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October 07, 2004

Vioxx: 'Inflammation' Spreads - Other Similar Drugs To Be Investigated

Merck & Co has decided to pull its blockbuster arthritis and acute pain drug Vioxx, after evidence of an increased risk of heart attacks built up to levels that could not be contained any more. Patients and doctors are being warned to discontinue use and return unsold stocks of the drug.

The recall was reported on September 30, but the plot now seems to thicken. According to an AP story on yahoo news, scientists in Britain and the United States are calling for a review of a whole class of similar drugs that may have the same devastating effect on heart health.

Apparently, there had been plenty of warning signs on the side effect for years, but the FDA allowed Merck to gloss over them and continue heavy direct-to-consumer advertising, allowing the drug to turn into a billion-dollar seller, damaging heart health in the process.

The European Medicines Agency in London announced Wednesday it would review all drugs of this type in the wake of Merck & Co.'s decision to voluntarily withdraw Vioxx. Pfizer's Bextra, another best selling pain drug, is next in line, according to recent reports (see links at end of article).

Reports: Other Drugs May Raise Heart Risks

Original at Yahoo! Health - AP


Scientists in the United States and Great Britain are calling for a fresh look at Celebrex and other medications similar to Vioxx, the heavily advertised arthritis drug pulled from the market last week after a study suggested it doubled the risk of heart attacks and strokes.

The European Medicines Agency in London announced Wednesday it would review all drugs of this type in the wake of Merck & Co.'s decision to voluntarily withdraw Vioxx.

In the United States, a cardiologist who had researched these drugs published an article in the New England Journal of Medicine (news - web sites) suggesting problems might extend to the entire class of medications, not just Vioxx. Another prominent doctor writing in the same journal charged that the Food and Drug Administration did not do everything needed to make sure the drug was safe. He also called for a congressional review of the matter.

An FDA spokeswoman said the agency had no comment. Last week, FDA officials said problems were limited to Vioxx.

Pfizer, which makes Celebrex and a newer, similar drug called Bextra, disputed the medical journal reports and said its drugs are safe.

"The proof is really in the real-world data, and it hasn't been borne out," Pfizer's medical director, Dr. Gail Cawkwell, said of the heart problem risk.

The medical journal published two reports on the issue Wednesday on the Internet - more than two weeks ahead of their planned print publication - to help inform doctors and patients considering whether to stop using the drugs.

Studies done five years ago when Celebrex and Merck & Co.'s Vioxx were approved suggest the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist. FitzGerald led the studies, which were designed by him but funded by the drug companies.

"I've been concerned all along," he said. "I believe this is a class effect," not just a problem with Vioxx, he said.

Cawkwell of Pfizer called his contention "an interesting theory," but said, "there is no evidence" of increased risk of heart problems among the 75 million Americans who have taken Celebrex. Long-term studies are not yet available on Bextra, which was approved in 2001.

Celebrex is the 10th most popular drug in the United States, with annual sales of $2.7 billion, up 5 percent in a year, according to IMS Health, a company that tracks drug industry trends.

An article in the medical journal by Dr. Eric Topol of the Cleveland Clinic chastised the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when hints of them first appeared years ago, and for allowing the company to blitz consumers with TV ads touting the drug.

Vioxx was the largest prescription drug withdrawal in history, "but had the many warning signs along the way been heeded, such a debacle could have been prevented," Topol wrote. "Neither Merck nor the FDA fulfilled its responsibilities to the public...I believe there should be a full Congressional review of this case."

Merck and FDA officials said the mechanism underlying the problem with Vioxx wasn't known.

But FitzGerald and colleagues published two studies in 1999 and another in 2001 suggesting that by selectively blocking one of the two substances called prostaglandins that lead to inflammation, these so-called cox-2 inhibitors were sparing the stomach at the expense of the heart.

"There's a good prostaglandin and a bad prostaglandin as far as the heart is concerned," he explained.

Suppressing both, as older painkillers like aspirin and other non-steroidal anti-inflammatory drugs, or NSAIDS do, helps the heart. But shutting down just the "good" one raises the risk of high blood pressure, hardening of the arteries and clotting, he reports.

FitzGerald also challenged Pfizer's contention that no science shows increased risk from Celebrex. The original report from one study involving Celebrex found no increased risk of heart problems, but it covered only six months of a year-long study, according to the cardiologist. A look at the full data "reveals signs of increased cardiovascular risk," he writes.

The medical journal will publish the new reports in its Oct. 21 print edition.

Republican Congressman Tom Davis of Virginia, who chairs the House Government Reform Committee, has sent a letter to FDA's acting commissioner, Dr. Lester Crawford, giving him two weeks to answer questions about how FDA tracks problems with drug safety, how it dealt with issues surrounding Vioxx, and whether the agency will study potential risks in similar drugs.

"In light of Merck's withdrawal of Vioxx from the market and other recent news stories examining FDA's review of the safety and efficacy of antidepressant drug use by children, I am concerned whether FDA has been sufficiently aggressive in monitoring drug safety," Davis wrote.


Associated Press writer Linda A. Johnson in Trenton contributed to this report.

See also related:

Merck now under criminal investigation by the Justice Department for Vioxx scandal

The Vioxx scandal: damning Senate testimony reveals drug company, government complicity
Several scientists testifying before the Senate Finance Committee on November 17 provided substantial evidence that the drug company Merck and the US Food and Drug Administration (FDA) knew of safety problems years before the drug Vioxx was withdrawn from the market.

New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks
The incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos, according to preliminary results of a study presented yesterday at the American Heart Association meeting in New Orleans.

Arthritis drug warnings 'ignored'
Vioxx was linked to heart problems - the arthritis drug should have been taken off the market years before it was finally withdrawn, say researchers.

After Vioxx: Pfizer's Bextra Found To Increase Heart Attacks
New York Times - Pfizer Warns of Risks From Its Painkiller
Pfizer warned doctors yesterday that one of its best-selling painkillers, Bextra, might increase the risk of heart attack or stroke in coronary artery bypass surgery patients. The announcement comes just two weeks after Merck removed from the market its painkiller, Vioxx, which is in the same class of medicines as Bextra, because a study showed that the risk of heart attacks doubled for patients who had taken Vioxx 18 months or longer. Pfizer said a clinical study involving more than 1,500 patients showed that those who had undergone bypass surgery and had taken Bextra intravenously and orally were at higher risk for heart attacks.

FDA Official Alleges Pressure to Suppress Vioxx Findings
By Marc Kaufman, Washington Post Staff Writer - Friday, October 8, 2004
A Food and Drug Administration official who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen. Charles Grassley (R-Iowa).

FDA silenced expert who raised concerns about Vioxx: U.S. Senator
WASHINGTON (AP) - The U.S. Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the U.S. Senate finance committee said Thursday.

Good Riddance to a Bad Drug
New York Times - By ERIC J. TOPOL

After Vioxx Recall, Other Drugs Under the Microscope

Before Recall, Vioxx Approved for Kids!

Now Experts Are Saying Celebrex Is Also a Problem

Bextra: Study finds risk with Pfizer drug
By Gardiner Harris The New York Times - Thursday, November 11, 2004
Patients who had been given the Pfizer painkiller Bextra had more than twice as many heart attacks and strokes as those given placebos, according to preliminary results of a study presented at an American Heart Association meeting in New Orleans

Report: Bextra heart risks similar to Vioxx
Study shows arthritis drug has high incidence of attacks, stroke

Arthritis drug Bextra found to promote heart attacks and strokes

Arthritis drug adds warning label - By Rita Rubin, USA TODAY
WASHINGTON The government is warning of potential heart problems associated with the use of the painkiller Bextra in people who have recently had heart bypass surgery. The Food and Drug Administration said Thursday it is adding the warning to the labels of Bextra, as well as strengthening the label warnings that there is the possibility of severe skin reactions with the drug.

How did Vioxx debacle happen? - By Rita Rubin, USA TODAY

Forbes: Merck Faces Huge Fallout Over Vioxx Suits
Already wounded by the withdrawal of its Vioxx pain reliever from the market, Merck & Co. must now contend with hundreds of lawsuits over the drug's side effects - lawsuits that threaten to further damage the company's finances and reputation.

JAMA Proposes Independent Drug Safety Board

Forbes Magazine: Face Of The Year: David Graham

Pfizer's Celebrex could have a problem

All Celebrex Ads Ruled "Misleading"

HMO Bans Pfizer's Cox-2 Inhibitor Bextra
January 30, 2005 - The largest HMO in the United States has banned the dispensing of the arthritis painkiller Bextra made by Pfizer, because it could possibly up the risk of heart attacks and strokes in some patients. It's the first time Kaiser Permanente has banned the use of a drug approved by the US Food and Drug Administration.

Pfizer Says 1999 Trials Revealed Risks With Celebrex
New York Times - February 1, 2005: Celebrex, the popular arthritis and pain medicine from Pfizer, sustained another blow yesterday when the company acknowledged that a 1999 clinical trial found that elderly patients taking the drug were far more likely to suffer heart problems than patients taking a placebo.

Cardiologist to testify at FDA hearing: Animal tests implicated in Vioxx tragedy
On February 17, John J. Pippin, M.D., FA.C.C., will testify before Food and Drug Administration (FDA) officials and present a new report detailing how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs. Dr. Pippin will represent the nonprofit Physicians Committee for Responsible Medicine (PCRM).

Pfizer takes painkiller Bextra off market, FDA wants warnings on others
Thursday, April 7, 2005 - BY CONNIE CASS - ASSOCIATED PRESS
WASHINGTON - The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.

Doctors Sue Merck Over Vioxx Animal Tests
WASHINGTON, 14 July 2005 In a lawsuit to be filed this week, the Physicians Committee for Responsible Medicine (PCRM) and plaintiff Nancy Tufford allege that Merck wrongfully relied on animal tests that showed Vioxx to be safe while setting aside mounting evidence that Vioxx increases risk of cardiac events in human patients. PCRM has obtained previously undisclosed Merck data that form one of the cornerstones of the legal challenge.

August 2005: First Vioxx Verdict A Big Defeat For Merck

The Boston Globe: Lessons from Vioxx
December 19, 2005
MERCK PHARMACEUTICAL company took the pain reliever Vioxx off the market more than a year ago, after a clinical study found that it caused heart attacks. And now instead of helping people with chronic pain, it is the subject of thousands of lawsuits contending that it helped to kill them. The drug might be doing some good in limited use today, if only the Food and Drug Administration had slowed the approval process enough for the data about danger to catch up with the marketing hype...

March 2007: Merck loses key US Vioxx lawsuit
The jury awarded $18m to Frederick Humeston, who suffered a heart attack after taking Vioxx for knee pain, and a further $2m to his wife. This was the second case brought by Mr Humeston after an earlier suit failed. Fresh evidence on the dangers of Vioxx prompted the new trial. The jury in the second case found that Merck had failed to provide adequate warnings about the health risks associated with Vioxx.

Vioxx Caused Heart Attacks In Two Weeks!
This is one study many people have been waiting three years to see - except Merck people. Known as Victor, the study suggests that increased heart risks associated with Vioxx began immediately after people took the painkiller. That contradicts Merck's assertion, since it withdrew Vioxx in September 2004, that the drug caused serious heart risks only after 18 months of use.


posted by Sepp Hasslberger on Thursday October 7 2004
updated on Friday December 10 2010

URL of this article:


Related Articles

Furberg Says Bextra Similar to Vioxx - Fired From FDA Panel
According to a piece in the Wall Street Journal, Curt D. Furberg, a professor at Wake Forest University in Winston-Salem, North Carolina, was removed from an FDA panel reviewing the safety of COX-2 inhibitors. These are drugs of the same class as the recently withdrawn painkiller Vioxx, which was found to be causing tens of thousands of heart attacks. Furberg looked at the data and found similarities between Vioxx and... [read more]
November 13, 2004 - Sepp Hasslberger

FDA Shenanigans
FDA Shenanigans ..."Of course, what we're witnessing in all of this is some of the most cynical cronyism you can imagine. Congressmen, regulators, and lobbyists accommodate one another as they please, but when it comes to the needs of citizens, or cities and states struggling in the current economic climate, we're given restrictions and left to our own devices. A couple of centuries ago a certain tea party in Boston... [read more]
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Neurontin Suicides: FDA Still Turning A Deaf Ear Charges Rep Hinchey
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US Health System Needs Radical Overhaul: New York Times
25 October 2004 - In last Sunday's New York Times, editors Donald Barlett and James Steele called for a radical overhaul of the US health system. While the calamitous failure of pharmaceutical suppliers to come up with a sufficient quantity of flu vaccine provides the immediate backdrop for the article, the discussion goes much deeper. It is really about why the US health system has dismally failed to deliver on... [read more]
October 25, 2004 - Sepp Hasslberger

Paxil, Zoloft, Xantax - Drug Induced Violence
23 August 2004 - The New York Times reports on the Murder case of Christopher Pittman coming up for trial. The 12-year-old has shot his grandparents and put their house on fire, but he says it was the effect of the drug he was on at the time - the antidepressant Zoloft. The case comes amid widespread allegations that antidepressant drugs cause many to commit suicide, a charge hotly denied... [read more]
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FDA Covers Up Report - Mosholder: 'Antidepressants Double Suicides in Children'
According to a recent article published in the British Medical Journal, a scientific report by one of its researchers, Dr. Andrew Mosholder, showing that antidepressant drugs double the suicide rate in children taking them, was suppressed by the FDA. Instead of owning up to its mistake and issuing generalized warnings, the agency has launched a criminal investigation to find out which employees leaked Dr. Mosholder's report. Apart from the FDA's... [read more]
August 12, 2004 - Sepp Hasslberger




Readers' Comments

A recent article commenting the Vioxx drug recall from WC Douglass, received through the Alternative Medicine Forum:

From: "WC Douglass"

Subject: Pulling the wool
Date: Tue, 12 Oct 2004 09:21:09 -0400

Daily Dose

Tuesday October 12, 2004


The silent treatment, part one

Just last week, I told you about Merck & Co.'s "voluntary" yanking of the blockbuster arthritis drug Vioxx from pharmacy shelves because an ongoing clinical trail (studying a currently UNAPPROVED use of the drug, by the way) indicated the medication posed an increased risk for heart attack and stroke among long-term users.

One thing about the story I found curious was that the Food and Drug Administration was seemingly nowhere to be seen in the press reports. Usually, drug-makers pull a pill from the market only after pressure from the FDA - which only tends to happen after a lot of people die or a lot of doctors get their pants sued off. But the stories in Reuters, the AP and others mentioned little, if anything, about the FDA's position. So where was the FDA on the Vioxx issue?

They were covering up for it.

According to an October 8th Associated Press story, the FDA silenced one of their top experts, Dr. David Graham, who raised concerns about Vioxx's safety WEEKS BEFORE Merck yanked the drug from shelves. Testifying before a panel of Senate investigators just days ago, the doctor told of intense pressure, exclusion and intimidation, even thinly-veiled threats by his colleagues at the FDA for raising a red flag about the drug's safety. He further testified to the generally hostile environment at that government agency with regard to ANY evidence of drug safety issues.

Graham, the architect of a 40,000+ patient research project on arthritis medications, concluded well before Merck halted its Vioxx trial that high doses of Vioxx over long periods tripled the risk of heart attack and sudden cardiac events. He was scheduled to present his findings at a conference in late August, but when the FDA reviewed the synopsis of his presentation, they put the kibosh on it!

Hmm. A 20-year veteran FDA expert sounds an alarm about a popular prescription drug and gets gagged by his superiors. Days later, the Senate launches an investigation with the expert as a key witness. Meanwhile, the manufacturer "voluntarily" pulls the drug, citing its own research and good conscience...

Pretty slick, huh? Merck probably smelled a brouhaha coming in the mainstream media when Graham's testimony became public knowledge, so they positioned themselves as not only the source of the information, but also the solution. I wonder: Did the FDA have a hand in formulating this strategy? A fringe benefit of Merck's highly public handling of the situation would have been that it takes some of the accountability pressure off the agency.

As scary as all of this is, it isn't the only instance of the FDA sweeping drug safety findings under the rug in recent history. Next Dose, I'll tell you how these bureaucratic bullies smothered another expert whose testimony could've saved the lives of God-knows-how-many young Americans.

First, though, more news on the arthritis drug front...


A bad week for arthritis drugs

Seems Vioxx isn't the only arthritis drug causing health problems - and Merck isn't the only pharmaceuticals manufacturer engaging in some astute "damage control." Ironically, the news you're about to read appeared in print on the same day that the Vioxx cover-up story I just told you about broke. Shrewdly timed, as I'm sure you'll agree in a moment.

According to a recent Associated Press article, a drug-making subsidiary of Johnson and Johnson named Centocor expanded its warning label on the 28th top-selling drug in the country, Remicade (a rheumatoid arthritis medication), to include language reflecting an INCREASED CANCER RISK.

The company's own research concludes that the arthritis drug contributes to a three-fold increase in the incidence of deadly lymphoma (cancer of the lymphatic system). Funny how this conclusion failed to reveal itself in the stacks of research Centocor no doubt submitted back when they applied for their patent...

As if this isn't alarming enough, this announcement marks the second time in just a six-week period when Remicade's warning label had to be changed to reflect a risk of death. In late August, Centocor added a caution against fatal blood and nervous system disorders after 12 people died in clinical trials of the medication.

Predictably, the FDA claimed those deaths couldn't be definitively linked to the drug. Kind of makes you wonder whose side they're really on...

Never doubting whose side I'M on,

William Campbell Douglass II, MD


Copyright (c)1997-2004 by, L.L.C.
The Daily Dose may not be posted on commercial sites without written permission.

Posted by: Sepp on October 13, 2004 03:56 PM


Merck has another arthritis drug out there that needs some serious looking into.
Arcoxia (another Cox-2), which is not approved in the US, is available in many other countries. It is currently before the FDA for their approval. Merck submitted this this in 2002, then pulled the submission later. It was given back to the FDA in June 04.
I was in a clinical trial for this drug from March 00 to APril 01. AT the end of the trial I was told that it would be available shortly to buy, but until that time, Merck supplied me with free Vioxx. I found this a little strange because I had always been told that Vioxx would not help my form of arthritis, Ankylosing Spondilitis. Well needless to say, on September 10,2001, I suffered an unexplainable heart attack.
12 months on one type of Cox-2, then another 6 months on Vioxx equals 18 months. Sound familiar?
Arcoxia needs to be looked at big time before FDA releases it!

Posted by: Ed on October 13, 2004 06:00 PM


The Vioxx - heart disease/stroke studies need to be looked at from the point of view of REMOVING asprin from the patient's care. We may be seeing the LACK of asprin's anti-clotting effects rather than a direct "Vioxx" complications since asprin is usually removed from therapy when Vioxx medications are substituted. The percentage of "complications" seem to be the same as for the incidence of patients "protected" by asprin from stroke/heart disease.

Posted by: Robert Fuson, MD on November 27, 2004 05:25 PM


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