Aa
failrure to address or admit damage
do you suppose anyone will ever own up to the devastation of treatment for hep c. i am a nurse was treated with peg intron in 02. got toxic was able to work briefly after i learned to talk again then in 03 04 got sicker and sicker - continue to have progressive frontal lobe damage autoimmune nightmare has destroyed my family cant work short term memory shot - yet ask any hepatologist and it didn't happen. now there are black box issues coming out of the wordwork - when did doctors, nurses or anyone altruistic leave medicine. i cannot even use a stove because if forget it. answer from all but one hepatologistg was never heard of it. they really should read and study the meds they are going to use even if they ignore it and continue to fill their pockets./ i am not the only one this happened to but we will be denied and ignored because basically hep c is a bad person disease and who cares. wish i had en ergyh to get active but i don't and didnt seem to matter anyway i have a wonderful doc now who i used to work for so she knows first hand what has happened to me so i get treated well. but i cannot tell you how many weird things i have had or what feeling good is. least i dont zombie sleep for days at the time anymore and sometimes i am not nauseated and in total fog - but now am having so many falls and potentially dan gerous things. i can;'t remember where i put things if anyon e inturrupts me dont really have any concept of time. or anything. they all know what they did and for alll you others affected hang in there and this nurse believes - remember to laugh even if no one else understands the joke. i miss my work, my brother doesnt let me see his kids, my son treats me like i dedliberately did this to affect his life, afterall disability and nursing salary are way different - but cant keep up with money anyway have been know not to check mail for a month or two. probably will never see this post because none of this ever happened or so i have been told. God bless all those affected and han g in there.
Crime against humanity? Not so. You are not entitled to demand that anybody invest in developing a medication simply because you do not want to try the available cure. As for public funding, don't you live in Argentina? How about approaching that government to fund the research you are demanding.
Mike, I have to possibly disagree with a few things said. Like you I am also impatient. I am a little frustrated that these things move so slowly but I also understand why. There is little doubt that early approval of some of these compounds would save lives and it is tempting to look at the numbers and rationalize that is what should drive the approval process. Even so, I understand that the FDA has to strike a balance..... I mean they have to attempt to satisfy both sides; the greatest speed and yet maintaining standards so that the drugs we end up taking are both safe and effective.
You may not be aware of it but Vertex DID attempt a trial (Prove 2) in which in 1 arm NO RIBA was attempted. What happened was a 40% SVR rate. That means that 60% were not cured and have possibly produced Telaprevir resistant virii that could resist further attempt to be treated with any PI's such as Telaprevir or Boceprevir.
So you can understand that being to willing to try potentially weak or ineffective solutions to a cure may not really be doing people a favor.. I "get" your impatience but I want you to understand there are a few members of this forum who failed in that trial and they are not happy campers; they now can't get into other trials. I know another member here whose trial shut down due to causing low neuts. The drug compound WAS effective just not as safe as it should be. Would you be the person who would approve it? It's tempting but if one goes down that road too easily we could end up with a lot of borderline safe drugs. My own father was a Vioxx patient that died a few years before the recall. We didn't know at the time that it probably caused his death.
I write just to expose a few issues with being to proactive in approving drugs.
One thing that I would really like to see the FDA do for further HCV trials is allow the selected use of EOT-12 week PCR's as equivalent to the official 24 week EOT PCR's. For people on Telaprevir and Boceprevir I don't believe that there is significant difference between the 2 results, but they do end up further slowing the approval process.
By the way...... this is important to consider. In one of the Berkson threads there was a link. I Think it came from Berkson himself in an interview. He asked the interviewer if the knew what it cost to get a drug approved nowadays? The answer was 1 billion dollars. I want to point out that anything that gets done needs money in a HUGE way. Even early failures are immensely expensive. Pushing forward without caution can cause an even worse result. Take a look at the recall that Toyota is now engaged in. There is no easy way.
best,
Willy
You may not be aware of it but Vertex DID attempt a trial (Prove 2) in which in 1 arm NO RIBA was attempted. What happened was a 40% SVR rate. That means that 60% were not cured and have possibly produced Telaprevir resistant virii that could resist further attempt to be treated with any PI's such as Telaprevir or Boceprevir.
So you can understand that being to willing to try potentially weak or ineffective solutions to a cure may not really be doing people a favor.. I "get" your impatience but I want you to understand there are a few members of this forum who failed in that trial and they are not happy campers; they now can't get into other trials. I know another member here whose trial shut down due to causing low neuts. The drug compound WAS effective just not as safe as it should be. Would you be the person who would approve it? It's tempting but if one goes down that road too easily we could end up with a lot of borderline safe drugs. My own father was a Vioxx patient that died a few years before the recall. We didn't know at the time that it probably caused his death.
I write just to expose a few issues with being to proactive in approving drugs.
One thing that I would really like to see the FDA do for further HCV trials is allow the selected use of EOT-12 week PCR's as equivalent to the official 24 week EOT PCR's. For people on Telaprevir and Boceprevir I don't believe that there is significant difference between the 2 results, but they do end up further slowing the approval process.
By the way...... this is important to consider. In one of the Berkson threads there was a link. I Think it came from Berkson himself in an interview. He asked the interviewer if the knew what it cost to get a drug approved nowadays? The answer was 1 billion dollars. I want to point out that anything that gets done needs money in a HUGE way. Even early failures are immensely expensive. Pushing forward without caution can cause an even worse result. Take a look at the recall that Toyota is now engaged in. There is no easy way.
best,
Willy
One little scientist with a good heart sitting in a lab is going to get this done. "
Correction >>> Is NOT going to get this done.
Correction >>> Is NOT going to get this done.
I don't see collusion or corruption, just regulation and the restrictions that come with it. "
I have to agree whole heartidly with newleaf. Had you been around this forum even five years ago you would have seen that all the drugs in trial did not pan out. It was not the fact that they were not trying, they just did not come to fruition.
Now, these days you see the miracles of PIs shortening the term of treatment and also increasing the odds of succes and it is literally to me miraculous. Watch an "Andiamo" who has treated 90 times win the battle! Wow.
I thank God that there are guidelines and restrictions that come along with this tedious work otherwise God knows what people would willingly subject themselves to in the vain attempt to be healed with things that were not legitimate.
A crime? I just don't see how any educated person can believe that we've come this far already in a few short years because big pharma is out to get us. Rather how far we have succeeded in closing the door to failure.
Business IS business after all and investors do expect to see profits in all aspects of the world - otherwise there is no push to get it done. One little scientist with a good heart sitting in a lab is going to get this done.
it seems hard to keep this thread on topic.
Funding for trials comes from the pharmaceutical companies themselves. There was an early level trial called Inform that used 2 polymerase inhibitors. It was short,it's purpose was to see if patients could tolerate the PI's and the results for the short time frame were phenomenal. Now that they are moving forward into more advanced trials, they have split the 2 PI's into 2 trials, each with SOC. As I understand the reasoning for the design change from 2 PI's together to 1 PI + SOC, is that the FDA will not approve a trial enrolling large numbers of people (phase 2 & expecially 3's, which can enroll thousands) to exclude the standard regimen. They consider it inhumane to treat a serious disease with experimental drugs only and require the inclusion of a proven cure.
I don't see collusion or corruption, just regulation and the restrictions that come with it.
Funding for trials comes from the pharmaceutical companies themselves. There was an early level trial called Inform that used 2 polymerase inhibitors. It was short,it's purpose was to see if patients could tolerate the PI's and the results for the short time frame were phenomenal. Now that they are moving forward into more advanced trials, they have split the 2 PI's into 2 trials, each with SOC. As I understand the reasoning for the design change from 2 PI's together to 1 PI + SOC, is that the FDA will not approve a trial enrolling large numbers of people (phase 2 & expecially 3's, which can enroll thousands) to exclude the standard regimen. They consider it inhumane to treat a serious disease with experimental drugs only and require the inclusion of a proven cure.
I don't see collusion or corruption, just regulation and the restrictions that come with it.
Interferon and ribavirin are dangerous drugs. I don't think anyone would argue with that. A crime (I don't use that word lightly) is being committed if no valid therapies are being funded, supported, and eventually approved that do not include these drugs, and that seems to be the present case, undoubtedly because of collusion between government and the corporations that produce and sell these drugs. In short, corruption. Crime against humanity would not be too strong an expression to use, considering the number of infected people.
I believe that some day there will be a huge international scandal when the truth about the collusion between supposedly public officials and private drug companies becomes known, even if that collusion is only to the extent of shares in these companies owned by those officials. However, I don't believe that is the extent of the corruption. No, it goes much further.
It is a fact that trials of drugs that can combat HCV independently of SOC are not being funded, and the manufacturers of these drugs are afraid even to propose a trial that does not include SOC. This is obvious from the trials information websites. The funding and support going to new medications is going to those, like the viral gene inhibitors, Alinia, et cetera, that are testing the new medications together with interferon and ribavirin. Those that are not, like the anti-HV vaccine (which is not only preventative but curative), cannot find public funding and are not being supported by the larger medical institutions. What are they afraid of?
Is the prejudice for SOC and against anything else just because doctors and hospitals receive money for prescribing SOC? I think not. The corruption is more far-reaching. It goes all the way back to the AMA and the ways in which medical personnel are chosen for public office in regulatory and other public health agencies, and to the undisclosed pecuniary interests of politicians in supporting those companies whose stock they own, and their interest in defeating alternatives that could lower the value of their shares.
There is an enormous globalized corruption that has set in everywhere, and the terrible problem of treatment for hepatitis is part of it. Make no mistake about that.
I believe that some day there will be a huge international scandal when the truth about the collusion between supposedly public officials and private drug companies becomes known, even if that collusion is only to the extent of shares in these companies owned by those officials. However, I don't believe that is the extent of the corruption. No, it goes much further.
It is a fact that trials of drugs that can combat HCV independently of SOC are not being funded, and the manufacturers of these drugs are afraid even to propose a trial that does not include SOC. This is obvious from the trials information websites. The funding and support going to new medications is going to those, like the viral gene inhibitors, Alinia, et cetera, that are testing the new medications together with interferon and ribavirin. Those that are not, like the anti-HV vaccine (which is not only preventative but curative), cannot find public funding and are not being supported by the larger medical institutions. What are they afraid of?
Is the prejudice for SOC and against anything else just because doctors and hospitals receive money for prescribing SOC? I think not. The corruption is more far-reaching. It goes all the way back to the AMA and the ways in which medical personnel are chosen for public office in regulatory and other public health agencies, and to the undisclosed pecuniary interests of politicians in supporting those companies whose stock they own, and their interest in defeating alternatives that could lower the value of their shares.
There is an enormous globalized corruption that has set in everywhere, and the terrible problem of treatment for hepatitis is part of it. Make no mistake about that.
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