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“Show me the evidence” has to be one of the most-used phrases in the English language. Just take a look at the number of Google hits. And “prove it” has to be a close second. But if science has taught us anything, it’s that nothing can be proven — only disproven. The Big Bang theory, as an example, may be the predominant scientific theory to explain the origin of our universe, but it has so many band-aids that it threatens to break apart if just one more fissure is found. It can’t be proven, because cosmologists can’t do an experiment under controlled conditions to see what the outcome will be.
Which takes us to randomized controlled trials, which compare, generally, treatment with no treatment. As physicians and payers well know, the outcome of these trials doesn’t reflect what happens among a diverse group of patients in the “real world” — something akin to things in our universe not always working as we predict or assume they will.
In the article “Lies, Damned Lies, and Medical Science,” which appears in the November issue of the Atlantic, author David H. Freedman talks with John Ioannidis, MD, PhD, a crusader, if you will, for pushing holes into medical theories and standards of care accepted today by the medical community. Ioannidis also is pushing for more thoughtful studies and for the acknowledgement that “we could solve much of the wrongness problem, if the world simply stopped expecting scientists to be right” all of the time. Ioannidis’ paper “Why Most Published Research Findings Are False,” published in PLoS Medicine (Aug. 30, 2005) is, Freedman says, “the most downloaded in the journal’s history.”
Which takes us to Senior Contributing Writer Michael Dalzell’s informative cover story on the disenchantment with evidence-based medicine. He, too, refers to a PLoS Medicine article by United-Health executive Richard Smith that exemplifies the vitriol that abounds regarding current medical research and trial outcomes. But Mike’s story also talks about what is being done to begin developing a credible healthcare evidence base. Garrett Bergman, MD, CSL Behring’s North American senior director for medical affairs, adds his take on looking at the evidence base more realistically.
This issue of Biotechnology Healthcare focuses on three other pressing issues: The necessity to find a definitive coding solution for molecular tests if personalized medicine is to really be personalized, the effect of the new Biosimilars Act on the manufacture and use of follow-on biologics, and the coming of oral biologics and whether they will help cut costs.
One thing is for certain — we have today an unparalleled database of medical information that keeps growing and can be used to either support or refute current medical practices or to develop new ones. What is needed is a better alignment of interests.