Futura Medical Share Discussion Threads

[lbo] 09/12/2022 22:09

Petroc has even posted on a public bulletin board that class 2b medical device gels which have a CE Mark but cannot substantiate any effect beyond a placebo are in his words a ‘scam’ by ‘gangsters’.

Yet Med3000 is also a class 2b medical device drug free gel that also cannot substantiate any effect beyond a placebo! ROFLMAO

petroc 22 Nov '22 - 19:15 - 14137 of 14145

Flexiseq being a Russian scam, this makes interesting reading:



Flexiseq was a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive.



One specialist commentator felt that the clinical effectiveness has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness could be attributed to the placebo effect of rubbing a gel



As Study Placebo, Non-Drug Gel Not Qualified As Real Arthritis Remedy In UK

Study comparing Flexiseq to a placebo gel might have helped substantiate claim drug free, sustainable approach to joint pain and stiffness, clinically proven to treat osteoarthritis as effectively as a prescription painkiller," but marketer didn't provide those results when Advertising Standards Authority reviewed online ad claims challenged by a physician.

[lbo] 09/12/2022 22:03

Med3000 only has a CE Mark from a notified body which only carried out low class medical device conformity checks.

The courts have ruled that uncontrolled and unblinded studies are not sufficient to substantiate any claims of an effect beyond placebo. The Courts have also ruled a CE mark is of limited significance in terms of substantiating efficacy claims. As have the ASA in the UK. All the rulings and case law is consistent.



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] 09/12/2022 22:00

They FTC and ASA don’t have to mention Med3000. The same scientific and legal substantiation principle will apply to any similar lower class medical device or any health product which makes treatment claims and that includes MED3000. The case law is consistent.



Or are you now also falsely claiming that different rules of substantiation of an effect beyond a placebo will somehow apply to MED3000? Because that would be yet just another lie by you and even more proven fabricating by a ramper. Just like all your claims you continually fail to be able substantiate! Including your objectionable if not libellous post directed at ADVFN admin staff!

petroc - 30 Sep 2022 - 11:28:17 - 13543 of 14190

˜this cess pit of a BB, where LiarBO and the admin staff who follow each other, work hand in hand’



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.

[petroc] 09/12/2022 19:56

'A Validated user is a recognised subscriber of ADVFN. The identity of an Unvalidated user is unconfirmed.'

Is this why the BB allows LiarBO to spew his poison? Because he spends a few quid every year to stock bash?

Not that un- or validated user makes any difference - LiarBO still hides behind his cloak of anonymity.

For the record, I would never subscribe to this POS BB, as they allow people like LiarBO to try and dominate every discussion.

[petroc] 09/12/2022 19:45

Diddums, LiarBO.

[petroc] 09/12/2022 19:39

Quick description of LiarBO and his lying, scheming, dishonest stock bashing ways -

Stock bashing has become very common in the digital world and often occurs on online trading platforms. Sophisticated technology makes it easy for bashers to remain anonymous. As such, it can be difficult to track, identify, and stop bashers in their tracks.

As the internet makes participation in the stock market more accessible to more people, new investors emerging in the market are especially vulnerable to the tactics of stock bashers, and many investor boards exist to attempt to track perpetrators.

Though notoriously difficult to track, some bashers have been identified and prosecuted. From time to time, confessional essays about the tactics of bashers emerge online, although these essays are typically also either anonymous or pseudonymous. Many investors speculate this type of behavior tends to follow certain patterns, including a tendency for bashers to only bash stocks which are generally trending upwards and showing potential.

Having said that, financial regulators constantly monitor the markets for what they call bad actors or stock bashers. According to the Financial Industry Regulatory Authority (FINRA), investors may find it difficult to get information about these securities and any tidbits they may find can lead them to act even if it's misinformation. That's why FINRA warned investment firms and broker-dealers to put controls in place that would raise red flags on any suspicious activity

[lbo] 09/12/2022 18:55

Treating ED with a placebo based on deception is at the very least unethical but if its also at the expense of diverting men away from proper screening and more appropriate health interventions then its a form of medical malpractice.



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



For many, whether or not placebo use is ethical depends partly on whether patients are being deceived and whether there is a known better treatment.
A clinician who doesn’t deceive a patient, and who provides a placebo for something for which there is no known treatment, such as irritable bowel syndrome, might be ethically OK, says Jeremy Howick, of the Department of Primary Health Care Sciences, at the University of Oxford, and lead author of the Plos One study. But there is no evidence that this company is enhancing care. What they’ve been doing is completely unethical

[lbo] 09/12/2022 18:54

Its a rampers scam all based on a sham placebo medical device gel being ramped by ramping scammers making false claima they cannot substantiate all over the internet!



Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger, the effect of a sham device is almost three times that of an oral placebo.



Placebo Treatment: Don't Eat It, Rub it!

indications to suggest that a topical placebo induces stronger effects than an oral one.



Administrative Law Judge Upholds FTC's Complaint that POM Deceptively Advertised Its Products

erectile dysfunction claims were false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.

[petroc] 09/12/2022 18:12

Quick description of LiarBO and his lying, scheming, dishonest stock bashing ways -

Stock bashing has become very common in the digital world and often occurs on online trading platforms. Sophisticated technology makes it easy for bashers to remain anonymous. As such, it can be difficult to track, identify, and stop bashers in their tracks.

As the internet makes participation in the stock market more accessible to more people, new investors emerging in the market are especially vulnerable to the tactics of stock bashers, and many investor boards exist to attempt to track perpetrators.

Though notoriously difficult to track, some bashers have been identified and prosecuted. From time to time, confessional essays about the tactics of bashers emerge online, although these essays are typically also either anonymous or pseudonymous. Many investors speculate this type of behavior tends to follow certain patterns, including a tendency for bashers to only bash stocks which are generally trending upwards and showing potential.

Having said that, financial regulators constantly monitor the markets for what they call bad actors or stock bashers. According to the Financial Industry Regulatory Authority (FINRA), investors may find it difficult to get information about these securities and any tidbits they may find can lead them to act even if it's misinformation. That's why FINRA warned investment firms and broker-dealers to put controls in place that would raise red flags on any suspicious activity

[lbo] 09/12/2022 18:06

Placebos can be harmful especially medical devices which have undergone no long term safety studies. A CE mark only requires 'meets the General Safety' requirements of medical devices. https://www.massdevice.com/study-initially-ce-marked-medical-devices-higher-recall-rate/https://www.chemistryworld.com/news/researchers-call-for-stricter-rules-on-drug-like-medical-devices/4011093.articlehttps://www.bmj.com/company/newsroom/concerns-over-regulation-of-oral-powders-or-gels-sold-as-medical-devices-in-europe/https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/

[lbo] 09/12/2022 18:04

Oral PDE5i drugs are the proven safe, effective and accepted first line therapy for ED according to people and organisations who are qualified to make those recommendations. A ramper who is only making subjective statements based on him owning shares in a placebo gel and not the objective evidence is not what the the accepted standard of medical practice. Other therapies including Med3000 have not been validated with adequately controlled studies. You have also deliberately and repeatedly misrepresented the side effects and risks of the recommended first line therapy. It has many years of objective data in millions of users supporting why it is still the recommended first line therapy. Unlike Med3000 which has no non deficient data supporting its efficacy and very little and very short term safety data only in a very few number of users. Some of its impedance safety studies rely only on cadavers not real life people. Med3000 has been used on less then circa 400 people! While Viagra has been used on many millions. And even in those small tests Med3000 causes headaches, nausea and painful burning in men and women. So if Med3000 was used on millions it would cause terrible side effects and harm in thousands based on the percentages of side effects.https://www.washingtonpost.com/archive/lifestyle/wellness/2002/04/30/the-nocebo-effect-placebos-evil-twin/6945da76-fb8e-401e-a4f2-0439d36f4c6a/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.https://www.urologytimes.com/view/what-do-you-tell-your-patients-about-all-the-new-erectile-dysfunction-treatments-being-advertised-to-the-public-Its all in the American Urological Association [AUA] guidelines'The therapies have not been validated'what we have as standard of care, which includes pills, injections, penile prosthesis, and vacuum devices that we know work. Other therapies have not been included in the standard of care yet'The first line therapy recommended in the General practice guidelines on ED is oral PDE5I drugs. Which would be based on all the available objective evidence. It would not be based solely on a rampers subjective and unqualified personal view. Or if a person just own shares in a company with a placebo gel alternative and who may have a vested interest and biased opinion.https://www.guidelinesinpractice.co.uk/mens-health/primary-care-is-well-placed-to-assess-ed/453513.articleFirst-line therapyFor most men with ongoing confirmed ED, first-line treatment will be a phosphodiesterase-5 inhibitor (PDE5I).https://www.gponline.com/basics-erectile-dysfunction/article/1054447Phosphodiesterase 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are recommended as first-line therapy. With established safety profiles, these drugs are well tolerated and effectiveGPC prescribing lead Dr Andrew Green:'There is no doubt that sildenafil is a safe and effective drug’

[lbo] 09/12/2022 18:01

So the use of a placebo gel that only underwent a deficient medical device tests in a few men is now being claimed by the ramper to be better treatment then the recommended first line therapy that underwent years of placebo controlled studies by the wider scientific and academic community.



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.

[lbo] 09/12/2022 17:54

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.



What method-issues to consider when assessing Risk of Bias

Concealment of randomization

Those enrolling patients are aware of the group (or period in a cross-over trial) to which the next enrolled patient will be allocated (major problem in “pseudo� or “quasi� randomized trials with allocation by day of week, birth date, chart number etc.)

Blinding

Patient, caregivers, those recording outcomes, those adjudicating outcomes, or data analysts are aware of the arm to which patients are allocated (or the medication currently being received in a cross-over trial)

Loss to follow-up

Loss to follow-up and failure to adhere to the intention to treat principle in superiority trials; or, in non-inferiority trials, loss to follow-up and failure to conduct both analyses considering only those who adhered to treatment, and all patients for whom outcome data are available

Selective outcome reporting

Incomplete or absent reporting of some outcomes and not others on the basis of the results

Use of unvalidated outcome measures (e.g., patient-reported outcomes)


Considerations in the design of clinical trials for erectile dysfunction



The use of randomized controlled trials (RCTs) that are double-blinded and placebo-controlled is no doubt the optimum design for addressing clinical questions in ED and of paramount importance being the systematic and standardized approaches in the stages of design in order to avoid undesirable bias.