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If I tossed a coin many times, but only reported the result when it was heads, you would say it wasn't fair. This kind of reporting is common amongst drug companies when developing and testing new drugs, and so this is the quality of information doctors have available when deciding what drugs to treat you with. As a result, many drugs routinely prescribed by doctors probably have no beneficial effect, but may still cause dangerous side-effects, as well as costing millions.
If you would like doctors to have access to the result of every 'coin toss', regardless of the result, before writing your prescription, here's where to sign: http://www.alltrials.net/
If you would like doctors to have access to the result of every 'coin toss', regardless of the result, before writing your prescription, here's where to sign: http://www.alltrials.net/
In reply to Reach>Talent:
These assurances are a bit thin for me. GSK got absolutely crucified in Ben Glodacre's Bad Pharma and this campaign is gaining a lot of momentum. While I'm delighted that GSK see this as an important contribution to their marketing strategy, I hold back any genuine respect for their motivations and remain utterly skeptical about how they'll implement what they say they support.
I imagine that there are lengthy discussions going on at GSK and their competitors about exactly how they balance their response to this campaign with their commercial interests. We need an overhaul of the regulatory system and not to give the industry any options.
Well done Ben Goldacre, fantastic job.
> (In reply to Jonathan)
> http://www.guardian.co.uk/science/2012/oct/31/glaxosmithkline-backs-bmj-dis...
> http://www.guardian.co.uk/science/2012/oct/31/glaxosmithkline-backs-bmj-dis...
These assurances are a bit thin for me. GSK got absolutely crucified in Ben Glodacre's Bad Pharma and this campaign is gaining a lot of momentum. While I'm delighted that GSK see this as an important contribution to their marketing strategy, I hold back any genuine respect for their motivations and remain utterly skeptical about how they'll implement what they say they support.
I imagine that there are lengthy discussions going on at GSK and their competitors about exactly how they balance their response to this campaign with their commercial interests. We need an overhaul of the regulatory system and not to give the industry any options.
Well done Ben Goldacre, fantastic job.
In reply to Jon Stewart:
But then on the other hand, I've heard suggestions that a lot of Goldacre's evidence in Bad Pharma is selective at best...
But then on the other hand, I've heard suggestions that a lot of Goldacre's evidence in Bad Pharma is selective at best...
In reply to Tall Clare:
You mean selective in that he's selecting the circumstances where Pharma has failed in its duty??
That would rather be the point no?
> (In reply to Jon Stewart)
>
> But then on the other hand, I've heard suggestions that a lot of Goldacre's evidence in Bad Pharma is selective at best...
>
> But then on the other hand, I've heard suggestions that a lot of Goldacre's evidence in Bad Pharma is selective at best...
You mean selective in that he's selecting the circumstances where Pharma has failed in its duty??
That would rather be the point no?
In reply to Jonathan: I thought you already had to do this.. At least all pharm testing? or is that not the case?
In reply to Rollo:
Not quite... selective in that apparently he's chosen to ignore that which doesn't fit his hypothesis. Which is a neat loop back to the OP's subject!
Not quite... selective in that apparently he's chosen to ignore that which doesn't fit his hypothesis. Which is a neat loop back to the OP's subject!
In reply to IainRUK:
You have to register all trials but publication is optional.
You have to register all trials but publication is optional.
In reply to Jon Stewart:
While I'm delighted that Ben Goldacre sees this as an important contribution to his marketing strategy, I hold back any genuine respect for his motivations and remain utterly sceptical about how he'll stop being such a massive hypocrite.
The esteemed Dr. Goldacre is quite spectacularly guilty of using cherry picked data to back up his claims. His recent contribution to a debate on radio4 was absolutely loaded with out of date information and misleading statements. I'm all for open publication as it creates a nice level playing field, but I am strongly opposed to the idea of prescriber's being handed the data and expected to make value judgements based on it.
While I'm delighted that Ben Goldacre sees this as an important contribution to his marketing strategy, I hold back any genuine respect for his motivations and remain utterly sceptical about how he'll stop being such a massive hypocrite.
The esteemed Dr. Goldacre is quite spectacularly guilty of using cherry picked data to back up his claims. His recent contribution to a debate on radio4 was absolutely loaded with out of date information and misleading statements. I'm all for open publication as it creates a nice level playing field, but I am strongly opposed to the idea of prescriber's being handed the data and expected to make value judgements based on it.
In reply to Reach>Talent:
Since I'm not qualified to make a judgement on the accuracy of Ben Goldacre's evidence I can't stand up for him there.
But are you accusing him of being motivated to criticise the pharmaceutical industry by purely self-promotion and that his work will have no positive influence on patients? If so, that sounds like bitter defensiveness when, give or take where he might have given a skewed picture to support his argument, it's clear without his contribution that there's a corrosive tension between the aims of developing useful drugs and making as much profit as you can. (The Lucentis/Avastin scandal springs immediately to mind). I'm not suggesting there's a better way of funding the research to support innovation, but it's absolutely obvious that it's an industry that needs the knackers regulated off it, because the tensions are so severe and so devastatingly important to the lives of the global public.
As for BG being a hypocrite, I think it's very easy, but completely meaningless, to equate scientific misconduct by cherry-picking data to support a factual claim about the efficacy of a drug, and cherry picking evidence to support a political argument. In political debate, there is not a right answer, no best practice methodology, and it is simply not possible to apply objective testing of hypotheses. If you show me examples of BG's scientific misconduct I will agree that he's a hypocrite. If you dislike the way he argues a political point, then perhaps he could attain higher standards of objectivity there, but the two are not equivalent.
A lot of what he argues is simply that industry and regulators should actually do what they say they'll do, rather than making hollow claims and omitting to do work which will benefit patients but perhaps not their own commercial interests. I'm not certain on how you've interpreted BG's position. He is not arguing for abolition of the EMA etc approvals process so that prescribers just access trial data and make their own judgments. He's arguing for better quality trials (against best available treatment, in most appropriate Px, etc), publication bias regulated out of the system, better access to data held by regulators, and better communication of risks and benefits of drugs to patients.
Which part is it you disagree with and why?
Since I'm not qualified to make a judgement on the accuracy of Ben Goldacre's evidence I can't stand up for him there.
But are you accusing him of being motivated to criticise the pharmaceutical industry by purely self-promotion and that his work will have no positive influence on patients? If so, that sounds like bitter defensiveness when, give or take where he might have given a skewed picture to support his argument, it's clear without his contribution that there's a corrosive tension between the aims of developing useful drugs and making as much profit as you can. (The Lucentis/Avastin scandal springs immediately to mind). I'm not suggesting there's a better way of funding the research to support innovation, but it's absolutely obvious that it's an industry that needs the knackers regulated off it, because the tensions are so severe and so devastatingly important to the lives of the global public.
As for BG being a hypocrite, I think it's very easy, but completely meaningless, to equate scientific misconduct by cherry-picking data to support a factual claim about the efficacy of a drug, and cherry picking evidence to support a political argument. In political debate, there is not a right answer, no best practice methodology, and it is simply not possible to apply objective testing of hypotheses. If you show me examples of BG's scientific misconduct I will agree that he's a hypocrite. If you dislike the way he argues a political point, then perhaps he could attain higher standards of objectivity there, but the two are not equivalent.
A lot of what he argues is simply that industry and regulators should actually do what they say they'll do, rather than making hollow claims and omitting to do work which will benefit patients but perhaps not their own commercial interests. I'm not certain on how you've interpreted BG's position. He is not arguing for abolition of the EMA etc approvals process so that prescribers just access trial data and make their own judgments. He's arguing for better quality trials (against best available treatment, in most appropriate Px, etc), publication bias regulated out of the system, better access to data held by regulators, and better communication of risks and benefits of drugs to patients.
Which part is it you disagree with and why?
In reply to Jon Stewart:
Since I'm not qualified to make a judgement on the accuracy of Ben Goldacre's evidence I can't stand up for him there.
You won't get very far with that sort of sensible and honest attitude, this is UKC!
But are you accusing him of being motivated to criticise the pharmaceutical industry by purely self-promotion
I think the style of my initial response may have been overly harsh however I suspect that he is rather more vociferous in his views around the time he publishes new books.
that his work will have no positive influence on patients? If so, that sounds like bitter defensiveness when, give or take where he might have given a skewed picture to support his argument
That would be a very harsh view to take and not one that I would feel justified in. However there is a difference between 'giving a skewed picture' and deliberately restating a 'fact' that was 30 years out of date despite being corrected on numerous occasions. Those who campaign for honesty should make sure all their statements are (Insert the suitable PC term that replaces 'whiter than white').
A lot of what he argues is simply that industry and regulators should actually do what they say they'll do, rather than making hollow claims and omitting to do work which will benefit patients but perhaps not their own commercial interests.
The problem here is that the vast majority of the issues are down to interpretation but are being discussed as black and white.
He is not arguing for abolition of the EMA etc approvals process so that prescribers just access trial data and make their own judgments.
He has actually argued that GPs should be able to make judgements on trial data in addition to the regulatory process, I doubt most GPs or Mr Goldacre are up to the task.
We are talking about a lot of vastly complex data and I don't think that it should be assessed by non-experts with a view to altering practices: As for every 1 improved patient outcome you'll have hundreds of people not getting perfectly good drugs because the GP is scared by mortality data, which may be entirely justified.
He's arguing for better quality trials (against best available treatment, in most appropriate Px, etc)
Excellent goals, however his methods of promoting them need some adjustment.
publication bias regulated out of the system, better access to data held by regulators, and better communication of risks and benefits of drugs to patients.
I'd love to see this but I can't see it happening, you've got complex commercially sensitive information; huge quantities of personally identifiable information which is heavily regulated and extremely sensitive but critical to good analysis and the problem of explaining it which is no mean feat!
I'm glad Dr Goldacre is campaigning but I really wish he would pick his fights more carefully, smearing an entire industry simply isn't helpful and he should try to remember that.
Since I'm not qualified to make a judgement on the accuracy of Ben Goldacre's evidence I can't stand up for him there.
You won't get very far with that sort of sensible and honest attitude, this is UKC!
But are you accusing him of being motivated to criticise the pharmaceutical industry by purely self-promotion
I think the style of my initial response may have been overly harsh however I suspect that he is rather more vociferous in his views around the time he publishes new books.
that his work will have no positive influence on patients? If so, that sounds like bitter defensiveness when, give or take where he might have given a skewed picture to support his argument
That would be a very harsh view to take and not one that I would feel justified in. However there is a difference between 'giving a skewed picture' and deliberately restating a 'fact' that was 30 years out of date despite being corrected on numerous occasions. Those who campaign for honesty should make sure all their statements are (Insert the suitable PC term that replaces 'whiter than white').
A lot of what he argues is simply that industry and regulators should actually do what they say they'll do, rather than making hollow claims and omitting to do work which will benefit patients but perhaps not their own commercial interests.
The problem here is that the vast majority of the issues are down to interpretation but are being discussed as black and white.
He is not arguing for abolition of the EMA etc approvals process so that prescribers just access trial data and make their own judgments.
He has actually argued that GPs should be able to make judgements on trial data in addition to the regulatory process, I doubt most GPs or Mr Goldacre are up to the task.
We are talking about a lot of vastly complex data and I don't think that it should be assessed by non-experts with a view to altering practices: As for every 1 improved patient outcome you'll have hundreds of people not getting perfectly good drugs because the GP is scared by mortality data, which may be entirely justified.
He's arguing for better quality trials (against best available treatment, in most appropriate Px, etc)
Excellent goals, however his methods of promoting them need some adjustment.
publication bias regulated out of the system, better access to data held by regulators, and better communication of risks and benefits of drugs to patients.
I'd love to see this but I can't see it happening, you've got complex commercially sensitive information; huge quantities of personally identifiable information which is heavily regulated and extremely sensitive but critical to good analysis and the problem of explaining it which is no mean feat!
I'm glad Dr Goldacre is campaigning but I really wish he would pick his fights more carefully, smearing an entire industry simply isn't helpful and he should try to remember that.
In reply to Toby_W:
Yes, although soon to be leaving to work for small pharma. I get somewhat peeved at the whole industry and everyone who works in it tarred with the same brush. I suppose we all like a good stereotype but it isn't helpful when people start slinging them around and using words like regulation.
Yes, although soon to be leaving to work for small pharma. I get somewhat peeved at the whole industry and everyone who works in it tarred with the same brush. I suppose we all like a good stereotype but it isn't helpful when people start slinging them around and using words like regulation.
In reply to Reach>Talent:
Since the only interpretation that's previously had any influence has been that which is commercially motivated it seems helpful to hear the alternative. But as you say, the best way to make a point about honesty is to ensure you've put yourself beyond similar accusations.
This is depressingly easy to anticipate. So, as patients, we are better off trusting the marketing departments of big pharma to interpret data on our behalf, because the medics we employ aren't scientifically literate enough and will unintentionally end up harming us? Given the choice between being harmed by an incompetent doctor, whom I hold accountable, and by the commercial interests of big pharma, who are accountable to no one, I know which I'll choose, thanks.
It's all rather hard to make improvements, so let's just leave the world in mess? And that just happens to coincide with the commercial interests of the industry rather than the interests of patients. Depressingly easy to anticipate.
I think we'll see whether it's helpful (regardless of flaws in execution) if it results in better information about drugs becoming available to doctors and patients.
> (In reply to Jon Stewart)
> The problem here is that the vast majority of the issues are down to interpretation but are being discussed as black and white.
Since the only interpretation that's previously had any influence has been that which is commercially motivated it seems helpful to hear the alternative. But as you say, the best way to make a point about honesty is to ensure you've put yourself beyond similar accusations.
> He is not arguing for abolition of the EMA etc approvals process so that prescribers just access trial data and make their own judgments.
>
>
> We are talking about a lot of vastly complex data and I don't think that it should be assessed by non-experts with a view to altering practices: As for every 1 improved patient outcome you'll have hundreds of people not getting perfectly good drugs because the GP is scared by mortality data, which may be entirely justified.
This is depressingly easy to anticipate. So, as patients, we are better off trusting the marketing departments of big pharma to interpret data on our behalf, because the medics we employ aren't scientifically literate enough and will unintentionally end up harming us? Given the choice between being harmed by an incompetent doctor, whom I hold accountable, and by the commercial interests of big pharma, who are accountable to no one, I know which I'll choose, thanks.
> I'd love to see this but I can't see it happening, you've got complex commercially sensitive information; huge quantities of personally identifiable information which is heavily regulated and extremely sensitive but critical to good analysis and the problem of explaining it which is no mean feat!
It's all rather hard to make improvements, so let's just leave the world in mess? And that just happens to coincide with the commercial interests of the industry rather than the interests of patients. Depressingly easy to anticipate.
> I'm glad Dr Goldacre is campaigning but I really wish he would pick his fights more carefully, smearing an entire industry simply isn't helpful and he should try to remember that.
I think we'll see whether it's helpful (regardless of flaws in execution) if it results in better information about drugs becoming available to doctors and patients.
In reply to Jon Stewart:
So, as patients, we are better off trusting the marketing departments of big pharma to interpret data on our behalf, because the medics we employ aren't scientifically literate enough and will unintentionally end up harming us?
It may shock you to hear that we don't ask the marketing department to analyse our trial data, in much the same way we don't expect the guy who cuts the grass to design our air conditioning. We employ a lot of very talented statisticians, clinicians and experts on various areas of biology and chemistry to analyse our data. We leave marketing to do the complex stuff like coming up with product names that don't mean "arsefungus" in Norwegian, choosing the colour of the packet or working out how to fold the bloody patient information leaflet which makes folding an OS map in a gale seem easy.
It's all rather hard to make improvements, so let's just leave the world in mess? And that just happens to coincide with the commercial interests of the industry rather than the interests of patients.
No let us accept that what we have now isn't a mess and while it may not be perfect it is a whole lot better than doing nothing. This comment displays a total lack of appreciation for the complexity of the issue or how much has changed in the last 30 years.
So, as patients, we are better off trusting the marketing departments of big pharma to interpret data on our behalf, because the medics we employ aren't scientifically literate enough and will unintentionally end up harming us?
It may shock you to hear that we don't ask the marketing department to analyse our trial data, in much the same way we don't expect the guy who cuts the grass to design our air conditioning. We employ a lot of very talented statisticians, clinicians and experts on various areas of biology and chemistry to analyse our data. We leave marketing to do the complex stuff like coming up with product names that don't mean "arsefungus" in Norwegian, choosing the colour of the packet or working out how to fold the bloody patient information leaflet which makes folding an OS map in a gale seem easy.
It's all rather hard to make improvements, so let's just leave the world in mess? And that just happens to coincide with the commercial interests of the industry rather than the interests of patients.
No let us accept that what we have now isn't a mess and while it may not be perfect it is a whole lot better than doing nothing. This comment displays a total lack of appreciation for the complexity of the issue or how much has changed in the last 30 years.
In reply to Reach>Talent:
OK, well the division of organisational responsibilities aside, do you think BG is asking for the industry statisticians to be sacked and for presribers to do the analysis themselves? Your comment doesn't address the point, which is that the analysis should be transparent and well communicated, and that if something seems worthy of digging into, the more detailed information should be made available because that's in the public interest.
The point I have disagreed with is that you seem to think that doctors will make a worse decision the more data they are able to see, and withholding that information is in patients interests to protect us from doctors who will misuse it. It won't wash, and nor will a response about the responsibilities of the marketing department.
We're not really arguing about specifics here. Do you think that more rigorous regulation to address publication bias, poor quality clinical trials and poor communication of the results of trials would help patients or not?
> (In reply to Jon Stewart)
> It may shock you to hear that we don't ask the marketing department to analyse our trial data, in much the same way we don't expect the guy who cuts the grass to design our air conditioning. We employ a lot of very talented statisticians, clinicians and experts on various areas of biology and chemistry to analyse our data.
OK, well the division of organisational responsibilities aside, do you think BG is asking for the industry statisticians to be sacked and for presribers to do the analysis themselves? Your comment doesn't address the point, which is that the analysis should be transparent and well communicated, and that if something seems worthy of digging into, the more detailed information should be made available because that's in the public interest.
The point I have disagreed with is that you seem to think that doctors will make a worse decision the more data they are able to see, and withholding that information is in patients interests to protect us from doctors who will misuse it. It won't wash, and nor will a response about the responsibilities of the marketing department.
>
> It's all rather hard to make improvements, so let's just leave the world in mess? And that just happens to coincide with the commercial interests of the industry rather than the interests of patients.
>
> No let us accept that what we have now isn't a mess and while it may not be perfect it is a whole lot better than doing nothing. This comment displays a total lack of appreciation for the complexity of the issue or how much has changed in the last 30 years.
> It's all rather hard to make improvements, so let's just leave the world in mess? And that just happens to coincide with the commercial interests of the industry rather than the interests of patients.
>
> No let us accept that what we have now isn't a mess and while it may not be perfect it is a whole lot better than doing nothing. This comment displays a total lack of appreciation for the complexity of the issue or how much has changed in the last 30 years.
We're not really arguing about specifics here. Do you think that more rigorous regulation to address publication bias, poor quality clinical trials and poor communication of the results of trials would help patients or not?
In reply to Jon Stewart: If you don't trust "big pharma" (hate that phrase!) to interpret the results of clinical trals, why do you trust them to carry out clinical trials? Maybe they should just churn out lines of totally untested chemicals and each GP's surgery could conduct their own trials on them? Where does your lack of trust in these big companies end, and why?
In reply to Jon Stewart:
I think we'll see whether it's helpful (regardless of flaws in execution) if it results in better information about drugs becoming available to doctors and patients
Who said anything about better? We are just talking about more information. The problem is that you can't deal with the raw data, you have to have an analysis: A single regulatory file for a new drug can easily contain over 600000 sheets of A4 and each year hundreds of them are submitted for approval. Someone needs to compress it and turn it into a meaningful set of guidelines for patients. You can't just pick up page 73567 and hand it to a GP, or even taking chunks of data without a lot of background; how is a GP or for that matter a UK based regulator expected to know the differences in the way deaths are recorded in foreign countries and the impact this has on your data?
An accessible global repository for trial data is a great idea and will be great if it works but it is a huge undertaking with no certain pay-off for patients or anyone else.
I think we'll see whether it's helpful (regardless of flaws in execution) if it results in better information about drugs becoming available to doctors and patients
Who said anything about better? We are just talking about more information. The problem is that you can't deal with the raw data, you have to have an analysis: A single regulatory file for a new drug can easily contain over 600000 sheets of A4 and each year hundreds of them are submitted for approval. Someone needs to compress it and turn it into a meaningful set of guidelines for patients. You can't just pick up page 73567 and hand it to a GP, or even taking chunks of data without a lot of background; how is a GP or for that matter a UK based regulator expected to know the differences in the way deaths are recorded in foreign countries and the impact this has on your data?
An accessible global repository for trial data is a great idea and will be great if it works but it is a huge undertaking with no certain pay-off for patients or anyone else.
In reply to Reach>Talent:
Frankly, I think that standards are low throughout, in small biotech companies right through to large scale pharma, and there are equivalent problems in primary research too. The financial pressure of drugs coming off patent, along with the exorbitant costs of inefficient drug discovery, and an obsession with unjustified approaches (such as monotherapies for cancer) puts huge pressure to bias toward positive results. We all need to move to standard of open data as well as open publication and a far more worldwide coordinated and collaborative approach to basic and applied research. I also think, within reason, we need to lower the onerous exclusion on the basis of side effects that cuts so many trials short.
> Yes, although soon to be leaving to work for small pharma. I get somewhat peeved at the whole industry and everyone who works in it tarred with the same brush. I suppose we all like a good stereotype but it isn't helpful when people start slinging them around and using words like regulation.
Frankly, I think that standards are low throughout, in small biotech companies right through to large scale pharma, and there are equivalent problems in primary research too. The financial pressure of drugs coming off patent, along with the exorbitant costs of inefficient drug discovery, and an obsession with unjustified approaches (such as monotherapies for cancer) puts huge pressure to bias toward positive results. We all need to move to standard of open data as well as open publication and a far more worldwide coordinated and collaborative approach to basic and applied research. I also think, within reason, we need to lower the onerous exclusion on the basis of side effects that cuts so many trials short.
In reply to owlart:
Ideally trials would be carried out by an organisation without a vested interest in the results. In lieu of that, I think that those conducting the trials with vested interests should be more rigorously regulated than pretty much any other industry on earth. And while whoever is carrying out the trial needs to be interpreting the data, that data and how it's been analysed should be available to others so that it can be looked at again as new information about the drug, or the disease, or competitor drugs becomes available.
Tosh.
I'm not sure I can answer that, but anyone can see clearly where market forces work in opposition to objectivity and the interests of patients. I trust the pharmaceutical industry, like any other industry, to do whatever it can to increase profits. I do not expect that just because they are dealing with lives and deaths of patients, that their moral standards are any different to companies manufacturing televisions, or writing newspapers, or reselling used cars. Companies may be made up of people (who may individually have some sense of moral responsibility), but their purpose is to maximise profits and that is what they do. The responsibility for making companies behave in ways which satisfy moral requirements lies with government, via regulators.
> (In reply to Jon Stewart) If you don't trust "big pharma" (hate that phrase!) to interpret the results of clinical trals, why do you trust them to carry out clinical trials?
Ideally trials would be carried out by an organisation without a vested interest in the results. In lieu of that, I think that those conducting the trials with vested interests should be more rigorously regulated than pretty much any other industry on earth. And while whoever is carrying out the trial needs to be interpreting the data, that data and how it's been analysed should be available to others so that it can be looked at again as new information about the drug, or the disease, or competitor drugs becomes available.
> Maybe they should just churn out lines of totally untested chemicals and each GP's surgery could conduct their own trials on them?
Tosh.
> Where does your lack of trust in these big companies end, and why?
I'm not sure I can answer that, but anyone can see clearly where market forces work in opposition to objectivity and the interests of patients. I trust the pharmaceutical industry, like any other industry, to do whatever it can to increase profits. I do not expect that just because they are dealing with lives and deaths of patients, that their moral standards are any different to companies manufacturing televisions, or writing newspapers, or reselling used cars. Companies may be made up of people (who may individually have some sense of moral responsibility), but their purpose is to maximise profits and that is what they do. The responsibility for making companies behave in ways which satisfy moral requirements lies with government, via regulators.
In reply to Jon Stewart:
Ideally trials would be carried out by an organisation without a vested interest in the results.
If you can find an organisation without vested interests that can stump up £100000000 then I'm all ears.
In lieu of that, I think that those conducting the trials with vested interests should be more rigorously regulated than pretty much any other industry on earth
Well we can all go home then, we are already probably the most regulated industry on Earth (Agrochemicals possibly excepted).
Ideally trials would be carried out by an organisation without a vested interest in the results.
If you can find an organisation without vested interests that can stump up £100000000 then I'm all ears.
In lieu of that, I think that those conducting the trials with vested interests should be more rigorously regulated than pretty much any other industry on earth
Well we can all go home then, we are already probably the most regulated industry on Earth (Agrochemicals possibly excepted).
In reply to Jimbo W:
Frankly, I think that standards are low throughout
Can I ask what you do and what your experience of the pharma industry is?
Frankly, I think that standards are low throughout
Can I ask what you do and what your experience of the pharma industry is?
In reply to Jon Stewart:
You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
> Ideally trials would be carried out by an organisation without a vested interest in the results.
> In lieu of that, I think that those conducting the trials with vested interests should be more
> rigorously regulated than pretty much any other industry on earth.
> In lieu of that, I think that those conducting the trials with vested interests should be more
> rigorously regulated than pretty much any other industry on earth.
You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
In reply to Jon Stewart: How about those with a vested interest in running negative stories about "big pharma" (because it sells books), do you trust them? I'm sure that the situation isn't perfect, but equally, I'm sure that St. Goldacre is far from being as unbiassed as he'd like the drug companies to be.
In reply to Reach>Talent:
No. Making trial data accessible allows for more meta-analysis and better data for doctors and patients.
The point is that with the data in the public domain, people with the skills to do so (academics, perhaps funded publicly rather than by industry) can review the work that has gone before, and can scrutinise results which may have been polluted by commercial bias. A great idea certainly and a huge undertaking it may be, but the pay-off for patients is bleeding obvious.
We're talking about science here. Fundamental to science is the process of people examining and reexamining work that has gone before. We live in a world where market forces seem to consistently trump more serious, long term, and communal interests of the human race. I find it depressing that so few people seem to prioritise wide reaching, long term communal benefits above the freedom for companies to make short term commercial gains.
> (In reply to Jon Stewart)
> Who said anything about better? We are just talking about more information.
No. Making trial data accessible allows for more meta-analysis and better data for doctors and patients.
> The problem is that you can't deal with the raw data, you have to have an analysis: A single regulatory file for a new drug can easily contain over 600000 sheets of A4 and each year hundreds of them are submitted for approval. Someone needs to compress it and turn it into a meaningful set of guidelines for patients. You can't just pick up page 73567 and hand it to a GP, or even taking chunks of data without a lot of background; how is a GP or for that matter a UK based regulator expected to know the differences in the way deaths are recorded in foreign countries and the impact this has on your data?
> An accessible global repository for trial data is a great idea and will be great if it works but it is a huge undertaking with no certain pay-off for patients or anyone else.
The point is that with the data in the public domain, people with the skills to do so (academics, perhaps funded publicly rather than by industry) can review the work that has gone before, and can scrutinise results which may have been polluted by commercial bias. A great idea certainly and a huge undertaking it may be, but the pay-off for patients is bleeding obvious.
We're talking about science here. Fundamental to science is the process of people examining and reexamining work that has gone before. We live in a world where market forces seem to consistently trump more serious, long term, and communal interests of the human race. I find it depressing that so few people seem to prioritise wide reaching, long term communal benefits above the freedom for companies to make short term commercial gains.
In reply to Jimbo W:
an obsession with unjustified approaches (such as monotherapies for cancer)
Cancer isn't really my area but I'll go out on a limb and suggest this is for 3 reasons:
- Firstly most cancer treatments are pretty unpleasant, ethics committees aren't staffed by robots
- Your trials are really costly as they are mortality based, ie you need the patients to die before you can announce an endpoint!
- Populating a phase 3 trial is difficult as you need a lot of people who have conveniently all got a fast moving disease in the right stage, multi drug trials need a huge designed multi-variant approach which can't currently be simulated.
an obsession with unjustified approaches (such as monotherapies for cancer)
Cancer isn't really my area but I'll go out on a limb and suggest this is for 3 reasons:
- Firstly most cancer treatments are pretty unpleasant, ethics committees aren't staffed by robots
- Your trials are really costly as they are mortality based, ie you need the patients to die before you can announce an endpoint!
- Populating a phase 3 trial is difficult as you need a lot of people who have conveniently all got a fast moving disease in the right stage, multi drug trials need a huge designed multi-variant approach which can't currently be simulated.
In reply to owlart:
I'm a lot less worried about the consequences.
Discussed upthread.
> (In reply to Jon Stewart) How about those with a vested interest in running negative stories about "big pharma" (because it sells books), do you trust them?
I'm a lot less worried about the consequences.
> I'm sure that the situation isn't perfect, but equally, I'm sure that St. Goldacre is far from being as unbiassed as he'd like the drug companies to be.
Discussed upthread.
In reply to Coel Hellier:
In general that may be true. But when it comes to independence of research and scientific data, I think government funding (universities, research bodies) has a much better track record than commercial funding. I don't work in pharma but the chances of the companies I deal with publishing data that is against their commercial interests is variable at best and in some cases zero. I am sure the same is true in other areas.
> (In reply to Jon Stewart)
>
> [...]
>
> You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
>
> [...]
>
> You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
In general that may be true. But when it comes to independence of research and scientific data, I think government funding (universities, research bodies) has a much better track record than commercial funding. I don't work in pharma but the chances of the companies I deal with publishing data that is against their commercial interests is variable at best and in some cases zero. I am sure the same is true in other areas.
In reply to Jon Stewart:
No. Making trial data accessible allows for more meta-analysis and better data for doctors and patients.
If I made a pile of well conducted meta analysis that were actually helpful and a pile of badly designed and misleading meta analysis that gave entirely the wrong picture I'd challenge anyone without a good grounding in statistics and some knowledge of the initial trial design to tell them apart. How many meta analysis was it that showed MMR caused autism?
No. Making trial data accessible allows for more meta-analysis and better data for doctors and patients.
If I made a pile of well conducted meta analysis that were actually helpful and a pile of badly designed and misleading meta analysis that gave entirely the wrong picture I'd challenge anyone without a good grounding in statistics and some knowledge of the initial trial design to tell them apart. How many meta analysis was it that showed MMR caused autism?
In reply to Coel Hellier:
In principle I think that more public funding and involvement would be helpful yes. The consequences of those with commercial interests having too much control of the information is that the public get ripped off. God knows how you'd do the analysis, but I'd expect there to be a sweet spot whereby spending the extra money on research and regulation makes you big gains after you quit spending on useless or unnecessarily expensive drugs.
Sadly I suspect you're right. Not here to cheer me up, are you?
> (In reply to Jon Stewart)
>
> [...]
>
> You are essentially asking for massive public (i.e. government) funding and involvement.
>
> [...]
>
> You are essentially asking for massive public (i.e. government) funding and involvement.
In principle I think that more public funding and involvement would be helpful yes. The consequences of those with commercial interests having too much control of the information is that the public get ripped off. God knows how you'd do the analysis, but I'd expect there to be a sweet spot whereby spending the extra money on research and regulation makes you big gains after you quit spending on useless or unnecessarily expensive drugs.
> But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
Sadly I suspect you're right. Not here to cheer me up, are you?
In reply to Coel Hellier:
if they have a direct interest no. However you wouldnt need public sector but instead could limit the influence those paying for the trials have over them. So separate companies specialising in running the trials and then a cab rank (for example) system like barristers use to select the particular company to run each trial.
Wouldnt remove all the incentives (personal bribery for example) but the influence, deliberate or not.
> You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
if they have a direct interest no. However you wouldnt need public sector but instead could limit the influence those paying for the trials have over them. So separate companies specialising in running the trials and then a cab rank (for example) system like barristers use to select the particular company to run each trial.
Wouldnt remove all the incentives (personal bribery for example) but the influence, deliberate or not.
In reply to Jon Stewart:
In principle I think that more public funding and involvement would be helpful yes. The consequences of those with commercial interests having too much control of the information is that the public get ripped off. God knows how you'd do the analysis, but I'd expect there to be a sweet spot whereby spending the extra money on research and regulation makes you big gains after you quit spending on useless or unnecessarily expensive drugs.
You are almost certainly right although I think you'd be taking a long term view as I've got £20 that says you wouldn't get on the right side of the line in the first decade. It would be a massive boost to the UK science sector especially education but I'm still not convinced it would pay off in the sort of term that politicians care about
In principle I think that more public funding and involvement would be helpful yes. The consequences of those with commercial interests having too much control of the information is that the public get ripped off. God knows how you'd do the analysis, but I'd expect there to be a sweet spot whereby spending the extra money on research and regulation makes you big gains after you quit spending on useless or unnecessarily expensive drugs.
You are almost certainly right although I think you'd be taking a long term view as I've got £20 that says you wouldn't get on the right side of the line in the first decade. It would be a massive boost to the UK science sector especially education but I'm still not convinced it would pay off in the sort of term that politicians care about
In reply to Reach>Talent:
which is why academics who dont have a direct interest in any particular product in terms of sponsorship of departments etc come in handy.
Well that or watch as some of the competing companies start diverting some money to aggressive reviews of their opponents products.
> If I made a pile of well conducted meta analysis that were actually helpful and a pile of badly designed and misleading meta analysis that gave entirely the wrong picture I'd challenge anyone without a good grounding in statistics and some knowledge of the initial trial design to tell them apart.
which is why academics who dont have a direct interest in any particular product in terms of sponsorship of departments etc come in handy.
Well that or watch as some of the competing companies start diverting some money to aggressive reviews of their opponents products.
In reply to dissonance:
Not sure it would work in practice, possibly for small early trials but not for the big important late stage ones. It can be a nightmare finding ill people when you need them
Not sure it would work in practice, possibly for small early trials but not for the big important late stage ones. It can be a nightmare finding ill people when you need them
In reply to Reach>Talent:
You're ignoring the central point which is that bias is caused by motivation and incentives. Academics conducting a meta analysis without a vested interest in the results are motivated by getting it published because it shows something useful, and are motivated to do it right because it's going to be scrutinised, starting but not ending with peer review.
How many meta analysis was it that showed MMR caused autism?
Taking a single case of scientific misconduct to make a point that meta analysis is a dangerous game is surely not a good strategy when you're criticising BG's use of evidence?
> (In reply to Jon Stewart)
> If I made a pile of well conducted meta analysis that were actually helpful and a pile of badly designed and misleading meta analysis that gave entirely the wrong picture I'd challenge anyone without a good grounding in statistics and some knowledge of the initial trial design to tell them apart.
You're ignoring the central point which is that bias is caused by motivation and incentives. Academics conducting a meta analysis without a vested interest in the results are motivated by getting it published because it shows something useful, and are motivated to do it right because it's going to be scrutinised, starting but not ending with peer review.
How many meta analysis was it that showed MMR caused autism?
Taking a single case of scientific misconduct to make a point that meta analysis is a dangerous game is surely not a good strategy when you're criticising BG's use of evidence?
In reply to dissonance: That wouldn't really remove the influence they have over which trials to run. Very often choosing which questions to ask is as important as how they are asked, in terms of skewing understanding.
In reply to Jon Stewart:
Taking a single case of scientific misconduct to make a point that meta analysis is a dangerous game is surely not a good strategy when you're criticising BG's use of evidence?
I was merely pointing out that meta analysis don't always help and I am not going to use a more sensible example because I'm not risking getting sued.
Taking a single case of scientific misconduct to make a point that meta analysis is a dangerous game is surely not a good strategy when you're criticising BG's use of evidence?
I was merely pointing out that meta analysis don't always help and I am not going to use a more sensible example because I'm not risking getting sued.
In reply to Reach>Talent:
There's lots of reasons, for sure, but the reality is that cancer is a disease characterised by genomic instability and rapid evolution in which treatment with monotherapies e.g. B-Raf inhibitors for melanoma merely represents a transient environmental selective pressure. It seems consistently true historically that the evolutionary extinction of animals usually requires at least two coincident major environmental changes/challenges. The same will undoubtedly be true with regard to cancer, and many of us just can't understand why the mono-therapy approach is so persistent. I'm a clinical pathologist and basic researcher into cancer biology/DNA repair.
> an obsession with unjustified approaches (such as monotherapies for cancer)
> Cancer isn't really my area but I'll go out on a limb and suggest this is for 3 reasons:
> - Firstly most cancer treatments are pretty unpleasant, ethics committees aren't staffed by robots
> - Your trials are really costly as they are mortality based, ie you need the patients to die before you can announce an endpoint!
> - Populating a phase 3 trial is difficult as you need a lot of people who have conveniently all got a fast moving disease in the right stage, multi drug trials need a huge designed multi-variant approach which can't currently be simulated.
> Cancer isn't really my area but I'll go out on a limb and suggest this is for 3 reasons:
> - Firstly most cancer treatments are pretty unpleasant, ethics committees aren't staffed by robots
> - Your trials are really costly as they are mortality based, ie you need the patients to die before you can announce an endpoint!
> - Populating a phase 3 trial is difficult as you need a lot of people who have conveniently all got a fast moving disease in the right stage, multi drug trials need a huge designed multi-variant approach which can't currently be simulated.
There's lots of reasons, for sure, but the reality is that cancer is a disease characterised by genomic instability and rapid evolution in which treatment with monotherapies e.g. B-Raf inhibitors for melanoma merely represents a transient environmental selective pressure. It seems consistently true historically that the evolutionary extinction of animals usually requires at least two coincident major environmental changes/challenges. The same will undoubtedly be true with regard to cancer, and many of us just can't understand why the mono-therapy approach is so persistent. I'm a clinical pathologist and basic researcher into cancer biology/DNA repair.
In reply to anyone who might know:
Do we know what the scale of the problem is? Out of all the drugs being used and prescribed worldwide, what proportion would be administered differently if trials and analysis had been done under all the public-disclosure conditions?
Do we know what the scale of the problem is? Out of all the drugs being used and prescribed worldwide, what proportion would be administered differently if trials and analysis had been done under all the public-disclosure conditions?
In reply to tony:
Not sure anyone could estimate that, since it's Rumsfeldian stuff - unknown unknows.
> (In reply to anyone who might know)
>
> Do we know what the scale of the problem is? Out of all the drugs being used and prescribed worldwide, what proportion would be administered differently if trials and analysis had been done under all the public-disclosure conditions?
>
> Do we know what the scale of the problem is? Out of all the drugs being used and prescribed worldwide, what proportion would be administered differently if trials and analysis had been done under all the public-disclosure conditions?
Not sure anyone could estimate that, since it's Rumsfeldian stuff - unknown unknows.
In reply to owlart:
Jon does not appear to realise that quis custodiet ipsos custodes is legendary as an unsolvable conundrum. As soon as you set up any organisation, public or private, to do anything, it and the people who work in it immediately aquire a vested interest in that organisation continuing and growing bigger. The public sector is, notoriously, riddled with vested interests, which will defend their patch tenatiously.
Not least the need to play to his Guardian gallery and keep the lucrative BBC appearances coming in. Nothing like a bit of good old fashioned shroud waving and scaremongering for that, provided it is aimed at the acceptable targets that is.
It is curious that those who use the adjective "big" as entirely pejorative when applied to say pharmaceutical or oil companies are normally uncritical enthusisasts when it comes to big government, the biggest organisation of all. Why are they so convinced that that enormous structure is going to act so wisely and disinterestedly?
> (In reply to Jon Stewart) How about those with a vested interest in running negative stories about "big pharma" (because it sells books), do you trust them?
Jon does not appear to realise that quis custodiet ipsos custodes is legendary as an unsolvable conundrum. As soon as you set up any organisation, public or private, to do anything, it and the people who work in it immediately aquire a vested interest in that organisation continuing and growing bigger. The public sector is, notoriously, riddled with vested interests, which will defend their patch tenatiously.
> I'm sure that St. Goldacre is far from being as unbiassed as he'd like the drug companies to be.
Not least the need to play to his Guardian gallery and keep the lucrative BBC appearances coming in. Nothing like a bit of good old fashioned shroud waving and scaremongering for that, provided it is aimed at the acceptable targets that is.
It is curious that those who use the adjective "big" as entirely pejorative when applied to say pharmaceutical or oil companies are normally uncritical enthusisasts when it comes to big government, the biggest organisation of all. Why are they so convinced that that enormous structure is going to act so wisely and disinterestedly?
In reply to Coel Hellier:
massive? come on Coel- don't get emotive and political..
> (In reply to Jon Stewart)
>
> You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
>
> You are essentially asking for massive public (i.e. government) funding and involvement. But even if you had that, massive public-sector enterprises don't really have that much better a track record than private-sector ones.
massive? come on Coel- don't get emotive and political..
In reply to Reach>Talent: yeah, let Glaxo and Monsanto release their raw data so that we can analyse it ourselves- who are they/you kidding?
In reply to Simon4:
Not the case. To argue for more public investment in research and more rigorous regulation is not the same as assuming that that would create a perfect system. I understand very well that large public sector organisations are notoriously dreadful at doing anything. But you misinterpret "more rigorous regulation" for "the expansion of the public sector agency" to suit your own purpose.
The implication is that he simply doesn't have a point worth making, he is simply having an unjustified pop at the pharmceutical industry for his own purposes of selling books. Is that what you actually believe?
The problem, as ever, is that without considering the issues at hand, you are talking in generalisations about government and the public sector. It becomes a meaningless discussion, as to respond in kind I would be asking "so, you don't think anything should be regulated then?" and the discussion would descend further into drivel.
The problem in this instance is that commercial interests are not aligned with the need for scientific rigor which benefits patients. Sometimes market forces are aligned with what you (joe public) want to achieve and in those cases I would argue in favour of leaving the market to it.
By dividing everything into left and right, and arguing that government is always bad and the free market always delivers the right outcome (or something), you drag the discussion away from the issue at hand. Here the issue is that publication bias, driven by the commercial interests of drug companies, has distorted the information available on which medical decisions can be made. There is a simple proposition to address that problem: do you agree with it?
> (In reply to owlart)
> [...]
>
> Jon does not appear to realise that quis custodiet ipsos custodes is legendary as an unsolvable conundrum. As soon as you set up any organisation, public or private, to do anything, it and the people who work in it immediately aquire a vested interest in that organisation continuing and growing bigger. The public sector is, notoriously, riddled with vested interests, which will defend their patch tenatiously.
> [...]
>
> Jon does not appear to realise that quis custodiet ipsos custodes is legendary as an unsolvable conundrum. As soon as you set up any organisation, public or private, to do anything, it and the people who work in it immediately aquire a vested interest in that organisation continuing and growing bigger. The public sector is, notoriously, riddled with vested interests, which will defend their patch tenatiously.
Not the case. To argue for more public investment in research and more rigorous regulation is not the same as assuming that that would create a perfect system. I understand very well that large public sector organisations are notoriously dreadful at doing anything. But you misinterpret "more rigorous regulation" for "the expansion of the public sector agency" to suit your own purpose.
> [...]
>
> Not least the need to play to his Guardian gallery and keep the lucrative BBC appearances coming in. Nothing like a bit of good old fashioned shroud waving and scaremongering for that, provided it is aimed at the acceptable targets that is.
>
> Not least the need to play to his Guardian gallery and keep the lucrative BBC appearances coming in. Nothing like a bit of good old fashioned shroud waving and scaremongering for that, provided it is aimed at the acceptable targets that is.
The implication is that he simply doesn't have a point worth making, he is simply having an unjustified pop at the pharmceutical industry for his own purposes of selling books. Is that what you actually believe?
> It is curious that those who use the adjective "big" as entirely pejorative when applied to say pharmaceutical or oil companies are normally uncritical enthusisasts when it comes to big government, the biggest organisation of all. Why are they so convinced that that enormous structure is going to act so wisely and disinterestedly?
The problem, as ever, is that without considering the issues at hand, you are talking in generalisations about government and the public sector. It becomes a meaningless discussion, as to respond in kind I would be asking "so, you don't think anything should be regulated then?" and the discussion would descend further into drivel.
The problem in this instance is that commercial interests are not aligned with the need for scientific rigor which benefits patients. Sometimes market forces are aligned with what you (joe public) want to achieve and in those cases I would argue in favour of leaving the market to it.
By dividing everything into left and right, and arguing that government is always bad and the free market always delivers the right outcome (or something), you drag the discussion away from the issue at hand. Here the issue is that publication bias, driven by the commercial interests of drug companies, has distorted the information available on which medical decisions can be made. There is a simple proposition to address that problem: do you agree with it?
In reply to Jon Stewart:
I obviously have a lot more faith in humanity than you do: You do realise that the main problem with meta analysis isn't some sort of innate evil in the heart of man it is just good old fashioned incompetence? Conducting a meta analysis requires an intimate understanding of the raw data and its origins, external experts very rarely get the later part totally right.
I obviously have a lot more faith in humanity than you do: You do realise that the main problem with meta analysis isn't some sort of innate evil in the heart of man it is just good old fashioned incompetence? Conducting a meta analysis requires an intimate understanding of the raw data and its origins, external experts very rarely get the later part totally right.
In reply to Jon Stewart:
There is almost never a circumstance where you cannot get someone to produce an argument for more public spending (lets drop the loaded term "investment"), sometimes there is even a valid case for it, taking that issue in isolation. But the problem is that in practice every plea for more public spending is competing with every other, and we conspicuously do not have much money to throw around.
Obviously there has never been an academic in the world who has ever suggested that LESS research is required!
Not always, they can be but it depends on your standard of comparison. Compared with French or American bureacracy, UK bureacracy is a miracle of common sense and helpfulness!
The implication is that he may or may not have a substantive point, but he is very far from the monopoly possessor of virtue that he claims to be, also that he has a tame audience that will automatically cheer pretty much whatever he produces. I have heard various of his "bad science" pieces, the loaded tendentiousness of his examples is the most striking thing about them, rather than any conspicuous insight or iconoclasticism.
As you correctly say, that is a reductio-ad-absurdum (or playground taunts and talking in cliches).
Clearly regulation is needed, indeed it is already very strict, expensive and rigorous. But where is the evidence (post Thalidomide, which is a long time ago now), that there are gross abuses? Commercial interests are heavily constrained, but drug production is very, very expensive, especially when you remember that there is only a 10 year exclusive licence (someone will no doubt deny that if I am not correct), while for every drug that has the effect wanted there are 9 failures, or else the drug does what it is supposed to but fails on some other criteria, e.g. unacceptable side-effects.
Adding an extra layer of administrative and financial burden on drug-producers always sounds like a good idea, to those who don't have to bear the cost. But where is the argument that the cost-benefit justifies it?
I don't argue that, indeed private does everything best/public does everything best is an incredibly sterile argument, given that they are both clearly mutually dependent. Where the appropriate boundary lies in any given circumstance is however very much the point.
That is the claim, it is far from clear that it has been substantiated (by the way, I hope you never apply these considerations to our fine new aircraft carriers - bigger ships than we ever had when half the world was painted red, with the unfortunate feature that they can't fly any planes!)
The problem is that it is far from simple and is very expensive, if it works at all. That cost has to be bourne by patients/taxpayers.
> To argue for more public investment in research and more rigorous regulation
There is almost never a circumstance where you cannot get someone to produce an argument for more public spending (lets drop the loaded term "investment"), sometimes there is even a valid case for it, taking that issue in isolation. But the problem is that in practice every plea for more public spending is competing with every other, and we conspicuously do not have much money to throw around.
Obviously there has never been an academic in the world who has ever suggested that LESS research is required!
> ... large public sector organisations are notoriously dreadful at doing anything
Not always, they can be but it depends on your standard of comparison. Compared with French or American bureacracy, UK bureacracy is a miracle of common sense and helpfulness!
> The implication is that he simply doesn't have a point worth making, he is simply having an unjustified pop at the pharmceutical industry for his own purposes of selling books. Is that what you actually believe?
The implication is that he may or may not have a substantive point, but he is very far from the monopoly possessor of virtue that he claims to be, also that he has a tame audience that will automatically cheer pretty much whatever he produces. I have heard various of his "bad science" pieces, the loaded tendentiousness of his examples is the most striking thing about them, rather than any conspicuous insight or iconoclasticism.
> It becomes a meaningless discussion, as to respond in kind I would be asking "so, you don't think anything should be regulated then?" and the discussion would descend further into drivel.
As you correctly say, that is a reductio-ad-absurdum (or playground taunts and talking in cliches).
> The problem in this instance is that commercial interests are not aligned with the need for scientific rigor which benefits patients
Clearly regulation is needed, indeed it is already very strict, expensive and rigorous. But where is the evidence (post Thalidomide, which is a long time ago now), that there are gross abuses? Commercial interests are heavily constrained, but drug production is very, very expensive, especially when you remember that there is only a 10 year exclusive licence (someone will no doubt deny that if I am not correct), while for every drug that has the effect wanted there are 9 failures, or else the drug does what it is supposed to but fails on some other criteria, e.g. unacceptable side-effects.
Adding an extra layer of administrative and financial burden on drug-producers always sounds like a good idea, to those who don't have to bear the cost. But where is the argument that the cost-benefit justifies it?
> By dividing everything into left and right, and arguing that government is always bad and the free market always delivers the right outcome (or something), you drag the discussion away from the issue at hand.
I don't argue that, indeed private does everything best/public does everything best is an incredibly sterile argument, given that they are both clearly mutually dependent. Where the appropriate boundary lies in any given circumstance is however very much the point.
> Here the issue is that publication bias, driven by the commercial interests of drug companies, has distorted the information available on which medical decisions can be made.
That is the claim, it is far from clear that it has been substantiated (by the way, I hope you never apply these considerations to our fine new aircraft carriers - bigger ships than we ever had when half the world was painted red, with the unfortunate feature that they can't fly any planes!)
> There is a simple proposition to address that problem
The problem is that it is far from simple and is very expensive, if it works at all. That cost has to be bourne by patients/taxpayers.
In reply to Jonathan:
Your argument is as bad as the science you criticise.
> If I tossed a coin many times, but only reported the result when it was heads, you would say it wasn't fair. This kind of reporting is common amongst drug companies when developing and testing new drugs, and so this is the quality of information doctors have available when deciding what drugs to treat you with. As a result, many drugs routinely prescribed by doctors probably have no beneficial effect, but may still cause dangerous side-effects, as well as costing millions.
Your argument is as bad as the science you criticise.
In reply to Simon4:
How about the public money spent on Tamiflu (http://www.bmj.com/tamiflu ) or the shady dissing of Avantis for AMD by the manufacturers of Lucentin (http://www.bmj.com/content/344/bmj.e3162 ) or Paroxetine, the antidepressant that GSK knew increased the risk of suicide in young people but kept it to themselves ( http://www.nelm.nhs.uk/en/NeLM-Area/Evidence/Patient-Safety/500721/ )? Gross enough for you?
Above, and here for ease of reference:
Absolutely. I think it's pretty clear here that bad regulation is responsible for allowing the commercial interests of drug companies to run roughshod over the interests of patients, because market forces do not align their needs.
It's not an issue about people screeching for vast sums of new public spending for their cause, as you paint it to be. You can use that argument when it comes to benefits reform or public sector pensions, but it won't wash here because this is not a budget-balance issue.
The problem of publication bias is well known, and the fix, which you claim is "far from simple and very expensive" is to regulate to enforce the publication of all trials. This is a European system. Which budgets do you think it will displace much needed funds from that could be so much better spent? I can't see any justification at all for your bald assertion that publishing this data will divert funds from more necessary areas of spending.
> (In reply to Jon Stewart)
>
>
>
> Clearly regulation is needed, indeed it is already very strict, expensive and rigorous. But where is the evidence (post Thalidomide, which is a long time ago now), that there are gross abuses?
> Clearly regulation is needed, indeed it is already very strict, expensive and rigorous. But where is the evidence (post Thalidomide, which is a long time ago now), that there are gross abuses?
How about the public money spent on Tamiflu (http://www.bmj.com/tamiflu ) or the shady dissing of Avantis for AMD by the manufacturers of Lucentin (http://www.bmj.com/content/344/bmj.e3162 ) or Paroxetine, the antidepressant that GSK knew increased the risk of suicide in young people but kept it to themselves ( http://www.nelm.nhs.uk/en/NeLM-Area/Evidence/Patient-Safety/500721/ )? Gross enough for you?
> But where is the argument that the cost-benefit justifies it?
Above, and here for ease of reference:
> The consequences of those with commercial interests having too much control of the information is that the public get ripped off. God knows how you'd do the analysis, but I'd expect there to be a sweet spot whereby spending the extra money on research and regulation makes you big gains after you quit spending on useless or unnecessarily expensive drugs.
> [...]
>
> I don't argue that, indeed private does everything best/public does everything best is an incredibly sterile argument, given that they are both clearly mutually dependent. Where the appropriate boundary lies in any given circumstance is however very much the point.
>
> I don't argue that, indeed private does everything best/public does everything best is an incredibly sterile argument, given that they are both clearly mutually dependent. Where the appropriate boundary lies in any given circumstance is however very much the point.
Absolutely. I think it's pretty clear here that bad regulation is responsible for allowing the commercial interests of drug companies to run roughshod over the interests of patients, because market forces do not align their needs.
> [...]
>
> That is the claim, it is far from clear that it has been substantiated (by the way, I hope you never apply these considerations to our fine new aircraft carriers - bigger ships than we ever had when half the world was painted red, with the unfortunate feature that they can't fly any planes!)
>
> [...]
>
> The problem is that it is far from simple and is very expensive, if it works at all. That cost has to be bourne by patients/taxpayers.
>
> That is the claim, it is far from clear that it has been substantiated (by the way, I hope you never apply these considerations to our fine new aircraft carriers - bigger ships than we ever had when half the world was painted red, with the unfortunate feature that they can't fly any planes!)
>
> [...]
>
> The problem is that it is far from simple and is very expensive, if it works at all. That cost has to be bourne by patients/taxpayers.
It's not an issue about people screeching for vast sums of new public spending for their cause, as you paint it to be. You can use that argument when it comes to benefits reform or public sector pensions, but it won't wash here because this is not a budget-balance issue.
The problem of publication bias is well known, and the fix, which you claim is "far from simple and very expensive" is to regulate to enforce the publication of all trials. This is a European system. Which budgets do you think it will displace much needed funds from that could be so much better spent? I can't see any justification at all for your bald assertion that publishing this data will divert funds from more necessary areas of spending.
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