Talk:Prulifloxacin

Citation #7
Citation #7 had been marked as untrusted, so I've added bibliographic information to it. In order to prove the bibliographic information, I changed the URL so that it links to the entire report instead of a single out-of-context page. However, I do not see information on the previously linked-to page (15) that supports the three statements in the WP article that cite this source. I'll put the issue up for discussion instead of removing the statements. MatthewBurton (talk) 19:04, 8 April 2010 (UTC)

In response to your concerns:

You are aware, (I hope anyhow) that you are NOT allowed to copy the text of the supporting statements found within the annual report word for word. That is considered to be plagiarism. Rather you are expected to paraphrase them without losing or confusing their original meaning. This may be why you were unable to find the exact statements with the annual report as they were not plagiarised.

The first statement;

As the patent for prulifloxacin has already expired, the sponsor has stated that this may have an effect on the commercial prospects of prulifloxacin within the United States market

This is supported on page 34 of the the Optimer 2008 Annual report.

The second statement;

The sponsor (in the United States) intends to conduct a Phase 4 trial of prulifloxacin subsequent to NDA submission to compare prulifloxacin to ciprofloxacin

This is supported on page 1 of the Optimer 2008 Annual report.

The third statement;

Such regulatory agencies could then prevent further development of prulifloxacin or ultimately deny its approval. The sponsor of prulifloxacin has stated that such a delay or denial would significantly harm the commercial prospects of prulifloxacin.

This is supported on page 23 of the the Optimer 2008 Annual report.

So for clarification within the citation you could simply make note to see page (23) as referenced above. For example:

"Annual Report 2008". Optimer Pharmaceuticals, Inc.. http://216.139.227.101/interactive/optr2008/. Retrieved 2010-04-08. See page 23.

Additionally on Page 20 it is stated that

"If we do not receive regulatory approval for and successfully commercialize fidaxomicin and prulifloxacin we will not generate any revenues from product sales for several years if at all and we may not be able to continue operations." (emphasis added for clarification)

It would therefore be a factual statement that if Optimer is screwed on the patent issues, they may very well go broke. And there can be NO argument that this would indeed have a negative effect on the commercial prospects of prulifloxacin within the United States market. And such a delay or denial would significantly harm the commercial prospects of prulifloxacin. All of which is stated numerous times within the Annual Report.

So as all three statements have been sufficiently cited to, (chapter and verse if you will) there is no need or reason to remove them. To do so now would be considered vandalism and no doubt reverted by other editors down the road.Davidtfull (talk) 01:58, 14 April 2010 (UTC)


 * I simply asked for clarification due to the fact that your citations were not clear. With regard to plagiarism, there is nothing wrong with excerpting the occasional quote, as long as you do quote the content and mention that it is from a copyrighted source instead of presenting the content as your own. With regard to vandalism: the purpose of this page is to discuss changes before making them. I initiated that discussion with the purpose of proceeding in good faith, so please keep this in mind when preemptively accusing me of vandalism. MatthewBurton (talk) 14:21, 14 April 2010 (UTC)

Vandalism is mostly limited to teenagers, it is defined by wikipedia as intentional harm to the encyclopedia (for recreational or malicious reasons). I don't think deletion of content in this case would meet the criteria of vandalism, per WP:VANDAL as it is a WP:GOODFAITH content disagreement, which seems to be resolved now. I think that the content should stay however, as it is appropriately sourced. Most wikipedia templates have the |quote= field for quoting blocks of text or alternatively as has been done in this case, clarification can be given on the talk page.-- Literature geek |  T@1k?  21:59, 14 April 2010 (UTC)


 * On a side note no one had accused anyone here of pre-emptive vandalism or any other misdeed. It had simply been pointed out that unjustified deletions would more than likely be reverted by others.  Nothing more, nothing less, was being said.  Sorry if anyone found that somehow to be offensive.Davidtfull (talk) 04:25, 5 May 2010 (UTC)

Various updating, COI declaration
The U.S. sponsor of this drug's trials has requested that I update this article with more current information. All such information will be well-sourced. Additionally, I'll be reviewing some of the assertions in the current revision for citations and will raise any issues on the Talk page before taking any action. MatthewBurton (talk) 15:53, 30 April 2010 (UTC)


 * What exactly is your relationship with Optimer (and their public relations firm, Porter Novelli) and why have they asked you to edit an article on wikipedia on their behalf? Just asking for a bit more clarification than you provided is all.Davidtfull (talk) 04:18, 5 May 2010 (UTC)


 * I have no direct relationship with Optimer. Porter Novelli occasionally contracts me to insure their article updates comply with Wikipedia standards. This article is among them. (FWIW, Porter Novelli Life Sciences--the branch of PN representing Optimer--was recently spun off into a new company, Canale Communications.) MatthewBurton (talk) 15:20, 5 May 2010 (UTC)

So it was not the U.S. sponsor of this drug's trials (Optimer Pharmaceuticals) that has requested that you update this article, as you previously stated. Rather you are being paid by the PR firm, Canale Communications, (formerly known as Porter Novelli Life Sciences) to promote prulifloxacin via this Wikipedia article.

Hence I would assume that your contract with Canale Communications would require that you edit this article to present prulifloxacin in the best possible light. Which I would also assume may present an insurmountable conflict of interest depending upon the edits being made.

Nevertheless we have established thus far that you are not employed by Optimer Pharmaceuticals, Porter Novelli, or Porter Novelli Life Sciences. You are being paid by Canale Communications to edit this particular article. Although one of the above firms may have employed you to work on other wikipedia articles that they may have a financial interest in. Correct? Or am I still somehow getting it wrong here?


 * It is wrong to assume that I am required to present the drug in the best possible light, just as it would be wrong of me to assume that you, given your position, have an interest in painting it in its worst possible light. I am paid to update the article in a way that conforms to Wikipedia guidelines. As I said before, all of my edits will be well-sourced. As the CONFLICT page states, it is perfectly acceptable to make edits that I believe a neutral editor would agree with. Please assume good faith. MatthewBurton (talk) 15:24, 10 May 2010 (UTC)

I have been assuming good faith so please quit stating that you believe otherwise. If your edits are legitamate and supported by your references then you have nothing to be concerned about.Davidtfull (talk) 06:16, 14 May 2010 (UTC)

Present perfect vs past perfect
Regarding "the drug has/had been studied," a recent edit is explained:


 * "'had' is the past tense of 'has.' Since the studies are completed, 'had' is the proper verb to use here, not 'has'."

In this case, "has"/"have" is used not as an action verb, but as an auxiliary verb in the present perfect tense. The sentence refers to the current status of the drug, thus "has been" is correct, not "had been." "Had been" (the past perfect tense) would be correct if the sentence read, for example, "Until five years ago, the drug had been tested only in Europe and Japan..." MatthewBurton (talk) 15:06, 4 June 2010 (UTC)
 * I agree with Mathew, has is appropriate in this instance.-- Literature geek |  T@1k?  22:01, 4 June 2010 (UTC)


 * Guess that puts us at an impasse as I continue to disagree for the following reasons: :)


 * Perfective verbs mean past or future, but not present activities – an activity that is happening now cannot be ended, so it cannot be perfective. English tense system has only two basic tenses, present and past; past perfect tense is used to refer to an event that has been completed. Something that had occurred in the past. (Had)  The present perfect tense is a tense we use when we are interested in the present. (Has)


 * The sentence does not refer to the current status of the drug, but rather reports upon a prior action, that being the fact that it had been tested in two specific phase three trials some time in the past. It’s current or future status remains unknown, and no attempt was made within the sentence to address whatever that may be. The present perfect tense (has) is a tense we use when we are interested in the present result of the action. (Id at Practical Application)  The context of the sentence in question simply reported upon a past event. Hence we are not talking about something occurring in the present that needs a reference to a past event to clarify.  The testing has been already been completed and the sentence does not attempt to address the ramifications of this.  It speaks directly, and solely, to a specific past event. (had)


 * The two trials referred to are not taking place in the present. So this is an event that is done and over with.  Ancient history.  My objection to the use of “has” is that it implied a present relevance to these trials that the sentence does not contain.  Matthew’s rebuttal, as eloquent as it may have been, has failed to convince me otherwise.  As such I respectfully disagree that the use of “has” is appropriate; considering the context of the sentence in question.  But this is a purely academic debate, as I really do not care enough one way or the other, to object any further than this.  In fact I believe that the sentence:


 * Until five years ago, Prulifflocacin had only been tested in Italy and Japan…


 * Would be far more appropriate and should be employed instead. Thus ending the current discussion on a harmonious note.Davidtfull (talk) 05:44, 5 June 2010 (UTC)


 * David, as you said, the perfect tense pertains to events of the past or future. But there is a present perfect tense that pertains not to present events, but rather to the present status of past events; using it in reference to the tests doesn't mean the tests are ongoing; if they were, we would say "the drug is being tested." But because the tests are complete, we say there HAVE been two tests (using have, the plural form of has). Maybe disassociating it from the topic will make it clearer: George H.W. Bush HAS been elected president one time. The election is over. But because we're talking about how many times he's been elected as of today, we use the present perfect tense. We could use the proposed "Until five years ago..." solution, but that wouldn't put it to rest; we'd have to write something like, "Since then, it has been tested twice." MatthewBurton (talk) 14:20, 7 June 2010 (UTC)


 * Within an article dated February 4th, 2009, Giannarini makes reference to additional ongoing Phase III randomized, placebo-controlled studies testing prulifloxacin for the treatment of traveler's diarrhea. Now we all agree that the two trials you are referring to where completed a year earlier.  Since the drug had already been approved in Italy and Japan logic would dictate that Giannarini is referring to additional Phase III trials that are either ongoing, or in the planning stages here in the United States.  Or perhaps Giannarini is mistakenly referring to the same trials as you and is completely unaware that the trials you are referring to have already been completed a year prior to his writing this paper?  No, because he makes reference to them:


 * "Results are awaited from recently completed and ongoing Phase III randomized, placebo-controlled studies testing prulifloxacin for the treatment of traveler's diarrhea."


 * If there are additional trials that you are unaware of, then you cannot attempt to address how many times the drug has been tested at the present time. It appears here, based upon Giannarini’ article, that we do not know how many Phase III trials there have been, or will be, conducted in the United States. I would presume based upon the bush example that we are talking about how many times the drug has been tested in the United States as of today.  The distinction being we know how many times bush had been elected President, unfortunately more than zero, but less than two.  Here, if Giannarini is correct, we do not know how many times this drug has been tested in the United States, as of today, now do we?  Other than more than zero but no less than two.  The exact number remains elusive.


 * The only known fact, that the citations used support, is that it had been tested in two specific Phase III randomized, controlled trials involving patients with Acute Bacterial Gastroenteritis (also known as traveler's diarrhea). This much we have ascertain.  The remaining trials referred to by Giannarini remain the unsolved mystery, which requires the use of “had” rather than “has”.  The reason being that because we're talking about how many times the drug had been tested in phase III trials in the United States, (within the context of the sentence), and we do not know how many times this has occurred as of today, we should not (in my humble opinion) use the present perfect tense until this has been determined.  Capice?  Purely an academic discussion taking place here.  Just adding further clarification regarding my point of view is all.  Verbal volley ball.  Balls in your court now.  :)Davidtfull (talk) 03:49, 8 June 2010 (UTC)


 * As it reads now, "has" is grammatically correct, "had" incorrect. We have a third opinion that agrees, so I will change it. MatthewBurton (talk) 14:12, 8 June 2010 (UTC)

(outdent) Had as I read it implies something that happened at one point in time but it is no longer the case. For example, I had a blue car, implies that I no longer have a blue car. Thus had implies that the trials were carried out but now were no longer carried out which doesn't make sense. That is why I preferred has, as it means they were carried out and it is still the case that they were carried out and will always be the case that they were carried out. I dunno if that makes sense. I passed English but not with flying colours (UK English spelling of colours hehe). :) To start another debate if people are in the debating mood, there is always the possibility of using, "have", "was" or "were" carried out. :)-- Literature geek |  T@1k?  00:21, 10 June 2010 (UTC)


 * "...Had as I read it implies something that happened at one point in time but it is no longer the case..." This is the heart of my argument LG.


 * At one point in time there had been only two phase III studies done in the United States. And had I not uncovered evidence of additional studies I would not of had any issues with this.  But at this point in time there are more than two phase III studies.  As such the use of has "...In the United States, Prulifloxacin has been tested in two Phase III randomized, controlled trials involving patients with Acute Bacterial Gastroenteritis (also known as traveler's diarrhea)..." is incorrect.  Since the facts being referred to in the sentence have changed, then the use of "has" would no longer be valid.


 * The sentence is referring to past history, not the current status of these studies. The sentence is referring to, as you had stated so eloguently; "something that had happened at one point in time but is no longer the case"...They had a blue car at one time (two studies), now we don't know what color the car is since it has been repainted... (number of existing phase III studies) :) True, it had been tested in two phase III studies (that we know of).  BUT, it also has been tested in any number of other phase III studies that are either ongoing or in the planning stage.  Or even abandonded, for all we know, due to unexpected results.


 * If we simply remove the specific number of studies that have been done, as well as what they were done for, then this would cease to be at issue. For indeed Prulifloxacin has been tested in Phase III clinical trials in the United States.  This is a proven fact, as such this will remain a proven fact, and it will always be a proven fact that phase III studies were carried out. How many and what for, which are NOT proven facts, then become irrelevant if we make no mention of them.  Problem solved.Davidtfull (talk) 03:42, 10 June 2010 (UTC)

Blacklisted Links Found on Prulifloxacin
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 * http://www.drugfuture.com/chemdata/prulifloxacin.html
 * Triggered by  on the local blacklist

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