Ridiculous cost of clinical trials hinder new bug repellant

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Duckie
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Duckie »

Make no mistake- claiming using arsenides to treat leukemia is some great success of TCM is laughable, the kind of kneejerk judgement of worth that makes me want to imitate Stark and talk about tribalism. My example was to show the depths of the insanity of traditional pre-toxicology medicine men using Flower of Antimony as a medicine. It's potentially useful in cancer treatment after all other options fail because it makes cells undergo apoptosis. Taking Pi Shuang (what I am informed its non-western name is, I only know the systematic and alchemical name) is like burning germany to the ground in order to delay the soviets from reaching berlin.

It's a chemical toxic enough that it'll possibly kill the diseased parts of you before it kills you or cripples your quality of life, like many last-ditch cancer treatments used in western medicine, except not as targeted or efficient because it hasn't been medicinalised, purified, and modified. It's used well past the point I'd consider euthanasia if I had leukemia. If that's a positive side of TCM, count me firmly in the Western camp.
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PainRack
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by PainRack »

Simon_Jester wrote:Yes. Happily, we now know arsenic and mercury are poisonous, even if this was not known (or known but somehow not internalized) by premodern medicine in the East or West, we had the same problems; over here mercury was a popular treatment for syphilis for a long time.

I think we're actually in fairly close agreement about the facts of the case, but are approaching them from very different angles. Many traditional remedies are useless, and many more are actively harmful. Some are worthwhile and can be taken at low enough doses that significant side effects at those levels would show up in mortality statistics, let alone in clinical trials. Others might be worthwhile but we can't make any reasonable estimates of safe dosage levels.
You utterly fail to understand why I'm still rebutting you. Do you or do you not concede that it is literally impossible to gauge safety based on history of usage alone?
I would support the use of an herbal remedy only:
If it's taken at a dosage low enough that we can easily find evidence of safe use, either because of a specifically constructed study or because vast numbers of people have been taking it at that level during the modern era without detectable health consequences. Arsenic, mercury, tobacco, and massive overdoses of Vitamin C all fail this test, even though all have been passed off as medicine by well-intentioned quacks.
And how do you KNOW that there was no detectable health consequences if the studies haven't been done? History of usage alone is worthless, because we already know from TCM and other drugs such as Vitamin C that we are utterly unable to detect safety problems from there.
The fact that something has been used in traditional medicine is not enough to get it past the conditions I describe above in and of itself. I'm aware of the gaping hole in traditional medicine (both mine and that used on the other end of my ancestors' continent), and try to close it by using only those of its recommendations that scientific medicine has come close to confirming. I do not, under any circumstances, consider longstanding traditional use to be evidence of a positive effect. At absolute best, I consider it to be negative evidence indicating (but not guaranteeing) the absence of a negative effect.
I'm not arguing that you're using herbs or other medicines uselessly. My contention here isn't the point that you are using herbal medicine, I have no qualms whatsoever.

The point of contention here is yours and JSF argument that history of usuage equals to a proven track for safety, as humanity would had noticed any major problems from using such medicines. Even in our modern era, that's simply not true. I already brought up two modern practices/drugs that was in use for decades, promoted by modern medicine which have now been shown to be actually HARMFUL. If humanity was so wise and intelligent that we could discover potential problems from drug use, why didn't we notice the above problems until the late eighties and 21st century respectively?
Make no mistake- claiming using arsenides to treat leukemia is some great success of TCM is laughable, the kind of kneejerk judgement of worth that makes me want to imitate Stark and talk about tribalism. My example was to show the depths of the insanity of traditional pre-toxicology medicine men using Flower of Antimony as a medicine. It's potentially useful in cancer treatment after all other options fail because it makes cells undergo apoptosis. Taking Pi Shuang (what I am informed its non-western name is, I only know the systematic and alchemical name) is like burning germany to the ground in order to delay the soviets from reaching berlin.
Errr...... isn't treatment of APL now acceptable using arsenic and Vitamin A? Granted, I haven't actually nurse this form of AML before so I really have no idea what's the current medical protocol. Actually, scrap that:D I don't really fucking remember the differentiation anyway:D
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Duckie
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Duckie »

I haven't a clue if it's standard protocol, but to me it's a pretty damn self-destructive way of winning, even if it does work. If "Controlled Dose of Arsenic" is in fact the standard Leukemia treatment, then it turns out the unintentionally poisoning panacea of the chinese and alchemists turns out to have a real use, just like many poisons do. Nothing more and nothing less- the idea of using arsenic to treat cancer is then not a TCM idea at all, and it's hardly a triumph (let alone that the TCM way is less controlled and dosage-monitored due to being pre-science) to have independently come to the same conclusion as science by sheer accident.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Simon_Jester »

PainRack wrote:You utterly fail to understand why I'm still rebutting you. Do you or do you not concede that it is literally impossible to gauge safety based on history of usage alone?
I concede, but not unconditionally.

It is impossible to completely gauge safety based on the fact that people have used something. People have smoked tobacco, and even done so medicinally, and it isn't safe. People have used a lot of deadly stuff.

I maintain that it is possible to partially judge safety based on usage if and only if one would expect a lack of safety to be visible. Sometimes, looking at history of usage, the consequences of that use, and applying modus tollens allows us to place an upper bound on the dangers of using something.

If eating broccoli were as dangerous as smoking tobacco, we would expect a noticeable correlation between broccoli consumption and death, one that would likely have attracted attention in the past. It's still possible that this could somehow have been overlooked for several decades, and that next year we will discover the broccoli is actually poisonous. But it isn't likely, which is why you will seldom find a doctor who advises against introducing broccoli to your diet because "for all we know, it might be poisonous."

By contrast, we know quite well that arsenic is poisonous, and we know it for a reason: because arsenic kills so many of the people exposed to it. Things that are more deadly are also more obviously deadly when people review general statistics and start wondering "why does Group A drop dead more often than Group B?" Some studies are done because there is a suspicious difference in outcomes between two groups; things that generate large differences in outcome are likely to attract such studies.

This approach has serious limits, I admit, and I'll go into more detail on what I think they are below.
And how do you KNOW that there was no detectable health consequences if the studies haven't been done? History of usage alone is worthless, because we already know from TCM and other drugs such as Vitamin C that we are utterly unable to detect safety problems from there.
History of usage alone is not entirely useless, but it is of limited use. The best it can possibly do is place an upper bound on the dangers of a treatment. Generally, a HIGH upper bound, because stuff can get past the radar, as you describe. But there has to be an upper bound somewhere. A traditional remedy that caused thalidomide-like teratogenic effects would tend to draw attention to itself in the modern era, much as thalidomide (or arsenic) did.

Something less damaging can escape notice more easily, so history of usage cannot possibly rule out low or mid-level side effects, I agree.

But to take your example of talcum powder and daily showering causing bedsores:

Which is more likely to cause bedsores, applying talcum and daily showers, or failing to move the patient? I would predict that failing to move the patient will cause bedsores far more often than using talcum powder. My reason for thinking so is the same sort of thing I talked about above: we knew that failing to shift the patient's posture caused bedsores a hundred years ago.

Any effect that would be obvious enough to be detected so early in the history of modern (quasimodern?) medicine would have to be fairly large. Effects that escape detection for decades are likely to be smaller, small enough that they are not noticed until someone specifically goes looking for them.
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PainRack
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by PainRack »

Simon_Jester wrote:I concede, but not unconditionally.
If so, then that's it. The decision to then consume and use a product rests entirely on the person own judgement.
I'm just highlighting the fact that the so called risk/benefits isn't as easy as suggested and that there are potential hidden risks.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

Since this ended the thread and is going to be involved in my own posting, I'll throw my opinion in directly alongside Simon_Jewster. I agree with him that SOME things are reasonably held to a standard of "safety" based on traditional history and the lack of toxicity and/or long term side effects...SO FAR. But yes PainRack is absolutely correct, it's still not 100% or a free pass on them all.
Simon_Jester wrote:
I concede, but not unconditionally.

If so, then that's it. The decision to then consume and use a product rests entirely on the person own judgement.
I'm just highlighting the fact that the so called risk/benefits isn't as easy as suggested and that there are potential hidden risks.
Just understand we both obviously feel that the risk vs. rational benefit is more than reasonable to justify our interest in certain supplements.


Erik Von Nein Wrote:

Yes, however, that's only altering one variable (the ivy), whereas in your example you altered at least three. One being the cessation of one treatment, the second being the assurances of another treatment from a trusted family member, and the third being the application of the third treatment. There are too many variables to conclusively say that the application of this treatment is what for sure caused the improvement. It could be, but it could also be placebo, it could be stopping the previous treatment helped the former, or it could be a combination of all three. That's why the personal anecdote isn't any kind of standard of evidence for the efficacy of a given treatment. You can use it to segue into a series of greater study and information, such as saying the historical use suggests some benefit, but you can't throw a personal anecdote and say with any certainly that was the cause.
This doesn't make sense to what I described..somehow I think you've misunderstood the chain of events...here. I'll go step by stepp.

A (Mother gets Trigeminal Neuralgia, sometime about 15 years ago..discovers she's deathly allergic to Carbamazepine..(tegretol), and therefore the most preferred drug treatment (because of efficacy), is rendered unusable.

B) They eventually find that Dilantin, even though it's an older drug of choice, is effective for her and at a relatively low dosage too...so she stays pain free on that.

c) Her liver enzymes start looking worrisome. Doctor says it's the Dilantin because she doesn't take any other form of medication, she has good cholesterol, perfect weight, etc. etc. They warn she may have to stop medication and look for alternatives if it gets worse.

d) She mentions this to me and if I remember correctly it's been months and they haven't gotten any worse, but they are distinctly elevated and they don't like it..I discuss the hepatoprotective benefits abscribed to milk thistle and some of the comprehensive formulas that use other herbs and substances all with SOME reasonable theory of benefit derived at least from tradititional usage and modern investigation into the herbs, and at best, some with very promising clinical studies that suggest a significant effect on the liver and the biochemical guideposts used to measure it's function.. the aminotransferases AST, ALT...etc.

E) I did a little research to see if any of the herbs in question would cause any reasonable interference with the cytochrome P450 pathway, whether inducing or inhibiting. I will assume most people involved in this thread are knowledgeable enough about this body system and the detoxification pathways of the live...but in case you're not, the long story short is that in humans the cytochrome 450 path is directly involved in the breakdown and metabolism of oh...roughly 75% of the drugs taken by the body...sometimes it's through other pathways.but this is the major one. Basically you want to know this because if an herb or substance affects the metabolism of a prescibed drug, this could reduce or lower the blood levels and therefore cause problems with the dosage.

F) Seeing no warning flags, we cautiously had her start them up ...low dosage and then up to an optimal "protective" amount daily. Her face pain didn't increase, so we were quite certain it wasn't lowering the Dilantin's dosage...and she was also on a very low dosage in the first place and had a very comfortable upper ceiling anyway...many are prescribed 4x + to control seizures of more severity involving epilepsy and such..
In any case, we saw no concerns at the onset of the herbal formula.

Her next bloodwork showed a definite drop in her liver enzymes, AND significant beneficial change in her cholesterol ..particularly her HDL..it's an optimal aim to have your HDL higher than your LDL, the doctor was extremely surprised by her eventual results...(I'm speaking of a bit later after being on the formula for a consistent many months...just mentioning it here for interest's sake....)...Her LDL was well below what was considered adequate, and her good cholesterol was extremely high. The doctor said she had never seen such good cholesterol.

In any event, she continued to show liver enzmes that regressed back to normal levels and this remained so for years. At one point she told me what happened when she went off. I live in Toronto., her in Nova Scotia, so I miss a lot of day to day...She said at one point she ran out of the liver formula, meant to get around to picking it up and after awhile didn't bother. She felt the same, and didn't think too much about it. She'd been complacent for quite awhile with her blood work and overall health. Then she said her next blood work showed a rise in ther liver enzymes again..the first time in years. She told the doctor about the formula and said she just recently stopped taking it due to laziness. Even she said well maybe you should go back on it since it seemed to be helpful, we'll monitor you and see if they reduce again..otherwise you may not be able to remain on this drug.

So she bought it again, started them up, and they dropped down again to normal. She was happy, the doctor was happy..the tests looked normal, and she continued on that way again for years. As she went off the Dilantin due to her remission, I'm not sure if she still takes them....but probably because she loves her wine....and it wouldn't surprise me if that combined with the Dilantin was the reason for the one - two punch to the liver...however the formula is ostensibly just as helpful at helping to detoxify alcohol and protect against it's type of damage as well.

So hopefully you understand the entire story a bit more and I'll leave it until you can comment on this with that as a basis if you have anything more to ask in relation.
What's poor logic is using one example to inductively conclude benefit from a product. It's call "hasty generalization." Yes, I realize you aren't necessarily engaging in poor reasoning, but that's what a single case means.
Ok. Conceded, but only to a degree...as Simon_Jestor has also been echoing my arguments regarding even singular cases as being relevant even though they are not CONCLUSIVE of anything...they still have significance because of their example. As to how much or what worth it might be, in this case I'm not arguing for what science demand as necessary, I'm defending the interest level for individuals and part of the process of investigating a product for consideration of use.

To put it in reverse...if I had 3 friends who used a formula that claimed to lower blood pressure and all 3 said they broke out in a rash from it, I am well aware this isn't good enough to use to dismiss the product, it's all anectdotal....you can't PROVE it was the produt giving the rash..however, I'd be interested to know that and in all likelihood would avoid the product and look for others with better accolades behind them.. :wink:
Justforfun000 wrote:
The point is, each individual experience is COMPLETELY relevant. In fact 2 people out of 500 can still skew the statistics enough to warrant a claim of adverse effects. In this case we don't care about the 99+% percent that have no problem, we now focus the attention on the oddball ones and their reactions. In this case, we are actually seeing the same exaltation of a singular unusual response without corroboration, but in reverse. Do you see what I'm getting at?


Erik Von Nein Wrote:
Not really. Mind being clearer?
Just as one person is an "island unto of themself", and the bell curve in medicine always shows that some odd few will fall outside the spectrum of expected response to a product or treatment, in this case where they focus on adverse effects, they actually exalt the odd person out and their reaction to the product. Even though their singular example would have been statistically irrelevant, and not particularly useful.....in context with a proper study, it BECOMES significant and useful.

So again, it's why I kind of argue that even though I understand and agree that anectodotal cases are never conclusive in and of themself, they are not worthless and you can still derive some info regarding a treatment and it's effects if you can reasonable evaluate a causal connection. It totally depends on the case and the facts however.
Let's skip to this quote, since it boils down what you've said already. You say that his personal qualifications, which, when it comes to scientific study and standard of evidence, is greater than your own, you claim that it alone isn't enough to make someone qualified for making medical decisions. So, what is?
A combination of many things. Your personal doctor naturally, but also yourself and your own understanding of your body and it's health history. Quite frankly, these days you are well advised to be your Doctor's partner in health, and this extends to many nutritional decisions and lifestyle choices.

There is much to be said for the internet. You can find a great deal of solid and reputable information on many diseases and their treatment as well as comprehensive explanations about every medical test run from blood to MRI and learn and understand what they all are, why they are performed, how their results indicate concerns and considerations to your doctor, etc. You have to know where to look of course and as long as you stick to pubmedcentral and studies from the Mayo clinical as a basic starting point instead of Townsend letter for Doctors ..you are on the right track.

So to suggest that degrees alone confer a SUPERIOR opinion regarding you and your health choices, this is far too simplistic. You can be very well informed and have a very good yardstick to measure certain health decisions made for yourself.

One example, I was on something once that can cause kidney problems if used for very long periods of time...doing a fair bit of research myself, I discovered the best way to evaluate this would be to get a 24 hour urine collection test ordered. I went to the doctor and brought up my concerns and lo and behold, he thought we should do a 24 hour collection test.

What I'm getting at is that because of my own research and knowledge regarding medicine and the human body, I was able to become educated enough to know exactly what was reasonable to do or have recommended based on my specific health situation. So a layperson can still possess understanding and reasonable capacity of thought to make decisions for themselves. You don't "need" a degree, you simply need information and understanding.

Now in my example I focused on a very specific medical test and it's something the doctor would have to order and get evaluated ANYWAY, so i's not like you could do it yourself, but the point can be extrapolated over to other things. I just wanted to clarify my point in that regard.
Personal study can cover a lot of material, or a little. Or it might mean absolutely nothing. Like I've said before, homeopaths like to rail on doctors and degrees and appeal to their own personal authority. Saying "I've studied the issue, so I think I'm qualified to make medical decisions" is a poor statement. Again, that's why people jumped on you for saying it.
Now maybe from the above, you can understand why it may NOT be necessarily such a poor statement. It depends on the DEGREE of your knowledge and how accurate it may be.
Also, using studies and research conducted by others means you are using someone else's qualifications to better your decision making.
And in truth, EVERYBODY in medicine does this except for people directly involved in the testing and research of a particular substance or treatment. Eventually peer-review helps validate it further...the fact remains that we learn from other people's efforts.We don't all need to reproduce them, we just have to be satisfied they have merit in the first place.
Appealing to your own amateur studies and vague "research" while then declaring you know enough to prescribe treatments can be viewed as extremely arrogant, especially when the evidence of your personal studies were rather easily ripped apart.
I never said that I knew enough to prescribe treatments based on any of those personal examples I gave. This is exaggerating my position by a wide margin. First of all "prescribe" insinuates telling others what to do or take. In the case of my mother, I suggested something for benefit yes, but I also had her read about it, get a feel for the reasons behind he formula and why it might be beneficial to her, and so SHE made the decision..not me.

In regards to myself, if I read many tantalizing studies and reports on the possible wonders of brocolli and the antioxidants and phytochemicals contained within, then when I "prescribe" them to myself by increasing my daily intake of this food/herbal...(see it's in a grey area here..hence my point again about why a separate class from drugs is warranted), am I being arrogant and foolishly discounting my doctors advice? Should I NEED him to read all of the clinical studies and get back to me to give me the thumbs up before making such a nutrional...excuse me....MEDICAL decision? Do you get my drift about what I'm tongue-in-cheek hinting at here? There is a degree of capability that is reasonable in regards to your personal health choices.

Lastly, those studies were not truly "ripped apart". They had some flaws or if we can be more forgiving, some lack of a better funded and more conclusive investigation. But as Aly said, they weren't WORTHLESS, they are simply too preliminary.

In any event, this is referencing some random studies or info I was posting as examples of what I could find when I deliberately searched for supporting info regarding a company's product and their ingredients. It was mainly to show that in the case of that particular company as their company "About us" profess, they endeavour for the best herbal and/or vitamin-like substances out there with as much research as possible suggesting potential benefit and then formulates them based on what studies showed the most promise based on dosage and so forth.

That particular product "Ortho-mind" is a relatively new one, I posted the random google searches MAINLY for the point of showing how I become interested in something like this and why I feel they are significantly better supported through reason and reference than powdered rhinocerous horn or homeopathic belladonna. I wasn't laying out studies with the express purpose of saying, "SEE...this PROVES it works...why are you all jumping on me?". This is where I got strawmanned in the beginning and people overdrew my argument FAR beyind where I was going with them and it took a long time to get back to the heart of what I was trying to say in the first place. We finally did around page 6 or so I think. :roll:
Holding a degree doesn't automatically make your right. However, the qualifications give you greater weight when it comes to a debate between someone with one and someone without one.
Depends on the context and the debate. If purely to evaluate the limits of a certain study as evidence, then in that singular example regarding Aly and I, absolutely. I bow to him and his explanations of why they are insignificant alone or what have you.

But it doesn't necessarily give him greater weight on the entire spectrum of herbal medicine and what many companies may have as supporting references of worth and what you may personally already know.

As another example....there is a company here that produced something derived from Ginseng that has had some very promising clinical studies on it's effects on colds and flus. Two different reference based parts of their product:
CVT-E002™ at two 200 mg capsules daily (COLD-fX®) has been studied in randomized and placebo-controlled clinical trials which have been published in respected peer-reviewed medical and scientific journals.

Early clinical trials of COLD-fX were conducted in groups of high-performance professional athletes. The positive and encouraging results of this and other research led to further clinical research in healthy adults and seniors. The safety and efficacy of COLD-fX has been demonstrated in these trials, allowing this natural health product the comprehensive therapeutic claim “to help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system”.

A Randomized Controlled Clinical Trial of COLD-fX in Nursing Home Seniors.

Reference: McElhaney, J. et al. 2004. A Placebo-Controlled Trial of a Proprietary Extract of North American Ginseng (CVT-E002) to Prevent Acute Respiratory Illness in Institutionalized Older Adults. Journal of American Geriatric Society; 52: 13-19.

In this randomized controlled study, two methods were used to see whether institutionalized seniors contracted upper respiratory infections after daily intake (two 200 mg capsules) of CVT-E002 (COLD-fX):

symptoms alone (one respiratory and one constitutional symptom)
symptoms plus laboratory confirmation of respiratory viral infection

No effect was seen in the incidence of acute respiratory illness as defined by symptoms alone. The authors suggested that the definition for ARI in this study may have been too non-specific resulting in cases that overlapped with allergies or other medical conditions. Using the second, more sensitive method, this study reported that in this group of nursing home seniors (the majority of whom had received the influenza vaccine), there was an 89% relative risk reduction in the incidence of influenza and respiratory syncytial virus infections which had been confirmed through both laboratory testing and clinical symptoms.

This study was a U.S. Phase II authorized trial.

Abstract available via PubMed: click here

A Randomized Controlled Clinical Trial of COLD-fX in the General Population

Reference: Predy, G. et al. 2005. Efficacy Of An Extract On North American Ginseng Containing Poly-Furanosyl-Pyranosyl-Saccharides For Preventing Upper Respiratory Tract Infections: A Randomized Controlled Trial. Canadian Medical Association Journal; 173(9): 1043-1048.

This randomized controlled study investigated the effect of CVT-E002 (COLD-fX) intake (two 200mg capsules daily) for four months in 323 generally healthy adults who suffered at least two upper respiratory infections in the previous year. Statistically significant effects* were shown for both primary (number of colds) and secondary endpoints:

reduced average number of respiratory infections (Jackson-verified) per person by 25%
reduced number of recurrent (two or more) respiratory infections by 56%
reduced severity (total symptom score) by 31%
reduced duration of symptoms by 35%

*relative risk

The Office of Dietary Supplements Division of the National Institutes of Health (NIH) in the U.S. selected this clinical trial for inclusion in its Annual Bibliography of Significant Advances in Dietary Supplements Research. An international team of 50 scientific reviewers chose it as one of 25 selections drawn from more than 1,000 papers published in 58 of the world’s leading peer reviewed medical journals. The NIH, one of the world’s foremost medical research centres and an adjunct of the U.S. Department of Health and Human Services, is considered the steward of medical and behavioral research in the United States.

Abstract available via PubMed: click here

A Randomized and Controlled Trial of COLD-fX in Community-Dwelling Seniors

Reference: McElhaney, J.E. et al. 2006. Efficacy of COLD-fX in the prevention of respiratory symptoms in community dwelling adults: a randomized, double-blind, placebo controlled trial. Journal of Alternative and Complementary Medicine; 12(2): 153-157.

A randomized, double-blind, placebo-controlled study of CVT-E002 (COLD-fX) (two 200 mg capsules daily) in 43 immunocompetent community dwelling of adults aged 65 years or older, showed that ingestion of COLD-fX over four months reduced the relative risk and duration of respiratory symptoms late in the flu season by 48% and 55%, respectively. During the last two months of the trial, significantly fewer subjects in the COLD-fX group (32%) reported respiratory symptoms compared to the placebo group (62%). The duration of symptoms during the last two months was reduced from 12.6 days in the placebo group to 5.6 days in the COLD-fX treatment group. COLD-fX was shown to be safe and well-tolerated.
Abstract available via PubMed: click here
and
Our immune system is how we defend ourselves from germs, including bacteria and viruses. Stress, fatigue, travel and a poor diet can weaken this internal defence mechanism allowing germs to penetrate and make us sick. Taking COLD-fX daily offers added protection from illness. It helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.

Or, at the first sign of cold or flu symptoms, try COLD-fX Extra Strength a new three day dosage.

The Discovery
In 1992, Dr. Jacqueline J. Shan assembled a team of 25 international scientists from the University of Alberta whose vision was the discovery and development of natural health products for disease prevention and health maintenance. This team of experts primarily focused on ways to apply the rigor and standardization of Western science to natural medicines of the East.

In doing so, they developed an internationally recognized technology called Chemical and Biological FingerPrinting. This proprietary process was used to screen thousands of natural candidates with potential immune boosting effects and discovered that particular components (polysaccharides) of North American ginseng produced the strongest effect. We now know this discovery as COLD-fX, a ChemBioPrint product.

ChemBioPrint® - A Mark of Quality
Chemical and Biological FingerPrinting was developed to discover and standardize natural health products for disease prevention and health maintenance. It is a proprietary technology that:

1) Identifies the active components in a natural source;
2) Fingerprints the active components for chemical composition and biological activity;
3) Provides a standardized, quality manufacturing process

With the ability to confirm the consistency of each product batch, consumers can be confident that all ChemBioPrint products including COLD-fX and COLD-fX Extra Strength are safe, effective, and standardized.

Clinical Trials
Years of innovative research and clinical trials have shown that 200 mg of COLD-fX twice daily:

* Enhanced the body’s first line of defense: the Natural Killer (NK) and Macrophage immune cells
* Enhanced production of cytokines which are critical to activate the body’s second line of defense, the T-lymphocytes
* Reduced the relative risk of recurrent colds and flu
* Reduced the severity and duration of cold and flu symptoms
* Was safe and well-tolerated

Pivotal COLD-fX Trial in Healthy Adults (18-65yrs)
A randomized, double-blind, placebo-controlled trial was conducted on 323 healthy adults from the general population (18-65 years of age) with a history of at least two upper respiratory infections in the previous year. COLD-fX taken at 2 x 200 mg daily for 4 months was found to reduce the relative risk of recurrent colds (56%), the severity of cold symptoms (31%) and the duration of symptoms (35%). In this study, COLD-fX was shown to be safe and well-tolerated.

Predy, G.N. et al. 2005. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial. CMAJ. 173(9): 1043-1048.

From 42 of the 323 subjects recruited, 2 blood samples were collected before and after treatment. These samples were used for the determination of white blood cell differential counts, enumeration of lymphocyte subsets and measurement of plasma levels of immunoglobulin A (IgA). COLD-fX treatment at 2 x 200 mg daily for 4 months was shown to increase the number of T-helper and Natural Killer (NK) cells and decrease the level of immunoglobulin A in the plasma.

Predy, G.N. et al. 2006. Immune modulating effects of daily supplementation of COLD-fX (a proprietary extract of North American ginseng) in healthy adults. J. Clin. Biochem. Nutr. 39: 162-167.

Pivotal COLD-fX Trial in Nursing Home Seniors
A randomized, double-blind, placebo-controlled trial in institutionalized older adults at a dose of 400 mg daily (2 x 200 mg) for 8-12 weeks demonstrated that COLD-fX significantly reduced the relative risk of developing laboratory confirmed influenza (flu) or respiratory syncytial virus (RSV) illness by 89%. In this study, COLD-fX was shown to be safe and well-tolerated.

McElhaney, J.E. et al. 2004. A placebo-controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults. JAGS. 52: 13-19.

COLD-fX Trial in Community-Dwelling Seniors
A randomized, double-blind, placebo-controlled study of COLD-fX in 43 immunocompetent community-dwelling adults aged 65 years or older, showed that COLD-fX at 2 x 200 mg daily for 4 months reduced the relative risk and duration of respiratory symptoms by 48% and 55%, respectively. During the last 2 months of the trial, significantly fewer subjects in the COLD-fX group (32%) reported respiratory symptoms compared to the placebo group (62%). The duration of symptoms during the last 2 months was significantly shorter in the COLD-fX treatment group at 5.6 days as compared to the placebo group at 12.6 days. COLD-fX was shown to be safe and well-tolerated.

McElhaney, J.E. et al. 2006. Efficacy of COLD-fX in the prevention of respiratory symptoms in community-dwelling adults: a randomized, double-blind, placebo-controlled trial. J. Altern. Complement. Med. 12(2): 153-157.

Pilot COLD-fX Trial in High Performance Athletes
In an open study on 14 high performance athletes taking 2 x 200 mg of COLD-fX daily for 8 months, 50% (7 of 14) reported that COLD-fX allowed them to recover faster from a cold and 57% (8 of 14) reported that they felt less "run down" while travelling compared to the previous season. The treatment schedule was safe and well-tolerated.

Manuscript in preparation.

Pilot COLD-fX Trial in High Performance Athletes
The specific immune response to reported cold or flu infections was evaluated before and after 1 month of using COLD-fX (2 x 200 mg daily) versus a control group in 37 high performance athletes. The levels of TNF-y and IL-2, important immunologic mediators, were reduced in the control group (-50% and -25% respectively), however there were statistically significant differences in the COLD-fX with TNF-y and IL-2 increasing by 40% and 5% respectively. COLD-fX was shown to be safe and well-tolerated.

Manuscript in preparation.

COLD-fX Doping Control Urinalysis Trial in Athletes
A doping urinalysis trial was conducted under strict ethical and doping control guidelines in 40 athletes taking 400 mg of COLD-fX daily (2 x 200 mg) for 28 days. The results demonstrated that COLD-fX did not contain or generate banned substances within the body that might create a positive doping control test. COLD-fX was also shown to be safe and well-tolerated.

Goel, D.P. et al. 2004. Doping-control urinalysis of a ginseng extract, Cold-fX, in athletes. Int. J. Sport Nutr. Excer. Metab. 14: 1-8.

Pilot Trial in High Performance Athletes – acute three day dosage
In an open study on 8 high performance athletes, an acute dosing regimen of COLD-fX was followed at the onset of cold or flu-like symptoms: 3 x 200 mg capsules TID on day 1 (total 9 capsules = 1800 mg), 2 x 200 mg capsules TID on day 2 (6 capsules = 1200 mg), and 1 x 200 mg capsules TID on day 3 (3 capsules = 600 mg). 71% (5 of 7) reported that study product prevented the cold from developing and that it made them feel better. It was also shown to be safe and well-tolerated.
However this particular product still may need a bit more behind it before it has the complete thumbs up...as this article explains:

http://www.canada.com/calgaryherald/new ... 7d&k=13640
VANCOUVER -- A pharmaceutical expert has raised questions about the scientific claims made by CV Technologies Inc. concerning its flagship product, Cold-fX, which has become Canada's most popular cold and flu remedy.

James McCormack, a professor at the University of B.C. faculty of pharmaceutical sciences who specializes in evaluating and interpreting clinical drug trials, said in an interview that before the public buys into the company's motto, "trust the science," they need to look at the science.

One key to the company's financial success has been marketing. During the three months ending Dec. 31, it spent nearly $2.6 million, or 14 per cent of its gross revenue, on advertising and marketing. This pays for the TV, radio and newspaper ads that have made Cold-fX almost as common as colds. According to market research agency ACNielsen, Cold-fX now ranks as the country's bestselling cold and flu remedy.

The company's chief spokesman is Don Cherry, famous for his flashy suits and bombastic pronouncements. To leaven his patter, the company adds the tag line, "Trust the science."

At the Vancouver Sun's request, McCormack and a colleague, Peter Loewen, an associate professor at UBC's faculty of pharmaceutical sciences, reviewed the company's last three clinical trials. In all three trials, the researchers were not able to show that Cold-fX statistically reduced the percentage of subjects who ended up getting a cold.

The first two trials were conducted in 2000 and 2001, and involved 198 nursing home residents with an average age of about 82. Roughly half were given the ginseng extract used in Cold-fX and half a placebo.

The main purpose of these studies was to see whether the ginseng extract would reduce the incidence of acute respiratory illnesses (flu and respiratory syncytial virus, or RSV, a virus that causes flu-like symptoms), as defined by subjective symptoms such as cough, sore throat and runny nose. The researchers, reporting the results in the Journal of the American Geriatrics Society, found "no significant difference between the placebo and the ( Cold-fX) groups for the number of (acute respiratory illnesses) defined by symptoms." They also found "no significant difference in the severity or duration of symptoms related to (acute respiratory illnesses) between the two groups in either study."

The secondary purpose of the studies was to measure the difference in the incidence of laboratory-confirmed (typically by a viral culture) acute respiratory illnesses between the two groups. In the placebo groups, six and 12 per cent of the subjects in the two studies contracted flu or respiratory syncytial virus. In the ginseng groups, these percentages were lower -- zero and two per cent -- which suggests the ginseng had some therapeutic benefit. However, in each case, the "p value" -- the probability that chance explained the difference -- was high enough that these differences, by the researchers' own admission, were not deemed statistically significant.

It was only by combining the two studies that the result (nine per cent for the placebo groups versus one per cent for the ginseng groups) became statistically significant.

McCormack says combining the two studies erodes the credibility of the results: "Taking two studies that don't show a benefit and then adding them together to get a positive result is a form of data mining. It's torturing the data until it confesses."

He says these results are "hypothesis generating," meaning they raise a theory that may be worth investigating, "but they are not definitive evidence that Cold-fX works."

Company president, CEO and chief scientific officer Jacqueline Shan insists that combining the two studies is a well-recognized and often-used procedure. "If it wasn't a legitimate procedure it would never have been accepted for publication by the Journal of the American Geriatrics Society."

Loewen agrees that combining studies is a well-accepted process and does not constitute "data-mining" as long as it has been pre-planned: "Otherwise, it comes down to the trickier question as to whether the researchers did a second study because they didn't like the initial results."

Shan said the company decided to conduct a second trial, not because it didn't like the initial results, but because it ran into a logistical problem: "The number of naturally occurring illnesses during the first season was deemed to be insufficient to be able to perform any meaningful analysis, therefore, a second trial was performed. It is the pooled analysis of these two studies that provides the meaningful results," she said.

Taking the combined figures at face value, the absolute reduction in laboratory-confirmed illness was eight percentage points (from nine per cent to one per cent). But on a relative basis, the reduction was a much more impressive-sounding 89 per cent (the eight-per-cent reduction divided by the nine-per-cent starting figure). Using this relative figure, the company boasted that "Cold-fX reduces the risk of colds, flu and respiratory illness by 89 per cent," a statement that both Loewen and McCormack dismiss as "technically accurate, but quite misleading."

Loewen notes that, contrary to the company's claim, the two studies showed that Cold-fX didn't reduce the effects of acute respiratory illnesses, as measured by symptoms. He says this point is critical: "The patient has no interest in, or knowledge of, whether their illness is laboratory-confirmed or not. They don't care and we don't look for that in clinical practice. The study showed no difference in feeling sick, which was the primary endpoint."

He also noted that some 36 per cent of nursing-home residents reported symptoms of cold or flu, of which only nine per cent, or one-quarter, were laboratory confirmed. It was this reduction in laboratory-confirmed illnesses that became the key outcome.

"What about those other three-quarters of people who, for all intents and purposes, got sick? Are we to say that because their illnesses were not laboratory-confirmed, it wasn't relevant to them?" he asks. "Well, of course it was. That's why they (the researchers) picked symptoms-based outcomes as their endpoint. They could have said, 'Our interest is only laboratory-confirmed illnesses,' but they knew the clinically relevant endpoint was clinically diagnosed illnesses."

Shan argues that finding a reduction in laboratory-confirmed cases is "more powerful" than finding a reduction in cases defined by symptoms alone. She notes that people can easily mistake allergy symptoms, for example, for cold symptoms, but with laboratory confirmation "we cannot mistake the condition experienced by the patient for any condition other than a true acute respiratory illness."

Shan says that relative risk reductions are commonly used to quantify the efficacy of anti-viral drugs. In any event, she says, both relative and absolute risk reductions figures were reported in the company's news release.

McCormack also notes the incidence of laboratory-confirmed illnesses in both the placebo and ginseng groups is relatively small (nine per cent and one per cent), which means that Cold-fX, even if it does work, would be a questionable expenditure for most people.

"Based on these results, 13 nursing-home patients would have to take Cold-fX for two to three months to prevent one case of a laboratory-confirmed flu or RSV," he calculates.

For an herbal-based cold remedy, Cold-fX is expensive. Bottles of 180 capsules are selling at Costco for $57, or about 36 cents per capsule. The recommended dosage is two capsules per day, so if 13 subjects took the recommended dosage for two and half months, the cost would be $702. In other words, 13 nursing-home residents would have to spend $702 to prevent just one case of laboratory-confirmed flu.

"The increasing sales of Cold-fX indicate many people find it works for them," Shan says. "They make the economic judgment that the benefits of disease prevention outweigh the associated costs."

She also stated in a news release that "the increased public demand for our products is proof of the power of prevention."

But McCormack says high demand for Cold-fX proves only that the product is popular, not that it works: "Nobody who takes Cold-fX will be able to tell if it works for them. That's because colds occur randomly and symptoms vary in their severity. Who can say for sure that they didn't get a cold because of a particular product, or that their cold symptoms were moderated because of that product?"

Assume, for example, that one-third of the populace gets a cold every year. Assume also that the entire populace is given a placebo masquerading as a cold remedy. Obviously one-third of the population will still get a cold.

"Even though the placebo didn't reduce the number of colds, the two-thirds who didn't get a cold will swear by it," McCormack notes. "That is one of the many problems with anecdotal observation."

In October 2005, the company released the results of another clinical trial led by Dr. Tapan Basu, then a professor in the University of Alberta's faculty of agricultural, food and nutritional sciences, and Dr. Gerald Predy, Edmonton's chief medical health officer. This study consisted of 279 subjects, half of whom were given the ginseng extract used in Cold-fX and half a placebo. The main purpose was to see whether the ginseng group caught fewer colds.

Over a four-month period, subjects in the ginseng group experienced, on average, one-quarter of a cold less than the placebo group. That means each person has to spend a total of $86 to prevent one-quarter of a cold.

Recognizing that more studies are needed, the company is now funding a much larger study involving 720 subjects in three cities, Toronto, Edmonton and Vancouver. The subjects are all over 65 and were previously vaccinated against flu. The purpose is to see whether Cold-fX can prevent laboratory-confirmed flu and cold viruses, and alleviate the severity and length of symptoms.

Shan said the clinical trial, which could have an impact on Cold-fX's future sales, is still in its early stages. No release date has been set.
© (c) CanWest MediaWorks Publications Inc.
Ok...I have to get some work done...will continue with other points later..
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Re: Ridiculous cost of clinical trials hinder new bug repellant

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'One person's experience' is an anecdote and an outlier. Anyone who is actually aware of how things are understood and learned will quickly discover those do, in fact, render them useless. Indeed, your whacky anecdote of happy-fun-cuddliness is pointless: Cryptogenic remission and occasional jumps in enzymes are observed, documented, and researched.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

Simon_Jester Wrote:
But I have two problems with trying to dismiss the anecdote outright, and especially with doing so contemptously:
- This is not purely a question of the effect of the herbal on mother-of-JFF, because there is at least one study result. I lost track of where the issue of the quality of the study was raised, and that's a legitimate question, but an anecdote that would be irrelevant in isolation may nonetheless serve as a useful illustration of a technique that's already been found to work by a study.
- JFF's argument never really hinged on the effect of a specific herbal treatment on his mom. He brought it up, but even if we could somehow travel back in time and establish that he was really giving his mom sugar pills all along and that somehow she experienced an extended years-long placebo benefit from them, it wouldn't really change anything.

If this were the linchpin of his entire case, if he had said nothing more than "they worked for my mother," then yes, that should be thrown out entirely. But he has made many other arguments about biochemistry*, about various controlled studies, about reasons why even a highly effective herbal treatment would be slow to make it past the FDA, and so on. The only reason to spend so much time focused on his anecdote is that it his weakest argument, one that can be dismissed as an outright fallacy without needing to be refuted as a matter of fact the way claims about a study result would.
Thank you. That's what's irritating as fuck to me personally and that made me feel like it was just a big gang-up because not a SINGLE CONCESSION was given to any points I raised no matter HOW valid until Mike stepped in and agreed with some of my observations in regards to the flawed system of analysis and testing in regards to herbals being classified as drugs. Also the very nature of the classes of "food", "drug", "herbal". And even then,do you think they'd actually give ME credit for that? No, Stark even made it sound like Mike was the progenitor of said arguments..and when I pointed out that he was only echoing what I already said, his lame ass excuse was "Sadly that didn't help your major points". It's like, fuck, sulk much? Seems a little ridiculously chidish to me.

When you have numerous people deliberately ignoring all points you make that have any validity to them and focus on only the weakest ones they can pick apart, and then use that exclusion to justify deeming me a stupid, credulous idiot, then I have a right to call foul. How the hell is that being fair? So all of a sudden any smart arguments or related points that show that I actually HAVE a brain and some knowledge regarding the related subjects is completely irrelevant? Just because you want to narrowly focus on the easiest weaknesses to jump on, this alone justify's you in branding me an idiot?

I'm pleased to see that not everyone agrees or think's that is fair or accurate and I'm apreciative that at least ONE individual comes forward to show that support with his voice. The silence of others seems to indicate agreements for the people bashing me as he interpretes their choice not to post on the thread as silent support for the attackees. It's somewhat expected that people would naturally defend someone being unfairly maligned here, so when it doesn't happen, it seems to indicate agreement with the criticizers. I saw it that way, and so did he. Maybe people here should keep that in mind if they don't wish that to be how they and the rest of the observers are perceived. Speak up and give an opinion one way or the other. A consensus is helpful when more voices are added to the picture after all...
Stark wrote:
You have totally missed the point, but you're being pathetically tribal ('he's on my side of the fence yay'). Nobody is saying chemicals from herbs aren't sometimes beneficial - the issue is your totally broken mindset for declaring something 'useful'. I've even expressly stated this in the past,
You've definitely called his mindset broken; no question there. I went through your posts looking for where you explicitly said something along the lines of "I'm not saying chemicals from herbs aren't sometimes beneficial."

Mixed in with about a dozen posts laden with contempt and insults, the only thing I found was:

Stark wrote:
Holy shit you just don't get it.

This isn't a crusade against traditional medicine. It's a rejection of USELESS medicine (and potentially dangerous etc) which is why testing is important. Nobody really gives a FUCK if it's an ancient chinese solution to athlete's foot or whatever - only RESULTS matter. You know what happens to 'alternative' therapies when they're proven to work?

THEY'RE NOT ALTERNATIVE ANYMORE. They're actual, factual, testable and reliable therapies.

Championing 'alternative' medicine appears to be a tribal crusade here, dividing medicine into regular medicine and alternative, secret-of-the-ancients medicine you have to have an open mind to use. In reality, there are useful therapies, and useless therapies, and that's it. Testing is needed to determine the safety and efficiacy of a therapy.

For an "express" statement, that's a pretty roundabout way of saying that herbal stuff works sometimes.

Moreover, you seem to have missed the point of why he even gives a crap about any of this stuff being "traditional" in the first place. Hint: it's NOT because he thinks it proves the stuff is all that effective.
Absolutely correct. But Stark seems to demonstrate a deliberate bias against me in regards to this issue at least. He isn't willing to give me the slightest benefit of the doubt by interpreting anything I say positively. He's determined to paint me negatively. I don't know why...I can't recall any history of us clashing...but I have a poor memory for such things. Maybe there's a grudge against me I'm unaware of..in any event, while some of his criticisms are undoubtedly valid, his overexaggeration of my position and extreme hostility seems unwarranted to me and I find that more than irritating coming from somebody who is obviously intelligent. I can expect anything from idiots, but Stark isn't an idiot. I do feel he's being a little unfair though.
Which is what I've said previously. So, we have no particular argument here. As far as the study talked about it was the promotional material JFF posted that Stark took issue with. The other study I was talking about Aly ripped on in the first page.
No, that was only ONE of the things he took issue with. He took my examples of google searching that I posted for the express purpose of showing how I could locate supportive research and references BESIDES the promotional material of the company. It was also done fairly quickly and without any great effort to locate the best particular studies out there. They were only meant to be a smattering example of why I felt the company had some degree of validity to their claims for supportive research being out there indicating potential benefit. Unfortunately many specific ones I happened to grab were not the best examples I might have been able to locate if I had searched more diligently. In that respect, my bad. That's I have to be hung on the cross for it seems to be a bit extreme, but that's what they chose to do.

Erik von Nein Wrote:

Which is why I mentioned the low standards with his posting of the sources he did have. Using promotional material and a study Aly pointed out the deficiencies in shows this. I quoted him from when he first brought it up and where he said "Listening to you people, I should go to her and say 'Who gives a fuck that you are getting any personal benefit from this product, it isn't really proof. They told me you're just wasting your money and you're an idiot.'" I took issue with his insinuation that her improvement is proof. It's something suggestive that it could have benefit, but it alone isn't proof, which is something we've all gone over already.

Where he to find the studies from the promotional material that show evidence of what he's talking about and are properly executed then I would have no problem conceding that it's assumed benefits are real enough.
Conceded. It would have served me better to choose better sources and examples.

PainRack Wrote:
As TCM shows, its entirely impossible to postulate safe dosages for traditional medicines based on long usuage.
I disagree. Not impossible, just insifficient IN AND OF itself, yes. Conceded that much. However, it's helpful and suggestive. which is all I really said
Let me see..... oooh. I know. Talcum powder and bathing. Its been now researched that the use of talcum powder and daily showering worsen the risk of bedsores. There goes the nursing community decades long practice, and indeed, CURRENT practice of encouraging people to cleanse themselves regularly to protect the skin. Ditto to soap and water.
Let's use an even more modern example. Heparin Saline.
http://findarticles.com/p/articles/mi_m ... _81218984/
So, heparin saline is just as effective as normal saline. To make matters worse, there's growing evidence that excessive use of heparin saline can lead to over-heparisanation and cause a medical problem.

And this stuff has been in use for DECADES.
And yes, as this shows, what SEEMS to be safe based on 'traditional' usage bore out to have concerns. This will happen, but the RATIO of how many things turn out to be demonstrably wrong from the traditional history of apparent safety has so far been comfortably correct in the main when concerning a great deal herbals and their very long history of traditional use for medicine.
And how do you KNOW that there was no detectable health consequences if the studies haven't been done? History of usage alone is worthless, because we already know from TCM and other drugs such as Vitamin C that we are utterly unable to detect safety problems from there.
You are overreaching on some conclusions. Vitamin C is STILL considered to be reasonably safe within a generally accepted level of dosage. We are not "utterly unable" to detect safety problems, we just cannot do so ABSOLUTELY. It's simply an insufficient amount of research to establish firmly, not completely dismiss as worthless.
The point of contention here is yours and JSF argument that history of usuage equals to a proven track for safety, as humanity would had noticed any major problems from using such medicines. Even in our modern era, that's simply not true. I already brought up two modern practices/drugs that was in use for decades, promoted by modern medicine which have now been shown to be actually HARMFUL. If humanity was so wise and intelligent that we could discover potential problems from drug use, why didn't we notice the above problems until the late eighties and 21st century respectively?
Correct me if i'm wrong, but wasn't one of your examples arsenic? Arsenic is a known poison, and I do not believe that it has been considered as 'benign' as herbal products like milk thistle and ginseng...

You're exemplifying the exceptions to the rule and implying they are indicative of being "the rule".

Simon_Jester Wrote:
I maintain that it is possible to partially judge safety based on usage if and only if one would expect a lack of safety to be visible. Sometimes, looking at history of usage, the consequences of that use, and applying modus tollens allows us to place an upper bound on the dangers of using something.
Precisely what I was saying.
If eating broccoli were as dangerous as smoking tobacco, we would expect a noticeable correlation between broccoli consumption and death, one that would likely have attracted attention in the past. It's still possible that this could somehow have been overlooked for several decades, and that next year we will discover the broccoli is actually poisonous. But it isn't likely, which is why you will seldom find a doctor who advises against introducing broccoli to your diet because "for all we know, it might be poisonous."
again, sensible, and completely in line with what I was saying in regards to traditional use and safety.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

'One person's experience' is an anecdote and an outlier. Anyone who is actually aware of how things are understood and learned will quickly discover those do, in fact, render them useless. Indeed, your whacky anecdote of happy-fun-cuddliness is pointless:
Useless is a very definite judgement that leaves no room for anything other than complete dismissal. I'll agree for the purposes of pharmaceutical standards of safety and efficacy, it's useless in and of itself, but as I have argued, I believe it still has usefulness for it's actual data it presents.

What 'whacky anectode' of happy-fun-cuddliness are you referring to? I can't say I get the reference to any anectdotal example I've listed unless you're just painting my mother's personal good results of her own bloodword in relation to her usage of an herbal product and the probability of it being responsible for the beneficial lowering of her enzymes. Would like more clarification before I respond to that fully please?
Cryptogenic remission and occasional jumps in enzymes are observed, documented, and researched.
Yes of course. But not in a consistently reproducible and lasting fashion which is what makes the example of my mother more compelling then that.

Edited due to quote tags mistake.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

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One person's experience' is an anecdote and an outlier
Just for a futher comment on this....the very fact one person's ADVERSE reaction to a drug in a clinical study is still enough warrant it as a possible adverse effect demonstrates that even these individual anectdotes, even though they are an outlier, are still worthy enough for consideration and the inclusion of them as potential side effects. That in itself shows that they are never considered worthless.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by SirNitram »

Of course I'm talking about your rambling about your mother. What else was there? It was an anecdote. You clearly either don't know what anecdote means, or you'd realize there's no useful data there. Don't you get what Anecdote and Outlier mean? Or is this why this thread is seven pages?

And yes, retard, completely cryptogenic situations are not reliably repeated. Only goddamn morons like you don't realize that's explicit in the word 'Cryptogenic'. If there were known things to vary, it's not be a big mystery.

The idea it was 'Consistantly reproducable' when you only give one time when the liver enzymes simply happened to spike around that time proves you're a goddamn moron. That's not consistant reproduction

Here's what I'm attempting to get through your apparently lead-painted skull: You Don't Know Shit On This Subject. You're just another of those pro-CAM retards who pretends you can skip the science and research and knowledge if it 'Makes you feel good'.

All this reminds me of Linus Pauling, after his Nobel Prize peak, as he descended into his '1 to 10 thousand mg of Vit C a day cures the cold! Cancer! Prevents cancer!' whackiness, still resurging every few years.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

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And in the same vein as stark we descend into immediate insults and contempt...I'd be lying if I didn't say I expected that from you although I gave you the benefit of the doubt it might be after at least one more post. :roll:
Of course I'm talking about your rambling about your mother. What else was there? It was an anecdote. You clearly either don't know what anecdote means, or you'd realize there's no useful data there. Don't you get what Anecdote and Outlier mean? Or is this why this thread is seven pages?
Your conclusion of "useful" is not shared by me, so we'll just have to disagree on that. I understand perfectly the definition of both words, your personal conclusion in this case is what I disagree with, not the definition of the words.
And yes, retard, completely cryptogenic situations are not reliably repeated. Only goddamn morons like you don't realize that's explicit in the word 'Cryptogenic'. If there were known things to vary, it's not be a big mystery.
Adverse effects are not necessarily "reliably repeated". Hence the meaning of the word "adverse". I think you might need a little language refresher on word definition yourself. :lol:
The idea it was 'Consistantly reproducable' when you only give one time when the liver enzymes simply happened to spike around that time proves you're a goddamn moron. That's not consistant reproduction
Oh they just "happened to spike" did they? Now you're giving a declarative medical statement on my mother's bloodwork. They had spiked in the FIRST place and the doctor thought it eminently reasonable to conclude it was the Dilantin. The fact that the liver formula in question reproduced an effect TWICE that resulted in the lowering of the enzymes after they spiked for the SECOND time...not ONCE... is the reproducible part of the argument. Take a little more effort to get your facts correct please.
Here's what I'm attempting to get through your apparently lead-painted skull: You Don't Know Shit On This Subject. You're just another of those pro-CAM retards who pretends you can skip the science and research and knowledge if it 'Makes you feel good'.
Ad Hominem and strawman. Does this really deserve any other response?
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Justforfun000
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

And just to further prove my point...the word outlier:

1. What is an outlier?

"Outlier" is a scientific term to describe things or phenomena that lie outside normal experience.

Adverse:

Adverse medical events are negative patient outcomes that can occur as
the result of health care treatment and not due to the patient's illness.
They are often unanticipated and unexpected outcomes of health care
that do, or have the potential to, negatively impact a patient's health and
quality of life.

See how nicely the terms unanticipated and unexpected square with outlier?

Now do try and make a point that actually refutes my understanding and response to your usage of the word before you arrogantly condemn me.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

And Sir Nitram....I want a simple answer to a direct question..

If my mother happened to be with me and you heard this entire conversation about her personal experience, and now you've read the entire thing, so you can see how she PERSONALLY sees what is in all probability a benefit from these liver herbs, would you make a declarative statement to her saying either A) She should NOT take them because there isn't any conclusive evidence they are actually helpful or B) She should because she personally seems to derive benefit and has shown no evidence of harm or concern from them.

Maybe you have a C)...if so, I want to know what it is because it's all very well and good to put yourself on a pedestal and pontificate on what is smart or stupid to do based on your belief of what good medical decisions should be made on and how strong the criteria of evidence is necessary in your mind to ingest ANYTHING that may have a medicinal effect. It's all very well and good to label somebody 'credulous' or 'pro-cam', or whatever your flavour of insult may be, but I want to see how your philosophy plays out in the REAL world when dealing with actual situations and people's choices. Tell me exactly what you would tell her she should do or NOT do as the case may be. I'm very curious.
You have to realize that most Christian "moral values" behaviour is not really about "protecting" anyone; it's about their desire to send a continual stream of messages of condemnation towards people whose existence offends them. - Darth Wong alias Mike Wong

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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by SirNitram »

So your response to having the very basic concepts you've been ignoring is an Appeal To Emotion and humping your previous anecdote. Noted, you cowardly fuck. I see you've not bothered to post one iota of true rebuttal to the points I've raised, and now you're just outright changing the subject. In short, you're a waste of text.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

So your response to having the very basic concepts you've been ignoring is an Appeal To Emotion and humping your previous anecdote. Noted, you cowardly fuck. I see you've not bothered to post one iota of true rebuttal to the points I've raised, and now you're just outright changing the subject. In short, you're a waste of text.
???

THAT I wasn't expecting! I answered you honestly and earnestly on every single line of your statements. I raised very specific rebuttals to what you said, and how the fuck is that changing the subject?

I honestly don't understand you at times so I'm going to re-read that very carefully and see what I can decipher.
So your response to having the very basic concepts you've been ignoring
Ok, spell out the very basic concepts.

Secondly lay out exactly how I've been 'ignoring' them.

Don't give me wishy-washy bullshit or vague generalizations either Nitram, you either spell it out logically and fairly in accordance with board rules or don't bug my ass!

Ignoring is a pretty strong statement. If you feel I've OVERLOOKED something, or (in your mind) am densely refusing to grasp a valid point, than please lay it out very cogently and I'll do my best to respond.

You know, just for the record, we aren't enemies man. I don't dislike you or have any reason for personal enmity against you OR your arguments, so this quick downward spiral into mud slinging is truly unwarranted. You're not talking to a wool-headed Creationist trying to argue personal beliefs against evolutionary biology, I'm someone espousing an interest in herbal medicine for it's as of yet unproven and relatively untapped benefits it can offer us all in the field of medicine. I know a lot of the meat of the argument here is on the criteria of evidence and how that ties into someone's desire and decision to use something as a supplement, but my arguments here have NEVER been presented as "Herbal medicine is superior to pharmaceutical drugs and orthodox medical treatments". It's also never been that "Herbal medicine is practically almost always safe and anything that has been used for hundreds of years demonstrates a CLEAR proof of effectiveness". All of that bullshit has been total strawmen of my points and I wasn't the only one to finally see that and call it out.

So if you're going to be fair and serious with this, lay it out in a decent manner that properly addresses what I have actually said. I'm not trying to ignore or deflect you. I've answered you as best I could based on the very limited amount of postings you've made in this thread.
I see you've not bothered to post one iota of true rebuttal to the points I've raised
Indeed? I would have thought posting definitions showing the words I used along with their context made perfect sense even to your attempted rebuttal with outlier and cryptogenic. Maybe you just didn't like that I rebutted you successfully. I note that you didn't tear my responses apart by showing what was wrong with them. Just pretended I didn't rebut you.

You may be a respected member and a mod, but you're only as good as your last post. If you're going to be unfair and not play by the rules, then you are hardly a shining example of how people should be conducting themselves in debates.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Simon_Jester »

Justforfun000 wrote:Since this ended the thread and is going to be involved in my own posting, I'll throw my opinion in directly alongside Simon_Jewster. I agree with him that SOME things are reasonably held to a standard of "safety" based on traditional history and the lack of toxicity and/or long term side effects...SO FAR. But yes PainRack is absolutely correct, it's still not 100% or a free pass on them all.
Simon "Jewster"? Huh?
Ok. Conceded, but only to a degree...as Simon_Jestor has also been echoing my arguments regarding even singular cases as being relevant even though they are not CONCLUSIVE of anything...they still have significance because of their example. As to how much or what worth it might be, in this case I'm not arguing for what science demand as necessary, I'm defending the interest level for individuals and part of the process of investigating a product for consideration of use.
Could you please spell my name right? Just once?
Justforfun000 wrote:Simon_Jester Wrote:
Ah. So you CAN spell my name right. Once.
I'm pleased to see that not everyone agrees or think's that is fair or accurate and I'm apreciative that at least ONE individual comes forward to show that support with his voice. The silence of others seems to indicate agreements for the people bashing me as he interpretes their choice not to post on the thread as silent support for the attackees. It's somewhat expected that people would naturally defend someone being unfairly maligned here, so when it doesn't happen, it seems to indicate agreement with the criticizers. I saw it that way, and so did he. Maybe people here should keep that in mind if they don't wish that to be how they and the rest of the observers are perceived. Speak up and give an opinion one way or the other. A consensus is helpful when more voices are added to the picture after all...
Look, I am not interested in joining a crusade to end the practice of piling on individual posters who make unpopular claims and support them with arguments ranging from adequate to "stereotypical crappy" Even though sometimes that's me.

Leave me out of this; if I'm going to get embroiled in an argument with senior members of the board, I at least want the pleasure of starting the argument myself.
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OK, you are now two up and two down on the spell check issue. I will call off my evil minions; 50% puts you back up into the domain of forgivably bad spelling.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by SirNitram »

Justforfun000 wrote:And in the same vein as stark we descend into immediate insults and contempt...I'd be lying if I didn't say I expected that from you although I gave you the benefit of the doubt it might be after at least one more post. :roll:
Why did you stupidly expect to not be insulted when you debate so dishonestly? Oh, wait, this is WAAAAAAAAAAAAAAAAAAAAAAAH NITRAM IS MEAAAAAAAAAAAAAAN posting.
Of course I'm talking about your rambling about your mother. What else was there? It was an anecdote. You clearly either don't know what anecdote means, or you'd realize there's no useful data there. Don't you get what Anecdote and Outlier mean? Or is this why this thread is seven pages?
Your conclusion of "useful" is not shared by me, so we'll just have to disagree on that. I understand perfectly the definition of both words, your personal conclusion in this case is what I disagree with, not the definition of the words.
See, here's what seperates me from you: You think you can declare what is useful and applicable on your own belief, I stick to the scientific method, and rigorous testing that it requires. Hence you're a 'Belief will make butterflies!' retard and I'm not.
And yes, retard, completely cryptogenic situations are not reliably repeated. Only goddamn morons like you don't realize that's explicit in the word 'Cryptogenic'. If there were known things to vary, it's not be a big mystery.
Adverse effects are not necessarily "reliably repeated". Hence the meaning of the word "adverse". I think you might need a little language refresher on word definition yourself. :lol:
So your excuse to the fact you claimed reliable repeatability when none exist is to... Try and insult the fundamental notion we should only trust reliable, repeatable testing.
The idea it was 'Consistantly reproducable' when you only give one time when the liver enzymes simply happened to spike around that time proves you're a goddamn moron. That's not consistant reproduction
Oh they just "happened to spike" did they? Now you're giving a declarative medical statement on my mother's bloodwork. They had spiked in the FIRST place and the doctor thought it eminently reasonable to conclude it was the Dilantin. The fact that the liver formula in question reproduced an effect TWICE that resulted in the lowering of the enzymes after they spiked for the SECOND time...not ONCE... is the reproducible part of the argument. Take a little more effort to get your facts correct please.
Gods, you're a pathetic sad sack of shit. One incident with one prescription, one with a completely different set of circumstances, does not count as reproducable because they are not the same. Similarly, you pathetic cretin, two data points is not reproducable data in any form of science.
Here's what I'm attempting to get through your apparently lead-painted skull: You Don't Know Shit On This Subject. You're just another of those pro-CAM retards who pretends you can skip the science and research and knowledge if it 'Makes you feel good'.
Ad Hominem and strawman. Does this really deserve any other response?
Yea, you conceding because once again, I prove you're a no-nothing on this subject. Worse, you attack me for pointing this out, and 'Don't agree' and think that isn't an invitation to be mocked in a topic on medicine.
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by PainRack »

Justforfun000 wrote: Thank you. That's what's irritating as fuck to me personally and that made me feel like it was just a big gang-up because not a SINGLE CONCESSION was given to any points I raised no matter HOW valid until Mike stepped in and agreed with some of my observations in regards to the flawed system of analysis and testing in regards to herbals being classified as drugs. Also the very nature of the classes of "food", "drug", "herbal". And even then,do you think they'd actually give ME credit for that? No, Stark even made it sound like Mike was the progenitor of said arguments..and when I pointed out that he was only echoing what I already said, his lame ass excuse was "Sadly that didn't help your major points". It's like, fuck, sulk much? Seems a little ridiculously chidish to me.
Except that the history of the terms herbals,food and drugs is loaded with meanings that has negative connotations in modern healthcare. Indeed, you yourself subscribed to some of those myths and fallacies, remember the "herbs have no side effects" mythoid you quoted?

There are real problems with the classifications of food and drugs. However, the ONLY real problem between the classification of drugs and herbals is an entirely negative dilenma that emerges from the fact that the ammendents that differentiated herbals from drugs was made when the FDA didn't regulate drug therapies for effectiveness.... only safety. So, when the 1964(iirc) ammendent was made to regulate drug therapies for effectiveness, herbal supplements skipped this massive regulatory requirement purely by being classed differently!

Indeed, I can very well argue that this the main reason why Milk Thistle sylimarin isn't patented as a drug and companies instead choose to patent their own brands of herbal meds. The fact that you don't have to invest such a huge massive start up cost when other competitors can undercut you easily.

May I remind you that the real reason why Milk Thistle is still a fringe medication is very simple? No drug company out there has actually invested the money to find the effective dosage, safe therapeutic doses and other guidelines that guide drug delivery. This even though glucosamine, a drug with much more dubious efficacy already has an effective loading dose attached to it?
And of course, CAM is wasting public money on energy therapy, touch therapy and etc than in investigating actual worthwhile therapies. Do it well and you already have an additional medication for treating death cap mushroom poisoning.
I disagree. Not impossible, just insifficient IN AND OF itself, yes. Conceded that much. However, it's helpful and suggestive. which is all I really said
And as pointed out, absolutely nonsense. How is it helpful and suggestive when no one has ever looked to see whether its safe? Its only when actual anaylsis has been done to determine safety that some gauge of safety can be measured.
And TCM itself has had chinese scholars examining and analyzing the texts, the herbs and conducting experiments to determine safety and effectiveness in the past.
Again, your argument is that usuage can provide a helpful and suggestive indication of safety. This.Is.Nonsense. Even in a field where partial analysis had been done, TCM is still littered with dangerous poisons and worthless therapies.

And yes, as this shows, what SEEMS to be safe based on 'traditional' usage bore out to have concerns. This will happen, but the RATIO of how many things turn out to be demonstrably wrong from the traditional history of apparent safety has so far been comfortably correct in the main when concerning a great deal herbals and their very long history of traditional use for medicine.
Really?Kava rings a bell?
You are overreaching on some conclusions. Vitamin C is STILL considered to be reasonably safe within a generally accepted level of dosage. We are not "utterly unable" to detect safety problems, we just cannot do so ABSOLUTELY. It's simply an insufficient amount of research to establish firmly, not completely dismiss as worthless.
Wrong. We could only find the safety problems related to megadoses when scientific analysis was done, not semi-casual correlation of patient data...... And god help us if no useful patient data was actually collected, as is common in health quackery in the States.
Correct me if i'm wrong, but wasn't one of your examples arsenic? Arsenic is a known poison, and I do not believe that it has been considered as 'benign' as herbal products like milk thistle and ginseng...

You're exemplifying the exceptions to the rule and implying they are indicative of being "the rule".
Considering that there are an enormous number of dangerous, ineffective therapies that have been slowly ruled out by science, you sir, are full of it. You are yourself applying selective bias on potentially useful therapies...... that had been examined and researched by SCIENTIFIC STUDY.
Cow urine raise a mind? Bloodletting? Leaches? Homeopathy? Mercury poisoning?
TCM study, again, I repeat the word, STUDY, has shown in ancient history that some chinese herbs were dangerous in some combination, and thus, peasants collecting herbs in the field for usuage were doing actual harm to themselves. Granted, this was actually couched in the words of heatiness, yin/yang and etc due to the methodology of TCM in ancient China, but again, history of use did not indicate safety. It was study and self scarifice. One of the fathers of TCM in China was a doctor who systematically collected tales of herbs and treatments used by the various different provinces of china and then tested each and every one of them on himself or his immediate family members.
In doing so, he increased the herbal knowledge of TCM and similarly removed/streamlined other herbal concoctions and therapies.

Similarly, potential herbal therapies from Europe or India has also been run through the gauntlet of study. History of usuage alone is WORTHLESS. Attempting to argue that I'm the one using selective bias to weigh the scales is laughable, this when study, including modern scientific study has already exposed or removed the dangerous potential therapies in use in CAM.

again, sensible, and completely in line with what I was saying in regards to traditional use and safety.
And again, I highlight the examples of Talcum Powder and Heparin saline, to show how decades of mainstream use, even when it actually worsens an existing problem will not highlight risks if the data ISN"T being collected. Lung cancer was lucky. The popularisation of tobacco smoking to the masses occurred during an era when America medical information networks were being set up and expanded. Note that NOBODY, absolutely NOBODY caught on to the problems of tobacco smoking/chewing in Europe, the Arab world and China when no such medical data was being collected during the 17th century and 18th century
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by PainRack »

Justforfun000 wrote:And just to further prove my point...the word outlier:

1. What is an outlier?

"Outlier" is a scientific term to describe things or phenomena that lie outside normal experience.

Adverse:

Adverse medical events are negative patient outcomes that can occur as
the result of health care treatment and not due to the patient's illness.
They are often unanticipated and unexpected outcomes of health care
that do, or have the potential to, negatively impact a patient's health and
quality of life.

See how nicely the terms unanticipated and unexpected square with outlier?

Now do try and make a point that actually refutes my understanding and response to your usage of the word before you arrogantly condemn me.
You are an idiot. Adverse reactions are measured statistically and scientifically too.

Do you even know what an outlier really is?

For an experiment measuring height and potential energy(say measured in deformation of playdoh when a weight is dropped from a height),you can get outlier results that occur because of something going wrong. Something dropped at 5m would cause a greater dent than something dropped at 1m. Yet, you got a greater dent for the second... Maybe if you analysed the specific incident, it was because of some random variable such as the playdoh was damaged, the ball was hit or etc. Its still an outlier result.

Similarly, an outlier result can also refer to people who rests outside of the bell curve. For any given incident, you expect something to be played out on a bell curve. Some people may measure extremely low or high on said curve, these people are outliers.


ADVERSE reactions may have the same reasons as the above. Some random variable that screwed the result or the fact that they're just plain different. HOWEVER, its possible to actually measure the incident of said adverse reaction for drugs, that's why the phamarcist drug guide carries something like in less than 1% of patient, in less than 10% of patients, said adverse reaction such as hearing loss from vancomycin occured. This even when we know why vancomycin induces hearing loss!

If you receive a blood product, there's a reason why there is a statistic that says the adverse reaction of febrile reaction, blood borne disease of hepatitis B/C, HIV infection and agglutination exists!
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Re: Ridiculous cost of clinical trials hinder new bug repellant

Post by Justforfun000 »

Sorry SJ...I can't believe I spelled your name wrong that many times. :oops:

As to the rest of the posts, I'm just going to concede this argument. It's not worth the headache.
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