| The betrayal of intellectual property and the incentive to produce |
| Our Genes - Genetic Politics |
| Written by Gavin Chait |
| Tuesday, 31 March 2009 00:00 |
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In 1993, after four years of research, Napoleone Ferrara had a breakthrough while studying tumour-development in mice. He had discovered an inhibitor for tumour angiogenesis, the process by which cancer grows uncontrollably in the body. Gordon Ide had identified that new blood vessel development was essential to providing oxygen and nutrients for tumour growth back in the early 1900s. Ferrara was first find to a molecular inhibitor for vascular endothelial growth factor (VEGF), a main protein involved in inducing angiogenesis. Genentech, where Ferrara worked, immediately set about the lengthy process of clinical trials on a number of related cancers. Calamity struck in September 2002, when the drug, now called bevacizumab, failed to meet its primary efficacy endpoint of progression-free survival in a phase III breast cancer trial. In 2004, they finally hit success. A trial consisting of 925 patients diagnosed with previously untreated metastatic colon cancer indicated that patients on bevacizumab had a median end-point survival time of five months longer than those without. This was the best result ever seen in a Phase III trial for any drug. The FDA approved bevacizumab, now under the name of Avastin, for colorectal cancer treatment on 26 February 2004. Genentech, and their new owners, Roche, had spent $ 2.5 billion in the drug’s development and allocated a further $ 1 billion for as many as an additional 450 clinical trials for about 30 types of cancer. Most of those trials will fail, expensively. From 2004 the clock started ticking. They now had twelve years in which to recover all their costs, as well as the costs for all the other drug research that never made it out of the pipeline. Treatment can cost as much as $100,000 a year and is earning Roche over $ 3.2 billion in revenue annually. These apparently thick profits at Roche and other pharma companies have earned the ire of legislators around the world. Reigning in Big PharmaThe US Senate has introduced a bill to lower the price of biotech drugs which cost Americans more than $ 40 billion per year. The proposal from Senators Charles Schumer and Susan Collins would cut patent protection down to five years. "It's past time we created a way for generic versions of these expensive drugs to come to market," Schumer said. The European Union is considering similar legislation. However, regulations, price caps and the like in Europe have already resulted in adverse reactions from drug makers. One tactic is the use of the “patent cluster”. Says The Economist: “A firm keen to defend a blockbuster due to go off-patent may file dozens or hundreds of new patents, often of dubious merit, to confuse and intimidate potential copycats and maintain its monopoly. An unnamed drugs firm once took out 1,300 patents across the EU on a single drug.” In addition, where reimbursement becomes impossible, drugs aren’t investigated at all. Tuberculosis and malaria remain deadly in Africa for lack of research funding. The Bill and Melinda Gates Foundation have reinvigorated research into the diseases the affect the world’s poorest, but it requires billions of dollars in private-sector donations to keep this process going. Thomas Jefferson, the third president of the United States, said patents should draw “a line between the things which are worth to the public the embarrassment of an exclusive patent, and those which are not.” However, in the case of medical research, is short-term political expediency starting to get in the way of long-term scientific advancement? Stifling innovationNew drug pipelines throughout the world are notoriously thin. There are few new antibiotics available once bacteria develop immunity to the present batch. Political and social antagonism have already prevented research into stem cells and genetically modified foods. Drug companies also have to bear responsibility for decades if their drugs cause any harm. Lederle Laboratories, a manufacturer of a live oral vaccine for polio, was fined $ 22.5 million in 2009 for having potentially caused polio in the father of a girl who was immunised with their drug in 1979. Fifty years ago polio killed 2,000 people a year in the US alone. Now no-one in the developed world dies from it. Despite the clear benefits of medical research, the litigiousness of lawmakers adds significant, and potentially unending, further costs to drug development. If companies, spending billions of dollars on primary research, are given an ever-shrinking time in which to recover their costs, they may decide not to conduct the research at all. Adam Smith, writing in the Wealth of Nations, wrote: “It is not from the benevolence of the butcher, the brewer, or the baker, that we expect our dinner, but from their regard to their own self-interest. We address ourselves, not to their humanity but to their self-love, and never talk to them of our own necessities but of their advantages." Pharmaceutical companies are not in it for their customer’s health, but for their own profits. This is an incentive that works extremely well, having seen human life-spans shoot up from 20 to 30 years in Medieval Britain, to almost 70 in the developed world now. There is certainly a need for patent reform. So called “patent trolls” squat on ideas they have no intention of developing simply hoping to sue genuine researchers for unwittingly trespassing on their “ideas”. This is costing legitimate companies billions of dollars in court and settlement fees annually. But this is a problem of making patenting too easy, not too long. Certainly, patents should not be in perpetuity, but they should be commensurate with the cost of development. The debate should not be about political expediency, but about what level of “embarrassment” an exclusive patent is worth in terms of acting as an incentive to others to produce life-improving innovation. It is already obvious that patents are overly politicised. No clearer picture of that exists than in the difference between patents, and copyrights. Copyrights are, after all, merely another form of patent but limited to written words, music or artistic creations. Here, copyright patents are enforceable for up to 70 years after the death of the creator. The EU’s European Commission is backing the extension of this right to 95 years. A popular song can take a few hours to produce and require the labour of a small number of people. A popular drug can save the lives of millions, cost billions to produce and involve the creative efforts of thousands. Yet the former receives protection for two lifetimes, while the latter is expected to be a charitable effort. Lest we wind up a planet full of sickly, short-lived, people, with perpetual protection over our poetry, it is time for regulators to relook at patent protection. Acknowledgements & Sources:“Persistence—luck—Avastin”, Journal of Clinical Investigation, 1 April 2004 “Costly Cancer Drug Offers Hope, but Also a Dilemma”, The New York Times, 6 July 2008 “Generic biotech effort picks up steam in Congress”, Associated Press, 27 March 2009-03-30 “Bill Would Let Copycats Compete With Biotech Drugs”, The New York Times, 26 March 2009-03-30 “Staten Island man awarded $22.5M in polio case”, Staten Island Advance, 20 March 2009-03-30 “Monopolies of the Mind”, The Economist, 11 November 2004 “Patently absurd”, The Economist, 4 December 2008 “Musicians urge copyright change”, BBC, 26 November 2008 |
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