Some aspects are down to a manufacturer data submission but they risk a europe wide recall if they get it wrong so there is good incentive to be sure of your result.

Of course things will always slip through and some products are designed just to pass the test and exploit loop holes. However manufacturers are now wary of not complying with the “spirit” of the regulations after some hefty fines from the EPA in the US.

just wondering, though, who is going to publish trials that didn’t show any significance? or in which the protocols were determined to have problems?

i’m more familiar with academic/basic science journals, which (generally speaking) are not interested in something unless it’s contributing new & convincing information.

can anyone enlighten me as to what journals or registries or (etc) are currently on board to disseminate papers about trials that didn’t “work”?

My real object is to the governments proposed ID card scheme.

1) It is _insanely_ expensive and every available piece of evidence I have seen suggests that it will be much more expensive to implement than the government estimates. (By insanely expensive I mean that any proposed benefits of of the scheme would be much more cost-effectively met by spending the money in other ways such as increased police, customs and intelligence service manpower).

2) The technical difficulties of the scheme – as proposed – are immense. I’m not sure that it is technically possible to achieve the required results in the time frame they are proposing. I’m not an expert on this – but I have (in the past) done research on face processing (one of the proposed biometrics) and I still try and keep up with the literature in the area. Most likely the technical difficulties with be fudged – diluting any potential benefits but still retaining many of the risks (including lots of wasted investment and many of the potential errors).

3) The dangers of the system have been massively underestimated. These include threats to civil liberties, data protection issues (for which this particular government has an appalling recent record) and the likely rate of errors (due to the aforementioned technical difficulties). A particular worry is that if they did get the system to work anyone who already has a false identity (or has stolen someone’s identity) could easily get on the system when it starts up.

I’m optimistic though, that such legislation may be helpful in changing attitudes in the research community as well. We still have a ways to go in persuading reviewers and editors of juried journals that negative and no-difference results are important.

Maarten, do you have compulsory ID cards in Belgium, like they do in France? If not, I don’t understand the point of your first comment. If so, then in what sense are they compulsory if you’re not legally required to carry them at all times and the state don’t have the authority to check that you are complying with that law? I think you’re being disingenuous by saying that they can only stop you and demand to see your papers if they think you’re doing something wrong, since not carrying your papers and producing them on demand is doing something wrong.

I certainly didn’t imply that Belgium has no democracy. But there is a difference between mere democracy and a strong tradition that the state is answerable to the people — a tradition that, in Britain, predates democracy by centuries. For instance, European monarchs used to be surprised when they discovered that British monarchs could not punish their subjects without their first being found guilty of something in court. When you are required to carry proof of your official state-sanctioned existence with you at all times and the state’s authorities can stop and demand that you produce it for their inspection at any time, then you are answerable to the state, not the other way around. The fact that every few years you get to elect who runs the state to which you are answerable doesn’t change the fact that you’re answerable to it.

An ad hominem argument is one which attempts to dispute a point by attacking the person making it. I did no such thing. I didn’t say that compulsory ID cards are a bad idea because the Belgians have no sense. I said that compulsory ID cards are a bad idea and that therefore the Belgians have no sense for not opposing them. Just as, by the way, most of the British have no sense for exactly the same reason.

I notice that the developed world’s most powerful wholly unelected legislative body is based in your capital, by the way. Just saying, like.

I’m sure Ben would rather this thread stayed closer to the topic of science, so I’ll stop now.

Ben has previously written about (and alluded to suc here) the need for all sorts of approval before a doctor could perform a study on his patients whereby he randomised them to one of two groups where we don’t know which medicine is better.
Now, aside from this probably being a very small study, and thus rather underpowered, it’s also an unnecessary protocol. If a GP knows that he has patients on a variety of different medicines for the same condition, he can go back and look at the records (and indeed proactively look at the records) to see which is working best (both for safety and efficacy), or he could farm out anonymised data to a friendly statistician who could then do the same without knowing which group referred to which product. The GPRD is already a tool for this, covering about 10% of the patients in the country.

And I can’t see how ID is linked to getting rid of the presumption of innocence. We don’t do that, it would turn the very principles of our idea of justice upside down.

And noone will ever stop you to see if you have the state’s permission to walk down the street. They can ask for your papers, yes, but there are other reasons for that. For example, you do something wrong, they check you ID to make sure they fine you, and not your neighbour.

Furthermore, it’s hardly polite to say we don’t have any sense for not fighting it. Ad hominems don’t make for good arguments, you know.

I have a friend from mainland Europe whose life has been made enormously difficult for the last few years because people hostile to her have effectively brought about the cessation of her official existence. This is only possible when you need the state’s paperwork to prove your existence in the first place.

The MHRA want “absolute clarity in the legislation as to the information that must be supplied to the regulator”

As the MHRA report begins with the disclaimer that “Legal constraints make it impossible to disclose any information … except … already in the public domain” it seems hard to imagine that the MHRA are pressing for research data to be made available to anyone othe than themselves.

Seems like they want more opportunities for opacity.

So please, when you are issuing your next commands to government, put in a plea for access to more than just drug trial data.

Summary here – www.npa.co.uk/newsarticle.php?id=d658fec5a5e0ad0404233d6e9bc10d90

Could I ask a question about the Seroxat issue?

While I agree totally that companies should disclose potentially important information as early as possible, is the Seroxat/increased suicidality tendency really an issue specific to Seroxat?

My understanding is that the greatest risk of suicide with depressed subject is not when they are at rock bottom, because they don’t have the strength or motivation to do something about suicide. However, when they start to recover (as they might do after taking anti-depressants for a while), they may then have more strength to plan a suicide, reasoning that they never want to go back to the bottom again.

If this is the case, it would be true of any antidepressant, not just Seroxat.

So I guess my question is “What evidence is there that this effect is worse in Seroxat than any other drug?”

(PS I don’t work for GSK, so no vested interest

In short, lots of things – thing is, the British government’s scheme is not simply for an ID card, but more for an identity register. You should visit www.no2id.co.uk for a full discussion about this, but essentially:

- the government is proposing a national identity register i.e. individual checking and numbering of the population — marking many personal details as “registrable facts” to be disclosed and constantly updated and kept in a central database with provision for use across the private and public sectors.

- Overseas ID cards are not comparable: Many western countries that have ID cards do not have a shared register. Mostly ID cards have been limited in use, with strong legal privacy protections. the records are not linked. Belgium has made use of modern encryption methods and local storage to protect privacy and prevent data-sharing, an approach opposite to the Home Office’s.

Furthermore:

- the Government has not made a case that the cards will actually will help with any of the areas one might hope such a scheme might do so for example terrorist attacks. It is likely that the scheme will actually make us less safe – we have seen that the UK government is rather clumsy when it come to data retention.

- the scheme is massively expensive and relies on unproven technology

- the scheme also raises questions of unchecked executive powers for instance the government could essentially ‘unperson’ a citizen by removing their card

- there are examples of identity cards being instrumental for the purposes of discrimination (and worse) against minorities. For example during the Rwandian genocide identity cards, originally issued by the Belgians, were used to ascertain Hutu from Tutsi.

No2id is encouraging British citizens to ‘take a pledge’ against ID cards – I encourage anyone who feels stongly about this to do so.

www.no2id.net/pledge/

On the other point of this posting – how about divorcing the conducting of drug trials completely away from the pharmaceutical companies? Trials could be conducted by a non-commerical organisation whom the pharmaceutical companies would be obliged to fund, thus removing the bias that creeps in to trials which are conducted ‘in-house’ by people who have a vested interest in their success.

A whole _new_ industry? Are you kidding?