Statin drugs are virtually useless for most patients who take them. So, how did they get approved in the first place and how have doctors been led to believe that they work?
Drugs get approved because the FDA requires very little evidence of efficacy in order to approve a drug, and allows drug companies to continue marketing drugs in spite of evidence from follow-up studies (when they are conducted, which is seldom) showing that they should be removed from the market. An example is the ENHANCE trial, which evaluated the use of Vytorin. The study showed that for patients taking Vytorin, a combination of Zocor and Zetia, the rate at which artery clogging plaques developed almost doubled as compared to hose taking Zocor alone. It took 20 months for the makers of these drugs to make public the results of this trial, during which Vytorin and Zetia sales grew to over $5 billion.
Business Week featured an article on January 17, 2008 titled Lipitor: For Many People Cholesterol Drugs May Not Do Any Good. Dr. James Wright, Director of Canada’s Therapeutic Initiative, said in this article:
No benefit in people over the age of 65, no matter how much their cholesterol declines, and no benefit for women of any overall reduction in total deaths or illnesses requiring hospitalization despite big reduction in bad cholesterol. Most people are taking something with no chance of benefit and a risk of harm.
The article also said,Data suggest that for patients without heart disease, only one in 100 is likely to benefit from taking statins for years. In other words, the drugs have a 99% failure rate. Yet billions of dollars worth of them are sold annually.
I have written many times about the statistical sleight of hand used by drug companies and oncologists to promote cancer drugs. The same thing is true of statin drugs. Lipitor is advertised as reducing the risk of heart attack by 36%. However, look a little closer and youâ€™ll see that even in newspaper ads for the drug, the small print says that 3% of patients taking sugar pills had heart attacks as compared to 2% of those taking Lipitor. In other words, the absolute benefit is about 1%, not 36%. The aggressive promotion of this drug is even more egregious when considering that 10-15% of those who take it experience significant side effects. All for a 1% advantage in terms of heart attack risk, and no reduction in the risk of mortality.
The same holds true with other drugs directed at regulating cholesterol levels. Torcetrapid, made by Pfizer, lowered LDL levels by 46%, and when used with Lipitor, raised HDL by 106%. But it increased the rate of deaths and adverse cardiovascular events.
- Several things lead to the continuation of this travesty:
- The FDA approval process – The FDA allows drugs to be approved for use when they are shown to be 1% more effective than placebo
- Most doctors do not know how to analyze statistical results of studies to ferret out the actual benefits of drugs for patients.
- Most doctors allow pharmaceutical reps to provide them with information about drug use and efficacy
- Most patients do not know how to ask the right questions before agreeing to a drug regimen.
- Most doctors and other medical professionals, as well as most patients, do not know that dietary excellence is an effective option.
Side Effects of Statin Drugs
According to a study published in Drug Safety* most
doctors dismiss the possibility that symptoms reported by their patients
could be caused by statin drugs. The researchers focused on the three
most common side effects from statins, which are muscle pain, cognitive
disorders and nerve injuries.
In the study, patients related their symptoms to 138 doctors. When patients complained about muscle pain, tightness, cramping or weakness, 38% of the doctors acknowledged the possibility that statins could be the cause, while 62% dismissed the possibility.
Patients complaining about impaired memory or thinking reported that 29% of the doctors acknowledged that statins could be the cause, while 71% dismissed the possibility.
And for those patients presenting with nerve injuries that included pain, weakness or loss of function, only 35% acknowledged the potential role of statins, while 65% dismissed the possibility.
The patients were provided with materials prior to their doctors appointments that helped them to relate a clear description of their symptoms, and an analysis of the patients’ symptoms concluded that 80% of the cases met the criteria for a probable drug reaction.
After the appointments, patients were asked to describe their doctors’ attitudes and responses to their complaints. Some doctors wrote off the symptoms to imagination or aging. Some of them insisted that statin drugs do not cause side effects. Overall nearly 2/3 of the doctors failed to identify their patients’ symptoms as being side effects of drugs.
Not only is this frustrating to any patient, it is frightening in terms of the implications for public health. Doctors are supposed to report side effects to the FDA Medwatch system. This is supposed to be one of the mechanisms for the FDA to determine whether or not a drug is safe to remain on the market. It may be, based on this information, that only a fraction of the side effects from drugs are actually being reported.
For your information, here are some of the comments made by doctors and reported by patients involved in this study:
- “Can expect some problems at your age”
- “Well, you’re no youngster”
- “No way, you’re just getting old”
- The doctor shrugged and said some people just lived with it and then laughed
- Made me feel like I was alone in my inability to take statins because of minor discomfort
- Said I must continue, protecting the heart was most important
- Suggested it was my imagination
- Told me I just didn’t like taking pills
- That is not a side effect of this drug
- Not possible
- Almost impossible
- Statin drugs do not cause memory loss, and may, in fact, help it
- Can’t be the statins, thinks they are miracle drugs
- Said that only 1% of statins have side effects
Of course, there are doctors who understand the side effects of drugs, including statins, and are conscientious about recognizing and dealing with these issues. Unfortunately, they are in the minority, which leaves the patient to assume control of his or her health care!
Zetia is a popular drug (close to $5 billion in sales for 2007) prescribed for people with elevated cholesterol. It is often prescribed along with other cholesterol-lowering medications, and is an ingredient, along with Zocor, in Vytorin, another best-selling cholesterol-lowering drug.
According to a recent article in the New York Times, Merck and Schering Plough have conducted studies on Zetia that found increased risks of liver damage, but the companies never reported the results of those studies. The studies were conducted between 2000 and 2003, and are not currently listed on industry websites where companies are supposed to register the results of all drug trials that were ongoing after October 2002.
According to Schering, the FDA has reviewed the findings of the unpublished studies and continues to approve Zetia for use along with other statin drugs. However, the governments of both Australia and Canada have issued warnings about links between Zetia and hepatitis, pacreatitis, and depression since 2005. The FDA has done nothing about the fact that the studies were not registered as required.
Merck and Schering continue to refer to published studies of Zetia in which no safety issues were identified. However, these studies covered periods of only 12 weeks, while liver damage and other side effects take significantly longer to develop. Even so, those trials showed that 11 times as many people who took Zetia along with other cholesterol lowering medications developed serious health problems as compared with those who only took a statin drug.
Overall, cholesterol-lowering drugs are some of the most widely prescribed drugs by doctors, who rarely talk to their patients about lowering cholesterol through diet and lifestyle. Most medical professionals continue to hold onto the false beliefs that elevated cholesterol is hereditary, that diet and lifestyle are not sufficient to lower it, and that people will not make the changes necessary to lower their cholesterol through diet and lifestyle. I think more of them would if they knew that the risks of taking statin drugs are quite serious.
One of my major complaints about medicine and health is that consumers are not making informed choices. I’m convinced and my experience has shown that many people will choose to adopt a program of dietary excellence and optimal habits if they are shown both efficacy of that plan, as well as the dangers of pharmaceutical intervention. The problem is that most people are not being given this information. This is particularly true for statin drugs, prescribed for lowering cholesterol.
A recent analysis of 23 large clinical trials involving statin drugs appeared in the Journal of the American College of Cardiology.* The authors had no financial connections to drug companies.
Statin drugs are known to cause liver damage, which is identified through blood tests. When liver cells die, liver enzymes are released, so elevated blood enzyme levels are indicative of damage. In this analysis, the higher the dose of the statin drug prescribed, the greater the percentage of patients with liver damage. For example, high-dose Lipitor caused 4 times more liver injuries than low-dose Lipitor in one study and 5.5 times greater in another study. Millions of patients are given these drugs in high doses, which means that hundreds of thousands of patients are likely to develop liver injuries, some of them permanent, as a result.
The same held true with muscle pain and weakness, a condition known as rhabdomyolysis. The rate of rhabdomyolysis, which can also cause kidney injury, kidney failure and death, was more than 7 times greater with high-dose Zocor than lower doses.
The most disturbing correlation, however, was statin use and cancer. The authors noted that “there was a highly significant inverse relationship between achieved LDL levels and rates of newly diagnosed cancer.” We know from research such as that reported in The China Study that lower cholesterol levels are actually correlated with lower cancer rates, which means that the causative effect in these studies has to be the increasing doses of statin drugs required to achieve lower LDL levels in these patients.
The risks associated with statin drugs are significant and unnecessary, in view of the fact that cholesterol can be lowered as quickly and sometimes more so with diet and lifestyle.
*Alsheikh-Ali, AA, et al, “Effect of the magnitude of lipid lowering on risk of elevated liver enzymes, rhabdomyolysis, and cancer,” Journal of the American College of Cardiology 2007;50:419-20.