STATIN RISKS

There is mounting concern that statins may not be so safe as a preventive medicine as previously believed. Statins may turn a healthy you into a patient, taking a lifetime of medication. Under the current cholesterol-based guidelines, 80 million people should be taking statins. 50% of them are. You may be one of them.

The benefits may not outweigh any side effects for a healthy person to take statins. There is great skepticism about healthy people taking a long-term stain.

THE NEW STATIN

When doctors look for new statin candidates, they measure the degree of inflammation in the body rather than look for bad cholesterol. Yet there is no good medical evidence that inflammation is a direct cause of heart problems.

There is a push now for a newly approved statin, Crestor, to market a new advertising campaign for healthy people to take this product. The food and drug administration recently approved the drug for use in normal healthy people. This will add another 6 ½ million people who have no cholesterol problems and no signs of heart disease to be candidates for statins.

 The drug will be peddled to men over 50 and women over 60. All you must show is one factor like smoking, any rise in blood pressure, in addition to a blood test called CPA, showing some elevated inflammation in your body.

Despite this, the FDA approved a new use for statins in normal people because of a recent medical clinical trial with Crestor. It showed a very small reduction in strokes, heart attacks and other heart problems in people who took this drug.

Now the deputy director of the FDA, Dr. Colman, said that this was not a mandate for doctors and patients but an option. Crestor statin was approved in December by a 12 to 4 vote. Dissenters questioned the value of the CPA test that measures elevated levels of body inflammation.

DIABETES RISKS

There exists a risk of taking statins and the development of diabetes. Lancet, a British medical journal, reported concerns showing that statins increase a healthy person’s risk of developing type II diabetes by 9%. ( Lancet. 2010;375:735-742. Epub 2010 Feb 16)

Although most statin trials to date had not found a relationship between statin use and diabetes incidence, the recent JUPITER (Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events)[1] trial that reported an increased risk for diabetes in patients assigned to the rosuvastatin arm seconded concerns raised several years ago when the PROSPER (PROspective Study of Pravastatin in the Elderly at Risk)[2] trial reported similar findings with pravastatin. However, most trials had not looked at diabetes as a secondary outcome

It is possible that patients who developed diabetes were more dysglycemic, and that statins gave them a small "nudge" converting them to diabetes.

WOMEN AND STATINS

Time magazine article March 23, 2010 Catherine Elton
examined the relative risks and benefits of statins for women.

Millions of healthy American women are taking statins, which have never been shown to reduce MI or lengthen life and have an untold number of side effects, worse in women than men."

The article questions whether lipid lowering medications have value in women and do statins work equally for men and women?.

Women certainly have a lower risk of coronary heart disease than men at any age and over entire lifetime. Because of this they may not reach risk thresholds that indicate need for the drug. Yet heart disease is the leading killer of women and status are believed to be effective and safe.

Women have a lower absolute risk of ischemic events than men. Women also have fewer hospitalizations for unstable angina and revascularization. One must weigh the risks and benefits as well as the relative costs. Muscle damage is also a bit more common in women.

Yet women are more likely than men to suffer severe side effects from statins and other drugs. Women also tend to be older when they are prescribed statins, are more likely to develop diabetes than men, and It is possible that hormonal fluctuations and lower body weights play a role.

POSITION 0F THE AHA
The American Heart Association (AHA) issued a commentary reminding "patients that controlling cholesterol is critical for preventing coronary heart disease and reducing heart attack. People who experience myoapathy with statins should seek other alternatives.”

THE PLAYERS BEHIND THE SCENE

A clinical trial on which the FDA approved the drug, only looked at people who had low cholesterol and a positive test, called C. reactive protein (CRP).

The inventor of the test, Dr. Ridker from Harvard, persuaded the drug company to pay for this study He tried to get the National Institutes of Health and two other companies (Pfizer and Bayer) to do the study, but was turned down. He chose the candidates for the study, led the study, and wrote the conclusions of the study.

The company making Crestor, AstraZeneca, made four and one half billion dollars on this drug last year. There will be no generics for this product, and the drug is protected for many years. Compared to taking generic statins for a few pennies, the drug sells for $3.50 a day.

Incidentally, Dr. Ridker, receives royalties from his CRP test and everyone taking this statin will require his test on a regular basis.

COMMENTARY

Many patients complain of muscle aches and pains, weakness, memory problems, cognitive difficulties, and transient global amnesia from taking statins.

 Doctors regularly will check your liver and at times it will have high enzymes. They will tell you even though your liver tests are off, the benefits of lowering your bad cholesterol and reducing your risk of heart disease offset the thought of quitting the drug.

Over the past 10 years, there is a steady expansion of people who are statin candidates. Various advisory panels have recommended these new cholesterol guidelines. Many are paid consultants for the drug industry. Many experts also receive research and honorary grants, consulting work, speakers’ fees, and serve on safety and monitoring boards of drug companies. These financial benefits play a role in many of their analyses.

The health benefits of statins in the very healthy are very misleading. They have very little risk factors to begin with. To claim that taking this drug will lower their risk of a heart attack by 40% is hard to accept. This statistic is clinically not significant.

Five hundred people would have to take this statin for a year to avoid one usually survivable heart attack, and many would experience the higher risk of side effects with this drug.

500 people taking this drug at $3.50 a pill, will cost $650,000 to prevent one heart attack each year. This does not include the regular costs for Dr .Rikers CPA test. Apparently the drug company. Dr Riker, and the FDA believe it is worth it. Others like myself disagree.

The big point is with any treatments, benefits should outweigh the risks. Statins in the healthy will turn a lot of healthy people like you, into patients, and commit you to a lifetime of medication.