Experimental surgery?

[sharlon]

i really discard the term experimental for the treatments we are giving our children. while no outcome gauranteed be can base our possible outcome on those who have gone before us. i am grateful to those who preceeded my daughter in surgery and treatment for bpi, as those who follow her will benefit from the experiences she has both good and bad. i think it is the general nature of things to evolve and improve techniques as time progresses as in any area of medical practice (except of course the narrow minded who continue to injure ) the reality is that our children are faced with this injury now and we have to make decisions based on treatments that are available now. i sincerely hope that someone will benefit from marlin's treatment in the future based upon what has worked for her and what has not. as i have been to tch for surgery and clinic i have seen some older children who have not had the benefit of the treatments and who have had very little recovery. i have talked to mothers who felt that they couldn't put their infant through surgery and who have regreted their decision later, unfortunately to late to make any real difference. one piece of advise my pt gave me when marlin was about 3 months old, "don't wish you would have gone" and she based that on past experiences with children she had treated. the neurologist we use locally researched tch for us and has been monitoring her recovery has since refered more patients there based on the remarkable difference it has made in the original prognosis.

[francine]

Nettie - your children have had great outcomes and that's just fantastic - but what I was thinking about were those with very severe injuries and flail arms without recovery even at a late age... I view it much like a cancer drug trial where someone needs significant help but is only getting a placebo and died for the good of others. That kind of thing is heartbreaking for me- even though I intellectually understand that the needs of the many outway the needs of the one.

[phaliscak]

Sorry, there are no placebo drugs in cancer trials, but I understand the point you are tring to make.

Patty

[phaliscak]

If this is the case why do they do this with deadly illnesses? Surely they must realize that a placebo is like doing nothing? So they make the person think they are taking something so they look humane, giving them false hope while all along knowing they have sentenced a child or an adult to a certain painful death. I can understand doing that for say, a pimple cream! A deadly illness is nothing to play with.

[lizzyb]

Just my ten cents; I have been on and still am on a clinical trial and believe me, they do not play around. Admittedly, the trial I am on is not for a drug to treat a potentially deadly condition like cancer, but it is conducted along the same lines.

People are asked to apply for the trials, and suitable candidates are selected carefully from these applicants. This process alone can take a very long time. The selected applicants are then left in absolutely no doubts about what the trial is all about, how it will be conducted, time frames etc and every single detail is dicussed and made clear to the applicant. At all stages, the applicant can leave the study/trial if they feel uncomfortable in any way. Every slight change or symptom or possible side effect is discussed, noted and recorded. There are also regular medical check ups including blood work etc.

The trial I am on is a fairly small one in comparison to some, and believe me, the amount of paperwork involved is enourmous and everything is checked by outside auditors. You are informed every step of the way about the trial at regular, lengthy interviews and appointments where you are given the drug(s)

Believe me NO-ONE is given false hope on a clinical trial; on the contrary; they explain right from the start that (1) you may have the placebo and (2)the drug might not work anyway.

[Sophie's Mom]

You may not think this seems ethical, but clinical trials are done with experimental treatments in which the outcome is not known. In many cases, a treatment will have the same effect as the placebo, in some cases the placebo will do better. The purpose is to compare the treatment with doing nothing. There is also a "placebo effect" in which sometimes we will improve simply because we have been seen by a caring doctor or nurse and (as patients) may attribute it to a medicine, when in fact the medicine was just a sugar pill.

Clinical trials have strict protocols and their purpose is to tell us how effective treatments are. They are usually approved by review boards before getting funded. They also tell us side effects. Some get worse. If we could prove or knew for sure that the treatment works, we wouldn't use clinical trials for that particular treatment. If there is some evidence, but not strong evidence, that the treatment works, then it is unethical to do a "randomized" clinical trial (in which we are randomly selected for treatment or placebo) and we have to look at results taking into account that patients and their doctors had a choice - those results do not tell us as much as a randomized trial would because there are so many uncontrolled factors, and that is why in the case of BPI we have so many difficult choices to make. At this point in time, their is no longer a way to properly do a randomized control trial because of ethical reasons. Perhaps in the two villages study (I'm not familiar with it) it was in a time when there was still very little known about the outcomes of surgery vs. no surgery.

If I ever had the courage to participate in a clinical trial, I would probably hope to have the placebo just in case the treatment actually killed you! lol

Nice discussion,
Tina (an epidemiologist)

[claudia]

Yes, I did embark on "life altering treatment" for my daughter. This life with surgery is a far cry from what she would have had without it. I know this. My ped. neuro says it every time she sees my daughter. The docs at TCH said it. Hers was (is) a very severe injury. Why has she done so well? Ah, surgery is a one-time event. The therapy, ot and pt each 2x week, with 2 very experienced therapists it the key. My ot has been at it for 25 years and is the rare therapist to have seen about 20 obpi patients in her career. I have THAT benefit as well. She has seen severe and not so severe injuries. Juliana is the only surgical candidate she has dealt with. I am the only parent of a bpi that she has had who wanted to do it.
I sleep well at night too. I know that I have done everything possible to give her the most function from her arm.
I am so happy that there are kids out there who do not need surgery. I am so happy for people whose children spontaneously recover. I will be even happier when we can say that our kids had obpi--it is that thing that doesn't happen anymore.
I dawns on me as I write this that life is experimental. We buckle our seatbelts-they save lives. But people still die in car accidents. We eat right (?), don't smoke, don't drink. what ever it is, but people die of cancer. We do what we can.
I try to see the glass as half full. Even though I know it isn't always.
hope it helps,
claudia

[admin]

Well, I am not sure why I am actually replying to this topic b/c my daughter did not need the nerve surgery or any other surgeries yet...BUT...
If Ella was unable to move her arm and I knew it was a severe injury I would run so fast to let her have the surgery. Yes, it may be considered experimental in some opinions, but I wouldn't care even if Ella was the first child who they were going to try this on. If the doctors told me the surgery may help her or may not help her I would take trying to help her. At least I would feel as if I did all I can and no matter what at least we tried to give her some movement. Now, Ella is 13 months old and has never had a surgery, but she is most likely going to need some muscle surgeries in her years to come. So looking back at her when she was newborn-12 months, I would have choosen nerve surgery if she was unable to move her arm with no doubts in my mind.
Now, about different specialists with different opinoins/views...
I think that each person is different in every aspect of life, therefore I think that this is brought out in the field each person practices. I also believe that their opinions reflect what these doctors have seen hands on in previous children. I agree with doctors studying this and other surgeries b/c if they never started studying this to begin with our children and ourselves would be lost. I think every medical condition needs studying until there is a cure. Sounds crazy, but in my opinion we could come close to a cure for anything these days. I am not saying that a BPI can be cured, but some day who knows what may happen just from the studies they are doing today in 2002.
Krista

[Judy-T]

Karen, I had to respond to your comment about the majority of kids not being in pain. I did not have pain until my teen years. It was then excruciating and i lived on muscle relaxers and tylnol 3 .I think if kids can keep up a regular therapy plan this could possibly help with the pain. I still live with pain. It is just part of my life. More studies need to be done on growing older with erbs.I know every case is different ,but i had to voice my opinion from personnal experience. Judy