Protecting Innovation and Progress in Medical Care

Presentation before the Federal Coordinating Council
For Comparative Effectiveness Research

**Click here to watch the webcast.**

Thank you for inviting my comments today about the role of comparative effectiveness research in American health care.  My name is Grace-Marie Turner, and I am president of the Galen Institute, a nonprofit research organization dedicated to patient-centered health reform solutions.  I am a former member of the National Advisory Council for the Agency for Healthcare Research and Quality where I had the pleasure of working with Dr. Carolyn Clancy.  I appreciate her and your leadership on this important issue.

It is widely agreed that doctors and patients need improved information about medicines and treatments to make the best decisions about patient care.  However, many are concerned about how the new federal program or programs governing comparative effectiveness research will be structured, what goals will be established, what type of information will be gathered and how it will be used.  I would like to share some of our views and concerns with you.

A core concept of comparative effectiveness research is to make recommendations on the merits of competing medical treatments.  While employing “evidence-based medicine” is, of course, sound policy – we all want to get better value in health spending – many people are concerned about the impact of centralizing control over research and recommendations about health treatments and choices.
 
President Obama has repeatedly told Americans they won’t have to give up the health care they have if they are satisfied with it. In his Questions and Answers statement during the campaign, he further stated that his “plan will not tell you which doctors to see or what treatments to get. …No government bureaucrat will second-guess decisions about your care.”

Many Americans are concerned that federal authority could move decisions away from patients and their doctors.  There are specific concerns that the new Federal Coordinating Council for Comparative Effectiveness Research will have new and untested power to impact the medical treatments available to Americans.
 
The concerns are largely based upon whether or not comparative effectiveness research findings will be used to make clinical or spending decisions.  House Appropriations Chairman David Obey (D-Wis.) said for example, he believes that drugs and treatments "that are found to be less effective and in some cases, more expensive, will no longer be prescribed."  This caused a political uproar, with some legislators urging that the council be strictly limited to studying “clinical” effectiveness and not “cost-effectiveness”.  I strongly urge the council to focus exclusively on clinical effectiveness in directing research, as AHRQ does today.

Many people also are concerned that decisions could be susceptible to political influences and that the unique medical needs of individual patients may not be fully considered.  Experts from Europe and Canada, where comparative effectiveness systems are established, warn that those who fall outside the mainstream have a more difficult time receiving the treatments they need. 

The complexities of the clinical decision-making process are enormous, including the necessity of taking into account the needs of patients who have rare diseases and multiple conditions.  In making broad clinical effectiveness decisions, it is very difficult to take into account individual differences in responses to drugs and treatments, especially disadvantaging patients who do not respond well to standard care.  It is imperative that the research structure you establish respect these individual needs.

CER certainly has a place in the health care system in which multiple entities are analyzing and reviewing research, but it is extraordinarily difficult for one centralized government decision-making body to take into consideration the individual needs of multiple payers and 300 million Americans.

It is imperative that America use CER to provide the highest quality of information, not to dictate how doctors and patients use that information. The risk is that a centralized system conceived to compile information about the relative effectiveness of medical treatments could turn into a tool to reward doctors who follow recommendations and punish those who don't.  Doctors and hospitals would be directed to follow the recommendations, and their reimbursement – and risk of lawsuits – likely would depend on compliance.  Comparative effectiveness boards, not doctors, would be making decisions about which treatments would be available, and the system would become more and more rigid as doctors fear repercussions if they go against the rules.

Comparative effectiveness reviews also have the risk of stifling innovation.

If allowed to dictate the preferred practice of medicine, physicians are concerned that centralized comparative effectiveness decision-making could replace their experience, wisdom and knowledge with bureaucracies that reduce decisions to formulas.  In the name of protecting their bottom lines, public and private health care plans might refuse to cover treatments and procedures that don't have the approval of this centralized agency.

The CER process must be structured so as to not slow the adoption of new medicines and other innovations in medical practice, including surgeries.  Physicians and hospitals, fearing lawsuits, would also be much less likely to try treatments not yet analyzed and approved by the comparative effectiveness body – even if early evidence suggests a treatment might work for a particular ailment or set of patients.   And medical companies would be less likely to pursue research on new and potentially life-saving drugs, biologics, and medical devices when faced with another major bureaucratic hurdle to introducing their products to market. Ultimately, funds for new research would shrivel. 

The health sector would become more rigid and less open to innovation in the process.  Federal standards must be flexible enough to accommodate the ever-changing and evolving nature of any science, especially medicine.

Many hope that comparative effectiveness research could be used to lower health spending. 
Professor Michael Schlander, a well-respected German physician, medical researcher and economist, found that decisions by the National Institute for Health and Clinical Excellence in the U.K. have actually led to higher spending for the National Health Service, not the savings that had been expected.

Those with experience in CER abroad say it is almost impossible to integrate clinical findings and cost estimates because they use different methods of evaluation. As a result, many subjective decisions are made in what is believed to be an objective scientific process.

A new study from the Institut économique Molinari in France says that approval processes in Europe are increasingly “tough, heavy-handed and costly … Despite the best intentions, the inevitable consequence of these regulations is to push up the cost of innovation substantially, to undervalue its benefits and to reduce the number of new products by making certain projects unprofitable.”

I urge you to put patients first in all you do and in your coordination with federal agencies and Congress.  Comparative effectiveness reviews must focus on creating quality information about medical treatments and then allow doctors and patients to make decisions. 

We have seen through numerous large clinical trials and meta-analyses of trials that there are nuances and subtleties in assessing the research that are often missed and even distorted in the news coverage about the findings.  The risk is great that this pattern could be repeated by research that you would fund.  

The infrastructure created to advance comparative effectiveness research is crucially important. The Council has an opportunity to contribute to development of a knowledge-based health care system.  Rather than serving as an arbitrator that makes final decisions on the value of one treatment over another, the federal government can play a crucial role in aggregating information about the effectiveness of various medicines and treatments and disseminating that information to researchers, clinicians, and patients. This would allow the process of learning and innovation to continue in our health care system so a patient-centered health care system can continue to evolve. 

Thank you again for inviting my comments.  I look forward to helping in any way that I can as you move forward with your work.

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About the author

Presentation before the Federal Coordinating Council
For Comparative Effectiveness Research

**Click here to watch the webcast.**

Thank you for inviting my comments today about the role of comparative effectiveness research in American health care.  My name is Grace-Marie Turner, and I am president of the Galen Institute, a nonprofit research organization dedicated to patient-centered health reform solutions.  I am a former member of the National Advisory Council for the Agency for Healthcare Research and Quality where I had the pleasure of working with Dr. Carolyn Clancy.  I appreciate her and your leadership on this important issue.

It is widely agreed that doctors and patients need improved information about medicines and treatments to make the best decisions about patient care.  However, many are concerned about how the new federal program or programs governing comparative effectiveness research will be structured, what goals will be established, what type of information will be gathered and how it will be used.  I would like to share some of our views and concerns with you.

A core concept of comparative effectiveness research is to make recommendations on the merits of competing medical treatments.  While employing “evidence-based medicine” is, of course, sound policy – we all want to get better value in health spending – many people are concerned about the impact of centralizing control over research and recommendations about health treatments and choices.
 
President Obama has repeatedly told Americans they won’t have to give up the health care they have if they are satisfied with it. In his Questions and Answers statement during the campaign, he further stated that his “plan will not tell you which doctors to see or what treatments to get. …No government bureaucrat will second-guess decisions about your care.”

Many Americans are concerned that federal authority could move decisions away from patients and their doctors.  There are specific concerns that the new Federal Coordinating Council for Comparative Effectiveness Research will have new and untested power to impact the medical treatments available to Americans.
 
The concerns are largely based upon whether or not comparative effectiveness research findings will be used to make clinical or spending decisions.  House Appropriations Chairman David Obey (D-Wis.) said for example, he believes that drugs and treatments "that are found to be less effective and in some cases, more expensive, will no longer be prescribed."  This caused a political uproar, with some legislators urging that the council be strictly limited to studying “clinical” effectiveness and not “cost-effectiveness”.  I strongly urge the council to focus exclusively on clinical effectiveness in directing research, as AHRQ does today.

Many people also are concerned that decisions could be susceptible to political influences and that the unique medical needs of individual patients may not be fully considered.  Experts from Europe and Canada, where comparative effectiveness systems are established, warn that those who fall outside the mainstream have a more difficult time receiving the treatments they need. 

The complexities of the clinical decision-making process are enormous, including the necessity of taking into account the needs of patients who have rare diseases and multiple conditions.  In making broad clinical effectiveness decisions, it is very difficult to take into account individual differences in responses to drugs and treatments, especially disadvantaging patients who do not respond well to standard care.  It is imperative that the research structure you establish respect these individual needs.

CER certainly has a place in the health care system in which multiple entities are analyzing and reviewing research, but it is extraordinarily difficult for one centralized government decision-making body to take into consideration the individual needs of multiple payers and 300 million Americans.

It is imperative that America use CER to provide the highest quality of information, not to dictate how doctors and patients use that information. The risk is that a centralized system conceived to compile information about the relative effectiveness of medical treatments could turn into a tool to reward doctors who follow recommendations and punish those who don't.  Doctors and hospitals would be directed to follow the recommendations, and their reimbursement – and risk of lawsuits – likely would depend on compliance.  Comparative effectiveness boards, not doctors, would be making decisions about which treatments would be available, and the system would become more and more rigid as doctors fear repercussions if they go against the rules.

Comparative effectiveness reviews also have the risk of stifling innovation.

If allowed to dictate the preferred practice of medicine, physicians are concerned that centralized comparative effectiveness decision-making could replace their experience, wisdom and knowledge with bureaucracies that reduce decisions to formulas.  In the name of protecting their bottom lines, public and private health care plans might refuse to cover treatments and procedures that don't have the approval of this centralized agency.

The CER process must be structured so as to not slow the adoption of new medicines and other innovations in medical practice, including surgeries.  Physicians and hospitals, fearing lawsuits, would also be much less likely to try treatments not yet analyzed and approved by the comparative effectiveness body – even if early evidence suggests a treatment might work for a particular ailment or set of patients.   And medical companies would be less likely to pursue research on new and potentially life-saving drugs, biologics, and medical devices when faced with another major bureaucratic hurdle to introducing their products to market. Ultimately, funds for new research would shrivel. 

The health sector would become more rigid and less open to innovation in the process.  Federal standards must be flexible enough to accommodate the ever-changing and evolving nature of any science, especially medicine.

Many hope that comparative effectiveness research could be used to lower health spending. 
Professor Michael Schlander, a well-respected German physician, medical researcher and economist, found that decisions by the National Institute for Health and Clinical Excellence in the U.K. have actually led to higher spending for the National Health Service, not the savings that had been expected.

Those with experience in CER abroad say it is almost impossible to integrate clinical findings and cost estimates because they use different methods of evaluation. As a result, many subjective decisions are made in what is believed to be an objective scientific process.

A new study from the Institut économique Molinari in France says that approval processes in Europe are increasingly “tough, heavy-handed and costly … Despite the best intentions, the inevitable consequence of these regulations is to push up the cost of innovation substantially, to undervalue its benefits and to reduce the number of new products by making certain projects unprofitable.”

I urge you to put patients first in all you do and in your coordination with federal agencies and Congress.  Comparative effectiveness reviews must focus on creating quality information about medical treatments and then allow doctors and patients to make decisions. 

We have seen through numerous large clinical trials and meta-analyses of trials that there are nuances and subtleties in assessing the research that are often missed and even distorted in the news coverage about the findings.  The risk is great that this pattern could be repeated by research that you would fund.  

The infrastructure created to advance comparative effectiveness research is crucially important. The Council has an opportunity to contribute to development of a knowledge-based health care system.  Rather than serving as an arbitrator that makes final decisions on the value of one treatment over another, the federal government can play a crucial role in aggregating information about the effectiveness of various medicines and treatments and disseminating that information to researchers, clinicians, and patients. This would allow the process of learning and innovation to continue in our health care system so a patient-centered health care system can continue to evolve. 

Thank you again for inviting my comments.  I look forward to helping in any way that I can as you move forward with your work.

SHARE THIS ARTICLE

About the author