Futura Medical Share Discussion Threads

[lbo] 01/12/2022 11:53

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�).

[petroc] 01/12/2022 11:17

I doubt very much that Futura is aiming MED3000 at young men and the recreational Viagra market! And if LiarBO thinks that rubbing a bit of gel on your helmet during foreplay is less discreet than 'I'm sorry darling, I didn't realise a shag was on the cards tonight so I'll just take one of these and I'll be ready in an hour!' then he's talking out of his backside as usual.

[lbo] 01/12/2022 10:54

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. 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] 01/12/2022 10:45

What happened next gets to the FTCs allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.



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 and the FTC 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] 01/12/2022 10:35

'Firstly C140 you cannot make accurate indirect cross comparisons between the saffron gel study and FM57 of FM71.' Says LiarBO. And yet he constantly compares the two trying to show MED3000 in a bad light!
He then goes on to castigate Mikethebike: 'How many times have you repeatedly posted the same misleading post.' The irony of that one is unbelievable! LiarBO the stock basher, who goes about his business bashing the stock by constantly copy/pasting the same tired old comments, has the gall to complain about someone else repeating themselves! Which reminds me:

[lbo] 01/12/2022 09:59

Poor mike knows all about buying in when everything appears 'rosy' according to the rampers! mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-lifeAnd where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remunerationI just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[lbo] 30/11/2022 23:02

Futura has openly admitted in an RNS back in 2021 it was using the ‘least burdensome’ route of the De Novo medical device registration for Med3000. This only requires a low threshold of effect over baseline for ˜reasonable assurance’ of some effect including even just placebo effect for lower class medical device registration. This has allowed Futura like other medical device manufacturers exploit ‘the 2002 Medical Devices User Fee Act’ which requires the FDA to use the least burdensome route for that low class device. So the FM71 study was deficient as it was an uncontrolled and an unblinded study and ˜prone to bias. So even if if Med3000 is given medical device registration. FM71 still has not met the standards of the FTC to substantiate any claims of an effect beyond a placebo and the FTC has jurisdiction over the marketing claims of these lower class medical devices. Similar applies to FM57. It was not an adequately controlled study as it was designed to study Med2005 not the placebo MED3000 gel.



Devices are subject to weaker standards than drugs because they are regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA OK

Journalists need to scrutinize the claims.
Journalists have a responsibility to report this lack of evidence, but they often dont. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really dont know what we are getting with many of these devices

Ninety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the least burdensome route

For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials, the gold standard, are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined reasonable assurance that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices.



In terms of advertising and promotion, for most over-the-counter medical devices, the FDA and FTC exercise joint regulatory authority over product labelling and advertising. The FDA has primary jurisdiction over labelling for all medical devices and advertising for restricted devices (typically Class III), while FTC has primary jurisdiction over advertising of unrestricted medical devices (Class I and most Class II devices). The FDCA prohibits the distribution or receipt in interstate commerce of a misbranded medical device, which includes a device bearing false or misleading labelling. Claims in device labelling, including product websites, that are outside the scope of the device cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA

[petroc] 30/11/2022 19:16

It also gives me great pleasure to know that when I post something like that, LiarBO has to sit there fuming knowing that he can't respond quickly because it will just prove me right! Bwaahahahaha! Jump, LiarBO, jump!

[petroc] 30/11/2022 17:53

You'll notice that LiarBO reacts to comments within about 5 minutes, which means he has an alert set for when someone posts on this thread. It gives me great pleasure to think of him jumping up and rushing over to his keyboard frantically every time I make a comment!