Lipitor News

What are "statins"?
Lipitor (atorvastatin calcium) is a synthetic cholesterol-lowering drug produced by the pharmaceutical company Pfizer and distributed by Parke-Davis (a division of Pfizer Inc.) It belongs to a group of prescription drugs called "statins." These drugs are HMG-CoA reductase inhibitors and work by selectively blocking a key enzyme in cholesterol production. The enzyme HMG-CoA reductase and the drug both compete for a place in the chain of events that lead to the production of cholesterol. Because the drug does not eliminate the enzyme altogether, cholesterol is still made by the body. What it does do is take the place of the enzyme in the steps of cholesterol production, stopping it at a key step, therefore reducing the amount of cholesterol that the body produces.

Statin drugs have surged into popularity over recent years for their effectiveness in lowering cholesterol. In 2004, Lipitor was the most widely prescribed drug (75 million prescriptions dispensed) with the statin drug class topping all drug sales at $15.5 billion. It has been suggested that the popularity of statin use is due to an increase in the number of individuals diagnosed with high cholesterol, heart disease, and diabetes, as well as an increase in marketing the drugs to physicians and the public. Indeed, pharmaceutical companies have invested large sums of money to educate the public about the benefits of statin use. In 2004, Pfizer spent $120 million in Lipitor advertising.

Statins are primarily prescribed for individuals with multiple risk factors for developing heart disease. These risk factors include a family history of heart attack or heart disease, high blood pressure, high LDL cholesterol ("bad" cholesterol), low HDL cholesterol ("good" cholesterol), age, smoking, or Type 2 diabetes. Physicians concur that lifestyle changes such as eating a healthy diet and an increase in exercise should be the first steps in any attempt to lower cholesterol, whether or not you are prescribed a cholesterol-lowering drug. Studies have found, however, that there is a genetic component to cholesterol levels. You could have the healthiest of lifestyles, but still have high cholesterol because of an inherited defect in your body's metabolism. This knowledge has certainly been added to the marketing arsenal of pharmaceutical companies and could contribute to the recent increase in statin popularity.

Risks & Side Effects
However, as with any drug, there are potential side effects associated with use. In the case of Lipitor, the prescribing information provided by Pfizer lists relatively few. During clinical trials, the most frequently reported adverse reactions that were associated with taking the drug were constipation, flatulence, dyspepsia (stomach pain that is related to gastrointestinal dysfunction), and abdominal pain.

Although the above listed side effects appear to be rather benign and statins are often promoted as a safe and effective tool in cholesterol management, there are several rather severe warnings and potential hazards associated with taking Lipitor and any statin drug. Cholesterol is a very important part of fetal development. Because statins limit cholesterol production and this has the potential to cause fetal harm, they should not be taken by women who are pregnant or nursing. In fact, it is recommended that women of childbearing age should only be prescribed statins when they are highly unlikely to conceive. The FDA has given Lipitor a Pregnancy Category X rating. This means that studies have demonstrated risks to the fetus while taking the drug and these risks far outweigh the potential benefits.

Another severe warning that comes with taking Lipitor is the potential for developing liver dysfunction. Statins have been associated with an elevation of liver enzymes. When patients have stopped taking the drug, these enzyme levels typically go back down. It is suggested that those patients with a history of liver disease or who consume large quantities of alcohol use caution when taking the drug. It is also recommended that liver function be monitored prior to drug use, as well as throughout treatment.

One of the most serious side effects that have come to light with statin use is statin-induced myopathy (muscle disease or damage). The gravity of this side effect first came to public attention in 2001 when Bayer pulled its statin, Baycol, from the market because of rhabdomyolysis-related deaths due to Baycol use. Rhabdomyolysis is the potentially fatal breakdown of muscle proteins into the bloodstream. Some of these proteins are toxic to the kidneys and can lead to kidney damage, and in severe cases, death. Although at the time Bayer and the FDA indicated that rhabdomyolysis seemed to be related only to Baycol use, all statin drugs have come under scrutiny for the potential danger they can cause to patients. The prescribing information for Lipitor does state that muscle pain or weakness has been reported in Lipitor-treated patients and in rare instances, rhabdomyolysis.

Criticism & Controversy
Myopathies and rhabdomyolysis have brought a considerable amount of criticism to the marketing and prescribing of statin drugs. The watchdog group Public Citizen Health Research Group (www.citizen.org) has petitioned the FDA to change the labeling of all statin drugs to include a much more severe and specific warning about myopathies and rhabdomyolysis. They recently petitioned for the removal of Crestor (rosuvastatin) from the market because of the increased number of patients that develop kidney damage while taking the drug as compared to other statin drugs. While the petition was denied, the FDA has issued a public health advisory alerting physicians to carefully read the Crestor product label and dosage recommendations.

The most recent controversy involving statin drugs focuses on Pfizer and their marketing of Lipitor. In September 2005, a class action lawsuit was filed on behalf of Teamsters Local No. 5 Health Plans, several individuals, and the consumer advocacy group Health Care for All. It is alleged that Pfizer has been misleading women and seniors about the link between Lipitor and heart disease in the interest of promoting profits and sales. Although it is true that Lipitor does lower cholesterol, the lead attorney for the lawsuit states that Pfizer has promoted Lipitor to women and the elderly with no history of heart disease even though there is no clinical evidence that taking the drug would benefit them. Four studies are cited (www.lipitor-classaction.com/main.php?l1=Studies) for the basis of the lawsuit. The ASCOT Study found that the women who took Lipitor developed 10% more heart attacks and heart disease deaths than those taking the placebo. The PROSPER Study, ALLHAT Study, and Framingham Heart Study all concluded that statin therapy does not significantly reduce the risk of developing heart disease or stroke in elderly patients that do not already have a history of heart disease.

So, it seems, taking Lipitor or any statin drug to lower cholesterol in the hopes of preventing heart disease in the elderly may be futile and a waste of money. The lawsuit charges that Pfizer, by marketing Lipitor to these groups as a means of preventing heart disease, has created an artificial demand for the drug. At a time when rising healthcare and prescription costs for the elderly is an important issue, these are not trivial charges. There is currently no generic version of Lipitor and in 2005 the average monthly cost of taking it was $123. According to Consumer Reports, the elderly make up a majority of the population taking statin drugs.