fda letter





by Morley Evans, © 3 July 2003
v 1.09


The symptoms I began to suffer in January 1992 match very well the symptomatic profile of those who suffer adverse effects of Zocor (simvastatin) and similar cholesterol lowering statin drugs such as Lipitor (atorvastatin).

The symptoms I experienced while taking statin drugs include:

  • muscle: general stiffness, pain and weakness with “sausage fingers” and aching hands and wrists, sharp pains in feet and ankles, muscle atrophy
  • nerve: shooting pains, tingling, throbbing general pain, numbness especially in fingers, degenerating overall coordination resembling a balance problem or drunkenness, objects held unexpectedly dropped, feet feel as if they are on fire
  • temperature control: daytime chills and “ringing wet” night sweats
  • connective tissue: stiffness, pain, swelling and a grinding sensation in joints, bursitis, temporary relief from pain after forced painful motion
  • digestive: heartburn, incontinence, diarrhœa, frequent urination
  • cognitive: inability to think coherently or remember
  • sleep dysfunction: chronic insomnia with interruption once asleep
  • fatigue: exhaustion beyond sleep deprivation
  • itching
  • hair loss
  • exercise intolerance
  • tinnitus (ringing ears)
  • dramatic weight fluctuations (up and down between 180 and 125 lbs.)
  • dysphagia (difficulty swallowing)
  • impaired dexterity: inability to button a shirt and difficulty dressing

My daily schedule during the worst periods involved dozing off and on all day under a blanket in a la-z-boy. I would then toss and turn all night in a bed with wet sheets. At night, my hands were throbbing claws that produced sharp pain when pressed against the blankets that covered me. Occasionally, I would be able to put myself together to go out for a few hours. I was able to work only a few hours a day on my computer. Reading was particularly difficult: I could manage only a paragraph or two at a time. I would find relief from pain by taking very hot baths, as many as three per day.

The overriding and constant phenomenon throughout the period from January 1992 to June 2000 was pain — with the exception of the period from May 1998 to February 2000 when I was not taking a statin drug and my condition improved. This break is the first indication of what had been causing my problems, but other factors confused the issue and prevented identification of cause.

These other factors include errors in the pharmachological list from my pharmacy which omitted Zocor from the prescriptions it filled and prevented others from making an accurate diagnosis, and assurances from the physician who prescribed Zocor that it wasn’t responsible for my problems — after he accepted (four years along the way) that I had problems.

While some symptoms were relieved by drugs that were prescribed, other symptoms were aggravated while these new drugs created new side effects. Layer upon layer of medication was added to Zocor and then to Lipitor.

Apart from transient pain, weakness, and chronic fatigue, I am relatively symptom free at the present time. I have taken no statin drugs since June 2000 when I experienced a “stroke” (subdural hæmatoma). The current absence of symptoms is the second indication that statin drugs were responsible for my problems that began in January 1992.



We are taught we can fix something if we can measure it. Measurement is accepted as “objective evidence”. We often forget that what we are actually measuring is a proxy that is assumed to represent something else. A corollary to this proposition is that if a phenomenon cannot be measured, it does not exist. Rarely does it occur to someone that we may not be able to measure something because we do not know how to measure it. Moreover, some things cannot be measured: happiness?

Can we measure pain? Or do we have to take the patient’s word for it? Do we have a test for itching? No? It is all problematic: “You can't prove you are in pain now. How will you prove you were in pain then?”

Some doctors deny a patient’s complaints by resorting to pseudo science (such as half-baked genetics, statistical innumeracy and amateur psychology). They dismiss a patient’s complaints as psychosomatic hypochondria. “You are in pain? Take this antidepressant. You are actually depressed. Trust me. I’m a doctor.”

Doctors have authority which is usually all they need.

hypochondria (-k-) n. morbid depression without real cause; (unnecessary ) anxiety about one’s health. [LL, f. Gk hupokhondria soft parts of the body below ribs (whence melancholy was thought to arise; as HYPO-, khondros sternal cartilage)] - Oxford English Dictionary

Some variation of hypochondria has probably been the dodge of bad doctors throughout history. With regard to the nebulous field with which medicine must deal, are we to believe the patient who says he is in pain because he feels it, or are we to believe the doctor because he has a medical degree?

Whereas a bigot clings obstinately to his theory, (such as: “I’m a doctor, so I must know what I’m doing.”) dissembling and making ad hoc adjustments, a scientist tests his theory to attempt to destroy it. He discards his own faulty ideas in his effort to find the simplest explanation with the greatest explanitory power. Authority is utterly worthless in science and in the search for truth. (See Sir Karl Raimund Popper: The Logic of Scientific Discovery.)

It has come to pass that in 2003, medicine has become the largest single expense in Canada. Powerful political forces would improve its recognized shortcomings by spending more money. A system-wide examination of the fundamentals is instead required. Medicine should begin with the question: Is what we are doing really science based, or does it actually belong with 19th century patent medicine quackery and ecclesiastical courts of the Dark Ages?

Doctor, heal thyself.



Symptoms are themselves proxies for disease: they often indicate which disease is causing distress. Many diseases have the same symptoms, as there are a finite number of possible symptoms and an infinite number of things that can cause disease and death. The list of symptoms above could indicate the presence of plasmodium falciparum the parasite which causes malaria. Or it could be dengue, caused by a virus. A diagnostician might suspect these if he knew the patient had spent time in places where tropical diseases can be contracted. Or they could suggest pellagra which would indicate vitamin B deficiency. Hemlock poisoning or snake or spider venom could be responsible. Or they could be the side effects of a drug the doctor had prescribed, something like Zocor. He would withdraw the medication and see what happens. Or the doctor could suspect chronic depression, or death rays from outer space and prescribe Elavil. He might prescribe an antibiotic, or say, “Take two aspirin and call me next month.” There are many choices.

Which one is the right one? (eenie, meenie, minie, moe)

A competent doctor would eliminate the most unlikely causes until he is left with a probable suspect. He would consider the absence of fever and phlegm and adjust his assessment. An incompetent doctor would stop looking. He might say, “Well, we can rule out Leishmaniasis, so there is probably nothing wrong with you. Have you seen a psychiatrist?” A technologically minded doctor might ignore everything but his thermometer and conclude that everything is fine since nothing out of the ordinary registered on his instrument. But some physicians would consider changes in the patient’s life that coincided with the onset of symptoms. They would know that the most likely solutions to most problems are usually found in the ordinary, not in the exotic — after a careful examination of the circumstances. Most importantly, such responsible people check their own work first: the hallmark of science. Scientists know they make mistakes and they do their best to find and correct them.

Doctors are not created equal. Some are good, some are not.



“Money doesn’t talk, it swears.” - Bob Dylan

How could the medical care I received, with regards to the symptoms above, have been so careless, so reckless, so inept? My problems were ignored, then they were misdiagnosed. Apart from one physician’s ignorance and arrogance, is it really a mystery? (Though my condition probably was a mystery to him.)

Money has always had a well recognized effect on perception and “gold rush” behaviour has been well documented — as recently as the “high tech bubble” of the last decade. Statin drugs today are “America’s most popular prescription drugs” and Big Pharma is licking it’s chops as potential new hordes of statin users world-wide are added to financial spreadsheets.

BILLION$ upon BILLION$ what victims?

Greed supported by bad science is driving the health care industry to take to the air to CARPET BOMB CHOLESTEROL! Everybody is joining the frenzy. Victims? Who cares: “You can’t make an omelette without breaking a few eggs.” (Eggs? Don’t eggs have cholesterol?) And so, statin victims become mere collateral damage in the War on Cholesterol. It’s all for a good cause: better health. Right?