Talk:IPLEDGE program

message: I have submitted basic information about iPLEDGE. Philiphughesmd 18:25, 6 March 2006 (UTC)
thread_title:  Early discussions 

message: At the moment, the article seems to be little more than a list of problems (however significant) with the program, moreso than a source of information on the program/website, and background history explaining its purpose and methods. --NEMT 20:50, 30 November 2006 (UTC)
thread_title:  Article needs work 

message: I've added a new section that explains the project's previous incarnation and background, thus providing some continuity as to why it takes the current (restrictive) form it does. I added four new refs and some inlines where appropriate, but I'm still hacking on them. I'm having major issues with the whole Criticism section, because it's quite POV and completely unreferenced except for a non-critical source at the bottom. I'll see if I can't chase up some of these sources, but I'd like to go pruning on some of the most POV stuff. Bullzeye contribs 11:02, 7 February 2009 (UTC)
thread_title:  Revamp 

message: Is it technically possible for a male to get pregnant? Are they referring to 'trans'-men? 93.161.104.154 (talk) 14:24, 25 October 2009 (UTC)
replies: text: First, let me make the observation that sarcasm such as that above is notably noncontributory toward our supposed goal of improving articles.  That said -- when iPledge was first introduced, many of us (dermatologists) asked why it was necessary to enroll male patients at all, given that the stated goal of the registry was to prevent pregnancy.  The answer we received was that they didn't want men stockpiling isotretinoin and giving it to their girlfriends.  We then asked how enrolling men in the registry was going to prevent that -- and received no answer. DoctorJoeE talk to me! 18:55, 5 December 2011 (UTC)
thread_title:  "Males pledging not to get pregnant" 

message: How soon after one stops taking it is it safe to become pregnant again? This was not mentioned in the article.  — Preceding unsigned comment added by Luvdalz68 (talk • contribs) 07:43, 26 February 2015 (UTC)
replies: text: That is probably because there is no definitive consensus on the answer. The FDA has so far studiously avoided making an "official" recommendation.  Isotretinoin is water soluble, and so leaves the body quickly, at least in theory. (It is undetectable in the bloodstream 48 hours after the last dose is taken.)  Furthermore, it affects embryogenesis, and not chromosomes, so once it's gone it's no longer a threat -- again, at least in theory.  While some have speculated about retention in the liver and elsewhere, there is no credible evidence to support it that I'm aware of.  Recommendations for how long to wait after completing isotretinoin treatment before attempting pregnancy vary all over the map -- from one menstrual period to a year or more.  I personally believe that one menstrual period is sufficient, but I recommend three, out of an abundance of caution (or perhaps cowardice).  So if anything were to be added to the article in this regard, I would suggest something similar to the above, i.e. one month to one year, depending on who you talk to -- and I'm sure there are citations to support that. DoctorJoeE review transgressions/talk to me! 21:48, 26 February 2015 (UTC)
thread_title:  How long does Isotretinoin stay in the body? 

message: These sounds like something the FDA has written:
Due to the nature of restricted distribution programs in general, and ETASU REMS programs specifically, stakeholder burden has always been balanced against control and compliance.
The duality of prescribers' feelings about isotretinoin can be seen in the two paragraphs below, and also explain why the burden associated with the Program is warranted, given the risks to patient/fetal safety.  — Preceding unsigned comment added by Rosskey711 (talk • contribs) 21:41, 17 October 2015 (UTC)
thread_title:  FDA meddling with this article?  

message: It seems a bit unclear who (i.e. what organization) is receiving and storing the information that is being provided to the site, and it seems odd to have a mandatory program that requires information to be provided, without what seems to be the usual HIPAA and federal privacy assurances and without a clear identification of who the information is being provided to. The article says that one of the criticisms of the iPLEDGE website is that "the website provides no information about who administers the site". I have confirmed that I am having some difficulty finding a clear identification of who operates the site on the website itself.
Looking at the "Terms of Use" (ToU) of the website, it seems to be phrased as an agreement between "you" and "the sponsors of the Site". I don't know whether it is really possible to have a binding contract with an unidentified party. Somewhere else in the ToU, it refers to "the companies that sponsor iPLEDGE (i.e., the manufacturers)", so perhaps "the sponsors of the Site" and presumably the administration of the site are in the hands of some group of (not clearly identified) drug manufacturers.
However, the ToU says "iPLEDGE uses your identifiable personal information to ...", so it is referring to iPLEDGE as a distinct entity. It also says that "Before information is reported to the companies that sponsor iPLEDGE (i.e., the manufacturers) or the FDA, your personal identifying information is removed." That seems to imply that "iPLEDGE" is an entity that appears to be distinct from "the companies that sponsor iPLEDGE (i.e., the manufacturers)" and is also distinct from "the FDA".
If the program is operated by the federal government, I believe there are some regulations about the need for the government to provide a privacy notice when requesting personal information. I also don't find any mention of HIPAA anywhere.
I also find a "Non-Compliance Action Policy", which is an 18-page PDF document. But the document does not seem to clearly identify who issued the document. It has no letterhead or signature. In a few places in that document, there is a mention of the "Isotretinoin Products Manufacturing Group (IPMG)". Perhaps that is the name of the entity.
—BarrelProof (talk) 19:45, 6 March 2018 (UTC)
thread_title:  Who operates the site, and HIPAA and governmental privacy considerations