A voice for women's health

Clinical Trials Unleashed - October 2011

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 here.

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

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