This is an audio podcast interview which is a new addition to Bob Fiddaman's blog.
Fiddaman, a Paxil/Seroxat withdrawal survivor and mental health activist, is also the author of the book The Evidence, However, Is ClearThe Seroxat Scandal.
For my deaf readers, if a transcript becomes available I will post or link to it. Shane's mother has a blog where she writes this about her son:
"My name is Leonie and my son’s name was Shane Clancy. He Killed himself and another young man on Aug 16th 2009. He was on cipramil (celexa) for three weeks. He never had a violent bone in his body.I know without a shadow of doubt that the drug caused Shane to behave like this. The jury at Shane’s inquest returned an open verdict..(rejecting a suicide verdict). Professor David Healy who was the expert witness at the inquest clearly stated that this can happen to a small minority of people who can have a bad reaction to these anti-depressants. This becomes a major problem when there are millions of people across the globe being treated with these drugs! After the inquest Lundbeck (the makers of cipramil) stated on RTE news that their drug could not have caused this and there was no evidence to support our claim. The Irish college of psychiatry came out to defend Lundbeck and dismiss what we were saying. The Irish Medicines Board say that the patient information Leaflet give sufficient warning and we dont need a black box warning here like they have in canada and the usa."
FIDCAST - EPISODE I - AN INTERVIEW WITH LEONIE FENNELL, MOTHER OF SHANE CLANCY.
FIDCAST - Episode one features an interview with Leonie Fennell, the mother of 22 year old Shane Clancy, who, after only 17 days on the SSRi Cipramil [Celexa], killed a young man and seriously injured two other people before killing himself.
http://fiddaman.blogspot.com/
Wednesday, March 30, 2011
Tuesday, March 29, 2011
Academic freedom? was Dr.Mark Foster fired for speaking his views on psychiatric medications?
Dr. Mark Foster has been writing letters to Robert Whitaker after reading Whitaker's book, Anatomy of an Epidemic.
"It seems to me that she is a person who was originally medicated because it was assumed by well-meaning medical professionals that she lacked the aptitude or desire to cope with life on her own terms. I wasn't involved in that decision, so I don't want to judge, and maybe their approach served a purpose in its time. But I think they underestimated her. I almost did, too. She is resilient, and has a glowing fire of resolve and toughness within her that is now shining through. She has just completed a very difficult thing, this Effexor withdrawal, and I believe her victory will bolster her self-concept and sense of inner strength. That bodes well for her future mental and emotional wellness, no medicines required."
The letters have been a great story in itself reading a transformation of sort of a doctor and patients while sorting out a medicated life vs. medicating life situations and the rest.
Here's an excerpt from March 15, 2011
"It seems to me that she is a person who was originally medicated because it was assumed by well-meaning medical professionals that she lacked the aptitude or desire to cope with life on her own terms. I wasn't involved in that decision, so I don't want to judge, and maybe their approach served a purpose in its time. But I think they underestimated her. I almost did, too. She is resilient, and has a glowing fire of resolve and toughness within her that is now shining through. She has just completed a very difficult thing, this Effexor withdrawal, and I believe her victory will bolster her self-concept and sense of inner strength. That bodes well for her future mental and emotional wellness, no medicines required."
I appreciate Dr.Foster's time and patience, as well as willingness to take that road with a patient.
That, is a rare event in the world of psychiatry, where medication is the base and often the only thing offered to patients in America (from psychiatrists).
Often, and all too common, patients are medicated for life situations and many patients are actually never asked about 'what's happening' in their lives that could spur a mental health crisis. The drugs added can often cause more problems, such as withdrawals when the patient stops taking the meds, or wants to take a new approach to wellness.
Dr. Mark Foster was terminated by his employer, Littleton Adventist Hospital on March 15, 2011
Is this a case of loss of Academic Freedom? Is this a case of the hospital firing a doctor for blogging? expressing views in a public forum? the hospital claims "without cause"--no reason.
Robert Whitaker has thoughts at the Mad in America blog about the termination of Dr. Mark Foster:
Excerpt from Whitaker's article on the termination of Mark Foster
"As I reported in Anatomy of an Epidemic, there is a long list of physicians and researchers who have had their careers threatened, or suffered a career setback, for having publicly questioned the merits of psychiatric medications. Forty years ago, Loren Mosher was ousted from his position as head of schizophrenia studies at the NIMH after running a study, the Soteria Project, that showed better outcomes for the patients treated in the Soteria home with minimal use of psychiatric medications than those treated conventionally with antipsychotics. After Peter Breggin spoke about how antipsychotics can cause tardive dyskinesia on the Oprah Winfrey show, NAMI filed a complaint with the Maryland State Commission on Medical Discipline, asking that the commission take away his medical license. In 2000, Irish psychiatrist David Healy spoke about how SSRIs could stir suicide, and when he did, the University of Toronto’s Centre for Addition and Mental Health, where Healy had accepted an offer to head up its mood and anxiety program, rescinded the job offer. Nadine Lambert, a psychologist at the University of California at Berkeley, reported in 1998 that children treated with stimulants for ADHD had elevated rates of cocaine abuse and cigarette smoking as adults; soon the National Institute on Drug Abuse stopped funding her work. When Joseph Glenmullen, a clinical instructor in psychiatry at Harvard Medical School published Prozac Backlash, Eli Lilly mounted a campaign to discredit him. After Gretchen LeFever, a psychologist at East Virginia Medical School, published research showing that an overly high number of children in Virginia schools were being diagnosed with ADHD, an anonymous “whistleblower” charged her with scientific misconduct."
Dr.Mark Foster wrote letters to Whitaker after reading and reviewing the book, on Foster's own blog.
Questions beg to be answered.
Monday, March 28, 2011
Regina Holliday: "Just A Girl"- The Power of the Story in Patient Art Advocacy
I've been fortunate to read and learn so much from a great and diverse population of people by spending time on Twitter. Pharmaceutical company representatives, whistle blowers, advocates, doctors, patients, caregivers...the list goes on and on. There is a gem shining brightly amongst the crowd and her name is Regina Holliday. Her story, as a patient advocate is a powerful and poignant one. Here is one of my 'tweets' from today: View this w/out tears welling up:"Just a Girl" http://slidesha.re/h1Qdia by @ReginaHolliday brilliant - patient art advocacy - slide # 17 Please click on the slide show story : (view full screen, keep tissues handy)
Regina's blog, Regina Holliday's Medical Advocacy Blog is definitely worth reading. An inspiration like no other. She's truly remarkable. Regina Holliday has taken her grief, and her husband's story and placed it into a tangible place where many people might not have words to express their emotions--by painting the story onto permanent wall murals. Emotions, feelings, the scraps of paper, the notes are all used in a way that so many people who have experienced hospital settings this way can relate and for this sharing of herself, I thank Regina.
Regina's blog, Regina Holliday's Medical Advocacy Blog is definitely worth reading. An inspiration like no other. She's truly remarkable. Regina Holliday has taken her grief, and her husband's story and placed it into a tangible place where many people might not have words to express their emotions--by painting the story onto permanent wall murals. Emotions, feelings, the scraps of paper, the notes are all used in a way that so many people who have experienced hospital settings this way can relate and for this sharing of herself, I thank Regina.
Thursday, March 24, 2011
it's time to laugh
via Rebecca Skloot, author NYTimes Bestselling book THE IMMORTAL LIFE OF HENRIETTA LACKS on twitter.
Wednesday, March 23, 2011
inspiration
There is
in every true
woman's heart
a spark of heavenly fire,
which lies dormant
in the broad daylight
of prosperity;
but which kindles up,
and beams and blazes
in the dark hour
of adversity.
--Washington Irving
Monday, March 21, 2011
Seroquel trialed on Veterans with dementia residing in a Tuscaloosa VA Medical Center by Depakote maker ABBOTT
There is something completely wrong with the pharmaceutical company Abbott trialing Depakote and antipsychotic Seroquel on U.S. veterans, due to the fact that Seroquel has a black box WARNING label for use in these people:
"Seroquel Recall/Black Box Warning Information:
Black Box warnings on Seroquel alert consumers that Seroquel should not be used to treat senile dementia or Alzheimer’s, as this could lead to serious injury or death.
Depakote ER is an anti-convulsant drug often prescribed for mood disorders such as bipolar disorder.
Depakote ER black box warnings & side effects:
"Depakote ER Uses:
Depakote ER is used in the treatment of manic episodes associated with bipolar disorder, which are characterized by an abnormally elevated or irritable mood. Depakote ER can be used for short-term treatment (less than three weeks) of manic symptoms including hyperactivity, reduced need for sleep, poor judgment, and aggressiveness, as well as the depressed mood and loss of interest that occurs with mixed episodes of bipolar disorder.
Depakote ER is also used in the treatment of certain types of epileptic seizures.
Depakote ER can be taken to prevent migraine headaches, but cannot treat the headaches once they occur.
Depakote ER Recall/Black Box Warning Information:
The FDA issued an updated warning on all antiepileptic drugs, including Depakote ER, concerning the increased risk of suicidal thoughts or actions associated with the drugs. Studies showed that patients receiving antiepileptic medications had twice the risk of suicidal thoughts or behavior as compared to patients taking a placebo.
Patients should be monitored for notable changes in behavior that could indicate the emergence or worsening of depression or suicidal thoughts.
Liver Damage
A Black Box warning on Depakote ER states that potentially fatal liver failure has occurred in patients taking Depakote ER and similar medications, with incidents occurring usually in the first six months of treatment.
Pancreatitis
Depakote ER has been linked to cases of life-threatening pancreatitis, or inflammation of the pancreas, and incidents can happen as soon as treatment starts or after several years of use. "
---
The reason these drugs are prescribed for patients with dementia is FOR BEHAVIOR CONTROL WITH PHARMACEUTICALS--THIS IS CALLED CHEMICAL RESTRAINTS.
The study:
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
This study is currently recruiting participants.
Verified by Tuscaloosa Research & Education Advancement Corporation, March 2007
Sponsor: Tuscaloosa Research & Education Advancement Corporation
Collaborator: Abbott
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00315900
Purpose
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
Agitation Dementia
Drug: Depakote ER
Drug: Seroquel
Phase III
Inclusion Criteria:
•Veterans
•Males or females
•Aged 55 or older
•With a diagnosis of dementia (either Alzheimer’s disease, vascular dementia, or mixed Alzheimer’s and vascular dementia)
•Residing in a Tuscaloosa VA Medical Center (TVAMC) NHCU bed
•Admitted to a NHCU bed at Tuscaloosa VA Medical Center
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315900
Contacts
Contact: John L Shuster, MD (205) 554-2000 ext 3627 John.Shuster@med.va.gov
Locations
United States, Alabama
Tuscaloosa VA Medical Center Recruiting
Tuscaloosa, Alabama, United States, 35404
Principal Investigator: John L Shuster, MD
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Abbott
Investigators
Principal Investigator: John L Shuster, MD Tuscaloosa VA Medical Center
---
Do you think these veterans with dementia have informed consent? do you think they understand the risk they are taking in this drug trial?
"Seroquel Recall/Black Box Warning Information:
Black Box warnings on Seroquel alert consumers that Seroquel should not be used to treat senile dementia or Alzheimer’s, as this could lead to serious injury or death.
Depakote ER is an anti-convulsant drug often prescribed for mood disorders such as bipolar disorder.
Depakote ER black box warnings & side effects:
"Depakote ER Uses:
Depakote ER is used in the treatment of manic episodes associated with bipolar disorder, which are characterized by an abnormally elevated or irritable mood. Depakote ER can be used for short-term treatment (less than three weeks) of manic symptoms including hyperactivity, reduced need for sleep, poor judgment, and aggressiveness, as well as the depressed mood and loss of interest that occurs with mixed episodes of bipolar disorder.
Depakote ER is also used in the treatment of certain types of epileptic seizures.
Depakote ER can be taken to prevent migraine headaches, but cannot treat the headaches once they occur.
Depakote ER Recall/Black Box Warning Information:
The FDA issued an updated warning on all antiepileptic drugs, including Depakote ER, concerning the increased risk of suicidal thoughts or actions associated with the drugs. Studies showed that patients receiving antiepileptic medications had twice the risk of suicidal thoughts or behavior as compared to patients taking a placebo.
Patients should be monitored for notable changes in behavior that could indicate the emergence or worsening of depression or suicidal thoughts.
Liver Damage
A Black Box warning on Depakote ER states that potentially fatal liver failure has occurred in patients taking Depakote ER and similar medications, with incidents occurring usually in the first six months of treatment.
Pancreatitis
Depakote ER has been linked to cases of life-threatening pancreatitis, or inflammation of the pancreas, and incidents can happen as soon as treatment starts or after several years of use. "
---
The reason these drugs are prescribed for patients with dementia is FOR BEHAVIOR CONTROL WITH PHARMACEUTICALS--THIS IS CALLED CHEMICAL RESTRAINTS.
The study:
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
This study is currently recruiting participants.
Verified by Tuscaloosa Research & Education Advancement Corporation, March 2007
Sponsor: Tuscaloosa Research & Education Advancement Corporation
Collaborator: Abbott
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00315900
Purpose
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
Agitation Dementia
Drug: Depakote ER
Drug: Seroquel
Phase III
Inclusion Criteria:
•Veterans
•Males or females
•Aged 55 or older
•With a diagnosis of dementia (either Alzheimer’s disease, vascular dementia, or mixed Alzheimer’s and vascular dementia)
•Residing in a Tuscaloosa VA Medical Center (TVAMC) NHCU bed
•Admitted to a NHCU bed at Tuscaloosa VA Medical Center
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315900
Contacts
Contact: John L Shuster, MD (205) 554-2000 ext 3627 John.Shuster@med.va.gov
Locations
United States, Alabama
Tuscaloosa VA Medical Center Recruiting
Tuscaloosa, Alabama, United States, 35404
Principal Investigator: John L Shuster, MD
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Abbott
Investigators
Principal Investigator: John L Shuster, MD Tuscaloosa VA Medical Center
---
Do you think these veterans with dementia have informed consent? do you think they understand the risk they are taking in this drug trial?
AstraZeneca earns $5.3 billion from antipsychotic Seroquel & the illegal off-label marketing fines keep stacking up
VIA AllGov:
Seroquel is So Profitable, AstraZeneca is Glad to Pay Millions in Penalties
"...pharmaceutical manufacturer AstraZeneca, maker of the anti-psychotic drug Seroquel (quetiapine fumarate). On March 10, AstraZeneca agreed to pay $68.5 million as part of the largest multi-state consumer protection settlement on record for unlawful marketing of Seroquel. This is in addition to last year’s $520 million to settle accusations of burying side effect and safety information related to the drug.
But these settlements are easily absorbed by a company that made $5.3 billion just last year selling Seroquel, a drug that was approved for treatment of schizophrenia, bipolar disorder, psychiatric conditions in children and as an add-on for patients taking anti-depressants. However, AstraZeneca has made its real profits on the drug by marketing it for use against symptoms and maladies for which it had never been approved, such as Alzheimer's, autism, obsessive dementia, anger management, anxiety, attention-deficit hyperactivity disorder and post-traumatic stress disorder."
-David Wallechinsky
Seroquel is So Profitable, AstraZeneca is Glad to Pay Millions in Penalties
"...pharmaceutical manufacturer AstraZeneca, maker of the anti-psychotic drug Seroquel (quetiapine fumarate). On March 10, AstraZeneca agreed to pay $68.5 million as part of the largest multi-state consumer protection settlement on record for unlawful marketing of Seroquel. This is in addition to last year’s $520 million to settle accusations of burying side effect and safety information related to the drug.
But these settlements are easily absorbed by a company that made $5.3 billion just last year selling Seroquel, a drug that was approved for treatment of schizophrenia, bipolar disorder, psychiatric conditions in children and as an add-on for patients taking anti-depressants. However, AstraZeneca has made its real profits on the drug by marketing it for use against symptoms and maladies for which it had never been approved, such as Alzheimer's, autism, obsessive dementia, anger management, anxiety, attention-deficit hyperactivity disorder and post-traumatic stress disorder."
-David Wallechinsky
Friday, March 18, 2011
Bristol-Myers Squibb caught in major health fraud AGAIN : former L A Lakers turned whistleblower Lucius Allen
VIA LA Times:
Bristol-Myers Squibb, makers of the antipsychotic Abilify are back in the news, it appears the 2007 Corporate Integrity Agreement (CIA) with the OIG and fine from the DOJ means nothing to this pharmaceutical company, which paid out just $5 million less in fines than AstraZeneca for illegal marketing of Seroquel. BMS topped out at $515 million and AstraZeneca came in just above in the scandalous sales race fined with $520 million.
From the LA Times March 18, 2011
"Pharmaceutical giant Bristol-Myers Squibb bribed thousands of California doctors and pharmacists to promote its drugs, using illegal kickbacks, lavish gifts and "happy hours" with the Los Angeles Lakers to expand its market share in the state, state officials said.
California Insurance Commissioner Dave Jones announced Friday that his office had joined a previously sealed whistleblower lawsuit against the company, calling it the largest health insurance fraud case ever pursued by a California state agency."
AND
"Two of the three whistleblowers in the case are former Lakers player Lucius Allen and his wife, Eve, who worked for the drug company as employees and provided access to the basketball team, whose players participated in "Lakers Dream Camps" set up by the drug company for doctors and their family members, the lawsuit said. The lawsuit was filed in 2007 but was sealed until the state joined the case recently.
New York-based Bristol-Myers Squibb issued a statement: "Bristol-Myers Squibb believes this lawsuit has no merit and the company will defend itself vigorously."
Huh. Where have I read that before?
Drugmaker AstraZeneca Plc agreed to pay $68.5 million (42.7 million pounds) to resolve allegations by U.S. state regulators that its marketing of the multibillion-dollar antipsychotic drug Seroquel was deceptive.:
"“AstraZeneca believes that the remaining claims, which are in various stages of litigation, are without merit, and we intend to vigorously defend ourselves,” company spokesman Tony Jewell said.
--
*update
While digging around the Google box I found more on Lucius Allen: not just basketball
Mr. Allen has been with the Bristol-Myers Squibb Pharmaceutical Company since 1996, and has moved through the ranks very rapidly. He is currently a Cardiovascular Risk Specialist (CRS), and is now ranked #8 nationally out of 150 CMRS. Lucius Allen is also a Sales Trainer for Territory Business Managers (TBMs), and pioneered the “Hospitalist Initiative” for BMS which has developed into a National Program impacting Hospital Formularies to include BMS products. Prior to being promoted to a Cardiovascular Risk Specialist, he was ranked nationally #3 out of 550 TBMs. Among his numerous awards, Lucius Allen is a three time BMS Excellence Award Winner.
Allen is the Director of Emmaus Medical, Inc in Torrance, CA.
Read the Complaint Against Bristol-Myers Squibb HERE (47 pages)
Bristol-Myers Squibb, makers of the antipsychotic Abilify are back in the news, it appears the 2007 Corporate Integrity Agreement (CIA) with the OIG and fine from the DOJ means nothing to this pharmaceutical company, which paid out just $5 million less in fines than AstraZeneca for illegal marketing of Seroquel. BMS topped out at $515 million and AstraZeneca came in just above in the scandalous sales race fined with $520 million.
From the LA Times March 18, 2011
"Pharmaceutical giant Bristol-Myers Squibb bribed thousands of California doctors and pharmacists to promote its drugs, using illegal kickbacks, lavish gifts and "happy hours" with the Los Angeles Lakers to expand its market share in the state, state officials said.
California Insurance Commissioner Dave Jones announced Friday that his office had joined a previously sealed whistleblower lawsuit against the company, calling it the largest health insurance fraud case ever pursued by a California state agency."
AND
"Two of the three whistleblowers in the case are former Lakers player Lucius Allen and his wife, Eve, who worked for the drug company as employees and provided access to the basketball team, whose players participated in "Lakers Dream Camps" set up by the drug company for doctors and their family members, the lawsuit said. The lawsuit was filed in 2007 but was sealed until the state joined the case recently.
New York-based Bristol-Myers Squibb issued a statement: "Bristol-Myers Squibb believes this lawsuit has no merit and the company will defend itself vigorously."
Huh. Where have I read that before?
Drugmaker AstraZeneca Plc agreed to pay $68.5 million (42.7 million pounds) to resolve allegations by U.S. state regulators that its marketing of the multibillion-dollar antipsychotic drug Seroquel was deceptive.:
"“AstraZeneca believes that the remaining claims, which are in various stages of litigation, are without merit, and we intend to vigorously defend ourselves,” company spokesman Tony Jewell said.
--
*update
While digging around the Google box I found more on Lucius Allen: not just basketball
Mr. Allen has been with the Bristol-Myers Squibb Pharmaceutical Company since 1996, and has moved through the ranks very rapidly. He is currently a Cardiovascular Risk Specialist (CRS), and is now ranked #8 nationally out of 150 CMRS. Lucius Allen is also a Sales Trainer for Territory Business Managers (TBMs), and pioneered the “Hospitalist Initiative” for BMS which has developed into a National Program impacting Hospital Formularies to include BMS products. Prior to being promoted to a Cardiovascular Risk Specialist, he was ranked nationally #3 out of 550 TBMs. Among his numerous awards, Lucius Allen is a three time BMS Excellence Award Winner.
Allen is the Director of Emmaus Medical, Inc in Torrance, CA.
Read the Complaint Against Bristol-Myers Squibb HERE (47 pages)
Thursday, March 17, 2011
Corporate Criminal Conduct on a Global Scale: ADHD drug Strattera fraudulently marketed by Eli Lilly
VIA Bonkers Institute Corporate Criminal Conduct on a Global Scale
from the Bonkers Institute site
ADHD drug Strattera fraudulently marketed by Eli Lilly
Side-by-side comparison of Eli Lilly web sites --screen shots in United States and China
Lilly's U.S. web site clearly warns on every page: What is the most important information I should know about Strattera? In some children and teens, Strattera increases the risk of suicidal thoughts or actions.Lilly's web site in China says nothing about any suicide risk — patients are told nothing about any Strattera side effects at all.
Side-by-side comparison of Eli Lilly web sites -click the link to view of March 5, 2011 screenshots
VIA Bonkers Institute: (click on site for more pics) -- Little Sampler of Chinese ADHD Remedies
from the Bonkers Institute site
ADHD drug Strattera fraudulently marketed by Eli Lilly
Indications: tics, Tourette syndrome, conduct disorders and comorbid ADHD. Ingredients: atomoxetine hydrochloride, pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate and one or more of the following: FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink. The United States pharmaceutical giant Eli Lilly and Company began marketing Strattera in China in 2007.
A comparison of Eli Lilly web sites lillychina.com and strattera.com reveals striking differences in the way Eli Lilly promotes Strattera in China.
Side-by-side comparison of Eli Lilly web sites --screen shots in United States and China
Lilly's U.S. web site clearly warns on every page: What is the most important information I should know about Strattera? In some children and teens, Strattera increases the risk of suicidal thoughts or actions.Lilly's web site in China says nothing about any suicide risk — patients are told nothing about any Strattera side effects at all.
Side-by-side comparison of Eli Lilly web sites -click the link to view of March 5, 2011 screenshots
VIA Bonkers Institute: (click on site for more pics) -- Little Sampler of Chinese ADHD Remedies
from Bonkers site
"Lilly's arrogant disregard for patient safety is apparent in China, where the company aggressively promotes Strattera not only for ADHD but also for anxiety, conduct disorder, oppositional defiant disorder, tics, Tourette's Syndrome and God knows what else.
In an undated letter from Eli Lilly and Company, U.S. Medical Division, Neuroscience, addressed to "Dear Patients and Consumers," Medical Director Cherri Miner explained that in response to the FDA's September 2008 request to immediately cease the dissemination of false and misleading Strattera promotional materials, "Lilly stopped using these materials... Lilly later discovered that webpages from Strattera.com were unexpectedly available through indirect links on the internet between December 8, 2008 and April 3, 2009.
These webpages and pdf files could have been viewed by anyone interested in information about Strattera.
Once Lilly became aware of this issue, the webpages and pdf files were removed from the internet."Three years ago Eli Lilly agreed to remove false statements from strattera.com for the simple reason that Lilly was required to do so.
Today Lilly allows false statements on lillychina.com because the company is not required to remove them. Lilly's ethical standards are questionable to say the least. "
Wednesday, March 16, 2011
Happy Birthday, Herrad!
Happy Birthday, Herrad!! Everyone send your St.Patrick's Day Birthday wishes to Herrad! author of the candid and often poignant blog: Access denied-living with multiple sclerosis
Happy Birthday, Herrad with love and wishes for a grand day!
Monday, March 14, 2011
Alison Hymes released to recover at home: no locked down psychiatric hospital
UPDATE
Victory! no locked psychiatric hospital civil commitment!
A friend of Alison Hymes is going to be taking care of Alison while she recovers at home.
via
http://bipolarblast.wordpress.com/2011/03/14/update-action-to-uphold-human-rights-successful/
below is a snippet from the link above
"OKAY! I just spoke to Alison’s doctor and he said she seemed great and that he wouldn’t even be concerned about her driving skills, but then tried to chalk it up to the high dose of seroquel. she just got better in the last 3 days because of us. i reminded him that those statements about her functioning aren’t compatible with commitment criteria. he agreed. I think he [is] going to discharge her."
Victory! no locked psychiatric hospital civil commitment!
A friend of Alison Hymes is going to be taking care of Alison while she recovers at home.
via
http://bipolarblast.wordpress.com/2011/03/14/update-action-to-uphold-human-rights-successful/
below is a snippet from the link above
"OKAY! I just spoke to Alison’s doctor and he said she seemed great and that he wouldn’t even be concerned about her driving skills, but then tried to chalk it up to the high dose of seroquel. she just got better in the last 3 days because of us. i reminded him that those statements about her functioning aren’t compatible with commitment criteria. he agreed. I think he [is] going to discharge her."
Sunday, March 13, 2011
Mental Health activist Alison Hymes facing 6 month involuntary commitment to Western State Hospital in Virginia:help her via petition
*UPDATE March 14, 2011- Alison Hymes released from hospital, no 6 month commitment-recovering at home with friend.
While reading news on Twitter in the early hours of the morning today, I was shocked, and stunned to see tweets about mental health activist and advocate Alison Hymes facing a 6 month civil commitment in the state of Virginia. Alison fought a battle with failing kidneys from Lithium, had a transplant, a bad reaction to steroids, and now faces a continued spiral of being caught in the system--with what she fought for the hardest: make Virginia laws tougher to commit people, stop commiting people who are not a danger to society...and it seems to be an ironic and bittersweet event that she now faces what she fought so hard!
Alison is well known in the mental health blogging world, and I "know" her from her blog as well as the Furious Seasons blog where many of us outspoken bloggers spent time in the comment section discussing psychiatric medications, and rights of patients among other topics.
* Here's a February 2008 WaPo article where Alison is quoted:
Proposals to Force More Involuntary Treatment Stir Debate:
"Alison Hymes, a Charlottesville consumer advocate who served on a state Supreme Court task force on mental health law reform, writes a blog about such issues. She wrote that if the state requires mental health providers to turn over patient records, "mental health practice in this state will never be the same. Patients/clients/consumers will not be able to trust their secret thoughts and feelings with their clinicians. Clinicians will not be able to abide by the ethical standards of their professions. People will not seek help and those who are already receiving therapy, such as myself, will quit."
--
THIS IS A PETITION FOR ALISON HYMES
Friends of Alison Hymes: We demand that psychiatric malpractice be investigated and her human rights upheld -click there, read and then please sign.
Note signature #28 is Psych Rights Jim Gottstein
"Mr. Gottstein is most known around the US and internationally for subpoenaing and releasing the Zyprexa Papers in late 2006, resulting in a series of New York Times articles and an editorial calling for a Congressional investigation. In January of 2009, Eli Lilly pled guilty and agreed to pay $1.4 Billion in civil and criminal fines for the activities revealed by the Zyprexa Papers."
Gottstein's comment on the petition:
"Name: Jim Gottstein on Mar 12, 2011
Comments: I know Alison pretty well and it is an outrage to have her committed. I would be pleased to testify on her behalf if I can do it by telephone. Alison has already lost her kidneys due to psych drugs and I am very concerned she will be killed by any more psychiatric drugging."
Read all of the comments and then please take a minute to sign, Alison could be you, or me or your friend, mother, sister or neighbor. She needs to have a choice of care and in a safe environment. Let's get this thing loaded with support and signatures!
Here's my comment on the petition
Name: Stephany on Mar 13, 2011
Comments: "Shocked is an understatement. After many years of advocating via blogging, this feels like one of the family has been threatened with 6 month commitment. Alison fought for less people to be committed who were not dangers to society and this is a bittersweet irony that she herself is now being threatened with what she feared could happen to others in Virginia. Locked psych hospitals are not hospitals, they are not medically able to care for someone as medically fragile as Alison. The addition and slamming down of her body with more psych drugs could be life threatening, and I am concerned for her life at this point."
Thank you!
While reading news on Twitter in the early hours of the morning today, I was shocked, and stunned to see tweets about mental health activist and advocate Alison Hymes facing a 6 month civil commitment in the state of Virginia. Alison fought a battle with failing kidneys from Lithium, had a transplant, a bad reaction to steroids, and now faces a continued spiral of being caught in the system--with what she fought for the hardest: make Virginia laws tougher to commit people, stop commiting people who are not a danger to society...and it seems to be an ironic and bittersweet event that she now faces what she fought so hard!
Alison is well known in the mental health blogging world, and I "know" her from her blog as well as the Furious Seasons blog where many of us outspoken bloggers spent time in the comment section discussing psychiatric medications, and rights of patients among other topics.
* Here's a February 2008 WaPo article where Alison is quoted:
Proposals to Force More Involuntary Treatment Stir Debate:
"Alison Hymes, a Charlottesville consumer advocate who served on a state Supreme Court task force on mental health law reform, writes a blog about such issues. She wrote that if the state requires mental health providers to turn over patient records, "mental health practice in this state will never be the same. Patients/clients/consumers will not be able to trust their secret thoughts and feelings with their clinicians. Clinicians will not be able to abide by the ethical standards of their professions. People will not seek help and those who are already receiving therapy, such as myself, will quit."
--
THIS IS A PETITION FOR ALISON HYMES
Alison Hymes of Charlottesville, Virginia, suffered from iatrogenic kidney disease due to psychiatric malpractice and misdiagnosis more than a decade ago. Alison underwent a kidney transplant in October 2008 to save her life from the iatrogenic kidney failure. As a former therapist and a user of psychiatry, Alison dedicated her time and her life to mental health advocacy and the rights of users and survivors of psychiatry and the mental health system. She served as President of the Mental Health Planning Council in her area for several years, remaining an active advocate even while dealing with such very critical personal health issues.
Friends of Alison Hymes: We demand that psychiatric malpractice be investigated and her human rights upheld -click there, read and then please sign.
Note signature #28 is Psych Rights Jim Gottstein
"Mr. Gottstein is most known around the US and internationally for subpoenaing and releasing the Zyprexa Papers in late 2006, resulting in a series of New York Times articles and an editorial calling for a Congressional investigation. In January of 2009, Eli Lilly pled guilty and agreed to pay $1.4 Billion in civil and criminal fines for the activities revealed by the Zyprexa Papers."
Gottstein's comment on the petition:
"Name: Jim Gottstein on Mar 12, 2011
Comments: I know Alison pretty well and it is an outrage to have her committed. I would be pleased to testify on her behalf if I can do it by telephone. Alison has already lost her kidneys due to psych drugs and I am very concerned she will be killed by any more psychiatric drugging."
Read all of the comments and then please take a minute to sign, Alison could be you, or me or your friend, mother, sister or neighbor. She needs to have a choice of care and in a safe environment. Let's get this thing loaded with support and signatures!
Here's my comment on the petition
Name: Stephany on Mar 13, 2011
Comments: "Shocked is an understatement. After many years of advocating via blogging, this feels like one of the family has been threatened with 6 month commitment. Alison fought for less people to be committed who were not dangers to society and this is a bittersweet irony that she herself is now being threatened with what she feared could happen to others in Virginia. Locked psych hospitals are not hospitals, they are not medically able to care for someone as medically fragile as Alison. The addition and slamming down of her body with more psych drugs could be life threatening, and I am concerned for her life at this point."
Thank you!
Thursday, March 10, 2011
AstraZeneca Seroquel diabetes lawsuit victim receives letter: cases are not closed, this is not over
The law firm Saiontz and Kirk handed over their lawsuits to the Miller Firm without the consent of the anonymous plaintiff that received this letter. *(victim was prescribed antipsychotic Seroquel off-label use)
After an enormous self-advocating effort by the plaintiff, and many phone calls inquiring of the status of the plaintiff's case this letter has surfaced.
Victims should not have to do the footwork and constantly persist to find out information lawyers who represent them should be giving them.
These 2 law firms have done nothing to keep in contact with this plaintiff, and when telephoned have answered questions as if they were completely clueless as to the happenings of the Seroquel litigation.
In fact, the Miller Firm goes down as the best answer yet: "When you find out more call us". They had not even heard of the settlement last August 2010, as read about in Bloomberg.
My anonymous source took it straight back to the attained legal counsel that began in the Spring of 2008; and demanded that the firm (on the letter head and authors of this letter) find out what was going on with the cases and to contact the Miller Firm who they had passed the case.
This has taken months of persistent self-advocacy,(entering into years) and it is something injured clients should not have to do.This plaintiff calls and asks and demands answers and after all of that...here's what the person received via letter on March 10, 2011.
♦No definitive answer of the dollar amount of the settlement and a vague promise of "3 weeks" to hopefully hear from the Miller Firm about the AstraZeneca settlement.
My source will seek counsel to go to a jury trial if the dollar amount is not acceptable for the lifetime disease Seroquel left on the person's body. Damage to a vital organ, where a lifespan is now shortened as a result of diabetes. What price does one place on that?
NOT $10,000. NOT $12,000.
March 7, 2011
Saiontz and Kirk
..."it is our understanding that values on client's cases have not been fully determined at this time and that a settlement packet,which will include the amount of the offer, will be sent to you, hopefully, in the next three weeks."
After an enormous self-advocating effort by the plaintiff, and many phone calls inquiring of the status of the plaintiff's case this letter has surfaced.
Victims should not have to do the footwork and constantly persist to find out information lawyers who represent them should be giving them.
These 2 law firms have done nothing to keep in contact with this plaintiff, and when telephoned have answered questions as if they were completely clueless as to the happenings of the Seroquel litigation.
In fact, the Miller Firm goes down as the best answer yet: "When you find out more call us". They had not even heard of the settlement last August 2010, as read about in Bloomberg.
My anonymous source took it straight back to the attained legal counsel that began in the Spring of 2008; and demanded that the firm (on the letter head and authors of this letter) find out what was going on with the cases and to contact the Miller Firm who they had passed the case.
This has taken months of persistent self-advocacy,(entering into years) and it is something injured clients should not have to do.This plaintiff calls and asks and demands answers and after all of that...here's what the person received via letter on March 10, 2011.
♦No definitive answer of the dollar amount of the settlement and a vague promise of "3 weeks" to hopefully hear from the Miller Firm about the AstraZeneca settlement.
My source will seek counsel to go to a jury trial if the dollar amount is not acceptable for the lifetime disease Seroquel left on the person's body. Damage to a vital organ, where a lifespan is now shortened as a result of diabetes. What price does one place on that?
NOT $10,000. NOT $12,000.
March 7, 2011
Saiontz and Kirk
..."it is our understanding that values on client's cases have not been fully determined at this time and that a settlement packet,which will include the amount of the offer, will be sent to you, hopefully, in the next three weeks."
New Jersey Attorney General Announces Multi-State Settlement with AstraZeneca Over Allegedly Deceptive Marketing of Seroquel
State of New Jersey Office of The Attorney General
- Paula T. Dow, Attorney General
Attorney General Announces Multi-State Settlement with AstraZeneca Over Allegedly Deceptive Marketing Practices
TRENTON – Attorney General Paula T. Dow announced today that New Jersey has entered into a $68.5 million, multi-state settlement agreement with pharmaceutical manufacturer AstraZeneca that resolves allegations the company deceptively marketed its anti-psychotic drug Seroquel.
Under the settlement agreement, New Jersey will receive approximately $1.85 million. Thirty-six states and the District of Columbia also are party to the settlement, described as the largest-ever multi-state, consumer-protection-based pharmaceutical settlement.
A Verified Complaint, filed in New Jersey Superior Court today along with a Final Consent Judgment memorializing the settlement, charges that AstraZeneca engaged in unfair and misleading practices when it marketed Seroquel for unapproved or off-label uses. The Complaint also alleges that AstraZeneca failed to adequately disclose the potential side effects of Seroquel to health care providers, and withheld negative information contained in scientific studies regarding the safety and efficacy of Seroquel.
“This is an important settlement for all New Jersey residents,” said Attorney General Dow.
“This case sends a message that we take seriously the duty pharmaceutical companies have to supply clear, accurate and complete information about their products to health care providers, and to market their products without deception or misleading claims.”
“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas R. Calcagni, Acting Director of the Division of Consumer Affairs.
“The importance cannot be overstated, when the health and safety of New Jersey residents are at stake,” Calcagni said.
Following a three-year investigation by the participating states, the Delaware-based AstraZeneca agreed not to promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses, which are not approved by the U.S. Food and Drug Administration.
In addition to the overall $68.5 million payment, terms of the settlement include provisions that address specific concerns identified in the states’ investigation. The agreement specifically requires AstraZeneca to:
♦Publicly post its payments to physicians on a Web site
♦Have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing
♦Have policies in place to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use
♦Cite to Seroquel’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only
Although a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. AstraZeneca allegedly marketed Seroquel for a number of off-label uses, including for use in pediatric and geriatric populations, specifically in nursing homes for Alzheimer’s Disease and dementia, as well as for anxiety, depression, sleep disorders, and post traumatic stress disorder. AstraZeneca promoted Seroquel for such uses even though Seroquel was not, at the time it was marketed, approved for treatment of these conditions, and AstraZeneca had not established that Seroquel was safe and effective for these uses. Atypical anti-psychotics, including Seroquel, can produce dangerous side effects including weight gain, hyperglycemia, diabetes, cardiovascular complications and increased risk of mortality in elderly patients with dementia.
In addition to New Jersey, the following states and the District of Columbia participated in the settlement: Florida, Illinois, Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Money paid to New Jersey as a result of the AstraZeneca settlement will be used for consumer protection initiatives. Deputy Attorney General Gina M. Betts, assigned to the Division of Law’s Consumer Fraud Prosecution Section, handled the matter on behalf of the State."
-New Jersey Office of the Attorney General
- Paula T. Dow, Attorney General
Attorney General Announces Multi-State Settlement with AstraZeneca Over Allegedly Deceptive Marketing Practices
TRENTON – Attorney General Paula T. Dow announced today that New Jersey has entered into a $68.5 million, multi-state settlement agreement with pharmaceutical manufacturer AstraZeneca that resolves allegations the company deceptively marketed its anti-psychotic drug Seroquel.
Under the settlement agreement, New Jersey will receive approximately $1.85 million. Thirty-six states and the District of Columbia also are party to the settlement, described as the largest-ever multi-state, consumer-protection-based pharmaceutical settlement.
A Verified Complaint, filed in New Jersey Superior Court today along with a Final Consent Judgment memorializing the settlement, charges that AstraZeneca engaged in unfair and misleading practices when it marketed Seroquel for unapproved or off-label uses. The Complaint also alleges that AstraZeneca failed to adequately disclose the potential side effects of Seroquel to health care providers, and withheld negative information contained in scientific studies regarding the safety and efficacy of Seroquel.
“This is an important settlement for all New Jersey residents,” said Attorney General Dow.
“This case sends a message that we take seriously the duty pharmaceutical companies have to supply clear, accurate and complete information about their products to health care providers, and to market their products without deception or misleading claims.”
“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas R. Calcagni, Acting Director of the Division of Consumer Affairs.
“The importance cannot be overstated, when the health and safety of New Jersey residents are at stake,” Calcagni said.
Following a three-year investigation by the participating states, the Delaware-based AstraZeneca agreed not to promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses, which are not approved by the U.S. Food and Drug Administration.
In addition to the overall $68.5 million payment, terms of the settlement include provisions that address specific concerns identified in the states’ investigation. The agreement specifically requires AstraZeneca to:
♦Publicly post its payments to physicians on a Web site
♦Have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing
♦Have policies in place to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use
♦Cite to Seroquel’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only
Although a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. AstraZeneca allegedly marketed Seroquel for a number of off-label uses, including for use in pediatric and geriatric populations, specifically in nursing homes for Alzheimer’s Disease and dementia, as well as for anxiety, depression, sleep disorders, and post traumatic stress disorder. AstraZeneca promoted Seroquel for such uses even though Seroquel was not, at the time it was marketed, approved for treatment of these conditions, and AstraZeneca had not established that Seroquel was safe and effective for these uses. Atypical anti-psychotics, including Seroquel, can produce dangerous side effects including weight gain, hyperglycemia, diabetes, cardiovascular complications and increased risk of mortality in elderly patients with dementia.
In addition to New Jersey, the following states and the District of Columbia participated in the settlement: Florida, Illinois, Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Money paid to New Jersey as a result of the AstraZeneca settlement will be used for consumer protection initiatives. Deputy Attorney General Gina M. Betts, assigned to the Division of Law’s Consumer Fraud Prosecution Section, handled the matter on behalf of the State."
-New Jersey Office of the Attorney General
AstraZeneca settles $68.5 million to U.S. States for illegal marketing of antipsychotic SEOQUEL: AstraZeneca denies allegations
VIA Bloomberg:
AstraZeneca to Pay $68.5 Million to U.S. States Over Seroquel Marketing:
AstraZeneca Plc (AZN) agreed to pay $68.5 million to 37 U.S. states and the District of Columbia to resolve allegations that the company deceptively marketed its anti-psychotic drug Seroquel.
The settlement is separate from a $520 million agreement London-based AstraZeneca reached with the U.S. last year over the marketing of Seroquel, said Tony Jewell, a company spokesman. AstraZeneca doesn’t admit wrongdoing and the settlement doesn’t resolve lawsuits brought by about seven states, including South Carolina and Mississippi, Jewell said in an interview today.
“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” Jewell said. The company intends to “vigorously defend ourselves” in the remaining lawsuits, he said."
AND
"The office of New Jersey Attorney General Paula Dow announced the settlement today. In addition to paying the $68.5 million, AstraZeneca officials agreed to ban financial incentives tied to off-label marketing, instruct salespeople not to market Seroquel to doctors who are unlikely to prescribe it for an approved use, and post payments to doctors on a website, according to the statement. "-Bloomberg
AstraZeneca to Pay $68.5 Million to U.S. States Over Seroquel Marketing:
AstraZeneca Plc (AZN) agreed to pay $68.5 million to 37 U.S. states and the District of Columbia to resolve allegations that the company deceptively marketed its anti-psychotic drug Seroquel.
The settlement is separate from a $520 million agreement London-based AstraZeneca reached with the U.S. last year over the marketing of Seroquel, said Tony Jewell, a company spokesman. AstraZeneca doesn’t admit wrongdoing and the settlement doesn’t resolve lawsuits brought by about seven states, including South Carolina and Mississippi, Jewell said in an interview today.
“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” Jewell said. The company intends to “vigorously defend ourselves” in the remaining lawsuits, he said."
AND
"The office of New Jersey Attorney General Paula Dow announced the settlement today. In addition to paying the $68.5 million, AstraZeneca officials agreed to ban financial incentives tied to off-label marketing, instruct salespeople not to market Seroquel to doctors who are unlikely to prescribe it for an approved use, and post payments to doctors on a website, according to the statement. "-Bloomberg
Wednesday, March 09, 2011
Why former CEO of Pfizer should not be the next U.S. Commerce Secretary: Dept of Justice & Corporate Integrity Agreement: conflicts! criminal actions!
VIA Pharmalot:
"Earlier today, President Obama nominated US Commerce Secretary Gary Locke to be the next US ambassador to China and former Pfizer ceo Jeff Kindler is among the names being mentioned as a possible successor, according to Bloomberg News, citing unnamed sources.
The 55-year-old Kindler, you may recall, spent four years as the Pfizer ceo before unexpectedly resigning last December amid ongoing tension with some board members (see here and here). And there has long been speculation that he would next look to Washington, DC, whenever he left the drugmaker.
Last July, in fact, Kindler was named by Obama as a member of a presidential advisory board devoted to increasing US exports. And the portly one had already angled to become a Democratic mover and shaker. Three years ago, for instance, he participated in a healthcare roundtable discussion about healthcare at the Democratic National Convention in Denver (see this). And his contributions to the Democratic Party and its candidates were widely publicized (look here)." (read more at Pharmalot at the link above).
--
Pfizer's CIA: U.S. Department of Justice
CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND PFIZER INC
Pfizer Inc (pfizer) hereby enters into this Corporate Integrity Agreement (CIA) with the Office ofInspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives ofthe Food and Drug Administration (FDA requirements). Contemporaneously with this CIA, Pfizer is entering into a Settlement Agreement with the United States. Pfizer wil also enter into settlement agreements with various States (State Settlement Agreement and Release) and Pfizer's agreement to this CIA is a condition precedent to those agreements.
Prior to the Effective Date, Pfizer established a compliance program and initiated certain voluntary compliance measures. In addition, in May 2004, Pfizer entered into a CIA with the OIG in connection with the May 2004 settlement with the United States ofa different matter. Pfizer shall continue to fulfill its obligations as required under the 2004 CIA, including the submission of its final Annual Report in September 2009 and responding to any requests for additional information from the OIG in connection with its 2004 CIA.
A. The period of the compliance obligations assumed by Pfizer under this CIA shall be five reporting periods, as defined below. The effective date of this CIA shall be the date on which the final signatory executes this document (Effective Date). The first Reporting Period shall be from the Effective Date through December 3 i, 20 i O. The second and subsequent Reporting Periods shall be from January i through December 3 i of each of the subsequent four calendar years."--
There are 79 pages of the Corporate Integrity Agreement for Pfizer
From BusinessWire
Pfizer-September 02, 2009:
"Pfizer Inc today announced that it has finalized a previously reported agreement in principle with the U.S. Department of Justice (DOJ) to settle an investigation regarding past off-label promotional practices related to Bextra, which Pfizer voluntarily withdrew from the market in 2005. The final agreement also resolves other DOJ investigations involving alleged past off-label promotional practices concerning Zyvox, Geodon and Lyrica, allegations related to certain payments to healthcare professionals involving these and nine other Pfizer medicines, and several related qui tam actions. Pfizer previously disclosed a related $2.3 billion charge to its fourth-quarter and full-year 2008 earnings in connection with the DOJ agreement in principle on January 26, 2009. No additional charge to the company’s earnings will be recorded in connection with this settlement."
"In addition, the company has reached agreements with attorneys general in 42 states and the District of Columbia to settle state civil consumer protection allegations related to its past promotional practices concerning Geodon. The company will pay a total of $33 million to the settling states and will take a charge in that amount to third-quarter 2009 earnings." (Continued in linked article)
---
*Geodon, antipsychotic
---
AMERICA DESERVES BETTER THAN EX-CEO'S FROM PHARMACEUTICAL COMPANIES THAT COMMITTED CRIMES AGAINST INNOCENT PEOPLE VIA ILLEGAL MARKETING AND PROMOTION OF DANGEROUS DRUGS!
DON'T INSULT AMERICANS FURTHER OBAMA.
--
Further reading of my previous posts:
Thursday, August 28, 2008-
Pfizer's million dollar view : Democratic National Convention and pharma: drug us!:
"The list of health-oriented sponsors reads like a roll call of drugmakers: Merck, Amgen, Pfizer, AstraZeneca, Novartis, Mylan, Abbott and Eli Lilly. Five of those companies--Pfizer, AstraZeneca, Lilly, Amgen and Merck--have put CEO power behind their cash. AstraZeneca and Lilly dispatched their CEOs--David Brennan (photo) and John Lechleiter (photo), respectively--to receptions and luncheons the companies sponsored. Pfizer's Jeff Kindler (photo) and Amgen's Kevin Sharer (photo) participated in a health roundtable. And at a PhRMA-sponsored brunch, Merck CEO Richard Clark (photo) and AstraZeneca's Brennan mingled with the invitation-only crowd. [(Seroquel).]
And tonight, when Barack Obama accepts the Democratic nomination, Pfizer folks will be on hand in coveted sky box seats reserved for those donors who've given more than $1 million."
---
Monday, October 20, 2008-Pfizer's $894 Million dollar court settlement
Pfizer had million dollar box seats at the Democratic National Convention, and it just gives thought to how much pharmaceuticals have a stake in our lives.
This settlement is for painkillers, and in my opinion, the Zyprexa and Seroquel lawsuits should be getting massive media attention also.
~
"Pfizer can now say "done deal" on most of the lawsuits over its painkillers Celebrex and Bextra. The cost? $894 million. As of today, the drugmaker has reached agreements in principle to settle with up to 92 percent of the outstanding personal injury plaintiffs, who had alleged that the drugs had caused heart attacks, strokes, or other serious health problems."
"Earlier today, President Obama nominated US Commerce Secretary Gary Locke to be the next US ambassador to China and former Pfizer ceo Jeff Kindler is among the names being mentioned as a possible successor, according to Bloomberg News, citing unnamed sources.
The 55-year-old Kindler, you may recall, spent four years as the Pfizer ceo before unexpectedly resigning last December amid ongoing tension with some board members (see here and here). And there has long been speculation that he would next look to Washington, DC, whenever he left the drugmaker.
Last July, in fact, Kindler was named by Obama as a member of a presidential advisory board devoted to increasing US exports. And the portly one had already angled to become a Democratic mover and shaker. Three years ago, for instance, he participated in a healthcare roundtable discussion about healthcare at the Democratic National Convention in Denver (see this). And his contributions to the Democratic Party and its candidates were widely publicized (look here)." (read more at Pharmalot at the link above).
--
Pfizer's CIA: U.S. Department of Justice
CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND PFIZER INC
Pfizer Inc (pfizer) hereby enters into this Corporate Integrity Agreement (CIA) with the Office ofInspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives ofthe Food and Drug Administration (FDA requirements). Contemporaneously with this CIA, Pfizer is entering into a Settlement Agreement with the United States. Pfizer wil also enter into settlement agreements with various States (State Settlement Agreement and Release) and Pfizer's agreement to this CIA is a condition precedent to those agreements.
Prior to the Effective Date, Pfizer established a compliance program and initiated certain voluntary compliance measures. In addition, in May 2004, Pfizer entered into a CIA with the OIG in connection with the May 2004 settlement with the United States ofa different matter. Pfizer shall continue to fulfill its obligations as required under the 2004 CIA, including the submission of its final Annual Report in September 2009 and responding to any requests for additional information from the OIG in connection with its 2004 CIA.
A. The period of the compliance obligations assumed by Pfizer under this CIA shall be five reporting periods, as defined below. The effective date of this CIA shall be the date on which the final signatory executes this document (Effective Date). The first Reporting Period shall be from the Effective Date through December 3 i, 20 i O. The second and subsequent Reporting Periods shall be from January i through December 3 i of each of the subsequent four calendar years."--
There are 79 pages of the Corporate Integrity Agreement for Pfizer
From BusinessWire
Pfizer-September 02, 2009:
"Pfizer Inc today announced that it has finalized a previously reported agreement in principle with the U.S. Department of Justice (DOJ) to settle an investigation regarding past off-label promotional practices related to Bextra, which Pfizer voluntarily withdrew from the market in 2005. The final agreement also resolves other DOJ investigations involving alleged past off-label promotional practices concerning Zyvox, Geodon and Lyrica, allegations related to certain payments to healthcare professionals involving these and nine other Pfizer medicines, and several related qui tam actions. Pfizer previously disclosed a related $2.3 billion charge to its fourth-quarter and full-year 2008 earnings in connection with the DOJ agreement in principle on January 26, 2009. No additional charge to the company’s earnings will be recorded in connection with this settlement."
"In addition, the company has reached agreements with attorneys general in 42 states and the District of Columbia to settle state civil consumer protection allegations related to its past promotional practices concerning Geodon. The company will pay a total of $33 million to the settling states and will take a charge in that amount to third-quarter 2009 earnings." (Continued in linked article)
---
*Geodon, antipsychotic
---
AMERICA DESERVES BETTER THAN EX-CEO'S FROM PHARMACEUTICAL COMPANIES THAT COMMITTED CRIMES AGAINST INNOCENT PEOPLE VIA ILLEGAL MARKETING AND PROMOTION OF DANGEROUS DRUGS!
DON'T INSULT AMERICANS FURTHER OBAMA.
--
Further reading of my previous posts:
Thursday, August 28, 2008-
Pfizer's million dollar view : Democratic National Convention and pharma: drug us!:
"The list of health-oriented sponsors reads like a roll call of drugmakers: Merck, Amgen, Pfizer, AstraZeneca, Novartis, Mylan, Abbott and Eli Lilly. Five of those companies--Pfizer, AstraZeneca, Lilly, Amgen and Merck--have put CEO power behind their cash. AstraZeneca and Lilly dispatched their CEOs--David Brennan (photo) and John Lechleiter (photo), respectively--to receptions and luncheons the companies sponsored. Pfizer's Jeff Kindler (photo) and Amgen's Kevin Sharer (photo) participated in a health roundtable. And at a PhRMA-sponsored brunch, Merck CEO Richard Clark (photo) and AstraZeneca's Brennan mingled with the invitation-only crowd. [(Seroquel).]
And tonight, when Barack Obama accepts the Democratic nomination, Pfizer folks will be on hand in coveted sky box seats reserved for those donors who've given more than $1 million."
---
Monday, October 20, 2008-Pfizer's $894 Million dollar court settlement
Pfizer had million dollar box seats at the Democratic National Convention, and it just gives thought to how much pharmaceuticals have a stake in our lives.
This settlement is for painkillers, and in my opinion, the Zyprexa and Seroquel lawsuits should be getting massive media attention also.
~
"Pfizer can now say "done deal" on most of the lawsuits over its painkillers Celebrex and Bextra. The cost? $894 million. As of today, the drugmaker has reached agreements in principle to settle with up to 92 percent of the outstanding personal injury plaintiffs, who had alleged that the drugs had caused heart attacks, strokes, or other serious health problems."
European Commission Approves XEPLION(R) for Treatment of Schizophrenia:paliperidone palmitate:Janssen,J &J
I've been watching this for a very long time-take a look at the DSM code labels it covers!. paliperidone palmitate is an active metabolite of Risperdal, now in monthly long acting injectable form in Europe. Already in place as Invega Sustenna in the U.S.
Here's the news release: March 2011
European Commission Approves XEPLION(R) for Treatment of Schizophrenia:
BEERSE, Belgium, March 9, 2011 /PRNewswire/ -- Janssen-Cilag International NV today announced that XEPLION(R) (paliperidone palmitate), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia.
Schizophrenia is relatively common and the prevalence is similar around the world. The lifetime risk for schizophrenia is estimated to be one person in 100, and appears to be the same for men and women up to age 60 years.[1] Schizophrenia is a devastating mental illness for both the patients and their families and friends, as it seriously impairs a person's ability to think clearly, relate to others and to function properly in society. While there is no cure, many people with the illness respond well to antipsychotic medicines, the mainstay of treatment for schizophrenia.
However, further relapses can have a terrible effect on the lives of patients with schizophrenia and their families. Frequent relapses and hospitalisation can increase the person's isolation and make it even more difficult for them to find and keep a job.[2],[3],[4],[5],[6] Prevention of future relapses is a crucial goal of therapy and patients who stay on continual treatment are more likely to achieve optimal outcomes.[7],[8]
Patients with schizophrenia who are non-adherent to medication are up to five times more likely to relapse than those patients who are adherent and continue on medication, significantly increasing the likelihood of hospitalisation,[9] which in turn increases the overall cost of care.
"Relapse can have a devastating effect on patients with schizophrenia and more needs to be done to actively improve adherence to medication if we are to break the cycle of decline," said Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr RodrÃguez Lafora, Madrid, Spain.* "Long-acting injectable antipsychotics such as XEPLION(R) can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients."
Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson
*Professor Fernando Cañas has at times been a paid consultant of Janssen
-----
THE SAME DAY Johnson & Johnson goes on trial for possible for violation of South Carolina's Unfair Trade Practices Act on allegations of deceptive marketing of the antipsychotic Risperdal:
"A Spartanburg County jury will decide whether a global drug company violated the state’s Unfair Trade Practices Act on allegations of deceptive marketing.
The trial is the fourth nationwide against Johnson & Johnson subsidiary Janssen Pharmeceutica, a New Jersey-based company. Circuit Judge Roger Couch is presiding over the case, which is expected to last for a three-week period.
If a jury determines Janssen willfully violated the act, Couch will then award damages.
During his lengthy opening argument, Spartanburg attorney Don Coggins, of Harrison, White, Smith, and Coggins law firm, told jurors they will decide whether Janssen violated the state statute by failing to openly disclose “the whole truth” about Risperdal, an antipsychotic drug manufactured by Janssen used to treat schizophrenia and acute bipolar disorder, in exchange for “huge, huge profits."
hat tip for Risperdal trial article to PharmaGossip.
Hat tip to Gary Monk for the EU approval of XEPLION news release, former Product Manager (Marketing) at Janssen-Cilag.
Bloomberg:
J&J Misled South Carolina Officials About Drug, Jury Told:
"Johnson & Johnson duped South Carolina officials into buying the antipsychotic drug Risperdal for Medicaid patients by making false claims about its safety and effectiveness, a lawyer for the state told jurors.
Officials of J&J, based in New Brunswick, New Jersey, made misleading claims about Risperdal’s health risks in a letter sent to South Carolina regulators and doctors to protect sales of a medicine that generated $33 billion in revenue for the drugmaker during a 13-year period, the lawyer, Donald Coggins Jr., said today in state court in Spartanburg, South Carolina.
“This case is about corporate responsibility and not going out to lie to defenseless people in pursuit of the almighty dollar,” Coggins said in opening statements of the trial of the state’s lawsuit against Johnson & Johnson.
The state’s case centers on drug safety claims that J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit made in November 2003 correspondence to 700,000 doctors across the U.S., including 7,200 in South Carolina."
Here's the news release: March 2011
European Commission Approves XEPLION(R) for Treatment of Schizophrenia:
BEERSE, Belgium, March 9, 2011 /PRNewswire/ -- Janssen-Cilag International NV today announced that XEPLION(R) (paliperidone palmitate), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia.
Schizophrenia is relatively common and the prevalence is similar around the world. The lifetime risk for schizophrenia is estimated to be one person in 100, and appears to be the same for men and women up to age 60 years.[1] Schizophrenia is a devastating mental illness for both the patients and their families and friends, as it seriously impairs a person's ability to think clearly, relate to others and to function properly in society. While there is no cure, many people with the illness respond well to antipsychotic medicines, the mainstay of treatment for schizophrenia.
However, further relapses can have a terrible effect on the lives of patients with schizophrenia and their families. Frequent relapses and hospitalisation can increase the person's isolation and make it even more difficult for them to find and keep a job.[2],[3],[4],[5],[6] Prevention of future relapses is a crucial goal of therapy and patients who stay on continual treatment are more likely to achieve optimal outcomes.[7],[8]
Patients with schizophrenia who are non-adherent to medication are up to five times more likely to relapse than those patients who are adherent and continue on medication, significantly increasing the likelihood of hospitalisation,[9] which in turn increases the overall cost of care.
"Relapse can have a devastating effect on patients with schizophrenia and more needs to be done to actively improve adherence to medication if we are to break the cycle of decline," said Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr RodrÃguez Lafora, Madrid, Spain.* "Long-acting injectable antipsychotics such as XEPLION(R) can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients."
Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson
*Professor Fernando Cañas has at times been a paid consultant of Janssen
-----
THE SAME DAY Johnson & Johnson goes on trial for possible for violation of South Carolina's Unfair Trade Practices Act on allegations of deceptive marketing of the antipsychotic Risperdal:
"A Spartanburg County jury will decide whether a global drug company violated the state’s Unfair Trade Practices Act on allegations of deceptive marketing.
The trial is the fourth nationwide against Johnson & Johnson subsidiary Janssen Pharmeceutica, a New Jersey-based company. Circuit Judge Roger Couch is presiding over the case, which is expected to last for a three-week period.
If a jury determines Janssen willfully violated the act, Couch will then award damages.
During his lengthy opening argument, Spartanburg attorney Don Coggins, of Harrison, White, Smith, and Coggins law firm, told jurors they will decide whether Janssen violated the state statute by failing to openly disclose “the whole truth” about Risperdal, an antipsychotic drug manufactured by Janssen used to treat schizophrenia and acute bipolar disorder, in exchange for “huge, huge profits."
hat tip for Risperdal trial article to PharmaGossip.
Hat tip to Gary Monk for the EU approval of XEPLION news release, former Product Manager (Marketing) at Janssen-Cilag.
Bloomberg:
J&J Misled South Carolina Officials About Drug, Jury Told:
"Johnson & Johnson duped South Carolina officials into buying the antipsychotic drug Risperdal for Medicaid patients by making false claims about its safety and effectiveness, a lawyer for the state told jurors.
Officials of J&J, based in New Brunswick, New Jersey, made misleading claims about Risperdal’s health risks in a letter sent to South Carolina regulators and doctors to protect sales of a medicine that generated $33 billion in revenue for the drugmaker during a 13-year period, the lawyer, Donald Coggins Jr., said today in state court in Spartanburg, South Carolina.
“This case is about corporate responsibility and not going out to lie to defenseless people in pursuit of the almighty dollar,” Coggins said in opening statements of the trial of the state’s lawsuit against Johnson & Johnson.
The state’s case centers on drug safety claims that J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit made in November 2003 correspondence to 700,000 doctors across the U.S., including 7,200 in South Carolina."
Tuesday, March 08, 2011
1 Boring Old Man blog, and reflecting on 4 years of blogging!
photo of miniature daffodils from my old garden planter box
--
i've got cut daffodils in a vase that are brightening my day every time i look at them!
be sure to catch up or keep up with the Boring Old Man blog where this week he linked to my clinical research trials post.
The doctor was able to tie the whole thing together with the main theme of the day over there: Seroquel and how it got to market, and all of the internal trial data, etc. One thing is clear this drug got past the sniff test at the FDA because AstraZeneca buried, cooked and promoted just what they wanted with data, and made sure the FDA was presented a nice and tidy package that would gain approval. Just my opinion, but look at the facts in the Boring Old Man blog Seroquel series, authored by a retired psychiatrist, who, while writing post after post is also reflecting personal thoughts as it pertains to the Seroquel topic.
It's been fun and interesting to see how the information and things have come out about Pharma and the internal workings of drug companies over the last 4 years.
Yes, that's how long I've been rambling on here, after finding a great blog where the author was the only one at the time writing about dangers of psych meds, and the childhood bipolar diagnosis explosion.
Journalist Philip Dawdy's blog, Furious Seasons (now on hiatus) gave my blog a boost back in 2007 with the thinking blogger award. It's been great! Many thanks to Philip, who was a mentor of sort while I learned the 'art of blogging', as well as one of my long time support of my daughter and myself during some very difficult times and psych ward events & hospitalizations.
Thanks to all of my readers and to readers of Furious Seasons who come over periodically and check on how things are going.
I'd be remiss if I didn't give a shout out to fellow blogger and Furious Seasons commenter Bob Fiddaman, on the release of his BOOK due out in April 2011. Fid has taken the Seroxat Sufferers blog one step further and wrote a book about his Paxil/Seroxat withdrawals.
Thanks for all of the support from all of my readers, past and current over the last 4 years, much as gone down and there is much more to look forward to in the future.
"Always go too far, because that's where you'll find the truth."~Camus
*hey thanks for the congrats posts! Borepatch! and Mark! it's been great making friends and meeting people from all around the world!
Thursday, March 03, 2011
the struggle within: acceptance does not mean giving up hope, or forgetting
...and then after questioning my life and my loss of faith in humanity, i embarked on the last leg of the journey that i had dreaded and needed to complete, which was moving to a new home, a new area, a new life. a 'pop-up' book type of transition where it's all new and different. i'm not the first person to have moved, and i have moved greater distances than this last one. the journey, though was entangled in processing of my memories mentally and physically. packing away items, throwing away items and old junk. clearing out resulted in the ultimate purge of my lifetime.
in a way it was forcing me to close chapters and doors on pain. simple as it sounds, it was, at times the most gruesome event i could fathom myself feeling, and dealing with; each day opening boxes from the old garage and finding a time capsule of sort of a life left behind due to my daughter's mental health demise of a decade, where life just basically appeared to stop, in its tracks.
though life, along with the years moved on, in a continual rise and set of the sun, and a continual change of the seasons. those 2 things: sunrise/sunset and seasons are always on time, never failing to do what expected. we can count on it. life changes and we can count on that too.
i've learned.
this we knew would come of this event, but processing it through my mind required complete and total shut down of feeling. that was a monumental task for me. it was a mandatory requirement to my adjustment to where i am now. turn off the emotions. oh how easy it sounds. there were times i was in a complete breakdown of emotions when moving, and it does not work in that situation. nothing is accomplished, anguish takes over and the pain becomes insurmountable. don't step into that trap. there is a time and place for emotions.
a time and place for emotions in extreme situations. i thought many times how i 'wasn't like anyone else', unable to be stoic or remain calm and just get it done. i was processing decades of items, emotions, and feelings and all the while opening boxes to sort-choose to keep-or throw away-or place in storage--and my mind would be flooded from all directions.
in essence i was given an opportunity to look at my life, all 51 years of it, in photos, objects and memories. what a clearance of many things that ended up being.
i'm here. i made it, by the grace of God. it's difficult to see your naked truth. your life as it was, turned out to be and knowing it is up to you to carve out your future. nothing to hold you back but yourself. that's a lot of personal responsibility, and at times a task i can see myself doing, other times a task appearing overwhelming, and recently, a realization that my list got shorter.
i have checked off the foreclosure worry, the house is done and over...other things almost completed in the big ticket items list that was a dark cloud over my head. it's down to work and education continuance now, and as i think about those last 2 items i can finally envision myself...living. i've always been living. but, the lingering acceptance of my daughter as she is now, being in the moment and understanding 'this is what it is'...has been the most difficult and now i know why.
sometimes, it takes time to think, process and learn. i realized, that when i thought about my daughter and how she is now, that deep down in my heart i worried, or felt, that if i accepted it at face value, that meant i was forgetting her. as a mother i know i will never forget her. as a person i don't want to forget her. some days memories creep in and i have a heart pang. i recently heard a person call out "mom". it was coming from behind me, and it was my daughter's voice.
it was my daughter.
some people who heard it did not know who it was, because they had never heard her speak.
well, it was like any other day. as if she was always here, the same voice, the same person. no more struggling to remember her voice, or wondering if any more.but then, the lucidity does not last. there are a few sentences, the voice seems to be important to me. i remind myself i remember all of her memories and realize i was trying to make sure i remembered them for her, so she wouldn't be forgotten. the vicious cycle of remembering, was taking a toll.
it was keeping me entombed.
just like those boxes left as time stood still. you can't control time or events, and once you let go of trying to control what you can't you will truly be able to live. without guilt, without worry. let it go.
that is what i have learned.
in a way it was forcing me to close chapters and doors on pain. simple as it sounds, it was, at times the most gruesome event i could fathom myself feeling, and dealing with; each day opening boxes from the old garage and finding a time capsule of sort of a life left behind due to my daughter's mental health demise of a decade, where life just basically appeared to stop, in its tracks.
though life, along with the years moved on, in a continual rise and set of the sun, and a continual change of the seasons. those 2 things: sunrise/sunset and seasons are always on time, never failing to do what expected. we can count on it. life changes and we can count on that too.
i've learned.
this we knew would come of this event, but processing it through my mind required complete and total shut down of feeling. that was a monumental task for me. it was a mandatory requirement to my adjustment to where i am now. turn off the emotions. oh how easy it sounds. there were times i was in a complete breakdown of emotions when moving, and it does not work in that situation. nothing is accomplished, anguish takes over and the pain becomes insurmountable. don't step into that trap. there is a time and place for emotions.
a time and place for emotions in extreme situations. i thought many times how i 'wasn't like anyone else', unable to be stoic or remain calm and just get it done. i was processing decades of items, emotions, and feelings and all the while opening boxes to sort-choose to keep-or throw away-or place in storage--and my mind would be flooded from all directions.
in essence i was given an opportunity to look at my life, all 51 years of it, in photos, objects and memories. what a clearance of many things that ended up being.
i'm here. i made it, by the grace of God. it's difficult to see your naked truth. your life as it was, turned out to be and knowing it is up to you to carve out your future. nothing to hold you back but yourself. that's a lot of personal responsibility, and at times a task i can see myself doing, other times a task appearing overwhelming, and recently, a realization that my list got shorter.
i have checked off the foreclosure worry, the house is done and over...other things almost completed in the big ticket items list that was a dark cloud over my head. it's down to work and education continuance now, and as i think about those last 2 items i can finally envision myself...living. i've always been living. but, the lingering acceptance of my daughter as she is now, being in the moment and understanding 'this is what it is'...has been the most difficult and now i know why.
sometimes, it takes time to think, process and learn. i realized, that when i thought about my daughter and how she is now, that deep down in my heart i worried, or felt, that if i accepted it at face value, that meant i was forgetting her. as a mother i know i will never forget her. as a person i don't want to forget her. some days memories creep in and i have a heart pang. i recently heard a person call out "mom". it was coming from behind me, and it was my daughter's voice.
it was my daughter.
some people who heard it did not know who it was, because they had never heard her speak.
well, it was like any other day. as if she was always here, the same voice, the same person. no more struggling to remember her voice, or wondering if any more.but then, the lucidity does not last. there are a few sentences, the voice seems to be important to me. i remind myself i remember all of her memories and realize i was trying to make sure i remembered them for her, so she wouldn't be forgotten. the vicious cycle of remembering, was taking a toll.
it was keeping me entombed.
just like those boxes left as time stood still. you can't control time or events, and once you let go of trying to control what you can't you will truly be able to live. without guilt, without worry. let it go.
that is what i have learned.
Seroquel causes premature death: Study: 50 yr old diabetics die 6 years sooner: AstraZeneca pays chump change to victims
It's apparent that it is business as usual with lawsuits and settlements built into the budget for AstraZeneca.
Beholding a CIA (Corporate Integrity Agreement) with the U.S. Department of Justice, and fined $520 million for off-label marketing of Seroquel, AstraZeneca is in the process of settling approximately 26,000 lawsuits of victims who became diabetic after taking the antipsychotic Seroquel.
Seroquel is being remarketed as an add-on antidepressant, and responsible for deaths of American veterans who have survived war only to come home and die by off-label use of Seroquel.
Attorney General Eric Holder, said at the at the AstraZeneca Settlement Announcement
WASHINGTON, D.C. ~ Tuesday, April 27, 2010:
"Today, we are here to announce the latest results of that effort. The pharmaceutical company AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians and violating the federal Anti-Kickback statute, all in furtherance of supporting the drug’s use for a host of illnesses for which it was never approved.
According to the settlement, AstraZeneca’s illegal marketing of the drug led to millions of dollars in false claims against federal and state programs like Medicare and Medicaid.
These were not victimless crimes – illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets.
As we have said, we will not let such actions stand. This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies."
Indeed, the crime committed by AstraZeneca by selling Seroquel (company documents show the company insiders KNEW it caused diabetes but sold the drug anyway) has created a public health epidemic and no one has bothered to listen.
By way of off-label promotion, and promoting the drug for use for insomnia, innocent victims have diabetes as a result.
Other victims have used Seroquel for the intended use of the antipsychotic: psychosis symptom relief, for depression, anxiety and more.
This is a crime that does indeed have victims.
AstraZeneca is settling lawsuits for $348 million to date, which pays out to approximately $10,000-25,000 per victim, take away taxes and attorney fees.
What price do you place on a shortened lifespan? how does one embrace the knowledge that their lives are shortened by 6 years, according to this study?
Diabetes is "the seventh leading cause of death in the U.S", according to this article:
"NEW YORK – A 50-year-old with diabetes dies six years sooner than someone without the disease, and not just from a heart attack or a stroke, new research suggests.
The large international effort to measure diabetes' toll found the disease also raises the risk of dying prematurely from a host of other ailments, even breast cancer and pneumonia.
"It's quite a wide sweep of conditions," said Dr. John Danesh of Cambridge University in Britain, who led the team of researchers. While most people think of heart problems, diabetes surprisingly "appears to be associated with a much broader range of health implications than previously suspected."
AND
"Diabetes, the seventh leading cause of death in the U.S., affects about 26 million Americans, or 8 percent, including 7 million who haven't been diagnosed. Most in the study were thought to have the most common kind — Type 2 — which occurs when the body makes too little insulin or cannot use what it does make to regulate blood sugar.
High blood sugar can damage nerves and blood vessels, and is a major cause of heart disease."
How would you feel if you used Seroquel for a few months off-label, prescribed by a doctor, for insomnia and became diabetic as a result of the use neuroleptic Seroquel?
How would you feel if you read the article that says your life could be shortened by 6 years as a result?
Beholding a CIA (Corporate Integrity Agreement) with the U.S. Department of Justice, and fined $520 million for off-label marketing of Seroquel, AstraZeneca is in the process of settling approximately 26,000 lawsuits of victims who became diabetic after taking the antipsychotic Seroquel.
Seroquel is being remarketed as an add-on antidepressant, and responsible for deaths of American veterans who have survived war only to come home and die by off-label use of Seroquel.
Attorney General Eric Holder, said at the at the AstraZeneca Settlement Announcement
WASHINGTON, D.C. ~ Tuesday, April 27, 2010:
"Today, we are here to announce the latest results of that effort. The pharmaceutical company AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians and violating the federal Anti-Kickback statute, all in furtherance of supporting the drug’s use for a host of illnesses for which it was never approved.
According to the settlement, AstraZeneca’s illegal marketing of the drug led to millions of dollars in false claims against federal and state programs like Medicare and Medicaid.
These were not victimless crimes – illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets.
As we have said, we will not let such actions stand. This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies."
Indeed, the crime committed by AstraZeneca by selling Seroquel (company documents show the company insiders KNEW it caused diabetes but sold the drug anyway) has created a public health epidemic and no one has bothered to listen.
By way of off-label promotion, and promoting the drug for use for insomnia, innocent victims have diabetes as a result.
Other victims have used Seroquel for the intended use of the antipsychotic: psychosis symptom relief, for depression, anxiety and more.
This is a crime that does indeed have victims.
AstraZeneca is settling lawsuits for $348 million to date, which pays out to approximately $10,000-25,000 per victim, take away taxes and attorney fees.
What price do you place on a shortened lifespan? how does one embrace the knowledge that their lives are shortened by 6 years, according to this study?
Diabetes is "the seventh leading cause of death in the U.S", according to this article:
"NEW YORK – A 50-year-old with diabetes dies six years sooner than someone without the disease, and not just from a heart attack or a stroke, new research suggests.
The large international effort to measure diabetes' toll found the disease also raises the risk of dying prematurely from a host of other ailments, even breast cancer and pneumonia.
"It's quite a wide sweep of conditions," said Dr. John Danesh of Cambridge University in Britain, who led the team of researchers. While most people think of heart problems, diabetes surprisingly "appears to be associated with a much broader range of health implications than previously suspected."
AND
"Diabetes, the seventh leading cause of death in the U.S., affects about 26 million Americans, or 8 percent, including 7 million who haven't been diagnosed. Most in the study were thought to have the most common kind — Type 2 — which occurs when the body makes too little insulin or cannot use what it does make to regulate blood sugar.
High blood sugar can damage nerves and blood vessels, and is a major cause of heart disease."
How would you feel if you used Seroquel for a few months off-label, prescribed by a doctor, for insomnia and became diabetic as a result of the use neuroleptic Seroquel?
How would you feel if you read the article that says your life could be shortened by 6 years as a result?
Wednesday, March 02, 2011
Seroquel trial suicide victim Dan Markingson's Mother Replies to University of Minnesota VP Mulcahy
This is via Bill Gleason
Bill Gleason is an Associate Professor at the University of Minnesota in the Department of Laboratory Medicine and Pathology. He's also a fellow at the U's Supercomputer Institute.
*this is a direct copy of his post & Mary's Letter
Dr. Mulcahy's original letter appeared in the Minnesota Daily.
"I'd encourage interested readers to read it as well as my own comments at the end of the article.
With the permission of Mary Weiss, I here reprint her letter. It should receive widespread attention in the community. Steps should be taken, including an independent investigation, to assure that such incidents do not occur in the future. To argue that what happened is not illegal is a far cry from the Hippocratic Oath: First do no harm."
Mary Weiss writes in today's Daily:
I am Mary Weiss, mother of Dan Markingson, who died while in a University of Minnesota clinical drug study.
In a Feb. 24 letter to the editor published in the Minnesota Daily, “The Markingson case deserves better from the Daily,” R. Timothy Mulcahy, vice president for research at the University, states, among other things, that the University did not profit from the study in which Dan died.
So, this study was revenue neutral? Does the University not profit from their clinical drug research? Who would possibly believe this?
Mulcahy states non-University psychiatrists found no wrongdoing. Of course they found no wrongdoing: These psychiatrists were paid to find no wrongdoing by virtue of the fact that they were “expert witnesses” for the University. Other medial professionals have since disagreed with thisassessment.
Dr. Harrison G. Pope, Jr., professor of psychiatry at Harvard Medical School, said about the study, “There is virtually no evidence that this vulnerable, severely psychotic and mentally incompetent patient was capable of understanding the study to which he was consenting.”
Or take the statement of James I. Hudson, also a professor of psychiatry at Harvard, who summed up his professional opinion of the doctor who conducted the study, saying, “Dr. [Stephen] Olson’s errors, omissions, improper acts and failures were to a reasonable degree of medical certainty, a substantial contributing factor and a proximate cause of Mr. Markingson’s death.”
Dr. Keith A. Horton, licensed psychiatrist in the state of Minnesota, said in his expert testimony, “It is my opinion that this case represents a violation of biomedical standards upon which there is a widespread consensus for informed consent and human subjects’ protection.”
Mulcahy states also in his article, “The University is steadfast in its commitment to the protection of all research subjects.”
If this had been the case, “Dan’s Law” — which was passed unanimously in both the Minnesota House and Senate in 2009 — would have been entirely unnecessary.
This law now prevents anyone on a stay of civil commitment from entering a psychiatric clinical drug study and also prohibits any doctor from putting his or her own patients into his or her own clinical drug study.
Also, Mulcahy states that “proper care was provided” to Dan. I don’t think many people would consider it “proper care” when on April 9, 2004, Easter Sunday — less than a month before he died — Dan was psychotic, and I, his distraught mother, left voice messages for Olson and also Jeanne Kenney, the study’s coordinator.
I said, “Do we have to wait for him to kill himself or someone else before anyone does anything?” thinking for sure someone would call me back in the morning and re-hospitalize Dan.
Unbelievably, no one responded — though Kenney did write my message verbatim in her study file. Evidently, the outcome of the study was more important than making a patient well or keeping him alive.
Also, Mulcahy states that no laws were violated by the University. In fact, the University was given immunity by a Hennepin County judge who cited the Minnesota law which states “[Minnesota] and its employees are not liable for … a loss caused by the performance or failure to perform a discretionary duty.”
Horton also said, “It is my opinion that no university or medical center should tolerate or condone the improper, coercive, unethical practices documented in the case of Dan Markingson. Correction measures should be instituted to prevent future injuries to vulnerable patients.”
But no correction measures have been taken. And the University still tolerates and condones improper, coercive, unethical practices.
What is it going to take for them to change? I really don’t know. Hopefully not the death of another parent’s precious child."-Mary Weiss, Dan's mother
No laws have been broken? And the angels wept. "-Bill Gleason
Bill Gleason is an Associate Professor at the University of Minnesota in the Department of Laboratory Medicine and Pathology. He's also a fellow at the U's Supercomputer Institute.
*this is a direct copy of his post & Mary's Letter
Dr. Mulcahy's original letter appeared in the Minnesota Daily.
"I'd encourage interested readers to read it as well as my own comments at the end of the article.
With the permission of Mary Weiss, I here reprint her letter. It should receive widespread attention in the community. Steps should be taken, including an independent investigation, to assure that such incidents do not occur in the future. To argue that what happened is not illegal is a far cry from the Hippocratic Oath: First do no harm."
Mary Weiss writes in today's Daily:
I am Mary Weiss, mother of Dan Markingson, who died while in a University of Minnesota clinical drug study.
In a Feb. 24 letter to the editor published in the Minnesota Daily, “The Markingson case deserves better from the Daily,” R. Timothy Mulcahy, vice president for research at the University, states, among other things, that the University did not profit from the study in which Dan died.
So, this study was revenue neutral? Does the University not profit from their clinical drug research? Who would possibly believe this?
Mulcahy states non-University psychiatrists found no wrongdoing. Of course they found no wrongdoing: These psychiatrists were paid to find no wrongdoing by virtue of the fact that they were “expert witnesses” for the University. Other medial professionals have since disagreed with thisassessment.
Dr. Harrison G. Pope, Jr., professor of psychiatry at Harvard Medical School, said about the study, “There is virtually no evidence that this vulnerable, severely psychotic and mentally incompetent patient was capable of understanding the study to which he was consenting.”
Or take the statement of James I. Hudson, also a professor of psychiatry at Harvard, who summed up his professional opinion of the doctor who conducted the study, saying, “Dr. [Stephen] Olson’s errors, omissions, improper acts and failures were to a reasonable degree of medical certainty, a substantial contributing factor and a proximate cause of Mr. Markingson’s death.”
Dr. Keith A. Horton, licensed psychiatrist in the state of Minnesota, said in his expert testimony, “It is my opinion that this case represents a violation of biomedical standards upon which there is a widespread consensus for informed consent and human subjects’ protection.”
Mulcahy states also in his article, “The University is steadfast in its commitment to the protection of all research subjects.”
If this had been the case, “Dan’s Law” — which was passed unanimously in both the Minnesota House and Senate in 2009 — would have been entirely unnecessary.
This law now prevents anyone on a stay of civil commitment from entering a psychiatric clinical drug study and also prohibits any doctor from putting his or her own patients into his or her own clinical drug study.
Also, Mulcahy states that “proper care was provided” to Dan. I don’t think many people would consider it “proper care” when on April 9, 2004, Easter Sunday — less than a month before he died — Dan was psychotic, and I, his distraught mother, left voice messages for Olson and also Jeanne Kenney, the study’s coordinator.
I said, “Do we have to wait for him to kill himself or someone else before anyone does anything?” thinking for sure someone would call me back in the morning and re-hospitalize Dan.
Unbelievably, no one responded — though Kenney did write my message verbatim in her study file. Evidently, the outcome of the study was more important than making a patient well or keeping him alive.
Also, Mulcahy states that no laws were violated by the University. In fact, the University was given immunity by a Hennepin County judge who cited the Minnesota law which states “[Minnesota] and its employees are not liable for … a loss caused by the performance or failure to perform a discretionary duty.”
Horton also said, “It is my opinion that no university or medical center should tolerate or condone the improper, coercive, unethical practices documented in the case of Dan Markingson. Correction measures should be instituted to prevent future injuries to vulnerable patients.”
But no correction measures have been taken. And the University still tolerates and condones improper, coercive, unethical practices.
What is it going to take for them to change? I really don’t know. Hopefully not the death of another parent’s precious child."-Mary Weiss, Dan's mother
No laws have been broken? And the angels wept. "-Bill Gleason
Subscribe to:
Posts (Atom)
Posts
