REAL WORLD EVENT DISCUSSIONS

The US - land of the suggestible?

POSTED BY: 1KIKI
UPDATED: Monday, October 26, 2015 17:45
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Sunday, October 25, 2015 2:39 PM

1KIKI

Goodbye, kind world (George Monbiot) - In common with all those generations which have contemplated catastrophe, we appear to be incapable of understanding what confronts us.





American Placebo
Wed, 10/07/2015 - 7:00am
McGill University


A new study finds that rising placebo responses may play a part in the increasingly high failure rate for clinical trials of drugs designed to control chronic pain caused by nerve damage. Surprisingly, however, the analysis of clinical trials conducted since 1990 found that the increase in placebo responses occurred only in trials conducted wholly in the U.S.; trials conducted in Europe or Asia showed no changes in placebo responses over that period.

In a paper accepted for publication in the journal Pain, researchers at McGill University in Montreal analyzed the results of 84 clinical trials of drugs conducted around the world from 1990 to 2013. Over that period, the pain inhibition experienced by patients in the placebo group increased steadily, reaching an average 30 percent decrease in pain levels by 2013. Similar increases in placebo response have previously been observed in studies of clinical trials of antidepressants and antipsychotic drugs. Those studies, however, didn't pinpoint the U.S. as the source of the trend.

The authors examined reported features of the clinical trials to determine what factors might be responsible for the changes over time. They found that in the U.S., but not elsewhere, trials are becoming longer (from an average of four-weeks long in 1990 to 12 weeks in 2013) and larger (from an average of fewer than 50 patients in 1990 to an average of more than 700 patients in 2013).

"The data suggest that longer and larger trials are associated with bigger placebo responses," said Jeffrey Mogil, the E.P. Taylor Professor of Pain Studies at McGill and senior author of the new paper. "This, in turn, tends to result in the failure of those trials - since it makes it harder for pharmaceutical companies to prove that the drug being tested is more effective than treatment with a placebo."

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"It remains to be determined why the United States is an outlier with respect to its clinical trials," added Alexander Tuttle, a doctoral student in psychology at McGill, and co-first author of the paper. He and his co-authors note, however, some potentially important differences between the U.S. and other countries. These include the existence of direct-to-consumer drug advertising in the U.S. (New Zealand is the only other country in the world that allows this), the greater spread of for-profit "contract research organizations" in the U.S., and perhaps greater exposure to the placebo concept in popular media in the U.S.

"The greater the improvement in patients treated with placebo in clinical trials, the more difficult it can be to demonstrate the beneficial effects of pain-relieving medications," said Robert H. Dworkin, Professor of Anesthesiology, Neurology, and Psychiatry at the University of Rochester School of Medicine and Dentistry. Prof. Dworkin, who was not involved in the McGill study, said "This important study increases our understanding of these placebo-group responses, and thereby provides a basis for improving the design of clinical trials and accelerating the development of analgesic medications that can bring greater relief to patients suffering from chronic pain."

http://www.dddmag.com/news/2015/10/american-placebo?et_cid=4863382&
;et_rid=366206770&type=headline



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Monday, October 26, 2015 1:50 AM

SIGNYM

I believe in solving problems, not sharing them.


Quote:

"It remains to be determined why the United States is an outlier with respect to its clinical trials,"
Because of American exceptionalism??

*runs away, giggling*

--------------
You can't build a nation with bombs. You can't create a society with guns.

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Monday, October 26, 2015 10:11 AM

SECOND

The Joss Whedon script for Serenity, where Wash lives, is Serenity-190pages.pdf at https://www.mediafire.com/two


“How's your pain today?” asks the researcher.

“It's much better!” the typical American answers.

Americans are a “positive” people. This is our reputation as well as our self-image. We smile a lot and are often baffled when people from other cultures do not return the favor. In the well-worn stereotype, we are upbeat, cheerful, optimistic, and shallow, while foreigners are likely to be subtle, world-weary, and possibly decadent. American expatriate writers like Henry James and James Baldwin wrestled with and occasionally reinforced this stereotype, which I once encountered in the 1980s in the form of a remark by Soviet émigré poet Joseph Brodsky to the effect that the problem with Americans is that they have “never known suffering.” (Apparently he didn’t know who had invented the blues.) Whether we Americans see it as an embarrassment or a point of pride, being positive—in affect, in mood, in outlook—seems to be engrained in our national character. – from BRIGHT-SIDED How the Relentless Promotion of Positive Thinking Has Undermined America by Barbara Ehrenreich

The Joss Whedon script for Serenity, where Wash lives, is Serenity-190pages.pdf at www.mediafire.com/folder/1uwh75oa407q8/Firefly

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Monday, October 26, 2015 5:29 PM

1KIKI

Goodbye, kind world (George Monbiot) - In common with all those generations which have contemplated catastrophe, we appear to be incapable of understanding what confronts us.


"The data suggest that longer and larger trials are associated with bigger placebo responses ... It remains to be determined why the United States is an outlier with respect to its clinical trial."



But to provide more support for that idea, the researchers could do some things with the data already available:

1) look specifically at trial length as a statistical driver of placebo effect
2) look to see if failures of that statistical effect are found only outside the US
3) examine foreign studies specifically for that effect

Given that the data is there - and the only barrier to doing that analysis is devising new parameters and running the computer a few more times - I'm surprised it wasn't either studied, or reported in the news article.

For very significant studies - for example, a recent research breakthrough that could lead to a universal vaccine for HIV - I tend to follow up by purchasing the article.

For insignificant studies like this one, I don't follow up. But I find overall that when the researchers themselves are very tentative about their conclusions, as these researchers are (and the trend is to overstate the importance of any study to keep dollars flowing in), the door is wide open.

Anything is possible.




SAGAN: We are releasing vast quantities of carbon dioxide, increasing the greenhouse effect. It may not take much to destabilize the Earth's climate, to convert this heaven, our only home in the cosmos, into a kind of hell.

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Monday, October 26, 2015 5:45 PM

1KIKI

Goodbye, kind world (George Monbiot) - In common with all those generations which have contemplated catastrophe, we appear to be incapable of understanding what confronts us.


http://www.nature.com/news/strong-placebo-response-thwarts-painkiller-
trials-1.18511


One possible explanation is that direct-to-consumer advertising for drugs — allowed only in the United States and New Zealand — has increased people’s expectations of the benefits of drugs, creating stronger placebo effects.

But Mogil’s results hint at another factor. "Our data suggest that the longer a trial is and the bigger a trial is, the bigger the placebo is going to be," he says. Longer, bigger US trials probably cost more, and the glamour and gloss of their presentation might indirectly enhance patients’ expectations, Mogil speculates.

Some larger US trials also use contract research organizations that can employ nurses who are dedicated to the trial patients, he adds — giving patients a very different experience compared to those who take part in a small trial run by an academic lab, for instance, where research nurses may have many other responsibilities.

Mogil suggests it is also worth investigating the elements that generate the more powerful placebo response in US trials (more advertising? more hoopla? more personal attention?), and then incorporating those elements (such as the relationship between patient and nurse) into patient care.



In other words, more advertising.

Other studies I've read about indicate that placebo effects tend to fade over longer-term studies.

And then there's my personal experience auditing private, contract for-profit laboratories - they tend to not report disappointing results knowing that the person writing the check can always take their business elsewhere and gets the results they want.

Aside from subtle and not-so-subtle bias in the contract lab, the possibilities amount to 1) more advertising, 2) more hoopla as advertising, and 3) more personal contact as advertising.

Which is what I expected. "The US - land of the suggestible?" Or, in less charitable terms - "land of the propagandized?"




SAGAN: We are releasing vast quantities of carbon dioxide, increasing the greenhouse effect. It may not take much to destabilize the Earth's climate, to convert this heaven, our only home in the cosmos, into a kind of hell.

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