If those so much more learned than us can;t agree, if
BRAF=v-raf murine sarcoma viral oncogene homolog B1
KRAS=v-ki ras 2 Kirsten rat sarcoma 2 viral oncogene homolog
MACC1-metastasis associated in colon cancer 1 gene
Don't ask me what any of this means.....Other interesting acronymns or things you might want to check out that I've read about (should be on google by now I guess):
beta-catenin
LRP1B
mTORC1;mTORC2;EMT-seems connected
anti-DLL4 and Kras mutations
RRM2B(p53R2)
MiR-141-maybe biomarker for mets
I recall reading IV chemo was first tried in 1942; 5-FU was first synthesized in 1958, enhanced in the early 1990s with the addition of leucovorin....Most of the chemo used for CRC was approved by the FDA between 1996 and 2006 (for instance,Xeloda-2001; Oxi-2002; Avastin-2004;Vectibix-2006)...CEA testing became standard around 1996....
If you think about it....admittedly more should be available .....but damn, this stuff is not that old......
Comments
-
backups and budgets at the FDA
Made a lot of things move very slowly. In 1992 this dam was broken by the Prescription Drug User Fee Act:
http://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act
This, combined with Richard Nixon's "War on Cancer" opened the floodgate to quite a lot of new medications and breakthroughs.
AIDS was the driving force behind the legislation, and it is not without controversy even today. Some say that the very fact that Pharma funds the approval process puts pressure on the FDA to approve things that should not be approved. I understand the issues involved, but given the state of politics today and in 1992, the only way the FDA would get a bigger budget for drug approvals was through a user fee.
Here is the history from Wiki:
History
The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the the FDA. All three groups felt that drug approvals were taking far too long. For some patients, a drug waiting for approval and not yet available for sale could make the difference between life and death. Pharmaceutical companies had to wait to begin to recoup the costs of research and development. The FDA estimated that a delay of one month in a review’s completion cost its sponsor $10 million. The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market. The FDA had not received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be used to speed drug review. The 1992 law became possible when the FDA and industry agreed on setting target completion times for reviews and that promise these fees would supplement federal appropriations instead of replacing them. [1]
[edit]AIDS epidemic
Main article: AIDS
The length of the drug approval process fell under severe scrutiny during the early years of the AIDS epidemic. In the late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA headquarters which resulted in roughly 180 arrests.[2] In August 1990, Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.[3] Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options.[4] All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted 2 years later, in 1987.[5]
AIDS activists, desperate for new treatments, were outraged at the cost of those first drugs and the slow pace of drug development. These activists bombarded the government and drug companies with complaints and public protests. The activists won a major victory in 1989, when Burroughs Wellcome implemented a 20% price cut on AZT, then still the only treatment for HIV. Even after this price concession, the 12-pill-per-day AZT regimen cost patients $6,400 a year. AIDS activists expressed their anger by trashing booths at medical conventions and continuing vocal public protests. Gradually, drug companies established relationships with AIDS activists and the two sides came together to improve clinical trials. By August 1991, relations had warmed up so much that ACT-UP founder Larry Kramer wrote Bristol-Myers Squibb chief Richard Gelb a letter of congratulations on the imminent approval of Videx. AIDS groups fought for the reauthorization of the Orphan Drug Act and the passage of the Prescription Drug User Fee Act in 1992. [6]0 -
A bit on the War on CancerBuckwirth said:backups and budgets at the FDA
Made a lot of things move very slowly. In 1992 this dam was broken by the Prescription Drug User Fee Act:
http://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act
This, combined with Richard Nixon's "War on Cancer" opened the floodgate to quite a lot of new medications and breakthroughs.
AIDS was the driving force behind the legislation, and it is not without controversy even today. Some say that the very fact that Pharma funds the approval process puts pressure on the FDA to approve things that should not be approved. I understand the issues involved, but given the state of politics today and in 1992, the only way the FDA would get a bigger budget for drug approvals was through a user fee.
Here is the history from Wiki:
History
The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the the FDA. All three groups felt that drug approvals were taking far too long. For some patients, a drug waiting for approval and not yet available for sale could make the difference between life and death. Pharmaceutical companies had to wait to begin to recoup the costs of research and development. The FDA estimated that a delay of one month in a review’s completion cost its sponsor $10 million. The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market. The FDA had not received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be used to speed drug review. The 1992 law became possible when the FDA and industry agreed on setting target completion times for reviews and that promise these fees would supplement federal appropriations instead of replacing them. [1]
[edit]AIDS epidemic
Main article: AIDS
The length of the drug approval process fell under severe scrutiny during the early years of the AIDS epidemic. In the late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA headquarters which resulted in roughly 180 arrests.[2] In August 1990, Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.[3] Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options.[4] All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted 2 years later, in 1987.[5]
AIDS activists, desperate for new treatments, were outraged at the cost of those first drugs and the slow pace of drug development. These activists bombarded the government and drug companies with complaints and public protests. The activists won a major victory in 1989, when Burroughs Wellcome implemented a 20% price cut on AZT, then still the only treatment for HIV. Even after this price concession, the 12-pill-per-day AZT regimen cost patients $6,400 a year. AIDS activists expressed their anger by trashing booths at medical conventions and continuing vocal public protests. Gradually, drug companies established relationships with AIDS activists and the two sides came together to improve clinical trials. By August 1991, relations had warmed up so much that ACT-UP founder Larry Kramer wrote Bristol-Myers Squibb chief Richard Gelb a letter of congratulations on the imminent approval of Videx. AIDS groups fought for the reauthorization of the Orphan Drug Act and the passage of the Prescription Drug User Fee Act in 1992. [6]
http://en.wikipedia.org/wiki/War_on_cancer
Even today we describe cancer as one disease, but in truth it is over 200 different kinds of diseases, each with its own treatment.
Progress? Again from Wiki:
A 2010 report from the American Cancer Society found that death rates for all cancers combined decreased 1.3% per year from 2001 to 2006 in males and 0.5% per year from 1998 to 2006 in females, largely due to decreases in the 3 major cancer sites in men (lung, prostate, and colorectum) and 2 major cancer sites in women (breast and colorectum). Cancer death rates between 1990 and 2006 for all races combined decreased by 21.0% among men and by 12.3% among women. This reduction in the overall cancer death rates translates to the avoidance of approximately 767,000 deaths from cancer over the 16-year period. Despite these reductions, the report noted, cancer still accounts for more deaths than heart disease in persons younger than 85 years.[45][46]
As we sit here, in 2011, it often feels like our odds should be much better. It is difficult to realize that just 40 years ago this diagnoses would have been a death sentence for the vast majority. Today the survival rates are greatly improved, and the science is still getting better, so our children may have an even greater chance of surviving cancer should they get it.
The bacillus that caused Bubonic Plague was discovered in Hong Kong in 1901. It was another 30 years before they found a cure (antibiotics). These things move very slowly. Science still does not fully understand how a single cancer cell settles in and starts its replication process. Without that, a drug based cure is a difficult thing to find. There is study going on, on all fronts, and maybe something will come along in this generation.0 -
Pharma and User FeesBuckwirth said:backups and budgets at the FDA
Made a lot of things move very slowly. In 1992 this dam was broken by the Prescription Drug User Fee Act:
http://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act
This, combined with Richard Nixon's "War on Cancer" opened the floodgate to quite a lot of new medications and breakthroughs.
AIDS was the driving force behind the legislation, and it is not without controversy even today. Some say that the very fact that Pharma funds the approval process puts pressure on the FDA to approve things that should not be approved. I understand the issues involved, but given the state of politics today and in 1992, the only way the FDA would get a bigger budget for drug approvals was through a user fee.
Here is the history from Wiki:
History
The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the the FDA. All three groups felt that drug approvals were taking far too long. For some patients, a drug waiting for approval and not yet available for sale could make the difference between life and death. Pharmaceutical companies had to wait to begin to recoup the costs of research and development. The FDA estimated that a delay of one month in a review’s completion cost its sponsor $10 million. The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market. The FDA had not received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be used to speed drug review. The 1992 law became possible when the FDA and industry agreed on setting target completion times for reviews and that promise these fees would supplement federal appropriations instead of replacing them. [1]
[edit]AIDS epidemic
Main article: AIDS
The length of the drug approval process fell under severe scrutiny during the early years of the AIDS epidemic. In the late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA headquarters which resulted in roughly 180 arrests.[2] In August 1990, Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.[3] Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options.[4] All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted 2 years later, in 1987.[5]
AIDS activists, desperate for new treatments, were outraged at the cost of those first drugs and the slow pace of drug development. These activists bombarded the government and drug companies with complaints and public protests. The activists won a major victory in 1989, when Burroughs Wellcome implemented a 20% price cut on AZT, then still the only treatment for HIV. Even after this price concession, the 12-pill-per-day AZT regimen cost patients $6,400 a year. AIDS activists expressed their anger by trashing booths at medical conventions and continuing vocal public protests. Gradually, drug companies established relationships with AIDS activists and the two sides came together to improve clinical trials. By August 1991, relations had warmed up so much that ACT-UP founder Larry Kramer wrote Bristol-Myers Squibb chief Richard Gelb a letter of congratulations on the imminent approval of Videx. AIDS groups fought for the reauthorization of the Orphan Drug Act and the passage of the Prescription Drug User Fee Act in 1992. [6]
Stumbled on this Pharma trade site article on user fees.
http://www.pharmalot.com/2010/08/a-big-surprise-fda-user-fees-are-going-up/
Personally, I found it, and the comments below, pretty funny.0 -
One last comment
It is not so much that there is disagreement, rather it is the way science works. First you need a testable hypothesis, then you start running tests. Once it passes or fails you publish the results. Someone else repeats the test to see if they get the same results, then they publish, then they do it again. Sooner or later there is a consensus that the hypothesis is true or false.
Let's say the hypothesis is that citric acid kills pancreatic cancer cells. The first round of tests is all in a test tube. If true, someone has to create a delivery system to get it to the tumor, then they test it on mice. If it passes that, maybe they begin human trials, each of which can take a year or more, and the same process of test, publish, test again publish again happens with the human trials.
Eventually, if all goes well, you pay for the FDA to review all the published material, and that can take another year or two.
In the meantime, if you are paying attention to the earlier part of the process, it can seem that the "experts" can't agree on anything. You are looking at sausage being made, it is not a pretty site, but the end result can be delicious! ;-)
Blake0 -
What really annoys meBuckwirth said:One last comment
It is not so much that there is disagreement, rather it is the way science works. First you need a testable hypothesis, then you start running tests. Once it passes or fails you publish the results. Someone else repeats the test to see if they get the same results, then they publish, then they do it again. Sooner or later there is a consensus that the hypothesis is true or false.
Let's say the hypothesis is that citric acid kills pancreatic cancer cells. The first round of tests is all in a test tube. If true, someone has to create a delivery system to get it to the tumor, then they test it on mice. If it passes that, maybe they begin human trials, each of which can take a year or more, and the same process of test, publish, test again publish again happens with the human trials.
Eventually, if all goes well, you pay for the FDA to review all the published material, and that can take another year or two.
In the meantime, if you are paying attention to the earlier part of the process, it can seem that the "experts" can't agree on anything. You are looking at sausage being made, it is not a pretty site, but the end result can be delicious! ;-)
Blake
Is that some fool in the media gets hold of it at round one and yells for all to hear that theh have found a cure forxxxx cancer and then in a very small voice adds that it will probably be available to the public in a bout ten years. Of course ten years and 5 thousand dead mice later there is no sign of it.ron.0 -
mice and friendsron50 said:What really annoys me
Is that some fool in the media gets hold of it at round one and yells for all to hear that theh have found a cure forxxxx cancer and then in a very small voice adds that it will probably be available to the public in a bout ten years. Of course ten years and 5 thousand dead mice later there is no sign of it.ron.
hi ron,
mice and friends, my friend.
Its sux but that the systems we have.
However we have hope here.
Look at my collageen stoma post.
We are a very vocal forum. We can at raise awareness.
Hey maybe less hernia.
One small step, at least itis a start.
Hugs
pete0 -
Brief item at firstscience.com, dated 3/25 on "FDA considerspete43lost_at_sea said:mice and friends
hi ron,
mice and friends, my friend.
Its sux but that the systems we have.
However we have hope here.
Look at my collageen stoma post.
We are a very vocal forum. We can at raise awareness.
Hey maybe less hernia.
One small step, at least itis a start.
Hugs
pete
new rules to speed up confirmatory trials of drugs granted accelerated approval."
Each research team seems to focus on a specific gene,protein, pathway, etc in hopes of discovering a new angle of attack....Even those doing nanotech research and experiments have their own approaches, be it carbon-or diamond-or gold/platinum-or something else-based nanostructures (or containers) inside of which would be even smaller-sized nanoparticles of a chemo that would only be released inside the cancer cell to minimize collateral damage. How soon stuff like this gets to be practiced on people remains to be seen, tho use of nanotech has been applied, I believe, to the brain and heart, as well as other organs.......steve
(but not the Wurlitzer)0 -
Ronron50 said:What really annoys me
Is that some fool in the media gets hold of it at round one and yells for all to hear that theh have found a cure forxxxx cancer and then in a very small voice adds that it will probably be available to the public in a bout ten years. Of course ten years and 5 thousand dead mice later there is no sign of it.ron.
Those particular media fools are usually the editors. When the news was that x cancer was cured in a mouse it makes the front page. When it turns out that 60% of the cured mice developed full paralysis two weeks later, well that was reported, on page 6 of the classified ads.
Hey Pete,
Have you gone back to that Collagen post? There was a question and, and someone pointed out some unresolved issues. It also needs to be pointed out that surgery is not a drug, and the testing/approval protocols are completely different.
If you want an example of someone on the board spreading the word about an advance in the surgical world, go look at the posts of William Marshall on the esophageal board (just below ours in the directory) regarding laproscopic surgery. While laproscopic is now the standard for say, removing a rectum, it is relatively recent for esophageal cancer treatment. William is something of an evangelist for the technique and the surgeons who have trained in it.0 -
i'll check out william post on the esophagael boardBuckwirth said:Ron
Those particular media fools are usually the editors. When the news was that x cancer was cured in a mouse it makes the front page. When it turns out that 60% of the cured mice developed full paralysis two weeks later, well that was reported, on page 6 of the classified ads.
Hey Pete,
Have you gone back to that Collagen post? There was a question and, and someone pointed out some unresolved issues. It also needs to be pointed out that surgery is not a drug, and the testing/approval protocols are completely different.
If you want an example of someone on the board spreading the word about an advance in the surgical world, go look at the posts of William Marshall on the esophageal board (just below ours in the directory) regarding laproscopic surgery. While laproscopic is now the standard for say, removing a rectum, it is relatively recent for esophageal cancer treatment. William is something of an evangelist for the technique and the surgeons who have trained in it.
I think another interesting difference between new surgical procedures and drugs is the drugs are marketed and pushed hard by salespeople, where the surgical just has to be accepted by conventions and publications. It took years fo example for the tme surgical technique to spread through the USA after it was pioneered in europe.
http://www.rcsed.ac.uk/journal/vol44_1/4410012.htm
I'll put this up as a post.
cheers,
Pete0 -
Concurrent linescoloCan said:Brief item at firstscience.com, dated 3/25 on "FDA considers
new rules to speed up confirmatory trials of drugs granted accelerated approval."
Each research team seems to focus on a specific gene,protein, pathway, etc in hopes of discovering a new angle of attack....Even those doing nanotech research and experiments have their own approaches, be it carbon-or diamond-or gold/platinum-or something else-based nanostructures (or containers) inside of which would be even smaller-sized nanoparticles of a chemo that would only be released inside the cancer cell to minimize collateral damage. How soon stuff like this gets to be practiced on people remains to be seen, tho use of nanotech has been applied, I believe, to the brain and heart, as well as other organs.......steve
(but not the Wurlitzer)
The Bubonic Plague bacillus was discovered at the same time by two separate teams, one from France and one from Japan.
Multiple people invented the telephone at around the same time, with some believing Bell only got the patent because Antonio Meucci failed to renew his.
Darwin and Wallace raced to be the first to publish a theory of evolution.
Teams led by Sabin, Koprowski and Cox simultaneously created oral vaccines for Polio.
The Germans were working to create a nuclear weapon when they were defeated (the Manhattan Project was well ahead of them at the time).
Science works on concurrent lines, with multiple teams trying to find the best path to the solution. We know that Ovarian cancer could be wiped out in a generation with a vaccine for HPV, killing that cancer in its most infantile stage. That should lead to even more vaccines as viruses that lead to cancer are discovered.
With 200 types of cancer (ever hear of heart cancer? Very rare, but a business associate of mine has it), each of these cures will take time, in many cases generations. I believe we are at the beginnings of renaissance in cancer research.0 -
Cancer is such a complex disease.....Buckwirth said:Concurrent lines
The Bubonic Plague bacillus was discovered at the same time by two separate teams, one from France and one from Japan.
Multiple people invented the telephone at around the same time, with some believing Bell only got the patent because Antonio Meucci failed to renew his.
Darwin and Wallace raced to be the first to publish a theory of evolution.
Teams led by Sabin, Koprowski and Cox simultaneously created oral vaccines for Polio.
The Germans were working to create a nuclear weapon when they were defeated (the Manhattan Project was well ahead of them at the time).
Science works on concurrent lines, with multiple teams trying to find the best path to the solution. We know that Ovarian cancer could be wiped out in a generation with a vaccine for HPV, killing that cancer in its most infantile stage. That should lead to even more vaccines as viruses that lead to cancer are discovered.
With 200 types of cancer (ever hear of heart cancer? Very rare, but a business associate of mine has it), each of these cures will take time, in many cases generations. I believe we are at the beginnings of renaissance in cancer research.
I wonder if any studies have been done of twins or siblings with the same variety of cancer; how close in time of Dx?
were stages identical?
werebiomarkers the same?
Was Tx and response similar?
Wouldn't be surprised if differences were the same as those among nonrelated people...
To try to find similarities among all or many or most cancer types or focus on one specific form of cancer.....so many variables.......so much to consider yet the dedicated researchers do as sung by Del Shannon : they "Keep Searchin"0
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