Futura Medical Share Discussion Threads

[lbo] 30/9/2022 15:22

Just like with Pain. ED is primarily a self-assessed condition. Amazing how its the two indications that placebo gels are being claimed to have ‘magic’ effects! LOL

Clinical assessment of the therapeutic intervention is not done with a measurable laboratory value or physical finding but is derived from patient reporting and in ED indirectly from partner perception.

In the course of ED and Pain evaluation, therapy selection, and outcome assessment, the patient and physician enter into an intimate communicative relationship in which there is some element of bias. Physician bias arises from the desire to achieve an excellent response without side effects, and patient bias may occur in the additive unconscious need to please the physician. This may lead to treatment outcome inaccuracies, with an over-reporting of efficacy and an under-reporting of treatment side effects.




Percentage change from baseline has the lowest statistical power and was highly sensitive to changes in variance.

[petroc] 30/9/2022 15:19

Hahaha! I knew LiarBO would sneak back in and edit his post! That's why I copy/pasted it immediately so everyone could have a laugh at his expense! And now he looks even more silly because he's tried to change it surreptitiously. Oh, the humiliation of accidentally calling me Petroc the Proven!

[petroc] 30/9/2022 14:27

'Scientists are still learning exactly how paracetamol works. Paracetamol is thought to reduce the intensity of pain signals to the brain and reduce fever. Unlike non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol has minimal effect in relieving inflammation. This is an important consideration as some types of body pain (like osteoarthritis pain) are caused by inflammation.' hxxps://www.nurofen.com.au/pain-advice/about-nurofen/what-is-paracetamol/

[petroc] 30/9/2022 14:25

'LBO30 Sep '22 - 14:09 - 13549 of 13549
0 0 0
LOL

More lies and misinformation from Petroc the proven.' Hey, I like that! Petroc the Proven - that's got a certain ring to it!

[lbo] 30/9/2022 14:09

LOL

More lies and misinformation from Petroc the proven liar. And apparently even his boyfriend/girlfriend has now dumped him probably for being a liar too! ROFLMAO



Acetaminophen blocks pain by inhibiting the synthesis of prostaglandin, a natural substance in the body that initiates inflammation. Acetaminophen reduces fever by acting on the hypothalamus region of the brain which regulates temperature.

Meanwhile MED3000 just works by ‘magic’ and or possibly some sort of disputed CIVD mechanism or possibly by some evaporative hocus pocus! LOL

[petroc] 30/9/2022 13:21

Hahaha! Even if it were true I had a boyfriend, even if it were true that I had ED, at least it would mean I had someone to share my life with, unlike yourself, LiarBO, as you sit in your bedroom in your pants all day long, furiously bashing your keyboard in your endless spiteful spat against FUM because you lost all your money by stupid investing. The only other person in your life is mummy, who drags you out every bank holiday down to Marks and Sparks to buy you new pants because the old ones are worn out and so disgusting from all your gels, ointments and creams you keep trying that she refuses to wash them! BTW, speaking of 'magic' and the fact you think that it's a problem that they don't know exactly how MED3000 works, may I just point out that it hasn't seemed to have caused the makers of paracetamol any problems not knowing exactly how that works either.

[lbo] 30/9/2022 13:00

Seems they know how Rugiet ready works so quickly but not MED3000! As MED3000 relies on ‘magic’ and hocus pocus magic is real according to the rampers as there is no evidence that the magicians assistant was not actually sawed in half! And the rampers even claim they don’t need to prove their magic potion works in fantasy land! But the fact remains any advertiser of the supposed magic potion in the real world will have to! ROFLMAO




A product that contemporary technology does not understand must establish that this ‘Magic’ actually works. Proof is what separates an effect new to science from a swindle . . . . If a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer. FTC v. QT, Inc., 512 F.3d 858, 862-63 (7th Cir.

Trinity Research even openly admitted the hypothesised effects ‘believed’
to be happening by Futura are ‘disputed’and Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But unfortunately it does need to be proven to substantiate its marketing claims or fall foul of the FTC, ASA and the Courts.

Trinity research:

Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar. Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as medical device



There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel

[lbo] 30/9/2022 12:37

Again you cannot substantiate any of your false claims with any evidence. But yet again you are confirming you are just a proven liar who only makes unsubstantiated claims. And now again proven to be using multi-IDs to try ramp Futura all over the internet claiming ‘FACTS’ that were proven not to be false.



It is the advertisers s responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you. When submitting evidence for new or breakthrough claims, sound data, relevant to the advertised claim(s), should be collated to form a body of evidence. The totality of this evidence is important; marketers should not ignore sound data that does not support the new claim, especially where current opinion is divided. Where evidence is limited to very few studies, the studies should have robust results to ensure the basis for the claim is sound

[lbo] 30/9/2022 11:19

Again just saying there is no evidence it doesn’t work is not according to the FTC and ASA evidence it does work!

The onus is on the person/company making the questionable claims to be able to substantiate the claims to the FTC and ASA with evidence from adequately controlled studies.

Which you have failed to do yet again! Please show one adequately controlled study that can substantiate any effect beyond a placebo?

You cant even provide results from just a simple blind direct efficacy comparison study against a standard cooling lubricant/arousal gel and substantiate any claim its even having any effect beyond an arousal gel would! LOL



Advertising and labeling claims are a primary way companies try to grab consumer attention and distinguish one product from another. As the market becomes crowded, competition has increased and claims have become increasingly aggressive and, sometimes, overreaching. Companies must balance the desire to sell products against the fundamental principle that material claims must be substantiated with the appropriate level of support. If not, companies are at risk of action from regulatory agencies such as FTC and FDA, offices of state attorneys general, local district attorneys, competitors and, of course, plaintiffs lawyers.

The primary regulator of advertising claims is FTC.

FTC identifies principles that are generally accepted to yield reliable test results. A well-designed and carefully controlled study with the blinding of both subjects and researchers is generally viewed as more likely to yield reliable results.

Advertisers must carefully consider each claim and ensure that proper support exists. Otherwise, in this era of ‘claims litigation," a company may find itself on the receiving end of unwanted action from a variety of sources.




According to the FTC, Massachusetts-based NeuroMetrix, Inc. and its CEO, Shai Gozani, sold Quell transcutaneous electrical nerve stimulation device to consumers, touting it as clinically proven and FDA cleared’ for widespread chronic pain relief. The FTC says that the defendants lack scientific evidence to support widespread chronic pain-relief claims, and their claims about clinical proof and the scope of FDA clearance for this use are false.

[lbo] 30/9/2022 00:02

So who should we believe? The anonymous unvalidated ramper or the FTC, ASA and the SMSNA? LOL

The FM57 trial did not set out to measure the efficacy of Med3000. From previous rulings it can be seen that the ASA and FTC will consider that the reported effectiveness of Med3000 in FM57 was a post-hoc finding, due to the risk of that being a false positive finding. The ASA will also be concerned that there was not an adequate placebo control for Med3000 in the FM57 trial or in FM71. FM71 was also an unblinded study.



And the percentage who have subjectively reported an improvement is only over baseline. Still doesn’t substantiate a claim that the improvement reported had even anything to do with the gel itself.



Large improvements vs. baseline are common in the placebo groups in clinical trials of a wide range of conditions. This improvement is sometimes attributed to the 'placebo effect', implying that the placebo caused the improvement

There are many reasons why symptoms can improve over the course of a trial, of which the placebo effect is only one. To measure the actual effect of a placebo, we would need to compare the placebo to a control group who got no treatment at all. This hasn't been done for MED3000


ED is primarily a self-assessed condition.

Clinical assessment of the therapeutic intervention is not done with a measurable laboratory value or physical finding but is derived from patient reporting and indirectly from partner perception.

In the course of ED evaluation, therapy selection, and outcome assessment, the patient and physician enter into an intimate communicative relationship in which there is some element of bias. Physician bias arises from the desire to achieve an excellent response without side effects, and patient bias may occur in the additive unconscious need to please the physician. This may lead to treatment outcome inaccuracies, with an over-reporting of efficacy and an under-reporting of treatment side effects.




Percentage change from baseline has the lowest statistical power and was highly sensitive to changes in variance.

[lbo] 29/9/2022 23:54

And yet again its you who is acting like a little ‘boy’ who cannot comprehend that the FTC, ASA and consumers don’t need to prove anything.

‘ASA will not seek out the evidence to establish the veracity of the claim for you’

The person or company making the claims needs to be able to substantiate their claims with adequately controlled study’s if they claim their product is having any effect beyond a placebo.



It is the advertisers s responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you. When submitting evidence for new or breakthrough claims, sound data, relevant to the advertised claim(s), should be collated to form a body of evidence. The totality of this evidence is important; marketers should not ignore sound data that does not support the new claim, especially where current opinion is divided. Where evidence is limited to very few studies, the studies should have robust results to ensure the basis for the claim is sound



The following are a few of the common issues companies must resolve when determining whether the appropriate substantiation exists for their claims.

One important caveat to keep in mind is that, if an advertiser expressly states or implicitly suggests a certain level of scientific evidence exists, it must have at least that level of evidence. So, statements like “clinically proven" or “scientifically shown" require at least one or more clinical trials to support the claim. Additionally, an advertiser should not suggest a clinical trial has been conducted on the product if the study relied upon was conducted on a single ingredient or on another product.

the ‘gold standard’ is a well-designed, double-blinded, placebo-controlled clinical trial appropriately conducted on the actual product.

[lbo] 29/9/2022 19:39

According the FTC and ASA ‘clinically proven’ claims require to be substantiated with adequately controlled studies. Only multi-ID rampers like you hiding behind anonymous unvalidated user names can get away with the ‘deceit’ of claiming ‘FACTS’ ‘it works’. In the real world the advertisers answer to consumer laws, the ASA, the EU courts and the FTC.





The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence,



What standards are applied to evidence? The position taken by the ASA is a tried and tested one which has developed over the course of many years. It reflects the opinion of the wider scientific and academic community, rather than judgements made solely by the ASA. There are many aspects that are taken into consideration when evidence is reviewed and each claim is judged on its merits alongside the evidence presented to support it. Evidence submitted for health claims should normally include at least one adequately controlled experimental human



In each of the six cases filed, FTC alleged that the companies not only lacked scientific substantiation for their claims regarding the health benefits of their CBD/CBG products, but also falsely represented that their claims were either scientifically proven or had been confirmed by the U.S. government.

Under the proposed orders settling FTC complaints in each of these cases, the companies and their owners are prohibited from making prevention, treatment, or safety claims similar to the ones the companies made about their products about any dietary supplements, foods, and drugs unless they have the human clinical testing to substantiate such claims, and are required to have competent and reliable scientific evidence for any other health-related product claims. Specifically, the testing must be: (1) randomized, double-blind, and placebo-controlled

[lbo] 29/9/2022 19:32

Just saying there is ‘no shred of evidence that it doesn’t work’ is not evidence to substantiate it does work to the ASA and FTC! ROFLMAO



A product that contemporary technology does not understand must establish that this ‘Magic’ actually works. Proof is what separates an effect new to science from a swindle . . . . If a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer. FTC v. QT, Inc., 512 F.3d 858, 862-63 (7th Cir.

Trinity Research even openly admitted the hypothesised effects ‘believed’
to be happening by Futura are ‘disputed’and Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But unfortunately it does need to be proven to substantiate its marketing claims or fall foul of the FTC, ASA and the Courts.

Trinity research:

Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar. Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as medical device



There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel

[lbo] 29/9/2022 19:26

And what you keep seeming to fail to understand. Is that the burden of proof is on those making the claims about a product to be able to substantiate it has any effect beyond a placebo with adequately controlled studies. Its not up to the FTC or the ASA to provide any evidence. They are not the ones trying to make claims that cannot be substantiated.



It is the advertisers s responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you. When submitting evidence for new or breakthrough claims, sound data, relevant to the advertised claim(s), should be collated to form a body of evidence. The totality of this evidence is important; marketers should not ignore sound data that does not support the new claim, especially where current opinion is divided. Where evidence is limited to very few studies, the studies should have robust results to ensure the basis for the claim is sound

[petroc] 29/9/2022 17:31

BTW, LiarBO, I expect you to come up with at least three unrelated copy/pasted comments that don't address the fact that there is no evidence that suggests that MED3000 doesn't work.

[petroc] 29/9/2022 17:29

I see you didn't manage to come up with a single shred of evidence that MED3000 doesn't work then. Unsurprising really, as there isn't any. Unlike all the evidence that says it does work, however much you try to rubbish the responses of all the people who have tested it.