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Friday, May 21, 2010

My Personal Experience with Lipitor

The day after our visit with Dr. Star, we had an appointment with Dr. George Babbitt (whose code-name alas, won’t make sense without a background in American Literature).

As it happened, this first appointment with a physician did absolutely nothing to ease my growing suspicion of modern cardiac medicine. He reiterated the message from Dr. Ghoul: my medical needs could not be met in Naples and I was being referred to a surgeon in Tampa for a heart transplant.

I asked Dr. Babbitt about the Lipitor dose he had prescribed me. By then, I had already found for myself the safety and efficacy FDA studies that originally approved Lipitor. These studies had used doses of 2.5 mg and 5 mg daily. Yet interestingly, the lowest available dose of Lipitor manufactured by the pharmaceutical company, Pfizer, was 10mg – double the highest dose used in the FDA studies for safety and effectiveness!

If that wasn’t enough to raise my eyebrows, Dr. Babbitt prescribed 80 mg daily doses of Lipitor – 16 to 32 times the doses used in the FDA studies. I told my doctor about my research on the FDA studies.

“You shouldn’t worry about those FDA reports – I have studies showing that 80 milligrams per day are safe, and more effective than those lower doses.”

I asked him who had done his studies.
“Pfizer.”

I didn’t tell him that I was already aware of the Pfizer sponsored studies.
I suspect that Dr. Babbitt never saw the actual Pfizer studies, but had simply taken the word of a “detail man,” a representative of a drug manufacturer who calls on doctors to promote the products from that company. I wondered if he would be so enthusiastic about high-dose Lipitor had he actually read the study.

In 2005, the New England Journal of Medicine published a report funded by Pfizer that described the efficacy of high-dose Lipitor in cardiovascular disease. The authors concluded that high-dose Lipitor (80 mg) was superior to a ‘standard dose’ (10 mg) in reducing negative cardiovascular events in coronary heart disease (CHD) patients. Ten thousand CHD patients participated in the five-year study. Half of them received a daily dose of 80 mg of Lipitor, while the other half received a control, ‘standard’ dose of 10 mg/day.

The Pfizer study observed a reduction in major cardiovascular events in the high-dose Lipitor group (heart attack and/or stroke) over the course of the experiment. In the 80 mg group, 8.7% (or 434 patients) suffered a major cardiovascular event, compared to 10.9% (or 548 patients) of patients in the standard 10 mg group. When you do the math, that’s a difference of 2.2% – or 104 fewer cardiovascular incidences in the high-dose Lipitor group – a statistically significant improvement over standard treatment. Furthermore, only 126 patients in the 80 mg/day Lipitor group died from cardiovascular problems during the study, as compared to 155 in the 10 mg/day group.

I was surprised to discover that treatments were tested and put into practice with such small efficacy ratings. But, 2.2% is better than nothing, right?

Not when you take into account that in this same study, 158 deaths due to non-cardiovascular events occurred in the 80 mg/day group (3.2%), versus only 127 (2.5%) in the lower dose condition. Cancer, particularly lung and gastrointestinal, was responsible for more than half of these deaths. Hemorrhagic stroke and other, non-traumatic causes contributed to the remainder of non-cardiovascular deaths in both treatment conditions. However, this difference of 31 more deaths from non-cardiac related causes in the high-dose group brings the total deaths to 282 in the 10 mg Lipitor group, and 284 in the 80 mg group – statistically, that means there was no difference at all. Your chances of survival were actually 1 in 5000 lower if you took a high dose rather than a standard dose of Lipitor.

Between the actual statistics revealing the serious side effects associated with Lipitor and other statin drugs, and the failure to improve overall survival rate by using higher doses of Lipitor, I suspected that my doctor, had he actually been up on the facts, could have made a wiser choice. However, the professional to whom I was entrusting my life didn’t seem to be as well informed on the subject as I was. Later I was to discover that this isn’t unusual; it doesn’t take much research to be better informed than some doctors.

However, it was easy to understand why the drug salesmen from Pfizer only talked about the (tiny) advantage in reducing cardiac events and failed to mention the fact that there was no overall advantage in reducing death.

So why were the patients in the high-dose Lipitor study dying more frequently from non-cardiovascular causes? At this point, the mechanisms underlying this effect are unclear – we just can’t tell. But as one expert in the field wrote, “we need further reassurance as to the safety of this approach before making this higher dose a standard practice in CHD pharmacological therapy.” Despite their prevalence, the statins are not the only available method that can be used to lower LDL-C levels. Hybrid therapies with other drugs, natural therapies, and nutrition can all be effectively used for this purpose. But my highly paid doctor didn’t know that, either.

Muscle Pain and Weakness
Shortly after I left the hospital, I began experiencing significant pain in my arms and shoulders. I don’t want to sound melodramatic, but the pain was incessant, a relentless twenty-four hours a day, every long day. On a severity scale from 1 to 10 (10 being excruciating, 1 being a hangnail), my pain fluctuated between 6 and 8. I struggled to dress myself, to the point that I stopped wearing T-shirts because of the sheer pain it caused to pull them on over my head. I couldn’t sleep because I couldn’t get comfortable, and even when I did slip into unconsciousness, pain shook me awake again. The upper body exercises I needed to do in preparation for surgery were impossible.

We hired two massage therapists to try to help me cope with the pain. They each came to our home once a week. On Thursdays came Frau Athena, so named after the Greek goddess of wisdom, war, arts, industry, justice and skill. Frau Athena was a German woman, as beautiful, strong, highly skilled, intelligent, and kind as the goddess. She knew that pain was part of the process of healing through massage, and showed no qualms about inflicting pain on me. Once, I muttered a weak joke (through clenched teeth) as she kneaded my aching muscles, “I told you, I don’t know where the diamonds are.”

“Dustin Hoffman from Marathon Man,” she quickly responded, amused by the attempt.
Frau Athena always ended my sessions by simply being gentle and kind; more than once did I fall asleep during the soothing massage & foot rub during the last few minutes of her therapy sessions.

On Saturdays came my other massage therapist – code name Bruce Lee – the Buddhist who practices massage therapy as if it were a martial art. A long-time friend of the family, he has a kind heart, but his technique is more competent than kind – he all but beat me up for my own good, a sort of ‘tough love’ massage therapy. Bruce Lee knows more about physiology and human chemistry than most of the doctors I’d been working with. He’s worked several years with Dr. Nobel; together, the two of them probably make the best alternative medicine team in the world. What’s more, Bruce Lee is not just a massage therapist: he also owns a successful Pilates studio and acts as a health consultant to some of the most wealthy and successful people in the nation. I joked that he could always moonlight for the CIA because he could get terrorists to talk by administering therapy, and no one could call it torture because he is licensed to do it.

But in addition to my constant pain, I was rapidly growing weaker and my muscle mass was noticeably deteriorating. I was horrified to see my usually well-muscled upper arms begin to wrinkle and shrink. After only a month of drug treatment, Bunny and I compared photos taken of me in the hospital to my appearance at that current point.

The difference in muscle size and tone was painfully obvious. On the first anniversary of my heart attack, as I finish this manuscript, I am still experiencing pain in my arms and shoulders. After less than six weeks on the medications, I had already researched the effects of Lipitor, and realized that the pain and weakness was not a side effect of the heart attack – but a side effect of the drug being used to treat the heart.

When that realization sank in, I actually got frightened. See, some of the side effects from statin drugs have killed people, and those same side effects were characterized by muscle pain and weakness. I knew that just because I had the symptoms, it didn’t necessarily guarantee that my medicine was going to prove fatal. However, my irrational self began to think, “The heart attack didn’t kill me but now the doctors and drug companies are going to kill me in a slow and agonizing way. Better to have died quickly, if I have to die anyway. If I am going to die someday let’s just get it over with”

Excerpt from: “I FIRED MY DOCTORS AND SAVED MY LIFE”
by Sam and Bunny Sewell

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