60
Minutes In Depth Reporting Reveals:
Nov. 14, 2004
"(CBS) When
the pharmaceutical giant Merck pulled its blockbuster pain
medication Vioxx off the market in late September, it became the
largest prescription drug recall in history.
The company says it took immediate action after a new study showed
that Vioxx doubled the risk of heart attacks and strokes in some
patients.
|
However, according to internal Merck
documents 60 Minutes has seen, and interviews with outside
scientists, Merck had concerns that Vioxx could possibly cause
cardiovascular risks long before it was pulled off the market. |
Some 20 million Americans took Vioxx
in the five-and-a-half years it was being sold. It may have
contributed to thousands of heart attacks and sudden deaths. Three
government investigations are now underway to determine just how and
why Vioxx became a prescription for trouble. Correspondent Ed
Bradley reports.
When Vioxx first hit the market under a barrage of TV commercials,
it was hailed by Merck as a miracle drug.
It was one of a new class of drugs called COX-2 inhibitors that
could reduce all kinds of pain, especially arthritis, without
causing serious gastrointestinal discomfort and bleeding - a risk
seen in older drugs like aspirin, Aleve and Advil.
With annual sales of about $2.5
billion, Vioxx was one of the most successful new drugs ever. It was
prescribed to people like 39-year-old Janet Huggins, who had been
diagnosed with early stage rheumatoid arthritis.
According to her medical records, Huggins was in otherwise excellent
health. But that was until Sept. 25, when she died of a sudden heart
attack - less than a month after she started taking Vioxx. She was
buried on the very day Merck took Vioxx off the market. Huggins'
husband Monty is suing Merck, holding the company responsible for
her death.
"The morning of her funeral, I had just gotten dressed and my sister
walked in and told me that she had just seen on the news that Vioxx
had been pulled from the market. And when she told me that, I can't
explain what hit me," says Monty Huggins. "I dropped straight to the
floor. It was just a shock, because this is a 39-year-old female
that's in good shape and is healthy and she's got a heart attack."
He says that if the drug had been taken off the market a month
earlier, "I believe my wife would be here."
But was it Vioxx? Merck says it believes that many of the deaths
being attributed to Vioxx could be explained by any number of other
causes. The company insists it has acted responsibly, saying it
withdrew Vioxx as soon as it received what it says was surprising
data from a clinical trial it was conducting, called the APPROVe (Adenomatous
Polyp Prevention on VIOXX) study, designed to determine if Vioxx
could prevent colon polyps.
Instead, Merck found something potentially worse: Patients taking
Vioxx for longer than 18 months were twice as likely to suffer a
heart attack or stroke than those taking a placebo.
Merck declined a request from 60 Minutes for an
on-camera interview, but CEO Raymond Gilmartin explained the
company's decision in a Sept. 30 news conference..."
Click To Read the full 60 Minutes Transcript >
Vioxx FAQs
» What is Vioxx?
» Why did Merck take Vioxx off the market?
» How can an arthritis drug lead to heart attack
and stroke?
» What are the side effects of Vioxx?
» What does this mean for Celebrex or Bextra, the
other two drugs in the class known as COX-2 inhibitors?
» What can I take instead of Vioxx or Celebrex?
» What should I do if I am currently taking Vioxx?
» What should I do if I have been a victim of
prescription drugs?
» If I file suit against the manufacture of
Vioxx, what are my chances of winning?
» How common is pharmaceutical / prescription
negligence?
What is Vioxx?
Vioxx is a popular anti-inflammatory medication introduced to the U.S.
market in 1999, and used to be prescribed to ease the pain, swelling and
other symptoms of osteoarthritis. Before drugmaker Merck & Co. withdrew
it from the worldwide market September 30, 2004, it was most commonly
given to patients with Osteoarthritis. Vioxx belongs to a class of
medications known as cyclooxygenase-2, or COX-2, inhibitors. Sales
topped $2.55 billion in 2003.
Vioxx – a non-steroidal, anti-inflammatory drug (NSAID) – is in a class
of drugs commonly referred to as "Cox-2 Inhibitors". It comes in liquid
or pill form, and is prescribed to relieve the symptoms of
osteoarthritis. It can also be used to treat acute pain in adults such
as those patients who experience severe pain associated with
menstruation. Vioxx works by blocking COX-2 enzymes in the body that
trigger pain and inflammation.
Why did Merck take Vioxx off the market?
Merck pulled its best-selling arthritis drug off the market based on
data indicating the drug increases the risk of heart attack and stroke
among users.
Merck announced the immediate, voluntary worldwide withdrawal after a
three-year colon cancer clinical trial with 2,600 patients revealed that
18 months after patients started taking Vioxx, test results showed an
increased risk of heart attacks and other cardiovascular complications.
84 million people have used Vioxx since 1999.
In previous years, Merck consistently denied any possible links between
Vioxx and cardiovascular problems.
The drug was licensed in June 1999. Since then, more than 20 million
Americans have taken the drug at one time or another. In September 2001,
the FDA sent Merck an eight-page warning letter about the company’s
promotional campaign for Vioxx. The letter indicated that the campaign
minimized “the potentially serious cardiovascular findings that were
observed” in a trial that compared the drug to naproxen, a
less-expensive painkiller. The FDA charged that Merck discounted the
fact that "patients on Vioxx were observed to have a four to five-fold
increase" in heart attacks, compared with patients on naproxen.
How can an arthritis drug lead to heart attack and
stroke?
Scientists say they are not sure. However, several studies have
indicated that Vioxx and other COX-2 inhibitors are known to raise blood
pressure and increase the risk of heart attack. Drugs such as Vioxx and
Pfizer's Celebrex inhibit Cox-2, an enzyme that triggers pain and
inflammation.
Vioxx has also been associated with several other life-threatening side
effects, including blood clots, angina and nonbacterial meningitis,
severe intestinal damage, ulcerations and bleeding, and kidney damage.
What are the side effects of Vioxx?
Vioxx side effects may include, but are not limited to, heartburn, nausea,
diarrhea, upper respiratory tract infection, swelling of the lower
extremities (legs and/or feet), high blood pressure, itching, stomach
ulcers or bleeding, fatigue, vomiting, dark urine, and black stools.
In addition to increasing risk of heart attack and stroke, patients
taking Vioxx were found to be four times more likely to suffer from
heart attack than those taking Naproxen (Aleve). Vioxx is more likely to
cause severe intestinal damage, ulcerations and bleeding, blood clots
and toxic epidermal necrolysis (a fatal skin disease), than other
arthritis pain relievers.
Other health problems include:
- Serious kidney problems that could lead to acute kidney failure.
- Serious liver problems.
- Allergic reactions, such as swelling of the face, lips, tongue, and
throat which can cause difficulty breathing or swallowing.
- The FDA reports that Vioxx has also been linked to at least five cases
of a non-bacterial type of meningitis, a rare but serious side effect.
These conditions may come about suddenly with few or no symptoms. If
left untreated, hospitalization or even death can occur.
If you, or a loved one, have taken Vioxx and experienced any side
effects, contact our pharmaceutical negligence lawyers today, for a
free evaluation -
1.800.536.HELP
What does this mean for Celebrex or Bextra, the other
two drugs in the class known as COX-2 inhibitors? In light of the Vioxx study findings, several top scientists have stated
that the finding of an elevated risk of heart attacks and strokes
applies to all COX-2 inhibitors. Clinical trials of Celebrex and Bextra
did not reveal the same problems as Vioxx because participants were
allowed to take aspirin, which has proved to reduce the risk of
cardiovascular problems.
Pfizer, maker of Celebrex and the less-prescribed Bextra, stands by its
products. But studies are continuing to review the link of these drugs
to cardiac problems.
More About Vioxx &
Celebrex >
What can I take instead of Vioxx or Celebrex? Older medications like ibuprofen, naproxen or simply aspirin have been
used as alternatives for Vioxx and Celebrex.
What should I do if I am currently taking Vioxx? Contact your doctor to discuss discontinuing use of Vioxx and possible
alternative medications. If you have experienced any side effects,
contact a lawyer to review your case. We understand your medical
concerns take priority, but don't ignore your legal right to
compensation.
Your state's law may limit your time to bring a legal claim. To protect
your rights, you need to have your personal injury claim evaluated
immediately.
Free Vioxx Case
Evaluation >
What should I do if I have been a victim of
prescription drugs / pharmaceutical negligence? You may be experiencing pain and suffering and severe financial
hardships. You should not go through this difficult time alone. You, the
patient, should not be paying for your doctor's mistakes or negligence.
If you or a loved one are living with the consequences of the effects
from Vioxx, it is important to contact an experienced
lawyer who can protect your rights and get you the compensation to which
you are entitled.
Our Vioxx Lawyers have a track record of success representing your
rights against drug manufacturers. We are available to discuss your
potential claim, and answer any questions you might have. Call us for a
Free Case Evaluation :
1.800.536.HELP
If I file suit against the manufacture of Vioxx,
what are my chances of winning? Every case is different; however, patients who were prescribed Vioxx and
experienced serious health conditions (such as a heart attack, stroke,
or kidney failure) because of it have an excellent chance to recover
monetary compensation for the losses that they have incurred.
There is evidence that suggests Merck knew of the health risks
associated with Vioxx, but continued to heavily market the arthritis
drug. Brown & Crouppen litigates your case against the giant drug
manufacturers. Have your claim evaluated today,
click here.
How common is pharmaceutical / prescription
negligence? Prescription drug side effects, or Adverse Drug Events (ADE’s) result in
more than 550,000 injuries and over 100,000 deaths each year, according
to the Journal of the American Medical Association. Nearly one out of every five medication doses given in hospitals and
nursing facilities is improperly dispensed or prescribed. More than 40
potentially harmful drug errors occur, on average, in hospitals on a
daily basis. (Archives of Internal Medicine).
In pediatric emergency rooms, according to statistics, doctors
misprescribe 4 in every 1,000 prescriptions written. (presented at the
American Academy of Pediatrics conference). Unfortunately, pharmaceutical negligence/malpractice, by doctors and
pharmacists, is too common. The prescription drugs and victims of these
medications are widespread.
If you feel that you, or someone you love, has been injured by
prescription/pharmaceutical negligence, please contact us for a free
evaluation.
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