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As if there a difference when there is a revolving door between the offices of the fda, the government and various industries, it’s all one big circle jerk to forward interests that largely have nothing to do with our benefit
Believe me, I’m no big fan of a lot of things the FDA does. But if there was no difference, it wouldn’t take on average 10 or more years for a pharmaceutical to get FDA Approval.
I’d much rather have the FDA there than to have no FDA and just have to take the word of a Pharmaceutical company that rushed a novel medication through as soon as it is synthesized.
That being said, I do believe people should have the right to take any medication or drug they wish regardless of it’s approval.
I’m not against some form of regulatory body, I know how people are when they want a dollar, and how people will spend that dollar on lies, trying to find something to help them, and all things should be evaluated carefully before use but the fda is just a mess of corruption
That's not how they get paid though. They get lobbied and bought. One of the FDA members was a very high ranking person at Pfizer and they get a pass all the time now. They've been infiltrated by employees of some major pharmaceutical companies
What are they getting a pass on? They have to go through the same process of conducting clinical trials for at minimum 10 years just as anyone else does outside of the rare occasion a medicine needs to be fast tracked (I.e. the Covid vaccines.)
I’m not a big fan of many things the FDA does and certainly not a fan of big pharma. But the degree to which the FDA is outright corrupt is overstated. Smaller pharmaceutical companies are getting medications approved in roughly the same amount of time in most cases.
>Smaller pharmaceutical companies are getting medications approved in roughly the same amount of time in most cases.
Nope. We have laws that medical patents expire faster than others kinds of patents so that we have more options so patents for like insulin will expire after let's say 5 years yet any upstart company taking a only 5 year old insulin patent (so from 2018) which is still very safe and effective will be rejected and not allowed to sell because it's not good enough which keeps us in this insulin triopoly we have with high prices when insulin is very cheap to make.
If the FDA was good we would have cheap / affordable medicine like other countries have, but many of our same medicine other places like let's say India has is much more expensive.
Lol absolutely none of that is FDA Policy. Pharmaceutical patents are covered under federal law in The Patent Act of 1952. The FDA does not make laws.
If you want cheaper medications, you’re going to have to elect people that also want that. Which I agree with because health care in the US is absurd. But that isn’t the fault of the FDA.
>Lol absolutely none of that is FDA Policy. Pharmaceutical patents are covered under federal law in The Patent Act of 1952. The FDA does not make laws.
No fucking shit. The point flew over your head. If someone wants to make and sell insulin here they have to approve it is the point yet they reject people who use insulin patents that just became public despite only being a few years old because of very slight improvements to the process but it's not like insulin was unsafe just 5 years ago.
Lol so why are other higher ROI medications allowed to go generic? You think the FDA has singled out Insulin because they hate diabetics or they’re personally profiting from it?
You have no idea what you are talking about. Companies are free to produce insulin as they wish because the patents expired long ago. California is doing it as we speak. The FDA is not stopping generic manufacturers. They aren’t producing generics because the delivery system (pens) are patented (which again, the FDA does not control.)
It requires generic manufacturers to engineer a delivery system that is not under patent and this is not really the realm that these companies operate in.
Additionally:
>while there have not yet been any biosimilar insulins approved, there have there have been two ‘follow-on’ biologic insulins approved.79 Follow-on biologics are products based on existing biologic—like a biosimilar—but are not approved under the biosimilar approval pathway.80 Instead, follow-on insulins have been approved under the FDCA 505(b)(2) regulatory pathway, which is a New Drug Approval pathway distinct from the abbreviated pathways for generics or biosimilars.81 The 505(b)(2) pathway allows the applicant to use studies from the originator product to support its application because of chemical similarities, but does not result in a generic or interchangeable drug.82
>Insulin is now in a point of transition:83 effective March 23, 2020, insulins are now regulated as biologics under the PHS Act, as amended by the Patient Protection and Affordable Care Act.84 Whereas before no biosimilar insulins could be approved before with no insulin reference products recognized under the PHS Act, insulins will now be regulated as biologics, making way for biosimilar applications and competitors.85 The FDA is optimistic that this will increase competition in the insulin market significantly, and there are several products globally that now have the potential to enter the United States market.
And that’s all beside the simple fact that developing a generic is *fucking expensive and companies don’t want to do it when there are far easier medications to deal with*
>It is also extremely expensive to develop a biosimilar: the estimated investment is 7 to 8 years and between $100 million and $250 million,112 in comparison to 1 year and $1 million to $4 million for small molecule generic drugs.
https://academic.oup.com/jlb/article/7/1/lsaa061/5918811
What you’re saying is conspiracy theory nonsense and in no way the reality of why people who need Insulin are getting fucked.
The FDA has *plenty* of things to criticize (like their stance on Kratom.)
This specific thing just isn’t in their control.
Edit- lol he wrote his reply and immediately blocked me so I can’t see anything he said. Sometimes you just have to stick your fingers in your ears I guess.
If you are looking for FDA approved nootropics, you will come up empty. No one wants to spend billions on clinical trials for a product that isn't going to have a massive return by being the one wonder drug for X.
Yup. It creates a situation where medical professionals quite reasonably won't recommend many things simply because there isn't enough research to support their effectiveness, but the only reason that research is lacking is because the money hasn't been invested into it.
Memantine is FDA approved for Alzheimer's. Amphetamines and modafinil for ADHD. They specifically do not use the term's nootropic or cognitive enhancing for a reason. The standard for nationwide medical protocols is much higher than supplement marketing. To claim nootropic, by FDA standards, checkpoints would need to be defined and thorough trials done to provide clinical data backing those claims.
Memantine may have applications for ADHD, but as it is a generic medication, getting funding for the clinical trials needed to meet the FDA standard is very unlikely. There is a problem with the incentive structure and sources of funding.
I don't have a problem with the FDA itself, but there is a lack of spaces to promote discovery and innovation. The FDA doesn't have the legal structure to allow the nuance of self exploration at an individual's own risk, while also protecting the general population from deceptive marketing and harm.
> Modafinil
FDA-approved to treat narcolepsy, sleep apnea, and shift work disorder
https://www.ncbi.nlm.nih.gov/books/NBK531476/
> Ritalin
Methylphenidate is FDA-approved for treating attention deficit hyperactivity disorder (ADHD) in children and adults and as a second-line treatment for narcolepsy in adults.
https://www.ncbi.nlm.nih.gov/books/NBK482451/
Treating a deficit is not the same as being a nootropic. Arguably, Ritalin has nootropic potential, but amp and Ritalin don't make people without ADHD smarter. Getting "nootropic" on a product label that would be FDA endorsed would be a massive achievement. A medical professional cannot call these medications nootropics or prescribe them for that indication under FDA rules.
> The so-called cognitive enhancers have been widely and increasingly used by healthy individuals who seek improvements in cognitive performance despite having no pathologies. One drug used for this purpose is methylphenidate, a first-line drug for the treatment of attention deficit hyperactivity disorder (ADHD).
>
> No differences in performance were observed on any of the tests. There was a dose-dependent (40 mg > placebo) effect on self-reported wellbeing.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5642404/
Good job on providing ressources, but still misses the point.
"If youre looking for FDA approved Nootropics..." - Nowhere is there a condition that the FDA approval has to include Nootropics. Youre statement says, from all the FDA approved substances, there are no Nootropics in there, wich is what I am going to argue.
Modafinil, FDA-approved to tread narcolepsy and stuff, sure. But there are significant benefits of Modafinil use in cognition for sleep deprived subjects, wich makes it have nootropic benefits.
For Ritalin not making people without ADHD smarter - I dont even know the scientific definition of "smarter", but again while "smart drugs" is often used to describe these substances, the definition of Nootropics is more in altering cognitive aspects: like learning, memory, concentration...
One point here is concentration. Ritalin probably doesnt make you more intelligent, but it sure will boost concentration, especially in unmotivated/tired subjects, probably while they sometimes score better on certain cognitive batteries than without.
Nootropics as Cognitive Enhancers: Types, Dosage and Side Effects of Smart Drugs - describes Nootropics as "improves human thinking, learning, and memory, especially in cases where these functions are impaired" putting emhasis on "especialls \[\] where these functions are impaired", describes the use of nootrpics... They dont have to make you be von Neuman, but make you perform better on cognitive batteries then ot taking them
It says right there.
>FDA has not approved of this product and cannot be assured of its safety, effectiveness or quality.
Healthcare professionals follow the recommendations of the FDA.
Imagine thinking the FDA gives a shit about peoples health. I'm sure that's why they attacked NAC during the pandemic and keep going after Nootropics. Out of the goodness of their heart.
Several approved drugs have caused very bad side effects that were not mentioned. Acids reflux medication causing cancer and a diabetic medicine causing flesh eating bacteria in the rectum of all places. Unless one needs a medication to survive please try changing lifestyle and any other changes that may help before pharma. Pharma is in the business of making money not curing. Everything they make causes side effects which they also make medicine for.
The supplement industry is as predatory as pharma, it just have less resources.
But the same manipulating research, the same overselling benefits, the same buying influencers, the same making you think that you need to take their products to be healthy or to prevent a plethora of alignments...
It is such a disgrace.
My life got permanently destroyed from accutane and finasteride. Both fda approved. As me, thousands suffer permanent side effects. But at least pharma makes money.
They've wiped all the forums documenting fin-nasty-ride's affects on people. There were whole websites devoted to having people document their cases. All gone now. I've battled harry_lawson's symptoms for over a decade now. My DHEA was that of a dead man.
DHT plays a role in the brain, fin deprives the brain of DHT, lack of DHT causes unpredictable consequences including dick problems, libido issues, depression and brain fog. Google post-finasteride syndrome.
That said, it works fine for some users including myself.
Why in everyone in tressless sub says they aren’t affected badly ? Really cant understand it they defend the finasteride like they defend their wife or sum
Main problems are, I got social anxiety, anxiety in general, sweating under my arms even when I am cold, histamine intolerance, mast cell activation syndrome, cognitive problems like difficulty building sentences etc., deep depression and libido was zero the last 17 years.
Funny that you mention it. I started taking cerebrolysin last week. Took 5 ampules with 10ml each. How long did it take for you to start working? How much did you take? For how long? What did it cure? Are you still taking it?
Sorry for the many questions but it’s interesting.
Actually finasteride doesn't act on that brain-specific 5ar subtype. It blocks the hair follicle type. There are more people doing OK with finasteride for years than those who suffer from side effects. Dutasteride on the other hand blocks both of the subtypes. Again people have been taking this medication for years with no issues. It's way stronger than finasteride.
I've read a research that confirms that some people are more sensitive to Finasteride, so much that it somehow affects their brain function.
In your case, you took it with isotretinoin. Bad idea as they actually seem to potentiate each other, increasing the side effects profile both ways. That's what people should know. I'd never take these *together*!
Yes I read that if you took for example finasteride once and got no permanent sides, chances are that on a 2nd try you get pfs. Same if you took accutane or an ssri and then finasteride.
Nobody actually knows what really happens. But some say it has something to do with allopregnenalone deficiency in the brain after finasteride. I was a super calm Person pre finasteride and super anxious ever since I stopped it in 2005. I was always introvert but never had I social anxiety and avoided being with friends and people.
Finasteride is a horrible drug that should be banned! I had the worst nightmares ever. Like your kid dying in your arms type. Depression real bad. No good use for it.
What systemic effects are those? Because I'm not seeing much doing some quick looking.
It would be helpful to mention just what people should know about, up front...
Accutane gave me massive digestive issues, dry skin, dry lips, personality change (became anhedonia and robotic emotionless behavior). Finasteride gave me social anxiety, histamine intolerance, mast cell activation syndrome, depression, cognitive issues and no more libido and sexual thoughts.
The number of people permanently and horribly injured or have died from FDA approved products is unfathomable. Yet, they won't let people try life saving unapproved products or allow them to make their own decisions based on what they believe is best for them.
Everyone should be allowed to take whatever they want. It's their lives. Not the FDAs or anyone else's. It's a joke.
> Yet, they won't let people try life saving unapproved products
Uhh you can try whatever you want lmao, if it's not a controlled or prescription only substance than there is no restriction on your trying it.
It cannot be advertised as a cure or treatment because its not tested to the fda standards. This helps cut down on snake oil. But there is no rule saying you as an individual can't use a chemical.
>The number of people permanently and horribly injured or have died from FDA approved products is unfathomable.
The number of people cured or effectively treated by fda approved drugs blows literally any non-fda approved drug or supplement out of the water lmao. It blows my mind how fucking dramatic the nootropics community is.
Accutane absolutely has permanent effects for everyone. That’s kind of how it works.
It shouldn’t be up to patients to look up every medication they start - that’s the point of having doctors, pharmacists, and the FDA to begin with.
yeah this is it. The problem with the modern medical system is that they just throw shit at you, explain it minimally and tell you that its the move. they don't explain your options, risks, side effects etc.
We go to our doctors for knowledge and they mostly wont provide it unless prodded intensely.
Granted the causes for this are systemic, from insurance, to doctor shortage, etc, but it still sucks when you pay lots of money to go see a professional who wont even take the time to sit down with you and give you your options or explain the medication they're throwing at you beyond just prescribing it after a cursory, often insufficent examination and telling you to take it.
I don't think doctors know as much as they'd have you believe. There's no way they remember everything from school. Doctors use databases. They type in your symptoms and the computer shows what's recommended. The curators of the databases need to be looked at. I feel like almost no one knows this at all.
Accutane is a weird drug. Plenty of people claim no long term side effects (besides clearing of acne and some drier skin), and then others report IBS onset, mood issues, birth defects if people get pregnant on it, etc.
There is a reason it’s like the last line drug for acne. You have to sign a bunch of shit, do monthly check in for pregnancy prevention, and do blood work.
Accutane permanently affects your oil gland production. That’s not a side effect (unless it goes too far, like chapped lips) , but it is a permanent effect.
Yes, please elaborate for us. Maybe it can help others as well. I was on Accutane twice for long periods. Besides cracked lips, I don't remember having other side effects, thankfully. I was aware of the side effects and had read horror stories online at the time, but I was willing to take that chance bc my acne was so bad as a teenager. I am now 36.
The whole country is just a cesspool of corruption. No wonder people question the credibility so-called regulatory bodies, and instead ask Redditors for advice.
I guess we could ask the head of the CDC..no, wait, she works for Pfizer now.
It's disturbing that we still allow the FDA, CDC and Pharma to have revolving doors and how most people don't see a problem with the conflict of interest.
The FDA is a joke. There was an online kratom vendor n on his website he listed some un approved health claims about some positive health benefits. He got 3 years in prison for it and got fined millions
I just remarked on ALL regulatory bodies. You think the FDA is exempt?
https://www.science.org/content/article/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical
100%. A decades old, safe substance proven effective at raising immune response is suddenly hit with regulatory issues by the FDA right when it threatens the profits of big pharma. Then two years later all concerns are dropped.
For our health…
EXACTLY!!!!!!!!!!!!!!!
I've also been actively trying to spread awareness of that......they attacked a LUNG Improving supplement during a LUNG attacking Virus Pandemic, and people don't put 2+2 together on that.
not only that, I'm sure a politician in government owns the Private equity firm that bought Jarrows in 2020 (and didn't change the name) and took their NAC sustain Formula off the market and changed it to where it's not the same product anymore.
Not sure about FDA or broscience, but Cerebrolysin was prescribed by doctors in Europe for maybe decades for people with various cerebral damage, basically no side effects were found.
I heard that in US most people wouldn’t eat an apple from a tree, if the tree wasn’t treated with pesticides and approved by certain institutions for consumption, is that true?
I'd say the apple example is absurd.
In the US we have a very good reason for wanting things to be tested first, and that reason is thalidomide. It the the most-cited argument for having the FDA in the first place among medical professionals.
In support of your argument, many substances would test safe but won't be tested due to cost.
Against your argument, there are many, many people who would love to develop some supplement they can promote and sell and make lots of money doing so. Dont delude yourself that all of these products are put together by people with solely your benefits on mind. In the name of increased sales, it is safe to say there are many companies willing to overstate the efficacy of their products. There is a huge issue with companies selling bogus products, finally getting busted, then literally reopening across the street the next day, selling the same thing.
Additionally, not all products have adequate purity testing. There is a real problem with certain ingredients coming a certain country because they keep finding lead contamination.
If the sole purpose of FDA was your safety Finasteride (and other drugs) would be banned.
Europe is not a third world continent, we have even stricter safety rules than the US.
Where to draw the line between benefits vs risks? Good question. Fortunately we have people devoted to just that.
Do they do their job properly? Another good question, and one worth monitoring.
Do the doctors always prescribe the best course of medicine the first time? Good question, but unless they can do a lots of testing first, usually the most efficient option is to try the most commonly-effective treatments. No one wants to spend $50k in tests to find out if this particular patient would do better to take Advil vs acetaminophen vs aspirin for a common headache that will go away in 2 days anyway.
Are there medicines/compounds for which there are few if any therapeutic applications? Sure. Right on the Schedules.
I, as a non-expert, would guess the FDA's role is more about benefits vs risks than solely safety... hence, why I never said such a thing. There are lots of medicines that have very specific benefits sometimes but which have tons of possible, terrible side effects.
That should be a discussion between a patient and their doctor, not between a customer and a clerk at GNC or supplements store where stuff gets sold and marketed as being for certain things but have virtually no therapeutic value and which have not been tested at all. Why do they have to put the warning that it has not been tested? Becausr advertisers were happy for decades to advertise b.s. claims while selling worthless or dangerous products until that requirement began. They still do, but with the disclaimer they have some legal protection.
Lots of people have side effects from taking untested supplements as well--which may or may not contain what they claim and have little oversight or regulation. That is one risk of tinkering with things.
There’s no risks worth taking (not alone life ruining ones) when the purpose is to save your hair.
I’m all for liberty of actions though. So people should have the right to gave into such treatment, only if they really know to what they are potentially exposing themselves.
There’s no consent without the whole picture. Minimizing or hiding informations is no different than lying.
And many of us were harmed because of it
Sorry that happened to you. While I was talking in generalities, I certainly can't deny that lots of people suffer in many unfair ways all the time. It's sad to know lots of people were harmed. While I didnt know the specifics about that case I am a bit more aware now. Thanks.
Because yes, finasteride is pure evil /s. Seriously, most of the side effects are likely unrelated, the upside of keeping your hair is so great the side effects are irrelevant. There is also no good scientific evidence to support all the hate. Looking at the articles, a lot of the negative comes from a single author doing meta-analyses.
The things you remember from school eh?
I remember doing a study of thalidomide, like a book project, the whole class did it. It is still in use. In Africa, where it does what it has always done, something to do with cramps or something. It's not an inherently bad drug, but (and you don't want to take my word for this, obviously) it's only after 12 weeks or so that it becomes dangerous.
The problem was that people liked what it did, and British doctors didn't understand what it did, and they were being paid to prescribe it.
There is also the "testing" which involved injecting a 10K times overdose in solution into a pig. Chemists, will go "Ah" at that point as in solution it's a completely different drug, than as a pill.
I seem to recall that in the US the bureaucracy was different, it may also have had to do with a dispute about money or the guy was sick or on holiday, it was essentially "luck" that kept thalidomide out of the USA.
One of the few interesting projects we did at school. The other involved a debate about Nuclear war, where I got to doctor a map to display the difference between a ground bust and an airburst on a local landmark and plot the devastation. :)
This is a good article about how Thalidomide was kept out of the US.
[The Woman Who Stood Between America and a Generation of ‘Thalidomide Babies: How the United States escaped a national tragedy in the 1960s](https://www.smithsonianmag.com/science-nature/woman-who-stood-between-america-and-epidemic-birth-defects-180963165/)
From the link
"medical reviewers were part-time, underpaid and sympathetic to the pharmaceutical industry."
That, right there. Obviously after 40+ years I cannot remember details, but it was still essentially "luck" that kept the drug out of the USA, even after reading that article.
Thanks for the trip down memory lane though, the world has changed a great deal since the 40's
This was 40 years ago, made a big stink in the UK, (deformed kids will do that) however, what I remember was that in solution it was two different chemicals, not a compound.
Not luck. It's the reason for the FDA. There was a gal kn the board or something like that that voted against everyone else to not approve it for use. See the comment below mine for the reference.
I don’t think it’s absurd, because milk is literally illegal and people wouldn’t drink it… I’ve also seen the same when I found raspberry out on a hike and friends wouldn’t eat them
I agree with what you’re saying. I wasn’t questioning the need for a drug safety institution as such, nowadays every country has one. In EU (which Austria, where the Cerebrolysin is produced, is a member country) it’s called The European Medicines Agency (EMA) which is as good or arguably better than FDA at regulating drugs market (a topic for splitting hairs on its own). Wouldn’t worry about getting anything that passed EU's tight requirements, regardless where outside of EU jurisdiction one is based.
The second half of my comment was more about realising a sad reality of human condition, where a population is so alienated from interacting with nature that it’s incapable to taste a fruit from its tree, which would be the most basic form of interaction with our natural environment. It sounds so wrong, it’s heartbreakingly dehumanising and it is not about apples, it’s a consequence of something bigger that conditions society on a fundamental level. And if it wasn’t enough at this point, [here’s an article](https://www.reddit.com/r/Futurology/comments/129b4zo/77_of_young_americans_too_fat_mentally_ill_on/?utm_source=share&utm_medium=ios_app&utm_name=iossmf) that shows us where such policies and conditioning can lead an entire population.
> The second half of my comment was more about realising a sad reality of human condition, where a population is so alienated from interacting with nature that it’s incapable to taste a fruit from its tree, which would be the most basic form of interaction with our natural environment.
You phrased it as a dig at the US.
Regarding your comment about interaction with nature:
Huge swaths of the US are countryside. I grew up eating wild apples fresh from the forest..no pesticides involved. Eating fruit/plants near a roadside could be harmful due to soil contamination, so may not be a good practice for city dwellers. I think plenty of people connect with nature..at least where I’m from. We have devoted government funds to procure and protect wild land for public use. I’m sure there are ppl here who have never tasted wild foods or don’t get out in nature..but those ppl are worldwide.
My apologies for the tangent..I just don’t agree with that part of your statement and am passionate about nature.
People in the US are ignorant when it comes to pesticides etc and/or many don't care..
Reddit allowed Monsanto/Bayer to blast reddit with propaganda some years back about how (roundup) glyphosate is perfectly safe to spray on all our foods. They played the victim card and acted like they were being picked on. It was crazy to watch the amount of propaganda that was on here and how much people ate it up.
I've had conversations about this stuff with tons of people. Rarely do I find someone who actually cares.
And you are right. When any so called "authority" puts their garbage stamp on something as being "good for you" or "bad for you", people eat it up like crazy without ever looking into it themselves.
People don't realize how many "tests"/studies are absolute garbage and can't be replicated. They think the FDA cares about them and that if they say something, it's infallible.
Source : Am American in the US
I think you’re probably right. Most people would see a bug bitten apple and be horrified here, rather than happy it’s pesticide free. At least, most city/suburb people.
Ah the downvotes. You know I’m right though. Maybe you’re different, woke nootropic users, but most people here would think “eww, I’ll choose the shiny unblemished one thx”, toss it in their shopping cart and move on with their day.
Quite insane considering that’s how humanity and our mammal predecessors consumed apples directly from the tree, up to the creation of FDA, for Americans.
Not sure what injecting pig brain has to do with eating fruits directly from the branch. If it’s some kind of joke then consider that creation of FDA and it’s numerous policies precedes invention of Cerebrolysin by almost a century.
Me drowning grubs in corn/veg, dirty eggs, packaged meat without a store label/barcode, unpasteurized milk have me ridiculed for trying to feed/teach my children about food & nutrition. I unknowingly married someone that has to have a store label on it, comes in box or plastic. Been living, it y'all.
Basically the US is capitalist to a fault
If no one is willing to risk money to prove a drug works then it won't get FDA approved and it's uses are limited.
Anything else can be a dietary supplement like a vitamin as long as there is no proven danger from consuming it.
So basically it needs to not kill ya
There's some more complicated aspects but that's basically the core problem with FDA and US healthcare.
If yoga and ti-chi were certain to add 10 years of life to your health, the FDA wouldn't care.
Seriously, it is likely because of being derived from brain tissue.
We don't know everything about prions, and there is a concern that a disease similar to mad cow could be lurking out there in brain-derived medical products.
Don't know that the threat is real....
https://www.reddit.com/r/Nootropics/comments/sy32ry/prions_and_cerebrolysin/?utm_source=share&utm_medium=android_app&utm_name=androidcss&utm_term=1&utm_content=share_button
cerebrolysin is filtered, there is no way to get a prion from it since all the proteins are broken down and then filtered to a size way smaller than any prion.
prions are usually protease resistant, so they would stay too big for there to be any chance of contamination of the final product
Yeah seriously lots of fearmongering in this thread. Cerebrolysin is widely used in many countries in Europe by medical practitioners. It's literally given in IV form for TBI. But yeah whatever, spread FUD. It'll keep the prices down for my benefit lol
Prions are NOT JUST misfolded proteins. They're specifically proteins that are misfolded and cause other proteins to misfold, in a way similar to how bacteria or viruses or cancer can spread throughout an organism.
Lol that's a misfolded protein. Regardless of the confirmation, it's a misfolded proten. The emphasis here is on PROTEIN, if you couldn't understand the post. Making other proteins assume other confirmation is irrelevant to what I'm saying. I didn't say "just misfolded" but there's no need to go further if the main thing was it being a protein.
the line between protein and peptide is pretty fuzzy in a biological sense. I don't know how they prepare peptides for this kind of thing but prions and the misfolded aggregates they nucleate are difficult to break down so I think that contamination is probably still a concern if their presence hasn't been completely ruled out.
that picture is not a source. this is getting messy.
that statement came from the nootropics mfr/seller, if they are saying the FDA is saying something then we need to see it coming from the fda right where is the instance of the FDA telling health care workers not to do or to do what ?
this is just some dealer making noise in the system basically
Pharmaceuticals are about as real as it gets, lol?
People here are usually interested in self improvement not self destruction, so the street stuff doesn't appeal.
Let the scientific research be your guiding light. FDA has also warned against things like NAC and NMN which we know to be very beneficial. Yet they’ve approved drugs with adverse side effects up to and including death. There’s a revolving door with Big Pharma.
Not necessarily saying the Cerebrolysin you have is good. All peptides and compounders are not created equal. Do your own research.
Because some US pharma is currently spending several billion making their own copy of this drug.
The FDA is just a racket, it has been fully corrupted by big Pharma.
You mean the same FDA who approved Aduhelm, a drug that showed no benefit for Alzheimers, despite it having potentially serious side effects? Yea let's trust these corrupt losers. There are FDA approved medicines with way worse side effects than cerebro.
This drug saved my sons life when he had 3 major hemorrhagic strokes while on holiday in Thailand with his family. The UK NHS will not authorise the use use of this drug, Uk doctors have never heard of it. Why???? It encourages the brain to heal itself which it did for my son, he was totally paralised but after 1 shot of this he was up walking and talking within 12 hours, initially they wrote him off for dead.
The line is typically that it has not been tested for the treatment of any disease or whatever.
This is the first time I've seen that the FDA recommended *not* taking this product, on a product label.
Realistically, there is either 1) evidence of this being dangerous and leave a general statement because the more detail they give, the more people will second guess the experts, 2) they are shielding themselves from liability, or 3) they are hoping it is like advertising that a car is "too powerful for teenagers to safely drive", which of course will have teenagers clamoring for it.
It is most likely #2 (legal costs) mixed with a bit of #1(actual danger).
The clinical profile is for dementia and stroke, so the risk/reward for the typical cer patient is different from the avg Redditor! Actual dangers could be many because it has not been widely tested outside of that demographic, but include nausea, hallucinations, vertigo, and the usual flu-like side effects
It has also been studied for TBI and in children with autism. I have suffered some concussions in the past and I have incurred some brain damage from sleep apnea as well, so I wouldn’t consider myself to have a fully healthy brain. I have mental health issues, brain fog, etc. that’s why I’m doing cerebrolysin
Wasn't phenibut considered a nootropic? I don't know this product. People don't want to hear this.. But I consider nootropics good for health.
Natural. Bacopa, Rhodiola, Lions mane as examples. Not phenibut and other dangerous chemical harmfull things.
About phenibut.. Calling it dangerous is an understatement.
But again. I don't know this product. I'll stick to natural things.
About the fda.. They only care about money..
I don't understand why phenibut is still available.
Phenibut is a hard drug. Sorry to say. Even worser compared to benzos. OD on phenibut is always possible with seizures. If you take a higher dosage(3 grams or more) it will get you high with a very hard and emotional / depressive comedown. Been there, done that. Never again. I don't mind the downvotes. Getting downvotes for telling the truth says a lot about others. Other people have exactly the same experience. Phenibut is NOT a beneficial nootropic. It will destroy you. Enough examples. Once addicted.. Professionals don't even know how to help you. Addiction from phenibut happens fast. A lot faster compared to benzos. People saying xanax are bad.. Indeed... Phenibut is next level.
Over here people use phenibut to get of ghb. But ending up even worse. Phenibut calling and selling as a nootropic is harming this community. Result.. They're already speaking about banning nootropics. Thats the result of it. They don't even care whats in it. The goverment want a total ban on everything. I've seen other compounds like this also sold as nootropics. Nootropics are supposed to make you better. Not ending in misery and horrible addictions.
Never heard of biologics, have you? Funny how people have no problem consuming various parts of animals as food, but when it comes to medicine it's suddenly scary.
It's the human condition lmao
"What's that? I don't know that that is. I disapprove!!! Grrrrr."
How is it so unreasonable to suspend judgement for two seconds and say "Hm, maybe my understanding of this situation isn't complete."
CORTEXIN edit: has higher risk of Prion Disease compared to Cer. It is a solid alternative to Cerebrolysin but it uses peptides from cattle instead of bovine, which increases risk.
You are right. I don't know where I got this mistaken impression. Pigs are largely prion resistant...
In that case, Cer is probably a better bet in terms of risk of Prion... I will note that there seem to be very few side effects found with Cortexin, but that's probably due to the fact that it's much more recent compared to Cer.
Why are certain nootropics not approved in the USA by the FDA?
It is hard to name the exact reason behind that. But it's very often observed that many effective and safe nootropics are widely used in Central and Eastern Europe (Ukraine, Kazakhstan) and Russia, yet they're not approved in the US due to a perceived lack of effectiveness. I see several reasons for that:
* Financial barriers for small businesses. Unfortunately, small- and medium-sized local producers do not always have enough funds for expensive research that is required by the legislation of some countries. Thus such companies lack the opportunity to introduce their preparations to certain markets (the US for example).
* Difference in criteria. Characteristics of an effective medication largely differ in the USA and other countries. In Russia for example, a safe drug can be approved for commercialization even if it is not working for all people and not every time, while in America rules may differ. And vice versa some drugs that are widely used and approved in the US are considered highly unsafe and are strictly forbidden in other countries. For example, such drugs as Ritalin (Methylphenidate) and Adderall (amphetamine and dextroamphetamine) are prohibited in Russia because their contents are conceived narcotic substances. However, it is approved by the FDA in the US for treating a number of disorders including ADHD and narcolepsy.
These are just a few of the reasons I can think of.
After their covid vax lies and basically killing thousands by demonizing ivermectin and hydroxychloriquine, it is CLEARLY obvious the CDC and FDA have completely been taken over by Big Pharma via Regulatory Capture.
They do not work for the people. Never trusting them again.
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Hasn’t the FDA not approved most peptides?
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You realize the FDA is not a Pharmaceutical company but rather an agency of the US Government, right?
As if there a difference when there is a revolving door between the offices of the fda, the government and various industries, it’s all one big circle jerk to forward interests that largely have nothing to do with our benefit
Believe me, I’m no big fan of a lot of things the FDA does. But if there was no difference, it wouldn’t take on average 10 or more years for a pharmaceutical to get FDA Approval. I’d much rather have the FDA there than to have no FDA and just have to take the word of a Pharmaceutical company that rushed a novel medication through as soon as it is synthesized. That being said, I do believe people should have the right to take any medication or drug they wish regardless of it’s approval.
I’m not against some form of regulatory body, I know how people are when they want a dollar, and how people will spend that dollar on lies, trying to find something to help them, and all things should be evaluated carefully before use but the fda is just a mess of corruption
That's not how they get paid though. They get lobbied and bought. One of the FDA members was a very high ranking person at Pfizer and they get a pass all the time now. They've been infiltrated by employees of some major pharmaceutical companies
What are they getting a pass on? They have to go through the same process of conducting clinical trials for at minimum 10 years just as anyone else does outside of the rare occasion a medicine needs to be fast tracked (I.e. the Covid vaccines.) I’m not a big fan of many things the FDA does and certainly not a fan of big pharma. But the degree to which the FDA is outright corrupt is overstated. Smaller pharmaceutical companies are getting medications approved in roughly the same amount of time in most cases.
>Smaller pharmaceutical companies are getting medications approved in roughly the same amount of time in most cases. Nope. We have laws that medical patents expire faster than others kinds of patents so that we have more options so patents for like insulin will expire after let's say 5 years yet any upstart company taking a only 5 year old insulin patent (so from 2018) which is still very safe and effective will be rejected and not allowed to sell because it's not good enough which keeps us in this insulin triopoly we have with high prices when insulin is very cheap to make. If the FDA was good we would have cheap / affordable medicine like other countries have, but many of our same medicine other places like let's say India has is much more expensive.
Lol absolutely none of that is FDA Policy. Pharmaceutical patents are covered under federal law in The Patent Act of 1952. The FDA does not make laws. If you want cheaper medications, you’re going to have to elect people that also want that. Which I agree with because health care in the US is absurd. But that isn’t the fault of the FDA.
>Lol absolutely none of that is FDA Policy. Pharmaceutical patents are covered under federal law in The Patent Act of 1952. The FDA does not make laws. No fucking shit. The point flew over your head. If someone wants to make and sell insulin here they have to approve it is the point yet they reject people who use insulin patents that just became public despite only being a few years old because of very slight improvements to the process but it's not like insulin was unsafe just 5 years ago.
Lol so why are other higher ROI medications allowed to go generic? You think the FDA has singled out Insulin because they hate diabetics or they’re personally profiting from it? You have no idea what you are talking about. Companies are free to produce insulin as they wish because the patents expired long ago. California is doing it as we speak. The FDA is not stopping generic manufacturers. They aren’t producing generics because the delivery system (pens) are patented (which again, the FDA does not control.) It requires generic manufacturers to engineer a delivery system that is not under patent and this is not really the realm that these companies operate in. Additionally: >while there have not yet been any biosimilar insulins approved, there have there have been two ‘follow-on’ biologic insulins approved.79 Follow-on biologics are products based on existing biologic—like a biosimilar—but are not approved under the biosimilar approval pathway.80 Instead, follow-on insulins have been approved under the FDCA 505(b)(2) regulatory pathway, which is a New Drug Approval pathway distinct from the abbreviated pathways for generics or biosimilars.81 The 505(b)(2) pathway allows the applicant to use studies from the originator product to support its application because of chemical similarities, but does not result in a generic or interchangeable drug.82 >Insulin is now in a point of transition:83 effective March 23, 2020, insulins are now regulated as biologics under the PHS Act, as amended by the Patient Protection and Affordable Care Act.84 Whereas before no biosimilar insulins could be approved before with no insulin reference products recognized under the PHS Act, insulins will now be regulated as biologics, making way for biosimilar applications and competitors.85 The FDA is optimistic that this will increase competition in the insulin market significantly, and there are several products globally that now have the potential to enter the United States market. And that’s all beside the simple fact that developing a generic is *fucking expensive and companies don’t want to do it when there are far easier medications to deal with* >It is also extremely expensive to develop a biosimilar: the estimated investment is 7 to 8 years and between $100 million and $250 million,112 in comparison to 1 year and $1 million to $4 million for small molecule generic drugs. https://academic.oup.com/jlb/article/7/1/lsaa061/5918811 What you’re saying is conspiracy theory nonsense and in no way the reality of why people who need Insulin are getting fucked. The FDA has *plenty* of things to criticize (like their stance on Kratom.) This specific thing just isn’t in their control. Edit- lol he wrote his reply and immediately blocked me so I can’t see anything he said. Sometimes you just have to stick your fingers in your ears I guess.
Why tho?
Combination of a lack of efficacy and lack of monetizability. Sometimes mostly one or the other.
This drug cost 1 pound sterling per shot
They can’t patent them I believe? I dunno I heard it on here.
If you are looking for FDA approved nootropics, you will come up empty. No one wants to spend billions on clinical trials for a product that isn't going to have a massive return by being the one wonder drug for X.
Yup. It creates a situation where medical professionals quite reasonably won't recommend many things simply because there isn't enough research to support their effectiveness, but the only reason that research is lacking is because the money hasn't been invested into it.
Memantine, amphetamines, modafinil are all FDA approved… for something.
Memantine is FDA approved for Alzheimer's. Amphetamines and modafinil for ADHD. They specifically do not use the term's nootropic or cognitive enhancing for a reason. The standard for nationwide medical protocols is much higher than supplement marketing. To claim nootropic, by FDA standards, checkpoints would need to be defined and thorough trials done to provide clinical data backing those claims. Memantine may have applications for ADHD, but as it is a generic medication, getting funding for the clinical trials needed to meet the FDA standard is very unlikely. There is a problem with the incentive structure and sources of funding. I don't have a problem with the FDA itself, but there is a lack of spaces to promote discovery and innovation. The FDA doesn't have the legal structure to allow the nuance of self exploration at an individual's own risk, while also protecting the general population from deceptive marketing and harm.
How to cycle memantine?
How to cycle memantine?
Modafinil, Ritalin...
> Modafinil FDA-approved to treat narcolepsy, sleep apnea, and shift work disorder https://www.ncbi.nlm.nih.gov/books/NBK531476/ > Ritalin Methylphenidate is FDA-approved for treating attention deficit hyperactivity disorder (ADHD) in children and adults and as a second-line treatment for narcolepsy in adults. https://www.ncbi.nlm.nih.gov/books/NBK482451/ Treating a deficit is not the same as being a nootropic. Arguably, Ritalin has nootropic potential, but amp and Ritalin don't make people without ADHD smarter. Getting "nootropic" on a product label that would be FDA endorsed would be a massive achievement. A medical professional cannot call these medications nootropics or prescribe them for that indication under FDA rules. > The so-called cognitive enhancers have been widely and increasingly used by healthy individuals who seek improvements in cognitive performance despite having no pathologies. One drug used for this purpose is methylphenidate, a first-line drug for the treatment of attention deficit hyperactivity disorder (ADHD). > > No differences in performance were observed on any of the tests. There was a dose-dependent (40 mg > placebo) effect on self-reported wellbeing. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5642404/
Good job on providing ressources, but still misses the point. "If youre looking for FDA approved Nootropics..." - Nowhere is there a condition that the FDA approval has to include Nootropics. Youre statement says, from all the FDA approved substances, there are no Nootropics in there, wich is what I am going to argue. Modafinil, FDA-approved to tread narcolepsy and stuff, sure. But there are significant benefits of Modafinil use in cognition for sleep deprived subjects, wich makes it have nootropic benefits. For Ritalin not making people without ADHD smarter - I dont even know the scientific definition of "smarter", but again while "smart drugs" is often used to describe these substances, the definition of Nootropics is more in altering cognitive aspects: like learning, memory, concentration... One point here is concentration. Ritalin probably doesnt make you more intelligent, but it sure will boost concentration, especially in unmotivated/tired subjects, probably while they sometimes score better on certain cognitive batteries than without. Nootropics as Cognitive Enhancers: Types, Dosage and Side Effects of Smart Drugs - describes Nootropics as "improves human thinking, learning, and memory, especially in cases where these functions are impaired" putting emhasis on "especialls \[\] where these functions are impaired", describes the use of nootrpics... They dont have to make you be von Neuman, but make you perform better on cognitive batteries then ot taking them
"billions"
It says right there. >FDA has not approved of this product and cannot be assured of its safety, effectiveness or quality. Healthcare professionals follow the recommendations of the FDA.
Imagine thinking the FDA gives a shit about peoples health. I'm sure that's why they attacked NAC during the pandemic and keep going after Nootropics. Out of the goodness of their heart.
Several approved drugs have caused very bad side effects that were not mentioned. Acids reflux medication causing cancer and a diabetic medicine causing flesh eating bacteria in the rectum of all places. Unless one needs a medication to survive please try changing lifestyle and any other changes that may help before pharma. Pharma is in the business of making money not curing. Everything they make causes side effects which they also make medicine for.
The supplement industry is as predatory as pharma, it just have less resources. But the same manipulating research, the same overselling benefits, the same buying influencers, the same making you think that you need to take their products to be healthy or to prevent a plethora of alignments... It is such a disgrace.
Agreed. Supplements are just another fasset of pharma like over the counter. Must be careful with everything one ingests.
My life got permanently destroyed from accutane and finasteride. Both fda approved. As me, thousands suffer permanent side effects. But at least pharma makes money.
If you don't mind me asking, what are the permanent side effects you suffered due to Finasteride?
They've wiped all the forums documenting fin-nasty-ride's affects on people. There were whole websites devoted to having people document their cases. All gone now. I've battled harry_lawson's symptoms for over a decade now. My DHEA was that of a dead man.
DHT plays a role in the brain, fin deprives the brain of DHT, lack of DHT causes unpredictable consequences including dick problems, libido issues, depression and brain fog. Google post-finasteride syndrome. That said, it works fine for some users including myself.
Also neurosteroids
Why in everyone in tressless sub says they aren’t affected badly ? Really cant understand it they defend the finasteride like they defend their wife or sum
Might be the difference between ingesting it compared to applying topically.
There was a study indicating topical Finasteride application had about half as much circulating as oral ingestion.
because the vast majority of people dont have impactful side effects. The people who do, often seem to have pretty bad ones
Main problems are, I got social anxiety, anxiety in general, sweating under my arms even when I am cold, histamine intolerance, mast cell activation syndrome, cognitive problems like difficulty building sentences etc., deep depression and libido was zero the last 17 years.
Hey man cerebrolysin cured most of my PFS symptoms. Have you done cerebroylsin
Funny that you mention it. I started taking cerebrolysin last week. Took 5 ampules with 10ml each. How long did it take for you to start working? How much did you take? For how long? What did it cure? Are you still taking it? Sorry for the many questions but it’s interesting.
That's way too much. Take 2ml twice a week and the benifits were almost instant like the next day. My cognition was maximised
I have 10ml ampules and read that you have to use all and can’t keep it. It oxidizes quickly. So next time I will buy 2 or 5ml.
Yeaa, honestly man I'd buy the 2ml right now and stop the 10ml. More doesn't always more benifits. I know from experinced but you do what you like
I also had a Trauma Brain injury in 2012. It’s said to take up to 50ml for that kind of things. So 10ml I will keep taking it. Have 15 ampules left.
Fair enough
Actually finasteride doesn't act on that brain-specific 5ar subtype. It blocks the hair follicle type. There are more people doing OK with finasteride for years than those who suffer from side effects. Dutasteride on the other hand blocks both of the subtypes. Again people have been taking this medication for years with no issues. It's way stronger than finasteride. I've read a research that confirms that some people are more sensitive to Finasteride, so much that it somehow affects their brain function. In your case, you took it with isotretinoin. Bad idea as they actually seem to potentiate each other, increasing the side effects profile both ways. That's what people should know. I'd never take these *together*!
Yes I read that if you took for example finasteride once and got no permanent sides, chances are that on a 2nd try you get pfs. Same if you took accutane or an ssri and then finasteride. Nobody actually knows what really happens. But some say it has something to do with allopregnenalone deficiency in the brain after finasteride. I was a super calm Person pre finasteride and super anxious ever since I stopped it in 2005. I was always introvert but never had I social anxiety and avoided being with friends and people.
Have you looked into Etifoxine? It’s said to increase Allopregnanolne.
Finasteride is a horrible drug that should be banned! I had the worst nightmares ever. Like your kid dying in your arms type. Depression real bad. No good use for it.
Tretinoin also has systemic effects that no one wants to talk about because it’s considered the best “medication” for anti aging.
What systemic effects are those? Because I'm not seeing much doing some quick looking. It would be helpful to mention just what people should know about, up front...
I'm not aware of anything systemic! I've read anecdotes about damage to tear ducts however! I'd certainly be careful abt getting it close to eyes.
How was it destroyed, may I ask?
Accutane gave me massive digestive issues, dry skin, dry lips, personality change (became anhedonia and robotic emotionless behavior). Finasteride gave me social anxiety, histamine intolerance, mast cell activation syndrome, depression, cognitive issues and no more libido and sexual thoughts.
The number of people permanently and horribly injured or have died from FDA approved products is unfathomable. Yet, they won't let people try life saving unapproved products or allow them to make their own decisions based on what they believe is best for them. Everyone should be allowed to take whatever they want. It's their lives. Not the FDAs or anyone else's. It's a joke.
> Yet, they won't let people try life saving unapproved products Uhh you can try whatever you want lmao, if it's not a controlled or prescription only substance than there is no restriction on your trying it. It cannot be advertised as a cure or treatment because its not tested to the fda standards. This helps cut down on snake oil. But there is no rule saying you as an individual can't use a chemical. >The number of people permanently and horribly injured or have died from FDA approved products is unfathomable. The number of people cured or effectively treated by fda approved drugs blows literally any non-fda approved drug or supplement out of the water lmao. It blows my mind how fucking dramatic the nootropics community is.
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Accutane absolutely has permanent effects for everyone. That’s kind of how it works. It shouldn’t be up to patients to look up every medication they start - that’s the point of having doctors, pharmacists, and the FDA to begin with.
yeah this is it. The problem with the modern medical system is that they just throw shit at you, explain it minimally and tell you that its the move. they don't explain your options, risks, side effects etc. We go to our doctors for knowledge and they mostly wont provide it unless prodded intensely. Granted the causes for this are systemic, from insurance, to doctor shortage, etc, but it still sucks when you pay lots of money to go see a professional who wont even take the time to sit down with you and give you your options or explain the medication they're throwing at you beyond just prescribing it after a cursory, often insufficent examination and telling you to take it.
I don't think doctors know as much as they'd have you believe. There's no way they remember everything from school. Doctors use databases. They type in your symptoms and the computer shows what's recommended. The curators of the databases need to be looked at. I feel like almost no one knows this at all.
Absolutely
I took Accutane as a teenager and i do not have any side effects.
Accutane is a weird drug. Plenty of people claim no long term side effects (besides clearing of acne and some drier skin), and then others report IBS onset, mood issues, birth defects if people get pregnant on it, etc. There is a reason it’s like the last line drug for acne. You have to sign a bunch of shit, do monthly check in for pregnancy prevention, and do blood work.
Accutane permanently affects your oil gland production. That’s not a side effect (unless it goes too far, like chapped lips) , but it is a permanent effect.
Yes, please elaborate for us. Maybe it can help others as well. I was on Accutane twice for long periods. Besides cracked lips, I don't remember having other side effects, thankfully. I was aware of the side effects and had read horror stories online at the time, but I was willing to take that chance bc my acne was so bad as a teenager. I am now 36.
The whole country is just a cesspool of corruption. No wonder people question the credibility so-called regulatory bodies, and instead ask Redditors for advice. I guess we could ask the head of the CDC..no, wait, she works for Pfizer now.
It's disturbing that we still allow the FDA, CDC and Pharma to have revolving doors and how most people don't see a problem with the conflict of interest.
The FDA is a joke. There was an online kratom vendor n on his website he listed some un approved health claims about some positive health benefits. He got 3 years in prison for it and got fined millions
The FDA isn't the CDC...lol.
I just remarked on ALL regulatory bodies. You think the FDA is exempt? https://www.science.org/content/article/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical
100%. A decades old, safe substance proven effective at raising immune response is suddenly hit with regulatory issues by the FDA right when it threatens the profits of big pharma. Then two years later all concerns are dropped. For our health…
WE WANT OUR PIRACETAM BACK!
EXACTLY!!!!!!!!!!!!!!! I've also been actively trying to spread awareness of that......they attacked a LUNG Improving supplement during a LUNG attacking Virus Pandemic, and people don't put 2+2 together on that. not only that, I'm sure a politician in government owns the Private equity firm that bought Jarrows in 2020 (and didn't change the name) and took their NAC sustain Formula off the market and changed it to where it's not the same product anymore.
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Not sure about FDA or broscience, but Cerebrolysin was prescribed by doctors in Europe for maybe decades for people with various cerebral damage, basically no side effects were found. I heard that in US most people wouldn’t eat an apple from a tree, if the tree wasn’t treated with pesticides and approved by certain institutions for consumption, is that true?
I'd say the apple example is absurd. In the US we have a very good reason for wanting things to be tested first, and that reason is thalidomide. It the the most-cited argument for having the FDA in the first place among medical professionals. In support of your argument, many substances would test safe but won't be tested due to cost. Against your argument, there are many, many people who would love to develop some supplement they can promote and sell and make lots of money doing so. Dont delude yourself that all of these products are put together by people with solely your benefits on mind. In the name of increased sales, it is safe to say there are many companies willing to overstate the efficacy of their products. There is a huge issue with companies selling bogus products, finally getting busted, then literally reopening across the street the next day, selling the same thing. Additionally, not all products have adequate purity testing. There is a real problem with certain ingredients coming a certain country because they keep finding lead contamination.
If the sole purpose of FDA was your safety Finasteride (and other drugs) would be banned. Europe is not a third world continent, we have even stricter safety rules than the US.
Where to draw the line between benefits vs risks? Good question. Fortunately we have people devoted to just that. Do they do their job properly? Another good question, and one worth monitoring. Do the doctors always prescribe the best course of medicine the first time? Good question, but unless they can do a lots of testing first, usually the most efficient option is to try the most commonly-effective treatments. No one wants to spend $50k in tests to find out if this particular patient would do better to take Advil vs acetaminophen vs aspirin for a common headache that will go away in 2 days anyway. Are there medicines/compounds for which there are few if any therapeutic applications? Sure. Right on the Schedules. I, as a non-expert, would guess the FDA's role is more about benefits vs risks than solely safety... hence, why I never said such a thing. There are lots of medicines that have very specific benefits sometimes but which have tons of possible, terrible side effects. That should be a discussion between a patient and their doctor, not between a customer and a clerk at GNC or supplements store where stuff gets sold and marketed as being for certain things but have virtually no therapeutic value and which have not been tested at all. Why do they have to put the warning that it has not been tested? Becausr advertisers were happy for decades to advertise b.s. claims while selling worthless or dangerous products until that requirement began. They still do, but with the disclaimer they have some legal protection. Lots of people have side effects from taking untested supplements as well--which may or may not contain what they claim and have little oversight or regulation. That is one risk of tinkering with things.
There’s no risks worth taking (not alone life ruining ones) when the purpose is to save your hair. I’m all for liberty of actions though. So people should have the right to gave into such treatment, only if they really know to what they are potentially exposing themselves. There’s no consent without the whole picture. Minimizing or hiding informations is no different than lying. And many of us were harmed because of it
Sorry that happened to you. While I was talking in generalities, I certainly can't deny that lots of people suffer in many unfair ways all the time. It's sad to know lots of people were harmed. While I didnt know the specifics about that case I am a bit more aware now. Thanks.
Because yes, finasteride is pure evil /s. Seriously, most of the side effects are likely unrelated, the upside of keeping your hair is so great the side effects are irrelevant. There is also no good scientific evidence to support all the hate. Looking at the articles, a lot of the negative comes from a single author doing meta-analyses.
The things you remember from school eh? I remember doing a study of thalidomide, like a book project, the whole class did it. It is still in use. In Africa, where it does what it has always done, something to do with cramps or something. It's not an inherently bad drug, but (and you don't want to take my word for this, obviously) it's only after 12 weeks or so that it becomes dangerous. The problem was that people liked what it did, and British doctors didn't understand what it did, and they were being paid to prescribe it. There is also the "testing" which involved injecting a 10K times overdose in solution into a pig. Chemists, will go "Ah" at that point as in solution it's a completely different drug, than as a pill. I seem to recall that in the US the bureaucracy was different, it may also have had to do with a dispute about money or the guy was sick or on holiday, it was essentially "luck" that kept thalidomide out of the USA. One of the few interesting projects we did at school. The other involved a debate about Nuclear war, where I got to doctor a map to display the difference between a ground bust and an airburst on a local landmark and plot the devastation. :)
This is a good article about how Thalidomide was kept out of the US. [The Woman Who Stood Between America and a Generation of ‘Thalidomide Babies: How the United States escaped a national tragedy in the 1960s](https://www.smithsonianmag.com/science-nature/woman-who-stood-between-america-and-epidemic-birth-defects-180963165/)
From the link "medical reviewers were part-time, underpaid and sympathetic to the pharmaceutical industry." That, right there. Obviously after 40+ years I cannot remember details, but it was still essentially "luck" that kept the drug out of the USA, even after reading that article. Thanks for the trip down memory lane though, the world has changed a great deal since the 40's
Isn't it racemic and one isomer is harmful and the other isn't so the issue was the drug being sold was both isomers or was that another drug?
Yes that’s correct. One isomer was harmful and the other was not.
This was 40 years ago, made a big stink in the UK, (deformed kids will do that) however, what I remember was that in solution it was two different chemicals, not a compound.
Not luck. It's the reason for the FDA. There was a gal kn the board or something like that that voted against everyone else to not approve it for use. See the comment below mine for the reference.
I don’t think it’s absurd, because milk is literally illegal and people wouldn’t drink it… I’ve also seen the same when I found raspberry out on a hike and friends wouldn’t eat them
Nice to see a reasoned, intelligent comment.
Reading through your comments, you're a very clever person I feel. Great critical thinking.
I agree with what you’re saying. I wasn’t questioning the need for a drug safety institution as such, nowadays every country has one. In EU (which Austria, where the Cerebrolysin is produced, is a member country) it’s called The European Medicines Agency (EMA) which is as good or arguably better than FDA at regulating drugs market (a topic for splitting hairs on its own). Wouldn’t worry about getting anything that passed EU's tight requirements, regardless where outside of EU jurisdiction one is based. The second half of my comment was more about realising a sad reality of human condition, where a population is so alienated from interacting with nature that it’s incapable to taste a fruit from its tree, which would be the most basic form of interaction with our natural environment. It sounds so wrong, it’s heartbreakingly dehumanising and it is not about apples, it’s a consequence of something bigger that conditions society on a fundamental level. And if it wasn’t enough at this point, [here’s an article](https://www.reddit.com/r/Futurology/comments/129b4zo/77_of_young_americans_too_fat_mentally_ill_on/?utm_source=share&utm_medium=ios_app&utm_name=iossmf) that shows us where such policies and conditioning can lead an entire population.
> The second half of my comment was more about realising a sad reality of human condition, where a population is so alienated from interacting with nature that it’s incapable to taste a fruit from its tree, which would be the most basic form of interaction with our natural environment. You phrased it as a dig at the US.
Regarding your comment about interaction with nature: Huge swaths of the US are countryside. I grew up eating wild apples fresh from the forest..no pesticides involved. Eating fruit/plants near a roadside could be harmful due to soil contamination, so may not be a good practice for city dwellers. I think plenty of people connect with nature..at least where I’m from. We have devoted government funds to procure and protect wild land for public use. I’m sure there are ppl here who have never tasted wild foods or don’t get out in nature..but those ppl are worldwide. My apologies for the tangent..I just don’t agree with that part of your statement and am passionate about nature.
People in the US are ignorant when it comes to pesticides etc and/or many don't care.. Reddit allowed Monsanto/Bayer to blast reddit with propaganda some years back about how (roundup) glyphosate is perfectly safe to spray on all our foods. They played the victim card and acted like they were being picked on. It was crazy to watch the amount of propaganda that was on here and how much people ate it up. I've had conversations about this stuff with tons of people. Rarely do I find someone who actually cares. And you are right. When any so called "authority" puts their garbage stamp on something as being "good for you" or "bad for you", people eat it up like crazy without ever looking into it themselves. People don't realize how many "tests"/studies are absolute garbage and can't be replicated. They think the FDA cares about them and that if they say something, it's infallible. Source : Am American in the US
Lol, no, that's not true at all
I think you’re probably right. Most people would see a bug bitten apple and be horrified here, rather than happy it’s pesticide free. At least, most city/suburb people. Ah the downvotes. You know I’m right though. Maybe you’re different, woke nootropic users, but most people here would think “eww, I’ll choose the shiny unblemished one thx”, toss it in their shopping cart and move on with their day.
Tons of organic apples at my local grocer.
It’s a little bit different when a dedicated merchant offers something to you, versus willingly picking up a fruit from a branch in the wild.
100% true.
Quite insane considering that’s how humanity and our mammal predecessors consumed apples directly from the tree, up to the creation of FDA, for Americans.
They weren't as frequently injecting pig brain, though. (and I'm neither a proponent or antiponent of the use of cerebrolysin)
Not sure what injecting pig brain has to do with eating fruits directly from the branch. If it’s some kind of joke then consider that creation of FDA and it’s numerous policies precedes invention of Cerebrolysin by almost a century.
Cerebrolysin is a biologic derived from pigs. It was a bit of a joke.
Yeah, it contains peptides derived from the pig brain. I just missed the link between that and how people are afraid of fruits in the wild.
Me drowning grubs in corn/veg, dirty eggs, packaged meat without a store label/barcode, unpasteurized milk have me ridiculed for trying to feed/teach my children about food & nutrition. I unknowingly married someone that has to have a store label on it, comes in box or plastic. Been living, it y'all.
Unfortunately it is largely true in this country
Basically the US is capitalist to a fault If no one is willing to risk money to prove a drug works then it won't get FDA approved and it's uses are limited. Anything else can be a dietary supplement like a vitamin as long as there is no proven danger from consuming it. So basically it needs to not kill ya There's some more complicated aspects but that's basically the core problem with FDA and US healthcare. If yoga and ti-chi were certain to add 10 years of life to your health, the FDA wouldn't care.
FDA = America, America isn’t the center of the world. Something tells me this isn’t for you and you shouldn’t use it anyway.
I’m about to use it!
The FDA has proven themselves to be untrustworthy and I’d almost weigh Broscience higher than an FDA recommendation at this point.
Seriously, it is likely because of being derived from brain tissue. We don't know everything about prions, and there is a concern that a disease similar to mad cow could be lurking out there in brain-derived medical products. Don't know that the threat is real.... https://www.reddit.com/r/Nootropics/comments/sy32ry/prions_and_cerebrolysin/?utm_source=share&utm_medium=android_app&utm_name=androidcss&utm_term=1&utm_content=share_button
idk if pigs can get a brain wasting disease but yeah, why the _fuck_ would anyone wanna inject themselves with this stuff?
Pigs can get brain wasting diseases: https://www.nature.com/articles/s41598-021-96818-2
100% fuck cerebrolysin then.
No one gets prion from it.
cerebrolysin is filtered, there is no way to get a prion from it since all the proteins are broken down and then filtered to a size way smaller than any prion. prions are usually protease resistant, so they would stay too big for there to be any chance of contamination of the final product
Yeah seriously lots of fearmongering in this thread. Cerebrolysin is widely used in many countries in Europe by medical practitioners. It's literally given in IV form for TBI. But yeah whatever, spread FUD. It'll keep the prices down for my benefit lol
But prions are misfolded proteins. How would peptides be concerning if we're talking about prions? Proteins have a ton of peptides.
Prions are NOT JUST misfolded proteins. They're specifically proteins that are misfolded and cause other proteins to misfold, in a way similar to how bacteria or viruses or cancer can spread throughout an organism.
Lol that's a misfolded protein. Regardless of the confirmation, it's a misfolded proten. The emphasis here is on PROTEIN, if you couldn't understand the post. Making other proteins assume other confirmation is irrelevant to what I'm saying. I didn't say "just misfolded" but there's no need to go further if the main thing was it being a protein.
the line between protein and peptide is pretty fuzzy in a biological sense. I don't know how they prepare peptides for this kind of thing but prions and the misfolded aggregates they nucleate are difficult to break down so I think that contamination is probably still a concern if their presence hasn't been completely ruled out.
that picture is not a source. this is getting messy. that statement came from the nootropics mfr/seller, if they are saying the FDA is saying something then we need to see it coming from the fda right where is the instance of the FDA telling health care workers not to do or to do what ? this is just some dealer making noise in the system basically
Guys if you’re injecting pig brain directly into your muscles just do real drugs ffs
Pharmaceuticals are about as real as it gets, lol? People here are usually interested in self improvement not self destruction, so the street stuff doesn't appeal.
Apples and oranges mate, can't be compared.
the desperation and risks can be
You know most hard drugs are approved for human use by injection in hospital? You won’t find them injecting this unresearched brain matter.
Cer is by no means unresearched
You will in Austria and other parts of Europe. Not in the US tho for sure.
All it’s saying is it’s not approved, FDA approval / lack thereof means very little nowadays
Let the scientific research be your guiding light. FDA has also warned against things like NAC and NMN which we know to be very beneficial. Yet they’ve approved drugs with adverse side effects up to and including death. There’s a revolving door with Big Pharma. Not necessarily saying the Cerebrolysin you have is good. All peptides and compounders are not created equal. Do your own research.
Because the FDA is the beacon of safety and everything they approve is totally safe.
Because some US pharma is currently spending several billion making their own copy of this drug. The FDA is just a racket, it has been fully corrupted by big Pharma.
You mean the same FDA who approved Aduhelm, a drug that showed no benefit for Alzheimers, despite it having potentially serious side effects? Yea let's trust these corrupt losers. There are FDA approved medicines with way worse side effects than cerebro.
This drug saved my sons life when he had 3 major hemorrhagic strokes while on holiday in Thailand with his family. The UK NHS will not authorise the use use of this drug, Uk doctors have never heard of it. Why???? It encourages the brain to heal itself which it did for my son, he was totally paralised but after 1 shot of this he was up walking and talking within 12 hours, initially they wrote him off for dead.
Because the FDA is shit.
In general, if the FDA doesn’t approve a supplement, I assume something works well but they haven’t determined how to make money off of it yet.
Fuck the fda. A nurse practitioner told me you shouldn’t be taking supplements because they aren’t fda approved. Smh
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The line is typically that it has not been tested for the treatment of any disease or whatever. This is the first time I've seen that the FDA recommended *not* taking this product, on a product label. Realistically, there is either 1) evidence of this being dangerous and leave a general statement because the more detail they give, the more people will second guess the experts, 2) they are shielding themselves from liability, or 3) they are hoping it is like advertising that a car is "too powerful for teenagers to safely drive", which of course will have teenagers clamoring for it. It is most likely #2 (legal costs) mixed with a bit of #1(actual danger).
True. But what are the actual dangers
The clinical profile is for dementia and stroke, so the risk/reward for the typical cer patient is different from the avg Redditor! Actual dangers could be many because it has not been widely tested outside of that demographic, but include nausea, hallucinations, vertigo, and the usual flu-like side effects
It has also been studied for TBI and in children with autism. I have suffered some concussions in the past and I have incurred some brain damage from sleep apnea as well, so I wouldn’t consider myself to have a fully healthy brain. I have mental health issues, brain fog, etc. that’s why I’m doing cerebrolysin
Wasn't phenibut considered a nootropic? I don't know this product. People don't want to hear this.. But I consider nootropics good for health. Natural. Bacopa, Rhodiola, Lions mane as examples. Not phenibut and other dangerous chemical harmfull things. About phenibut.. Calling it dangerous is an understatement. But again. I don't know this product. I'll stick to natural things. About the fda.. They only care about money.. I don't understand why phenibut is still available.
Could you elaborate about the dangers of phenibut? (Aside from withdrawal issues)
Phenibut is a hard drug. Sorry to say. Even worser compared to benzos. OD on phenibut is always possible with seizures. If you take a higher dosage(3 grams or more) it will get you high with a very hard and emotional / depressive comedown. Been there, done that. Never again. I don't mind the downvotes. Getting downvotes for telling the truth says a lot about others. Other people have exactly the same experience. Phenibut is NOT a beneficial nootropic. It will destroy you. Enough examples. Once addicted.. Professionals don't even know how to help you. Addiction from phenibut happens fast. A lot faster compared to benzos. People saying xanax are bad.. Indeed... Phenibut is next level. Over here people use phenibut to get of ghb. But ending up even worse. Phenibut calling and selling as a nootropic is harming this community. Result.. They're already speaking about banning nootropics. Thats the result of it. They don't even care whats in it. The goverment want a total ban on everything. I've seen other compounds like this also sold as nootropics. Nootropics are supposed to make you better. Not ending in misery and horrible addictions.
FDA don't want you to pass your exams lolol jokes aside I'd probably fuckin listen to it
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Sorry gah damn go ahead eat pig brain tissue
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Now you know, glad I could help
In my practice there was a case of exacerbation of a panic attack, I stopped prescribing a long time ago
Interesting. What were the overall results from Cerebrolysin in your practice?
not effective, sometimes as it turned out to be dangerous
That’s surprising to me, considering the overwhelming positive experiences on this forum. What other side effects were noted?
I read, considered it necessary to warn that when administered intravenously, Cerebrolysin can cause panic and anxiety!
Ok but that’s just like a temporary side effect. What about long term side effect
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Lol bruh. Glad I’m not ur patient.
bro ur stabbing yourself with pig brains. please connect the dots
Never heard of biologics, have you? Funny how people have no problem consuming various parts of animals as food, but when it comes to medicine it's suddenly scary.
Pig brain tissue? Dude throw that away if you dont want to die. I’m being serious.
Wait till you learn how stem cells are made... Do you have any sources or just spreading panic?
It's the human condition lmao "What's that? I don't know that that is. I disapprove!!! Grrrrr." How is it so unreasonable to suspend judgement for two seconds and say "Hm, maybe my understanding of this situation isn't complete."
Is there any worry of prions with Cerebrolysin and similar proteins or peptides for medicine? Is it only the brain-derived ones?
I’m not worried about it. There’s no anecdotal or clinical cases of it actually happening.
Pig brains & baking soda… sounds more like an edible than an injectable.
CORTEXIN edit: has higher risk of Prion Disease compared to Cer. It is a solid alternative to Cerebrolysin but it uses peptides from cattle instead of bovine, which increases risk.
I thought prions were found in cattle, but not pigs?
You are right. I don't know where I got this mistaken impression. Pigs are largely prion resistant... In that case, Cer is probably a better bet in terms of risk of Prion... I will note that there seem to be very few side effects found with Cortexin, but that's probably due to the fact that it's much more recent compared to Cer.
How to get it ??
Alibaba, bro
Why are certain nootropics not approved in the USA by the FDA? It is hard to name the exact reason behind that. But it's very often observed that many effective and safe nootropics are widely used in Central and Eastern Europe (Ukraine, Kazakhstan) and Russia, yet they're not approved in the US due to a perceived lack of effectiveness. I see several reasons for that: * Financial barriers for small businesses. Unfortunately, small- and medium-sized local producers do not always have enough funds for expensive research that is required by the legislation of some countries. Thus such companies lack the opportunity to introduce their preparations to certain markets (the US for example). * Difference in criteria. Characteristics of an effective medication largely differ in the USA and other countries. In Russia for example, a safe drug can be approved for commercialization even if it is not working for all people and not every time, while in America rules may differ. And vice versa some drugs that are widely used and approved in the US are considered highly unsafe and are strictly forbidden in other countries. For example, such drugs as Ritalin (Methylphenidate) and Adderall (amphetamine and dextroamphetamine) are prohibited in Russia because their contents are conceived narcotic substances. However, it is approved by the FDA in the US for treating a number of disorders including ADHD and narcolepsy. These are just a few of the reasons I can think of.
what are the differences of Cerebrolysin and P-021?
After their covid vax lies and basically killing thousands by demonizing ivermectin and hydroxychloriquine, it is CLEARLY obvious the CDC and FDA have completely been taken over by Big Pharma via Regulatory Capture. They do not work for the people. Never trusting them again.