Sick babies denied treatment in DNA row, page 1

Sick babies denied treatment in DNA row

www.smh.com.au

BABIES with a severe form of epilepsy risk having their diagnosis delayed and their treatment compromised because of a company's patent on a key gene.

It is the first evidence that private intellectual property rights over human DNA are adversely affecting medical care.

Deepak Gill, head of neurology at the Children's Hospital at Westmead, said he would test at least 50 per cent more infants for the SCN1A gene - which would diagnose the disabling Dravet syndrome - if the hospital could conduct the test in-house.

But rights to the gene are controlled by the Melbourne-based Genetic Technologies, which has already threatened to stop public hospitals testing for breast cancer gene mutations, and the hospital will not risk a similar problem.

(visit the link for the full news article)



Mod Edit: Fixed broken link

[edit on 12/3/2008 by maria_stardust]

Well it looks like the fire that Monsanto started with creating patents on living things is starting to rollover into actual medicine for humans. I wonder how the Hippocratic oath plays into this.

There is really no justification that I could even imagine to make this seem acceptable. Anyone care to help?

www.smh.com.au
(visit the link for the full news article)

Mod Edit: Fixed broken link

[edit on 12/3/2008 by maria_stardust]

reply to post by Maxmars

---

Lets not go overboard here.

There are some vital aspects of medical innovation that have effectively come out of profit seeking and patent protection. Some people see this profit as immoral, but they never consider where innovation would be without it.

Im involved in medical research. My primary motivation is not solely to help people... its also to make a profit. Frankly I just wouldn't bother innovating if I couldn't make a living out of it; or if my inventions could simply be taken and used by others.

Profit in healthcare is not bad; it motivates and drives healthcare providers to greater heights.

This case outlined by the OP is a specific (and horrible) malfesiance.

Profit is fine as long as its warranted. The fundamental basis of patent law states that you cannot patent discoveries... you can only patent innovations. Genes are clearly discovered in my opinion, and cannot be patented. I would also say that certain naturally occuring chemicals (such as penicillin, insulin etc) should not be patented.

The IP judge in this case was way off.

Originally posted by 44soulslayer
reply to post by Maxmars

---

Lets not go overboard here.

...

Profit in healthcare is not bad; it motivates and drives healthcare providers to greater heights.

I agree - however there are a few caveats with that dynamic. Namely, if there is a cure for something discovered, but needs funding, the price for the vaccine/etc. will be extremely expensive, so that only the rich or those with great insurance can afford it - which in turn makes sure that the funding for the research can continue.

I just don't agree with that concept. The profit angle effectively prevents those without funds from getting the help they need.

doing some more research into this company, "Melbourne-based Genetic Technologies"

www.theage.com.au...

Genetic Technologies' claim to have patent control over methods for researching non-coded, or "junk", DNA.

The Melbourne-based Genetic Technologies has consistently warned it would sue any company, research institution or university that infringed its patent over the so-called junk DNA.

In the past, scientists concentrated on a tiny 1.5 per cent slice of the human genome, dismissing the remaining 98.5 per cent DNA system as useless.

But since early sequences of the human genome were released in 2000, scientists around the world realised the non-coded sections of DNA played a role in switching particular genes on and off and so were crucial in finding cures for gene-related diseases.

I'm not a medical expert, so this could be a totally false assumption... but it sounds less of a "patent" and more like claiming undiscovered territory. Almost like coming to a new land, and planting a flag to claim it, without any real authority to do so.

www.biotechnews.com.au...;971175812

GTG was set up in 1989 and provides a range of commercial genetic testing services for humans, animals and plants. It provides DNA profiling services, including paternity tests and forensic DNA analysis, genetic diagnostics for several diseases in humans and animals, and trait analysis for animals and plants.

...

GTG specialises in non-coding DNA and has over 100 patent applications, as well as granting 36 licences. In addition to genetic testing and its out-licensing program, the company has a dedicated research program in genetics and genomics.

and another article (sorry, forgot to grab the source link)

In December 2005, GTG settled a protracted lawsuit with Applera for an estimated US$7.5 million "in cash and in kind -- equipment, reagents, and intellectual property," said Jacobson. The deal also included other business opportunities, although there is no attached financial value on them.

The Applera lawsuit was widely regarded as a bellwether dispute. With its sixth and most drawn-out lawsuit successfully settled, there is little to prevent Jacobson and GTG to extend its list of patent licensees from the current number of around 30 to potentially hundreds of previously identified targets.

"We have 2000 entities in our database, of which 400 have been looked at and seem to be commercially significant," says Jacobson. "We are now expanding the licensing team and we're looking to appoint licensing contractors in the US, Europe, and Asia." GTG seeks to hire representatives on both the west and east coasts of the US, as well as in English- and German-speaking parts of Europe.

It sounds like this company has just as much resources dedicated to filing lawsuits, as they do for research. Interesting. I wonder what their business model is.

reply to post by scientist

---

Isnt that moot though?

The only other alternative is if the state forcibly extricates the intellectual property from the inventor and uses taxpayers money to bring the idea to market in such a manner that it can be used by all.

The poor couldn't afford the medicine anyway... how would preventing the rich from accessing it be any more moral?

I mean look at malaria... its a bloody deadly disease yet its hardly being researched by the mainstream guys. Why? Because poor people from the third world cannot afford to fund research/ pay for treatment.

The only solution that remains is either charity or state interventionism. I much prefer the prior

Edit: sorry I forgot to mention that the case you outlined can be solved via VC-type charities. Basically when an inventor gets a great idea, the development costs are paid for the drug on a timeline scale to get it to market. The end cost is thus much lower (but still in line with market considerations), and the VC charity gets to be involved with bringing a radical idea to the market.

For every problem that is seemingly created by capitalism and laissez faire economics, there is also a solution in my opinion!

[edit on 3-12-2008 by 44soulslayer]

reply to post by scientist

---

And in response to your second post, these guys seem to be the very people who form the bane of every medical inventor's existence at the moment (barring the credit crunch)!

They engage in a type of IP predatory activity known as patent sharking.

HBR has a great article about this. If you have a subscription, its worthwhile checking it out. I think you can access a free preview for non-members here : harvardbusinessonline.hbsp.harvard.edu...


In essence these idiots have no intention of ever bringing an idea to market. They just patent generic points of novelty and sit on them, waiting for someone to infringe the patent and thus extort vast sums of money from them via lawsuits.

This is not what patents were designed for, and I believe patent law should be amended to include usage provisions which require the inventor to have a clear path to market as opposed to being able to simply "hoarde" innovations.

Originally posted by 44soulslayer
reply to post by Maxmars

---

Lets not go overboard here.

There are some vital aspects of medical innovation that have effectively come out of profit seeking and patent protection. Some people see this profit as immoral, but they never consider where innovation would be without it.

Im involved in medical research. My primary motivation is not solely to help people... its also to make a profit. Frankly I just wouldn't bother innovating if I couldn't make a living out of it; or if my inventions could simply be taken and used by others.

Profit in healthcare is not bad; it motivates and drives healthcare providers to greater heights.

This case outlined by the OP is a specific (and horrible) malfesiance.

Profit is fine as long as its warranted. The fundamental basis of patent law states that you cannot patent discoveries... you can only patent innovations. Genes are clearly discovered in my opinion, and cannot be patented. I would also say that certain naturally occuring chemicals (such as penicillin, insulin etc) should not be patented.

The IP judge in this case was way off.

My comments do appear dark and cynical, however I have always maintained that the notion that innovation can only be fully realized by business is incorrect thinking.

The drive to 'succeed' and 'create' should (ethically speaking) be totally independent of commercial consideration. Once the objective is measured in terms of 'return on investment' the purpose of the effort becomes corrupted, especially in a world where the purse strings are zealously guarded by bean counters.

I know that 'good things' have come from medical research. But of late we see that we can now begin to question seriously, exactly the nature and quality of these good things. The quality and importance of the human condition should NEVER be tied to the exchange of money. It always - as in inevitably - ends with someone assigning a 'value' to our existence; ie. is it 'worth it' to extend a terminally ill persons life by x-months, let' say?

Should the 'cure' for xyz disease be 'marketed' if we are not going to make over 50% return? Etc.

It is common and almost tiresome that innovation seems to be attached to 'commercial research for profit' by a meme of capitalistic exploitation.

Here is a good example.... a working test to determine if a person will suffer the horrible disease of lupus exists. BUT NO PLACE ON EARTH CAN YOU GET THE TEST DONE! Why? Profit - as in - not enough.

....What Roth figured out to do next was to fail again--to fail again while making good on his promise to create something of immediate benefit to human beings. See, it's notoriously hard to diagnose the autoimmune disease lupus. But back when he was doing RNA splicing, Roth had figured out a way to do it, and now he set about trying not only to develop the test but to take it to market--himself. And he did it. For three years, that's all he did, nonstop: He developed the test, got the patent, and then went out and got FDA approval for what he had created. He was, as far as he knows, the first scientist ever to get FDA approval for a diagnostic test all by himself, without the help of a corporation, in an academic setting. Now he had just what he wanted--something that solved a problem, something that actually helped people.

You know how many people it helped? Roth makes a steering wheel with his arms to show how many people it helped. It helped nobody. It was a big zero. Not because it didn't work; rather, because there was no market for it. Or because there was a market for it, but it wasn't big enough to convince any pharmaceutical company to manufacture and distribute it....

Source: www.esquire.com...

If you think that the commercial interest aspect of medical advances is ethically pristine; guess again. I would not be surprised if they have suppressed more advances and discoveries than they have released - simply because it potentially interfered with revenue flow.

reply to post by Maxmars

---

I think there are two overarching points which I would like to make in response.

The first is that the world is an inherently awful place. Everyone is selfish. Nobody enters into a venture solely because they think it is an ethical thing to do, unless they specifically do it for charity. My contention is that nobody can make a real living out of doing good, unless their time is compensated for by someone else. I openly acknowlege that I am just as motivated by profit as I am by the thought of helping people through a disease. There is an interesting duality in my drive (and indeed in the motivations of other inventors)... I will keep researching for as long as I live. Most of my bosses have enough wealth to retire (and theyre about 40 years old...), but they continue to work because its their vocation and their raison d'etre.

So money isn't everything, but it is the first step. Without it, no thoughts of philanthrophy may occur. Charity starts at home etc etc.

The second point is that no human system can bear making choices about who is worth saving and who isnt. That is why we use a free market system on healthcare.

Is it worth spending $12,000 on a test for Lupus when $50 spent on a mosquito net could save ten times as many people?

Is it worth spending thousands on research into chemotheraphy to extend a cancer patient's life by a few years, or would that money rather be spent on saving a child's life.

I know you believe that healthcare is a fundamental human right, but the simple fact is that the funds needed to ensure the vitality of every human are mind boggling. In every thing we do, we have to rationalise. Would it be better to give a heart patient better angiostents or an amputee better prosthetic limbs? The sheer number of factors, causes, interpretations and outcomes are unfathomable!

Furthermore there is the point of : Who makes the calls? Who decides were money must go, and where it must be taken from?

I believe that no man, and no man made system can make that call. That is the reason for leaving the "decision" to the markets.

[edit on 3-12-2008 by 44soulslayer]

reply to post by 44soulslayer

---

I can respect that. It is better than leaving it to human judgment. At least the market is impersonal enough to eliminate bias.

But the acceptance of the idea of 'cost' eludes me. In reality, assuming the patient did not have to pay anything. How much money does the pharmaceutical company actually lose? I'm not interested in how much profits they would have made, just how much they have spent.

These chemicals and little pills, how much do they actually cost?

When profit margins rise to the level of thousands of percents, and we determine that its the "cost" it looks daunting, when you consider how much of that cost is arbitrarily demanded profit, the picture shows a different model at work.

Still, there is no denying that I speak of ideals, and I can accept that the ideal is not a goal but a path. The problem is we are not on the path of creating a human future devoid of avoidable suffering, we are on a path of doing so prioritizing by profit model. The two paths are neither parallel nor lead to the same place, in my opinion.

[edit on 3-12-2008 by Maxmars]

reply to post by Maxmars

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The bog standard, run of the mill pills against cancer or heart disease etc are all in fierce competition with one another.

To create one of these big boys can cost up to $100 million just up to the point of innovation and logistics. Then there is the actual cost of manufacturing. Because of litigations etc, everything has to be produced to a standard which is unmatched in any other sphere of the world... the regulations are known informally as GMP (good manufacturing practice).

For example, GMP requires the use of stainless steel which is purer than aerospace grade (316L and 420)! GMP also requires stringent security checks, batch records, operating theatre conditions on the manufacturing floor, skilled machine toolers and operators etc.

To compound this, drugs often fail to reach the market due to regulatory concerns. Imagine spending $100m just to have to slapped down at the end... the only way to recoup losses is to offset it against a successful drug (known as a blockbuster).

I think its easiest to consider the industry in toto. How much does a pharmaceutical company make every year? $20 billion at most? Healthcare is a multi-trillion dollar industry worldwide in terms of turnover, and yet the profit segment of that is comparatively negligible. Compare that to oil companies, who really only find oil, pump it out of the ground and sell it on... and make four times the amount of money. If we seek to demonise profits, there are far more sinister candidates for the top spot than medical companies.

reply to post by scientist

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Indeed you are right to a certain extent. However I believe that after a certain amount of success, people shift their attention to charity. Its what I have always seen and what I hope to do one day. A man who is a millionaire at 40 cannot retire since he would die of boredom. As a scientist, he has no real inclination to waste money on crap like yachts etc. So what I've noticed is that many of these chaps end up funding further research into diseases; or funding operations to cure cataracts in third world countries etc - all the things that some people say should be done without profit, but would ironically stop if profit stopped.

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