Futura Medical Share Discussion Threads

[lbo] 20/6/2022 12:08

Flexiseq is also a non medicated placebo gel like Med3000 placebo gel.



Flexiseq was also the placebo in the studies of IDEA-033. Another transdermal delivery gel delivering Ketoprofen. Similar to TPR100 which is jusy demasys delivering Diclofenac.

Flexiseq like Med3000 is just the delivery gel with no drug and was also only approved as a class 2 medical device gel and has highly questionable efficacy beyond that of a placebo. Same as Med3000

[lbo] 20/6/2022 11:00

https://www.asa.org.uk/rulings/pro-bono-bio-entrepreneur-ltd-a17-400871.htmlJust like in the failed IDEA-033 studies in which Flexiseq was the placebo which were then relied on to get it approved as a medical device gel. Med3000 had been used as the placebo treatment in the FM57 study on Med2005 and therefore the researcher had initially believed Med3000 had no therapeutic effect. The trial did not set out to measure the efficacy of Med3000. therefore, considered that its reported effectiveness by the advertiser was a post-hoc findingalso concerned that there was not an adequate placebo control for Med3000 in the trial. therefore, considered that the study did not provide adequate evidence for the claim clinically provenhttps://www.nice.org.uk/advice/mib80One 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 gelhttps://www.ftc.gov/business-guidance/blog/2021/04/look-back-post-hoc-analysisWhat happened next gets to the FTC’s allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.

[lbo] 20/6/2022 10:51

A placebo or not?

Something else has changed since the old version of Futura's FAQ. In the previous version, Futura seemed to accept that MED3000 was acting as a placebo. Describing the results of the second trial, they said that "the placebo effect was far greater than first indicated and presents an exciting opportunity in its own right."

But in the current FAQ, and across the current site, Futura seem reluctant to describe MED3000 as a placebo.


But if you look back before Med2005 failed its phase 3 study. Its on the record that Med3000 was just the placebo gel in FM57.



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

[lbo] 20/6/2022 10:49

Seems some still dont understand the difference between marketing a placebo as a placebo or deliberately marketing a placebo as working some unproven novel way which will lead to misleading claims by consumers.





Head On

Headache? Just roll a little Head On across your forehead and get ready for sweet relief. Everything about this product screamed "fake!" from the start and yet some people bought it thinking the mystery balm would somehow penetrate their skull and neutralize the ouchy thing in their head. And if that doesn't do the trick, there's always extra strength Head On, brimming with extra strong mystery brain balm. Thankfully, legal pressure forced the makers of this ridiculous product to stop advertising that it cures headaches

[lbo] 20/6/2022 09:32

Any placebo like Med3000 also can causes many serious side effects too. Even in FM57 headaches and burning were reported by using the placebo Med3000 gel.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.ox.ac.uk/news/science-blog/harmful-placebosA new review of data from 250,726 trial participants has found that 1 in 20 people who took placebos in trials dropped out because of serious adverse events (side effects). Almost half of the participants reported less serious adverse events. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death.https://www.bbc.com/future/article/20150210-can-you-think-yourself-to-deathhttps://pharmaceutical-journal.com/article/feature/nocebo-the-placebo-effects-evil-twinhttps://www.technologynetworks.com/drug-discovery/news/50-of-trial-subjects-who-took-a-placebo-reported-suffering-an-adverse-event-31303750% of Trial Subjects Who Took a Placebo Reported Suffering an Adverse Event

[mikethebike4] 20/6/2022 08:59

LBO

- just to make sure you have got the right facts :-

Viagra (Sildenafil) is taken orally or by injection into a vein

side effects may include (official):

sensitivity to light
muscle aches
heartburn
nose bleeding
flushed skin
problems falling asleep
tingling in the arms, feet, legs, or hands
numbness in the arms, feet, legs, or hands
headache
diarrhea
heartburn
trouble differentiating between colors like blue and green
seeing a blue tinge on things

Viagra may also cause serious side effects that require immediate medical attention. Symptoms may include:

chest pain
fainting
blurred vision
severe, sudden loss of vision
ringing in ears
sudden loss of or decrease in hearing
dizziness
rash
burning during urination
itching during urination
shortness of breath that worsens
an erection that lasts longer than 4 hours

No side effects with Med3000 !!!!

Viagra/Sildenafil has all those mentioned above - no wonder because it is internal and not applied externally as is MED3000

[lbo] 20/6/2022 08:37

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6834358/Odds estimates indicated the largest likelihood of placebo response occurred in men who were black, were younger than 45 years, had mild ED, and did not have diabetes. The likelihood of a placebo response decreased as ED duration increased. The frequency of common adverse events was similar between placebo responders and nonresponders.

[glavey] 20/6/2022 07:46

Getting over excited, Pet?

[lbo] 19/6/2022 12:26

Why ‘approved’ medical devices in the U.S. may not be safe or effective

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 didn’t 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,”

[mikethebike4] 18/6/2022 17:45

Now do you understand LBO ???

We have tried to put you right but you still keep ignoring the fact that :-

Viagra (Sildenafil) is taken orally or by injection into a vein

side effects may include (official):

sensitivity to light
muscle aches
heartburn
nose bleeding
flushed skin
problems falling asleep
tingling in the arms, feet, legs, or hands
numbness in the arms, feet, legs, or hands
headache
diarrhea
heartburn
trouble differentiating between colors like blue and green
seeing a blue tinge on things

Viagra may also cause serious side effects that require immediate medical attention. Symptoms may include:

chest pain
fainting
blurred vision
severe, sudden loss of vision
ringing in ears
sudden loss of or decrease in hearing
dizziness
rash
burning during urination
itching during urination
shortness of breath that worsens
an erection that lasts longer than 4 hours

No side effects with Med3000 !!!!

Viagra/Sildenafil has all those mentioned above - no wonder because it is internal and not applied externally as is MED3000

[petroc] 18/6/2022 17:13

You'll have to give the pistachios a go, LiarBO, next time you're doing some helmet polishing! Lol! You silly little man!

[lbo] 18/6/2022 15:10

‘I think this study design isnot appropriate for the evaluation of this relationship,because its main limitation is the lack of a control group, which makes it difficult to establish a causal relationship.

The effect of pistachio on ED may be a placebo effect because de Araujo et al.2 showed that treatment of ED with oral placebo agents demon-strates clinical effects, improving erectile functionand quality of erection. In addition, in recent years patients have more positive attitudes to complementary medicine.3 We see in our daily practice a large number of patients who think herbal medicine has more effect and lower adverse effect than conven-tional treatments. This positive attitude can increase the placebo effect of herbal medicine

[lbo] 18/6/2022 14:58

'some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function–Erectile Function Domain (IIEF-EFD) scores'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6834358/Results:A total of 4360 men were included; 13.5% were responders. Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds=20.2, P

[lbo] 18/6/2022 14:02

https://www.asa.org.uk/rulings/pro-bono-bio-entrepreneur-ltd-a17-400871.htmlMed3000 had been used as the placebo treatment in that FM57 study, and therefore the researcher had initially believed Med3000 had no therapeutic effect. The trial did not set out to measure the efficacy of Med3000. therefore, considered that its reported effectiveness by the advertiser was a post-hoc findingalso concerned that there was not an adequate placebo control for Med3000 in the trial. therefore, considered that the study did not provide adequate evidence for the claim clinically provenhttps://www.nice.org.uk/advice/mib80One 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 gelhttps://www.ftc.gov/business-guidance/blog/2021/04/look-back-post-hoc-analysisWhat happened next gets to the FTC’s allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.