Today’s court day was long and without dramatic moment, but filled with substantive testimony from a single expert witness – NYC Lawyer Arnold Friede. He’s an interesting man – born in a holocaust survivor camp in Germany and immigrating to the US [Pennsylvania] as a 2 year/old. After graduating in Law from George Washington and doing several clerkships, he became a lawyer for the FDA. Later he worked for Pfizer and then in practice – specializing in FDA Law. He’s now a senior, but is sharp as a tack and has a knack for saying very complex things simply, yet he’s never been an Expert Witness [first time, billing @ $525.00/hour]. The topics were Janssen’s misbranding and off-label promotion of Risperidal – including the off-label promotion for use in children and adolescents. Those things are illegal.
Here’s the short version: The FDA early on specifically prohibited Janssen from promoting Risperdal as either safer or more efficacious that Haldol [or any other first generation drug]. They didn’t comply [in spades], and were sent a warning letter [which they essentially ignored]. They were mandated to send a dear doctor letter about the later warning about Diabetes. Instead, they used the letter to claim superiority for Risperdal. Another warning from the FDA was required to get them to send another more appropriate letter. Mr. Friede analyzed reams of documents and concluded they were guilty of misbranding [prohibited superiority] and off-label promotion [children and adolescents]. They showed this at three levels – corporate business plans, training programs for their representatives, and in the field [call notes filled out by their reps]. The latter was particularly convincing: sales reps detailing psychiatrists about Risperdal’s superiority over Haldol and others, sales reps detailing child psychiatrists about use in kids when there was no approved indication. Some exhibits were bizarre – telling the reps to say the prohibited thing in "every selling situation" – stamped with "for your information, not to be used in a selling situation." I thought it was a slam-dunk. On cross examination, they picked and picked. Mr. Fried maintained his composure and didn’t miss a beat as they tried to put words in his mouth [but I’m not on the jury].
On the side of my mind, I was thinking about the day before, and the life Allen Jones has lived for a decade. In a comment, aek said, "The norm for whistle blowers is that they get sick and die. This man is effectively ostracized. Observing him without supporting him in a real and personal manner just perpetuates the ostracism. Whether or not he eventually wins a monetary award will not mitigate his suffering." I don’t know if I would’ve said it quite that way, but that’s the point – I don’t know because I haven’t lived it. It’s actually not for me to say. There are some human experiences that others can’t really understand. I learned a bit about that half a life ago when I developed a painful back problem that never got better, even with surgery. I learned to not talk about it, because even well-meaning responses were alienating. People would recount their own back stories [but they got better]. It helped me out to understand that they had nothing in their own catalog of experiences that fit mine. They couldn’t under-stand. Then treating people with PTSD, I learned that the afflicted regularly feel misunderstood, particularly if someone says, "I understand," or tries to relate it to their own experience. Trauma is associated with a fragmentation of cognitive and emotional function accompanied by unique features, and that’s true even of soldiers with similar military circumstances.
My guess is that a decade of being a "whistle-blower," awaiting a trial that will either validate or deny your narrative has some similarities to the plight of traumatized people. How could another person know what that’s like to have a "whistle-blower" identity, 24 hours of every day? It’s obvious in this trial how much preparation has gone into just the three days I’ve been sitting through. So the coming suit has to have been a constant preoccupation. I doubt that finally testifying or even the jury’s decision will turn off the strain of the last eight to ten years. Others may know the details or be passionate about the issues, but they can’t know the consequences of being locked in the past [the period when it all happened and the decisions of those days] and the future [the coming trial, or appeal]. Like in PTSD, it’s a unique experience. With it, one must feel isolated. Without it, you’re not you.
Risperal reproached.
Johnson and Johnson is a trusted brand we associate with babies.
Risperdal,Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use. A report by Dr. Cooper at Vanderbilt University states that 2.5 million children are now taking atypical antipsychotics. Over half are being given them for Attention Deficit Hyperactivity Disorder,many of these foster children.
Weight gain, increases in triglyceride levels and associated risks for (life-long) diabetes and cardiovascular disease.This is profit-mongering pure and simple a script for Zyprexa can cost $450 bottle.Sadly,big pharma promotional tactics have the same public integrity perception as big tobacco.-Daniel Haszard
*Tell the truth don’t be afraid*
It’s not simply the obstacles in life that shape or define who we are as a person, anymore than those calendar marked events of our trumpeted victories. For we all most certainly face both in some significant degree or another..some events have the power stop us in our tracks..knock us down, wound us, leave lasting impressions or reminding scares that linger with us in time & experience.
I happen believe it’s what you “do” with those obstacles/trials within the constraints of these circumstances that make us what we truly are & create a deeper/greater meaning to our lives…life is seldom a constant, but an ever involving process..
It been said that the devil is out there, there are those that deny it exist, those that bury it’s presence, and those that turn away & run for safer ground…and then there are those that stand up, step out on to the floor & learn to dance with the demon…sore toes & all learning through sacrifice and persistence how to turn personal tragedy into a greater triumph…
The Mickey’s, Jones, and the whole host of other inspiring voices we see each day around us or even perhaps in our own life; are from those that made a conscious choice to do the “right thing”, take a road less traveled, and then acted upon it…as the poet R. Frost wrote…that has made all the difference
Thank you for writing this. There is so little literature and virtually no research or clinical application about whistle blowing and ostracism. When I blog about either, I lose readers and “hits”. On a core fundamental basis, I think that it’s limbically perceived as dangerous for people to affiliate – even mentally – with those deemed the “undesirable other” and those who are ostracized.
I have learned never, ever to let my guard down for even a moment with others because that will precipiate an instant and permanent withdrawal. Therefore, my entire life is lived as a secret – a lie.
And since all supports have been withdrawn – family, friends, trusted professionals (there is no such thing), there is no longer any reference point or reason to go forward.
C Fred Alford writes about this so well in his Whistleblower Narratives book, and Kipling Williams is one of 2 researchers who writes about ostracism. I wrote Dr. Alford to ask if he had come across a single whistleblower who by any definition had gone on to have a satisfactory life. He couldn’t identify any. I keep searching for role models, but except for the rare whistleblower who wins a large $ reward (and that is always ID’ed as the definition of a successful life) and has the means by which to purchase support and re-entry into society, there doesn’t seem to be anything or anyone at all out there. It’s extreme alienation, and it validates the historical use of ostracism as a death sentence.
There is an awful feeling of helplessness to move forward because to do so relies on others’ willingness to help and trustworthiness – and those are no longer available to me. But moreso, is the horror at not being able to help others who find themselves in the same vacuum. Alford describes this in the whistleblower group meetings where they are “stuck” in their narratives. It’s stagnate because they have been removed from fresh air, so to speak.
Well wishes are empty words which come and go but which lead to no meaningful relationships, social acceptance, career opportunities, family support, etc.
My experience tells me that Allen Jones will be a long forgotten hiccup to you, while he struggles until his death to deal with the “big lie” that society is based on anything true and good. I so hope that I’m wrong.
The link at my name goes to my cut and paste of Alford’s list of what’s included in the what I termed the “big lie”. I wish he had a web presence because his work is readable and doesn’t repel readers, as does mine.
Interesting study on the whistleblower topic
http://www.nejm.org/doi/full/10.1056/NEJMsr0912039
New England Journal of Medicine
Whistle-Blowers’ Experiences in Fraud Litigation against Pharmaceutical Companies
“Despite the negative experiences and dissatisfaction with levels of financial recovery, 22 of the 26 relators still felt that what they did was important for ethical and other psychological or spiritual reasons. Relators offered a range of advice for others who might find themselves in similar situations (Table 4TABLE 4
Whistle-Blowers’ Advice for Others Considering the Qui Tam Process.
). Some offered strategic suggestions, such as hiring an experienced personal attorney, and many suggested a need to mentally prepare for a process more protracted, stressful, and conflict-ridden, and less financially rewarding, than prospective whistle-blowers might expect.”
I know exactly how Allen feels. I too sacrificed me career to try and stop the drugging of my mother (with the same TMAPS drugs). The hard part is knowing just how corrupt the gov. at every level is. I know: I found out the hard way starting in 2001 as I was wrongfully banned from seeing my mother for most of 4 years, for daring to notice and complain about drugs. Sadly, I also know that even the Attorney General and others are too influenced by pharma. I gave them enough hard evidence; care, justice, and accountability has been bought at every level of go. I have years of documents to prove all. The common factor between 3 nursing homes which banned me was that a large nursing home chain owned the pharma services provider co. which was contracted with the state to monitor and help prescribe at their own and all area homes. Now an x-rep for that same large chain heads DHS.Now a minute goes by that my heart doesn’t ache and I am not ashamed of this whole gov.. Who understands, who cares; when I found Allen I regained some faith in humanity!
Thanks so much for your coverage. I wish I were there and I hope that I will find some way to get there. My husband is terminally ill with cancer. My plight is very similar to those you write about; as not a minute goes by that I have not been sickened by all that I and too many others had to find out the hard way. I feel totally betrayed. I’m even angry at our schools for not teaching us the real truth about how egregiously corrupt that our government has become. Yes, after so many years, the pain, financial hardships of seeking care and justice, dealing with feelings of betrayal by friends and family who just want to resume life and disregard my need to see justice served and these crimes against us stopped. I keep expecting public outrage; but, it’s not there; and now I am sure that it must be because of something added to the water. Do we really understand who the real terrorists are?
Thank you Alllen, we all wish we could be there. You have our prayers!