Friday, May 26, 2006

Elevated Cholesterol: Take Zocor or Lipitor or Take Your Chances on Your Own?

One's health is not static.

After getting both knees replaced, after enduring months of rehab torture at the hands of pain-loving Iron Mike, after a week in the hospital with a misaligned pelvis followed by more brutal rehab, and after thumbing my nose at it all and taking up fiercely-fought singles tennis; after all that, you would think that the sinister forces trying to bring me (and everybody else) down would back off.

But no, after a battery of blood tests at the VA, I get the results with the following note from Dr. Donna Santora:

George, I am concerned with your elevated cholesterol levels. I looked back over the past nine years and they have always been elevated when checked at the VA. I do not have any labs from Dr. Marelli to compare these to. have you ever been on cholesterol-lowering medication? I feel you should be on medication at this point for cardiac protection. (The VA starts with Zocor.) Please discuss these lab results with Dr. Marelli and let me know what you decide. We look forward to seeing you at your next visit. Please remember to bring any outside labwork with you.

Total cholesterol was 233; she said it should be less than 200. Low density lipoprotein, the "bad" cholesterol, was 169; she said it should be under 130. This bad news was accompanied by some good news. High density lipoprotein, the "good" cholesterol was 53; this should be above 40. Triglycerides were 57; this was well under the upper limit of 150.

Everything else was fine. Liver function tests were normal. Electrolytes were normal. PSA was 2.78, unchanged from past tests and normal. Thyroid function was normal. Urinalysis was normal. The complete blood count was within normal range.

So, everything was normal except for the elevated cholesterol. This was not news to me. For eight years, my previous VA doctor, Dr. Susan Krantz, had been asking me to consider taking a cholesterol-lowering drug such as Zocor or Lipitor. I kept holding her off, saying that I wanted to "depend on the resources of my own body for as long as possible."

Over the same years, Dr. Marelli, knowing of my reluctance to go on a statin drug, took a "let's keep an eye on it" approach. But then, in 2004, he sent me a letter saying he was concerned about my elevated cholesterol. This was his letter:

Dear George,

Your recent results have been reviewed. I apologize for the delay. These were done at the later portion of April.

The results include a cholesterol of 237. The good cholesterol is 42. These numbers give you a ratio of 5:6, which is high. The ratio should be below 4.

I would like sit down and discuss your lipids in more detail. Please call the office and arrange a brief morning appointment in the next month or so to do so. I look forward to seeing you then.


Daniel R. Marelli MD

Well, I thought at the time, at least he was looking at the calendar and not his watch in suggesting an appointment between annual visits. But in the seven years I had been seeing him, this was the first time he had suggested an additional visit to discuss a medical problem.

While the cholesterol problem was not news to me, Dr. Santora's note had an alarmed tone and sent me rethinking. Was I really at risk for a cardiac "event"? Other than age (68) and high cholesterol, as far as I knew I lacked the other major risk factors for coronary heart disease.

But I did know that of the major risk factors for heart disease, elevated cholesterol is considered a biggie. Both produced by the body and derived from what we eat, excess cholesterol leads to a clogging of the arteries and interferes with blood flow. Heart disease is the number one killer of both men and women in the U.S.

The other major risk factors for heart disease are:

Diabetes. Having this disease, an excess of sugar in the blood because of the failure of the pancreas to produce enough sugar-absorbing insulin, automatically puts you in the highest risk category for coronary heart disease. According to these last blood tests, I have glucose levels slightly above normal levels.

Heredity. For a male, a family history in which your father, brother, or son had coronary heart disease before age 55; for a female, the disease in your mother, sister, or daughter before age 65. My father died at 26 of rheumatic heart fever, an inflammatory disease of the pericardium and heart valves, which is not hereditary and rarely dangerous today. My mother, who was obese and a diabetic, died of heart failure at age 86. My four siblings, of which I am the oldest, are all in their sixties and in good health and with no heart disease.

Age – Male Over 45. The risk of heart disease for men is three to four times higher than for women in midlife. It is especially important for men as they age to reduce the risks they can control. At age 68, I have age risk up the gazoo. Even my oldest son, Greg, who is 42, will soon be saddled with this male risk factor.

Age – Post-Menopausal Female. Before menopause, women have lower cholesterol than men of the same age. After the age of menopause, women's LDL levels tend to rise. At age 62, my wife Barbara and ace patient advocate, has reached this stage. Her latest total cholesterol count was 218, with an LDL of 142 and an HDL of 59, for a TC/HDL ratio of 3.7. Both of her parents lived into their mid-eighties and there is no history of heart disease in her family.

Low HDL. (less than 40 mg/dl): We're okay here. Barbara's HDL is an excellent 59 while mine is 53, up from 42 two years ago.

High Blood Pressure. (above 140/90 mm Hg). No problem here, with both of us scoring consistently below this level. My blood pressure is always around 120/70-80.

Smoking. Neither of us have ever smoked. Let's amend that. At age 12, I found a few dollars in an alley and, along with some acting-out friends, blew the entire amount on a movie and a carton of cigarettes. (A few bucks went a long way then.) As a matter of honor, I smoked a whole pack in one afternoon of playing grown-up. I got sick to my stomach. I got a headache so bad I thought my head was going to explode. I never smoked another cigarette. All four of my siblings, however, became heavy smokers. Amazingly, given the significant known risks of smoking, all remain healthy.

Even though obesity and physical inactivity are not on the above list of standard risk factors for coronary heart disease, they probably should be. The two are often connected. Together, they place extraordinary burdens on the heart which increases the risk of diabetes, high blood pressure, elevated cholesterol, and artherosclerosis. By virtue of my authority as a patient, I hereby add obesity and physical inactivity to the list above.

I am not obese and neither is my wife Barbara, though both of us are 20 to 30 pounds above recommended weights. I am highly active physically, playing tennis three or four times a week. Barbara is less active physically but still active, walking two or three miles at least twice a week and working hard doing yard work and other home chores.

Of all the above risk factors, I have two: age – at 68 or 21 years beyond the 45 years that is the onset of this risk factor; and elevated cholesterol. The first I can't do anything about. That leaves me the second to deal with: a cholesterol count considered of enough concern for Dr. Marelli to request a sit-down discussion.

Federal health officials have sharply raised the cholesterol bar for Americans at moderate to high risk for heart disease. Moderate risk is defined as having one of the risk factors cited above. High risk is defined as having established heart disease along with another condition such as diabetes or high blood pressure, or smoking or a recent heart attack. My age and cholesterol level classifies me as high risk.

New standards would seem to make me a medical person of interest, to say the least. I'm expected to reduce LDL (bad cholesterol) to under 130. These new standards carry recommendations for more aggressive use of cholesterol-reducing drugs, including higher doses, to meet them.

With an LDL of 169, I would seem to be walking into Dr. Marelli's office as a cardiac event waiting to happen. As is Dr. Santora and as was Dr. Krantz before her, Dr. Marelli would be under pressure to recommend that I start taking a cholesterol-lowering drug.

Despite my fervent wish to lead a drug-free life, despite the risk of side effects of muscle weakening and liver complications (small but there nevertheless), despite the fact that once you go on statins you're on them for life, going on a cholesterol-reducing drug would seem the rational thing to do.

And, anyway, what do I know compared to new information published in the journal Circulation and endorsed by the U.S. Centers for Disease Control and Prevention, the American Heart Association, and the American College of Cardiology? The new guidelines are backed by these organizations as written by nine of the country's top cholesterol experts and reviewed and endorsed by an additional 80 experts. They were based on five different clinical studies since 2001.

But just for the sake of discussion, let's step back for a moment. To start with, eight of the nine authors of the report received money from the makers of the most widely used cholesterol-lowering drugs, according to the Center for Science in the Public Interest. The money came in the form of consulting and speaking fees, research grants, support for clinical studies, and travel expenses to educational seminars sponsored by the companies.

These companies stand to gain financially, and in a big way, from increased cholesterol drug usage. An estimated 11 million Americans take statins. The new guidelines are likely to make that number go a lot higher and those already on statins are likely to have their doses increased.

Merrill Goozner of the Center for Science and the Public Interest said, “It's outrageous they didn't provide disclosure of the conflicts of interest.” He said it doesn't mean that their research is wrong but that doctors and the public have a need to know “that the people who are giving you this advice have their research funded by a party who has a self interest in the outcome of that research.”

After consumer groups like the Center for Science and the Public Interest attacked the report as tainted with conflicts of interest, the authors of the study, as well as the National Institutes of Health, conceded the ties to the drug industry. But the authors defended the new guidelines as based on sound science.

Dr. James Cleeland, coordinator of the National Cholesterol Education Program, which oversaw the recommendations, said: “If you excluded all the people who have any financial connections to industry, you'd exclude all the people who are most expert.. The recommendations passed muster as they went through layers and layers of review.”

Dr. Gary Palmer, a vice president of the cardiovascular medical group at Pfizer, which makes Lipitor – the number one statin seller – also dismissed the criticism. He said, “We have over 70 million patient-years of experience worldwide, so we're able to comment on our efficacy and safety profile with confidence.”

That may be so, but statins have also gained wide usage in a relatively short time. They have come into use too recently for longitudinal studies to have been completed on possible longterm side effects. The science on which statin use – and now recommendations for increased usage – is based might more accurately be described not as sound but as on probation pending longterm clinical confirmation.

It is also a science in which the interests of patients are not necessarily the main driving force. Clinical studies on new and existing drugs are routinely funded by their manufacturers, as were the studies that led to this most recent recommendation for more aggressive LDL cholesterol standards.

Finally, it is not science based on my body. It is based on studying the reactions of large numbers of other bodies under controlled conditions, taking great pains to see that some are given a certain treatment and some a placebo. Patient reactions are observed and the results are then quantified in percentages. In medicine, new knowledge marches to the steady drumbeat of dry statistics.

But I am not a statistic. My body -- though it has a head, arms, legs, internal organs, and the same basic operating system of every human body – is not exactly like the bodies used in these studies. Not only is it not exactly the same, but it may be unique in important ways.

In my case, 68 years of individualized living, food choices, environmental exposure, physical and emotional experiences, and wear and tear are reflected in my physical plant – for good or for ill. And the sum total of all this customized living makes me different, perhaps very different, from the people in those studies.

Bottom line: the clinical studies on which doctors must rely to treat the patient do not reflect these individual differences. Therefore drugs introduced as a result of these studies are not necessarily a good idea for everybody, especially when longterm effects are unknown.

Dr. Marelli was thirty minutes late for his appointment to discuss my cholesterol level. He has a very busy practrice and for years has not accepted new patients. He came into the examination room carrying his trusty manila folder and apologizing for being late.

“Thank you for your letter about my cholesterol,” I said. “It was a wake-up call. There's nothing like seeing it in writing to make you realize that something is serious.”

“What do you think?”

Dr. Marelli is patient-centered and a listener.

“I think I would like to avoid the statins if at all possible. The only risk factors I have for coronary disease are my age and high cholesterol. I don't smoke. I'm not a diabetic. I'm not obese. My blood pressure is good. I'm physically active. There's no heart disease in my family history. I have four healthy younger siblings, all in their sixties and no heart disease."

Dr. Marelli nodded.

“In fact, thanks to your letter, I have made diet changes. I've stopped drinking coffee. I used to drink seven or eight cups a day, with cream in each. Now I drink green tea. Every morning I used to have two English muffins slathered with butter and jelly. Now I have one slice of whole wheat toast with a brush of butter and no jelly. At night I used to have pie or cookies with my coffee. Now I have green tree and a little nonfat yogurt with blueberries or strawberries.”

“I see that your weight is down.”

“Yes. I've lost ten pounds, from 198 to 188. Little changes in something you eat every day make a big difference.”

“Good, very good.”

“The other thing that bothers me about the statins are the side effects. They are so new that there hasn't been enough time for any longterm studies on these side effects. Who knows what the side effects will turn out to be.”

“That's true. The statins are only about ten years old.”

“Also, these new aggressive cholesterol guidelines are riddled with conflicts of interest. I did a little research and found out that eight of the nine authors of the new guidelines are being paid by the drug manufacturers who will benefit from increased statin usage. It gives me a queasy feeling in my stomach.”

“I don't disagree with anything you said. If I did, I would say so. I think your position is perfectly reasonable. I also think that making changes in your diet and getting your weight down are important and can help get your cholesterol down. I would suggest that you keep working on that and we'll test you again in December and see where we are. You feel okay about that?”

“Yes, perfect.”

That discussion took place two years ago. Since then I have lost ten more pounds (yea!) and cut down on donuts, candy, and ice cream, though I went back to drinking coffee. But a funny thing happened. My cholesterol count remained almost exactly the same.

So last week, ( May 24, 2006)I was back in Dr. Marelli's office and showed him the VA lab results and Dr. Santora's note. "She thinks the time has come for me to go on a statin. At the VA, it is Zocor."

“What do you think?” he said, looking over the VA lab results.

As always, Dr. Marelli lets the patient take the lead.

"I have to tell you, I still feel the same. All those tests I had in Seattle a year ago (following a near-fainting incident) showed no blockage. The scan of the carotids was clear. The echocardiogram showed no blockage or obstruction of blood flow to the heart. The brain scan was completely normal. I just think my body produces more cholesterol than it needs."

"That is possible."

"I mean I have always had a healthy diet but in the last year I ate super healthy, just about cutting out anything fatty, and lost almost twenty pounds. And what happens? My cholesterol remains the same. Plus it's not super high. If it were, I might go for a statin."

"Also, I see that although your glucose is slightly high it is more than offset by your jump in HDL, or good cholesterol, from 42 to 53. This brings your ratio of down to 4.5. The ratio was 5.3 last time, a significant improvement."

"What if we hold off on the statin and retest in the fall? That'll give me a change to focus on it and we can look at it again then. Would you mind letting Dr. Santora know what we're doing?"

"Yes, I'll be talking to her. Maybe I'll write her an old-fashioned letter."

Finally, Dr. Marelli asked me to get up on the examination table. He listened to my heart. He took my pulse. It was 70. He took my blood pressure. It was 120/78.


He did a rectal exam. "No blood. Have a great Memorial Day weekend."

And, with a smile, he was out the door.

So long and keep moving.

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At February 18, 2009 2:48 AM, Anonymous Anonymous said...

My name is Todd Thomas and i would like to show you my personal experience with Zocor.

I am 55 years old. Have been on Zocor for 4 years now. Zocor did lower my cholesterol. I also have RA and did not know which caused pain stopped Zocor, pain improved dramatically, but weakness remains. Dr says permanent damage. Now I my cholesterol is high.

I have experienced some of these side effects -
Leg pain and weakness

I hope this information will be useful to others,
Todd Thomas


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