Sometimes the Congressional Record is worth reading.
Here’s a colloquy that includes Senators Baucus, Enzi, Hatch, Roberts, and Feinstein. The date, February 6, 2009. The topic, $1.1 billion for a “Federal Coordinating Council on Comparative Effectiveness.” The highlights are mine. The words are their own.
Mr. BAUCUS. I understand Senator ENZI has comments regarding the provisions for comparative clinical effectiveness research included in The American Recovery and Reinvestment Act of 2009 which is being considered in the Senate this week.
Mr. ENZI. I am pleased to see that in its consideration of this bill, the Appropriations Committee made sure this research will evaluate comparative clinical effectiveness, not comparative cost-effectiveness. In addition, the committee’s report language references provisions of the existing comparative effectiveness research program at HHS that ensure that the agency developing comparative information does not use it to set national practice standards or coverage restrictions. I also believe that comparative effectiveness research must be conducted using an open and transparent process, and must consider differences in how people respond to treatment. It is my understanding that the Comparative Effectiveness Research Act of 2008, which you introduced with Senator CONRAD last Congress, is consistent with these principles. I would like to see the $1.1 billion used consistently with these principles, and ask that you advocate for these principles in conference.
Mr. HATCH. I agree that the primary focus of comparative effectiveness research should be clinical effectiveness not cost. We can all agree that the ‘‘one size fits all’’ approach is the wrong approach for the American health care system. Based on our own personal experiences we all know that what works best for one person, does not always work the same for another. I look forward to working in a bipartisan and inclusive manner to come up with prudent legislation that will not only help us realize the true potential of comparative effectiveness but also preserve patient choice and innovation—the two hallmarks of our health care system.
Mr. ROBERTS. I would associate myself with the remarks of Senator ENZI, and would underscore that it is very important to require full openness, transparency and accountability in how research priorities are set and how studies are conducted and communicated. Without this openness, patients have no assurance that their voice will be heard in the process, and no ability to understand how results are being used in decisions that directly affect their health. I look forward to working with my colleagues to ensure that strong provisions for openness, transparency, and accountability are put in place.
Mrs. FEINSTEIN. I thank my colleagues for their efforts on this issue. I agree that comparative effectiveness research holds great promise to improve medical care by giving physicians and patients valuable information on treatment options. It is my understanding that the new Federal coordinating council included in the language is intended to coordinate the comparative effectiveness research efforts taking place across Federal agencies and with funds we are providing in this bill. However, there is some concern that the language, as currently written, allows the council to expand its activities beyond mere coordination. I think my colleagues would agree that the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.
Mr. BAUCUS. I thank Senator FEINSTEIN for pointing that out. I agree. The coordinating council should look across agencies to coordinate resources and activities of the federal government with respect to comparative effectiveness research. Its charge should not go beyond that. The language of the bill could be clarified to make that point clear. And I will support clarification of it in conference.
(Here’s the complete colloquy.)
$1.1 billion to “coordinate” resources and activities? That’s a lot of mazuma. And not a single job created. Well, maybe one coordinator and a few assistants. And at $1.1 billion, they’ll be earning more than any GS-14 I ever met.
And that’s with benefits.
And speaking of $1.1 billion, that also happens to be the mid-range savings projected for what implementation of FDA-recommended genetic testing for warfarin will deliver in one year. (The savings will be realized through the prevention of 85,000 serious bleeding events and 17,000 strokes annually.) Yet FDA is not slotted to receive a single shekel from the stimulus package.
“Clarification in conference,” indeed.
Here’s a colloquy that includes Senators Baucus, Enzi, Hatch, Roberts, and Feinstein. The date, February 6, 2009. The topic, $1.1 billion for a “Federal Coordinating Council on Comparative Effectiveness.” The highlights are mine. The words are their own.
Mr. BAUCUS. I understand Senator ENZI has comments regarding the provisions for comparative clinical effectiveness research included in The American Recovery and Reinvestment Act of 2009 which is being considered in the Senate this week.
Mr. ENZI. I am pleased to see that in its consideration of this bill, the Appropriations Committee made sure this research will evaluate comparative clinical effectiveness, not comparative cost-effectiveness. In addition, the committee’s report language references provisions of the existing comparative effectiveness research program at HHS that ensure that the agency developing comparative information does not use it to set national practice standards or coverage restrictions. I also believe that comparative effectiveness research must be conducted using an open and transparent process, and must consider differences in how people respond to treatment. It is my understanding that the Comparative Effectiveness Research Act of 2008, which you introduced with Senator CONRAD last Congress, is consistent with these principles. I would like to see the $1.1 billion used consistently with these principles, and ask that you advocate for these principles in conference.
Mr. HATCH. I agree that the primary focus of comparative effectiveness research should be clinical effectiveness not cost. We can all agree that the ‘‘one size fits all’’ approach is the wrong approach for the American health care system. Based on our own personal experiences we all know that what works best for one person, does not always work the same for another. I look forward to working in a bipartisan and inclusive manner to come up with prudent legislation that will not only help us realize the true potential of comparative effectiveness but also preserve patient choice and innovation—the two hallmarks of our health care system.
Mr. ROBERTS. I would associate myself with the remarks of Senator ENZI, and would underscore that it is very important to require full openness, transparency and accountability in how research priorities are set and how studies are conducted and communicated. Without this openness, patients have no assurance that their voice will be heard in the process, and no ability to understand how results are being used in decisions that directly affect their health. I look forward to working with my colleagues to ensure that strong provisions for openness, transparency, and accountability are put in place.
Mrs. FEINSTEIN. I thank my colleagues for their efforts on this issue. I agree that comparative effectiveness research holds great promise to improve medical care by giving physicians and patients valuable information on treatment options. It is my understanding that the new Federal coordinating council included in the language is intended to coordinate the comparative effectiveness research efforts taking place across Federal agencies and with funds we are providing in this bill. However, there is some concern that the language, as currently written, allows the council to expand its activities beyond mere coordination. I think my colleagues would agree that the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.
Mr. BAUCUS. I thank Senator FEINSTEIN for pointing that out. I agree. The coordinating council should look across agencies to coordinate resources and activities of the federal government with respect to comparative effectiveness research. Its charge should not go beyond that. The language of the bill could be clarified to make that point clear. And I will support clarification of it in conference.
(Here’s the complete colloquy.)
$1.1 billion to “coordinate” resources and activities? That’s a lot of mazuma. And not a single job created. Well, maybe one coordinator and a few assistants. And at $1.1 billion, they’ll be earning more than any GS-14 I ever met.
And that’s with benefits.
And speaking of $1.1 billion, that also happens to be the mid-range savings projected for what implementation of FDA-recommended genetic testing for warfarin will deliver in one year. (The savings will be realized through the prevention of 85,000 serious bleeding events and 17,000 strokes annually.) Yet FDA is not slotted to receive a single shekel from the stimulus package.
“Clarification in conference,” indeed.
