Clinical trials - GAIN or LOSS?
 

In August, 2000, I allowed experimental brain surgery to be done on me. Although only six people were enrolled in the Phase I (Safety), I felt I needed to do this. Of course I had only begun to learn about the drug approval process and how risky it was to do what I did. But I do not regret it.

Four years after the first cohort of six had surgery, a 48% improvemennt was holding. The sponsor had also obtained fast-track aproval from the FDA.
I thought we had found the cure. Then on July 8, 2008, after 72+ people had the same surgery and half with a sham (fake) surgery control, the trial stats failed to meet its endpoints, and the trial was halted. I still hung onto hope and still do. I dont think that the trial I was in (called Spheramine and later the STEPS trial) was the cure, but we learn from failures, too.

I want to share what I wrote in my online journal about how I decided to join in such a trial. Read it, then consider during Parkinson Awareness Month (April) if you mighht feel the same. We have everything to gain and everything to lose, but also nothing to either gain or lose if you dont try.


Date:
05/23/00
Notes

Soooo tired tonight, but just wanted all of you to know that I am an addict. I check out this site as often as I do my own e-mail. It's a place for "people" first (as I said in journal entry last time; and it's for Parkinson's "people" next.

Don't ever give up - hope is the one thing to which we must cling~ Just when I was about to give up one day, the strangest thing happened.I had been out running around and parked in the driveway. Then I literally "fell" out of the car and lumbered my way into the kitchen via the back door. My legs felt like jello and the remaainder of my body was kinda "doing its own thing."

I sat down (excuse me I flopped down) in my favorite chair that reclines. I was so give out and in slow motion that I couldn't even make it recline! So I just sat there - letting life breathe back into my body.

I dozed off enough to regain a micro-chip of energy, which I used to retrieve my cordless phone from the bedroom. The bed was too inviting! I spilled myself crossways onto the bed and finally managed to get on my back. Then I punched in all the necessary codes to listen to my phone messages. That's when it happened.

There was a message from a research nurse at a PD center of excellence asking me if I would be interested in participating in an experimental study. Oh yeah - probably a brain transplant or something. I saved the message.

I had nearly fotten about the saved message until the next day. I guess I could at least return the call. An R.N. answered and told me a movement specialist I had seen had referred my name to her. She gave a brief overview of the stereotactic procedure (the halo and drill show) and said she would be mailing info to me.

Life with PD went on (as it does), and my neuro started me on Comtan to help make my other meds more effective. It immediately started working. I had more "on" time and was flying high. As has been the case with me, however, after 6 months to 1 year with my meds, the efficacy wears down. And then the info on the research project arrived in the mail.

After reading the 10-page document, I sat down in the same recliner I had fallen into days ago and cried. Really cried! This sounded too good to be true! No cost - little risk - no ethical issues -a 90% success rate thus far, and the promise of no PD (if it worked)! It claims, in fact, to reverse some of the damage done by PD.

The catch? The surgery had never been done on humans - only primates (NOW I knew why they contacted me! My genetic code and primates must be very similar! LOL)

I've checked it out and can find no loopholes thus far. And yes, I'm willing to pay the sacrificial price if it means a possible cure for someone else. I will hopefully receive a call for a screening appointment in late summer. And the screening is very extensive - my prayer is that I will pass screening as I have other health issues. If I pass, I could POSSIBLY be the second human to have this procedure done.

I may sound clandestine about all this, because I don't know how much I should be telling. And I definitely do not want to do anything to deter my number getting called! So bear with me - I will share it ALL when I know what I can share.

Lift your glasses now (clink!) "TO THE CURE!"
Peggy

Peggy, you are an astonishing woman. I read your post with tears in my eyes and thought of the similar route that I'm going through on my own. You give me courage to take the next steps. I'm now enrolled in five clinical trials. But none of them involve brain surgery. I vowed when I started on this route that I would never take pills or have surgery as part of being part of the tests. The next thing I knew I was in a study that involves having a spinal tap. That wasn't bad at all, which opened the door to even more experimentation. Now I'm in one study that involves taking increasingly large doses of pills over three months. And three functional MRIs during the same time frame. My husband is also involved in some of these tests as a control so he has spinal taps and FNMRIs as well. He claims he would rather have a spinal tap over an FnMRI any day. I don't mind either one. The pills in this particular test are given to Alzheimer's patients and now they are testing them on Parkinson's patients to see if they will have any effect on our ability to remember. That is, will they slow the onset or progression of dementia. my latest federal study is with the NIH and that will start in May. I'm not sure exactly what they study but they will have me come back over nine years. So it's got to be something longitudinal.

How did I decide to get involved in all of this stuff? I thought well, somebody has to do it or we're never going to find the answers to this problem. It seems to me that there are multiple causes for Parkinson's and multiple iterations of Parkinson's so there needs to be a rather large group of people who are willing to put their lives on the line to find answers through research. I figured that since I'm already 67 and I have no one directly relying on me, I'm a little more disposable than people who have small children or growing families. I have children and grandchildren as well who are of course at risk for having Parkinson's and in my family ALS as well, so if we can find answers in my generation, perhaps our next generations won't have to deal with it.

My glass is lifted with yours "TO THE CURE!!"

[QUOTE=pegleg;972918]In August, 2000, I allowed experimental brain surgery to be done on me. Although only six people were enrolled in the Phase I (Safety), I felt I needed to do this. Of course I had only begun to learn about the drug approval process and how risky it was to do what I did. But I do not regret it.

Four years after the first cohort of six had surgery, a 48% improvemennt was holding. The sponsor had also obtained fast-track aproval from the FDA.
I thought we had found the cure. Then on July 8, 2008, after 72+ people had the same surgery and half with a sham (fake) surgery control, the trial stats failed to meet its endpoints, and the trial was halted. I still hung onto hope and still do. I dont think that the trial I was in (called Spheramine and later the STEPS trial) was the cure, but we learn from failures, too. m QUOTE

Peg, we learn from the failures unless the failures are covered up and made unavailable. That is what is going on. Half the trials are buried and no one sees them. That's what the petition is about - ALL must be available. Is the info from your trial available? It should be.

I have been in 3 trials. Never published. Betrayal. Science fraud. They only publish the money-makers.

Peg, we learn from the failures unless the failures are covered up and made unavailable. That is what is going on. Half the trials are buried and no one sees them. That's what the petition is about - ALL must be available. Is the info from your trial available? It should be.

I have been in 3 trials. Never published. Betrayal. Science fraud. They only publish the money-makers.[/QUOTE]

Peg,
Here is the petition, I promote with Parkinson's U.K. as the orgs in America seem to be on the other side.
http://www.alltrials.net/

thanks for your efforts peg!
 

that was incredibly brave of you.
the ceregene gene therapy results will be out soon, lets hope they are good and some of us will have to decide if we want to be in their next trial if they can get funding.

Thanks,Bob . . . But
 

Thank you, Bob. Although this appears to be a well-established petition, similar efforts have been initiated for years. However, this is one of the first global petitions that I have seen. I am not certain if this petition would have as much impact as one might be that is directed through a large body such as the American Academy of Neurology (AAN) or even the American Medical Association (AMA); but I'm sure you have researched this well. Just for the record, it takes about 10,000 signatures to attract attention, so our work is cut out for us!

My intent with this topic/thread was to emphasize how absolutely imperative it is for people with Parkinson's to sign up for clinical trials, especially when only 1 in 10 people with Parkinson's volunteer for a trial. FOX TRIALS HAS MADE A GALLANT EFFORT IN SOLICITATING PARTICIPATION IN CLINICAL TRIALS. Please visit their website:
https://www.michaeljfox.org/foundation/faq.html

I am VERY supportive of any effort to report trial results and to hasten such reporting. It was ludicrous for me, as a participant in the trial in which I participated, to have to wait from July, 2008 (when the trial was halted) until the results were actually made public.*
Here is a news release from Fox Trials
https://www.michaeljfox.org/foundati...=76&category=3
*But the actual publication of results published in a refereed journal come 2-3 years later.

And if the results are bad, is it acceptable that the bad results be kept hidden, and only good results shown? Are Parkinson's organizations so feeble that they cannot insist that ALL results be published? Do we have to agree to accept that we offer up our living brains and bodies for experimentation, if the conclusions of the study are going to be deliberately falsified by hiding the negative results and promoting the positive results?

All it would take to solve this would be a requirement that all studies be registered before they start, and published after they are finished, Evidence-based science is mere deception - or let's call it witchcraft - if the evidence is cooked.

What this guy is asking for is not far-fetched. He is simply asking that the scientists, both Pharma and academic, refrain from blatant misconduct in the form of research fraud. I do not see why this is anti-Pharma, anti-free-entreprise, or anti-American; or why it would impede getting financing for trials; when all that is being asked is that the scientific truth be told.

This guy is saying that something needs to be fixed. I think that Parkinson's orgs should address the question; and at least insist that research funded by donations through them be conducted in an ethical manner, and that it be one of the conditions of the funding, that all results, good or bad, be published.
This guy is going to win his argument sooner or later:
http://www.ted.com/talks/ben_goldacr....html?c=540521
okay, try this one:
http://www.ted.com/talks/ben_goldacr....html?c=540521

It could be used to increase donations
 

It could be used to increase donations, as in, “when you donate money for Parkinson’s Research through the MJF Foundation, rest assured that the Foundation maintains close contact with the researchers, holds them accountable to follow evidence-based science processes, watches over the research process, and requires that all research results – whether good or bad – are published and made available to other researchers, doctors, health agencies, patients, and the general public. Give now, knowing that your donation will be supervised and will contribute to research conducted under the highest ethical standards of medical science.”

Peg,
(1) This petition is not my creation, it is from Ben Goldacres, a doctor and writer.
(2) 10,000 signatures? As of three days ago, we have 40,000 signatures

it's a hot topic outside of the USA
 

40,000 signatures, plus a hundred orgs, have signed in the past few weeks, press coverage is massive, outside of the U.S.A. It is a hot topic, especially in the U.K., where the government stockpiled a billion dollars worth of Tamiflu, purchased from Roche, in a panic about one of those bird flu – swine flu frenzies that gets orchestrated every few years. In the case of Tamiflu, it was at the level of doctors and their patients that doubts about the usefulness of the drug started to grow. Approved by state regulators, approved by scientists, discovered to not live up to its promise, by doctors and patients. And for once, they were listened to, what with a billion dollars of the drug stockpiled in a government warehouse.

U.K. scientists found out that Roche had hidden the negative studies entirely and cooked the books on the rest, but Roche refused to release the data, and still today, several years later, no one except Roche has had access to the information needed; not even enough to compare it to other drugs.

Well, tempers heated up in the U.K., and they have put together about 100 investigations showing that falsifying the data and hiding thousands of entire studies is the norm, not the exception. Half of the studies in clinical trials are never published, and it just happens to be the half that says the drug is crap.
Well, after the scandal of the corruption in the world financial markets, the sub-prime derivative multi-trillion dollar transfer of bank debts to the taxpayers – there is anger in the streets, about fraud and greed and legalized theft, and that anger has now focused on the medical world, and Ben Goldacre’s campaign just hit the right place and the right time with the right tone, and it is blazing like wildfire.

Parkinson’s U.K. is in the middle of it, having signed the petition. This would be an opportunity for patient orgs in the U.S.A. to support Parkinson’s U.K. (Not so easy in other countries, Switzerland for example, the P.D. org there is partly financed by Roche, proud makers off Tamiflu, and some sort of levo-dopa)

You Yankees and Texans and what not are behind the curve on this one. It’s an opportunity to be Holy. And hey – 40,000 signatures in the first few weeks – did I never tell you that until I became a spastic, I was a salesman. I did a lot of work with the Inuit in the Arctic, and every one of them now has a refrigerator.

I think the American pd orgs should climb aboard this one, in co-operation with Parkinson’s U.K., so at least there will be fewer multi-national hissy fits at the world PD congress this October. Besides it would be the right thing to do, as quaint as that notion sounds in a world of mega-corruption and nastiness.

Lots of press: https://www.google.ca/search?hl=en&g...iw=784&bih=412