Risperdal "defective" makers in trial

[Isabelle]

because risperdal almost killed my son and caused so much pain from which he had not recover or would ever ....i have the pleasure to inform you that the estate of Arkansas has decided to sue Janssen and Janssen calling risperdal a "defective" drug, that they were misled about the effectiveness of the drug. I hope Arkansas wins... and others follow

http://www.furiousseasons.com/legal%20documents/arrisperdalsuit.pdf

http://www.nwaonline.net/articles/2007/11/21/news/112107arantipsych.txt

thank you my friend for email me this news

[Kristen (ColeysMom)]

WOW!

Thanks to you guys, when Coley's Neuro suggested this for him, we DECLINED!

PHEW!!!!!

KJ

[JungleWoman]

The most 'educated' ped at Aaron's doctor's office pushed it without ever even seeing Aaron in person, saying the reason he woke up at nights was because he was 'probably afraid of sleeping'. Good thing I knew better than to allow that bullsh*t off the cuff like that.

Drug em up seems to be on their minds constantly.

Thank you Isabelle.

[Kristen (ColeysMom)]

That's a PERFECT example of the Drs GUESSING what goes on in these kids minds...they F'n don't know!

The more I learn here and about my son, and the more he gets better, the more I KNOW these wacked out behaviors are calls for HELP, not something to be tossed into that damned junk heap the 'experts' affectionately call autistic tendencies...F'ERS! Makes me SO mad! Poor kids are SCREAMING for help and get a line of bull$hit for their troubles!

Coley's neuro wanted to give it to him for his sleep disturbances too...

Here, here! Thank you Isabelle!

[tgrimes]

This is a ridiculous lawsuit, on so many levels... what a waste of arkansas taxpayer money. This is one case I hope big pharma wins and here's why:
a. the suit is about prescribing when not MEDICALLY necessary - wouldn't that be the medicaid doctors the STATE is in charge of? Sounds like a state medicaid problem to me.

b. Little Rock? - Don't they have an illicit drug problem even worse than this

And three, dig deeper. Pfizer subsidiary of little rock just happens to (in addition to providing major employment for that town) have landed a sweet state partnership in some obesity reduction program.
Remember, that obesity was caused in large part by risperdal according to the attorney general.
So let me guess pfizer's the only big pharma NOT on the proposed s-list of this attorney general.
Hmm... I smell pork burning... (and a good stock buy)

[Isabelle]

tgrimes i see what you mean. the lawyers for the makers are going to have the field and run with a lot of money....but if the state can prove that maker reps cajoled (is that a word?), with "benefits" and money, medicaid doctors into prescribing risperdal for whatever...that's something different, right? still the makers are responsible

[Isabelle]

That's a PERFECT example of the Drs GUESSING what goes on in these kids minds...they F'n don't know!

Poor kids are SCREAMING for help and get a line of bull$hit for their troubles!

Coley's neuro wanted to give it to him for his sleep disturbances too...

Here, here! Thank you Isabelle!

you are welcome, but it was a good friend who emailed me with it.
you know at some point the people is going to say it's enough and sent all doctors back to the old kind of school of medicine whose motto was "to do no harm".

[Kristen (ColeysMom)]

Grimey...I'm sure you are right, it does seem like it ALL comes down to money now a days...how foolish of us to think this actually had anything to do with someone in power caring about our kids, or anyone other than themselves for that matter!

But I'm sure they can still prove that with deceptive marketing, prescribing was not correct. This could be the start of a war between the drug companies...that would be nice! A fight to the death would be even better!

[mc4_a]

tgrimes i see what you mean. the lawyers for the makers are going to have the field and run with a lot of money....but if the state can prove that maker reps cajoled (is that a word?), with "benefits" and money, medicaid doctors into prescribing risperdal for whatever...that's something different, right? still the makers are responsible

Yes, and since we hold lawmakers responsible for their actions when they are influenced by special interest money...oh wait, no we don't.

I do agree I find the relationship between doctors and pharma companies a little too cozy sometimes, but the doctor is the one ultimately responsible for writing the prescription. It's the doctors that need to have their feet held to the fire.

The trouble is that too many doctors stop reading journals once they start practicing and rely on the drug companies to advise them on effective drugs. That's a recipe for the drug company with the biggest mouth getting the nod when it's time to prescribe. Or maybe the doctor over prescribing the drugs because they have only listened to the hype and think the drug is some kind of miracle.

[mc4_a]

And I only hope this lawsuit does not stop the availability of Risperdal. While it sounds like many of you had trouble with it, it was a life saver for my child. I think you all need to keep in mind that not everyone had a bad experience with the drug.

I'm not saying it's the case for the examples listed above but I find a lot of doctor prescribe it incorrectly, using very high doses and suggesting ad hoc delivery of the drug. These are both big no-nos that can lead to a bad situation. Again, it's the doctor that needs to be mindful about what is prescribed and how it is prescribed.

[Mother's Heart]

"ad hoc delivery of the drug"
what does that mean?

[JungleWoman]

Again, it's the doctor that needs to be mindful about what is prescribed and how it is prescribed.

I absolutely agree--- and I know that some children benefit HUGELY from it, and for that Im thankful.

In our experiences with traditional medicine, they dont even look at Aaron and are prescribing things! VERY BAD FORM!!! (And I might also add that this doctor hadnt even looked at his chart yet-- he repeatedly said 'i'll have to look at his chart' over and over! -- it was just a conference between him and me)

Never had much help from the traditional medical community at all, sadly-- its probably where the bitterness comes from.

[mrsjerome]

Vioxx was a drug that helped for a lot of people too. However when too many people were keeling over from it . It had to be taken off the market. People or their survivors with adverse effects sued Merck and just reached a settlement worth x amount of dollars. because it was cheaper for Merck to do this than fight the litigation.
From what I understand Risperdal and some of the newer anti-psychotics are not that much different from the older drugs as their manufacturers make them out to be. The biggest difference is the cost of the drug. Just speculating if a Dr. prescribed one of the older anti-psychotics would the results not have been the same for some that claimed Risperdal really benefited their child.
I also hear that the state of Texas is contemplating filing a similar lawsuit as Arkansas.
I don’t believe these lawsuits will ever go to trial but a settlement will be reached between the states and the manufacturer. It will be more than likely such as in the Vioxx case cheaper for them in the long run.
The tobacco companies in recent years were sued by the states and settlements were reached between the respective parties.
If some of these newer anti-psychotics like risperdal are eventually taken off the market remains to be seen. I would look to more warnings ordered by the FDA first. If people start bringing too many complaints of the drug’s adverse effects, I believe the FDA will look further into it.
Yep it will be bonanza time for the trial lawyers but what they make is only a spit in the ocean from what these pharma companies are reeling in.
You know we live in a merry-go round in this country. Someone gets damaged by a medical professional that person is sued a settlement is reached the professionals malpractice insurance goes up the cost is passed to the insurances and consumers. And we go round and round again. In the case of the drug companies whatever they pay out will just be passed to increases in price for their products.
Would like to see more of an accountability at the top of the chain instead of passed down to the bottom.
Would like also to see a disassociation between the Drs. & the pharmaceutical Companies. no more being paid for lectures vacations and free lunches The DR. should know enough without having to be entertained by the pharma companies. This goes for the advertising on TV too. We shouldn't have to talk to our dr. about whatever drugs are being advertised on the TV. The Dr. should have the expertise himself without the patient telling him or her about these great medicines

[mc4_a]

"ad hoc delivery of the drug"
what does that mean?

In this case I mean doctors sometimes instruct their patients to deliver the medication when there is a behavior problem and only then. Child acts out at school? Give them the drug in a big doses.

This is very much counter to how drugs like this should be administer (steady, consistent doses with no huge changes).

[mc4_a]

Never had much help from the traditional medical community at all, sadly-- its probably where the bitterness comes from.

Yes, it's understandable. Many doctors don't have a clue when it comes to these things so they make recommendations based on very shaky evidence. Fortunately, my doctor specializes in children with developmental disabilities (her own child has Down Syndrome).

Finding a good doctor is like finding a good mechanic. They are hard to come by and you better hold on to them once to find them.

[mc4_a]

...
Yes, it all is very unsavory. We need to regulate these things much better all the way around.

[Kristen (ColeysMom)]

But where do docs get the idea that drugs like this can be used in various ways...like the ways in which you suggest are inappropriate?

I'm sure they don't make it up on their own...

And it sure does seem like the FDA SHOULD be held accountable in some way...perhaps the FDA should be elected positions or something...never thought about that, just the fact that they don't seem to do a very effective job...or even a satifactory one. Seems like every time we turn around we (the public) has been used as a testing ground for one thing versus another...

[JungleWoman]

Does anyone even trust the FDA anymore to make safe decisions?


And when do they deal with food anymore??? I never heard if my tomato soup was FDA approved or not-- didnt stop me from eating it.

Just like the 'caution' on every herb or natural remedy you find in healthfood stores about how its not been evaluated by the FDA to do what it says its done for thousands of years. Since when do they get to be the final authority??? The FDA is no standard in my home.

[mrsjerome]

Anyone working at the FDA making decisions on the safety of drugs vaccines etc. need to disclose their own financial statements to verify that they have no connection whatsoever to any pharmaceutical, vaccine, and other industries whose products come under their jurisdiction. Doing this would at the very least insure the public that they do not have any vested interest in the companies and products that are being tested.
The system we have now is fractured. Whether it can be repaired or not is pure speculation.

[peglem]

But where do docs get the idea that drugs like this can be used in various ways...like the ways in which you suggest are inappropriate?

I'm sure they don't make it up on their own...

And it sure does seem like the FDA SHOULD be held accountable in some way...perhaps the FDA should be elected positions or something...never thought about that, just the fact that they don't seem to do a very effective job...or even a satifactory one. Seems like every time we turn around we (the public) has been used as a testing ground for one thing versus another...


The doctors get the idea to use the drugs in various ways from the manufacturers- BUT, we pay for their medical expertise, not the advice of some salesman, so I can't see not holding the docs accountable.

The FDA approves drugs for specific uses- doctors very frequently use them off label. There are times, i think when it does make sense to do this, but in my opinion, the doctor better make darn sure they get it right!

JW- I don't have much respect for the FDA either. I think the food part is that they're in charge of labeling laws or something. Although, they can do things like keep people from using stevia in diet soft drinks instead of artificial sweetener. That always struck me as strange (must be politics in that one!) that you can sell stevia, but not add it to manufactured food or drinks.

[matika]

Apples
Peanuts
Strawberries

Ya know, how much you wanna bet there is more people having bad reaction to those natural foods, then those kids who are prescribed this type of medications?,, ok maybe I am exagerating, but, What I am trying to say, not everyone will react ok to everything. Light for goodness gratious, as natural as that is, some people are allergic to sunlight. I am not one to believe we should medicate our kids. I sure waited before I took that route, and much against my will, cause I know of the risks, but to see my son literrally suffer due to his anxiety, his resstlessness and hiperactivity, his legs and arms and torso full or bruices because he hit himself when he slip, fall, banged himself against something, I am sorry but I had to go down this route, for his safety, for his peace of mind, which he is much more calmer and pleasant, not because he is druged and doped, but because he is more in control of his feelings and his body.

I so much which I did not had to medicate him, I wish my kids where normal, God knows I and we all wished that, if not right now, at one time or another.

Rachel had gone on Risperdal but we took her off of it because in her case it was just making her worse, and I insisted the doctor started her at a very very low dose, and she did, so small, it was hard to measure, and the bottle was 300 doses at the dosage she prescribed.

What about the parent, we trust ourselfs to the hand of the doctors, but common, if the doctor said to jump off a cliff would you?, in the same way we all have to be responsible and use loggic and caution, especially when it comes to our kids.

I do not know all the details of the case, I don't want to, I hardly know all the details of mine, I do my best, but there is always a much bigger picture to things then one side along, or even both, can present.

Just sticking my foot on this one, Cause it was a heck of a hard decition to make when I decided my kids should try medication for their behabior. A biolation of what I promised not ever to do even a year ago *sigh*

Blessings

matika

[peglem]

Beky- If the medication is helping your child then you're doing the right thing. Stop kicking yourself. I think the lawsuit involves more adults than kids, anyway. Here's the gist: (according to Peggy, so w/ a grain)

Arkansas' medicaid has been paying for risperdal for patients "off label" use. Some patients developed side affects. So the state then had to pay for treatment for the side affects. So the state is suing the pharmaceutical companies for overmarketing the product, causing the poor doctors to prescribe it too much at state expense. As far as I could tell, the state was not claiming risperdal is always bad (just not neccessarily better than the cheaper, older drugs it has replaced). I don't really get the basis for the case because if the drug were not "medically neccesary" then why did the doctor prescribe it? Aren't dr.s in charge of deciding medically neccesary? Its not like they were just giving it out for every little complaint...And if the dr. didn't have medical verification of need- whay did they prescribe in the 1st place.

Oops! That's more than the gist...got carried away.
I ended up medicating my girl- I had to try, like your son, she was so miserable!

[mc4_a]

Part of the problem with the FDA is they are too small to really be able to follow everything going on. Then you have the corruption, incompetence and so on. I'm not sure having a bigger FDA would be a good thing though. They were most certainly go after herbal supplements first rather than facing the real problems (food and drug safety).

[JungleWoman]

Beky,

I agree with mc4--- you are doing the right thing if this med is helping!!

You and I have talked extensively about our kids' struggles and everything and Im so glad that Joshua is doing well on what he's on and I know your decision wasnt an easy one.

My beef is with inconsideracies of Aaron's doctors--- drug em up and get em out of here as fast as possible, after all, we take Medicaid from most the parents who come in here-- gotta make up for the $$ we're losing. *Thats how I feel anyway*

Our area is horrible about that sort of thing.

Beky, have you been able to schedule an appointment with someone in Eugene or Portland to see Rachel-- I vaguely remember you mentioning that.

[matika]

BUT I like kicking my self :p

Well, about Rachel. I talked to the pediatrician, and she said she would call the hospital so to schedule an EKG for her, she had one a few years ago and nothing showed up. I told her yes, I like to try that, but if that don't show anything I like an MRI done,, I hate to put her trhough that, but if there is something going on in her I like to know the soonest the best, with that said. I still have not gotten a call from the hospital to set up the appointment. I am discourage with the poor lack of follow up this doctor has, and our regular doctor has...

So, I found a new doctor I will be switching us to, she is new to the clinic and taking new patients. She specializes in neurollogy apparently according to her profile paper the clinic sent me, and she also has interest in alternative medicine, which many doctors are not. also geriatric and women and children health. So it's worth given her a try. I haven't hear much about her from anyone, I am just going at it from the point of view that, if our doctor aint good, then trying something new, I would have nothing to loose.

I am starving now I am off.

beky

[JungleWoman]

Beky,

That sounds wonderful! If you can go to a clinic that will take your kids' SSI medical AND she's interested in alternative medicine-- that will save you a LOT of money (and stress) if she is willing to do the DAN protocol with you or whatever you and her think is the best options for your kids.

I looked at our Naturopathic dr's graduating class--- there was more than 1 MD that graduated with her-- I thought that was pretty awesome that some MDs see the benefits of the old school medicine!

[LauraP]

The position of Director of the FDA (like all these agencies) is a Presidential appointment, and most of these people are interested in remaining in politics and following their appointer, so they don't usually speak up. The current Administration is pushing industry deregulation and has refused any oversight, so why would FDA feel like they have to do their job?

Why are we surprised when so many things go wrong? Profit-making corporations don't WANT oversight, so having an anti-oversight administration is golden for them.

Aack. DOn't get me started...

[Anna-Banana]

Risperdal...freaked my runner boy to the point that he was terrified to come out of his bedroom, even after we had just bought him (and the other kids), a new swingset. For Aaron this was about 4 yrs. ago.

Two of the boys I watch, ages 10 and 9, both on risperdal, benefitted the older boy, to the point that it was everything he'd been needing for at least 2 yrs. Amazing and wonderful!!
The youngest boy, just doesn't seem that this is what he needs....he's not freaked out on it like my Aaron was, but he is most assuredly NOT the boy he used to be, isn't the happy, froliking child he was in the summer. Sleeps, wakes to eat, and sleeps again. Now...this kid used to go full steam ahead on everything...never needed a rest, posted ALL the signs of ADHD, hyper was an understatement of him! LOL
The mom is thinking of telling the Dr. that this is not the type of med. this kid needs, we all miss the lil stinker he is most famous for. :O) Adderall also, didn't do what is was supposed to do.

Soooooooo, as someone told me..."Ya either have to 'play' the meds. game, or ya don't. You'll never know unless you try it for a reasonable amount of time.". MY personal reasonable amount of time would probably be about 3-6 months. JMHO..

[mc4_a]

...A follow-up here. I know we discussed how are these off label recommendations are passed to doctors and we were unsure about what that process is like.

Check out the click on the 60 minutes homepage called "Prescription For Addiction" http://www.cbsnews.com/sections/60minutes/main3415.shtml. The first part of the video is a bit OT, but stay with it. It gets very interesting.