Bayer is facing a $100 million lawsuit, the first of thousands, for its cholesterol drug Baycol. Baycol was pulled off the market after it was linked to at least 52 deaths worldwide, including 31 in the United States.
The lawsuit, which claims the drug produces a muscle-destroying side effect, has yielded information that suggests Bayer disregarded disturbing research on Baycol (cerivastatin) before it was removed from the market.
The side effect, rhabdomyolysis, is a rare disorder in which muscle tissue breaks down, which can lead to organ failure and death. Baycol is one of the cholesterol-fighting drugs known as statins, which are taken by about 8 million Americans.
Baycol was approved in 1997 and had become Bayer’s third best-selling drug by the time it was pulled from the marked in 2001.
Bayer was forced to release confidential company documents to the U.S. courts as a result of the lawsuit. At the trial, the plaintiff’s lawyers argued that documents show that Bayer was aware of problems associated with Baycol since its 1997 approval and that Baycol was 79 more likely to cause rhabdomyolysis than competing drugs.
They also suggested that not all adverse events were reported to the FDA, though Bayer said that it kept the FDA fully informed.
Bayer faces about 7,800 lawsuits from former Baycol users, mostly in the United States, and has paid $125 million to settle about 450 cases related to Baycol use.
BMJ March 1, 2003;326:518
The real tragedy is that virtually no one taking Baycol, or for that matter any of these statin drugs, would need to take them at all if they were following a proper nutrition plan.
There are, however, a rare group of individuals who have familial hypercholesterolemia. This genetic defect, which occurs in about one in 500 people, does not seem to respond favorably to the grain and sugar restriction program.
But, this is probably less than one percent of the people taking the statin drugs.
If you were to believe the "experts," half of Americans should be placed on these statin drugs.
Statins were introduced in 1987 and have quickly become blockbuster drugs with total annual sales now worth more than $14 billion. Leading products include Pfizer’s Lipitor, Merck's Zocor, and Bristol-Myers Squibb’s Pravachol.
If you were on Baycol my suggestion would be to immediately switch over to an optimized eating plan and have your cholesterol level rechecked. Not only will the program control your cholesterol, but it will also reduce your insulin levels, decrease your rate of aging, lower your weight and reduce your risk of diabetes and cancer.
Please remember that elevated cholesterol levels are nearly always related to disturbances in insulin metabolism. If you are eating sugars and grains your body needs to produce insulin to prevent the sugar from increasing in your blood and causing you to dive into a fatal hyperglycemic coma.
While the insulin saves your life acutely, it does so at quite a price. One of these costs is that it will cause your cholesterol levels to become less ideal, in addition to increasing your weight and overall risk of heart and chronic degenerative diseases.
It is also important to remember that the total cholesterol level itself is not an important risk factor unless it is over 300. It is actually the ratio between the level of total cholesterol and HDL that is far more predictive of heart disease.
The ideal HDL/cholesterol ratio should be higher than 25 percent, and generally speaking the higher the better. Levels below 15 percent are a serious problem.
The ideal triglyceride/cholesterol ratio should be below 2.0.
If you did not know any better and just listened to the "experts" you would think cholesterol is an evil substance and that most of us would benefit from lowering our cholesterol as much as possible.
This is not so. Cholesterol is a vitally important substance that is responsible for building our cell membranes and many of our hormones. If the level drops too low we are actually at increased risk for depression.
However, there are some people who appear to benefit from statin drugs, but it is probably far less than five percent of the people who currently take them. These are individuals with total cholesterol above 350 who have inherited liver processing problems.
If these individuals take the statin drugs however, they should also take Coenzyme Q10, which is important for heart health and, like cholesterol, is reduced when one takes these drugs.
The proper way for nearly everyone else to control their cholesterol levels is by reducing their grain intake by following the food choice program I recommend.
Related Articles:
New Cholesterol Guidelines Issued Bayer Company Hurting Due to Drug-Related Lawsuits Baycol Pulled From Market as Numerous Deaths Linked to It The Baycol Recall: How Safe Is Your Statin?
New Cholesterol Guidelines Issued
Bayer Company Hurting Due to Drug-Related Lawsuits
Baycol Pulled From Market as Numerous Deaths Linked to It
The Baycol Recall: How Safe Is Your Statin?