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Letters

What changes are needed to the current direction and interpretation of clinical cancer research to meet the needs of the 21st century?

Matthew P Doogue and Kathleen M Knights
MJA 2009; 191 (3): 190

To the Editor: Articles by Olver and Haines1,2 have catalysed robust discussion about the relationship between the pharmaceutical and device industries and the medical profession.3 These authors advocate changes in the direction of clinical cancer research and in health policy.2 In an era in which research into medicines is dominated by industry, they argue for greater scrutiny of data in a resource-constrained environment, and for fundamental changes in the collection, interpretation and ownership of data. We find their arguments sound and equally applicable to other areas of medicines research and health policy.

Their primary recommendation is for “. . . a system to follow up and evaluate the outcomes of all treatments . . .” That is, that we exercise our duty to patients by monitoring and analysing existing clinical data to inform health care policy. There is a great deal of valuable clinical data collected that are not readily accessible because of ownership or privacy issues. For example, much business involving public health dollars is labelled “commercial in confidence”, and laboratory data held in many pathology databases are not accessible at all. The likely benefits to patients and society of transparency and data linkage in health care are greater than possible benefits to individuals of secrecy and privacy.

Quality use of medicines (QUM) is one of the central objectives of Australia’s national medicines policy. QUM means selecting management options wisely; choosing suitable medicines if a medicine is considered necessary; and using medicines safely and effectively.4 Olver and Haines also identify issues relating to quality use of research. Quality use of research might include: supporting research into monitoring clinical outcomes related to drug use; supporting research into better use of existing drugs; and supporting truly independent guideline development.

There continue to be advances. For example, registration of trials in public databases, such as the Australian New Zealand Clinical Trials Registry, should reduce publication bias.5 However, the decline of independent public sector clinical drug research and the marketing-based design of phase III and, increasingly, phase II industry-funded studies contribute additional bias to the available information.

Olver and Haines’ arguments apply to all therapeutics, and particularly to all drug therapies. We strongly support their proposals for health data linkage and for quality use of research. These fit within existing health policy, and our continued failure to make full use of clinical data is an ethically compelling reason for improved political and clinical governance.

Matthew P Doogue, Convenor, Clinical Special Interest GroupKathleen M Knights, President

Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), Adelaide, SA.

kathie.knightsATflinders.edu.au

  1. Haines IE, Olver IN. Are self-regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry? Med J Aust 2008; 189: 263-266. <eMJA full text> <PubMed>
  2. Olver IN, Haines IE. What changes are needed to the current direction and interpretation of clinical cancer research to meet the needs of the 21st century? Med J Aust 2009; 190: 74-77. <eMJA full text> <PubMed>
  3. Van Der Weyden MB. Doctors and the pharmaceutical industry: time for a national policy [editorial]? Med J Aust 2009; 190: 407-408. <eMJA full text> <PubMed>
  4. Australian Government Department of Health and Ageing. Publications. Quality Use of Medicines (QUM) strategy. http://www.health.gov.au/internet/main/publishing.nsf/Content/nmp-pdf-natstrateng-cnt.htm (accessed May 2009).
  5. Australian New Zealand Clinical Trials Registry [website]. http://www.anzctr.org.au/ (accessed May 2009).

(Received 6 Apr 2009, accepted 12 May 2009)


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©The Medical Journal of Australia 2009 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377