Futura Medical Share Discussion Threads

[lbo] 30/1/2023 18:59

We are all still waiting for you to show where I or the research I referenced stated what you posted:

‘guaranteed to give a placebo response in 150% of patients’


Yet again you have been caught out telling more lies on ADVFN. Nobody except you used the word ‘guaranteed’ and claimed a placebo response in 150% of patients’

The research that was 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.

So that explains the placebo effect of Eroxon. Especially when you also consider the Eroxon tests were also inadequately controlled and inadequately blinded which also increases placebo response!



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.




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

[petroc] 30/1/2023 18:39

If LiarBO wants to state on the internet that Eroxon's only effect is down to placebo, then he has to supply some evidence to support that claim, whatever he bleats about the ASA etc about burdens of proof. All I have to do is quote actual trial results that have been undertaken. There are NO trial results that even suggest that Eroxon doesn't work as stated, so therefore there is not a shred of evidence to support LiarBO's lying and devious claim. He has nothing! Even his Dutch 'witness' who left a review of Eroxon gave it 3 out of 5, which is on a par with the trials that FUM have carried out, i.e. over 60% of men with ED have used it and confirmed it works. This is not a wild, ramping claim that LiarBO says it is, it is confirmed results from clinical trials.

[petroc] 30/1/2023 18:38

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 study (12.1 Objective claims must be backed by
evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.) but an adequately controlled observational
human study might be sufficient in some circumstances.

Yes, that's the bit of wording that LiarBO the stock basher keeps missing out, and then proclaiming what the ASA says.

As you can see, there is no mention in the CAP code of having to pass a double blinded, placebo controlled trial for a medical device. A simple, adequately controlled human trial is sufficient, and Eroxon has been through two of those, and a Home Use Test, and passed with flying colours.

So everyone can see (again) that LiarBO is lying and manipulating the information in order to bash the stock.

[petroc] 30/1/2023 18:37

Look at LiarBO lying again! The CAP code DOES NOT SAY THAT DEVICES NEED TO BE DOUBLE BLIND AND PLACEBO CONTROL TESTED. It says individual cases should be judged on their own merits, rather than ON JUDGEMENTS MADE SOLELY BY THE ASA. Therefore whenever LiarBO bleats on about the ASA deciding what the CAP code includes, he's talking out of his ass, as usual. Evidence submitted for health claims should normally include at least one adequately controlled experimental human study. It's only the lying stock basher LiarBO who says that FM57 and 71 are not adequate, they easily surpass what the CAP code requires.

LiarBO has helpfully supplied the link for everyone to read the CAP code rules.

[lbo] 30/1/2023 17:22

Yet again with Petroc its all about bias and fraud with his claims on ADVFN



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




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)

[lbo] 30/1/2023 17:18

Cant wait for Petroc to explain how an adequately controlled placebo study can be be carried out non deficiently if its inadequately unblinded! ROFLMAO



Strengths and Limitations

A primary study limitation is that the FM71 test arms were unblinded and thus those assigned to use the Med3000 gel could have been influenced by placebo effect.

That is men in the med300 arm in FM71 were led to believe the Med3000 gel had potential for increased effect based in the misleading post hoc findings of FM57; this would have primed the men to expect and notice more effect from using the gel in FM71.




Because the trial was not placebo-controlled the product had not provided adequate evidence to support the claim’

˜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’



Med3000 was just the placebo in the FM57 study 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 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

[petroc] 30/1/2023 17:13

Look at LiarBO lying again! The CAP code DOES NOT SAY THAT DEVICES NEED TO BE DOUBLE BLIND AND PLACEBO CONTROL TESTED. It says individual cases should be judged on their own merits, rather than ON JUDGEMENTS MADE SOLELY BY THE ASA. Therefore whenever LiarBO bleats on about the ASA deciding what the CAP code includes, he's talking out of his ass, as usual. Evidence submitted for health claims should normally include at least one adequately controlled experimental human study. It's only the lying stock basher LiarBO who says that FM57 and 71 are not adequate, they easily surpass what the CAP code requires.

LiarBO has helpfully supplied the link for everyone to read the CAP code rules.

[lbo] 30/1/2023 16:43

And yet again Petric is proven wrong by the ASA rulings on CAP code substantiation which will also apply to Med3000. And you can’t have an adequate placebo controlled study if the study is unblinded! ROFLMAO. Just confirms you have no clue what you are talking about and its actually you have has proven yourself to be ‘talking out of his ass’



Because the trial was not placebo-controlled’ the product ‘had not provided adequate evidence to support the claim’

‘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’



Med3000 was just the placebo in the FM57 study 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 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

[petroc] 30/1/2023 16:30

Look at LiarBO lying again! The CAP code DOES NOT SAY THAT DEVICES NEED TO BE DOUBLE BLIND AND PLACEBO CONTROL TESTED. It says individual cases should be judged on their own merits, rather than ON JUDGEMENTS MADE SOLELY BY THE ASA. Therefore whenever LiarBO bleats on about the ASA deciding what the CAP code includes, he's talking out of his ass, as usual. Evidence submitted for health claims should normally include at least one adequately controlled experimental human study. It's only the lying stock basher LiarBO who says that FM57 and 71 are not adequate, they easily surpass what the CAP code requires.

LiarBO has helpfully supplied the link for everyone to read the CAP code rules.

[lbo] 30/1/2023 15:05

And Mike you all along conveniently forget to take into account that unlike Med3000. Viagra has a proven effect in many adequately controlled and fully blinded studies just beyond a placebo and has many other associated benefits! Even in the unblinded deficient FM71 test. Med3000 was proven to be still less effective then the lowest possible dose of Tadalafil. And no such other health benefits associated with just using rubbing in a placebo Med3000 gel. Which still cannot even substantiate its having an effect beyond a placebo gel or even an arousal gel would in those same deficient Med3000 tests.





Medications to treat erectile dysfunction that contain phosphodiesterase type 5 inhibitors (PDE-5i) have wider health benefits in men with type 2 diabetes and/ or known heart conditions. PDE-5i drugs include sildenafil, vardenafil, and tadalafil.

New research now shows that PDE-5i treatment for erectile dysfunction is linked to a significant reduction in the risk of major adverse cardiovascular events and death in healthy men.



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

[lbo] 30/1/2023 14:38

Yet just more misleading posts from Petroc and again his claims are proven false. The substantiation principles of the relevant medical device and health product rulings are all applicable to any medical device



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




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.

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



Med3000 was just the placebo in the FM57 study 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 will therefore consider that its reported effectiveness by Futura was ’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



As Study Placebo, Non-Drug Gel Not Qualified As Real Remedy In UK

Study comparing to a placebo gel might have helped substantiate claim

marketer didn't provide those results when Advertising Standards Authority reviewed online ad claims challenged by a physician.

[petroc] 30/1/2023 14:26

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 study (12.1 Objective claims must be backed by
evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.) but an adequately controlled observational
human study might be sufficient in some circumstances.

Yes, that's the bit of wording that LiarBO the stock basher keeps missing out, and then proclaiming what the ASA says.

As you can see, there is no mention in the CAP code of having to pass a double blinded, placebo controlled trial for a medical device. A simple, adequately controlled human trial is sufficient, and Eroxon has been through two of those, and a Home Use Test, and passed with flying colours.

So everyone can see (again) that LiarBO is lying and manipulating the information in order to bash the stock.

[petroc] 30/1/2023 13:55

If LiarBO wants to state on the internet that Eroxon's only effect is down to placebo, then he has to supply some evidence to support that claim, whatever he bleats about the ASA etc about burdens of proof. All I have to do is quote actual trial results that have been undertaken. There are NO trial results that even suggest that Eroxon doesn't work as stated, so therefore there is not a shred of evidence to support LiarBO's lying and devious claim. He has nothing! Even his Dutch 'witness' who left a review of Eroxon gave it 3 out of 5, which is on a par with the trials that FUM have carried out, i.e. over 60% of men with ED have used it and confirmed it works. This is not a wild, ramping claim that LiarBO says it is, it is confirmed results from clinical trials.

[petroc] 30/1/2023 12:10

If LiarBO wants to state on the internet that Eroxon's only effect is down to placebo, then he has to supply some evidence to support that claim, whatever he bleats about the ASA etc about burdens of proof. All I have to do is quote actual trial results that have been undertaken. There are NO trial results that even suggest that Eroxon doesn't work as stated, so therefore there is not a shred of evidence to support LiarBO's lying and devious claim. He has nothing! Even his Dutch 'witness' who left a review of Eroxon gave it 3 out of 5, which is on a par with the trials that FUM have carried out, i.e. over 60% of men with ED have used it and confirmed it works. This is not a wild, ramping claim that LiarBO says it is, it is confirmed results from clinical trials.