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The Great Crestor Hype
With great fanfare, the establishment medical journal The New England Journal of Medicine (NEJM) published a paper "Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein."[1] Rosuvastatin (Crestor) is a drug marketed by the pharmaceutical company AstraZeneca as a HMG-CoA reductase inhibitor (they called it a 'super-statin'). AstraZeneca funded this study, and the lead author is one of the patent holders for the high sensitivity C-Reactive Protein test (hs-CRP),[2] a sensitive blood marker of inflammation. Of course there are no real vested interests apart from the health of the nation, and as such, the American Heart Association meeting wondered whether it should be "put in the water".[3] This harks back to the PolyPill hypothesis,[4] where it was suggested everyone should take pharmaceutical medication before they inevitably get ill. Shares in AstraZeneca rose since the NEJM publication,[3] as it would cost $116 USD per month for an individual (over $1,300 USD per year) to take it daily, according to USA Today.[5] This means that each life saved would cost approximately $557,000 (if you believe the studies). AND that does not include the cost of the patented hs-CRP test (more expensive than a cholesterol test). And according to The Blog of Michael R Eades MD,[6] the drug might only give a little protection to a very few people:
If you believe the data from this study..., it indicates that men over 50 and women over 60 with normal LDL-cholesterol levels AND elevated C-reactive protein levels who took the very expensive ($3.50 per day) statin drug rosuvastatin (Crestor) minimally reduced their risk of developing heart disease or dying of any cause as compared to those who took placebo.
So what else should we put in the water - the toxic chemical fluoride? But that's another story ...
What is counted by medics as 'high' cholesterol has been gradually dropping over the years as drug companies push the 'benefits' of statins as a simple magic bullet to the ubiquitous deaths from heart disease. Yet simple epigenetic cardiovascular disease risks such as low birth weight in males who regain a normal or above average Body Mass Index in childhood,[7] or men with shorter legs[8] or shorter index fingers than ring fingers[9] (high 2D:4D ratio) are ignored until the individual becomes a patient with heart disease later in life.
Back to the paper, which was dubbed the JUPITER trial: "The primary objective of the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) was to investigate whether treatment with rosuvastatin, 20 mg daily, as compared with placebo, would decrease the rate of first major cardiovascular events." Eades translates this as "by God we’re going to prove that statins prevent something. "[6]
And what it did prove is that more people taking Crestor got diabetes than the people not taking Crestor:
We did detect a small but significant increase in the rate of physician-reported diabetes with rosuvastatin, as well as a small, though significant, increase in the median value of glycated hemoglobin. Increases in glucose and glycated hemoglobin levels, the incidence of newly diagnosed diabetes, and worsening glycemic control have been reported in previous trials of pravastatin, simvastatin, and atorvastatin.
Even though physician-reported diabetes was been significantly increased in this and previous Crestor studies, and statins are given to people who have diabetes because they have diabetes, the authors say that "further study is needed before any causative effect can be established or refuted." Eades suggests that this is why the study was stopped when it was by outside observers. Ok, let's further poison our water supply with an expensive drug that gives people diabetes (not to mention muscle pain) all in the name of health.
References:
1. Ridker PM, Danielson E, Fonseca FA, et. al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med. 2008 Nov 9.
2. US Patent 6040147 - Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease. Paul M Ridker.
3. "Cholesterol Pills in the Water? Crestor Market Widens (Update3)". Bloomberg.com news, Nov 10 2008.
4. Wald NJ, Law MR. "A strategy to reduce cardiovascular disease by more than 80%". BMJ 2003;326:1419 (28 June), doi:10.1136/bmj.326.7404.1419
5. "Crestor would save lives at $500,000 each" Steve Sternberg, USA Today, Nov 10 2008.
6. Eades, M. Weblog: "Truth versus hype in the Jupiter study" 10. November 2008.
7. Eriksson JG, Forsén T, Tuomilehto J, Winter PD, Osmond C, Barker DJP "Catchup growth in childhood and death from coronary heart disease: longitudinal study." BMJ 1999;318;427-431
8. Davey Smith G, Greenwood R, Gunnell D, Sweetnam P, Yarnell J, Elwood P. "Leg length, insulin resistance, and coronary heart disease risk: The Caerphilly Study." J. Epidemiol. Community Health 2001;55;867-872 doi:10.1136/jech.55.12.867
9. Manning JT, Bundred PE, Flanagan BF. "The ratio of 2nd to 4th digit length: a proxy for transactivation activity of the androgen receptor gene?" Med Hypotheses. 2002 Sep;59(3):334-6. Pubmed 12208164
7 comments
Caveat emptor!
Over 25 years ago my mother was hospitalized for septicemia and because her CRP was elevated she was put in ICU with heart patients. I asked if the staff if they thought she had had a heart attack or stroke and "oh no. its what we do if CRPs elevated even though its likely something else." All she needed was a room, and care to get rid of the infection. I am sure Medicare/sec. ins were charged a lot more this way. I don't remember the what the charges were.
I just read your article and said hooray! Someone recognizes the Crestor danger! 3 years ago, my cholesterol was 220-my MD gave me samples of Crestor. Within days I experienced terrible pain in my pancreas,liver area radiating up into my back. The pain grew worse every day-after 5 days my doctor sent me to the emergency room - pancreas and liver tested normal, no muscle tests done. I stopped the Crestor and all the pain went away over the course of 2 or 3 days. One year later I was rushed to the hospital with blood sugar over 550 and sudden traumatic type 1 diabetes. I am now insulin dependent. There is no diabetes in my family and I was not overweight. The only connection to this sudden type 1 is the incredible pain I had suffered one year earlier caused by my bodies reaction to the Crestor. The Crestor compromised my pancreas, my beta cells were gradually destroyed and I have type 1. I know that in my case the Crestor and my bodies reaction to it directly caused me to contract type 1 diabetes. I am so glad that you recognize the Crestor-diabetes connection and hope you continue to make your voice heard. I have reported my history to the FDA and to Johns Hopkins Health Alerts and have been met with silence.
Vicki
The way that this is reported is thus in Table 3:
Nonfatal myocardial infarction: Crestor 22 Placebo 62
Any myocardial infarction: Crestor 31 Placebo 68
Subtract Nonfatal myocardial infarctions from Any myocardial infarctions and you get Fatal Myocardial infarctions, a statistic which is NOT reported in the list of "end points." But simple math gives us the information that there were 9 fatals in the Crestor group as opposed to 6 in the placebo group.
A great reason to end the trial. While not significant, this relative rate approaches significance at five years (significant with a one-tail t-test) significant at 7 years, highly significant at 10 and at 20 years there are so many "0" after the decimal point that even the X-spurts would have to accept it.
With Baycol already banned what better reason to terminate? Big Pharma is generally more concerned about the bottom line than lives - vide VIOXX
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