Futura Medical Share Discussion Threads

[lbo] 01/2/2023 14:57

The FTC unlike the rampers will have jurisdiction over misleading Med3000 claims



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



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



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.

[lbo] 01/2/2023 14:53

And yet again Petroc defaults to making deliberately misleading posts to try deflect that he still cannot substantiate any of those false claims with any non deficient evidence!




After noting the FTC is not required to prove that a product is wholly ineffective in order to carry its burden that the sellers representations are false,

After reviewing the testimony of several experts at trial, Magistrate Denlow concluded that when an advertiser makes a medical, health-related claim it must possess a well-conducted, placebo controlled, randomized, double-blinded study, the gold standard. (Citing FTC v. SlimAmerica, Inc., 77 F. Supp. 2d 1263 [S.D. FLA].)

Any lower level of evidence would be deficient.

[lbo] 01/2/2023 11:59

And also still waiting for Petroc to show where I or the research I referenced stated what he falsely posted claiming I said'guaranteed to give a placebo response in 150% of patients'Over and over he has been caught out telling more lies on ADVFN. Nobody except Petroc used the word 'guaranteed' and claimed a 'placebo response in 150% of patients'The research that i 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'. That explains the placebo effect of Med3000/Eroxon. Especially when you also consider the Eroxon tests were also inadequately controlled and inadequately blinded which also increases placebo response!https://journals.sagepub.com/doi/abs/10.1177/026835559400900205?journalCode=phlaPlacebo Treatment: Don't Eat It, Rub it! indications to suggest that a topical placebo induces stronger effects than an oral one.https://s4be.cochrane.org/blog/2014/10/13/richards-reviews-sham-devices-placebos/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 placebohttps://blogs.bu.edu/ellisrp/2014/09/nejm-sham-controls-in-medical-device-trials/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.https://www.nice.org.uk/advice/mib80One 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

[lbo] 01/2/2023 11:54

Still waiting for Petroc to explain to ˜the wider scientific and academic community’ how an adequately controlled placebo study can be carried out in ED non deficiently if its inadequately blinded!



Strengths and Limitations

Again like other studies on other Futura products that have failed. 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 on the post hoc findings of FM57 and the fact it was being compared to oral Tadalafil in FM71. 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

[truant2tb1] 31/1/2023 22:48

Any idea on when the FDA clearance will come for this placebo??

[lbo] 31/1/2023 19:19

Its just a placebo-nomics ‘form of fraud’ by rampers like Petroc. Arousal gels already on the market have the same alcohol, water, glycol and cabomer ingredients as Med3000!



Ingredients Water, ethanol (35%), propylene glycol, glycerin, carbomer, potassium hydroxide.

‘After a few moments there was a slight sensation of "cold and heat". Anyone who knows the more special lubricants’





www.beautybay.com/p/the-u/arousal-gel/

water-based warming gel Ingredients Stimulant Gel Aqua, Glycerin, Propylene Glycol, Alcohol Denat, Carbomer




A placebo is anything that seems to be a "real" medical treatment -- but isn't. It could be a pill, a shot, or some other type of "fake" treatment. What all placebos have in common is that they do not contain an active substance meant to affect health



‘Selling brass as gold harms consumers independent of any effect’

Since the placebo effect can be obtained from an arousal gell) overcharging for a medical device gel that is represented as a miracle cure but works no better than a arousal gel ‘is a form of fraud’



Placebo-nomics: how bad was what Nurofen did?

Australian courts have ordered the makers of the brand to stop repackaging identical painkillers for different pains where does marketing end and deception begin?

Lies come in a wide range of ethical shapes and sizes. There are white ones, diplomatic ones, and there are mean, self-serving ones. Apparently there are even nice, Christmassy ones.

The Australian federal court yesterday ordered the drug giant Reckitt Benckiser to stop selling identical products marketed as specific Nurofen varieties for back pain, period pain, migraine pain and tension headaches. The company admitted the drugs sold in different coloured packets all contained the same active ingredient: 342mg of ibuprofen lysine. It also sold them at almost twice the price of Nurofen standard ibuprofen products.

Whether this constitutes deception or just marketing is probably one for the lawyers to argue over. Whatever its called, such practices might appear to fall pretty unequivocally towards the self-serving whopper end of the scale

[lbo] 31/1/2023 13:03

Also unlike the rampers. 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. A pathway with unblinded studies the same as Futura used that are ‘prone to bias’ results.

This path only requires a low ‘flimsy’ threshold of effect over baseline for ‘reasonable assurance’ of some effect including even just a placebo effect for lower class medical device registration! And it even appears as if the Med3000 trials were designed to build in even more bias due to the use of non standard inclusion criteria and allow for increased spontaneous recovery being wrongly attributed to the use of Med3000.

This has allowed Futura, like other medical device manufacturers, to 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, ASA or the Courts 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. So the efficacy of Med3000 in FM57 was a ‘post hoc’ finding.



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.