Futura Medical Share Discussion Threads

[lbo] 28/12/2022 17:15

‘certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims’




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

[petroc] 28/12/2022 13:40

BTW, truant, there isn't another gel to treat ED available, despite what LiarBO might claim.

[petroc] 28/12/2022 13:39

Bracelets? What the heck is that stock basher LiarBO trying to compare MED3000 with now? His mate truant will be appalled, given his faux outrage that MED3000 was compared to Cialis in FM71 and not another ED treatment gel. Bwahahaha! What a pair of clowns!

[petroc] 28/12/2022 12:50

Over 60% of men who have actually trialled MED3000 in both clinical tests and a real world test all confirm that MED3000 works for their previously diagnosed ED. LiarBO says it doesn't. Go figure.

[petroc] 28/12/2022 12:47

Hmmn, least burdensome and costly, or expensive and difficult? A no brainer really, as long as they can get it to market. Double blinded and placebo controlled trials can wait until later, when the money starts rolling in.

[lbo] 28/12/2022 12:16

Futura has openly admitted in an RNS back in 2021 it was using the ˜least burdensome’ route of just a De Novo medical device registration for Med3000.

This only requires a low threshold of effect over baseline for ˜reasonable assurance’ of some effect including even just placebo effect for lower class medical device registration!

This has allowed Futura, like other medical device manufacturers, exploit ˜the 2002 Medical Devices User Fee Act’. This act brought in via corporate lobbying by the medical device companies requires the FDA to use the least burdensome route to market for that low class device. So the FM71 study was deficient as it was an uncontrolled and an unblinded study and ‘prone to bias’ So even if if Med3000 is given medical device registration. FM71 still has not met the standards of the FTC to substantiate claims of an effect beyond a placebo and the FTC has jurisdiction over the marketing claims of these lower class medical devices. Similar applies to FM57. It was not an adequately controlled study as it was designed to study Med2005 not the placebo MED3000 gel.



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 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] 27/12/2022 11:23

'...a rub on gel - with known placebo effects -'

Another faux pas from the fantasising stock basher there. You'll need to take that one up with your mate LiarBO, Truant. He's the only one who 'knows' that MED has placebo effects. All the triallists who used it just confirmed that it works. Only LiarBO states that it's all placebo effect, even though he's never used it. Which also contradicts his other argument - how do you know if it works or not, unless you compare it with a placebo? As that hasn't been done yet, there's not a single person in the world - even LiarBO - who can say whether it works or is placebo response.

[petroc] 27/12/2022 10:41

You'd better take that up with the FDA, truant!

I see you're showing your ignorance again. You're obviously unaware that the comparison in FM71 between MED3000 and Cialis was in fact mandated by the FDA.

'The Company has agreed with the FDA to include tadalafil (Cialis®) at the lowest approved dose for on-demand use (5mg) for comparative purposes only on safety, speed of onset and efficacy; non-inferiority is not required to be shown.'

So not only does truant pretend to have shorts when he doesn't, he also gets his facts wrong when trolling and stock bashing! Even LiarBO is probably cringing with embarrassment! (Although he's a fine one to talk with all his trolling on Christmas day - now THAT was embarrassing!)

[truant2tb1] 26/12/2022 19:06

How can you run a so called trial comparing a rub on gel - with known placebo effects - to a pill (Cialis)?Surely a fair test is to compare MED3000 with another topically applied gel/placebo. Laughable that the RNS owes don't acknowledge this basic flaw in their supposed "trial"!Lemmings only