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 effect…The 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:

a fake therapy
a patient’s level to believe/expect the therapy will help them
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?

Multiple studies have shown that only 30% of the population responds with a placebo effect.
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

There is no placebo effect and 70-75% really do benefit from stem cell treatments
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:

Congestive heart failure patients doubling their ejection fractions?
MS patients recovering from their symptoms for 2, 3, 5 years?
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?

Lawrence Brown III was born blind and can now read

(but it’s all placebo effect)

Lawrence Brown III looks at the number “10” on a family laptop and tells his mother Georgina Brown what the number is as part of a daily exercise to see if his sight is improving. For most people, it is insignificant. But for Lawrence, 16, who has been blind since birth, it was an exceptional moment. “They call it a really good placebo effect,” Lawrence said. “Whatever, if it’s a placebo effect, I want some more.” The original article was pulled (perhaps successful stem cell treatments make some nervous), but there is a copy here - http://repairstemcell.wordpress.com/2009/08/09/stem-cell-therapy-shows-results-el-paso-times/

AUDREY Hynd-Gaw has travelled abroad for stem cell therapies to treat her multiple sclerosis…She…believes they have helped slow down the progress of her disease and given her more energy. She says she would like to go again. “I think it has worked for me,” the 39-year-old said. “It could be a placebo effect but if it works, that is fine with me.” - http://repairstemcell.wordpress.com/2009/02/21/stem-cell-tourists/

data?pid=avimage&iid=iovmE5qfgB7k

John Daly returns to the PGA tour with a healed rib

(but it’s all placebo effect)

Golfer Daly to Return Ahead of Schedule After Stem-Cell Surgery – By Dan Baynes

Oct. 14 (Bloomberg) — John Daly will return to the U.S. PGA Tour in two weeks after stem-cell surgery helped the two- time major champion recover from a rib injury ahead of schedule. Daly withdrew from the Australian events in September citing a flare-up of the rib injury he sustained when he stopped his downswing as a woman took his photograph at the 2007 Honda Classic. “My recovery from stem-cell surgery has been closely monitored,” Daly said in a statement released by the PGA of Australia. “I’m relieved things have begun moving in the right direction.”

via Golfer Daly to Return Ahead of Schedule After Stem-Cell Surgery – Bloomberg.com.

A now for the PLACEBO EFFECT GONE WILD poster child, Macie Morse…

Macie was legally blind and is now driving

(but it’s all placebo effect)

Macie Morse, a 16 year old from Colorado, has made dramatic improvement in her eyesight after receiving Stem Cells taken from cord blood to treat her Optic Nerve Hypoplasia. In yet another victory for stem cell research, Macie now has her driving learner's permit after being almost totally blind before the stem cell therapy.

Macie’s placebo effect was so powerful that it flew 7,000 miles to Colorado and convinced the police and DMV that she was no longer blind.

WARNING TO THE FBI, THE CIA and THE NSA!!

Do not be lulled into complacency by the innocent appearance and sweet disposition of this 17-year-old girl! The placebo effect is a factor of the power of the patients mind to influence one’s own self. Macie’s mind is so powerful that it convinced herself, her best friend, her mother, her doctors (on 2 continents), her classmates and teachers and the Colorado department of motor vehicles and countless others that she is no longer blind. Do not let your guard down around her! There is no telling what else she can do with a brain that powerful! She might even be able to convince YOU that YOUR stem cell treatments are working!

MACIE’s STORY:

Macie is 17 and was born with Optic Nerve Hypoplasia. Her eyes registered 20/4000 vision in one eye and in the other eye she only had light perception. She could watch TV only by pressing her nose against the glass. This is her story, in her own words. We join her in the middle of her Repair stem cell treatment…

Wednesday, July 30, 2008 - One more spinal next Wednesday. I have a spinal tomorrow as well at 2 so that should be good so after my six hours is up I can go to bed because your not really suppose to move to much even after the six hours.

Thursday, July 31, 2008 - Today will be my second to last spinal. Mom and I decided to add on one more spinal before we left. For some reason I'm not nervous this time. I will be glad to get it over with though. I'm more than sure everything will go great.

Friday, August 1, 2008 - I'm all done with the spinal I slept for 4 hours.

Thursday, August 7, 2008 - Yesterday was my last spinal, everything went great, the IV went great too, it only took one poke and I didn't even really feel it. I am all done with all my treatments and I will be coming home on Monday :) :) Being on this long trip here in china has definitely changed me and given me the hope that a few months ago I didn't even think was possible. Going through the treatments was tough at times and a few times I thought is this a good idea should I wait but once you get over that hill it all seems to just get better and better. Now my dream of becoming a vet and driving is stronger than ever and I now I know that even if I have to do another round of treatments that someday I am going to drive and I will be a vet. Before I never thought that that would be possible.

Saturday, August 9, 2008 - Last day here in China - Today is the last day here, all of my treatments have gone good, I'm feeling great and I am more than ready to go home! I'm definitely going to miss everyone here and everyone I've met I've made some great friends here. I've had a great time since I've been here and I've enjoyed learning new things and just being here is amazing, I never thought in a million years I would be getting stem cell treatment. I know I am one of the very fortunate ones to have improvements so quickly after the injections. Bye

Sunday, August 10, 2008 - Mom's post!! - One month ago I brought my little girl half way around the world in the hopes of improving her vision and I feel that we have succeeded. After two treatments we saw signs of improvements with her nystagmus (rapid and involuntary eye movements-dg) and after three injections Macie had noticed that she had more distance when reading or writing.

We didn't have any expectations for improvements while we were here in China because we were told that it usually takes some time, possibly up to three months to see any changes, so we were very delighted with our early surprise. A little gift from Heaven if you ask me!!! It's been so great to watch Macie with this big old smile on her face when she's reading or writing and not having to be so close to do it. She keeps telling me how she never thought it would be possible and now here she is. We are so thankful for this to be happening.

Dr. Tony did a great job with Macie and was very good about keeping Macie's spirits up when she needed a little boost. The other doctors that worked with us were Dr. Ma, Dr. William, Dr. Lisa and the king of the doctors according to Macie, Dr. Bing. He is fabulous. This guy was like a pot of gold to us, he has pretty good English, a great sense of humor and very personable. Dr. Bing was great to communicate with. He was also very good to answer all and any questions you had.

We had countless nurses that we had so much fun with. Yolanda was great. Thanks Yolanda!! Fiona and Jessica are the little sweethearts and then we had several more who we loved!!

The staff here is so amazing. We have had so much fun with our translators from the treatment center. Every translator is unique and special in their own way and can make your stay here so great. They are all our favorites!!! However, Mr. Happy Jack is something you just have to experience. He is the most energetic character I have ever met in my life. Jack you are a rock star!!

All in all our trip to China to me was very successful and I'm glad we did it and took a chance. Anything to help Macie gain some vision is worth it. I have no regrets of doing stem cell injections and look forward to the future of regenerative medicine. Thanks to everyone who helped make this possible, we couldn't have done it without all of your help.

Love you all,
Macie and Shel

Saturday, August 30, 2008 – We’re home and back to normal! - We got home last Wednesday evening. It was a very amazing and interesting trip, that’s for sure. :) All the treatments went great I've made some amazing and extremely nice friends along the way plus I got to learn some interesting facts and see some pretty amazing things. I had my first week of High School and I love it, and all of my teachers! I have greatly improved vision wise as well. Mom and I were driving home from school and normally I couldn't see the signs until about 10 feet away and very rarely did I read them…now, I can see the signs from over 100 feet away and can read the signs from about 10 feet away most of the time. Mom has me practicing on reading the signs. It's amazing! See ya! :) (A common expression like “See ya” takes on a whole new meaning! –dg)

Saturday, December 27, 2008 - Improvements - It’s been about 5 months since we got back. Since we have been back I have noticed some life changing differences for me. I have noticed that now I can see the outline of the tree tops on the mountains, a bunny in the pasture while I was riding, seeing snow fall, being able to watch T.V. while sitting on the couch, read a book form a good distance, school work is easier to do, I'm able to see the board from the second row. All of these improvements make me think of how much going to china was worth it. I know that if mom and I had to go again we would. It was totally worth it. I have an eye check up on Monday to see how everything is going. We’re hoping that I will have enough vision to drive with a special pair of glasses, trying not to get our hopes up to high but were definitely keeping our fingers crossed. I'll update soon.

Sunday, March 15, 2009 - A Whole New World - Hey Everyone, It's been pretty busy lately with school and riding horses. I still have been having improvements. One of the improvements I've had is…

Now I am actually DRIVING!! :)

I got my permit 3 days after my birthday!

TALK ABOUT A DREAM COME TRUE!

· Right eye vision improved from 20/200 to 20/80.

· Left eye vision improved from 20/4000 with very little light perception to 20/2100.

When we went to the Dr to see if I could drive I read the very top row of the reading chart about 3 feet away from my face. Mom started crying and I'll admit I got pretty teary eyed to. Driving has been going well we've just been driving around the neighborhood and stuff but I’m able to see the signs and lines stuff like that. It's a little nerve racking for mom and dad when they let me drive:)

Epilogue:

CBS-4's Shaun Boyd interviews Macie and her mother about their experiences with stem cell therapy -

“Though both said they were nervous about the new treatment, they knew it was their only chance to see Macie's life improve. She had few friends, bad grades and didn't know where else to turn,” Boyd wrote. "I was scared and nervous, but I tried to be strong and to be like 'this is my opportunity. I'm ready to do it,' " Macie said. She received spinal injections of cord blood stem cells each week for six weeks. After her third treatment, she realized she could read and knew the treatments were working.

“I saw snow fall for the first time," she told CBS4's Shaun Boyd.

“I yelled, Mom, stop talking, you have to see this," Macie said. She made her mother write out words on a piece of paper and hold it far away so she could read it back to her. Over the next few weeks and months, her vision gradually improved.

"What has been the most beautiful thing?" Boyd asked Macie. "I'd say many things -- but (probably) my mom's eyes." "What was it like when she said 'You have green eyes?'" Boyd asked her mother Rochelle. "My knees went weak. I felt like I had just fallen off a nine story building," Rochelle said, "That was a huge step for her in making that human connection. They say you can see the soul through the eyes."

Via http://www.9news.com/news/article.aspx?storyid=109967&catid=339 and http://cbs4denver.com/local/macie.morse.cell.2.954956.html

Macie before stem cells:

20/4000 vision in one eye and in the other eye she only had light perception- she could only make out light
Could only watch TV with her nose pressed against the glass

Macie after stem cells:

20/80 vision in one eye and the other is 20/400+
Driving her family's van and enjoying her new driving permit

http://www.9news.com/video/default.aspx?maven_playerId=newsarticleplayer&maven_referralPlaylistId=playlist&maven_referralObject=1035413742

Now after the Adult Stem Cell research has helped her, Macie is realizing her dreams.

But Macie is not alone. Macie is one of many patients who have made similar improvements from stem cell treatment in our “Optic Nerve Hypoplasia Club." Others such as Cody Fend, Cameron Petersen, Lydia Black, Lydia Olmsted and Rylea Barlett, Savannah Watring, Xavier Carballo, and Connor Corkern all have made great strides since receiving cord blood stem cells for their Optic Nerve Hypoplasia and Septo-Optic Dysplasia.

WHAT HAVE WE LEARNED?

Now you know that:

Some studies show there is “no evidence of any placebo effect in any of the studies cited." The reported improvements in heath were real but were due to other things that produced "false impressions of placebo effects."
Even the New England Journal of Medicine says: “compared with no treatment, placebo had no significant effect on binary outcomes, regardless of whether these outcomes were subjective or objective.”

The FDA thinks placebo effects are not significant enough to warrant requiring “that a drug study include a placebo control group.”

Even the NIH does not completely understand placebo effect as they are still “currently funding several studies related to the placebo effect.”
While only 30% of the population responds to treatments with a placebo effect, more than 70% have beneficial therapeutic responses when treated with repair stem cells.
While there certainly may be some placebo effects occurring in some patients, the majority of patients are showing REAL improvements.
There are hundreds or even thousands of patients who have had QUANTIFIABLE successes with stem cell treatments.
Some improvements are so significant and startling that there is no way that can be as a result of a placebo effect.

Based upon this information, can you now answer the questions:

ARE STEM CELL TREATMENT BENEFITS MERELY A PLACEBO EFFECT?

Of course you can!

ARE STEM CELL TREATMENT BENEFITS MERELY A PLACEBO EFFECT?

Of course they’re not!

What else do we know?

The majority of medical conditions CAN be improved with Repair Stem Cells!
Repair Stem Cells can return to you a realistic hope of recovery!
Your Quality of Life CAN improve to the point that you can once again participate in the activities you previously enjoyed!
The safety and efficacy of Repair Stem Cells ARE proven in over 1000 clinical trials in the US and around the world!
The Repair Stem Cell Institute can guide you to the one center that is best suited to treat YOUR condition!

Green light!

Green light means go! You may now take the next step in your plans for treatment! If you have any questions at all about stem cell treatments, clinical trials or the information you’ve seen here, please do not hesitate to contact the Repair Stem Cell Institute: http://repairstemcells.org or don@repairstemcells.org

Stem Cell Treatment NOW!

WHEN ALL ELSE HAS FAILED, STEM CELL THERAPY CAN IMPROVE YOUR QUALITY OF LIFE!

RSCI can help you take the next step towards a better quality of life.

[FIND ME THE RIGHT TREATMENT CENTER NOW!]

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