Vioxx Kills 55,000, and Big Pharma Knew it Was Coming
Or was it 500,000? And Where Was Mainstream Media?
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4.85 Billion dollars was paid out in damages by Merck when the FDA-approved Drug Vioxx Killed 55,000 people.
Many people have estimated up to half a million people died. Where was this in mainstream media? Where were the rallies and the uprising against big pharma and the FDA? Nowhere. That is because big pharma owns the FDA and the mainstream media. Does this disturb you? David
Graham, a scientist with the FDA, estimates that Vioxx may have caused 140,000 heart attacks or strokes and 55,000 deaths in just the United States.
Did you know they had the evidence in their possession of how deadly this drug was and they approved it anyway? No one was charged with any crime or corporate malfeasance. Nothing. No one paid the price for the 55,000 deaths.
In other countries, people go to jail for killing 55,000 to a half million people. Not here in the USA. Drug manufacturers are never held criminally liable for killing people. If they were so many people would be in jail that there would be no drug companies. We think we would be better off. Death by doctor kills 700,000+ people a year.
We actually see people defending Vioxx in comments on the internet. This baffles us to no end! The panel voted 17-15 to keep Vioxx for sale. Even excluding panelists with industry ties, the vote was 8-14 (losing) to approve Vioxx. If Vioxx was really as bad as some allege, why did 8 panelists (with no industry ties) favor its continued sale?
Merck’s Sales Force Lie To Doctors About the Deadly Drug
The House Committee on Government Reform uncovered Vioxx documents instructing Merck’s sales force to lie to doctors about the cardiovascular risk posed by Vioxx.
The documents made public by the House Committee on Government Reform showed that Merck directed its 3,000-person Vioxx sales force to avoid discussions with doctors about the cardiovascular risks identified in a major clinical trial of the drug in 2000. Instead, sales representatives were told to rely on a “Cardiovascular Card” that said Vioxx was protecting the heart rather than potentially harming it.
Vioxx was withdrawn from the market last September after another clinical trial found that people who had taken the drug for 18 months were five times more likely to have heart attacks and strokes than those on a placebo.
$2 billion in sales in two years, faster than any drug in Merck’s history. By November 2006, Merck’s legal costs were sizable: $610 million.
Prior to the FDA’s approval of Vioxx in May 1999, there was evidence that Merck had concerns that the drug may cause serious cardiovascular events. 96 Internal Merck documents showed that company executives and scientists were worried about Vioxx’s potential cardiovascular risks as early as November 1996-more than two years before selling the drug but rejected plans to conduct a study evaluating these risks.
A November 1996 internal memorandum by a Merck official indicated the company was struggling with a marketing dilemma, as Vioxx had limited market potential unless it could gain acceptance in the mass market for painkillers and be preferred to cheap over-the counter-drugs such as aspirin or ibuprofen, which cost about five cents a pill versus several dollars for Vioxx. 98 The author of the memorandum noted that Merck was reluctant to conduct a trial to prove Vioxx was gentler on the stomach.
At the time of approval, the FDA reviewer, Dr. Villalba, wrote a memorandum expressing his concern that the data available seemed to suggest that cardiovascular events are more frequent in patients taking Vioxx rather than a placebo.10
“Prescription Drugs Including Vioxx Kills Millions And No …” N.p., n.d. Web. 27 Feb. 2019 https://top-lifecoach.com/portfolio-item/prescription-drugs-including-vioxx-kill.
28,000 Excess Deaths Caused by Merck’s Blatant, Purposeful Avoidance
STATEMENT OF DAVID J. GRAHAM, M.D., MPH, ASSOCIATE DIRECTOR FOR SCIENCE, OFFICE OF DRUG SAFETY, CENTER FOR DRUG EVALUATION AND RESEARCH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, WASHINGTON, D.C.
Before approval of Vioxx, a study was performed by Merck named 090, which found a nearly seven-fold increase in heart attack risk with low-dose Vioxx. The labeling and approval said nothing about these heart attack risks. In November 2000, another Merck trial named VIGOR found a five-fold increase in heart attack risk with the high-dose form of Vioxx. About 18 months after the VIGOR results were published, FDA made a labeling change about heart attack risk, but it did not place these in the warning section of the labeling. Also, it did not ban the high-dose formulation in its use. Of note, the label change that FDA made had absolutely no effect on how often high-dose Vioxx was prescribed, so I ask, what good did it achieve? In March of 2004, another epidemiologic study reported that both high- and low-dose Vioxx increased heart attack risks compared to Celebrex, Vioxx’s leading competitor. Our study found similar results. A study report describing our work was put on the FDA website.
This report estimated that nearly 28,000 excess cases of heart attack and sudden cardiac death had been caused by Vioxx. I must emphasize to the committee that this is an extremely conservative estimate.
The FDA always claims that randomized clinical trials provide the best data. Applying the risk levels seen in the two Merck clinical trials, VIGOR and APPROVE, you obtain a more realistic and likely range of estimates for the number of excess cases. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30 to 40 percent probably died. For the survivors, their lives were changed forever. This range does not depend at all on the data from our Kaiser-FDA study. Indeed, Dr. Eric Topol at the Cleveland Clinic recently estimated 160,000 cases in an article published in the New England Journal of Medicine.
The Big Pharma Seven Year Safety Rule
“Most people who are harmed by prescription drugs [are] taking the drug as prescribed,” says Dr. Michael Carome, director of the Health Research Group at the consumer watchdog Public Citizen.
“We have what’s called a seven-year drug rule,” Carome explains. Within the first seven years after a drug is approved, it’s common for safety warnings – including the FDA’s strongest, the “black box” warning – to come to light, Carome says. And it’s within the same period, he adds, that drugs are often withdrawn from the market because of serious safety concerns.
“We advise people not to take the drug for seven years” after approval, he says, with exceptions only for actual breakthrough drugs, which Carome contends are few and far between.
However, some health experts and consumer advocates, including Carome, say that drugs approved in areas where a range of treatment options already exist – from managing diabetes to controlling cholesterol – tend to offer little or no new benefits, compared to less costly and more proven treatments already on the market, while increasing risk. “Newer patented drugs have much higher prices, and yet the vast majority of new patented drugs have been shown by independent review groups to be little or no better than older post-patent drugs that sell at generic prices,” Light adds.
Haskell’s rule of thumb: If you’re taking a new-to-you medication (whether newly approved or not), and you experience a new symptom, suspect the medication first. It may seem counterintuitive, and many doctors may be loathed to blame the drug they prescribed for how lousy you feel, but Haskell says it’s more important that patients report such symptoms, which could be side effects. Also, ask about alternatives to the medication.
Fri, 06 May 2005
STATEMENT OF DAVID J. GRAHAM,
I am currently the Associate Director for Science and Medicine in FDA’s Office of Drug Safety. During my career, I believe I have made a real difference for the cause of patient safety.
My research and efforts within the FDA led to the withdrawal from the US market of Omniflox, an antibiotic that caused hemolytic anemia; Rezulin, a diabetes drug that caused acute liver failure; Fen-Phen and Redux, weight loss drugs that caused heart valve injury; and PPA (phenylpropanolamine), an over-the-counter decongestant and weight loss product that caused hemorrhagic stroke in young women.
My research also led to the withdrawal from outpatient use of Trovan, an antibiotic that caused acute liver failure and death. I also contributed to the team effort that led to the withdrawal of Lotronex, a drug for irritable bowel syndrome that causes ischemic colitis; Baycol, a cholesterol-lowering drug that caused severe muscle injury, kidney failure and death; Seldane, an antihistamine that caused heart arrhythmias and death; and Propulsid, a drug for night-time heartburn that caused heart arrhythmias and death.
I have done extensive work concerning the issue of pregnancy exposure to Accutane, a drug that is used to treat acne but can cause birth defects in some children who are exposed in-utero if their mothers take the drug during the first trimester.
During my career, I have recommended the market withdrawal of 12 drugs. Only 2 of these remain on the market today-Accutane and Arava, a drug for the treatment of rheumatoid arthritis that I and a co-worker believe causes an unacceptably high risk of acute liver failure and death.
Because of the history of Mr. Graham having been involved in pulling deadly toxic drugs off the market, we suggest that you look at the two drugs that are still on the market even though he believes they should not be. Accutane and Arava.
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