Futura Medical Share Discussion Threads

[lbo] 29/9/2022 15:48

And FM71 and the so called ‘ real world testing’ were all unblinded and uncontrolled so all subject to ‘bias’. Nobody is claiming placebos don’t work in the real world. All those tests you referred to provide no evidence to substantiate any claim that Med3000 the gel itself is having any effect in ED beyond a placebo arousal gel. But what Med3000 may do is divert some men away from appropriate assessment and more effective treatments and interventions for ‘months’ from the real underlying causes of the ED.




‘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 didn’t t 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.

[lbo] 29/9/2022 15:42

The FM57 trial did not set out to measure the efficacy of Med3000. Therefore the ASA 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 trial.



And the percentage who have subjectively reported an improvement is only over baseline. Still doesn’t substantiate a claim that the improvement reported had even anything to do with the gel itself.



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', implying that the placebo caused the improvement

There are many reasons why symptoms can improve over the course of a trial, of which the placebo effect is only one. To measure the actual effect of a placebo, we would need to compare the placebo to a control group who got no treatment at all. This hasn't been done for MED3000


ED is primarily a self-assessed condition.

Clinical assessment of the therapeutic intervention is not done with a measurable laboratory value or physical finding but is derived from patient reporting and indirectly from partner perception.

In the course of ED evaluation, therapy selection, and outcome assessment, the patient and physician enter into an intimate communicative relationship in which there is some element of bias. Physician bias arises from the desire to achieve an excellent response without side effects, and patient bias may occur in the additive unconscious need to please the physician. This may lead to treatment outcome inaccuracies, with an over-reporting of efficacy and an under-reporting of treatment side effects.




Percentage change from baseline has the lowest statistical power and was highly sensitive to changes in variance.

[lbo] 29/9/2022 15:07

Please provide the ‘plenty of evidence’ from adequately controlled studies to substantiate your claims? Unlike you a proven liar and ramper the ASA and FTC ‘reflects the opinion of the wider scientific and academic community, rather than judgements made solely by the ASA’. So yet again its proven on ADVFN you are making many false claims that you cannot substantiate



The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence,



What standards are applied to evidence? The position taken by the ASA is a tried and tested one which has developed over the course of many years. It reflects the opinion of the wider scientific and academic community, rather than judgements made solely by the ASA. There are many aspects that are taken into consideration when evidence is reviewed and each claim is judged on its merits alongside the evidence presented to support it. Evidence submitted for health claims should normally include at least one adequately controlled experimental human



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.

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

[lbo] 29/9/2022 13:53

Please show where is the evidence MED3000 is having any effect beyond a placebo in any adequately controlled study!?



The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence,



What standards are applied to evidence? The position taken by the ASA is a tried and tested one which has developed over the course of many years. It reflects the opinion of the wider scientific and academic community, rather than judgements made solely by the ASA. There are many aspects that are taken into consideration when evidence is reviewed and each claim is judged on its merits alongside the evidence presented to support it. Evidence submitted for health claims should normally include at least one adequately controlled experimental human

[lbo] 29/9/2022 13:23

More poven lies from Petroc! Seems he doesn’t understand how association is not causal. He is probably one of the anti-vaxxers too who thinks all deaths after taking the COVID vaccines were proof the vaccines were killing people! ROFLMAO

LBO 28 Sep '22 - 22:41 - 13506 of 13519

‘Perspective’ indeed from a proven ramper!! ROFLMAO

There was only 96 men in FM71 so less then 50 men actually used MED3000. There was also burning reported by some of the men and women in FM57 and there was also adverse events reported in 18.5% of the placebo gel users in FM53.

Yet millions and millions of men have used Viagra safely over many many years. So thats billions of doses taken yet its only linked to a few deaths. More men die from deaths associated with alcohol ingestion per year.

And even placebo gels like MED3000 will be associated with deaths if taken by enough men over time.

The objective data over many years of use. After appropriate assessment and correct use has proven Viagra to be effective and safe. Viagra has a well-established efficacy and tolerability profile. From its introduction in 1998 to 2016, over 64m men worldwide were treated with sildenafil citrate. 'The safety profile of sildenafil citrate is based on over 9,570 patients in 74 double blind placebo-controlled clinical studies as well as postmarketing surveillance that has been gathered over 10 years.' And correlation is not causation.

Viagra studies have even showed men taking it live longer.

[petroc] 29/9/2022 13:16

At 2241 last night.

[lbo] 29/9/2022 11:48

Please show where I made the comment that ‘Viagra placebos kill’? Yet another one of your false facts! LOL

What I said was ‘More men die from deaths associated with alcohol ingestion per year. And even placebo gels like MED3000 will be associated with deaths if taken by enough men with ED over time’

With many millions of men taking erection erection drugs. Lots of men with heart disease will die from it whether or not they take erection medication. That’s all it is, an association. There’s s no proof of cause and effect

So yet again you fail to understand what was actually said! ROFLMAO



New research has found that half of participants who took a placebo in a clinical trial reported suffering from an adverse event (a side effect of the trial intervention). More surprisingly, 1 in 20 people who were taking placebos dropped out of their trials because of more serious adverse events. The study included data from 1,271 randomized trials and 250,726 trial participants. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death

[petroc] 29/9/2022 11:43

I see LiarBO can't keep up, so has to resort to going wildly off topic as usual. The fact remains, he made a comment that Viagra placebos kill as many people as Viagra itself. It looks like he's beginning to regret that comment. But no doubt he'll backtrack and say he didn't make that remark, it was someone else's that he copy/pasted, which is his usual get-out clause when cornered. Having said that, at least you can read his posts when they're copying someone else's words, as comments he makes on his own are barely readable, as though the comma on his keyboard doesn't work. And he has to chop up each sentence. Into smaller ones. Like this.

[lbo] 29/9/2022 11:21

How many people die a year from alcohol related deaths? Or obesity related deaths? Interesting how Petroc didn’t post the link to the article about his misrepresentation of deaths ‘after taking viagra’. Not deaths caused by Viagra! LOL

An estimated 95,000 people (approximately 68,000 men and 27,000 women) die from alcohol-related causes annually






Heart and circulatory deaths attributed to excess weight and obesity total around 31,000 every year in the UK, our new analysis reveals.

This is equivalent to around 85 deaths each day from heart and circulatory diseases which are attributable to a BMI (body mass index) of 25 or more, such as a heart attack or stroke. This is similar to the proportion of deaths from heart and circulatory diseases attributed to smoking – underlining the huge toll that excess weight takes on the nation’s health.


petroc - 28 Sep 2022 - 21:48:24 - 13505 of 13515

522 people have died after taking Viagra




‘another Viagra study presented here Tuesday came to a very different conclusion. This research, done in collaboration with Pfizer, Viagra's manufacturer, compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn't any real difference between the groups’

[lbo] 29/9/2022 11:12

‘Bwahahahaha’ is Petroc language for admitting he has yet again confirmed he has no clue what he is talking about! ROFLMAO

[petroc] 29/9/2022 10:24

Glavey, you'd better ask LiarBO that question. He was the one who originally posted that nugget about Viagra placebos killing people. But I'm sure he's glad of the support you attempted to provide when you saw him struggling. Bwahahahaha!

[lbo] 29/9/2022 10:15

No thank you for displaying your ignorance yet again! The likelihood of death with a placebo or Viagra in the study was nothing to do with what the placebo was substituting for’. If a male passenger takes viagra on a commercial plane hoping to join the mile high club. Yet the plane crashes. That would be a death associated with viagra or even Med3000 if he used that! Which he wont! LOL

correlation is not causation. Another Viagra study also said using a placebo was also just as likely to be associated with killing you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn't any real difference between the groups. With many millions of men taking erection drugs, any individuals s chance of serious side effects or death is tiny. One study authors estimate it to be on the order of 0.006 percent, just six in 100,000. Lots of men with heart disease will die from it whether or not they take erection medication. That’s s all it is, an association. There’s s s no proof of cause and effect. Viagra studies have even showed men taking it live longer.

[glavey] 29/9/2022 10:12

"a placebo given in a Viagra trial is just as likely to kill you as taking Viagra"

Gosh, I wonder if Pfizer thought of that?

[petroc] 29/9/2022 09:56

Thank you for displaying your ignorance yet again, LiarBO. The side effects from placebo depend entirely on what the placebo was substituting for. Therefore a placebo given in a Viagra trial is just as likely to kill you as taking Viagra; a placebo substitute for MED3000 might give one person some penile burning. You're really making yourself look stupid, LiarBO, keep going!

[lbo] 29/9/2022 09:47

And Futura said themselves MED3000 was a Placebo in FM57. So thank you for saying that Med3000 as its a placebo too is also ‘just as likely to kill you’ if its ever used by enough men for long enough.

ROFLMAO



PLO = Placebo (identical gel to MED2005 but without the active pharmaceutical ingredient glyceryl trinitrate)

[petroc] 29/9/2022 09:18

BTW, LiarBO, thanks for posting that comment saying another Viagra study showed that using a (Viagra) placebo is just as likely to kill you as using the actual drug. Yet another excellent reason to choose MED3000.

[petroc] 29/9/2022 09:14

Hmm. A little penile burning versus death. That's the true perspective and the choice men might make when looking at the downsides of using Viagra or MED3000. I know which I'd go for!

[lbo] 28/9/2022 22:41

‘Perspective’ indeed from a proven ramper!! ROFLMAO

There was only 96 men in FM71 so less then 50 men actually used MED3000. There was also burning reported by some of the men and women in FM57 and there was also adverse events reported in 18.5% of the placebo gel users in FM53.

Yet millions and millions of men have used Viagra safely over many many years. So thats billions of doses taken yet its only linked to a few deaths. More men die from deaths associated with alcohol ingestion per year.

And even placebo gels like MED3000 will be associated with deaths if taken by enough men over time.

The objective data over many years of use. After appropriate assessment and correct use has proven Viagra to be effective and safe. Viagra has a well-established efficacy and tolerability profile. From its introduction in 1998 to 2016, over 64m men worldwide were treated with sildenafil citrate. 'The safety profile of sildenafil citrate is based on over 9,570 patients in 74 double blind placebo-controlled clinical studies as well as postmarketing surveillance that has been gathered over 10 years.' And correlation is not causation.

Another Viagra study also said using a placebo was also just as likely to be associated with killing you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn't any real difference between the groups.

With many millions of men taking erection drugs, any individuals s chance of serious side effects or death is tiny. One study authors estimate it to be on the order of 0.006 percent, just six in 100,000. Lots of men with heart disease will die from it whether or not they take erection medication. That’s all it is, an association. There’s s no proof of cause and effect.

Viagra studies have even showed men taking it live longer.