Monday, October 27, 2008
The FDA approved, "safety and efficacy", ..... "were established in 4, 6, and 8 week trials", ..... and the "long term effects are unknown", ..... after 15 years of trials.
Tardive means: Late developing
Does it strike you as odd that the moderator in this video is rattling off an Industry Established Numbering System for these particular long term effects - of Atypical Antipsychotics - but somehow the FDA - holding its own $500 Million Conflict of Interest - Still claims the long term effects are "Unknown"?
Saturday, October 25, 2008
Atypical Antipsychotic Geodon Adverse Reactions Reported to the FDA, ..... and it's Still on the market.
How would You feel, if some pampered, elitist, $180,000 per year, and ON THE DRUG MONEY TAKE, Psychiatrist did This to Your Wife, Daughter, Sister, or Mother?
Gaze, Dear Reader, upon what today's 'Mental Health' Chemical Factories have planned for You and Your families.
Friday, October 24, 2008
"Because of the protections in the food and drug laws, and the Agency's implementation of those laws, Americans do not have to worry about the safety or effectiveness of literally thousands of products they use every day, from breakfast cereal to pain relievers, from contact lenses to vaccines."
Yeah, Sure. That's why those FDA Approved Psych Poisons have got their Makers in Court all over Hell's/America's half acre today.
"An important measure of our value as an Agency, and of our success at fulfilling our mission to promote and protect the public health, ...... It is a measure by which, I believe, we have done very well."
Done very Well? For WHO, ..... beside Yourself, Pharma and the American Funeral Directors Assc.
"We recognize that the industries we regulate have important contributions to make, .... "
Yes they Do. $500 Million Dollars worth, .... directly into FDAs "safe and effective" hot little hands.
"We heard from the members of this Committee and others in Congress that there were problems in how we do our job, ..... "
And you're Still hearing about them, and OUR Crystal Ball says today's FDA is going to being Hearing One Hell of a Lot MORE about them, ..... which is WHY FDA is currently pushing for Preemption, to run cover for its buddies in Pharma.
"The Agency has focused on approval times, and as I will describe today, we have seen real results. We know much remains to be done. Just as we are continuing to work with industry, ..... "
II. IMPROVING PRODUCT REVIEW TIMES
A. HUMAN DRUG REVIEWS AND APPROVALS
No area of FDA's responsibility has been more closely scrutinized by Congress, industry, health professionals and the public than the approval process for new drugs, or more specifically, the speed with which new therapies of proven effectiveness and safety are made available to those who need them. For years there has been public discussion of the so-called "drug lag," the concern that new therapies were consistently being approved in Europe more quickly than in the United States. Today we are approving drugs in time periods that are as fast or faster than any country in the world with a comparable system of patient protection. And we are doing it while maintaining the standards for safety and efficacy that make FDA approval the gold standard for the world.
Check our links on Psych Poison Adverse Reactions Reported To The FDA, and then You, Dear Reader, decide whether the FDA's "gold standard" might not be more accurately described as "Barnyard Gold".
"Excessive bail shall not be required, nor excessive fines imposed, nor CRUEL AND UNUSUAL PUNISHMENTS INFLICTED.
TARDIVE DYSKINESIA VIDEO OF AN ACTUAL EPISODE
Watch the VIDEO, ..... MIKE, and pat yourself on the back, for helping to assure that these "safe and effective" public health "breakthroughs" which you have "Done very well" to see speedily approved through "Working with Industry" continue to "Reach the Public" and aren't caught up in any unnecessary, regulatory, profit impairing delays.
Then explain to us just what HEINOUS CRIME this woman committed, which allowed some FDA approved Dope Dealing Psychic to toss her VIII Amendment right out the window, and CONSIGN THIS WOMAN, to a LIVING HELL, for THE REST OF HER LIFE? But WTF difference would the VIII Amendment make; when Psychiatry - with every Writ of Execution it Exudes - violates the ENTIRE BILL OF RIGHTS?
Folks; Once You've been prescribed Psych meds, you have to go somewhere to Buy them, and keep going back there to Keep buying them, because they CURE NOTHING, except your Doktor, your DRUG CO Stockholder, and your Pharmacist's, ..... personal piles of bills.
Michael A. Friedman, Elected To Rite Aid Board Of Directors
Forbes has Dr. Mike at a total Rite Aid Comp pkg of $228,668.00
Philanthropy.com has Dr. Mike receiving $1,086,092.00 as the CEO of "City Of Hope": a Non-Profit philanthropy dealing with cancer. Maybe they could make a Profit if they weren't coughing up $1,086,092.00 for their CEO, just like every Other Non-Profit who can afford Non-Profit status once they Mooch enough $$ to hire TAX FUNDED Experts to Write up the Extremely Profitable - Because YOU pay THEIR SHARE of TAXES - Non-Profit Paperwork.
We're betting that after YOU get through Feeding & Housing & Everything Elsing Your Spouse & Kids you're feeling pretty damn Non-Profited too. TRY, .... applying for 501 C3 status just like THESE Mooches have, ..... & See how far You get, while Your taxes are being spent to make up Dr. Mike's 'City Of Hope' $1,086,092.00.
And according to NNDB, that's just the Tip of the 'Connectivity' Industrial Iceberg for Dr. Mike.
Businesswire.com has Dr. Mike joining the California Healthcare Institute Board. Here we learn that: "He helped to streamline the FDA’s review and approval process and provided oversight of evaluations for drugs, biologics, medical devices and food ingredients."
Does that mean that Dr. Mike's "help" might win AstraZeneca FDA approval of their - 8,787 lawsuits with 13,000 injured and DEAD complainants - Seroquel for treating "General Anxiety Disorder"?
And, ..... Dr. Mike has also served as the Chief Medical Officer for This illustrious group of public spirited "Health Care Breakthrough" Innovators.
Pharmaceutical Research And Manufacturers Of America
Karen L. Katen: Director
W.J. Tauzin: President & CEO
Abbott Laboratories: Member Firm
Akin, Gump, Strauss, Hauer & Feld, LLP: Lobby Firm
Amgen Inc: Member Firm
Amylin Pharmaceuticals Inc: Member Firm
Barbor Griffith & Rogers, LLC: Lobby Firm
Bayer HealthCare: Member Firm
Boehringer Ingelheim Pharmaceuticals Inc: Member Firm
Bristol-Meyers Squibb Company: Member Firm
Capitol Hill Consulting Group: Lobby Firm
Cathy Abernathy Consultants: Lobby Firm
Cauthen, Forbes & Williams: Lobby Firm
Celgene Corporation: Member Firm
Cephalon Inc: Member Firm
Cormac Group: Lobby Firm
Cornerstone Government Affairs: Lobby Group
Covington & Burling LLP: Lobby Firm
Crowell & Moring: Lobby Firm
Dailchi Sankyo: Member Firm
Davidson & Co: Lobby Firm
Dutko Worldwide: Lobby Firm
Eisai Inc: Member Firm
Eli Lilly & Co: Member Firm
EMD Serano Inc: Member Firm
Genzyme Corporation: Member Firm
GlaxoSmithKline plc: Member Firm
Hart Health Strategies: Lobby Firm
HC Associates Inc: Lobby Firm
Hoffmann LaRoche Inc: Member Firm
Johnson & Johnson: Member Firm
King & Spalding: Lobby Firm
Loeffler Group: Lobby Firm
Mattoon & Associates: Lobby Firm
McManus Group: Lobby Firm
Merck & Co: Member Firm
Mickey Ibarra & Associates: Lobby Firm
Millennium Pharmaceuticals Inc: Member Firm
Novartis Corporation: Member Firm
Otsuka America Inc: Member Firm
Ovation Pharmaceuticals Inc: Member Firm
Parven Pomper Strategies Inc: Lobby Firm
Pfizer Inc: Member Firm
Proctor & Gamble Company: Member Firm
Purdue Pharma LLP: Member Firm
Sanofi-Aventis: Member Firm
Schering-Plough Corporation: Member Firm
Sepracor Inc: Member Firm
Shook, Hardy & Bacon LLP: Lobby Firm
Sidley Austin LLP: Lobby Firm
Sigma-Tau Pharmaceuticals Inc: Member Firm
Solvay Pharmaceuticals: Member Firm
Stuntz Davis & Staffier P.C.: Lobby Firm
Takeda Pharmaceuticals America Inc: Member Firm
Tongour Simpson Holsclaw Group: Lobby Firm
Valeant Pharmaceuticals International: Member Firm
Walker Martin & Hatch LLC: Lobby Firm
Walter Consulting: Lobby Firm
Williams & Jensen: Lobby Firm
Wilmer Cutler Pickering Hale & Dore: Lobby Firm
Wyeth: Member Firm
Some Former PhRMA Pals
2008 Democratic National Convention: Party Host
Michael A. Friedman: Chief Medical Officer
William C. Weldon: Chairman
Move along folks. Nothing to see here. Everything's fine. Just go to Rite-Aid and BUY your meds: Dr. Mike's profile is under Key Execs
1 in every 5 of you are 'Incurably Mentally Ill'. (backstory) and William C. Weldon, (backstory) wants to help you, with your 'Mental Illness'. Bill is the - $31.9 Million last year - CEO of Johnson & Johnson, who own Janssen, who make Risperdal.
Now; Go watch the Tardive Dyskinesia Video, ..... and offer up a prayer for that woman who has been 'Mental Healthed' right into Hell, ..... for Drug Money.
Tuesday, October 21, 2008
On page 2 IN the PDF & page 5 in the DRAWER on the FDA PDF sidebar we find:
(Thank God we're paying these USELESS BUREAUCRATS - who can't even match up PDF page numbers - top dollar. Let's hire Another 1300 of these TAX FED, debt ballooning clowns.) NOT!
f: Sudden death, with a LINE DRAWN THROUGH IT.
Whazzup wid dat? Did the people who suddenly died come back to life, or did the FDA decide that the however many minutes this stuff took to Make Those People SUDDENLY DEAD, wasn't 'SUDDEN' enough to rate a full blown "SUDDEN DEATH"?
"Approval of this labeling by FDA is not required before its use."
Hold the phone right there.
The FDA is PAID, and believe it or not, actually Empowered, to regulate Mr. Drug Manufacturer, ON BEHALF OF, & AT THE EXPENSE OF, THE AMERICAN PEOPLE, but, ..... It looks like we know whose Ass the FDAs nose was up back in 1996.
PDF Drawer pg #9: Our USELESS BUREAUCRAT page numberer missed the page itself this time, ..... on $2.2 Billion a year. Maybe he was too busy counting up those "USER FEES" to have time for OFFICIAL U.S. GOVT. TAX FUNDED DOCUMENTS, ..... which Directly affect not only the consumers Quality of Life, but the consumer's CONTINUED LIFE itself.
"The mechanism of action of Risperdal (risperidone), as with other antipsychotic drugs, is unknown. However, it has been proposed that this drug's antipsychotic activity is mediated through a combination of dopamine type 2 (5HT1), and serotonin type 2 (5HT1) antagonism. Antagonism at receptors other than D1 and 5HT1 may explain some of the other effects of RISPERDAL."
Would those 'other effects' be, like, HOMICIDE?
PDF Drawer pg 13 has:
Neuroleptic Malignant Syndrome
"A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental state, ..... "
So, AGAIN we find these Dope Dealing Moral Retards CAUSING mental Illness, while MURDERING the 'Mentally Ill' 1st Amendment violating Nut case: who's 9 years old and bored S**tless with his non-stop FEDERALLY DICTATED school diet of Recycling, Tree Hugging, and Diversity Sensitivity inflicted on him by an Equally bored out Their skull Ozone Depletion Terrorist who is Still having trouble differentiating between the writings of Karl Marx and Thom Jefferson.
Wiki has a few words on NMS for us.
"Neuroleptic malignant syndrome (NMS) is a life-threatening neurological disorder most often caused by an adverse reaction to neuroleptic or antipsychotic drugs. It generally presents with muscle rigidity, fever, autonomic instability and cognitive changes such as delirium, and is proven on a raised creatine phosphokinase (CPK). Treatment is generally supportive.
NMS is caused almost exclusively by antipsychotics, including all types of neuroleptic medicines along with newer antipsychotic drugs. The higher the dosage, the more common the occurrence. Rapid and large increases in dosage can also trigger the development of NMS. Other drugs, environmental or psychological factors, hereditary conditions, and specific demographics may cause greater risk, but to date no conclusive evidence has been found to support this. The disorder typically develops within two weeks of the initial treatment with the drug, but may develop at any time the drug is being taken. NMS may also occur in people taking a class of drugs known as dopaminergics when the dosage is reduced (i.e. Levodopa)."
To date no conclusive EVIDENCE has been found. Just like 'To date' No skull cracker has EVER found any Mental Illness in an autopsy, until these Morally Retarded, Financially Conflicted, Ideate Savants, set to Poisoning their Victim with the product which is 100% the Cause of NMS.
Risperdal's "mechanism of action is unknown".
If the FDA Admitted that the stuff works by SLEDGEHAMMERING a BRAIN so severely that that BRAIN SUFFERS IRREVERSIBLE DAMAGE from it, the Makers would be SUED RIGHT OFF THE PLANET. And then Where would the FDA go for its continued HALF a BILLION $$ in Drug and Device manufacturer "User Fees"?
And where would Former Govt. TAX FUNDED HEALTH CARE REGULATORY OFFICIALS - like Former Surgeon General David Satcher (backstory) and Former FDA Commisioner Jane Henney (backstory) - go, if those DRUG CO. BOARDS OF DIRECTORS weren't there anymore?
What a National Tragedy THAT would Be.
Especially since we're All cursed with this Army of TAX FUNDED, Retarded, Psychiatric Poisoning Leeches out there 'Sending A Message' (read Advocating) on behalf of the 'Mentally Ill' oops: we meant to say CHEMICAL FACTORIES.; we figured Dimmu was THE GUY to 'Send' OUR Message.
Are you listening? Marty, Chuck, Allen, and Joe?
Great band. Great tune. Thanks guys.