Distortions and half truths about statin drugs in media reports

March 2004, Warren Matthews

Summary

I just couldn't put off any longer commenting on an issue that has been making big news over the last few weeks which is about statin drugs and cholesterol. It has been reported that higher doses of statin drugs save lives, and LDL cholesterol should be lowered to 60.

I just couldn't put off any longer commenting on an issue that has been making big news over the last few weeks which is about statin drugs and cholesterol. It has been reported that higher doses of statin drugs save lives, and LDL cholesterol should be lowered to 60.

These media reports are either being prepared by the pharmaceutical companies, or, the journalists writing them are totally devoid of investigative skills and swallow what they are fed by interested 'parties' hook, line and sinker!

The fuss revolves around a study conducted by researchers at the Harvard Medical School to test the comparative efficacy of two statin drugs for lowering cholesterol. It was funded by the giant pharmaceutical company Bristol-Myers Squibb (BMS) who manufacture the statin drug known as Pravachol. The other statin drug used in the study is manufactured by Pfizer and called Lipitor.

The object of the study was to prove that taking just 40mgs a day of Pravachol was more effective that taking 80mgs a day of Lipitor! Only people who had been hospitalized with acute coronary syndrome were selected for the study... there were 4,162 of them, and they all began taking the drugs within 10 days from being discharged from hospital.

BUT NO CONTROL group was selected!

For two years the medical records of these 4,162 patients were followed and in a nutshell these were the results:

  • After 2 years 26% of the patients taking the 40mgs of Pravachol had either died, or experienced a variety of ill events, such as new heart attacks, bypass surgery, chest pains or strokes, or ended up back in hospital.
  • During the same period 'only' 22% of the patients on 80mgs of Lipitor had the same experience.
  • LDL cholesterol was lowered to an average of 95 in the Pravachol group and 62 in the Lipitor group.

This means that the LDL of the group getting double the dose was lowered a further 35% than the other group. That same group had less 'events' than the lower dose group. Whether this is coincidence or as a direct result of the higher doses who can say? There was no standard to compare the results with!

Nonetheless, these somewhat modest results have been sufficient to get the media into a frenzy with the catch cry that "statins save lives!" This will no doubt be followed by strong lobbying to suggest a Federal 'recommended' lowering of the LDL guideline 'bar' with the consequential prescribing of more statin drugs. In fact, advocates of statin drugs argue that more than 36 million Americans should be taking these drugs even if they are healthy.

Flawed logic...

Less heart disease and thus savings on hospital expenses! Sound principle, but wrong solution!

Consider this... Forbes magazine referred to a study in which doctors treated 5,168 high-risk blood pressure patients with Lipitor for three years to prevent 54 heart attacks and deaths. That's about $240,000 in drug spending per heart attack or death averted... IF these averted heart attacks could indeed be credited to the statin drug which is far from proved.

OK, those are the basic facts that have the pro-statin lobby so excited. Now, what about some of the facts in this study that are not getting a fair share of exposure.

About 33% of the subjects in the Pravachol group dropped out of the study as a result of adverse side effects, or a personal decision to withdraw. About 30% of the subjects in the Lipitor group also dropped out for the same reasons. Liver enzymes were elevated in 3.3% of the high dose group as opposed to 1.1% in the low dose group.

These very important issues are being downplayed in the interests of trying to expand the use of these drugs to people who don't really need them, and doubling the dose to those people who are already taking them.

The propaganda is working! We have noticed a definite increase in customers writing to us because their Doctor wants to put them on a statin drug, and they are wondering if there is a natural alternative. In some cases, their cholesterol is only slightly elevated when factoring in their HDL/LDL ratios. When you combine this with low triglyceride levels in many of these people... they are certainly not (in our opinion) candidates for a statin drug with all its inherent potential dangers, particularly to the liver.

What I find infuriating is that it is now being suggested to Doctors that when it comes to statins "more is better" and that by prescribing these drugs to their patients they will be doing them a big favor! This would be OK if it was true... but no one really knows if it is?

Extra prescriptions are being written on a FLAWED study!

It is flawed because you cannot have a 'proper' clinical study without a control group which was conspicuously absent in this study. I would take a bet that if the study was carried out with 1/3rd of the subjects on Pravachol, 1/3rd on Lipitor, and the other 1/3rd using natural alternatives combined with sensible life style changes that the last option would win hands down.

But... who is going to fund that? Certainly not the pharmaceutical companies who are likely to be the big losers! This type of study can only be funded by government and carried out by a truly independent institution... but that is an unlikely scenario.

Anyway, I hope that I have made my point OK. When you hear these upbeat news reports about a new wonder drug, or, how great the statin drugs are, absorb the information with an open mind and some skepticism and if you are interested in using them, take it upon yourself to dig around and find out if there is another side to the story. There may well be, and if you don't know all the facts you may be risking your health rather than improving it.

Just as a side note...

Did you know that because of the common complaints of patients taking statins which include memory loss, personality changes, irritability, and aching muscle pain that the National Institute of Health is in the midst of an independent study that will subject statin drugs and their side effects to scientific scrutiny?

Dr. Beatrice A. Golomb, MD, PhD. is the Principal Investigator of the NIH study. Dr. Golomb is affiliated with the University of California at San Diego. She also notes that among older elderly persons, for instance those over age 75 or 80, higher cholesterol is actually associated with living longer, rather than with dying earlier.

Finally, there is no doubt that excessive cholesterol levels do indeed present a heart and stroke risk. If this was not the case we would not have developed our natural cholesterol lowering formula, and included ingredients in our Total Balance to help normalize cholesterol.

What I object to is the push to get levels of cholesterol down to what is unnatural in many individuals and because of this 'push' there will in the future be a significant increase of serious side effects one of which, in my opinion will be an increase in Alzheimer's disease. Cholesterol is very important for the brain!

If your cholesterol levels are elevated then you must use natural methods to lower them to a level which works for your body, not to some impossibly low level set by a pharmaceutical company. We all have different levels that suit our own body. The statin drugs will certainly lower your LDL... but artificially by effectively 'strangling' your livers ability to manufacture it.

Who knows what the long-term outcome of this process will be?

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