Earlier this year, Johnson & Johnson (J&J) agreed to pay more than $1 billion in a civil settlement involving fraudulent marketing of their antipsychotic drug Risperdal – but federal prosecutors decided to hold out for more.
Now their illegal marketing of Risperdal for unapproved uses is set to cost them at least $1.5 billion in a settlement with the U.S. Justice Department, and sources say the final amount could end up exceeding $2 billion.
The amount could end up rivaling the largest health care fraud settlement in history -- $2.3 billion paid by Pfizer in 2009, also for illegally promoting uses of four of its drugs.
Risperdal Aggressively Promoted for Unapproved Uses for More Than a Decade
Risperdal was heavily promoted for unproven off-label uses for more than a decade, even after the U.S. Food and Drug Administration (FDA) issued warnings against the misleading claims. Doctors are well within their legal rights to prescribe a drug for off-label use; it’s actually a common, albeit sometimes dangerous, practice. However, drug companies may not promote them for uses other than those that are FDA-approved.
Research has shown that up to two-thirds of prescriptions for Risperdal were for unapproved uses that had little or no scientific support.i How did this happen? Simple -- J&J sent out an army of salespeople to doctor's offices, nursing homes, Veteran's Administration facilities, and jails to tout Risperdal as a proverbial miracle drug for mental illness and dementia.
The FDA told the company to stop the false and misleading marketing claims not once, not twice, but three times from 1994-2004, but J&J reportedly continued to include marketing the drug for unapproved uses right in their business plan.
In the years to follow, the FDA did eventually approve Risperdal for bipolar disorder and autism symptoms, but it was never approved for dementia, even though it was heavily marketed as a dementia drug. Outrageously, elderly dementia patients who were prescribed Risperdal for off-label uses were found to increase their chances of death by 54 percent within the first 12 weeks of taking it!ii
The thing is though, if you delve into the literature about any of the antipsychotic drugs so many of our advanced-stage AD loved ones are taking, you will find warnings about how Ativan/Seroquel/Zyprexa/etc, are NOT recommended for use in dementia patients, for whatever reason.
It is equally true that drug companies WILL be unscrupulous in selling their products. It's an established practice.
So there are at least 2 things we have to pay attention to: Is the drug being prescribed by a creditable practitioner with a good working knowledge of how this drug has affected similar patients? And, what do we observe when our LO uses it?
If it helps us manage some of the hellacious symptoms of AD, I don't care what it is/is not "approved" for, nor am I TOO worried about death warnings. I say this knowing nothing in particular about Risperdal specifically. That is not one we've used. Of course drug companies will try to push products of questionable value on us (Aricept 23 anyone?...why not two 10mg tabs?) But I care more about experience, and the oversight of an experienced practitioner who has worked with this stuff.
well from my expierence wife was on two meds til she entered ALF the local pill pusher then added many more an when questioned became quite upset that anyone would question his authority,in fact there is an investigation going on now because of "misuse " of meds by ALF,just how much kickback do DRs recieve from pharmacutical companys?
The issue isn't use of meds in an unapproved manner, but pharmaceutical companies pushing that use.
Our current psychiatrist has use medications "off label" but has always explained why, was familiar with the literature on this "off label" use, and always told us to contact her if we thought there were any problems. Side effects have never included anything lethal. I remember one side effect of one drug being itching, and if that happened to stop or go back to the lower dosage, and try increasing again in a month.
The danger is doctors who don't know what they are doing, and being pushed or bribed to do it.
I can understand your thinking, Don, because of the experience with your wife. I also think that the key issue is the expertise of the doctor who administers the drugs. I don't know of any drugs that were developed specifically for controlling dementia behaviors; consequently, all that are currently used for that purpose were developed for other psychiatric conditions. In the old days (when my father-in-law had AD), there were only drugs like Haldol that knocked the person out, so they were only used in case of emergencies. Consequently, he was involved in a physical fight with another patient and subsequently died from renal failure. At least today, by using the psych drugs off-label, dementia behaviors can be controlled and the patients can have some quality of life for their remaining years.
The doctor at the Alz. facility where my husband is a resident took my DH off Seroquel and put him on Risperdal. Each time I went to see DH he had a new bruise somewhere and had hit his head often when he fell. I spoke with the doctor a couple of weeks ago and had him put DH back on Seroquel but he is still falling. After this week is over and most of the tourists have gone home I am going to get an appointment with the nurse and find out what is going on and exactly what meds he is on. DH was also violent and I blame the risperadol for that so I will see if some things have improved.
Jean21, my DH was also taken off Seroquel and put on Risperidal when he entered the ALF 21 months ago. He was switched back after a bad agitation episode a couple of weeks ago. We've now transferred him to an Arden Courts ALF where he's getting much better care and is all of a sudden relaxed and content. Also cooperative for the first time.
Risperdal and some of the other drugs in that class come with a big BLACK BOX warning. I had to sign a waiver that stated I understood the risks before Sid's neurologist would prescribe it. That drug saved both our lives. He was so full of rage that both the doctor and I feared it would escalate into physical violence. He was out of control. I was on the verge of a nervous breakdown. He started out on 3 doses a day, which we were able to wean down to one small dose a day. It has kept him calm and me out of the hospital.
One has to weigh one risk against another.
On the other hand, every patient is different, and some have very bad reactions to the drugs. Doctors don't know until they try them on a particular patient.
Pris, My DH was doing fine in the facility so I am wondering why they changed his meds and when. I didn't know they were changed until I spoke with the doctor. I don't think they should be changing any meds unless the consult the primary caregiver and they have a good reason for changing. I may be in the minority for thinking that but that is how I feel!
The brain itself is a huge black box! Science has so little understanding of what is going on in there.
Drug companies develop chemicals to try to change things but since you cant see in the brain the only changes you can really test are the external behaviors. If somebody has a classic mental illness (bi-polar, schizophrenia, depression, etc.) Thir symptoms/behaviors are fairly consistant over a long time. You can experiment with differnt chemicals and figure out what is best.
Then you have our dementia folks and their toxic soup of a degenerating brain. They exhibit the all same symptoms of 'mental illness' and those symptoms NEED TO BE STOPPED for all the right reasons. Give them the pill and see if it works . . . . How can you EVER tell what is happening??
In a good drug test people should take a medication for a long time. 6 months at least, a year is better and commonly side effects emerge only after a drug has been released and people have been using it for many years.
In my situation my wife was driving (and functional) in January and here it is July. She no longer recognized her car when we sold it in May and she is now crying & whining for hours on end DESPITE multiple medications such that she cannot attend daycare and has to have home care. All this in only 6 months!
How much of any of this is related to her brain decomposition and how much to any of the meds? And how could ANYBODY EVER TEST FOR IT?? Couple all this with the fact that all our folks are older and any deaths or disabilites might actually be 'natural' for them at that age and not realted to any medications and any drug testing becomes pretty impossible very quickly. Hence a black box warning just to protect everybody.
Does it scare me? Not at all. My wife has a terminal disease. She is going to die. If there is ANYTHING that can make her even a little more comforatable while she is here (AND my life easier too!) then I am going for it.
Now, overmarketing drugs?? BIG PROBLEM. Allowing drug companies to market directly to consumers? ("Ask your doctor about. . ") NEVER should have happened.
My experience with Risperdal, Haldol, etc. was years ago. I don't think much has changed. It bothered me that many meds given for dementia were developed for mental illness - and there's a world of difference between the two. Maybe some can control some symptoms for some patients, but they sent DH up the wall. They made him much worse and, I know--against advice--I stopped them cold and there were no bad consequences. I haven't kept up with any new AD drugs--if there are any AD/dementia specific. Aricept was as effective as sugar pills. I felt I had good docs, but as it has been said, you won't know until you try. There's still a long way to go. Yes. overmarketing, 'ask your doc about.....' has led to much of the public expecting pills can do more than they really can, so everyone has to be careful for themselves and advocate for our LO's. With so many new advances, knowing what's what in medicine these days can be overwhelming.
Galantamine comes with a warning that it has shown to cause heart attacks. So what - let him have a fatal one. It would be better than what lies ahead.
Is there a document one can get signed so no meds can be changed without caregiver/guardian signing off on it except in case of emergency? By emergency I mean sudden violence that they need sedated.
True, there is difference Betty. I guess what I have seen in my husband as he steamrolled into the "psycho" stage of AD is similar enough to the type of struggle a mentally ill person has chronically, that I understand why they might be appropriate. I wish that, in addition to working tirelessly on prevention and cure, we could also develop some "gentler" remedies for the hard behaviors. May not be possible. This certainly would be a worthy co-project, along with cure, as we boomers push through senescence.