Talk:Iclaprim

Edits

User:209.93.147.123 please discuss your edits here. Please. The arguments you are making don't comply with our policies and guidelines but I cannot explain them to you if you just keep trying to force them in.

The content is:

• As of 2017 it had been through two Phase III clinical trials for complicated skin and skin structure infections, called ASSIST 1 and 2, that as of 2017 had not been published; a new drug application was filed with the FDA and was rejected due to failure to show non-inferiority and due to safety concerns, especially drug-induced QT prolongation. An application for marketing approval to the EMA was withdrawn in 2009; when the application was withdrawn the reviewing committee had noted that resistance to the drug has already been seen in the clinical trial data. As of 2017 it was in two Phase III trials to show non-inferiority to vancomycin in acute skin and skin structure infection called REVIVE 1 and 2.

• You want this to read:

As of 2017 it had been through two Phase III clinical trials for complicated skin and skin structure infections, called ASSIST 1 and 2, that as of 2017 had not been published - although the full profile for the drug was provided in an FDA briefing document; a new drug application was filed with the FDA and was rejected due to failure to show non-inferiority against the current US standard of care, vancomycin; additionally safety concerns such as drug-induced QT prolongation were raised which may have limited the use of the drug a the study dose in some patient classes. An application for marketing approval to the EMA was withdrawn in 2009; when the application was withdrawn the reviewing committee had noted insufficient data from clinical studies to justify the dosage proposed by the company. As of 2017 it was in two Phase III trials to show non-inferiority to vancomycin in acute skin and skin structure infection called REVIVE 1 and 2.

References

• Scientific publishing is a thing. You write up the trial and publish it in a journal. Saying "it is available via the FDA" is an entirely different matter. This is what the Abbas source directly notes. the content you propose "had not been published - although the full profile for the drug was provided in an FDA briefing document" is what we call WP:OR and is not acceptable in Wikipedia. That quoted phrase is not in any source, but comes out of your head. We don't do that here.
• You are adding "cushioning" content about long QT which is unsourced. This is unacceptable.
• You have removed the content summarizing the finding of the EMA committee (which in Wikipedia is an extremely reliable source) that resistance is already emerging, and are giving no policy based reason for this either.
• What you are doing is driven by what appears to be a conflict of interest and not by what the reliable sources actually say. This too is not OK in Wikipedia.
• You need to edit per the policies and guidelines. Jytdog (talk) 11:02, 13 September 2017 (UTC)

Understanding FDA

Note - the content below was left on my talk page in this diff, I pasted it here in this diff. Jytdog (talk) 11:41, 13 September 2017 (UTC) Firstly you seem very keen NOT to link to the FDA source data. Why is that?

The FDA rejecting in 2009 is important in the context of what was happening at the FDA at the time, a couple of scandals with poor drugs approved and accusations of being ineffective.

We are arguing over 2 statements of fact that you want removing.

1./ the FDA basically told arpida to go back and study against vancomycin, as that is what they had wanted to see in the first place.

The QT issue was raised by one of the cardiologists and Arpida could not answer it at the time so it was noted in the minutes summary. But NO restrctions were placed on QT prolongation patients in REVIVE. That's there as a statement of fact. Something else you did not want in this document.

If the FDA had serious concerns then they would not allow that patient class in the repeat trial.

So why are you so biased?

2./ The EPA looked at in vitro studies to note potential resistance - which is not a sound conclusion because other scientific explanations from inconsistency in the dose or formula to impurities in the sample can cause similar outcomes.

The phase 2 HABP studies showed far superior action to vancomycin in the lung - I just don't understand what your MOTIVE is for making this article so NEGATIVE. Are you shorting share in Motif Bio? Do you work for a competitor or a company preparing a takeover bid? — Preceding unsigned comment added by 209.93.147.123 (talk) 11:17, 13 September 2017 (UTC)

• Please read the message in the section above. You are being way too aggressive for somebody who doesn't understand how this place works. I will answer your question. I have no connection to this company or to the antibiotics space. I work in the CNS space. I own no stock in any biotech company.

I work on COI issues across wikipedia and it is common as dirt for people to abuse Wikipedia to promote drugs and your edits look exactly like that. You are editing based on your personal knowledge and feelings. You are removing well-sourced negative information based on your own authority. This is not OK here.

Please disclose your connection to this product and the company - your note above makes it even more clear that you have one. Jytdog (talk) 11:20, 13 September 2017 (UTC)

@209.93.147.123: Who says "the FDA basically told arpida to go back and study against vancomycin, as that is what they had wanted to see in the first place"? Where can I read about that? What's your source? Without sources, your assertions are worthless to our encyclopedia. Similarly, who says "The QT issue was raised by one of the cardiologists and Arpida could not answer it at the time so it was noted in the minutes summary"? Where can I read that in a published source? Where can I check that "NO restrctions were placed on QT prolongation patients in REVIVE"? A statement of fact ought to be really easy to check – why can't you tell us where you got your "facts" from?

Or are we to surmise that you are making all of these claims based on your own experience, knowledge, assumptions, etc.? Well sorry, but Wikipedia is not the place for your original research - get it published in a respectable journal and we can summarise it. Until then, it has no place in a Wikipedia article. --RexxS (talk) 16:52, 13 September 2017 (UTC)

Edit warring

I have protected this page for one week. This is just a stop-gap measure, as the roaming IP will continue as long as they like once the protection has expired. @Jytdog: everybody involved has violated 3RR, and a range block would only be another temporary measure. Only someone with appropriate knowledge of the drug is going to know who is right and who is wrong on those edits. Please take this to WP:ANEW. — Maile (talk) 11:41, 13 September 2017 (UTC)

User:Maile66 thanks for protecting the page. As you know, the "correct" answer in Wikipedia is that content reflects what reliable source say, and in this case that is what MEDRS sources say. The IP is a new user with an WP:APPARENTCOI and what you wrote there is very unhelpful, as part of the problem is that they are trying to edit based on their own authority. Would you please confirm that WP:OR is not OK, and that we follow reliable sources here? Please. Jytdog (talk) 11:44, 13 September 2017 (UTC)

@Jytdog: you have already linked the Wikipedia policies on this. Please take this either to WP:ANEW or WP:ANI. — Maile (talk) 11:53, 13 September 2017 (UTC)

Now that the page is protected the IP will hopefully slow down and start engaging with the policies. It was just easy to see them citing what you wrote as an excuse not to engage. So thanks for clarifying. Jytdog (talk) 11:56, 13 September 2017 (UTC)

@Maile: Please think again about your assertion that "Only someone with appropriate knowledge of the drug is going to know who is right and who is wrong on those edits". As editors, we have no way of confirming who has "appropriate knowledge" and who hasn't. That is why we have policies of verification and no original research, as I'm sure you are well aware. The only content acceptable in Wikipedia is that which can be verified from a reliable source, regardless of the expertise of the editor. You've been around long enough to remember the Essjay controversy and I'm sure you didn't intend to imply that anyone claiming expertise can decide what is acceptable content on a Wikipedia article – particularly one subject to WP:MEDRS. I'd be grateful if you struck your comment, as it sets a bad example for observers and makes life harder for those who are trying to maintain standards of sourcing on Wikipedia. Thanks, --RexxS (talk) 18:03, 13 September 2017 (UTC)

I won't strike it. But I will clarify my meaning. And if that doesn't work for anybody else ... ah, well ... I've been around since 2006, but only fully active since about 2010. And for a few years after that, I was swimming upstream trying to figure out all of Wikipedia's ins-outs-guidelines-dictates-and the iffy stuff like IAR. I wasn't participating in the various boards, and not reading what was on them. The controversy you have linked probably is memorable to you and others who were paying attention to it. I never even heard of it before. And I would say that admins, like the non-admins, are working in their own little area of interest and not aware of every blow-up that happens, even if it seems like the event of the century to those who followed it. I understand what you are trying to say about sourcing - verifiable sourcing, not "truth" without it, not what somebody else digs up to support their POV. I wasn't contradicting that. My meaning was that there is a lot of technical medical terminology in this article and the sources. And unless you have a particular interest in this subject ... or a background that helps you understand the very words in sources ... you aren't going to get it, verifiable sourcing or not. You could say the same thing about reading political sources for some country you've never studied - unless you're familiar with it, you don't know what is correct vs. what you believe is correct sourcing. Do you see anywhere that I contradicted anything about No Original Research? It's one of the first dictates of Wikipedia. All of you ... please quit reading something into what I wrote ... this is the end of my comments on this article. Please leave me out of this discussion going foward. — Maile (talk) 20:00, 13 September 2017 (UTC)

What you have written is OKish but just comes at it from the wrong angle. The IP editor doesn't understand WP and actually thinks it is OK to make changes based on their own expertise. You don't have to do anything but read what they wrote here on the talk page, to see that this is what they were doing and how they were arguing. It is true that to make sense out of the content, you have to either already know about the subject matter, or take the time to read the sources and understand them. But the problem was more fundamental than that - not relying on the sources at all. But again I appreciate you locking the article, which is what was needed. Jytdog (talk) 22:36, 13 September 2017 (UTC)

Abbas article

Copied content left on my talk page in this diff here Jytdog (talk) 11:47, 13 September 2017 (UTC)

Article somewhat missed the point - a non-inferiority study is not ALWAYS about bringing a new product to the market that is better at treating a condition. It is OFTEN about bringing alternatives to the current Standard of Care.

For example in ABSSSI vancomycin is a great first-line therapy for the majority of ABSSSI patients, but it is a somewhat dirty drug used in large doses (due to growing resistance) and can cause issued in some patient classes (diabetics, renally impaired patients, etc).

So therapies like iclaprim might prove useful for certain patient classes.

And with growing antibiotic resistance it is important also to have a plurality of therapies available - in case the first line doesn't work. Especially to have therapies between the first and last line, keeping the last line under-utilised to reduce resistance.

The Arpida ASSIST trials were somewhat botched. The clinical research organisation seems to have been haphazard in the selection of trial centres, and the study for some reason set out to prove something that the FDA didn't ask to see.

It's simply incomplete to say the FDA rejected the application outright, and it is incorrect to infer there were safety reasons behind the rejection. That is conflating 2 separate issues: the rejection was because the study couldn't show non-inferiority to the US standard of care (vancomycin). Read the meeting transcript - Arpida tried statistically to model the results against linezolid to what they would be against vancomycin but it was pointed out that the statistical remodelling introduced uncertainties that left the proof outside the required confidence interval of 95%.

The safety concerns were raised by the numerous experts at the meeting - each along their own speciality. Cardiologist asked about the couple of observed QT prolongations. The meeting summary notes the conclusion that a restriction should be included *if* it was approved. However that restriction was not placed when Motif Bio sought approval for the new trials. Why would that be?

The new dose reduces peak concentrations - that were thought to be responsible for the observed QT prolongation - twice-daily dosing at a slower infusion increases the overall time an active dose remains in the system.

Medical science does not warrant such a negative slant to be inferred with innuendo (the papers weren't published for ASSIST - yes, because Arpida went bankrupt).. — Preceding unsigned comment added by 209.93.147.123 (talk) 11:40, 13 September 2017 (UTC)

All you are doing is talking at me. Please read the sections above and reply there. Please also disclose your connection with the company and product. Thanks. Jytdog (talk) 11:47, 13 September 2017 (UTC)

Your critique of the Abbas article is not relevant in Wikipedia. Editors have no personal authority here. We follow sources. This drives people crazy. But that is how Wikipedia works. Otherwise we would have anonymous people aggressively asserting Truth based on their own authority. Think about that. Any tinfoil hat wearing wierdo could act exactly like you are acting. This is not a mad max world. There is a foundation of policies and guidelines that makes this place work. You are ignoring it. Your opinion about Abbas has no meaning here and while your reflections on matters like how the CRO performed and dosing are interesing, they are also irrelevant here.

The only thing that is relevant, is what MEDRS sources say. That is the only thing that content depends on. Jytdog (talk) 11:51, 13 September 2017 (UTC)

Promotional edit notes

User:Jdfirth - Here, you wrote Please leave in - Cystsic Fibrosis researchis a major NEW development area for this drug. Also highly relevant to CF sufferers and carers following developments in treatment for this severe complication of the disease.

here is a pubmed search for "Iclaprim cystic fibrosis". You know how many publications there are? Zero. You know how many of those are reviews per MEDRS? Zero. Please don't make promotional claims in WP. Thanks Jytdog (talk) 06:18, 16 September 2017 (UTC)

Also please avoid adding unsourced content to Wikipedia, and please avoid using press releases for ongoing events as you did here -- this is just a republished press release. Jytdog (talk) 06:44, 16 September 2017 (UTC)