It was 8 posts ago we noted the 8,787 lawsuits filed against the makers of Seroquel: Which, the FDA, ..... said was "safe and effective", despite an admission that the "Mechanism of Action Is Unknown".
AboutLawsuits.Com has 13,000 plaintiffs claiming injury or DEATH from Seroquel.
Does 13,000 People wanting a piece of a manufacturer's financial hide sound like that manufacturer's product is "Safe And Effective", ..... to you, if you speak "Regular English" and not Psychiatric Ideations?
Thursday, September 25, 2008
Monday, September 22, 2008
He's Dead, Jim!
The FDA: "Efficacy and Safety were established", ..... in 4, 6, and 8 week trials, and the "Long Term Effects are Unknown" after 15 years of Investigating, and Labeling.
10/06/2006: pg 25
Here's our FDA approved nugget again.
Associated With Discontinuation of Treatment
"Suicide attempt was associated with discontinuation in 1.2% of RISPERDAL®-treated patients compared to 0.6% of placebo patients, but, given the almost 40-fold greater exposure time in RISPERDAL® compared to placebo patients, it is unlikely that suicide attempt is a RISPERDAL®-related adverse event (see PRECAUTIONS)"
A 100% Increase?
Let's Hear it for the $2.2 Billion Dollar FDA.
"May the Sewers of Rangoon Back Up Into Your Breakfast."
Johnny Karnak Carson
10/06/2006: pg 25
Here's our FDA approved nugget again.
Associated With Discontinuation of Treatment
"Suicide attempt was associated with discontinuation in 1.2% of RISPERDAL®-treated patients compared to 0.6% of placebo patients, but, given the almost 40-fold greater exposure time in RISPERDAL® compared to placebo patients, it is unlikely that suicide attempt is a RISPERDAL®-related adverse event (see PRECAUTIONS)"
A 100% Increase?
Let's Hear it for the $2.2 Billion Dollar FDA.
"May the Sewers of Rangoon Back Up Into Your Breakfast."
Johnny Karnak Carson
Thursday, September 18, 2008
Congress Barbecues FDA part 1
The FDA and Risperdal go back to at least 12/29/93
The latest approved label (approved 08/14/2008) is not available on this site for RISPERDAL, NDA no. 020272
The FDA and Zyprexa go back to at least 09/30/96
The latest approved label (approved 08/14/2008) is not available on this site for ZYPREXA, NDA no. 020592
There's a lot of "Label is Not Available" on FDA's site. On an annual budget of $2.2 Billion FDA can damn well afford to Make it available on site: Their site, which Everybody Else, is Paying for.
And it took these Investigating Ideates 15 years to gum shoe this? While they were Taking The Money, ..... From the Manufacturers of these Atypical Antipsychotics, ..... to conduct their Investigations of "Disorders" which Their fellow Psychiatrists voted into Money Makers, by a Show of Hands?
Where is the self proclaimed "trusted, independent, efficient gatekeeper it is now" FDA on this, ..... Today?
Why, would the FDA - NOW that the Floodgates of Naked Eye SCIENCE & NOT Psychiatry's Bull S**T Ideations, are opening Against those manufacturers - want to Preempt Your Right to Sue those manufacturers, ..... who Grease this FDA with a Half $ Billion a year"?
What might be the Real purpose of FDA labels, ..... when you can even Find the label ..... of FDA labels like this one?
10:06:2006 pg. 13
"The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown."
In "Regular English": the product causes tardive dyskenisia - which is brain and CNS damage - and the Psychiatrists who Cause tardive dyskenisia, "Treat" the Agony They Directly Caused, FOR MONEY, by Poisoning the Victim with even More of the Product to cover up their Opinionated skullduggery.
Read the FDA document. It speaks of 6-8 week trials, and the Long term Effects are "unknown", in Trade for a Half $ Billion a year.
Maybe FDA was too busy counting up that DRUG MONEY to find out what the Long Term Effects were, in between labels informing us that "efficacy and safety were established" in 417 Children aged 13-17, ..... only 3 pages After admitting that cardiopulmonary arrest and sudden death were "temporally, ..... but not necessarily causally related" to use of the product.
So just What Have these FDA-ocrats been doing for 15 years?
The last video is obviously a satire, ..... or is it?
And make sure to include a fork. We wouldn't want the FDA to burn itself on those Half $ Billion Dollar Pies.
Thanks again to Hissey Kientz LLP, Congressmen Waxman and Braley, and of course, the Onion.
The latest approved label (approved 08/14/2008) is not available on this site for RISPERDAL, NDA no. 020272
The FDA and Zyprexa go back to at least 09/30/96
The latest approved label (approved 08/14/2008) is not available on this site for ZYPREXA, NDA no. 020592
There's a lot of "Label is Not Available" on FDA's site. On an annual budget of $2.2 Billion FDA can damn well afford to Make it available on site: Their site, which Everybody Else, is Paying for.
It's now 12 & 15 years down the "Investigative" road and only Now have the Investigators Finally copped to the fact that the newer - Vastly More Expensive Atypical Antipsychotic Poisons - are Worse, ..... In Children, ..... than the older Typical Antipsychotic Poisons.
And it took these Investigating Ideates 15 years to gum shoe this? While they were Taking The Money, ..... From the Manufacturers of these Atypical Antipsychotics, ..... to conduct their Investigations of "Disorders" which Their fellow Psychiatrists voted into Money Makers, by a Show of Hands?
Where is the self proclaimed "trusted, independent, efficient gatekeeper it is now" FDA on this, ..... Today?
Why, would the FDA - NOW that the Floodgates of Naked Eye SCIENCE & NOT Psychiatry's Bull S**T Ideations, are opening Against those manufacturers - want to Preempt Your Right to Sue those manufacturers, ..... who Grease this FDA with a Half $ Billion a year"?
What might be the Real purpose of FDA labels, ..... when you can even Find the label ..... of FDA labels like this one?
10:06:2006 pg. 13
"The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown."
In "Regular English": the product causes tardive dyskenisia - which is brain and CNS damage - and the Psychiatrists who Cause tardive dyskenisia, "Treat" the Agony They Directly Caused, FOR MONEY, by Poisoning the Victim with even More of the Product to cover up their Opinionated skullduggery.
Read the FDA document. It speaks of 6-8 week trials, and the Long term Effects are "unknown", in Trade for a Half $ Billion a year.
Maybe FDA was too busy counting up that DRUG MONEY to find out what the Long Term Effects were, in between labels informing us that "efficacy and safety were established" in 417 Children aged 13-17, ..... only 3 pages After admitting that cardiopulmonary arrest and sudden death were "temporally, ..... but not necessarily causally related" to use of the product.
So just What Have these FDA-ocrats been doing for 15 years?
The last video is obviously a satire, ..... or is it?
And make sure to include a fork. We wouldn't want the FDA to burn itself on those Half $ Billion Dollar Pies.
Thanks again to Hissey Kientz LLP, Congressmen Waxman and Braley, and of course, the Onion.
Tuesday, September 16, 2008
Braley Grills FDA Spokesman On The Constitution
At 0.35: "I'm sorry. I don't know the 7th Amendment."
Amendment VII
"In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law."
This FDA-ocrat took an oath to uphold the Constitution, to get his FDA-ocrat job.
How in the Hell can this Squirrel execute the duties of his office, if he doesn't even know What the Hell he's supposed to be upholding?
And this Federal Agency - jammed packed with Squirrels just like this one - wants to Preempt Your 7th Amendment because This Agency - the FDA - knows Everything, ..... except the 7th Amendment.
PS:
1:26 "It [the Supremacy Clause] speaks to the relationship between Federal Law and State Law."
We have read the Constitution, Many times, and the Constitution speaks of Congress being empowered to make Law. The FDA may write Regulations, which sadly have the Power of Law behind them, BUT: they remain Regulations. What Dr. Rocky here is slipping to us is the mindset that FDA is Empowered to craft LAW, ..... based on his selective - "I don't Like that part so I Won't pay any attention to it, and we'll just make it go away." - reading, .... of the Constitution, ..... which DOES NOT, ..... have a Single Sparrow Fart In It about Any FDA.
Hat tip and Thanks to Hissey Kientz LLP for the vid. Hissey Kientz has more fascinating clips at
http://www.youtube.com/hkllp
Amendment VII
"In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law."
This FDA-ocrat took an oath to uphold the Constitution, to get his FDA-ocrat job.
How in the Hell can this Squirrel execute the duties of his office, if he doesn't even know What the Hell he's supposed to be upholding?
And this Federal Agency - jammed packed with Squirrels just like this one - wants to Preempt Your 7th Amendment because This Agency - the FDA - knows Everything, ..... except the 7th Amendment.
PS:
1:26 "It [the Supremacy Clause] speaks to the relationship between Federal Law and State Law."
We have read the Constitution, Many times, and the Constitution speaks of Congress being empowered to make Law. The FDA may write Regulations, which sadly have the Power of Law behind them, BUT: they remain Regulations. What Dr. Rocky here is slipping to us is the mindset that FDA is Empowered to craft LAW, ..... based on his selective - "I don't Like that part so I Won't pay any attention to it, and we'll just make it go away." - reading, .... of the Constitution, ..... which DOES NOT, ..... have a Single Sparrow Fart In It about Any FDA.
Hat tip and Thanks to Hissey Kientz LLP for the vid. Hissey Kientz has more fascinating clips at
http://www.youtube.com/hkllp
Sunday, September 14, 2008
FDA Preemption: Cosmic Debris
Lawyers and Settlements: - If You're new to the discussion - has an overview of the antipsychotic problem.
"The Oil Of Aphrodite, and The Dust Of The Grand Wazoo."
FDA Aims To Hire 1,300
Of FDA's $2.2 Billion annual budget only $1.7 Billion is Govt funding and the remaining $500,000,000.00 is from Industry "User Fees".
Are We the Only ones noting the Half a $ Billion Dollar Conflict Of Interest here?
Take the $ Out of FDA's hands. Let Congress Re-Fund the FDA on the basis of FDA showing results in trade for TAX PAYER FUNDING: I.E. that FDA is Actually working for the Citizens it's Supposed to be working for, NOT the Industry Giants paying it a Direct Half Billion in Grease.
Stop charging Pharma "User Fees".
If One, single, red, blood drenched Cent trades hands between Pharma and FDA; send Both traders to prison, Period. If Anybody takes a Cent for Any reason Whatever, After their Govt. tenure; same deal: Prison. Then and Only then will the American people have Any chance of real accountability, and real protection.
Hiring 1,300 more of the Same is going to get us 1,300 more of the Same: who keep jiggling syntax in label changes to even Further expand Pharma's legally allowable Advertising gibberish.
BECAUSE:
When the stuff Finally wins FDA approval for the treatment of Dandruff: and it Kills your kid and you sue the makers, what you hear in Court will be:
"Your Honor; Our product is FDA approved for Dandruff, for Chrissakes. How the Hell could Our Dandruff SAFE Antipsychotic have possibly laid their child out Lead Pipe Stiff?"
"Case Dismissed."
In "Regular English": FDA is currently Taking The Money from Pharma; Half a $ Billion Bucks from Pharma. Cloak it in Any Bureaucratese you like. It's a $ Half Billion Dollar COI. Handing FDA 1,300 MORE employess, And Preemption, will Worsen the problem, because that's what it's Designed to do.
NIH blows $23 Billion a year, with No Oversight regarding WHAT it's wasted on. (NYT 1/19/08) Transfer the Half Billion lost in FDA Industry "User Fees" out of the NIH budget. Then perhaps we can force even the FDA itself to speak "Regular English" regarding antidepressants, and antipsychotics.
And to their prescribing Ideates, the Rest of us can offer up a hearty;
"Take Your Meditations, and Your Preparations, and Ram It Up Your, ..... "
"The Oil Of Aphrodite, and The Dust Of The Grand Wazoo."
FDA Aims To Hire 1,300
Of FDA's $2.2 Billion annual budget only $1.7 Billion is Govt funding and the remaining $500,000,000.00 is from Industry "User Fees".
Are We the Only ones noting the Half a $ Billion Dollar Conflict Of Interest here?
Take the $ Out of FDA's hands. Let Congress Re-Fund the FDA on the basis of FDA showing results in trade for TAX PAYER FUNDING: I.E. that FDA is Actually working for the Citizens it's Supposed to be working for, NOT the Industry Giants paying it a Direct Half Billion in Grease.
Stop charging Pharma "User Fees".
If One, single, red, blood drenched Cent trades hands between Pharma and FDA; send Both traders to prison, Period. If Anybody takes a Cent for Any reason Whatever, After their Govt. tenure; same deal: Prison. Then and Only then will the American people have Any chance of real accountability, and real protection.
Hiring 1,300 more of the Same is going to get us 1,300 more of the Same: who keep jiggling syntax in label changes to even Further expand Pharma's legally allowable Advertising gibberish.
BECAUSE:
When the stuff Finally wins FDA approval for the treatment of Dandruff: and it Kills your kid and you sue the makers, what you hear in Court will be:
"Your Honor; Our product is FDA approved for Dandruff, for Chrissakes. How the Hell could Our Dandruff SAFE Antipsychotic have possibly laid their child out Lead Pipe Stiff?"
"Case Dismissed."
In "Regular English": FDA is currently Taking The Money from Pharma; Half a $ Billion Bucks from Pharma. Cloak it in Any Bureaucratese you like. It's a $ Half Billion Dollar COI. Handing FDA 1,300 MORE employess, And Preemption, will Worsen the problem, because that's what it's Designed to do.
NIH blows $23 Billion a year, with No Oversight regarding WHAT it's wasted on. (NYT 1/19/08) Transfer the Half Billion lost in FDA Industry "User Fees" out of the NIH budget. Then perhaps we can force even the FDA itself to speak "Regular English" regarding antidepressants, and antipsychotics.
And to their prescribing Ideates, the Rest of us can offer up a hearty;
"Take Your Meditations, and Your Preparations, and Ram It Up Your, ..... "
Saturday, September 13, 2008
Sign The Anti FDA Preemption Petition
"Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press, or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances."
If being Ordered to Submit, Lay Down and Die, by a TAX FUNDED Government Agency's Imperial GD Edict, because Corporate Pharmaceutical Interests are more important than your Life, doesn't constitute one King Hell Grievance, then What Does?
Pharma's Rigged Junk Science has encroached Bloody Damn Well too far already. Allowing Pharma - whose Products are Neither Safe Nor Effective - to Preempt Your Right to Legal Redress, In Court, when Pharma's product cripples or kills You and Your family because the FDA says They own the FINAL WORD on whether or not Your LIFE is Compensible or even Contestable, In Court, is beyond intolerable.
It's Tyranny.
The FDA is telling America, and the World, to Sit down, Shut up, and Die, without even a whimper. God Forbid Pharma should be held accountable to anyone beyond its own stockholders.
Put Your foot down and sign the petition. It's 1st up, on the side, under Activism.
If being Ordered to Submit, Lay Down and Die, by a TAX FUNDED Government Agency's Imperial GD Edict, because Corporate Pharmaceutical Interests are more important than your Life, doesn't constitute one King Hell Grievance, then What Does?
Pharma's Rigged Junk Science has encroached Bloody Damn Well too far already. Allowing Pharma - whose Products are Neither Safe Nor Effective - to Preempt Your Right to Legal Redress, In Court, when Pharma's product cripples or kills You and Your family because the FDA says They own the FINAL WORD on whether or not Your LIFE is Compensible or even Contestable, In Court, is beyond intolerable.
It's Tyranny.
The FDA is telling America, and the World, to Sit down, Shut up, and Die, without even a whimper. God Forbid Pharma should be held accountable to anyone beyond its own stockholders.
Put Your foot down and sign the petition. It's 1st up, on the side, under Activism.
Friday, September 12, 2008
Risperdal FDA History, and APA Sexism
Cleaning up this putrid miasma of Dope Dealing Killers is NOT a spectator sport. Here's FDA material for you to dig through, as you play "Where's Waldo" to pick up FDA Newspeak, ....... ahhem, ........ Weasel Speak, in This round of Clue meets Cluebat, on your way to discovering it was the Doktor, who "Did it in the office" with a Prescription Pad, ....... because;
You, are a woman.
We don't usually read Ms magazine, but Paula Caplan gets a hat tip and a thank you, ..... because, ..... If you are a woman, and you confess it to a Psychiatrist, You can be Profitably CRIPPLED and KILLED with this FDA approved product listed below, for being, ..... "Incurably Mentally Ill", ..... a couple of days out of every month, ..... for being, a woman.
World Net Daily has the Amer. Psychological Assc. contradicting long observed fact to condone the Creation of emotional suffering.
In Regular English, this is called "Job Security."
However, should you decide to Have those children after all;
This FDA approved product is Also extremely efficacious for turning them into tardive dyskinesia afflicted cripples, on its way, ... to Killing them. And the FDA currently wants to Steal Your Right To Sue, because the FDA Knows Better.
If the FDA knows So GD Much Better; Why, ...... did they have to go through all of these Revisions in the 1st place? Might that be because;
The FDA Doesn't give an actual S**T about You?
"Clinical Trials" are performed on Live human beings, and what follows is a record of FDA merely adjusting the wording, as those Live human beings become Crippled and Dead human beings, ..... for the black and unspeakable Crime, ..... of Violating the 1st Amendment. They spoke words which Psychiatric Opinion condemned them for, as being "disordered".
We're betting that your sock drawer is "disordered" too.
Risperdal:
02/28/1996: Review
03/07/1996: Review
10/17/1997: Review
07/02/1999: Labeling Revision: Letter
07/02/1999: Labeling Revision: Label
03/03/2002: Efficacy Supplement with Clinical Data To Support
11/19/2002: Labeling Revision
09/10/2003: Review
09/10/2003: Labeling Revision Letter
10/29/2003: Labeling Revision Letter
11/21/2003: Labeling Revision Letter
12/04/2003: New Or Modified Indication Letter
12/04/2003: New Or Modified Indication Label
12/04/2003: New Or Modified Indication Letter
12/04/2003: New Or Modified Indication Label
08/17/2005: Labeling Revision Letter
08/17/2005: Labeling Revision Label
10/06/2006: New Or Modified Indication Letter
10/06/2006: New Or Modified Indication Label
10/06/2006: New Or Modified Indication Letter
10/06/2006: New Or Modified Indication Label
08/22/2007: Patient Population Alerted Letter
08/22/2007: Patient Population Alerted Label
08/22/2007: Patient Population Alerted Letter
08/22/2007: Patient Population Alerted Label
08/14/2008: Labeling Revision Letter
So how do Psychiatrists determine that you Need to be poisoned in the 1st place?
For just a wee Pinch of the nitwits, scumbags and fakirs comprising Psychiatry's Diagnosing Infallibility, click [Ideates]. We're working on more.
You, are a woman.
We don't usually read Ms magazine, but Paula Caplan gets a hat tip and a thank you, ..... because, ..... If you are a woman, and you confess it to a Psychiatrist, You can be Profitably CRIPPLED and KILLED with this FDA approved product listed below, for being, ..... "Incurably Mentally Ill", ..... a couple of days out of every month, ..... for being, a woman.
World Net Daily has the Amer. Psychological Assc. contradicting long observed fact to condone the Creation of emotional suffering.
In Regular English, this is called "Job Security."
However, should you decide to Have those children after all;
This FDA approved product is Also extremely efficacious for turning them into tardive dyskinesia afflicted cripples, on its way, ... to Killing them. And the FDA currently wants to Steal Your Right To Sue, because the FDA Knows Better.
If the FDA knows So GD Much Better; Why, ...... did they have to go through all of these Revisions in the 1st place? Might that be because;
The FDA Doesn't give an actual S**T about You?
"Clinical Trials" are performed on Live human beings, and what follows is a record of FDA merely adjusting the wording, as those Live human beings become Crippled and Dead human beings, ..... for the black and unspeakable Crime, ..... of Violating the 1st Amendment. They spoke words which Psychiatric Opinion condemned them for, as being "disordered".
We're betting that your sock drawer is "disordered" too.
Risperdal:
02/28/1996: Review
03/07/1996: Review
10/17/1997: Review
07/02/1999: Labeling Revision: Letter
07/02/1999: Labeling Revision: Label
03/03/2002: Efficacy Supplement with Clinical Data To Support
11/19/2002: Labeling Revision
09/10/2003: Review
09/10/2003: Labeling Revision Letter
10/29/2003: Labeling Revision Letter
11/21/2003: Labeling Revision Letter
12/04/2003: New Or Modified Indication Letter
12/04/2003: New Or Modified Indication Label
12/04/2003: New Or Modified Indication Letter
12/04/2003: New Or Modified Indication Label
08/17/2005: Labeling Revision Letter
08/17/2005: Labeling Revision Label
10/06/2006: New Or Modified Indication Letter
10/06/2006: New Or Modified Indication Label
10/06/2006: New Or Modified Indication Letter
10/06/2006: New Or Modified Indication Label
08/22/2007: Patient Population Alerted Letter
08/22/2007: Patient Population Alerted Label
08/22/2007: Patient Population Alerted Letter
08/22/2007: Patient Population Alerted Label
08/14/2008: Labeling Revision Letter
So how do Psychiatrists determine that you Need to be poisoned in the 1st place?
For just a wee Pinch of the nitwits, scumbags and fakirs comprising Psychiatry's Diagnosing Infallibility, click [Ideates]. We're working on more.
Saturday, September 6, 2008
8,787 Seroquel Lawsuits/Some FDA History
Psychiatric News has:
Seroquel Litigation: 8,787 lawsuits Filed Against Astrazeneca
Delawareonline.com has:
Astrazeneca's Seroquel On FDA Warning List
Chicagotribune.com: has:
FDA Lists 20 Drugs Under Scrutiny
Let's roll back the clock.
May 6, 1999 : NDA [New Drug Application] #20-639 / HHS/FDA to Zeneca Pharmaceuticals
"4. The mechanism of action of Seroquel, as well as other antipsychotic drugs, is unknown. Therefore materials that discuss how Seroquel "works" without discussing the theoretical nature of this information are misleading. (e.g. brochures #SQ1059, PR1048)"
March 21 2000: has Former FDA Commissioner Jane E. Henney concerned over consumers purchasing drugs on the internet.
"As you know, the establishment of FDA as it exists today grew out of a time early in the century when consumers were victimized by dishonest purveyors of fraudulent potions and compounds that were ineffective, dangerous, or both."
Her summation:
"1. A significant public health risk exists when a consumer is at risk for harm (1) from the use of the product, (2) as the result of not taking approved drugs for a specific disease or condition, or (3) by delaying medical treatment recognized as safe and effective for a specific disease or condition."
Nov. 22 2000: NYT has FDA Commissioner Dr. Henney proposing simplifying drug package insert labels because the info is "cumbersome" and "dense", ..... so Doctors often ignore them. Medication errors Kill up to 7000 per year versus 6000 deaths from workplace accidents.
Try that in Any other line of work, and See how far you get: Killing your customers because you won't even Try to understand the potentially Lethal product you're selling them. But then again: Psychiatrists make more $ in 15 minutes of Drug Dealing than in 45 minutes of therapy.
January 22, 2001: FDA Commissioner Dr. Henney resignation.
March 27, 2001: FDA Approval Letter
"We have completed the review of this supplemental application and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the submitted final printed labeling (package insert submitted February 28, 2001). Accordingly, this supplemental application is approved effective on the date of this letter."
March, 2001: Seroquel Label
May 10, 2001: has FDA Acting Principle Deputy Commissioner Bernard Schwetz testifying before the US Senate.
"We will ensure that FDA will not become a bottleneck in getting these public health breakthroughs to the public while serving as the trusted, independent, efficient gatekeeper it is now. "
Protecting Volunteers and the Integrity of Data in Clinical Trials
"FDA, whose product reviews depend on the validity of clinical trial data, monitors the entire system. The Agency conducts about 1,200 trial-associated inspections per year (1,100 domestic and 100 foreign), some of which involve extensive interviews with IRB members and examination of their records, procedures, and responsiveness to participants’ concerns. "
Monitors the entire system with 200 Inspectors for 350,000 test sites? Here's 2 Contrarian views from Gardiner Harris of the NYT. [11/19/2004] [9/28/07]
October 10, 2001: has Acting Deputy Commissioner Bernard Schwetz again:
"The primary objective of the American system of public health is to prevent disease before it occurs."
mechanism of action, ..... is unknown?
Seroquel's 1,656 Adverse Reaction/side effects aren't currently "unknown" to the FDA, but it's still on the market.
safe and effective?
8,787 Lawsuits?
So, ..... Who's This Former FDA Commissioner we find, on the Board of Directors of AstraZeneca?
Seroquel Litigation: 8,787 lawsuits Filed Against Astrazeneca
Delawareonline.com has:
Astrazeneca's Seroquel On FDA Warning List
Chicagotribune.com: has:
FDA Lists 20 Drugs Under Scrutiny
Let's roll back the clock.
May 6, 1999 : NDA [New Drug Application] #20-639 / HHS/FDA to Zeneca Pharmaceuticals
"4. The mechanism of action of Seroquel, as well as other antipsychotic drugs, is unknown. Therefore materials that discuss how Seroquel "works" without discussing the theoretical nature of this information are misleading. (e.g. brochures #SQ1059, PR1048)"
March 21 2000: has Former FDA Commissioner Jane E. Henney concerned over consumers purchasing drugs on the internet.
"As you know, the establishment of FDA as it exists today grew out of a time early in the century when consumers were victimized by dishonest purveyors of fraudulent potions and compounds that were ineffective, dangerous, or both."
Her summation:
"1. A significant public health risk exists when a consumer is at risk for harm (1) from the use of the product, (2) as the result of not taking approved drugs for a specific disease or condition, or (3) by delaying medical treatment recognized as safe and effective for a specific disease or condition."
Nov. 22 2000: NYT has FDA Commissioner Dr. Henney proposing simplifying drug package insert labels because the info is "cumbersome" and "dense", ..... so Doctors often ignore them. Medication errors Kill up to 7000 per year versus 6000 deaths from workplace accidents.
Try that in Any other line of work, and See how far you get: Killing your customers because you won't even Try to understand the potentially Lethal product you're selling them. But then again: Psychiatrists make more $ in 15 minutes of Drug Dealing than in 45 minutes of therapy.
January 22, 2001: FDA Commissioner Dr. Henney resignation.
March 27, 2001: FDA Approval Letter
"We have completed the review of this supplemental application and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the submitted final printed labeling (package insert submitted February 28, 2001). Accordingly, this supplemental application is approved effective on the date of this letter."
March, 2001: Seroquel Label
May 10, 2001: has FDA Acting Principle Deputy Commissioner Bernard Schwetz testifying before the US Senate.
"We will ensure that FDA will not become a bottleneck in getting these public health breakthroughs to the public while serving as the trusted, independent, efficient gatekeeper it is now. "
Protecting Volunteers and the Integrity of Data in Clinical Trials
"FDA, whose product reviews depend on the validity of clinical trial data, monitors the entire system. The Agency conducts about 1,200 trial-associated inspections per year (1,100 domestic and 100 foreign), some of which involve extensive interviews with IRB members and examination of their records, procedures, and responsiveness to participants’ concerns. "
Monitors the entire system with 200 Inspectors for 350,000 test sites? Here's 2 Contrarian views from Gardiner Harris of the NYT. [11/19/2004] [9/28/07]
October 10, 2001: has Acting Deputy Commissioner Bernard Schwetz again:
"The primary objective of the American system of public health is to prevent disease before it occurs."
mechanism of action, ..... is unknown?
Seroquel's 1,656 Adverse Reaction/side effects aren't currently "unknown" to the FDA, but it's still on the market.
safe and effective?
8,787 Lawsuits?
So, ..... Who's This Former FDA Commissioner we find, on the Board of Directors of AstraZeneca?
Thursday, September 4, 2008
Ask Your Doctor, if it's "Right For You"
We don't watch TV. Do you? Is this a real commercial?
psychdrugdangers.com & the FDA have this stuff down for:
98 completed suicides
31 attempted suicides
103 deaths Not from suicide
4 instances of Murder
Does this stuff look like it's "Right For You?"
psychdrugdangers.com & the FDA have this stuff down for:
98 completed suicides
31 attempted suicides
103 deaths Not from suicide
4 instances of Murder
Does this stuff look like it's "Right For You?"
Wednesday, September 3, 2008
Abortion? No After Effects, Ever?
Catholic Exchange brings us More news from the Psych crowd that yet Again, They Just Refuse to be Blinded by that pesky old Real Science thing, when it interferes with their Ideating.
Breaking News!
When dealing with Psych, almost No word means what it means in regular English.
The grisly photographs are not hiding in the next 3 links, but those pages are out there if you Must view them.
"Abortion Trauma Can Last For Years"
"Women At Risk Of Post Abortion Trauma"
"Overview Of After Abortion Emotions"
abortion NEAR trauma will give you More links, at your own risk.
This [link] offers George Grant's 111 page PDF biography of the patron saint of abortion; Margaret Sanger. As Mr Grant points out - quoting historian Henry Cabot Lodge;
Mr. Grant also tells us that Margaret and Ernst Rudin - of Psychiatric Genetics and NAZI Holocaust infamy - were buddies.
Today we're Still, Tax Funding, Research into Psychiatric Genetics: 88 years after Wilhelm Wundt of "The human soul can no longer exist in the light of our current physiological knowledge." was plowed under. How unfortunate that Wundt's BS didn't get plowed under along with Wundt himself, which brings us to Malthus: who so inspired Margaret. Here's just a smidgen from Wiki:
Former Surgeon General David Satcher's page has:
"mental disorders affect nearly one in five Americans" [in the Preface]
And his 'Mental Health' Diagnosing sycophants are So, GD, Bloody Brilliant, ..... that they can't even operate a calculator. [300 Million/54 Million =1 in 5.5555556] 54 Million = 1 in 5 is Not an oversight. It's called "Mission Creep".
Since You, Dear Reader are Not Mentally Ill; look around at Your Own family, at Your work place, at Your social haunts; and pick out the 'Incurable' today's Mental Health/Malthusian Eugenicist DRUG MONEY has slated for destruction, ..... among EVERY 5 people You know.
Then You, put Your hand into Their pocket [through Government], and tell them to be grateful for being Euthanized, at Their OWN expense.
Welcome to today's 'Mental Health' Industry.
"The APA’s ideological bias in this report is so evident that a member of this professional body has broken ranks to oppose it. Dr. Rachel M. MacNair, a member of the APA’s Board of Division 48, accuses the APA of reinventing science to serve its ideology.“We have known for a long time that the word ‘choice’ in the abortion debate doesn’t mean what it means in regular English,” MacNair writes in a recent article entitled “Tales From an Insider: How The APA Denied Abortion’s Mental Health Risks.” “Now we find that ’science’ means what the American Psychological Association (APA) says it means, rather than what those of us trained in a university might have been taught.”
Breaking News!
When dealing with Psych, almost No word means what it means in regular English.
The grisly photographs are not hiding in the next 3 links, but those pages are out there if you Must view them.
"Abortion Trauma Can Last For Years"
"Women At Risk Of Post Abortion Trauma"
"Overview Of After Abortion Emotions"
abortion NEAR trauma will give you More links, at your own risk.
This [link] offers George Grant's 111 page PDF biography of the patron saint of abortion; Margaret Sanger. As Mr Grant points out - quoting historian Henry Cabot Lodge;
"Nearly all the historical work worth doing at the present moment in the English language is the work of shoveling off heaps of rubbish inherited from the immediate past."Margaret was a Racist Malthusian Eugenicist who peddled abortions as a mechanism to eventually Exterminate blacks, completely, along with every other color, which her ideological shibboleths deemed "lower grade material".
Mr. Grant also tells us that Margaret and Ernst Rudin - of Psychiatric Genetics and NAZI Holocaust infamy - were buddies.
Today we're Still, Tax Funding, Research into Psychiatric Genetics: 88 years after Wilhelm Wundt of "The human soul can no longer exist in the light of our current physiological knowledge." was plowed under. How unfortunate that Wundt's BS didn't get plowed under along with Wundt himself, which brings us to Malthus: who so inspired Margaret. Here's just a smidgen from Wiki:
"Malthusian theory also influenced British policies in Ireland during the 1840s: the government neglected relief-measures during the Irish Potato Famine (1845-1849), seeing mass starvation as a natural and inevitable consequence of the island's supposed over-population."Malthus dropped dead 2 days before Christmas in 1834, ..... and we Still haven't buried the stinker. History has Repeatedly disproven his predictions, ..... and Hitler's gangsters a Century later were Still chasing them through the camps: murdering Millions as "Useless Bread Gobblers".
Former Surgeon General David Satcher's page has:
"mental disorders affect nearly one in five Americans" [in the Preface]
And his 'Mental Health' Diagnosing sycophants are So, GD, Bloody Brilliant, ..... that they can't even operate a calculator. [300 Million/54 Million =1 in 5.5555556] 54 Million = 1 in 5 is Not an oversight. It's called "Mission Creep".
Since You, Dear Reader are Not Mentally Ill; look around at Your Own family, at Your work place, at Your social haunts; and pick out the 'Incurable' today's Mental Health/Malthusian Eugenicist DRUG MONEY has slated for destruction, ..... among EVERY 5 people You know.
Then You, put Your hand into Their pocket [through Government], and tell them to be grateful for being Euthanized, at Their OWN expense.
Welcome to today's 'Mental Health' Industry.
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