CLINICAL TRIALS UNLEASHED
October 2011
In September 2011 the government issued its response to the Report of the Health Committee on its Inquiry into improving New Zealand’s environment to support innovation through clinical trials.
The government’s response makes for grim reading as it outlines how they plan to reduce the number of ethics committees from seven to four and streamline the process to make the main objective of ethics committees that of supporting clinical trials rather than protecting patients.
The Health Committee’s clinical trials report was also focused on the need to take advantage of the dollars attached to “supporting innovation through clinical trials.” The Health Committee came up with a total of 54 recommendations, comprising eight key recommendations and 46 more detailed ones.
The 8 key recommendations were:
• Simplify and streamline ethical review processes
• Collaboration between the Ministry of Health, the Ministry of Science and Innovation, the Ministry of Economic Development, and New Zealand Trade and Enterprise
• A national health research action plan that fosters innovation and commercialisation
• A national framework for clinical trial research through DHBs
• Build constructive and transparent relationships with the international biotechnology and pharmaceutical industries
• Ensure excellent scientific infrastructure to run clinical trials
• Establish a long-term objective in research and development investment
• New Zealand to urgently assess Australian and UK clinical trial reports.
Growing the clinical trial industry
The Health Committee was clearly alarmed that New Zealand was missing out on the lucrative market for clinical trials. Chapter 3 of their report described the steps that need to be taken for New Zealand to create an effective clinical trials environment. The report stated “New Zealand needs to be attractive to overseas sponsors of multinational research projects. An environment conducive to pharmaceutical companies funding these trials in New Zealand is required if the clinical trial industry is to grow.”
The Committee was told that one of the important factors for a productive clinical trial environment for pharmaceuticals was “the efficiency with which the New Zealand health system can interface with the pharmaceutical companies to deliver an efficient clinical trial outcome.” (1)
One of the things obviously standing in the way is New Zealand’s ethics committees. Hence the need for the changes which “will result in a more efficient, consistent and transparent Health & Disability ethics committee review process.” (2)
While there is a token reference to “significant ethical issues” and “the protection that committees offer to participants in such research,” the government intends to alter the structure of ethics committees to ensure that they do not obstruct the pharmaceutical industry or stand in the way of delivering “efficient clinical trial outcomes.” This is how they plan to do it.
Ethics committees prostituted
The number of ethics committees will be reduced from seven to four as of 1 July 2012 and will continue to meet monthly.
The numbers on each committee will be reduced from twelve to eight. With another token gesture, this time to the Cartwright Inquiry, the government says it is important that lay people continue to have a strong voice and that they continue to make up approximately one half of the ethics committee membership as the Cartwright Inquiry report recommended, so “at least three members” of each committee will be lay. Since when did half of eight equal three?
The number of applications that require a full review by an ethics committee will be reduced, and the number of expedited reviews for applications for some low-risk clinical trials will be increased. Who gets to decide what is “low-risk” is not stated.
The intention seems to be that all observation studies proposals will be exempted from ethical review, so issues about privacy and protection of patient data in such studies will be exempt.
It will be the responsibility of the investigator and sponsor to obtain the peer review report on the scientific merit of the proposal – how’s that for a conflict of interest? The ethics committee won't even see a copy, its role being confined to checking that this has been done. It seems that scientific aspects of a proposal are no longer the business of ethics committees, though without that information, it is impossible for them to evaluate matters such as risks/safety for participants and scientific worth (a recognised ethical issue).
New timelines for review are to be introduced and monitored. Under the updated operating procedures for ethics committees a timeline of 35 days will be imposed for a full review and 15 days for an expedited review. Ethics committees “will be required to report regularly against these time-lines, and are expected to exceed them in most cases.”
Applications online
The government is also supportive of the development of electronic (online) applications and a centrally managed system for ethics committee review – meaning centrally managed by the Ministry of Health.
The ability for researchers to make minor changes to their research after it has received ethics committee approval will also be introduced. No prizes for guessing who will decide what are “minor changes.”
Fortunately the government rejected the Health Committee’s recommendation to make research a core activity undertaken by district health boards, and fund DHBs to undertake clinical research as a front-line activity. The objectives of DHBs must remain centred on “the improvement, promotion and protection of the health of people and communities, and the reduction of health disparities,” the report states.
Importance of independence
The report of the government’s response is another nail in the coffin for the concept of independent ethics committees whose primary objective is protecting patients. Those currently in charge in government and in the Ministry of Health have forgotten the lessons learned from both the Cartwright and Gisborne inquiries.
Ethics committees were never going to be appropriately managed and safe from being amended to suit professional and commercial interests by being placed within the Ministry of Health. Consumer groups have argued for more than a decade that responsibility for ethics committees should be placed within the office of the Health & Disability Commissioner.
The November 2008 issue of the AWHC’s newsletter featured an article detailing concerns being voiced by the chairperson of the Health Research Council’s Ethics Committee (HRCEC) following the slashing of ethics committees in 2004. The article raised issues about the focus of ethics committees shifting away from the protection of patients. The article is featured below.
Women’s health groups attending the Gisborne Inquiry into Cervical Screening were also strongly opposed to the National Screening Unit being placed within the Ministry of Health and warned of the risks involved if the National Cervical Screening Programme was left at the mercy of the MOH. In June 2011 the “Report of the Parliamentary Review Committee regarding the NZ Cervical Screening Programme” was released. This report also makes for grim reading. Sandra Coney’s outline of the risks involved for the NCSP if it was placed within the Ministry has been proved to be dismayingly accurate. The same has proved true for New Zealand’s ethics committees.
Right 7 (10)
One of the reassurances given to women’s health groups when Right 7 (10) of the Code was amended to permit research to proceed without patient consent when tissue removed was sought to be used for research purposes was that the ethical review process would provide a strong and effective safeguard. How hollow that reassurance now sounds!
The government’s report reveals the result of the battle between the need for independent ethics committees focused on protecting patients vs the interests of the pharmaceutical/ research industries.
The score: Drug Companies 1
Patients 0
References
1. Health Committee. “Inquiry into improving New Zealand’s environment to support innovation through clinical trials.” June 2011.
2. “Government Response to the Report of the Health Committee on its Inquiry into improving New Zealand’s environment to support innovation through clinical trials.”
Researchers also opposed to the decimation of New Zealand ethics committees -
www.odt.co.nz/opinion/opinion/181806/research-participants-need-protection
CONCERNS OVER NZ’s ETHICS COMMITTEES
November 2008
The October 2008 issue of the Health Research Council’s newsletter Ethics Notes featured a timely article that provided a critical look at some of the problems with the current system of ethical review of research in New Zealand. The article was written by Dr Tim Dare, a lawyer who is the chair of the Health Research Council’s Ethics Committee (HRCEC) and a member of the clinical ethics committees of the Auckland and Waitemata District Health boards. It confirms some of the concerns that women’s groups have had over the past decade.
Cartwright Report
Today’s structure and function of ethical review committees was established in the wake of the report of the Cartwright Inquiry that found that “the lack of the systematic seeking of consent to inclusion in research or treatment (except for operative procedures) and the inadequate procedures for approval and surveillance of research and treatment, pose a serious risk to patients’ rights.” One of Judge Silvia Cartwright’s recommendations was that all health research should be reviewed by an independent ethics committee. She also recommended that the ethics committee at National Women’s Hospital should be disbanded because it had “failed in significant areas.”
Lay membership
As part of a raft of measures introduced nationwide following the Cartwright Inquiry, hospital ethics committees were disbanded and independent ethics committees were established by the Area Health Boards with the expectation that they would abide by the national standard that had just been developed by the then Department of Health. The new ethics committees were comprised of 50% lay members and 50% health professionals/ scientific members with the chairperson having to be a lay member. Fifteen regional ethics committees were set up throughout the country but within a few years it was reported there were significant differences in their membership, scope and in how they operated.
In April 1993 the Department of Health announced that ethics commit-tees would be moved out of the Area Health Boards. An Interim Ethics Taskgroup was established to review both the existing ethics committees and the 1991 standard for ethics committees. This and further changes to the health system eventually resulted in the establishment of the Health and Disability Ethics Committees.
NEAC
Following the passage of the New Zealand Public Health and Disability Act in 2000, the National Ethics Advisory Committee (NEAC) was established and its members were finally appointed in December 2001.
NEAC’s statutory functions are to provide advice to the Minister of Health on ethical issues of national significance regarding health and disability research and services, to determine nationally consistent ethical standards and to provide scrutiny for such research and services.
Gisborne Inquiry
The cervical screening scandal in Gisborne resulted in a second major Inquiry in 2000 and the release of another report in 2001 that among other things recommended changes to the system of ethical review. NEAC undertook a review of the ethics committees system and a report with the committee’s recommendations went to the Minister of Health in December 2003.
Ethics committees slashed
This resulted in the number of ethics committees being reduced to six and the addition of new national multi-centre ethics committee responsible for the review of all multi-centre and national research. Whereas under the previous system each of the 13 ethics committees had its own exclusive geographical jurisdiction, the six new ethics committees had their jurisdiction widened to four regions, with the two busiest regions having two committees each. These changes were implemented in 2004.
Multi-region ethics committee
However, Dr Tim Dare’s article reveals that the new system has not worked entirely as planned. He reports that:
“The multi-region practice was creaky and time consuming, though it had some serendipitous advantages. One committee acted as the ‘lead committee,’ co-ordinating responses from the remaining committees. Though it was almost certainly not its goal, the system provided uniformity: no answer went back to researchers until the co-ordinating lead committee had seen the input from the contributing committee.”
Furthermore, the expectation that the new multi-region committee would drastically reduce the work of the six regional ethics committees was soon revealed to be totally unfounded. Dr Dare who was chair of the busiest regional ethics committee at the time of the restructuring, says it quickly became clear that there had been a miscalculation. Both the multi-region committee and some of the regional committees were swamped. Since then Dr Dare says that chairs have being raising concerns about the capacity of their committees to manage their workload ethically.
“There have been attempts to address these problems. In 2007 a system of expedited review of observational research was introduc-ed. The aim was both to assist researchers and reduce committee workloads. While the system may have reduced committee workload, it seems to have increased the work-load on chairs and deputy chairs who bear most of the burden of providing expedited reviews. More recently changes have been introduced to allow research to be sent ‘out of region’ to less busy committees.”
Lack of consultation
As Tim Dare points out, not only are these latter changes to the terms of reference inconsistent with the assumption of regional review for local research which has underpinned the system of ethical review, they were made without consulting with the Health Research Council Ethics Committee (HRCEC).
Given that one of the HRCEC’s responsibilities is “to give in relation to ethics committees established by other bodies, advice on membership, procedures, and standards to be observed by those committees,” as well as to provide second opinions for the ethics committees, such a lack of consultation is of considerable concern.
Tim Dare concludes his article with the warning:
“Not only do excessive workloads threaten ethical review directly, they also endanger the goodwill of committee members (who, given current meeting fees, may fairly be regarded as volunteers). The HRCEC remains concerned that no long-term solution to the workload pressures on ethics committees has been found.”
The above changes have all been documented in the AWHC’s newsletters over the past decade. They were always accompanied by the call for ethics committees to be made completely independent of the Ministry of Health and to be located within the Office of the Health and Disability Commissioner. We made this recommendation again when preparing our submission on the review of the H&DC Act and the Code of Consumers’ Rights in 2009.
In 2008 there were a number of events commemorating the 20th anniversary of the release of the Cartwright Report on 5 August 1988. None of them addressed the issue of what happened to the Cartwright Report’s recommendations regarding ethics committees. The report stated: “New treatment procedures are not systematically reviewed by the Ethical Committee but will be considered if put to it.” When the Area Health Board ethics committees were first established it was expected that they would review new treatment procedures, but the workload of reviewing research proposals quickly put an end to any serious attempt to fulfil that task.
As stated above the Cartwright Inquiry revealed that rights of patients at National Women’s Hospital had been seriously neglected. The Cartwright Report called for a system of ethical review to be put in place that “focused on the protection of patients.” The changes that were made in the first few years after the release of the Cartwright Report went a considerable way towards addressing the issue. However, as with some of the other areas to do with the issues that were bought to light during the Cartwright Inquiry, two decades have seen a loss of ground and a resulting tendency to focus on the needs and desires of researchers, the medical profession and the health system.
The AWHC has major concerns around what has happened to our system of ethical review after the Ministry of Health took control of the ethics committees. It is time to put the spotlight on whether they are really focused on the protection of patients, and to consider placing them under the umbrella of the Office of the Health and Disability Commissioner.
References
• “The Report of the Cervical Cancer Inquiry 1988”
• “Ethical review of research in New Zealand” Ethics Notes October 2008
