Patent-ly Obvious…?

Patent-ly ObviousSomething important happened a few months back.  Something which you probably don’t know anything about, because it wasn’t given the prominence it deserved.  But you should know about it, because it could, potentially, impact every single one of us.

An Australian grandmother won a landmark legal case, which has major ramifications for scientific research.  And what did she win?

She won the right for Australians to own their own bodies……..

Say……….WHAT????  What the hell does THAT mean??  Of course Australians own their own bodies!  They’re not slaves!

Ah……but that’s the thing.  Up until she won that case, there were people in Australia who didn’t own their own body….at least, not all of it.  There were teeny weeny bits of every Australian that actually, legally, belonged to someone else.  And it’s not just Australians….there are literally billions of people in the same situation.  Even YOU, sitting there, reading this may not legally own all of yourself.  Maybe even ME, as I write this, may not own all of myself…..

Let me explain.  In my last post, I spoke about the way that scientists are starting to identify and characterise tumour-specific genes and gene mutations, which they will use to develop new therapies and improve treatment planning.  Which is all very well and good, obviously, but it raises an interesting question.  One which has probably never occurred to most people before.

Who owns these genes?

“Huh?” I here you ask, “What do you mean, who OWNS them?  How can anyone “own” a gene?”  Well, that’s a good question.  And it takes us into a very tricky, and VERY controversial area:  Gene Patenting.

In one sense, it sounds like madness.  How can you patent a human gene?  After all, these tumour-specific genes are present in cancer patients, aren’t they?  They aren’t artificial or synthetic.  They are part of the patients’ genetic makeup.  They are entirely natural.  So, how could it be possible for another person or business to OWN them?  It would mean that a cancer patient’s genome didn’t belong to them.  Part of their genome would actually belong to some other person or persons.  How the hell could that be possible?

Well, as mad as it sounds, this is EXACTLY what happens.  Many of the genes which have been identified – genes which are an entirely natural part of the human genome – are currently under patent.  They are owned by Biotech companies who are able to profit from their commercial exploitation.

But….how can this be??  How can you patent a naturally occurring gene?  And how can you make money from it?

Well……technically you can’t.  A patent only covers a new, novel concept or invention.  Therefore, any organism which is found in nature cannot be patented.  And this is why you cannot patent a plant or animal which is found in the wild.

So, surely this means that anyone who tried to patent a human gene would be laughed out of the building, right?  Nope.  This is because, in order to identify a gene in the first place, you have to use some sophisticated scientific techniques, which require specialised Hi-tech equipment.  Both of which had to be thought of.  Both of which had to be created.  And both of which can be PATENTED.  This is the loophole in the patenting laws which Biotech companies can exploit.  While the GENE cannot be patented because it’s natural, the METHOD used to identify it can.  And therefore, anything found by using that method comes under the terms of the patent and can be exploited commercially.  And has been.  Oh boy…..has it ever!  The numbers are a little unclear, but one recent study suggested that as much as 41% of the genes in the human genome have been patented in this fashion!

Now, to say that this had been controversial is a bit of an understatement.  Research scientists object because it stifles their work.  If their research identifies new genes then their work – their effort – will become the property of someone else, so why bother?  Other biotech companies object because it eats into any potential profits from their own products.  Clinicians object because it increases the costs of new diagnostic tests & treatments.  And lots of people across the board (scientists, doctors, patients, politicians, lawyers), they object for ethical reasons and question the legality of a gene – a naturally occurring object – being under patent.

The legal wrangles have been rumbling on for years.  The U.S. Supreme Court ruled against the gene patenting in 2013.  Which is great, obviously, but if the company holds patents in different countries, then the rules need changing in every one.  So the U.S. decision is not enforceable anywhere else.

Which brings us to the Australian case.  In a nutshell, a breast cancer patient called Yvonne D’Arcy brought a case against a Biotech company called Myriad Genetics which holds a patent for the BRCA1 gene.  BRCA1 is involved in DNA repair processes, and BRCA1 mutation has long been known to be associated with an increased risk of hereditary breast and ovarian cancers.    Now, an important point here is that Mrs D’Arcy didn’t have a BRCA1 mutation herself, so her decision wasn’t based on self-interest.  Instead, Mrs D’Arcy objected to this patent on the basis that it increased the costs of genetic screening and could, therefore, mean lower identification rates for women with a predisposition for breast and ovarian cancers.

Initially, the Australian Federal Court ruled in the company’s favour, but Mrs D’Arcy appealed and, at the end of 2015, the Appeal Court ruled that the BRCA1 protein, both the normal active form and the mutant which indicates of susceptibility to breast and ovarian cancer, was not a “patentable invention”.

Success!…and it seems as if the tide is turning.  Already, there are cases being brought in Canada against the patenting of genes and it looks as if the number of patents being filed for genetic sequences is falling worldwide.  So hopefully, one day, private businesses will no longer be able to claim ownership of naturally occurring genes and genetic material.

But until then, the fight goes on….

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Rosenfeld, J., & Mason, C. (2013). Pervasive sequence patents cover the entire human genome Genome Medicine, 5 (3) DOI: 10.1186/gm431

Liddicoat J, Whitton T, & Nicol D (2015). Are the gene-patent storm clouds dissipating? A global snapshot. Nature biotechnology, 33 (4), 347-52 PMID: 25850055

ResearchBlogging.org
AG McCluskey (2016). Patent-ly Obvious…? Zongo’s Cancer Diaries

The One And Only

Marginal Gains 2We are living in an age of transition.  Things are changing in the world of oncology, and these changes are going to have major ramifications for the clinical experiences of future cancer patients.  In the last 30 years, there has been a huge improvement in cancer survival, as shown in the figure.  Now, there are multiple reasons for these improvements.

The development of, and the advances in, diagnostic testing methods has led to earlier disease detection – and earlier diagnosis improves the likelihood of survival.  Also, improvements in scanning machinery coupled to the huge advances in computer technology has led to the development of precise, real time 3D imaging of tumours which has improved the targeting of radiotherapy beams and surgical excision – which has, itself also been proved by advances in keyhole surgery techniques.  Finally, the ongoing development of new chemotherapy drugs has increased the front-line and post-operative treatment options available to clinicians.

Now, all of this has made a difference.  A massive difference.  But more needs to be done.  And one big change that is coming – one that is being mentioned more and more – is the future potential of Personalised Medicine.

And this, Personalised Medicine, is the transition I started this post with.  Clinicians are starting to change the way they think about cancer – about what it is.  Or, to be more accurate, what they are – not a single disease, remember!  And this is leading to changes in how clinicians appraise the different treatment options available.

Now, I’ve mentioned before, cancer is an umbrella term for multiple diseases (see No Cure For Cancer…?).  So, breast cancer is different from colorectal cancer, which is different from lung cancer….etc, etc.  And I also mentioned in No Cure For Cancer…? that lung cancer is not one, single disease either, but can be subdivided into a variety of different cancers, which may require a variety of different treatments.

This type of thinking isn’t new, it’s how clinicians have thought about cancer for many years, and has, therefore, influenced both disease diagnosis and treatment scheduling.  But this is now changing.  It’s becoming more and more obvious that even this myriad of subdivisions is actually overly simplistic and the reality of each patient’s individual disease is much more complicated.

The reason for this is actually very simple.  Each of us is a unique individual.  We have our own unique genetic makeup.  Also, our own individual life experiences mean that the environmental factors we are exposed to, while not completely specific to each individual, are not going to be exactly identical to anybody else’s either.

And, as I’ve mentioned previously, cancer derived from a patient’s own cells.  Therefore, logically, if each patient is unique and their disease arises from themselves then this must mean that each patient’s disease is unique too!  The specific environmental factors each person is exposed to, coupled to the distinct genetic makeup of every individual, means that the risk of developing cancer (in any form) is likely to be different from person to person.  But, also, the way a cancer grows and spreads will likely be different from person to person too, as will the way the tumour responds to treatment, even if the tumours themselves appear to be similar at first.

So, consider the situation where two patients get diagnosed with the same disease, at the same stage, on the same day.  They may appear to be identical and, up till now, this has been the criteria used by clinicians to plan treatment options.  Oh, there will certainly be a whole lot of tests done to look at tumour markers, but on the whole the treatment options that are chosen will be based on size, position & stage of disease.

But actually, there is no guarantee that these two patients will respond to the same treatment in the same way.  This is because their tumours, despite the outward similarity, will actually be very different at an intracellular level.  They will have different genetic backgrounds, different metabolic rates and will be exposed to different environmental factors.  All because of the differences between the patients themselves.

And it is this – the fundamental differences between the tumours – that influence the success of different forms of treatment.  Different chemotherapy drugs target different proteins inside cells (the “Bills” from my Drug Discovery posts).  So, in the example above, the two patients with outwardly similar tumour will be treated with the same chemotherapy drug.  But, if one patient lacks the protein that drug targets, or has a mutation in the gene that makes it (which in turn changes the way it is put together), then the drug won’t work in this patient.  And the tumour will progress in that patient.

But this is starting to change.  Scientists are starting to investigate the tumours from individual patients, in order to identify the specific genes and other tumour-specific markers that can influence drug activity, tumour growth, disease progression etc, etc.  Recently, a major study in Breast cancer identified 93 different genes which could influence Breast cancer growth and development.  Now, these 93 genes don’t all do the same things, they are all different.  And not all 93 have to be present to get the disease.

But the presence or absence of these specific genes can influence how a tumour grows.  So, patient 1 might have, say, 5 of them.  If so, which 5?  What do those individual genes control?  Patient 2, however, has 10 of them – a different subset, with no overlap to patient 1’s markers.  What do these 10 genes control?  How will they influence tumour growth, treatment efficacy, etc?

And this is just the beginning.  Similar genotyping studies are being carried out for other types of cancer.  And it will be the results of these studies that will change treatment planning.  In future, when a patient is first diagnosed, as well as assessing the position, placement and stage of the disease, clinicians will also assess the specific genetic makeup of that individual patent’s individual tumour.  And then they will tailor the treatments they offer, in order to meet that patient’s specific requirements.

So remember:  You are an individual.  Your disease is also individual.  And, in future, your treatment will be individual too.

Welcome to the age of Personalised Medicine.

 

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Nik-Zainal, S., Davies, H., Staaf, J., Ramakrishna, M., Glodzik, D., Zou, X., Martincorena, I., Alexandrov, L., Martin, S., Wedge, D., Van Loo, P., Ju, Y., Smid, M., Brinkman, A., Morganella, S., Aure, M., Lingjærde, O., Langerød, A., Ringnér, M., Ahn, S., Boyault, S., Brock, J., Broeks, A., Butler, A., Desmedt, C., Dirix, L., Dronov, S., Fatima, A., Foekens, J., Gerstung, M., Hooijer, G., Jang, S., Jones, D., Kim, H., King, T., Krishnamurthy, S., Lee, H., Lee, J., Li, Y., McLaren, S., Menzies, A., Mustonen, V., O’Meara, S., Pauporté, I., Pivot, X., Purdie, C., Raine, K., Ramakrishnan, K., Rodríguez-González, F., Romieu, G., Sieuwerts, A., Simpson, P., Shepherd, R., Stebbings, L., Stefansson, O., Teague, J., Tommasi, S., Treilleux, I., Van den Eynden, G., Vermeulen, P., Vincent-Salomon, A., Yates, L., Caldas, C., Veer, L., Tutt, A., Knappskog, S., Tan, B., Jonkers, J., Borg, �., Ueno, N., Sotiriou, C., Viari, A., Futreal, P., Campbell, P., Span, P., Van Laere, S., Lakhani, S., Eyfjord, J., Thompson, A., Birney, E., Stunnenberg, H., van de Vijver, M., Martens, J., Børresen-Dale, A., Richardson, A., Kong, G., Thomas, G., & Stratton, M. (2016). Landscape of somatic mutations in 560 breast cancer whole-genome sequences Nature DOI: 10.1038/nature17676

Morganella, S., Alexandrov, L., Glodzik, D., Zou, X., Davies, H., Staaf, J., Sieuwerts, A., Brinkman, A., Martin, S., Ramakrishna, M., Butler, A., Kim, H., Borg, �., Sotiriou, C., Futreal, P., Campbell, P., Span, P., Van Laere, S., Lakhani, S., Eyfjord, J., Thompson, A., Stunnenberg, H., van de Vijver, M., Martens, J., Børresen-Dale, A., Richardson, A., Kong, G., Thomas, G., Sale, J., Rada, C., Stratton, M., Birney, E., & Nik-Zainal, S. (2016). The topography of mutational processes in breast cancer genomes Nature Communications, 7 DOI: 10.1038/ncomms11383

ResearchBlogging.org
AG McCluskey (2016). The One And Only Zongo’s Cancer Diaries

Fight The Good Fight?

 

Fight the good fightInteresting story in the Guardian last week.  “CRUK defends use of amateur boxing events for fundraising.”

Basically, CRUK have been working with a company called Ultra White Collar Boxing (UWCB) who organise amateur boxing matches in order to raise funds for cancer research.  This has drawn criticism from boxing’s governing bodies, Boxing Scotland and England Boxing, both of which highlight the potentially serious health risks to the participants.  In response, a CRUK spokesman replied, “….UWCB adhere to all necessary health and safety procedures….(and) has raised an incredible £3.7m for the charity.  Cancer Research UK receives no government funding, so we rely solely on the money we receive from our supporters.”

Now, this raises an interesting question about how charity fundraising is carried out.

There are a helluva lot of charities out there, all trying to raise money and increase public awareness about their chosen area.  When it comes to cancer, the best known of these is obviously CRUK, which has an interest in cancer as a whole, ie. in ALL forms of cancer and in all types of treatment & care provision.  But, as well as CRUK, there are many, many other cancer charities out there.

These tend to be smaller organisations, with a more focused remit.  Often they will be interested in specific types of cancer, eg. Prostate Cancer UK, Breast Cancer Now, Neuroblastoma UK (who have funded a lot of my work through the years) and many, many others.

Also, there are other organisations out there, who are less interested in particular diseases, but are more interested in the specific patients who are affected (eg. Children With Cancer), or in patient care provision (eg. MacMillan Cancer Support).  Others are interested in funding specific types of study (eg. the Hadwen Trust).

But, whatever the specific organisation, you’ll often find that the people involved in setting up & running these charities have a very personal reason for doing so.  Either they have suffered from cancer themselves, or else a loved one has (and in the case of the people involved with Neuroblastoma UK – a childhood cancer, remember – I can tell you from personal experience that listening to their stories is utterly heartbreaking.)

And there is no doubt that the work these people do is good.  The money they raise – the money they distribute – makes a real difference.  The research they fund provides insight into the fundamental causes of cancer.  They help to find new targets for drug development and other new treatment methods.  They fund the clinical trials to test these new treatments.  They fund patient support groups.  They fund hospices.  These people work tirelessly, with total dedication, to try and improve cancer treatments and patient care, and I have nothing but the UTMOST respect for them.

But the Guardian story raises an interesting question.  One which I’m not sure I can answer.  How should money be raised?  What’s an appropriate way of fundraising?  And, crucially, what is not appropriate?  Now, it seems obvious that there are certain people that cancer charities shouldn’t be taking money from.  Criminal organisations, for instance.  Or Tobacco companies….Especially the latter.  So, not all donations are acceptable.

But where do you draw the line?  And do UWCB’s activities cross that line?  Is it right for cancer charities (or any charities) to take the money raised by these boxing events?  After all, the health risks of boxing have been debated repeatedly over the years.  So, should a health charity take money from an organisation whose activities might have serious health consequences?

It’s a tricky question.  But the thing is, if the answer is “No, they shouldn’t take that money”, well that just opens a can of worms, because there are plenty of other activities used for fundraising which could be considered dangerous too.  So, is it OK to take money from someone doing a sponsored marathon?  Or a hill climb?  Because both of these activities can also be incredibly dangerous if the participant is under prepared.  What about bungee jumping?  Or sky diving?  These could also be considered dangerous pursuits, but I’ve never seen any objections to the use of money raised from these activities either.

Now, certainly, it could be argued that boxing is different.  It involves acts of intentional harm.  Shouldn’t that be taken into account?  Well…..maybe so.  But then, surely, this brings up the subject of free will.  The participants in these events are not being forced into it, nor are they being hoodwinked.  On the contrary, the people involved are, in general, well aware of the potential risks and are still choosing to take part.  So, should their personal opinions and choices be dismissed?  Again, I’m not sure I can say Yay or Nay.

And remember, these activities have raised millions.  That should count for something, right?  Well, actually, we’re on firmer ground here.  The amount means nothing.  After all, as I said earlier, the tobacco companies would be more than happy to shovel gazillions into cancer charities (and possibly still do, in countries where they can get away with it).   But the good that money could do would be off-set massively by the validation the tobacco companies would gain from the gesture – and would then use to justify their activities.

So, the end does not always justify the means.  Those involved in running the charities have to decide, on a case by case basis, whether to accept a donation or not.  Most times, they’ll get it right.  But sometimes, they’ll get it wrong.  Whether this is one of those times….?  I don’t know.  But I do know that they’ll make the choices that seem correct to them at the time.

And what more could any of us ask?

 

PS.  The eagle-eyed will have noticed that I’ve provided links to the cancer charities mentioned in this post.  Just click on the name of the charity, and you’ll be taken to their website.  Please:  follow a link.  Make a donation.  However big or small an amount, any money you can give can make a difference.  Cheers.

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O’Toole, L., Nurse, P., & Radda, G. (2003). An analysis of cancer research funding in the UK Nature Reviews Cancer, 3 (2), 139-143 DOI: 10.1038/nrc994

ResearchBlogging.org
AG McCluskey (2016). Fight The Good Fight? Zongo’s Cancer Diaries