Cholesterol and heart attacks - Study to save statins
CategoriesStatin 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
Ask the Doctor: Dangers of High Statin Doses
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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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.
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