"FDA approved" = the check cleared from big pharma
Actual person in biotech....you realize the vast majority of stuff fails right? Amd Is not approved/doesn't pass success criteria in clinical trials? Go actually educate yourself on how the industry works. Subscribe to Endpoints or Stats newsletter. It's days after day, week after week of the FDA giving the Mutumbo Finger wave to literally everyone. But that might be too hard for your pea brain to understand. Stick to what you know, janitorial work or plumbing or sanitation, whatever it is you do.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this. BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.
People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
The article states only 3 studies have been published, that does not mean only 3 studies have been completed. I’m sure very few people on this board understand the clinical research process. This article doesn’t mention any pre-clinical trials or phase 1 or 2 trials. Also, it doesn’t mention any current ongoing trials. However, it does mention BMS has released summaries of where the drug has been taken by patients for a year, which means either these studies are still ongoing or just haven’t been published yet. In addition, most drugs also go through phase 4 post-market clinical trials where the drug is studied for a much longer period of time to assess long term safety and efficacy. So this article is not including a lot of information and counting on the general public’s lack of understanding of the clinical trial process.
I say all this from a place of knowledge and experience from working in the clinical research industry, both pharmaceutical and medical device, for over 25 years. I am currently working on 2 long-term post market studies that are both over 10 years long. Medications have been pulled from the market based on findings in long term studies.
Regarding the cost of new drugs. The clinical trial process is extremely expensive and costs are well into the high millions+. Companies only have set time period for a drug patent before a drug can go generic. They have to be able to recoup the money spent on the clinical trials and make a profit of they will not stay in business. If these companies go out of business then there will not be new drug developments.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this. BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.
People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
The FDA OK for KarXT, now known as Cobenfy, demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.
Yeeeeeeears of development started by a startup that BMS bought. Including Phase 1 and 2 trials.
Again: all the plumbers, janitors, sanitation workers, website founders, etc, on here who think they are suddenly pharmaceutical executives or clinical trial gurus with something important or profound to say on a topic they know almost less than nothing about: stay in your lane. It will save you much embarrassment.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this. BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.
People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
People love to complain about how we pay too much for defense, it is true we do. But we pay 4% of GDP on defense. It can easily be argued we should pay less of that, and more of that money should go directly to US security and not security of other nations.
But the US spends 18% of GDP and rising on healthcare. Healthcare is clearly breaking the bank and absolutely is the most corrupt industry in America. The FDA does not exist to protect the people. It exists to enforce monopolies for some of the largest corporations in the world and ensure them a steady stream of revenue.
To say the FDA isn't protecting people is simply a lie. I work in the biotech manufacturing sector and the products we make are highly regulated by the FDA. We have audits nearly year round in our facilities making sure protocols are being followed, with patient safety being literally the first thing they care about.
Again: all the plumbers, janitors, sanitation workers, website founders, etc, on here who think they are suddenly pharmaceutical executives or clinical trial gurus with something important or profound to say on a topic they know almost less than nothing about: stay in your lane. It will save you much embarrassment.
Obviously, this anonymous poster has an opinion. I'm okay with him having his own opinion.
On the other hand, here is an opinion with documentation from an expert... Marcia Angell, MD, medical journalist, author, and former editor for the New England Journal of Medicine, one of the most respected medical journals in the world.
In her book The Truth About the Drug Companies: How They Deceive Us and What to Do About It, she reveals how Big Pharma lobbyists have gamed the system over the years to the point that the FDA is nearly a puppet for Big Pharma.
Here's a link to a AI summary of the book, but having actually read the book itself, the situation is worse.
After their "objective" tour in leadership of the FDA/CDC, for example, these heads often go on to high six figure "advisory" positions with the very pharmaceutical companies over which they are providing oversight.
Again, from an AI search:
Compensation: Head of the FDA, $140-203k depending on bonuses
Compensation: Board of Advisors Member, Pfizer Corp: $300,000
It's very easy to see how, especially in the gray areas of some studies and approvals, these "objective" authorities decide in favor of the pharmaceutical industry that will soon be paying them $300,000/year for a part time job.
There are other books on this topic. Do a search. Read them. Ask ChatGPT or CoPilot to do a summary. Then, dig deeper and ask it to expand on subpoints. Or, just buy the book.
---- Here's the Copilot summary. Ask these questions yourself if you want to get the footnotes.
You Sent by you: Provide a book review of the book The Truth About Drug Companies by Marsha Angel. Copilot Sent by Copilot: “The Truth About the Drug Companies: How They Deceive Us and What to Do About It” by Marcia Angell, M.D., is a compelling exposé of the pharmaceutical industry. Angell, a former editor-in-chief of the New England Journal of Medicine, leverages her extensive experience to reveal the inner workings and ethical lapses of drug companies. Key Points: Marketing Over Innovation: Angell argues that pharmaceutical companies prioritize marketing over genuine innovation. She claims that a significant portion of their budget is spent on marketing rather than on research and development1. Influence on Medical Practices: The book highlights how drug companies exert considerable influence over medical research, education, and practice. This includes funding clinical trials and medical education, which can lead to biased outcomes and practices2. High Drug Prices: Angell debunks the justification that high drug prices are necessary to fund research. Instead, she suggests that these prices are more about maximizing profits1. Regulatory Failures: The book also discusses the failures of regulatory bodies like the FDA in adequately overseeing the pharmaceutical industry, often due to conflicts of interest3. Reception: The book has been praised for its thorough research and clear, impassioned prose. Critics appreciate Angell’s insider perspective and her call for significant reforms in the industry43. Conclusion: “The Truth About the Drug Companies” is a must-read for anyone interested in understanding the complexities and ethical issues within the pharmaceutical industry. Angell’s insights provide a sobering look at how far the industry has strayed from its original mission of discovering and manufacturing useful drugs. Have you read this book, or are you considering it? What aspects of the pharmaceutical industry are you most interested in? Learn more 1goodreads.com2penguinrandomhouse.ca3bmj.com4rethinkingcancer.org5ahrp.org6amazon.com7nybooks.com8nybooks.com9archive.org+6 more You Sent by you: Expand on keypoint #2, the influence on medical practices. Copilot Sent by Copilot: Certainly! In “The Truth About the Drug Companies,” Marcia Angell delves deeply into how pharmaceutical companies influence medical practices in several significant ways: Funding and Bias in Clinical Trials Pharmaceutical companies often fund clinical trials for their own drugs. While this might seem beneficial, Angell argues that it can lead to biased results. Companies may design trials in ways that favor positive outcomes, such as comparing their new drug to a placebo instead of an existing treatment, or selecting patient populations that are more likely to respond well to the drug. Additionally, negative results might be underreported or not published at all, skewing the medical literature. Influence on Medical Education Drug companies also play a substantial role in medical education. They sponsor continuing medical education (CME) courses, which doctors are required to take to maintain their licenses. These courses can subtly promote the use of the sponsoring company’s drugs. Angell points out that this creates a conflict of interest, as the primary goal of these courses should be to educate doctors, not to market products. Relationships with Healthcare Providers Pharmaceutical companies often establish close relationships with healthcare providers through various means, such as offering free samples, funding research, and providing financial incentives. These relationships can influence prescribing behaviors, sometimes leading doctors to favor newer, more expensive drugs over older, equally effective, and cheaper alternatives. Ghostwriting and Medical Journals Another concerning practice is ghostwriting, where drug companies hire professional writers to produce articles that are then published under the names of respected researchers. This can give undue credibility to the company’s drugs and influence the opinions of other healthcare professionals who read these journals. Impact on Guidelines and Policies Pharmaceutical companies can also affect medical guidelines and policies. They may fund patient advocacy groups, which can then lobby for the approval and coverage of specific drugs. Additionally, some members of guideline committees may have financial ties to drug companies, potentially leading to recommendations that favor certain medications. Conclusion Angell’s book highlights the pervasive and often subtle ways in which pharmaceutical companies can shape medical practices to their advantage. This influence can compromise the objectivity of medical research, education, and practice, ultimately affecting patient care. Are there any specific aspects of this influence that you find particularly concerning or interesting? 2of5 This conversation 'Provide a book review of the book The Truth About Drug Co...' was shared with you on 11:02 AM
This post was edited 9 minutes after it was posted.
From a safety perspective, this a pill combining two medications:
Xanomeline, a acetylcholine receptor agonist
and Trospium, an anticholinergic medication with limited activity in the CNS (the idea being it blocks the nasty side effects of xanomeline in the bladder and bowel).
Trospium is regularly used for overactive bladder and xanomeline was developed in the 1990s as a possible treatment for Alzheimer's disease (similar mode of action as Aricept which is used to modestly treat the symptoms of Alzheimer's disease).
Anyways, there's pretty good safety data on both these medications and it's not like they are new classes of medications or anything majorly experimental. Just something new for schizophrenia.
Actually the main clinical trial lasted OVER ONE YEAR, not 5 weeks. 75% of patients had improvement of 30% or better without the nasty side effects. Of course it is going to be terribly overpriced. That is what these companies do. But it looks like a very good dru
I agree, it's a short study, and yes, the FDA offers "priority review vouchers" that drug companies pay for to expedite drug review (news flash, all drug reviews are paid for by the manufacturer, thanks to PDUFA, a law that was enacted to speed up the drug review process). However, the mechanism of both drugs is well-known; the novelty is to combine them so that the trospium blocks the active drug xenomeline's deleterious effects in the gut, but does not block the muscarinic receptors in the brain because it cannot cross the blood-brain barrier. The FDA approves all manner of "me too" drugs (basically copy-cats of existing drugs meant to dilute marketshare of competitors), so it's refreshing to see them actually approving a novel mechanism.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this. BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.
People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
Yeeeeeeears of development started by a startup that BMS bought. Including Phase 1 and 2 trials.
Again: all the plumbers, janitors, sanitation workers, website founders, etc, on here who think they are suddenly pharmaceutical executives or clinical trial gurus with something important or profound to say on a topic they know almost less than nothing about: stay in your lane. It will save you much embarrassment.
I do business in biotech and sell to these companies stfu. You don’t know anything either. I could buy your whole company and soul you lil b. I’ll call you my girlfriend while I make some dodecahedrons in the lab. Stfu
I agree, it's a short study, and yes, the FDA offers "priority review vouchers" that drug companies pay for to expedite drug review (news flash, all drug reviews are paid for by the manufacturer, thanks to PDUFA, a law that was enacted to speed up the drug review process). However, the mechanism of both drugs is well-known; the novelty is to combine them so that the trospium blocks the active drug xenomeline's deleterious effects in the gut, but does not block the muscarinic receptors in the brain because it cannot cross the blood-brain barrier. The FDA approves all manner of "me too" drugs (basically copy-cats of existing drugs meant to dilute marketshare of competitors), so it's refreshing to see them actually approving a novel mechanism.
Best post. Rojo, stay in your lane and don’t embarrass Cornell further.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this. BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.
People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
This guy admitted to his letsrun peeps last week that he literally didn't know that food calorie intake is tied to body mass, and he seriously talks about "If I was in charge of the FDA..."?
Actually, maybe he IS in charge. That would explain a lot.
I agree, it's a short study, and yes, the FDA offers "priority review vouchers" that drug companies pay for to expedite drug review (news flash, all drug reviews are paid for by the manufacturer, thanks to PDUFA, a law that was enacted to speed up the drug review process). However, the mechanism of both drugs is well-known; the novelty is to combine them so that the trospium blocks the active drug xenomeline's deleterious effects in the gut, but does not block the muscarinic receptors in the brain because it cannot cross the blood-brain barrier. The FDA approves all manner of "me too" drugs (basically copy-cats of existing drugs meant to dilute marketshare of competitors), so it's refreshing to see them actually approving a novel mechanism.
The mechanisms of both drugs in fen-phen (fenfluramine and phentermine) were both well known.
People love to complain about how we pay too much for defense, it is true we do. But we pay 4% of GDP on defense. It can easily be argued we should pay less of that, and more of that money should go directly to US security and not security of other nations.
But the US spends 18% of GDP and rising on healthcare. Healthcare is clearly breaking the bank and absolutely is the most corrupt industry in America. The FDA does not exist to protect the people. It exists to enforce monopolies for some of the largest corporations in the world and ensure them a steady stream of revenue.
To say the FDA isn't protecting people is simply a lie. I work in the biotech manufacturing sector and the products we make are highly regulated by the FDA. We have audits nearly year round in our facilities making sure protocols are being followed, with patient safety being literally the first thing they care about.
Or, maybe, and hear me out, don't get on the internet and make a fool of yourself? You have zero idea what went into conceiving, developing, testing, or approving this or any medication.
Phase 3 trails are to determine if a drug works in a statistically meaningful population. While safety data is also analyzed, much of that work was done before the phase 3 study. This drug has been in development for years. You can't start a phase 3 trial without already showing that the potential drug is likely safe. BMS bought the company that did all the early heavy lifting with this drug. It was known as KarXT for years if you want to dig up the data.
You literally fucccking though they just decided 5 weeks ago to start dosing people with some random chemical mixture. And the EFFICACY for this drug apparently can be assessed over 5 weeks. Do you know some drugs are SINGLE DOSE? And can be evaluated in a very short time frame? Did you want to rerun trials of those where people take it (needlessly) for months on end?? What sense would that make?
Do yourself a favor and STOP TALKING.
+1
anyone who is involved in clinical trials is shaking their heads at the comments in this thread.
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