Futura Medical Share Discussion Threads

[petroc] 01/11/2022 17:42

LiarBO caught lying again! (I know- it's getting boring) He quoted '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.' Can you see the glaring and malicious error in his calculations? A placebo is used in a clinical trial as a comparator, and the patients believe they're getting the trialled drug, in this case, Viagra. Because the patients believe they're taking Viagra, then the placebo side effects are going to be what they perceive Viagra gives you. As a placebo is supposed to have no clinical effects whatsoever, they are never going to use MED3000, a proven treatment for ED, in a Viagra trial, so there is no possible way that MED3000 will give you any of those horrible side effects that Viagra can. When Dermasys was used as a placebo against MED2005, it was found to be as efficaeous as MED2005, and if memory serves, the side effects included a couple of headaches and one instance of penile burning. That's a far cry from what LiarBO is claiming.

[lbo] 31/10/2022 23:42

Its ‘official’ too that men get all those side effects from ingesting Alcohol too! And Alcohol is actually associated with more deaths per annum then oral PDE5i drugs have ever been since they were first launched. Yet you keep ingesting alcohol Mike!? And even placebos like Med3000 have ‘official’ side effects like headaches, nausea and penile burning.



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.

[petroc] 31/10/2022 19:17

I think LiarBO's even more demented than we thought, Mike! He's showing clear signs of paranoia when he comes out with stuff like 'The multi-ID rampers are back using all their names to try ‘swindle’; the naive into buying their shares! LOL'. Presumably he thinks you and I are the same person (using 'all' our names LOL!) just because we both take exception to his nonsense. Does he think that he has a massive audience of people hanging on his every word? Or does he think that everyone that disagrees with him are the same person? Either way, it's a bit worrying that people like that have access to computers. Perhaps he has a phone hidden up his jacksie when the 'nurses' come round. No wonder his favourite topic is rubbing lubricants on his bell end!

[lbo] 31/10/2022 14:36

Yale study finds lack of supporting evidence for FDA’s De Novo medical device evaluation process





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

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

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.

[mikethebike4] 31/10/2022 14:34

No LBO

Anything and everything you say is mumbo-jumbo

[mikethebike4] 31/10/2022 14:22

No LBO

Anything and everything you say is mumbo-jumbo

[lbo] 31/10/2022 14:17

Now according to the rampers evidence based science which has proven Oral PDE5I drugs to to be safe and effective making them the recommended first line therapy is now ‘mumbo jumbo’! Yet the flimsy standards for medical devices is not! ROLMAO



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] 31/10/2022 11:38

the medical device De Novo classification process under the FD&C Act (section 513(f)(2) (21 U.S.C. 360c(f)(2)), which provides a pathway for certain new types of devices to obtain marketing authorization as class I or class II 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 juris- diction 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 devices’ cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA.

[mike2042] 31/10/2022 10:28

Thats right, LBO is a paid deramper his job is to cause doubts to surface in retail investors minds making them sell their FUM holdings at this current low, low price. His work provides the investors who pay him with 'discounted' stock ahead of revenues ramping up.

[lbo] 30/10/2022 10:59

So the De Novo pathway for medical device registration is based more on ‘corporate lobbying’ rather then evidence based science? Futura admitted in its RNS on 20 December 2021 that it was exploiting the same ‘least burdensome approach’

‘corporate lobbying has since prompted Congress to ease regulations and make it easier for 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’





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.



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

[lbo] 30/10/2022 10:46

So Med3000 as its just a medical device gel is in a ‘regulatory grey zone’

‘Although no evidence of side effects associated with the three products has been published, there is no proof of safety either’



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



Concerns over regulation of oral powders or gels sold as medical devices in Europe

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.

there was insufficient or no information on: the derivation of the products; the ratio of the relevant constituents; toxicity; factors affecting absorption and potential interactions with other drugs; maximum safe doses; and potential long term harms.

Although no evidence of side effects associated with the three products has been published, there is no proof of safety either, note the researchers

MedDevs for use in Europe are regulated by a business arm of the EU called GROW, rather than the European Medicines Agency, and 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.

[lbo] 30/10/2022 07:39

‘Anybody with any sense would give more credence to officially acknowledged’.

You mean like the SMSNA acknowledged on their official website that MED3000 was too good to be true! Making it a snake oil not the real deal!

LOL



A Non-Medicated Gel to Treat Erectile Dysfunction: Snake Oil or the Real Deal?

Until then, this gel will likely remain just as it initially seems: too good to be true.

[lbo] 30/10/2022 07:34

Oh the irony!!!


‘all things which cannot be proven - I saw a flying pig the other day !!!’

But a gel made from just alcohol and water which has shown no effect beyond a placebo in any adequately controlled study is not a ‘flying pig’



ROFLMAO