Wednesday, November 13, 2013

New Statin Guidelines: Should People Be Concerned?

Yesterday, according to widely circulated press reports, the nation’s first new guidelines in a decade for statins use were released. This was with the stated objective of preventing heart attacks and strokes. These guidelines call for twice as many Americans — one-third of all adults — to consider taking cholesterol-lowering statin drugs.

The guidelines, issued by the American Heart Association and American College of Cardiology, disclose a big change. They offer doctors a new formula for estimating a patient’s risk that includes many factors besides a high cholesterol level.   The formula includes age, gender, race and factors such as whether someone smokes. Cholesterol, especially the "bad" LDL still factors in, and the threshold point for the red statin flag is 190.  Interestingly,  the guidelines for the first time take aim at strokes, not just heart attacks. Partly because of that, they set a lower threshold for using medicines to reduce risk.

The definition of high cholesterol hasn't changed, but the treatment goal has. Instead of aiming for a specific number,  say 150, using whatever drugs get a patient there, the advice stresses statins such as Lipitor and Zocor and identifies four groups of people they help the most.  More interesting: Doctors say the new approach will limit how many people with low heart risks are put on statins simply because of a cholesterol number. Yet under the new advice, 33 million Americans — 44 percent of men and 22 percent of women — would meet the threshold to consider taking a statin. Under the current guidelines, statins are recommended for only about 15 percent of adults.

This is important to know, because statins aren't without serious side effects. The (Physician's) Prescription Drug Reference (PDR) and the drug information inserts commonly list the following as major side effects of statin use: muscle pain (myalgia), muscle breakdown (leading to kidney damage since broken down muscle proteins end up being absorbed), joint pain, liver damage and fatigue. On account of this regular monitoring is needed to ensure the patient isn't being adversely affected.

Jay S. Cohen in his book,  'Statin Drugs and Their Natural Alternatives', Square One Publishers, 2005), writes (p. 84):

"Statin -triggered muscle pain can lead to prescriptions for muscle relaxants, which can cause lethargy or weakness. Muscle or joint pain can lead to prescription of anti-inflammatory drugs which can cause stomach pain, depression, ringing in the ears and eventually damage to kidneys or gastric hemorrhage"

In other words, even one or two side effects can soon lead to a "prescription cascade" with more meds needed to deal with the side effects arising from the statin. No wonder so many seniors have found themselves in the "donut hole" and the average over-65 senior takes six meds!

More worrisome is a point Cohen makes (p. 86)as to the PDR and drug info inserts being outdated as to side effects inventory:

"There is no routine, expeditious method for incorporating (side effects) information into package inserts or the PDR unless it is very serious or lethal. Thus, the lists in package inserts and the PDR are usually incomplete and outdated. However, many doctors assume the information has been updated for each yearly edition of the PDR. Most drug write-ups have not."

One of the glaring examples of this (ibid.) is memory loss, dysfunction and cognitive impairment. Cohen again:

"Statin-related memory deficits are a perfect example. For years, evidence has been mounting that statins can impair cognitive and memory functioning, yet many statin package inserts do not list cognitive problems or forgetfulness among their side effects. These reactions may be subtle but they can also be very serious."

He then cites examples of older patients believing they have Alzheimers, or have that they've suffered a stroke. In one case, a woman's language was totally garbled and when she meant to ask: 'Please pass the bread', it came out: 'Please pass that elephant!' As with the neuropathy, merely halting the statins didn't always stop the cognitive problems and decline. Often they continued for months, or years.

Truth be told, given this hidden side effect, it could well be that many who believe they're in the initial stages of Alzheimers are actually suffering from statin side effects unreported in the lists inserted into the packages.

Let's also get clear that the increased (2-3x) factor use of these drugs, especially Lipitor and Zocor, stands to rocket Big PhRma's profits through the roof. This was actually pointed out in a Forbes article several years ago, in reference to reaching a $55m profits per year mark - and the need to rationalize more widespread statin use to achieve it. And WHO are these "experts" that become part of panels that provide these recommendations anyway? As one physician quoted yesterday (Dr. George Mensah) noted:

"It is practically impossible to find a large group of outside experts in the field who have no relationships to industry,”

Well, I mean wouldn't you think they'd have a vested interest in seeing a wider use and distribution of these drugs in order to more completely line their own pockets? I would! But then maybe as a cynic and curmudgeon this is what I'd always be disposed to see. But call me distrustful.

The other thing people need to be aware of, is that the sort of inflammation that leads to heart attacks and strokes is NOT from cholesterol per se, but rather a chemical known as c-reactive prtein, or CRP. It is this chemical that incites the inflammation that causes artery walls to respond by lining themselves. Yes, the presence of excess cholesterol can increase the probability of inflammation, but it's CRP which is the catalyst.

One other thing to be aware of, especially men at risk - say for strokes- is that a good aspirin regimen can achieve results as good as statins, without the risk of side effects. I myself take two 'baby' (81 mg) aspirin, one after lunch, one at night to achieve this. The decrease in stroke potential for such a regimen is estimated to be roughly 35% according to my primary care doc. (But any would-be aspirin user needs to check with his or her doc first before embarking on this alternative.

All of which is reason to be wary of docs pushing statins, since a prescribed 20 mg of Lipitor, based on the drug insert info, may in fact be an overdose for a drug-sensitive 70-year old -  who suddenly develops pulmonary fibrosis or kidney problems because of it. This is why as Cohen notes low doses are always recommended if one does start a statin regimen.

For those who do take this statin path, just be aware of the risks. Also, be aware that we are entering a period when (given budget constraints and the yen to transfer more costs onto patients)   prescription drug expense is likely to dramatically increase. Since we all need to be stewards of health care cost control, this is an additional factor to be reckoned into any decision.

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