The New York Times provided an article on CCE today. The article states:
"The administration plans to spend $1.1 billion over the next few years on studies like the one conducted by Dr. Deyo, to compare the effectiveness of competing treatments for common conditions like back pain, heart disease and prostate cancer. The studies will be publicly released, to help doctors and patients decide which treatment options they want to pursue."
As we have stated before in three examples the results that often go to an administrator such as the one in the Times article provide the correct answers to often the wrong question. For example, as we have already shown:
1. Colon Cancer: A Canadian study allegedly showed that colonoscopies are not effective for screening the ascending and transverse colon for neoplasia. The fact of the study is that the Canadian physicians who performed the examinations were not proficient and not experienced enough to make a determination and that the colonoscopies were performed too infrequently. That was not the way the press reported it. If the Government administrators use this paper as a basis for clinical effectiveness then many people will die unnecessarily.
2. Ovarian Cancer: As we have also shown, there are papers which say that annual screening for ovarian cancer does not alter mortality. True, the cancer grows rapidly. But quarterly screening does reduce it by 80%! The question should have peen posed; how frequently should a person be screened to reduce mortality by say 80%. That questions was not asked. It was asked and answered in a Government study, however. Namely one can truly reduce ovarian cancer mortality by 80% with screening every three months. The problem is that the cost is monumental for every life saved. That and that alone is the issue. Also there is te increase in the false alarm rate and surgeries which are not necessary.
3. Prostate Cancer: This was the recent NEJM flap. They asked the question; did measuring PSA with a 4.0 threshold and acting thereupon significantly reduce mortality. The true question that should have been asked was; what level of PSA significantly reduce mortality. The question posed and answered was the wrong question. It may have been the right one when the study started almost fifteen years ago but seven years ago we knew that a PSA for men under 65 was reset to 2.0. One must be careful not to jump to the conclusions of the New York Times which stated that categorically PSA testing of any kine was without merit. Well, it was the New York Times, not known for their determination of the facts as they are but only as they see them. But if the information bastion of the current Administration can categorically deny the efficacy of the PSA then what would one ever expect out of a Government official!
The problem with CCE in these three examples is that Government bureaucrats, not known for their brilliance, will take studies that benefit the reduction in benefits and costs, and use them as a basis of CCE mandates. This will result in no reduction in mortality and morbidity. It will in fact be counter-productive,
As Garber and Tunis state in this weeks NEJM:
" The deepest concern about CER is that it will be misused, which is why some legislators seek to prohibit information on comparative effectiveness from influencing coverage policy and payment decisions. But surely these decisions will not be improved by discouraging the use of the most relevant and valid information about what works and in whom. CER is not a panacea, but it is a key to individualized care and innovation, not a threat. An initiative to advance our knowledge about the effectiveness of clinical strategies can hasten the day when personalized medicine transforms health care."
In another commentary in NEJM Avron states:
"As the stimulus bill was being debated in January and February, the opposition to CER found its voice in commentators who claimed that these studies will inevitably lead to government domination of the doctor–patient relationship, “cookbook medicine,” and rationing. Certainly, important issues do arise in trying to translate CER findings into specific decisions regarding patient care and reimbursement, but much of the attack relied on overt mis-characterizations of the legislation’s content. Scott Gottlieb, a deputy FDA commissioner in the last administration, stated that the Congressional Budget Office had determined that CER “won’t actually save much money” — a contention he based on an article that said precisely the opposite. “The risk,” he said, “is that the conclusions will be flawed and still used to restrict coverage decisions, especially by Medicare.”
Avron states just the opposite from my prior examples. Avron appears to be saying that the Government administrators are competent and unbiased enough to make life saving decisions. For those of us who have spent a few years in Washington, we know all too well that Washington is the last place you would want such a decision to be made. Why not have the professional societies do this. In many ways it is akin to medical licensing. Why not have the professionals that are performing the studies and treating the patients make the recommendations, and change them as needed. Imagine if HHS wrote Harrison's! They would find a low cost beltway bandit to write the document. Would we accept it? What if we were forced to!
Finally the NEJM correspondence by Naik and Petersen state:
"Surprisingly little attention has been paid to what we believe is the most critical question facing CER: Will its results significantly improve the quality and safety of the health care received by the average patient? Policymakers and research funders, such as the National Institutes of Health, often assume that the final steps in the translation of clinical research — the decision to act on new medical evidence and its implementation implementation of its findings into practice requires substantial investment and planning that will involve health care providers, patients, and other local stakeholders."
CCE is an important process, in fact it is critical. However it is a professional communal communications process or performing studies, critically assessing the studies, disseminating the results and then reassessing. It is iterative. Many times the wrong question is studied and answered. Then we focus on the answer and forget about what question was asked. We are arguing that CCE must move forward but the current Administration's centralized plan and its ensuing use of it as a rationing tool is at best problematic and at worst it flies in the face of the Hippocratic oath.
"The administration plans to spend $1.1 billion over the next few years on studies like the one conducted by Dr. Deyo, to compare the effectiveness of competing treatments for common conditions like back pain, heart disease and prostate cancer. The studies will be publicly released, to help doctors and patients decide which treatment options they want to pursue."
As we have stated before in three examples the results that often go to an administrator such as the one in the Times article provide the correct answers to often the wrong question. For example, as we have already shown:
1. Colon Cancer: A Canadian study allegedly showed that colonoscopies are not effective for screening the ascending and transverse colon for neoplasia. The fact of the study is that the Canadian physicians who performed the examinations were not proficient and not experienced enough to make a determination and that the colonoscopies were performed too infrequently. That was not the way the press reported it. If the Government administrators use this paper as a basis for clinical effectiveness then many people will die unnecessarily.
2. Ovarian Cancer: As we have also shown, there are papers which say that annual screening for ovarian cancer does not alter mortality. True, the cancer grows rapidly. But quarterly screening does reduce it by 80%! The question should have peen posed; how frequently should a person be screened to reduce mortality by say 80%. That questions was not asked. It was asked and answered in a Government study, however. Namely one can truly reduce ovarian cancer mortality by 80% with screening every three months. The problem is that the cost is monumental for every life saved. That and that alone is the issue. Also there is te increase in the false alarm rate and surgeries which are not necessary.
3. Prostate Cancer: This was the recent NEJM flap. They asked the question; did measuring PSA with a 4.0 threshold and acting thereupon significantly reduce mortality. The true question that should have been asked was; what level of PSA significantly reduce mortality. The question posed and answered was the wrong question. It may have been the right one when the study started almost fifteen years ago but seven years ago we knew that a PSA for men under 65 was reset to 2.0. One must be careful not to jump to the conclusions of the New York Times which stated that categorically PSA testing of any kine was without merit. Well, it was the New York Times, not known for their determination of the facts as they are but only as they see them. But if the information bastion of the current Administration can categorically deny the efficacy of the PSA then what would one ever expect out of a Government official!
The problem with CCE in these three examples is that Government bureaucrats, not known for their brilliance, will take studies that benefit the reduction in benefits and costs, and use them as a basis of CCE mandates. This will result in no reduction in mortality and morbidity. It will in fact be counter-productive,
As Garber and Tunis state in this weeks NEJM:
" The deepest concern about CER is that it will be misused, which is why some legislators seek to prohibit information on comparative effectiveness from influencing coverage policy and payment decisions. But surely these decisions will not be improved by discouraging the use of the most relevant and valid information about what works and in whom. CER is not a panacea, but it is a key to individualized care and innovation, not a threat. An initiative to advance our knowledge about the effectiveness of clinical strategies can hasten the day when personalized medicine transforms health care."
In another commentary in NEJM Avron states:
"As the stimulus bill was being debated in January and February, the opposition to CER found its voice in commentators who claimed that these studies will inevitably lead to government domination of the doctor–patient relationship, “cookbook medicine,” and rationing. Certainly, important issues do arise in trying to translate CER findings into specific decisions regarding patient care and reimbursement, but much of the attack relied on overt mis-characterizations of the legislation’s content. Scott Gottlieb, a deputy FDA commissioner in the last administration, stated that the Congressional Budget Office had determined that CER “won’t actually save much money” — a contention he based on an article that said precisely the opposite. “The risk,” he said, “is that the conclusions will be flawed and still used to restrict coverage decisions, especially by Medicare.”
Avron states just the opposite from my prior examples. Avron appears to be saying that the Government administrators are competent and unbiased enough to make life saving decisions. For those of us who have spent a few years in Washington, we know all too well that Washington is the last place you would want such a decision to be made. Why not have the professional societies do this. In many ways it is akin to medical licensing. Why not have the professionals that are performing the studies and treating the patients make the recommendations, and change them as needed. Imagine if HHS wrote Harrison's! They would find a low cost beltway bandit to write the document. Would we accept it? What if we were forced to!
Finally the NEJM correspondence by Naik and Petersen state:
"Surprisingly little attention has been paid to what we believe is the most critical question facing CER: Will its results significantly improve the quality and safety of the health care received by the average patient? Policymakers and research funders, such as the National Institutes of Health, often assume that the final steps in the translation of clinical research — the decision to act on new medical evidence and its implementation implementation of its findings into practice requires substantial investment and planning that will involve health care providers, patients, and other local stakeholders."
CCE is an important process, in fact it is critical. However it is a professional communal communications process or performing studies, critically assessing the studies, disseminating the results and then reassessing. It is iterative. Many times the wrong question is studied and answered. Then we focus on the answer and forget about what question was asked. We are arguing that CCE must move forward but the current Administration's centralized plan and its ensuing use of it as a rationing tool is at best problematic and at worst it flies in the face of the Hippocratic oath.
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