We agree with AstraZeneca's attorney that patients should follow the "advice of their physicians that they use FDA-approved therapies." Further, according to AstraZeneca's attorney "[f]or persons taking Crestor on their physicians' advice," they should not "stop taking the drug without the knowledge of their physician" as this "may result in serious complications and injury." We agree with AstraZeneca that it is important that the medical community maintain the "ability to convey accurate information to patients and to provide needed professional medical assistance." Please consult your physician regarding any questions or concerns that you have regarding medications and medical treatment.

However, we believe that there is a problem, such as we have seen recently in the news with Vioxx, in that the FDA has not always been a good regulator in recent years. This may leave people at risk of taking drugs that may later turn out to be dangerous. For example, on March 4, 2004, Public Citizen called on the U.S. Food and Drug Administration (FDA) to immediately remove the cholesterol-lowering drug rosuvastatin from the market. The drug, marketed by AstraZeneca as Crestor, has been linked to cases of life-threatening muscle damage and kidney failure or damage.

The problem according to another press release from Public Citizen, is that "[i]t becomes clearer by the day that this drug is uniquely toxic without offering any unique benefit, and that it must be removed from the market". However, according to counsel for AstraZeneca, in a letter to this firm, "studies have shown that Crestor offers features unique among the currently marketed statins, including: (1) the greatest efficacy for lowering serum LDL cholesterol; and (2) significant increases in beneficial HDL-C."
 

And, the problem, in general, with pharmaceutical products and politics is that the pharmaceutical industry paid lobbyists give astronomical sums of money to presidential and other political candidates. Just as many of these pharmaceutical manufacturers complain of the monies given by Trial Lawyers to political candidates in order to help maintain access to the civil justice system for individuals who have been harmed by unsafe drugs, one can only wonder what the pharmaceutical lobbyists expect as a result of making their large political contributions.

There are currently six statin drugs on the market:

• atorvastatin (Lipitor)

• fluvastatin (Lescol)

• lovastatin (Mevacor)

• pravastatin (Pravachol)

• simvastatin (Zocor)

• rosuvastatin (Crestor)

A seventh statin, cerivastatin (Baycol) was removed from the market in 2001 because of adverse reactions and serious side effects, including rhabdomyolysis.

Statins work by reducing production of cholesterol in the liver and by increasing the ability of the liver to remove LDL (bad) cholesterol from the blood. Statins reduce the level of LDL cholesterol in the blood and can reduce triglyceride levels and increase levels of HDL (good) cholesterol.

The newest statin, rosuvastatin (Crestor) has been marketed as a "super-statin" because AstraZeneca claims it reduces LDL cholesterol to a greater degree than the other approved statin drugs.

The approval of rosuvastatin (Crestor) is controversial because it follows the recall of Bayer’s cerivastatin (Baycol) which was also a super-statin. In 2001, Baycol was removed from the market because it caused life threatening side effects like rhabdomyolysis, a fatal muscle disorder. Side effects were reported with Crestor that appeared reminiscent of the Baycol experience. Cases of rhabdomyolysis were seen with Crestor during drug trials, particularly with the 80 mg. dose.

Crestor won FDA approval in August 2003 in 5, 10, 20, and 40 mg. doses, but not the 80 mg. dosage. In recent months there have been reports of serious side effects resulting from use of Crestor.

The FDA already has records of seven patients with rhabdomyolysis, including, according to Public Citizen, a 39-year-old American who died after using a 20-mg. dose, and a second death from an unspecified country. However, according to counsel for AstraZeneca, in a letter to this firm, "[a]lthough an adverse event report regarding the death of a 39 year-old woman came to AstraZeneca (and was in turn submitted to the FDA), subsequent investigation revealed that autopsy records for this patient established that she died of an actue myocardial infarction. In other words, the patient's death had nothing to do with Crestor."

Four patients with acute kidney failure, including a 79-year-old American man who died plus five additional patients with kidney damage. Crestor interacted dangerously with the blood-thinner Coumadin, commonly used by heart-disease patients; one Crestor-Coumadin interaction resulted in a hemorrhage. Who knows how many cases have not yet been reported to the FDA. Some studies show that only one-tenth of the actual cases are reported to the FDA.

The fact that so few patients on the 20 or 40 mg. doses took the drug for a sufficient period of time to have had a chance to develop rhabdomyolysis seems to have imparted a false sense of security about the safety of these doses concerning muscle toxicity. It is certainly possible that the FDA will require that Crestor be removed from the market after further damage to patients occurs.