EU proposes abandoning of principle ethics in medical research

[Skybird]

I did noit trust mny eyes when reading this:

German link (FAZ)
(http://www.faz.net/aktuell/feuilleton/europaeische-plaene-rueckfall-in-mittelalterliche-forschungsethik-11900958.html)

Holy squid.

In July this year, the EU commission released a proposal that wants to enforce in Europe that all medical research shall be allowed without any ethical assessment of purpose, method, and effect for the patient. In other words, when a hundred years ago patients got intentionally infested with Syphilis or Amobia to study the disease (patients died), doing like this should again be legal in Europe. What's more, for evaluation of drug effects and patents, no longer the effect and positive use for the patient shall be considered, but exclusively the communal interest - health on an individual level, as well as personal well-being, shall play no role anymore, but exclusively the communal interest, which means the financial aspect and the legal guarantees the producing industry so far had to accept. Finally, the rights of patients should effectively be neutralized, while the insurances dividends payed for sponsors of medical studies - have increased by 800% ! And last, the standards of medical studies should be imo labelled completely arbitrarily, because the evaluation of studies that for example assess the efficiency of a new drug should no longer follow widely greed criterions and academcial standards, but should be issue of national industrial self-regulation, in other words it is the pharma-lobby left with assessing the efficiency of drugs, technology, and how much worth a new poatent should be.

Lobbyism again has worked wonders in Brussel. The proposal was released in summer holiday, combined with pressure to push it through in national parliaments as quickly as possible, in the holidays, so that nobody should note.

Some of this is not any different to the standards by which Nazi-doctors conducted medical experiments in KZ-laboratories.

I know why I dispise the EU totally and completely, and want to see it getting bombed into ashes better yesterday than tomorrow. That since some time it practices its evil in growing openness and frankness shows how safe and strong the EU feels itself. And that is bad news for every free European.

Even if - maybe - the proposal does not get accepted by governments: the mere fact that things like this, that lobbyistic stunts like this are tried again and again, many being successful, speaks out against the principle structure of the system. The EU stinks.

[Tribesman]

So this is just a nonsense story where a proposal has been made that two words are changed in a document that has been changed about 20 times already. The proposed change makes no alteration to the legal requirement written into the document which states that it has to be in compliance with the Helsinki declaration.
Yet another Oh no its the EU dictatorship:wah::wah::wah: that turns out to be bollox.
Still I suppose it makes a break from his "oh no its the muslims out to get us" or "the catholics are taking over the world"

[Respenus]

I'm sorry to burst your bubble Skybird, but a quick search reveals the real extent of this newest scare (however your criticism of loobyism is as welcome as always, in fact you should be glad the the EP managed to force the Commission to commit to greater transparency as regards its experts groups in order to make sure that not only business interest are represented).

Now back the proposal at hand. Everything you wish to find on this subject is available here (http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm), more precisely, the heading "Revision of Clinical Trials Directive". While I admit I only had a quick glance (read: used search function of the word 'ethic'), the best I could come up with is that ethical considerations are left under the control of MEMBER STATES and that in all cases of experimentation, consent must be given by the person undergoing the tests.

I admit, there might be something else far more insidious hidden inside the Regulation proposal, which may still be modified by the EP and the Council, so you have plenty of time to get someone to remove the offending article. If you really want, you can demand that the German parliament declares the Regulation to be against the principle of subsidiarity, although I am doubtful your claim would stand considering this Regulation relates to the Internal market.

@Tribesman: Since I know that Sky ignores your posts, I find it unnecessary to constantly attack his persona. You don't agree with his arguments, fine, people rarely do. But please make an effort to engage him/other readers in a serious discussion and not mock people. If you find that difficult, just let the matter slide or even better, write a counter topic. It would make things far easier for all of us, if we could avoid generalisations.

[Tribesman]

@Tribesman: Since I know that Sky ignores your posts, I find it unnecessary to constantly attack his persona. You don't agree with his arguments, fine, people rarely do. But please make an effort to engage him/other readers in a serious discussion and not mock people. If you find that difficult, just let the matter slide or even better, write a counter topic. It would make things far easier for all of us, if we could avoid generalisations.

I don't really do generalisations as people write various things and what they write is what they write, even skybird writes some good stuff on occasion.
However if he writes crap it gets treated as crap same as any other poster.
If he makes up nonsense then he gets treated as someone who makes up nonsense.
if someone constantly makes up nonsense on one or several topics then their writing on all those particular topics gets treated as one and the same when they make up nonsense
The proposed new document must by law comply with both the helsinki declaration and of course EU human rights legislation.
This "secret" legislation which is being "sneaked out" during the holidays has been in the worked on with full public consultation since 2009.
If it is passed it will be worked on by all the States for a further 3 years until it fully replaces the existing document.
Therfore his whole attempt on the story is pure bollox, just like for example his attempt was over the EU "dictatorship" standardising the CE trade marks was.

As I have said before, the EU is a hell of a balls-up, you shouldn't have to make stuff up to show that.
If someone has to make stuff up then it is saying more about themselves than the institution they want to complain about and what it says about them isn't very pleasant.

[soopaman2]

This kind of reminds me of something I read a long time ago.

It was a debate about whether the information attained by Josef Mengele, and Japans unit 731 was "ethical" as medical research.

As a recap, they froze people and attempted to bring them back, amputated limbs, and switched them with others, exposed them to high altitude pressures, extended water immersion experiments etc... I am sure googling "unit 731" or Mengeles experiments, will net you a good idea what they did. Unit 731 was way worse in this case, as it was done for amusement as well as science.

It had brutal results on the Chinese and Jews who had to endure this.

But as barbaric as it was, it had viable medical data. The article drew no conclusion, it allowed you to do it yourself.

But it is a definite debate considering how into eugenics the Germans were at that time, and just how heartless (barbaric, rascist, I can't find a right word, I am dumb, pardon me) the Japanese were.

The validity was always called into question due to the outright barbarism of the acts.

Sure a far extreme case(s), but who decides ethics?

[Skybird]

Respenus,

your link leads to directives that are valid until today. The article of the (conservative) FAZ that I summarised is about how they want to change the status quo. Directive 2001/20-EU they want to almost delete completely by content.

The FAZ is the German equivalent to the Times. It is no quickshooting yellow press paper.

The German Bundesärztekammer (Federal Medical Association of doctors) and the Medical Ethics Commission oppose the proposals completely and have rung General Quarters to fight against it. Somewhere else I read the ethics work group of parliament also has become aware of the issue and starts to fight against it.

My summary of the major paragraph in my opening post is no opinion by me, but just repeats the major points of the article. My opinion starts after that.

[Tribesman]

Respenus,

your link leads to directives that are valid until today. The article of the (conservative) FAZ that I summarised is about how they want to change the status quo. Directive 2001/20-EU they want to almost delete completely by content.

So simple to read a link isn't it. :doh:
The link Respenus posted contains the directive that is valid for three years after the new proposal is enacted into law, it contains all the events going back to 2008 involving the process of drafting the proposal and it contains the new proposal.
Just for good measure it contains the full 2009 public consultation and the 2011 paper, its amazing just how much information on the new proposal Respenus single link provides.
Who knows perhaps its another one of his invisible ink pieces of legislation where everything that is wrtten is false and only Skybird can see the real document:rotfl2:

My summary of the major paragraph in my opening post is no opinion by me, but just repeats the major points of the article. My opinion starts after that.
Yet neither reflects the facts you have been presented with, your failure to even register facts that are clearly and plainly placed before your eyes by Respenus says a lot about you.:yep:

A further example of nonsense...
Somewhere else I read the ethics work group of parliament also has become aware of the issue and starts to fight against it.

At what stage was this proposal sent to that body for consultation and approval by them before being passed back for the next stage of the prosess?
Simple stuff isn't it, and all the information can be found in a single link