A PWP friend of several years has been visiting for a few days. She was here to help me with my first post-op visit which had to be completed off meds. As she drove away last night she had tears in her eyes and thanked me for what I have done for her and all PWPs by participating in the CERE-120 trial, in the attempt to find a cure for this disgusting disease we all must endure daily for the rest of our lives.

Science has never come easy. It is filled with risks, whether it is testing a new vaccine for the first time or traversing the galaxies as astronauts in search of whatever they search for out there in the dark void of space. It isn’t easy and never will be. As I sit here this morning typing away on this reply, and having just returned from Philly yesterday evening, I find it hard to believe that I may have been shammed. My scores were significant yesterday. My tremor is still present, but is it far less than it has been in many years. If this is a placebo effect, I will keep it!! But if it is from the “real thing” then yippee…are we another step closer to a “cure” for this crappy disease…maybe so. Did I take a sham risk for the sake of everyone in this thread and in the PD community as a whole. Yes.

As Howard stated above, “we are the pioneers” of our PD generations. The author of this thread took a very pioneering leap of faith a few years ago by being one of the original six Spheramine recipients in a Phase I trial…talk about unknown…yes, I know it did not include a sham component, but Phase II has included sham. Some of us are willing to take the risks that come with pioneering, some are not. In either case, it is a personal decision. Sham surgery is deemed by many physicians as necessary to “view” the placebo effect, which can be. It is entirely possible that after a time sham may be abandoned as unnecessary.

Did I take the sham component of CERE-120 lightly…NO!! But, the day came when I had to make a decision to take the risk involved or not. I had to ask myself, do I continue with this decision and why. The why was a selfish choice. I knew that my only option at this point was DBS…hardware, battery change surgeries, programming, risk of infection and hardware removal, the possibility of having to endure the surgery a second time to replace what was removed, etc. Now some might say, but DBS is a known and that taking that risk is a no-brainer…no sham involved. Okay, so that makes it okay? It is still an invasion to the brain, with the risk of infection greater than CERE-120. The risk of infection with DBS isn’t just the brain, but the other parts of the body. My personal reaction could have also happened with DBS…seizure from brain swelling. Would I do the CERE-120…absolutely!

Do those of you here in this thread think that sham has never been used in other surgical settings.

The Connection.org, Show Originally Aired: 7/16/2002
http://www.theconnection.org/shows/2...716_b_main.asp

“Sham ops on arthritic knees are as successful as the real thing, which is to say, neither works at all. Faked surgery has some ethicists worried. It's one thing to hand out candy, quite another to slice into flesh on a hunch that it's worthless, exposing patients to the dangers of anesthetics and infections. But finding out what really works and what's wishful thinking could save money, time, and misery for the many creaky-jointed amongst us.”

Will we ever get passed either of the two views below…both valid. Hopefully Not! This topic…sham surgery…needs to stay of the table of discussion.

University of South Florida, Sham surgery may put patients at risk
http://student.bmj.com/back_issues/0300/news/52a.html

“Researchers carrying out sham surgery have pointed out that all clinical trials have been approved by review boards at bodies such as the US National Institutes of Health and the Food and Drug Administration. They also argue that subjects in the trials have decided to participate and that preventing patients from deciding what risks they are willing to take is a direct violation of the principle of autonomy.

“But many researchers are unhappy with the use of sham surgery in finding a treatment for Parkinson's disease. Dr Ruth Maklin of the Albert Einstein College of Medicine in New York has voiced her opposition to the surgery in the New England Journal of Medicine. "Performing a surgical procedure that has no expected benefit other than the placebo effect violates the ethical and regulatory principal that the risk of harm to subjects must be minimised in the conduct of research," said Dr Maklin.”

Sham Surgery Returns as a Research Tool
By SHERYL GAY STOLBERG, April 1999
http://www.nytimes.com/library/revie...cs-review.html

“In 1939, long before high-tech drugs came along to treat the chest pain known as angina, an Italian surgeon named Fieschi devised a simple technique. Reasoning that increased blood flow to the heart would ease his patients' pain, he made tiny incisions in their chests and tied knots in two arteries. The results were spectacular. Three quarters of all patients improved." One third were cured.

“Two decades later, the National Institutes of Health paid a young cardiologist in Seattle, Dr. Leonard A. Cobb, to conduct a novel test of the Fieschi technique. Cobb operated on 17 patients. Eight had their arteries tied; the other nine got incisions, nothing more. In 1959, the New England Journal of Medicine published his findings: The phony operations worked just as well as the real thing.

“That was beginning of the end of the procedure, known as internal mammary artery ligation; within two years, it became a footnote in the medical history texts. It was also the beginning and the end, apparently, for sham surgery in this country. By the early 1970s, an ethics revolution had transformed human experiments, and the idea of surgery as placebo was unthinkable.

“Unthinkable until now. Sham surgery is on the rise, to the horror of some doctors who say it is immoral and to the delight of others who say it is time to apply the same rigorous scientific standards to surgery as to the rest of the medical profession. And with it comes a host of thorny questions.

“The results of the first sham brain surgery study were reported last week in Toronto by a team of neurologists. Forty people with Parkinson's disease participated. Each had neurosurgery: four tiny holes, drilled through the forehead into the skull. But only half got the injections of fetal cells that might have repaired their damaged brains; the other half got nothing. One year later, three members of the placebo group said their symptoms had improved.”

Sham surgery can be ethical and safe
http://jnnp.bmj.com/cgi/content/full/74/2/202
"Sham surgery is justified in clinical trials in Parkinson’s disease provided strict criteria are followed to ensure that it is used safely and effectively, according to an article which defends the practice in judging outcome of fetal tissue implantation treatment.

"Sham surgery is controversial and used rarely. Its recent use in two trials assessing treatment for Parkinson’s disease has, naturally enough, provoked much ethical debate. According to bioethicist Ruth Macklin, the concept of sham surgery controls produces, "tension between the highest standards of research and the highest standards of ethics." Other critics see the bigger picture, recognising that clinical trials need to benefit patients, society, and research, though still opposing sham surgery as unnecessary.

"The article’s author, a neurologist, emphasises the paramount need to exclude false positive results in these trials in the interests of patient and public safety. In Parkinson’s disease this need can be fulfilled only by sham surgery controls, he argues, because of the significant and sustained placebo effect reported in medical clinical trials and its confounding of subjective outcomes so often relied on for assessing treatment. A recently published trial using sham surgery controls in the United States showed that despite promising initial results the long term results differed little between treatment and control arms because of the significant surgical placebo effect. "The recent experience with intracerebral fetal tissue grafting for Parkinson’s disease suggests that sham surgery controls can be done in a safe and ethical manner."

Full Article: http://jme.bmj.com/cgi/content/full/...665fdbf66171c3