Gary Gray (Brand, Australian Labor Party, Shadow Minister for Resources) Share this | Hansard source

I rise to speak in this debate on the Medical Research Future Fund Bill 2015 as a former executive director of the Western Australian Institute for Medical Research. This foundation is now known as the Harry Perkins Institute of Medical Research. It is named after the very significant first Chair of the Western Australian Institute for Medical Research, Mr Harry Perkins. I worked for the Western Australian Institute for Medical Research at a time when the Howard government had begun to take a real interest in medical research, led by then health minister Michael Wooldridge. Michael Wooldridge should be recognised in this place as having been a science and medical research health minister. He was a minister who placed front and centre the need to lift medical research to a prime role in our public health care systems.

At that time, the government and the minister sponsored a report into medical research by Peter Wills. The Wills report still stands as a seminal piece of work teasing out and understanding the role that medical research plays in our public hospital system. What I mean by that is not the role that medical research plays in understanding disease, defining therapies, creating better cures and creating better health care; it is actually the understood impact that public hospitals participating in both medical research and patient care produce better outcomes for having medical research incorporated into the health management protocols at a clinical level within public hospitals.

This revelation provided a great imperative for the government to better integrate research into our public hospitals, producing what Peter Wills, in his report, called a virtuous cycle'—a virtuous cycle to improve health care, a virtuous cycle to improve outcomes in public hospitals, a virtuous cycle to incorporate clinical practice in medical research into the same organisations' instruments and, on some occasions, the same people to produce better outcomes. This would improve, of course, the science itself, the understanding of disease, the creation of better therapies, the creation of better clinical practices and the provision of better outcomes. Minister Wooldridge is to be congratulated for that work.

Australia has a proud record in medical research. We often like in this place to take great pride in our Nobel laureates in medical research. In Western Australia, the work of Barry Marshall and Robin Warren is greatly acknowledged and recognised not simply for the outstanding work that it is but because their work on helicobacter, on stomach ulcers, defines a better place for medicine in our public hospital systems and importantly in tackling an area of disease that was massively debilitating. The use of surgical interventions to deal with stomach ulcers would incapacitated patients potentially for some months and perhaps even for years; whereas the understanding of helicobacter and the treatment of ulcers as being the result of a bacterial infection created very genuine steps in medical research that gave people not just a better chance of diagnosis and recovery but also meant that the impact of the medicine and the treatment itself was much more mild and benign and left patients more capable of dealing with their work, their jobs, their lives and their families immediately following the intervention by the therapies developed by Marshall and Warren.

I was reminded of this late last year on the death of Don Metcalf, who was one of the great researchers at the Walter and Eliza Hall Institute of Medical Research in Melbourne, one of the great researchers into cancer therapies and blood borne diseases. Don did his work with Professor Glenn Begley, who later became the scientific chief executive officer at the Western Australian Institute for Medical Research. Glenn left the Institution for Medical Research in the early 2000s and took up a position as global head of haematology and oncology research at Amgen in California. Glenn's work at Amgen defined a whole new area of drug therapies. He was responsible at the time for building the haematology and oncology research program within Amgen. He also had scientific responsibility for marketing Amgen products, involving preparation and presentations at multiple FDA face-to-face meetings and at FDA drug advisory committee meetings. That experience allowed Professor Begley to have a unique perspective of therapies and of many of the new discoveries that were being considered by Amgen.

A little background on Glenn: in his early studies he first described the human G-CSF and in later clinical studies he first demonstrated that G-CSF 'mobilised' blood stem cells but hastened hematopoietic recovery compared with bone marrow transplantation. What this means in English is that the work that Begley and his team did better understood the hormonal response to bone marrow transplants and in managing that hormonal response meant that a bone marrow transplant could be done in a better way to create a healthful effect more beneficially and to ensure a reduced rate of rejection from bone marrow transplantations. The finding revolutionised the approach to clinical cell transplantation and his basic research focused on haematopoietic regulation. He defined the functions of CSFs and their receptors using animal models. He was the first to molecularly clone the transcription factor SCL and demonstrate its critical role in leukaemia and normal haematopoiesis. Dr Begley is board certified in Australia as a medical oncologist, as a laboratory haematologist and also he has a PhD in the cellular and molecular biology. He is highly significant in this field. He has published over 200 scientific papers and was elected to the prestigious American Association of Physicians in 2008.

In an article published in 2012 in the journal Nature,Professor Begley considered where cancer science was and he put it under the spotlight as he discovered some disturbing results. He discovered:

Over the decade, before pursuing a particular line of research, scientists … in the haematology and oncology department at … Amgen in Thousand Oaks, California, tried to confirm published findings related to that work.

During a decade, as head of the global cancer research facility at Amgen, Glenn Begley had identified 35 landmark publications, papers in top journals from reputable labs, for his team to reproduce. Begley sought to double-check the findings before trying to build on them for drug development. Scientific findings were confirmed in only six—that is, in 11 per cent of the cases. Another way of viewing that is that 47 out of 53 papers could not be replicated. Even under the limitations of preclinical research this could only be described as a shocking result.

When Amgen's replication team of about 100 scientists could not confirm the reported results, they contacted the authors. Those who cooperated discussed what might account for the inability of Amgen to confirm the results. Some let Amgen borrow antibodies or other materials used in the original study or even to repeat the experiments under the original author's direction. Some authors required the Amgen scientists to sign a confidentiality agreement barring them from disclosing data at odds with the original findings:

The world will never know which 47 studies, many of them highly cited, are apparently wrong—

said Professor Begley. This is critically important. Begley went on to say:

It was shocking. These are studies the pharmaceutical industry relies on to identify new targets for drug development. But if you're going to place a $1 million or $2 million or $5 million bet on an observation, you need to be sure it's true, that it is accurate and that it is good science. As we tried to reproduce these papers we became convinced that you can't take anything at face value—

in this area of science. Begley talked about one particular meeting with a lead scientist at one of the studies being looked at. Professor Begley said, 'We went through the paper line by line, figure by figure.' He said that he explained that they re-did the original experiment 50 times and could not replicate the original result. He said that they had done it six times and got the result once. The scientist said that they had done it six times and got the result that was reported just once. But he put it in the paper because it made the best story.

I just want to repeat that. If you contemplate this in the context of the scientific research that is being done, you have Amgen carrying out 50 tests on a published piece of scientific research that could not replicate the result that had been published. Then, on interrogation, the scientist said that they had done the experiment six times, that on one occasion they had got that result and that they published that result because that apparently made the best story. This is deeply disturbing.

A team at Bayer HealthCare in Germany produced similar results to those which Begley and his team had reproduced at Amgen. In a 2011 paper titled, 'Believe it or not', they analysed in-house projects that built on 'exciting published data' from basic science studies. Exciting published data does not necessarily mean accurate published data. It does not necessarily mean published data that will lead to a therapy. It does not necessarily mean data that will lead to a cure. It means merely that it was published data and that it was exciting. If you go back to the original scientist's commentary, the scientist argues that the material was published because it made the best story. This is not just disillusioning; it is deeply disturbing.

The Germans also concluded that the key data could not be reproduced. Of 47 cancer projects at Bayer during 2011, less than one-quarter could reproduce previously reported findings, despite the efforts of three or four scientists working full time for up to a year. Bayer dropped that research project. These investigators were all competent, well-meaning scientists who truly wanted to make advances in cancer research. They wanted to save lives, they wanted to make recovery processes better, they wanted to restore health and they wanted to give people better and more healthy lives.

I mention these stories not simply because they are true or because they are disturbing but because nowhere in this bill do we see any mechanisms that would fix the problem that has been identified in medical research in the United States and made public by a very significant Australian cancer research in Professor Begley. We need to give this consideration because we are talking here of a medical research fund that measures many tens of billions of dollars, that will potentially have an impact on medical research that will cast a shadow down the corridors of time for many generations. Fixing medical research to make sure that medical research works in the scientific interest is a critically important thing to do. It is what good science is based on, it is what good medicine can be built upon and it is ultimately what the work of the Wills inquirers discovered for Michael Wooldridge in 1999. It ultimately relates to good health care, good patient care and better outcomes in our public hospital systems.

As Wills reported so many years ago, in 1999, there is a virtuous cycle. Let's not see that virtuous cycle broken by bad science, let's not see that virtuous cycle broken by wasted public money and let's not see that virtuous cycle broken by a culture and practice in research laboratories that pursues the idea of publishing material that is of a sexy nature as opposed to publishing material that is important scientific discovery. The line that the in-house projects were published because they were exciting data, exciting for a media story, is deeply, deeply concerning. We need to have science that is built on good practice, that is published because it provides insights and that then, in our public hospital systems, can provide better medicine. This is an important part of what we do in this place.

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