Futura Medical Share Discussion Threads

[lbo] 03/11/2022 11:56

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.



When Futura describe the efficacy of MED3000, they are talking about improvement seen over the course of the treatment period known as 'change vs. baseline'.

Large improvements vs. baseline are common in the placebo groups in clinical trials of a wide range of conditions. This improvement is sometimes attributed to the 'placebo effect'

[lbo] 02/11/2022 16:17

Yeah the share price is 'doing wonders'! LOLmikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141Having 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 saysmikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141Company is massively over valued if you go by 'concrete' results !mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141I 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 sharesUnfortunately 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 wordsmikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591As 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 9713why should it be any different this time when you've still got the same useless lot running the showmikethebike4 - 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

[petroc] 02/11/2022 14:41

There goes LiarBO, again using trial data and then immediately rubbishing the trials! You couldn't make it up! Except that he does! 'asFM57 was inadequately controlled. So was FM71 and it was unblinded. And so was the consumer test' Boohoo! Diddums!

[lbo] 02/11/2022 14:15

And yes even placebos too can cause side effects!In FM71 alone. 4.3% of MED3000 users had headaches and 4.3% of MED3000 users also noted nausea.And an instance of mild local burning was noted in MED3000 users too. Ouch!https://www.washingtonpost.com/archive/lifestyle/wellness/2002/04/30/the-nocebo-effect-placebos-evil-twin/6945da76-fb8e-401e-a4f2-0439d36f4c6a/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.https://www.ox.ac.uk/news/science-blog/harmful-placebosA new review of data from 250,726 trial participants has found that 1 in 20 people who took placebos in trials dropped out because of serious adverse events (side effects). Almost half of the participants reported less serious adverse events. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death.

[petroc] 02/11/2022 13:58

Poor old LiarBO, the resident stock basher, doesn't know if he's coming or going! One minute he's using trials like FM71 to 'prove' that MED3000 has bad side effects, the next he's telling us that those same trials are valueless! Then he trumpets 'and then there's MED3000,' and goes on to talk about some post hoc findings on some fish oil! He really can't keep his lies and misinformation in order, can he? That's why they say honesty is the best policy, you don't trip up as much.

[lbo] 02/11/2022 13:02

THERE ARE LIES, DAMNED LIES AND STATISTICS

And then there is MED3000! LOL



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.

FM57 was inadequately controlled. So was FM71 and it was unblinded. And so was the consumer test.

The FM57 study and FM71 did not even set out to measure the efficacy of Med3000 itself. Therefore the ASA and FTC will consider that the reported effectiveness of Med3000 by Futura was a post-hoc finding, due to the risk of that being a false positive finding. The ASA will also be concerned that there was not an adequate placebo control for Med3000 in the FM57 and FM71 studies.






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

the prostate cancer claims were false and unsubstantiated because, among other reasons, the study the POM respondents relied on was neither ‘blinded’ nor controlled.

the 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.

[lbo] 02/11/2022 11:37

LOL

It was an unblinded and uncontrolled study as Futura exploited the ‘least burdensome’ route of the De Novo medical device pathway. Yet still ‘overall tadalafil showed a greater improvement in erectile function than MED3000’



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.



When Futura describe the efficacy of MED3000, they are talking about improvement seen over the course of the treatment period known as 'change vs. baseline'.

Large improvements vs. baseline are common in the placebo groups in clinical trials of a wide range of conditions. This improvement is sometimes attributed to the 'placebo effect'

[petroc] 02/11/2022 11:23

Funny that LiarBO should bring up FM71. Let's remind ourselves how well that went, in case anyone has forgotten.
'Co-primary endpoints that were agreed to with the U.S. Food and Drug Administration (FDA) were met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks.
Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study.
Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate, and severe ED sufferers.
Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favourable side-effect profile.' Key takeaways there were the words 'clinically important' and 'clinically effective' and also 'no serious adverse events'.

[lbo] 01/11/2022 23:56

Petroc proven wrong yet again! LOL

What about the cases of nausea reported with Med3000 in FM71!? And why did Futura try to explain the cases of Headaches with Med3000 by saying ‘ headache is a known side-effect of prescription oral medications for ED’

Because Med3000 as a placebo. Yet believed by a man to be a ‘viagra type gel’. Could cause any or even all of the same side effects as Viagra including headaches and nausea! Or all of any of the listed side effects by mikethebike4. If the man believes its a ‘viagra type gel’ and knows any of the listed side effects of viagra! ROFLMAO



Just thinking that you're re drinking can get you buzzed

If someone hands you a drink that looks, smells, and tastes alcoholic, chances are you’ll feel its intoxicating effects even if it contains no alcohol at all. Thats the placebo effect, according to a classic review of studies in the journal Addictive Behaviors. Whats more, those intoxicating effects are in line with your beliefs about what alcohol does to you.



˜You are the active ingredient’



A new review of data from 250,726 trial participants has found that 1 in 20 people who took placebos in trials dropped out because of serious adverse events (side effects). Almost half of the participants reported less serious adverse events. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death.



Placebo Effect Accounts for More Than Two-Thirds of COVID-19 Vaccine Adverse Events, Researchers Find

[petroc] 01/11/2022 17:42

LiarBO caught lying again! (I know- it's getting boring) He quoted '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.' Can you see the glaring and malicious error in his calculations? A placebo is used in a clinical trial as a comparator, and the patients believe they're getting the trialled drug, in this case, Viagra. Because the patients believe they're taking Viagra, then the placebo side effects are going to be what they perceive Viagra gives you. As a placebo is supposed to have no clinical effects whatsoever, they are never going to use MED3000, a proven treatment for ED, in a Viagra trial, so there is no possible way that MED3000 will give you any of those horrible side effects that Viagra can. When Dermasys was used as a placebo against MED2005, it was found to be as efficaeous as MED2005, and if memory serves, the side effects included a couple of headaches and one instance of penile burning. That's a far cry from what LiarBO is claiming.

[lbo] 31/10/2022 23:42

Its ‘official’ too that men get all those side effects from ingesting Alcohol too! And Alcohol is actually associated with more deaths per annum then oral PDE5i drugs have ever been since they were first launched. Yet you keep ingesting alcohol Mike!? And even placebos like Med3000 have ‘official’ side effects like headaches, nausea and penile burning.



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.



A new review of data from 250,726 trial participants has found that 1 in 20 people who took placebos in trials dropped out because of serious adverse events (side effects). Almost half of the participants reported less serious adverse events. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death.

[petroc] 31/10/2022 19:17

I think LiarBO's even more demented than we thought, Mike! He's showing clear signs of paranoia when he comes out with stuff like 'The multi-ID rampers are back using all their names to try ‘swindle’; the naive into buying their shares! LOL'. Presumably he thinks you and I are the same person (using 'all' our names LOL!) just because we both take exception to his nonsense. Does he think that he has a massive audience of people hanging on his every word? Or does he think that everyone that disagrees with him are the same person? Either way, it's a bit worrying that people like that have access to computers. Perhaps he has a phone hidden up his jacksie when the 'nurses' come round. No wonder his favourite topic is rubbing lubricants on his bell end!