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"I detest the man who hides one thing in the depths of his heart and speaks forth another"
-Homer  


ARTICLE #1

from: http://www.forbes.com/feeds/ap/2004/10/15/ap1592625.html 

Associated Press
Update 1: Pfizer to Study Arthritis Drug More
10.15.2004, 09:29 AM

In light of the increased focus on alternative treatment options for people with arthritis, Pfizer Inc. plans to conduct further studies to confirm the long-term cardiovascular safety profile of its anti-inflammatory drug Bextra.

The announcement comes just two weeks after Merck & Co. withdrew its blockbuster arthritis pain drug Vioxx, a high-margin product that had accounted for almost 20 percent of its profit, because of an increased risk of heart attacks and stroke.

Pfizer's Bextra, which was introduced in the United States in 2001, is indicated for the relief of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea, or painful menstrual cramps.

Since 2002, Bextra's label has included information regarding the risk of a very rare but serious skin reaction. Pfizer said this risk also exists with many other medications.

The risk exists with Bextra primarily within the first two weeks of therapy and, while very rare, it occurs at a reported rate greater than similar products such as arthritis drug Celebrex. Pfizer said it is working with regulatory authorities to update the Bextra product label.


Immediately following Merck's announcement last month about Vioxx, Pfizer said it was "confident in the long-term cardiovascular safety" of Celebrex.

Pfizer also reviewed trial data about the cardiovascular profile of Bextra. Available clinical information for Bextra suggests there is no increased risk of cardiovascular thromboembolic events, or blood clots, in people treated for osteoarthritis and rheumatoid arthritis, Pfizer said.

In addition, Bextra has been studied in several surgical settings. In studies in general surgery, Bextra in combination with the investigational drug parecoxib showed no increased risk of cardiovascular thromboembolic events. However, in two trials in a high-risk surgery known as coronary artery bypass graft, an increase in cardiovascular events was observed in patients receiving Bextra alone or in combination with parecoxib, the company said.

Bextra is not approved for use in any surgical setting in the United States.

New York-based pharmaceuticals giant Pfizer earned almost $4 billion on sales of $45 billion in 2003.

ARTICLE #2

For the full article from: http://www.nj.com/business/ledger/index.ssf?/base/business-0/109816748319500.xml

Drug makers' trials and troubles

Merck and Pfizer do damage control in wake of Vioxx recall
Tuesday, October 19, 2004
BY DAVID SCHWAB
Star-Ledger Staff

Asked last night whether doctors should avoid prescribing other arthritis pain medicines similar to Vioxx, Janet Woodcock, acting deputy commissioner for operations of the Food and Drug Administration responded: "Clinicians have to evaluate the data and make benefit/risk decision for patients."

The FDA has said it is unclear whether other drugs like Vioxx could pose similar dangers and said it will be looking for additional long-term studies. [these 'studies' are being done on YOU, without your knowledge or permission.]

David Schwab can be reached at dschwab@starledger.com or (973) 392-5835.


ARTICLE #3
from:  http://www.nationaljusticeleague.com/press_release_4-06-04.htm [for the full article]
 
PRESS RELEASE - APRIL 06, 2004

NATIONAL JUSTICE LEAGUE
2205 Hilltop Drive - Suite 2022
Redding CA 96002
PRESS RELEASE - April 06, 2004
Phone: 530-248-3483
Fax: 530-248-3483
Email:
info@nationaljusticeleague.com
Website: http://www.nationaljusticeleague.com

SACRAMENTO-- April 6th, Lawsuits were filed in three separate California courts against twelve companies who either produce or use the artificial sweetener aspartame as a sugar substitute in their products. The suits were filed in Shasta, Sonoma and Butte County, California.

The suits allege that the food companies committed fraud and breach of warranty by marketing products to the public such as diet Coke, diet Pepsi, sugar free gum, Flintstone's vitamins, yogurt and children's aspirin with the full knowledge that aspartame, the sweetener in them, is neurotoxic.

Aspartame is a drug masquerading as an additive. It interacts with other drugs, has a synergistic and additive effect with MSG, and is a chemical hyper-sensitization agent. As far back as 1970, Dr. John Olney founded the field of neuroscience called excitotoxicity when he did studies on aspartic acid, which makes up 40% of aspartame, and found it caused lesions in the brains of mice. He made world news on the aspartame/brain tumor connection in l996. Dr. Ralph Walton, Professor and Chairman of the Department of Psychiatry, Northeastern Ohio Universities College of Medicine has written of the behavioral and psychiatric problems triggered by aspartame-caused depletion of serotonin.

Aspartame causes headache, memory loss, seizures, vision loss, coma and cancer. It worsens or mimics the symptoms of such diseases and conditions as fibromyalgia, MS, lupus, ADD, diabetes, Alzheimer's, chronic fatigue and depression.

Aspartame liberates free methyl alcohol. The resulting chronic methanol poisoning affects the dopamine system of the brain causing addiction. Methanol, or wood alcohol, constitutes one-third of the aspartame molecule and is classified as a severe metabolic poison and narcotic.

Recent news is full of reports of world-class athletes and other healthy consumers of aspartame suddenly dropping dead. Sudden death can occur from aspartame use because it damages the cardiac conduction system.


ARTICLE #4

from:  http://www.sltrib.com/utah/ci_2434365
Lawsuit blames Zoloft for teenager's suicide
By Pamela Manson
The Salt Lake Tribune - 10/27/04
 
A South Jordan couple on Tuesday accused pharmaceutical giant Pfizer Inc. of negligence in their daughter's "tragic, maddening, wrongful death" for allegedly failing to warn doctors of a link between its antidepressant Zoloft and teenage suicide.
   
In a suit filed in U.S. District Court, the parents of Shyra Marie Kallas say the 15-year-old shot herself in November 2002, less than a month after her family physician prescribed the antidepressant.
   
The girl originally went to see the doctor for warts but said, as part of her patient history, that she felt overwhelmed with school work, according to Ken and Angela Kallas' suit.
"Her doctor then did precisely what Pfizer's salesmen regularly encourage doctors to do, i.e., he (a) diagnosed 'depression' and (b) prescribed Zoloft," claims the suit, which seeks unspecified damages.
   
The legal action alleges Pfizer knew of an association between Zoloft and side effects that increase the risk for suicide. However, it claims, the company continued to overpromote the medication and misled the public about the risk, touting Zoloft as the "number one doctor-trusted antidepressant."
   
Pfizer representatives could not be reached for comment Tuesday.  In its 2004 third-quarter performance report released last week, the New York City-based company said, "Zoloft is not approved for pediatric depression. In fact, there have been no suicides in the Zoloft pediatric clinical program.
"Pfizer remains confident in the proven safety and efficacy of Zoloft to treat millions of patients with mood and anxiety disorders."
 
In an Oct. 15 advisory, the Food and Drug Administration said all antidepressants will now carry labels that include a boxed warning about the increased risk of suicide they pose to children and adolescents.
Shyra was described in her obituary as a star athlete who loved art, nature and camping with her family.
   

ARTICLE #5

From: http://www.kpho.com/Global/story.asp?S=2553717&nav=23KuT1nD

NEWARK, N.J. (AP) -- Reputed street gang members, organized crime associates and at least two pharmacists were arrested Thursday, accused of being part of a ring that sold the powerful painkiller OxyContin in the Boston area, authorities said.

The ring operated from Arizona to Boston, and was based in New Jersey, said Robert O'Leary, a Union County prosecutor.

Authorities were still carrying out search and arrest warrants Thursday morning, and planned to release additional details later in the day.

At least two pharmacists, two members of the Bloods street gang and "two known organized crime associates" had been arrested by midmorning, Union County Prosecutor Theodore Romankow said.

"This case is highly unique in that it involves traditional organized crime figures, street gangs and pharmacists selling OxyContin in huge quantities over the counter," O'Leary said. "They were all making megabucks doing this.

"The OxyContin wound up in the greater Boston area, where it wound up on the street," he said.

OxyContin was initially hailed as a breakthrough in the treatment of severe chronic pain when it was introduced in 1996. The drug has become a problem in recent years, however, after drug abusers discovered that crushing the time-release tablets and snorting or injecting the powder yields an immediate, heroin-like high.

The drug has been implicated in more than 100 overdose deaths nationwide.

Prescription painkillers such as OxyContin now rank second to marijuana as the most-abused drugs in the country, according to the Substance Abuse and Mental Health Administration.
 
 
   (Copyright 2004 by The Associated Press.  All Rights Reserved.) 11.11.04


ARTICLE #6

World / US from: http://news.ft.com/cms/s/addaa248-3388-11d9-b6c3-00000e2511c8.html

 

Pfizer chief urges new consensus on healthcare
By Christopher Bowe in New York
Published: November 11 2004 02:00 | Last updated: November 11 2004 02:00

The US urgently needs a national debate on healthcare following the re- election of President George W. Bush, according to Hank McKinnell, a leading figure in the industry.

A bipartisan commission should be formed to take a broad look at how treatment is provided, and its costs to patients and companies, the chief executive of Pfizer, the world's largest drugmaker, said in an interview.

"People are so angry and frustrated that they are reaching out to all sorts of wacky ideas," Mr McKinnell said. "We need some way to reach a national consensus here."

His comments came as Pfizer detailed savings of $41.9m (32m, 22m) over two years from an experimental programme in Florida designed to show that preventive medicines and improved patient management can reduce illness and expensive hospital stays.

The preventive value of medicines is drugmakers' rallying cry to counter intensely negative public perception of excessive charges. Pfizer is gauging interest in similar programmes with large manufacturers burdened by heavy retiree health costs, as well as with several European countries.

Mr Bush's re-election is seen as favourable to the pharmaceuticals industry. The administration wants to keep government out of pricing drugs and backs running a new subsidised prescription drug plan in Medicare, a federal health programme for the elderly, using private insurers.

John Kerry, Mr Bush's defeated Democratic opponent, proposed allowing government to use its buying power to push prices lower.

Nevertheless, Medicare is facing insolvency in the coming decades as the first of a wave of baby boomers retires. The drug benefit alone is expected to cost $500bn by 2013, during which time federal budgetary deficits are expected to increase. Because of that, a Bush administration focused simply on implementing the Medicare drug benefit would leave the industry open to attack for rising drugs and healthcare costs in the near future, not least by the government itself.

"We need to take a more forward approach to healthcare, while the administration is satisfied with Medicare . . . It's too early to declare success," Mr McKinnell said. "We've got a two-year window for legislation."

One possible leader for a commission to seek national consensus on the proper course for drug and healthcare spending could be John Breaux, a Democratic senator from Louisiana who is soon to leave the Senate.

Mr McKinnell is confident a US consensus would not form around nationalised healthcare or government-controlled pharmaceutical prices. "I think right is on our side," he said.

Pfizer's Florida plan is a test of this thinking. Audited results of 150,000 of 2.1m impoverished patients on state medical aid showed better patient management and medicine use could prevent long-term problems. Pfizer's programme, which guaranteed savings in exchange for fewer price concessions, has been extended to September 2005. But the state has said it would demand drug price discounts whether the programme continued or not.

Pfizer is seeking similar programmes in Germany, Italy and Sweden. Political acceptance in Europe could prove even more difficult as Pfizer has taken an aggressive stand in German price controls, refusing to cut prices for cholesterol drug Lipitor. It has a pilot effort in the UK.

 


ARTICLE #7

Date:  11/06/04
IN BRIEF / PHARMACEUTICALS
 
Pfizer Discloses 2 State Probes
 
Pfizer Inc., the world's largest drug maker, said New York Atty. Gen. Eliot Spitzer requested information about the promotion of some of its drugs for unapproved uses.

Pfizer said Connecticut Atty. Gen. Richard Blumenthal also requested materials on so-called off-label promotion of its Zoloft antidepressant. The company disclosed the probes in a regulatory filing.

Doctors sometimes prescribe medications for applications that haven't been approved by regulators. Although such use is legal, promotion of drugs for off-label use isn't.

Shares of Pfizer declined 27 cents to $28.79 on the NYSE.

ARTICLE #8

from: http://www.newmediaexplorer.org/sepp/index.htm

Date: November 06, 2004

CDC, Media Hype The Flu - Facts Show Different Picture

Vaccine maker Chiron had their license suspended and a year's worth of flu vaccines produced in a British factory was not approved for sale in the US - contamination problems. The media treated us to stories of seniors standing in line for hours to "get the flu shot". What they did not say was that the flu is nowhere near as dangerous as they told us previously. Who has not heard of the "36,000 flu related deaths" every year that were brought to our attention every time it was time to "get the shot"?

Well, it appears that these deaths were so much scare mongering, arguably planted in the media to make people bare their arms for the poison needle. Thimerosal, a mercury containing preservative, which is part of most vaccines, is poisonous by any standard. Unfortunately the Centers for Disease Control and the Food and Drug Administration are denying that this neurotoxic heavy metal has anything to do with the autism epidemic that is sweeping the countries where vaccines are most heavily promoted.

So maybe it was a good thing that half of the US flu vaccine went missing this year? Quite possibly so, says Jon Rappoport who followed developments and published what he found on his excellent site nomorefakenews.com You can find his articles on what he calls the flu scam here.

Now that US elections are over, we can expect more hype from the media. But certainly the facts do not add up to that great urgency to go down and "get your shot immediately". Tommy Cichanowski of The Tortoise Shell Life Science Puzzle Box has forwarded a message with some of the facts we should know - the information was compiled by Frank Hartman.


ARTICLE #9

From: http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=6818262
Date: 11/15/04
 
FDA: Won't Change System Post-Vioxx
Mon Nov 15, 2004 03:20 PM ET
By Lisa Richwine and Susan Heavey

NEW YORK (Reuters) - U.S. health regulators see no need to tighten government safety standards despite the withdrawal of Merck & Co. Inc.'s arthritis drug Vioxx, a top Food and Drug Administration official told Reuters on Monday, saying current safeguards were working. [NOTE: be advised that FDA "approval" is NOT a guarantee of safety]

Dr. Janet Woodcock, the FDA's acting deputy commissioner for operations, said the Vioxx recall was an isolated case and did not signal problems with the agency's safety monitoring or a cozy relationship with drug makers, as some critics have charged.

"I don't think (Vioxx) teaches us a lot about other drug classes or raises alarms about the entire system," Woodcock said at the Reuters Health Summit.

Merck withdrew Vioxx in September after a study showed the painkiller doubled the chances of heart attacks and strokes. Signs of heart problems had been mounting for years, but Merck said earlier trials did not provide clear evidence of danger.

The FDA concurred but asked Merck to further explore possible side effects, Woodcock said.

Lawmakers and other critics say the FDA was too lax in monitoring Vioxx as well as antidepressants, which recently were shown to raise the risks of suicidal behavior in children and teenagers.

Woodcock said both cases showed "the whole system is working."

In the case of Vioxx, she said the FDA asked Merck to study the drug's risks. An FDA reviewer was the first to spot a possible link between suicidal behavior and the depression drugs, Woodcock said.

"We have safety standards for each class of drugs, and we should continue those," Woodcock added. ["safety standards" equals statistically insignificant deaths/damage]

The FDA is taking a closer look at drugs like Vioxx in a class of medicines called COX-2 inhibitors. The agency also has ordered an external review of the way it monitors the safety of medicines after they hit the market.

A Senate hearing on Thursday will further examine the FDA's handling of Vioxx, including charges that top officials pressured an FDA reviewer to soften his concerns about Vioxx's hazards.

Woodcock said the FDA does not suppress its reviewers' findings, but it does aim to give the public a consistent message. "We completely dispute the idea that there's any suppression of reviewers," she said. [the consistent message is "keep buying/using the drugs"]

Officials have realized the public wants "more information, even though it might be preliminary," Woodcock said. Legal restrictions often prevent the FDA from releasing confidential information, she said. [it's absolutely none of my business why or how I die]

But companies could register their clinical trials and post the results on a public database, she said. That would also allow the FDA to speak freely about the data, if the company made it public sooner, Woodcock added.

 


 
 
 

May my beloved partner ROMI rest in peace  - no matter wherever her bits and pieces/frozen carcass may be held hostage.

                         

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