Futura Medical Share Discussion Threads

[lbo] 10/12/2022 11:33

The use of percentage change from baseline as an outcome in a controlled trial is statistically inefficient

Percentage change from baseline has the lowest statistical power and was highly sensitive to changes in variance



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.

[lbo] 10/12/2022 11:30

Trinity Research even openly admitted the hypothesised effects believed’ to be happening by Futura are disputed’. Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But it does need to be shown and proven to substantiate its marketing claims or fall foul of the FTC, ASA and the Courts.

Trinity research:

Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar. Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as a medical device



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.



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

[lbo] 10/12/2022 10:26

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.



The court did not concur with the defendants arguments. It stated that the CE conformity assessment is neither an official approval procedure nor an administrative legal act. The so-called notified bodies which carry out conformity checks and award the CE-certificates are private companies. The tests carried out by these companies therefore rather amount to plausibility checks, which, moreover, only concern individual aspects, for example, of a production process. A products alleged) therapeutic effectiveness is not (necessarily) examined. In effect, the court enjoined the defendant from continuing the advertising of the product.

[lbo] 09/12/2022 23:27

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 ‘claims litigation," a company may find itself on the receiving end of unwanted action from a variety of regulatory agencies such as FTC and FDA, offices of state attorneys general, local district attorneys, competitors and, of course, plaintiffs lawyers.

Here is a company who made false claims about its medical device being ‘clinically proven’ and that the FDA had reviewed and ‘approved’ its medical device for its advertised pain relief and other health benefits. The FTC challenged all those claims as false and hit them with a judgement for $22 million. The FDA does not approve class 1 or 2 devices like Willow Curve or Med3000. And if there is no adequately controlled studies to support claims of ‘clinically proven’ for medical devices. They challenge that too and impose massive fines on companies that make claims that cannot be substantiated to consumers.

[lbo] 09/12/2022 23:23

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

[lbo] 09/12/2022 23:21

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.

[petroc] 09/12/2022 23:20

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