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October 2009

Special Edition

 

 

In This Issue

·         Stem Cell Treatment Benefits Merely a Placebo Effect

 

·         When Placebo Effects Go Wild

 

·         What Have We Learned?

 

 

 

Don Margolis
Founder and Chairman
don@repairstemcells.org

 

www.RepairStemCells.org
Bangkok, Thailand

 

In the last newsletter we answered the question:

DO STEM CELL TREATMENTS WORK?”

 

In this newsletter we will answer the second most important question the prospective stem cell treatment recipient faces:

 

ARE STEM CELL TREATMENT BENEFITS MERELY A PLACEBO EFFECT?

 

Ok, what is the placebo effect?  H. K. Beecher evaluated 15 clinical trials concerned with different diseases and found that 35% of 1,082 patients were satisfactorily relieved by a placebo alone.  A reanalysis of Beecher’s data by Kienle and Kiene (1997) found "no evidence of any placebo effect in any of the studies cited by him." The reported improvements in heath were real but were due to other things that produced "false impressions of placebo effects."

 

 

 

In May 2001, The New England Journal of Medicine published an article that called into question the validity of the placebo effect. "Is the Placebo Powerless? An Analysis of Clinical Trials Comparing Placebo with No Treatment" by Danish researchers Asbjørn Hróbjartsson and Peter C. Götzsche "found little evidence in general that placebos had powerful clinical effects." Their meta-analysis of 114 studies found that "compared with no treatment, placebo had no significant effect on binary outcomes, regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effectThe high levels of placebo effect which have been repeatedly reported in many articles, in our mind are the result of flawed research methodology," said Dr. Hróbjartsson, professor of medical philosophy and research methodology at the University of Copenhagen.*

 

 

 

And bear in mind that while it is believed that the Placebo Effect can do some things, there are limits:  “Because placebos often have an effect, even if it does not last long, some people think that the placebo produced a "cure." But placebos do not cure. And in studies where doctors are looking at whether a tumor shrinks, placebos would be expected to have very little, if any, effect on cancer growth.” - http://www.cancer.org/docroot/ETO/content/ETO_5_3x_Placebo_Effect.asp

 

?   ?

 

Confused? I don’t blame you. Sometimes hard science is anything but.  If placebo effect was a huge problem and completely understood then all trials would be placebo controlled, right?  In fact;

  • The FDA doesn't require that a drug study include a placebo control group
  • The NIH obviously does not completely understand placebo effect because they are currently funding several studies related to the placebo effect.

 

Let’s for the sake of argument, define “Placebo Effect” and see if benefits from stem cells meets that definition:  “Placebo Effect: Also called the placebo response. A remarkable phenomenon in which a placebo -- a fake treatment, an inactive substance like sugar, distilled water, or saline solution -- can sometimes improve a patient's condition simply because the person has the expectation that it will be helpful. Expectation to plays a potent role in the placebo effect. The more a person believes they are going to benefit from a treatment, the more likely it is that they will experience a benefit.” - http://www.medterms.com/script/main/art.asp?articlekey=31481

 

So Placebo Effect is dependent upon:

  1. a fake therapy
  2. a patient’s level to believe/expect the therapy will help them
  3. a patient’s ability to believe the therapy will help them

 

 

Of course, the gold standard for FDA approved drug testing is a clinical trial utilizing the double-blind study.  The double blind study uses a “placebo” in order to eradicate any possibility of a “placebo effect”.  50% of the patients receive the medicine and 50% receive a placebo.  In some studies, 33% of the patients receive the medicine, 33% receive a placebo and 33% receive nothing.  This type study even more accurately limits the possibilities of a “placebo effect”.  (Too bad for the 66% not getting any therapy but I guess this falls under: “the needs of the many outweigh the needs of the few.”) 

 

 

Nocebo effect

 

Side note:  the opposite of a placebo effect is a NOCEBO” or negative effect.”  This is when the patients report that they are getting worse or that unpleasant side effects have occurred, a word derived from the Latin “nocere” and meaning ‘inflicting damage.’  Turn on the TV and you will see one commercial after another, describing the negative effects of drugs.  What are the chances that current drugs, with their associated laundry list of complications broadcasted over and over on the TV everyday are causing NOCEBO effects?  Well, if NOCEBO are dependent upon the patient’s expectations of negative effects…I would guess that there is an epidemic of NOCEBO’s all over the US.  And the coup de gras?  The last line is always: “Ask your doctor if xyz-drug could help you,” feeding directly into that concern.

 

So…

ARE STEM CELL TREATMENT BENEFITS MERELY A PLACEBO EFFECT?

 

  1. Multiple studies have shown that only 30% of the population responds with a placebo effect. 
  2. More than 70% of those treated with repair stem cell treatments have beneficial therapeutic responses to the treatment. 

 

70% benefit from stem cells

(but it’s all placebo effect)

 

So, either

  1. There is no placebo effect and 70-75% really do benefit from stem cell treatments
  2. Given the 70-75% benefit, if 30% ARE placebo effect, then 40-45% are real

 

Even at the lower number of 40-45%, that isn’t bad considering a drug’s effectiveness requirement is in the single digits for it to pass FDA requirements and be brought to market!!

 

 

 

 

 

 

WHEN PLACEBO EFFECTS GO WILD

Let’s assume the benefits are all placebo effect.  Here are a few questions and cases that confuse me. 

How can we explain the many, many results of clinical trials and peer-reviewed studies of stem cell treatments of:

  1. Congestive heart failure patients doubling their ejection fractions?
  2. MS patients recovering from their symptoms for 2, 3, 5 years?
  3. Type 1 diabetics (insulin dependent) halving or completely going off their insulin for 2-5 years?

 

 

James’ dead left ventricle came back to life and now pumps blood

(but it’s all placebo effect)

 

How can we explain the case of James Eilert? 

40% of his left ventricle was totally dead.  Two months after treatment he did a follow up metabolic stress test using the standard Bruce protocol and scored 10.1 mets with a vo2 of 32. This was a 20% and 12.5% increase!  The doctor that had done his prior test considered his improvement “absolutely stunning!” This put him in the 95th percentile for men his age (out of a 100 men his age, 50 of them could not match the performance of a guy with 40% of his left ventricle dead!).

 

How do you explain the conclusive results of these clinical trials (there are hundreds if not thousands of others): 

·         “Cord blood transplantation should be considered as frontline therapy for young patients with lysosomal and peroxisomal storage diseases.”

  • “Transplantation of umbilical-cord blood from unrelated donors in newborns with infantile Krabbe's disease favorably altered the natural history of the disease.”

 

Dallas Hextell improves and Duke University records it

(but it’s all placebo effect)

 

Dallas, a 2-year-old from Sacramento, California, received an infusion of his own umbilical cord blood as part of a Duke University clinical trial. Within five days, he showed improvements in the limitations imposed by the condition. 

 

video: http://www.msnbc.msn.com/id/21134540/vp/23569985#23569985
via http://www.youhavealawyer.com/blog/2008/03/26/cerebral-palsy-improvement/

 

Can a 2 year old really convince himself that he is better?