Important op-ed by Scott Gottlieb in today's Wall Street Journal on the continuing jihad against incremental innovation via poorly designed studies and slanted reporting thereof.
As Scott writes:
"The difficult nature of these "comparative" drug studies, the sort contemplated in Schip, requires more care, not less. These studies are hard to execute by their nature, a fact given short shrift by policy makers who believe the conclusions gleaned from the research will provide immediate cost savings.
For one thing, as the Allhat study proved, detecting small clinical differences between two active drugs, such as whether one pill lowers blood pressure more than another, requires very large studies that often fail to capture all of the patient preferences and characteristics that go into real world medical decisions. And once the study is completed, determining whether small differences are clinically meaningful can take years of follow up.
When the trials are under-funded and too small, or are poorly designed or conducted, important differences are not detected, which supports the theory that older drugs are as good as newer ones even if that is not true. This flawed science seems just fine with those who support these trials largely for cost purposes."
And many top clinical experts agree. Click on the link below and see what Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University have to say on the topic.
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine. This language disintermediates physicians, hurts patients and helps nobody other than payors (both public and private).
And that's not public health -- it's politics