Futura Medical Share Discussion Threads

[lbo] 26/12/2022 13:46

Even placebos can be harmful especially medical devices which have undergone no long term safety studies. A CE mark only requires ‘meets the General Safety’ requirements of medical devices. Some of the MED3000 safety studies on impedence testing was only on dead bodies!



findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms



Researchers call for stricter rules on drug-like medical devices

More oversight is needed over products in the grey area between medical device and medication

Powders, tablets and gels used like medications but registered as medical devices the same category plasters and pacemakers fall into need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone don’t need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients

According to European regulations, medical devices are used for diagnosis, prevention or treatment of disease, but unlike drugs their primary mode of action isn’t biological. The definition includes everything from medical software to wound dressings and surgical instruments

Manufacturers need to demonstrate medical devices safety and performance. An organisation called a notified body then assesses the products conformity and grants it a CE mark. But Van Winckel and her colleagues found only poor clinical evidence for the three devices they investigated. Studies were small or of low quality, often missing placebo controls. In some cases, there was no data at all, for example to show the effect

The researchers also highlighted the lack of safety information in the devices instruction leaflets. There was no or little mention of interactions with other compounds, maximum safe dose or adverse effects



Oral powders or gels, sold as medical devices in the European Union (EU), aren’t regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

require only certification with a CE (quality) kitemark before the product can be marketed.

This process doesn’t require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

It also means that these products can automatically be sold without a prescription across the EU, and actively marketed to patients and clinicians.

[lbo] 25/12/2022 10:43

The tests have not showed Med3000 is having any effect beyond a placebo or even a standard arousal gel/cooling lubricant would if the user believed it was a treatment for ED.



When making health-related claims, courts have consistently held that an advertiser must have a reasonable basis to make the claim at issue. This standard is satisfied where the advertiser possesses competent and reliable scientific evidence supporting the claim (citing Sterling Drug, Inc. v. FTC, 741 F.2d 1146 [9th Cir. 1984]). 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.



˜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’



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.

[glavey] 25/12/2022 05:18

Unlike the participants the product hasn't been 'rolled out' though.

[petroc] 24/12/2022 23:26

Over 60% of men who used MED3000 in two clinical trials and one real world trial said that it worked. LiarBO, who has never used it, says it doesn't work. Hmmn, who to believe?

[petroc] 24/12/2022 23:24

Anybody want to take investment advice from a fantasist and a proven liar? If so, truant and LiarBO are at your service! Heh heh heh!

[truant2tb1] 24/12/2022 21:58

Worth noting how WT Lamb Investments and Robin Lamb (ex Director) have been reducing their holdings in the last yr.

JOIN THE DOTS!!!

[lbo] 24/12/2022 21:47

More like there is no non deficient evidence to substantiate its having any effect beyond any placebo arousal gel/cooling lubricant would in psychogenic ED if the user just believes ‘it works’.



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


All Futura have done with MED3000 is open the door for Reckitt to sell similar lubricants/arousal gels as medical device placebo treatments for ED. And report Med3000 to the ASA, FTC etc for being misleading if it doesn’t inform consumers that MED3000 itself has no proven effect in ED beyond a placebo. As it has no proven efficacy in an adequate placebo controlled study or even against any standard cooling lubricant/arousal gels in an ED study.



‘You are the active ingredient’

Even the analysis on market forecasts knows Reckitt who is the market leader in lubricants will be only one to gain from marketing lubricants as placebo treatments for Erectile Dysfunction




Reckitt Benckiser was the defined leader and the ultimate four Personal lubricant vendors with leading brands such as Durex Play and K-Y Jelly.

KEY GROWTH FACTORS

Increasing prevalence of erectile dysfunction

9 Market Growth Enablers
9.1 Increasing Prevalence of Erectile Dysfunction

[petroc] 24/12/2022 19:49

Hahahaha! I posted a link about Viagra patients who gave up on it , and thus I've 'proven' that MED3000 tests were deficient! LiarBO seems to have a very strange idea of what 'proven' means! You can tell that when he calls me a 'proven' liar, and a 'proven' deramper! That is why my avatar is titled 'Petroc the Proven', just to highlight what a fool LiarBO is!

It also highlights his idea of what 'truth' is!

[petroc] 24/12/2022 16:18

LiarBO calls the 60% plus of men with ED who trialled MED3000 'liars', because they confirmed that it works. LiarBO has never even seen MED3000, let alone used it. Make your own minds up.