This is not a blog about the pitfalls of Big Pharma. I'm not a conspiracy theorist that believes the pharmaceutical industry is only a money making machine that does not care about the health and lives of the people it is manufacturing drugs for. And I am not a person who tries to avoid pharmaceutical drugs at all costs. There is a time and place for pharma drugs; in situations that could mean the difference between life and death; in situations that could mean the difference between suffering and a good quality of life.
Those types of drugs are not the subject of this post.
The useless drugs I am referring to, are those that continue to be prescribed by physicians for no good reason.
The following is an example of one of these useless drugs.
In a non-emergency condition, when a physician tells you that you will ________ unless you take a certain drug, ask your physician to show you the evidence of his/her statement. Fill in the blank. You will: die, or lose your kidneys, or have a heart attack, or have a stroke, etc., etc.
The stimulus for this blog came about from an interaction I had last week with a primary care physician. His patient with early stage dementia (possibly vascular in origin), was taking a cholesterol lowering medicine called Ezetrol. The patient was intolerant to statins, - drugs that are seen to be the gold standard for hyperlipidemia, - and thus he prescribed the useless fibrate drug, Ezetrol.
I was aware of the non-efficacious data regarding fibrates, so I encouraged the patient to discontinue the drug because I was very concerned about lowering cholesterol in a person with a neurodegenerative (maybe neurovascular) disease.
I was concerned, because I follow the work of neurologist Dr. Perlmutter, who wrote Grain Brain. His views on cholesterol and neurodegeneration make common sense. Cholesterol is linked to improved memory, concentration and learning. The brain consists of 25% fat, and cholesterol is crucial for the manufacture of cell membranes and neurosteroids, which are essential for synapse formation, maturation, and nerve transmission. In short, cholesterol is crucial for proper brain wiring. Cholesterol helps ensure that the lights are on and somebody is home.
Having had a mother who succumbed to a neurodegenerative disease, and knowing that treatment and cure for most neuro-degenerative diseases are minimal to non-existent at present, I take brain nutrition and brain fat very seriously. Cholesterol lowering drugs in these patients make absolutely no sense. I am aware of the potential studies regarding Alzheimer's disease and statins, and if these drugs prove to be efficacious, they will not be as a result of their lipid-lowering effect, but because of their ability to alter blood viscosity and improve oxygenation in the brain. That is my predicted opinion.
Back to the story.
This physician told the patient, that if the Ezetrol was discontinued, a fatal stroke could follow.
I called up the physician to discuss the matter, and in an authoritative and arrogant tone, he said this to me: “Ezetrol in a statin-intolerant patient with hyperlipidemia who has had previous strokes is proper standard of care”. He added, that it would be “medically negligent to discontinue the drug” because it was “preventing this patient from having a fatal stroke”.
Either this physician was not up to date on the available data, or there was new information in the world of cholesterol lowering drugs that I was not aware of.
I sought out information from the evidence based drug therapy site called Therapeutics Initiative (TI). From the meta-analysis of randomized controlled trials, a paper entitled Serious Adverse Event Analysis: Lipid-lowering Therapy Revisited states, "analysis of SAEs (serious adverse effects) and mortality does not support the use of statins for primary prevention or the use of fibrates for primary or secondary prevention".
This means that a drug like Ezetrol has zilch benefit, and in fact, people on fibrates have a 1 in 200 chance of dying from a non-CHD (coronary heart disease) cause while on the drug.
I contacted a doctor who was previously involved with TI, and he informed me that using fibrates was not standard of care.
Whether it was “proper standard of care” or not, didn’t matter much to me. After all, I was part of a profession where there are no naturopathic-specific standards of care, and I knew that “proper standards of medical care” do not always address the health needs of all people. One size does not fit all.
However, I was very concerned about his bold statement of medical negligence and his unwavering belief that this patient would indeed be harmed by depriving her of a necessary treatment. I was of a different opinion, and believed the exact opposite: this drug could potentially be harmful for this person, with zero benefit regarding stroke prevention.
I looked further to see what evidence there actually was, and all I could come up with was a recent study entitled, "Lipid management in the prevention of stroke: a meta-analysis of fibrates for stroke prevention". One of the concluding statements in the abstract states,
“Our study indicated that fibrate therapy might play an important role in reducing the risk of fatal stroke in patients with previous diabetes, cardiovascular disease or stroke.”
However, when you look at the numbers in Table 3, the above concluding statement is, well, . . . hogwash. In what universe where you have a P value of 0.26, can you make any efficacious concluding statement about secondary prevention and fatal strokes? According to that study, the best you can say, is that you think fibrates change the risk of stroke somewhere between a 77% decrease and a 47% increase, so what you are actually saying, is that there is no difference, and that any difference is due to random chance. Thus the null hypothesis is accepted and this drug is one big DUD.
A paper entitled, “How confidence intervals become confusion intervals”, clearly shows how clinicians must be able to interpret and understand confidence intervals than just rely on (false) conclusions made by the authors of a scientific paper.
Next time your doctor prescribes a pharmaceutical medication for you and you are reticent about taking it, ask your PCP to guide you to the evidence that supports his/her position.
Next time your doctor delivers the threat of illness or death upon you if you do not abide by a certain treatment or procedure, ask him/her to guide you to the evidence that supports this position.
Coincidentally, one would think I had a vendetta against Ezetrol, since I described its uselessness in this blog awhile back, where the drug caused a nephrologist to falsely believe that his patient was in progressive renal failure.
Drugs are useful when used wisely.