SandyGeorgia (talk | contribs) →Clinical data updates with press references: Reply another section with nothing actionable that is clogging the page Tag: Reply |
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:# You've requested that text be added about the DOJ investigating short sellers based on three sources, not one of which ''ever mentions Cassava''; please read [[WP:SYNTH]]. I am compelled to again explain that Wikipedia is not a WEBHOST, and text must be based on reliable, independent, third-party sources, that is [[WP:POV|neutral]] and avoids [[WP:OR|original research]]. We can't take a DOJ investigation unrelated to Cassava and use it to draw connections in this article; that is synthesis of sources. |
:# You've requested that text be added about the DOJ investigating short sellers based on three sources, not one of which ''ever mentions Cassava''; please read [[WP:SYNTH]]. I am compelled to again explain that Wikipedia is not a WEBHOST, and text must be based on reliable, independent, third-party sources, that is [[WP:POV|neutral]] and avoids [[WP:OR|original research]]. We can't take a DOJ investigation unrelated to Cassava and use it to draw connections in this article; that is synthesis of sources. |
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: That leaves me very little, but a bit, left to work with from your suggestion when I start looking more in depth tomorrow. [[User:SandyGeorgia|'''Sandy'''<span style="color: green;">Georgia</span>]] ([[User talk:SandyGeorgia|Talk]]) 04:55, 19 August 2022 (UTC) |
: That leaves me very little, but a bit, left to work with from your suggestion when I start looking more in depth tomorrow. [[User:SandyGeorgia|'''Sandy'''<span style="color: green;">Georgia</span>]] ([[User talk:SandyGeorgia|Talk]]) 04:55, 19 August 2022 (UTC) |
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::In response to above: |
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::1. If you want a date of Phase 3 start, I don't know. It must be somewhere. I don't think it is that important. Omicron paused everything industry wide, so start date is not that relevant. |
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::2. I agree. Number of planned enrollees was stuffed into the "other concerns" earlier, juxtaposed with the article falsely claiming "enrollment has slowed." It is unnecessary. |
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::3. Sounds good. Take it out, along with the planned enrollment numbers. |
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::4. Agree. Old news still being rehashed as FUD. Certainly doesn't belong in the intro. |
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::5. The Compliance Week article shows the financial COI of the petitioners. It specifically covers this kind of thing so should have the expertise needed. Also, here is a Bloomberg article reporting that the short-sellers made $100 million by shorting the stock and then filing the petition, which they knew would tank the stock price (and yes, is illegal market manipulation for financial gain): https://www.bloomberg.com/news/articles/2021-08-31/cassava-short-sellers-reap-100-million-in-august-stock-rout#xj4y7vzkg |
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::6. You can omit, but DOJ investigations are supposed to be confidential so would not state. However, as this stock is one of the most shorted stocks (there are dynamic rankings), it surely is part of that massive investigation. [[User:SighSci|SighSci]] ([[User talk:SighSci|talk]]) 19:46, 19 August 2022 (UTC) |
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{{u|SighSci}} this [https://en.wikipedia.org/w/index.php?title=Cassava_Sciences&oldid=1105320435 17:18, August 19, 2022 version of the lead] is what I have done so far from your post above. Some of your requests are not actionable for the reasons I mentioned, and this is still a work in progress. I've eliminated the need for a source to document the need for a precise date Phase 3 trials started by rewording the sentence; the precise date isn't that relevant to this article anyway. I've also reworked everything so that content in the lead can be cited to secondary sources when they are available, minimizing [[WP:UNDUE]] content. I've worked in more general company info that belongs in any company lead (likely more is needed, but we can get to that once the rest is better managed). {{pb}} We still have to resolve [[#No products approved by the FDA]] and [[#SavaDx]]; discussion of those can continue below in those sections. This is only a first pass, as I continue to try to sort the mess on this page, and the lead will surely continue to evolve and change. {{pb}} That said, is there anything else that you see as needing urgent attention in the lead, while we continue to try to sort the rest? [[User:SandyGeorgia|'''Sandy'''<span style="color: green;">Georgia</span>]] ([[User talk:SandyGeorgia|Talk]]) 19:17, 19 August 2022 (UTC) |
{{u|SighSci}} this [https://en.wikipedia.org/w/index.php?title=Cassava_Sciences&oldid=1105320435 17:18, August 19, 2022 version of the lead] is what I have done so far from your post above. Some of your requests are not actionable for the reasons I mentioned, and this is still a work in progress. I've eliminated the need for a source to document the need for a precise date Phase 3 trials started by rewording the sentence; the precise date isn't that relevant to this article anyway. I've also reworked everything so that content in the lead can be cited to secondary sources when they are available, minimizing [[WP:UNDUE]] content. I've worked in more general company info that belongs in any company lead (likely more is needed, but we can get to that once the rest is better managed). {{pb}} We still have to resolve [[#No products approved by the FDA]] and [[#SavaDx]]; discussion of those can continue below in those sections. This is only a first pass, as I continue to try to sort the mess on this page, and the lead will surely continue to evolve and change. {{pb}} That said, is there anything else that you see as needing urgent attention in the lead, while we continue to try to sort the rest? [[User:SandyGeorgia|'''Sandy'''<span style="color: green;">Georgia</span>]] ([[User talk:SandyGeorgia|Talk]]) 19:17, 19 August 2022 (UTC) |
Revision as of 19:46, 19 August 2022
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Edits needed to keep this page neutral
Inaccuracies were corrected and detail were previously added to keep this page balanced and neutral. They were immediately reversed and called "suspect" and "problematic." The original page had a negative bias and was part of a negative media and social media campaign on this company. Please keep this page fair and neutral. The "experts" quoted are all negative (and tied to the failed Citizen's Petitions) and so should be called "skeptics" not "experts," as just one example. 2600:1700:5431:1280:C5A:D4CF:987B:A482 (talk) 14:56, 30 July 2022 (UTC)
IP 2600, Please review WP:OR and WP:RS and WP:MEDRS and WP:COI and WP:NPOV for samples of some Wikipedia policies and guidelines. Wikipedia follows secondary reliable sources; it doesn't decide what to write as original research. In this edit, I see multiple problems:
- Use of a primary source for overlabeling results
- Original research and editorializing in the second bit, about benefits not outweighing risks (stick to what sources say).
- Considerable insertion of results from primary studies.
- Marginal sources; plenty of mainstream sources have covered this.
- Text not verified by sources.
- POV editorialzing "suddenly subjected to intense scrutiny by actors paid by the short sellers"
- Original research and editorializing (one sample only, it's everywhere): Only two of these PLOS papers are Cassava papers, and none discuss simufilam or even Alzheimer's disease. An additional retraction was a collaboration with Servier published in Alzheimer's Research & Therapy, for which Dr. Wang was and is still blind to group, making it impossible to manipulate data for a certain outcome.
I'm stopping there, as it's abundantly clear that most of the content reverted was poorly sourced editorializing and original research, suggestive that conflict-of-interest editing is occurring here. I am not reverting, as I'm uninterested in getting involved in a DOJ legal matter but suggest that the bulk of the article should simply be deleted. SandyGeorgia (Talk) 17:35, 30 July 2022 (UTC)
Cleanup
I have cleaned most of the advert-y and non-policy-based content. I've tried to fill in many of the citations, but have NOT verified that all sources are accurately represented (many were not); please do not assume that any citation I have cleaned up the formatting on is accurately represented in this (woeful) article.
The article over-relies on press releases and primary documents, when secondary sources covering most of the issues are available. SandyGeorgia (Talk) 21:46, 31 July 2022 (UTC)
- Thank you for your efforts! ScienceFlyer (talk) 23:36, 31 July 2022 (UTC)
- Here's a good primary article for balance of the whole situation: https://www.complianceweek.com/risk-management/the-cassava-sciences-saga-short-sellers-gaming-the-fda-and-the-damaging-ripple-effects/31416.article SighSci (talk) 01:57, 17 August 2022 (UTC)
- Continued below at #Compliance week article research should be added. There is nothing actionable in this section, which should be archive closed so we can focus on what does need to be done without the repetition. SandyGeorgia (Talk) 19:05, 19 August 2022 (UTC)
Enrollment in Phase 3 studies
The last sentence of the Phase II section expressing the opinion that "enrollment has slowed" has been proven wrong by the recent disclosure that over 400 subjects have enrolled in Phase 3. Please remove the sentence and reference and update to cite current enrollment. Additionally, complaints about the small sample size of the first interim analysis of the 12-month open-label study should be tempered by the recent disclosure of similar results in double the sample size (63 of 100 subjects IMPROVED in cognition scores after one year; this is a population known to decline). 104.10.252.226 (talk) 17:04, 5 August 2022 (UTC)
- Additionally, in this Phase II section, the focus on Dr. Wang being an advisor to the company (and therefore conflicted) is misleading. It also This passage needs to note, as is disclosed in the same sources, that Dr. Wang was and still is blind to treatment group. Not knowing what samples correspond to simufilam versus placebo makes it impossible to manipulate data, as is the implication with this complaint about conflict of interest. 104.10.252.226 (talk) 17:28, 5 August 2022 (UTC)
- Please provide reliable third-party independent sources for your assertions. SandyGeorgia (Talk) 18:20, 5 August 2022 (UTC)
- Here is one source (besides company press release) for the above information: https://seekingalpha.com/article/4529663-cassava-sciences-some-learnings-from-q2-2022-earnings
- Clinicaltrials.gov for NCT04079803 shows that the labs measuring biomarkers (both CSF and the plasma p-tau181) were blind to treatment, as indicated by the following: "Masking:
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)"
- Outcomes assessor means both cognitive testing and biomarker testing personnel. Here is the link to the trial registration: https://clinicaltrials.gov/ct2/show/NCT04079803?term=simufilam&draw=2&rank=6 104.10.252.226 (talk) 21:05, 5 August 2022 (UTC)
- You've provided one independent source, seekingalpha.com. Since I have never heard of it, and can't even get past all of its ridiculous popups, please visit WP:RS and WP:RSN to establish why you believe it meets Wikipedia guidelines for reliability. (Hint, I have a script installed that redflags non-reliable sources, so I can tell you not to waste your time on it. It's flaming.) Please also visit the policy page, WP:DUE. And then WP:OR; Wikipedia follows secondary sources--it doesn't analyze primary studies and sources. If real sources don't mention something, it's rarely due weight to include it. When you want to add something to a Wikipedia article, it is expedient to provide a WP:RS, or for biomedical content, a WP:MEDRS. Please also understand the difference between primary, secondary and tertiary sources, and how to use them; a solid read of the policy and guideline pages I've listed above will provide a guide to everything that was wrong in this article because of what looks like WP:COI and WP:POV editing. And what Wikipedia is WP:NOT. You haven't provided any useful information or sources upon which text can be based. SandyGeorgia (Talk) 01:40, 6 August 2022 (UTC)
- Thanks. We will all just have to wait until CUNY finally states their conclusion so that reliable sources can write a reliable article (in contrast to the hit pieces in WSJ and NYT that only sought sources that fit a preconceived negative narrative and who were directly involved in the failed citizen's petition to halt a Phase 3 program of a promising drug candidate for Alzheimer's disease). All reputable journalists are choosing to wait until CUNY speaks. At that time, this story will substantially change. And, as the company disclosed last fall, these government agency investigations were initiated at the same time as the petition -- likely by the very same people. 104.10.252.226 (talk) 14:58, 6 August 2022 (UTC)
- Good reason to go ahead and remove all of the primary and non-reliable sourcing from this article; the editing that went on here was dreadful, and much of that poor editing is still in the article. I do hope you have read all of the policy and guideline pages I've linked above, because, if that editing continues, I'll be requesting administrative attention to this article. SandyGeorgia (Talk) 15:02, 6 August 2022 (UTC)
- As of this August 6 version, Ì believe the article is now down to reliable sources or Cassava press releases only when they can be justified as having been mentioned by secondary sources. I could have missed some. If further adjustments are needed, please refer to reliable published independent sources. Also keep in mind that this is the company article, not the drug article. The article was previously going in to excess detail about specific drugs. SandyGeorgia (Talk) 16:08, 6 August 2022 (UTC)
- Thanks. We will all just have to wait until CUNY finally states their conclusion so that reliable sources can write a reliable article (in contrast to the hit pieces in WSJ and NYT that only sought sources that fit a preconceived negative narrative and who were directly involved in the failed citizen's petition to halt a Phase 3 program of a promising drug candidate for Alzheimer's disease). All reputable journalists are choosing to wait until CUNY speaks. At that time, this story will substantially change. And, as the company disclosed last fall, these government agency investigations were initiated at the same time as the petition -- likely by the very same people. 104.10.252.226 (talk) 14:58, 6 August 2022 (UTC)
- You've provided one independent source, seekingalpha.com. Since I have never heard of it, and can't even get past all of its ridiculous popups, please visit WP:RS and WP:RSN to establish why you believe it meets Wikipedia guidelines for reliability. (Hint, I have a script installed that redflags non-reliable sources, so I can tell you not to waste your time on it. It's flaming.) Please also visit the policy page, WP:DUE. And then WP:OR; Wikipedia follows secondary sources--it doesn't analyze primary studies and sources. If real sources don't mention something, it's rarely due weight to include it. When you want to add something to a Wikipedia article, it is expedient to provide a WP:RS, or for biomedical content, a WP:MEDRS. Please also understand the difference between primary, secondary and tertiary sources, and how to use them; a solid read of the policy and guideline pages I've listed above will provide a guide to everything that was wrong in this article because of what looks like WP:COI and WP:POV editing. And what Wikipedia is WP:NOT. You haven't provided any useful information or sources upon which text can be based. SandyGeorgia (Talk) 01:40, 6 August 2022 (UTC)
- Please provide reliable third-party independent sources for your assertions. SandyGeorgia (Talk) 18:20, 5 August 2022 (UTC)
Neuroscience article
- If you only include company press releases that have been mentioned by secondary sources, you are failing to report outcomes of all journal investigations and specifically omitting a journal who investigated an allegation and found no evidence of manipulation (Neuroscience). Unlike the other two journals that found no evidence of data manipulation, Neuroscience decided not to maintain an expression of concern on the article while CUNY completes their investigation. This Neuroscience article itself could be cited, even though there is no expression of concern: https://pubmed.ncbi.nlm.nih.gov/16084657/ This section should be balanced, and currently it is not (nor is the entire article). Furthermore, the planned enrollment in the Phase 3 trials is stuffed into "other concerns." Clearly it does not belong there but could be mentioned after the statement that the drug is in Phase 3 trials. The following sentence claiming that patient enrollment has slowed (by Stat) is from April, was wrong then and is very outdated now. It should be removed. SighSci (talk) 19:12, 16 August 2022 (UTC)
- Well, thank you for registering an account; now we can begin to address your edits. First, please read and acknowledge the information at WP:COI as necessary. SandyGeorgia (Talk) 19:41, 16 August 2022 (UTC)
- Read. I will only make suggestions. Per this policy, short-sellers of Cassava stock, or anyone paid by them or connected to efforts to impede Cassava, should not have been editing. About the Neuroscience article, it turns out there is actually an editorial note stating that no evidence of manipulation was found that can be cited: https://www.sciencedirect.com/science/article/pii/S0306452221005789?via%3Dihub. Again, this should be included if this section is to be complete or balanced. Note that there are only three published papers that involve Cassava Sciences' drug. It may be more relevant to focus on those, rather than the portion of Cassava's academic collaborator's long list of publications that are unrelated to Alzheimer's or Cassava (but also falsely accused and used to smear Cassava). SighSci (talk) 23:48, 16 August 2022 (UTC)
- Excellent progress. Which text about a "long list of publications that are unrelated to Alzheimer's" are you referring to? I will start a separate post to sort the Neuroscience text, so the formatting will be more easily followed. Please recognize that "regular" (i.e. ongoing, or long-standing) Wikipedia editors are not solely immersed in the vagaries of one particular article or topic, rather addressing multiple issues across many types of articles daily, so the more precise you can be, the sooner issues can be addressed. SandyGeorgia (Talk) 01:28, 17 August 2022 (UTC)
- Thanks. The long list is that Dr. Wang has published well over 100 papers and "issues" have been raised with over 30 on PubPeer, by the same small group of people. Editors may or may not have investigated by requesting original high-res images, but they are expected to if they see a need. Any honest errors have been found, for sure. SighSci (talk) 01:53, 17 August 2022 (UTC)
- SighSci, in trying to format a response to your concerns, I am realizing that I am confused about what you are asking/stating relative to what was in the article when I started to clean up a biased, COI, and unreliably sourced version. I don't know what you want changed at this point. You are referencing (above) a February 2022 correction about a naloxone paper. The text now in the article references a December 2021 correction about an entirely different paper. And the Michaels/Wall Street Journal piece, used as a source, refers to a November 2021 correction. What is in the article now never alleges data manipulation; it says an error was found that "does not affect the conclusions of the article". Unless you can be more specific, it appears that you want something corrected that is never incorrect, and I am becoming concerned that we are discussing different Neuroscience papers. It looks like we had best take this from the top and get on the same page. For expediency here, please reference exact wording now in the article, so I can be sure what you are referring to and get this addressed as soon as feasible. For example, I see no text in the article about Wang and well over 100 papers, or issues with 30 being raised on PubPeer, so I don't know what you want changed vis-a-vis that comment. Try to format your talk page posts as ... here is what the article says now, based on X source, and here is my proposed change, based on Y source. SandyGeorgia (Talk) 02:18, 17 August 2022 (UTC)
- OK. The "journals investigate" section mentions three journals - JNS, PLOS and NBA. One of them (PLOS) mentions 5 articles, none of which discuss the drug or even Alzheimer's. If PLOS is to be included, a fourth journal (Neuroscience -- different from Journal of Neuroscience [JNS]) should also be mentioned. That is the editorial note I recently found and linked to above.
- First, this section should start, "In response to allegations, " instead of "Following the public controversies." They did not independently reassess but were responding to specific allegations posted on Pubpeer and apparently reached out to the authors. The text now states: The journal published a correction along with the original images in December 2021 remarking that the "error does not affect the conclusions of the article". This sentence omits the main finding: after examining original images that were requested of the author, JNS found "no evidence of data manipulation." An honest error was found and this is the correction. The sentence should state: "After examining original images, the journal found no evidence of data manipulation [might need to cite company press release here because the erratum does not state this] but identified an error and published an erratum, including original images of blots alleged to be manipulated." Please reference only #31, not the hit piece #10 for this sentence. The following sentence now reads: "After further data concerns were brought to the attention of the journal, it issued an expression of concern stating: "These and other concerns are currently under investigation by the academic authorities at the City University of New York (CUNY). JNeurosci will await the outcome of that investigation before taking further action." It should be changed to this: "After receiving additional complaints about the original blot images posted, the editor issued an expression of concern acknowledging an ongoing investigation by the City University of New York (CUNY) and stating JNeurosci "will await the outcome of that investigation before taking further action." No need to extensively quote.
- The first part of the next paragraph now reads: "PLOS One re-examined all the Burns and Wang's research papers in March 2020 and found "similarities in background pixels" in the Western blot data. Five of Wang's papers were retracted, two of which were co-authored with Burns that include the original papers on the discovery of FLNA binding as it relates to opioid receptor signaling. Three papers are on prenatal cocaine." It should be changed to this: "PLOS One re-examined all five of Dr. Wang's research papers and retracted all of them based on "similarities in background pixels" in the Western blot data.[cite retraction notices here] None of these papers are about simufilam or Alzheimer's disease. Two illustrate FLNA's role in opioid receptor signaling. The other three have no Cassava coauthors and discuss prenatal cocaine." Note that citations 35-37 are two retraction notices repeated twice. No need to extensively quote the retraction notices. Otherwise, the multitude of Wang papers that are not related to Cassava that have been cleared -- or even republished with data repeated by a different lab with the same result -- should all be discussed here. This all gets too long for this page that is about Cassava, not Wang, who has published with many different companies and academics on many different topics.
- The last paragraph also does not need to extensively quote the expression of concern. I suggest this: The journal Neurobiology of Aging examined a 2017 paper on simufilam. [cite paper here, #38] Using AI-based figure proofing software, the editors found "no compelling evidence of data manipulation intended to misrepresent the results."[cite expression of concern here, #39] The journal did identify errors and issued an expression of concern, again acknowledging the ongoing investigation by CUNY.[cite expression of concern here, #39] SighSci (talk) 14:04, 17 August 2022 (UTC)
- A new paragraph should be inserted before the PLOS paragraph. I suggest this:
- Neuroscience investigated an allegation of image manipulation in a 2005 paper of Wang and Burns and found no evidence of data manipulation.[cite this editorial note: https://www.sciencedirect.com/science/article/pii/S0306452221005789?via%3Dihub] SighSci (talk) 14:08, 17 August 2022 (UTC)
- Ack. I see there are two distinct journals (Neuroscience and Journal of Neuroscience). Unless other editors get to it sooner, I will work on this later today after reviewing all secondary sources again, but your suggestion to ignore a high-quality reliable independent third-party source (The Wall Street Journal, citation #10 in the current version) is not in accordance with Wikipedia policies and guidelines. Also, I suggest not mentioning in talk discussions citations by their current number in the article, as Wikipedia is dynamic, and those can change over time. For example, you might mention instead of #10, Michaels WSJ November 2021, or a PMID or DOI for a medical journal article. SandyGeorgia (Talk) 14:40, 17 August 2022 (UTC)
- To clarify - I think I might have removed the Neuroscience article (I am not sure, but I remember seeing it and being confused why it was there). The current articles in that section all relate to FLNA (aka filamin A), I thought were relevant because Cassanova's drug simufilam is thought to act via binding FLNA. The exception being a couple of the PLOS One articles which I left in there because they seemed to be all retracted at the same time due to overlapping issues.
- On the other hand the Neuroscience article does not relate to FLNA or Alzheimer's (based on the abstract), so it was not clear to me what the relevancy was to this article. I thought it made more sense to only focus on the articles that relate to the FLNA/drug, since otherwise the article is going to have to list every article related those researchers which has been investigated, which seems a very excessive (I was curious so started looking up what that would involve, and so far have found 8 articles which have been retracted and another 2 with an expression of concern).
- In my opinion it would be easier to add a sentence to the start of the section stating that it was focusing on FLNA/simufilan papers, rather then list every article, but I will let someone else make that decision (I am very impression at SandyGeorgia efforts improving this article so I don't want to mess up there work) ZICgene (talk) 12:02, 18 August 2022 (UTC)
- That was meant to say "I am very impressed at @SandyGeorgia efforts", apologies for the typo ZICgene (talk) 12:42, 18 August 2022 (UTC)
- Thx, ZICgene; I need a block of time to get through the mess of stuff on this talk page and sort it out, and then make the edits, and a friend popped up with a medical situation yesterday that took most of my day, and same today. I do hope someone else can pitch in to start on the pieces, but it's been quite hard to decipher not only what is needed, but also what is policy compliant. SandyGeorgia (Talk) 12:58, 18 August 2022 (UTC)
- No worries, hope your friend feels better soon! I don't mind helping tracking down some stuff for this section, I have just been reluctant to jump in because I am not familiar with wikipedia's rules are about company's articles (usually I just edit obscure science articles). ZICgene (talk) 14:01, 18 August 2022 (UTC)
- Thanks, the mess on this page is going to take quite some time to decipher, as the damage from COI/POV editing is extensive and the disorder on this talk page makes it hard to know where to begin. If anyone is inclined to help, the earlier version listed below at #To be recovered was not entirely policy compliant, but is worth a read. Cassava stock jumped today on what is described in sources as insider trading based on the possibility of a buyout, so it's easy to see the potential for manipulation in this article. SandyGeorgia (Talk) 14:53, 18 August 2022 (UTC)
- No worries, hope your friend feels better soon! I don't mind helping tracking down some stuff for this section, I have just been reluctant to jump in because I am not familiar with wikipedia's rules are about company's articles (usually I just edit obscure science articles). ZICgene (talk) 14:01, 18 August 2022 (UTC)
- Thx, ZICgene; I need a block of time to get through the mess of stuff on this talk page and sort it out, and then make the edits, and a friend popped up with a medical situation yesterday that took most of my day, and same today. I do hope someone else can pitch in to start on the pieces, but it's been quite hard to decipher not only what is needed, but also what is policy compliant. SandyGeorgia (Talk) 12:58, 18 August 2022 (UTC)
- Thanks ZICgene and SandyGeorgia.
- Of the five PLOS papers that were retracted (with many people disagreeing), only two involve FLNA (and not the drug), and for its role in opioid receptor signaling -- not Alzheimer's. The other three are about prenatal cocaine, not AD and not FLNA, and have no Cassava authors. "All the Burns and Wang papers" is inaccurate, because only two include Burns. All are irrelevant, unless you consider any work on FLNA by these two as relevant. True, they were simultaneously retracted for an issue involving pixels in the background of original blots in areas cropped out of the published images. No one has articulated what it is. If the three non-Cassava, non-simufilam papers are to be included (the prenatal cocaine ones), the Neuroscience one should be too -- at least that one includes a Cassava author. Up to you.
- Importantly, new news today is that the remaining publication on simufilam (in JPAD) was cleared of allegations. So now ALL THREE simufilam papers have been cleared by editors. Here is the citation of today (not press release): https://www.marketwatch.com/story/cassava-sciences-academic-journal-found-no-evidence-of-data-manipulation-271660829914 SighSci (talk) 22:21, 18 August 2022 (UTC)
- I should have some time to catch up tomorrow; some of the problems here are because people were using primary sources, rather than secondary mentions, and it looks like you are saying some of the wrong primary sources worked their way in. I have been iPad editing on the road most of the day, and have to be able to sit at a real computer to sort this ... perhaps tomorrow. I first want to re-read all secondary sources, and make myself a chart of what's what. Thanks for the patience, SandyGeorgia (Talk) 22:36, 18 August 2022 (UTC)
- I just spent some time going back over these papers to make sure I understood the connection of these papers to this Simufilam/PTI-125 before I commented again, and I still think there is a link there that makes it valid to include the PLoS ONE papers.
- Unfortunate this explanation needs to include some biology jargon, but I will try to keep it as simple as possible.
- The PLoS ONE papers (“High-Affinity Naloxone Binding to Filamin A Prevents Mu Opioid Receptor–Gs Coupling Underlying Opioid Tolerance and Dependence” and “Naloxone's Pentapeptide Binding Site on Filamin A Blocks Mu Opioid Receptor–Gs Coupling and CREB Activation of Acute Morphine”) establish that FLNA contains a 5 amino acid peptide/region that is a target for drugs. The same papers establish that drugs binding that peptide/region alters the behaviour of FLNA.
- The later paper that identifies Simufilam/PTI-125 as a novel compound to treat Alzheimer’s (“Reducing amyloid-related Alzheimer's disease pathogenesis by a small molecule targeting filamin A”) proposes Simufilam/PTI-125 acts by binding FLNA at the same peptide/region. Since this paper is based on the same region as the earlier PLoS ONE papers, those PLoS ONE papers are basically the foundation for the later research. There retraction raises major questions about the mechanism by which Simufilam/PTI-125 acts. That is why it is relevant to include those two PLoS ONE studies in the article. ZICgene (talk) 12:49, 19 August 2022 (UTC)
- ZICgene thanks for pitching in. Unless I am misunderstanding (which may be the case), there are two issues we need to separate, which SighSci may be also misunderstanding. At this (company) article, the topic is not only Alzheimer's; it's anything relevant to the company. How far we go in to the relationship between Wang/Burns/Cassava depends on what secondary sources say. At the drug article (simufilam) we stay on topic which is the research leading to the experimental drug; that could include non-Cassava work, again, if secondary sources lend support. If a paper, as SighSci says, has no Cassava authorship, it may still be relevant at the drug article. I will put together a table so we can all get on the same page; I have needed to be home at a regular computer to pull all this together, so we can sort the proper use of primary sources and press releases, which are rife throughout these articles (this one, and Lindsay Burns and simufilam). SandyGeorgia (Talk) 14:27, 19 August 2022 (UTC)
- This "Journals investigate" section really needs to be overhauled, especially in light of yesterday's news on the JPAD paper (the third simufilam paper). Now, all three papers on simufilam have been cleared of allegations of data manipulation by the respective editors. Here are two citations for the news of the third clearance: https://www.marketwatch.com/story/cassava-sciences-academic-journal-found-no-evidence-of-data-manipulation-271660829914, https://seekingalpha.com/news/3874626-cassava-sciences-cleared-of-data-manipulation-by-medical-journal-shares-rise-17?source=content_type%3Areact%7Cfirst_level_url%3Amarket-news%7Csection_asset%3Atrending%7Csection%3Atechnology
- The current first paragraph about JNS (the first simufilam paper) fails to mention that they found no evidence of data manipulation, communicated to the company who did a press release in Nov. 2021 but also shown in the erratum notice that could also be cited. The expression of concern is a placeholder until the CUNY investigation reports out.
- The second simufilam paper (NBA), currently the final paragraph of this section, should be moved up in priority because it involves the drug. This might be a good place to add the third paper's clearance (JPAD), discussed above.
- Remember if you talk about all five PLOS retractions, three have nothing to do with the company, the drug or FLNA, but instead are about prenatal cocaine. If these are to be included, you should also mention the 2005 Neuroscience article that at least has a Cassava author. This page is about Cassava, not Dr. Wang. If it were about Dr. Wang, there are many more papers that have been investigated and cleared of allegations that could be listed. This list actually shows the extent of the attacks on him personally that are being used to damage his reputation and that of the company in an effort to impede the ongoing Phase 3 clinical trials (like the failed petition to the FDA). But I don't suggest you should include them.
- Somewhere on this page (suggest in the FDA petition section), this article should be cited (it shows the financial COI of the petitioners): https://www.complianceweek.com/risk-management/the-cassava-sciences-saga-short-sellers-gaming-the-fda-and-the-damaging-ripple-effects/31416.article
- Thanks for all your work! SighSci (talk) 17:30, 19 August 2022 (UTC)
- That was meant to say "I am very impressed at @SandyGeorgia efforts", apologies for the typo ZICgene (talk) 12:42, 18 August 2022 (UTC)
- Ack. I see there are two distinct journals (Neuroscience and Journal of Neuroscience). Unless other editors get to it sooner, I will work on this later today after reviewing all secondary sources again, but your suggestion to ignore a high-quality reliable independent third-party source (The Wall Street Journal, citation #10 in the current version) is not in accordance with Wikipedia policies and guidelines. Also, I suggest not mentioning in talk discussions citations by their current number in the article, as Wikipedia is dynamic, and those can change over time. For example, you might mention instead of #10, Michaels WSJ November 2021, or a PMID or DOI for a medical journal article. SandyGeorgia (Talk) 14:40, 17 August 2022 (UTC)
- SighSci, in trying to format a response to your concerns, I am realizing that I am confused about what you are asking/stating relative to what was in the article when I started to clean up a biased, COI, and unreliably sourced version. I don't know what you want changed at this point. You are referencing (above) a February 2022 correction about a naloxone paper. The text now in the article references a December 2021 correction about an entirely different paper. And the Michaels/Wall Street Journal piece, used as a source, refers to a November 2021 correction. What is in the article now never alleges data manipulation; it says an error was found that "does not affect the conclusions of the article". Unless you can be more specific, it appears that you want something corrected that is never incorrect, and I am becoming concerned that we are discussing different Neuroscience papers. It looks like we had best take this from the top and get on the same page. For expediency here, please reference exact wording now in the article, so I can be sure what you are referring to and get this addressed as soon as feasible. For example, I see no text in the article about Wang and well over 100 papers, or issues with 30 being raised on PubPeer, so I don't know what you want changed vis-a-vis that comment. Try to format your talk page posts as ... here is what the article says now, based on X source, and here is my proposed change, based on Y source. SandyGeorgia (Talk) 02:18, 17 August 2022 (UTC)
- Thanks. The long list is that Dr. Wang has published well over 100 papers and "issues" have been raised with over 30 on PubPeer, by the same small group of people. Editors may or may not have investigated by requesting original high-res images, but they are expected to if they see a need. Any honest errors have been found, for sure. SighSci (talk) 01:53, 17 August 2022 (UTC)
- Excellent progress. Which text about a "long list of publications that are unrelated to Alzheimer's" are you referring to? I will start a separate post to sort the Neuroscience text, so the formatting will be more easily followed. Please recognize that "regular" (i.e. ongoing, or long-standing) Wikipedia editors are not solely immersed in the vagaries of one particular article or topic, rather addressing multiple issues across many types of articles daily, so the more precise you can be, the sooner issues can be addressed. SandyGeorgia (Talk) 01:28, 17 August 2022 (UTC)
- Read. I will only make suggestions. Per this policy, short-sellers of Cassava stock, or anyone paid by them or connected to efforts to impede Cassava, should not have been editing. About the Neuroscience article, it turns out there is actually an editorial note stating that no evidence of manipulation was found that can be cited: https://www.sciencedirect.com/science/article/pii/S0306452221005789?via%3Dihub. Again, this should be included if this section is to be complete or balanced. Note that there are only three published papers that involve Cassava Sciences' drug. It may be more relevant to focus on those, rather than the portion of Cassava's academic collaborator's long list of publications that are unrelated to Alzheimer's or Cassava (but also falsely accused and used to smear Cassava). SighSci (talk) 23:48, 16 August 2022 (UTC)
- Well, thank you for registering an account; now we can begin to address your edits. First, please read and acknowledge the information at WP:COI as necessary. SandyGeorgia (Talk) 19:41, 16 August 2022 (UTC)
- If you only include company press releases that have been mentioned by secondary sources, you are failing to report outcomes of all journal investigations and specifically omitting a journal who investigated an allegation and found no evidence of manipulation (Neuroscience). Unlike the other two journals that found no evidence of data manipulation, Neuroscience decided not to maintain an expression of concern on the article while CUNY completes their investigation. This Neuroscience article itself could be cited, even though there is no expression of concern: https://pubmed.ncbi.nlm.nih.gov/16084657/ This section should be balanced, and currently it is not (nor is the entire article). Furthermore, the planned enrollment in the Phase 3 trials is stuffed into "other concerns." Clearly it does not belong there but could be mentioned after the statement that the drug is in Phase 3 trials. The following sentence claiming that patient enrollment has slowed (by Stat) is from April, was wrong then and is very outdated now. It should be removed. SighSci (talk) 19:12, 16 August 2022 (UTC)
Planned enrollment in Phase 3 trials
SighSci wrote: Furthermore, the planned enrollment in the Phase 3 trials is stuffed into "other concerns." Clearly it does not belong there but could be mentioned after the statement that the drug is in Phase 3 trials.
- If you can be more specific about what you want addressed, Wikipedians can get to it quicker. The Other concerns section has the text:
According to a Cassava Sciences press release, the first trial would enroll about 750 participants, and the second 1,000.[29] Stat stated that enrollment had slowed as of April 2022, as people were deterred from enlisting due to the prevailing controversies.[30]
You want this mentioned "after the statement that the drug is in Phase 3 trials"; since the words Phase 3 don't occur anywhere in the article, where is it precisely that you propose this text be moved? (Phase III is mentioned for another drug.) You also state that:The following sentence claiming that patient enrollment has slowed (by Stat) is from April, was wrong then and is very outdated now. It should be removed.
Do you have a reliable, independent, third-party source stating that it "was wrong then" or "is outdated"? SandyGeorgia (Talk) 04:38, 17 August 2022 (UTC)
- The details of how many subjects are planned to be included in each of the trials is a non sequitur in the "other concerns" section -- it could naturally follow the first mention that the company is conducting Phase 3 trials of its drug -- in the intro. The Stat article made an unfounded claim that patient enrollment had slowed and added this to the "concerns" section. This opinion was based on enrollment numbers released in April, when the trials had barely initiated. It is now August and the company reported over 400 subjects enrolled. This will have to cite a press release because it is not really "news," but regardless, using old numbers for this type of claim is inaccurate. The latest number is here: https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-reports-second-quarter-financial-results-2022 SighSci (talk) 17:44, 17 August 2022 (UTC)
- See response below re overuse of Cassava press releases. SandyGeorgia (Talk) 19:07, 17 August 2022 (UTC)
- Also, please stop disclaiming WP:RS like The Wall Street Journal and STAT. These are considering reliable sources for Wikipedia, and your disagreement with them should be based on equally reliable sources, not Cassava company statements and press releases. Cassava's positions can be stated if done so neutrally and according to due weight, and not done in a self-serving manner. STAT and WSJ are reliable sources. If you claim them to be "wrong", you need an equally reliable independent third-party neutral source that backs up your claim. SandyGeorgia (Talk) 19:13, 17 August 2022 (UTC)
Clinical Trial Data
There should be a section added that covers all of their clinical trials and the results including interim results. I could add that as a section if that's okay. It really is the most important part of the cassava story. 72.184.147.25 (talk) 01:04, 17 August 2022 (UTC)
- Why? If it's not covered by secondary sources, it's probably WP:UNDUE here. Wikipedia is WP:NOTNEWS and WP:NOT a webhost (for Cassava press releases and primary sources); it follows secondary sources, does not lead. SandyGeorgia (Talk) 01:14, 17 August 2022 (UTC)
- PS, you may also be mixing up what might be appropriate for a drug article vs what is appropriate for the company article. At any rate, I'm not even sure that primary source results would be welcome at a drug article. SandyGeorgia (Talk) 03:14, 17 August 2022 (UTC)
- Here is a news article that mentions the recent clinical data: https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-reports-second-quarter-financial-results-2022 SighSci (talk) 18:21, 17 August 2022 (UTC)
- That is not a news article; that is a Cassava press release (not an independent third-party source and certainly not neutral). A friend has had a medical emergency and I won't be able to complete these edits today; if you could come to a better understanding of Wikipedia sourcing, it would save time. We need to look at removing a lot of the press releases already used. They may be used on a limited basis to state Cassava's position, but not to source factual information. Please read WP:V, WP:OR, WP:RS and WP:PSTS. It would save a lot of time, and corrections could be done much quicker, if your requests were short and based on Wikipedia policy. SandyGeorgia (Talk) 19:10, 17 August 2022 (UTC)
- Sorry, sent the wrong link (I am not that dense). Here is the news article. https://www.marketwatch.com/story/cassava-sciences-shares-extend-rally-after-board-member-sanford-robertson-increases-stake-271660752662?mod=newsviewer_click
- Also, here is another news article from today stating that a different journal (JPAD) also found no evidence of data manipulation in a simufilam paper. Now all three published papers involving the drug have been cleared of allegations of manipulation by the respective journal editors. https://www.marketwatch.com/story/cassava-sciences-academic-journal-found-no-evidence-of-data-manipulation-271660829914
- Please update the "journals investigate" section! SighSci (talk) 15:32, 18 August 2022 (UTC)
- Best wishes to your friend; hope all is ok. SighSci (talk) 15:34, 18 August 2022 (UTC)
- Thanks. But you are still providing dressed up or outright press releases that reflect what Cassava states or claims, rather than independent news reporting. I should be able to start digging in to all of this tomorrow. When marketwatch basically repeats Cassava press releases, that's not independent third-party reliable sourcing. SandyGeorgia (Talk) 04:24, 19 August 2022 (UTC)
- PS, I have a google alert set up for Cassava Sciences, so if there is any real reporting from reliable sources, I'm likely to see it; the batch I got tonight from google is all nothing but newswires recycling Cassava Sciences press releases. We don't do it that way on Wikipedia. SandyGeorgia (Talk) 05:06, 19 August 2022 (UTC)
- Agree we need to avoid churnalism. Alexbrn (talk) 05:19, 19 August 2022 (UTC)
- That is not a news article; that is a Cassava press release (not an independent third-party source and certainly not neutral). A friend has had a medical emergency and I won't be able to complete these edits today; if you could come to a better understanding of Wikipedia sourcing, it would save time. We need to look at removing a lot of the press releases already used. They may be used on a limited basis to state Cassava's position, but not to source factual information. Please read WP:V, WP:OR, WP:RS and WP:PSTS. It would save a lot of time, and corrections could be done much quicker, if your requests were short and based on Wikipedia policy. SandyGeorgia (Talk) 19:10, 17 August 2022 (UTC)
- Here is a news article that mentions the recent clinical data: https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-reports-second-quarter-financial-results-2022 SighSci (talk) 18:21, 17 August 2022 (UTC)
There is nothing actionable in this section, which like so many others is filling the talk page with repetitive information and impeding progress. It would be helpful to archive close the unuseful sections here so we can focus on the policy-based content improvements. See also #Clinical data updates with press references and #Enrollment in Phase 3 studies. This is the company article; once we get it sorted, perhaps the unregistered and new editors will have a better sense of Wikipedia policies and guidelines and what sort of info might be useful at the drug article, simufilam, and that does not bear repetition here. SandyGeorgia (Talk) 19:03, 19 August 2022 (UTC)
To be recovered
There is a lot of well-sourced content to be recovered from this version of the article, before COI editing. There seem to have been two different, but equally damaging, kinds of COI/POV editing occurring here—the common variety of puffery to inflate along with less common variety attempts to deflate—neither surprising considering the situation, but both requiring attention. Some good text needs to be recovered and re-instated if someone has time. SandyGeorgia (Talk) 03:52, 17 August 2022 (UTC)
Intro needs help
The intro should talk about what is current first, not that the company was established under a different name with a different focus 24 years ago. This paragraph should be moved to the end or deleted: "Established in 1998 as Pain Therapeutics, the company moved its focus from opioids to drug development for neurodegenerative diseases and changed its name. Cassava initially worked on three drugs: Oxytrex and Remoxy, which were pain drugs, and PTI-901, which aimed to treat irritable irritable bowel syndrome. None of the drugs have been approved by the Food and Drug Administration (FDA)."
Suggested first paragraph: Cassava Sciences (symbol: SAVA) is a pharmaceutical company based in Austin, Texas, U.S. Its founder, chief executive officer and president is Remi Barbier. Cassava is developing simufilam (previously known as PTI-125 and sumifilam), an oral-tablet drug candidate for the treatment of Alzheimer's, as well as SavaDx, a blood-based diagnostic for Alzheimer's disease. Phase 3 trials of simufilam started in 2021. According to a Cassava Sciences press release, the first trial would enroll about 750 participants, and the second 1,000.[1] As of August 2022, over 400 people had enrolled in the trials. [2]
After this sentence: "A Citizen Petition was filed to the FDA in an attempt to suspend the clinical trials, but it was rejected as the FDA ruled the request fell out of the purview of the Citizen Petitions." Please add the following: "Because the petition was filed by short-sellers, many viewed it as market manipulation for financial gain." Please cite this article for this new sentence: https://www.complianceweek.com/risk-management/the-cassava-sciences-saga-short-sellers-gaming-the-fda-and-the-damaging-ripple-effects/31416.article
At the end of the paragraph discussing the DOJ investigation, please add this sentence and citations below: "Reuters and Bloomberg also reported that the DOJ launched an expansive investigation into "short and distort" campaigns of short-sellers who aim to profit from manipulating stocks."
- https://endpts.com/biotech-short-seller-lands-on-feds-watch-list-amid-sweeping-probe-report/
- https://www.reuters.com/markets/europe/us-doj-launches-expansive-probe-into-short-selling-bloomberg-news-2021-12-10/
- https://www.bnnbloomberg.ca/hedge-funds-ensnared-in-expansive-doj-probe-into-short-selling-1.1694005 SighSci (talk) 18:19, 17 August 2022 (UTC)
- Generally (so I can start looking at all of this tomorrow):
- Is there an independent source supporting start of Phase 3 trials?
- The number of planned enrollees in a trial is excess detail for a lead; Wikipedia is WP:NOT a webhost, or a recruiting tool. This is the company article; there is a drug article. The number of planned enrollees is probably not apt for the lead over there either.
- It's unlikely that anything based on the company's press releases is WP:DUE for the lead, particularly when it contradicts WP:RS.
- I don't believe the FDA matter belongs in the
articleoopsie, lead at all; it's a dated and resolved issue. - The entire sentence proposed beginning with
Because the petition was filed by short-sellers, many viewed
is POV, and a MOS:WEASEL, contradicted by secondary sources, and not likely to be supported by the source you provide (which I can't read because it's member-only content). Please provide extensive (avoiding WP:CHERRY, that is, both sides of the story) quotes from the article so I can see if anything from it can be unweasled and converted to encyclopedic (WP:NOTNEWS) prose.- Further, if we are to use complianceweek.com at all, please explain why you think it meets Wikipedia's requirements for reliable sources. Things like: what is its reputation for fact-checking, its journalistic credentials, its journalistic oversight, its policies for retracting and correcting errors, other important reliable sources that use it? What are the staff qualifications and expertise? Etc ... SandyGeorgia (Talk) 05:40, 19 August 2022 (UTC)
- You've requested that text be added about the DOJ investigating short sellers based on three sources, not one of which ever mentions Cassava; please read WP:SYNTH. I am compelled to again explain that Wikipedia is not a WEBHOST, and text must be based on reliable, independent, third-party sources, that is neutral and avoids original research. We can't take a DOJ investigation unrelated to Cassava and use it to draw connections in this article; that is synthesis of sources.
- That leaves me very little, but a bit, left to work with from your suggestion when I start looking more in depth tomorrow. SandyGeorgia (Talk) 04:55, 19 August 2022 (UTC)
- In response to above:
- 1. If you want a date of Phase 3 start, I don't know. It must be somewhere. I don't think it is that important. Omicron paused everything industry wide, so start date is not that relevant.
- 2. I agree. Number of planned enrollees was stuffed into the "other concerns" earlier, juxtaposed with the article falsely claiming "enrollment has slowed." It is unnecessary.
- 3. Sounds good. Take it out, along with the planned enrollment numbers.
- 4. Agree. Old news still being rehashed as FUD. Certainly doesn't belong in the intro.
- 5. The Compliance Week article shows the financial COI of the petitioners. It specifically covers this kind of thing so should have the expertise needed. Also, here is a Bloomberg article reporting that the short-sellers made $100 million by shorting the stock and then filing the petition, which they knew would tank the stock price (and yes, is illegal market manipulation for financial gain): https://www.bloomberg.com/news/articles/2021-08-31/cassava-short-sellers-reap-100-million-in-august-stock-rout#xj4y7vzkg
- 6. You can omit, but DOJ investigations are supposed to be confidential so would not state. However, as this stock is one of the most shorted stocks (there are dynamic rankings), it surely is part of that massive investigation. SighSci (talk) 19:46, 19 August 2022 (UTC)
SighSci this 17:18, August 19, 2022 version of the lead is what I have done so far from your post above. Some of your requests are not actionable for the reasons I mentioned, and this is still a work in progress. I've eliminated the need for a source to document the need for a precise date Phase 3 trials started by rewording the sentence; the precise date isn't that relevant to this article anyway. I've also reworked everything so that content in the lead can be cited to secondary sources when they are available, minimizing WP:UNDUE content. I've worked in more general company info that belongs in any company lead (likely more is needed, but we can get to that once the rest is better managed).
We still have to resolve #No products approved by the FDA and #SavaDx; discussion of those can continue below in those sections. This is only a first pass, as I continue to try to sort the mess on this page, and the lead will surely continue to evolve and change.
That said, is there anything else that you see as needing urgent attention in the lead, while we continue to try to sort the rest? SandyGeorgia (Talk) 19:17, 19 August 2022 (UTC)
Compliance week article research should be added
There is a great compliance week article that covers the Cassava Sciences story with deep research from 2017 though the FDA denial of the citizens petition.
The author is an investigative reporter and Compliance week is a business intelligence service on corporate governance, risk, and compliance that features daily news and analysis, a quarterly print magazine, proprietary databases, industry-leading events, and a variety of interactive features and forums.
She tells the story of early grants from the NIH, positive results from early studies, approval of their phase 3 program under SPAs. She goes on to cover the events surrounding the citizens petition filing that stated:
"In the original CP, dated Aug. 18, Thomas certified that “to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.”
and
"Yet, on Aug. 26, Labaton Sucharow issued a press release revealing the new information that Thomas’ clients “also hold short positions in Cassava stock.” Short selling is the practice of investors betting on a company’s stock price falling—a strategy the Department of Justice is currently investigating.
She talks about some of the other conflicts of interest from the filers of the CP. She talked about how "The other short seller was Geoffrey Pitt, a cardiologist and professor at Weill Cornell Medical College. According to anarticle in The New Yorker published in January 2022, Pitt had never shorted a stock before but decided to do so after Thomas agreed to take their case."
She goes on to discuss how Citizens petition is frequently used to game the FDA and how the FDA denied the CP. Jaclyn did extensive research and it is a great investigative article that loops in many of the events covered on this wiki page. Mnachtrab (talk) 09:13, 19 August 2022 (UTC)
- Please see my post just above this one at #Intro needs help, and answer the specific questions I asked about this source. "Jaclyn did extensive research and it is a great investigative article" is an opinion that doesn't address the reliability of a source in ways that Wikipedia requires. "The author is an investigative reporter" gives us ZERO facts to go on, nor does repeating the About info from Compliance Week's website. Anyone can put up a website. I have searched the archives at WP:RSN, and have found nothing there; we are likely to end up there, waiting at least a week for answers as to whether we can use this source, if someone doesn't answer those questions here. Who is their staff, what are their journalistic credentials, what is their reputation for fact-checking, how do they handle retractions, what other reputable sources rely on them ... things like that are needed to establish reliability. I need to once again remind that Wikipedia is not a webhost, and filling this talk page with information that is completely irrelevant to Wikipedia's policies and guidelines is only making it longer and harder to get the content matters settled. There is ZERO in this post I can use. We already know the events surrounding the FDA petition, as we have that from multiple reliable sources, including the Charles Piller podcast, The New Yorker, The Wall Street Journal, The New York Times, etc. We know there was short-selling; it's not a crime. Wikipedia's readers are not served by using a paywalled source (that they can't read) to state what is already available from high-quality reliable sources they can find online or in their local library. SandyGeorgia (Talk) 15:08, 19 August 2022 (UTC)
- And finally, it appears (??) that posters here are wanting to use Compliance Week to infer that the short-sellers of Cassava stock were gaming the FDA. See WP:SYNTH and more importantly, WP:BLP; Wikipedia is not going to be adding any such content until/unless a high quality reliable source does precisely and explicitly that. Not having read the Compliance Weekly source, I nonetheless doubt they have done that either; I would think they wouldn't be eager to open themselves to a lawsuit by making such a claim, so I doubt that article gives us anything we don't already have. SandyGeorgia (Talk) 15:26, 19 August 2022 (UTC)
Clinical data updates with press references
Pharmaceutical companies release a lot of data through press release, company filings or presentations. If you look at Biogen they reference these in their updates. https://en.wikipedia.org/wiki/Biogen
That said, with a reasonably quick search of their history, there are articles that cover each of their data updates on their trials. Phase 2b https://www.neurologylive.com/view/sumifilam-improves-multiple-alzheimer-disease-biomarkers-in-phase-2b-study
“The results point to the potential for Sumifilam to become a transformative treatment for patients with Alzheimer disease.”
Jeffrey Cummings, MD, ScD, founding director, Cleveland Clinic Lou Ruvo Center for Brain Health, and Chambers Professor of Brain Science, University of Nevada–Las Vegas, said in a statement.1 “I am pleased to see early evidence of disease-modifying effects in patients with this investigational drug. The data appear to represent a step forward toward urgently needed treatments for Alzheimer disease.”
Open label 6 month update https://www.neurologylive.com/view/simufilam-improves-cognition-behavior-alzheimer-disease
“The Cassava Sciences agent showed 6-month improvements in both ADAS-Cog and NPI scores, and a phase 3 trial is expected to begin in late 2021.”
“The study, funded by the National Institutes of Health (NIH), showed that after 6 months of treatment with the altered filamin A (FLNA) restoration agent that cognition scores measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) improved by 1.6 points from baseline scores of 15.5, equivalent to a 10% mean improvement. Additionally, dementia-related behavior—including anxiety, delusions, and agitation—improved by 1.3 points from baseline scores of 4.5 on the Neuropsychiatric Inventory (NPI). This improvement equaled a 29% mean improvement at 6 months.”
“The timing of the purchase comes shortly after the company provided an update for simufilam, Cassava's lead drug candidate to treat Alzheimer's disease, a brain disorder that destroys memory and other important mental functions. The Austin, Texas-based company said on Aug. 3 that an interim analysis on 100 patients who completed at least 12 months with simufilam showed that overall ADAS-Cog12, a cognitive scale, scores improved by an average of 1.5 points and that the drug appears safe and well tolerated.”
Mnachtrab (talk) 10:23, 19 August 2022 (UTC)
- First a general response; see WP:OTHERSTUFFEXISTS. What any other (C-class) article has is irrelevant to this article. (Perhaps if you referenced a Featured article, we'd have a starting place for discussion.)
- There is a proper way to use primary sources and press releases on Wikipedia; in this suite of articles we have not seen that. Please see WP:PSTS.
- "The Austin, Texas-based company said" see the discussion above at #Clinical Trial Data.
- This article is about the company; to whatever extent any trial data is relevant, that is more likely to be at the simufilam article.
- First a general response; see WP:OTHERSTUFFEXISTS. What any other (C-class) article has is irrelevant to this article. (Perhaps if you referenced a Featured article, we'd have a starting place for discussion.)
- I will look at the neurologylive sources to see if there is anything useful to this article, but the more I have to process through repetitive off-topic posts on this talk page, the less time I am going to have to actually work on improving the article. SandyGeorgia (Talk) 14:49, 19 August 2022 (UTC)
- I have now looked at the neurologylive sources and do not find anything useful for this (the company) page; there is a page for simufilam where detail about past trials and their numbers and dates if appropriate can be explored. At any rate, if biomedical claims are made anywhere on Wikipedia, they should be based on WP:MEDRS sources. There is nothing actionable in this section. SandyGeorgia (Talk) 19:21, 19 August 2022 (UTC)
- Next, if the editors appearing at this page would like to see the proper use of sources in a similar topic (related to Cassava through the Charles Piller report in Science, as the Cassava investigation led to the University of Minnesota investigation as a side-product), please review Sylvain Lesné, which is a policy-compliant article. You will see there, if you take the time, that there is limited use of primary sources; that is, only when they are backed by secondary references or when they are used for uncontroversial or non-self-serving information about the topic of the article. Please understand what Wikipedia is and is not; it is not a webhost, not promotional, and not for publishing original thought. SandyGeorgia (Talk) 15:28, 19 August 2022 (UTC)
SavaDx
... is mentioned in the lead but nowhere in the article, and there appear to be no high quality sources that have paid any attention to it. Does anyone have an independent third-party reliable source that discusses it? If not, it doesn't belong in the lead (which by the way does not even bother to tell us its a blood test). SandyGeorgia (Talk) 17:04, 19 August 2022 (UTC)
No products approved by the FDA
... is mentioned in the lead, but is uncited. I know I've seen that in a reliable source; if anyone knows where to find that, it will save me the time of looking back through them. Else it will have to wait for me to find it again as I re-read all sources. SandyGeorgia (Talk) 17:05, 19 August 2022 (UTC)
Table of primary sources
@ZICgene and Alexbrn: are either of you able to help fill in Talk:Cassava Sciences/Primary sources ? It should give us a way to sort through the mess at all three articles (here as well as simufilam as well as Lindsay Burns, which is also chock full of primary sources). If so, for the love of all things good and holy and sanity-producing, PLEASE use:
- {{PMID}} to reference articles, erratum, and expression of concern when available
- ISO dates (yyyy-mm-dd) for table sortability
- vancouver-style author format on author names, which you can get by plugging in the PMID to this citation template filler.
If I had gotten on this article before it was clobbered by POV/COI editing, we would have gotten all of this right from the beginning; sorting it out now is one big headache. I'd appreciate any help you can lend as I sort through the secondary sources again. A sample is given: if you use the last row of the table, please be sure to add a new blank row so others can see which column is which via the inline comments. SandyGeorgia (Talk) 18:43, 19 August 2022 (UTC)