8. Allars Report
The Findings of the Allars Inquiry (Summarised)
Many of the human pituitary glands (from which the hormones were derived), were removed illegally from cadavers.
The exclusion criteria ( a crude safety mechanism requiring that certain "unsafe" glands be excluded from the collection and production process to minimise the transmission of disease to recipients) were not distributed to those collecting the glands, largely untrained and unskilled mortuary attendants. Most mortuary attendants and pathologists contacted by the Inquiry were not even aware that exclusion criteria existed.
In 1971 the exclusion criteria were amended. Glands from persons with "neurological diseases of the central nervous system due, or possibly due, to viral infection" were not to be collected after the Department's Human Pituitary Advisory Committee (the `HPAC') was warned of the potential of contamination of the product with slow viruses. At that time CJD was thought to be a slow virus. HPAC took no steps to ensure that the amended criteria were made known to all pathologists and mortuary attendants collecting the glands. There was no response by the Department's Fractionation Subcommittee (the `FSC', responsible for supervising matters relevant to production) to the possibility of unconventional slow viral infection of glands and therefore the final product.
The 1971 amendment to the exclusion criteria was omitted, without explanation, in 1977 when the exclusion criteria were further amended ( at that time there was considerable evidence supporting the possible slow viral contamination of the products).
Amendments to the exclusion criteria were:
"... drafted in a reactive fashion ... there was no proactive mechanism for ensuring that new sources of disease came to light. With the exception of [ an occasion in 1971, the HPAC] ...took no steps to ensure that it was abreast of current scientific knowledge of disease potentially affecting human pituitaries".
HPAC failed to ensure compliance with the exclusion criteria.
Members of the Department's HPAC and its Subcommittees, did not have the necessary expertise in the fields of virology and neuropathology and, with the exception of one occasion, failed to seek expert advice when required.
In many instances the administration of the hormones was experimental.
The informed consent of patients was often not obtained with recipients being largely unaware that the hormones were a human biological product derived from pituitary glands removed at post-mortem.
It was found that this was a matter associated with risk and should have been disclosed to recipients. The risk of infection from treatment with a product derived from cadavers at post-mortem was a material risk in view of the known transmissible diseases, such as hepatitis, and ought to have been disclosed.
In the case of recipients of CSL's infertility hormone human pituitary gonadotrophin (hPG) , many of the side effects, some of which were life threatening, were not disclosed to recipients at all or they were not told of potential seriousness of the side effects. Recipients were not advised of a relatively safer alternative to hPG, human menopausal gonadotrophin (hMG) derived form the urine of menopausal women..
The hormones, prior to their listing as pharmaceutical benefits, were not subjected to the existing regulatory structure as required, which was established by the Commonwealth after the Thalidomide disaster to ensure that therapeutic goods for use in humans were safe and efficacious.
CSL's pituitary hormone products were dealt with in a manner inconsistent with the normal course of listing and testing of a pharmaceutical benefit.
The then Director-General of Health and the Pharmaceutical Benefits Advisory Committee (PBAC) proceeded to have the hormones listed as pharmaceutical benefits without the necessary tests being performed on the hormones by the National Biological Standards Laboratory, a Departmental Laboratory, to determine that they were safe and efficacious for use in humans.
The then Director-General of Health failed to insist on written advice from NBSL prior to recommending to the Minister that the products be listed, about the possible viral contamination of the products after a NBSL officer warned in 1965 that
- there was no safe way of limiting the collection of glands to safe cadavers and
- large viral particles, including serum hepatitis, would proceed the hormone through the column, thereby contaminating it.
It was noted by the Allars Inquiry:
"... the history of the listing of the hormones is one of circumvention of the PBAC and direct dealings between HPAC and the Director-General of Health and the Minister..."
The Inquiry also found that the Government decision-makers who established the scheme of regulation by experts committees must also take responsibility for placing the medical practitioners and scientists (members of HPAC and its Subcommittees) in a position where they had such a responsibility, and where the normal mechanism for testing and review by NBSL and other Departmental bodies, in the light of scientific knowledge, had been circumvented.
Members of the Department's Committee and Subcommittees failed to recognise the limits of their expertise.
The expertise of those members in the particular fields in which they practiced disqualified them from serving in the role of regulator.
The Minister, on the advice of the Director-General of Health:
" .... placed in the hands of those who ought to have been the regulation the very power of regulation itself".
HPAC failed in its regulatory role (this failure was also highlighted by the Committee in it's Report).
The Minister's decision to list the hormones as pharmaceutical benefits under s.100 National Health Act 1953 was an abuse of power and legally invalid (the Committee also highlighted this aspect of the AHPHP in it's Report).
The Department's HPAC, which oversaw the administration of the AHPHP, was belated in their response to the growing evidence of the transmission of CJD.
Research allocations of hormones for research projects involving some recipients were an abuse of power.
Some batches of CSL's hormones were contaminated with hepatitis and pyrogens.
HPAC failed to regulate the use of hGH and hPG outside of the official AHPHP in terms of the non-CSL hormone products produced in Melbourne and administered to patients.
During the AHPHP there were instances of the hormones being administered to recipients in research projects which fell outside of the guidelines for treatment developed by the Department's Subcommittee. The HPAC did not seek research protocols for these projects and failed to ensure that the consent of the subjects of the research was obtained pursuant to the National Health and Medical Research Council's (NHMRC) Statement on Human Experimentation (the Committee shared these concerns on the ethical aspects of the AHPHP).
The Order in Council made in 1969 authorising the use of the hormones for research purposes was in excess of power and the research allocations of hormone were unlawful.
Some decisions of two of the Department's Subcommittees, the Human Growth Hormone Subcommittee (HGHSC) and the Follicle Stimulating Hormone Subcommittee (FSHSC) were open to criticism on ethical grounds. For example:
- The HGHSC failed to appreciate that a particular scheme whereby recipients in different states were unknowingly part of comparative study, stepped across the line between making clinical observations and conducting a research study.
- The FSHSC failed to pay sufficient regard to the ethical considerations which arose from its approval to use out of date hPG in recipients despite concern being raised by CSL.
- The FSHSC failed to apply adequate sanctions in cases where medical practitioners treated recipients without the necessary approval.
- The FSHSC failed to treat hyperstimulation, a potentially fatal condition, as a central concern of the committee.
- The FSHSC failed to respond in a decisive manner to cases of multiple births and congenital abnormalities
- The FSHSC failed to consider cases of maternal deaths after hPG treatment when details became available.
These unfortunate aspects of the AHPHP were also highlighted by the Committee.
In a submission to the recent Inquiry of the Committee, Associate Professor Allars stated that she believed that the litigation would be settled after the Report of her Inquiry became available.
Despite the damning findings of the Allars Inquiry negligence has not been proven.
The Committee also called upon the Commonwealth to formally acknowledge the deficiencies in the operation and oversight of the AHPHP, the experimental nature of aspects of the treatment under the program and the anxiety and stress that has been caused to recipients.
In addition to these recommendations the Committee made a number of important findings as outlined below.
The Findings of the Committee
The Committee noted:
" The Department's attitude displays a want of compassion and care for a group of people who were receiving news which would impact on them for the rest of their lives ... while there remains a group of untraced recipients, there will be doubts as to whether the Department has taken adequate steps to protect public safety by informing recipients of the risk of CJD and not to donate blood or organs".
As there were delays in informing recipients of the risks of CJD and that they could not make blood or organ donations, some recipients may have inadvertently made donations.
In this respect the Committee found:
" ... the Department failed to act promptly to minimise the possibility of a person treated with human pituitary-derived hormone from donating blood and organs and thereby called into question its commitment to maintaining the highest levels of public safety in Australia".
The Committee had a number of reservations about the Government's response in implementing some of the recommendations of the Allars Inquiry.
In two respects it was found that the Department has relied upon an overly restrictive interpretation of a secrecy provision contained in s.135A National Health Act 1963
"to delay and/or prevent documents being made available [to the legal representatives of recipients and to recipients themselves]".
The Committee was of the opinion that:
"Departmental actions in this regard may have been deliberately obstructionist".
The Committee was
"... concerned that relevant documents appear to have been provided with material unnecessarily expunged or withheld totally from the legal advisers acting for the recipients".
In this sense, the Committee was referring to relevant documents of the Allars Inquiry which were discovered to this firm during the litigation. These documents contain the identity and evidence of various former Departmental and CSL's officers which is favourable to the cases of the recipient-Plaintiffs and which, obviously, harms the defence of the Commonwealth and CSL.
A sixth month delay on the part of the Department in the provision of relevant Allars documents to this firm during discovery
"could be regarded as deliberately obstructionist".
It was noted that
"a range of possibly relevant Departmental and CSL files have been destroyed"
The destruction of these files was apparently in accordance with standard Australian Archives Procedures. The Committee noted that according to these procedures destruction of the documents could only take place with the consent of the Department.
The Committee considered that
"the action of the Department (as the Defendant) in advising AGS in the release or refusal of documents to the plaintiff and yet having full access to the same records in instructing AGS on their defence is at least inappropriate, if not unethical".
The Committee commented on the Department's evidence before the Senate Committee, where it attempted to divert responsibility away from the Department for HPAC's failure to ensure that the exclusion criteria were made known to those collecting glands and to ensure compliance:
" The Committee considers that the Department's statements ... raises serious concerns about its understanding of the ethical matters and accountability issues raised by gland collection and the monitoring of exclusion criteria as detailed in the Allars Report"
Following the enactment of uniform tissue legislation, the Committee noted:
" ... the Health Department failed to act to ensure that glands for the AHPHP were collected in a lawful manner. Not only did the Department have a role in overseeing the AHPHP, but it also had representatives on HPAC and should have ensured that legislation was complied with".
Some of the members of the Department's Subcommittees did not know that there were restrictions on the collection of glands.
The Committee considered:
" ... that the Allars Inquiry raises serious concerns about the role of government agencies in the establishment, control and accountability of the AHPHP .... the Department's comments about the decision making process in relation to the AHPHP and the matters addressed by the Allars Inquiry concerning the role of government agencies and accountability issues raise doubts as to whether the Department understands its responsibilities in this area".
The Committee noted the finding of the Allars Inquiry that the power to regulate was entrusted to those who ought to have been regulated and commented that it appeared that this arrangement was never challenged.
In relation to the criticism that was levelled at the Department during the Committee's public hearings, the Committee considered that:
" ... it is no excuse for the Department to say that `the decisions taken regarding the establishment and administration of the AHPHP were taken up to three decades ago and were based on the standards of the day. In fact this statement is erroneous".
In relation to the Department's response to the recent sixth case of CJD in the Australian recipient community, the Committee was:
"... concerned that it appears that the Department has again failed to respond adequately to a situation which has far reaching implications not only for one particular recipient and her family but also the whole recipient community"
The Department was also criticised for failing to advise recipients of the sixth case prior to the media disseminating the information. The Department's approach was considered to be "passive and overly officious".
The Department failed to respond to developments between 1985 and 1988 which raised "serious concerns" about the decision-making processes in the Department.
The Report concluded:
" ... the Committee is concerned that incorrect or incomplete information was provided to the Allars Inquiry concerning possible contamination of batches of hormone and whether or not they were distributed for recipient treatment. The Committee considers that this had added to the distress of some recipients and should not have occurred".
MACEDONE CHRISTIE WILLIS
3 November, 1997