OK, so this is about drugs being used for dementia, not Parkinson's - although a serious percentage of PWP also end up with dementia. But what bothers me here, is the government making $1.5 Billion by convicting the drug company... imagine how much medical research could be done with 1.5 billion dollars. And there was another, larger fine before this, and there are many smaller fines. Pharma adds the cost of the fines to the drugs, and make huge profits; the government rakes in billions.... all from turning our disease into a marketable commodity... and we can't get research done, we can't get home visits from PD nurses and so on for ever. These are crimes committed against sick people. Why does the government get to confiscate the money?

Abbott Laboratories guilty, fined $1.5 billion

OIG Posts News about Large Off-Label Drug Promotion

Good afternoon to all from Washington, DC. This is a special news Email related to the Department of Justice announcement regarding Abbott Laboratories off label promotion of Depakote.
------------------------------------------------------------------------------
Abbott Labs to pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote http://go.usa.gov/V5

Global Health Care Company Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration, the Justice Department announced today.
The resolution – the second largest payment by a drug company – includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.
“As a result of OIG’s joint investigation with our federal and state partners, Abbott Laboratories will enter one of the pharmaceutical industry’s largest settlements and pay $1.5 billion for unlawfully promoting its drug Depakote, including to nursing home patients with dementia,” said HHS Inspector General Daniel R. Levinson. “Our integrity agreement will hold Abbott accountable for preventing future violations of federal health care laws and FDA requirements, which will protect federal programs, taxpayers and our most vulnerable patients.”
------------------------------------------------------------------------------
(That’s the entire press release.

Bob
I am so glad you posted this "Pharma adds the cost of the fines to the drugs, and make huge profits; " I wondered when someone was going to get it. We need tort reform more than anything I can think of - we need to stop calling pharma the bad guy and work with them! They must have us to test the drugs, and if we don't start acting that way (that we are a MUST), then we will never find the cure.

We need someone like you to head up a group to demand all orgs work together toward the same goal. They will never merge or will they? In 2000 I was walking in Central Park in New York City, only 6 weeks after I allowed some little bio-tech company in New Jersey drill into my brain and add transplanted cells never before done to any human. Was I nuts? No, desperate! And I still am.

How will we ever find the cure if people with and without the disease don't join clinical trials. Afraid? The future is a fear far worse! Go to the Fox Trial Finder site and get started. https://foxtrialfinder.michaeljfox.org/

Or join up with the genetic testers 23andme https://www.23andme.com/

Don't just write here in the forum about the blah life we have from taking L-dopa (sinement) too long. The scientists have painted themselves in a corner with this disease. I have had it (endured it) for 18 years and nothing new (just copycat drugs in a different dispensing version).

I walked in the Unity Walk again this year - the entire 1.4 miles! Over 1.5 million dollars was made and thousands of people there (I didn't even see Mike Fox there ) I was busy trying to run Abbott down to find when duodopa was coming. Jeez!

I know I'm not the only dedicated soul on this forum - Perry Cohen, Paula W., Linda Herman, Bren and Nan, - Lindy, Conductor, oh I can't name them all - but there are so many fighters. But we have to work WITH the drug companies if anything gets cured. We have patient power - let's use it!

I am tired and rambling, but please be bold like Bob Dawson and tell it like it is - like it should be - and it will be. "Build it (cure it) and they will come!"
Peggy

I meant to add that paying these fines doesn't hurt most big pharma companies; I think there are times when they may even budget for such things. But it is most definitely reflected in the price of drugs.

It may be that you feel it's the "principal of it," but I suggest that it only gives more control to the sponsors who pass the cost of fighting in court onto the patients by upping med prices. We have the power together (people with Parkinson's), to bring about change in this area
Peggy

Quote:
“…We need someone like you to head up a group to demand all orgs work together toward the same goal…
…please be bold like Bob Dawson and tell it like it is - like it should be - and it will be. "Build it (cure it) and they will come!"…
Gosh, Peggy, I hardly know what to say. I think there should be a Parkinson’s group, concentrated heavily on going viral at low cost and almost no infrastructure…
But I’m not the one. Too old, too broke, too singular. The duties keep falling in the Young On-setters; I’m an Old Out-setter, fading into space.
Your second message: yes, Pharma builds the cost of lawsuits and criminal penalties into the cost of the drugs – one of them had to pay a billion dollars – and their stock immediately shot upwards, because they had budgeted two billion, and had it included in the price of the drug, so they made an extra billion in profits because the penalty was half of what they expected.
There are thousands of examples that show the medical industry behaving like ruthless drug dealers. What set me off a few years ago was (1) Amgen GDNF fiasco – the attitude, the lies, the moral corruption; (2) the famous shortage of sinemet – and we never did find out the truth, and there is still no back-up supply – if one factory goes down, we could be without sinemet within days and (3) one-third of medical research papers submitted for peer review, making fraudulent and false claims, sometimes direct falsification, and the silence of the medical industry that followed… except for a few researchers coming out and saying that they avoid peer review…. Because the peer review system enforces the status quo…
But I do agree with you that doing nothing more than identifying the bad guys gets us nowhere.
It’s one of the first things you begin to notice when you are diagnosed with PD.
There is no war against PD, there is a huge empire that lives off it, and the entire PD scene should be studied as an extreme example of just how dysfunctional a system can be.
Huge effort and cost, no results in research. Global problem; no global contacts among PD orgs. Doctors in some clinics paying $400,000 per year in liability insurance – lawyers take 50 to 75% of whatever they can extort. Hospital personnel with no clue why I need to have pills with me; PWP in isolation with no one following their story, PWP being fired even though still competent… and so on and so on.
The whole PD system does not work at all.
And as you say, it requires patient power.
Not patient begging

My husband would have willingly participated in clinical trials--he did join 23andme's efforts in the very beginning. He never "qualified" or fit the criteria for selection. now when the criteria for DBS has been liberalized, his disease has progressed so much, he still does not qualify.

olsen
stories like yours break my heart. What are we going to do everybody - sit and let us be finished off???
Sigh
Peg

Olsen,
Has your husband tried applying for a DBS study at the NIH / NINDS ? They might have more liberal criteria for participants. They are currently recruiting for a study – Deep Brain Stimulation Surgery for Movement Disorders -- the clinicaltrials.gov record is at:
http://clinicaltrials.gov/ct2/show/NCT01581580

When I was at the NIH last year for another study I talked to some of the clinicians who were also working on the DBS study, and they and I thought it might be a good option for me. They use more advanced techniques and equipment than our local neurosurgical center can provide and they complete the electrode implantation surgery in one session; also provide good follow-up care and adjustments . The NIH covers all medical expenses, plus traveling expenses, hotel and food for the participant and a care giver. I decided not to have dbs surgery at this time, but if I did I would have seriously considered this option. A member of our support group did participate in this study last year and he had only good things to say about the medical team and the care he received . He said he’s doing well. One more thing to consider though is that at this time, if you have dbs , that will probably exclude you from joining gene therapy studies . Lots of decisions…

Peg,

I couldn't agree more. However, it is not as easy as getting the word out like the Trial Finder. Pharma often wants drug naive participants and we get mired in complex psychological issues - namely the denial bubble diagnosed PWP live in. I was invited to join in a dopa agonist trial when I was first diagnosed. I was no way going to admit to having it. Think back to when you were first diagnosed? Were you ready to take on sham surgery or unproven pills? Many YO people also have families so invasive procedures involving the brain- not so popular.

In my mind, simply trying to get people to sign up without showing need will not cut it. Clinical trials need to be promoted as opportunity for something more innovative and useful than what we have now. They also need to know Amgen and facts about how little treatment options have changed in 40 years of research. I have tried carrying that message to YO forums and in chat rooms. People just say "oh really" than go on chatting. They are in such mild stage of disease it doesn't apply to them. I had people say that it doesn't apply to them because by the time they need treatment,there will be a cure!
In fact, I don't want to single any individual group out but I must point out that a newer patient oriented group records many polls and, I have read but one on clinical trials. In reading comments, it is clear the group is already aware and participatory. We need to reach out beyond our own peer group, but how to do that without scaring them off?

While we need to work on persuading people to step up for clinical trials, pharma in turn needs to design trials for more advanced stages.

Laura
You always come up with some extremely thought-provoking comments. And most of the time, they are both valid and reliable. I think we need a totally redesigned approval system, along with a pressing move to get experienced patients a place at the bargaining tables of important stakeholders.

I believe the research world would be amazed at our experiences, capabilities, and knowledge. We have much to offer (and our services are cheap!). I am not sure which group you mean in your comment about a newer group who has done lots of surveys. Can you message or email me with more specifics before I comment here?

You are a well-read and prolific writer. You could help in that capacity . So when and where do we sign up?
Peggy

Laura, perhaps Parkinson's movement might have something to offer you, or vice versa, there are YO people there with drive and a real will to make things happen globally, and perhaps this is an energy that could be tapped into. There are certainly people your age, creative and capable, and perhaps short video could be a place to start. Your posts are always so full of life and ideas, hope you are finding some of these people and making the connections you need.

You have a strong voice, much appreciated, and a will to see this stuff happen.

Don't ever get disheartened, there is always tomorrow, and another attempt at getting the world to take a fresh look at PD.

Olsen, I too found it hard to read your story, this should not be happening. I have a real belief in medicine being there for the patient when they need it, and know that the reality is often very far from that.

Lindy