Futura Medical Share Discussion Threads

[petroc] 28/9/2022 21:48

522 people have died after taking Viagra. One person suffered penile burning after using MED3000. How's that for perspective.

[petroc] 28/9/2022 20:14

Hahaha! ONE person reported penile burning, and he probably had a graze or something.

[lbo] 28/9/2022 19:51

Interesting James didn’t mention that Medical device registration with the FDA is not based just on the science. But rather rather on ‘corporate lobbying’ and the fact ‘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’ The same ‘least burdensome’ route Futura admitted in the 22nd March 2021 that it was exploiting. So its ‘safety’ is only based on ‘reasonable assurance’. Let’s hope that burning penile pain that Med3000 caused in FM71 and its other study doesn’t turn into something worse over time. Wouldn’t be the first time a medical device over time was found to be not safe and had to be recalled for injuring people.



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 didn’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.



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

[lbo] 28/9/2022 19:36

But the FTC and ASA don’t care are what ‘James said’ or the rampers say. As its just a subjective opinion and belief. Where is the objective evidence from any adequately controlled study to substantiate Med3000 is have any effect beyond a placebo? It can’t even be substantiated that its having any effect even beyond what a cooling lubricant/arousal gel would have had in an uncontrolled 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

[petroc] 28/9/2022 18:02

'A topical gel, MED3000, is technically a medical device rather than a drug. “It has an excellent safety profile,” James said.
Its safety profile was superior to that of tadalafil in a recent Phase 3 study. In addition, a single instance of localized mild penile burning was recorded in 1551 intercourse attempts. “No local side effects were recorded in female partners,” James added.
In the FM71 study, MED3000 had a superior safety profile over 5 mg of tadalafil. In that study, 19% of tadalafil recipients had a headache, while 4% of MED3000 users did. Similarly, 4% of the tadalafil arm reported either backache or chest pain, while 0% of MED3000 users did. MED3000 users, however, were more likely to experience nausea. A total of 4% of the MED3000 group reported that symptom compared to no tadalafil recipients.
“Aside from side-effects, MED3000 has no potential to cause adverse drug interactions, unlike oral ED drugs,” James said. hxxps://www.drugdiscoverytrends.com/futura-medicals-med3000-could-disrupt-the-market-for-pde5i-drugs-like-viagra-and-cialis/

[lbo] 27/9/2022 19:41

They would need to raise a lot more money just to cover all the fines and consumer lawsuits regarding misleading claims. If they make some of the rampers claims without disclaimers and clear label warnings. How long then before someone claims the more serious condition underlying their ED went undiagnosed for up to ‘six months’. Because they followed a label claiming it was ok as it was ‘a clinically proven treatment for ED’. Lawsuits could claim the user didn’t understand the gel was only a placebo that caused a delay in treating the more serious underlying causes of their ED.



Med3000 was the placebo in FM57. 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 and the FTC will therefore consider that its reported effectiveness by Futura was a ‘post-hoc finding’ . FM71 was also an unblinded and uncontrolled study so again cannot substantiate any claim that MED3000 is having any effect beyond a placebo .And so was the Consumer HUT uncontrolled and unblinded.



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




In each of the six cases filed, FTC alleged that the companies not only lacked scientific substantiation for their claims regarding the health benefits of their CBD/CBG products, but also falsely represented that their claims were either scientifically proven or had been confirmed by the U.S. government.

Under the proposed orders settling FTC complaints in each of these cases, the companies and their owners are prohibited from making prevention, treatment, or safety claims similar to the ones the companies made about their products about any dietary supplements, foods, and drugs unless they have the human clinical testing to substantiate such claims, and are required to have competent and reliable scientific evidence for any other health-related product claims. Specifically, the testing must be: (1) randomized, double-blind, and placebo-controlled

[lbo] 27/9/2022 19:27

And will the packaging/leaflet also have a obvious warning its only a medical device placebo gel and has not shown any effect beyond a placebo in an adequately controlled study? LOL



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. FTC v. QT, Inc., 512 F.3d 858, 862-63 (7th Cir.

Trinity Research even openly admitted the hypothesised effects ˜believed’ to be happening by Futura are ˜disputed’ and Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But unfortunately it does need to be proven to substantiate its marketing claims 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 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

[petroc] 27/9/2022 19:11

Don't worry your ugly big head about MED3000 masking other conditions like the blue pills do, LiarBO. The Eroxon websites states 'If you have a medical condition you may need to speak to a doctor to discuss your condition to see if Eroxon® is suitable for you to use. Eroxon® will come with a leaflet, part of which will cover warnings and precautions and recommend users have a check-up with their doctor as soon as possible within the first 6 months of using Eroxon® to ensure that any erection problems are not caused by another serious health condition.' There, that should allay your fears.

[petroc] 24/9/2022 13:07

Glad you agree that MED3000 works, LiarBO. Does it feel better now that you've finally admitted it?

[lbo] 24/9/2022 11:29

ROFLMAO

petroc - 18 Sep 2022 - 14:23:27 - 13419 of 13486
Glad to see you've remembered your instructions, LiarBO. When I say jump, you say how high?

It seems its actually I who says jump and you say how high. Like the data you are easily manipulated!!! LOL

So on the record you are now calling all these respected and impressive organisations like the SMSNA, the FTC, the ASA and EU Courts all fools for applying the required scientific standards to substantiate an effect beyond placebo?

[petroc] 24/9/2022 11:25

Because LiarBO will go back and delete his comment before everyone sees his stupidity, I've copied it for eternity! 'What are ‘august organisations’? And you accused others of being ‘semi-literate’!? LOL' Yes, that's what LiarBO said at 1046 on the 24th September. Bwahahahahaha! I bet he wishes he hadn't!