Latest Drugwonks' Blog
Here is the second installment from our recent health care leadership forum on patient-centric medicine. These are the comments of Ralph Snyderman, M.D., recipient of the 2007 Leadership in Personalized Medicine Award from the Personalized Medicine Coalition.
Dr. Snyderman is Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine. He oversaw the development of the Duke University Health System, one of the few fully integrated academic health systems in the country. This integrated health system now provides an increasing continuum of care throughout North Carolina and beyond. Dr. Snyderman describes how the current health system is broken and how patient centric medicine could help repair it.
"We all recognize that the current healthcare system is broken. We’re spending $2.2 trillion a year, not on a healthcare system but a sick-care system that is highly inefficient.
Seventy-five cents of every healthcare dollar is spent for the acute treatment of generally late-stage chronic disease, which is often preventable.
The patient, of course, is in a quandary. I only know of two industries in which the consumer is given so little attention. One is the airline industry, which pretty much doesn’t care about the consumer. And, ironically, the healthcare system. The consumer is in there, but always as byproduct of all the technologies, the capabilities, that are being developed.
The likelihood of an individual developing a chronic disease is based on a number of things. Number one is their baseline inherited risk. That’s then modified by environmental or initiating events, exposure to things or various behaviors which may lead to preclinical progression, disease initiation. All of this develops over time, most often many years.
The irony is that as you wait, there tends to be an accumulation of disease burden. Once it becomes clinically manifest, and then there tends to be an inflection, a crescendo, in which things can get steadily worse in a series of acute events. Our current healthcare system is designed to focus on acute events. That’s where the cost is high and reversibility is low because there was a buildup of pathology.
Now the good news is that now we have powerful emerging technologies that are very producing powerful, and we’re developing important therapeutics, plus important diagnostics, including those that will enable personal clinical risk prediction,. Genomics, proteomics, metabolomics, new medical technologies, informatics and system biology, which is an approach to understanding the multiple networks of genes and metabolic systems, can all have a positive impact in empowering personalized health risk assessment..
We need to communicate that the power of these new technologies is allowing us to develop the capabilities of predicting risk in a much shorter time-frame and actually being able to predict risk across a person’s life. That’s a whole different approach to health care -- individualized risk prediction.
We’ll be able to measure what’s actually going on in a person’s circulation and tissues to determine if they are progressing along a disease pathway. It’s fairly clear that with risk prediction tools along with powerful digital imaging, metabolic imaging and other technologies, we can start to determine disease initiation and progression. We are going to get so much better with in being able to track development of problems very early on. Individuals are different. And where somebody might benefit from a thiazide diuretic, somebody else may be very badly harmed. We cannot assume that everybody will benefit from the same approaches or therapies.
We are beginning to understand that severe adverse outcomes can be predictable on a personalized basis, and the benefits of various therapies could be predicted at a personalized level.
A number of companies have sprung up to try to develop predictive tools for disease events, to personalize therapy. By studying a population of patients and outcomes, you can try to determine what individual factors helped predicted determine the outcome. Whether they be clinical data, genetic data, proteomic data, any other digital kind of information can be analyzed in clinical cohorts with the use of various types of biostatistical algorithms to come up with a predictive model. The power of these models is going to get better as we have more precise clinical data.
There is an emerging movement, what some people call P-4 Medicine or what I call prospective health care—personalized, predictive, preventative, and participatory. It would be personalized to the individual; predictive, so we could anticipate events before they occur, and then try to prevent them. The patient’s participation is a key feature. It’s hard to imagine a fix until we build this in, that people get invested in being more responsible for their own health.
For prospective healthcare to create an individual strategic health plan to for each patient, we need to develop these risk assessment and therapeutic evaluation tools. How is health care itself delivered to an individual over time? Our delivery system is designed for acute intervention that is not integrated and doesn’t provide continuity of care. The reimbursement system has a lot to do with that. Institutions can lose a lot of money trying to do the right thing in providing continuity of care.
At Duke, we have a prospective healthcare program where the participating population is university employees who get their care from Duke. They Duke is are essentially self-insured, so it’s one of those areas in which the reimbursement systems actually align. We have employees who stay with us very often for their entire professional lives. With the right tools, you can then, based on the chronic disease, divide the population into those that are low risk, high risk, early chronic disease, late chronic disease, and align the resources to the needs of the individual patient. So that in those individuals who may be high risk are given, we give them a lot of help in terms of risk modification, and allow helped them to develop their own strategic health plans. The general concept is to divide the population based on their specific risks and their health status and then give them access to the level of support they need.
The individual needs to play an active different role. We need to do something to raise the attention of the public of health as a value. One of the things that amuses me seems to be that over the last three to six months, virtually every major industry that contributes to environmental pollution has become green. Every oil company is green. General Motors is green. Everything is green to try to save the planet. Well, what about health? What about the individual? We talk about a sustainable planet, but what about a sustainable individual? We really need to get the appreciation of health as a value, similar to what we’re doing with the planet as a value."
Dr. Snyderman is Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine. He oversaw the development of the Duke University Health System, one of the few fully integrated academic health systems in the country. This integrated health system now provides an increasing continuum of care throughout North Carolina and beyond. Dr. Snyderman describes how the current health system is broken and how patient centric medicine could help repair it.
"We all recognize that the current healthcare system is broken. We’re spending $2.2 trillion a year, not on a healthcare system but a sick-care system that is highly inefficient.
Seventy-five cents of every healthcare dollar is spent for the acute treatment of generally late-stage chronic disease, which is often preventable.
The patient, of course, is in a quandary. I only know of two industries in which the consumer is given so little attention. One is the airline industry, which pretty much doesn’t care about the consumer. And, ironically, the healthcare system. The consumer is in there, but always as byproduct of all the technologies, the capabilities, that are being developed.
The likelihood of an individual developing a chronic disease is based on a number of things. Number one is their baseline inherited risk. That’s then modified by environmental or initiating events, exposure to things or various behaviors which may lead to preclinical progression, disease initiation. All of this develops over time, most often many years.
The irony is that as you wait, there tends to be an accumulation of disease burden. Once it becomes clinically manifest, and then there tends to be an inflection, a crescendo, in which things can get steadily worse in a series of acute events. Our current healthcare system is designed to focus on acute events. That’s where the cost is high and reversibility is low because there was a buildup of pathology.
Now the good news is that now we have powerful emerging technologies that are very producing powerful, and we’re developing important therapeutics, plus important diagnostics, including those that will enable personal clinical risk prediction,. Genomics, proteomics, metabolomics, new medical technologies, informatics and system biology, which is an approach to understanding the multiple networks of genes and metabolic systems, can all have a positive impact in empowering personalized health risk assessment..
We need to communicate that the power of these new technologies is allowing us to develop the capabilities of predicting risk in a much shorter time-frame and actually being able to predict risk across a person’s life. That’s a whole different approach to health care -- individualized risk prediction.
We’ll be able to measure what’s actually going on in a person’s circulation and tissues to determine if they are progressing along a disease pathway. It’s fairly clear that with risk prediction tools along with powerful digital imaging, metabolic imaging and other technologies, we can start to determine disease initiation and progression. We are going to get so much better with in being able to track development of problems very early on. Individuals are different. And where somebody might benefit from a thiazide diuretic, somebody else may be very badly harmed. We cannot assume that everybody will benefit from the same approaches or therapies.
We are beginning to understand that severe adverse outcomes can be predictable on a personalized basis, and the benefits of various therapies could be predicted at a personalized level.
A number of companies have sprung up to try to develop predictive tools for disease events, to personalize therapy. By studying a population of patients and outcomes, you can try to determine what individual factors helped predicted determine the outcome. Whether they be clinical data, genetic data, proteomic data, any other digital kind of information can be analyzed in clinical cohorts with the use of various types of biostatistical algorithms to come up with a predictive model. The power of these models is going to get better as we have more precise clinical data.
There is an emerging movement, what some people call P-4 Medicine or what I call prospective health care—personalized, predictive, preventative, and participatory. It would be personalized to the individual; predictive, so we could anticipate events before they occur, and then try to prevent them. The patient’s participation is a key feature. It’s hard to imagine a fix until we build this in, that people get invested in being more responsible for their own health.
For prospective healthcare to create an individual strategic health plan to for each patient, we need to develop these risk assessment and therapeutic evaluation tools. How is health care itself delivered to an individual over time? Our delivery system is designed for acute intervention that is not integrated and doesn’t provide continuity of care. The reimbursement system has a lot to do with that. Institutions can lose a lot of money trying to do the right thing in providing continuity of care.
At Duke, we have a prospective healthcare program where the participating population is university employees who get their care from Duke. They Duke is are essentially self-insured, so it’s one of those areas in which the reimbursement systems actually align. We have employees who stay with us very often for their entire professional lives. With the right tools, you can then, based on the chronic disease, divide the population into those that are low risk, high risk, early chronic disease, late chronic disease, and align the resources to the needs of the individual patient. So that in those individuals who may be high risk are given, we give them a lot of help in terms of risk modification, and allow helped them to develop their own strategic health plans. The general concept is to divide the population based on their specific risks and their health status and then give them access to the level of support they need.
The individual needs to play an active different role. We need to do something to raise the attention of the public of health as a value. One of the things that amuses me seems to be that over the last three to six months, virtually every major industry that contributes to environmental pollution has become green. Every oil company is green. General Motors is green. Everything is green to try to save the planet. Well, what about health? What about the individual? We talk about a sustainable planet, but what about a sustainable individual? We really need to get the appreciation of health as a value, similar to what we’re doing with the planet as a value."
I received a nice 20 page glossy report from Blue Cross Blue Shield Association entitled:
"The Pathway to Covering America:Ensuring Quality, Value and Access." Let's set aside the image of a pathway covering something (isn't that a bit convoluted?) and the semi-fictitious factoids about health care (people without coverage get sicker and die sooner than those with coverage, sort of true but not always so for many, many reasons).
The heart of the proposal is the claim that "America needs an independent institute to support research comparing the relative effectiveness of new and existing medical procedures, drugs, devices and biologics" and that "Medicare and other public program should be required to consider the Institute's research in developing pay for performance, coverage, reimbursement and other policies."
So social scientists culling through research -- using meta- analysis mostly -- will create practice guidelines that will dictate to doctors and patients what care they will receive. All paid for by a tax on our premiums.
BCBS says that the Institute should contract with existing entities to facilitate research and collaborate with "institutes that receive comparative research contracts to identify best practices...in order to maximize research dollars."
Guess who has an "existing" entity?
BCBS. In the form of a Technology Evaluation Center. And it is already "one of the 14 Evidence-Based Practice Center for the US Agency for Healthcare Research and Quality. It also provides evaluations to Medicare and Medicaid. BCBS says: " TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not! Who would think such a thing! But imagine if Phrma or BIO instead of BCBS or Kaiser were running a TEC that in turn would be part and parcel of the Comparative Effectiveness Institute right off the bat. The screams about conflict would be heard round the world.
Meanwhile, here's a flavor of how slow-footed and lethal TEC transfer can be.
The munchkins at TEC central went on and on about how there was, for off-label indications of sunitinib or Nexavar (hepatocellular carcinoma), no studies were found that met selection criteria for this assessment (Who died and made them king?) That included use for renal cell carcinoma. So in otherwords the progression free survival of patients on Nexavar reported in the NEJM means nothing, as does the reports of efficacy in several other studies. (See Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.) But of course " assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not. We will leave that to the national Comparative Effectiveness Board which will collaborate with TEC to maximize research dollars.
Let's see Healthcare Renewal and the other conflict of interest police defend this one. Letting people die to save dollars...
"The Pathway to Covering America:Ensuring Quality, Value and Access." Let's set aside the image of a pathway covering something (isn't that a bit convoluted?) and the semi-fictitious factoids about health care (people without coverage get sicker and die sooner than those with coverage, sort of true but not always so for many, many reasons).
The heart of the proposal is the claim that "America needs an independent institute to support research comparing the relative effectiveness of new and existing medical procedures, drugs, devices and biologics" and that "Medicare and other public program should be required to consider the Institute's research in developing pay for performance, coverage, reimbursement and other policies."
So social scientists culling through research -- using meta- analysis mostly -- will create practice guidelines that will dictate to doctors and patients what care they will receive. All paid for by a tax on our premiums.
BCBS says that the Institute should contract with existing entities to facilitate research and collaborate with "institutes that receive comparative research contracts to identify best practices...in order to maximize research dollars."
Guess who has an "existing" entity?
BCBS. In the form of a Technology Evaluation Center. And it is already "one of the 14 Evidence-Based Practice Center for the US Agency for Healthcare Research and Quality. It also provides evaluations to Medicare and Medicaid. BCBS says: " TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not! Who would think such a thing! But imagine if Phrma or BIO instead of BCBS or Kaiser were running a TEC that in turn would be part and parcel of the Comparative Effectiveness Institute right off the bat. The screams about conflict would be heard round the world.
Meanwhile, here's a flavor of how slow-footed and lethal TEC transfer can be.
The munchkins at TEC central went on and on about how there was, for off-label indications of sunitinib or Nexavar (hepatocellular carcinoma), no studies were found that met selection criteria for this assessment (Who died and made them king?) That included use for renal cell carcinoma. So in otherwords the progression free survival of patients on Nexavar reported in the NEJM means nothing, as does the reports of efficacy in several other studies. (See Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.) But of course " assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not. We will leave that to the national Comparative Effectiveness Board which will collaborate with TEC to maximize research dollars.
Let's see Healthcare Renewal and the other conflict of interest police defend this one. Letting people die to save dollars...
After a delicious buffet lunch of tunafish and ice tea, the inaugural meeting of the FDA's Risk Communications Advisory Committee returned to begin the second half of Day One with the open public comment portion of the program.
The first person to speak was a free-lance reporter who bitterly complained about the agency's "permission to speak" rule. This means that FDA employees cannot speak to reporters without permission.
Her main beef was that her calls were not returned promptly (if at all) and that access was often not granted -- at the discretion of a press officer and without explanation or justification.
Okay, a couple of points here.
First, of course FDA employees need permission before they speak to the press. This is appropriate otherwise chaos ensures. However, access should be denied only under the most limited circumstances -- and that denial should not be at the discretion of a press officer. In any event, access should be granted (broadly) or denied (rarely) with alacrity.
When I was at FDA, the press office reported to me. I held a meeting with all of the press officers and my prop was a telephone. I held it up and pointed out to the staff that the phone came with buttons "at no additional charge." My point was that reporter calls should be returned as soon as humanly possible.
A few years later, shortly after I announced that I was leaving the agency, I received a call from an FDA beat reporter who said she was sad I was leaving because, "I returned her calls."
Talk about a low bar.
It's not about "permission to speak," it's about permission to speak regularly -- and on deadline.
The first person to speak was a free-lance reporter who bitterly complained about the agency's "permission to speak" rule. This means that FDA employees cannot speak to reporters without permission.
Her main beef was that her calls were not returned promptly (if at all) and that access was often not granted -- at the discretion of a press officer and without explanation or justification.
Okay, a couple of points here.
First, of course FDA employees need permission before they speak to the press. This is appropriate otherwise chaos ensures. However, access should be denied only under the most limited circumstances -- and that denial should not be at the discretion of a press officer. In any event, access should be granted (broadly) or denied (rarely) with alacrity.
When I was at FDA, the press office reported to me. I held a meeting with all of the press officers and my prop was a telephone. I held it up and pointed out to the staff that the phone came with buttons "at no additional charge." My point was that reporter calls should be returned as soon as humanly possible.
A few years later, shortly after I announced that I was leaving the agency, I received a call from an FDA beat reporter who said she was sad I was leaving because, "I returned her calls."
Talk about a low bar.
It's not about "permission to speak," it's about permission to speak regularly -- and on deadline.
While Peter was trying to calm the risk communication waters..here's my suggestion about embedding reporters: Don't.
There was some important research in JAMA about how 60 percent of adolescents don't respond to the first anti-depressants they receive but respond well to the second line of meds and cognitive behavioral therapy. That jives with earlier results of cross-over studies that demonstrate about 60 percent failure rate among depressed adults and their first SSRIs.
Read More
Of course that could explain why, in many studies, you get the zero effect vs placebo. That, and as Fred Goodwin has pointed out, the FDA refuses to allow crossover designs (adaptive trials of a sort) in neuropharm. And of course as genetic testing gets closer in antidepressants, as David Meltzer and others noted at a conference held by the ...that trial, error and miss approach to medication might be history.
But you had to search mightily for that story yesterday in the media or the blogosphere.
Instead, it was a sloppy meta-analysis (meta, as in sort of, analysis as in let the computer do it) of lots of placebo controlled trials of varying quality, design, exclusivity criteria that seemed to suggest what anyone who has taken an antidepressant knows is crap: they don't work. And of course while the media and the blogosphere sneer at the source research funding they are willfully blind to the incredibly poor study design of the meta-analysis in question as well as the limits of meta-analysis in general. Here's one of many hard sci bloggers piling on the silly stew of studies that was passed off as science.
"Way too loose of p-values for false positives in studies, in medicine (and social sciences) compared to natural sciences, is one reason to not read too much into any individual study that claims antidepressants are ineffective, like the Public Library of Science meta-analysis of individual studies did.
P-values of the same looseness as in medicine/social sciences have been used to claim intercessory prayer actually works on sick people (http://www.religioustolerance.org/medical6.htm), for example, or here (http://skepdic.com/refuge/bunk21.html)
"I’m not saying that the results of a meta-analysis are no stronger than the weakest study in its umbrella. I am saying that, with p values as loose as they are in health/medicine (and social sciences), is that no massive amount of individual research studies being included under one meta-analysis will make the meta-analysis’ results anything more than a little bit stronger than the best individual study.
In other words, in medicine, and in social sciences, meta-analysis adds a very modest bump, nothing more. The problem is, most people believe it does much more than that when it doesn’t.
Or, to put it another way, meta-analysis is no better than the material it’s analyzing."
Read More
And here's another question: if they don't work, then why do they have such horrible but rare side effects? Is it really possible that drug companies just pumped drugs that were completely worthless except for the fact that they caused kids to commit suicide?
But that's precisely the mindset of the media and to even more greater extent http://www.pharmalot.com and http://www.fiercepharma.com. Both sites totally ignored the JAMA study and focused on the meta-analysis. The JAMA study was a randomized controlled trial and the meta-analysis...well what can I say except what my high school English teach used to say regarding the difference between Cliff Notes and a novel: that meta-analysis is to real research what masturbation is to sex. Does anyone do any analysis of related analysis anymore or are journalist and bloggers just posting the facts that fit their pre-conceived notions. Does it tell you anything that the meta-analyses are easy to churn out and rush into print just before, say, the next FDA meeting of import?
Such perspectives only encourage people not to take medicines or encourage them to stop taking them because they "don't work." It's irresponsible.
Oh yeah... Here's the study that made antidepressants worthless....
Read More
There was some important research in JAMA about how 60 percent of adolescents don't respond to the first anti-depressants they receive but respond well to the second line of meds and cognitive behavioral therapy. That jives with earlier results of cross-over studies that demonstrate about 60 percent failure rate among depressed adults and their first SSRIs.
Read More
Of course that could explain why, in many studies, you get the zero effect vs placebo. That, and as Fred Goodwin has pointed out, the FDA refuses to allow crossover designs (adaptive trials of a sort) in neuropharm. And of course as genetic testing gets closer in antidepressants, as David Meltzer and others noted at a conference held by the ...that trial, error and miss approach to medication might be history.
But you had to search mightily for that story yesterday in the media or the blogosphere.
Instead, it was a sloppy meta-analysis (meta, as in sort of, analysis as in let the computer do it) of lots of placebo controlled trials of varying quality, design, exclusivity criteria that seemed to suggest what anyone who has taken an antidepressant knows is crap: they don't work. And of course while the media and the blogosphere sneer at the source research funding they are willfully blind to the incredibly poor study design of the meta-analysis in question as well as the limits of meta-analysis in general. Here's one of many hard sci bloggers piling on the silly stew of studies that was passed off as science.
"Way too loose of p-values for false positives in studies, in medicine (and social sciences) compared to natural sciences, is one reason to not read too much into any individual study that claims antidepressants are ineffective, like the Public Library of Science meta-analysis of individual studies did.
P-values of the same looseness as in medicine/social sciences have been used to claim intercessory prayer actually works on sick people (http://www.religioustolerance.org/medical6.htm), for example, or here (http://skepdic.com/refuge/bunk21.html)
"I’m not saying that the results of a meta-analysis are no stronger than the weakest study in its umbrella. I am saying that, with p values as loose as they are in health/medicine (and social sciences), is that no massive amount of individual research studies being included under one meta-analysis will make the meta-analysis’ results anything more than a little bit stronger than the best individual study.
In other words, in medicine, and in social sciences, meta-analysis adds a very modest bump, nothing more. The problem is, most people believe it does much more than that when it doesn’t.
Or, to put it another way, meta-analysis is no better than the material it’s analyzing."
Read More
And here's another question: if they don't work, then why do they have such horrible but rare side effects? Is it really possible that drug companies just pumped drugs that were completely worthless except for the fact that they caused kids to commit suicide?
But that's precisely the mindset of the media and to even more greater extent http://www.pharmalot.com and http://www.fiercepharma.com. Both sites totally ignored the JAMA study and focused on the meta-analysis. The JAMA study was a randomized controlled trial and the meta-analysis...well what can I say except what my high school English teach used to say regarding the difference between Cliff Notes and a novel: that meta-analysis is to real research what masturbation is to sex. Does anyone do any analysis of related analysis anymore or are journalist and bloggers just posting the facts that fit their pre-conceived notions. Does it tell you anything that the meta-analyses are easy to churn out and rush into print just before, say, the next FDA meeting of import?
Such perspectives only encourage people not to take medicines or encourage them to stop taking them because they "don't work." It's irresponsible.
Oh yeah... Here's the study that made antidepressants worthless....
Read More
Blogging to you directly from the glamorous Gaithersburg Hilton and the inaugural meeting of the FDA's Risk Communications Advisory Committee.
Star of the morning was FDA Commissioner von Eschenbach.
Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."
The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."
Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.
"Help us dialogue," the Commissioner asked the committee.
Communications hint to Commissioner: "Dialogue" is not a verb.
To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.
He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.
Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.
The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.
Amen again-- and God's Speed.
Star of the morning was FDA Commissioner von Eschenbach.
Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."
The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."
Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.
"Help us dialogue," the Commissioner asked the committee.
Communications hint to Commissioner: "Dialogue" is not a verb.
To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.
He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.
Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.
The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.
Amen again-- and God's Speed.
Two cheers for Congresswoman Rosa L. DeLauro for holding yesterday’s FDA oversight hearing.
Throughout her career, Representative DeLauro has expressed a brazen disregard for drug safety, continually calling on policymakers to open our borders to an uncontrollable influx of untested, impure, expired, and counterfeit drugs from around the world.
Today, however, drug importation was noticeably absent from the agenda.
Perhaps importation was left off the agenda because of the recent report that contaminated heparin, manufactured in China, is responsible for at least four deaths. Or perhaps she ignored importation because today’s hearing comes just one year after dozens of cats and dogs died of kidney failure after ingesting contaminated pet food -- and only one year after counterfeit Colgate toothpaste containing diethylene glycol infiltrated the U.S. market.
Regardless of her reasoning, it seems grossly irresponsible to grandstand for drug safety on one day and call for the importation of foreign drugs on another.
Let’s look at the facts. The World Health Organization estimates that eight to 10 percent of today’s global medicine supply chain is counterfeit. According to the Food and Drug Administration, that figure jumps to 50 percent or higher in some countries.
Without legalized prescription drug importation, the number of counterfeit drug investigations has increased four-fold since the late 1990s. Just imagine what will happen if such a thoughtless policy were codified.
Perhaps Representative DeLauro will take this opportunity to publicly denounce drug importation and take action to keep counterfeit drugs out of the U.S. medicine supply.
Perhaps not.
Throughout her career, Representative DeLauro has expressed a brazen disregard for drug safety, continually calling on policymakers to open our borders to an uncontrollable influx of untested, impure, expired, and counterfeit drugs from around the world.
Today, however, drug importation was noticeably absent from the agenda.
Perhaps importation was left off the agenda because of the recent report that contaminated heparin, manufactured in China, is responsible for at least four deaths. Or perhaps she ignored importation because today’s hearing comes just one year after dozens of cats and dogs died of kidney failure after ingesting contaminated pet food -- and only one year after counterfeit Colgate toothpaste containing diethylene glycol infiltrated the U.S. market.
Regardless of her reasoning, it seems grossly irresponsible to grandstand for drug safety on one day and call for the importation of foreign drugs on another.
Let’s look at the facts. The World Health Organization estimates that eight to 10 percent of today’s global medicine supply chain is counterfeit. According to the Food and Drug Administration, that figure jumps to 50 percent or higher in some countries.
Without legalized prescription drug importation, the number of counterfeit drug investigations has increased four-fold since the late 1990s. Just imagine what will happen if such a thoughtless policy were codified.
Perhaps Representative DeLauro will take this opportunity to publicly denounce drug importation and take action to keep counterfeit drugs out of the U.S. medicine supply.
Perhaps not.
During my tenure at Hudson Institute, we held a National Press Club shindig in honor of Barry Goldwater. Among those invited was William F. Buckley, Jr. -- and the RSVPs came to me.
Returning from lunch with my father, a "Big L" liberal, I quickly went to check my voicemail as he puttered around my office. The first message caught my Dad's attention.
"Hello Peter. This is William F. Buckley and I will certainly attend the event for Senator Goldwater."
My father just smiled and said that he was proud of me.
Thanks Bill.
Returning from lunch with my father, a "Big L" liberal, I quickly went to check my voicemail as he puttered around my office. The first message caught my Dad's attention.
"Hello Peter. This is William F. Buckley and I will certainly attend the event for Senator Goldwater."
My father just smiled and said that he was proud of me.
Thanks Bill.
According to a story in today’s Washington Post, “If it seems as though the Food and Drug Administration has been issuing a new drug safety warning almost every week, that's because, for the past three months, it has.â€
“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.â€
"We are trying to act in a responsible way," Seligman says.
According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''
And that’s the rub, because too much information can be as dangerous as too little.
According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.â€
In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.
Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.â€
Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.
Here's a link to the complete article:
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html
“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.â€
"We are trying to act in a responsible way," Seligman says.
According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''
And that’s the rub, because too much information can be as dangerous as too little.
According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.â€
In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.
Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.â€
Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.
Here's a link to the complete article:
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html
"I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," Dr. von Eschenbach says. "This is a systemic overhaul that must go on over a period of years."
In the recent on-line version of Health Despair there were two reports that seemed to send the same old messages: more folks unable to pay for increasingly expensive health care premiums. As Boomers move into Medicare, the cost will be unsustainable.
Wrong on both counts.
The U.S. Economy And Changes In Health Insurance Coverage, 2000-2006
John Holahan * Allison Cook insists the eroding insurance coverage is a matter of eroding wages and rising premiums.
Not so simple. Insurance coverage increased for kids and when you back out illegal immigrants the number is of uninsured kids is even lower. (I thought there was a SCHIP crisis!)
During the 2000-2004 period studied, the greatest percentage increase in adult uninsurance was among rich and middle class folks. 3.4 million increase in uninsured adults and children between 2004 and 2006, 700,000 were middle-income Americans and 800,000 were higher-income Americans. The authors fail to point out that there was an increase in people receiving coverage in the private market from 2004-2006 which is about the time HSAs began to expand. All other categories of coverage experience a decline. Except government coverage.
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.2.w135v1
Turning to the growth in medical spending in the article: Health Spending Projections
Through 2017: The Baby-Boom Generation Is Coming To Medicare
The article states: "The primary drivers of personal health care spending growth during the projection period are medical prices and utilization, followed by smaller impacts from population growth and the age-sex mix."
Gee, I thought it was disease.
"As a result, health is projected to consume an expanding share of the economy, which means that policymakers, insurers, and the public will face increasingly difficult decisions about the way health care is delivered and paid for."
But what about technologies that reduce the burden of disease even as they increase life expectancy? Here's what another article in Health Affairs noted:
"A sixty-five-year-old with a serious chronic illness spends $1,000-$2,000 more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy."
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.r18
There are signals all over the place that our health care system has reached a tipping point on its own, pushed by consumers, mainly boomers, towards prevention, value, personalized care. The point would be to unleash this power by giving this generation and the next more control over the course of their health and care. Why not reward people for staying healthier, longer? Yet we are setting up a regulatory and reimbursement system that discourages such advances.
The closer we move to prevention and prediction, the more valuable health care becomes. The more we spend on more effective care the better off we are. If we spend 30 percent of out GDP on such things, isn't that better than spending 30 percent of it on services and technologies like heart and lung machines, drugs that only work half the time in half the people? Yet that is exactly where the command and control models of European, Canadian and Medicare want to take us.
Wrong on both counts.
The U.S. Economy And Changes In Health Insurance Coverage, 2000-2006
John Holahan * Allison Cook insists the eroding insurance coverage is a matter of eroding wages and rising premiums.
Not so simple. Insurance coverage increased for kids and when you back out illegal immigrants the number is of uninsured kids is even lower. (I thought there was a SCHIP crisis!)
During the 2000-2004 period studied, the greatest percentage increase in adult uninsurance was among rich and middle class folks. 3.4 million increase in uninsured adults and children between 2004 and 2006, 700,000 were middle-income Americans and 800,000 were higher-income Americans. The authors fail to point out that there was an increase in people receiving coverage in the private market from 2004-2006 which is about the time HSAs began to expand. All other categories of coverage experience a decline. Except government coverage.
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.2.w135v1
Turning to the growth in medical spending in the article: Health Spending Projections
Through 2017: The Baby-Boom Generation Is Coming To Medicare
The article states: "The primary drivers of personal health care spending growth during the projection period are medical prices and utilization, followed by smaller impacts from population growth and the age-sex mix."
Gee, I thought it was disease.
"As a result, health is projected to consume an expanding share of the economy, which means that policymakers, insurers, and the public will face increasingly difficult decisions about the way health care is delivered and paid for."
But what about technologies that reduce the burden of disease even as they increase life expectancy? Here's what another article in Health Affairs noted:
"A sixty-five-year-old with a serious chronic illness spends $1,000-$2,000 more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy."
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.r18
There are signals all over the place that our health care system has reached a tipping point on its own, pushed by consumers, mainly boomers, towards prevention, value, personalized care. The point would be to unleash this power by giving this generation and the next more control over the course of their health and care. Why not reward people for staying healthier, longer? Yet we are setting up a regulatory and reimbursement system that discourages such advances.
The closer we move to prevention and prediction, the more valuable health care becomes. The more we spend on more effective care the better off we are. If we spend 30 percent of out GDP on such things, isn't that better than spending 30 percent of it on services and technologies like heart and lung machines, drugs that only work half the time in half the people? Yet that is exactly where the command and control models of European, Canadian and Medicare want to take us.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
