Background on Vioxx - What they knew, and when they knew it
On September 30, 2004 the blockbuster arthritis drug Vioxx (rofecoxib) was finally pulled from the market due to the alleged increased risk of heart attack, stroke, and other cardiovascular events linked to the drug.
The FDA records reveal that the FDA sent warning letters to Merck and Company, Inc., the manufacturer of Vioxx. One of the warning letters dated in 2001, demanded Merck to reconsider their advertising campaigns and reassess the cardiovascular safety of Vioxx. The FDA claimed that Merck had "engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, (Merck's) promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions." This means that both the FDA and Merck were aware that taking Vioxx could increase the risk of heart attack up to five times than the risk of someone not taking the drug.
Merck's financial statements showed that last year, Merck grossed over $2.55 billion dollars from the sale of Vioxx alone. The drug had an aggressive $49 million dollar annual budget for its advertising campaign. According to the Washington Post, Vioxx allegedly caused up to 27,000 heart attacks, just in the United States.
According to the FDA, approval of Vioxx was based solely on information provided by Merck. This means that Merck was under the big pharmaceutical company "Honor System". The drug was on a fast-track six month approval process in order to remain competitive with other anti-inflammatory drugs just entering the market. Now, the FDA estimates that those who have taken Vioxx have a 50% greater chance of heart attack than those not taking the drug. Those who have taken the drug for more than 18 months are at the greatest risk.
Updated label warnings on Vioxx prescriptions state that Vioxx may cause adverse cardiovascular events including, but not limited to:
- Heart attack
- Sudden death
- Congestive heart failure
- Hypertensive crisis
- Pulmonary edema
- Transient ischemic attack
- Atrial fibrillation
- Hematoma
- Palpitation
- Tachycardia
- Stroke
- Cerebrovascular accident
- Deep vein thrombosis
- Myocardial infarction
- Pulmonary embolism
- Unstable angina, angina pectoris
- Bradycardia
- Irregular heartbeat
- Premature ventricular contraction
- Venous insufficiency
Your Legal Rights
The law provides various legal remedies for persons injured by Vioxx. These remedies include compensation for:
- Pain and Suffering
- Wrongful Death Damages
- Medical Expense
- Loss of Earnings
How We Can Help You Get Compensated For Your Loss
If you or a loved one has been injured by Vioxx, Viles and Beckman, LLC can help. The firm has already filed a class action lawsuit against Merck and Company, Inc., in regards to the undue risks associated with Vioxx, and is handling hundreds of individual claims. Fill out the form on the right side of this page for a free case evaluation or call us, or stop by our office for a free information packet. The class action seeks free ongoing health monitoring for those who have taken Vioxx, monetary compensation for medical bills, punitive damages, and pain and suffering. Viles and Beckman will also help you get a refund if you have purchased the drug. Anyone who has taken Vioxx may be a part of the class action. Remember, at Viles and Beckman, LLC all work is based on a contingency fee system which means the firm never collects a fee unless compensation is successfully recovered for you.
Viles and Beckman, LLC has a proven track record of dealing with large companies and was the first law firm to file a class action lawsuit against the manufacturers of the diet drug Phen Fen, which also caused heart problems. Viles and Beckman helped lead the successful effort to recall defective tires in the Ford/Firestone class action and has been featured on CNN, MSNBC, Good Morning America, and CBS Evening News. The firm has also been featured in the Wall Street Journal, New York Times, Washington Post, and other publications. Viles and Beckman, LLC has been nationally recognized for their extensive work towards defending the rights of the consumer and demanding that goliath companies take responsibility for their actions. The team at Viles and Beckman, LLC hopes to promote corporate accountability and to protect the rights of consumers worldwide.
Merck Admits Data Error
Source: New York Times Company May 31, 2006
In an admission that could undermine one of its core defenses in Vioxx-related lawsuits, Merck said yesterday that it had erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use.
That statistical analysis test does not support Merck's 18-month theory about Vioxx, the company acknowledged yesterday.
But Dr. Peter S. Kim, Merck's chief scientist, said the company stood by the overall findings it reported in 2005 -- including the conclusion that the drug's heart risks were not apparent if patients took it less than 18 months.
But outside scientists said yesterday that Merck's admission, when considered along with other clinical trials of the drug and studies tracking real-world Vioxx use, supports critics' longstanding claims that Vioxx caused heart problems quickly.
"There never was any evidence for the 18-month story," said Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University.
The 18-month issue is crucial both for the 20 million Americans who took Vioxx, an arthritis drug and painkiller, and for Merck's future. Merck faces at least 11,500 lawsuits, covering 23,000 people, from patients who say that Vioxx caused their heart attacks and strokes. Merck cited the 18-month theory when it withdrew Vioxx, a painkiller, from the market in September 2004, based on preliminary findings from a clinical trial called Approve.
In defending the lawsuits, Merck has consistently taken the position that Vioxx can cause heart problems only if it is used continuously for more than 18 months. But in the five Vioxx court cases in which juries have reached decisions so far, Merck has lost three times -- twice in cases in which the heart attack victim had taken the drug for fewer than 18 months.
Merck has based the 18-month theory largely on data from the Approve study, in which the company tracked 2,600 patients in a test to see whether Vioxx could prevent colon polyps.
In the Approve study, twice as many patients taking Vioxx suffered heart attacks or strokes as those taking a placebo, or sugar pill. But most of the difference appeared to occur after patients had taken Vioxx for 18 months in a row, Merck has said.
When it reported the Approve results in The New England Journal of Medicine early last year, Merck said that it had performed a statistical test to examine whether Vioxx's risk changed over time. That test found with almost total certainty that the drug had significantly higher risk than placebo only after the 18-month benchmark -- but no extra risk before that time.
Yesterday, Merck said it had made a mistake in reporting that result last year.
In reality, the test that the company said it had used to check the results shows that there is a 7 percent chance that Vioxx has an equally high risk of causing heart attacks both before and after the 18-month benchmark is reached.
That 7 percent figure may seem like a relatively small chance of error, but scientists say it is high enough to mean that Merck has not proved its theory.
Critics had recently raised new questions about the Approve trial's results, after the company submitted new data to the Food and Drug Administration as part of a one-year follow-up study of patients in the trial.
Some outside scientists said that the new data indicated that Vioxx's dangers became evident after only about four months of use. Merck disputed that interpretation and said yesterday that its newly discovered mistake was unrelated to that new data.
Dr. Kim said yesterday that Merck found its mistake only last week and immediately told the F.D.A. and the non-Merck researchers who had taken part in the Approve study, which was published in the March 17, 2005, issue of The New England Journal of Medicine.
"We came forth quickly to let the study authors know about the error, let the regulatory agencies know about the error," Dr. Kim said.
But Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, and a frequent critic of Merck, said the mistake the company disclosed yesterday was yet another example of Merck's mishandling data to make Vioxx seem safer.
"They're acknowledging that they misrepresented the Approve data, when they reported that there was a statistically significant difference between the first and the second 18 months," Dr. Nissen said. "There is no biologically plausible reason to expect an 18-month delay. I never thought it made any sense."
Dr. John Baron, a professor at the Dartmouth medical school and one of the authors of the original journal article about Approve, said Merck's mistake was relatively minor. In general, trying to calculate whether risks change over time is very difficult, Dr. Baron said.
"The assessment of this constancy is something of an art. It's not a 'cut and dry, it's there or it's not' business," he said.
"The evidence that the Vioxx effect begins immediately or quickly, or however you want to describe it, is far from conclusive. The evidence that it doesn't begin until 18 months is also not something that has been proven."
Data Suggest Risks Started Earlier
Source: New York Times Company May 19, 2006
Previously unpublished data from the study that led the drug maker Merck to halt sales of its blockbuster painkiller Vioxx appear to show the drug raised the risk of heart attack and stroke within just a few months, not after at least 18 months' use, as Merck has consistently argued.
The company disputed that Thursday, saying it was "not scientifically appropriate" to draw conclusions based on a key graph in a 108-page report on the data. The news, first reported by National Public Radio, comes after prominent doctors said Merck misrepresented other data from the same study last week.
Merck officials said last week that the new data, from a follow-up of patients a year after they stopped taking Vioxx, showed heart and stroke risks ended soon after they stopped taking it. The officials also said patients who later had such complications did not have a legitimate lawsuit. But several doctors said that depending on how one interpreted the data, the heart and stroke risks could persist for at least a year or longer.
Now, a closer look at that same data indicates that the increased cardiovascular risk with Vioxx use most likely begins as early as four to six months and then gets bigger, said Dr. Steven Nissen, a Cleveland Clinic cardiologist and frequent Vioxx critic who is leading an international study of the risks of other painkillers.
"It didn't really make a lot of sense that nothing happened for 18 months and then all of a sudden you would see a hazard," Dr. Nissen said.
Reduce Your Risk
Source: American Heart Association
What You Can Do on Your Own:
- Don't use tobacco - It's the No. 1 preventable cause of serious illness such as heart disease, stroke, lung cancer and emphysema.
- Be physically active - It can build endurance, control blood pressure, reduce cholesterol levels, aid in weight control and reduce your risk of developing diabetes.
- Eat healthy foods - Foods high in saturated fat, trans fat and cholesterol contribute to atherosclerosis, a primary cause of heart attack and stroke. Consuming too much salt (sodium) can cause high blood pressure in some people.
- Watch your weight - Obesity is a major risk factor.
- Avoid excessive alcohol - One or two drinks a day may help increase "good" HDL cholesterol, but heavy drinking can contribute to high blood pressure, heart disease and stroke.
What You Can Do With Your Doctor's Help:
- Have regular checkups - A doctor can pinpoint major risk factors such as smoking, elevated cholesterol or blood pressure, excess weight and diabetes.
- Control your cholesterol - A simple blood test can show your blood cholesterol level. If it's too high, dietary changes, exercise, weight loss, and/or drug therapy can bring it down to a safer level.
- Keep tabs on your blood pressure - Even if it's less than 120/80 mm Hg, have it checked at least every two years. If it's 120/80 or above, have it checked more often, according to your doctor's recommendations.
- Keep diabetes in check - Your doctor can detect diabetes or a pre-diabetic condition and prescribe a program to minimize the risk.
Risks You Can't Control:
- Age - The risk gradually increases as people age, but this doesn't mean that younger people are immune. Advanced age significantly raises the risk of heart attacks or strokes.
- Sex - Before menopause, women have a much lower death rate from coronary attack than men. Women's risk rises sharply after menopause, but it still remains lower than men's in the same age group. Each year more women than men have a stroke.
- Heredity - Some families have a higher-than-normal genetic risk of heart attack and stroke. African Americans are more likely than Caucasians to have high blood pressure, and they tend to have strokes earlier in life and with more severe results.
Warning Signs
Source: The American Heart Association
Act in Time
The American Heart Association and the National Heart, Lung, and Blood Institute have launched a new "Act in Time" campaign to increase people's awareness of heart attack and the importance of calling 9-1-1 immediately at the onset of heart attack symptoms.
Dial 9-1-1 Fast
Heart attack and stroke are life-and-death emergencies - every second counts. If you see or have any of the listed symptoms, immediately call 9-1-1. Not all these signs occur in every heart attack or stroke. Sometimes they go away and return. If some occur, get help fast! Today heart attack and stroke victims can benefit from new medications and treatments unavailable to patients in years past. For example, clot-busting drugs can stop some heart attacks and strokes in progress, reducing disability and saving lives. But to be effective, these drugs must be given relatively quickly after heart attack or stroke symptoms first appear. So again, don't delay - get help right away!
Statistics
Coronary heart disease is America's No. 1 killer. Stroke is No. 3 and a leading cause of serious disability. That's why it's so important to reduce your risk factors, know the warning signs, and know how to respond quickly and properly if warning signs occur.
Heart Attack Warning Signs
Some heart attacks are sudden and intense - the "movie heart attack," where no one doubts what's happening. But most heart attacks start slowly, with mild pain or discomfort. Often people affected aren't sure what's wrong and wait too long before getting help. Here are signs that can mean a heart attack is happening:
- Chest discomfort. Most heart attacks involve discomfort in the center of the chest that lasts more than a few minutes, or that goes away and comes back. It can feel like uncomfortable pressure, squeezing, fullness or pain.
- Discomfort in other areas of the upper body. Symptoms can include pain or discomfort in one or both arms, the back, neck, jaw or stomach.
- Shortness of breath. May occur with or without chest discomfort.
- Other signs: These may include breaking out in a cold sweat, nausea or lightheadedness
As with men, women's most common heart attack symptom is chest pain or discomfort. But women are somewhat more likely than men to experience some of the other common symptoms, particularly shortness of breath, nausea/vomiting, and back or jaw pain.
If you or someone you're with has chest discomfort, especially with one or more of the other signs, don't wait longer than a few minutes (no more than 5) before calling for help. Call 9-1-1... Get to a hospital right away.
Calling 9-1-1 is almost always the fastest way to get lifesaving treatment. Emergency medical services staff can begin treatment when they arrive - up to an hour sooner than if someone gets to the hospital by car. The staff are also trained to revive someone whose heart has stopped. Patients with chest pain who arrive by ambulance usually receive faster treatment at the hospital, too.
If you can't access the emergency medical services (EMS), have someone drive you to the hospital right away. If you're the one having symptoms, don't drive yourself, unless you have absolutely no other option.
Stroke Warning Signs
The American Stroke Association says these are the warning signs of stroke:
- Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
- Sudden confusion, trouble speaking or understanding
- Sudden trouble seeing in one or both eyes
- Sudden trouble walking, dizziness, loss of balance or coordination
- Sudden, severe headache with no known cause
If you or someone with you has one or more of these signs, don't delay! Immediately call 9-1-1 or the emergency medical services (EMS) number so an ambulance (ideally with advanced life support) can be sent for you. Also, check the time so you'll know when the first symptoms appeared. It's very important to take immediate action. If given within three hours of the start of symptoms, a clot-busting drug can reduce long-term disability for the most common type of stroke.
Cardiac arrest strikes immediately and without warning. Here are the signs:
- Sudden loss of responsiveness (no response to tapping on shoulders).
- No normal breathing (the victim does not take a normal breath when you tilt the head up and check for at least five seconds).
If these signs of cardiac arrest are present, tell someone to call 9-1-1 and get an AED (if one is available) and you begin CPR immediately.
If you are alone with an adult who has these signs of cardiac arrest, call 9-1-1 and get an AED (if one is available) before you begin CPR.
Use an AED as soon as it arrives.
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