Futura Medical Share Discussion Threads

[petroc] 19/1/2023 13:16

More than twice as many men with ED who have trialled MED3000 in three separate trials confirmed that it worked, compared to the small group who didn't see any benefit.

[petroc] 19/1/2023 13:15

LiarBO, thank you for providing that link about placebo effect in ED treatment trials. They made it quite clear that men in the placebo cohorts did see a small improvement, but not nearly as much as the men in the drug cohorts.

'The effect size in the placebo arm showed a small to moderate improvement of erectile function (Hedges g [SE], 0.35 [0.03]. The overall effect size in the drug arm showed a large response, 1.25 [0.07]. A comparison between responses in the drug and placebo arms revealed a large difference in favor of active drug.

Which goes to suggest that over 60% of men who trialled MED3000 were seeing real improvements based on the treatment, rather than mere placebo response. Over 60% is not a 'small to moderate improvement' in anybody's book!

[lbo] 19/1/2023 11:38

Med3000 has never shown any effect beyond a placebo in any adequately controlled study!



Uncontrolled Trials

This design incorporates no control arm. This design is usually utilized to determine pharmacokinetic properties of a new drug (Phase 1 trials). Uncontrolled trials are known to produce greater mean effect estimates than a controlled trial, thereby inflating the expectations from the intervention. There is a threat of inherent bias and results are considered less valid than RCT. Another issue is use of this design in spontaneously resolving maladies that might again overstate the effect



Administrative Law Judge Upholds FTC's Complaint that POM Deceptively Advertised Its Products

erectile dysfunction claims were false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.



Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim ‘AcceleDent’ is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.

On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.

[lbo] 19/1/2023 11:29

ROFLMAO

And what about the retrospective view on FM57 or the fact FM71 was unblinded, uncontrolled and of a smaller size! What about all the confounding in those unblinded uncontrolled tests!!!! How ironic the ramper is disproving all the MED3000 tests with his own post!

Note how he never made those comments about the language about MED3000 only just having ‘potential’ to be an effective treatment’ not claiming that it is an effective treatment and that its all just based on what the ‘company believes’. Again the words used in the posts he has been posting repeatedly over an over! LOL



Med3000 was also just the placebo in the FM57 study Therefore Futura had initially believed Med3000 had no therapeutic effect. The FM57 study did not set out to measure the efficacy of Med3000. The ASA will therefore consider that its reported effectiveness by Futura was a ‘post-hoc finding’

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

a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive

had been used as the placebo treatment in that study, and therefore the researcher had initially believed it had no therapeutic effect. The trial did not set out to measure the efficacy

its reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding

We were also concerned that there was not an adequate placebo control in the trial. We, therefore, considered that the study did not provide adequate evidence for the claim ‘clinically proven’



One specialist commentator felt that the clinical effectiveness has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness could be attributed to the placebo effect of rubbing a gel

[petroc] 19/1/2023 10:40

Hahaha! Truant has closed his fantasy short! Priceless!

[truant2tb1] 18/1/2023 22:54

Closed my short, taken small profits and will be back on any spike. Anyone thinking this is a viable business is going to learn the hard way in the next 18 months

[petroc] 18/1/2023 19:17

Hahaha! Sue me then, LiarBO!

[lbo] 18/1/2023 14:45

‘this era of ‘claims litigation’ a company may find itself on the receiving end of unwanted action from a variety of sources’

How long before Reckitt wrecks the rampers lies once and for all after they get their hands on some Med3000 which only contains alcohol, glycol, water and carbomer! LOL

˜When A Claimed Trade Secret Isn't In Fact A Secret’






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.

[lbo] 18/1/2023 14:42

It is the advertisers 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



Unfair commercial practices

When you buy goods and services anywhere in the EU from a website, a local shop or a seller outside your home countrys EU law protects you against unfair commercial practices. When promoting, selling or supplying products, companies must give you enough accurate information to enable you to make an informed buying decision. Find out more about contract information. If they fail to provide this information, their actions may be considered unfair. You have the right to seek redress if you are treated unfairly.

Misleading and aggressive practices

You are protected against 2 main categories of unfair commercial practices: misleading practices, either through action (giving false information) or omission (leaving out important information) aggressive practices that aim to bully you into buying Certain commercial practices are prohibited in all circumstances. Some of the most common are listed below:

Whenever a product is advertised as therapeutic, curing allergies, reversing hair loss, helping you lose weight, etc. you have the right to know if such claims have been scientifically confirmed. In many cases, claims like these are not medically backed up and are simply too good to be true

[lbo] 18/1/2023 14:39

And then will come the consumer lawsuits! LOL



Assessment

Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.

CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.

There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy




Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim AcceleDent, is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.

On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.



Assessment

Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.

CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.

There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy



Med3000 was just the placebo in the FM57 study Therefore Futura had initially believed Med3000 had no therapeutic effect. The FM57 study did not set out to measure the efficacy of Med3000. The ASA will therefore consider that its reported effectiveness by Futura was a ‘post-hoc finding’

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

a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive

had been used as the placebo treatment in that study, and therefore the researcher had initially believed it had no therapeutic effect. The trial did not set out to measure the efficacy

its reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding

[petroc] 18/1/2023 13:22

The stock basher doesn't want it known that more than twice as many men with ED who have actually trialled MED3000 all confirmed that it works!

It's all part of his stock bashing scheme!

hxxps://whatanutter.com/bashingthisstockforfiveyears/sadloser