Futura Medical Share Discussion Threads

[lbo] 11/12/2022 18:13

The gold standard for clinical trials is the randomized, double-blind clinical trial; patients are randomly assigned to get treatment or a placebo, and neither the patient nor the person evaluating them knows which patients received the treatment being studied. An uncontrolled study, which is scientifically inferior for demonstrating safety or effectiveness, is when the patients are evaluated, but there is no comparison to patients getting a different treatment or a placebo.




Does it work?

MED3000 was recently granted a CE mark as an approved medical device in the EU. Does this mean it works? No. Unlike drugs, medical devices don't need to be proven efficacious to be sold; they only need to show conformity with safety regulations, which the CE mark indicates.

So how effective is MED3000 really?

The first thing to note is that MED3000 has never been shown to be more effective than any control treatment - because it was the control treatment.

When Futura describe the efficacy of MED3000, they are talking about improvement seen over the course of the treatment period (which was 1 month in the first trial, 3 months in the second), known as 'change vs. baseline'.

Large improvements vs. baseline are common in the placebo groups in clinical trials of a wide range of conditions. This improvement is sometimes attributed to the 'placebo effect', implying that the placebo caused the improvement. (Futura have used 'placebo effect' terminology - see below). But this is too simplistic.

There are many reasons why symptoms can improve over the course of a trial, of which the placebo effect is only one.



To measure the actual effect of a placebo, we would need to compare the placebo to a control group who got no treatment at all. This hasn't been done for MED3000, but in trials of other placebos for various disorders, the effect of placebo over no treatment is often very small.

[lbo] 11/12/2022 14:41

Petroc has posted a link proving that ED, especially psychogenic ED, can spontaneously recover needing no further treatment. So Petroc has proven himself that all the MED3000 uncontrolled and unblinded tests were deficient as they have not proven MED3000 itself is having any effect!



‘There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel’

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

˜spontaneous recovery of erectile function without further treatment’



In age-specific analysis, spontaneous recovery of EF was the most common reason for respondents aged 30 -39 years (58.8%

The proportion of discontinuation due to spontaneous recovery of EF was greater in the non-comorbid group (47.7%)



randomised clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? A protocol for a meta- epidemiological study of PDE-5 inhibitors A particular treatment effect may exert both nonspecific and specific effects. A non-specific treatment effect is an outcome that does not arise according to an intended mechanism of action. This can be a response to a placebo but can also reflect a spontaneous symptom improvement





The gold standard for clinical trials is the randomized, double-blind clinical trial; patients are randomly assigned to get treatment or a placebo, and neither the patient nor the person evaluating them knows which patients received the treatment being studied. An uncontrolled study, which is scientifically inferior for demonstrating safety or effectiveness, is when the patients are evaluated, but there is no comparison to patients getting a different treatment or a placebo.

In 2007, the FDA Advisory Committee rejected the TMS device for depression because of the failure to show benefit compared to a sham treatment.3 A sham treatment is the device equivalent of a placebo; it is designed to seem as similar to real treatment as possible, so that the study can be randomized and double-blind. That is very important for studies of treatments for depression, because depression tends to ebb and flow over time. Therefore, the comparison of a placebo or sham control makes it possible to determine if the treatment actually is beneficial and if it has unpleasant or unsafe side effects.

[lbo] 11/12/2022 12:49

Futura has openly admitted in an RNS back in 2021 it was using the 'least burdensome' route of the De Novo medical device registration for Med3000. This only requires a low threshold of effect over baseline for â '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 exploit 'the 2002 Medical Devices User Fee Act' which requires the FDA to use the least burdensome route 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 EUCourts to substantiate any 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.

[lbo] 11/12/2022 11:06

Unfair commercial practices

When you buy goods and services anywhere in the EU from a website, a local shop or a seller outside your home countrys EU law protects you against unfair commercial practices. When promoting, selling or supplying products, companies must give you enough accurate information to enable you to make an informed buying decision. Find out more about contract information. 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

You are protected against 2 main categories of unfair commercial practices: misleading practices, either through action (giving false information) or omission (leaving out important information) aggressive practices that aim to bully you into buying Certain commercial practices are prohibited in all circumstances. Some of the most common are listed below:

Whenever a product is advertised as therapeutic, curing allergies, reversing hair loss, helping you lose weight, etc. you have the right to know if such claims have been scientifically confirmed. In many cases, claims like these are not medically backed up and are simply too good to be

[lbo] 11/12/2022 10:57

Because the Med3000 tests were not adequately placebo controlled the ASA will consider that MED3000 has not provided adequate evidence to support claims its clinically proven to treat anything beyond a placebo and other claims like the rampers are making are misleading and cannot be substantiated with deficient tests prone to bias.



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