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Is The Placebo Effect Getting Stronger?

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 Posted 11/10/2010 4:26:47 AM
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A long but very interesting read on that pesky placebo effect and what it reveals about the powers of the human mind, how little is really known about it, how it's driving big pharma crazy, and what it may tell us about our own ability to heal...

Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.

Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn't introduced a truly new product in three years, and its stock price was plummeting.

In interviews with the press, Edward Scolnick, Merck's research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company's reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. "To remain dominant in the future," he told Forbes, "we need to dominate the central nervous system."

His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive's dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.

Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people's health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.

Ultimately, Merck's foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.

MK-869 wasn't the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson's disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn's disease, an intestinal ailment, citing an "unusually high" response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It's not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.

The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests.

Cont:

http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect?currentPage=1


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 Posted 11/10/2010 7:35:26 AM
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I used to tell clients that there's no placebo effect in animals.  That was in response to improvements they might have had from my acupuncture treatments.   But then I saw some patients that didn't seem improved after acupuncture.  But the owner swore the dog acted better.   Placebo by proxy?  Dogs intuit their owner's mood.   If the owner feels better, the dog might feel better.  

kevin
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 Posted 11/10/2010 7:53:25 AM
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kaypeeoh (11/10/2010)
I used to tell clients that there's no placebo effect in animals.  That was in response to improvements they might have had from my acupuncture treatments.   But then I saw some patients that didn't seem improved after acupuncture.  But the owner swore the dog acted better.   Placebo by proxy?  Dogs intuit their owner's mood.   If the owner feels better, the dog might feel better.  

kevin


Placebo by proxy, I like that!


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"Principle is a terrible thing, because it demands not what is convenient but what is right. " - Jonathan Turley
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 Posted 11/27/2010 5:59:06 AM
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An interesting read, thank you. It is amazing how little we know and how complex is the healing process. A related good read I had few years ago is the small book: "The Whole Story: Alternative Medicine On Trial?" by Toby Murcott who also treat this problematic.

I liked the conclusion of the book drawn by Professor Sir Iain Chalmers (1998) “..the most important concept required to promote the concept of integrated health care is likely to be humility among those whose practices will be put to the test, within both orthodox and complementary medicine..”

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 Posted 12/6/2010 4:04:48 AM
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  • albedo (11/27/2010)

An interesting read, thank you. It is amazing how little we know and how complex is the healing process. A related good read I had few years ago is the small book: "The Whole Story: Alternative Medicine On Trial?" by Toby Murcott who also treat this problematic.

I liked the conclusion of the book drawn by Professor Sir Iain Chalmers (1998) “..the most important concept required to promote the concept of integrated health care is likely to be humility among those whose practices will be put to the test, within both orthodox and complementary medicine.. [/quote]


As Dr. Sarno says (author of The Minbody Prescription and other books), Mind-Body should be written and viewed as Mindbody, as the two cannot be seen as separate entities or treated as separate systems as they are by most of mainstream medicine.

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 Posted 12/6/2010 4:06:51 AM
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As Dr. Sarno says (author of The Minbody Prescription and other books), Mind-Body should be written and viewed as Mindbody, as the two cannot be seen as separate entities or treated as separate systems as they are by most of mainstream medicine.

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Author, industry consultant, and owner of Brinkzone.com

LEF Member, since 1993!

"Principle is a terrible thing, because it demands not what is convenient but what is right. " - Jonathan Turley
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 Posted 12/9/2010 8:50:25 AM
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The placebo effect seems to be scientific proof of the power of belief.  I wonder if the placebo effect also works against us as well as for us. If you believe something you use, ingest, or experience is bad for you, even if it is not, will you see negative results due to the placebo effect ? If so, are the negative results as significant as the positive results obtained when you believe something is good for you ?  

I wonder if the placebo effect is just a short term phenomena. Most of these trials are relatively short term, but if they were longer, perhaps the placebo effect would fade.  As unlikely as it seems, could sugar pills produce positive effects short term ?  Sugar is after all fuel for the body. Are we using the same type of placebo pills or has something changed with them ?  It seems to me they should be using distilled water pills or a pill that is as inert as possible. Ideally, for a placebo, you want something that produces the least amount of reactions in the body possible, and sugar definitely produces reactions in the brain and body. Are they really using "sugar pills" or is that just what placebo pills have come to be called most of the time ? The placebo pill must be as inert as possible. 

Since the placebo effect seems effective, we should try to learn more about it and try to find ways to amplify it for good outcomes and reduce it for negative outcomes (if it works in both directions). As a kid, when I was sick and went to the doctor I remember I would many times start to feel a little better in the waiting room. I think this was because I expected the doctor to make me better once I got in to seem him although I dreaded getting shots so perhaps my body was getting better so I would not have to get a shot Smile
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 Posted 12/27/2010 2:45:46 PM
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I've often wondered what would happen to the placebo effect if the trial group were all Christian Scientists!
Since this group already uses (presumably) positive mentalizing for curative effect, then there may be
no room for the sugar pills to have a statistical effect.
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 Posted 12/29/2010 12:49:22 PM
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kench (12/27/2010)
I've often wondered what would happen to the placebo effect if the trial group were all Christian Scientists!
Since this group already uses (presumably) positive mentalizing for curative effect, then there may be
no room for the sugar pills to have a statistical effect.


Would be an interesting study no doubt!


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Author, industry consultant, and owner of Brinkzone.com

LEF Member, since 1993!

"Principle is a terrible thing, because it demands not what is convenient but what is right. " - Jonathan Turley
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