Futura Medical Share Discussion Threads

[lbo] 30/8/2022 17:47

Yes as I previously said and showed. I have been a long standing shareholder and been posting about FUM on ADVFN for over 14 years. Now why don’t you answer where is there evidence from any adequately placebo controlled blind study to substantiate Med3000 claims with no disclaimer of a ‘Clinically Proven’ effect beyond a placebo? As required by the ASA, the FTC and the Courts. Also why don’t you answer the clear questions about the more relevant patent issues that have been asked?

[haveapunt1] 30/8/2022 17:43

LBO. Seeing as you “hold” and clearly think the company is a scam, spend all day slating it, preach the product FUM have is placebo. Why not sell? It’s risen a good 20% the last month, so now is a good time to sell if your so dead against the company. Any sane investor would not spend all day here moaning . A sane investor that no longer believes in the company, sells his stock and retains his capital to invest elsewhere. My only guess is your reluctant to sell as your sitting on a heavy loss, and remain so bitter about it, you have little better to do than post here all day long wining and moaning, copy and pasting from google.

[haveapunt1] 30/8/2022 17:39

LBO, it was not a “personal question”. Get a grip

[lbo] 30/8/2022 17:13

The last time I checked this was the ‘In Futura a winner for 2015 BB’? (Quite ironic since its 2022). Perhaps you are on the wrong BB on ADVFN if you want to ask personal questions about any poster’s shareholdings? Especially when its obvious from my posts over many years that I have been a long standing shareholder from the start.



But more Interesting is that I too gather that I am still waiting. On the more relevant answers to any of the relevant questions about Futura on the Futura BB. That I have asked? What does that say about your ‘very sad’ ‘agenda’?. To quote the football phrase. Play the ball not the man!



(by extension, idiomatic, colloquial) To object to someone's argument by attacking the argument itself instead of them or a facet of their personality




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. FTC has often required this standard in consent decrees, requiring two such studies for future claims made by companies governed by such decrees.





Any future prevention, treatment, or safety claims about dietary supplements, foods, and drugs, however, must be supported by competent and reliable evidence, defined as randomized, double-blind, placebo-controlled human clinical trials to support the claims.

[haveapunt1] 30/8/2022 16:56

I gather LBO still hasn’t actually answered my question still from last week. Given he can’t, I think we have all seen his agenda. Very sad. Let him have his time, and I will just keep asking the same question. He will ignore it, and reinforce his agenda here for all to see. For the life of me I don’t see why people here even give him typo time. Just ignore and filter

[petroc] 30/8/2022 14:40

As I said before, LiarBO, if you can keep getting away with posting your stock bashing anti-FUM propaganda, they're not likely to stop me calling you what I like, especially as it's all true, you lying, deceitful, stock bashing manipulator.

[lbo] 30/8/2022 07:53

I see you have breached the ADVFN T&Cs yet again still feeling the need to resort to obscene language. Still no sign of you showing where there is any adequate placebo controlled blind study to substantiate any claim that Med3000 is having any effect beyond a placebo?

Med3000 is just a class 2 medical device gel. Same as flexiseq gel. Med3000 was 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. FM71 is also not an adequately controlled study to substantiate any claims it is having any effect beyond a placebo.






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. We understood that the Aerosure Medic was classified as Class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. 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 of the device.

[lbo] 29/8/2022 14:12

Selling brass as gold harms consumers independent of any effect on pain. Since the placebo effect can be obtained from sugar pills, charging $200 for a device that is repre- sented as a miracle cure but works no better than a dummy pill is a form of fraud. Thats not all. A placebo is necessary when scientists are searching for the marginal effect of a new drug or device, but once the study is over a reputable professional will recommend whatever works best.
Medicine aims to do better than the placebo effect, which any medieval physician could achieve by draining off a little of the patients blood. If no one knows how to cure or ameliorate a given condition, then a placebo is the best thing going. Far better a placebo that causes no harm (the Q-Ray Ionized Bracelet is inert) than the sort of nostrums peddled from the back of a wagon 100 years ago and based on alcohol, opium, and wormwood. But if a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the con- sumer. See Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992) (a statement violates the FTC Act “if it is likely to mislead consumers, acting reasonably under the cir- cumstances, in a material respect�).



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] 29/8/2022 11:46

So inappropriately marketing a placebo as a ‘clinically proven’ treatment for ED when the consumer may not have been informed they were being treated with just a placebo will most likely lead to consumer lawsuits. As its clear other more appropriate treatments exist for not just the real underlying organic causes but even Psychological ED including psychotherapy for the real underlying psychological cause.




A good number of men receiving a placebo in clinical trials for erectile dysfunction drugs experienced an improvement in their function, researchers said in a report published online March 20 in JAMA Network Open.

This placebo effect was most pronounced in men with post-traumatic stress disorder (PTSD), suggesting that for some men psychology is more important than physiology in dealing with erectile dysfunction, said lead researcher Alexander Stridh of the Karolinska Institute's department of clinical neuroscience, in Stockholm.

"The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors, as in post-traumatic stress disorder," Stridh said.

"This paper highlights the importance of taking into account the underlying cause of [erectile dysfunction] in each individual, which could also help determine what the best treatment option would be," Stridh said. Some men might benefit more from psychotherapy, others with a pharmaceutical approach, he added.

"It is clear that Viagra and other [erectile dysfunction drugs] work very well in many cases, but we should not disregard the importance of psychological aspects of [erectile dysfunction], particularly in individuals who have no clear physiological causes for [the condition]," Stridh said.

[petroc] 29/8/2022 10:30

You can dress it up any way you like, LiarBO, throw in some smoke screens and lies, but there's no getting away from the FACT that 60% of subjects found it worked for them, compared to that made up 50% you keep claiming for placebos. That was from clinical trials and real world testing. You use the words 'adequately controlled test' and yet you've previously bleated on about MED3000 being 'just a device' which doesn't actually require the level of controlled tests you're referring to.

[lbo] 29/8/2022 09:24

Says the ramper who posted it was a ‘FACT’ that Med3000 was ‘clinically proven’. Yet the ASA, FTC and EU courts all have said it is not a ‘FACT’. Not even Futura have claimed it was a ‘FACT’ and unlike the ramper Futura always use the necessary disclaimers. As Med3000 has yet to been shown to have any effect beyond a placebo in any adequately controlled study.



Med3000 was the placebo in FM57. 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



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. We understood that the Aerosure Medic was classified as Class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. 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 of the device.

[petroc] 28/8/2022 18:26

I see you're still using full stops when you should be using commas, LiarBO. Better stick to your usual copy/pasting, eh? At least you might get something right!