Latest Drugwonks' Blog
Although HTAs seem not to have hit my home country yet, because of socialized medicine this appears generally without giving its name.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests.
The Weekly Standard
The Real Reformer
McCain's superior prescription for health care.
by Robert Goldberg
03/10/2008, Volume 013, Issue 25
http://www.weeklystandard.com/Content/Public/Articles/000/000/014/818zqeqa.asp
John McCain's proposal for health care reform is more than a plan for making health care more affordable and for controlling costs through deregulation and market competition. It is also an attempt to restore independence and human dignity to patients. Both of his potential opponents in the fall presidential race speak only of extending the government's role in health care--a position supported in the main by large corporations, unions, and the managed-care lobbies. McCain's patient-centered position makes him--not Clinton or Obama--the force for change in health care.
McCain's plan is based around patient-centered initiatives that already have broad support among Republicans in Congress. They include letting people buy health insurance nationally instead of only from state-regulated firms; giving people the choice of purchasing coverage through cooperatives or other organizations (churches or civic groups, for example); expanding health savings accounts; and making health insurance portable by giving people tax credits of up to $5,000 per family to buy their own coverage instead of getting it through an employer.
His chief concern is for people to take ownership of their health care. McCain likes to note that "Ronald Reagan said nobody ever washed a rental car. And that's true in health insurance. If they're responsible for it, then they will take more care of it."
At the heart of McCain's proposals is his effort to allow veterans, particularly soldiers returning from Iraq with traumatic brain injury and mental illness, to get care anywhere rather than just through the Veterans Health Administration (VA): "America's veterans have fought for our freedom. We should give them freedom to choose to carry their VA dollars to a provider that gives them the timely care at high quality and in the best location."
What stirs McCain are stories like that of Sergeant Eric Edmundson who returned from Iraq unable to walk or talk after being hit by a roadside bomb. Edmundson was sent to a VA hospital in Richmond, Virginia, for rehabilitation care. After six months, doctors said he was in a permanent vegetative state and tried to send him to a nursing home where he would be discharged from the Army. But Edmundson's father found out that his son could use his GI vocational benefits (available only after he received VA care but also only if he remained in the service) to receive treatment at one of the world's leading traumatic brain injury (TBI) centers: the Rehabilitation Institute in Chicago. His father prevailed over VA objections. After six months of therapy at the Chicago center, Edmundson was able to talk and walked out of the rehab center under his own power.
The VA system that McCain is attacking is the starting point for the Democratic plans for universal health care. Both Hillary Clinton and Barack Obama want to expand the VA's electronic health care system to the rest of the country. Obama has promised to spend $50 billion on electronic health records based on the VA model. And Clinton likes to claim credit for that model, which she calls an astounding success:
We started during the Clinton administration to transition the VA system to a paperless system. .  .  . The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning.
In fact, as a government audit discovered, the VA's paperless system has created a huge bottleneck, losing track of 53,000 veterans.
Last year, Obama introduced legislation requiring the VA to treat each returning vet in 30 days. Yet, the VA already had such a requirement, and, according to internal VA audits, 25 percent of all vets wait more than 30 days for their first exam. Of the veterans kept waiting, 27 percent had serious service-connected disabilities, including amputations and chronic problems such as frequent panic attacks. Iraq war vets often have to wait six months for their first appointment.
In some VA hospitals, vets wait 18 months for surgeries--a record worse than Canada's or England's national health care systems. The VA's budget for its health care system has doubled since 2001, and Obama still proposes to give more money.
The differences between McCain and the Democratic candidates on health care boil down to freedom of choice. Clinton and Obama want in varying degrees to force Americans to enroll in health plans designed by the government and pay premiums set by the government. Companies that don't cover workers would be required to pay an additional tax to subsidize what amounts to Medicaid for all. If previous experience with S-chip is a guide, it will lead private firms to dump employees into government-run plans. Both Obama and Clinton would limit what drugs and services plans pay for to what the government deems "cost effective."
If you don't want government health care, you won't be able to set up a health savings account as they will be illegal. McCain would increase the opportunities for individuals to choose the care that's best for them by giving patients and doctors the dollars, information, and freedom to make medical decisions instead of a government agency.
Indeed, if Eric Edmundson's father had possessed the freedom to take his son to the best place for care instead of waiting for a bureaucrat's approval, his son would have been walking sooner. McCain's health care plan reflects his desire to make the medical system for vets embody the same freedom and dignity they fought for in Iraq. That's a powerful vision for reforming the whole health care system.
Robert Goldberg is the vice president of the Center for Medicine in the Public Interest.
© Copyright 2008, News Corporation, Weekly Standard, All Rights Reserved.
The Real Reformer
McCain's superior prescription for health care.
by Robert Goldberg
03/10/2008, Volume 013, Issue 25
http://www.weeklystandard.com/Content/Public/Articles/000/000/014/818zqeqa.asp
John McCain's proposal for health care reform is more than a plan for making health care more affordable and for controlling costs through deregulation and market competition. It is also an attempt to restore independence and human dignity to patients. Both of his potential opponents in the fall presidential race speak only of extending the government's role in health care--a position supported in the main by large corporations, unions, and the managed-care lobbies. McCain's patient-centered position makes him--not Clinton or Obama--the force for change in health care.
McCain's plan is based around patient-centered initiatives that already have broad support among Republicans in Congress. They include letting people buy health insurance nationally instead of only from state-regulated firms; giving people the choice of purchasing coverage through cooperatives or other organizations (churches or civic groups, for example); expanding health savings accounts; and making health insurance portable by giving people tax credits of up to $5,000 per family to buy their own coverage instead of getting it through an employer.
His chief concern is for people to take ownership of their health care. McCain likes to note that "Ronald Reagan said nobody ever washed a rental car. And that's true in health insurance. If they're responsible for it, then they will take more care of it."
At the heart of McCain's proposals is his effort to allow veterans, particularly soldiers returning from Iraq with traumatic brain injury and mental illness, to get care anywhere rather than just through the Veterans Health Administration (VA): "America's veterans have fought for our freedom. We should give them freedom to choose to carry their VA dollars to a provider that gives them the timely care at high quality and in the best location."
What stirs McCain are stories like that of Sergeant Eric Edmundson who returned from Iraq unable to walk or talk after being hit by a roadside bomb. Edmundson was sent to a VA hospital in Richmond, Virginia, for rehabilitation care. After six months, doctors said he was in a permanent vegetative state and tried to send him to a nursing home where he would be discharged from the Army. But Edmundson's father found out that his son could use his GI vocational benefits (available only after he received VA care but also only if he remained in the service) to receive treatment at one of the world's leading traumatic brain injury (TBI) centers: the Rehabilitation Institute in Chicago. His father prevailed over VA objections. After six months of therapy at the Chicago center, Edmundson was able to talk and walked out of the rehab center under his own power.
The VA system that McCain is attacking is the starting point for the Democratic plans for universal health care. Both Hillary Clinton and Barack Obama want to expand the VA's electronic health care system to the rest of the country. Obama has promised to spend $50 billion on electronic health records based on the VA model. And Clinton likes to claim credit for that model, which she calls an astounding success:
We started during the Clinton administration to transition the VA system to a paperless system. .  .  . The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning.
In fact, as a government audit discovered, the VA's paperless system has created a huge bottleneck, losing track of 53,000 veterans.
Last year, Obama introduced legislation requiring the VA to treat each returning vet in 30 days. Yet, the VA already had such a requirement, and, according to internal VA audits, 25 percent of all vets wait more than 30 days for their first exam. Of the veterans kept waiting, 27 percent had serious service-connected disabilities, including amputations and chronic problems such as frequent panic attacks. Iraq war vets often have to wait six months for their first appointment.
In some VA hospitals, vets wait 18 months for surgeries--a record worse than Canada's or England's national health care systems. The VA's budget for its health care system has doubled since 2001, and Obama still proposes to give more money.
The differences between McCain and the Democratic candidates on health care boil down to freedom of choice. Clinton and Obama want in varying degrees to force Americans to enroll in health plans designed by the government and pay premiums set by the government. Companies that don't cover workers would be required to pay an additional tax to subsidize what amounts to Medicaid for all. If previous experience with S-chip is a guide, it will lead private firms to dump employees into government-run plans. Both Obama and Clinton would limit what drugs and services plans pay for to what the government deems "cost effective."
If you don't want government health care, you won't be able to set up a health savings account as they will be illegal. McCain would increase the opportunities for individuals to choose the care that's best for them by giving patients and doctors the dollars, information, and freedom to make medical decisions instead of a government agency.
Indeed, if Eric Edmundson's father had possessed the freedom to take his son to the best place for care instead of waiting for a bureaucrat's approval, his son would have been walking sooner. McCain's health care plan reflects his desire to make the medical system for vets embody the same freedom and dignity they fought for in Iraq. That's a powerful vision for reforming the whole health care system.
Robert Goldberg is the vice president of the Center for Medicine in the Public Interest.
© Copyright 2008, News Corporation, Weekly Standard, All Rights Reserved.
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
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.
