Futura Medical Share Discussion Threads

[lbo] 21/1/2023 14:59

Millions and millions of men have used Viagra safely over many many years. So thats billions of doses taken yet its only linked to a few deaths. More men die from deaths associated with medical devices per year. And even placebo gels like MED3000 claiming to be a treatment for ED with no appropriate assessment will be associated with deaths and thousands of reports of side effects if it ever manages to be used by enough men over time.

The objective data over many years of use. After appropriate assessment and correct use has proven Viagra to be effective and safe. Viagra has a well-established efficacy and tolerability profile. From its introduction in 1998 to 2016, over 64m men worldwide were treated with sildenafil citrate. 'The safety profile of sildenafil citrate is based on over 9,570 patients in 74 double blind placebo-controlled clinical studies as well as postmarketing surveillance that has been gathered over 10 years.' And correlation is not causation. Meanwhile there is no medium and long term safety data on Med3000 use in the real world.



In the past 10 years, medical device quality issues have caused 83,000 patient deaths 409.5 million medical device units were recalled in 2016-2017, averaging 58.19 million units per quarter.



So medical device gels like Med3000 ‘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’



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 dont 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 isnt 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), arent 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 doesnt 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] 21/1/2023 14:52

Men who use Viagra are 25% less likely to suffer early death: USC study




Viagra and Heart Health: Why Taking ED Drugs May Help Extend Your Life Too





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.



A new review of data from 250,726 trial participants has found that 1 in 20 people who took placebos in trials dropped out because of serious adverse events (side effects). Almost half of the participants reported less serious adverse events. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death.

[lbo] 21/1/2023 14:42

Oh no the rampers still haven’t found a way to ban the truth from exposing a swindle!



˜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





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






Ingredients Aqua, Glycerin, Propylene Glycol, Alcohol Denat, Carbomer, Potassium Sorbate,

[joestalin] 21/1/2023 12:27

See what I mean?

[lbo] 21/1/2023 12:12

Really Joe!? Maybe the company should also come for you after all your defamatory posts against them over the years!? LOL


JoeStalin - 30 Sep 2019 - 10:07:37 - 5937 of 10774
FUTURA a winner for 2015 - says it all!


JoeStalin - 18 Jul 2018 - 09:00:46 - 4354 of 10775
'jam tomorrow' is a very easy promise to make.


JoeStalin - 22 Jun 2018 - 14:12:24 - 4288 of 10775
What's another year after all?
At FUM, time is measured in decades.


JoeStalin - 25 Apr 2018 - 16:07:34 - 4147 of 10775
There seems to be an unlimited number of ways of saying "Jam tomorrow".


JoeStalin - 21 Mar 2018 - 13:50:44 - 3985 of 10775
A lifestyle company, but not for the shareholders.

[joestalin] 21/1/2023 12:10

He will merely come back with another id. This idiot has nothing else to do with his life.

[lbo] 21/1/2023 12:02

The EU laws still apply on ‘Unfair commercial practices’

‘must give you enough accurate information to enable you to make an informed buying decision’

If they fail to provide this information, their actions may be considered unfair’

‘You have the right to seek redress if you are treated unfairly’

Misleading and aggressive practices

giving false information) or omission (leaving out important information) aggressive practices

Like the rampers posting all tests were passed with flying colours yet always omitting to post that the tests were also alll deficient as they were unblinded and uncontrolled



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

[keifer derrin] 20/1/2023 21:10

Hey LBO, be careful as FUM might come for you, especially as I've already advised them about you

Nighthawk Energy may sue bulletin board ‘de-rampers’

[petroc] 20/1/2023 16:43

Liarbo, thank you for providing that charming little anecdote by the man who tried MED3000 and found that it worked. That's in line with the over 60% of triallists who also found that it worked, compared to half their number who felt no benefit. That's a far greater proportion than you'd expect to find had they all received a placebo. Of course, they didn't receive a placebo, they got MED3000, and confirmed that it worked. These were men who had been diagnosed with ED, and of course the inclusion rules dictated that they had to have had an erection of sorts once during the last three months, otherwise they'd just be flogging a dead horse, getting people who were totally incapable of getting wood to trial this innovative treatment.