Nineteen

Ian Frazer sat deep in thought. The last twelve months, as Australian of the Year, had taught him so much, and he was about to put it to the test. Now as president of Cancer Council Australia – a term that would run from 2007 until 2010 – he sat pondering the issue that sat on his desk. A private company had taken out patents over human genes and other biological material. The claims made by the patent holder, Myriad Genetics, included not only the isolated genetic mutations linked to breast and ovarian cancers, but to the proteins involved in the mutations and biological materials relevant to diagnostic tests. This would give Myriad Genetics monopoly control over the material. Ian didn’t like the idea of someone ‘owning’ a gene.

Each person is made up of more than twenty thousand genes, and they provide vital information about us, including our susceptibility to disease. While patents had been issued over them before, there was growing concern about the practice. If a company was allowed to own a gene or other naturally occurring biological material, anyone else would be prohibited from using it for research, and Ian thought this could delay cures and treatments. Ian believed that the human genome was public property. He believed anyone should be able to patent a method of looking at genes, but there should be nothing patentable in the fact that genes existed – whether they were normal or not. The issue had come across his table courtesy of patent expert Luigi Palombi, who was trying to have the practice stopped. Unrest was also growing in the medical community about gene patenting. Ian Frazer decided it was a priority, and while the Cancer Council’s many challenges would always be broad, he would lend his personal support to this issue.

Other issues that were naturally the domain of the Cancer Council – skin cancer, smoking, and bowel cancer – took up most of its discussions, and Ian Frazer went to countless meetings and breakfasts with politicians to argue the Cancer Council’s position. These three issues were also the biggest focus for the Cancer Council’s chief executive officer, Ian Olver. Olver, an oncologist, researcher, and bioethicist, knew Ian Frazer well. Their relationship was an easygoing one, built on mutual respect, an understanding of each other’s roles, and a shared passion for the cancer council’s objectives. Ian saw his role as supporting his CEO, and Olver welcomed the pragmatic approach the president brought to the table. Olver also knew he had Ian’s strong support, and marvelled at how the former Australian of the Year was able to respond to every email Olver fired off within hours of receiving it – irrespective of what country Ian might be visiting, or what time of day or night it was. Others say the same; it was as though he never left the computer.

Skin cancer, which causes the death of 1,700 Australians every year, was always going to be a high priority, and Ian Olver didn’t miss an opportunity to drive home the message that sun and sand carried serious danger. Ian Frazer, who had begun his own research into skin cancer, supported him. With one in four teens suffering sunburn on a typical summer weekend, the Cancer Council roped in cricket star Michael Clarke to front a campaign, lobbied government hard for funds, and even lined 1,700 towels along the beach at Bondi to show the stark reality of how many lives were lost each year to skin cancer. Each small win was celebrated – the take-up of ‘No Hat, No Play’ policies, programs to apply sunscreen to children in childcare centres, and to deck out playground facilities with shade. The solarium industry fizzled quickly, under the torch of media criticism, rapidly declining by thirty-two per cent over the three years to 2009.

To the public, smoking remained the Cancer Council’s main focus. But with one in five Australians a daily smoker, and Australia boasting higher smoking rates than Sweden, the United States, Portugal, and Canada, it was harder to make headway. The Cancer Council knew that many smokers wanted to give up but struggled with the addiction, while young people, irrespective of warnings, continued to take it up. How do you destroy the myth that smoking makes young adults look more attractive, even more worldly? The Cancer Council joined other anti-tobacco organisations to lobby federal and state governments on two fronts: first, make cigarettes less obvious and attainable; second, make them less appealing, particularly to young people.

At the end of Ian Frazer’s first year as president, the Tasmanian parliament passed some brave legislation: the display of tobacco products in all retailers except specialist tobacconists would be phased out over four years. Olver knew this would apply pressure elsewhere. At every opportunity the Cancer Council would repeat, like a broken record, that each year 7,700 Australians died from cancers caused by smoking. About the same number of smoking-related deaths came from other illnesses such as emphysema, heart disease, and stroke. The lobby was relentless, and community antagonism towards smokers helped to create a groundswell of support for change, with a key legislative victory announced by the federal government early in 2010: compulsory plain packaging for tobacco products. It would target the two issues central to the Cancer Council’s fight against smoking, led by Ian Olver and backed by Ian Frazer: the availability and appeal of tobacco, particularly to young people.

But it was bowel cancer, and the chance to reduce its toll, that was top of the Cancer Council’s agenda during Ian Frazer’s reign as president. They wanted all Australians aged fifty and over to be screened for bowel cancer, which was stealing eighty lives each week. Ian joined Olver to lobby both sides of politics, reminding them that screening was also recommended by the National Health and Medical Research Council. It wasn’t a cheap plan, the Cancer Council knew that, but screening prevented up to a third of bowel cancer deaths among the screened population. Extending it to all Australians over fifty just made good common sense. While some progress was made during Ian Frazer’s presidency, the Cancer Council continued to lobby government to broaden its current screening processes. Eventually, in the 2012 budget, the federal government announced a timetable for delivering the whole program.

With forty thousand cancer deaths each year in Australia – and one-third of those preventable through lifestyle changes and early detection – smoking, bowel cancer, and skin cancer were always going to dominate the discussions during the time Ian Frazer was president. Indeed, those same three issues had been the focus when Ian had served as vice-president to Judith Roberts, and later when Hendy Cowan, who served as Ian’s vice-president, took over.

Cancer Council staff liked Ian in the role of president. While he didn’t see it as his job to interfere, he was a strong sounding board. Judith Roberts was struck by the way he made decisions; he considered the ‘people’ impact and his logic followed from there. He was always direct and could bring meetings back to focus when they started to meander. Hendy Cowan, a stickler for procedure, reminded his president a couple of times to adhere to the meeting rules, while Ian just wanted to get things done – by yesterday.

Cowan thought his president never really looked comfortable in a suit, and wondered how he had got to where he was with no semblance of an ego. Other Cancer Council staff thought the same. Ian would talk about his family if asked, and his university, even his research, but he didn’t speak about himself. Some put it down to shyness, others thought he liked to be taciturn, but they were all aware of the influence he carried with the politicians who ran Canberra. They knew that senior politicians doing their research on a health issue would pick up the phone and call Ian Frazer, to ask his advice. And he was happy to provide it. He was also very keen not to be seen, in any way, to be using his position for himself. Hendy Cowan learnt that very early on, when he invited Ian into the swish Qantas Chairman’s Lounge at Sydney airport. The two men had been in Sydney for a meeting and Ian was waiting to board a flight back to Brisbane. Ian looked uncomfortable, finally admitting that he was worried it would be construed as misusing his position. His embarrassment only grew when he ventured into the lounge to be recognised by everyone.

But while lobbying over skin and bowel cancer and the death tally from smoking took up the long days put in by Ian Olver, Ian Frazer’s attention kept coming back to the issue of whether someone should own part of the human genome. Could he elevate the issue so that the public – those who had responded to him as Australian of the Year and had shown such a willingness to listen and learn – would want to fight it too? He wanted people to understand that gene patenting had the power to frustrate investigations into new cancer treatments, including vaccines. He needed them to understand that patenting a particular gene meant that researchers could not then carry out crucial work unless they had consulted the private companies that owned the patent their work might infringe. But he also knew, despite the efforts of a few politicians, including federal Labor MP Melissa Parke and federal Liberal Senator Bill Heffernan, that the issue didn’t carry big political currency. It wasn’t the talk of the day like interest rates, and, despite its importance, it was hard to sell as a crucial, urgent policy debate.

Ian Olver was in a mini-bus on his way to Canberra airport when biotechnology patent expert Luigi Palombi telephoned him. Luigi’s passion came across quickly; he’d been interested in the issue for years, but his attention to gene patenting resurfaced when he read a report in the Canberra Times suggesting that testing for a particular type of breast cancer was under threat as a result of a patent being awarded. Luigi saw red and offered himself to the Cancer Council as an adviser on the issue. The offer was quickly taken up by both Ian Olver and Ian Frazer.

Ian shared Luigi’s concern that women might not be able to be tested for a particular gene involved with breast and ovarian cancer because someone owned the test. The patents had been taken out by Myriad Genetics in the United States (the exclusive rights to the patents in Australia were held by Melbourne-based Genetic Technologies) and related to the human gene known as BRCA1, as well as BRCA2 genetic mutations. Mutations on the BRCA1 gene were associated with increased risk of hereditary breast and ovarian cancer. While IP Australia, the national patents body, had been granting ‘ownership’ of specific human genes, the Myriad Genetics patent showed the real impact of the policy. You can’t block people from diagnostic tests because of intellectual property, Ian thought. How can a company treat part of an individual’s make-up as its own exclusive property, Luigi thought. They felt that no one had the right to claim they had invented genes or other biological materials that might be triggers for cancer. It was a powerful combination: Ian, a patent holder of something that might eliminate cervical cancer, Luigi, who held a degree in economics and a PhD in law, relating to the patenting of biological materials.

Together, they worked on raising the profile of gene patenting as a public health issue. Luigi understood the power Ian Frazer wielded. He wanted Ian to take a public position, to tell people about the consequences of commercial enterprise owning chunks of the human genome. Ian Frazer agreed, and in August 2009 he put pen to paper in an opinion piece that was published in the Weekend Australian.

As a scientist and patent holder, I can understand why clinical researchers seek to have their inventions patented, he wrote. Individuals or corporations whose talent and hard work result in a useful invention ought to benefit from a system that protects their investment of time and effort – and their willingness to make the invention public – by ensuring their labour and creativity are rewarded. According to Ian, patent law had been developed as an incentive to ingenuity, to help make the benefits of invention widely available to further develop novel uses for the invention. However, patenting of a naturally occurring gene sequence and claiming the right to benefit from the use of that gene sequence by others fails on both counts.

Its timing was perfect, published one week after a Senate committee began hearing on the issue. Right through the legal battle over Ian Frazer’s patent, he did not stop communicating with scientists on the other sides. Science was about team work, with each team using what another team had discovered to advance its own research. That’s how real advances were made, Ian thought, and that was the point that hit home in his first public support for a ban on gene patenting: Science sits on the cusp of a surge in the use of genes in the diagnosis and treatment for major illnesses, he wrote. The collegiate tradition of sharing raw data among researchers must be allowed to continue unfettered so new technologies can be developed to benefit all.

It wasn’t just an issue in Australia, with Bill Clinton and Tony Blair announcing almost a decade earlier that gene patents should be banned. The thrust of their message was wider than genes, and enveloped the patenting of any natural phenomena that might impede scientific discovery. The case that had sparked attention in Australia had also been heard in the United States. There, Myriad Genetics was granted a patent, and this was mirrored by IP Australia. When a higher US court then overturned the patent, it was reinstated on appeal. In 2012 the US Supreme Court agreed to take the case for a second time. In Australia, the same fight has been unfolding before the courts, where Luigi has assisted Maurice Blackburn Lawyers, Cancer Voices Australia, and Brisbane woman Yvonne D’Arcy, who represents the human side of the debate. They challenged biotech companies Myriad Genetics and Melbourne-based Genetic Technologies, essentially asking the Federal Court to determine whether we own our genes once they are outside our body. The case focused on the patent over mutations to the BRAC1 gene. But while hundreds of gene patents have been handed out over the years, no Australian court had ever ruled on whether it was legal. For that reason, the Federal Court decision in February 2013 that allowed the private companies to hold a patent over BRCA1 was groundbreaking. The opponents immediately flagged an appeal.

Yvonne D’Arcy was first diagnosed with breast cancer in 1998, at the age of fifty-two. In 2009 she found she harboured a second and unrelated cancer in her breast. She doesn’t fit the category of a genetic cancer sufferer – where the BRCA1 is involved – but she knows what it is like to receive that gut-wrenching news that you have cancer. For that reason, she says she is suing Myriad Genetics for those women without the power to fight, those women who might be carrying a gene patented by a company. At the moment, women can get tested for the abnormal gene, which often leads to cancer, but it remains a breach of the patents held by Myriad Genetics. While no other supplier of the test has been sued, it doesn’t rule out the possibility, and Luigi wants that stopped, using both the courts and parliament to advance the cause.

But despite the rhetoric, the political will continued to only chug along for change. Luigi knew he had to build a political groundswell of support and knew Ian Frazer had the best chance to do that. Luigi, an articulate and educated advocate for the cause, admired Ian Frazer and his patient, even-minded, and unbiased approach. He also knew that Malcolm Turnbull had had a long chat to the cancer council president before standing up in parliament and arguing against the patenting of genes. He was one of only a few politicians demanding change, but he was a crucial and senior player in the mix. Yet Ian Frazer’s support was a double-edged sword, which Luigi found difficult to reconcile. While his support to ban the ownership of genes was the springboard for debate on the issue in parliament, as well as on talkback radio, and as the promise of change grew, they had a difference of opinion. Ian Frazer didn’t want to go as far as Luigi Polambi. It was a matter of degrees about what should and should not be legislated, about what could and could not be patented. But just as Ian Frazer’s backing raised attention to the issue, his decision not to support the specific bill that ended up in federal parliament – the Patent Amendment (Human Genes and Biological Materials) Bill 2010 – hurt Luigi’s argument for big reform, at least in the eyes of many politicians.

Both remain committed to changing the status quo in Australia, despite achieving some reforms in the Raising the Bar Bill 2011, an amendment to the Patents Act 1990. While tightening up some criteria, it did not address the central issue of whether a gene could be patented. Luigi will continue to bring cases through the courts and fire up our politicians to what he sees as gross injustice. And Ian Frazer remains committed to reform, continuing to attend meetings despite leaving the Cancer Council Australia presidency behind at the end of 2010.