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Many years ago my husband was asked to participate in a new drug test.. he had been taking prevacid and the manufacturer was running tests on a new drug. The GI doc he went to was very much into drug testing (probably his main income).
The exams were free and he was paid.. he even got a tshirt!:)
Sometime during the first few months he started to have problems with tingling in his hands. Not knowing if the drug was causing the problem he was dropped from the study. Did they try to determine the cause of the tingling? NO.
Seems that when a new drug is in testing phase... they can drop as many people as they want to... and they won't effect the outcome of the drug testing. The people who are dropped are treated as if they were never in the test group. The test group for statistical purposed is made up only of those who make it past a specific time period.. that is why they keep adding people to these tests... may take hundreds to get the final test group.. only those people who make it past the start up with NO side effects of any kind no matter what the cause might be .. will be considered as "the test group".
Maybe everyone already knows this.. but it was a surprise to us!
grannyh
what I learned about how new drugs are tested
Moderators: Rosie, Stanz, Jean, CAMary, moremuscle, JFR, Dee, xet, Peggy, Matthew, Gabes-Apg, grannyh, Gloria, Mars, starfire, Polly, Joefnh
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Gabes-Apg
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I knew this - and it is a large part of the basis for my cynacism of big pharma.
They will manipulate the tests and protocols of new drugs and ingredients to suit themselves (and their profit margin)
i am not totally critical of doctors, my main issue is that doctor and specialists ongoing learning is reliant on big pharma, and these tainted studies.
They will manipulate the tests and protocols of new drugs and ingredients to suit themselves (and their profit margin)
i am not totally critical of doctors, my main issue is that doctor and specialists ongoing learning is reliant on big pharma, and these tainted studies.
Gabes Ryan
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
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Linda in BC
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Joefnh
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Connie do you know which phase of initial testing that they were in. Usually during phases 1 or 2 of the initial testing, they will discontinue certain patients with side effects as the testing is setup to review the actual positive effects and duration of effect (how long it works well). They will record the side effect and continue the testing until the phase is complete.
As the testing enters phases 3 & 4 they will begin to workup each individual with negative side effects and begin focusing on those to determine their cause and make a determination if the testing and medication can proceed further. I am not sure what happened in your husbands case, and they certainly should have described what they were doing in better detail. Those types of events can leave the wrong impression.
--Joe
As the testing enters phases 3 & 4 they will begin to workup each individual with negative side effects and begin focusing on those to determine their cause and make a determination if the testing and medication can proceed further. I am not sure what happened in your husbands case, and they certainly should have described what they were doing in better detail. Those types of events can leave the wrong impression.
--Joe
Joe
My husband has barretts esophagus. The test drug did seem to be helping. But after he mentioned the tingling in his fingers.. they described how the testing works... he had to be removed immediately since he was about to start the next phase and they didn't want anyone with any possible side effect in the next phase because they weren't allowed to drop anyone in that phase.
It was a blind study..there was no way of knowing if he was actually getting the real drug..except that he was doing better..the scopes showed healing. He has never had a scope look that good since.. and that has to be at least 8 years ago.
grannyh
It was a blind study..there was no way of knowing if he was actually getting the real drug..except that he was doing better..the scopes showed healing. He has never had a scope look that good since.. and that has to be at least 8 years ago.
grannyh
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MaggieRedwings
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This is downright scary to me. I am trying to elimate the 2 drug other than the heart medication I take. Lipitor I think is a waste and my new doc has to be reminded by me to order blood tests and Spireva seems to do zilch.
Thanks for the news.
Maggie
Thanks for the news.
Maggie
Maggie Scarpone
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Resident Birder - I live to bird and enjoy life!
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Resident Birder - I live to bird and enjoy life!
According to federal guidelines they say you only need to have blood work while on cholesterol drugs..once a year... my doctor does 6 month tests and medicare will pay for it every three months. Since I have CC I want to be extra sure nothing bad is going on..so have opted for three month tests.
grannyh
grannyh
My observation is that "real" market research is more statistically and methodologically robust than most "scientific" drug research. Reason being that such commercial research looks for a true marketing advantage versus real world competitors, while drug research just has to pass muster with (ivory tower) academia and FDA (i.e. no real competition). Yet the academic institutions that conduct such "second rate" research are paid considerable more than commercial market research organizations.
Ant
Ant
All of the statistic problems aside.. what usually causes problems is when a drug is used for a disease other than the one it was approved for.
Entocort was approved for Crohns disease. Then doctors who didn't read the insert..or ignored it after reading it.. decided to use it for all IBS diseases.. they killed off a few folks and the drug was pulled from the US market. When it came back on the market, doctors had to get approval from Prometheus labs to use it in non Crohn's patients... it was at that point that I was able to get entocort.
grannyh
Entocort was approved for Crohns disease. Then doctors who didn't read the insert..or ignored it after reading it.. decided to use it for all IBS diseases.. they killed off a few folks and the drug was pulled from the US market. When it came back on the market, doctors had to get approval from Prometheus labs to use it in non Crohn's patients... it was at that point that I was able to get entocort.
grannyh
Ant,
You are right on the money with that observation. To get FDA approval, drug companies simply have to "coax" their new drug to "jump through all the FDA hoops", and then they "have it made". They don't have to worry about whether it actually has a competitive advantage, or even whether or not it actually benefits any patients, because they have a "captive" market, and an extremely effective distribution system, (doctors), eager to prescribe it. Even if it kills patients, they can sell enough to make huge profits, before it's withdrawn from the market. All other industries have to produce products that actually meet consumer needs and desires, in order to be successful.
Grannyh,
If drugs were not allowed to be used for off-label purposes, there would be no drugs available to treat MC - as you know, there are exactly zero drugs approved and labeled for treating MC. It has always been this way, and I doubt that this situation will change, anytime soon.
Tex
You are right on the money with that observation. To get FDA approval, drug companies simply have to "coax" their new drug to "jump through all the FDA hoops", and then they "have it made". They don't have to worry about whether it actually has a competitive advantage, or even whether or not it actually benefits any patients, because they have a "captive" market, and an extremely effective distribution system, (doctors), eager to prescribe it. Even if it kills patients, they can sell enough to make huge profits, before it's withdrawn from the market. All other industries have to produce products that actually meet consumer needs and desires, in order to be successful.
Grannyh,
If drugs were not allowed to be used for off-label purposes, there would be no drugs available to treat MC - as you know, there are exactly zero drugs approved and labeled for treating MC. It has always been this way, and I doubt that this situation will change, anytime soon.
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Tex,
I am thrilled that drugs can be used off label! My point was that DOCTORS improperly prescribed it and caused it to be totally pulled from the US market.
When I was diagnosed I was told about entocort and the fact that it had been pulled from the market.. but not why. Because it had been pulled from the market I was afraid to try it. I read on this site about people having success with it.. so when I decided to try a drug for relief of CC.. I asked for entocort when it again became available. Have been happy with the results ever since.
Without this site, I never would have tried it:)
grannyh
I am thrilled that drugs can be used off label! My point was that DOCTORS improperly prescribed it and caused it to be totally pulled from the US market.
When I was diagnosed I was told about entocort and the fact that it had been pulled from the market.. but not why. Because it had been pulled from the market I was afraid to try it. I read on this site about people having success with it.. so when I decided to try a drug for relief of CC.. I asked for entocort when it again became available. Have been happy with the results ever since.
Without this site, I never would have tried it:)
grannyh
I agree with you about the improper uses. IBS is a prime example of a situation where that privilege is easily abused, (prescribing inappropriate drugs), because doctors don't have the foggiest idea what causes the "disease" in the first place, so why would they presume that they know how to treat it? They surely feel desperate to do something, though, so they prescribe something, hoping for a miracle. 
Incidentally, I think you're very wise to have your liver enzymes checked at least 4 times a year. The liver is not something to be taken lightly, and if something goes wrong, (due to an adverse drug effect, or whatever), by the time a year passes, it could be pretty well "trashed".
It seems that quite a few doctors start a patient on drugs in this class, and advise the patient that "we'll" need to do blood tests every 3 months, to make sure that the liver enzymes are OK, etc., but unless the patient makes a point of it, a lot of them seem to forget the followup tests, after the first one.
Tex
Incidentally, I think you're very wise to have your liver enzymes checked at least 4 times a year. The liver is not something to be taken lightly, and if something goes wrong, (due to an adverse drug effect, or whatever), by the time a year passes, it could be pretty well "trashed".
It seems that quite a few doctors start a patient on drugs in this class, and advise the patient that "we'll" need to do blood tests every 3 months, to make sure that the liver enzymes are OK, etc., but unless the patient makes a point of it, a lot of them seem to forget the followup tests, after the first one.
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Dear Tex,
Just to build on the research/commercial point..... if second rate research passes academic and bureaucratic muster, a drug can get patent approval (i.e. monopoly power) and we know what historian, Lord Acton, observed about "all power corrupting and absolute power corrupting absolutely". Government is meant to be the check and balance against this....but instead they seem to be colluding......or if I am generous just blissfully ignorant....
Best ant
Just to build on the research/commercial point..... if second rate research passes academic and bureaucratic muster, a drug can get patent approval (i.e. monopoly power) and we know what historian, Lord Acton, observed about "all power corrupting and absolute power corrupting absolutely". Government is meant to be the check and balance against this....but instead they seem to be colluding......or if I am generous just blissfully ignorant....
Best ant