You can't patent ethics



Recently you may have missed the news that Yvonne D’arcy won her case in the Australian High Court. D’arcy had been involved in legal action against Myriad Genetics, a US biotech firm that developed a test to determine if people have a predisposition towards breast cancer. This was ground breaking stuff — and showed that, at least sometimes, the human will overcome corporate goals.

To discuss why this result is so important, we need to go back to the early years of the 21st century — 2003 to be exact. A quick disclaimer is required here. My medical training is limited to occasionally being able to get a ‘band-aid’ to remain where I want it for a period of more than a couple of hours: so the explanation of why this court case and its implications are important isn’t full of medical English.

In 2003, scientists completed the mapping of the human genome: in essence humans could now read and manipulate the biological codes written in the 3 billion building blocks of who we are and how we exist — our genome (or DNA). The formal project took 13 years. Although DNA had been identified 50 years prior to the finalisation of the Genome Project, and some items of DNA were worked on prior to ‘the project’, it took a while to work out what the 3 billion building blocks actually did. While it took 50 years to gain the understanding, now that we have it, those with the knowledge can compare what is in your body to what is expected to be there and identify a treatment for you, rather than for the average person of your age, gender, weight and so on, which leads to less adverse side effects and the better use of resources.

U.S.News reported:
Genomic medicine may help determine a person's risk of developing several specific medical conditions, including:
Cancer
Cardiovascular disease
Neurodegenerative diseases
Diabetes
Obesity
Neuropsychiatric disorders

Researchers are actively investigating the genomic and genetic mechanisms behind — and developing predictive testing for — such diverse medical conditions as:
Infectious diseases, from HIV/AIDS to the common cold
Ovarian cancer
Cardiovascular disease
Diabetes
Metabolic abnormalities
Neuropsychiatric conditions, such as epilepsy
Adverse drug reactions
Environmental exposure to toxins
It is possible to ask your general practitioner to arrange for your DNA to be mapped to identify potential problems. Before you go rushing down to see your doctor, however, consider this: if you discover that you have a predisposition for a form of cancer, you would have to disclose that information to your partner, your family as well as potentially those that make a business decision to insure you. In addition, in a similar way to saying those that live in Southern Tasmania are less likely than Queenslanders to acquire skin cancer, while you may have a predisposition it doesn’t necessarily follow that you will acquire the particular cancer. In May 2013, actor Angelina Jolie decided to undergo a preventative double mastectomy due to family history of breast cancer, supported by testing that revealed she carried mutated BRCA1 and BRCA2 proteins — indicators of a predisposition towards acquiring breast cancer. She had no signs of breast cancer when she underwent the operation and while the probability is that she would have developed the condition, it’s not a certainty.

Those who have, or have seen those close to them, endure cancer treatment over the years would be aware that medical advances, such as better testing, have meant that treatments for cancer are more effective and less debilitating now than they were 10 or more years ago. While in the past, it was common for people to lose their hair and be incapacitated for days after treatment; it is a far less common occurrence today. To an extent, this is an outcome of personalised medicine; the science has identified the correct targeting and dosage of the medicine to reduce adverse side effects while still being effective.

Medical science could now go from ‘taking a punt’ on a standardised dose of medicine having a beneficial effect to creating medicine based on the person it is meant for. Personalised medicine is still in its infancy — there seems to be a lot of potential for further advances. As you would expect however, some of the testing and development for the processes to be used is expensive. And here is the point of this article.

Some companies will develop a process, be it for medicine, software or vehicle safety (as examples) and patent it. According to IP Australia (the Government body that registers patents in Australia), a patent is:
… a right that is granted for any device, substance, method or process that is new, inventive, and useful. A patent is legally enforceable and gives you (the owner), exclusive rights to commercially exploit the invention for the life of the patent.
Others may determine that the invention is so important to humanity or their reputation that they decide not to profit directly from the invention. You sometimes hear of ‘open source’ computer software — it is software that is developed by a group and freely available for use by anyone. The theory is that others will improve further on the developed software, to the benefit of all.

Some things cannot be patented: again according to IP Australia:
You cannot patent human beings or the biological process for their generation, artistic creations, mathematical models, plans, schemes or other purely mental processes.
The Human Genome Project has identified that a piece of protein known as BRCA1 and BRCA2 suppresses tumours in breasts and other organs by trying to fix damaged DNA or destroy what it can’t fix. A company in the USA called Myriad Technologies developed a test to determine the ‘health’ of the BRCA1 and BRCA2 protein and patented the mutated ‘indicator’ proteins that it identified during its research.

Myriad Technologies launched their product that would test for the mutated BRCA1 and BRCA2 protein in 1996. Myriad, a spin off from the University of Utah and others, had a business practice of ensuring exclusivity for its testing product to allow a return of the money that investors placed into the company. Myriad, which commenced operations in 1994, employed around 2,000 people, was publically traded and boasted revenue of USD723.1 million in 2015

After Myriad had sent a number of research bodies ‘cease and desist’ letters in regard to the identification of mutated BRCA1 and BRCA2 protein, the US Association of Pathologists as well as some researchers took Myriad to court over the patenting of ‘non-patentable material’. After a prolonged period and a number of court cases, the plaintiffs won the final avenue of appeal in the US court system, thus invalidating the patents.

Yvonne D’arcy — assisted by a well-known legal firm — was going through a similar struggle in Australia. After an appeal to the High Court, she won the case, which ensures that others can supply test kits for the proteins in question. A legal precedent has now been created, making it more certain that the court system will not entertain future claims of a similar nature.

Unfortunately it was not the first time that a company that commercialises medical research had relied on exclusivity to gain a return on their investment. In 2004, a subsidiary of the Mayo Clinic in the USA commenced offering testing for some auto-immune diseases where the drug dosage had to be managed to ensure benefit to the patient, rather than buying the ‘test kit’ from Prometheus, who licenced the technology embedded in the tests from a Montreal hospital. Prometheus sued the Mayo Clinic subsidiary in the California District Court and lost. The case was appealed through the US Court system leading to the patent being invalidated.

Medical research is expensive and has to be done correctly. That is why it is so expensive. When the product has an unintended side effect, the results can be deadly. Thalidomide was ‘invented’ in 1957 and was routinely given to pregnant mothers in the late 1950s and early 1960s to overcome the effects of ‘morning sickness’ across various countries, including Australia. Unfortunately, the drug caused a large number of birth defects and miscarriages. While the drug is still in use, regulators across the world introduced controls over the development and usage of drugs as a result of the shortcomings surrounding the inappropriate use of that drug early in its life.

So where to from here? We now have the technology to determine at a human protein level what is needed to sustain a healthy life — and the technology to individually treat people to rectify mutated or defective DNA on a personal level. Unfortunately the research and development of these options is not cheap. Our society operates on the basis that we are all entitled to receive reward for our labour — regardless of the type of labour. By the same token, the cost of research and some profit for the drug development company could preclude the availability of the drug for those without sufficient income.

Yvonne D’arcy and her legal team have made a stand that suggests that companies that go from nothing to over USD700 million in revenue in a period of about 20 years is not equitable or fair to those that cannot afford the testing that is potentially life saving. As a result, the testing for the ‘breast cancer’ DNA should be a lot cheaper due to competition. In contrast the medical development company would suggest to you that they need to make money ‘while the sun shines’ as the next project may cost tens of millions and then be a complete failure at the final hurdle before release.

While no one would want another Thalidomide tragedy, the cost to government of health care in Australia is increasing rapidly. There is a need for proper research, development and testing — all of which costs money. While former Treasurer Hockey’s claim that ‘The starting point is if our health and welfare and education systems stay exactly the same, Australia is going to run out of money to pay for them’, might be overblown, there has to be a point where the ethics of trying to provide a reasonable quality of life for people and the cost of doing so can balance.

If there were no legal way to protect the investment made in researching, developing and commercialising a test or drug that contains human proteins — and is therefore not able to be patented — would the test or drug come to market? There are other options to commercialise the product and retain some control but they would reduce profit margins. Would that be acceptable to the company shareholders? The dilemma is profit versus human condition. It’s a shame that (in Australia anyway) only ethics towards shareholders is legislated.

What do you think?
The world of medical research and new drugs and tests is a complex one. As 2353 explains, attempts to patent genetic material have been overturned in US and Australian courts but will that slow down essential research if companies cannot protect their ‘discoveries’? There are many conflicting issues involved that need to be guided by medical ethics but do profits or ethics come first?

Next week 2353 continues looking at ethics when he compares the ethical behaviour of some corporations and our government in ‘The year of morals and ethics’.

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7/11/20152353 I enjoyed your piece. You expose a dilemma; profiting from worthwhile endeavour versus the common good that the endeavour offers. The key, as is so often the case, is 'balance’. How can a firm that puts up large amounts of risk capital to explore biological phenomena be fairly compensated while at the same time members of the public are able to benefit from the endeavour, even if not wealthy? It’s the old story of self-interest versus the common good, and as such is not easily resolved in a way that satisfies all parties. On the one hand it offends those involved in healthcare to see those who would benefit from a test or intervention deprived of it because it is patented and they cannot afford an exorbitant fee for it, while on the other hand healthcare people expect firms working in the biological arena to use their expertise and financial resources to ‘invent’ new products that benefit patients. In the field of pharmaceuticals, there is protection for firms that produce new ones in the form of a limited-period patent. Once it expires the pharmaceutical can be manufactured and sold by others. That seems to have worked over the years, and even when the product is very expensive while under patent, governments have stepped in and subsidized it for needy cases until the patent has expired. Somehow, attempting to patent a biological object that is part of so many humans seems beyond the pale. The courts have agreed. However, those involved in healthcare would not want firms working in the biological area to cease their endeavours because there’s ‘nothing in it for them’. To some extent we are seeing this already in the development of new antibiotics. As the number of resistant organisms grows and the task of discovering new ones becomes more complicated and expensive, antibiotic manufacturers are becoming reluctant to risk the large amounts of capital needed to develop new ones, especially when the chance of success seems to be diminishing. There ought to be some way of balancing the financial risk for firms developing biological products and the benefit to patients and the community of their endeavours. Avarice will always produce a bad result. A fair return to the firms and laudable benefit to the community ought both to be possible. This is where governments, who are the ‘middlemen’ in this balancing act, ought to be prominent. But sometimes that would require ‘the wisdom of Solomon’, something for which governments are generally not noted!

Ken

10/11/20152353 One good thing that has come out of this is that the courts have ruled that genetic material cannot be patented. The fact that corporations even tried to do that suggests that profits over-ride ethics for many. Or as you say, ethics is only legislated in terms of a company's behaviour towards its shareholders. We do, however, have medical ethics bodies which examine research (among other matters) and suggest whether or not research is ethical. A limited patent does seem the best approach and as Ad stated it does seem to have worked for many years. But now, as seen in the TPP negotiations, the big US pharmaceutical companies are seeking longer patents in other countries. Perhaps there is an argument in favour of that insofar as the cost of research has increased but it would come at a considerable cost to health systems in countries like Australia and also make some drugs unaffordable. This is perhaps a case where Australia does need to adopt a 'conservative' view -- namely, if it ain't broke, don't fix it.

TalkTurkey;

12/11/20152353 For someone medically limited to bandaid applications you sound pretty well across the ethical issues. I've always been haunted by a line here sung by Joan Baez in "All My Trials" ttps://www.youtube.com/watch?v=UIH1KccVlHk "If living were something money could buy, Then the rich would live - and the poor would die .." Sorry Joanie but that IS the case. Less extremely in First World countries, and especially in such ones as Australia with a relatively benign public health system, than in most places, but everywhere the more affluent the individual the greater the life expectancy. Some Australian newspaper (not the Australian itself, I think) a few days ago ran a headline complaining WTTE that 'disability is a burden costing the Aus economy $17 billion p.a.' Well? What else are we to do? - Turn the disabled into Soylent Green? Apart from the lucky few who are taken out by lightning or a truck or in some other merciful means choofed off with despatch, we will all be disabled at some, if not several times in our lives. Then, yes, we are burdensome. That's the way God planned it. That's the way God wants it to be. https://www.youtube.com/watch?v=M62hsj7izbI Problem is the profit motive doing the driving, rather than humanity. And it isn't the pharmaceutical companies that are primarily at fault, because they are always going for the profit of course, but the connivance of Government in pandering to them and in failing to provide sufficient incentive to research themselves. This seems to be so particularly in wrt the USA whose litigiousness is legendary. And its antithesis, it seems, is to be found just across the water in economically-impoverished yet socially-rich Cuba, which it seems not only leads the world in immunology, but also trains large numbers of medics from and for places even poorer than itself. A matter of priorities. This I've written is simplistic and shallow I know but one thing, let us not let our still-decent Australian health system be dragged towards that of the US...

Ken

12/11/2015TT Not simplistic at all but perceptive and to the point. I agree that Cuba is a classic example of what can be done when the pharmaceutical companies do not have free reign in a laissez-faire market economy.

2353

13/11/2015TT, You've hit the nail on the head. At times the correct answer shouldn't be 'Its the economy stupid' - but frequently it is. There has to be an alternative to the profit motive. If a cricketer can be feted for scoring a century in the Perth (cricket) Test Match that starts today and that is considered a reward (yes he is well paid on top of that but from my understanding the Cricket Australia contract doesn't offer a monetry reward for scoring a certain number of runs), why isn't there some alternative system available for say drug companies that do spend a lot of money in developing something that is beneficial to humans and at least need those costs reimbursed. I don't have the answer - but in asking the question hopefully someone much cleverer than I will think about it. Thanks for the complementry post.

TalkTurkey

14/11/2015Comrades Coincidental with this lead article, I have been in touch with a friend of mine with chronic Hep C, and also a chronic Cannabis smoker. He is currently undergoing treatment with the retroviral AbbVie Viekira Pak, a course in which costs $88K in the US and over $100K here. (He is covered by insurance - just as well!) There is allegedly a very good chance with this drug of his completely eliminating the virus, though he will still have cirrhosis and some fibrosis even if so. He has recently been told by his medicine man that he must quit smoking Cannabis, though until recently it was OK with the same bloke. We don't know any new reason, and I have combed the Web searching . I just think that the tycoons of the pharmaceutical, alcohol and tobacco industries, who see self-medication by people with Cannabis as a burgeoning threat to their profits, are putting the hard word on medical practitioners in a last-ditch effort to prevent the legalisation of medical Cannabis. BUT against this, in California, with the last few weeks, Cannabis in the bloodstream is no longer a barrier to receiving treatment with anti-virals. Anyway, as we speak the 66th Annual Liver Convention is meeting in San Francisco, (all this weekend), and I look forward to reading of its deliberations. http://www.aasld.org/events-professional-development/liver-meeting I have written to the author of the site below, whose Damascene conversion is very germane as well as very recent. And she is going to the meeting in San Francisco herself. http://blogs.hepmag.com/lucindakporter/2015/08/hepatitis_c_marijuan.html Lucinda I'm in Australia, not infected myself but with a good friend with Hep C and he's currently on AbbVie's Viekira Pak course. His medic, having known about his chronic Cannabis use for a long time, and thought it was OK, has suddenly changed his mind and said it's a No-No. Not to do with the Viekira it seems but for some other reason to do with cirrhosis. Unspecified. Just DON'T, M'kay? I have read your paper of August 19 2015, Hepatitis C, Marijuana and the Liver, in which you have humbly and bravely reversed your opinion as to the damage Cannabis might do, and provided a doubting enquirer with several references which support your change of mind. Frankly I anticipated that no serious contraindications against Cannabis use would be found, and your conversion from contrary position to the pro-Cannabis arguments make me doubly convinced. What I want to ask you, please, is that you enquire diligently of the current 66th Liver Convention in San Francisco whether there is new, conclusive evidence of Cannabis exacerbating cirrhosis &/or fibrosis. ( This should be of interest to you too in light of your own article of course.) I personally have good reason to believe in the efficacy of Cannabis in pain relief, suppression of nausea and stimulation of appetite, and if medical practitioners such as those in question in my friend's case are under the influence of pharmaceutical, tobacco and alcohol companies, to the extent of frightening patients away from Cannabis, then I look to such courageous and disinterested persons as yourself to remind them of the absolute principle: Do No Harm. Thank you. I do hope to hear from you. Bruce* *(TalkTurkey)
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