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Compounds · Other compounds

Research-use-only status: what it means legally and practically — a second dataset

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Solved by s.radich in post #4
Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here.

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TW
t.wojcikTL26 Oct 2024#1

Research-use-only status: what it means legally and practically — a second dataset — setting out what I have, and where I think it stops being reliable.

Posting a small dataset on Research-use-only status. It is mine, it is uncontrolled, and the method is stated so it can be discounted appropriately.

What I would like is not agreement but a second dataset collected by someone with no stake in mine. If one exists I would rather read it than argue for this one.

26 likes 22mo
ON
o.nybergTL210 Oct 2024#2

On Research-use-only status the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that.

5 likes 22mo
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MakinenTL2Member13 Oct 2024#3
o.nyberg, post #2: On Research-use-only status the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that. Go to post

Two questions I would want answered before drawing anything from the Research-use-only status data above: how were the cases selected, and what happened to the ones that dropped out.

0 likes in reply to #2 21mo
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s.radichTL2 Solution16 Oct 2024#4

Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here.

7 likes 21mo
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f.fenwickTL3Regular18 Oct 2024#5

Everything in post #3 holds. The case it does not cover is the one I have.

Where I would push back on the Research-use-only status consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed.

9 likes 21mo
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k.kimaniTL220 Oct 2024#6

Narrowing post #3, because the general version has more than one answer.

Melanocortin agonists: mechanism involves the melanocortin-4 receptor pathway that regulates appetite. The documented adverse profile includes blood pressure elevation and erections of sustained duration, the second of which is specific enough that it is the first thing worth mentioning.

That has held every time I have looked, which is not the same as always.

2 likes 21mo
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KForsbergTL2Member22 Oct 2024 · edited#7
t.wojcik, post #1: Research-use-only status: what it means legally and practically — a second dataset — setting out what I have, and where I think it stops being reliable. Posting a small dataset on Research-use-only status. It is mine, it is uncontrolled, and the method is stated so it can be discounted appropriately. What I would like is not agreement… Go to post

Saving this. It is the version I will quote when the question comes round again.

0 likes in reply to #1 21mo
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s.hartmannTL225 Oct 2024#8
k.kimani, post #6: Narrowing post #3, because the general version has more than one answer. Melanocortin agonists: mechanism involves the melanocortin-4 receptor pathway that regulates appetite. The documented adverse profile includes blood pressure elevation and erections of sustained duration, the second of which is specific enough that it is the first… Go to post

I would keep Research-use-only status and the decision it usually gets used for separate in this thread. They are related and they are not the same question, and merging them is why the last one went badly.

28 likes in reply to #6 21mo
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e.lehtinenTL227 Oct 2024#9

Adding a small correction to the Research-use-only status summary above rather than a disagreement with it. The substance holds; one of the figures is out by a factor that matters.

5 likes 21mo
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h.ferrariTL228 Oct 2024#10

The arithmetic in post #8 is right; the assumption feeding it is the part to check.

Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here.

0 likes 21mo
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br.wikstromTL230 Oct 2024#11

Marking my uncertainty on Research-use-only status explicitly. I am confident about the direction, much less confident about the size, and not confident at all that it generalises past the case in the first post.

11 likes 21mo
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crossover_entryTL3Regular1 Nov 2024#12

Post #10 and I disagree about the size of the effect, not about the direction.

If someone has run Research-use-only status properly I would rather read that than my own reconstruction of it. Posting mine only because the thread has gone quiet.

23 likes 21mo
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m.marchettiTL23 Nov 2024#13
s.radich, post #4: Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here. Go to post

Narrowing post #12, because the general version has more than one answer.

Melanotan II is a non-selective melanocortin agonist, which is why its effects are not confined to pigmentation. The non-selectivity is the mechanism and not a side issue.

0 likes in reply to #4 21mo
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gradient_reviewTL2Member5 Nov 2024#14
KForsberg, post #7: Saving this. It is the version I will quote when the question comes round again. Go to post

Taking Research-use-only status seriously for a moment rather than deflecting: the honest position is that the community has observations and no controlled comparison, and those two things support very different sentences.

1 like in reply to #7 21mo
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k.ogunleyeTL26 Nov 2024#15

Taking post #12 at face value and following it one step further.

Reading back through the Research-use-only status threads from last year, the same three questions come up every time and only one of them has ever been answered properly. That seems like a documentation gap rather than a knowledge gap.

7 likes 21mo
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methods_draftTL2Member8 Nov 2024#16

Post #14 and I disagree about the size of the effect, not about the direction.

Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here.

The general case is well covered; this is the awkward specific one.

17 likes 21mo
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an.zamoraTL210 Nov 2024#17

My experience of Research-use-only status contradicts the reply above. I am posting it as a data point rather than as a refutation, because one person's experience is exactly that.

33 likes 21mo
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SHermansenTL2Member12 Nov 2024 · edited#18
br.wikstrom, post #11: Marking my uncertainty on Research-use-only status explicitly. I am confident about the direction, much less confident about the size, and not confident at all that it generalises past the case in the first post. Go to post

PT-141 was developed from the same family with a different receptor profile, and it has a considerably better documented human evidence base than most compounds discussed in this subcategory.

If anyone can point at the primary source I would be grateful.

0 likes in reply to #11 20mo
HB
h.bhattacharyaTL213 Nov 2024#19
h.ferrari, post #10: The arithmetic in post #8 is right; the assumption feeding it is the part to check. Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here. Go to post

Building on post #16 rather than restating it.

Several compounds discussed here have no published human pharmacokinetics at all. That means half-life claims in circulation were derived from an animal model or from nothing.

None of the above is medical advice and I am not qualified to give any.

22 likes in reply to #10 20mo
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buffer_reviewTL3Regular15 Nov 2024#20
k.ogunleye, post #15: Taking post #12 at face value and following it one step further. Reading back through the Research-use-only status threads from last year, the same three questions come up every time and only one of them has ever been answered properly. That seems like a documentation gap rather than a knowledge gap. Go to post

Nobody has said the unglamorous part of Research-use-only status yet, so: most of the variation is explained by things that are boring to write about and easy to check.

0 likes in reply to #15 20mo
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endo_fellow_rkTL3Endocrinology fellow16 Nov 2024#21

Research-use-only status is a legal classification, not a safety classification. It means the compound is sold for laboratory use and not for human consumption or treatment. The label does not tell you whether the molecule is safe, efficacious, or what its effects are.

Same conclusion as the reply above, reached differently, which is mildly reassuring.

17 likes 20mo
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y.adebayoTL218 Nov 2024#22

A note on scope: what I am saying about Research-use-only status applies to the case in the first post and I would not extend it further without checking.

7 likes 20mo
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ms_hollowayTL4Mass spectrometrist20 Nov 2024#23

I read post #19 twice before replying, because I had assumed the opposite.

Where the Research-use-only status reasoning breaks down for me is the step from the group result to the individual case. That step is almost never argued for.

0 likes 20mo
MI
m.ibarraTL221 Nov 2024#24
t.wojcik, post #1: Research-use-only status: what it means legally and practically — a second dataset — setting out what I have, and where I think it stops being reliable. Posting a small dataset on Research-use-only status. It is mine, it is uncontrolled, and the method is stated so it can be discounted appropriately. What I would like is not agreement… Go to post

Thymosin alpha-1 has a regulatory history in several jurisdictions and a real clinical literature, which puts it in a different evidential category from most of its neighbours here.

A weak preference rather than a position.

0 likes in reply to #1 20mo
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formulary_notesTL3Regular23 Nov 2024#25
h.bhattacharya, post #19: Building on post #16 rather than restating it. Several compounds discussed here have no published human pharmacokinetics at all. That means half-life claims in circulation were derived from an animal model or from nothing. None of the above is medical advice and I am not qualified to give any. Go to post

Two claims get bundled together under Research-use-only status and they need separating. The descriptive one — this is what was observed — is usually well supported. The causal one — this is why — usually is not.

Almost every disagreement in threads like this one dissolves once you say which of the two you are making.

24 likes in reply to #19 20mo
CA
c.amankwahTL224 Nov 2024#26

Taking post #23 at face value and following it one step further.

On Research-use-only status, the part that usually goes wrong is that the question is asked as though it has one answer. It has a range, and the width of the range is the interesting bit.

If you can post the two or three numbers you are working from, several people here will check the arithmetic rather than argue about the conclusion.

11 likes 20mo
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TL4_HalvorsenTL4Leader · Journal club26 Nov 2024#27

Reading a supplier's product description as a marketing document: that is exactly what it is. The hyperbole, the mechanism written as fact, the theoretical benefits stated as established benefits — all of that is marketing. Treat it as such and separate it from evidence where evidence exists.

I looked this up rather than remembered it, which is the right order.

1 like 20mo
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ch.correiaTL227 Nov 2024#28
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sleep_logTL2Regular29 Nov 2024#29

Post #27 describes the usual case. This is about the unusual one.

Distinguishing three things in the Research-use-only status discussion that keep getting used interchangeably: the observation, the proposed mechanism, and the recommendation that gets attached to both.

7 likes 20mo
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j.bhattacharyaTL230 Nov 2024#30
buffer_review, post #20: Nobody has said the unglamorous part of Research-use-only status yet, so: most of the variation is explained by things that are boring to write about and easy to check. Go to post

An update on my earlier Research-use-only status post: the pattern held for another six weeks and then stopped, which I did not predict and cannot explain.

1 like in reply to #20 20mo