Press release:
FOREST LABORATORIES, INC. AND GEDEON RICHTER PLC:
"FOREST LABORATORIES, INC. AND GEDEON RICHTER PLC ANNOUNCE POSITIVE PHASE III RESULTS WITH THE INVESTIGATIONAL ANTIPSYCHOTIC CARIPRAZINE IN PATIENTS WITH ACUTE MANIA ASSOCIATED WITH BIPOLAR I DISORDER
2/8/2012
BUDAPEST Hungary, and NEW YORK, February 8, 2012 -- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced preliminary top-line results from a Phase III clinical trial of cariprazine (RGH-188), an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder.
For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that cariprazine treated patients with acute manic episodes experienced significant improvements in symptoms compared to placebo-treated patients observed as early as day five of treatment and at each subsequent time point studied. The results of this study were consistent with the results observed in the two previously completed pivotal placebo-controlled cariprazine studies in this patient population. Further analyses of the data will be completed in the coming weeks. Cariprazine is also currently being investigated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment for Major Depressive Disorder.
“As we continue to move forward with the development of this important compound, these positive phase III results further demonstrate the opportunity for cariprazine as a potential new treatment option for patients suffering from bipolar mania” said Marco Taglietti, MD, Senior Vice President of Research and Development and President, Forest Research Institute.
“In the three consecutive positive trials, statistically significant results demonstrated improvement in symptoms compared to placebo, importantly including the low dose range arm. We consider today’s results a major milestone achieved on the long road towards bringing such a promising product to the market,” commented Zsolt Szombathelyi, MD, Research Director of Gedeon Richter Plc. "
---------------
This trial is recruiting participants and sponsored by the pharmaceutical company, collaborating with the partner pharmaceutical company. Looks like the indications are wanna-be Seroquel now that Seroquel is a soon-to-be-generic "wonder-drug".
Wednesday, February 08, 2012
Tuesday, February 07, 2012
The Chronicle of Higher Education: Carl Elliott: "I was being asked to lend my name to an article which the public relations office would ghostwrite"
via The Chronicle of Higher Education:
Faking It for the Dean
February 7, 2012, 2:13 pm
By Carl Elliott
Snippet:
"Then I read her email more carefully. I had initially thought I was being asked to write an article. In fact, however, I was being asked to lend my name to an article which the public relations office would ghostwrite, but which would be published under my byline. A reporter would interview me on the topic of my choice and write an article based on the interview. When I called the public relations officer back, I explained that it seemed deceptive to take credit for an article that I didn’t actually write. She bristled; the conversation turned chilly; and by the time we hung up, we had both agreed that I would make a very poor “author.”
Continue reading Brainstorm blogger Carl Elliott's article.
Note:
Carl Elliott, is the author of the Mother Jones article about Dan Markingson and the Seroquel CAFE trial gone bad--which you can read HERE--"The Deadly Corruption of Clinical Trials"
Faking It for the Dean
February 7, 2012, 2:13 pm
By Carl Elliott
Snippet:
"Then I read her email more carefully. I had initially thought I was being asked to write an article. In fact, however, I was being asked to lend my name to an article which the public relations office would ghostwrite, but which would be published under my byline. A reporter would interview me on the topic of my choice and write an article based on the interview. When I called the public relations officer back, I explained that it seemed deceptive to take credit for an article that I didn’t actually write. She bristled; the conversation turned chilly; and by the time we hung up, we had both agreed that I would make a very poor “author.”
Continue reading Brainstorm blogger Carl Elliott's article.
Note:
Carl Elliott, is the author of the Mother Jones article about Dan Markingson and the Seroquel CAFE trial gone bad--which you can read HERE--"The Deadly Corruption of Clinical Trials"
Friday, February 03, 2012
New blog to read: "MY BLOG and A DOG A psychotherapist's thoughts about life"
BY Mick Bramham, psychotherapist in the U.K.and a nice friend I've been chatting with on Twitter.Check out his blog! MY BLOG and A DOG-A psychotherapist's thoughts about life which showcases his dog Boris as well as neighboring ponies. My daughter,who loves horses and dogs, would love a pastureland setting like that!
Wednesday, February 01, 2012
Saturday, January 28, 2012
Harvard Sanctioned doctors Biederman, Wilens and Spencer to teach CME
SUNDAY, JULY 03, 2011
The Harvard Mea Culpa: Biederman, Wilens and Spencer , "Dear Colleagues"
VIA The Harvard Crimson.
Three Professors Face Sanctions Following Harvard Medical School Inquiry
Investigation by Medical School and Massachusetts General Hospital punishes psychiatrists accused by senator
"The conclusion of the two institutions’ investigation is the latest development in a three-year saga that brought intense scrutiny on the Medical School, as well as ties between academia and industry. Following Grassley’s investigation, legislation was proposed both in the State House and in Congress that would increase disclosure requirements for industry-sponosored gifts.
After Grassley issued his report, the Medical School said that it would be reviewing the doctors’ cases as well as reexamining its current regulations and improving implementation.
At Harvard, a review established the first University-wide set of guidelines pertaining to conflict of interest policies last summer. As of this past January, new conflict of interest guidelines at the Harvard Medical School include changes such as a prohibition on faculty from accepting personal gifts and tighter limits on faculty compensation from outside companies. "-Harvard Crimson
--------------
March 2012
CME by Grassley investigated and Harvard sanctioned doctors!
Ethical?
The Ethical and Safe On- and Off-Label Use of Psychotropics in Practice**
Thomas J. Spencer, MD; Timothy E. Wilens, MD; Janet Wozniak, MD
Moderator: Joseph Biederman, MD
Child & Adolescent Psychopharmacology 2012--Annah Abrams, MDPradeep G. Bhide, PhD Joseph Biederman, MD Barbara Coffey, MD, MSEsther J. Dechant, MDAlysa E. Doyle, PhD Oliver Freudenreich, MD Daniel A. Geller, MDPaul Hammerness, MDAude Henin, PhDDina R. Hirshfeld-Becker , PhD Michael S. Jellinek, MD Gagan Joshi, MDMichael Monuteaux, ScDRoy H. Perlis, MD Jefferson B. Prince, PhDRonald Schouten, MD, JD Thomas J. Spencer, MDCraig Surman, MD Karen Wagner, MD, PhD Timothy E. Wilens, MD Janet Wozniak, MD
Go to the link and click 'Agenda', 'Faculty' and 'CME Information' for details.
This is incredible to me, that these doctors are still able to push this agenda after stats such as Biederman's 4000% increase in Childhood Bipolar influence, Wagner's co-authorship of the scandalous PAXIL 329 study, the Harvard Sanction of Biederman, Spencer and Wilens... and the CME is pharmacology for kids and teens.
Just when you think the KOL influence is gone, think again$$$$$
Go to 1 Boring Old Man blog for a more detailed look at this: "inertia..."
Friday, January 27, 2012
North Carolina to monitor kids on Medicaid taking antipsychotics
via Hickory Daily Record
Read the article HERE.
"Child Medicaid recipients who are prescribed powerful antipsychotics now have the state looking over the shoulders of their doctors.
Last year, the state rolled out a web-based program called A+Kids (Antipsychotics — Keep It Documented for Safety) that will help it document the antipsychotics being prescribed to children under 18 years old.
According to information from the state, more than 20,000 children on Medicaid were prescribed antipsychotics in 2010.
Heavily medicated
Children being medicated with antipsychotic and other mood-altering medications have been in the news in recent months. Many of those reports have highlighted the number of those prescribed the medications who are in foster care as opposed to those also on Medicaid not in the foster system.
That’s because of a report from the US Government Accountability Office released at the end of last year that found foster children, some younger than a year old, in five states studied “were prescribed psychotropic drugs at higher rates than nonfoster children in Medicaid during 2008.” The five states were Florida, Massachusetts, Michigan, Oregon and Texas.
The report goes on to say sometimes the doses exceeded FDA maximum levels.
Dr. Randall Best, chief medical officer for North Carolina Department of Health and Human Services Division of Medical Assistance, said nationwide, 4 percent of child Medicaid patients are prescribed these medications compared to 1 percent of children with private health insurance. The number of foster children prescribed the medications is even higher, he said.
Why are so many kids being prescribed antipsychotics is a question that’s arisen, Best said. The medications being prescribed to children are not unique to North Carolina, he said. There’s been a big increase in antipsychotics being prescribed to children in recent years.
Generally, studies for medications are done on adults and are approved through those studies. Off-label medications also are commonly prescribed to adults.
These medications are very powerful drugs and have serious indications. Children need to be monitored because the medications can cause significant problems, including endocrine issues such as rapid weight gain and diabetes. The medications also can cause things such as tremors and other neurological problems, Best said."
Friday, January 20, 2012
To the Attorney General of Texas demanding a criminal investigation of J&J Janssen marketing practices of antipsychotic Risperdal
Sign the petition at the upper right corner of the blog
"To the Attorney General of Texas demanding a criminal investigation of J&J Janssen marketing practices of antipsychotic Risperdal"
The Petition
As a result of the state of Texas vs Janssen settlement of $158 million dollars; to seek and find justice for those who have been harmed by the illegal marketing of the antipsychotic Risperdal; for criminal investigation of J&J Janssen on behalf of those who used the drug as a result of deceptive marketing practices; for admission of guilt by J&J Janssen, this petition is signed by those supporting and seeking truth, and justice, and criminal charges placed to parties responsible for withholding information, hiding data and purposely deceiving the public, including Medicaid patients and providers. The public who have been deceived by J&J Janssen and the children who have been harmed by taking Risperdal due to illegal marketing practices deserve to see a criminal investigation.
---
With thanks to the whistleblower Allen Jones, expert witnesses Joseph Glenmullen, and Bruce Perry, to the 1 Boring Old Man blog author and retired psychiatrist who traveled to the trial and reported with interesting, heartfelt posts for all of us to read.
I believe it is time for the pharmaceutical companies caught in illegal marketing practices to be held accountable to the people they injured by pushing the drugs to populations such as children and elderly. I believe there should be top down accountability with more than monetary fines that pharma companies build into their budgets as "business as usual". The CIA's (Corporate Integrity Agreements)and Department of Justice fines are not doing the job they should be in policing these companies, they just keep on breaking the laws, in an insulting and dangerous manner to the people who are the most vulnerable: the people who take their medicines.
I wonder,at times if these drugs such as the antipsychotic Risperdal, or Zyprexa for example were not heavily marketed to children and doctors if there could have been a shift in the childhood bipolar diagnoses explosion, and how many kids are on or were on these drugs as a result of the marketing--would they have different outcomes--if their doctor had not considered Risperdal as a result of the marketing off-label for the antipsychotic. Accountability, and an admission of guilt to the crime of illegal marketing is what is left out of cases like the Texas Risperdal case. J&J Janssen and companies like Lilly and AstraZeneca et al, never do admit guilt in comments in media...never admit guilt even when evidence is stacked high.
That is wrong.
Please sign the petition to carry forward the quest for truth and honesty, accountability to the Attorney General of Texas, let the AG know we want the next dimension beyond what the whistleblowers have done for everyone. I personally would like to have known the trial outcome of a jury verdict. I have questions on why the case was settled and the jury trial stopped. I know I am not alone with these and more questions.
I do hope Allen Jones (and other whistleblowers) can find solace in knowing many of us are grateful and appreciate what he went through to shed light on a subject that affects us all.
Attorney General Of Texas
"To the Attorney General of Texas demanding a criminal investigation of J&J Janssen marketing practices of antipsychotic Risperdal"
The Petition
As a result of the state of Texas vs Janssen settlement of $158 million dollars; to seek and find justice for those who have been harmed by the illegal marketing of the antipsychotic Risperdal; for criminal investigation of J&J Janssen on behalf of those who used the drug as a result of deceptive marketing practices; for admission of guilt by J&J Janssen, this petition is signed by those supporting and seeking truth, and justice, and criminal charges placed to parties responsible for withholding information, hiding data and purposely deceiving the public, including Medicaid patients and providers. The public who have been deceived by J&J Janssen and the children who have been harmed by taking Risperdal due to illegal marketing practices deserve to see a criminal investigation.
---
With thanks to the whistleblower Allen Jones, expert witnesses Joseph Glenmullen, and Bruce Perry, to the 1 Boring Old Man blog author and retired psychiatrist who traveled to the trial and reported with interesting, heartfelt posts for all of us to read.
I believe it is time for the pharmaceutical companies caught in illegal marketing practices to be held accountable to the people they injured by pushing the drugs to populations such as children and elderly. I believe there should be top down accountability with more than monetary fines that pharma companies build into their budgets as "business as usual". The CIA's (Corporate Integrity Agreements)and Department of Justice fines are not doing the job they should be in policing these companies, they just keep on breaking the laws, in an insulting and dangerous manner to the people who are the most vulnerable: the people who take their medicines.
I wonder,at times if these drugs such as the antipsychotic Risperdal, or Zyprexa for example were not heavily marketed to children and doctors if there could have been a shift in the childhood bipolar diagnoses explosion, and how many kids are on or were on these drugs as a result of the marketing--would they have different outcomes--if their doctor had not considered Risperdal as a result of the marketing off-label for the antipsychotic. Accountability, and an admission of guilt to the crime of illegal marketing is what is left out of cases like the Texas Risperdal case. J&J Janssen and companies like Lilly and AstraZeneca et al, never do admit guilt in comments in media...never admit guilt even when evidence is stacked high.
That is wrong.
Please sign the petition to carry forward the quest for truth and honesty, accountability to the Attorney General of Texas, let the AG know we want the next dimension beyond what the whistleblowers have done for everyone. I personally would like to have known the trial outcome of a jury verdict. I have questions on why the case was settled and the jury trial stopped. I know I am not alone with these and more questions.
I do hope Allen Jones (and other whistleblowers) can find solace in knowing many of us are grateful and appreciate what he went through to shed light on a subject that affects us all.
*Bloggers: Click 'sign' tab on petition, and on the right side bar of the petition page is a "Spread the word" button to click "Help promote this petition with a widget on your site" for a widget badge html to place on your blog if desired.
Attorney General Of Texas
Thursday, January 19, 2012
Allen Jones is pleased, says the 1 Boring Old Man blog: Risperdal Texas trial outcome
"Here’s an example of how the settlement brings pain and anguish back for me as a parent of a child who is a “product” of the Biederman/pharma psychiatric crime against humanity:
from twitter.
I am one who does say it is a crime to consider biz as usual part of this process. I know the trial wasn’t about the kids or the people being given justice, all the same, I had a glimmer of hope that this trial would end with a JURY verdict, not a settlement.
I do thank Allen Jones, Bruce Perry and Joseph Glenmullen for their testimonies.
It is important to never forget the children harmed in Texas and all over the country, at the expense of their health, J&J Janssen made a profit and for these children, justice remains to be served."
from twitter.
I am one who does say it is a crime to consider biz as usual part of this process. I know the trial wasn’t about the kids or the people being given justice, all the same, I had a glimmer of hope that this trial would end with a JURY verdict, not a settlement.
I do thank Allen Jones, Bruce Perry and Joseph Glenmullen for their testimonies.
It is important to never forget the children harmed in Texas and all over the country, at the expense of their health, J&J Janssen made a profit and for these children, justice remains to be served."
J&J to pay $158 million to settle Risperdal case -- not 1 billion as expected!
Marketwatch J&J to pay $158 million to settle Risperdal case:
"Johnson & Johnson's Janssen Pharmaceuticals unit said Thursday it has reached a settlement with the State of Texas under which it will pay $158 million "in full resolution of all claims" in litigation over its antipsychotic drug Risperdal. The deal will cover claims brought by the state in 2004 for Medicaid overpayment from 1994 to 2008 "and will circumvent potentially lengthy and costly appellate activities," the company said."
With expert witnesses such as Bruce Perry, Joseph Glenmullen and whistle blower Allen Jones testifying, no wonder J&J Janssen wanted to settle, but the question remains, as to why they got off so cheap!!
"Johnson & Johnson's Janssen Pharmaceuticals unit said Thursday it has reached a settlement with the State of Texas under which it will pay $158 million "in full resolution of all claims" in litigation over its antipsychotic drug Risperdal. The deal will cover claims brought by the state in 2004 for Medicaid overpayment from 1994 to 2008 "and will circumvent potentially lengthy and costly appellate activities," the company said."
With expert witnesses such as Bruce Perry, Joseph Glenmullen and whistle blower Allen Jones testifying, no wonder J&J Janssen wanted to settle, but the question remains, as to why they got off so cheap!!
J&J Janssen reported to have settled Risperdal case
GO to 1 Boring Old Man read to UPDATE in this post at Boring Old Man blog Reports there settlement talk
Also in that post: J&J Hid 3 Risperdal Diabetes Studies From FDA, Texas Jury Told--Bloomberg
Glenmullen testified
"Jan. 19 (Bloomberg) -- Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.
As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday.
That study concluded Risperdal caused “medically serious weight gain” that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added."
Source: Johnson & Johnson Settles Suit With Texas
Also in that post: J&J Hid 3 Risperdal Diabetes Studies From FDA, Texas Jury Told--Bloomberg
Glenmullen testified
"Jan. 19 (Bloomberg) -- Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.
As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday.
That study concluded Risperdal caused “medically serious weight gain” that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added."
Source: Johnson & Johnson Settles Suit With Texas
Wednesday, January 18, 2012
Alison Bass: From the Pentagon Papers to Allen Jones: Why it’s so hard to be a whistleblower
This is worth reading:
"From the Pentagon Papers to Allen Jones: Why it’s so hard to be a whistle blower" , by Alison Bass
From the Pentagon Papers to Allen Jones: Why it’s so hard to be a whistleblower Alison Bass is the author of Side Effects.
"From the Pentagon Papers to Allen Jones: Why it’s so hard to be a whistle blower" , by Alison Bass
From the Pentagon Papers to Allen Jones: Why it’s so hard to be a whistleblower Alison Bass is the author of Side Effects.
"Another thing I know is that the off-label marketing of Risperidal for kids was Janssen directed, Janssen executed, and blatant" 1 Boring Old Man
"Another thing I know is that the off-label marketing of Risperidal for kids was Janssen directed, Janssen executed, and blatant."
Writes retired psychiatrist and 1 Boring Old Man blogger, regarding his thoughts from sitting in on the Texas Janssen Risperdal trial.
Writes retired psychiatrist and 1 Boring Old Man blogger, regarding his thoughts from sitting in on the Texas Janssen Risperdal trial.
Woman with schizophrenia nearly forced to have abortion
Court strikes decision for mentally ill woman’s abortion
Backs rights those ruled incompetent
"Earlier this month, a Norfolk probate judge declared a pregnant woman with schizophrenia incompetent and ordered her to undergo an abortion, stating she could be “coaxed, bribed, or even enticed’’ into the hospital for the procedure.
Unbidden, the judge further directed that the 32-year-old woman be sterilized “to avoid this painful situation from recurring in the future.’’
Yesterday, the state’s appeals court struck down the decision in unusually harsh terms, saying the woman had clearly expressed her opposition to abortion as a Catholic."
---
This is atrocious!
Thank goodness she had this taken to the Appeals Court. It is not a crime to have mental illness, nor should people be treated this way, it's eugenics!
Backs rights those ruled incompetent
"Earlier this month, a Norfolk probate judge declared a pregnant woman with schizophrenia incompetent and ordered her to undergo an abortion, stating she could be “coaxed, bribed, or even enticed’’ into the hospital for the procedure.
Unbidden, the judge further directed that the 32-year-old woman be sterilized “to avoid this painful situation from recurring in the future.’’
Yesterday, the state’s appeals court struck down the decision in unusually harsh terms, saying the woman had clearly expressed her opposition to abortion as a Catholic."
---
This is atrocious!
Thank goodness she had this taken to the Appeals Court. It is not a crime to have mental illness, nor should people be treated this way, it's eugenics!
Tuesday, January 17, 2012
Just say NO to Internet Censorship
http://sopastrike.com/
" Stop Online Piracy Act (SOPA). In the Senate the bill is called the PROTECT IP Act (PIPA). SOPA has gotten more attention than PIPA because it was moving faster in the legislative process. But PIPA is just as dangerous, and now it is moving faster.
PIPA would give the government new powers to block Americans' access websites that corporations don't like. The bill lets corporations and the US government censor entire websites and cut sites off from advertising, payments and donations.
This legislation will stifle free speech and innovation, and even threaten popular web services like Twitter, YouTube, and Facebook.
The bill is scheduled for a test vote in the Senate on Jan. 24th"
http://fightforthefuture.org/pipa
U.K. new blog by a mental health nurse whistle-blows on abuse
The blog, simply titled Dear Blog has a new post up detailing inside abuses witnessed by this U.K. mental health nurse.
*Update 1 18 12
blog posts are removed, see comment at Dear Blog
On Twitter HERE
*Update 1 18 12
blog posts are removed, see comment at Dear Blog
On Twitter HERE
Sunday, January 15, 2012
The Marketing of antipsychotic Risperdal to kids:" I was by now fully alert and fighting the impulse to stand up and say, "Are you serious?" the trial
1 Boring Old Man blogger, and retired psychiatrist writes about the J&J Janssen Risperdal trial in Texas, now on the subject of marketing the antipsychotic to children.
Excerpt:
Excerpt:
"As they droned on, nit-picking the call-notes ["How do you know when the note says 'kids' that they meant...?"], my mind wandered. Then, they produced the fourth document. It was Janssen’s request for approval for children [1996] to the FDA – the one turned down in the third document [above]. Mr. Friede hadn’t seen it. It was as advertised – saying since people were already using Risperdal in kids, why not approve it? I was still not fully attentive, but then I got the gist of where the cross-examiner was going. He was suggesting that Janssen was applying for approval with no supporting data or studies for altruistic reasons. He suggested that since it was already being used in kids and teens, Janssen wanted approval so their drug reps could talk to doctors about the proper doses – to keep doctors from using excessive doses of Risperdal. I was by now fully alert and fighting the impulse to stand up and say, "Are you serious?" "
Thursday, January 12, 2012
Pharmaceutical crimes and corruption: Deadly twist to the pharma-doctor Serbian bribery story
AstraZeneca was indicted in Serbia for alleged bribery, and the former head of the Institute of Radiology and Oncology in Belgrade is found dead, of possible suicide, hanged in a forest.
VIA The Seroquel Lawsuit blog
November 2011
AstraZeneca Indicted for Bribery - pharmaceutical corporate crime wave continues unabated - What CIA ?
January 2012
Nenad Borojević, former head of the Institute of Radiology and Oncology in Belgrade & The Doctor at the center of AstraZeneca's Bribery & Violations of the Foreign Corrupt Practices Act was found hanged in a forest.
November 2011
AstraZeneca Indicted for Bribery - pharmaceutical corporate crime wave continues unabated - What CIA ?
January 2012
Nenad Borojević, former head of the Institute of Radiology and Oncology in Belgrade & The Doctor at the center of AstraZeneca's Bribery & Violations of the Foreign Corrupt Practices Act was found hanged in a forest.
Whistleblower Allen Jones testifies "“The account was used to deposit money from drug companies" J&J Janssen Risperdal trial
VIA Bloomberg Business:
J&J Whistle-Blower Recounts Firing After Finding Payments
Bloomberg
"Jan. 12 (Bloomberg) -- A whistle-blower who sued Johnson & Johnson over the marketing of its antipsychotic Risperdal said he was fired after probing company payments to a top pharmacist in Pennsylvania’s government who hid the money.
Allen Jones testified today in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said.
Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “to the attention of” Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent “in care of” of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said.
“The account was used to deposit money from drug companies,” Jones said in the trial’s third day of testimony. “There were real problems here. On many levels, the account was improper.”
Read entire HERE.
Be sure to check 1 Boring Old Man blog daily daily, as he is the retired psychiatrist who travelled to sit in on the trial, and is blogging the trial as it goes.
J&J Whistle-Blower Recounts Firing After Finding Payments
Bloomberg
"Jan. 12 (Bloomberg) -- A whistle-blower who sued Johnson & Johnson over the marketing of its antipsychotic Risperdal said he was fired after probing company payments to a top pharmacist in Pennsylvania’s government who hid the money.
Allen Jones testified today in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said.
Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “to the attention of” Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent “in care of” of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said.
“The account was used to deposit money from drug companies,” Jones said in the trial’s third day of testimony. “There were real problems here. On many levels, the account was improper.”
Read entire HERE.
Be sure to check 1 Boring Old Man blog daily daily, as he is the retired psychiatrist who travelled to sit in on the trial, and is blogging the trial as it goes.
Dan Abshear: "The Mean and Unclean TeenScreen
An article by ex-pharma-rep Dan Abshear who is currently working to help "homeless military Veterans get back on their feet".
"TeenScreen tacitly considers the pharmaceutical industry their sponsor, as indicated by the amount of money this industry gives NAMI, which is about 3 million dollars a year. Eli Lilly is the top briber of NAMI, as they are the top drug company with the most prescribed psychotropic drugs, unfortunately.
Front groups, they are, that wear the masks of advocacy groups. Over half of the revenue of such groups comes from the pharmaceutical industry. TeenScreen is no different."-Dan Abshear
Go read the entire article HERE.
"TeenScreen tacitly considers the pharmaceutical industry their sponsor, as indicated by the amount of money this industry gives NAMI, which is about 3 million dollars a year. Eli Lilly is the top briber of NAMI, as they are the top drug company with the most prescribed psychotropic drugs, unfortunately.
Front groups, they are, that wear the masks of advocacy groups. Over half of the revenue of such groups comes from the pharmaceutical industry. TeenScreen is no different."-Dan Abshear
Go read the entire article HERE.
Wednesday, January 11, 2012
2004:"My name is Allen Jones, I am a whistleblower"..."
This week the J&J Janssen trial began in Austin, Texas.It is the complex story of paid officials, a medical model called TMAP (Texas Medication Algorithm Project)Teen Screen, and the marketing of an antipsychotic named Risperdal. In the pdf document linked HERE, you'll find whistleblower Allen Jones tell his story, which is gripping, and 66 pages long. I implore you to read it.
Allen Jones, Texas v Janssen pdf lawsuit document HERE filed 12-2008
2005:Medicating Aliah-Mother Jones
"The case of Aliah Gleason raises troubling—and long-standing—questions about the coercive uses of psychiatric medications in Texas and elsewhere. But especially because Aliah lives in Texas, and because her commitment was involuntary, she became vulnerable to an even further hazard: aggressive drug regimens that feature new and controversial drugs—regimens that are promoted by drug companies, mandated by state governments, and imposed on captive patient populations with no say over what's prescribed to them."
News from the trial 1.11.12
Bloomberg Business Week J&J Paid Texas Official to Speak Around the U.S., Jury Told:
"Jan. 11 (Bloomberg) -- Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to the company’s Risperdal medicine, the official told jurors today."-Bloomberg
"The case of Aliah Gleason raises troubling—and long-standing—questions about the coercive uses of psychiatric medications in Texas and elsewhere. But especially because Aliah lives in Texas, and because her commitment was involuntary, she became vulnerable to an even further hazard: aggressive drug regimens that feature new and controversial drugs—regimens that are promoted by drug companies, mandated by state governments, and imposed on captive patient populations with no say over what's prescribed to them."
--------
News from the trial 1.11.12
Bloomberg Business Week J&J Paid Texas Official to Speak Around the U.S., Jury Told:
"Jan. 11 (Bloomberg) -- Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to the company’s Risperdal medicine, the official told jurors today."-Bloomberg
Sunday, January 08, 2012
1 Boring Old Man: "the games begin": Texas, Risperdal, TMAP
Excerpt from 1 Boring Old Man; click on title of this post to go to the retired psychiatrist's blog to read the entire article:
Nine hours and counting from now the TMAP/J&J suit finally makes it to a courtroom and the jury selection begins. I’ve only known about this case for a year. But for Allen Jones, it has been a decade since he first got the scent of the wrongdoing alleged in this case. The whistle-blower suit itself was filed eight years ago. I have no clue what it would be like to have something like this on my mind every day for a decade, much less what it would feel like to finally be going to court and testifying in a matter of days. Certainly, the financial stakes are high – the lawyers speak of a billion dollars. But there will be other high stake issues at play in this courtroom. This case brings up so many of the deceptive practices that characterized the invasion of the pharmaceutical industry into academic psychiatry and psychiatric practice, all put into action behind closed doors. With this case, there are added twists. J&J targeted public mental health care. The taxpayers of the State of Texas were the victims along with the State’s mentally ill in hospitals, clinics, and prisons. TMAP was run by academic psychiatrists from Texas’ medical schools
, and the psychiatrists who administered TMAP, traveling the country as TMAP evangelists to other States, were employed by the Texas Mental Health system. It’s hard to wrap my mind around the fact that the State’s own academic and institutional doctors were themselves agents of Johnson & Johnson in defrauding the State’s taxpayers and the State’s mentally ill. Getting this story into the public eye is as important as any punitive damages that might come in this suit. Let the games begin…
, and the psychiatrists who administered TMAP, traveling the country as TMAP evangelists to other States, were employed by the Texas Mental Health system. It’s hard to wrap my mind around the fact that the State’s own academic and institutional doctors were themselves agents of Johnson & Johnson in defrauding the State’s taxpayers and the State’s mentally ill. Getting this story into the public eye is as important as any punitive damages that might come in this suit. Let the games begin… Texas AG goes to court this week: J&J and antipychotic Risperdal case
And the 1 Boring Old Man author, a retired psychiatrist is on the way to go witness this case in person:
"I started medical school at twenty-two, and went out of my way to change my specialty to psychiatry at thirty-three. It felt like the thing I was supposed to be doing. At the risk of sounding corny, I always felt honored to be allowed to practice medicine, and particularly psychiatry as I have known it. Now at seventy, if people are going to trivialize that, to treat it like some entrepreneurial business venture that doesn’t have to do with the fate of the patients being treated, and if some psychiatrists participated in that venture, I want to hear it in person. I’ve always thought that the question "If a tree falls in the forest and no one hears it – does it make a sound?" has an definite answer. "No!" That’s certainly true in psychotherapy – step one to untying the knots is having your story heard by another person. I just want the J&J/TMAP story heard, so that’s why I’m going to to Texas to be one of the people that hears it…"
This doctor deserves a standing ovation.
AG Austin,Texas:State attorney general sued drug company
Abbott: state paid excessively to Johnson & Johnson for Risperdal:Statesman.com
"Texas Attorney General Greg Abbott is pitted against one of the largest multinational pharmaceutical companies in a trial starting this week that could bring the state more than $1 billion one of its largest potential awards since a multibillion-dollar tobacco settlement in 1998.
Abbott is charging that Johnson & Johnson Inc., its wholly owned subsidiary Janssen Pharmaceutical LLC and five other related companies defrauded the state in a "sophisticated marketing scheme" that caused the Texas Medicaid Program to pay too much for Janssen's schizophrenia drug Risperdal, the lawsuit says.
The state also questions the companies' marketing practices and alleges that the companies misled state health officials about the drug's effectiveness, the risk of side effects and its suitability for pediatric use.
The trial is scheduled to begin 9 a.m. today in Judge John Dietz's 250th state District Court in Travis County.
The drug companies have denied the allegations in court documents and in a statement issued last week.
"Janssen is prepared to vigorously defend itself against these claims," the company said. "We are committed to ethical business practices and have policies in place to ensure that our products are only promoted for their FDA-approved indication. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action."
Texas got involved with Risperdal litigation about six years ago, when Abbott's office joined a lawsuit filed by corporate whistle-blower Allen Jones, who is a former employee of the office of the inspector general of Pennsylvania.
Jones has questioned the process for how Risperdal was approved in Texas and how that information was used by other states in their approval processes.
Jones filed suit in 2004 after his investigation in Pennsylvania led him to examine the companies' track record in Texas. As a whistle-blower plaintiff, he alleged that the companies overcharged the states and overstated the drug's effectiveness.
Risperdal, approved by the FDA in 1993, was one of Johnson & Johnson's top-selling drugs. Sales dropped off when Risperdal got generic competition in June 2008. Originally, the drug was only approved for adults, but later the FDA allowed it for children and the elderly.
Texas' case alleges that the drug companies prevented state health officials from receiving "truthful information about the safety, efficacy, appropriate uses and cost-effectiveness of Risperdal."
------
Wouldn't it be nice to see some prison time for such illegal practices? fines, large or small are not doing the job.
"I started medical school at twenty-two, and went out of my way to change my specialty to psychiatry at thirty-three. It felt like the thing I was supposed to be doing. At the risk of sounding corny, I always felt honored to be allowed to practice medicine, and particularly psychiatry as I have known it. Now at seventy, if people are going to trivialize that, to treat it like some entrepreneurial business venture that doesn’t have to do with the fate of the patients being treated, and if some psychiatrists participated in that venture, I want to hear it in person. I’ve always thought that the question "If a tree falls in the forest and no one hears it – does it make a sound?" has an definite answer. "No!" That’s certainly true in psychotherapy – step one to untying the knots is having your story heard by another person. I just want the J&J/TMAP story heard, so that’s why I’m going to to Texas to be one of the people that hears it…"
This doctor deserves a standing ovation.
AG Austin,Texas:State attorney general sued drug company
Abbott: state paid excessively to Johnson & Johnson for Risperdal:Statesman.com
"Texas Attorney General Greg Abbott is pitted against one of the largest multinational pharmaceutical companies in a trial starting this week that could bring the state more than $1 billion one of its largest potential awards since a multibillion-dollar tobacco settlement in 1998.
Abbott is charging that Johnson & Johnson Inc., its wholly owned subsidiary Janssen Pharmaceutical LLC and five other related companies defrauded the state in a "sophisticated marketing scheme" that caused the Texas Medicaid Program to pay too much for Janssen's schizophrenia drug Risperdal, the lawsuit says.
The state also questions the companies' marketing practices and alleges that the companies misled state health officials about the drug's effectiveness, the risk of side effects and its suitability for pediatric use.
The trial is scheduled to begin 9 a.m. today in Judge John Dietz's 250th state District Court in Travis County.
The drug companies have denied the allegations in court documents and in a statement issued last week.
"Janssen is prepared to vigorously defend itself against these claims," the company said. "We are committed to ethical business practices and have policies in place to ensure that our products are only promoted for their FDA-approved indication. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action."
Texas got involved with Risperdal litigation about six years ago, when Abbott's office joined a lawsuit filed by corporate whistle-blower Allen Jones, who is a former employee of the office of the inspector general of Pennsylvania.
Jones has questioned the process for how Risperdal was approved in Texas and how that information was used by other states in their approval processes.
Jones filed suit in 2004 after his investigation in Pennsylvania led him to examine the companies' track record in Texas. As a whistle-blower plaintiff, he alleged that the companies overcharged the states and overstated the drug's effectiveness.
Risperdal, approved by the FDA in 1993, was one of Johnson & Johnson's top-selling drugs. Sales dropped off when Risperdal got generic competition in June 2008. Originally, the drug was only approved for adults, but later the FDA allowed it for children and the elderly.
Texas' case alleges that the drug companies prevented state health officials from receiving "truthful information about the safety, efficacy, appropriate uses and cost-effectiveness of Risperdal."
------
Wouldn't it be nice to see some prison time for such illegal practices? fines, large or small are not doing the job.
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