U.S. Soldiers Suffering at Hands of Lawmakers, Big Pharma

Posted on June 27, 2011 by Kay Van Wey

us soldier Pictures, Images and Photos 

We hear the reports on the news all the time about military service personnel who have survived bombings in Iraq and Afghanistan, but who have also lost limbs or have been seriously injured. They remind us of the great sacrifice they are making to protect our freedom. But the news media do not tell us about the stories of service personnel who were injured and have subsequently become addicted to prescription pain killers.

The wars of today are different than those fought previously.  In both World Wars I and II, thousands of U.S. soldiers died on foreign soil fighting for the freedom that we hold so dearly.  Today, soldiers are still dying, but due to advancements in medical technology, many are also surviving.  Unfortunately for those survivors, many live in fear and pain even after returning home.
 
Thanks to lobbying efforts by the pharmaceutical industry and its various pain management groups, lawmakers were convinced that prescription drugs would cure these ailing soldiers.  In 2008, two bills were passed that provided greater access to prescription pain killers and other drugs for active-duty soldiers and veterans.  One of the bills was the Veterans Pain Care Policy Act, and the other was the Military Pain Care Policy Act of 2008, which required the Department of Defense to implement a program where comprehensive pain care would be provided for active and retired military service men and women.  
 
In 2010, the U.S. Army Surgeon General expressed concern that soldiers were being overmedicated.  This came just two years after the passage of the Military Pain Care Policy Act of 2008, in which a study revealed that the comprehensive pain care provided was in the form of highly addictive prescription pain killers.
 
A study conducted by the U.S. Army found that 14 percent of soldiers had been prescribed an opiate prescription drug to treat their pain, and 95 percent of those prescriptions were for OxyContin or its generic, Oxycodone.  Other commonly prescribed drugs for soldiers include Seroquel, an antipsychotic drug, and Valium, an anti-anxiety drug.  All of the aforementioned drugs are highly addictive and have disastrous side effects, including irritability, suicide, and reduced reaction times.
 
After the results of the study came out, Lieutenant General Eric Schoomaker remarked, “we’re very concerned about the panoply of drugs that are being used and the number of drugs that are being used.”  A Military Times report found that one out of every six service members is on some type of psychiatric drug.  In a 2008 survey conducted by the Pentagon, 15 percent of soldiers said they had abused prescription drugs within the past month.
 
Lawmakers are now calling on the military to closely monitor the prescriptions that are given to soldiers, while others in the military want the focus to shift to alternative pain management practices like yoga, meditation, acupuncture, and movement therapy. Currently, the Department of Defense does not keep track of prescriptions given to service members.
 
Whatever the military and lawmakers decide, they must not let the pharmaceutical industry bully them into giving our already injured soldiers highly addictive and dangerous pain pills.
 
I would like to thank Marianne Skolek, a staff writer at Salem-News.com and an activist for victims of OxyContin and Purdue Pharma. She first wrote about the devastating effects these highly addictive painkillers are having on our troops and brought it to my attention. You can read her full article at http://www.salem-news.com/articles/june232011/drugged-soldiers-ms.php.
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Lipitor More Effective than Zocor

Posted on June 24, 2011 by Kay Van Wey

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In a recent study out of the United Kingdom, researchers from St. George’s University, the University of London, and the University of Glasgow, found that high dose statin drugs increased the risk of patients contracting type-two diabetes.  But when the study compared Lipitor to Zocor and its generics, researchers found that Lipitor was more effective in decreasing the patient’s risk of a heart attack.

 
This finding comes on the heels of the FDA announcement that Zocor’s labeling would be changed to reflect newer restricted prescribing practices of the drug.  Zocor and its generic, Simvastatin, will no longer be prescribed at the 80 mg dosage to patients who are new to the drug.  And patients taking certain other drugs may have to limit their intake of Zocor because of possible adverse drug reactions.
 
Where patients do need a high dose of statins though, doctors may have to chose the pricier Lipitor, which costs $1.20 a day, over generic Simvastatin, which costs a mere $0.04 a day.
 
Over the five-year study, researchers found that more than eight percent of participants developed diabetes, while 20 percent of patients had a major heart problem.  The study did not look at the recent findings by the FDA that 80mg Simvastatin can cause severe muscle damage and deterioration.
 
Professor Kausik Ray of St. George’s University noted that patients already taking high doses of statins should not stop taking these drugs, but should be monitored by their doctors more closely.  But he reiterated that “[t]he net benefit of Simvastatin is clearly very low and patients on Simvastatin 80 mg should be moved to Atorvastatin 80 mg instead.”
 
Unfortunately, for those without health insurance, Lipitor will be more costly than Simvastatin.  “I don't think we can wait for loss of [Lipitor's] patent to stop using Simvastatin 80 mg,” Ray said.  
 
Lipitor is scheduled to lose its U.S. patent protection this coming November.
 
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Zocor's Harmful Side Effects

Posted on June 17, 2011 by Kay Van Wey

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Zocor (generic Simvastatin) is a drug prescribed to lower cholesterol in patients with high cholesterol.  The drug was first introduced on the market in 1991 by major pharmaceutical company Merck.  But nearly 10 years later, after studies showed a risk of patients developing severe muscle damage, or rhabdomyolysis, the FDA required Merck to put a warning on Zocor’s label explaining the risk for muscle injury in patients taking 80mg, the highest dosage of the drug.

Further studies since then have shown that the higher the dosage of Zocor a patient takes, the more likely he or she is to develop some form of muscle damage.  Patients who develop rhabdomyolysis, the most severe form of muscle damage, are at risk for kidney failure and even death.

If you are currently taking Zocor, Vytorin, or one of Zocor’s generic equivalents, and you develop sudden unexplained muscle pain, you should contact your healthcare professional immediately. 

Other signs of rhabdomyolysis include dark or red urine, weakness, muscle stiffness or aching, and muscle tenderness.  Additionally, patients with the condition may experience fatigue, weight gain, seizures, and joint pain.

If you or a loved one took or are taking Zocor, Vytorin, or any generic equivalent of Simvastatin and have experienced severe muscle pain or have been diagnosed with rhabdomyolysis, contact Van Wey Law today.
 

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Did Merck Know about Zocor's Dangers?

Posted on June 15, 2011 by Kay Van Wey

Since the Food and Drug Administration (FDA) announced restrictions on prescribing 80mg doses of Zocor (generic name Simvastatin), many have questioned whether Merck, the maker of Zocor, knew about the drug’s potential to cause severe muscle damage without providing more warning to patients.

This is not the first time Merck has been accused of withholding information about negative results of its drugs in medical studies.  In 2004, after heavily promoting its blockbuster drug Vioxx, Merck voluntarily pulled Vioxx off the market, because studies revealed the drug increased the risk of heart attacks, blood clots, and strokes in patients.  

Lawsuits against Merck popped up all over the country, with one of the first in Angleton, Texas.  In that case, the jury awarded the plaintiff, the widow of a man who had taken Vioxx, $24.5 million in mental anguish and economic losses.  Additionally, she was awarded $229 million in punitive damages after the jury found that Merck had acted recklessly in selling Vioxx, despite having knowledge of the drug’s heart risks.  However, the trial court reduced this based on Texas’ cap on punitive damages.
 
In other cases across the country, plaintiffs’ lawyers argued that Merck knew about the dangers Vioxx posed, but attempted to conceal those dangers from the public and doctors.  In fact, a congressional committee found that Merck instructed its sales people not to address negative research findings when talking with doctors.  Overall, the company’s goal was sales, not education.
 
Now people are asking whether Merck knew about the dangers associated with 80mg Zocor, but failed to disclose those dangers.
 
Dr. Steven Nissen of the Cleveland Clinic was the first doctor to link Vioxx to an increased risk of heart attacks and strokes in 2001.  Unfortunately, it wasn’t until three years later that Merck actually pulled the drug off the market.  Dr. Nissen is now calling on the FDA to take the 80mg dose of Simvastatin off the market.  He says that the Zocor label change is too little too late, especially since many experts have been worried about the 80mg dose for years.  Dr. Nissen stopped prescribing the high dose drug in 2004, noting that the risk associated with it is clear and has been known now for several years.
 
Nearly 10 years ago, the FDA required Merck to change its label for Zocor to warn patients about the risk of rhabdomyolysis.  In 2004, a large study, known as the A to Z Trial, found that there was a higher rate of muscle damage, including rhabdomyolysis, in patients taking Simvastatin.  Four years later, a second study, known as SEARCH, found that out of 6,000 patients taking the 80mg dose, 53 developed muscle damage, while only three patients developed muscle damage while taking the 20mg dose.  The FDA has even admitted that of the 148 deaths reported from rhabdomyolysis, about half were patients taking 80mg of Simvastatin.
 
Although the FDA is not allowed to factor cost into its decision to keep a drug on the market, in a recent interview, a representative for the FDA said one of the benefits of Simvastatin was that it was the cheapest, most powerful statin available to patients.  So it was difficult for the FDA to pull a drug off the market that cost a mere $0.04 a day, when other cholesterol-lowering medicines cost upwards of $1.20 a day.  Dr. Nissen says that Simvastatin was pushed by pharmacies to save costs, despite the risks associated with taking the drug.
 
The FDA does not know how many patients taking 80mg Simvastatin have suffered muscle damage, but recent estimates suggest more patients than first thought could be suffering from the side effect.
 
One thing is clear: if Merck hid the dangers of Zocor, lawsuits brought across the nation will uncover these deceptive practices.
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Muscle Damage Risk Higher in Women

Posted on June 14, 2011 by Kay Van Wey

With the new warnings released by the Food and Drug Administration (FDA) about Simvastatin, marketed under Zocor and Vytorin, some doctors are questioning the rates of occurrence of muscle damage in patients taking the 80mg dose.

 
Rhabdomyolysis, a condition which breaks down muscle and releases dangerous proteins into the blood stream, affects an estimated five out of every 100,000 people taking an 80mg dose of Zocor for a year.  Based on studies, researchers say that the condition is rare, but that it can lead to kidney failure and even death.
 
Despite the latest statistics, some doctors believe that Simvastatin may cause muscle pain more frequently than what the statistics show.  All statins can cause muscle pain and weakness.  Researchers estimate that five to 10 percent of patients taking 80mg of Simvastatin experience muscle pain and weakness, but they concede that as many as a third of these patients could be suffering with these side effects.
 
Symptoms of rhabdomyolysis include muscle pain, tenderness, weakness, dark or red urine, and unexplained tiredness.  If you are taking Simvastatin and are experiencing or have experienced any of these symptoms, experts say you should contact your healthcare professional immediately.
 
Consumer Reports advises anyone taking cholesterol-lowering drugs to start out at the lowest necessary dose.  If you have high cholesterol, and your doctor recommends you take a statin, you should discuss any side effects of the drug with him.
 
The danger for rhabdomyolysis is greater in older women and in those who are taking Simvastatin with other drugs for blood pressure.  Consumer Reports gives the following advice for people who are taking other prescriptions along with Simvastatin:
 
  • Take no more than 20mg of Simvastatin with amlodipine (market name Norvasc)
  • Take no more than 20mg of Simvastatin with diltazem (market name Cardizem) or verapamil (market name Verelan)
  • Take no more than 20mg of Simvastatin with amiodarone (market name Cordarone)
  • Take no more than 20mg of Simvastatin with ranolazine (market name Ranexa)
  • Never use Simvastatin with cyclosporine, danazol, gemfibrozil, or posaconazole.
 
Of course, you should always consult your doctor before you stop taking any of your medicines.  If you are worried about your medicines interacting, tell your doctor.
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Merck Redesigns Zocor Label after FDA Study

Posted on June 13, 2011 by Kay Van Wey

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 Merck, the manufacturer of Zocor, drug name Simvastatin, announced it would be redesigning the label of its blockbuster drug.  The redesign comes on the heels of a seven year study that found that patients who took the higher dose of Zocor were at a higher risk of developing rhabdomyolysis, a disease that causes muscle fibers to break down and release myoglobin, a protein that damages the kidneys.

Symptoms of rhabdomyolysis include muscle cramps, muscle tenderness and stiffness, pain, and spasms.  The disease usually occurs in patients over the age of 65 or in those patients who have renal impairment or uncontrolled hypothyroidism.

Sales of the drug have been high in recent years, especially because the generic Simvastatin is available at a relatively low cost compared to some other statins currently on the market.  An estimated 1.2 million Americans are currently taking the 80 milligram dose of Simvastatin, the highest dose sold legally in the United States.

Despite its low cost, researchers urge that patients should talk with their doctors about switching to a newer generation statin, like Crestor, which has had a greater success rate with reducing cholesterol levels, without the harsh side effects.

Before muscle deterioration and damage became a worry to researchers, some worried that statins caused nerve damage.  

In 2002, Dr. David Gaist, MD, a researcher from Denmark, found that patients taking statins were at a nearly 16 times increased risk of developing neuropathy, compared to patients not taking statins.  And those taking statins for two or more years were at a 26 times higher risk for developing neuropathy.  Gaist concluded that the larger the dose given to the patient, the higher the risk that the patient would develop nerve damage.

Although the study conducted by the FDA did not reveal a link between Simvastatin and neuropathy, Dr. Gaist was on the right track with his research and the dangers posed by an increased dosage. Ultimately, Dr. Gaist’s report shows that the concern about the effects of Simvastatin on the human body was well-founded, even before the FDA saw fit to study the drug’s effects.

If you or a loved one has suffered from rhabdomyolysis while taking Simvastatin, call Van Wey Law today.

 

 

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FDA warns of muscle damage from high doses of Zocor

Posted on June 10, 2011 by Kay Van Wey

 The FDA recently announced that it will require the makers of Simvastatin (generic) and Zocor to strengthen their warnings. It seems that the FDA has been studying the effects of this drug for 7 years.  The FDA study revealed that some of the patients in the study taking the highest dosage (80 mgs) of Simvasatin or Zocor  sustained muscle damage. 

Critics question why the FDA waited so long to issue the warning about the increased risk of muscle damage associated with Zocor and it's generic equivalent, Simvastatin.

The kind of muscle damage associated with Simvastatin and Zocor can lead to a condition known as rhabdomyalisis which can shut down the kidneys and result in death.

It is estimated that 2.1 million Americans are taking the 80mg dose of Simvastatin or Zocor. If you or a loved one are taking either of these drugs, particularly at higher doses, you would be well advised to call your doctor as soon as possible and discuss your options.

To learn more about Zocor lawsuit, visit vanweylaw.com. If you are interested in learning more about how dangerous drugs like Zocor stay on the  market, download your free copy of attorney Kay L. Van Wey's recent book on the subject, "Prescription Drug Safety. Seven Secrets the Pharmaceutical Industry Does Not Want You To Know".

 

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Zocor Shown to Cause Severe Muscle Damage

Posted on June 9, 2011 by Kay Van Wey

This past Wednesday, the Food and Drug Administration (FDA) released a revision of the prescribing information for the drug simvastatin, market name Zocor, which is prescribed to patients with high cholesterol.  

 
The news comes after the FDA’s review of a seven year study on the drug.  The FDA found that the drug, when prescribed at its highest dose of 80 milligrams (mg), put patients at a higher risk for severe muscle damage than patients who were prescribed the drug at a lower dose.  Further, research has shown that out of 1,000 patients taking the 80mg dose of simvastatin, 61 experienced some form of muscle damage.  In sharp contrast, out of 10,000 patients taking a 40mg dose of the same drug, only 8 experienced muscle damage.
 
Zocor is a statin, which lowers high levels of cholesterol.  Just last year, Zocor was the second most prescribed drug in the United States, with 94 million prescriptions written, not including prescriptions for its generic form.  (Source IMS Health, Inc.)  Other drugs that contain simvastatin include Vytorin and Simcor.
 
Of the millions of patients taking Zocor, about 12 percent, or 1.2 million people, take the pill in its 80mg dose.  The FDA is advising doctors not to prescribe the 80 mg dosage of simvastatin to patients who have never taken the drug before.  Additionally, the FDA advises that the drug not be taken with certain other medicines, including antibiotics, anti-fungal medicines, and drugs to treat HIV.
 
Zocor is known to cause myopathy, a potentially serious form of muscle damage, and rhabdomyolysis, which is a breakdown of muscle fibers, causing a release of the fibers into the blood stream.
 
Every three out of four patients that take Zocor are protected from major cardiac events, but one out of every four patients suffers some form of muscle damage.  Some doctors argue that this label change by the FDA is seven years too late.
 
If you or a loved one has taken Zocor, Vytorin, Simcor, or a generic form of these drugs and has experienced severe muscle damage, contact Van Wey Law today.
 

 

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