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FDA vs. WMD - breaking news
 
from:  http://www.kirotv.com/health/4355467/detail.html?treets=sea&tml=sea_natlbreak&ts=T&tmi=sea_natlbreak_1_08340104072005
 
FDA Asks Pfizer To Remove Bextra From Market
 
POSTED: 6:22 am PDT April 7, 2005
UPDATED: 6:35 am PDT April 7, 2005

The government has asked Pfizer to withdraw the painkiller Bextra from the market because it increases the risk of heart attack and stroke.

Regulators also want all other anti-inflammatory drugs in the same class to carry the strongest safety warning possible.

The Food and Drug Administration has been studying the safety of the so-called Cox-2 inhibiters since Merck voluntarily pulled Vioxx from the market last year after heart problems were reported in some users.

Advisers to the FDA recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.

The FDA also is asking manufacturers of over-the-counter nonsteroidal anti-inflammatory drugs to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding.
 
from: http://www.kirotv.com/health/4149792/detail.html

New Data Prompts Renewed Call For Celebrex Ban

POSTED: 7:33 am EST February 1, 2005

A consumer watchdog group is renewing its call that the arthritis drug Celebrex be pulled off the market.
 
from:  http://www.citizen.org/publications/release.cfm?ID=7351
 
The FDA is once again siding with a large pharmaceutical company, in this case Pfizer, in refusing to ban the two Pfizer COX-2 selective drugs Celebrex and Bextra.
 
Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence. Breathing extra live into them is surely beneficial to Pfizer executives and stockholders but is a step backward for an agency that is supposed to be part of the Public Health Service.
 
Free e-mail alert subscription sign up for PUBLIC CITIZEN: http://www.citizen.org/
 

from: http://www.prescriptionwarning.com/004728.html

[posted 3/22/05] For full article, visit the above provided website.

With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket

Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug has reportedly killed more Americans than the entire Vietnam War is apparently not sufficient for the FDA to characterize it as unsafe.

With this decision, a "safety approval" by the FDA has now become meaningless. If the agency can put its stamp of public safety approval on a drug that has killed tens of thousands of Americans and that was removed from the market by its own manufacturer following the revelation of studies showing alarming increases in heart attack risk, then what, pray tell, could possibly be the FDA's definition of a dangerous drug?


from:  http://www.drkoop.com/newsdetail/93/524547.html
[exerpts only, visit site for full article]

Journal Commentary Labels FDA 'Timid and Toothless' 

New England Journal of Medicine article claims agency is too tied to the drug industry.

WEDNESDAY, March 16 (HealthDay News) -- The U.S.

Food and Drug Administration continues to sweat under the spotlight as a commentary in the prestigious New England Journal of Medicine accuses the agency of seeming "timid and toothless."

The article, by Dr. Susan Okie, a contributing editor to the journal, appears in the March 17 issue of the publication.

The FDA and the drugs it approves have been under scrutiny for months. Two episodes have drawn particular attention to the agency. In September, the makers of the painkiller Vioxx removed the drug from the market following the revelation it had negative effects on the heart. And there has also been criticism of the FDA's slowness in acknowledging studies linking adolescent use of antidepressants to an increased risk of suicidality.

These controversies, Okie wrote, "have raised questions about the agency's ability to fulfill one of its fundamental missions -- to ensure that the benefits of prescription drugs outweigh their risks."

But, according to the article, the FDA's problems go beyond this to include questions of post-marketing drug safety  monitoring, lack of leadership, pressure to approve new drugs quickly and dubious ties to industry.

It hasn't always been this way, she said. "Earlier, it functioned as a pretty effective regulatory agency," Okie said. "It had a much more watchdog posture vis-a-vis the pharmaceutical industry."

What changed?

Part of the problem has been leadership, or lack thereof, Okie claimed. The FDA has lacked a permanent leader for most of the time George W. Bush has been in the Oval Office, since Dr. Mark McClellan, who served from November 2002 until March 2004, was never replaced. Dr. Lester Crawford has served as acting commissioner for a total of almost three years before and after McClellan. Last month, he was nominated to fill that position permanently.

#

"You have an administration that is very pro-business, anti-regulatory, and there's been a tendency to manage all of these agencies from the top with a kind of pro-business stance," Okie said.

The Prescription Drug User Fee Act (PDUFA), which Congress passed in 1992 and which requires pharmaceutical companies to pay fees to the FDA, may also have contributed to changes. While the act was initially a response to complaints about the slowness of the FDA's approval process, many critics say it has speeded things up too much.

"PDUFA fees tie the agency to that source of revenue," Okie said. "There's more of a rush to move on things and, I think, more of a client relationship with the pharmaceutical industry."

One scientist, Elizabeth Barbehenn -- who worked for the agency for 13 years -- told Okie, "We were on the clock. We had just so much time to get a review done." Another (unnamed) scientist said that when he first joined the FDA 15 years ago, "there was an absolute emphasis on safety. It is very, very clear that the emphasis now is getting drugs approved." 

Along with the emphasis on speed came a discouraging of internal dissent. In February 2004, one medical reviewer was prevented from presenting his findings linking the use of antidepressant drugs in youth with increased suicidality, and FDA whistleblower Dr. David Graham was told to alter the conclusions of his Vioxx study.

Recently, however, there have been some signs of hope in the agency, according to Okie. One of those is the nomination of Crawford to head the agency. "If the new commissioner takes a more activist role and is allowed to take more of a leadership activist role, that could change a lot of things," she said. "A strong leader would do a lot."

Also, Graham's superiors at the FDA allowed him to present his findings on Vioxx at the FDA advisory committee hearings on cox-2 inhibitors.

#

The FDA did not respond to a request for comment. 

 

 
from: http://www.newstarget.com/004728.html
Tuesday, February 22, 2005 Commentary - Author Mike Adams

With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket

Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug has reportedly killed more Americans than the entire Vietnam War is apparently not sufficient for the FDA to characterize it as unsafe.

With this decision, a "safety approval" by the FDA has now become meaningless. If the agency can put its stamp of public safety approval on a drug that has killed tens of thousands of Americans and that was removed from the market by its own manufacturer following the revelation of studies showing alarming increases in heart attack risk, then what, pray tell, could possibly be the FDA's definition of a dangerous drug?

For the FDA to consider a drug dangerous, it apparently has to kill more than 60,000 Americans. I'm curious what threshold must be reached before the FDA actually does its job and seeks to protect the U.S. public. Do 250,000 people have to die before the FDA calls a drug unsafe? 500,000 people? How about a million people?

There can no longer be any doubt whatsoever about the FDA's true purpose. Regardless of what the agency publicly states, when it comes time to make key decisions about the safety of U.S. consumers, the FDA will side with drug companies every time. We've seen it time and time again: with the FDA's reluctance to pull obviously dangerous drugs off the market in a timely fashion (Rezulin, for example), with the FDA's attempts to silence its own drug safety scientists (censorship of Dr. David Graham, for example), and with the FDA's collusion with drug companies in suppressing clinical trials and other forms of evidence that raise safety questions about prescription drugs. Corruption runs deep at the FDA, it seems.

This decision with Vioxx and other COX-2 inhibitors was a defining moment for the U.S. Fraud and Drug Administration. It was a moment where the agency could have sided with public safety and held fast to a position of responsibility and ethics. Instead, it chose to favor drug company profits and put its stamp of approval on a class of drugs that is arguably the most deadly drugs ever to hit the open market.

A sane, ethical FDA would have not only banned COX-2 inhibitors outright, it would have put an end to direct-to-consumer advertising that ultimately led to the over-hyping and over-prescribing of these painkillers in the first place. Most people taking COX-2 inhibitors don't even need them. They would be better off with simple over-the-counter painkillers or, better yet, natural health treatments like nutrition, herbal remedies and supplements that work far better than prescription drugs for stopping arthritis pain (and without all the negative side effects). Astaxanthin supplements, for one, greatly ease arthritis pain. So do whole food concentrates made from cherries, blackberries and other fruits. There are dozens of other natural health strategies that ease pain as well.

To pull off this public charade of a serious meeting about COX-2 inhibitors, meeting organizers paraded a line of pain victims in front of FDA panelists and got them to beg for the availability of COX-2 inhibitors. The implied message was, "If we can't have Vioxx, we'll suffer!" What this faulty argument fails to mention is the whole universe of alternative treatments, healing foods and natural health therapies that end arthritis pain at least as well as prescription drugs. Nowhere was there a discussion of other choices these patients might make to treat their pain. Instead, it was a fool's choice: Vioxx or nothing.

And thus the whole FDA panel meeting was a sham. It was contrived from the start and designed to do one thing: to give the panel justification to reinstate Vioxx and avoid banning COX-2 inhibitors as a class of drugs. This, in turn, would dramatically boost stock prices of drug companies and keep the drug profit machine churning away for years to come. (I wouldn't be surprised if the vast majority of the people on the FDA advisory panel, by the way, own stock in the very drug companies impacted by this decision.)

It was brilliant theater, but bad medicine. And with this decision, whatever credibility the FDA thought it had remaining has now evaporated. The agency is suddenly the laughing stock of the world. It has taken what many consider to be the most dangerous class of prescription drugs ever introduced and rubber stamped the whole class with the label of "FDA approved."

The very label of "FDA approved" is now synonymous with "Poison." It sort of makes you wonder about all the other drugs the agency has approved, doesn't it? The agency sure has a funny way of defining "safe."

And if you, like many Americans, were holding out in the hopes that the FDA would, for once, do the right thing and protect the American public, you now realize that the agency is so blatantly corrupt that only radical, wholesale reform will ever restore any sense of credibility.

There is an abundance of evidence available right now, published in peer-reviewed medical journals like the British Medical Journal, showing COX-2 inhibitors to be deadly drugs. That's not to mention the internal drug company memos and emails leaked to the press that directly acknowledge the dangers of these drugs. No reasonable person can argue that these drugs are not dangerous. Yet the FDA will no doubt claim there's not enough evidence to show COX-2 inhibitors are dangerous enough to ban them.

I find this fascinating. When the FDA is attacking herbs and nutritional supplements, they will claim there's not enough evidence to prove they are safe. But when it comes to prescription drugs, the agency says there's not enough evidence to prove they're dangerous. All drugs approved by the FDA, it seems, are deemed safe until proven deadly. And even when proven deadly, they apparently aren't deadly enough to warrant banning them.

The FDA is now so clearly the regulatory puppet of Big Pharma that it has proven itself unable to reform from within. It's time for the U.S. public and its legislative representatives to revoke the power of authority over drug safety that has been granted to the FDA in monopoly fashion. It's time to put the power of drug safety into the hands of people who actually care about safety, not those who benefit from drug sales. And it's time to end the oppressive, Dark Ages reign of the U.S. Fraud and Drug Administration which is not only complicit in the deaths of literally hundreds of thousands of Americans, but which seems determined to continue its campaign of power and corruption, no matter what the cost in the American lives.

Dr. Sidney Wolfe (PublicCitizen.org) was right all along. I say we team Dr. Wolfe with Dr. Graham and let them run the FDA. They can start by firing all the bureaucrats that landed us in this drug safety mess in the first place.


from: http://www.newstarget.com/002330.html
Friday, March 04, 2005 Commentary  - Author, Mike Adams

One in ten hospital patients harmed by preventable medical mistakes

This is the latest from the World Health Organization: preventable medical mistakes harm 10% of hospital patients. That's on top of the 100,000+ people who are actually killed each year by the use of prescription drugs according to the Journal of the American Medical Association. Dr. Gary Null's Death By Medicine study puts the total annual number of deaths caused in the United States by conventional medicine at around 750,000.

It's difficult to fully appreciate the magnitude of this problem until you realize that if, indeed, 750,000 people are killed each year by prescription drugs and conventional medical doctors, then modern health care is the leading cause of death in the United States, killing more people than even cancer.
News summary:
Source:
http://abcnews.go.com/Health/wireStory?id=203020


from: http://www.newstarget.com/005138.html
Friday, March 04, 2005 Commentary - Author, Mike Adams

Investigators recommend dead bodies be implanted with chips to stop cadaver trade

In investigation into the sale and distribution of cadavers and parts of cadavers at UCLA has recommended that bodies and body parts be implanted with identification chips. These radio-frequency identification (RFID) chips will allow investigators to determine where the bodies and their parts came from. Since the trade of human cadavers and cadaver parts is illegal, investigators are keen to prevent this sort of commercial venture. If you enjoy this article, you may also be interested in an article entitled 'Acomplia drug hype reveals mythology of prescription drugs, shortcut philosophy of American culture.'
News summary:
Source:
http://www.livescience.com/scienceoffiction/technovel_organs_050215.html



 


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