Re: Co-operation? Surely not!!

[Guest guest]

Terry

To my knowledge there are groupings in the European Union eg Prof Maitland at York University (the original York, not the new one!) shares with colleagues across the EU

Science histrory is full of stories of "I invented this first" or "he pinched that idea from me", so I don't think the concern is new, the partnership idea is certainly better and more productive.

I have one worry that we haven't got the transfer of research across the pond. The UK drug approval agency NICE don't seem to take a lot of note ref the USA's research, I wonder why? Do they worry about profit motivation.

Co-operation? Surely not!!

Governments, fund raising bodies and individuals have given billions to scientists for research into prostate cancer and other diseases. Did you ever have the impression that these good people slaved away to try to find cures or causes, sharing their ‘Eureka’ moments with each other to create short cuts and avoid duplication of work. I did, sorta, but it turns out I was way wrong.

Read this bit in the New York Times http://tinyurl.com/RareShareNY and see this:

<snip> In 2003, a group of scientists and executives from the National Institutes of Health, the Food and Drug Administration, the drug and medical-imaging industries, universities and nonprofit groups joined in a project that experts say had no precedent: a collaborative effort………. <snip>

and

<snip> The key to the ….. project was an agreement as ambitious as its goal: not just to raise money, not just to do research on a vast scale, but also to share all the data, making every single finding public immediately, available to anyone with a computer anywhere in the world. No one would own the data. No one could submit patent applications, though private companies would ultimately profit from any drugs or imaging tests developed as a result of the effort. “It was unbelievable,” said Dr. Q. Trojanowski, ……. “It’s not science the way most of us have practiced it in our careers. But we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately.” <snip>

"It’s not science the way most of us have practiced it in our careers"- what an indictment! Reminds me of something I came across in The New England Journal of Medicine in 1997 – thirteen years ago

<snip> The many recent changes in therapeutic approaches to localized prostate cancer are exciting and preoccupying but to patients they are bewildering and can seem dangerous. Until the trials now under way have been completed, we have no firm guidelines for advising our patients about which therapeutic option is best. This means that education is more important than ever, but the art of multidisciplinary counseling is hampered by rivalries that seem more common among prostate-cancer specialists than in other cancer specialties. This must change. <snip>

Hands up anyone who has seen any change in the co-operation between the various branches of the prostate cancer industry.

Why can’t we as taxpayers, voters, contributors to causes demand and insist that any funds we contribute must only be used for research that is shared in this manner. As the good doctor quoted in the article says:

<snip> “This one makes sense. The development of reliable and valid measures of Alzheimer’s [for Alzheimer’s read ANY] disease requires such large science with such limited returns on the investment that it was in no one company’s interest to pursue it.” <snip>

and

<snip> “We weren’t sure, frankly, how it would work out having data available to everyone, …. but we felt that the good that could come out of it was overwhelming. And that’s what’s happened.” <snip>

Gee, what a surprise – co-operation leads to better outcomes – who’d a thought it? E Pluribus Unum: Ex Unitate Vires and so on might give a clue.

Can we do anything at our level to influence the course of research? Well, we could if we got off our tails and actually did something, like insisting that all fundraisers co-operation as a standard requirement; by getting lobby groups like US-Too to insist on that caveat for all funds, to lobby your representatives. Will it happen? Probably not, most of us are happy to critcise but apathetic about getting involved.

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going strong

Read A Strange Place for unbiased information at http://www.yananow.net/StrangePlace/index.html

[Guest guest]

ative groups are a longtime feature of oncology research. There are many

such groups: the Children's Leukemia Group, Cancer and Leukemia Group B (CALGB)

and others. Just google " cancer working group " and see how many there are.

Here is the URL for the prostate cancer working group:

http://www.udel.edu/ctcr/research/pcwg.htm

-- In ProstateCancerSupport , " Terry Herbert " <ghenesh_49@...

wrote:

Governments, fund raising bodies and individuals have given billions to

scientists for research into prostate cancer and other diseases. Did you ever

have the impression that these good people slaved away to try to find cures or

causes, sharing their 'Eureka' moments with each other to create short cuts and

avoid duplication of work. I did, sorta, but it turns out I was way wrong.

Read this bit in the New York Times http://tinyurl.com/RareShareNY and see this:

<snip In 2003, a group of scientists and executives from the National Institutes

of Health, the Food and Drug Administration, the drug and medical-imaging

industries, universities and nonprofit groups joined in a project that experts

say had no precedent: a collaborative effort.... <snip and <snip The key to the

.... project was an agreement as ambitious as its goal: not just to raise money,

not just to do research on a vast scale, but also to share all the data, making

every single finding public immediately, available to anyone with a computer

anywhere in the world. No one would own the data. No one could submit patent

applications, though private companies would ultimately profit from any drugs or

imaging tests developed as a result of the effort. " It was unbelievable, " said

Dr. Q. Trojanowski, ... " It's not science the way most of us have practiced

it in our careers. But we all realized that we would never get biomarkers unless

all of us parked our egos and intellectual-property noses outside the door and

agreed that all of our data would be public immediately. " <snip

" It's not science the way most of us have practiced it in our careers " - what an

indictment! Reminds me of something I came across in The New England Journal of

Medicine in 1997 - thirteen years ago

<snip The many recent changes in therapeutic approaches to localized prostate

cancer are exciting and preoccupying but to patients they are bewildering and

can seem dangerous. Until the trials now under way have been completed, we have

no firm guidelines for advising our patients about which therapeutic option is

best. This means that education is more important than ever, but the art of

multidisciplinary counseling is hampered by rivalries that seem more common

among prostate-cancer specialists than in other cancer specialties. This must

change. <snip

Hands up anyone who has seen any change in the co-operation between the various

branches of the prostate cancer industry.

Why can't we as taxpayers, voters, contributors to causes demand and insist that

any funds we contribute must only be used for research that is shared in this

manner. As the good doctor quoted in the article says:

<snip " This one makes sense. The development of reliable and valid measures of

Alzheimer's [for Alzheimer's read ANY] disease requires such large science with

such limited returns on the investment that it was in no one company's interest

to pursue it. " <snip and <snip " We weren't sure, frankly, how it would work out

having data available to everyone, .. but we felt that the good that could come

out of it was overwhelming. And that's what's happened. " <snip

Gee, what a surprise - co-operation leads to better outcomes - who'd a thought

it? E Pluribus Unum: Ex Unitate Vires and so on might give a clue.

Can we do anything at our level to influence the course of research? Well, we

could if we got off our tails and actually did something, like insisting that

all fundraisers co-operation as a standard requirement; by getting lobby groups

like US-Too to insist on that caveat for all funds, to lobby your

representatives. Will it happen? Probably not, most of us are happy to critcise

but apathetic about getting involved.

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going strong

[Guest guest]

There are, as xenophonami points out, cooperative groups in

cancer research. However, I think the kind of cooperation that

Terry is calling for is much deeper than what any of the

cooperative groups provide.

The " raw data " of medical research is jealously guarded.

Oftentimes an article will be published that says something like:

96 patients suffered grade II toxities.

29 patients relapsed.

155 patients had PSA > 10.

The correlation between treatment and response was. .72 with a

confidence interval of .05

But that's all you get. If you want to see the actual raw

numbers from which those statistics were derived, you face a

stone wall. If you want to actually see the biopsy slides or

blood samples, you face a stone wall with broken glass and barbed

wire on top and vicious pit bulls patrolling the perimeter.

The first line of defense is " patient confidentiality " . You ask

Dr. Fuzz for his data and he says: " Oh we'd like to give you the

raw numbers, but that would violate patient confidentiality. "

To which you, as a scientist, respond: " That's okay, replace the

names on the documents with numbers. "

Fuzz: " Oh no, we can't do that. First of all, we don't have the

staff to do it. "

You: " I'll pay for it. "

Fuzz's secretary: " I'm sorry, Dr. Fuzz is out of town right now. "

I'm not kidding about this. I know an actual case where a

scientist at NCI was trying to study PSA bounce and contacted

four major clinics to try to get data from them. He has money to

pay for preparing the data, but he hit the stone wall on all four

of them.

The real reasons have nothing to do with patient confidentiality,

which is a trivial problem to solve. I suspect that the real

reason is that, if someone saw the raw data, they might do the

math for themselves. If they came up with anything different, or

anything more important, than what the original authors

published, the authors would look like fools, or worse. And a

lot of those authors aren't nearly as confident about their

methods and results as their publications might suggest.

That's one factor. Another is that the raw data is valuable. It

can lead to drug development or other salable products that are

worth money to the docs and their institutions. Never mind that

the U.S. government actually paid for the development of the

data, it's still necessary to pry it out of the hands of the guys

who have it.

Right now, there is some incentive to hold data private.

Sometimes that incentive is strong, sometimes weak. But there is

zero incentive to release it.

The situation is a lot like copyright. There are books that have

not been published in years and the copyright holders have no

intention to republish them. In fact, that's the case for the

vast majority of all copyrighted material. But try to find a

single publisher who voluntarily releases those copyrights into

the public domain. The publishers have no good reasons to hold

onto the thousands of copyrights they own, but zero reason to

release them. So they hold onto them. It's a perfectly natural

reaction.

What we need is what Terry called for:

" Why can’t we as taxpayers, voters, contributors to causes

demand and insist that any funds we contribute must only be

used for research that is shared in this manner. "

There is a movement in government for this to happen. We have to

support it, but the public is totally unaware of the existence of

the issue and the private interests who hold the data will

undoubtedly lobby Congress to keep this from happening.

Fortunately, as the saying goes, rich, white Senators get cancer

too. Even some of the " private property is sacred " crowd can

understand that their own health and the health of their families

is at stake.

Alan

[Guest guest]

I'll go along with this idea.

What institutions and legislative forces exist in the UK and other

countries to ensure that all health stakeholders (including patients)

benefit from sharing research data ?

Such legislation would have to be quite explicit, specific and

representing a sea-change in the attitude of " ownership " of scientific

data.

How would it overcome the self-interest of global pharmaceutical

companies ? Companies like BP who - even in th face of a major

environmental disaster and huma tragedy - do not seem answerable even to

the US Congress ?

Sam.

>

> There are, as xenophonami points out, cooperative groups in

> cancer research. However, I think the kind of cooperation that

> Terry is calling for is much deeper than what any of the

> cooperative groups provide.

>

> The " raw data " of medical research is jealously guarded.

> Oftentimes an article will be published that says something like:

>

> 96 patients suffered grade II toxities.

> 29 patients relapsed.

> 155 patients had PSA > 10.

> The correlation between treatment and response was. .72 with a

> confidence interval of .05

>

> But that's all you get. If you want to see the actual raw

> numbers from which those statistics were derived, you face a

> stone wall. If you want to actually see the biopsy slides or

> blood samples, you face a stone wall with broken glass and barbed

> wire on top and vicious pit bulls patrolling the perimeter.

>

> The first line of defense is " patient confidentiality " . You ask

> Dr. Fuzz for his data and he says: " Oh we'd like to give you the

> raw numbers, but that would violate patient confidentiality. "

>

> To which you, as a scientist, respond: " That's okay, replace the

> names on the documents with numbers. "

>

> Fuzz: " Oh no, we can't do that. First of all, we don't have the

> staff to do it. "

>

> You: " I'll pay for it. "

>

> Fuzz's secretary: " I'm sorry, Dr. Fuzz is out of town right now. "

>

> I'm not kidding about this. I know an actual case where a

> scientist at NCI was trying to study PSA bounce and contacted

> four major clinics to try to get data from them. He has money to

> pay for preparing the data, but he hit the stone wall on all four

> of them.

>

> The real reasons have nothing to do with patient confidentiality,

> which is a trivial problem to solve. I suspect that the real

> reason is that, if someone saw the raw data, they might do the

> math for themselves. If they came up with anything different, or

> anything more important, than what the original authors

> published, the authors would look like fools, or worse. And a

> lot of those authors aren't nearly as confident about their

> methods and results as their publications might suggest.

>

> That's one factor. Another is that the raw data is valuable. It

> can lead to drug development or other salable products that are

> worth money to the docs and their institutions. Never mind that

> the U.S. government actually paid for the development of the

> data, it's still necessary to pry it out of the hands of the guys

> who have it.

>

> Right now, there is some incentive to hold data private.

> Sometimes that incentive is strong, sometimes weak. But there is

> zero incentive to release it.

>

> The situation is a lot like copyright. There are books that have

> not been published in years and the copyright holders have no

> intention to republish them. In fact, that's the case for the

> vast majority of all copyrighted material. But try to find a

> single publisher who voluntarily releases those copyrights into

> the public domain. The publishers have no good reasons to hold

> onto the thousands of copyrights they own, but zero reason to

> release them. So they hold onto them. It's a perfectly natural

> reaction.

>

> What we need is what Terry called for:

>

> " Why can’t we as taxpayers, voters, contributors to causes

> demand and insist that any funds we contribute must only be

> used for research that is shared in this manner. "

>

> There is a movement in government for this to happen. We have to

> support it, but the public is totally unaware of the existence of

> the issue and the private interests who hold the data will

> undoubtedly lobby Congress to keep this from happening.

>

> Fortunately, as the saying goes, rich, white Senators get cancer

> too. Even some of the " private property is sacred " crowd can

> understand that their own health and the health of their families

> is at stake.

>

> Alan

>