Revision as of 00:25, 2 October 2023 editMariedegournay (talk | contribs)326 edits →Sourcing regarding post-drug disorder: new sectionTag: New topic← Previous edit | Revision as of 00:26, 2 October 2023 edit undoMariedegournay (talk | contribs)326 edits →Sourcing regarding post-drug disorderNext edit → | ||
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Misplaced Pages is an encyclopedia, not a medical review organization, so I understand it cannot adjudicate on something like this. Nevertheless, editors should understand that this is an iatrogenic disorder (caused by medical treatment). There is a commercial bias built into the medical literature because so much of the evidence base came from Merck-sponsored studies. Meanwhile, as Leliefeld et al pointed out (see previous topic), there is a lack of research on post-drug harms. There is no money for such studies. Drug-related harms are threatening to medicine, so physicians may tend to deny and avoid these conditions. Again, Misplaced Pages can't adjudicate, but it seems a good encyclopedia should account for these circumstances, even when a source meets its criteria. An analogy here would be ], denied for decades as malingering or depression, or ]. Just because there are medical authorities or sources which cast doubt on a disease, that does not mean the disease is invalid. | Misplaced Pages is an encyclopedia, not a medical review organization, so I understand it cannot adjudicate on something like this. Nevertheless, editors should understand that this is an iatrogenic disorder (caused by medical treatment). There is a commercial bias built into the medical literature because so much of the evidence base came from Merck-sponsored studies. Meanwhile, as Leliefeld et al pointed out (see previous topic), there is a lack of research on post-drug harms. There is no money for such studies. Drug-related harms are threatening to medicine, so physicians may tend to deny and avoid these conditions. Again, Misplaced Pages can't adjudicate, but it seems a good encyclopedia should account for these circumstances, even when a source meets its criteria. An analogy here would be ], denied for decades as malingering or depression, or ]. Just because there are medical authorities or sources which cast doubt on a disease, that does not mean the disease is invalid. | ||
Experienced wikipedians can be paranoid about ulterior motives of other editors |
Experienced wikipedians can be paranoid about ulterior motives of other editors, but they should also understand that conflicts of interest are rampant in medical “research” on pharmaceuticals. ] (]) 00:25, 2 October 2023 (UTC) |
Revision as of 00:26, 2 October 2023
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Post finasteride syndrome
I strongly feel like this section is outdated and uses low quality evidence.
Since this year there are diagnostic criteria for PFS published in "International Journal of Risk & Safety in Medicine" https://content.iospress.com/articles/international-journal-of-risk-and-safety-in-medicine/jrs210023. This should be mentioned along with an outline of those criteria.
Other than that there are at least two papers that discuss a possible epigenetic pathomenachism:
"Altered methylation pattern of the SRD5A2 gene in the cerebrospinal fluid of post-finasteride patients: a pilot study" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6652249/ Conclusion: "For the first time, we demonstrate a tissue-specific methylation pattern of SRD5A2 promoter in PFS patients. Although we cannot conclude whether this pattern is prenatally established or induced by finasteride treatment, it could represent an important mechanism of neuroactive steroid levels and behavioural disturbances previously described in PFS."
Epigenetic Effects of Finasteride on Human Leydig Cells https://faseb.onlinelibrary.wiley.com/doi/abs/10.1096/fasebj.2020.34.s1.03823
This should at least be mentioned.
Other than that there is one part in the current article that needs to be removed: "It has common features with other self-diagnosed "mystery syndromes" such as morgellons syndrome or multiple chemical sensitivity."
1. It is quoted incorrectly. In the cited source you cannot find this quote word by word. This is where it was taken from, but it is edited:
"In our opinion, PFS demonstrates some analogies to such controversial “mystery syndromes” as amalgam illness, multiple chemical sensitivity, Morgellons disease, and Koro for the following reasons: patients complain of symptoms that cannot be adequately explained biologically, and the frequency of consultations for the conditions parallels the respective media coverage, which points to a high degree of suggestibility."
2. As it is made clear in the source this is a personal opinion of the authors.
3. There is no evidence in the source to back up this opinion.
4. The only reason given for that opinion is the reason that there is no known biological explanation. Jumping from the lack of knowledge to a conclusion is a mockery of evidenced based medicine. Moreover there are attempts to explain the syndrome (see epigenetic changes I mentioned before).
5. The source is low quality "evidence" at best. It is a single case report (https://en.wikipedia.org/Wikipedia:Identifying_reliable_sources_(medicine)) about a patient of the authors, which they use as the basis for really bold claims that are entirely unsupported.
Franzpuntila (talk) 17:45, 28 November 2021 (UTC)
"Finasteride" is repeated many times in the Pharmacokinetics section.
Try reading this out loud, it doesn't really flow. Not sure how to improve it while staying clear though..
- At steady-state with 1 mg/day finasteride, mean peak concentrations of finasteride were 9.2 ng/mL (25 nmol/L). Conversely, following a single 5 mg dose of finasteride, mean peak levels of finasteride were 37 ng/mL (99 nmol/L),
Ckiedits (talk) 15:55, 20 March 2022 (UTC)
Extended-confirmed-protected edit request on 21 March 2022
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In the Adverse Effects section the comment on contraindication in pregnancy should be improved. The current text is:
Finasteride is contraindicated in pregnancy. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride.
I suggest, based on Refs 36 and 37, that the above be altered to:
Finasteride is contraindicated for women who are pregnant or become pregnant while exposed to it, as it may cause abnormalities in a male fetus. Exposure through skin contact to broken or crushed tablets is identified by as a risk vector. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride.
The motivation for this edit is to clarify the information on a serious risk and when it applies. Silverfoil92 (talk) 04:50, 21 March 2022 (UTC)
- Removing a floating 'by' from the suggested text.
- Finasteride is contraindicated for women who are pregnant or become pregnant while exposed to it, as it may cause abnormalities in a male fetus. Exposure through skin contact to broken or crushed tablets is identified as a risk vector. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride. Silverfoil92 (talk) 04:52, 21 March 2022 (UTC)
- Not done for now: please establish a consensus for this alteration before using the
{{edit extended-protected}}
template. Dr.Pinsky (talk) 18:24, 26 March 2022 (UTC)
- Not done for now: please establish a consensus for this alteration before using the
Adverse Effects section - exposure and pregnancy
I wish to propose an addition to the Adverse Effects section. For the comment on contraindication in pregnancy I think it could be improved. The current text is:
Finasteride is contraindicated in pregnancy. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride.
I suggest, based on Refs 36 and 37 (manufacturers' prescribing information as deposited with the FDA), that the above be altered to:
Finasteride is contraindicated for women who are pregnant or become pregnant while exposed to it, as it may cause abnormalities in a male fetus. Exposure through skin contact to broken or crushed tablets is identified as a risk vector. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride.
The motivation for this proposed edit is to (i) specify the reason as to why finasteride is contraindicated (abnormalities in the male fetus may be caused) and (ii) to add a comment that skin contact is a risk vector. I think that the latter is important to include as this is important information for someone who may have come into contact with finasteride unwantedly due to the serious consequences.
Silverfoil92 (talk) 13:56, 31 March 2022 (UTC)
Separate article for post-finasteride syndrome
Hi all,
I recently drafted an article for post-finasteride syndrome, which I hope addresses some of the concerns raised about the original version of the article (search Draft:post-finasteride syndrome to view the article). After submitting for review, I was notified that I should start a discussion here to seek consensus as to whether the topic merits its own article, as opposed to a sub-section of the finasteride article. I personally believe PFS should be covered in its own article, in order to address the reporting, research, and controversy surrounding the topic in sufficient depth.
Does anyone have any thoughts on this action, or suggestions for improving the draft as it currently stands?
Best,
Xardwen (talk) 20:04, 28 June 2023 (UTC)
- There is currently a locked redirect at Post-finasteride syndrome, following disruptive editing, largely by IPs, in April 2021. Because the title is protected, a reviewer can't accept Draft:Post-finasteride syndrome. If a reviewer wants to accept Draft:Post-finasteride syndrome, they will first have to find an administrator to unlock the title, and I wouldn't expect an administrator to unlock the title without seeing a consensus in favor of creating an article. Robert McClenon (talk) 05:42, 29 June 2023 (UTC)
- Sounds good, thanks for the note- in the event that no other editors feel compelled to comment and establish a consensus, is there another place where I should go to raise this issue?
- Best,Xardwen (talk) 05:53, 3 July 2023 (UTC)
Recent developments & sources
Editors may want to consider the following for the article.
Regulatory news
1. Boxed warnings were added to finasteride (1 mg) packaging per ANSM
France's national regulator ANSM required all manufacturers add a red boxed warning to all finasteride 1 mg boxes on sexual and psychiatric adverse effects. Organon, the current marketing authorization holder, removed the drug from the market in France.
Source: Finastéride 1 mg (Propecia et génériques) : ajout de mentions d’alerte sur les boîtes pour renforcer l’information sur les effets indésirables. ANSM (France). November 30, 2022.
2. FDA required new disclosure of risk of suicidal ideation and behavior to finasteride (1 mg) label
Source: Levine, Dan. FDA requires disclosure of suicide risk for anti-baldness drug. Reuters. June 10, 2022.
3. Health Canada alerting doctors to risk of suicidal ideation and self-injury
Health Canada Safety Review, Jan 19 2023
From key points: “Health Canada's review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury..." The agency will update product information and inform healthcare professionals through a regulatory communication.
4. UK Medicines and Healthcare products Regulatory Agency (MHRA) launches a safety review of finasteride
Source: Ennals, Ethan. “Watchdog launches investigation into hair loss pill...” Daily Mail. March 4, 2023.
Medical literature
New review: Leliefeld HHJ, Debruyne FMJ & Reisman Y. The post-finasteride syndrome: possible etiological mechanisms and symptoms. Int J Impot Res. 2023. doi:10.1038/s41443-023-00759-5
A statement of limitations is relevant: "LIMITATIONS. Scientific literature on the PFS has the intrinsic limitation, by definition, that symptoms can persist or even appear after cessation of the 5ARIs and therefore have been unnoticed and not documented in the literature. The earlier mentioned lack of quality studies has hampered our knowledge of the presence, frequency and duration of the side effects...” Mariedegournay (talk) 23:44, 1 October 2023 (UTC)
Sourcing regarding post-drug disorder
I have seen bad-faith behavior by experienced wikipedia editors regarding editing of the post-finasteride syndrome section. Specifically, one of the editors inserted a low-quality source, and they seemed to be making arbitrary decisions about the quality of other sources depending on whether those sources supported their view. While I was not directly involved in a conflict, I stopped editing when I realized that the editing process was vulnerable to such abuse.
The source the editor featured is: Trüeb, et al (August 2019). "Post-Finasteride Syndrome: An Induced Delusional Disorder with the Potential of a Mass Psychogenic Illness?". Skin Appendage Disorders. doi.org/10.1159/000497362
It is a case report which does not contribute any systematic evidence. It makes a psychological claim, but the authors are dermatologists without apparent training in psychiatry. There was no formal psychiatric evaluation of the patient. The case summary is very subjective and judgmental (describing the patient as “humorless and oversensitive” — doesn't seem professional for the doctors to put this in an article). From this one case, which lacked a serious clinical investigation, the authors created an elaborate and bizarre theory. The wikipedia editor highlighted this article, but overlooked dozens of other articles on the syndrome with a wide range of views. This is the most extreme of the lot, and I do not see how it would meet sourcing standards, given how stringent editors often are about medical sourcing. (I wonder why this was an exception.)
Editors should understand that most of the clinical trial evidence base was sponsored by Merck. The remainder was mostly by dermatologists who do not pay close attention to drug harms—and do not usually have expertise psychiatry or sexual medicine. Some literature that casts doubt on the syndrome from 2014–2020 was authored by physician-scientists who were contracted with Merck to promote Propecia or co-published articles with its researchers. For example, Dr. Antonella Tosti, Dr. Jerry Shapiro, Dr. Kevin McVary and Dr. Steven Kaplan. (By the way, Tosti is co-Editor-in-Chief at Skin Appendage Disorders where the above article by Dr. Trüeb appeared.)
Misplaced Pages is an encyclopedia, not a medical review organization, so I understand it cannot adjudicate on something like this. Nevertheless, editors should understand that this is an iatrogenic disorder (caused by medical treatment). There is a commercial bias built into the medical literature because so much of the evidence base came from Merck-sponsored studies. Meanwhile, as Leliefeld et al pointed out (see previous topic), there is a lack of research on post-drug harms. There is no money for such studies. Drug-related harms are threatening to medicine, so physicians may tend to deny and avoid these conditions. Again, Misplaced Pages can't adjudicate, but it seems a good encyclopedia should account for these circumstances, even when a source meets its criteria. An analogy here would be myalgic encephalomyelitis, denied for decades as malingering or depression, or Long COVID. Just because there are medical authorities or sources which cast doubt on a disease, that does not mean the disease is invalid.
Experienced wikipedians can be paranoid about ulterior motives of other editors, but they should also understand that conflicts of interest are rampant in medical “research” on pharmaceuticals. Mariedegournay (talk) 00:25, 2 October 2023 (UTC)
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