I get a kick out of politicians and policymakers who worship at the altar of evidence based medicine without knowing what the hell they are even talking about or even knowing the quality of the evidence. As if by default the information produced by a bunch of government paid contractors who punch up all the 'reliable' studies -- randomized clinical trials -- will come up with an objective answer that can be used to guide every doctor and every payment decision.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.
