Talk:Fisher Wallace Laboratories

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wish there was a page on the device — Preceding unsigned comment added by 70.126.203.145 (talk • contribs) 16:48, 9 April 2015‎ (UTC)

Withdrawn petition

Since Fisher Wallace withdrew its petition (see document linked here) it apparently no longer stands by it. It is not a reliable source anyway as it is essentially a legal brief and is a WP:SPS. Jytdog (talk) 08:01, 1 June 2016 (UTC)

Sources for FDA stuff

See:

• FDA docket FDA-2011-N-0504
• advisory meeting notice
• stuff related to that advisory meeting
• Federal Register notice where FDA withdrew PMA requirement
• relevant CFR and classification
• Liss 510k

- Jytdog (talk) 08:04, 1 June 2016 (UTC)

AFD

@Jytdog: Are you aware this article has been nominated for deletion. You may want to comment. MB (talk) 05:41, 30 June 2016 (UTC)

Suggestion for Improvement

RCraig09, I noticed that you removed the part I added about the medical device in treating chronic pain. Could you explain why? Thanks! ProductOfMyEnvironment (talk) 22:04, 4 August 2016 (UTC)

• First, the reference you cited, Fisher-Wallace's own petition for reclassification, would not be considered an independent source and is thus not a reliable source in this context (see Wikipedia:Identifying reliable sources and Wikipedia:Independent sources).
• Second, the source you cited does not even mention chronic pain—and thus the source doesn't even support all of the subject matter you added.

The text you added is an essentially verbatim quote from the company's website FAQ (here), which is also not an independent source in this context. Further, people with a Wikipedia:Conflict of interest should not edit articles with which there is a COI, though such individuals may submit an "Edit request" on a talk page, very preferably citing specific reliable sources, so that the community can consider the proposed content. —RCraig09 (talk) 22:31, 4 August 2016 (UTC)

RCraig09 I see. Thanks for explaining! I looked at the original version of the article, and used the same language that was included there. I didn't understand why it was taken down. I didn't look at the sources correctly, which I'm guessing is why. It appears to be factually correct, although I acknowledge that the way it was cited was incorrect. I looked through the page you sent, about having a conflict of interest, and will say that I don't have one.

So, to confirm, would this be the appropriate source to use to highlight that their electronic has approval to treat chronic pain? http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K896226 ProductOfMyEnvironment (talk) 17:14, 5 August 2016 (UTC)

ProductOfMyEnvironment I think this FDA reference could be used as a WP:primary source for a narrow statement such as: "In 1990 Liss Body Stimulator Model SBL501-M received [[Federal Food, Drug, and Cosmetic Act#Premarket_notification_(510(k),_PMN)|510K]] Premarket Notification as a transcutaneous nerve stimulator for pain relief." You should be especially careful and specific here, because of the quarter-century time delay between that Notification and any device that is now marketed. On further reflection, I think it would probably behoove you in the long run to find recent reliable WP:secondary source(s) that explain the regulatory history/status more comprehensively. You can search for such sources by Googling the product and clicking on "News" (near the top) to get a list of Google News sources; of course mainstream news sources are likely (though not guaranteed) to be more WP:reliable than just any Google hit. This Wikipedia article has a recent history of a battle between overly positive and overly critical editors, so proper sourcing and careful descriptions are especially important. —RCraig09 (talk) 20:12, 5 August 2016 (UTC)

RCraig09 I see, thank you for giving me a thorough response! I'm going to do some reading and get back to you on this. ProductOfMyEnvironment (talk) 21:59, 5 August 2016 (UTC)

Stardate 2016-08-18, supplemental. ProductOfMyEnvironment, WP:UGC relates to personal and group blogs, distinguished from articles in otherwise reliable sources that happen to have the word "blog" in their URL (such as the Scientific American reference you just deleted here). See the "Exceptions" sub-section of WP:UGC, and also WP:BLOGS. —RCraig09 (talk) 15:46, 18 August 2016 (UTC)

Thanks for explaining this. I appreciate your thoughtful interactions. ProductOfMyEnvironment (talk) 16:17, 19 August 2016 (UTC)

Off Topic

Hi jytdog, can you explain why you removed the content I added in about healthcare practitioners being able to authorize these types of medical devices? Thanks! ProductOfMyEnvironment (talk) 20:30, 19 August 2016 (UTC)

Per WP:OFFTOPIC, the content was not about Fisher Wallace, and it wasn't even about their product, but rather details about regulation of the device. This article is about Fisher Wallace. Jytdog (talk) 20:33, 19 August 2016 (UTC)

jytdog I see. Thank you for clarifying on that. Much appreciated. ProductOfMyEnvironment (talk) 22:52, 19 August 2016 (UTC)

Hi jytdog, the section "A 2014 Cochrane review found insufficient evidence to determine whether or not CES devices with alternating current are safe and effective for treating depression" is off topic, in my opinion. It is an opinion on a category of medical devices, not an objective fact about the company or its medical device, in particular.ProductOfMyEnvironment (talk) 19:44, 2 September 2016 (UTC)

I only have a minute but wanted to reply. Fisher Wallace argued strenously before the FDA (and the public) that its device was substantially similar to the others and should be regulated under 510k. So.. it is. And the Cochrane review reads on the class of devices including the Liss. And if I recall you were the one advocating for this article saying what the device is used for, and if we do that, we need to also provide the best evidence about it. There you go. Jytdog (talk) 20:19, 2 September 2016 (UTC)

Hi jytdog, I appreciate the feedback! I'm a bit unclear about your assertion. The Fisher Wallace device was declared substantially equivalent to the Neurotone 101, which was not included in the review. Furthermore, there have been Fisher Wallace specific studies that were published after this review was conducted, making this assertion even more out of place. The page speaks about what the device is regulated and approved for because that is relevant to how a company operates. The content from the Cochrane review is an assertion of an opinion. If individuals wish to learn about CES devices, they can easily do so on the CES page, which is already linked to this page. This is what is essentially described on the WP: OFFTOPIC page. ProductOfMyEnvironment (talk) 20:31, 2 September 2016 (UTC)

Yeah we go by reviews, and independent ones, not by primary sources (the studies you mention). The most recent reviews, as they come out. This is explained in WP:MEDRS. Will reply more later. I do understand that the company is unhappy about the evidence base, but it is what it is. We cannot kowtow - we follow our policies. Jytdog (talk) 20:46, 2 September 2016 (UTC)

Hi jytdog, I appreciate the engagement. I think you are overlooking my point of view. I agree with the validity and authority of the assertion about CES devices. It's appropriate for the CES page, where it appears to be re-stated word for word. This is not a page about CES devices and their safety or effectivness. It's a company page. There is no assertion of safety or effectiveness elsewhere on the page because it's not an article about that. I don't know how the company feels about the article, but I see no issue with the evidence base myself. That's why I'm not arguing the validity of the argument. I am asserting that it is off topic. ProductOfMyEnvironment (talk) 21:15, 2 September 2016 (UTC)

This is a one product company. if we mention what the devices are for then we mention the evidence. there is no way - at all - that we are going to say what they are for and not describe the evidence. Jytdog (talk) 22:16, 2 September 2016 (UTC)

The content sourced to Cavuoto, McCarty and Thibault has direct bearing on the company itself. And for what it's worth, the Cochran review does mention F-W's model SLB500-B in the "Description of the intervention" section and FW-100 under "Characteristics of ongoing studies". This WP article is sparse in its contextualizing and arranging content, but the specific content now being discussed seems to be on-topic and could properly be part of a more comprehensive article that tells the company story. —RCraig09 (talk) 04:00, 3 September 2016 (UTC)