Clinical Study of PFS Launched at Baylor College of Medicine

[axolotl]

@slick1

So anyone can enlighten us ? How are you going to find out the study is out there published ?

awor co-designed this study for a reason, so you can expect it will be posted promptly in the PFS research category of the forum. We will also make a blog post and topic regarding the implications shortly after.

[Greek]

For anyone reading this anxiously waiting for the study to publish, please consider taking some time to fill out our survey and also order a 23&Me kit.

As one study publishes it’s findings, this is your chance to help with the next one.

[orthogs]

Without being excessively cynical nor pessimistic, I have a strange feeling that the motivation for the floating of the 23&Me in-house study (and the survey) only months before the impending release of the 5+ year Baylor Study is because there is knowledge that the study has not yielded any conclusive answers. One feels that waiting for results and then choosing a path based on the findings would make more sense from the perspective of optimising resource allocation.

The motivation to get another study rolling would be imperative to allow those who have been holding out for years for the Baylor Study to have ongoing hope when inconclusive results are released (which, if true, would be both pragmatic and thoughtful).

I’m also puzzled why the Milano Study’s has been purposed with examining possible epigenetic changes when that was supposedly within the purview of the Baylor Study (and which has been worked on for over 5 years).

Perhaps I’m just reading too far into things?

[holyhead]

I believe some here already have some knowledge of the results and what was discovered already from Baylor back as far as a year ago…

[Lostinaustin]

I’ve had the same suspicions but I’m not trying to be overly pessimistic or a conspiracy theorist. Especially since the forum admin was involved in the study’s design. Regardless, I wouldn’t put all my hopes in the Baylor study anyway, the chances of it having all the answers we seek is extremely low anyways with how science works.

[holyhead]

I dont put any hope in the thing…

[Dubya_B]

@orthogs

I’m also puzzled why the Milano Study’s has been purposed with examining possible epigenetic changes when that was supposedly within the purview of the Baylor Study (and which has been worked on for over 5 years).

Perhaps I’m just reading too far into things?

The Milano epigenetic study is supposedly looking into methylation of the 5-ar gene in rodents that were fed finasteride. The Baylor study is supposedly looking into the involvement of the AR in PFS patients. I think that is where the difference lies.

And as someone who has been helping a bit with this site behind the scenes, nothing has been said or done that indicates the results of the Baylor study will be inconclusive or fruitless. The timing of the 23andMe project and survey was purely due to the site overhaul being completed. Just coincidental.

[Scott.H]

Well let’s at least wait for the thing to actually come out. I’m heavily prone to conspiracies as well, but the fact is, we don’t know anything until we have it in our hands.

Also, I always think this is one thing to keep in mind. Should a peer-reviewed study come out that demonstrates definitive findings that an FDA approved drug has caused permanent, life-destroying side-effects in a large amount of people, it would be a fairly massive blow to both Merck and the FDA’s reputation. Obviously Merck would do anything in it’s power to halter that… but assuming they haven’t influenced the study, or restricted the results in any way, the University would need to prepare to defend themselves from the onslaught of the drug industry. It would make sense that those operating the study would take a considerable amount of time to ensure their findings are reproducible and bullet-proof. I almost see the study’s large time-frame as a positive, rather than a negative, at least with regards to what any findings might be.

There have been posts on here (I can’t recall who said it - someone help me here) wherein they’d been told the study had found a “major discovery.” It would be interesting to see who said that and when; I have absolutely zero idea how anyone could know that with how infamously secretive this study has been on here.

Of course, I don’t want to give any kind of false hope - but I do have some hope that a 5 year study should at least give us SOMEthing.

Again, any University that concludes a study whose findings directly disprove what a drug company has been communicating to its users, then that University would find itself in an interesting position. I’m not sure how declarations between educational systems vs. private corporations works, but it would potentially have massive legal implications.

[Mcbbould]

If folks know more and not willing share, that’s disgusting. I don’t care if it’s in the name of the community, or whatever/ Nobody here is allowed to play god, and being transparent and truthful is ALWAYS the right thing to do. There is enough politics in the world.

[Lostinaustin]

Don’t worry man it’s just people talking out of their ass. I don’t think any forum members not involved with the study directly have any actual info on the results.

[axolotl]

Hey guys, I think I should address a few things. Firstly, I understand the frustration at things being slow moving. However, it would be beneficial to think about the use of making some of these posts before the publication of a study it is clear not many know anything regarding the objectives of.

@orthogs

I have a strange feeling that the motivation for the floating of the 23&Me in-house study (and the survey) only months before the impending release of the 5+ year Baylor Study is because there is knowledge that the study has not yielded any conclusive answers. One feels that waiting for results and then choosing a path based on the findings would make more sense from the perspective of optimising resource allocation.

I can assure you this is not correct. Regardless of it being prudent to not place all eggs in one basket, they are not achieving the same things. Publications as recent as 2019 use validated scales to deny the condition exists and make insulting hypotheses about patients. Realities and peculiarities of the condition are not represented in literature at all (as a professor publishing on PFS said to me in person), and scientists with pet theories that are not mechanistically possible ignore part of the symptom profile. Anecdotes, particularly in such a volume of alternative health theories, are not useful to scientists - the Walf et al publication from last year is a perfect example of the need for this. They abstracted symptoms from 244 cases from this site to create a data set. However, this has an added layer of abstraction from the self reports and is not adhering to uniform scales, so it’s far less useful. We need clear data directly reported in validated measures scientists understand to go forward for a whole number of reasons, and the analytics system will allow both complex exploration and very clear representation of the data. We need to firmly establish what is happening as much as why.

Regarding resource allocation, the survey costs nothing but a bit of time. As we are doing the work, the 23 and me project only is the cost of the kit per participant. Last time I checked we were around 50, with about half of the participants having 23andme results prior to us undertaking this. So that’s about 1500 between participants if everyone submitting newly paid. This is not even approaching a drop in the ocean for the study in question or the required funds for anything useful thereafter. More than one scientist has told us a solid result from it would be difficult to disregard, and although it’s only a chance, it’s up to patients to individually decide if it’s worth contributing.

@orthogs

I’m also puzzled why the Milano Study’s has been purposed with examining possible epigenetic changes when that was supposedly within the purview of the Baylor Study (and which has been worked on for over 5 years).

Because it’s not that simple. “Epigenetic” means the site and cell specific expression of genes. It’s a vast and complex field. Milano’s research is incomparably more limited in scope, and as @Dubya_B says, focused narrowly on the 5ar isozymes.

@Mcbbould

If folks know more and not willing share, that’s disgusting. I don’t care if it’s in the name of the community, or whatever/ Nobody here is allowed to play god, and being transparent and truthful is ALWAYS the right thing to do. There is enough politics in the world.

I don’t think you’ve thought this through. Sharing information regarding unpublished scientific research can jeopardise publication. And, in isolation, what good will that information actually do you right now? Would you be able to interpret it? It would be my expectation that when this publishes certain voices who like to lay it all out as simple and give people a pseudo prescription will be more than happy to give you pages of “this is why”. And regarding said voices, then as now…

From 2010:

@awor

it is distracting my efforts to get a scientist interested in researching the most LIKELY TRUE cause of our problem […] (receptor, gene expression, whatever). The current state of this forum hurts my credibility when I’m talking with these people. Right now, if I point them to this place they’ll think we’re a bunch of nut cases. Everybody seems to have their own pet theory. Everybody is diagnosing everyone and too many people around here seem to think that they are world class endocrinologists.

I do get the impression from the tone of some of these posts that people believe this study even happening was an inevitability. It was not. Instead of indignance and reading into the tea leaves, I think it’s important that everyone should spare a thought at what an uphill struggle it was and endeavour to pull together with efforts in the future.

We all want this to be a positive step for us. Obviously both the economic system and bizarre and rare medical situation we are in mean a lot of the worries are entirely valid. It’s not much use, however, using said frustrations and concerns to keep digging down rabbit holes about how what and why before it’s even published. We simply need to see what comes out in the paper(s). We are aware of more than is public and all I can say is based on that we remain cautiously optimistic the findings will be important.

Finally, the only relevant communication regarding this study was awor’s update. I am pasting it below for those who did not see it.

@awor

As the older members on this site may recall, I have been strongly involved in PFS research. I am one of the original founding members of the PFS Foundation. Together with a few others, I helped initialize the first PFS studies. The most promising study on PFS to date, in which I was deeply involved during the design phase, will hopefully publish in 2018. My work with PFS research has taught me that solving PFS is a long-term project. We won’t solve it in a forum, be it called propeciahelp.com or otherwise. But what we can do, is keep this problem on the map, by making the community as visible as possible. We can consolidate our knowledge and experiences in one place, like we have in the past.
[…]
I understand people have been missing feedback on the studies, published or not. Unfortunately, I cannot comment on ongoing studies. Whatever can be officially communicated will be published on pfsfoundation.org . All I can say at this point, after almost 10 years of PFS research, is that the picture is finally starting materialize. It is my hope that we will have a basic understanding of PFS at the molecular level within the next 12-18 months, representing a huge milestone in PFS research. With this understanding, we can then start thinking about what can be done about it. It will at least take some of the guesswork out of finding therapeutic options. Even though this milestone is coming within reach, we are not quite there yet. This is the main reason why neither the Foundation, nor any of the scientists or myself have been in a position to make any statements related to the root cause. Everyone of course has their own ideas and theories, but those are worth nothing. We can’t act on theories. In order to be effective, we need clear and precise molecular level targets.

Likely, further studies will then be needed, which will “zoom in” on some of the findings, or work on discovering effective therapeutic options. “Solving” remains a long, steep uphill battle, and will require lots of funds. There are no short cuts if we want to be effective. We desperately need to understand the biological root cause of PFS so can achieve victory one day, and are not just poking around in the dark.

I would like to wrap up the science topic with my take on the future of the scientific process and where my hopes currently lie.

I have reason to believe that the persistent side effects arising from:

• 5ARI’s (finasteride, saw palmetto, dutasteride)
• 13-cis-retinoic acid (Accutande, etc.)
• Various Antidepressants
• GnRH Analogs (Lupron, etc.)

are related in terms of a common molecular mechanism. Assuming a better understanding of the underlying mechanisms of PFS in the foreseeable future, it will then be realistically feasible to validate this hypothesis against the aforementioned patient groups. If it turns out to be true, such a common denominator would be the best thing that could happen to us all. We would then be talking about a problem of global interest, and funding of research will hopefully become a problem of the past. As said, division weakens. However, the opposite is equally true: Large groups are relevant, which inherently gives them power.

[Chapman]

Brilliant Axo. I’d never seen that post from Awor from 2010, relatively new here (about 2 years). Can’t wait to see the results of the study.

[lakehouse]

lmao this place never fails to bring out the conspiracies

[slick1]

Study havent been published yet and so much speculations… already

[Sawproblemo]

I believe I read someone say it’s in the peer review process which takes about a month

[pvdl]

I am very thankful to awor for organising this study. Its more than what 99.99% of forum members have done for this community. So lets tread lightly, even if the study turns out to be a failure. Lets not immediately jump to conspiracy theories even if the study is not successful.

[Dubya_B]

One month sounds a little early.

Some info on peer review process: https://scientistseessquirrel.wordpress.com/2015/08/31/how-long-should-peer-review-take/

I have seen 17 weeks on average quoted in a couple places, including this discussion: https://phys.org/news/2017-03-inefficient-scientific-peer-months-average.html

[Cooper]

They were saying its only matter of time to get it all published? (few weeks ago) I can’t find that thread now. Are we going to wait 17 weeks more to read the Baylor study now? Im confused…

[Jaime]

Yes, it looks like the peer review process takes time, unfortunately. You can’t publish a study saying “I discovered this!!” without other people going over your work, and that might take time. I know it sucks, but it helps me to pretend that the study is never going to come out, it was never initiated in the first place, and there is nothing there. I’m just going to keep on meditating, taking my aminos and other little supplements, and move on without Baylor. I feel your pain, Cooper. We all feel it.

[Dubya_B]

No one can say how much longer it will take except possibly the scientists conducting the review. It is out of the authors’ hands at this point now that it has been submitted.

According to the graph, it’s reasonable to expect publication any time between this week and 5 months from now, being that the study was said to have been submitted at least a month ago.