The New England Journal has published a brief article bemoaning the CER, CCE, words in the Senate Bill. They state:
"Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research. In the currently proposed legislation, there are two general constructs for the conduct of CER. The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee (the relevant portion of the bill, .... begins on page 1129).
This approach contrasts with that generally taken by science agencies in the United States, such as the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ), which have strict conflict-of-interest rules to ensure that science is free of inappropriate commercial influence. Unlike the Senate Finance Committee bill, the bill from the Senate HELP Committee and the versions developed in the House make the AHRQ responsible for CER, thereby recognizing and preserving the independence of the scientific process. The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not “within the bounds of and entirely consistent with the evidence.” Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome. This move would be a major retrograde step that would both inhibit the conduct of CER and call its integrity into question. In addition, because researchers and their institutions will seek to avoid such punishment, this provision is likely to result in prolonged arguments, taking place out of public view, regarding which data are acceptable to publish, thereby impeding and delaying publication. The American public, which would be paying for this research, deserves better."
We have been following this since HR 3200 and before. The CER/CCE will "kill" medicine as we know it. Only what the Government says is true will be allowed and those with differing views will be persecuted. I suspect that hidden in the IRS related text they will be driven to extremes. One should read this Bill very carefully, which does take time, but given what damage it will do to this country and its people it is worth the effort.
"Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research. In the currently proposed legislation, there are two general constructs for the conduct of CER. The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee (the relevant portion of the bill, .... begins on page 1129).
This approach contrasts with that generally taken by science agencies in the United States, such as the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ), which have strict conflict-of-interest rules to ensure that science is free of inappropriate commercial influence. Unlike the Senate Finance Committee bill, the bill from the Senate HELP Committee and the versions developed in the House make the AHRQ responsible for CER, thereby recognizing and preserving the independence of the scientific process. The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not “within the bounds of and entirely consistent with the evidence.” Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome. This move would be a major retrograde step that would both inhibit the conduct of CER and call its integrity into question. In addition, because researchers and their institutions will seek to avoid such punishment, this provision is likely to result in prolonged arguments, taking place out of public view, regarding which data are acceptable to publish, thereby impeding and delaying publication. The American public, which would be paying for this research, deserves better."
We have been following this since HR 3200 and before. The CER/CCE will "kill" medicine as we know it. Only what the Government says is true will be allowed and those with differing views will be persecuted. I suspect that hidden in the IRS related text they will be driven to extremes. One should read this Bill very carefully, which does take time, but given what damage it will do to this country and its people it is worth the effort.
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