Tuesday, November 24, 2009

Big pharma



Literally ten years and billions of R&D dollars after William Potter first sounded the alarm about the placebo effect, his message has finally gotten through.
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In the spring, Potter, who is now a VP at Merck, helped rev up a massive data-gathering effort called the Placebo Response Drug Trials Survey.
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Under the auspices of the NIH, Potter and his colleagues are acquiring decades of trial data—including blood and DNA samples—to determine which variables are responsible for the apparent rise in the placebo effect.
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Merck, Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis, Johnson & Johnson, and other major firms are funding the study, and the process of scrubbing volunteers' names and other personal information from the database is about to begin.
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In typically secretive industry fashion, the existence of the project itself is being kept under wraps.
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NIH staffers are willing to talk about it only anonymously, concerned about offending the companies paying for it.
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For Potter, who used to ride along with his father on house calls in Indiana, the significance of the survey goes beyond Big Pharma's finally admitting it has a placebo problem.
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It also marks the twilight of an era when the drug industry was confident that its products were strong enough to cure illness by themselves.
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Before I routinely prescribed antidepressants, I would do more psychotherapy for mildly depressed patients, says the veteran of hundreds of drug trials.
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Today we would say I was trying to engage components of the placebo response—and those patients got better.
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To really do the best for your patients, you want the best placebo response plus the best drug response.
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The pharma crisis has also finally brought together the two parallel streams of placebo research—academic and industrial.
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Pfizer has asked Fabrizio Benedetti to help the company figure out why two of its pain drugs keep failing.
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Ted Kaptchuk is developing ways to distinguish drug response more clearly from placebo response for another pharma house that he declines to name.
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Both are exploring innovative trial models that treat the placebo effect as more than just statistical noise competing with the active drug.
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Benedetti has helped design a protocol for minimizing volunteers' expectations that he calls "open/hidden."
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In standard trials, the act of taking a pill or receiving an injection activates the placebo response.
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In open/hidden trials, drugs and placebos are given to some test subjects in the usual way and to others at random intervals through an IV line controlled by a concealed computer.
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Drugs that work only when the patient knows they're being administered are placebos themselves.
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Ironically, Big Pharma's attempt to dominate the central nervous system has ended up revealing how powerful the brain really is.
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The placebo response doesn't care if the catalyst for healing is a triumph of pharmacology, a compassionate therapist, or a syringe of salt water.
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All it requires is a reasonable expectation of getting better.
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That's potent medicine and big pharma is not doing very well compared to the placebo effect
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NYT

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