Research findings from a study involving cholesterol-lowering statin drugs came out this week. And virtually all the reports treated the ‘miracle drug’ status of statins as a given.
Here’s what this study really is: A groundbreaking landmark for those who make their living selling statins.
Statins: The basics
Here’s a quick outline of the statins study that was posted on the New England Journal of Medicine web site this week. (The study will be published next month.)
US researchers at Harvard Medical School tested two different statin dosages on a group of 4,162 patients who had been hospitalised 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 40mg dose of pravastatin (brand name: Pravachol), and half received 80mg 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-statins forces crowed with glee as if this study were the last word on the subject.
If these people 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.
Statins: The up shift
Critics of the study point to a number of obvious drawbacks. As we’ve known for some time now, statins 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 be-all and end-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 US newspaper the New York Times that, ‘Everyone needs to shift up one level in their intensity of cholesterol treatment.’
Statins: 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 drug giant 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 statins ‘super doses’ was ‘super premature,’ to say the least.
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