Media Hype Over Crestor May Be Hazardous To Your Health
Major new media outlets have become very exited over Crestor, which is a cholesterol-lowering drug produced by AstraZeneca and is within a classification of drugs called “Statins”. The manufacturer began a four-year study called “Jupiter” and ended it after two years claiming astounding results.
Reuter has reported, “The 17,802-patient study was stopped more than two years early by independent safety monitors because the benefit from 20 milligrams of Crestor daily was so pronounced - 142 heart events with Crestor versus 251 on placebo. For every 25 patients treated, one serious heart event was avoided. Heart attacks were cut by 54 percent, strokes by 48 percent and the need for angioplasty or bypass was cut by 46 percent compared with a placebo. Study subjects taking Crestor were also 20 percent less likely to die from any cause, a secondary goal of the trial” (see Reuter’s report).
The idea behind all this media hype is the prior scientific discovery that C-reactive protein (CRP) levels are a better indicator of risk of heart attack than low-density lipoproteins (LDL), also known as “bad cholesterol”. Elevated CRP’s are an indicator of arterial inflammation, which purportedly increases the risk of heart attack more than LDL’s. The makers of Crestor wanted to see if their product would lower CRP’s in people with normal cholesterol levels thereby preventing heart attacks in a previously untreated population.
The conclusion made by participating cardiologists is that they can start prescribing Crestor to everybody to prevent fifty percent of all heart attack deaths and twenty percent of deaths from any cause. Notwithstanding that, there may be some merit to the “startling results”, this rush to begin prescribing this drug indiscriminately is reckless and a danger to the well being of an unsuspecting public for several reasons.
First, there is a risk to taking Crestor because there are reported side effects that range from minor discomfort to catastrophic illness and death. The known side effects of Crestor are headache, nausea, vomiting, diarrhea, muscle pain, liver failure, muscle breakdown (rhabdomyolysis) and kidney failure. In fact, Crestor and the other Statins are so potentially injurious to the liver that periodic liver function studies conducted on all patients during administration of this drug is a standard of care and they have to discontinue use if the liver enzyme levels are 300% above normal or baseline (Source: MedicineNet.com) .
Second, AstraZeneca, the manufacturer of Crestor, the largest selling cholesterol-reducing drug in the world, orchestrated the study and funded it in order to justify new reasons for prescribing it to people with normal cholesterol levels. Of course, a favorable result would exponentially increase the sales of the drug in question because it means that the entire adult population of the world would believe that Crestor is a miraculous life-extending drug. The potential profit is in the trillions with a retail charge of $3.45 per day per person. Therefore, the research had a built-in bias with a strong stake on the part of the investigators in a desired outcome. Hence, the results are highly suspect.
Third, appropriate scientific methodology requires that non-related independent medical researchers repeat the experiment to verify the results. Although the study involved about 18,000 people, we do not know what confounding variables existed or the statistical significance of the findings to rule out the possibility that the difference in the heart attack rates of the treated versus control groups would have occurred anyway. Moreover, we do not know what the subject selection criteria were so this sample may not have been a microcosm of the entire population. Normally in a study involving disease prevention, the sample size has to be much larger than 18,000 and for much longer than two years.
Additionally, Mark A. Hlatky, M.D. in an editorial published in the New England Journal of Medicine warned that before expanding the use of drugs like Crestor the “evidence should be examined critically”. Dr. Hlatky noted the significant relative reductions in risk between the control and treated groups, but also pointed out that absolute differences in risk were more clinically important. (NEJM) The author also stated “To understand who might benefit from high-sensitivity C-reactive protein testing, there should be a detailed analysis of how the estimated (and actual) cardiovascular risk of the screened subjects changed on the basis of their high-sensitivity C-reactive protein levels, particularly in relation to generally accepted risk thresholds and in key subgroups such as women.” He also warned that there was no data on the benefit of lowering LDL levels to 55 in healthy individuals and no data on the risk of committing healthy individuals to twenty years of drug therapy.
In conclusion, in view of the potentially devastating side effects of the drug called Crestor, there is a risk of liver and kidney damage in reducing the risk of heart attack. There is also insufficient evidence to justify indiscriminate prescribing of Crestor to people with normal cholesterol levels. This is not the same as taking low-dose aspirin. While there may be some justification for prescribing Crestor to people with normal cholesterol to treat high CRP levels, the provider owes a duty to the patient to warn of the possible side effects. Furthermore, the prescribing of Crestor for anything other than lowering high LDL’s is an off-label use and more research is needed before doctors can be justified in changing the standards of care.
Reported by Thomas A. Sharon, R.N., M.P.H.