Dear jllanguille,

I am so sorry for all you have been through. I hope you were consulted by the doctor, as well as your mother, about the risks. I hope you realize because you may have agreed with your mother, to take the risks, you are not left feeling the guilt.

I don't know if you are feeling guilty, you should have no feelings of guilt. You might allow your anger to work to provide a positive change for future patients involved in research. As Jean said, "How come no one heard about this?"

Reachers have professional pyschologists to keep the family of the patient feel like they are heard and offer symphathy and convince the patient that no one was at fault and how much worse your mother would have been even without participating in the trial.

Remember, you are not alone. Paula is the best person who can offer you help. Take up her offer and Private Message her. She knows who to contact to bring your mother's experience to the light of people directly involved with Research Ethics with the power to make the Research
hospital enforce their contract with the patient. Your mother's participation in the research is heroic. The people involved in holding up their end of the contract are despicable.

Will pray that a higher power helps you make a decision that is right for you.

Vicky

The language they use to characterize what happened minimizes it to the greatest degree possible while remaining truthful.

For example "experienced brief periods of confusion (lasting up to 5 days)", means is she has constant, ongoing and frequently terrifying hallucinations that cause her to try to flee, and these began immediately after the surgery and persist until now, 2 1/2 years later. Because of the hallucinations, she is restrained every moment of the waking day.

You need a good lawyer!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! !!

if you are in regular contact with Schering, (which I believe you are), I am sure we would all be interested in their position regarding jllanguille's Mother and their standard of post operative care.

Can you assist us ?

Neil.

aftermathman,

I have already addressed this subject in general to BayerSchering by email.
If I get an answer I will post it here.

I can understand all the people who experienced trouble after the surgery.
I am wondering that obviously nobody can say something positiv about the Spheramine approach given the positive phase I results. What is wrong?

frank

any response is sure to be interesting.

Currently there is a lot of frustration in the PD community re. the conduct of clinical trials. This covers, amongst other things, the role of sham surgery, whether trial participants are given the information to allow them to make an informed consent and the standard of post operative care should complications arise, as is seen in this case.

Clinical trials for PD often tread new ground (e.g. gene therapy), and may involve major brain surgery. In addition participants are sometimes told to freeze or reduce their meds and cannot seek alternative meds for the duration of the trial. After all this the procedure may end up being a sham.

Everyone on this board (I imagine), wants Spheramine to succeed, Titan investors moan about the duration of the STEPS trial, question marks over Titan / Schering welfare of trial participants don't help either community.

You're getting some insight into the human investment in drug research, its a difficult place to be.

Neil.

frank_ger,

This is the first time we've heard about the adverse events. Jllanguille has not much choice but to react negatively, but for others this treatment may hold real hope.

These trials are very risky but then so is living with Parkinson Disease. I think what bothers us often about these adverse events is the lack of compassion and caring for people who do experience these events.

Thanks for sharing your information.

Paula

Who thinks of all the right questions at the right time. We dont realize whats missing until it's needed. As I read Jllanguilles agony I reread the consent form. It is very thorough so I thought I'll quote 2 paragraphs/

"Your doctor may also be an investgator of this researcch study. As an investigator, your doctor is interested both in your critical welfare and in the conduct of this study. Before entering this study or at any time during the research, you may want to ask for second opinion about your care from another doctor who is not an investigator
in this study."

Does the first sentence say "may also be" and the last say
"ask for second opinion about your care from another doctor who is not"

Then paragraph 2
In the event that an injury occurs as a direct result of the effects of your study participation, BERLEX labs agrees to pay for all reasonable and necessary medical expenses not covered by insurance or a third party payer. The sponsor will not pay for medical expenses that are unrelated to the study or attributable to the natural course of any underlying disease or treatment process. The sponsor will not pay for any expenses caused by the institutes negligence or willful misconduct."

I believe herein lies the root of jllanguilles problem.
1- What insurance carrier covers clinical trials?
2-Who determines if the injury is unrelated to the study?
3-Wouldnt negligence have to be determined by a third party.
4-Who else would be qualified to make that diagnosis?
5-Without getting paid?

OK paula, you asked......Patients Bill of Rights
In addition to those questions
When joining the study, a nice option would be for my neurologist to be certified to do my followup testing. No testing happens at the institute he isnt already doing.

A formal outlined (STEPS if you would) process is to be outlined for patient issues that arise. This must require the patient immediate gets seen for care. If thiscare isnt immediately avail. (Im thinking 72 hours) Emergecy procedures for the hospital or state are provided.

Lists of Qualified Doctors not affiliated with the study should be available.

I read somewhere each study patient costs in the vicinity of 150,000 Sponsors could have the option of joining a pool that covers costs such as jllanguilles or post their own bond. It would certainly show who believes in their product Thats enough for now thats the bad thing about this forum is its hard to shut me up

Paula mails coming
Bob
PS Id still do it again

Bob T,

That is very true, you can't think of everything and don't know what to ask till you need it or something happens. But that is changing....not as quickly as we'd like it to but then we aren't exactly fully staffed and paid employees either,lol. Your comments are what we need because we are trying to create a tool for participants to use. It needs to be in objective terms that are measurable that all involved can check off as done. Don't want to be too picky or unreasonable but anything has to be better than the one sided documents that have been used thus far.

They need to spend more than the 150,000 if that is what it takes now. It shouldn't cost the patients any expenses if they ever expect to get random sampling of all cultures.

ok stopping for now and thank you! Glad I asked! Glad you answered!

paula

Bob T,

It is really interesting to me that they changed that clause in the informed consent. I wonder if they did it as a result of what happened to my mother. The clause in the informed consent she signed says:

"If you are injured as a direct result of research procedures your care will be provided at no cost"

When did you sign your contract? I wonder if they changed it because I called them on it for my mom. I contacted Titan/Berlex/Schering in 03/2006. The study was unblinded for my mother and her neurologist told me her precipitous decline was directly attributable to the Spheramine. He said he didn't know what to do for her, because her decline was not characteristic of PD.