DAVID GRANOVSKY

Archive for October 12th, 2009|Daily archive page

THE STEM CELL PLACEBO EFFECT

In VICTORIES & SUCCESS STORIES on October 12, 2009 at 11:08 am

STOP! #2

Do not take one step further in your plans for treatment or read one more word until we answer this question, unequivocally and without a shadow of a doubt:

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 patients level to believe/expect the therapy will help them
  3. a patients 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.”)

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”, meaning inflicting damage.  Turn on the TV and you will see commercials, over and over, 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. ~70-75% of those treated with repair stem cell treatments typically have a beneficial response to the treatment.

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 ain’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?

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 blurted out “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 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.”

How can we explain the case of Dallas Hextell?

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 expect to be cured of his Cerebral Palsy by a repair stem cell treatment? Can a 2 year old even understand these concepts?

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, 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/

How do you explain Macie’s story and Kenidee’s story?

MACIE’s STORY

I would like you to introduce you to Macie.  She is 17 and was born with Optic Nerve Hypoplasia.  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. They’ll be coming to get me in a little less than an hour. I’m more than sure everything will go great I’ll talk to ya’ll later :)  Bye

Friday, August 1, 2008 – I’m all done with the spinal I slept for 4 hours thankfully. It was a bit different this time. I woke up in the room where they made me go to sleep, for a few minutes I thought that I had some how woken up before they gave me the injection, after a few minutes I realized they had kept me until almost all of the anesthesia wore off.

Thursday, August 7, 2008 – Hey everyone!  I am so sorry I haven’t been updating lately. 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 :) :) I’m so excited to come home I’ve been coming up with every little reason I can think of to start packing.  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. Most likely in the next few years I will be getting treatments again it may not be here but wherever it is we’ll be there. 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!! – Well, I can’t believe in about 12 hours we will be headed back to the United States. This has been the most amazing chapter in my life as an individual and as a mother.  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) 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.

While we were here, we had Dr. Tony who 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. They try so hard to talk in English. Yolanda was great because she would boss Macie around when she didn’t want to mind me. 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. 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 – Where home and back to normal! – We got home last Wednesday evening FINALLY! After 7 weeks in china we were home. 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.  That next day mom went to work and I went with her to get all my books and figure out my classes. On Friday I went to school and mom went to work, we were both pretty tired but we did it. I had my first week of High School and I love it, and all of my teachers! It’s nice to get back to my normal life and to be home. 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! :)

Saturday, December 27, 2008 – ImprovementsIt’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 good distance from the book, 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 WorldHey 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!

My vision has improved from 20/200 to 20/80 in my right eye and in my left I went from very little light perception to 20/2100, which is pretty good. 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:

Though both said they were nervous about the new treatment, they knew it was their only chance to see Morse’s life improve. She had few friends, bad grades and didn’t know where else to turn.

“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,’ ” Morse 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 yelled, Mom, stop talking, you have to see this,” Morse 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.

“I saw snow fall for the first time,” she told CBS4′s Shaun Boyd.
“What has been the most beautiful thing?” Boyd asked Morse.
“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 Morse, a 16 year old from Colorado, has made dramatic improvement in her eyesight after receiving Adult 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 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:

Macie joins our ” Optic Nerve Hypoplasia Club” with others who  have made similar improvements from this stem cell research.  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

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