Cholesterol and heart attacks - Study to save statins
Statin drugs still rake in billions but are threatened by declining trust of patients. In February, a new study announced "dramatic results". The study was not double blind, it was not an intervention trial - it simply examined the medical records of 551 heart failure patients and the likelyhood of death within one year of their first heart failure.
According to Dr. Gregg Fonarow, "patients who took statins were 55 percent less likely to die during the year after they were prescribed the drugs than patients who did not get them". This is contrary to the results of previous double blind intervention studies which weren't able to prove a significant reduction in heart attacks of those taking statins. Fonarow says that more studies are needed now, presumably to revive the sagging public image of these outright dangerous drugs.
According to a pharma-sponsored "medical education" website, Dr. Gregg Fonarow has received grant or research support, been a consultant, and served on the speakers bureau for the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. Nevertheless, the press has no qualms to promote low quality studies from biased sources as "revolutionary". Go figure. Jenny Thompson of the Baltimore Health Sciences Institute, has some interesting comments.
This was two months ago - February 2004. Since then, the pharmaceutical propaganda machine has continued to churn out what Dr. Mercola recently termed lunatic recommendations for taking statins. Not surprising - only a tiny fraction of drug advertising, according to the British Medical Journal, is supported by evidence and billions in revenues are at stake.
Statins highly recommended - according to their pharmaceutical sponsors:
Cholesterol Drugs May Fight Heart Failure - Study
Statins dangerous, according to patients who experience the "side effects" and physicians who have been warning for yearsThe Vitamin C Foundation's Statin Drug Alert
Crestor and Other Statins: Are They Really Worth the Risk?
The Truth About Cholesterol-Lowering Drugs (Statins), Cholesterol, and Health
Lunatic Recommendations For Statin Drug Use
THE HIDDEN ORIGIN OF STATIN DRUGS
And here the comments from Jenny Thomson of the HSI Research Institute Baltimore:Broken Ground
Health Sciences Institute e-AlertMarch 11, 2004
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Dear Reader,
Revolutionary. Groundbreaking. A landmark.
Those were some of the reverent terms that TV network news anchors used as they gushed like smitten schoolgirls over a new study of cholesterol-lowering statin drugs this week. And virtually all of them treated the "miracle drug" status of statins as a given. What's more, the general consensus from anchors and their "medical expert" sidekicks was that "super doses" of statins are now preferred over low or moderate dosage.
Here's what this study really is: A revolutionary and groundbreaking landmark for those who make their living selling statins. Because statin drugs now seem to have become the drugs that sell themselves with the help of fawning mainstream commentators who "report" that 11 million Americans are currently taking statins, but "36 million should be."
Should be? Thanks, but no thanks, guys. Please count me and millions of others out of the "should be" group.
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The basics
-------------------------------------------------Here's a quick outline of the statin study that was posted on the New England Journal of Medicine web site this week. (The study will be published next month.)
Researchers at Harvard Medical School tested two different statin dosages on a group of 4,162 patients who had been hospitalized for an acute coronary syndrome. All subjects began taking their drugs within 10 days of being discharged from the hospital, and their medical records were then
followed for an average of two years. Half the group received a daily 40 mg dose of pravastatin (brand name: Pravachol), and half received 80 mg per day of atorvastatin (brand name: Lipitor).The Harvard team specifically monitored occurrences of death due to stroke, heart attack, bypass surgery and other cardiovascular events. Results showed that the death rate in the Lipitor group was 28 percent lower than the Pravachol group. Furthermore, LDL cholesterol was lowered to an
average of 62 in the Lipitor group, but only to 95 in the Pravachol group.This 95 level would be considered just fine among those in mainstream medicine who insist that everyone should aim for an LDL of 100 or lower. But because the Lipitor group average dropped a full 33 points more than the Pravachol, and because the death rate was significantly lower in the Lipitor group, the pro-statin forces crowed with glee as if this study were the last word on the subject. If these folks had their way, the book on statins would now be closed and virtually everyone over the age of 45 would start taking daily super doses of Lipitor immediately.
No doubt, the results are impressive. As long as you overlook certain details.
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The up shift
-------------------------------------------------Critics of the study point to a number of obvious drawbacks. As we've known for some time now, statin drugs carry along some unpleasant side effects, ranging from muscle aches to liver damage. In this particular study, one third of the subjects in the Pravachol group dropped out due to an adverse event or a patient's decision to stop taking the drug, and more than 30 percent in the Lipitor group dropped out for the same reasons.
Also, for a drug that's intended to be taken for the remainder of a patient's life, two years is not nearly long enough to fully understand the extent of side effects (especially at the higher dosage) or the comparison of the death rates associated with the two drugs.
In addition, there was no control group! In a true clinical study it's customary to include a group of subjects who receive no therapy or a placebo - or even (heaven forbid) a natural therapy - in order to put the effects of the drugs (both good and bad) into perspective. Without a control group, we don't know if the outcomes are really as dramatic as they're being made out to be.
So this trial is not the end-all and be-all that the mainstream wants us to believe it is. But the fact that it's been interpreted that way will encourage many doctors to prescribe the drug even more aggressively and at higher doses. The study's lead author, Dr. Christopher P. Cannon, told the New York Times that, "Everyone needs to shift up one level in their intensity of cholesterol treatment."
And if they do, healthcare costs - already rising at an alarming rate - will go through the roof. According to Reuters Health, a typical starting dose of Lipitor runs about $900 per year. If everyone "shifts up one level" to 80 mg, they'll spend an additional $500 yearly. And that's for the rest of their lives.
The bean counters at Pfizer (Lipitor's maker) will have to start working nights and weekends if 36 million Americans do as they're advised and start taking 80 mg of Lipitor every day.
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A major miscalculation
------------------------------------------------This study has one more unique wrinkle. It was sponsored by a drug company. Now, knowing that, you might reasonably jump to the conclusion that it was sponsored by Pfizer. After all, the cards seem to have been significantly stacked against Pravachol. But in fact, the study was sponsored by Bristol-Myers Squibb (BMS), Pravachol's maker.
Experts in the field speculate that BMS executives apparently had good reason to believe that, even at the different dosages, Pravachol would produce better results than Lipitor. Needless to say, whatever the strategy might have been, it seems to have backfired.
Dr. Andrew G. Bodnar is a senior vice president for strategy and medical and external affairs for BMS. In what we can only imagine was a shell-shocked state, Dr. Bodnar told the New York Times that his company was surprised. But given the outcome, Dr. Bodnar gladly offered some information about an important safety issue. He told the Times that liver enzymes were elevated in 3.3 percent of the Lipitor group, but only in 1.1 percent of the Pravachol group. And he noted that when Liver enzyme levels rise, patients must be advised to stop taking the drug or reduce the dose.
So again, the length of the study is a major factor. Given that over a period of many years we simply don't know what percentage of patients will experience dangerous liver enzyme levels, the unconditional thumbs-up that the media gave the concept of statin "super doses" was "super premature," to say the least.
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If you want to start receiving your own copy of the HSI e-Alert, visit HSI Baltimore.com
Ball of Confusion
Health Sciences Institute e-AlertMarch 23, 2004
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Dear Reader,
Are you rethinking the importance of your HDL level?
You might be if you listened to the news reports last week about the sudden "confusion" surrounding high-density lipoprotein (HDL), also known as the "good" cholesterol.
But guess what? The confusion is completely manufactured. And why is it manufactured?
Do you even have to ask?
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Highs and lows
-------------------------------------------------In a nutshell, here's how LDL and HDL work: LDL transports cholesterol from the liver to the rest of the body, and HDL returns cholesterol to the liver where it's disposed of.
According to the National Institutes of Health (NIH), the optimal LDL level is anything less than 100 mg/dL (milligrams of cholesterol per deciliter of blood). The "near optimal to above optimal" range is 100-129. "Borderline high" is 130-159. And anything over 160 is considered "high."
The NIH guidelines call for HDL cholesterol to be 60 mg/dL or more in order to help reduce heart disease risk. HDL lower than 40 is considered dangerous.
All of that seems pretty clear. So where does the sudden confusion about HDL come from? Prepare to be not the least bit shocked: It comes from high-profile promoters of cholesterol-lowering statin drugs.
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Freeform extrapolating
-------------------------------------------------Last week a New York Times article reported that "some scientists" point to "new and continuing" studies suggesting that HDL may not effectively counteract the potentially harmful effects of elevated LDL. The Times article was picked up by a number of other newspapers and media outlets.
The primary scientist singled out by the Times is Dr. Steven Nissen - a prominent cardiologist with the Cleveland Clinic, and an outspoken advocate of statin use. He's also a leading proponent of the statin-friendly concept that LDL should be lowered as much as possible - well below the NIH's "optimal" mark. Last November, the Associated press quoted Dr. Nissen as saying, "There is no such thing as too low an LDL."
Remarking on the HDL question this past week, he told the Times that, "There is so much confusion about this that it is unbelievable."
Dr. Nissen cites a recent study that he headed up - a study I told you about in the e-Alert "Broken Ground" (3/11/04). The trial enrolled more than 4,260 subjects, each of whom had been hospitalized with "an acute coronary syndrome." In other words, these were not average Joes who merely had elevated LDL levels. Subjects were divided into two groups. For two years, one group took 40 mg daily of a statin drug, and another group took 80 mg per day of a statin. Results showed that the higher dosage lowered LDL better than the lower dosage. The rate of death was also slightly lower in the high dose group. Dr. Nissen notes that HDL played no role in plaque growth among subjects in the study. He told the Times that LDL was the only factor that mattered.
But one of several problems with this study is that there was no control group. Without a control group (that is; a group not taking statins to compare against the other subjects who all were), there's no way of knowing if the HDL and LDL outcomes are really as significant as Dr. Nissen is
convinced they are.-------------------------------------------------
Believability
-------------------------------------------------So when the Times article refers to "some scientists" pointing to "new and continuing" studies, it's apparently referring only to Dr. Nissen and this single study of his that wasn't even designed to examine the effects of LDL vs. HDL on plaque growth in the first place.
The Times article does mention one other trial: the Framingham Heart Study, which is the ongoing, landmark study that has included many thousands of subjects since its inception in 1948. The Times notes that Framingham data clearly demonstrates how higher levels of HDL are actually associated with a decreased risk of heart disease.
Dr. Nissen described the recent confusion about HDL as "unbelievable." I agree completely. I don't believe it.
But I believe it WILL help sell statin drugs.
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NSPM!
--------------------------------------------------When Dr. Nissen's study was released earlier this month, the media reported the results with fawning respect for the idea that "superdoses" of statins should now be considered the norm in order to drive LDL as low as possible.
So with major news outlets getting out the message that statin superdoses should be used, and then two weeks later reporting that you can't depend on HDL to help lower heart disease risk (but you CAN depend on statins), I don't think it's too much of a stretch to go ahead and officially declare March as NSPM; "National Statin Promotion Month."
Just imagine how many people will respond to these reports by asking their physicians to raise their statin dosage. The doctor on TV said it was a good idea. And the guy on the morning show said HDL might not even matter anymore. Imagine! The "good cholesterol" has let us down!
Here's the best way to observe NSPM: Ignore the manufactured "confusion" about HDL, and be deeply suspicious of the flawed study that encourages millions of people to start taking large, expensive doses of statins.
Because they're both unbelievable.
See also:Patients Can Report Statins' Adverse Effects On New Web Site
A new web site at the University of California, San Diego (UCSD) School of Medicine - http://www.statineffects.com - will enable people from around the world to self-report adverse effects of statin drug use, or use of other cholesterol drugs. The site will provide access to a broad group of people, facilitating the opportunity for patients to confidentially share information about their experience.The Benefits of High Cholesterol
People with high cholesterol live the longest. This statement seems so incredible that it takes a long time to clear one's brainwashed mind to fully understand its importance. Yet the fact that people with high cholesterol live the longest emerges clearly from many scientific papers.
posted by Sepp Hasslberger on Wednesday February 18 2004
updated on Saturday December 4 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/02/18/cholesterol_and_heart_attacks_study_to_save_statins.htm
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