Exclusive story from anonymous victim of the Seroquel diabetes side effect
History
1. Spring 2008 victim diagnosed with diabetes, without previous history of diabetes after taking Seroquel (antipsychotic) made by AstraZeneca. The person was given Seroquel OFF-LABEL for depression and sleep, neither use was FDA approved.
2. Spring 2008 victim contacted attorney that specializes in drug injury lawsuits.
3. Within a few months that attorney group passed the file and the case of the victim over to a new attorney group without permission of the victim, or choice.
4. Miller Firm, now in possession of the case of this victim proceeded to handle the case without communication to the client with exception:
Client was asked to fill out a form, with information without ever speaking to the client/victim personally via phone other form of communication.
5. Two (2) items were in total mailed to victim. One was the info packet to fill out, the other and last piece of mail/communication was in July 2009.
NO other communication happened FROM the Miller Firm. Only contact was from victim/client phoning and inquiring re: the case and litigation updates.
Victim during this time of 3 years obviously still suffers from permanent body damage from the antipsychotic, Seroquel, and has not been compensated in any way for the life time harm done.
August 2010
Miller Firm has been absent in communication, and at one time when Bloomberg published the "settlement" story of the $198 million the victim again phoned the Miller Firm, and was told the lawyer was on vacation. No return phone calls were given to the client/victim, the burden lay on victim to contact and seek answers as to the status of the AstraZeneca settlement. The secretary said they had not heard anything about the settlement, once again and the secretary told the client/victim they appeared to know more information than the attorney group and to "call back when you have more information".
February 2011
Client/victim phoned original attorney group who passed the case over to Miller Firm inquiring as to the status of victim settlement offer and asking again the question of "will either firm be representing these cases in court? individually? take any of the cases to trial?
The answer IS NO.
The client/victim, after 3 years of waiting for 2 attorney groups that advertise in drug injury cases have both said not one case will be taken to trial, the client/victim has one choice: accept the offer of settlement (yet to be determined, rumored at $10K before fees removed) or take NOTHING.
The victim/client asked the original firm to contact the Miller Firm. The original firm did, and via email was told that NO case would go to trial, they will not represent the client further, and once the victim chooses to refuse the offer, the victim/client's case will BE CLOSED.
Leaving the diabetes victim, injured by off-label use of the antipsychotic SEROQUEL with nothing, except the injury. NO justice, no financial compensation, no medical compensation for care, all the while AstraZeneca was fined $520 million by the US Dept of Justice for illegal marketing of Seroquel, the internal documents PROVE the company KNEW diabetes was a side effect and the FDA approved it anyway.
THIS IS AN INJUSTICE AND THE FDA ALONG WITH ASTRAZENECA SHOULD BE SUED, TAKEN TO TASK AND PEOPLE IN THE DOCUMENTS SHOULD BE IMPRISONED.
WHO IS LEFT TO SUFFER? INNOCENT VICTIMS!
Suffering at the hands of corporate greed, unethical business practices and attorneys who WILL have income off of the backs of the victims who choose to take the low ball offer for a life time damage to their body.
IF ANY LAWFIRM reads this and is interested in representing my anonymous client/victim (or others) IN COURT, leave a comment.
All comments are moderated, spam will be tossed.
Monday, February 28, 2011
Brian Reid: Oh, The Humanity: Pharma Social Media Turns a Corner: AstraZeneca tweet chat & me
Many thanks, to Brian Reid for this thoughtful article on the social media pharma chat conducted by AstraZeneca 2-16-11, where I was a vocal participant (see my previous post-"David vs Goliath, AZ vs me")
Oh, The Humanity: Pharma Social Media Turns a Corner
Posted by: Brian Reid 2-24-11
"The winter of 2007 was a turning point for online health journalism: in a matter of weeks, Ed Silverman’s Pharmalot launched, quickly becoming a cheeky blog of record for the industry, and the Wall Street Journal began its Health Blog, giving one of the most influential print publications an online home to drive the health news of the day. Four years later, both sites — an countless other blogs, Twitter accounts and the link — have made online pharma news a ubiquitous and vital part of the information ecosystem.
Now industry is catching up, not just by the numbers (there are now literally hundreds of pharma blogs, Twitter accounts and Facebook pages) but in tone. Because online has long been a place where human conversations trump corporate-speak, it’s important to flag great examples where the industry begins interacting with a human touch.
This month, two pharmaceutical-industry giants took big steps towards demonstrating that human touch. The first was the launch of a log by PhRMA, the industry trade association **. The Catalyst, as it is called, is still in its early days, but it’s already showing the power of engagement. The regular postings aren’t stale regurgitation of taking points, but thoughtful feedback to the news of the day, responding to news articles and blogs, musing on what the Jeopardy-playing robot Watson might mean for medicine and celebrating Valentine’s Day with heart-healthy tips.
And last week, AstraZeneca waded into new territory by hosting a “tweetchat”: a focused, all-comers exchange on Twitter. The event focused on prescription drug costs, tracked the hashtag #rxsave. The event was not exactly a meeting of the like-minded: it brought out fierce critics of the company, and it doesn’t appear than a hour of typing changed any minds.
But it might have changes some hearts. “ Soulful Sepulcher,” a patient advocate, unabashed critic and vocal participant in the tweetchat, wasn’t mollified by the responses. But she got an audience with AstraZeneca, and that was hugely important. “I WAS HEARD BY ASTRAZENECA,” she tweeted. “All that matters now.”
The launch of a blog and the initiation of a single tweetchat doesn’t signal a new era in industry communications. But like the appearance of Pharmalot and the WSJ Health Blog four years ago, these may be early signals of a coming sea change."
** WCG consults with PhRMA.
By: Brian Reid
Brian Reid is a director at WCG in the product group, where he specializes in media. He is a former journalist who believes content really is king. Find me on: Twitter
------
A few of my tweets from that chat
http://twitter.com/soulflsepulcher/status/38025626761822209
No cure for Schizophrenia: Seroquel was illegally marketed/AZ fined 520$million.Some Sz pts have diabetes now #mentalhealth #rxsave
http://twitter.com/soulflsepulcher/status/38049979989757952
RT @pharmagossip How many Corporate Integrity Agreements has @AstraZenecaUS had? http://bit.ly/hXAYav and http://bit.ly/earhXM #rxsave
http://twitter.com/soulflsepulcher/status/38055676647309312
RT @AstraZenecaUS next tweet chat? @soulflsepulcher will we host one?let's see how this goes&how FDA guidance on SM turns out #rxsave
Saturday, February 26, 2011
Drug trials : SCCT doctor in ProPublica "Dollars for Docs" database: who trials the drugs you take? they earn a living doing it
Have you ever wondered how some drug trials are conducted? they aren't always at a University (such as Dr.Charles Schulz and the infamous Seroquel trial suicide scandal at the University of Minnesota ) . Have you ever wondered how the drugs approved by the FDA were trialed? who conducted the trials? and who were the people trialing (your) the drugs?
I've become aquainted with South Coast Clinical Trials in Southern California, as a result of participating in social media 'live' pharmaceutical engaging 'chats' where social media PR hover and connect, network and promote themselves, their companies.
It's where I became aware of Dan Sfera, who has contacted me via Twitter and we discussed drug trials (I asked if he conducted them) and I also asked if he had children as participants, which he told me "No", thankfully.
He offered (attempted to promote via sales pitch) to video tape my "story" as a 'bad experience' for his blog, Clinical Trials Guru, of which I declined. My 'story' is beyond bad experience and remains here on my blog.
Being the person I am, I could not resist taking a look at this clinic, once I started 'following' Dan on Twitter, to check the doctors he works with for pharmaceutical income, and I had also asked which companies they worked with due to the psychiatric nature of his business, and that was not answered in specific company names.
From the South Coast Clinical Trials website:
Dr. Adonis Sfera, MD (relative?)
is a board certified psychiatrist who has been serving the Southern California area for over 15 years. For the past 10 years, he has been involved in more than 50 studies, with a particular emphasis on psychiatric trials. He founded South Coast Clinical Trials, Inc. in 2001, and has been either the Principal Investigator or the Sub-Investigator in all of our studies since then. He also maintains a private practice in general and geriatric psychiatry at our Anaheim site.
Dr. Johnny Edrozo, MD
a board certified psychiatrist specializing in general, geriatric and child psychiatry, has been affiliated with SCCT since 2005. He is the Principal Investigator as well as Sub-Investigator for a number of our studies. In addition to his research activities, Dr. Edrozo also has a private practice in general, geriatric and child psychology in Anaheim.
Dr. Edrozo ProPublica Dollars for Docs, database
EDROZO, JOHNNY AGUINALDO
Calif. Cerritos
Pfizer
$828 2009
Q3-Q4 Professional Advising: $53.00, Meals: $387.00, Business Related Travel: $346.00, Educational Items: $42.00 EDROZO, JOHNNY AGUINALDO
Dan Sfera, BS, MBA
a regulatory and contract specialist, is responsible for business development and is the Anaheim Site Director. In addition, Mr. Sfera is the Site Liaison for the company and is in charge of obtaining new studies as well as handling all of the necessary study start-up activities for our multiple sites. Dan serves as the liaison between South Coast Clinical Trials and SCCT’s pharmaceutical sponsors or Contract Research Organizations, ensuring that each and every facet of the trials are in full compliance with the Food and Drug Administration and Institutional Review Boards.
Press Release Advertised on the site
"The suicide rate in Bipolar Disorder is higher than any other mental disorder,” said Dr. Johnny Edrozo, a board certified psychiatrist who also functions as a principal investigator for South Coast Clinical Trials. “We are partnering with major pharmaceutical companies to find treatments that directly save people’s lives.”
I did not find a financial disclosure for conflict of interest (COI) for Dr. Edrozo, and for obvious ethical reasons and transparency to clients, this should be known that the doctor receives personal income from a pharmaceutical company that sells psychiatric medications. (Pfizer).
Here's one of the videos from the Clinical Trials Guru site of 2 people who have participated in multiple drug trials, which can be an income sustaining practice, where some people may call them and others who do this for a living, "human guinea pigs" or "professional guinea pigs". Some people seek out drug trials just for the money, or the medications.
Dan is a savvy business man, that is apparent when speaking with him. As the pharmaceutical industry is a business, and profits are to be made, it is wise to know as much as possible before entering a drug trial. Make sure to have complete informed consent, and that may take research by YOU (participant) to read far more than what has been given by the clinic you attend.
Antipsychotics such as Seroquel and Abilify are being touted as add-on antidepressants and the side effects of diabetes and permanent movement disorders, among many side effects remain the same for the drugs...they remain atypical antipsychotics, neuroleptics with possible life changing side effects that one must consider deeply before earning a quick buck in a drug trial.
I've become aquainted with South Coast Clinical Trials in Southern California, as a result of participating in social media 'live' pharmaceutical engaging 'chats' where social media PR hover and connect, network and promote themselves, their companies.
It's where I became aware of Dan Sfera, who has contacted me via Twitter and we discussed drug trials (I asked if he conducted them) and I also asked if he had children as participants, which he told me "No", thankfully.
He offered (attempted to promote via sales pitch) to video tape my "story" as a 'bad experience' for his blog, Clinical Trials Guru, of which I declined. My 'story' is beyond bad experience and remains here on my blog.
Being the person I am, I could not resist taking a look at this clinic, once I started 'following' Dan on Twitter, to check the doctors he works with for pharmaceutical income, and I had also asked which companies they worked with due to the psychiatric nature of his business, and that was not answered in specific company names.
From the South Coast Clinical Trials website:
Dr. Adonis Sfera, MD (relative?)
is a board certified psychiatrist who has been serving the Southern California area for over 15 years. For the past 10 years, he has been involved in more than 50 studies, with a particular emphasis on psychiatric trials. He founded South Coast Clinical Trials, Inc. in 2001, and has been either the Principal Investigator or the Sub-Investigator in all of our studies since then. He also maintains a private practice in general and geriatric psychiatry at our Anaheim site.
Dr. Johnny Edrozo, MD
a board certified psychiatrist specializing in general, geriatric and child psychiatry, has been affiliated with SCCT since 2005. He is the Principal Investigator as well as Sub-Investigator for a number of our studies. In addition to his research activities, Dr. Edrozo also has a private practice in general, geriatric and child psychology in Anaheim.
Dr. Edrozo ProPublica Dollars for Docs, database
EDROZO, JOHNNY AGUINALDO
Calif. Cerritos
Pfizer
$828 2009
Q3-Q4 Professional Advising: $53.00, Meals: $387.00, Business Related Travel: $346.00, Educational Items: $42.00 EDROZO, JOHNNY AGUINALDO
Dan Sfera, BS, MBA
a regulatory and contract specialist, is responsible for business development and is the Anaheim Site Director. In addition, Mr. Sfera is the Site Liaison for the company and is in charge of obtaining new studies as well as handling all of the necessary study start-up activities for our multiple sites. Dan serves as the liaison between South Coast Clinical Trials and SCCT’s pharmaceutical sponsors or Contract Research Organizations, ensuring that each and every facet of the trials are in full compliance with the Food and Drug Administration and Institutional Review Boards.
Press Release Advertised on the site
"The suicide rate in Bipolar Disorder is higher than any other mental disorder,” said Dr. Johnny Edrozo, a board certified psychiatrist who also functions as a principal investigator for South Coast Clinical Trials. “We are partnering with major pharmaceutical companies to find treatments that directly save people’s lives.”
I did not find a financial disclosure for conflict of interest (COI) for Dr. Edrozo, and for obvious ethical reasons and transparency to clients, this should be known that the doctor receives personal income from a pharmaceutical company that sells psychiatric medications. (Pfizer).
Here's one of the videos from the Clinical Trials Guru site of 2 people who have participated in multiple drug trials, which can be an income sustaining practice, where some people may call them and others who do this for a living, "human guinea pigs" or "professional guinea pigs". Some people seek out drug trials just for the money, or the medications.
Don's interview with two people who have done multiple Clinical Studies. from Don Walters on Vimeo. (one on the right "used to be homeless" "schizophrenic".)
Dan is a savvy business man, that is apparent when speaking with him. As the pharmaceutical industry is a business, and profits are to be made, it is wise to know as much as possible before entering a drug trial. Make sure to have complete informed consent, and that may take research by YOU (participant) to read far more than what has been given by the clinic you attend.
Antipsychotics such as Seroquel and Abilify are being touted as add-on antidepressants and the side effects of diabetes and permanent movement disorders, among many side effects remain the same for the drugs...they remain atypical antipsychotics, neuroleptics with possible life changing side effects that one must consider deeply before earning a quick buck in a drug trial.
Thursday, February 24, 2011
Pharmalive: Study: The More a Drug is Marketed, the Less the Benefit to Patients
VIA PharmaLive:
Drug Marketing Increases Risk Of Illness, Study Finds
From Targeted News Service (February 23, 2011)
STRATFORD, N.J., Feb. 23 -- University of Medicine and Dentistry of New Jersey issued the following news release:
"The more widely drug companies market a drug, the less many users of the drug tend to benefit from its use and the more likely they are be harmed by it, a new report finds. Researchers Donald Light, PhD, of the UMDNJ-School of Osteopathic Medicine and Howard Brody, MD, of the University of Texas Medical Branch call their finding the Inverse Benefit Law, and describe it in a paper published online in the American Journal of Public Health.
"The Inverse Benefit Law means that the more widely a drug is marketed, the more diluted becomes its effectiveness," noted Light, "but the more people are exposed to its harmful side effects. The Inverse Benefit Law applies to most drugs advertised on television or in other mass media."
In one example, Light and Brody point out that expert guidelines have steadily lowered the blood glucose levels that determine a diagnosis for diabetes. As this threshold was lowered from 140 milligrams per deciliter to 126 and then to 110, millions of additional patients received medications originally formulated to treat people above the original, higher thresholds. The authors argue there is little evidence that people at the lower thresholds are helped by the medications, and yet all were exposed to the drugs’ potential side effects.
According to the authors, drugs intended to treat severe mental illness are also overused. "One serious example is the widespread promotion and use of anti-psychotics for adults and children who are not psychotic," Light said.
The authors say marketers also overreach by creating medical problems out of factors that are weakly associated with a serious clinical condition, such as high cholesterol as a risk factor for heart disease in people not already at risk. They write that lowering cholesterol levels in people already at risk is beneficial, but much less so when taken by people not already at risk."
AND
"Patients’ health can be improved, the authors believe, by restricting promotion of medications for unapproved uses as well as mass direct-to-consumer advertising. The U.S. is only one of two countries that allow consumer advertising of prescription medications, a practice that may put undue pressure on physicians and nurse practitioners to prescribe drugs their patients do not need."
Read entire article HERE.
Drug Marketing Increases Risk Of Illness, Study Finds
From Targeted News Service (February 23, 2011)
STRATFORD, N.J., Feb. 23 -- University of Medicine and Dentistry of New Jersey issued the following news release:
"The more widely drug companies market a drug, the less many users of the drug tend to benefit from its use and the more likely they are be harmed by it, a new report finds. Researchers Donald Light, PhD, of the UMDNJ-School of Osteopathic Medicine and Howard Brody, MD, of the University of Texas Medical Branch call their finding the Inverse Benefit Law, and describe it in a paper published online in the American Journal of Public Health.
"The Inverse Benefit Law means that the more widely a drug is marketed, the more diluted becomes its effectiveness," noted Light, "but the more people are exposed to its harmful side effects. The Inverse Benefit Law applies to most drugs advertised on television or in other mass media."
In one example, Light and Brody point out that expert guidelines have steadily lowered the blood glucose levels that determine a diagnosis for diabetes. As this threshold was lowered from 140 milligrams per deciliter to 126 and then to 110, millions of additional patients received medications originally formulated to treat people above the original, higher thresholds. The authors argue there is little evidence that people at the lower thresholds are helped by the medications, and yet all were exposed to the drugs’ potential side effects.
According to the authors, drugs intended to treat severe mental illness are also overused. "One serious example is the widespread promotion and use of anti-psychotics for adults and children who are not psychotic," Light said.
The authors say marketers also overreach by creating medical problems out of factors that are weakly associated with a serious clinical condition, such as high cholesterol as a risk factor for heart disease in people not already at risk. They write that lowering cholesterol levels in people already at risk is beneficial, but much less so when taken by people not already at risk."
AND
"Patients’ health can be improved, the authors believe, by restricting promotion of medications for unapproved uses as well as mass direct-to-consumer advertising. The U.S. is only one of two countries that allow consumer advertising of prescription medications, a practice that may put undue pressure on physicians and nurse practitioners to prescribe drugs their patients do not need."
Read entire article HERE.
Another day, another doctor paid by pharma: NYT ask the 'Expert' ADHD article has no financial disclosures
Dr.David Bransford, a psychiatric physician in private practice in Minnesota alerted me to this doctor, when he left the link to this NYT 'ask the expert' article about ADHD.
The article is a Q & A in the NYT where an 'expert' answers readers questions and this time it's on ADHD. Dr. Russell Barkley, clinical professor of psychiatry at the Medical University of South Carolina is the doctor answering the questions.
Dr.Russell Barkley
Is in ProPublica Dollars for Docs database.
Dr.Barkley is a paid speaker for Eli Lilly, makers of the ADHD drug Strattera.
BARKLEY, RUSSELL A
S.C.
Mount Pleasant
Eli Lilly
$21,352
2010Q1-Q3
Healthcare Professional Education Programs: $2138, Advising/Consulting and International Education Programs: $19125, Travel Expenses: $89
BARKLEY, RUSSELL A
BARKLEY, RUSSELL A.
S.C.
Mount Pleasant
Eli Lilly
$59,834
2009Q1-Q4
Healthcare Professional Education Programs: $31475.0, Advising/Consulting and International Education Programs: $28359.0
BARKLEY, RUSSELL A.
Though this pharma income the doctor receives may not influence his decisions to drug patients, one never knows how he influenced countless other doctors listening to him speak as an 'expert' in ADHD.
The New York Times presents poor journalism quality when the 'expert' giving advice in an ADHD column has a financial interest in a drug company that sells ADHD medication, that is called COI-Conflict of Interest, so at the minimum the NYT should have a financial disclosure disclaimer of Dr. Russell Barkley at the end of the article.
In essence the NYT is promoting Lilly, Strattera and the doctor being a highly influencial KOL paid speaker/shill for Lilly by not being transparent with the financial interests of Barkley.
Thanks to Dr.Bransford, who watches out for these issues as a doctor on the front lines who DOES NOT take pharmaceutical income.
The article is a Q & A in the NYT where an 'expert' answers readers questions and this time it's on ADHD. Dr. Russell Barkley, clinical professor of psychiatry at the Medical University of South Carolina is the doctor answering the questions.
Dr.Russell Barkley
Is in ProPublica Dollars for Docs database.
Dr.Barkley is a paid speaker for Eli Lilly, makers of the ADHD drug Strattera.
BARKLEY, RUSSELL A
S.C.
Mount Pleasant
Eli Lilly
$21,352
2010Q1-Q3
Healthcare Professional Education Programs: $2138, Advising/Consulting and International Education Programs: $19125, Travel Expenses: $89
BARKLEY, RUSSELL A
BARKLEY, RUSSELL A.
S.C.
Mount Pleasant
Eli Lilly
$59,834
2009Q1-Q4
Healthcare Professional Education Programs: $31475.0, Advising/Consulting and International Education Programs: $28359.0
BARKLEY, RUSSELL A.
Though this pharma income the doctor receives may not influence his decisions to drug patients, one never knows how he influenced countless other doctors listening to him speak as an 'expert' in ADHD.
The New York Times presents poor journalism quality when the 'expert' giving advice in an ADHD column has a financial interest in a drug company that sells ADHD medication, that is called COI-Conflict of Interest, so at the minimum the NYT should have a financial disclosure disclaimer of Dr. Russell Barkley at the end of the article.
In essence the NYT is promoting Lilly, Strattera and the doctor being a highly influencial KOL paid speaker/shill for Lilly by not being transparent with the financial interests of Barkley.
Thanks to Dr.Bransford, who watches out for these issues as a doctor on the front lines who DOES NOT take pharmaceutical income.
Tuesday, February 22, 2011
FDA Orders New Cautions on Antipsychotic Drugs: Babies at risk being born suffering withdrawals & extrapyramidal symptoms
Women be careful when using ANY medication while pregnant, and now the FDA has confirmed babies are being born with adverse event symptoms from mothers who took antipsychotics while pregnant.
FDA Orders New Cautions on Antipsychotic Drugs: -MedPage Today
Published: February 22, 2011
WASHINGTON -- All antipsychotic drugs, including older agents as well as second-generation products, must contain new label information regarding their use in pregnancy, the FDA said.
In particular, the new labeling will address the risk of extrapyramidal symptoms (EPS) and withdrawal syndromes in newborns.
"FDA has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs to include consistent information about the potential risk for EPS and/or withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy," the agency said in a notification to healthcare professionals.
The FDA has identified 69 episodes of neonatal EPS or withdrawal in adverse event reports submitted to the agency through October 2008.
Among the symptoms listed in the reports: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder.
However, blood levels of the drugs involved were not provided in the reports, the agency said, so it was "not possible to determine whether the events resulted from antipsychotic drug toxicity or withdrawal."
Onset of symptoms ranged from birth to one month later, and the severity varied as well. The FDA indicated that some infants recovered within hours while others needed intensive care and prolonged hospitalization.
Most of the cases also involved other potential causes of the symptoms, such as other psychotropic drugs and medical problems associated with the pregnancy or delivery.
"However, there were some cases which suggest that neonatal EPS and withdrawal may occur with antipsychotics alone," the FDA said.
The agency's announcement did not indicate which specific antipsychotic drugs were named in the adverse event reports.
In any event, the FDA is requiring the standardized cautions be carried on all antipsychotic drugs -- 20 different types sold under 23 brand names are included in the order. These range from the first antipsychotic drug used in modern practice, chlorpromazine (Thorazine), to such newer agents as aripiprazole (Abilify) and quetiapine (Seroquel).
All the products are approved to treat schizophrenia; some also have been cleared for bipolar disorder."
--
FDA site announcement
http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm
FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns
Safety Announcement
[2-22-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder, and have been shown to improve daily functioning in individuals with these disorders. Common brand names for antipsychotic drugs include Haldol, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, and Invega (see List of Antipsychotic Drugs below).
Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
Additional Information for Healthcare Professionals
Know that antipsychotic medications cross the placenta.
Be aware that neonates exposed to antipsychotic medications during the third trimester of pregnancy are at risk for EPS and/or withdrawal symptoms following delivery.
Counsel patients about the benefits and risks of taking antipsychotic drugs during pregnancy.
Monitor neonates exhibiting EPS or withdrawal symptoms. Some neonates recover within hours or days without specific treatment; others may require prolonged hospitalization.
Report adverse events involving antipsychotic drugs to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.
--
Clearly this is cause for alarm and concern for women who are taking antipsychotics such as Seroquel and Abilify that are being touted for depression treatment. These drugs are potent neuroleptics, and to see babies born suffering withdrawals from the neuroleptics in their body is heartwrenching to think about.
LIST OF ANTIPSYCHOTICS
Abilify-aripiprazole
Clozaril-clozapine
FazaClo ODT-clozapine
Fanapt-iloperidone
Geodon-ziprasidone
Haldol-haloperidol
Invega-paliperidone
Invega Sustenna-paliperidone
Loxitane-loxapine
Moban-molindone
Navane-thiothixene
Orap-pimozide
Risperdal-risperidone
Risperdal Consta-risperidone
Saphris-asenapine
Seroquel-quetiapine
Seroquel XR-quetiapine
Stelazine-trifluoperazine
Thorazine-chlorpromazine
Zyprexa-olanzapine
Zyprexa Relprevv-olanzapine
Zyprexa Zydis-olanzapine
Symbyax-olanzapine and fluoxetine
No Current Brand Name
fluphenazine
No Current Brand Name
perphenazine
No Current Brand Name
perphenazine and amitriptyline
No Current Brand Name
prochlorperazine
No Current Brand Name
thioridazine
FDA Orders New Cautions on Antipsychotic Drugs: -MedPage Today
Published: February 22, 2011
WASHINGTON -- All antipsychotic drugs, including older agents as well as second-generation products, must contain new label information regarding their use in pregnancy, the FDA said.
In particular, the new labeling will address the risk of extrapyramidal symptoms (EPS) and withdrawal syndromes in newborns.
"FDA has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs to include consistent information about the potential risk for EPS and/or withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy," the agency said in a notification to healthcare professionals.
The FDA has identified 69 episodes of neonatal EPS or withdrawal in adverse event reports submitted to the agency through October 2008.
Among the symptoms listed in the reports: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder.
However, blood levels of the drugs involved were not provided in the reports, the agency said, so it was "not possible to determine whether the events resulted from antipsychotic drug toxicity or withdrawal."
Onset of symptoms ranged from birth to one month later, and the severity varied as well. The FDA indicated that some infants recovered within hours while others needed intensive care and prolonged hospitalization.
Most of the cases also involved other potential causes of the symptoms, such as other psychotropic drugs and medical problems associated with the pregnancy or delivery.
"However, there were some cases which suggest that neonatal EPS and withdrawal may occur with antipsychotics alone," the FDA said.
The agency's announcement did not indicate which specific antipsychotic drugs were named in the adverse event reports.
In any event, the FDA is requiring the standardized cautions be carried on all antipsychotic drugs -- 20 different types sold under 23 brand names are included in the order. These range from the first antipsychotic drug used in modern practice, chlorpromazine (Thorazine), to such newer agents as aripiprazole (Abilify) and quetiapine (Seroquel).
All the products are approved to treat schizophrenia; some also have been cleared for bipolar disorder."
--
FDA site announcement
http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm
FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns
Safety Announcement
[2-22-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder, and have been shown to improve daily functioning in individuals with these disorders. Common brand names for antipsychotic drugs include Haldol, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, and Invega (see List of Antipsychotic Drugs below).
Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
Additional Information for Healthcare Professionals
Know that antipsychotic medications cross the placenta.
Be aware that neonates exposed to antipsychotic medications during the third trimester of pregnancy are at risk for EPS and/or withdrawal symptoms following delivery.
Counsel patients about the benefits and risks of taking antipsychotic drugs during pregnancy.
Monitor neonates exhibiting EPS or withdrawal symptoms. Some neonates recover within hours or days without specific treatment; others may require prolonged hospitalization.
Report adverse events involving antipsychotic drugs to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.
--
Clearly this is cause for alarm and concern for women who are taking antipsychotics such as Seroquel and Abilify that are being touted for depression treatment. These drugs are potent neuroleptics, and to see babies born suffering withdrawals from the neuroleptics in their body is heartwrenching to think about.
LIST OF ANTIPSYCHOTICS
Abilify-aripiprazole
Clozaril-clozapine
FazaClo ODT-clozapine
Fanapt-iloperidone
Geodon-ziprasidone
Haldol-haloperidol
Invega-paliperidone
Invega Sustenna-paliperidone
Loxitane-loxapine
Moban-molindone
Navane-thiothixene
Orap-pimozide
Risperdal-risperidone
Risperdal Consta-risperidone
Saphris-asenapine
Seroquel-quetiapine
Seroquel XR-quetiapine
Stelazine-trifluoperazine
Thorazine-chlorpromazine
Zyprexa-olanzapine
Zyprexa Relprevv-olanzapine
Zyprexa Zydis-olanzapine
Symbyax-olanzapine and fluoxetine
No Current Brand Name
fluphenazine
No Current Brand Name
perphenazine
No Current Brand Name
perphenazine and amitriptyline
No Current Brand Name
prochlorperazine
No Current Brand Name
thioridazine
Monday, February 21, 2011
"adverse drug reactions related to diabetes mellitus are expected to accumulate from now on"-2002 Seroquel internal document-diabetes
Sent: Tuesday, September 17, 2002 5:08 AM
: To: Brecher, Martin
C,c: Melville, Margaret G; Schwartz, Jack A; Dev, Vikram J; Geller, Wayne; Nakajo, Hirochika;
Higuchi Sadao
Subject: Re: Effect of Seroquel on diabetes mellitus
DearBrecher-san,
How are you?
I am sorry to rush you but how is trial No.0041 going? I would really appreciate it if you would let me know the results. Thank you in advance.
Since May, there is one or two severe (or moderate) spontaneous report on diabetic ketoacidosis or hyperglycemia every month. As you may have already know, we received two spontaneous reports related to diabetes mellitus last week. There was a death case in these reports. Considering this situation, adverse drug reactions related to diabetes mellitus are expected to accumulate from now on.
We assume that we have to discuss with the MHLW over the revision of the labeling in course of time and, we believe that the results of this trial will be very useful. We need your cooperation.
Best regards,
Sumie Ishiguro
http://dida.library.ucsf.edu/pdf/hpv09b10
---
Nothing changed it only got worse for consumers
The lawsuits poured in and AstraZeneca paid out $350 million to date in settlements and was fined $520 million by the U.S. Department of Justice for illegal marketing of Seroquel. Business as usual. The antipsychotic is now being re-marketed as an anti-depressant.
: To: Brecher, Martin
C,c: Melville, Margaret G; Schwartz, Jack A; Dev, Vikram J; Geller, Wayne; Nakajo, Hirochika;
Higuchi Sadao
Subject: Re: Effect of Seroquel on diabetes mellitus
DearBrecher-san,
How are you?
I am sorry to rush you but how is trial No.0041 going? I would really appreciate it if you would let me know the results. Thank you in advance.
Since May, there is one or two severe (or moderate) spontaneous report on diabetic ketoacidosis or hyperglycemia every month. As you may have already know, we received two spontaneous reports related to diabetes mellitus last week. There was a death case in these reports. Considering this situation, adverse drug reactions related to diabetes mellitus are expected to accumulate from now on.
We assume that we have to discuss with the MHLW over the revision of the labeling in course of time and, we believe that the results of this trial will be very useful. We need your cooperation.
Best regards,
Sumie Ishiguro
http://dida.library.ucsf.edu/pdf/hpv09b10
---
Nothing changed it only got worse for consumers
The lawsuits poured in and AstraZeneca paid out $350 million to date in settlements and was fined $520 million by the U.S. Department of Justice for illegal marketing of Seroquel. Business as usual. The antipsychotic is now being re-marketed as an anti-depressant.
Sunday, February 20, 2011
good afternoon from my garden
the balcony porch garden tulips are beginning to bloom. love the color!
Ad agency dumpster diving: Seroquel
VIA Archives of General Psychiatry
Long-term Antipsychotic Treatment and Brain Volumes
Long-term Antipsychotic Treatment and Brain Volumes
A Longitudinal Study of First-Episode Schizophrenia
Beng-Choon Ho, MRCPsych; Nancy C. Andreasen, MD, PhD; Steven Ziebell, BS; Ronald Pierson, MS; Vincent Magnotta, PhD
Arch Gen Psychiatry. 2011;68(2):128-137. doi:10.1001/archgenpsychiatry.2010.199
Context Progressive brain volume changes in schizophrenia are thought to be due principally to the disease. However, recent animal studies indicate that antipsychotics, the mainstay of treatment for schizophrenia patients, may also contribute to brain tissue volume decrement. Because antipsychotics are prescribed for long periods for schizophrenia patients and have increasingly widespread use in other psychiatric disorders, it is imperative to determine their long-term effects on the human brain.
Objective To evaluate relative contributions of 4 potential predictors (illness duration, antipsychotic treatment, illness severity, and substance abuse) of brain volume change.
Design Predictors of brain volume changes were assessed prospectively based on multiple informants.
Setting Data from the Iowa Longitudinal Study.
Patients Two hundred eleven patients with schizophrenia who underwent repeated neuroimaging beginning soon after illness onset, yielding a total of 674 high-resolution magnetic resonance scans. On average, each patient 3 scans (2 and as many as 5) over 7.2 years (up to 14 years).
Main Outcome Measure Brain volumes.
Results During longitudinal follow-up, antipsychotic treatment reflected national prescribing practices in 1991 through 2009. Longer follow-up correlated with smaller brain tissue volumes and larger cerebrospinal fluid volumes. Greater intensity of antipsychotic treatment was associated with indicators of generalized and specific brain tissue reduction after controlling for effects of the other 3 predictors. More antipsychotic treatment was associated with smaller gray matter volumes. Progressive decrement in white matter volume was most evident among patients who received more antipsychotic treatment. Illness severity had relatively modest correlations with tissue volume reduction, and alcohol/illicit drug misuse had no significant associations when effects of the other variables were adjusted.
Conclusions
Viewed together with data from animal studies, our study suggests that antipsychotics have a subtle but measurable influence on brain tissue loss over time, suggesting the importance of careful risk-benefit review of dosage and duration of treatment as well as their off-label use.
Saturday, February 19, 2011
Call to action! 67 yr old Elizabeth Ellis of Moorhead, Minnesota :Forced ECT, forced inpatient hospitalization for refusing ECT
VIA MINDFREEDOM:
(direct copy and paste)
GATEWAY: Stop the Forced Outpatient Electroshock of Elizabeth Ellis!
Elizabeth and Forced Shock: An intro
Elizabeth Ellis of Moorhead, Minnesota has received more than a dozen involuntary court-ordered electroshocks in the Winter of 2011, including an outpatient forced electroshock on 12 January 2011.
Elizabeth, 67, is a retired school counselor and teacher, with a master's degree in counseling. She strongly objects to electroshock, and its impact on her memory and mind.
So on 28 January 2011, Elizabeth sat at home with her supportive husband Robert (photo on right). Elizabeth refused to report for another outpatient ECT - also known as electroconvulsive therapy.
Apparently, her "sit in" has cost Elizabeth her liberty on 18 February 2011. She faces "months" of "maintenance" forced electroshock.
Most recent news:
19 February 2011: Probably because Anoka psychiatric institution was full, we understand Elizabeth was driven quite some distance away from her home to a psychiatric facility. When we discover the name of the facility, we'll announce it.
18 February 2011 - Alert 3:
Tonight, MindFreedom was informed by Elizabeth's daughter, Susan Opp, that Elizabeth has been picked up and placed in a hospital.
Because the Minn. Governor's office has been non-responsive after three weeks, local advocates suggest concerned people contact Elizabeth's elected US Congresspeople:
US Sen. Al Franken web form:
http://www.franken.senate.gov/?p=email_al
St. Paul office phone: (651) 221-1016
.S. Senator Amy Klobuchar: http://www.klobuchar.senate.gov/emailamy.cfm
U.S. Rep Collin Peterson: http://www.collinpeterson.house.gov/contact.html
Note: To use the Peterson web form, you need a district zipcode. You can address your comment 'c/o Elizabeth Ellis' and use her address:
606 20TH AVE S
MOORHEAD MN 56560
---
Her daughter locked her up
"Elizabeth's 69-year-old sister had been dying from cancer for some time. Elizabeth was of course upset. While MindFreedom has not heard of any report of danger to self or others by Elizabeth, some felt that Elizabeth's emotional reactions at this time were "unusual," such as keeping her eyes closed in the hospital even while walking, or keeping her mouth open with her head at an angle.
Literally hours after Elizabeth's sister died, literally feet away from her sister's death bed in the hospital, Elizabeth's daughter, Susan, decided to hold her mom in a small room, and ask psychiatric personnel to lock up her mother on the spot for a psychiatric evaluation. Susan told MindFreedom she felt this made sense since it was convenient because Elizabeth was at the hospital anyway for her sister's death."
---
Minnesota state operated mental health facilities.
Recent news about Minnesota state ran mental health facilities
Friday, Feb 4,2011--BUSTED USING TASERS ON PATIENTS.
Take action, this could be YOU or someone you know who was discharged from a psychiatric hospital with a court-ordered 'treatment' program for outpatient care. Discharge plans with court ordered treatment( meds, ECT) are COMMON IN FACT USUALLY THE NORM.
There is a grave injustice being done to Elizabeth Ellis, it is time for the barbaric treatment of people to stop, all in the name of "psychiatric care in America".
--
This is a letter/email Elizabeth wrote to MindFreedom before she was removed from her home for forced ECT:
16 February 2011
To MindFreedom International Director, David W. Oaks:
As I informed you this afternoon, I am in danger of receiving more electroshock treatments from ANOKA (Anoka Metro Regional Treatment Center - AMRTC) or any other state-operated facility in Minnesota.
I received through the mail a Notice of Intent to Revoke Provisional Discharge signed on 14 February 2011 by Kirstin Wegenast, LSW for Clay County, Minnesota, and an Order to Transport dated February 15th signed by the Judge.
I called Kirstin on the 14th. She was indifferent to my pleas.
My public defender, Peter Karlson, said the Sheriff could pick me up at any moment and transport me.
I visited with Peter this forenoon and after much consideration, he agreed to challenge the court on these decisions for hospitalization and continuing ECT. But he wanted a good backup plan.
We put together an affidavit which he will file tomorrow in which I agreed to medication, counseling, psychiatric visits and monitoring by the county.
I will be seeing psychiatrist Dr. Nels Langsten in St. Paul this weekend and I have a good counselor of my faith lined up.
I put in a call today to Janna Peterson but didn't get her. When she visited me earlier this month, she seemed very interested in my situation.
My daughter is for my continuing treatments.
My husband supports me.
As far as I am concerned, I am in good mental health -- active, talking, eating, sleeping. I see no reason for continuing ECT. The county says they are just trying to save my life.
I question whether it's not their face they are trying to save.
In apprreciation for all you do.
Elizabeth
http://www.mindfreedom.org/shield/ellis/plea-from-elizabeth
(direct copy and paste)
GATEWAY: Stop the Forced Outpatient Electroshock of Elizabeth Ellis!
Elizabeth and Forced Shock: An intro
Elizabeth Ellis of Moorhead, Minnesota has received more than a dozen involuntary court-ordered electroshocks in the Winter of 2011, including an outpatient forced electroshock on 12 January 2011.
Elizabeth, 67, is a retired school counselor and teacher, with a master's degree in counseling. She strongly objects to electroshock, and its impact on her memory and mind.
So on 28 January 2011, Elizabeth sat at home with her supportive husband Robert (photo on right). Elizabeth refused to report for another outpatient ECT - also known as electroconvulsive therapy.
Apparently, her "sit in" has cost Elizabeth her liberty on 18 February 2011. She faces "months" of "maintenance" forced electroshock.
Most recent news:
19 February 2011: Probably because Anoka psychiatric institution was full, we understand Elizabeth was driven quite some distance away from her home to a psychiatric facility. When we discover the name of the facility, we'll announce it.
18 February 2011 - Alert 3:
Tonight, MindFreedom was informed by Elizabeth's daughter, Susan Opp, that Elizabeth has been picked up and placed in a hospital.
Because the Minn. Governor's office has been non-responsive after three weeks, local advocates suggest concerned people contact Elizabeth's elected US Congresspeople:
US Sen. Al Franken web form:
http://www.franken.senate.gov/?p=email_al
St. Paul office phone: (651) 221-1016
.S. Senator Amy Klobuchar: http://www.klobuchar.senate.gov/emailamy.cfm
U.S. Rep Collin Peterson: http://www.collinpeterson.house.gov/contact.html
Note: To use the Peterson web form, you need a district zipcode. You can address your comment 'c/o Elizabeth Ellis' and use her address:
606 20TH AVE S
MOORHEAD MN 56560
---
Her daughter locked her up
"Elizabeth's 69-year-old sister had been dying from cancer for some time. Elizabeth was of course upset. While MindFreedom has not heard of any report of danger to self or others by Elizabeth, some felt that Elizabeth's emotional reactions at this time were "unusual," such as keeping her eyes closed in the hospital even while walking, or keeping her mouth open with her head at an angle.
Literally hours after Elizabeth's sister died, literally feet away from her sister's death bed in the hospital, Elizabeth's daughter, Susan, decided to hold her mom in a small room, and ask psychiatric personnel to lock up her mother on the spot for a psychiatric evaluation. Susan told MindFreedom she felt this made sense since it was convenient because Elizabeth was at the hospital anyway for her sister's death."
---
Minnesota state operated mental health facilities.
Recent news about Minnesota state ran mental health facilities
Friday, Feb 4,2011--BUSTED USING TASERS ON PATIENTS.
Take action, this could be YOU or someone you know who was discharged from a psychiatric hospital with a court-ordered 'treatment' program for outpatient care. Discharge plans with court ordered treatment( meds, ECT) are COMMON IN FACT USUALLY THE NORM.
There is a grave injustice being done to Elizabeth Ellis, it is time for the barbaric treatment of people to stop, all in the name of "psychiatric care in America".
--
This is a letter/email Elizabeth wrote to MindFreedom before she was removed from her home for forced ECT:
16 February 2011
To MindFreedom International Director, David W. Oaks:
As I informed you this afternoon, I am in danger of receiving more electroshock treatments from ANOKA (Anoka Metro Regional Treatment Center - AMRTC) or any other state-operated facility in Minnesota.
I received through the mail a Notice of Intent to Revoke Provisional Discharge signed on 14 February 2011 by Kirstin Wegenast, LSW for Clay County, Minnesota, and an Order to Transport dated February 15th signed by the Judge.
I called Kirstin on the 14th. She was indifferent to my pleas.
My public defender, Peter Karlson, said the Sheriff could pick me up at any moment and transport me.
I visited with Peter this forenoon and after much consideration, he agreed to challenge the court on these decisions for hospitalization and continuing ECT. But he wanted a good backup plan.
We put together an affidavit which he will file tomorrow in which I agreed to medication, counseling, psychiatric visits and monitoring by the county.
I will be seeing psychiatrist Dr. Nels Langsten in St. Paul this weekend and I have a good counselor of my faith lined up.
I put in a call today to Janna Peterson but didn't get her. When she visited me earlier this month, she seemed very interested in my situation.
My daughter is for my continuing treatments.
My husband supports me.
As far as I am concerned, I am in good mental health -- active, talking, eating, sleeping. I see no reason for continuing ECT. The county says they are just trying to save my life.
I question whether it's not their face they are trying to save.
In apprreciation for all you do.
Elizabeth
http://www.mindfreedom.org/shield/ellis/plea-from-elizabeth
Friday, February 18, 2011
we have the same hands
If I could tell the world just one thing
It would be that we're all OK
And not to worry 'cause worry is wasteful
And useless in times like these
I won't be made useless
I won't be idle with despair
I will gather myself around my faith
For light does the darkness most fear
My hands are small, I know
But they're not yours, they are my own
But they're not yours, they are my own
And I am never broken
Poverty stole your golden shoes
It didn't steal your laughter
And heartache came to visit me
But I knew it wasn't ever after
We'll fight, not out of spite
For someone must stand up for what's right
'Cause where there's a man who has no voice
There ours shall go singing
My hands are small I know
But they're not yours, they are my own
But they're not yours, they are my own
I am never broken
In the end only kindness matters
In the end only kindness matters
I will get down on my knees, and I will pray
I will get down on my knees, and I will pray
I will get down on my knees, and I will pray
My hands are small I know
But they're not yours, they are my own
But they're not yours, they are my own
And I am never broken
My hands are small I know
But they're not yours, they are my own
But they're not yours, they are my own
And I am never broken
We are never broken
We are God's eyes
God's hands
God's mind
We are God's eyes
God's hands
God's heart
We are God's eyes
God's hands
God's eyes
We are God's hands
We are God's hands
--Hands lyrics, by Jewel
---
some days, little things become profound, or large...or grounding. other parents who have raised disabled kids, or had a child become disabled surely have had this moment.
Today, my daughter's hands looked old.
They say profound or memorable events can be described in six words.
I'M PROUD OF YOU BOB FIDDAMAN! thank you for being an advocate against drugging of children!
Seroxat Suffers blog author, and my long time friend and advocate across the pond has won an award for advocacy. This photo, which I promptly grabbed from his site, brought tears to my eyes.
"A show of solidarity in the fight against the drugging of children."-Bob Fiddaman
Go here and read about Fid's proud moment. He has worked his ass off advocating for adults and children injured from taking psych meds and for special kids born with defects from Paxil, when their moms took it while pregnant. He is a true warrior, based on his own pain and suffering from a Paxil withdrawal nightmare. He's just completed a book-- his personal story to be published in hardback too.
THANK YOU, FID.
Love and Hugs from me and my daughter.
Thursday, February 17, 2011
Dr Charles Schulz wins release of guilt! No conflict of interest! no unethical behavior! Seroquel suicide study's cloud dismissed by UMN
Apparently, the University of Minnesota condones professionals such as Dr Charles Schulz behaving badly. Dr Schulz, who is currently in charge of the Seroquel XR trial for Borderline Personality Disorder and sponsored by the drug maker AstraZeneca has been given the gift of "looking the other way" by the University of Minnesota.
Reporter Andy Mannix writes:
Charles Schulz cleared in U of M investigation:
"The University of Minnesota has found no violations in an internal investigation into Department of Psychiatry Chair Dr. Charles Schulz, according a letter signed by Mark Rotenberg, the college's General Counsel.
A nine-page complaint filed with the Board of Regents in December 2009 initiated the probe, which accused Schulz of allowing pharmaceutical companies to use his name on studies he didn't write or research, burying negative research results, and violating ethics policies.
The U of M broke the complaint down into nine allegations, and cleared Schulz on all accounts.
"After careful examination of each allegation, we found no University policy violations or other improper conduct by Dr. Schulz warranting University action against him," writes Rotenberg.
Mike Howard, the author of the complaint, says he's not satisfied with Rotenberg's response.
"[Rotenberg] tries to white wash it all," says Howard. "That's certainly not the case, and I don't accept that."
Howard is a family friend of Dan Markingson, a 26-year-old who committed suicide while enrolled in a study through the U of M in 2004.
Markingson's mother, Mary Weiss, had tried to remove him from the study, arguing he was not mentally fit to consent. After the suicide, she discovered Schulz was a co-investigator on the study, and had received money from the drug company funding the research.
Weiss eventually sued Schulz and the U of M for malpractice, but a judge threw the case out before it ever saw a courtroom. "
Continue reading the City Pages article here.
---
Mike Howard has left comments on this blog and I want him and Mary, Dan's mother to know I am outraged at this, though we cannot expect justice from corrupt and unethical money driven pharma companies-- we certainly should expect more from the University of Minnesota, where the trial took place and continues w the Seroquel XR version, same doctor, same sponsor!
Dr Charles Schulz receives/d income from AstraZeneca, which speaks a 1000 words.
Reporter Andy Mannix writes:
Charles Schulz cleared in U of M investigation:
"The University of Minnesota has found no violations in an internal investigation into Department of Psychiatry Chair Dr. Charles Schulz, according a letter signed by Mark Rotenberg, the college's General Counsel.
A nine-page complaint filed with the Board of Regents in December 2009 initiated the probe, which accused Schulz of allowing pharmaceutical companies to use his name on studies he didn't write or research, burying negative research results, and violating ethics policies.
The U of M broke the complaint down into nine allegations, and cleared Schulz on all accounts.
"After careful examination of each allegation, we found no University policy violations or other improper conduct by Dr. Schulz warranting University action against him," writes Rotenberg.
Mike Howard, the author of the complaint, says he's not satisfied with Rotenberg's response.
"[Rotenberg] tries to white wash it all," says Howard. "That's certainly not the case, and I don't accept that."
Howard is a family friend of Dan Markingson, a 26-year-old who committed suicide while enrolled in a study through the U of M in 2004.
Markingson's mother, Mary Weiss, had tried to remove him from the study, arguing he was not mentally fit to consent. After the suicide, she discovered Schulz was a co-investigator on the study, and had received money from the drug company funding the research.
Weiss eventually sued Schulz and the U of M for malpractice, but a judge threw the case out before it ever saw a courtroom. "
Continue reading the City Pages article here.
---
Mike Howard has left comments on this blog and I want him and Mary, Dan's mother to know I am outraged at this, though we cannot expect justice from corrupt and unethical money driven pharma companies-- we certainly should expect more from the University of Minnesota, where the trial took place and continues w the Seroquel XR version, same doctor, same sponsor!
Dr Charles Schulz receives/d income from AstraZeneca, which speaks a 1000 words.
AstraZeneca to pay $150 million MORE to settle diabetes Seroquel lawsuits total to date $348 million
VIA PHARMAGOSSIP
Thursday, February 17, 2011
AstraZeneca Said to Pay $150 Million to Settle More Seroquel Suits - Businessweek
By Jef Feeley
Feb. 17 (Bloomberg) -- AstraZeneca Plc agreed to pay $150 million to settle more lawsuits claiming its antipsychotic drug Seroquel causes diabetes, pushing the amount the drugmaker has paid to resolve cases over the medicine to almost $350 million, people familiar with the accords said.
AstraZeneca, the U.K.’s second-biggest drugmaker, will resolve about 6,000 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, two people familiar with the settlements said. They spoke on the condition of anonymity because they weren’t authorized to speak publicly about the accords. The cases settled for an average of about $25,000, the people said.
AstraZeneca, the U.K.’s second-biggest drugmaker, will resolve about 6,000 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, two people familiar with the settlements said. They spoke on the condition of anonymity because they weren’t authorized to speak publicly about the accords. The cases settled for an average of about $25,000, the people said.
The settlements signal AstraZeneca is seeking to put the Seroquel litigation behind it as it works to overcome setbacks in its drug-development pipeline, said Jeremy Batstone-Carr, London-based analyst for Charles Stanley & Co., who rates the drugmaker’s shares as “accumulate.”
“Legal cases represent one of the great imponderables that can act on shareholder sentiment,” Batstone-Carr said. “You try to clear the decks and get investors as great a degree of certainty as possible.”
The settlement, which resulted from a court-ordered mediation, leaves AstraZeneca now facing only about 4,000 Seroquel claims, the people said. The London-based drugmaker announced last summer it had resolved about two-thirds of the 26,000 suits over the drug that had been filed in courts around the U.S.
$198 Million Settlement
The company agreed in August to pay about $198 million to settle 17,500 suits, providing average payouts of more than $11,000. The company won the first jury trial over Seroquel in March 2010.
Continue reading via businessweek.com
Thursday, February 17, 2011
AstraZeneca Said to Pay $150 Million to Settle More Seroquel Suits - Businessweek
By Jef Feeley
Feb. 17 (Bloomberg) -- AstraZeneca Plc agreed to pay $150 million to settle more lawsuits claiming its antipsychotic drug Seroquel causes diabetes, pushing the amount the drugmaker has paid to resolve cases over the medicine to almost $350 million, people familiar with the accords said.
AstraZeneca, the U.K.’s second-biggest drugmaker, will resolve about 6,000 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, two people familiar with the settlements said. They spoke on the condition of anonymity because they weren’t authorized to speak publicly about the accords. The cases settled for an average of about $25,000, the people said.
AstraZeneca, the U.K.’s second-biggest drugmaker, will resolve about 6,000 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, two people familiar with the settlements said. They spoke on the condition of anonymity because they weren’t authorized to speak publicly about the accords. The cases settled for an average of about $25,000, the people said.
The settlements signal AstraZeneca is seeking to put the Seroquel litigation behind it as it works to overcome setbacks in its drug-development pipeline, said Jeremy Batstone-Carr, London-based analyst for Charles Stanley & Co., who rates the drugmaker’s shares as “accumulate.”
“Legal cases represent one of the great imponderables that can act on shareholder sentiment,” Batstone-Carr said. “You try to clear the decks and get investors as great a degree of certainty as possible.”
The settlement, which resulted from a court-ordered mediation, leaves AstraZeneca now facing only about 4,000 Seroquel claims, the people said. The London-based drugmaker announced last summer it had resolved about two-thirds of the 26,000 suits over the drug that had been filed in courts around the U.S.
$198 Million Settlement
The company agreed in August to pay about $198 million to settle 17,500 suits, providing average payouts of more than $11,000. The company won the first jury trial over Seroquel in March 2010.
Continue reading via businessweek.com
Wednesday, February 16, 2011
David vs. Goliath or me vs AstraZeneca in 'live' tweet chat
The questions I had asked during the pre-chat time using the hashtag #rxsave boiled down to these that i prepared for the actual live chat.
Transcript from tonight's #rxsave chat click >> http://ow.ly/3XZEL
http://twitter.com/soulflsepulcher/status/38055676647309312
Remaining on the highroad when being called an "anti-Seroquel" person as well as a possible 'hijacker'of the tweet chat thread by insiders of the social media crowd, i remained calm and tried to focus on how i would present myself:
"I am a parent/caregiver advocate. I ask tough questions to keep pharma cos accountable w truth, transparency. I expect it."
Questions I asked during the live chat hosted by makers of Seroquel: AstraZeneca
Q for @AstraZenecaUS #rxsave:what if patient signs up for program, gets Seroquel cheap, then becomes diabetic? litigation woes, yes?
Q for AZ #rxsave : will AZ ever be hosting tweet chat for patients/advocates& take & answer questions? Could be a GOOD idea (*this is the one they answered)
Elephant in #rxsave room: Can a drug co guilty of illegal marketing of drugs/fined by US Dept Justice host a "chat" & expect to gain consumer trust?
Q for @AstraZenecaUS #rxsave: Are rxsavings programs a way to keep people on more expensive drugs (such as Seroquel) ?
Q for @AstraZenecaUS #rxsave: i was wondering how you planned on gaining a new audience? how did u get word out to patients?
I am a parent/caregiver advocate. I ask tough questions to keep pharma cos accountable w truth, transparency. I expect it.
Q? what if a drug in the savings program #rxsave is in current litigation for diabetes side effects? do you promote the drug to patients?
Now, when AstraZeneca said this:
"In 2010 AZ helped more than 545k patients save $947mil on 4.1mil prescrips through these programs #rxsave" http://twitter.com/AstraZenecaUS/status/38045617238450176
I wanted to say this:
In 2010, AstraZeneca was fined $520 million dollars by the Department of Justice for the illegal marketing of Seroquel. AstraZeneca KNEW of the diabetes side effect from use of Seroquel, but they lied, skewed and manipulated data to their benefit and presented it to the FDA.The FDA approved Seroquel and people are continuing to be injured by the drug.
My friends were in lockstep and spoke up
Pharmagossip
RT @WriteWithStan: Q for @AstraZenecaUS #rxsave: Are rxsavings programs a way to keep people on more expensive drugs (such as Seroquel) ?
How many Corporate Integrity Agreements has @AstraZenecaUS had? Not one, but two: http://bit.ly/hXAYav and http://bit.ly/earhXM #rxsave
@tonyjewell @astrazenecaUS For the record http://bit.ly/9GeAWG Do you still deny any wrongdoing? #rxchat #socmed #hcsm #hcsmeu #mdchat
WritewithStan
Retired doctor blog rips into AstraZeneca-exposes internal Seroquel documents- http://tinyurl.com/4lw47wk #rxsave
New study CONFIRMS diabetes link & Seroquel http://tinyurl.com/47oex7w Seroquel & XR part of #rxsave Profit over Safety
---
What do I think about the chat with AstraZeneca? Nothing profound.
They are in the business to profit, I want accountability.
I'm glad I was acknowledged.
I feel I had to hang on to a life preserver and avoid the rocks when being tossed around as a often lone voice in the wilderness/ocean speaking for voiceless patients and consumers who have been injured by Seroquel, the antipsychotic being marketed as an antidepressant.
Pharmagossip and WriteWithStan were grounding me as i floated amongst the uncharted waters. I wont back down, I do not believe a drug company should attempt to promote themselves via low income people who are desperate for reduced price or free medications when they have such a criminal background.
In fact, most all of the major big pharma cos have CIA's (Corporate Integrity Agreements) due to being caught doing a criminal activity selling their product.
THAT does not build consumer trust.
I'm glad my voice was heard.There's more to it than that.
I look forward to the Twitter conversation when AstraZeneca hosts the forum I requested.
Transcript from tonight's #rxsave chat click >> http://ow.ly/3XZEL
http://twitter.com/soulflsepulcher/status/38055676647309312
Remaining on the highroad when being called an "anti-Seroquel" person as well as a possible 'hijacker'of the tweet chat thread by insiders of the social media crowd, i remained calm and tried to focus on how i would present myself:
"I am a parent/caregiver advocate. I ask tough questions to keep pharma cos accountable w truth, transparency. I expect it."
Questions I asked during the live chat hosted by makers of Seroquel: AstraZeneca
Q for @AstraZenecaUS #rxsave:what if patient signs up for program, gets Seroquel cheap, then becomes diabetic? litigation woes, yes?
Q for AZ #rxsave : will AZ ever be hosting tweet chat for patients/advocates& take & answer questions? Could be a GOOD idea (*this is the one they answered)
Elephant in #rxsave room: Can a drug co guilty of illegal marketing of drugs/fined by US Dept Justice host a "chat" & expect to gain consumer trust?
Q for @AstraZenecaUS #rxsave: Are rxsavings programs a way to keep people on more expensive drugs (such as Seroquel) ?
Q for @AstraZenecaUS #rxsave: i was wondering how you planned on gaining a new audience? how did u get word out to patients?
I am a parent/caregiver advocate. I ask tough questions to keep pharma cos accountable w truth, transparency. I expect it.
Q? what if a drug in the savings program #rxsave is in current litigation for diabetes side effects? do you promote the drug to patients?
Now, when AstraZeneca said this:
"In 2010 AZ helped more than 545k patients save $947mil on 4.1mil prescrips through these programs #rxsave" http://twitter.com/AstraZenecaUS/status/38045617238450176
I wanted to say this:
In 2010, AstraZeneca was fined $520 million dollars by the Department of Justice for the illegal marketing of Seroquel. AstraZeneca KNEW of the diabetes side effect from use of Seroquel, but they lied, skewed and manipulated data to their benefit and presented it to the FDA.The FDA approved Seroquel and people are continuing to be injured by the drug.
My friends were in lockstep and spoke up
Pharmagossip
RT @WriteWithStan: Q for @AstraZenecaUS #rxsave: Are rxsavings programs a way to keep people on more expensive drugs (such as Seroquel) ?
How many Corporate Integrity Agreements has @AstraZenecaUS had? Not one, but two: http://bit.ly/hXAYav and http://bit.ly/earhXM #rxsave
@tonyjewell @astrazenecaUS For the record http://bit.ly/9GeAWG Do you still deny any wrongdoing? #rxchat #socmed #hcsm #hcsmeu #mdchat
WritewithStan
Retired doctor blog rips into AstraZeneca-exposes internal Seroquel documents- http://tinyurl.com/4lw47wk #rxsave
New study CONFIRMS diabetes link & Seroquel http://tinyurl.com/47oex7w Seroquel & XR part of #rxsave Profit over Safety
---
What do I think about the chat with AstraZeneca? Nothing profound.
They are in the business to profit, I want accountability.
I'm glad I was acknowledged.
I feel I had to hang on to a life preserver and avoid the rocks when being tossed around as a often lone voice in the wilderness/ocean speaking for voiceless patients and consumers who have been injured by Seroquel, the antipsychotic being marketed as an antidepressant.
Pharmagossip and WriteWithStan were grounding me as i floated amongst the uncharted waters. I wont back down, I do not believe a drug company should attempt to promote themselves via low income people who are desperate for reduced price or free medications when they have such a criminal background.
In fact, most all of the major big pharma cos have CIA's (Corporate Integrity Agreements) due to being caught doing a criminal activity selling their product.
THAT does not build consumer trust.
I'm glad my voice was heard.There's more to it than that.
I look forward to the Twitter conversation when AstraZeneca hosts the forum I requested.
Monday, February 14, 2011
Study confirms association of Seroquel, quetiapine treatment and impairment of glucose stability
VIA PubMed
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Feb 1. [Epub ahead of print]
A prospective study of glucose homeostasis in quetiapine-treated schizophrenic patients by using the intravenous glucose tolerance test.
Chen CH, Lin TY, Chen TT, Chen VC, Lin NC, Shao WC, Lu ML.
Department of Psychiatry, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Department of Psychiatry, Taipei Medical University-Wan Fang Hospital, Taipei, Taiwan.
Abstract
Increasing attention has been paid recently to the potential diabetogenic effect of second-generation antipsychotics (SGAs). The objective of this prospective study was to evaluate the effects of quetiapine treatment on pancreatic beta-cell function in SGA-naïve schizophrenic patients. Seventeen schizophrenic subjects completed an eight-week trial. The metabolic parameters were assessed at weeks 0, 2, 4, and 8. We measured glucose homeostasis with the intravenous glucose tolerance test.
After the eight-week treatment, body weight and body mass index showed to be significantly increased compared to those at baseline.
No significant changes were found in serum levels of fasting glucose, insulin, total cholesterol, and high-density lipoprotein. Insulin resistance and insulin secretion were significantly increased.
Incidences of clinically significant weight gain and treatment-emergent metabolic syndrome were 11.8% and 11.8%, respectively. This study result confirms the association of quetiapine treatment and impairment of glucose homeostasis in schizophrenic patients.
Copyright © 2011. Published by Elsevier Inc.
---
But, AstraZeneca already knew those results before they marketed the drug.
This new study might benefit plaintiffs in litigation for contracting diabetes while taking the drug, Seroquel.
Hat tip to WriteWithStan on Twitter
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Feb 1. [Epub ahead of print]
A prospective study of glucose homeostasis in quetiapine-treated schizophrenic patients by using the intravenous glucose tolerance test.
Chen CH, Lin TY, Chen TT, Chen VC, Lin NC, Shao WC, Lu ML.
Department of Psychiatry, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Department of Psychiatry, Taipei Medical University-Wan Fang Hospital, Taipei, Taiwan.
Abstract
Increasing attention has been paid recently to the potential diabetogenic effect of second-generation antipsychotics (SGAs). The objective of this prospective study was to evaluate the effects of quetiapine treatment on pancreatic beta-cell function in SGA-naïve schizophrenic patients. Seventeen schizophrenic subjects completed an eight-week trial. The metabolic parameters were assessed at weeks 0, 2, 4, and 8. We measured glucose homeostasis with the intravenous glucose tolerance test.
After the eight-week treatment, body weight and body mass index showed to be significantly increased compared to those at baseline.
No significant changes were found in serum levels of fasting glucose, insulin, total cholesterol, and high-density lipoprotein. Insulin resistance and insulin secretion were significantly increased.
Incidences of clinically significant weight gain and treatment-emergent metabolic syndrome were 11.8% and 11.8%, respectively. This study result confirms the association of quetiapine treatment and impairment of glucose homeostasis in schizophrenic patients.
Copyright © 2011. Published by Elsevier Inc.
---
But, AstraZeneca already knew those results before they marketed the drug.
This new study might benefit plaintiffs in litigation for contracting diabetes while taking the drug, Seroquel.
Hat tip to WriteWithStan on Twitter
Average rate of gray matter loss: evidence of neuroleptic drug-induced brain damage
Average rate of gray matter loss: evidence of neuroleptic drug-induced brain damage.
The more drugs you've been given, the more brain tissue you lose.
What exactly do these drugs do? They block basal ganglia activity.
The prefrontal cortex doesn't get the input it needs and is being shut down by drugs.
That reduces the psychotic symptoms. It also causes the prefrontal cortex to slowly atrophy.
~ Dr. Nancy C. Andreasen, New York Times, Sept. 16, 2008
Both the older and the atypical neuroleptics shrink brain tissue during routine clinical exposure.
~ Dr. Peter R. Breggin, Brain Disabling Treatments in Psychiatry (2008)
*Neuroleptics,antipsychotics such as Haldol,Clozaril,Zyprexa,Risperdal, Seroquel
Retired doctor, '1 Boring Old Man' blog rips into AstraZeneca internal Seroquel documents: STUDY 15 YOU GAINED WEIGHT DUE TO LIES
The 1 Boring Old Man blog author, a retired psychiatrist has been doing a fantastic series, analyzing internal Seroquel documents:
Here's the latest: (the links here are in order from recent to beginning)
An Opinionated Postscript
" But I do damn the F.D.A. for approving the drug for other things that do nothing but validate off-label advertising and profiteering at the expense of our patients. They’re using F.D.A. approval as a gold-standard for their evidence-based medicine meme. Looking at those Clinical Trials we just reviewed, I didn’t see a whole lot of gold. In my opinion, that’s the place to start the reform movement. Every time I hear something like, "Now approved for augmentation of antidepressant monotherapy in treatment-resistant depression," I feel ashamed that I’m a Psychiatrist…"
http://1boringoldman.com/index.php/2011/02/14/seroquel-xii-an-opinionated-postscript/
Through a glass darkly
http://1boringoldman.com/index.php/2011/02/14/seroquel-xi-through-a-glass-darkly%e2%80%a6/
Matters Cerebral-Serebral
http://1boringoldman.com/index.php/2011/02/13/seroquel-x-matters-serebral/
"I’m sitting here almost 14 years later trying to figure out how much weight gain they knew about before the submitted their approval application in 1997. Lisa Arvanitis, on the other hand, is sitting back there at the time with weight gain information analyzed in every way possible [including my scattergram!]. They even had more than I knew from OLE [Open Label Extension - Zeneca gives medication away free to people after the trial ends who want it and continue to collect data]. And what they’re pondering is how to turn their weight gain problem into an asset? Now that’s hubris. "
Read the entire post with graphs and stats at the link above.
The Seroquel Series
Weighty Matters
http://1boringoldman.com/index.php/2011/02/13/seroquel-ix-weighty-matters/
Sins of Ommission
http://1boringoldman.com/index.php/2011/02/12/seroquel-viii-sins-of-ommission/
Seroquel the FDA finale
http://1boringoldman.com/index.php/2011/02/12/seroquel-vi-the-fda-finale/
Through the Looking Glass
http://1boringoldman.com/index.php/2011/02/11/seroquel-v-through-the-looking-glass/
Ooching
http://1boringoldman.com/index.php/2011/02/10/seroquel-iv-ooching/
Their best shot
http://1boringoldman.com/index.php/2011/02/10/seroquel-iii-their-best-shot%e2%80%a6/
Guessing
http://1boringoldman.com/index.php/2011/02/09/seroquel-ii-version-20-guessing/
Introduction to Atypical
http://1boringoldman.com/index.php/2011/02/08/seroquel-i-introduction-of-an-atypical/
Here's the latest: (the links here are in order from recent to beginning)
An Opinionated Postscript
" But I do damn the F.D.A. for approving the drug for other things that do nothing but validate off-label advertising and profiteering at the expense of our patients. They’re using F.D.A. approval as a gold-standard for their evidence-based medicine meme. Looking at those Clinical Trials we just reviewed, I didn’t see a whole lot of gold. In my opinion, that’s the place to start the reform movement. Every time I hear something like, "Now approved for augmentation of antidepressant monotherapy in treatment-resistant depression," I feel ashamed that I’m a Psychiatrist…"
http://1boringoldman.com/index.php/2011/02/14/seroquel-xii-an-opinionated-postscript/
Through a glass darkly
http://1boringoldman.com/index.php/2011/02/14/seroquel-xi-through-a-glass-darkly%e2%80%a6/
Matters Cerebral-Serebral
http://1boringoldman.com/index.php/2011/02/13/seroquel-x-matters-serebral/
"I’m sitting here almost 14 years later trying to figure out how much weight gain they knew about before the submitted their approval application in 1997. Lisa Arvanitis, on the other hand, is sitting back there at the time with weight gain information analyzed in every way possible [including my scattergram!]. They even had more than I knew from OLE [Open Label Extension - Zeneca gives medication away free to people after the trial ends who want it and continue to collect data]. And what they’re pondering is how to turn their weight gain problem into an asset? Now that’s hubris. "
Read the entire post with graphs and stats at the link above.
The Seroquel Series
Weighty Matters
http://1boringoldman.com/index.php/2011/02/13/seroquel-ix-weighty-matters/
Sins of Ommission
http://1boringoldman.com/index.php/2011/02/12/seroquel-viii-sins-of-ommission/
Seroquel the FDA finale
http://1boringoldman.com/index.php/2011/02/12/seroquel-vi-the-fda-finale/
Through the Looking Glass
http://1boringoldman.com/index.php/2011/02/11/seroquel-v-through-the-looking-glass/
Ooching
http://1boringoldman.com/index.php/2011/02/10/seroquel-iv-ooching/
Their best shot
http://1boringoldman.com/index.php/2011/02/10/seroquel-iii-their-best-shot%e2%80%a6/
Guessing
http://1boringoldman.com/index.php/2011/02/09/seroquel-ii-version-20-guessing/
Introduction to Atypical
http://1boringoldman.com/index.php/2011/02/08/seroquel-i-introduction-of-an-atypical/
Antipsychotics and brain shrinkage in kids: a comment at the Whitaker blog
VIA PHARMAGOSSIP's blog in full here:
Monday, February 14, 2011
Antipsychotics and brain shrinkage - Certified Fraud Examiner Andy Prough comments
Andy Prough is a Certified Fraud Examiner who has been investigating fraud and abuse in healthcare settings since 1992. Andy completed his professional training with the Association of Certified Fraud Examiners, and has gone on to complete specialized training in healthcare fraud and investigating conflicts of interest. Andy is the Vice President Elect of the Austin Chapter of Fraud Examiners. He has been very active with the state legislature, most recently serving on legislative advisory committees on the rights of children in foster care, and on the rights of families under investigation by Child Protective Services. Andy has also served on numerous state agency working groups and committees, including recent work with the Texas Dept. of Mental Health and Mental Retardation advisory committees on restricting the use of physical restraint and emergency medications in state mental hospitals. Recent reports by the Health and Human Services Office of the Inspector General, by the Texas Comptroller's Office, and by numerous federal government agencies indicate that healthcare fraud is a significant, increasing problem in our society, costing the US billions per year. Through specialized training and experience, Andy has developed professional skills in the investigation of whistleblower claims of fraud against government healthcare agencies.
Source: http://www.austinacfe.com/andy.htm
A recent piece in PharmaGossip looking at Robert Whitaker's blog: Here prompted a comment from an Andy Prough. ( Andreasen Drops Bombshell Antipsychotics Shrink the Brain)
*Comment is on Pharmagossip's blog http://pharmagossip.blogspot.com/2011/02/should-prescribing-of-antipsychotics-to.html
Here it is in full:
"Hi Robert,I'm a big fan, having read everything you publish (sometimes several times, in order to understand the nature of the damage). You've brought up some great questions here, related to Andreason's study. And clearly, you predicted this revelation yourself quite a few years ago when you first published Mad in America. I think the bigger question is whether the manufacturers will be held liable? They've had the same information for at least as long as you have. What happens when the corporate whistleblowers start coming forward, showing evidence of Big Pharma board meetings at which brain shrinkage among juveniles was discussed and discarded? How big will the bill be under the False Claims Act? Fines of $11,000 per incident and triple damages can add up quick.
Insider's prediction: A whole new expensive can of worms has just been opened!"
----
Considering my daughter was prescribed Zyprexa, Risperdal, Melleril, Haldol,Clozaril, Seroquel at age 11 thru 17 (under 18) starting in 1999... I say, OPEN THE CAN OF WORMS, her brain function has been in decline and not recovered! thank you very much liars of Pharma companies!
Monday, February 14, 2011
Antipsychotics and brain shrinkage - Certified Fraud Examiner Andy Prough comments
Andy Prough is a Certified Fraud Examiner who has been investigating fraud and abuse in healthcare settings since 1992. Andy completed his professional training with the Association of Certified Fraud Examiners, and has gone on to complete specialized training in healthcare fraud and investigating conflicts of interest. Andy is the Vice President Elect of the Austin Chapter of Fraud Examiners. He has been very active with the state legislature, most recently serving on legislative advisory committees on the rights of children in foster care, and on the rights of families under investigation by Child Protective Services. Andy has also served on numerous state agency working groups and committees, including recent work with the Texas Dept. of Mental Health and Mental Retardation advisory committees on restricting the use of physical restraint and emergency medications in state mental hospitals. Recent reports by the Health and Human Services Office of the Inspector General, by the Texas Comptroller's Office, and by numerous federal government agencies indicate that healthcare fraud is a significant, increasing problem in our society, costing the US billions per year. Through specialized training and experience, Andy has developed professional skills in the investigation of whistleblower claims of fraud against government healthcare agencies.
Source: http://www.austinacfe.com/andy.htm
A recent piece in PharmaGossip looking at Robert Whitaker's blog: Here prompted a comment from an Andy Prough. ( Andreasen Drops Bombshell Antipsychotics Shrink the Brain)
*Comment is on Pharmagossip's blog http://pharmagossip.blogspot.com/2011/02/should-prescribing-of-antipsychotics-to.html
Here it is in full:
"Hi Robert,I'm a big fan, having read everything you publish (sometimes several times, in order to understand the nature of the damage). You've brought up some great questions here, related to Andreason's study. And clearly, you predicted this revelation yourself quite a few years ago when you first published Mad in America. I think the bigger question is whether the manufacturers will be held liable? They've had the same information for at least as long as you have. What happens when the corporate whistleblowers start coming forward, showing evidence of Big Pharma board meetings at which brain shrinkage among juveniles was discussed and discarded? How big will the bill be under the False Claims Act? Fines of $11,000 per incident and triple damages can add up quick.
Insider's prediction: A whole new expensive can of worms has just been opened!"
----
Considering my daughter was prescribed Zyprexa, Risperdal, Melleril, Haldol,Clozaril, Seroquel at age 11 thru 17 (under 18) starting in 1999... I say, OPEN THE CAN OF WORMS, her brain function has been in decline and not recovered! thank you very much liars of Pharma companies!
Saturday, February 12, 2011
Should prescribing antipsychotics to children be banned? --WELL, YES!
VIA PHARMAGOSSIP NEWS
Sunday, February 13, 2011
Should the prescribing of antipsychotics to children be banned?
Andreasen Drops A Bombshell: Antipsychotics Shrink the Brain Psychology Today:
"Andreasen Drops A Bombshell: Antipsychotics Shrink the Brain by Robert Whitaker
Published on February 8, 2011
"In 1991, Nancy Andreasen began a long-running study of first-episode schizophrenia patients, which involved periodically measuring their brain volumes with magnetic resonance scans. In articles published in 2003 and 2005, she reported finding 'progressive brain volume reductions' in her patients, and that this shrinkage was associated with a worsening of negative symptoms, functional impairment and cognitive decline. But the implication was that this shrinkage was due to the disease, and that the drugs simply failed to stop it.
'The medications currently used cannot modify an injurious process occurring in the brain, which is the underlying basis of symptoms,' Andreasen wrote in her 2003 paper. ".......
Continue reading HERE.
Sunday, February 13, 2011
Should the prescribing of antipsychotics to children be banned?
Andreasen Drops A Bombshell: Antipsychotics Shrink the Brain Psychology Today:
"Andreasen Drops A Bombshell: Antipsychotics Shrink the Brain by Robert Whitaker
Published on February 8, 2011
"In 1991, Nancy Andreasen began a long-running study of first-episode schizophrenia patients, which involved periodically measuring their brain volumes with magnetic resonance scans. In articles published in 2003 and 2005, she reported finding 'progressive brain volume reductions' in her patients, and that this shrinkage was associated with a worsening of negative symptoms, functional impairment and cognitive decline. But the implication was that this shrinkage was due to the disease, and that the drugs simply failed to stop it.
'The medications currently used cannot modify an injurious process occurring in the brain, which is the underlying basis of symptoms,' Andreasen wrote in her 2003 paper. ".......
Continue reading HERE.
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia -ABBOTT
ABBOTT, makers of the anticonvulsant Depakote is trialing Depakote ER (extended release)against AstraZeneca's antipsychotic Seroquel on veterans with dementia in nursing home setting. Abbott has just been in the news for illegal marketing of Depakote for dementia and US Veterans Administration.(see link below)
Antipsychotics such as Risperdal and Seroquel have an FDA blackbox warning for use in elderly and with dementia.
REUTERS has just written an article titled, "Elderly get fewer antipsychotics after FDA warning":
"NEW YORK Tue Feb 8, 2011 5:19pm EST
NEW YORK (Reuters Health) - An official warning about newer antipsychotics in demented elderly people appears to have deterred some doctors from prescribing the drugs, a new U.S. study shows.
The so-called black box warning was issued by the Food and Drug Administration in 2005 after studies found elderly people on newer antipsychotics such as Janssen's Risperdal and AstraZeneca's Seroquel died sooner than those who didn't take the drugs.
"The black box warning is really the strongest warning that FDA has short of pulling the drug off the market," said Dr. Helen C. Kales, a psychiatrist at the University of Michigan in Ann Arbor, who worked on the study. "It looks like the warning did have its intended effect."
Some doctors use antipsychotics to control difficult behaviors in old people with dementia, although they haven't been specifically approved for the purpose."
NOW it seems that despite the FDA warnings, Abbott sees fit to trial the antipsychotic, SEROQUEL against the anticonvulsant Depakote in veterans with dementia.
THIS APPEARS UNETHICAL.
The Study
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.
Detailed Description:
This study is a prospective, single-center, randomized, double-blind, double-dummy, crossover trial of Depakote ER vs. Seroquel for agitated behaviors among veterans with dementia. After consent is obtained and after a washout period of one week or five half-lives after taper (if necessary), 20 eligible patients will be randomized to received one of two treatments. The first is DEPAKOTE ER, initiated at 250 mg daily. The other treatment will be Seroquel, starting at 25 mg BID. Both treatments will be co-administered with a placebo that matches the other drug (to preserve blinding). Using serial examinations and blinded laboratory reporting, doses will be adjusted to clinical response or to achieve a serum valproate level of at least 50 mcg/mL. After a treatment period of six weeks, patients will be crossed over to the other treatment without washout (doses will be adjusted concurrently) for a second six-week treatment period. The Cohen-Mansfield Agitation Inventory (CMAI) will be the primary outcome measure. Secondary measures include the Behavior Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD); Clinical Global Impression Scale – Severity; Clinical Global Impression Scale – Improvement; Barnes Akathisia Scale (BAS); and the Abnormal Involuntary Movements Scale (AIMS). Outcome measures will be performed at the end of each six-week treatment period to avoid carryover effects.
Criteria
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
Seroquel has been a suspected culprit in the deaths of soldiers and veterans already, and with the black box warning from the FDA for use in people with dementia, I find the disregard for patient safety by Abbott Laboratories shameful.
ABBOTT has just been in the news for illegal marketing of the drug DEPAKOTE for dementia.
"In the Abbott lawsuit, the former employees charge Abbott illegally marketed Depakote to treat dementia and behavior seen in Alzheimer’s patients to nursing homes and the US Veterans Administration. How so? Their lawsuit alleges the drugmaker provided sales reps with materials that required them to encourage nursing homes to use Depakote on an off-label basis and designed ‘Selling Skills Workshops’ for instructing reps on off-label marketing tactics.
What else? Abbott allegedly disguised seminars for docs that were actually sessions on off-label usage; offered reps bonuses and incentives for off-label promotion; failed to disclose that favorable articles were written by docs who were paid by Abbott; paid docs to prescribe the med; trained reps to avoid being detected when promoting off-label; and, generally, lied to nursing homes about the drug and its uses."
Read entire Depakote article at Pharmalot.
TELL ME WHY THIS STUDY IS STILL BEING CONDUCTED.
Antipsychotics such as Risperdal and Seroquel have an FDA blackbox warning for use in elderly and with dementia.
REUTERS has just written an article titled, "Elderly get fewer antipsychotics after FDA warning":
"NEW YORK Tue Feb 8, 2011 5:19pm EST
NEW YORK (Reuters Health) - An official warning about newer antipsychotics in demented elderly people appears to have deterred some doctors from prescribing the drugs, a new U.S. study shows.
The so-called black box warning was issued by the Food and Drug Administration in 2005 after studies found elderly people on newer antipsychotics such as Janssen's Risperdal and AstraZeneca's Seroquel died sooner than those who didn't take the drugs.
"The black box warning is really the strongest warning that FDA has short of pulling the drug off the market," said Dr. Helen C. Kales, a psychiatrist at the University of Michigan in Ann Arbor, who worked on the study. "It looks like the warning did have its intended effect."
Some doctors use antipsychotics to control difficult behaviors in old people with dementia, although they haven't been specifically approved for the purpose."
NOW it seems that despite the FDA warnings, Abbott sees fit to trial the antipsychotic, SEROQUEL against the anticonvulsant Depakote in veterans with dementia.
THIS APPEARS UNETHICAL.
The Study
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.
Detailed Description:
This study is a prospective, single-center, randomized, double-blind, double-dummy, crossover trial of Depakote ER vs. Seroquel for agitated behaviors among veterans with dementia. After consent is obtained and after a washout period of one week or five half-lives after taper (if necessary), 20 eligible patients will be randomized to received one of two treatments. The first is DEPAKOTE ER, initiated at 250 mg daily. The other treatment will be Seroquel, starting at 25 mg BID. Both treatments will be co-administered with a placebo that matches the other drug (to preserve blinding). Using serial examinations and blinded laboratory reporting, doses will be adjusted to clinical response or to achieve a serum valproate level of at least 50 mcg/mL. After a treatment period of six weeks, patients will be crossed over to the other treatment without washout (doses will be adjusted concurrently) for a second six-week treatment period. The Cohen-Mansfield Agitation Inventory (CMAI) will be the primary outcome measure. Secondary measures include the Behavior Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD); Clinical Global Impression Scale – Severity; Clinical Global Impression Scale – Improvement; Barnes Akathisia Scale (BAS); and the Abnormal Involuntary Movements Scale (AIMS). Outcome measures will be performed at the end of each six-week treatment period to avoid carryover effects.
Criteria
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
Seroquel has been a suspected culprit in the deaths of soldiers and veterans already, and with the black box warning from the FDA for use in people with dementia, I find the disregard for patient safety by Abbott Laboratories shameful.
ABBOTT has just been in the news for illegal marketing of the drug DEPAKOTE for dementia.
"In the Abbott lawsuit, the former employees charge Abbott illegally marketed Depakote to treat dementia and behavior seen in Alzheimer’s patients to nursing homes and the US Veterans Administration. How so? Their lawsuit alleges the drugmaker provided sales reps with materials that required them to encourage nursing homes to use Depakote on an off-label basis and designed ‘Selling Skills Workshops’ for instructing reps on off-label marketing tactics.
What else? Abbott allegedly disguised seminars for docs that were actually sessions on off-label usage; offered reps bonuses and incentives for off-label promotion; failed to disclose that favorable articles were written by docs who were paid by Abbott; paid docs to prescribe the med; trained reps to avoid being detected when promoting off-label; and, generally, lied to nursing homes about the drug and its uses."
Read entire Depakote article at Pharmalot.
TELL ME WHY THIS STUDY IS STILL BEING CONDUCTED.
Friday, February 11, 2011
life on twitter
transitioning from 51 yrs of house and yard life, and life in the woods w critters to an apartment is interesting, a challenge for sure less than 5 seconds ago via web
at times, it feels like i packed for a vacation, confined to small space w a few fav things.also am not sleeping well, thus jet lag feeling less than a minute ago via web
1st thing was to add blackout curtain to interior bedroom window w springrod. that prevents parking lot lights&porch lights in eyes at nite 2 minutes ago via web
looking at apt bldg across the way.size of my 1st big house, houses at least 9 families in one building.compartmentalized living. 3 minutes ago via web
POIGNANT, sad article by Angie Dickinson re her autistic spectrum daughter http://bit.ly/hICAUy via @carlacasilli and @stevesilberman 13 minutes ago via web
at times, it feels like i packed for a vacation, confined to small space w a few fav things.also am not sleeping well, thus jet lag feeling less than a minute ago via web
1st thing was to add blackout curtain to interior bedroom window w springrod. that prevents parking lot lights&porch lights in eyes at nite 2 minutes ago via web
looking at apt bldg across the way.size of my 1st big house, houses at least 9 families in one building.compartmentalized living. 3 minutes ago via web
POIGNANT, sad article by Angie Dickinson re her autistic spectrum daughter http://bit.ly/hICAUy via @carlacasilli and @stevesilberman 13 minutes ago via web
good morning from my garden
the new version of my garden! i'll be doing lots of containers and hanging baskets once the gardening season starts (when cold weather stops) so far these are tulips waiting to bloom!
Double cheeseburgers or Seroquel? Antipsychotics increase chance of heart disease in a few months of use!
Can't sleep? forget the antipsychotics off-label used such as Seroquel! unless you want increased chances of having heart disease!
VIA REUTERS-HEALTH:
"Antipsychotic medications, which have raised red flags in the past, may increase the risk of heart disease in as little as a few months, a new study says.
Among the people taking these drugs are patients with schizophrenia, who tend to have shorter-than-average life spans. So the role of antipsychotics in heart disease needs to be addressed, said co-author Debra Foley, senior lecturer at the Center for Youth Mental Health at the University of Melbourne in Australia.
Researchers have already reported that newer antipsychotics are associated with an increased risk of diabetes. The Food and Drug Administration put out warnings on this danger in 2004.
According to the new study, published in the Archives of General
Psychiatry, patients taking antipsychotics tended to gain weight after one month and had increases in their cholesterol levels after three to four months.
Obesity, high cholesterol, and diabetes all increase the risk of heart disease.
"This change in risk is evident early in the course of treatment, within several weeks of continuous use, but may continue to alter over several years," Foley told Reuters Health in an email. The "risk varies depending on the specific drug taken and how long it is taken for," she added.
About one in 100 adults in the U.S. has schizophrenia, according to the National Institute of Mental Health.
But antipsychotic drugs are also given to some patients with bipolar disorder, personality disorders, or anxiety, said Dr. Karen Graham, assistant professor of psychiatry at the..."
continue reading HERE.
VIA REUTERS-HEALTH:
"Antipsychotic medications, which have raised red flags in the past, may increase the risk of heart disease in as little as a few months, a new study says.
Among the people taking these drugs are patients with schizophrenia, who tend to have shorter-than-average life spans. So the role of antipsychotics in heart disease needs to be addressed, said co-author Debra Foley, senior lecturer at the Center for Youth Mental Health at the University of Melbourne in Australia.
Researchers have already reported that newer antipsychotics are associated with an increased risk of diabetes. The Food and Drug Administration put out warnings on this danger in 2004.
According to the new study, published in the Archives of General
Psychiatry, patients taking antipsychotics tended to gain weight after one month and had increases in their cholesterol levels after three to four months.
Obesity, high cholesterol, and diabetes all increase the risk of heart disease.
"This change in risk is evident early in the course of treatment, within several weeks of continuous use, but may continue to alter over several years," Foley told Reuters Health in an email. The "risk varies depending on the specific drug taken and how long it is taken for," she added.
About one in 100 adults in the U.S. has schizophrenia, according to the National Institute of Mental Health.
But antipsychotic drugs are also given to some patients with bipolar disorder, personality disorders, or anxiety, said Dr. Karen Graham, assistant professor of psychiatry at the..."
continue reading HERE.
Monday, February 07, 2011
Pharmagossip news: from BNET- How a single patent expiry (SEROQUEL) COULD WIPE OUT 40% OF ASTRAZENECA'S PROFITS
Monday, February 07, 2011
How a Single Patent Expiry (Seroquel) Could Wipe Out 40% of AstraZeneca’s Profits BNET
By Jim Edwards
"When AstraZeneca (AZN)’s controversial antipsychotic drug Seroquel loses its marketing exclusivity in early 2012, it could wipe out almost half — $4.3 billion — of the company’s entire pretax profit, if a recent investor note from an analyst has it right.
Although Seroquel has long been accused of triggering weight gain and diabetes in patients who use it — and AZ has paid out more than $1.1 billion in legal claims to settle those and other charges — the drug still earned $5.3 billion in revenues last year."
Read more at BNET with Jim Edwards.
How a Single Patent Expiry (Seroquel) Could Wipe Out 40% of AstraZeneca’s Profits BNET
By Jim Edwards
"When AstraZeneca (AZN)’s controversial antipsychotic drug Seroquel loses its marketing exclusivity in early 2012, it could wipe out almost half — $4.3 billion — of the company’s entire pretax profit, if a recent investor note from an analyst has it right.
Although Seroquel has long been accused of triggering weight gain and diabetes in patients who use it — and AZ has paid out more than $1.1 billion in legal claims to settle those and other charges — the drug still earned $5.3 billion in revenues last year."
Read more at BNET with Jim Edwards.
Study says SEROQUEL AND RISPERDAL may lead to loss of brain tissue
VIA PHARMAGOSSIP:
Monday, February 07, 2011
Drugs for Schizophrenia May Lead to Brain Tissue Loss - Bloomberg
Anti-psychotic drugs from AstraZeneca Plc and Johnson & Johnson may lead to loss of brain tissue or exacerbate declines in brain volume caused by schizophrenia, a study in the Archives of General Psychiatry found.
Researchers tracked 211 patients with newly diagnosed schizophrenia to determine if the progressive loss of brain tissue widely attributed to the disease may be affected by drugs to treat it, severity of the illness or substance abuse. More antipsychotic drug treatment, including duration and intensity, was linked to greater declines in brain volume. Severity of disease, alcohol and illegal drug use had no effect.
“What we found was that medication treatments are probably one of the contributing factors to brain volume declines we see in people with schizophrenia,” said lead researcher Beng-Choon Ho, a psychiatrist at the University of Iowa’s Carver College of Medicine in Iowa City. “It’s not a wise thing to jump to the conclusion that this is bad, although intuitively it seems like the first thing that people will conclude.
In reality, we still don’t quite understand what it means.”
Patients shouldn’t stop taking their medicines, which include London-based AstraZeneca’s Seroquel, Risperdal from New Brunswick, New Jersey-based J&J, Indianapolis-based Eli Lilly & Co.’s Zyprexa and a host of older, generic medications, the researchers said. Instead, they and their doctors should find the lowest effective dose, Ho said in a telephone interview.
“Pharmaceutical companies must continue the vigorous search for agents that are genuinely neuroprotective,” the researchers said. "
via bloomberg.com
--
MY OPINION
NOW TAKE SEROQUEL FOR OFF-LABEL SLEEP AIDE AND WONDER IF YOU'LL GET DIABETES OR LOSE BRAIN TISSUE OR COGNITIVE ABILITY! USE AT OWN RISK!
Anyone wondering why my daughter cannot think or speak or how long it takes her to form sentences when she does....take my word for it, dump the antipsychotics!
Monday, February 07, 2011
Drugs for Schizophrenia May Lead to Brain Tissue Loss - Bloomberg
Anti-psychotic drugs from AstraZeneca Plc and Johnson & Johnson may lead to loss of brain tissue or exacerbate declines in brain volume caused by schizophrenia, a study in the Archives of General Psychiatry found.
Researchers tracked 211 patients with newly diagnosed schizophrenia to determine if the progressive loss of brain tissue widely attributed to the disease may be affected by drugs to treat it, severity of the illness or substance abuse. More antipsychotic drug treatment, including duration and intensity, was linked to greater declines in brain volume. Severity of disease, alcohol and illegal drug use had no effect.
“What we found was that medication treatments are probably one of the contributing factors to brain volume declines we see in people with schizophrenia,” said lead researcher Beng-Choon Ho, a psychiatrist at the University of Iowa’s Carver College of Medicine in Iowa City. “It’s not a wise thing to jump to the conclusion that this is bad, although intuitively it seems like the first thing that people will conclude.
In reality, we still don’t quite understand what it means.”
Patients shouldn’t stop taking their medicines, which include London-based AstraZeneca’s Seroquel, Risperdal from New Brunswick, New Jersey-based J&J, Indianapolis-based Eli Lilly & Co.’s Zyprexa and a host of older, generic medications, the researchers said. Instead, they and their doctors should find the lowest effective dose, Ho said in a telephone interview.
“Pharmaceutical companies must continue the vigorous search for agents that are genuinely neuroprotective,” the researchers said. "
via bloomberg.com
--
MY OPINION
NOW TAKE SEROQUEL FOR OFF-LABEL SLEEP AIDE AND WONDER IF YOU'LL GET DIABETES OR LOSE BRAIN TISSUE OR COGNITIVE ABILITY! USE AT OWN RISK!
Anyone wondering why my daughter cannot think or speak or how long it takes her to form sentences when she does....take my word for it, dump the antipsychotics!
The Prozac, Paxil, Zoloft, Wellbutrin, Celexa, Effexor, Valium, Klonopin, Ativan, Restoril, Xanax, Adderall, Ritalin, Haldol, Risperdal, Seroquel WAR
VIA New York Magazine:
WHY OUR RETURNING SOLDIERS ARE FALLING APART
The Prozac, Paxil, Zoloft, Wellbutrin, Celexa, Effexor, Valium, Klonopin, Ativan, Restoril, Xanax, Adderall, Ritalin, Haldol, Risperdal, Seroquel, Ambien, Lunesta, Elavil, Trazodone War
As it approaches its tenth year, our nation’s longest war is showing signs of waning. Meanwhile, our soldiers are falling apart.
By Jennifer Senior Published Feb 6, 2011
Here's a snippet
"On September 6, 2006, as Booth was returning from a mission in Kirkuk, his Humvee rolled over an IED. He spent three years in San Diego in a Warrior Transition Unit, or WTU, where most badly injured soldiers go to convalesce, and four surgeries later, though he’d broken his neck, he was able to walk normally again. He no longer has any sensation in his right hand, though, and he lives with back spasms, headaches, stiffness in his neck, tingling and numbness in his right arm, and pain radiating down his spine and right side. Once a week, he goes to cognitive-behavioral therapy near his home, and he follows a carefully scripted drug regimen: Valium for spasms, Lyrica for pain, Topamax for headaches, and, on occasion, Klonopin for anxiety. “And that’s a lot less than what I used to be on,” he tells me. “Percocet for pain. Ambien for sleep, but they don’t want you on it for a long time because it’s habit-forming. Flexeril for spasms, but that makes you drowsy. OxyContin. Zoloft.”
READ THE ENTIRE ARTICLE HERE, at New York Magazine.
WHY OUR RETURNING SOLDIERS ARE FALLING APART
The Prozac, Paxil, Zoloft, Wellbutrin, Celexa, Effexor, Valium, Klonopin, Ativan, Restoril, Xanax, Adderall, Ritalin, Haldol, Risperdal, Seroquel, Ambien, Lunesta, Elavil, Trazodone War
As it approaches its tenth year, our nation’s longest war is showing signs of waning. Meanwhile, our soldiers are falling apart.
By Jennifer Senior Published Feb 6, 2011
Here's a snippet
"On September 6, 2006, as Booth was returning from a mission in Kirkuk, his Humvee rolled over an IED. He spent three years in San Diego in a Warrior Transition Unit, or WTU, where most badly injured soldiers go to convalesce, and four surgeries later, though he’d broken his neck, he was able to walk normally again. He no longer has any sensation in his right hand, though, and he lives with back spasms, headaches, stiffness in his neck, tingling and numbness in his right arm, and pain radiating down his spine and right side. Once a week, he goes to cognitive-behavioral therapy near his home, and he follows a carefully scripted drug regimen: Valium for spasms, Lyrica for pain, Topamax for headaches, and, on occasion, Klonopin for anxiety. “And that’s a lot less than what I used to be on,” he tells me. “Percocet for pain. Ambien for sleep, but they don’t want you on it for a long time because it’s habit-forming. Flexeril for spasms, but that makes you drowsy. OxyContin. Zoloft.”
READ THE ENTIRE ARTICLE HERE, at New York Magazine.
Sunday, February 06, 2011
Tufts Medical Center Dr.Kayoko Kifuji to pay $2.5 million for death of 4 YEAR OLD REBECCA RILEY
VIA Lawyers and Settlements blog:
ADHD Depakote & Clonidine Cocktail Settlement: No Cheers Heard
January 27th, 2011. By LucyC
"Remember Rebecca Riley? The four-year old who died of a clonidine overdose at the hands of her parents, Michael and Carolyn Riley, on December 13, 2006? This utterly tragic cautionary tale reached its final conclusion this week, with the announcement of a $2.5 million settlement to be paid by the Tufts Medical Center psychiatrist Dr. Kayoko Kifuji, who prescribed the clonidine and depakote cocktail as treatment for Rebecca’s attention deficit hyperactivity disorder (ADHD) and bipolar disorder. Most settlement announcements can have an air of the bittersweet coupled with a sense of vindication—but in this case, the settlement was for a cocktail that would never be followed by a “cheers!” from anyone—so there is only the sense of sadness all around.
When this case broke, Dr. Kifuji’s role ignited quite a controversy around her having prescribed these drugs in the first place. Clonidine is a high blood pressure medication that can be used as a sedative in children—for ADHD. Depakote was prescribed for bipolar disorder—it is an anti-convulsant also known as valproate semisodium or divalproex sodium.
According to the state medical examiner in Massachusetts, the four-year-old girl’s death at her family home was indeed the result of a drug overdose. Dr. Elizabeth Bundock, who served as the deputy chief medical officer in Vermont, concluded in her autopsy that Rebecca died from intoxication after being administered a combination of clonidine, Depakote and two over-the-counter cold and cough medications. Bundock testified during the trial that the drugs affected Rebecca’s brain, heart and lungs, leading to “a pump failure of the heart,” overworked lungs filled with bloody fluid, coma and death.
In 2007, the father, Michael Riley, and mother Carolyn Riley were charged with first and second degree murder respectively. They were found guilty. During those trials, in the summer of 2009, Dr. Kifuji was cleared of the criminal charges. Consequently, she had her medical licence reinstated and she returned to her practice at Tufts. "
Continue reading the article HERE.
Don't forget Rebecca Riley.
ADHD Depakote & Clonidine Cocktail Settlement: No Cheers Heard
January 27th, 2011. By LucyC
"Remember Rebecca Riley? The four-year old who died of a clonidine overdose at the hands of her parents, Michael and Carolyn Riley, on December 13, 2006? This utterly tragic cautionary tale reached its final conclusion this week, with the announcement of a $2.5 million settlement to be paid by the Tufts Medical Center psychiatrist Dr. Kayoko Kifuji, who prescribed the clonidine and depakote cocktail as treatment for Rebecca’s attention deficit hyperactivity disorder (ADHD) and bipolar disorder. Most settlement announcements can have an air of the bittersweet coupled with a sense of vindication—but in this case, the settlement was for a cocktail that would never be followed by a “cheers!” from anyone—so there is only the sense of sadness all around.
When this case broke, Dr. Kifuji’s role ignited quite a controversy around her having prescribed these drugs in the first place. Clonidine is a high blood pressure medication that can be used as a sedative in children—for ADHD. Depakote was prescribed for bipolar disorder—it is an anti-convulsant also known as valproate semisodium or divalproex sodium.
According to the state medical examiner in Massachusetts, the four-year-old girl’s death at her family home was indeed the result of a drug overdose. Dr. Elizabeth Bundock, who served as the deputy chief medical officer in Vermont, concluded in her autopsy that Rebecca died from intoxication after being administered a combination of clonidine, Depakote and two over-the-counter cold and cough medications. Bundock testified during the trial that the drugs affected Rebecca’s brain, heart and lungs, leading to “a pump failure of the heart,” overworked lungs filled with bloody fluid, coma and death.
In 2007, the father, Michael Riley, and mother Carolyn Riley were charged with first and second degree murder respectively. They were found guilty. During those trials, in the summer of 2009, Dr. Kifuji was cleared of the criminal charges. Consequently, she had her medical licence reinstated and she returned to her practice at Tufts. "
Continue reading the article HERE.
Don't forget Rebecca Riley.
Aricept, Pfizer and NIMH Scientist Charged with Criminal Conflict of Interest
VIA AHRP-Alliance for Human Research Protection-Vera Hassner Sharav
NIMH Scientist Charged with Criminal Conflict of Interest
Tuesday, 01 February 2011
CORRECTION: An Associated Press article about a federal criminal case accusing Dr. P. Trey Sunderland III of improperly accepting consulting fees from a drug maker, misstated the level of the charge against him. Dr. Sunderland was charged with "non-willful" criminal violation, a misdemeanor which carries a maximum one year prison term and $100,000 fine. It is NOT a felony, which is punishable by more than one year prison term.
Dr. Pearson "Trey" Sunderland III, Chief of Geriatric Psychiatry at the National Institute of Mental Health, pled guilty to criminal conflict of interest.
As reported by The Lost Angeles Times , the admission of a criminal violation by Dr. Sunderland came after years of denials and six months after he pleaded the Fifth Amendment, asserting his constitutional right against self-incrimination to a Congressional committee.The prosecution was the first of an NIH scientist under federal conflict-of-interest laws in 14 years.
Dr. Sunderland faced up to a year in prison and a $100,000 fine for secretly contracting with Pfizer pharmaceuticals as a paid consultant for work that overlapped his duties as a full-time public servant. Dr. Sunderland was head of the Alzheimer's research unit at NIMH. From 1998 to 2003, he received $285,000 in consulting fees from Pfizer pharmaceutical plus $15,000 in expenses.
The services Dr. Sunderland performed for the company included providing "access" to " a treasure trove of biological material"--namely, 3,200 tubes of spinal fluid samples costing the NIH (i.e., taxpayers) an estimated $6.4 million.
The spinal-fluid samples had been painfully collected from Alzheimer's patients at NIMH for the public good. Thanks to Dr. Sunderland, Pfizer exploited these patients' painfully acquired tissues to refine and market Aricept, garnering billions in profit: Aricept sales = $2 billion annually."
READ THE ENTIRE ARTICLE HERE.
NIMH Scientist Charged with Criminal Conflict of Interest
Tuesday, 01 February 2011
CORRECTION: An Associated Press article about a federal criminal case accusing Dr. P. Trey Sunderland III of improperly accepting consulting fees from a drug maker, misstated the level of the charge against him. Dr. Sunderland was charged with "non-willful" criminal violation, a misdemeanor which carries a maximum one year prison term and $100,000 fine. It is NOT a felony, which is punishable by more than one year prison term.
Dr. Pearson "Trey" Sunderland III, Chief of Geriatric Psychiatry at the National Institute of Mental Health, pled guilty to criminal conflict of interest.
As reported by The Lost Angeles Times , the admission of a criminal violation by Dr. Sunderland came after years of denials and six months after he pleaded the Fifth Amendment, asserting his constitutional right against self-incrimination to a Congressional committee.The prosecution was the first of an NIH scientist under federal conflict-of-interest laws in 14 years.
Dr. Sunderland faced up to a year in prison and a $100,000 fine for secretly contracting with Pfizer pharmaceuticals as a paid consultant for work that overlapped his duties as a full-time public servant. Dr. Sunderland was head of the Alzheimer's research unit at NIMH. From 1998 to 2003, he received $285,000 in consulting fees from Pfizer pharmaceutical plus $15,000 in expenses.
The services Dr. Sunderland performed for the company included providing "access" to " a treasure trove of biological material"--namely, 3,200 tubes of spinal fluid samples costing the NIH (i.e., taxpayers) an estimated $6.4 million.
The spinal-fluid samples had been painfully collected from Alzheimer's patients at NIMH for the public good. Thanks to Dr. Sunderland, Pfizer exploited these patients' painfully acquired tissues to refine and market Aricept, garnering billions in profit: Aricept sales = $2 billion annually."
READ THE ENTIRE ARTICLE HERE.
Saturday, February 05, 2011
Barkingdoc's Blog : Little Pharma: The Medication of U.S. Children
Hat tip Pharmagossip:
About:
"Maggie Kozel, MD is a board-certified pediatrician who graduated from Georgetown University School of Medicine in 1980, and did her pediatric residency training at Bethesda Navy Hospital, Bethesda, MD. Dr. Kozel moved to Rhode Island in 1990, where she practiced pediatrics for twelve years. She currently teaches high school science at Lincoln School in Providence, and has written a memoir, “The Color of Atmosphere: One Doctor’s Journey in and Out of Medicine.” Her blogs have been featured on NYT Well blog and Huffington Post as well as kevinmd and Sermo."
Little Pharma: The Medication of U.S. Children:
"The Wall Street Journal reported this week that a study of prescription patterns in 2009, conducted by IMS Health, showed that 25% of children in the US were on regular medication.
IMS Health is a firm that provides “marketing intelligence” to pharmaceutical companies. The firm’s job is to keep the $800 billion per year global pharmaceutical industry on a continued pattern of growth. Hopefully these consultants accomplished something quite different this week. Hopefully they provided our citizens with an overdue wake-up call.
One in four children in the U.S. are on chronic prescription medications. And this doesn’t even include all the prescriptions we write to treat acute illness, or use of over-the-counter products. It is an astounding number. We either have the sickest pediatric population in the world, or there is something very wrong with the way therapies are driven in our health care system."
Read entire article at Dr. Kozel's BLOG.
About:
"Maggie Kozel, MD is a board-certified pediatrician who graduated from Georgetown University School of Medicine in 1980, and did her pediatric residency training at Bethesda Navy Hospital, Bethesda, MD. Dr. Kozel moved to Rhode Island in 1990, where she practiced pediatrics for twelve years. She currently teaches high school science at Lincoln School in Providence, and has written a memoir, “The Color of Atmosphere: One Doctor’s Journey in and Out of Medicine.” Her blogs have been featured on NYT Well blog and Huffington Post as well as kevinmd and Sermo."
Little Pharma: The Medication of U.S. Children:
"The Wall Street Journal reported this week that a study of prescription patterns in 2009, conducted by IMS Health, showed that 25% of children in the US were on regular medication.
IMS Health is a firm that provides “marketing intelligence” to pharmaceutical companies. The firm’s job is to keep the $800 billion per year global pharmaceutical industry on a continued pattern of growth. Hopefully these consultants accomplished something quite different this week. Hopefully they provided our citizens with an overdue wake-up call.
One in four children in the U.S. are on chronic prescription medications. And this doesn’t even include all the prescriptions we write to treat acute illness, or use of over-the-counter products. It is an astounding number. We either have the sickest pediatric population in the world, or there is something very wrong with the way therapies are driven in our health care system."
Read entire article at Dr. Kozel's BLOG.
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