[olsen]

http://www.miller-mccune.com/health/...thought-38717/

Placebo Effect Stronger Than We Thought?
Double-blind trials have long been considered the gold standard to determine drugs’ effectiveness. Do we need to rethink that assumption, given the power of the placebo effect?
By Beryl Lieff Benderly



New understandings of how the brain works are undermining the assumptions that support one of the main elements of that traditional trial design: the placebo control. Finding the truth about experimental drugs — and the new medicines for diseases like Parkinson’s that patients need — now requires, he says, a better understanding of placebos. (MedicalRF.com)


In July 2001, the Amgen Corporation announced the failure, in a second-stage clinical trial, of an experimental drug to treat Parkinson’s disease, a degenerative illness that affects nerve cells in the brain. Such a failure was hardly unusual; only a minority of the drugs that undergo trials make it to the marketplace.
But for Perry Cohen, who had been diagnosed with Parkinson’s several years before, at age 50, the announcement brought both surprise and disappointment. Cohen, an MIT-trained PhD who had spent decades advising health-care organizations on how to evaluate medical care, had hopes for the Amgen drug, called NIL-A. Studies on animals had suggested that the drug could help regrow damaged nerve cells. Cohen had figured that if it worked, and he could get that kind of therapy early in his disease, he might have a chance of slowing or reversing the process that would otherwise rob him of the ability to control his body. He knew that the announcement very likely meant the end of Amgen’s investment in NIL-A.
Cohen suspected, and still believes, that something was wrong with the conclusions being drawn about some of these trials...

[johnt]

How do we explain that a type 1 trial is a success, but the following type 2 trial is a failure (though some participants report benefits)? It could be due to the placebo effect, but it could also be due to variations in the people selected: the heterogeneous nature of PD makes it difficult to select balanced groups. And, anyway, we don't want to know that a potential therapy has on average no impact on PD, what we want to know is that it has a 10% positive impact on "type A" PD and a 10% negative impact on "type B" PD.

Could we not consider "placebo distillation"? Let me explain how this might work.

We could start by measuring our symptoms and do this regularly during the process. This data would be available for all to see.

We would also start with, say, 10 potential therapies (nothing too invasive: think vitamin D, not DBS). Participants would select what potential therapy to start with (thus maximising the placebo effect). After a period of time, perhaps a month, participants would report back their results. Then make a decision on what therapy to use for the next period.

I suspect that over time people would choose to move from low scoring potential therapies to high scoring ones. (I use the phrase "potential therapy" because we have no way of knowing whether it is a true therapy or a placebo.) Knowing the apparent success of a therapy would enhance its placebo effect allowing it to rise higher. Knowing the apparent lack of success of a therapy would lessen its placebo effect, eventually it would drop out of consideration.

What should a person do if they had a good experience of an otherwise low performing potential therapy? If their scores were bettter than the average of other potential therapies, they should stay as they are. Perhaps they are a type B person in a mainly type A cohort.

At suitable periods new potential therapies could be added. In this way the process could run indefinitely.

Now I'm fully aware that the devil is in the detail. But worth a thought?

John

[LindaH]

The author of this article will be discussing "Placebos and Clinical
Trials" on the Leonard Lopate radio show on Monday, Jan 9th at 12 noon. on WNYC
see:
http://www.wnyc.org/shows/lopate/2012/jan/09/

"Beryl Lieff Benderly discusses the potential dangers of relying on double-blind clinical
trials, which she sees as damaging the chances for patients in dire need of getting
treatments. She also talks about why she thinks too many researchers are looking at what placebos aren't doing, as opposed to what they are. Her latest article, "Head
Games," is in the current issue of Miller-McCune.

You can listen to the show live or thru its archive at the above
web site.

[imark3000]

What is a placebo effect other than positive expectation?
Now they have "re-discovered" a fact known since ancient times that positive expectation is "physically" healing. What this article tells me is that in the case of PD, placebo (positive thinking) actually causes the re-vitalization of dopamine producing cells.
Science has only scratched the surface of a mountain of knowledge about the miracle of the brain.
So let us all stay positive! this is the best medicine in hand
Imad

[LindaH]

Originally Posted by imark3000

What is a placebo effect other than positive expectation?
Now they have "re-discovered" a fact known since ancient times that positive expectation is "physically" healing. What this article tells me is that in the case of PD, placebo (positive thinking) actually causes the re-vitalization of dopamine producing cells.
Science has only scratched the surface of a mountain of knowledge about the miracle of the brain.
So let us all stay positive! this is the best medicine in hand
Imad

The author of this article, Beryl Benderly, did an outstanding job explaining the placebo effect and its impact on clinical trials , focusing on PD research. She explained the viewpoints of patients and researchers who believe we need to learn more about the effect and how to harness its potential to improve the success of treatments, and to develop new clinical trial designs. She’s done her homework.

If you missed the show, it is available on the Leonard Lopate Show archives at:

http://www.wnyc.org/shows/lopate/2012/jan/

Linda

[paula_w]

linda it was so rewarding to hear them say what we've been saying for almost a decade. Well worth the time as well as was moondaughters Audio of Dr, Joseph Hickey, who strongly believes that there is lead, mercury, iron and other metal toxins in our bones, which escape when they are fractured and can cause cognitive issues, i must be getting stupider as we speak with the leg fracture.

Is there any gov agency who is preparing for individual -participatory medicine?l It's coming but only for those who manage to get their entire genome mapped - something most can't do.

the mayo clinic is doing a trial right now about individual medical treatment. much more precise [too scary?]than the sloppy callous treatment of Amgen. Greg D i think you once asked what happens from all of our advocacy; the answer is we bring about change. THe dr. in the nPR tape said there was something writtten about it in the Lancet in 2010, it is still notoriously referred to.

Dr. Hickey is concerned about bone metals causiing heart attacks,as well as neurological damage.