400 person study on lower INR (1.5-2.5) with mechanical valve

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Humboldtgrrl

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My practice is involved with a large number of drug studies on eye drugs for various retinal conditions. When these studies are initiated a lot of thought goes into trying to design the study as likely to work as possible. Recently one of the drug companies had a failed study. They analyzed the study and decided that the way it was set up allowed the study to fail. So feeling confident that their product would ultimately pass muster they set up another study done slightly differently which they hope will succeed. This INR stuff is a lot like that. Concoct weird statistics (adding bleeding+stroke) showing they are "superior" in one group and getting the FDA to OK this device. Also I think there is a trend for the FDA to OK things that possibly in the past would not be OKed. For example one of the drugs for Alzheimers was authorized even though it did not show direct clinical efficacy for Alzheimers. It only showed a marker being altered. Somewhat like the defense industry in the US there is a revolving door between government and industry in other departments like the FDA. So there may be conflicts of interest in making these decisions.
Side Bar Issue - any thots re Coselli's surgical prowess for aneurysm redo (original stent+AVR was done by another surgeon a year ago, but now has aneurysms at both end of the stent)? Have tried to link up you & my sister (toadhall blog name) up online before her Houston consult, but unclear that my limited techno-literacy efforts succeeded. TIA
 

slipkid

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Jun 12, 2014
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My practice is involved with a large number of drug studies on eye drugs for various retinal conditions. When these studies are initiated a lot of thought goes into trying to design the study as likely to work as possible. Recently one of the drug companies had a failed study. They analyzed the study and decided that the way it was set up allowed the study to fail. So feeling confident that their product would ultimately pass muster they set up another study done slightly differently which they hope will succeed. This INR stuff is a lot like that. Concoct weird statistics (adding bleeding+stroke) showing they are "superior" in one group and getting the FDA to OK this device. Also I think there is a trend for the FDA to OK things that possibly in the past would not be OKed. For example one of the drugs for Alzheimers was authorized even though it did not show direct clinical efficacy for Alzheimers. It only showed a marker being altered. Somewhat like the defense industry in the US there is a revolving door between government and industry in other departments like the FDA. So there may be conflicts of interest in making these decisions.

Wise man. I agree with everything you said above.

I used to work in the pharma industry. For about 5 years I was a programmer involved with creating the reports that were used for FDA submissions, mostly phase II clinical trials.

Adverse effects was always our biggest shall we say "challenge". Those reports would be reviewed & "massaged" (IE: altered) up the wazoo to increase the chances of FDA approval at the direction of the MDs overseeing the studies working for the pharma company. If the adverse events were too serious or common the data would be looked at with a microscope to find ways to exclude "outliers" resulting in a more favorable report, or simply scrap the study and implement a new study with more targeted "patient screening" likely to get better results.

Then add to this that the FDA is motivated largely by $$ as is the whole industry of course. The greater the perceived profits the more likely whatever it is will get approval by the FDA. And there are the ties of FDA employees who came from big pharma with relationships with their old companies even if not out in the open salary drawing situations. The whole system is corrupt and the FDA is largely toothless or at least chooses to be.

Yeah I'm generalizing but if you think the FDA's #1 focus is to protect patients I have some prime real estate avialable for sale real cheap down around New Orleans or Northern California you might want to invest in.

[Edit: By the word "you" above I don't mean vitdoc, I mean anyone reading my post. And - as I say "don't get me started" - what the FDA does regarding approving generics is downright pathetic IMO based on my own personal experience]
 
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tom in MO

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...Then add to this that the FDA is motivated largely by $$ as is the whole industry of course. The greater the perceived profits the more likely whatever it is will get approval by the FDA. And there are the ties of FDA employees who came from big pharma with relationships with their old companies even if not out in the open salary drawing situations. The whole system is corrupt and the FDA is largely toothless or at least chooses to be.

Yeah I'm generalizing but if you think the FDA's #1 focus is to protect patients I have some prime real estate avialable for sale real cheap down around New Orleans or Northern California you might want to invest in....

You are incorrect and slandering the FDA. I work in several areas that are regulated by the FDA. They are a dedicated group of public servants who call themselves "fraud fighters" in their internal training documents. I have had interactions with many FDA employees both at conferences, webinars, meetings and as a subject of FDA inspections. They come about once every 4 years because we are a "good" company thus our surveillance inspection rate is not high. They have all been good people dedicated to protecting your health but also to providing drugs, devices and treatments to ill people like you. In an FDA inspection one must always provide objective proof of compliance to the regulations and an effective product. The FDA are so good at their job they have leveled fines that range up to $2 billion dollars. See here:
FDA settlements

 
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Warrick

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Dec 26, 2015
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New Zealand
Shame to read that the FDA is bent more than a banana... as a "friends of NATO" country from what I've seen our pharmaceuticals industry here take all the approvals as gospel.
I'll flog a dead horse and say I have spoken to of a number of people on warfarin for Afib switched over to Dabigatran in the last few years
 

vitdoc

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When drugs/devices are certified by the FDA the products are evaluated by panels of “experts” who review the data and vote on approval or not.
The FDA gets the data ready from the manufacturer and makes sure it was done appropriately.

I am sure that most of the FDA people are honest and not in any way corrupt.

But huge amounts of money is sloshing around from the drug industry. These “experts “ often have various connections with the industry as consultants, testing locations or talking heads.
The experts probably feel that their recommendations are not biased. But with the money out there can they really be unbiased?
As drugs get more expensive the stakes get higher.

Given a few head scratchers that have passed FDA evaluation it just makes one wonder how well the system is working. I don’t think however that it is completely corrupt or inept.
 

slipkid

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Jun 12, 2014
Messages
406
Location
Schwenksville, PA, USA
You are incorrect and slandering the FDA. I work in several areas that are regulated by the FDA. They are a dedicated group of public servants who call themselves "fraud fighters" in their internal training documents. I have had interactions with many FDA employees both at conferences, webinars, meetings and as a subject of FDA inspections. They come about once every 4 years because we are a "good" company thus our surveillance inspection rate is not high. They have all been good people dedicated to protecting your health but also to providing drugs, devices and treatments to ill people like you. In an FDA inspection one must always provide objective proof of compliance to the regulations and an effective product. The FDA are so good at their job they have leveled fines that range up to $2 billion dollars. See here:
FDA settlements


Not been my experience in regards to some issues I alluded to but good to know that some at the FDA actually do their jobs as they should.
 

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