Latest Drugwonks' Blog
Sea Slug Offers Clues to Human Brain Disorders....
Why am I not surprised?
According to an article at livescience.com :
The marine slug has a relatively simple nervous system, with about 10,000 large neurons that can be easily identified, compared with about 100 billion neurons in humans. Even so, the animal is capable of learning and its brain cells communicate in ways identical to human neuron-to-neuron messaging
They found specific genes linked to learning and memory. "We've now identified a whole bunch of receptors for serotonin. So we can see what their function is in various cells and which ones participate in the learning process," Kandel told LiveScience.
The scientists also analyzed 146 human genes implicated in 168 neurological disorders, including Parkinson's and Alzheimer's diseases, and genes controlling aging. They found 104 counterpart genes in Aplysia, suggesting the animal will be a valuable tool in understanding and ultimately treating neurodegenerative diseases."
Why study a sea slug...there are so many members of Congress with even less complex neuron messaging systems that are hardly being used.....but I guess they want to look at a brain that somewhat similar to humans.
And speaking of intellectual sluggishness, this will get the actively ignorant activists at Breast Cancer (In)action launched into another work of junk science....
High-Tech Mammograms Will Change Breast Cancer Care
By Meryl Hyman Harris
HealthDay Reporter
posted: 31 December 2006
11:35 am ET
(HealthDay News) -- The mammogram is changing for the better.
New computer-driven technologies should make the yearly exam more accurate and easier on patients than ever before, experts say.
High-tech computer-based digital mammography is already available at about 10 percent of diagnostic centers in the country and growing steadily at a rate of about 4 percent a month, said Priscilla F. Butler, senior director of the American College of Radiology Breast Imaging Accreditation Programs.
While filmless mammography doesn't feel any different to women while they are being screened, doctors are discovering that there are benefits for particular patients.
A study of more than 40,000 women published last fall found that compared with standard mammograms, computer-based digital "pictures" were more beneficial for more than half the women.
The findings of that study, the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial, were that younger women with dense breast tissue, those under 50 and those who are premenopausal, would benefit most from digital mammograms. The range was so large that some doctors have since concluded that dense breast tissue in all groups is better seen with the help of a computer.
Here's the full article:
http://www.livescience.com/healthday/531925.html
Anti-screening kooks have tried to scare younger women away from mammograms by peddling a hodge-podge of smaller clinical trials in the form of meta-analyses showing no benefit. Well, a meta-analysis of crappy smaller studies is just a large cesspool..which is a perfect place to store Breast Cancer Action's so-called research. The DMIST will break new ground and move us to biomarker based prediction or nano-based prediction which in turn will lead to earlier intervention with private sector developed medicines which will lead to longer lives. THAT will really overwhelm the single cell messaging systems of opponents....
Why am I not surprised?
According to an article at livescience.com :
The marine slug has a relatively simple nervous system, with about 10,000 large neurons that can be easily identified, compared with about 100 billion neurons in humans. Even so, the animal is capable of learning and its brain cells communicate in ways identical to human neuron-to-neuron messaging
They found specific genes linked to learning and memory. "We've now identified a whole bunch of receptors for serotonin. So we can see what their function is in various cells and which ones participate in the learning process," Kandel told LiveScience.
The scientists also analyzed 146 human genes implicated in 168 neurological disorders, including Parkinson's and Alzheimer's diseases, and genes controlling aging. They found 104 counterpart genes in Aplysia, suggesting the animal will be a valuable tool in understanding and ultimately treating neurodegenerative diseases."
Why study a sea slug...there are so many members of Congress with even less complex neuron messaging systems that are hardly being used.....but I guess they want to look at a brain that somewhat similar to humans.
And speaking of intellectual sluggishness, this will get the actively ignorant activists at Breast Cancer (In)action launched into another work of junk science....
High-Tech Mammograms Will Change Breast Cancer Care
By Meryl Hyman Harris
HealthDay Reporter
posted: 31 December 2006
11:35 am ET
(HealthDay News) -- The mammogram is changing for the better.
New computer-driven technologies should make the yearly exam more accurate and easier on patients than ever before, experts say.
High-tech computer-based digital mammography is already available at about 10 percent of diagnostic centers in the country and growing steadily at a rate of about 4 percent a month, said Priscilla F. Butler, senior director of the American College of Radiology Breast Imaging Accreditation Programs.
While filmless mammography doesn't feel any different to women while they are being screened, doctors are discovering that there are benefits for particular patients.
A study of more than 40,000 women published last fall found that compared with standard mammograms, computer-based digital "pictures" were more beneficial for more than half the women.
The findings of that study, the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial, were that younger women with dense breast tissue, those under 50 and those who are premenopausal, would benefit most from digital mammograms. The range was so large that some doctors have since concluded that dense breast tissue in all groups is better seen with the help of a computer.
Here's the full article:
http://www.livescience.com/healthday/531925.html
Anti-screening kooks have tried to scare younger women away from mammograms by peddling a hodge-podge of smaller clinical trials in the form of meta-analyses showing no benefit. Well, a meta-analysis of crappy smaller studies is just a large cesspool..which is a perfect place to store Breast Cancer Action's so-called research. The DMIST will break new ground and move us to biomarker based prediction or nano-based prediction which in turn will lead to earlier intervention with private sector developed medicines which will lead to longer lives. THAT will really overwhelm the single cell messaging systems of opponents....
Es ist nichts schrecklicher als eine thatige Unwissenheit…That’s Goethe for “There is nothing scarier than an active ignorance.â€
I wrote that in response to a post I found something called The Health Care Blog back in July (Here's the link to my post way back then www.drugwonks.com/2006/07/too_many_cancer_drugs.html ) I bring it up as an example of the thinking that provides the left with its rationalization for price controls, restrictive formularies, biased arguments in favor of single payer health system (as in people wait in Europe and Canada cause they are so rural or because they like to wait or have a cultural preference to waiting).
It's the crap -- now applied to deadly illnessess -- that we have way too many drugs that add too little benefit marketed to exploit the sick and dying. And all this dovetails with something friends and acquaintances ask me with surprising regularity:
Don't the drug companies have a cure for cancer or HIV but just don't want to make it available since it would put them out of business?
So drug companies and biotech firms actually spend billions on medicines that fail to make it to market 92 percent of the time because.. Maybe someone could .explain how this fits into the conspiracy theory?
And the genetic tests that help identify which patients will respond best to what treatments... like this most recent test that predicts patients with eye cancer...
"Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients."
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within five years, due to metastasis to the liver and other organs.
"When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival, ..Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis."
See New Genetic Test Predicts Risk Of Metastasis In Patients With Deadly Eye Cancer http://www.sciencedaily.com/releases/2006/11/061116100809.htm
Yeah but that means even more cancer drugs. Don't we have enough already?
I wrote that in response to a post I found something called The Health Care Blog back in July (Here's the link to my post way back then www.drugwonks.com/2006/07/too_many_cancer_drugs.html ) I bring it up as an example of the thinking that provides the left with its rationalization for price controls, restrictive formularies, biased arguments in favor of single payer health system (as in people wait in Europe and Canada cause they are so rural or because they like to wait or have a cultural preference to waiting).
It's the crap -- now applied to deadly illnessess -- that we have way too many drugs that add too little benefit marketed to exploit the sick and dying. And all this dovetails with something friends and acquaintances ask me with surprising regularity:
Don't the drug companies have a cure for cancer or HIV but just don't want to make it available since it would put them out of business?
So drug companies and biotech firms actually spend billions on medicines that fail to make it to market 92 percent of the time because.. Maybe someone could .explain how this fits into the conspiracy theory?
And the genetic tests that help identify which patients will respond best to what treatments... like this most recent test that predicts patients with eye cancer...
"Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients."
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within five years, due to metastasis to the liver and other organs.
"When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival, ..Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis."
See New Genetic Test Predicts Risk Of Metastasis In Patients With Deadly Eye Cancer http://www.sciencedaily.com/releases/2006/11/061116100809.htm
Yeah but that means even more cancer drugs. Don't we have enough already?
Steve Hofman, my friend, mentor, fellow Yankee fan has come up with the best new health care idea for 2007.
In an article he has written for next week's Busineeweek (Jan 8, 2007) Steve suggests that the way to get Medicare's house in order is not -- as Democrats are demanding -- to impose price controls or restrict access to products or procedures. Rather:
"We need a way to mobilize recipients into an army ready to battle uncontrolled Medicare spending. Remember that modern armies have one thing in common: Members get paid. Every Medicare beneficiary must be paid to be part of the Medicare solution."
Pay seniors to save their own money and control Medicare spending to boot.
How would it work?
"Medicare beneficiaries would receive an annual rebate of 50 cents for each dollars they save the program. If someone saves Medicare $500, she would get $250. For saving Medicare $5000,, a beneficiary would get $2500. It's that simple."
There are right and wrong ways to cut spending. That's the point of Steve's proposal We have been doing all wrong for too long. We never gave seniors incentives to make healthy and economic choices, they same kind we all would make if we were investing our own dollars to pay our own bills.
One gee-whiz number to chew on: "If the 35 million nondisabled Medicare beneficiaries reduced their spending by a mere 5%, then $13.12 billion would be saved annually. And each 1% reduction adds $2.62 billion in further savings..."
That dough would be split 50-50 by seniors and the Treasury.
All the more reason to promote preventive and effective medicine. We haven't even begun to figure out what a combination of diet, exercise, preventive screens and right meds can do for the cost and impact on chronic illness, at least on a personal level. Steve's proposal makes it possible.
In an article he has written for next week's Busineeweek (Jan 8, 2007) Steve suggests that the way to get Medicare's house in order is not -- as Democrats are demanding -- to impose price controls or restrict access to products or procedures. Rather:
"We need a way to mobilize recipients into an army ready to battle uncontrolled Medicare spending. Remember that modern armies have one thing in common: Members get paid. Every Medicare beneficiary must be paid to be part of the Medicare solution."
Pay seniors to save their own money and control Medicare spending to boot.
How would it work?
"Medicare beneficiaries would receive an annual rebate of 50 cents for each dollars they save the program. If someone saves Medicare $500, she would get $250. For saving Medicare $5000,, a beneficiary would get $2500. It's that simple."
There are right and wrong ways to cut spending. That's the point of Steve's proposal We have been doing all wrong for too long. We never gave seniors incentives to make healthy and economic choices, they same kind we all would make if we were investing our own dollars to pay our own bills.
One gee-whiz number to chew on: "If the 35 million nondisabled Medicare beneficiaries reduced their spending by a mere 5%, then $13.12 billion would be saved annually. And each 1% reduction adds $2.62 billion in further savings..."
That dough would be split 50-50 by seniors and the Treasury.
All the more reason to promote preventive and effective medicine. We haven't even begun to figure out what a combination of diet, exercise, preventive screens and right meds can do for the cost and impact on chronic illness, at least on a personal level. Steve's proposal makes it possible.
Thinking back on all the postings Peter and I...posted, it's amazing to consider just how much of a hassle the echo chamber of journalists, politicians and anti-capitalist 'experts' have become to the advance of medical progress.
When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:
Go see it and see for yourself why you shouldn't go see it.
In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?
In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.
Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.
Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?
But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.
Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.
And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.
As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:
"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."
When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:
Go see it and see for yourself why you shouldn't go see it.
In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?
In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.
Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.
Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?
But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.
Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.
And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.
As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:
"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."
Excellent series of papers on the the relationship between obesity, diabetes, heart disease, inflammation, etc....the genetic and cellular mechanisms that control all and the variations thereof.
Here's the link..
http://www.nature.com/nature/supplements/insights/dia_obe_age/index.html
Oh wait, the supplement produced by Nature was sponsored by Nestle's the food conglomerate. Probably can't trust it...Must be some sort of conspiracy to make us think that gorging on hot chocolate and Nestle's Quik won't lead to weight gain...scrap it...I am sure Arnie Relman, Jerry Kassirer and everyone else who made their money selling reprints to drug companies wouldn't approve..
Here's the link..
http://www.nature.com/nature/supplements/insights/dia_obe_age/index.html
Oh wait, the supplement produced by Nature was sponsored by Nestle's the food conglomerate. Probably can't trust it...Must be some sort of conspiracy to make us think that gorging on hot chocolate and Nestle's Quik won't lead to weight gain...scrap it...I am sure Arnie Relman, Jerry Kassirer and everyone else who made their money selling reprints to drug companies wouldn't approve..
The rapidly advancing fields of proteomics and metabolomics may provide the tools necessary to develop predictive tools and tests for early and accurate screening of devastating mental illnesses such as schizophrenia and manic depression....
PLoS Med. 2006 Nov;3(11):e428.
Disease biomarkers in cerebrospinal fluid of patients with first-onset psychosis.
"....application of modern proteomics techniques, particularly mass spectrometric approaches, holds the potential to advance the understanding of the biochemical basis of psychiatric disorders and may in turn allow for the development of diagnostics and improved therapeutics."
PLoS Med. 2006 Aug;3(8):e327.
Metabolic profiling of CSF: evidence that early intervention may impact on disease progression and outcome in schizophrenia.
Short-term treatment with atypical antipsychotic medication resulted in a normalization of the CSF disease signature in half the patients well before a clinical improvement would be expected. Furthermore, our results suggest that the initiation of antipsychotic treatment during a first psychotic episode may influence treatment response and/or outcome.
No biological basis for mental illness?
"There is nothing more frightful than ignorance in action" Goethe
PLoS Med. 2006 Nov;3(11):e428.
Disease biomarkers in cerebrospinal fluid of patients with first-onset psychosis.
"....application of modern proteomics techniques, particularly mass spectrometric approaches, holds the potential to advance the understanding of the biochemical basis of psychiatric disorders and may in turn allow for the development of diagnostics and improved therapeutics."
PLoS Med. 2006 Aug;3(8):e327.
Metabolic profiling of CSF: evidence that early intervention may impact on disease progression and outcome in schizophrenia.
Short-term treatment with atypical antipsychotic medication resulted in a normalization of the CSF disease signature in half the patients well before a clinical improvement would be expected. Furthermore, our results suggest that the initiation of antipsychotic treatment during a first psychotic episode may influence treatment response and/or outcome.
No biological basis for mental illness?
"There is nothing more frightful than ignorance in action" Goethe
I don't always agree with John Carroll's take on the issues but the FieceBiotech, Healthcare, etc websites, comments are always thought provoking, pungent, well-written, intelligent and fair. In short, some of the best health care coverage and commentary out there...Here's John's view on the GAO study
In case you haven't heard, the Government Accounting Office recently crunched the numbers and reported back that the drug discovery industry keeps spending more on research while it comes up with fewer NDAs. The trend was tracked for 11 years through 2004. I'd be willing to bet, though, that a surge in early-stage trials will eventually lead to the promised land of more marketing applications. Maybe I'm just an optimist, but the research underway in the drug discovery area is solid and it takes a number of years before the proof shows up in the NDA process. Biotech is short on magic wands and magic lamps. It's a long, slow, expensive process.
Even a nodding acquaintance with the research world, though, is enough to excite the worst kind of skeptic. The highly touted world of personalized medicine is gradually becoming a reality with solid advances in genomics, biomarkers and diagnostics. We won't get to the promised land by the end of 2007, but we'll see more steady advances as successful companies are rewarded with increased share prices.
In case you haven't heard, the Government Accounting Office recently crunched the numbers and reported back that the drug discovery industry keeps spending more on research while it comes up with fewer NDAs. The trend was tracked for 11 years through 2004. I'd be willing to bet, though, that a surge in early-stage trials will eventually lead to the promised land of more marketing applications. Maybe I'm just an optimist, but the research underway in the drug discovery area is solid and it takes a number of years before the proof shows up in the NDA process. Biotech is short on magic wands and magic lamps. It's a long, slow, expensive process.
Even a nodding acquaintance with the research world, though, is enough to excite the worst kind of skeptic. The highly touted world of personalized medicine is gradually becoming a reality with solid advances in genomics, biomarkers and diagnostics. We won't get to the promised land by the end of 2007, but we'll see more steady advances as successful companies are rewarded with increased share prices.
As chair of the Manhattan Institute's 21st Century FDA Task Force my primary function was to try to effectively convey many of the concerns Nobel Prize winner Dr. Joshua Lederberg had regarding the future of drug discovery and development. Most of the time I failed miserably. It took many drafts and much education. I was very fortunate that Dr. Lederberg was so tolerant and patient with me. Every time you met with Dr. Lederberg you received a graduate seminar in molecular biology, physics, drug development or whatever the topic of discussion happen to be.
One particular topic of Dr. Lederberg's interest now and then was the "microbiome"... In 2003 he talked about it as the next great frontier of human biology and drug discovery. He coined the term of course and has helped promote research in this area of study of the human body as “a superorganism with an extended genome that includes not only its own cells but also the fluctuating microbial genome set of bacteria and viruses that share that body space.â€It has been estimated that the human body carries more microbial cells than it does human cells. Many of these microbes, however, have not been cultivated or characterized. Some of these unknown or poorly characterized microbes probably play critical roles in maintaining human health, and the interplay among pathogenic and nonpathogenic microbes, both transient and permanent members of our microflora, is likely to exert an important influence on disease. "
As Dr. Lederberg has written, “We need more research, not only on how bacteria are virulent, but how they withhold their virulence and moderate their attacks. We need to investigate how our microbiome flora – the ones that we live with all the time –don’t cause disease and instead protect us against their competitors.â€
This past summer researchers completed a map of this super-genome -- our DNA and the bacteria together -- to launch a new field of genetic research called metagenomics.
As Jeffrey Gordon, one of the researchers from the Center for Genome Sciences at Washington University,who did the mapping points out, "Prospecting for these 'natural products' and characterizing the pathways through which they operate should provide new insights into the function of many of our human genes, new ways for defining our health, new ways for identifying impending or fully manifest diseases, plus new treatment strategies."
What is it that Sir Isaac Newton wrote to Robert Hooke? "If I have seen further it is by standing on ye shoulders of Giants."
We have all seen further and with greater clarity -- and hope -- thanks to Dr. Joshua Lederberg.
One particular topic of Dr. Lederberg's interest now and then was the "microbiome"... In 2003 he talked about it as the next great frontier of human biology and drug discovery. He coined the term of course and has helped promote research in this area of study of the human body as “a superorganism with an extended genome that includes not only its own cells but also the fluctuating microbial genome set of bacteria and viruses that share that body space.â€It has been estimated that the human body carries more microbial cells than it does human cells. Many of these microbes, however, have not been cultivated or characterized. Some of these unknown or poorly characterized microbes probably play critical roles in maintaining human health, and the interplay among pathogenic and nonpathogenic microbes, both transient and permanent members of our microflora, is likely to exert an important influence on disease. "
As Dr. Lederberg has written, “We need more research, not only on how bacteria are virulent, but how they withhold their virulence and moderate their attacks. We need to investigate how our microbiome flora – the ones that we live with all the time –don’t cause disease and instead protect us against their competitors.â€
This past summer researchers completed a map of this super-genome -- our DNA and the bacteria together -- to launch a new field of genetic research called metagenomics.
As Jeffrey Gordon, one of the researchers from the Center for Genome Sciences at Washington University,who did the mapping points out, "Prospecting for these 'natural products' and characterizing the pathways through which they operate should provide new insights into the function of many of our human genes, new ways for defining our health, new ways for identifying impending or fully manifest diseases, plus new treatment strategies."
What is it that Sir Isaac Newton wrote to Robert Hooke? "If I have seen further it is by standing on ye shoulders of Giants."
We have all seen further and with greater clarity -- and hope -- thanks to Dr. Joshua Lederberg.
From the recent GAO study
“Over the past decade, new technologies including genomics and high-throughput screening have provided tools for researchers to discover and test compounds,†according to the report. “According to industry analysts, the use of these technologies has led to increasing expenses without a commensurate increase in the number of drugs developed.
“These analysts have found that although companies have invested substantial resources in acquiring technologies that have generated vast quantities of newly discover biological data, company researchers are still learning whether the data will lead to potentially valid drug candidates, resulting in compounds and drugs that have failed in either preclinical or early clinical testing.â€
The report also states that in general over the past several years “it has become widely recognized throughout the [drug development] industry that the productivity of its research and development expenditures has been declining; that is, the number of new drugs being produced has generally declined while research and development expenses has been steadily increasing.â€
Translation....companies are investing heavily in translational research to develop targeted therapies and move into personalized medicines in order to make medicines safer and more effective...It makes drug development more expensive in the long run while not having any effect on short term productivity or efficiency.
Consumers only care about what's new and what can help me as well they should. And they want less annoying TV ads. They want information that's useful. Setting aside the chronic conspiratorial types who believe the government is in cahoots with companies to drag kids off the streets to make them permanent zombies for profit -- and you know who you are -- both drug development and the patient-prescription- physician relationship must change to be more humane, personalized and holistic. The emphasis on genomic-based research -- away from large scale clinical trials and towards biomarkers -- is part of this positive trend.
We need regulatory and policy changes to support this revolution. The dribbings of Senator Durbin and the ravings of Congressman Stark do not bode well for the future...We at Drugwonks intend 2007 to be both a year of standing firm against this dimwitted and dimming tide and offering genunine patient-centric initiatives that embrace advances in science...
“Over the past decade, new technologies including genomics and high-throughput screening have provided tools for researchers to discover and test compounds,†according to the report. “According to industry analysts, the use of these technologies has led to increasing expenses without a commensurate increase in the number of drugs developed.
“These analysts have found that although companies have invested substantial resources in acquiring technologies that have generated vast quantities of newly discover biological data, company researchers are still learning whether the data will lead to potentially valid drug candidates, resulting in compounds and drugs that have failed in either preclinical or early clinical testing.â€
The report also states that in general over the past several years “it has become widely recognized throughout the [drug development] industry that the productivity of its research and development expenditures has been declining; that is, the number of new drugs being produced has generally declined while research and development expenses has been steadily increasing.â€
Translation....companies are investing heavily in translational research to develop targeted therapies and move into personalized medicines in order to make medicines safer and more effective...It makes drug development more expensive in the long run while not having any effect on short term productivity or efficiency.
Consumers only care about what's new and what can help me as well they should. And they want less annoying TV ads. They want information that's useful. Setting aside the chronic conspiratorial types who believe the government is in cahoots with companies to drag kids off the streets to make them permanent zombies for profit -- and you know who you are -- both drug development and the patient-prescription- physician relationship must change to be more humane, personalized and holistic. The emphasis on genomic-based research -- away from large scale clinical trials and towards biomarkers -- is part of this positive trend.
We need regulatory and policy changes to support this revolution. The dribbings of Senator Durbin and the ravings of Congressman Stark do not bode well for the future...We at Drugwonks intend 2007 to be both a year of standing firm against this dimwitted and dimming tide and offering genunine patient-centric initiatives that embrace advances in science...
Under his recycled piece of legislation, drug companies would be forced to sell as much of their old products at a government set price to foreign distributors or face criminal charges. At the same time, the FDA would be expanded to handle new duties, parcel inspection, warehouse inspection, pharmacy inspection and approving after the fact that drugs made for the European market -- though they vary in dosage form, formulation, coatings and packaging -- are equally safe and effective and bioavailable without any testing.
Meanwhile, our biotech and drug companies would still be barred and restricted and delayed from marketing products in foreign markets as they seek government -- I mean -- world market prices for the new medicines. All while the FDA is forced to spend more time handling the shipping and handling needs of European middlemen instead of drug safety and drug approval here at home.
Oh, and of course there would still be time to police the expanding array of internet drug sites that sell counterfeit meds or drain real meds from poor countries that would sold to us as well....
Meanwhile, our biotech and drug companies would still be barred and restricted and delayed from marketing products in foreign markets as they seek government -- I mean -- world market prices for the new medicines. All while the FDA is forced to spend more time handling the shipping and handling needs of European middlemen instead of drug safety and drug approval here at home.
Oh, and of course there would still be time to police the expanding array of internet drug sites that sell counterfeit meds or drain real meds from poor countries that would sold to us as well....
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