Futura Medical Share Discussion Threads

[lbo] 04/1/2023 13:58

Yes indeed ’ there is 'safe' and safe as you well know’ too!




In the past 10 years, medical device quality issues have caused 83,000 patient deaths 409.5 million medical device units were recalled in 2016-2017, averaging 58.19 million units per quarter.




findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms



Researchers call for stricter rules on drug-like medical devices

More oversight is needed over products in the grey area between medical device and medication

Powders, tablets and gels used like medications but registered as medical devices the same category plasters and pacemakers fall into need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone don’t need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients

According to European regulations, medical devices are used for diagnosis, prevention or treatment of disease, but unlike drugs their primary mode of action isn’t biological. The definition includes everything from medical software to wound dressings and surgical instruments

Manufacturers need to demonstrate medical devices safety and performance. An organisation called a notified body then assesses the products conformity and grants it a CE mark. But Van Winckel and her colleagues found only poor clinical evidence for the three devices they investigated. Studies were small or of low quality, often missing placebo controls. In some cases, there was no data at all, for example to show the effect

The researchers also highlighted the lack of safety information in the devices instruction leaflets. There was no or little mention of interactions with other compounds, maximum safe dose or adverse effects



Oral powders or gels, sold as medical devices in the European Union (EU), aren’t regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

require only certification with a CE (quality) kitemark before the product can be marketed.

This process doesn’t require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

It also means that these products can automatically be sold without a prescription across the EU, and actively marketed to patients and clinicians.

[black bird] 04/1/2023 12:08

has share/ prophet's a sell on fum due to no patent rubber stamp ?
BB

[black bird] 04/1/2023 11:44

patent for E/D formula, carn't find rubber stamp, long time now, has share prophets mentioned this, what are
S/P views sell. ? latest. unable to find notice on stockmendation. finally has share/ prophets said AVOID
BB

[lbo] 04/1/2023 11:26

Being pumped all over twitter again! Oh dear!



The conspirators used podcasts and social media to talk up stock prices

[j777j] 04/1/2023 10:12

Aaaaaaaaaaaaaaaaaaaaaaaaaaannnnnnnddd they are off!!



Happy 2023 to all

[broomrigg] 04/1/2023 08:52

Rampant buying first thing ;-)

[j777j] 04/1/2023 08:51

And they are under starters orders......

[petroc] 03/1/2023 19:15

One slimy character in particular to be vigilant of is the omnipresent stock basher. S/he (LiarBO) can be found on almost every discussion board / forum and too many times investors can make bad sell decisions by following the basher's misguided advice.

5. They post over and over and over (like LiarBO is doing with the exact same bashing posts all starting with the exact same sentence.

(Disregard the first one - I doubt anyone has been foolish enough to follow LiarBO's advice, especially after he invested more than he could afford in CSD500 - and lost the lot!)(Ha ha!)

[petroc] 03/1/2023 19:15

LiarBO seems to base his opposition to MED3000 entirely on a potential placebo effect. Although over 60% of men who have actually used it in clinical trials and a real world test all confirm that it works, LiarBO, who has never seen or used MED3000, claims it doesn't work, and that the results all point to a fantasy placebo response. He then links reams of rubbish about PE in an attempt to 'prove' his assertion.
Unfortunately for LiarBO there is an increasing swell of opinion in medicine to disprove the myth of placebo.

'... A good first step would be to see the placebo response for what it is a conceptual myth that sustains a broken medical system and covers up what we are really seeking our inherit healing capacity now freed by understanding how deeply meaning infuses us all.'

If anyone cares to read about it, try this: target='window'>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6707261/

At this point, LiarBO will be sticking his fingers in his ears shouting, 'No, no, no! They're all proven liars!' which he says about everyone who doesn't agree with him.


And another thing - just because something has the potential to cause a placebo response, doesn't mean it does. A bit like just because you're paranoid, it doesn't mean they're NOT out to get you!

'The placebo response is a myth. It does not exist in reality, and continuing to name it is hindering the optimal application of science to healing in medicine. On the surface, it is obvious that, when defined as a biological response to an inert pill (like a sugar pill), the idea of a response to a placebo is impossible. Inert treatments by definition do not produce responses. So why do we continue to ponder why people get better from taking inert substances and base our acceptance of legitimate treatments on demonstrating that they go beyond that response?'

Answer - vested interest. Read the article, all is explained.

[lbo] 03/1/2023 17:50

https://www.arnoldporter.com/-/media/files/perspectives/publications/2021/09/trends-and-developments.pdfIn 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

[lbo] 03/1/2023 17:48

Trinity Research even openly admitted the hypothesised effects believed to be happening by Futura are disputed. Trinity admitted no mechanism of action has to be even shown to get a medical device registered. But it does need to be shown and proven to substantiate its marketing claims of having any effect beyond a placebo 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 a 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.



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

[petroc] 03/1/2023 17:28

LiarBO seems to base his opposition to MED3000 entirely on a potential placebo effect. Although over 60% of men who have actually used it in clinical trials and a real world test all confirm that it works, LiarBO, who has never seen or used MED3000, claims it doesn't work, and that the results all point to a fantasy placebo response. He then links reams of rubbish about PE in an attempt to 'prove' his assertion.
Unfortunately for LiarBO there is an increasing swell of opinion in medicine to disprove the myth of placebo.

'... A good first step would be to see the placebo response for what it is a conceptual myth that sustains a broken medical system and covers up what we are really seeking our inherit healing capacity now freed by understanding how deeply meaning infuses us all.'

If anyone cares to read about it, try this: target='window'>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6707261/

At this point, LiarBO will be sticking his fingers in his ears shouting, 'No, no, no! They're all proven liars!' which he says about everyone who doesn't agree with him.


And another thing - just because something has the potential to cause a placebo response, doesn't mean it does. A bit like just because you're paranoid, it doesn't mean they're NOT out to get you!

'The placebo response is a myth. It does not exist in reality, and continuing to name it is hindering the optimal application of science to healing in medicine. On the surface, it is obvious that, when defined as a biological response to an inert pill (like a sugar pill), the idea of a response to a placebo is impossible. Inert treatments by definition do not produce responses. So why do we continue to ponder why people get better from taking inert substances and base our acceptance of legitimate treatments on demonstrating that they go beyond that response?'

Answer - vested interest. Read the article, all is explained.

[petroc] 03/1/2023 17:25

LiarBO calls the 60% plus of men with ED who trialled MED3000 'liars', because they confirmed that it works. LiarBO has never even seen MED3000, let alone used it. Make your own minds up.

[lbo] 03/1/2023 16:44

De Novo-winning devices often lack effectiveness data, analysis shows






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 the past 10 years, medical device quality issues have caused 83,000 patient deaths 409.5 million medical device units were recalled in 2016-2017, averaging 58.19 million units per quarter.



A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra.



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] 03/1/2023 15:41

One slimy character in particular to be vigilant of is the omnipresent stock basher. S/he (LiarBO) can be found on almost every discussion board / forum and too many times investors can make bad sell decisions by following the basher's misguided advice.

5. They post over and over and over (like LiarBO is doing with the exact same bashing posts all starting with the exact same sentence.

(Disregard the first one - I doubt anyone has been foolish enough to follow LiarBO's advice, especially after he invested more than he could afford in CSD500 - and lost the lot!)(Ha ha!)

[petroc] 03/1/2023 15:36

'Note how the ramper tried to yet again slice and dice the data! Its all about bias and fraud'

Actually, no, LiarBO, I didn't notice any slicing and dicing of data, just quoting a passage from the link that you helpfully provided. The heading was 'results', so presumably it was the bit that you wanted everyone to see?

If anyone around here slices and dices data, it's you, LiarBO. You have perfected it into an artform, and you constantly do it by bringing up studies and trials that have absolutely nothing to do with MED3000 and you try and slice it up to show that MED3000 doesn't work. For example, only yesterday you were stating that because Ivermectin doesn't work in the treatment of covid, then MED3000 doesn't work in the treatment of ED. Strangely, over 60% of men with ED who have actually used MED3000 all confirmed that it worked, which is nearly twice as many as those who didn't achieve any benefit. You also showed us evidence today that far fewer men taking a placebo got any benefit from it compared to men who were actually taking the ED treatment being tested.

You just forget what lies you've told and get them all mixed up, LiarBO. You really need to get your own house in order before accusing 'the rampers' of anything.