The FDA should focus more attention on the critical role of real-world clinical data, beyond just the initial clinical trials, in the ongoing assessment of drug and vaccine safety and efficacy.
The EPPC study was informative but I wonder why not publish it in a peer reviewed journal? Impact among clinicians and researchers would be greater, and there are some quality journals that would likely publish (even open access if need be). Of course then it would really rock the boat…
I've been burned so many times by commonly prescribed meds. For instance, I had an episode of atrial flutter 6 years ago. Initial treatment was with meds: beta blocker, then when that caused difficulty breathing, two different calcium channel blockers, both awful, then Eliquis which slowly crushed me over three months before I realized what it was doing and just quit it. The electrocardiologist I was seeing said he'd never heard of Eliquis causing side effects like mine. But if you go to FAERS, where side effects of meds are reported to the FDA, you can see the post marketing side effects for Eliquis, of which death is #1. And that's at close to 13% of all reported side effects for that med.
I wonder how many people are suffering horrendous side effects from prescription meds and just assume they have to put up with it.
Not sure why you believe this idea has not occurred to others previously. It has. Systems were put in place, reporting protocols were designed. But then those very systems were gamed, and they were abandoned in reality, if not formally. (VAERS?) Do you actually believe the Military Pharma complex was unaware of the huge damage, in terms of injury and death, and all manner of suffering that accompanied the COVID Vax? No. The issue is not how do we discover sixth grade logic; rather the issue is why does Pharma not give a hoot. To make it really easy, let's take the Catholic Church. The Church would not listen to the flock. Instead they made being injected an ethical and moral issue: "if you REALLY cared about your neighbor, if you really loved your brother, you would go get the Vax." And people did. And they got very ill and injured. And they died. The Vax never prevented the spread of the virus; it was never effective. And it was never safe. And yet, the Church created a commemorative coin, a "piece of silver" homage to the Vax. And that still exists today. And the Church never said, "We are really sorry that we helped unethical people, genocidal maniacs, murder the flock." And that is where you may want to apply your logic as to what should be done about the harm done to people. But, I doubt you will do that. It is more interesting to write about suffering than it is to ask, "Who the hell is harming so many people (making them suffer) and why is the Church jumping on the bandwagon?"
pHARMa seemed to be following the church model , sell people (on) something they can't see , and in spite of vast corruption , have great pr and make a fortune. amd of course the church gives 100% compliance to protect tax free status .
Respectfully, the Vioxx scandal occurred because Merck doctored and hid data in its randomized trials. This is widely known and well documented. Observational data later confirmed it, but couldn’t discover it. The mifepristone data are confounded and much less helpful than placebo comparator data, as I’m sure you know. Real world data is a euphemism for confounded and problematic, and were improperly cited by authorities everywhere to justify the covid vaccine studies that were inadequate and perhaps even misleading.
Such a great point, agreed: industry trial reports are not trustworthy, and the trials are often gamed. My Substack, however, is in part an attempt to show how a careful reading usually reveals the correct inference from such RCTs. (Example:, the new Alzheimer's drugs—https://researchtranslation.substack.com/p/why-the-alzheimers-drugs-wont-make). The irony of your point, IMHO, is that the correct fix is for the FDA to insist all original source data from industry RCTs be open access, transparent. Currently they are hidden. That's a real, long term fix. Performing 'real world' observational studies will not protect us from misrepresentation and subterfuge by industry in the reports they submit to journals. This can only help detecting rare, long term, and previously unstudied adverse effects. The original RCTs are what we need.
transparency would be wonderful, but we'll never get it. We can't even get the real info about all the failed studies that were supposed to be required on clinicaltrials.gov.
Post market vigilance has always been promised and then applied unevenly to passify users and the data is “lost” suppressed and/or discredited. They want their return on investment even for negative efficacies.
Excellent. I’ve been thinking this for years. Nobody wants to hear it. Everyone assumes the FDA wouldn’t approve a drug that hasn’t been thoroughly tested. Common sense leads people to believe and assume drug trials are infallible, complex, and rigorously tracked. They assume that’s the FDA’s job.
Since I was in high school Are advised all not to take new drugs when there are existing alternatives available unless there was No alternative on extremely compelling benefit that justified risk of unknown.
Of course I had qualified for Northwestern 6-year BS/MD program which was done arguably the number one most competitive MD program to get into. After qualifying for I ended up turning it down because I didn't want to be a physician that bad. Practicing would get boring and mechanical. Research was more challenging but too slow a timeline. And I really wanted to do hospital takeovers to fuck with those that deserved it.
So I did.
But my medical aptitude is very high and my advice is always been very good prescient.
I prefer to hear the experiences people sre having with a drug , the success doctors working in the trenches sre having , thousands and thousands of anecdotal evidence for me is worth more than righed RCTs
Dr. Aaron's quiet concentration is like that of an Olympic archer: flawlessly on the mark. Thank you. Thank you. Thank you.
Yes post-approval studies are key!
The EPPC study was informative but I wonder why not publish it in a peer reviewed journal? Impact among clinicians and researchers would be greater, and there are some quality journals that would likely publish (even open access if need be). Of course then it would really rock the boat…
Your message here really resonates!
I've been burned so many times by commonly prescribed meds. For instance, I had an episode of atrial flutter 6 years ago. Initial treatment was with meds: beta blocker, then when that caused difficulty breathing, two different calcium channel blockers, both awful, then Eliquis which slowly crushed me over three months before I realized what it was doing and just quit it. The electrocardiologist I was seeing said he'd never heard of Eliquis causing side effects like mine. But if you go to FAERS, where side effects of meds are reported to the FDA, you can see the post marketing side effects for Eliquis, of which death is #1. And that's at close to 13% of all reported side effects for that med.
I wonder how many people are suffering horrendous side effects from prescription meds and just assume they have to put up with it.
Not sure why you believe this idea has not occurred to others previously. It has. Systems were put in place, reporting protocols were designed. But then those very systems were gamed, and they were abandoned in reality, if not formally. (VAERS?) Do you actually believe the Military Pharma complex was unaware of the huge damage, in terms of injury and death, and all manner of suffering that accompanied the COVID Vax? No. The issue is not how do we discover sixth grade logic; rather the issue is why does Pharma not give a hoot. To make it really easy, let's take the Catholic Church. The Church would not listen to the flock. Instead they made being injected an ethical and moral issue: "if you REALLY cared about your neighbor, if you really loved your brother, you would go get the Vax." And people did. And they got very ill and injured. And they died. The Vax never prevented the spread of the virus; it was never effective. And it was never safe. And yet, the Church created a commemorative coin, a "piece of silver" homage to the Vax. And that still exists today. And the Church never said, "We are really sorry that we helped unethical people, genocidal maniacs, murder the flock." And that is where you may want to apply your logic as to what should be done about the harm done to people. But, I doubt you will do that. It is more interesting to write about suffering than it is to ask, "Who the hell is harming so many people (making them suffer) and why is the Church jumping on the bandwagon?"
pHARMa seemed to be following the church model , sell people (on) something they can't see , and in spite of vast corruption , have great pr and make a fortune. amd of course the church gives 100% compliance to protect tax free status .
Respectfully, the Vioxx scandal occurred because Merck doctored and hid data in its randomized trials. This is widely known and well documented. Observational data later confirmed it, but couldn’t discover it. The mifepristone data are confounded and much less helpful than placebo comparator data, as I’m sure you know. Real world data is a euphemism for confounded and problematic, and were improperly cited by authorities everywhere to justify the covid vaccine studies that were inadequate and perhaps even misleading.
confounded and problematic, but uncontrolled by Big Pharma and their contract research org. lackies. Who trusts these clinical trials anymore?
Such a great point, agreed: industry trial reports are not trustworthy, and the trials are often gamed. My Substack, however, is in part an attempt to show how a careful reading usually reveals the correct inference from such RCTs. (Example:, the new Alzheimer's drugs—https://researchtranslation.substack.com/p/why-the-alzheimers-drugs-wont-make). The irony of your point, IMHO, is that the correct fix is for the FDA to insist all original source data from industry RCTs be open access, transparent. Currently they are hidden. That's a real, long term fix. Performing 'real world' observational studies will not protect us from misrepresentation and subterfuge by industry in the reports they submit to journals. This can only help detecting rare, long term, and previously unstudied adverse effects. The original RCTs are what we need.
transparency would be wonderful, but we'll never get it. We can't even get the real info about all the failed studies that were supposed to be required on clinicaltrials.gov.
Perhaps I'm an idealist. I believe we can get there.
Post market vigilance has always been promised and then applied unevenly to passify users and the data is “lost” suppressed and/or discredited. They want their return on investment even for negative efficacies.
Excellent. I’ve been thinking this for years. Nobody wants to hear it. Everyone assumes the FDA wouldn’t approve a drug that hasn’t been thoroughly tested. Common sense leads people to believe and assume drug trials are infallible, complex, and rigorously tracked. They assume that’s the FDA’s job.
I will not take any med that I don't research first by checking FAERS data. I assume protecting myself is my job.
FDA should be dissolved and started over with conflict guardrails installed so no reward at the end for them.
Um, the FDA already does this. What do you think, for instance, that the Vaccine Safety Datalink project does?🤦🏻♂️
LOL. So now you're where I was 50 years ago.
Since I was in high school Are advised all not to take new drugs when there are existing alternatives available unless there was No alternative on extremely compelling benefit that justified risk of unknown.
Of course I had qualified for Northwestern 6-year BS/MD program which was done arguably the number one most competitive MD program to get into. After qualifying for I ended up turning it down because I didn't want to be a physician that bad. Practicing would get boring and mechanical. Research was more challenging but too slow a timeline. And I really wanted to do hospital takeovers to fuck with those that deserved it.
So I did.
But my medical aptitude is very high and my advice is always been very good prescient.
I prefer to hear the experiences people sre having with a drug , the success doctors working in the trenches sre having , thousands and thousands of anecdotal evidence for me is worth more than righed RCTs
I don’t trust the FDA to honestly do any surveillance. And about vaccines? HA.