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Author | Topic: Safety and Effectiveness of Herbs and Pharmaceuticals | |||||||||||||||||||||||||||||||
Granny Magda Member Posts: 2462 From: UK Joined: Member Rating: 3.8 |
Hi Subbie,
Caveat emptor indeed, but the fact is that a great many fools have held onto their money, thanks to legislation that forces Big Pharma to prove the efficacy of its wares. The system works. That is proven by the way that quacks have been driven out of pharmaceutical medicine, leaving only the "alternative" market unregulated. What makes you think that regulation of herbals would play out differently? Mutate and Survive
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subbie Member (Idle past 1282 days) Posts: 3509 Joined: |
Greetings, Granny! I don't think we've run into one another before.
the fact is that a great many fools have held onto their money, thanks to legislation that forces Big Pharma to prove the efficacy of its wares. You say that as if it's a good thing. I say it's not. So Big Pharma hasn't cheated them out of their money. That also means that they haven't had a chance to learn from a foolish mistake. As a result, they simply lost their money to some other scam. No improvement, as far as I can see. In fact, I'd say that the fact that we have this Big Brother agency making everyone think that medicine is safe just makes it easier for those on the fringes to take the fools' money. Effective by association, as it were.
What makes you think that regulation of herbals would play out differently? I never said that I thought it would. I said I thought that would be bad. Let people buy and use whatever nonsense they want to. What's it to you? Morons are going to waste their money somewhere or other. Why should the government protect them from some frauds but not others? So we start to regulate herbals. What's next? Magnet therapy? Aroma therapy? Copper bracelets? Gimmick diets? Cosmetics claims of younger-looking skin? There is virtually no end to quack remedies out there, and if the government is going to try to regulate it all in the same way that they do with drugs, the FDA would quickly become the biggest bureaucracy in the history of human civilization, probably eating up half the federal budget or more. Much better to spend that money to teach people how to evaluate claims of effectiveness and how to critically examine evidence, if you think it's the government's job to protect idiots from their idiocy. Those who would sacrifice an essential liberty for a temporary security will lose both, and deserve neither. -- Benjamin Franklin We see monsters where science shows us windmills. -- Phat
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Rrhain Member Posts: 6351 From: San Diego, CA, USA Joined: |
subbie writes:
quote: Um, what makes you think they don't do this already? As Title 21 specifically states, there a disclaimer that must be placed on all such products:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. As for your whine of "Why should the government protect them from some frauds but not others?" it is because the average person is not in a position to test the efficacy of chemotherapy. Somebody has to. This is not a license to consumers to turn their brains off, though. They still need to do their research, but the governmental activity is to help people make informed decisions. Rrhain Thank you for your submission to Science. Your paper was reviewed by a jury of seventh graders so that they could look for balance and to allow them to make up their own minds. We are sorry to say that they found your paper "bogus," specifically describing the section on the laboratory work "boring." We regret that we will be unable to publish your work at this time.
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subbie Member (Idle past 1282 days) Posts: 3509 Joined: |
Well, the very disclaimer that you quote shows that the FDA doesn't perform the same kind of testing for products bearing the disclaimer as it does on drugs.
As for your whine of "Why should the government protect them from some frauds but not others?" it is because the average person is not in a position to test the efficacy of chemotherapy. Somebody has to. This is not a license to consumers to turn their brains off, though. They still need to do their research, but the governmental activity is to help people make informed decisions. Whine? Nice. If it were only to give people information, then the sale of untested drugs, or drugs that were tested but not approved, wouldn't be illegal. Instead, the government would require companies to inform people that the drugs haven't been tested, or that testing failed to confirm the claims that the companies make for the drugs. No, FDA regulation is far more than just a full disclosure program for informed decision making. The FDA makes the decisions itself, then makes it a federal crime for anyone to prescribe the drug contrary to FDA decree. You are correct that the average person is not in a position to test the efficacy of just about any medical treatment. Of course, it doesn't follow from that fact that the government has to do it. There are hundreds, thousands of sources of information that people can turn to to see what those with informed opinions have to say about virtually anything. Learning how to investigate and evaluate claims would be of considerably more value to people than for them to rely on someone else to simply outlaw bad decisions. Those who would sacrifice an essential liberty for a temporary security will lose both, and deserve neither. -- Benjamin Franklin We see monsters where science shows us windmills. -- Phat
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Rrhain Member Posts: 6351 From: San Diego, CA, USA Joined: |
subbie responds to me:
quote: And thus, you show you missed the point: Since there has been no testing, why would anybody accept the claim that it does what the advertister says it does?
quote: Huh? Freedom of speech does not mean freedom to lie. If you're going to say that "X does Y," then you need to back it up. It's why all those cosmetic commercials make heavy use of the word "appear." They don't say it actually gets rid of your wrinkles...merely that the wrinkles "appear" to be "less noticeable." And that's why the "alternative" therapies are carefully advertised so as not to actually claim to be doing anything. With no real claim to prove, they avoid any regulation.
quote: Um, what do you think that disclaimer says? Here it is again:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. What part of "has not been evaluated" is in conflict with the phrase of "haven't been tested"?
quote: I never said it wasn't. The FDA is a lot of things and one of them is a means for people to learn about things they don't have the ability to find out for themselves.
quote: Incorrect. A doctor is allowed to prescribe any drug for any reason. It's pretty much the entire basis for the pediatric psychopharmacopeia. Drugs don't work the same in children as they do in adults and we really don't have much testing for any of the drugs that we have upon children. The only way we've found out anything is because doctors prescribed them off-label. It's how we dealt with childhood cancers: The drugs were tested off-label on children. The way we managed to get a hold on childhood cancers (at least the ones we have a hold on) is because the doctors banded together to organize all of this off-label use. Every child ever treated for cancer is part of a study. They just are. You don't leave the data sitting on the table waiting for somebody to notice it and collect it. You specifically share it with others so that we can see what's going on. So why don't the "alternative" practitioners do this? Make everything part of a study.
quote: I never said it did. And technically, the government doesn't do it, either. The government just organizes it. You have to do your own study and the report your findings to the FDA for evaluation.
quote: Indeed. They're called doctors. But in order to be trusted, you have to be evaluated. That's why there's such a thing as "malpractice." And there has to be. There has to be a way to weed out the wrong answers.
quote: That's the importance of a good education in science. But that doesn't solve the problem of the average person...even the average scientist...being incapable of doing the appropriate research. There's an old fake ad from Saturday Night Live for the "Leland Myers Home Headache Test." You take vial of blood, run a chemical analysis of it, and wait two hours. If the spot turns blue, you have a headache! Now, for something like a headache, that's obviously ridiculous, but how is the average person supposed to determine if they have a deficiency in a particular protein? And how are they supposed to go about finding an effective treatment for it? That requires an awful lot of time, equipment, money, and study that most people don't have the means to do. Who else is going to check on these things? Isn't that part of the function of government? Rrhain Thank you for your submission to Science. Your paper was reviewed by a jury of seventh graders so that they could look for balance and to allow them to make up their own minds. We are sorry to say that they found your paper "bogus," specifically describing the section on the laboratory work "boring." We regret that we will be unable to publish your work at this time.
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nator Member (Idle past 2198 days) Posts: 12961 From: Ann Arbor Joined: |
quote: So, sellers should be able to profit from the sale of a product as a cure for cancer when that product has not been shown to cure cancer?
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nator Member (Idle past 2198 days) Posts: 12961 From: Ann Arbor Joined: |
quote: 1) Do you believe that sellers should be able to legally lie to or mislead consumers? 2) Do you think that the food industry should also be similarly unregulated, and that consumers should bear the burden of making sure the flour they buy, for example, isn't cut with chalk, or the ground coffee they buy isn't mixed with dirt, or the lettuce they buy isn't full of E-coli? History is chock full of examples of the basic fact that business will not tend to be ethical and honest towards consumers or workers unless compelled to by power of law. This is particularly true in modern times since the advent of the corporation, which has allowed the owners of corporations to avoid a certain amount of personal responsibility for the behavior of their companies. Perhaps you disagree with this assesment of history? If so, please present your counterargument. 3) Marketing, advertizing, and merchandising is based upon powerful psychological manipulation techniques and works on everybody, not just idiots. Edited by nator, : No reason given.
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Granny Magda Member Posts: 2462 From: UK Joined: Member Rating: 3.8 |
Hey Subbie,
subbie writes: So Big Pharma hasn't cheated them out of their money. That also means that they haven't had a chance to learn from a foolish mistake.As a result, they simply lost their money to some other scam. Sure, unless they're dead, because they had no way of evaluating the various medicines on offer, and they happened to choose the wrong one. How can ordinary people be expected to make life or death decisions without proper studies to provide the information? How are they to judge the worth of an unregulated clinical trial? For that matter, how can doctors make informed decisions if there is no agreed system of regulation to ensure that all medicines actually do what they claim they do. Regulation allows everyone, patients, doctors, researchers and drug companies, to assess the real value (and dangers) of medicines. This has advanced medical science and saved countless lives. Without it we'd all be in the dark.
subbie writes: Let people buy and use whatever nonsense they want to. What's it to you? I'm curious. The above comment implies that you would support full decriminalisation and deregulation of recreational drugs, such as crack-cocaine. What do you say to that?
subbie writes: Why should the government protect them from some frauds but not others? Exactly my point. Why should people be protected from most forms of fraud, but not from charlatans who peddle snake oil? Selling unproven rubbish as if it were a useful medicine exploits the sick and the desperate. It is an especially despicable form of exploitative fraud.
subbie writes: So we start to regulate herbals. What's next? Magnet therapy? Aroma therapy? Copper bracelets? Gimmick diets? Cosmetics claims of younger-looking skin? Yes, that sounds about right, with the possible exception of the diets. Where there is a claim of curative properties, there should be evidence to back up that claim. No evidence, no dice. Furthermore, herbs with genuine active ingredients should only be available from qualified persons, in order to avoid medical complications brought on by improper use.If wacky alternative therapists want to be taken seriously, they should submit to regulation and clinical trials. Your claims about the necessary bureaucracy seem a little over blown to me. It is the industry that must pay for the testing, not the government. Believe me, they can afford it. In fact, many alternativists do perform trials, but, because they do so in an unregulated environment, many such trials aren't worth the paper they're printed on. Mutate and Survive
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Taqless Member (Idle past 5941 days) Posts: 285 From: AZ Joined: |
Hi Granny,
Delayed, but....... Granny Magda writes:
My position does not include the expanded statements you make regarding “mystical elements” which I guess are part of TCM. In the context I outlined involving herbal drugs I contend that while scientific inquiry 1000s of years ago among the Chinese did not mirror our current process that in no way means that it did not meet the basic definition of scientific inquiry: “Full inquiry involves asking a simple question, completing an investigation, answering the question, and presenting the results to others.”
That TCM is guided by scientific inquiry is open to debate.There is no doubt that early TCM practitioners were seeking to move away from random tribal superstitions, and towards a standardised system of medical knowledge.
This is speculative and OT.
We all know of examples of traditions that are false.
So that I’m clear on this, are you suggesting that our current system of scientific inquiry is “tradition” as well? If not, then please explain .
Certainly it has some improbable mystical elements, such as chi, the theory that illness is caused by in imbalance between "stagnation" and "catastrophism", and something called "kidney essence" that creates bone marrow and semen.
This is a topic all of its own.
I'm suggesting that TCM contains much that is useful, after all, they are not idiots. The thing is, you don't have to be an idiot to make mistakes. It will thus include much that is in error (dried lizard anyone?). Unless your position is that TCM in inerrant, you surely have to agree with me on this.
I agree, the Chinese “are not idiots”. However, inerrancy is not the point . as I think you yourself have pointed out .
Of course. That's why systems of feedback are built into modern medicine, such as the yellow card scheme here in Britain. You won't see those kind of set ups in herbalism. There isn't enough agreement amongst practitioners.
Agreed, but maybe this suggests that regulating those who dispense herbs might help the general public?
So is it still your contention that anecdotal evidence is the equal of clinical trials?
I think that to ask this question the assumptions are:1) The Chinese did not use ANY form of scientific inquiry, and 2) The Chinese did not have an organized manner to document their findings and either assumption is problematic. Granny Magda writes:
My comparisons were strictly meant to highlight the fact that a couple of herbs from your list of herbs with “serious side effects” matched a couple of FDA approved drugs that had similar “serious side effects”. Therefore, weakening the position that regulation and clinical trials somehow resolves these aspects of drugs. That was all.
Devil's clawFor musculo-skeletal pain, such as backache. May increase stomach acid and should be avoided by people with ulcers Taqless writes:
Valerian Sounds like a warning for ibuprofen.For insomnia. High doses may cause a drug "hangover" effect Taqless writes:
Precisely why; This is a common side-effect of anti-insomnia drugs.a) both herbs and pharmaceuticals should be regarded as drugs. b) both herbs and pharmaceuticals should be subject to clinical trial. c) both herbs and pharmaceuticals should be regulated. When discussing whether or not drugs, herbal or otherwise, should be regulated one has to leave side effects, interactions, and even effectiveness out as supporting evidence on either side of the issue. Although these are valid concerns, they are not somehow resolved by regulation:- Approved/Herbal drugs both have side effects - Approved/Herbal drugs both have interactions, and - Approved/Herbal drugs both have varying degrees of effectiveness across a diverse population. Therefore, one is left with whether or not the drug is “proven” and I agree that this is facilitated through scientific inquiry. So, whether or not a drug has been proven seems to be what we are addressing, and this might be slightly OT according to what Percy originally intended. Regardless, my better defined position would be that herbs established and used for 1000s of years in Chinese Medicine do not require regulation as long as they are used in the manner documented. However, as I've stated before if the drug is being used in a different manner (tea vs. pill, with another medication, etc.) it would need to be scientifically re-tested in the "new environment" using the methods currently accepted.
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Percy Member Posts: 22502 From: New Hampshire Joined: Member Rating: 4.9 |
Tagless writes: In the context I outlined involving herbal drugs I contend that while scientific inquiry 1000s of years ago among the Chinese did not mirror our current process that in no way means that it did not meet the basic definition of scientific inquiry: “Full inquiry involves asking a simple question, completing an investigation, answering the question, and presenting the results to others.” Naturally I disagree that anything resembling modern approaches to scientific investigation were performed by the ancient Chinese, but there's no need to debate this particularly point. Given a scientific question, just ask yourself what is the difference between a scientific study never performed versus a scientific study that was meticulously performed and then all the results lost? The answer becomes even more obvious when you consider the issue at a more detailed level. Even the most basic tools of medical inquiry, such as blood pressure, temperature and blood analysis, were not in the possession of the ancient Chinese. Systematic tracking of results using basic data like this could not possibly have been performed. Any results would have had to have been based upon self-reporting, i.e., asking people how they felt. Certainly they never performed the double-blind trials that would eliminate the placebo effect, and control of dosage levels would have been impossible. But let's get real here. While it would be unfair to claim that no systematic investigations were ever performed by the ancient Chinese, the reality is that Chinese herbal folk knowledge for the most part accumulated the way all such knowledge accumulates, gathered anecdotally and spread by word of mouth.
My comparisons were strictly meant to highlight the fact that a couple of herbs from your list of herbs with “serious side effects” matched a couple of FDA approved drugs that had similar “serious side effects”. Therefore, weakening the position that regulation and clinical trials somehow resolves these aspects of drugs. That was all. This paragraph asks the wrong question, which you acknowledge later, but let me emphasize anyway that no one questions that drugs, which includes herbs and pharmaceuticals, can have serious side effects. The issue is one of whether the requisite studies have been performed to reveal what the side-effects might be. You appear to agree with this at least somewhat when you say:
Therefore, one is left with whether or not the drug is “proven” and I agree that this is facilitated through scientific inquiry. But you go on to repeat your initial premise:
Regardless, my better defined position would be that herbs established and used for 1000s of years in Chinese Medicine do not require regulation as long as they are used in the manner documented. There's no documentation. There are no records of studies by the ancient Chinese. There's only folk knowledge, and the only thing resembling documentation is what people have recorded concerning this folk knowledge. Until you can point to the journals documenting the peer-reviewed double-blind placebo-based studies you have no assurance about things like safety, effectiveness, dosage level, potential side-effects, drug interactions, etc. --Percy
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nator Member (Idle past 2198 days) Posts: 12961 From: Ann Arbor Joined: |
Hi Subbie,
It seems to me that every time the issue of government regulation comes up, you post something negative about it, then you get several rebuttals, and then you disappear. Then, a few months later, the same thing happens in a different thread, as if the points you made weren't rebutted in the previous thread. Believe me, I'm all about keeping government intrusion in our lives to a minimum, but I am puzzled why you, an obviously intelligent professional, seem to have this poorly thought through, kneejerk, "It is always bad!!!" reaction to any and all government regulation. I am open to changing my mind about the utility of the FDA, but I just don't see how your stated position wouldn't lead to a huge backslide in the safety and effectiveness of the food and drugs that businesses sell to us. Can you please come back and continue the conversation?
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Granny Magda Member Posts: 2462 From: UK Joined: Member Rating: 3.8 |
Hello again Taqless,
My position does not include the expanded statements you make regarding “mystical elements” which I guess are part of TCM. How exactly do you propose to extricate the "mystical elements" from the more effective aspects of TCM? Mysticism is part and parcel of TCM, with many herbs being prescribed for their effect on qi, jing or other non-existent factors. Mysticism is there at diagnosis, in prescription and in the explanations of effects. You can't just pretend it isn't there.
I contend that while scientific inquiry 1000s of years ago among the Chinese did not mirror our current process that in no way means that it did not meet the basic definition of scientific inquiry: “Full inquiry involves asking a simple question, completing an investigation, answering the question, and presenting the results to others.” Perhaps you would like to substantiate that claim with some evidence of ancient Chinese science. Of course, you will find no such evidence.
Taqless writes: Granny writes: There is no doubt that early TCM practitioners were seeking to move away from random tribal superstitions, and towards a standardised system of medical knowledge. This is speculative and OT. No, that was based on a thing called "research". Whilst I wouldn't suggest that anyone rely 100% on Wikipedia, it does make it remarkably easy to look up stuff like this;
quote:All very laudable. Unfortunately, they did not go far enough, mostly for the reason that Percy has already pointed out. So that I’m clear on this, are you suggesting that our current system of scientific inquiry is “tradition” as well? If not, then please explain. I am quite happy to describe evidence-based medicine as a tradition. It's just that some traditions are simply more effective than others.
This is a topic all of it's own Quit dodging. I have demonstrated that TCM contains much that is untrue. The question for you to answer is how are we to the useful information from the nonsense? If TCM is willing to deal in such rubbish, why should we take any of its claims at face value?
I agree, the Chinese “are not idiots”. However, inerrancy is not the point . as I think you yourself have pointed out . Error is very much the point. I assume that you will not contest my claim that TCM contains much that is in error, so how are we to detect these errors without testing?
{maybe}... regulating those who dispense herbs might help the general public? That is what I have been saying all along.
Taqless writes: Granny writes: So is it still your contention that anecdotal evidence is the equal of clinical trials? I think that to ask this question the assumptions are:1) The Chinese did not use ANY form of scientific inquiry, and 2) The Chinese did not have an organized manner to document their findings and either assumption is problematic. 1) I never claimed any such thing, indeed, I specifically mentioned that TCM represents a move toward scientific enquiry. I contend that there was not enough science and that their methodology was insufficient, as explained above, by our host.2) This is not an assumption, but rather a fact. If you disagree, please provide evidence of the ancient Chinese equivalent of the FDA or the UK's National Institute of Clinical Excellence. (Hint - You won't find any such evidence, because it doesn't exist) It is actually worth taking a look at studies into TCM. I think we can agree that todays TCM practitioners (as opposed to their less empirical Classical Chinese Medicine forebears) are much better placed to conduct useful trials. They have knowledge of blood pressure, the placebo effect, double-blinding, all the modern improvements mention above. So let's see how reliable modern TCM trials might be. This from Ben Goldacre again; quote:The link is to PubMed and appears in the original article. Do those results sound impartial and scientific to you? Because they sound more like a North Korean election result to me. If we cannot even trust the modern research into this topic, it does not look good for ancient research, carried out without proper knowledge and equipment. Therefore, weakening the position that regulation and clinical trials somehow resolves these aspects of drugs. That was all. For god's sake, I never claimed that clinical trials would eliminate side effects! That would be a stupid claim. If you must put words in my mouth, please try to make them less stupid. Regulation allows us to make informed decisions about side effects and all the other factors that you describe.
So, whether or not a drug has been proven seems to be what we are addressing, and this might be slightly OT according to what Percy originally intended. Regardless, my better defined position would be that herbs established and used for 1000s of years in Chinese Medicine do not require regulation as long as they are used in the manner documented. The topic is " Safety and Effectiveness of Herbs and Pharmaceuticals". You have yet to demonstrate how either of those concerns is addressed by reference to Chinese tradition. Mutate and Survive
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Granny Magda Member Posts: 2462 From: UK Joined: Member Rating: 3.8 |
A bit of thread necromancy...
The effects of unregulated medicine have been made starkly clear this week as a Traditional Chinese Medicine practitioner escapes direct prosecution for administering poison.
quote: Yes, that's Mrs Woo. It would be funny if it didn't involve a woman being given cancer by a negligent quack.
quote: I like a judge with a gift for understatement.
quote: Note that the poison pills contained a substance known to be harmful. If someone had bothered to test this product before putting it to market, this need not have happened.
quote: Source If the RCHM are serious about regulation, then I applaud them. However, I am rather suspicious that their enthusiasm has a lot to do with their fear that upcoming Euro legislation might put them out of business altogether. Mutate and Survive Edited by Granny Magda, : Fix link.
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rockondon Member (Idle past 4953 days) Posts: 40 Joined: |
After reading the OP a few times, I've come to the conclusion that I really don't know what this thread is about.
Even so, I thought I'd throw out a few comments to try and stir debate. When I see someone promoting "natural" products, it is usually a substance that has not been shown to work effectively and instead of admitting to a lack of research to support its effectiveness they often move the goalposts and whine about things like big pharmaceutical companies. Lets talk about depression medications. The mainstay treatment for most types of depression usually begins with SSRI's (selective serotonin reuptake inhibitors). But check this out...Of 74 studies registered with the United States FDA, 37 with positive results were published in academic journals, while 22 studies with negative results were not published and 11 with negative results were published in a way that conveyed a positive outcome (one positive study was not published and three negative studies were published with results that were portrayed as negative). Overall, 94% of studies actually published were positive outcomes; when published and unpublished studies were included for analysis, the percentage of positive outcomes was 51% Selective serotonin reuptake inhibitor - Wikipedia However, one herb that has shown to be effective is St. John's Wort. It has a side effect profile similar to placebo. To put it another way, its about as harmful to you as drinking water. Now check this out...St. John's wort had similar efficacy to standard antidepressants. The rate of side effects was twice lower than for newer SSRI antidepressants and five times lower than for older tricyclic antidepressants. Hypericum perforatum - Wikipedia I've spent a lot of time in Detox and on the Psych ward lately (working, not as a patient - I know what you guys were thinkin ) and I've never seen anyone taking St John's Wort, but dozens of my patients were on SSRI's. Why are people taking these drugs and suffering all these side effects when St John's Wort seems just as good and with virtually no side effects?
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Coyote Member (Idle past 2134 days) Posts: 6117 Joined: |
Why are people taking these drugs and suffering all these side effects when St John's Wort seems just as good and with virtually no side effects?
Marketing?
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