Futura Medical Share Discussion Threads

[petroc] 18/12/2022 15:59

Yawn! Can LiarBO's comments and lies get any more boring?

[lbo] 18/12/2022 14:57

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,https://www.pall.com/en/medical/blog/the-importance-of-fda-510k-cleared-product.htmlA 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’

[petroc] 18/12/2022 14:44

Whatever a Viberect is I'm sure LiarBO has got one.

[lbo] 18/12/2022 14:01

‘Viberect is now the only therapeutic hand-held device for treatment of ED cleared for sale both in the US and EU’

Isn’t Med3000 also a hand held medical device!? LOL




The medical device is classified in one of four classes, based on rules using criteria that include invasiveness, duration of continuous contact, nature of tissue contact and whether the device is active or non-active. Most personal lubricants belong to class IIa. As well as declaring conformity to the MDD the manufacturer would need to apply to a notified body to carry out a conformity assessment.

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



Authors

Arthur L Burnett

The Viberect handheld device (Reflexonic, LLC, Chambersburg, PA, USA) is a new FDA-cleared ED treatment

This study provides evidence that Viberect produces a non-invasive, well-tolerated erectogenic effect. These results indicate that penile vibratory stimulation provokes erections



Reflexonic Achieves FDA Clearance, CE Marking, and ISO 13485:2003 Certification for VIBERECT ED Device in Less Than a Year

[petroc] 18/12/2022 13:54

'...just a low class 2b medical device' states LiarBO the stock basher. Like ventilators and surgical lasers.

[lbo] 18/12/2022 13:48

What standards are applied to evidence?

The position taken by the ASA is a tried and tested one which has developed over the course of many years. It reflects the opinion of the wider scientific and academic community, rather than judgements made solely by the ASA. There are many aspects that are taken into consideration when evidence is reviewed and each claim is judged on its merits alongside the evidence presented to support it. Evidence submitted for health claims should normally include at least one adequately controlled experimental human study



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.

[petroc] 18/12/2022 12:33

Take a leaf out of my book and post things about FUM and MED, LiarBO. None of your lies, mind!

[petroc] 18/12/2022 12:32

Pain reliever for dental braces? Try to keep on track, LiarBO, and desist with the unrelated and misleading links.

[lbo] 18/12/2022 12:02

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

[lbo] 18/12/2022 12:00

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 true




Advertising and labeling claims are a primary way companies try to grab consumer attention and distinguish one product from another. As the market becomes crowded, competition has increased and claims have become increasingly aggressive and, sometimes, overreaching. Companies must balance the desire to sell products against the fundamental principle that material claims must be substantiated with the appropriate level of support. If not, companies are at risk of action from regulatory agencies such as FTC and FDA, offices of state attorneys general, local district attorneys, competitors and, of course, plaintiffs lawyers. The primary regulator of advertising claims is FTC. FTC identifies principles that are generally accepted to yield reliable test results. A well-designed and carefully controlled study with the blinding of both subjects and researchers is generally viewed as more likely to yield reliable results. Advertisers must carefully consider each claim and ensure that proper support exists. Otherwise, in this era of Ëœclaims litigation," a company may find itself on the receiving end of unwanted action from a variety of sources.

[petroc] 18/12/2022 12:00

You know Mike is right.

[petroc] 18/12/2022 11:59

Go away, LiarBO.

[lbo] 18/12/2022 11:54

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



Selling 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




Bias and Fraud

There are numerous biases in medical research that render evidence from such research systematically misleading. Some of these biases are exacerbated by conflicts of interest, including fantastic financial incentives. The most important biases in medical research include confirmation bias, design bias, analysis bias, and publication bias. Arguably, some forms of bias, such as publication bias, should be considered as fraud. The pervasiveness of bias in medical research justifies one of the premises of the master argument for medical nihilism. Medical research is malleable due to the many biases, and such malleability allows for the production of evidence that suggests medical interventions are effective, whether or not they are in fact effective.



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.