TheNietzsche
Member
Oh I should have stopped several posts ago but I have insomnia and there's nothing on TV.
The FDA issues a warning against the use of SARMs
- Thread starter The Solution
- Start date
Oh I should have stopped several posts ago but I have insomnia and there's nothing on TV.
The_Old_Guy
Well-known member
Wow, this went south quick 
FDA, Doctors, Vaccines.... There is no black and white, 100% good or bad. There are actual protective actions, and ones based on money. It's up to each citizen to try and sort it out. There's enough info these days to get it "pretty right" I think.
FDA, Doctors, Vaccines.... There is no black and white, 100% good or bad. There are actual protective actions, and ones based on money. It's up to each citizen to try and sort it out. There's enough info these days to get it "pretty right" I think.
Jiigzz
Legend
The info out there provides so much confliction it's hard to sift through the BS. People don't care for published research, they just care about what appeals to their emotions the best.Wow, this went south quick
The other issue is that people's choices affect the lives of others - not just themselves. The flu vaccine is to protect the immunocompromised - young children, older adults and those who have a weakened immune system through other disease or disorder - and us failing to understand that could be a nail in their casket.
People shrug off the flu like it is nothing. That is because our medical system has worked to reduce its impact. Dangerous variants like the Spanish Flu killed millions of lives around 100 years ago.
Other diseases have almost wiped humanity out time and time again, but now we never face that level of pandemic because of advances in medical science.
Now, our main killers are bourne from our affluence: lifestyle diseases resulting from complications from obesity and cancer.
But some anti vaxxers are trying to shift us from the very thing that saved us and it is crazy. whether it be the "toxins" from vaccines, risk of autism (like seriously whut), or some other make believe outcome, they would do anything to watch humanity go back 1000 years and wipe itself out (my theory is that this is what they want so they can save the trees).
HIT4ME
Well-known member
This is so true. We forget so quickly. This is the other side of things - we have become so disconnected from the reality of life and death. I have a client who is in his 70's, and when he was 13 his dad had a stroke. They called the doctor. He said, "Have him lay down." Just 55 years ago that was the extent of medical care for heart attacks or strokes.
Now, not only do we operate but we have technology to make that incision as small as possible and leave the least damage behind. Oh, and we have become so disconnected and accustomed to such advances that we expect this care to be free and available to everyone.
There is no doubting that we have made huge strides in medicine. And no doubting there have been huge profits. There should be huge profits, too. Of course, not all huge profits have been honest profits and that clouds things.
TheNietzsche
Member
Well said. :clap2:
HIT4ME
Well-known member
Thus thread also reminds me of puerpal sepsis - the black death of childbed, which was actually caused by the "all knowing" doctors from the 1600-1800s and the guy who ultimately convinced them to just wash their hands was treated like a lunatic with crazy ideas for 30 years of his life before they even began to accept his theories.
As Jigzz is ultimately pointing out, everyone is fallible and nothing is certain. Logic/reason coupled with healthy doubt is all we can lean on.
As Jigzz is ultimately pointing out, everyone is fallible and nothing is certain. Logic/reason coupled with healthy doubt is all we can lean on.
Mike Arnold
Board Sponsor
The_Old_Guy
Well-known member
Some valid points, but this could turn into a *really* long thread now
I'm not an anti-vacc'er - but I sure as hell wouldn't give every single one on the schedule, to my newborn (god forbid I have one
) - but I sure as heck would give some/most. The Rota Virus is one profit making waste of a needle from my research on it, and that's just one. Then there is the HPV vacc - yeah, ok - pap smears worked pretty well so far, but take this - oh, and your son too... LOL BTW, at last check, in the US, with a population of over 310 million - a whopping ~4,000 die from cervical cancer - you should see the current HPV ads in the US - make you laugh your ass off. Such a money push.The Swine Flu panic of 2012? was such a non-starter, so few people actually caught it/died from it - they had to resort to just saying (by not actually testing for it) that all flu that year was Swine. I did mad research on it back then, on another site - including the profit margins for the various mfgs of it. 100 years ago doesn't matter - there is no WWI, almost everyone has in home heat, sanitation, hot showers with soap, etc...
Thank god we all didn't die from Ebola, huh?
Anyway, I'm sure this will get fun now De__eB
Well-known member
Ostarine is a custom synthetic compound that a private company has spent tens millions of dollars (will cross $100m this year) creating and testing.
They've completed 24 human trials totaling 1700 people, with six more underway. All of this done with private capital and not federal NIH funding/support.
So frankly it's pretty unethical and objectively illegal for companies to be paying their Chinese lab to synthesize it and violate GTX's intellectual property and sell it off-label at all.
And that's how it should be.
It's not like Ostarine was some natural common ingredient that super big evil big pharma pressured the FDA into pulling from the supplement market so pharma could profit off it.
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Supplement companies whine about spending a few hundred thousand on clinical trials to prove their products work before selling them, and how other companies will just rip off their formulas if they do have a proven product.
Now imagine you spend $100 million researching something and a bunch of internet shills are ripping it off.
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They've completed 24 human trials totaling 1700 people, with six more underway. All of this done with private capital and not federal NIH funding/support.
So frankly it's pretty unethical and objectively illegal for companies to be paying their Chinese lab to synthesize it and violate GTX's intellectual property and sell it off-label at all.
And that's how it should be.
It's not like Ostarine was some natural common ingredient that super big evil big pharma pressured the FDA into pulling from the supplement market so pharma could profit off it.
--
Supplement companies whine about spending a few hundred thousand on clinical trials to prove their products work before selling them, and how other companies will just rip off their formulas if they do have a proven product.
Now imagine you spend $100 million researching something and a bunch of internet shills are ripping it off.
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Mike Arnold
Board Sponsor
They apparently don't care very much...because they are well aware of what's going on, yet haven't filed any lawsuits against these supp companies. My guess is that if/when it is released as a script drug, then they will be much more likely to put their foot down.
TheNietzsche
Member
I'm not an anti-vacc'er - but I sure as hell wouldn't give every single one on the schedule, to my newborn (god forbid I have one
Obviously, it would be your right to vaccinate as you see fit. However, 4000 deaths from cervical cancer is far greater than the number of deaths confirmed to be from the HPV vaccine (zero). 4000 deaths is also higher than all reported vaccine adverse events reported in 2015. And HPV vaccines generally aren't given until 11-13 years of age. So I'm confused at the risk/benefit calculation you made here. Rotavirus, sure... although again I wonder as to the risks you're concerned about. There's no ethyl mercury in the rotavirus vaccine.
Also, dying from cervical cancer... what about those people who get it, fight it hard, suffer and then get cured? The survival rates for cervical cancer are 50-60% on average; but that doesn't mean people don't suffer whether or not they end up dying from the cancer.
This should be about a risk/benefit analysis and ultimately, what the science says about the risks. Healthy adults don't need to get flu shots, so that's fine. But many people - the elderly, severely ill folks, cancer/chem patients, etc. - COULD die from the flu. So again, risk/benefit.
Jiigzz
Legend
Some valid points, but this could turn into a *really* long thread now
I'm not an anti-vacc'er - but I sure as hell wouldn't give every single one on the schedule, to my newborn (god forbid I have one
The Swine Flu panic of 2012? was such a non-starter, so few people actually caught it/died from it - they had to resort to just saying (by not actually testing for it) that all flu that year was Swine. I did mad research on it back then, on another site - including the profit margins for the various mfgs of it. 100 years ago doesn't matter - there is no WWI, almost everyone has in home heat, sanitation, hot showers with soap, etc...
Thank god we all didn't die from Ebola, huh?
HPV causes cancer though - why would you even be opposed to vaccinating against it?
Skin,mouth, throat and cervical cancers are predominately caused by one or more of the HPV subtypes. The survival rate of cervical cancer is around 55-90% depending on when you catch it. In the US, 13,000 people ANNUALLY are diagnosed with cervical cancer. 1 in 3 will die because of it.
And that's just cervical.
If you don't have HPV, you don't get the cancer. In ten years you prevent 130,000 people from getting cancer.
The_Old_Guy
Well-known member
So does a lot of stuff - like over-cooked red meat and the sun. Too much smoke surrounding it, and not from internet crazies, but legit MDs and former CDC people. Did you get your son vaccinated?
Last comment, don't feel like a week long work assignment with 160 hours of research
The_Old_Guy
Well-known member
You seem to think my only reason for not doing something, is risk based. Not always - I don't like to reward douchebaggery either, which is rampant in the Rota case. And those numbers are nothing - that's my problem with a lot of these. The "but if you could save just one life" argument, rings hollow with me.
Jiigzz
Legend
So does a lot of stuff - like over-cooked red meat and the sun. Too much smoke surrounding it, and not from internet crazies, but legit MDs and former CDC people. Did you get your son vaccinated?
Ermm, no.
HPV literally causes cancer.
You're talking about repeated, over exposure that may contribute to cancer. I'm talking causes.
Jiigzz
Legend
Invalid Link Removed
Hospitalizations and emergency department visits due to rotavirus AGE were reduced by a median of 67% overall and 71%, 59%, and 60% in countries with low, medium, and high child mortality, respectively. Implementation of rotavirus vaccines has substantially decreased hospitalizations from rotavirus and all-cause AGE.
Definitely an ineffective vaccine. You use supplements that have worse data than this
But I jest, I could care less TBH. I wasn't vaccinated for rotavirus, nor is it very deadly. I think it is more to do with reducing hospital visits and overall healthcare costs that arise from it.
De__eB
Well-known member
You couldn't be more wrong.
They've sent out dozens of cease and desists and have coordinated numerous enforcement actions with FDA OCI regarding people who didn't comply with the C&Ds.
Additionally, FDA OCI in following up on those leads discovered numerous way more interesting cases than merely the sale of ostarine and has made numerous steroid import related indictments due to leads generated by GTX's lawyers and investigator.
They also have numerous other ongoing investigations.
OCI and the DEA/DOJ act slowly. They're fine with sitting on you, watching you, preparing a comprehensive indictment for you, nailing your importer, etc...
Pulling people for unrelated crimes also helps obfuscate the source of their interest/indictments.
A word to the wise for any of you out there that received a C&D letter over Ostarine in late 2016 and ignored it. You should tread extremely carefully. Because you are on FDA OCIs radar.
And it's the import fraud and money laundering that's going to get you, not the sale of Ostarine itself.
DemntedCowboy
Well-known member
Well, then I guess I'm screwed. I have had an unmarked car out in front my house for the last few days. They must be after me, can't have nothing to do with the former Hell's Angel in Witness Protection Next door, who did 12 years in San Quentin.... They are after me.....Ahhhhh
The_Old_Guy
Well-known member
Rarely. 95% of women who actually are infected with HPV, never develop cancer at all. Regular Pap Smears are better (lifetime protection - the vaccine isn't lifetime). This Dr. isn't an internet whacko anti-vacc'er - actually helped approve it, but has reservations:
Invalid Link Removed.
Made by Merck (Gardasil) - makers of that wonderful painkiller Vioxx - you can trust Merck to give you all the data. Chance of a female just developing cervical cancer in the US: 0.0041935483870968% of entire US population. If just talking Females in the US: 0.0083870967741935% of entire Female US population. If we are talking mortality (4,000 vs 13,000 contracted) the percentages are astronomically lower. If you *aren't* a US resident - you may get better mileage - make your own decisions. Remember to protect your son against cervical cancer too - Merck recommends it.
Just too much BS fear mongering - that's the problem these day$
Now I'm really done, dammit!
Jiigzz
Legend
I love that they include the entire US population - who don't all have cervixes - to make the data appear smaller. Moreover, 13,000 annually just for cervical cancer is quite high, when it is entirely preventable.Rarely. 95% of women who actually are infected with HPV, never develop cancer at all. Regular Pap Smears are better (lifetime protection - the vaccine isn't lifetime). This Dr. isn't an internet whacko anti-vacc'er - actually helped approve it, but has reservations:
Invalid Link Removed.
Made by Merck (Gardasil) - makers of that wonderful painkiller Vioxx - you can trust Merck to give you all the data. Chance of a female just developing cervical cancer in the US: 0.0041935483870968% of entire US population. If just talking Females in the US: 0.0083870967741935% of entire Female US population. If we are talking mortality (4,000 vs 13,000 contracted) the percentages are astronomically lower. If you *aren't* a US resident - you may get better mileage - make your own decisions. Remember to protect your son against cervical cancer too - Merck recommends it.
Just too much BS fear mongering - that's the problem these day$
Now I'm really done, dammit!
How much does it cost in the US for the vaccine to make it such a topic of hot debate
Mike Arnold
Board Sponsor
I wasn't wrong at all. Filing a "complaint" with the FDA is not the same thing as filing a lawsuit in a court of law. Filing a complaint with the FDA is what someone does when they don't feel like doing jack----. If they cared about it that much they would have sued. They would be slam-dunk cases...and they would make a lot more from many of those lawsuits than they would have spent in legal fees, as plenty of companies made big money off of Ostarine. We see plenty of industry scum doing it right now through less ethical means...and racking up the cash with lawsuits that are much harder to prove.
De__eB
Well-known member
They didn't file a 'complaint' with the FDA. They coordinated criminal legal action with FDA OCI, which they can't do on their own as a private business.
GTX doesn't have the legal authority to unmask random RC site whoeverthe**** that isn't even a registered business entity and they can't compel that companies web host to reveal the identity of the owner.
For example, Mike Arnold isn't even your real name, your website is registered through an anonymizer in panama, and your business is registered to Rob's wife.
How exactly would Ligand Pharmaceuticals or GSK go about suing you for selling GW-1516? What are they going to do, spend 3 years suing IML to unmask you?
How much do they really think they'd win in damages from every company selling a few hundred or thousand units of pharmaceutical drugs? How much would that distract from their actual work trying to do biomedical research? Do they need to employ people to spend all day scouring AM and related forums for every random person selling their patented products?
Mike Arnold
Board Sponsor
You're wrong about two of those things. The business is in my name alone...and my partner isn't married.
Regarding your last set of questions, I don't think it would cost them much or distract them at all. We see people doing it right now...every day, with one attorney...and they're making money. They are engaging in extortion, but the process is the same.
Oh...and we're done selling GW. After these few remaining bottles are gone, that's it.
De__eB
Well-known member
That's actually new from the 10/23 filing amendment then
I had actually looked the company registration up when I wanted to reach out to you about something else that we talked about, it does look like Gena is still registered on the company though.But whatever I don't actually care about that to any meaningful extent, it was just an example of possible issues with pharma companies playing whack-a-mole with online sellers of their research substances.
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I am fairly certain I know who you're referring to. And in that case, they're pretty clearly interested in reaching pre-trial settlements and license fees for the sale of their patented legal dietary supplement ingredients as dietary supplements.
In the case of these pharma companies, that's not really what they need to be looking for.
GTX or GSK or whoever can't license you those ingredients for use in supplements even if they wanted to. They don't want to make money off the drug in a settlement. There is no pre-trial option for them to remove the incentive for companies to sell these drugs online.
Sure, they can go around and send a C&D, and some people will comply, but to go further than that is going to require they play out a full civil trial, which is much more expensive than what the person you're referring to is doing, because like I explained the desired outcomes are different.
RK can non-disruptively get his piece of everyone's nitrate pie, because the ingredients are legal to sell and he legally owns them. GTX can't get a slice of the Ostarine pie because it *isn't* legal to sell.
Mike Arnold
Board Sponsor
....That's actually new from the 10/23 filing amendment then
She was just removed.
But whatever I don't actually care about that to any meaningful extent, it was just an example of possible issues with pharma companies playing whack-a-mole with online sellers of their research substances.
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I am fairly certain I know who you're referring to. And in that case, they're pretty clearly interested in reaching pre-trial settlements and license fees for the sale of their patented legal dietary supplement ingredients as dietary supplements.
The thing is, they don't own the patents to anything. I could completely understand why they keep suing people if that was the case, but what they're doing is far less honorable. They are literally going around suing every company that sells any type of non-DSHEA complaint compound that purports to have a similar function to their DSHEA complaint product...and then claiming unfair competitive advantage. Then, as you said, they attempt to extort money from them with the threat of trial. It's complete extortion. What makes it even worse is that they are massive hypocrites. They made their name on selling real, fully active, methaylated steroids as dietary supplements...and now...because they have no good ideas and stopped making money on their products, they go around suing everyone who does what they did 10 years ago. Fortunately, they are being sued by a large group of supp companies right now.
In the case of these pharma companies, that's not really what they need to be looking for.
I agree that it isn't worth it to them...which is why they aren't doing it...and why I said "they don't care that much"...because in the grand scheme of things it really isn't going to harm them.
GTX or GSK or whoever can't license you those ingredients for use in supplements even if they wanted to. They don't want to make money off the drug in a settlement.
Of course. It's just not worth it to them. They have bigger, more important things on their mind.
There is no pre-trial option for them to remove the incentive for companies to sell these drugs online.
Sure, they can go around and send a C&D, and some people will comply, but to go further than that is going to require they play out a full civil trial, which is much more expensive than what the person you're referring to is doing, because like I explained the desired outcomes are different.
They could do what this other guy is doing, but it makes no sense for them to do it. The incentive isn't big enough.
De__eB
Well-known member
Oh we're actually talking about a different person then...I think.
I actually assumed you were talking about RK/nitrates since he's the en-vogue litigator of the now.
Talking about the people at Nutrition Distribution? If not them then I'm not sure who has a big litigation campaign over dshea that used to sell methylated orals. I'm a litigation wonk though so I'm intrigued.
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Where these venture pharma companies run into issues is that they need to have a good rapport with the FDA.
A lot of these drugs have admittedly performance enhancing off-label uses.
They end up affecting the massive sports and sports doping industries.
They end up in the hands of people who don't understand them/shouldn't be taking them.
When the IOC complains to WADA who complains to the FDA who complains to GTX, if GTX wants any hope of their drug being approved in the future, they kinda have to cooperate and at least do something.
They care to the extent that negative publicity from doping cases involving their drugs harms their future profit potential and future drug approval potential.
I actually assumed you were talking about RK/nitrates since he's the en-vogue litigator of the now.
Talking about the people at Nutrition Distribution? If not them then I'm not sure who has a big litigation campaign over dshea that used to sell methylated orals. I'm a litigation wonk though so I'm intrigued.
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Where these venture pharma companies run into issues is that they need to have a good rapport with the FDA.
A lot of these drugs have admittedly performance enhancing off-label uses.
They end up affecting the massive sports and sports doping industries.
They end up in the hands of people who don't understand them/shouldn't be taking them.
When the IOC complains to WADA who complains to the FDA who complains to GTX, if GTX wants any hope of their drug being approved in the future, they kinda have to cooperate and at least do something.
They care to the extent that negative publicity from doping cases involving their drugs harms their future profit potential and future drug approval potential.
hyperCat
Active member
Ok, so at the risk of coming off as lazy, I'm not clear on how substances/compounds are classified by the FDA. I've heard the phrase "naturally occurring" or "exists in nature", which seems to imply that this is one criteria used to determine how any substance might be deemed legal or illegal. But it doesn't make sense to me. Testosterone is a naturally occurring hormone and is illegal unless you have a script. DHEA is also a naturally occurring hormone but is legal without a script. Yeah, they're different, but still both naturally occurring. And the argument for keeping DMAA a legal supplement is that it is a naturally occurring substance found in geranium plants, thus should be legal, as if that's the sole determining criteria. Tobacco is legal, but is known to cause cancer and a host of other health issues. It goes on and on. So there is obviously more I'm missing here, cause a lot of it just doesn't add up to me.
ZachH
Banned
Money
TheNietzsche
Member
Some of it is certainly related to money (isn't everything?) as ZachH said. However, one criticism of DSHEA is that it is relatively lenient to supplement makers in how the FDA regulates them. I could talk about this for days, but that's not the topic of this post.
As the law stands, a compound can only be included in a supplement if it is derived from a natural source*. DMAA included in supplements was almost exclusively synthetic and not derived from an extract of geranium. There's also conflicting evidence about whether DMAA is found in geranium at all. If DMAA is not present in geranium, then it likely isn't compliant with DSHEA (regardless of whether you agree with the law, it remains the law). It is also illegal to market known drugs, either approved or investigational, as dietary supplements (even when they meet DSHEA criteria; anyone remember pyridoxamine? A B6 derivative marketed as a supplement for years, but banned since now its an investigational diabetes drug.)
You are right in noting the sometimes arbitrary nature of this. Testosterone does occur in nature, but is also marketed as a drug for various purposes.
Natural sources as defined in DSHEA*:
hyperCat
Active member
Thank you for the explanations. So, "derived from a natural source" basically means it must be extracted directly from that source and not synthetically produced, even if the synthetic form would be identical?
TheNietzsche
Member
That I'm actually not 100% sure if it is in the law or not (perhaps someone can chime in?). However, they used that fact as evidence that DMAA wasn't legal under DSHEA.
bosskardo
Well-known member
I think the point was that it was left quite obscure so the FDA could enforce it where it wanted to.
Jiigzz
Legend
The main points of DSHEA are that, if it wasn't marketed and sold as a supplement prior to 1994, then anything new must have an NDI, which DMAA does not.
Hi Techs argument hinged on that DMAA was present in geraniums and identified prior to DSHEA, but the evidence has always been questioned from both parties.
Vitamin C is mostly synthetic and is legal to sell so that criteria isnt hard and fast either. The main difference between vitamin C and DMAA in cases like this is the dispute between legality in the first place.