The Reagan-Udall Foundation was created to promote new tools to accelerate the development a new generation of targeted medicines. The emphasis is on tools, meaning biomarkers, meaning coming up with validated measures and standards at a time when we have a lot of data and information but very little knowledge.
I hope the Foundation focuses on very mundane and important scientific work and provides hub for achieving consensus on measures and markers for qualifying and ap approving drugs based on actual biological differences and mechanisms. And I hope pharma does begin to more money into credible scientific projects that will help change the regulatory paradigm. The scientists in the companies want to do the right thing. I am not always so sure of the marketing types who still cling to the one size fits all blockbuster mentality and who have not yet realized that if drug companies don't get into the business of tracking the safety of their drugs in the post market -- using these tools in research and clinical settings -- they will continue to get clubbed by the likes of Nissen and Graham. If they don't seize the opportunity given to them in Reagan Udall then well....it's their own fault.
Of course, the fact that this might make drug development more efficient years from now (i.e. fewer clinical trials, more subpopulations targeted) and might help drug companies will drive the Marcia Angells, Kassirers, Avorns, etc crazy. Matt Perrone has an excellent piece that captures the knee-jerk "corporations are evil" bleating from the likes of The Union of Conceited Scientists.
Matt Perrone ought to brush up on what a biomarker is however otherwise he will continue to be misled by likes of David Ross who gave him this example:
"For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.
Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trails can be reduced. Some critics call their use a high-risk gamble.
"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.
He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure."
Note to Perrone and Ross: The reason people died was because the drug was prescribed to patients outside of the clinical trial guideline. Ross is using the "generic" definition of a biomarker, meaning biological measure that is linked to a disease state. A biomarker that captured genetic variations explaining why people more likely to die from the drug is now possible to develop using a blood test. I guess we shouldn't use that. Ditto, all those tests that can now screen to see which people respond to certain cancer drugs and avoid needless chemotherapy or which HIV drugs will work for them.
It should also be noted that Ross was one of the biggest loudmouths about the dangers of SSRIs which have been overhyped to the point that prescriptions are down and suicides are up.
This effort to eliminate measures like cholesterol, glycemic index, bone density, blood pressure as conditions of approval is just an effort to slow down drug approval and move it into the dark ages. It is being engineered by those who believe that the current approach to clinical evaluation is corrupt and corporatized. Supporters offer this more rigid and unreachable methods not because they are based on better science but because they reduce the number of new medicines that companies develop. The attack is political, pure and simple.
The battle lines are already being defined: The opponents of the Foundation and Critical Path oppose both because it might advance industry and industry is evil. (Even though most of the research will be done in collaboration with academia and NIH). Because corporations are involved it is inherently evil and corrupt. WHich allow the other side to distort the mission and the science all they want.
The headline in the WP "New FDA Research Center Rife WIth Risks" tells you that Reagan Udall has already been spun. How sick and sad is that?
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html
I hope the Foundation focuses on very mundane and important scientific work and provides hub for achieving consensus on measures and markers for qualifying and ap approving drugs based on actual biological differences and mechanisms. And I hope pharma does begin to more money into credible scientific projects that will help change the regulatory paradigm. The scientists in the companies want to do the right thing. I am not always so sure of the marketing types who still cling to the one size fits all blockbuster mentality and who have not yet realized that if drug companies don't get into the business of tracking the safety of their drugs in the post market -- using these tools in research and clinical settings -- they will continue to get clubbed by the likes of Nissen and Graham. If they don't seize the opportunity given to them in Reagan Udall then well....it's their own fault.
Of course, the fact that this might make drug development more efficient years from now (i.e. fewer clinical trials, more subpopulations targeted) and might help drug companies will drive the Marcia Angells, Kassirers, Avorns, etc crazy. Matt Perrone has an excellent piece that captures the knee-jerk "corporations are evil" bleating from the likes of The Union of Conceited Scientists.
Matt Perrone ought to brush up on what a biomarker is however otherwise he will continue to be misled by likes of David Ross who gave him this example:
"For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.
Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trails can be reduced. Some critics call their use a high-risk gamble.
"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.
He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure."
Note to Perrone and Ross: The reason people died was because the drug was prescribed to patients outside of the clinical trial guideline. Ross is using the "generic" definition of a biomarker, meaning biological measure that is linked to a disease state. A biomarker that captured genetic variations explaining why people more likely to die from the drug is now possible to develop using a blood test. I guess we shouldn't use that. Ditto, all those tests that can now screen to see which people respond to certain cancer drugs and avoid needless chemotherapy or which HIV drugs will work for them.
It should also be noted that Ross was one of the biggest loudmouths about the dangers of SSRIs which have been overhyped to the point that prescriptions are down and suicides are up.
This effort to eliminate measures like cholesterol, glycemic index, bone density, blood pressure as conditions of approval is just an effort to slow down drug approval and move it into the dark ages. It is being engineered by those who believe that the current approach to clinical evaluation is corrupt and corporatized. Supporters offer this more rigid and unreachable methods not because they are based on better science but because they reduce the number of new medicines that companies develop. The attack is political, pure and simple.
The battle lines are already being defined: The opponents of the Foundation and Critical Path oppose both because it might advance industry and industry is evil. (Even though most of the research will be done in collaboration with academia and NIH). Because corporations are involved it is inherently evil and corrupt. WHich allow the other side to distort the mission and the science all they want.
The headline in the WP "New FDA Research Center Rife WIth Risks" tells you that Reagan Udall has already been spun. How sick and sad is that?
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html
