Futura Medical Share Discussion Threads

[lbo] 06/2/2023 16:25

And the bias and fraud relates to the ‘bunk’ and ‘deficient’ tests the ramper keeps relying on. Which still do not substantiate Med3000 is having any effect beyond a placebo or even arousal gel would have in those same tests.



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

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.



Bias and Fraud

There are numerous biases in medical research that render evidence from such research systematically misleading. Some of these biases are exacerbated by conflicts of interest, including fantastic financial incentives. The most important biases in medical research include confirmation bias, design bias, analysis bias, and publication bias. Arguably, some forms of bias, such as publication bias, should be considered as fraud. The pervasiveness of bias in medical research justifies one of the premises of the master argument for medical nihilism. Medical research is malleable due to the many biases, and such malleability allows for the production of evidence that suggests medical interventions are effective, whether or not they are in fact effective.



What method-issues to consider when assessing Risk of Bias

Concealment of randomization

Those enrolling patients are aware of the group (or period in a cross-over trial) to which the next enrolled patient will be allocated (major problem in pseudo or quasi randomized trials with allocation by day of week, birth date, chart number etc.)

Blinding
Patient, caregivers, those recording outcomes, those adjudicating outcomes, or data analysts are aware of the arm to which patients are allocated (or the medication currently being received in a cross-over trial)

Selective outcome reporting
Incomplete or absent reporting of some outcomes and not others on the basis of the results

Use of unvalidated outcome measures (e.g., patient-reported outcomes)



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

[lbo] 06/2/2023 16:23

And again Petroc is proven wrong. The research linked clearly showed that

‘the placebo effect is not only similar for medical devices to medical trials; it is considerably larger’

So if the ‘placebo response to oral ED treatments in trials can be up to 50%’ and ‘medical devices can be considerably larger’. That clearly explains the placebo effect of Med3000/Eroxon the ramper keeps fixating on.

Especially when you also consider the Med3000/Eroxon tests were also inadequately controlled and inadequately blinded which is also known to increase
placebo response!



‘randomised clinical trials with inadequate blinding report enhanced placebo effects for intervention groups’


Also its known rubbing medical device placebo gels can have higher placebo effects then just swallowing a placebo tablet



‘Placebo Treatment: Don't Eat It, Rub it! indications to suggest that a topical placebo induces stronger effects than an oral one’



Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger, the effect of a sham device is almost three times that of an oral placebo



Placebo effects are even larger with procedures than with drugs. Researchers at the Institute of Medical Psychology in Munich recently quantified that power for various types of placebo treatments in studies of migraine prophylaxis. They found that 58% of patients had a positive response to sham surgery and 38% had a positive response to sham acupuncture, while only 22% had a positive response to oral pharmacologic placebos.



‘evidence demonstrates that placebo effects are modulated by contextual factors’

‘evidence suggests that sham procedures or medical devices that appear more complex have stronger effects; for example, sham surgeries and placebo acupuncture are generally more effective than inert pills’

placebo researcher Ted Kaptchuk (8) states that “with good showmanship, a well-designed, totally inert stage prop … can produce exaggerated placebo effects.�



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

[lbo] 06/2/2023 11:24

Arousal gels too are topically applied gel which utilises the same alcohol, water, glycol and carbomer ingredients as in the placebo Med3000 gel!




Ingredients

Water, ethanol (35%), propylene glycol, glycerin, carbomer










water-based warming gel Ingredients

Stimulant Gel

Aqua, Glycerin, Propylene Glycol, Alcohol Denat, Carbomer

[lbo] 06/2/2023 11:20

Mike (still at it !) - can this person ever sleep with a clear conscience I ask myself ? - I suppose he must have some serious embarrassment to 'hang over' him on this thread 24/7 considering what he has said about James Barder! LOL


mikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141

Having had similar waffling, 'smoke-screen' answers from Mr Barder over the years which have turned out to end in exactly nothing I am loathe to give any credence to virtually everything he says

mikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141

Company is massively over valued if you go by 'concrete' results !

mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141

I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.
I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the shares
Unfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !

mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591

"A couple of decent deals and will be back off to the races."
Do you have any idea of how long shareholders have been using these words

mikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591

As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.
All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!

mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713

why should it be any different this time when you've still got the same useless lot running the show

mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641

I 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-life
And where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remuneration
I 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] 05/2/2023 21:15

Yet again Petroc is proven wrong. The research linked clearly shows that

‘the placebo effect is not only similar for medical devices to medical trials; it is considerably larger’

So if the ‘placebo response to oral ED treatments in trials can be up to 50%’ and ‘medical devices can be considerably larger’. That explains the placebo effect of Med3000/Eroxon the ramper keeps harping on about it.

Especially when you also consider the med3000/Eroxon tests were also inadequately controlled and inadequately blinded which is also known to increase
placebo response!



‘randomised clinical trials with inadequate blinding report enhanced placebo effects for intervention groups’



‘Placebo Treatment: Don't Eat It, Rub it! indications to suggest that a topical placebo induces stronger effects than an oral one.’



Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger, the effect of a sham device is almost three times that of an oral placebo



Placebo effects are even larger with procedures than with drugs. Researchers at the Institute of Medical Psychology in Munich recently quantified that power for various types of placebo treatments in studies of migraine prophylaxis. They found that 58% of patients had a positive response to sham surgery and 38% had a positive response to sham acupuncture, while only 22% had a positive response to oral pharmacologic placebos.



‘evidence demonstrates that placebo effects are modulated by contextual factors’

‘evidence suggests that sham procedures or medical devices that appear more complex have stronger effects; for example, sham surgeries and placebo acupuncture are generally more effective than inert pills

placebo researcher Ted Kaptchuk (8) states that “with good showmanship, a well-designed, totally inert stage prop … can produce exaggerated placebo effects.”



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

[lbo] 05/2/2023 19:11

‘Recent’? Do you even know how old and outdated the original Cello and IPSOS Futura research is and that its not even based on Med3000?

It was even based on Med2002 not the placebo med3000 and on pricing before Viagra even came off patent!

And that it was based on just asking questions years ago about a very different MED2002 concept. A concept that even went on to fail at phase 3.



So it was not approved as a drug but rather just registered as a medical drvuce and it no longer meets efficacy claims in any adequately controlled and blinded study. Even in the unblinded and uncontrolled FM71 it was proven less effective then the lowest possible does of Tadalafil.

Even the Cello survey which is now over 5 years old was based on questions on MED2002. Not on a medical device placebo of questionable efficacy beyond a placebo. Yet still Cello showed 46 per cent of the doctors interviewed in France did not even consider MED2002 was an improvement over PDE5 inhibitors. And that was even before MED failed at Phase 3 becoming even less of an improvement and being left the equivalent of an arousal made of the same alcohol, water, glycol and carbomer ingredients



‘The respondents were shown a concept about MED2002 as part of the market research though they did not use the product as it is currently in clinical development’

‘respondents believed that the product, once approved, is highly differentiated from existing products and that its claims’

Yet its not highly differentiated from any other class 2 medical device gel/arousal gel already on the market with the same alcohol, water, glycol and carbomer ingredients which can replicate all the same effects of Med3000

[lbo] 05/2/2023 18:31

Arousal gels too are topically applied gel which utilises the same alcohol, water, glycol and carbomer ingredients as in the placebo Med3000 gel. https://www.farmaline.be/apotheek/bestellen/eroxon/IngredientsWater, ethanol (35%), propylene glycol, glycerin, carbomerDoesn't look 'unique' now! LOLhttps://www.tongabv.com/downloads/sell-sheets/251981.pdfhttps://saraluna.de/Kama-Sutra-Intensify-Plus-Female-Arousal-Gel-Cooling-15-ml_1https://theislandnow.com/hersolution-gel-review/amp/https://www.beautybay.com/p/the-u/arousal-gel/water-based warming gel IngredientsStimulant Gel Aqua, Glycerin, Propylene Glycol, Alcohol Denat, Carbomer