Fwd: Statin Advertising Passed Off As Research

[Guest guest]

Read this McDougall Announcement online: http://www.drmcdougall.com/misc/2008other/news081110crestor.html

 

Breaking News

 

Advertising Passed Off As Research

Confuses the Public Again

Study Published in New England Journal of Medicine

Expands the Indications for Statins—and the Public Suffers

 

Today’s (November 10, 2008) front page headlines worldwide

announced a simple test called “highly sensitive C-reactive protein”

(HS-CRP) and the most powerful cholesterol-lowering statin currently

on the market, Crestor (rosuvastatin), used together, could cut the

risk of heart attacks, strokes, and death from cardiovascular disease

in half.1 For the casual reader, Crestor appears to be a miracle

treatment with few risks and reasonable costs. Today’s

publication adds to the belief of a growing number of experts that

“statins are so wonderful that they should be added to our drinking

water” (like fluoride).

 

For this study nearly 90,000 people were examined, and most of

them were identified as being at increased risk for a heart attack,

stroke, and/or premature death. Rather than choosing professionalism

and treating the underlying causes of their health problems: their

diet and lifestyle; these researchers chose commercialism; creating

the most effective pharmaceutical advertising campaign ever devised.

And they have succeeded.

 

The study was funded by the maker of the drug, AstraZeneca, and

the lead author, Paul M Ridker MD, is listed as a co-inventor on

patents held by Brigham and Women's Hospital related to the use of

HS-CRP for the evaluation of a patient’s risk of heart disease.

 

Profits Are Determining Medical Care

 

The cost of Crestor (rosuvastatin) is about $3.45 per day—much

higher than that of generic statins. That amounts to $1259 a year just

for this drug. Doing the math, this means to prevent one event in one

“apparently healthy patient” would cost about $300,000 just for

the Crestor. These figures do not include the cost of doctors’

visits, the lab tests and the treatment of side effects from the

medications, including the serious adverse events caused by

Crestor.(Calculations: Absolute benefit of 1 event for 120 treated

patients for 1.9 years at $1259 = 120 x 1.9 x $1259 = $287,052.)

 

Heart attacks, strokes, and the need for surgery and drugs are

caused primarily by eating the Western diet, and secondarily by “bad

habits,” including cigarette smoking and lack of exercise. The

underlying disease, atherosclerosis, is reversible. There are no

side effects or added costs with diet-therapy—therein lies the

problem (no profit).

 

How Did They Get Those Results?

 

1) They stacked the deck with sick people, but passed them off as

“healthy” to the press and public. Previous studies of statins

have found that people at high risk for a heart attack or stroke will

benefit, but healthy people will not.2 The deception in this study

began by choosing high-risk test subjects and identifying them as

“apparently healthy men and women.”

 

The nearly 18,000 people selected for the study out of the

original 89,890 screened had very high HS-CRP levels of over 4.2

mg/L. Simply based on the HS-CRP these were not “apparently

healthy,” but rather, people at high risk for cardiovascular

disease. The cutoff value for high “bad” LDL-cholesterol level was

130 mg/dL. This allowed the inclusion of many high-risk

people—“good health” is associated with a LDL below 100 mg/dL. In

addition, the average blood pressure (134/80 mmHg) and total

cholesterol (186 mg/dL) numbers were too high for these people to be

considered “apparently healthy.”

 

The baseline median body mass index (BMI) was 28.3 (normal

18.5-24.9), indicating most of these people were overweight or obese.

At the beginning of the study 41% were reported to have “metabolic

syndrome.” (Metabolic syndrome is a combination of medical

disorders, such as abdominal obesity, elevated blood sugar,

triglycerides, and blood pressure, which considered together indicate

an increased risk of cardiovascular disease.)

 

2) They Emphasized Relative, Not Absolute Benefits

Reporting the “relative benefit” of a drug is the most common

method used by drug companies to deceive patients and their doctors.

In this case relative risk reduction was determined by dividing the

number of designated events (heart attacks, stroke, and deaths from

cardiovascular disease) for the treated (Crestor) group by the events

for the placebo group: 83 vs. 157. This mean the treated group had

half (53%) the chance of an event compared to placebo. This

figure is impressive.

 

However, the “absolute benefit”—the real life benefit a

person can expect from treatment—is a very different story. Consider

the numbers: nearly 18,000 people were treated for almost 2 years.

In absolute numbers this means 83/8901 or 0.9% of those people taking

Crestor had a serious event, as opposed to 157/8901 or 1.8% of those

in the placebo group. This is an absolute event reduction of less than

1%. In other words, 120 patients had to be treated with Crestor

for 1.9 years to prevent one designated event: heart attacks, strokes,

and death from cardiovascular disease.

 

3) Early Termination of the Study Is Impressive but Suggests

Dishonesty. The study was supposed to go on for 4 years, but was

stopped at 1.9 years for “ethical reasons.” It was considered

unethical to continue the study because continuation would mean

depriving the people in the placebo group of the advantage of the

treatment—Crestor in this case. “Early termination” of research

is a powerful technique used by pharmaceutical companies to enhance

the perceived value of the treatment in the minds of the medical

profession, the press, and the public. But it has been shown that

studies that are stopped early are biased and prone to exaggeration.3

According to a recent review in the Journal of the American Medical

Association, “RCTs (Randomized Controlled Trials) stopped early for

benefit are bec oming more common, often fail to adequately report

relevant information about the decision to stop early, and show

implausibly large treatment effects, particularly when the number of

events is small. These findings suggest clinicians should view the

results of such trials with skepticism.”4

 

No mention was made in this report about two other recent studies

(CORONA and GISSI-HF) where Crestor did not result in any improvement

in survival. 5,6

 

4) Researchers Underemphasized Serious Adverse Events from

Crestor. One of the most important findings from this study (found in

table 4) is the similar number of serious adverse events in both the

Crestor-treated and placebo groups—1352 (15.2%) vs. 1377 (15.5%).

How can that be? Wasn’t the number of events about half (83 vs. 157)

for those taking Crestor? The study focused on events (heart attacks,

strokes, and deaths from cardiovascular disease) that are expected to

respond favorably to treatment. The study, and the media that

followed, did not give appropriate attention to all adverse events

that occurred. Clearly, there was an increase in non-cardiac serious

adverse events in the Crestor group. Obviously, it is not in the

best interest of the sponsor of the study to give attention to this

findi ng.

 

The article did mention an increase in risk of diabetes in those

treated with Crestor (270 reports of diabetes, vs. 216 in the placebo

group). But there must be more. Amazingly, this study reported only

one case of serious muscle damage (rhabdomyolysis). The expected

rate is 3.16 fatal cases per million prescriptions written for

Crestor.7 This is 16 to 80 times higher than that reported for

other statins. Almost four years ago Dr. David Graham, FDA's associate

director for science and medicine, named Crestor as one of five drugs

that pose serious safety concerns and the FDA told AstraZeneca to pull

its ads for Crestor because they do not mention its risks of causing

acute kidney failure or rhabdomyolysis.

 

There is no long-term information on the safety of using these

high doses of Crestor to lower “bad” LDL-cholesterol to 55 mg/dL

(as they did in this study). This study was stopped after less

than 2 years, but patients prescribed statins can expect to take them

for 20 years and longer.

 

One More Deregulated System That Must Be Fixed

 

Neither the patient nor our over-burdened health care system can

thrive with this kind of deception from the pharmaceutical companies

and the medical journals. Fortunately, health care professionals are beginning to recognize

that what is happening in medical care is just like the tragedies we

have recently witnessed in the stock market and the housing

industries. Unregulated business practices lead to a few very

rich people becoming even richer, and severe suffering for the rest of

us. The time has come for change. Researchers and

publishers must be held accountable like stockbrokers and bankers.

Regulation enacted to protect the public is long overdue.

 

 

What is HS-CRP?

 

C-reactive protein (CRP) is a molecule produced in response to

inflammation. It is non-specific, in other words, it does not identify

the source of the inflammation, which could be due to an infection of

a toe, arthritis, or a bad cold. The connection to

cardiovascular disease (heart attacks and strokes) is that the sores

(like pustules) on the artery walls cause the CRP to rise. This

festering artery disease (atherosclerosis) is the underlying cause of

heart attacks and strokes. The elevated CRP is simply one sign

of the trouble—other signs are elevated blood pressure, blood sugar,

cholesterol and triglycerides.

 

Highly sensitive (HS) refers to laboratory methodology used to

increase accuracy. A level of less than 1mg/L indicates low risk, a

level between 1 and 3mg/L indicates moderate risk, and a level greater

than 3mg/L indicates high risk of active artery disease. The people in

this study were on average in the high-risk group, in need

of immediate and intensive dietary intervention.

 

Statins, like Crestor, are believed to be anti-inflammatory,

reducing HS-CRP levels. Even without the postulated benefit of

reduced inflammation, the cholesterol lowering effects of statins have

been shown to reduce the risk of serious cardiovascular events in

people at high risk. 2 A low-fat diet also cuts CRP in half in 4

weeks. 8 This reflects less inflammation, which means

healing the arteries as a result of following a healthier diet.

 

References:

 

1) Ridker,P Danielson, E Fonseca F, Genest J, Gotto A, Kastelein

J, Koenig W, Libby P, Lorenzatti A, MacFadyen J, Nordestgaard B,

Shepherd J, Willerson J, Glynn R, the JUPITER Study Group.

Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated

C-Reactive Protein. N Engl J Med. 2008; 359:2195-2207

 

2) Abramson J, Wright JM. Are lipid-lowering guidelines

evidence-based? Lancet. 2007 Jan 20;369(9557):168-9.

 

3) Hopewell S, Clarke M, Moher D, Wager

E, Middleton P, et al.

PLoS Medicine Vol. 5, No. 1, e20 doi:10.1371/journal.pmed.0050020

 

4) Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH,

Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC,

Schünemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B,

Thompson CA, Zhou Q, Mills E, Guyatt GH. Randomized trials stopped

early for benefit: a systematic review. JAMA. 2005 Nov

2;294(17):2203-9.

 

5) Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JG, Cornel

JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L,

Hjalmarson A, Hradec J, Jánosi A, Kamensk? G, Komajda M, Korewicki

J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberger

M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J;

CORONA Group. Rosuvastatin in older patients with systolic heart

failure. N Engl J Med. 2007 Nov 29;357(22):2248-61.

 

6) Gissi-Hf Investigators. Effect of rosuvastatin in

patients with chronic heart failure (the GISSI-HF trial): a

randomised, double-blind, placebo-controlled trial. Lancet. 2008 Aug

29.

 

7) Bruce J, Rabkin E., Martin V. Rhabdomyolysis associated

with current us of simvastatin and Nefazodone: Case report and current

review of the literature. Advanced Studies in Medicine 2003; 3:

168-172.

 

8)Rankin JW, Turpyn AD. Low carbohydrate, high fat diet increases

C-reactive protein during weight loss. J Am Coll Nutr. 2007

Apr;26(2):163-9.

 

© 2008 John McDougall

McDougall Wellness Center P.O. Box 14039, Santa Rosa, CA

95402

http://www.drmcdougall.com