I would not, although, both for the CSL and the department, Iwould estimate there to be in the vicinity of up to 300,000 documents. The plaintiff’s ownsolicitors have also looked through those documents. You may see file references and soyou crosscheck those file references as to whether those documents are relevant, and itmeans going to that file, of course, and looking at it. If they happen to be destroyed, thatis how you ascertain whether or not that particular file was relevant to the action andcertainly whether it should be included in the affidavit as being destroyed. If it does exist,you ascertain its relevance and therefore whether it is discoverable. In fact, it was a veryexhaustive process and it took a year or maybe a year and a half for the total exercise tobe completed.

Senator NEAL—Basically, any solicitor would be entitled to that information ifthey were acting on behalf of someone on the program?

Mr McDonald —They are entitled to obtain all relevant discoverable documents,basically. As I say, if a document is found to be relevant and to have been destroyed or ifit is missing for some reason, and it is not known to have been destroyed, then that is also

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placed in the affidavit.

Senator LEES—That is noted as well.

Mr McDonald —If you like, I can provide you with a copy of those affidavitswhich—

Senator LEES—If the work is already done, that is most helpful. In particular, Igo back to some of the things that seem to be missing, to look at what impact they havehad.

Mr McDonald —There were certainly files missing. In both departments, we aregoing back to 1965-66 files over 30 years or something. Certainly, there were filesdestroyed under the Archives Act.

Senator NEAL—But we are, in particular, interested in documents that ProfessorAllars had access to and that have been subsequently destroyed, not so much thedocuments that may have been present many years before.

Mr McDonald —I am not aware of the Allars documents; Mr Lucas handled thataspect.

Senator LEES—I am afraid that I am also interested in other related documentsthat may have importance. Thank you for that.

Mr Kaufman —Senator, I wonder if I could also assist. I seem to recall that it wasstated somewhere that the CSL submission to the Allars inquiry was missing. There wasno CSL submission to the Allars inquiry, so that document is certainly not missing.

Senator LEES—Did you give verbal evidence?

Mr Kaufman —I gave written evidence to Professor Allars.

Senator LEES—But there was nothing officially from CSL itself?

Mr Kaufman —Nothing from CSL.

Senator LEES—That is one document that we do not have to look for.

Mr Kaufman —The second thing on the general issue, following GeoffMcDonald’s comments, is that at CSL we have been able to provide documentation goingright back to the very early stages and that is really despite a statutory requirement to holdthose documents for a maximum of six years. Our archiving system is also modelled onguidelines provided to us by Australian Archives. While it may take some timeoccasionally to retrieve them, they are usually there.

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Senator NEAL—I wonder whether the department could tell me when the Allarsdocuments were extracted from archives after Professor Allars lodged them. Mr Carroll,you have already answered questions, but I am really looking at before the legal side of itstarted.

Mr Carroll —My understanding is that there are some occasions where peoplehave sought documents under FOI or have sought copies of their own transcripts and thatkind of thing. On those occasions, my understanding is that the department has retrievedthe documents to be able to provide them.

Mr Hughes—That is correct. The task force on a small number of occasionsretrieved files for individuals so they could have access to their own file under theFreedom of Information Act.

Senator NEAL—So did the department access the Allars documents? Mr Lucas,could you tell me when the department first accessed the Allars documents?

CHAIR —Mr Lucas, could you first say in what capacity you are appearing.

Mr Lucas—Certainly, Mr Chairman. I am from the Australian GovernmentSolicitor’s Office and my role with the case has been to handle the discovery aspectsrelating to the Allars inquiry documents.

Senator NEAL—I am sorry, I did not realise that is where you fitted in. What Iam really trying to find out is: did the department retrieve the Allars documents fromArchives before that litigation started?

Mr Lucas—Not to my knowledge, Senator.

Senator NEAL—Can I get a response from the department—maybe from Dr Loy?

Dr Loy —I think Mr Hughes has said that there were occasions on which, inresponse to FOI requests, personal information—

Mr Hughes—That is correct.

Senator NEAL—Were there any occasions, other than for FOI reasons, that thedocuments were retrieved?

Mr Hughes—No.

Senator NEAL—Nothing until the case started—is that correct?

Mr Hughes—No other files were retrieved from Archives relating to ProfessorAllars’s inquiry, other than individual files on requests for those files under freedom of

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information, until the request was made by the solicitors representing the plaintiffs.

Senator NEAL—Okay. Mr Lucas, are you aware of any documents that werelodged by Professor Allars and that were destroyed?

Mr Lucas—No, I am not, Senator.

Senator NEAL—Has there been any allegation that some were destroyed duringthe litigation?

Mr Lucas—Yes, there have been allegations like that made, I believe, byMacedones.

Senator NEAL—Which documents was it alleged were destroyed?

Mr Lucas—That I do not know. That was one of the difficulties that we have had.There have been general allegations made, as I recall, that the documents have beendestroyed, but we have never been given specifics as to what documents have beendestroyed.

Senator NEAL—When Professor Allars lodged the documents, was acomprehensive list lodged with them?

Mr Lucas—I was not there personally, Senator, but what I have done is toexamine the process that was followed by Australian Archives and the client department.What I understand was the situation was what is always the situation with documentsbeing archived: a packing list is compiled by those depositing the documents, with theassistance of Australian Archives, and the documents are then deposited with Archives andthat packing list is there for the assistance of people who want to access those documents.

Senator NEAL—Is there a correlation between the packing list and the documentsheld there? Are there any gaps at all?

Mr Lucas—We have not found gaps, Senator.Senator NEAL—You never sat down and made sure that every document listed

was actually there?

Mr Lucas—Documents are listed by reference to file title. There are thousands ofdocuments there. At one stage, about two months ago, I did not do it personally but twoparalegals under my supervision went through the files in the boxes at Australian Archivesto ensure that the items described in the packing list corresponded with what was in theboxes. They found that they did.

Dr Loy —Before you go on, could I just say that I made a definite statement earlier

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in the proceedings and my legal advisers slapped their foreheads and said, ‘Oh, no.’ I saidwe had provided all the minutes of the relevant subcommittees. What I should have said isthat we have provided all the minutes we have. I know that is an indefinite statement andwhat I undertake to do is to check through the records to see if there are any internalinconsistencies: are there mentions of meetings that we do not have records for? I do notknow that there are, but I will have that check made to make sure that what has beensupplied to you is the full record of the minutes of meetings.

Senator LEES—I thank you for that. Perhaps a time line might be the easiest wayto do it, just drawing up the lists year by year—

Dr Loy —Sure.

Senator LEES—We will see if there are gaps, such as an odd nine monthssomewhere.

Dr Loy —There is an example where, in November 1981, the HPAC resolved tomeet in May 1982. The next minutes we have are of November 1982, but they refer to thelast meeting as being in November 1981, so presumably the meeting in May wascancelled. But we will just check all of it for internal consistency to make sure what wehave given you is indeed the full record or, if there are some gaps that are identified, wewill let you know what they are.

CHAIR —Thank you, Dr Loy, for that undertaking. Mr Kaufman, to go back to theAllars inquiry: considering that CSL was so central to all of the events, why did CSL notmake a submission to that inquiry?

Mr Kaufman —We considered that we could best assist the inquiry with peoplewho were interviewed, such as myself, Dr Schiff, and a number of other people that youwill see—Dr Mason and others I cannot recollect; that people with detailed knowledge ina one-on-one interview with Professor Allars was the best way to assist in an inquiry.

CHAIR —Officers were made available?

Mr Kaufman —Correct.

CHAIR —Thank you, Mr Kaufman.

Senator LIGHTFOOT —Mr Kaufman, you are currently an employee of the CSLLtd?

Mr Kaufman —That is correct, Senator.

Senator LIGHTFOOT —You formerly worked for the CSL Commission?

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Senator LIGHTFOOT —How long has CSL Ltd been in the form it is? When didit float? When did it become corporatised?

Mr Kaufman —The CSL Commission became Commonwealth Serum LaboratoriesLtd, which was a public company, in 1991.

Senator LIGHTFOOT —So could I say that the Commonwealth SerumLaboratories then became corporatised as the CSL Commission, and then it floated? Is thatright? Then it became a public company?

Mr Kaufman —The CSL Commission was formed in 1961. Prior to that CSL wasa branch of the Department of Health. CSL Ltd—as it was then known, CommonwealthSerum Laboratories Ltd—came into being in 1991 and the company was floated in 1994as CSL Ltd.

Senator LIGHTFOOT —Mr Tuohy is the only other person on my list here whowas with the commission. Are there any other colleagues or people that you know heretonight who formerly worked for CSL in any fashion?

Mr Kaufman —Not to my knowledge, Senator, but I have only been there for 30years so maybe—

Senator LIGHTFOOT —I will ask the question generally: did any of you herework for the CSL in any of its forms? No. I am going to have to concentrate on you then,Mr Kaufman. When the company floated, it did pretty well, didn’t it, over the last coupleof years?

Mr Tuohy —I am the Company Secretary of CSL Ltd and I was the last secretaryof the CSL Commission.

Senator LIGHTFOOT —Perhaps I could switch to you, Mr Tuohy. Thank you foridentifying yourself.

Mr Tuohy —I can comment on the various aspects that you raise. TheCommonwealth Serum Laboratories were part of the department of health until 1961 whenthe Commonwealth Serum Laboratories Company was formed. At that time, all records ofthe department were retained by the department, other than stock standard things such asmethods of manufacture and so on to enable the Commonwealth Serum LaboratoriesCommission to set itself up. The Commonwealth Serum Laboratories Commissionfunctioned from 1961 until its conversion into an unlisted public company in 1991. At thattime, several of the key officers of the commission were obligated to resign and apply fortheir own positions if they wished to continue, a number did and some did not.

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In October of 1991, the name of the commission was changed to CSL Ltd. Theorganisation was 100 per cent sold by public float on 3 June 1994. At the time of thefloat, consideration was given to whether all the records of the commission should beretained by the Commonwealth. The decision was made that they would be left at CSLLtd. When this matter arose, Graeme Kaufman and I were made available to assist thedepartment to access those records.

Senator LIGHTFOOT —Where are those records now, predominantly?

Mr Tuohy —At CSL.

Senator LIGHTFOOT —At CSL Ltd?

Mr Tuohy —Yes.

Senator LIGHTFOOT —That is all the records?

Mr Tuohy —All the records from 1961 through to the present time remain at CSLbut, if I could be a bit more specific, a number of those have been archived withAustralian Archives, merely for reasons of storage. As Graeme mentioned, the organisationis extremely conservative in these matters. While batch records and so on are onlyrequired to be kept for six years, we have them back as far as they need go.

Senator LIGHTFOOT —How long were you with CSL in its various forms, MrTuohy?

Mr Tuohy —I joined in 1982 but my career has been in the sales and marketingside initially. I am a pharmacist by original profession. I then became secretary of the CSLCommission in 1988 and saw it through its conversion to an unlisted public company andits float. I have also been involved in provision of documentation for the Allars inquiry,the APQ and several other matters that have come to hand.

Senator LIGHTFOOT —I guess you know the history of the last four years, andthe very attractive share price of CSL Ltd. It has done very well, has it not?

Mr Tuohy —Yes, indeed.

Senator LIGHTFOOT —Did you have any shares, or did your family have anyshares in the float, Mr Tuohy?

Mr Tuohy —Yes.

CHAIR —I am not so sure that the private status of Mr Tuohy’s wealth is centralto the terms of reference.

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Senator LIGHTFOOT —Dr Loy said to Mr Kaufman—I think it was in answer toa question from Senator Neal—that CSL Ltd did not take part in the program. Dr Loy, doyou recall saying that?

Dr Loy —Yes.

Senator LIGHTFOOT —If there was just a name change, and a significant part ofthe CSL Commission, and the company prior to that, transferred to CSL Ltd, I am tryingto establish if there is a nexus between the commission and CSL Ltd. I also want toestablish whether officers of those companies, and I think it is incumbent upon thoseofficers to tell this committee, have significant shareholdings in CSL Ltd. I think it is asplain as that. There is no inference on that; I just want to find out what vested intereststhere are.

CHAIR —CSL Ltd is a public company. It is publicly traded and is a differententity from that when it was in government hands. Presumably Mr Tuohy, and othersenior management people, have compensation packages that may involve issues withshares or options. How that is at all relevant to the terms of reference, I am not sure. I amnot comfortable with the direction.

Senator LIGHTFOOT —Let me go to the next step and bypass Mr Kaufman,unless he wants to volunteer whether he has any shareholding in CSL Ltd. Why is it that,if there is no nexus between the CSL Commission, which developed the human pituitaryhormone, CSL Ltd is joined with the Commonwealth in settling damages claims forrecipients of the hormone?

Dr Loy —If plaintiffs take action against CSL Ltd then CSL Ltd needs to respondto those actions. The point I was simply trying to make in response to Senator Harradine’squestion was that the reason we determined that the officers of the CSL Commissionshould appear along with the department was so that there was a better reflection of thearrangements that existed at the time that the commission was a part of the healthportfolio, rather than people appearing separately as officers of a former body or indeedofficers of CSL Ltd. I was not trying to suggest that there was any lack of connection butrather that it was more sensible for the officers of the former commission to appear withthe department.

I should also mention that there is an indemnity agreement between theCommonwealth and CSL Ltd for the provision of Commonwealth indemnities with respectto incidences such as the present one, prior to the sale of CSL. If there is any suggestionthat there is a linkage between CSL Ltd having to pay damages or fund actions, there isan indemnity agreement that the Commonwealth made with CSL Ltd at the time of itsprivatisation.

Senator LIGHTFOOT —Do you believe that the Commonwealth will have to

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indemnify CSL Ltd—that is its current form—for any damages that may arise?

Dr Loy —There is an indemnity agreement, and I cannot go into the provisions ofit in any detail. Fundamentally, there was an indemnity agreement from theCommonwealth for matters arising involving CSL prior to the sale and the creation ofCSL Ltd.

Senator LIGHTFOOT —What about you, Mr Lucas? Could you give your opinionon whether you think the Commonwealth has completely indemnified CSL Ltd?

Mr Lucas—I am not in a position to say.

Senator LIGHTFOOT —What do you mean by saying that you are not in aposition to say?

Mr Lucas—As I said, initially, my involvement has related to the discovery of theAllars inquiry documents. The arrangements between CSL and the Commonwealth aboutthe indemnity upon the sale of CSL is a matter that I have not been involved with.

CHAIR —Senator Lightfoot, if you want to raise the issue of the nature of theindemnity agreement between the Commonwealth and the former CSL, Mr McDonaldmight be the appropriate person to ask that question.

Senator LIGHTFOOT —I am happy to have a resolution to the question. MrMcDonald, do you think that the Commonwealth has completely indemnified CSL Ltd?

Mr McDonald —With the floating of the company, there was an agreement by theCommonwealth to indemnify CSL in relation to the hormone program.

Senator LIGHTFOOT —Why then has the Commonwealth joined with CSL Ltd,as co-defendant?

Mr McDonald —That was at the prerogative of the plaintiff. For instance, theCommonwealth did not go about joining CSL Ltd as a defendant to this action or, in fact,seeking to suggest to the plaintiffs that they join. It was the solicitors for the plaintiff whodid that.

Senator LIGHTFOOT —Do you agree with that?

Mr McDonald —It is not for me to say.

CHAIR —That is a matter of fact.

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Senator LIGHTFOOT —I was just asking his opinion, Mr Chairman. I am findingit difficult to actually get going, for some reason.

CHAIR —Perhaps you should come to the point.Senator LIGHTFOOT —Perhaps, on the basis of the time, I will move on but,

before I do, let me just persist one more time. Perhaps Dr Loy could answer this. Do youthink that CSL in its present form is completely absolved from any blame?

Dr Loy —I would not want to raise the issue of blame. The indemnity agreementindemnifies CSL for amounts for which it becomes legally liable by way of compensationfor personal injury loss or damages through the use of growth hormones manufacturedfrom human pituitary glands and human pituitary gonadotrophin manufactured before 31December 1985. I gather there is a clause in the indemnity agreement, as you wouldexpect to find, that if the liability arises from punitive and exemplary damages awardedagainst CSL as a result of CSL deliberately or recklessly endangering the health and safetyof human life, then the indemnity does not operate. I would say that, for the circumstancesof the present issue, the indemnity covers whatever CSL might become liable for.

Senator LIGHTFOOT —You do not believe that, just because there has been achange to a limited liability configuration, if you like, that was the only thing that CSLcould rest on—the indemnity was absolutely and totally important in that regard. Is thatthe case?

Dr Loy —Clearly, it was important, given the nature of the products the CSLcommission was involved in, including hormones. It was important for there to be a clearposition at the time of the privatisation so that people could invest in CSL knowing whatthe situation was and so the government entered into this indemnity agreement.

Mr Tuohy —I would add that that indemnity was originally given to theCommonwealth Serum Laboratories in 1985 at the cessation of this program, and theindemnity agreement at the time of privatisation merely picks up the previously grantedindemnity.

Senator LIGHTFOOT —And that indemnified doctors and other technicians thatwere involved in the program?

Mr Tuohy —No, it was CSL.

Senator LIGHTFOOT —Just CSL?

Mr Tuohy —Yes. It did not indemnify doctors who treated patients or anythinglike that; it was confined to CSL.

Senator LIGHTFOOT —I want to perhaps explore with you, Dr Loy, the veryrecent announcement—I think it was yesterday or Friday at the latest—in Britain. First of

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all, do you believe there is a nexus between BSE and Creutzfeldt-Jakob disease?

Dr Loy —I am not competent to say.

Senator LIGHTFOOT —Are any of your colleagues here competent to say that?

Dr Mead—BSE and CJD are both described as transmissible spongiformencepalopathies and both are thought to be due to some malformation of a prion protein.That issue was described by Professor Masters earlier on. So BSE and CJD are forms ofthe disease in different species, and they have occurred in a number of species.

Senator LIGHTFOOT —Cross-species?

Dr Mead—On the issue of the cross-species: there is the CJD variant that has beenrecognised in the UK over the last few years, the theory being that it is linked to BSE. Ithink that is a strong possibility at this stage but not proven.

Senator LIGHTFOOT —It is a strong possibility but it is not proven?

Dr Mead—That is as I understand it.

Senator LIGHTFOOT —Is CJD a notifiable disease?

Dr Mead—Notifiable under public health law? No.

Senator LIGHTFOOT —Why isn’t it?

Dr Mead—Notification under public health law is normally determined for reasonsof either the need to take public health action or the need to have a record of surveillanceof the condition. In the case of CJD, the need to have a record of cases for epidemiologypurposes is served by having the register. Because cases of CJD would be almostexclusively dealt with by neurologists and because Professor Masters, running the register,can have relatively close contact with all the people likely to see cases, you get very goodascertainment of cases without requiring legal notification. There is a number ofconditions where you need information for epidemiological purposes that you can obtainby those sorts of networks and contacts, rather than requiring notification by law.

Senator LIGHTFOOT —So you are quite happy that it should not be classified asa notifiable disease?

Dr Mead—Yes.

Senator LIGHTFOOT —When the documentation was transferred from the CSLcommission to CSL Ltd—

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Mr Tuohy —No physical transfer took place; it was just left in situ.

Senator LIGHTFOOT —Are you quite happy that all that documentation wastransferred, that it is intact and that it is safely stored at the moment?

Mr Tuohy —Nothing was removed.

Senator LIGHTFOOT —Nothing was removed?

Mr Tuohy —No.

Mr Kaufman —Perhaps I can expand on that, since I negotiated with AustralianArchives for that documentation. The documents were our property but, recognising thatthe Commonwealth may have an interest if for no other reason than historical purposes,we elected to approach the Australian Archives to store very old documentation. We havebeen working with the Archives over a period of time to classify documents back from the1920s, which today are of great historical interest. We have a system in place to ensurethat destruction is authorised in accordance with sentencing schedules in a similar mannerto that Archives.

Senator LIGHTFOOT —Regardless of their historical category, I would imaginethat they would all be discoverable.

Mr Kaufman —Yes.

Senator LIGHTFOOT —I do not have any more questions.

CHAIR —Thank you, Senator Lightfoot; it is back to you, Senator Harradine.

Senator HARRADINE—Thank you. With regard to the NHMRC responses,would the NHMRC provide a copy of the minutes of AHEC as they relate to therecommendation of the Allars committee? That is to say those meetings of AHEC whichdealt specifically with the Allars recommendation.

Mr Wells —That is the three, being the ones of July 1994, December 1994 andSeptember 1995?

Senator HARRADINE—That is what it appears to be, yes.

Mr Wells —Yes, the record of the meeting.

Senator HARRADINE—I do not want the whole of the minutes of the whole ofthe committee meeting.

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Mr Wells —So, the record of the discussion relating to Allars?

Senator HARRADINE—Yes, thank you. Mr Kaufman, at the present moment,what is your position with CSL?

Mr Kaufman —I am general manager of the Biosciences Division, which producesdiagnostic products.

Senator HARRADINE—What was your position at all times relevant to theprogram?

Mr Kaufman —Just so I get the dates correct, Senator, from 1976 until 1978 I wasin charge of the laboratory that conducted biological assays on the pituitary hormones,amongst other things.

Senator HARRADINE—What is your professional background?

Mr Kaufman —I am a scientist, a biochemist, with microbiological qualificationsas well. From 1976 through to 1978, I was in charge of the bioassay of pituitary hormonesamongst a range of other biological assays including insulins, tuberculins, heparins,clotting factors—a wide range of biological assays. From September 1978 until December1979 I was working in the insulin area, which was the area that was responsible for themanufacture of the pituitary hormones. During 1980 I was studying. From 1981 to 1983 Iwas back in the insulin area in various positions. In January 1984 I became responsible forall manufacturing at CSL across all product ranges, both human and veterinary, andmaintained that position until April 1988.

Senator HARRADINE—In respect of the matter that we discussed beforehand,the use of iso-octane defatting procedures, that is a potential inactivator of hep B virusinfectivity. Is that correct?

Mr Kaufman —That is a fair summation.

Senator HARRADINE—You were saying that you were using some otherprocess, that this was only a sort of additional safeguard.

Mr Kaufman —I think the words were ‘added assurance’, or something like that.The principal process was the column.

Senator HARRADINE—When did you start using the iso-octane defattingprocedures as an added assurance?

Mr Kaufman —We started using the iso-octane procedure, as I understand it, fromthe start of the fractionation program that was a part of the Ferguson process and

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necessary to enable you to put it through the columns.

Senator HARRADINE—When was this started, the use of—

Mr Kaufman —In 1966, 1967.

Senator HARRADINE—You said that the process was necessary and yet you saidit was an added assurance. I am not understanding that very well.

Mr Kaufman —Without the defatting step the columns would have rapidly blockedthrough accumulation of lipids or fats on the column, so it was necessary to remove thoseprior to putting the material on to the column. It would also have blocked membranefilters.

Senator HARRADINE—I understand.

Mr Kaufman —It is separate from the hepatitis—

Senator HARRADINE—Yes, I have that. Was the iso-octane extraction forrelatively short periods?

Mr Kaufman —Yes. I cannot recall exactly the time but it was probably 10, 15,maybe 20 minutes when it was in contact with the iso-octane.

Senator HARRADINE—Could you take that on notice and give us an indicationof what was the period of time. Could you also indicate whether that period was likely tobe long enough to allow the process to go to completion and therefore render the productsafe.

Mr Kaufman —Senator, in the absence of any studies done to my knowledge withiso-octane, the second part of the question becomes very difficult to answer.

Senator HARRADINE—Really, your use of the technique was not really torender the pituitary hormone safe with respect to infectious hepatitis B. That was not itsprimary use?

Mr Kaufman —That is correct, Senator.

Senator HARRADINE—Are you saying that in the literature now there is a proofthat this technique is a potential inactivator of hep B virus infectivity?

Mr Kaufman —Senator, there is certainly data in the literature which says thathepatitis B virus is susceptible to solvents, as you would expect from its structure.

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Senator HARRADINE—Did CSL explore the use of the process to inactivate theHIV viruses in Factor VIII that it manufactured, as soon as it was found that the first HIVvirus isolated was an envelope virus?

Mr Kaufman —Senator, it is moving a little outside the terms of reference of thisinquiry because you are moving into blood products, but to the best of my knowledge wevery rapidly instituted heat treatment for Factor VIII concentrates. There is a solventdetergent process developed at the New York Blood Centre, to which we have a licence,but it requires extensive validation in accordance with current requirements of TherapeuticGoods and the other people involved in registration of new products.

Senator HARRADINE—It was first recognised in relation to the heat inactivationprocedures back in 1983, wasn’t it? The heat inactivation procedure was only partiallysuccessful, was it not?

Mr Kaufman —In terms of inactivating what, Senator?

Senator HARRADINE—In terms of inactivating the HIV virus in Factor VIII thatCSL manufactures, what was your process?

Mr Kaufman —I have a question for the chairman. Is this relevant to the terms ofreference? If it is, I will endeavour to assist the committee.

CHAIR —I was just giving that some thought. Senator Harradine, I do notunderstand the thrust of the questions in respect of the HIV issue.

Senator HARRADINE—I was really looking at the iso-octane defatting process inrelation to problems faced by haemophiliacs. Maybe it is not relevant, but I was interestedto hear that what Mr Kaufman is really saying is that the iso-octane technique was reallynot known at that time to be definitely an inactivator of hepatitis B virus.

Mr Kaufman —That is correct, Senator. I think we can sit here today, as I gave inevidence before the committee a couple of week ago, and say with hindsight, if you like,that it is an added assurance—I think they were the words I used.

Senator HARRADINE—You were in charge of the assay area in 1976-78?

Mr Kaufman —Yes, Senator.Senator HARRADINE—The evidence that you gave to this committee on 13

August 1997 left us in no doubt that CSL claims to have been aware of the value of iso-octane as an inactivating agent capable of ridding pituitary hormones of infectioushepatitis B virus. You described the iso-octane defatting process in your methods ofmanufacture for follicle stimulation hormone, human and growth hormone. You haveacknowledged that the iso-octane defatting process that you used to prepare pituitaryextracts for fractionation would destroy the infectivity of the envelope viruses. But you are

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now saying to us—or was I misunderstanding what you said previously—that it was justan added—

Mr Kaufman —I am reading the draft of theHansard:

We know that hepatitis B is an envelope virus and its infectivity will be destroyed by the actions ofsolvents—

that is absolutely correct—

and this is the basis for a standard technique of inactivating viruses.

That is also correct. Then I go on to say:

The iso-octane should have removed most of the infectivity.Senator HARRADINE—For the purposes of remedying infertility, what steps did

you take to attempt to ensure that there would not be hyperstimulation?

Mr Kaufman —I can answer that from a strict manufacturing point of view. Otherswould have to answer in terms of the clinical management of patients. From amanufacturing point of view, we carried out a bio-assay—and I have provided in thedocuments that came to the committee last Friday some details of that. We heard evidencea couple of weeks ago from Dr Whitten, describing biological assay techniques, and so on.CSL followed those techniques, with one exception. Dr Whitten correctly points out that athree-point assay—what he would understand, and I certainly understand, as a three-plus-three assay—is by far the best way to go.

At that stage the official assay in theBritish Pharmacopoeia—and it was theofficial assay until 1976—was what is called a two-plus-two assay which, as Dr Whittenhas pointed out, you cannot test for linearity. But we certainly did statistical tests forsignificance of slope, parallelism, variance, and so on, in the manner described by DrWhitten.

Senator HARRADINE—Yet your products did have the effect ofhyperstimulating—

Mr Kaufman —An important thing to note—if I can perhaps throw that across tomy colleagues in health who have some data on comparative studies around the world onhyperstimulation—

Senator HARRADINE—No. I would be interested in that, too, but I am interestedin your response. As a manufacturer of the product, were you aware of hyperstimulatoryeffects of of your product when used in certain circumstances?

Mr Kaufman —I think that if you go back through the minutes of the FSHsubcommittee you will find that those were in the early days. That is my recollection. It iscertainly not an issue that I recall being raised during my involvement in the program.

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Senator HARRADINE—So it happened in the early days. Are you saying that itdid not occur by the use of the program of hPG developed in your organisation at the laterstages?

Mr Kaufman —I think the experience globally was as—Senator HARRADINE—No, your experience—CSL.

Mr Kaufman —You can only compare it with some form of benchmark.Senator HARRADINE—You know when hyperstimulation takes place.

Mr Kaufman —The evidence, as I understand it, is that Australia experienced amuch lower level of hyperstimulation than occurred in other countries.

Senator HARRADINE—I am not asking whether it was lower or higher. I amasking whether it occurred and, if so, what steps you took. We are talking about asituation here where hPG is proved to be an experimental program which was utilised onhuman subjects. I suppose it was an exploitation of a natural desire to have children andthus the human subjects were readily available. It seems to me, with respect, that in thisarea of reproductive technology, anything goes with people such as those sciencetechnologists who are involved.

Therefore, I am asking you a simple question: could you provide the committeewith any documentation as to what steps you were taking to ensure—not to try, but toensure—that the products of your commission, CSL, would not cause hyperstimulation totake place?

Mr Kaufman —In one of the submissions, and I think it may have been DrWhitten’s, a very good explanation of biological assays was provided and it shows thevariation. He has some error bars showing the ovarian weight in the assay system which isdone in rats—these are rats that are very similar because they are in-bred and the assayswere under very controlled laboratory conditions—where with exactly the same dose youcan get a response that is well down. In other words, the ovary does not get much largerat all. On the other hand, the responses could be well up and the ovary can get very large.We took steps to ensure that our assay systems were at least equivalent to the standardsrequired by theBritish Pharmacopoeiaand other pharmacopoeias at the time.

Senator HARRADINE—I have heard that the World Health Organisation havebeen proven wrong many a time. Are you saying that they were proven right? Is itresponsible for you then, as an organisation, to make available products when you do notknow in certain situations whether hyperstimulation will take place?

Mr Kaufman —There is natural variation in any human to any drug, Senator.

Senator HARRADINE—In this instance, there were in some cases fataldivergences of might occur—not only fatal for the women, but fatal for the unborn human

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beings.

Mr Kaufman —We assayed that material in accordance with the best practice ofthat time and consistent with the evidence that Dr Whitten has provided to this committee.

Senator HARRADINE—Best practice was not enough, was it? People did die.

Mr Kaufman —I cannot comment on the clinical usage of that hormone. What Ican comment on is the manufacturing process and the assay process.

Prof. Whitworth —Perhaps I could add some comment from the clinicalperspective. It is certainly correct that hyperstimulation was, and is, a side effect ofgonadotropin treatment. In 1957, Professor James Brown developed an oestrogenmonitoring assay to monitor the ovarian response to hPG. This assay was introduced at thecommencement of the Australian human pituitary hormone program in 1967, specificallyto attempt to reduce the risks of hyperstimulation and multiple pregnancy.

I think the published evidence indicates that it was effective in that regard. Thepublication summarising the Australian program experience, a paper by Kovacs andcoworkers called ‘Induction of ovulation with hPG, the Australian experience’, publishedin the Australian and New Zealand Journal of Obstetrics and Gynaecologyin 1989, quotesa risk per treatment cycle of ovarian hyperstimulation of 7.8 per cent in Australia. In theeight other studies we have here, the risks are quoted as between eight and 83 per cent.More pertinent though, I believe, is the risk of severe ovarian hyperstimulation because,certainly in the Australian program, at least 75 per cent of hyperstimulation seen wasminimal and only 0.04 per cent was severe. That compares with the published experiencein other countries of up to 24 per cent.

Similarly, the Australian multiple pregnancy rate, according to that papersummarising the Australian experience, was 22 per cent. The four other references wehave to multiple pregnancies with gonadotropin programs range between 27 and 36 percent. That assay of Dr Brown’s was replaced in 1970 by a more accurate radioimmuneassay measuring oestrogen concentrations. The Human Pituitary Advisory Committeeinstituted a requirement that any specialist seeking to be approved by them to treat patientswith hPG must have access to a laboratory to carry out the assays required. Acomputerised recording system was developed in the department which doctors wererequired to provide information to on the outcome of treatment. Certainly,hyperstimulation remains a side effect of gonadotropin treatment to this present day.

Senator NEAL—Dr Mead, you said that you referred the matter of official andnon-official recipients to the minister. How long ago did you say that occurred?

Dr Mead—I said that that would be a decision for the minister. We are waiting onsome more information to put a recommendation and the case to the minister.

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Senator NEAL—So have you not actually referred the matter to the minister yet?

Dr Mead—No.

Senator NEAL—Is he aware of the matter?

Dr Mead—Yes, his office is aware of the matter.

Senator NEAL—What further information are you looking for?

Dr Mead—We have written back to the coordinator of the support group networkasking whether there is any further information they would want us to consider in makingthat decision.

Senator NEAL—How long ago was that requested?

Dr Mead—I cannot recall when that was sent.

Senator NEAL—A week, a month, a year? Would it be correct to say it was aweek ago?

Dr Mead—I think it was a couple of weeks ago—something of that order.

Senator NEAL—Can you check that please and confirm it. How long has it beensince those instructions were sought?

Dr Mead—I am not aware of the date when the instructions were soughtbecause—

Senator NEAL—Mr Carroll, could you tell us?

Mr Carroll —No.

Senator NEAL—Mr McDonald, could you tell us? When did you seek theinstructions on whether or not unofficial recipients should be included in the offer ofsettlement?

Mr McDonald —I could only say sometime in July to August, Senator.

Senator NEAL—Sometime?

Mr McDonald —I do not have the actual date.

Senator NEAL—Could you check on that, please.

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Mr McDonald —Yes, Senator.

Senator NEAL—Dr Mead, I am not sure if you are the right person to ask. Areyou are aware of what steps were taken to ensure that doctors did not provide thehormone to persons not actually approved to receive it?

Dr Mead—No, I am not aware of what steps were taken to prevent doctors fromusing the hormone for those who were—

Senator NEAL—People who were not authorised to receive it. What steps did thedepartment take?

Dr Mead—I am not aware of what steps were taken.

Senator NEAL—Who would be aware?

Dr Mead—I would have to take it on notice and find it in the record.

Dr Loy —As I recall, this problem was raised at the last hearings. I think MrMcDonald recalled a number of occasions on which there were activities by HPAC to takeup with doctors where they seemed to have been using the hormones in relation tounapproved patients. Whether that is the case or not, we will check my recollection there.Clearly, it would have been an issue for the FSH and HPAC to regulate the program, sothat the need for patients to be approved was clear to the treating doctors.

Senator NEAL—You could check whether, when the hormones were first beingdistributed, the doctors were given a letter or how the instructions were given. If it was byletter—

Dr Loy —Once the program was created, the only way they could get supplies ofthe hormone was to be ‘registered’ with the HPAC apparatus.

Senator NEAL—I am quite aware of that, but there seems to be quite a range ofevidence that suggests that doctors either used leftover hormones for other patients thatwere not approved or, alternatively, if their supply was a bit behind time from one patient,they would borrow from another patient’s supply to provide them with the necessary—

Dr Loy —Yes, that may well be the case. But your question was: who wasresponsible for following that up?

Senator NEAL—No, that was not my question. I wanted to know what steps thedepartment of health took to ensure that doctors did not provide the hormone to peoplewho were not approved.

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Dr Loy —Any steps would have been taken by HPAC, or the FHS subcommitteeas part of HPAC, not by the department as such.

Senator NEAL—Is there anyone here from HPAC who would be aware of that?

Dr Loy —You have the minutes. All that kind of issue is treated in the minutes andin Allars.

Senator NEAL—Not necessarily, because what HPAC said in its minutes is notnecessarily what was communicated to the doctors.

Dr Loy —My understanding of the program is relatively clear. Doctors, in order toreceive supplies of the hormone, had to sign up with HPAC and follow the protocols thatHPAC laid down. Some instances of doctors not doing that came to HPAC’s attention.They were discussed and matters were raised with individuals. You will find that in theminutes. That is not to say that that is a perfect system. Obviously, it was not.

Senator NEAL—I am not suggesting whether it is perfect or not. I am just tryingto establish what steps there were. We will go through the minutes. I notice that thedepartment of health submission, at the top of page 31, says:

Up until the late 1960s, CJD was generally unknown to the medical community and the diseasereceived little attention in the established medical textbooks.

There is probably some minor dispute with that, not major dispute. But then thesubmission jumps over and says:

Until 1985, there was no evidence of hormone recipients having developed CJD, hepatitis or anyother unusual reaction to the treatment.

Why doesn’t the department deal with the state of knowledge between the late 1960s andearly 1985?

Prof. Whitworth —That was a transition period of moving from one state to theother.

Senator NEAL—What do you mean by ‘state’?

Prof. Whitworth —From the late 1960s—from memory I think Professor Masterscovered this in the previous hearing—there was a gradual increase in knowledge of thecondition—

Senator NEAL—But my question was—

Dr Loy —With respect, Senator, I think you are just looking at those three

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sentences under the heading ‘State of knowledge’. The submission goes on under‘Warnings’ to discuss further how that state of knowledge developed. I am referring toGajdusek and the 1977 paper and so on. It is not just that we have left something outbetween the 1960s and 1985. Obviously we have not discussed it in the sort of detail youwill find in the Allars inquiry but it is briefly summarised on that whole page 31.

Senator NEAL—That is what I am wondering. That is about warnings, but thesubmission of the department does not actually say what the state of knowledge of thedepartment itself was. It is one thing to say that there were warnings available at the time,but the submission itself does not say whether or not the department of health had anyknowledge between those two dates. Are you saying that all the things contained under theheading ‘Warning’ were known to the department of health at the time they werepublished?

Prof. Whitworth —Until 1985, when the first deaths occurred in the United States,the department was not aware of the risk of CJD transmission through pituitary hormones.The department became aware of that risk in 1985 following those cases in the UnitedStates and the cessation of that program in the United States in April 1985. It was for thatreason that the Australian program was ceased one month later.

The state of knowledge from the late 1960s until the time of those proven cases in1985 was gradually evolving and that was the evidence provided by Professor Masters.We are not aware, and have no records, of any connection being made between CJDtransmission and the pituitary hormone program. So we are not aware of any warningshaving been given in Australia prior to the time of cessation of the program. We areaware, from the Morland judgment, that there is reason to believe that there were suchwarnings in the United Kingdom, but, as the judge points out in his judgment, there wereno warnings given anywhere else. He said that unlike in the United Kingdom, nowhereelse was the specific warning of the risk of CJD being transmitted through human growthhormone given.

Senator NEAL—What steps does the department of health take to ensure that theykeep up with current medical information?

Prof. Whitworth —Are you asking what we do currently, Senator?

Senator NEAL—Yes. What sorts of journals does the department monitor? That isprobably the main thing I am interested in.

Prof. Whitworth —Personally and through the department I receive copies of andread on a regular basis theLancet,the British Medical Journaland theMedical Journal ofAustralia. The department library has a range of journals available. I and many of mycolleagues have on-line access to Medline. In addition I take, on a personal basis, about adozen journals in the fields of nephrology and hypertension. The journals subscribed to by

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other individuals in the department relate to their particular speciality interests.

In matters of professional knowledge, however, and access to that knowledge, wewould not simply rely on the in-house expertise within the department because, veryclearly, the 30 or so medical officers in the department would not cover all the relevantspeciality areas. We would access that knowledge through the network such as the 4,000assessors we have on the NHMRC database, for example. We keep up with contemporaryknowledge on an individual basis but, more specifically, through networks and linkages toprofessional groups.

Senator NEAL—I notice you have mentioned theNew England Journal ofMedicinein your submission. I assume the department monitors that.

Prof. Whitworth —I would assume so. I do not take it personally, but I understandthat it is taken by the departmental library. Is that correct?

Mr Wells —Absolutely.

Senator NEAL—And it has been monitored for some time, I assume since the1970s when that article—

Dr Loy —I am sure most of our professional medical officers who had anything todo with general issues of this nature, including drug trials and clinical trials, would keepup with theNew England Journal of Medicine. It is one of the principal journals in whichsignificant research is published.

Senator NEAL—So you would expect the members in the Department of Healthand Family Services to be familiar with that particular journal and the things it contained?

Dr Loy —I would expect a number of them would be at any given time. Thedescription of the state of knowledge in the various structures of the program that is givenin the Allars report I would judge is a pretty fair description. The description of the stateof knowledge and the state of knowledge in Australia amongst the people concerned withthe program seems to me from my own reading, and I am not expert, to be a pretty fairdescription.

Professor Allars goes on to make some judgments about, if you like, what shouldhave been known or what inferences should have been drawn. I think there is an areawhere people can make different judgments and where it is very difficult to separate outwhat you are doing with the benefit of hindsight from putting yourself back in the positionof the people in 1980 or 1977, but I think the description of people coming slowly tosome grasp and understanding of what was going on seems to me to be a broadly accurateone.

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Senator NEAL—Your statement appeared to me to be quite correct when you saidthat there was no evidence of the hormone recipients developing CJD until 1985. But asthe Allars report mentions, there are fairly extensive articles contained in those sorts ofjournals and therefore you would have thought that the officials in the department wouldhave been quite familiar with it from 1977.

Dr Loy —I am sure they were familiar with them, but making the leap from sayingthat corneal grafts, that neurosurgical instruments transmit the CJD agent, to saying thatthis is a possibility through pituitary hormones, and then going further and saying it issuch a possibility that the program should be re-examined and stopped is a substantialintellectual leap that was not made in this country and was not made in any other country.

Prof. Whitworth —Senator, perhaps I could just add to that. In relation to thepivotal article that appeared in December 1977 by Gajdusek and Brown, where the authorsdrew attention to the corneal transplants to the neurosurgical electrode cases andrecommended that blood donations or organs not be collected from people with dementia,Professor Gajdusek, in addition to being an expert on transmissible spongiformencephalitides was also a paediatrician and hence would have known about pituitaryhormones programs in the United States and elsewhere, made no such connection and asfar as we are aware, at no stage advised that the program in the United States or elsewhereshould cease.

Senator NEAL—It does not seem that large a leap to me because he did not onlydeal with that. Just looking at the Allars report itself, Gajdusek’s paper 77 says that thedocumented case of CJD from corneal transplant suggests that other tissue transplantationmay also be a source of infection. It is known that the virus is present in peripheral tissueas well as the brain. The pituitary gland is part of the brain, is it not?

Prof. Whitworth —Well, it has connections with the brain, yes, Senator. All I cansay is that the fact is that, irrespective of we might think now, there is no evidence thatthose connections were made. The only evidence of a connection being made and awarning being given is in relation to Dr Dickinson in the UK. Despite the knowledge inthe United States and the paper by Gajdusek, the connection was not made until 1985.Even then, Dr Brown apparently felt that it might be a coincidence and was not convincedinitially that the programs should stop. Looking back, it is very difficult to be able to saywhether or not the connection should have been made. It may be correct that they shouldhave been made, but I think the fact is that they were not.

Senator NEAL—Has anyone here actually gone through the minutes already? Ifyou have not, just say that you have not. We will be going through them anyway.

Mr McDonald —Do you mean of all the committees?

Senator NEAL—Yes.

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Mr McDonald —I have, Senator.

Senator NEAL—Are you aware of any discussion in the minutes about reportswithin the medical journals related to CJD and the risks associated?

Mr McDonald —There are references in the HPAC minutes and also in thefractionation committee meetings as to the Gajdusek paper. It would probably be—

Senator NEAL—You do not remember—

Dr Loy —The fractionation subcommittee meeting of May 1980 was referred to inthe Allars report and is in the minutes that are available to you, and that was subsequentlyconsidered by HPAC. There is a quotation on page 356 of Allars of the minutes of thatfractionation subcommittee.

Senator NEAL—Was that the first time? You have obviously—

Mr Kaufman —There was a subsequent discussion recorded in the minutes of 5November 1982.

Senator NEAL—Was 1980 the first time that paper had been discussed, or anyother paper from any journal?

Mr Kaufman —I have not been through them in great detail.

Senator NEAL—I am sorry; because you volunteered that, I thought you had themall there.

Mr McDonald —I believe so, Senator.

Senator NEAL—I do not have any further questions.

CHAIR —Thank you, Senator Neal. I have a few questions on the counsellingsettlements rising out of the trust fund that has been established for the recipients. We hadsome evidence on the last day that the number of visits was limited to 15 and that somepersons require more extensive counselling of that. What arrangements are in place forthose people and have any persons been refused assistance for more than 15 visits to apsychiatrist?

Dr Mead—In my area, the 15 counselling sessions was a number that wascommenced when the counselling program was changed in October of last year, so peoplecould have had continuous counselling for any period of time until then. The number of15 was put in to trigger reconsideration of whether counselling was the appropriateintervention, and not to refuse service but to see whether it was ongoing the best care for

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the person and the decision is made by an independent group of experts in the field ofcounselling who are knowledgeable about CJD. To my knowledge, nobody has beenrefused service.

CHAIR —Nobody has been refused service, to your knowledge?

Dr Mead—Not to my knowledge.

CHAIR —Under the new arrangements, Dr Mead, how much choice is allowed forrecipients to determine which psychologists or psychiatrists best suits their individualneeds?

Dr Mead—The counselling panel that I referred to approves people for thepurposes of counselling and they have qualification criteria that they apply.

CHAIR —Are they professional criteria?

Dr Mead—Yes, professional criteria. The intention of the change in October lastyear was to provide more flexibility so that people from disciplines such as psychiatrycould be included, rather than confining the counselling arrangements to one organisation.

CHAIR —To your knowledge, have any psychiatrists or psychologists been refusedaccreditation under the new system?

Dr Mead—There has not been anyone refused approval for counselling. Approvalis either on the basis of their credentials or on the basis of an ongoing counsellingrelationship with an individual and no-one has been—

Senator LEES—Has anyone been limited in terms of the number of times theycan see their approved counsellor?

Dr Mead—Not that I am aware of.

Senator LEES—We have had evidence to the contrary.

Dr Dean—I am sorry, Senator. I did not hear the question.

CHAIR —Senator Lees asked if any person had been limited in the number ofcounselling sessions he or she might receive since the new regime was established. Wehad evidence here in Canberra a fortnight ago that a particular man had been refusedtreatment after 15 sessions, as I recall. Is that your recollection?

Senator LEES—He certainly said that he had been restricted in the number ofsessions he was able to access.

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Dr Dean—Senator, I have been to a number of the counselling meetings and I amnot aware of anyone who has been refused further counselling. Individuals are consideredon the basis of whether the counselling is the most appropriate method for them. Forinstance, if the person appeared to have an ongoing problem, it might be suggested thatperhaps the person should see a psychiatrist. But I am not aware of anyone who has beenrefused counselling after 15 sessions.

Senator LEES—What about access to a psychiatrist? Is that limited?

Dr Dean—This is not readily available in that it is not provided for through thecounselling fund, but there has been a situation where a psychiatrist has been accreditedbecause of the very special circumstances involving one of the recipients. Only one that Iknow of.

Senator LEES—Thank you.

CHAIR —What incidentals such as payment for travel are provided under the newarrangements?

Dr Dean—I am sorry, I cannot give you that information.

CHAIR —Who can? Dr Mead?

Dr Mead—I would have to take that on notice to get details of incidentalscovered.

CHAIR —Could you provide that, Dr Mead?

Dr Mead—Yes.

Senator HARRADINE—I have a couple of very quick questions. Have wereceived from the department copies of the consent forms that were provided toparticipants in the program over the whole period of the program? Did these consentforms alter during the lifetime of the program?

Dr Loy —I think the answer is that we have only provided what we have beenasked to provide. I do not think we have provided more detailed records. I am not surewhat exists by way of consent forms, but we can check that and answer it for you.

Senator HARRADINE—Could you then provide the consent forms that were usedfor presentation to the participants in the program at each stage of the program?

Dr Loy —By each stage, do you mean historically through the program?

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Senator HARRADINE—Yes, so that we can see how—

Dr Loy —We can check it and then provide whatever we have.

Senator HARRADINE—Mr Kaufman, are you aware of, or did your company orCSL have ongoing dialogue with those administering the program?

Mr Kaufman —The HPAC, we had always had a representative on thefractionation subcommittee. We did not have representatives on the growth hormone orFSH subcommittees which were the ones concerned with the clinical aspects, and we hada representative on the HPAC.

Senator HARRADINE—Who was your representative on the HPAC?

Mr Kaufman —I believe it started early with Dr Keen. I think Dr Duke was therefor some time and Dr Schiff also served in that capacity.

CHAIR —Thank you, Senator Harradine. There being no further questions, I thankyou, Professor Whitworth, Dr Mead and gentlemen, for being of assistance tonight, both inyour evidence and in providing all of that documentary material. I am sure it will beexamined with great interest by various members of the committee, and I am surequestions will be forthcoming in a range of forums.

Committee adjourned at 11.33 p.m.

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