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Old 10-01-2022, 02:53 PM
 
Location: Elsewhere
88,293 posts, read 84,292,537 times
Reputation: 114640

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Quote:
Originally Posted by Stone28 View Post
I tend to agree with the OP. I heard someone who has a lot of knowledge on the subject say that we are still in the dark ages when it comes to mental heath treatment.

One thing I will add, the human body can take a lot of punishment. We are way more resilient than many people realize.

As far as the long term effects, who knows? 30+ years ago they warned us about the "Crack babies". No one knows for certain.
The psychiatrist who prescribed my SSRI (Luvox)back in the 00s said that plainly: "You know you're all guinea pigs, right? 50 years from now psychiatrists will say, 'what the heck were they thinking?' about these drugs we use, but it's the best we've got right now".

Never before or since was I able to think so clearly as when I was on Luvox, one thought at a time, not five trains in different directions and a horror movie running in the background. It was so nice, for a while. Helped me sort things out and learn to manage the intrusive thoughts and obsessions. But it also dampened creativity and my toes moved all by themselves. After a while I learned to live OK with the OCD and not fear it, so I weaned myself off after 7 years. That was 13 years ago.

I hope they continue to research and find better ways to treat these illnesses and disorders. I tend to be of the mind of using meds in conjunction with therapy, when possible.
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Old 10-01-2022, 03:14 PM
 
3,113 posts, read 933,924 times
Reputation: 1177
Quote:
Originally Posted by suzy_q2010 View Post
That is a quality of life study, not one evaluating effectiveness.

You said "a lot" of studies have "no control". You still have not supported that claim.
No, it's to evaluate the tolerability of Niraparib. I.e side effects. How can you do that without a control? The real answer is you cannot.

Anyways, I'll do something better, here is an overview of some of the Single Arm Trials in Oncology that were used for approval.

Have fun

https://ascpt.onlinelibrary.wiley.co....1002/cpt.1965

Quote:
Our data shows that single-arm clinical studies leading to positive regulatory outcomes share common methodological approaches and end points, mostly comparing the overall response rate with a fixed success threshold as the primary analysis. The clinical indications in these approvals are clustered in late-line settings, hematological malignancies, and lung cancer. Our findings underline the need to reflect on the current practice, the methodological aspects, and end points in single-arm studies, and develop specific regulatory guidance on nonrandomized and novel study designs.
If you go to Table 1, they even list the drugs. This is for the EMA.

For the FDA:

Quote:
Background: Improved understanding of the underlying biology of cancer has led to a paradigm shift in cancer drug development and has paved the way for many products to receive accelerated or regular approval based on non-randomized/single arm trials (SATs). Given the high unmet medical need of cancer patients, challenges with lengthy and confounded survival endpoints, and difficulty enrolling rare biomarker-defined subsets of disease, SATs have been used to evaluate a variety of cancer therapies. Unlike time to event endpoints, the objective and clinically relevant endpoint of response rate (RR) and duration of response is interpretable in SATs, as spontaneous tumor shrinkage is not expected. Methods: A search of FDA databases identified all drugs and biologics approved for malignant hematology and oncology indications from January 1, 2001, to December 31, 2020 based on SATs. Data sources included approval letters, U.S. prescribing information, and clinical review documents. The definition of response varied by setting and time period (e.g. RECIST, WHO, IWG, etc.). Results: Between January 1, 2001 and December 31, 2020, FDA granted 153 new indications based on SATs, including 102 accelerated approvals (AAs) and 51 regular approvals (RAs). Overall, 69 approvals (45%) were for new molecular entities and 84 (55%) were expanded indications. Response rate was the most common endpoint used in the trial providing substantial evidence of efficacy to support approval [120/153, (78%)].
https://ascopubs.org/doi/abs/10.1200...5_suppl.e13572
 
Old 10-01-2022, 03:21 PM
 
3,113 posts, read 933,924 times
Reputation: 1177
And just to rub it in, Suzy:

Quote:
Despite the limitations, single-arm trials may be the only (or one of few) options for trials evaluating therapies for which placebos are not ethical and options for controlled trials are limited. Single-arm trials have been commonly implemented in oncology. Oncology trials often employ a dose at or near the maximum tolerated dose (MTD, known from Phase I trials) to deliver the maximum effect and thus frequently employ single dose trials. The primary endpoint is often tumor response, frequently defined as a percentage decrease in tumor size. Evans et.al. (Evans et al 2002) describes a Phase II trial evaluating low-dose oral etoposide for the treatment of relapsed or progressed AIDS-related Kaposi’s sarcoma after systemic chemotherapy. The primary objective of the trial was to estimate the objective tumor response rate. A response was defined as at least a 50% decrease in the number or size of existing lesions without the development of new lesions. A two-stage design was employed with the plan for enrolling 41 total subjects. However if there were no objective responses after the first 14 subjects have been evaluated, then the trial would be discontinued for futility, noting that if the true response rate was at least 20%, then the probability of observing zero response in the first 14 subjects is less than 0.05. Notably, responses were observed in the first 14 subjects, the trial continued, and etoposide was shown to be effective. Recently the FDA also granted accelerated approval of ofatumumab for the treatment of chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab based on the results of a single-arm trial.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059315/

They used the word "commonly", I used "a lot". But if you know anything about oncology studies, you'd know many (if not even most) are without controls.
 
Old 10-01-2022, 07:29 PM
 
Location: Georgia, USA
37,029 posts, read 41,087,048 times
Reputation: 44970
Quote:
Originally Posted by AfricanSunset View Post
No, it's to evaluate the tolerability of Niraparib. I.e side effects. How can you do that without a control? The real answer is you cannot.
The point is that they are looking at the side effects of a particular drug. There is nothing to copare to a control. The issue is the effect on quality of life.

Quote:
Anyways, I'll do something better, here is an overview of some of the Single Arm Trials in Oncology that were used for approval.
From your link:

"Our data shows that single-arm clinical studies leading to positive regulatory outcomes share common methodological approaches and end points, mostly comparing the overall response rate with a fixed success threshold as the primary analysis."

There is a comparator.


Quote:
For the FDA:
From the link:

"Of the 102 AAs, 38 (37%) have fulfilled their post-marketing requirement (PMR) to verify clinical benefit, 59 (58%) are pending verification of benefit, and 5 (5%) have been withdrawn from the market."

The single arm data were not the only evidence of efficacy.



Quote:
Originally Posted by AfricanSunset View Post
And just to rub it in, Suzy:



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059315/

They used the word "commonly", I used "a lot". But if you know anything about oncology studies, you'd know many (if not even most) are without controls.
From your link:

"This design [single arm trial] is employed when the objective of the trial is to obtain preliminary evidence of the efficacy of the treatment and to collect additional safety data, but is not generally used as confirmation of efficacy."

.
 
Old 10-01-2022, 07:41 PM
 
3,113 posts, read 933,924 times
Reputation: 1177
Suzy, what's your point? None of your slices and dices go back to you disputing that many trials in oncology don't have controls.

Let's just make this simple

1: First you interpreted my use of the word "control" to mean "placebo", showing you don't understand basic terms in clinical trials.

2. Then you disputed there were many trials in oncology without a control.

Quote:
Originally Posted by suzy_q2010 View Post

There is a comparator.
.
There is no control in a single arm trial. Comparing the "success threshold" between two different trials, or against some standard is not a control.

You're embarrassing yourself in your quest to have the last word.
 
Old 10-01-2022, 08:37 PM
 
Location: Georgia, USA
37,029 posts, read 41,087,048 times
Reputation: 44970
Quote:
Originally Posted by AfricanSunset View Post
Suzy, what's your point? None of your slices and dices go back to you disputing that many trials in oncology don't have controls.

Let's just make this simple

1: First you interpreted my use of the word "control" to mean "placebo", showing you don't understand basic terms in clinical trials.

2. Then you disputed there were many trials in oncology without a control.



There is no control in a single arm trial. Comparing the "success threshold" between two different trials, or against some standard is not a control.

You're embarrassing yourself in your quest to have the last word.
I am not the one embarrassing myself. Your links do not say what you claim they do, easily demonstrated by quotes from those links.
 
Old 10-01-2022, 08:46 PM
 
3,113 posts, read 933,924 times
Reputation: 1177
Quote:
Originally Posted by suzy_q2010 View Post
I am not the one embarrassing myself. Your links do not say what you claim they do, easily demonstrated by quotes from those links.
They demonstrate exactly what I claimed.

I said a lot of oncology trials have no control.

I linked to you 3 sources, sourcing all the single arm trials used in oncology, one saying they were 'commonly' used in oncology.

I'm sorry Suzy, but 2 + 2 = 4, "control" doesn't mean "placebo" and whatever you called a "comparator" is not a "control".

You're really embarrassing yourself. Because the more you post, the more I realize how you little know. I would have expected you to know at least this. Oh well. Keep posting, I know you like the last word.
 
Old 10-01-2022, 09:20 PM
 
3,113 posts, read 933,924 times
Reputation: 1177
The problem with surrogate endpoints and oncology trials:

Quote:
We examined all marketing approvals by the FDA from January 1, 2008, through December 31, 2012. We identified the pathway for approval (accelerated vs traditional) and the surrogate end point used, such as tumor response rate or PFS. This investigation of published reports was exempt from institutional review board approval.

[...]

During our study period, 36 of 54 contemporary cancer drug approvals (67%) were made on the basis of a surrogate end point. With several years of follow-up, 31 (86%) of these approvals (57% of the 54 drugs approved) have unknown effects on overall survival or fail to show gains in survival. Our results show that most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points.

Since 2008, the FDA has approved a higher percentage of drugs than previously,4 and cancer drugs are approved on the basis of surrogates that have poor correlations with overall survival.2 Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival. Enforcement of postmarketing studies is therefore of critical importance.
https://jamanetwork.com/journals/jam...rticle/2463590
 
Old 10-01-2022, 09:56 PM
 
13,564 posts, read 4,871,962 times
Reputation: 9599
Quote:
Originally Posted by NCSweettea View Post
I listen to a podcast the other day that had a guy who was a top pharmaceutical rep for about 20 years right out of college. He seen the pharmaceutical industry inside and out and upside down. And now he’s on a campaign to let people know the truth. That entire industry is corrupt and if I do say so myself “downright evil“. The stuff they’ve gotten away with would’ve earned you a front row seat in front of a firing squad in past errors of this country. It’s unbelievable what they do! People really need to wake up. “They get away with murder“. We’ve all heard that phrase. It’s even worse than that. They get away with murder while enriching themselves and silencing those who oppose them. Coverups, lies, deceit, evasion, bribes, kickbacks, payoffs, corrupt studies, The pharmaceutical industry in America makes the Italian mafia days look like a walk in the park.

The advice of this former pharmaceutical rep was to stay healthy naturally as long as you can. Do anything and everything in your power to get healthy and stay away from pharmaceutical medication’s. Do not trust anything your doctor or any pharmacy tells you about any medication. They’ve all been bought and sold.
"I listen to a podcast the other day...."

Don't need to read anything beyond that.
 
Old 10-02-2022, 02:57 AM
 
13,389 posts, read 6,410,753 times
Reputation: 10022
Quote:
Originally Posted by AfricanSunset View Post
Do you not find it concerning that over 60% of Americans stay on SSRIs for over 2 years? What do you think that this does to the brain over the long term (especially in kids) or even adults? Do you think that people should be on SSRIs or any other powerful psychotropic drugs for the rest of their lives to feel 'normal.'
I don't know about over 2 years, but there is some belief that staying on an SSRI for up to a year after you feel normal is preventative of future depressions. Unknown why, but allows whatever went wrong in the brain to heal and strengthen.
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