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Patients grope in the dark as new light shed on a vital drug

DUBAI - Life-threatening complications, including cases of renal failure and rhabdomyolysis, or muscle damage, have allegedly been reported in the US and the UK from users of a cholesterol-lowering drug, rosuvastatin, marketed under the trade name "Crestor" and manufactured by AstraZeneca Plc, according to Public Citizen, a US-based consumer advocacy group.

There are signs, however, that unsubstantiated claims about Crestor were leaked to the media by three American pharmaceutical companies, who manufacture similar statin drugs and are the main competitors of the Anglo-Swedish pharmaceutical company that manufactures Crestor. The aim, in all likelihood, is probably to create a lack of public confidence in the drug.

The drug has been approved by the US Food and Drug Administration (FDA) and in turn by the UAE Ministry of Health. According to Public Citizen, at least 11 cases of life threatening complications involving the drug have been brought to the FDA's attention.

Waleed Sabet, Product Manager, Gulf Region, for AstraZenica Plc, told Khaleej Times the drug had been found to be safe and effective by the FDA and he cited several articles in specialised medical journals reaffirming this fact. He said that the "noise" created in the media about Crestor has been engineered by AstraZenica's three main American competitors in the manufacture of statin drugs.

In the last 16 years, seven statin drugs were introduced onto the American market for the treatment of dyslipidemia, one of these, cerivastatin, marketed as Baycol, was withdrawn four years after its introduction due to a large number of fatal and nonfatal cases of rhabdomyolysis. Since 1997, only one statin was introduced onto the American market and that was Crestor

"After the withdrawal of Cerivastatin it was not easy for the FDA to approve a new statin. Crestor was first tested on 12,000 patients, the FDA scrutinised the results and the drug proved to be quite safe," Mr Sabet said.

Dr William Clifford Roberts, Editor in Chief of the American Journal of Cardiology, in an editorial, pointed to the safety of the drug and its efficacy in lowering low-density lipoprotein (LDL), also known as bad cholesterol, and its efficacy in lowering serum triglycerides. In addition, he said: "It has safety features in its 5mg to 40mg dose range similar to those of the other five statins presently available."

On the potential downside of rosuvastatin, Dr Roberts pointed out that there were no long-term outcome studies with such a new statin. He did point out that there were no long-term studies out on another similar statin before six years of its introduction on the market. He stressed that long-term studies on rosuvastatin were under way before it was approved by the FDA, with results expected in three years.

In his article, Dr Roberts pointed out that one side effect noted before approval of the drug was proteinuria or microscopic hematuria in under one per cent of patients taking the drug, a complication noticed primarily in patients receiving an 80mg dose, a dose which has not been approved by the FDA.

The consumer group Public Citizen, quoted in an article on Bloomburg.com, sent a letter to FDA Commissioner Mark McClellan asking him to halt Crestor sales. Since the drug won approval in August 2003, the group said that three US patients developed kidney failure or muscle damage and said one died, citing information from the FDA and other health agencies.

"The urgency of this petition is heightened by the fact that AstraZeneca is currently launching a major direct-to- consumer advertising campaign to promote the drug," Public Citizen's director of health research, Sidney Wolfe, wrote.

More than a dozen products have been pulled from the US market after Public Citizen asked the FDA to withdraw them, including the Rezulin diabetes drug and Redux diet pill, the Washington-based consumer group said.

AstraZeneca, the UK's second largest drug maker, said in January that total sales of Crestor reached $41 million in its first full quarter on the US market. Around one million patients take Crestor worldwide.

All statins are associated with rare cases of a breakdown of muscle cells. The condition can cause kidney damage and possible death when it overwhelms that organ's ability to clean up the debris left by dead muscle cells.

Public Citizen, which represents about 160,000 US consumers asked the FDA in July last year not to approve Crestor because of its potential for side effects.