Futura Medical Share Discussion Threads

[lbo] 02/1/2023 16:44

LOL

‘all involved small numbers of people. This is problematic, as most people recover from their episode of COVID whether treated or not’


Just like all the Med3000 deficient tests ‘involved small numbers’ and you proved yourself that ‘most people recover from their episode’ of psychogenic ED ‘whether treated or not’

petroc8 Dec '22 - 18:26 - 14487 of 14511

Most common reasons for the discontinuation

˜spontaneous recovery of erectile function without further treatment’



The placebo effect is that observed in the placebo arm of a clinical trial, and is produced by the placebo psychobiological phenomenon in addition to other factors, such as spontaneous remission, regression to the mean, biases, and judgment errors.



Uncontrolled Trials

This design incorporates no control arm. This design is usually utilized to determine pharmacokinetic properties of a new drug (Phase 1 trials). Uncontrolled trials are known to produce greater mean effect estimates than a controlled trial, thereby inflating the expectations from the intervention. There is a threat of inherent bias and results are considered less valid than RCT. Another issue is use of this design in spontaneously resolving maladies that might again overstate the effect

[petroc] 02/1/2023 16:41

The term stock basher refers to a person who engages in market manipulation to make the price of an asset fall. Stock bashers rely on misinformation campaigns to decrease confidence in a stock, leading to an undervaluation of that security.

In LiarBO's case, his manipulation is clear to see. He has nothing on MED3000 that might indicate it doesn't work, which is why he resorts to comments about Ivermection, Flexisec, and hundreds of gels and creams which he states are the same as MED3000.

[lbo] 02/1/2023 16:18

https://www.ftc.gov/sites/default/files/documents/cases/2008/01/080103qtrayseventhcircuitappealruling.pdfSelling brass as gold harms consumers independent of any effect on pain. Since the placebo effect can be obtained from sugar pills, charging $200 for a device that is repre- sented as a miracle cure but works no better than a dummy pill is a form of fraud. Thats not all. A placebo is necessary when scientists are searching for the marginal effect of a new drug or device, but once the study is over a reputable professional will recommend whatever works best.Medicine aims to do better than the placebo effect, which any medieval physician could achieve by draining off a little of the patients blood. If no one knows how to cure or ameliorate a given condition, then a placebo is the best thing going. Far better a placebo that causes no harm (the Q-Ray Ionized Bracelet is inert) than the sort of nostrums peddled from the back of a wagon 100 years ago and based on alcohol, opium, and wormwood. But if a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the con- sumer. See Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992) (a statement violates the FTC Act “if it is likely to mislead consumers, acting reasonably under the cir- cumstances, in a material respect

[lbo] 02/1/2023 16:09

Next Petroc will be claiming Ivermectin is still a proven effective treatment for COVID because some people gave testimonials that they associated getting better when taking it! ROFLMAO



folks observed that some who took Ivermectin did not get sicker and concluded its benefit. There were even lab studies that hinted at a benefit. But all involved small numbers of people. This is problematic, as most people recover from their episode of COVID whether treated or not.


petroc8 Dec '22 - 18:26 - 14487 of 14511

Most common reasons for the discontinuation

˜spontaneous recovery of erectile function without further treatment’

The research Petroc linked also highlighted ˜independent factors influencing discontinuation of the drug were cause of ED (psychogenic’ and ˜The proportion of the patients with psychogenic ED in the discontinuation group (47.4%) was significantly greater’

[lbo] 02/1/2023 12:23

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 placebo effect for lower class medical device registration!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 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.https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-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 OKJournalists 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 devicesNinety-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 routeFor 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.https://www.arnoldporter.com/-/media/files/perspectives/publications/2021/09/trends-and-developments.pdfIn 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

[lbo] 02/1/2023 12:13

It wont take long for Reckitt to launch a similar alcohol, water, glycol and Carbopol gel product via the 510k pathway

‘A De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device’

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



A company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately’

[lbo] 02/1/2023 00:16

Petroc is just a huckster shilling a placebo in bad faith!




THE PLACEBO PROBLEM: HOW SCAMMERS TAKE ADVANTAGE OF A PSYCHOLOGICAL EFFECT

The placebo effect is real. But so are the hucksters shilling it in bad faith.



PLO = Placebo (identical gel to MED2005 but without the active pharmaceutical ingredient glyceryl trinitrate)



After Phase III Failure, UK Firm Pushes Placebo to Treat Erectile Dysfunction



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. FTC v. QT, Inc., 512 F.3d 858, 862-63 (7th Cir.



The placebo effect is that observed in the placebo arm of a clinical trial, and is produced by the placebo psychobiological phenomenon in addition to other factors, such as spontaneous remission, regression to the mean, biases, and judgment errors.

Thanks Petroc for confirming that the Med3000 tests were deficient and prone to bias. Thanks for posting the link to research that confirms a lot of men with ED will just spontaneously recover and need no further treatment. Especially men with psychogenic ED. Thanks for also confirming Futura started FM57 at a baseline for the study of 62% of the men needing no real medical treatment as only men who reported they ˜can get an erection in one situation and not the other’ were included in the study. Specifically men who reported responding to manual stimulation were only included in a study of a gel that is massaged in. Which David Ralph previously admitted it was the massaging that causes the onset of stimulation! Thanks for also highlighting with that research the ˜independent factors influencing discontinuation of the drug were cause of ED (psychogenic’ and ˜The proportion of the patients with psychogenic ED in the discontinuation group (47.4%) was significantly greater’

So basically you have highlighted all the MED3000 tests were not only deficient but they were set up to be prone with even more bias with non standard inclusion criteria which led to a ‘significantly greater’ proportion of spontaneous remission.


petroc8 Dec '22 - 18:26 - 14487 of 14511

Most common reasons for the discontinuation

˜spontaneous recovery of erectile function without further treatment’