As many of you are aware, I was one of the original six in the first phase of the Spheramine trial (later called the STEPS trial). Phase I was open-label (meaning we knew we were getting the treatment); in the larger Phase II (72 participants), half received the treatment (the injection of donor retinal pigmented epithelial cells) and the other half underwent “sham” surgery (the implanting of the cells was faked without participants’ knowledge until it was revealed 12 months later).

Phase I participants were followed after receiving the cells for almost 9 years. The effects were astounding – official peer-reviewed results indicated that phase I participants maintained approximately 47% improvement over their own baseline results.

It’s very difficult for me to reply to this because at the moment my PD symptoms are “full-blown,” due to recent foot surgery. Debi, you may recall Paula and I visiting Fox Foundation 2 maybe 3 years ago. At that time I was nursing this broken foot wearing a moon boot. I must have a high pain threshold, because we walked all over New York City ! I procrastinated on a metatarsal fixation until 2 weeks ago knowing how the pain and anesthesia really messes me up, having had the same procedure in my other foot years earlier.

I say all this to say that I do not see how my improvement after Spheramine could have been placebo effect. And that claim may well not be made. I’m no statistician, but how can you truly compare the two phases of the trial since the protocol was so different. Phase I was transplanting dopamine-producing cells unilaterally (one side of brain); Phase II was done bilaterally (both sides)? And how do you “think” improvement of such symptoms as balance?

And while on this topic, how ethical is it to deceive trial participants, especially with sham brain surgery? If the word “deceive” seems strong, read this excerpt from the article Debi gave:

After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom.
The roots of the placebo problem can be traced to a lie told by an Army nurse during World War II as Allied forces stormed the beaches of southern Italy. The nurse was assisting an anesthetist named Henry Beecher, who was tending to US troops under heavy German bombardment. When the morphine supply ran low, the nurse assured a wounded soldier that he was getting a shot of potent painkiller, though her syringe contained only salt water. Amazingly, the bogus injection relieved the soldier's agony and prevented the onset of shock.
Source: http://www.wired.com/print/medtech/d...placebo_effect

Perry and the Parkinson Pipeline Project (I am a member as well as paula) are investigating whether sham surgery in Parkinson’s research is necessary, or is it even ethical? Watch for more on this.
Peggy