NationStates

Posted: **Tue Feb 09, 2010 1:50 pm**

Revolutionist Britain supports the idea of harmonising health care knowledge across the world, we see this resolution as a good way to get people started in the right direction.

Noting the objections on non-WA states paying, without being too flippant, there is no such thing as a free lunch. Without forms of funding, it is arguable that development would dry up with little funding, since all would be free. We would like to see a breakdown of costs, but our nation is quite happy to accept case-by-case variants. Might we suggest a more formal non-WA application procedure, to ensure fees are proportionate and reasonable, combined with double-blind clinical trials to ensure true impartiality in drugs testing?

Yours,
President-General Loki Kazan
Commandante-En-Jefe, Ruling Revolutionist Council,
Republic of Revolutionist Britain

Posted: **Tue Feb 09, 2010 2:15 pm**

Honored Sir,

You have made me comfortable enough with the resolution where it stands now to where I can offer my full support behind it. The only thing I would like to see if the data management plan (My IT specialist here in New Buckner would be more than happy to assist you in such a task if called upon to do such.) as well as a cost estimate of what this resolution will run, both in the short term and in the long term.

Thank you esteemed representative.

Posted: **Tue Feb 09, 2010 6:18 pm**

Frattica wrote:We think this resolution should have an indication of how much this "IDEA" will cost in material terms.

We believe this is too abstract, adn call for further elaboration of this. ehm.."idea".

PRF

And why should the esteemed ambassdor from Mousebumples do that, Sparky? Each nation's currency and economic system is different.
Excelsior,
Sen. Horatio Sulla

Posted: **Tue Feb 09, 2010 6:55 pm**

Revolutionist Britain wrote:Noting the objections on non-WA states paying, without being too flippant, there is no such thing as a free lunch. Without forms of funding, it is arguable that development would dry up with little funding, since all would be free. We would like to see a breakdown of costs, but our nation is quite happy to accept case-by-case variants. Might we suggest a more formal non-WA application procedure, to ensure fees are proportionate and reasonable, combined with double-blind clinical trials to ensure true impartiality in drugs testing?

I've toyed with creating a separate proposal to detail recommended procedures for drug trials. I agree that double-blind trials are the most effective; additionally, I prefer trials that have a control group (be it a placebo group or an alternate treatment group). And, of course, it is very unethical to conduct a study without fully informing prospective enrollees of the risks involved. (OOC: Tuskegee Syphilis Experiment)

I don't know that there is enough WA-wide interest to make it worth an entire proposal, but if you have any other ideas as to suggested setup/procedure for drug studies/clinical trials, I'd love to hear them.

The Palentine wrote:And why should the esteemed ambassdor from Mousebumples do that, Sparky? Each nation's currency and economic system is different.

I admit that I'm unsure as to how to address this as, mentioned by Senator Sulla. each nation has a different currency and economic system. The WA would approach the most cost effective way to accomplish the creation of the IDEA, and the costs may vary year by year. Additionally, would you want me to incorporate the costs of the additional funding that would be incurred by the WHA through this proposal? I would expect the highest costs would be initially, to create the IDEA and put the staff/structure in place. Any further costs would be no better than speculative, and, in my opinion, mostly worthless.

Additionally, why is the cost such a concern? Can you think of a more cost effective way to improve international health care outcomes through the spreading of drug information and the encouragement of additional drug research?

Posted: **Wed Feb 10, 2010 3:19 am**

Enslave all of the planet under a cloud infrastructure of inter-connected brains?

Posted: **Wed Feb 10, 2010 6:49 am**

New Buckner wrote:Enslave all of the planet under a cloud infrastructure of inter-connected brains?

Is that an honest suggestion of how to improve this proposal? Because, if so, I must respectfully disagree.

Also: further mod opinion updates on the mentioning of non-WA nations in GA law:

Ardchoille wrote:Just don't go nuts with mentioning non-WA nations, okay? Most of the time it can be avoided, and should be: one, because we don't want to give any deplorable Rouge Nations the encouragement of imagining that we spend so much as one minute of the WA's time thinking about them, and two, because the minute proposal writers start thinking outside the WA's walls, they expose themselves to the temptation of Metagaming.

(Oh, you may think you're different, you're strong, you can withstand it: but Metagaming erodes the moral fibre of even the most virtuous among us.)

I'm guessing that'll be the last mod contribution to the thread, but if I'm incorrect, I'll continue to update this thread as needed.

Posted: **Wed Feb 10, 2010 2:48 pm**

Mousebumples wrote:Is that an honest suggestion of how to improve this proposal? Because, if so, I must respectfully disagree.

That was a joke...although I must admit it would be a pretty nifty idea...I'll have to have our Ministry of Technology look into it...

Posted: **Thu Feb 11, 2010 3:13 pm**

Many thanks for the feedback. I know it may be a bit boring, but I might try to get a resolution drafted for Double Blind Trials. But suffice to say, you would have the Revolutionist vote.

Yours,
President-General Loki Kazan,
Commandante-en-Jefe, Ruling Revolutionist Council
Republic of Revolutionist Britain

Posted: **Thu Feb 11, 2010 3:29 pm**

Revolutionist Britain wrote:Many thanks for the feedback. I know it may be a bit boring, but I might try to get a resolution drafted for Double Blind Trials. But suffice to say, you would have the Revolutionist vote.

I'd be happy to work with you on a resolution that focused on clinical trial requirements. (double blind, informed consent, control groups, etc.) And if you can get such a thing passed into law, then I can edit out some of my detailing of what approved studies should entail. Alternatively, I/you/we could combine the extended funding for drug trials into a proposal regarding requirements for funding of said trials and general recommendations for conducting quality studies that would then yield quality results.

Of course, now is an inopportune time for me to be partaking in such a thing as my ULC proposal will be up for a vote later tonight, so that will be my focus on this board for the next few days.

And that's just something of a general announcement here for anyone else following this thread. If you have further comments and/or opinions, I'd love to hear them. However, I will probably be slow to reply for the next few days - but I will work on drafting a new version of the proposal at that time.

Posted: **Thu Apr 01, 2010 12:33 pm**

I am reviving this - now that ULC is (long-since passed) and I should be around-ish for the next few weeks. I'll be working on a new draft over the next few days. I will certainly need to take a few recently passed resolutions into account with the revision (notably WA#81 - Universal Clinical Trials Act) - so I'll review and toy with that over the next few days.

I was also thinking of creating a database within the ULC (perhaps called the Medical Expansion Database or MED ... although I am certainly open to suggestions on acronyms) that would allow for an easier spread of peer-reviewed medical articles that are already archived within the ULC and perhaps allow for an indexing (and the ability to pay for access) for those articles that are not ULC archived as of yet. Any particular thoughts on that subject?

Of course, additional thoughts and suggestions are more than welcome as well.

Thanks for your consideration,
Ambassador Lizzy Hall
Leader of the Doctoral Monkey Feet of Mousebumples
WA Delegate for Monkey Island

Posted: **Thu Apr 01, 2010 1:18 pm**

Mousebumples wrote:I am reviving this - now that ULC is (long-since passed) and I should be around-ish for the next few weeks. I'll be working on a new draft over the next few days. I will certainly need to take a few recently passed resolutions into account with the revision (notably WA#81 - Universal Clinical Trials Act) - so I'll review and toy with that over the next few days.

I was also thinking of creating a database within the ULC (perhaps called the Medical Expansion Database or MED ... although I am certainly open to suggestions on acronyms) that would allow for an easier spread of peer-reviewed medical articles that are already archived within the ULC and perhaps allow for an indexing (and the ability to pay for access) for those articles that are not ULC archived as of yet. Any particular thoughts on that subject?

Of course, additional thoughts and suggestions are more than welcome as well.

Thanks for your consideration,
Ambassador Lizzy Hall
Leader of the Doctoral Monkey Feet of Mousebumples
WA Delegate for Monkey Island

Quite a good idea and noting that we shouldn't go too deep to how it is funded for sake of simplicity it would be worth exploring the possibilities.

As for the Acronym, I would suggest Medical Information Database, or MID.

Yours etc,

Posted: **Thu Apr 01, 2010 6:58 pm**

Mousebumples wrote:I am reviving this - now that ULC is (long-since passed) and I should be around-ish for the next few weeks. I'll be working on a new draft over the next few days. I will certainly need to take a few recently passed resolutions into account with the revision (notably WA#81 - Universal Clinical Trials Act) - so I'll review and toy with that over the next few days.

I was also thinking of creating a database within the ULC (perhaps called the Medical Expansion Database or MED ... although I am certainly open to suggestions on acronyms) that would allow for an easier spread of peer-reviewed medical articles that are already archived within the ULC and perhaps allow for an indexing (and the ability to pay for access) for those articles that are not ULC archived as of yet. Any particular thoughts on that subject?

Of course, additional thoughts and suggestions are more than welcome as well.

Thanks for your consideration,
Ambassador Lizzy Hall
Leader of the Doctoral Monkey Feet of Mousebumples
WA Delegate for Monkey Island

Ambassador Hall,

I think that would be an excellent idea, and I like the MID acronym more, and the openness in which you present it. I like the revisions to the bill, is the OP what you are going off of as the initial "new" draft for this?

Posted: **Thu Apr 01, 2010 9:11 pm**

First off, thanks for your contributions, guys!

New Buckner wrote:I like the revisions to the bill, is the OP what you are going off of as the initial "new" draft for this?

I haven't "redrafted" since February, but I'm hoping to have some time to work on that this weekend/next week. I just thought I'd toss out the new idea that I had and get some feedback - rather than incorporating it into the new draft and having multiple complaints about the execution/etc. And since it was a new idea I thought of only as I was working on resurrecting this thread, I figured there might be some flaws/etc. that I'd neglected to notice with my only cursory consideration.

It's late here (and I'm more tired than I'd prefer for redrafting), but I'll hopefully have time to take a look at this tomorrow sometime. Thanks again for the feedback!

(And, hey, what about the Database Of Curative Treatments Under Study, or DOCTUS, which is the Latin for "having been taught" and is, I believe, the root from which the English word of "Doctor" is derived ... Yes, I'm being a total nerd about this acronym thing. In part, because I'm tired and playing with words/lettering is entertaining my half-awake brain. And in part, because I'm just enough of a geek to enjoy this sort of thing.)

Cheers!
Ambassador Lizzy Hall
Leader of the Doctoral Monkey Feet of Mousebumples
WA Delegate for Monkey Island

Posted: **Mon Apr 05, 2010 4:53 am**

When the new draft is posted, my staff and I will give it our up-most attention and be more than happy to provide feedback to you on it.

I like the connection with the latin meaning with the program name.

Posted: **Tue Apr 06, 2010 6:24 pm**

Here's the new version - without all the editing notes.

I'm going to check on modly vetting on two things before submission - so there's no need to point those out to me (unless you're a mod and feel like chiming in with a ruling ahead of schedule) ...
1. Does my referencing of ULC pass legal muster and not fall victim to "house of cards" ? I think it might work as is (after all, if ULC is ever repealed, then no articles/journals would be archived, and I think I've allowed for that eventuality within the text) - but I'll want to double check that.
2. It does "duplicate" the Universal Clinical Trials Act, to some extent, but I wanted to establish those same requirements for funding within this proposal, in the event that UCTA is ever repealed.

However, as a question: since UCTA allows for exceptions via appeal to the CEC, would it be possible to make that last clause (re: the control groups) a strong encouragement versus a requirement? I'd hate to contradict UCTA (and I'd prefer to allow for situations where having a control group may not be the best option for a given research study) - but I'm uncertain.

Thoughts? (specific text, of course, follows ... )

Council: General Assembly
Category: Education and Creativity
Area of Effect: Education

UNDERSTANDING that safety and efficacy are important standards with regards to drug therapy;

ACKNOWLEDGING that a single drug may cause different benefits and/or side effects in each of the many species that are native to WA member nations;

DESIRING to more fully understand the potential benefits and harms with regards to using drugs among different species;

CREATES the International Drug Education Agency (IDEA) as a sub-committee of the World Assembly Food and Drug Regulatory Agency (WAFADRA);

SPECIFIES that IDEA employees will collect all data related to drug therapy conducted within NS nations;
1. This research will include data collected with regards to medication therapy and recreational drug use to allow for a better understanding of the risks and benefits all sorts of drugs;
2. Publishers of said research will receive appropriate monetary reimbursement, as determined by IDEA, in exchange for allowing wider access to this research;
3. Said research data will be made available to, at minimum, all medical professionals within WA nations; individual nations may provide this information to others within their own borders as they deem appropriate;
4. Non-WA nations may apply for access to this information; depending on the relative strength/weakness of the aforementioned nation's economy, a nominal fee may charged by the IDEA for access, as determined on a case-by-case basis;

ESTABLISHES the Database Of Clinical Treatments Under Study (DOCTUS) as a drug information and education library within the framework of the Universal Library Coalition (ULC);
1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason;
2. All research data within DOCTUS will be accompanied by a link to the relevant journal article, if the research has been published;
(a) IDEA will endeavor to offer appropriate monetary reimbursement to journals that are not currently archived in the ULC so that their research can be accessed through DOCTUS by credentialed individuals.
(b) If a journal and/or individual article is not available through DOCTUS or the ULC, appropriate citations will be listed so that the information in question can be accessed through alternate avenues.

DETAILS that IDEA medical professionals will review all published research on medication therapy and issue quarterly IDEA newsletters;
1. The newsletters will be written by health care professionals and will detail the most significant discoveries in drug therapy, such as new indications for an already discovered drug, new concerns regarding side effects for an established drug, new recommendations for use in certain populations, etc.;
2. IDEA professionals may include non-binding recommendations regarding suggested changes to currently established medication therapy standards;
3. The IDEA Quarterly will be provided to all interested nations free of charge and will be archived within DOCTUS with the appropriate reference citations;

RECOMMENDS that Health Research & Development Division of the WHA accept applications for funding from WA member nations for further research regarding already discovered medication therapies to better understand their safety and efficacy with long-term use;
1. Applications for funding must include details of how the study would be conducted and what drug(s) would be studied;
2. Funded studies must employ informed consent of all participants in the study;
3. Studies must have a control group;

Posted: **Tue Apr 06, 2010 6:26 pm**

OOC: Quick mention, but the clause that begins "DETAILS..." has a [/b] at the end of part 3.

Posted: **Tue Apr 06, 2010 6:27 pm**

Krioval wrote:OOC: Quick mention, but the clause that begins "DETAILS..." has a [/b] at the end of part 3.

Thanks! I copy my editing note version to the "reposting" / bump post, and I clearly missed that piece of code. :palm:

Anyhow, fixed!

Posted: **Thu Apr 08, 2010 11:03 am**

*bumps*

Any comments/concerns/etc. on the current draft? Otherwise, I'll probably start consulting in moderation and work on making sure it's under the max character count. (It's currently in the neighborhood of 3,500, which is very workable with some judicious edits.)

Thanks for your consideration!

Posted: **Thu Apr 08, 2010 11:21 am**

Did I miss the category and strength? It's probably in there somewhere and I am skimming it too quickly.

Aleksei-kan Volkov
Imperial Chiefdom of Krioval

Posted: **Thu Apr 08, 2010 11:25 am**

Krioval wrote:Did I miss the category and strength? It's probably in there somewhere and I am skimming it too quickly.

It apparently got lost on one of the edits. Whoops.

Likely Education and Creativity: Education (if only given the title - and that the basic principle is to allow for greater research and education regarding drug therapy) - although if someone wants to make an argument for something else, I could perhaps be persuaded. However, I don't think anything else will fit quite so well.

And now to edit that back into the main post. Thanks!

Posted: **Thu Apr 08, 2010 12:04 pm**

DOCTUS doesn't appear to be bad at all, honoured ambassador. I think that is about all I can think of.

Posted: **Thu Apr 08, 2010 1:21 pm**

Charlotte Ryberg wrote:DOCTUS doesn't appear to be bad at all, honoured ambassador. I think that is about all I can think of.

Many thanks, Ambassador Harper!

Posted: **Thu Apr 08, 2010 1:49 pm**

Revised again to fix a few of the minor issues that have been niggling at me for the last few days ... (And I'll be heading over to Moderation shortly to file a Legality Assistance Request.)

Council: General Assembly
Category: Education and Creativity
Area of Effect: Education

UNDERSTANDING that safety and efficacy are important standards with regards to drug therapy.

ACKNOWLEDGING that a single drug may cause different benefits and/or side effects in each of the many species that are native to WA member nations.

DESIRING to more fully understand the potential benefits and harms with regards to using drugs among different species.

CREATES the International Drug Education Agency (IDEA) as a sub-committee of the World Assembly Food and Drug Regulatory Agency (WAFADRA).

SPECIFIES that IDEA will collect all drug-related data, including both medication therapy and recreational drug use research to allow for a better understanding of the risks and benefits all drugs.

ALLOWS for IDEA professionals to issue non-binding recommendations regarding suggested changes to currently established medication therapy standards.

ESTABLISHES the Database Of Clinical Treatments Under Study (DOCTUS) as a drug education branch of the Universal Library Coalition (ULC);
1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.
2. Said data will be made available to, at minimum, all medical professionals within WA nations; individual nations may provide this information to others within their own borders as they deem appropriate.
3. All research data within DOCTUS will be accompanied by a link to the relevant journal article, if the research has been published;
(a) IDEA will provide appropriate monetary reimbursement to journals that are not currently archived in the ULC so that their research can be accessed through DOCTUS by credentialed individuals.
(b) If a journal and/or individual article is not available through DOCTUS or the ULC, appropriate citations will be listed so that the information in question can be accessed through alternate avenues.
4. Non-WA nations may apply for access to DOCTUS; a nominal fee may charged by the IDEA for access, as determined on a case-by-case basis.

DETAILS that IDEA medical professionals will publish quarterly IDEA newsletters;
1. The newsletters will be written by health care professionals and will detail the most significant discoveries in drug therapy, such as new indications for an already discovered drug, new concerns regarding side effects for an established drug, new recommendations for use in certain populations, etc.
2. The IDEA Quarterly will be provided to all interested nations free of charge and will be archived within DOCTUS with the appropriate reference citations.

RECOMMENDS that Health Research & Development Division of the WHA accept applications for funding from WA member nations for further research regarding already discovered medication therapies to better understand their safety and efficacy with long-term use;
1. Applications for funding must include details of how the study would be conducted and what drug(s) would be studied.
2. Funded studies must receive the informed consent of all participants in the study.
3. Studies are strongly encouraged to have a control group of some nature.

CHARACTER COUNT: 3,078

Posted: **Thu Apr 08, 2010 9:17 pm**

Mousebumples wrote:SPECIFIES that IDEA will collect all drug-related data, including both medication therapy and recreational drug use research to allow for a better understanding of the risks and benefits all drugs.

[...]

1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.

These two clauses might be problematic, as some of these data might be proprietary and confidential. Perhaps IDEA should "...collect all publicly available drug-related data..." and "...archive all publicly available research data..."

Posted: **Thu Apr 08, 2010 10:59 pm**

New Rockport wrote:
Mousebumples wrote:SPECIFIES that IDEA will collect all drug-related data, including both medication therapy and recreational drug use research to allow for a better understanding of the risks and benefits all drugs.

[...]

1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.

These two clauses might be problematic, as some of these data might be proprietary and confidential. Perhaps IDEA should "...collect all publicly available drug-related data..." and "...archive all publicly available research data..."

(My main concern arises from a RL situation. Some drug companies have stalled on releasing this information for as long as possible. I could search out actual links if needed, but I can think of at least 3 examples off-hand ...

Purdue Pharma claimed to the FDA, when originally marketing Oxycontin (Oxycodone Extended Release) that it would be *less* addictive and *less* likely to be abused due to the new formulation. Actual use of Oxycontin in the market showed that to be demonstrably false. (I'm not positive if there was "hidden data" here, but at the very least, there was no *valid* supporting data for the original claim that was made.)
Some antidepressant manufacturers declined to publish certain Drug versus Placebo studies as there was not statistically significant benefit versus the placebo.
The makers of Vytorin stalled (and stalled ... and stalled) on publishing the data from their comparison with Zocor (Vytorin is a combination drug of Zocor + Zetia) as it did not have any statistically significant improvement over the single drug of Zocor ... which is generic.)

The point of this proposal is to expand education and knowledge of drug products - and I'm not sure how data points are proprietary and confidential. If the drug isn't on the market yet, I could see the point, perhaps - and I could definitely add in a clarifying clause for that. (Although - again IRL - drugs are patented in the US loooong before drugs even get near patient testing, so I wasn't concerned about drug product intellectual property; however, NS patent laws are not as clear, which I neglected to consider.) However, if the drug is being taken by patients worldwide, I am of the opinion that individual safety is more important that protecting company profits in these cases.

I'm not sure if I'm really addressing your concern - or that I'm clear on what your objection is. I've accounted for providing monetary reimbursement (I believe) to account for the intellectual property rights. What other concerns do you have regarding the release of unpublished data? (Additionally, why would drug studies be "confidential" ? If there's a precedent in your nation/other nations that I'm unaware of, please enlighten me.) I could also add in a clause stating that IDEA/DOCTUS subscribers are not allowed to publish studies based on not-yet-published data without the express consent of the involved scientists, but I'm not sure if that's what you're getting at.

I very much appreciate your consideration of this subject, and I look forward to further discussing this issue with you.

Yours,
Ambassador Lizzy Hall
Leader of the Doctoral Monkey Feet of Mousebumples
WA Delegate for Monkey Island

NationStates

[PASSED] International Drug Education